By James Mackenzie

GLASHUETTE, Germany (Reuters) – Like the intricate,
fabulously complicated watches made by its skilled artisans,
the former mining town of Glashuette in east Germany is a
rarity.

In this picturesque setting, traditional watchmakers make
timepieces so prized by connoisseurs that they can sell for
nearly $500,000 — making Glashuette a rare economic success
story in a region with a jobless rate of about 17 percent.

Glashuette was at the heart of a watchmaking industry that
rivaled Switzerland’s until Russian bombers destroyed its main
workshops on the day World War Two ended in Europe.

Forced nationalization of family-owned firms and 40 years
of communism apparently buried what survived the Russians until
the fall of the Berlin Wall sparked an unexpected revival
fueled by a renaissance in demand for high-quality mechanical
watches.

The gold and platinum watches now made by A. Lange & Soehne
or Glashuette Original, the two top firms in the town near the
Czech border, cost thousands of dollars and vie with Swiss
masters such as Patek Philippe or Vacheron.

“They are really very beautiful watches,” says Christian
Pfeiffer-Belli, editor of specialist publication Klassik Uhren.

The two firms’ success has encouraged others, such as
Nomos, a new company making less-expensive watches with a
distinctive look reminiscent of the 1920s Bauhaus school of
design.

“(Glashuette) is a very, very German name,” Pfeiffer-Belli
says. “And it works very well in Germany because there are a
lot of people who know Lange as a great brand from earlier
times.”

Around 800 people now work in the watchmaking trade in
Glashuette in Saxony, a notable success in a region where large
swathes of manufacturing industry have collapsed since German
reunification in 1990.

And the outlook is healthy: a strengthening global economy,
including an economic revival in brand-conscious Japan, has
fueled demand for luxury goods since the start of this year.

PRICE OF A HOUSE

Glashuette’s’s remote location, in a beautiful wooded
valley in the Erzgebirge region outside Dresden, is perfect for
nurturing the special skills of the traditional watchmaker.

“You need to be calm and you need to be able to deal with
very tricky problems,” said Kerstin Richter, as she delicately
turned a minute screw in a half-finished Lange watch.

The fantastic complexity of the clockwork mechanism and the
precision of each tiny component is what attracts enthusiasts
willing to pay the price of a house for a wristwatch that tells
the time no better than a $10 electronic throw-away.

Lange’s most complicated watch, the new Tourbograph, has
over 1,000 components with features like a hair-thin
transmission chain — made of 633 individual parts — to keep
the torque generated by the watch’s mainspring constant as it
unwinds.

That, and the “tourbillon” — a complex rotating component
designed to counter the disruptive effect of gravity on the
clockwork mechanism — are considered the acme of the
watchmaker’s art and go some of the way to explain the
Tourbograph’s $447,500 price tag.

Even cheaper models cost thousands of euros and take months
to complete. Connoisseurs, some now linked through Internet
chat rooms, obsessively ponder their watch’s finish or features
such as the “double rattrapante” or “whiplash index adjuster.”

MYSTIQUE AND HISTORY

As well as fine mechanics, the mystique of firms that
produce only a few thousand watches a year has been decisive —
and that has its roots in the town’s special tradition.

When Ferdinand Adolph Lange, a deeply religious man,
founded Glashuette’s first watchmaking firm in 1845, he trained
local workers including basket weavers and laborers and laid
great stress on fostering development of the then-impoverished
region.

Over the next century, during which time Lange was followed
by several other watchmaking dynasties, the town attained world
renown, typified in 1898 when Kaiser Wilhelm II presented the
Sultan of Turkey with a magnificent jeweled Lange watch now in
the Topkapi museum in Istanbul.

Lange’s great-grandson, Walter Lange, who picked his way
through the rubble of his family’s factory in May, 1945, has
consciously built on the tradition since his return in 1990
with partner Guenter Bluemlein to relaunch the Lange brand.

Much of the success has been down to foreign investors —
both Lange, owned by luxury goods group Richemont and
Glashuette, part of Swatch, are in Swiss hands.

But the technical skill of local craftsmen, kept alive
during the communist era by the nationalized VEB Glashuetter
Uhrenbetriebe (GUB), has also been decisive. GUB, which
included nationalized Lange, sold cheap mechanical watches to
the west for hard currency.

“The key to the revival was the period 1951-90,” says Frank
Mueller, president of Glashuette Original, the company that
emerged when GUB was privatized again in 1990.

While the watchmaking industry in the west was devastated
by the invention of the quartz watch, which allowed more
accurate timekeeping at a fraction of the cost of mechanical
watches, the east German industry was kept alive by state
support.

“It was absolutely decisive that the knowledge and
experience of these watchmakers wasn’t lost,” says Mueller.

By Cari Hammerstrom, The Monitor, McAllen, Texas, The Monitor, McAllen, Texas

Dec. 26–EDINBURG — Sexual assault nurse examiner Janie Cantu-Cabrera vividly remembers when police came to her four to five years ago with two teenaged sisters who had been drugged at a Pharr hotel party and then raped, possibly repeatedly.

The younger sister, who was 13 at the time, told the nurse that all she could recall was being trapped inside a bathtub while several faces hovered above her. Standing in the door frame was her older sister, 18, just watching.

The older sister, Cantu-Cabrera said, told the nurse that all she could remember from the previous night was seeing her sibling in the shower. Both of the girls reported feeling “funny” in the genital area.

“Both had physical findings of sexual assault,” Cantu-Cabrera said.

These girls were both likely drugged with Rohypnol, she said — a substance local teens still commonly abuse for recreation because of the euphoric state it can induce, and that predators use to facilitate rapes because of how it lowers victims’ inhibitions.

According to Juan J. Gonzales, Edinburg Consolidated Independent School District police chief, the prescription sleep aid Ambien is also “very popular” among local youth.

“It’s becoming more and more widely known,” he said.

These kind of reports make it especially important for revelers as they head out to parties this holiday season.

Even though statistics from the U.S. Drug Enforcement Administration point to a decrease in the availability of the drug on a national scale, Texas has experienced a spike in poison control calls and treatment admissions for Rohypnol, especially among Hispanic youth living along the border.

“It’s gotten worse,” Cantu-Cabrera said, referring to the recreational use of prescription drugs.

Kids as young as 12 years old are now taking Rohypnol, or roche pills as they are commonly called. Pills cost as little as $1. And although the pills are illegal in the United States, they can be bought with ease in Mexico and smuggled across the border.

And earlier this month at a meeting in which sexual assault victims’ advocates, law enforcement officials and nursing community members came together to discuss the establishment of a Sexual Assault Response Team, a specialist with the Texas Attorney General’s office also mentioned Ambien as a “date-rape drug” growing in popularity.

Experts working with sexual assault victims say they have never seen a confirmed case of Ambien used to commit a rape in Hidalgo County; however, some do see the potential for this type of abuse and are concerned about the trend the sexual assault community development specialist, Lisa Zapata-Maling, has recognized elsewhere in the state.

“It’s going to put someone to sleep,” said Vanessa Recio, a pharmacist with Saenz Pharmacy in Mission.

Recio said Ambien is widely prescribed, but it is mostly approved for adults. It is classified as a controlled medication, along with Vicodin and other strong medications with potential for abuse.

“You don’t see too many adolescents prescribed a sleep aid,” she said. “I don’t know I’ve ever dispensed an Ambien to a patient under 30.”

Ambien causes central nervous system depression and can impair cognitive thinking.

It’s one of the best drugs on the market to treat insomnia, said Andrea Lerma, a psychiatric clinical specialist at Tropical Texas MHMR, which is the state’s local mental health facility. Lerma prescribes Ambien with frequency for patients suffering from major depression, bipolar disorder and other mental health illnesses.

Some people, however, do experience Ambien amnesia when taking the drug, she said.

People have been known to get up and cook in the middle of the night or eat a lot. They wake in the morning to find candy wrappers or dirty pots and pans, she said, and they don’t remember any of it.

Lerma said she can see how Ambien could be used as a “date rape drug.”

It also has a short half-life, which means it is eliminated from the body very quickly.

One reason why Ambien has not yet gained as much popularity in Hidalgo County as roche pills is because of its price.

“Ambien is very expensive — $90 to $100 for a one month supply,” Lerma said. “It’s expensive over in Mexico, too.”

Ambien is more difficult to obtain, too, said ECISD Police Chief Gonzales.

“If kids are using it (Ambien), they are getting it somewhere else,” Cantu-Cabrera said.

Kids could be stealing their parents’ or grandparents’ pills, said Diana Cuellar, prevention educator with Women Together/Mujeres Unidas, a safe house for victims of sexual assault.

“Sleep aids in general are being abused,” Cuellar said. “”¦ Prescription sleep aids are very powerful.”

——

Cari Hammerstrom covers law enforcement and general assignments for The Monitor. You can reach her at (956) 683-4424.

—–

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By KRIS WISE

DAILY MAIL CAPITOL REPORTER

West Virginia, and particularly its southern counties, is struggling with an increase in births of babies addicted to methamphetamine and OxyContin.

Even more common, at least in the Charleston area, are babies born to mothers who are receiving medical doses of methadone – also an addictive drug – to try and get over their other drug addictions.

Doctors still are trying to figure out the long-term effects of such substances on newborns, but the short-term side effects seem to be even worse than problems seen with the so-called “crack babies” born in the 1980s, doctors said.

The effects of methamphetamine on the tiniest of patients are even more challenging for physicians to figure out.

“It’s really hard to separate all the different effects,” said Dr. Stefan Maxwell, chief of neonatology for Charleston Area Medical Center’s Women and Children’s Hospital. “Most of these people are party drug users. If they use one, they’re using others.”

Maxwell and his team of obstetricians have seen increased numbers of babies born to mothers addicted to the newly trendy and deadly drugs over the past several years.

With the rise in use of heroin and other opiates among West Virginians, and the appearance of methadone clinics in the state that try to wean users off such drugs, more and more women are getting pregnant while still in the throes of their addiction, Maxwell said.

The difference between pregnant women who use various types of drugs is that while cocaine users might pass on health problems to their babies, the infants are not born going through withdrawal.

Babies born to cocaine-addicted mothers are small and often have a host of physical problems connected to their size. They have small lungs and often suffer from breathing problems, and their organs often don’t function properly.

“Babies born after OxyContin and methadone use aren’t necessarily small at a gestational age,” Maxwell said. “It’s that they’re going through withdrawal.”

Methadone, OxyContin, heroin and other similar drugs all penetrate the placenta, giving babies in the womb proportional doses of the drugs their mothers take.

When they are born, infants need and crave the drug that was in their mother’s system. If they don’t get it, they go through a dangerous withdrawal phase just like adults.

“They are jittery, they are tremulous, they sometimes are sweating and they don’t eat properly,” Maxwell said. “It’s what we call narcotic withdrawal. It’s the same thing.”

After birth, the babies are given gradually decreasing doses of methadone no matter what drug had been in their system. They are slowly weaned off the drug until their addiction has passed.

But the process is a long one.

It’s one of the biggest challenges for doctors and hospitals dealing with drug-addicted newborns. The extended length of a hospital stay is hard on the infant, drains hospital resources and in most cases, costs more public dollars. The majority of these patients’ medical care is on the government’s tab.

“These babies are in the hospital for at least three weeks just trying to wean them off,” Maxwell said. “This is a four- or five- week hospital stay for a baby who should be in and out in two days.”

Maxwell couldn’t immediately provide statistics on how many babies in Charleston or in the state have been born with such addictions. But he said this year’s births were up over last year’s, and Charleston Area Medical Center has been receiving more referrals to help treat addicted newborns born in more rural parts of the state.

The addiction-counseling group Narcotics Anonymous reports on its Web site that in most states, hospitals have seen the annual number of such births double or triple in the past 10 years.

Kanawha County Metro Drug Unit Commander Chuck Carpenter said recently that the unit usually finds children living in the midst of the drug selling and manufacturing going on in many homes around the county.

“We see infants and we see 18 and 19-year-olds,” Carpenter said.

Kanawha County Prosecutor Bill Charnock’s office has prosecuted more than 80 people for selling or manufacturing methamphetamine over the past year. Charnock would not specifically discuss cases of pregnant woman found using or selling that and other drugs, but he said from his experience, the numbers are constantly increasing around the state.

Just last month, a St. Albans couple was arrested in connection with the February death of their infant son, 3-month-old Jacob McFarland. A judge issued a warrant for the parents’ arrest on charges of neglect leading to his death.

A report later released by the state Department of Health and Human Resources said the baby had been born with a drug addiction, was put on methadone and spent more than three weeks in the hospital, but he was never brought back for follow-up treatment.

Contact writer Kris Wise at [email protected] or 348-1244.

By Megan Rauscher

NEW YORK (Reuters Health) – Orally disintegrating tablets,
which dissolve on contact with saliva without the need for
water, may help people with swallowing difficulties take their
pills, researchers report.

The team studied 36 adults with dysphagia, or problems with
swallowing, while they downed conventional tablets or “RapiTab”
quick-dissolving tablets, in a crossover fashion.

While the subjects swallowed the pills, they underwent
endoscopy looking at their throat action, electrical recording
of muscle activity, and respiratory monitoring, according to
the report in the Archives of Otolaryngology–Head and Neck
Surgery.

“Our study identified a difference in the physiologic
aspects of swallowing associated with taking a conventional
pill versus a rapidly dissolving tablet form,” said study
leader Dr. Giselle Carnaby-Mann, a research scientist in the
department of psychiatry at the University of Florida in
Gainesville.

The patients took longer to swallow the regular tablet
form, required more muscular effort, a longer breath hold, and
multiple attempts to clear the regular tablet compared to the
rapidly dissolving form.

Patients with dysphagia clearly preferred the orally
disintegrating tablets to the conventional tablets,
Carnaby-Mann and her colleagues report.

It’s also worth noting, she said, that more than “60
percent of our sample demonstrated obvious difficulty
swallowing the conventional pill, and the swallowing behaviors
were significantly different.” This suggests that pill
swallowing “should be included as an assessment task in
standard evaluations of swallowing ability,” the researcher
said.

“It may be,” she explained, “that swallowing pills is very
different from swallowing more food-like substances … but at
this point this idea is still speculation.”

The RapiTab is manufactured by Schwarz Pharma Inc., of
Milwaukee, who funded the current study.

SOURCE: Archives of Otolaryngology–Head and Neck Surgery,
November 2005.

DALLAS and FORT WORTH, Texas, Dec. 23 /PRNewswire/ — Sam Hazen, President of HCA’s Western Group, has announced that James C. Scoggin, Jr., currently Executive Vice President of the Methodist Healthcare System in San Antonio, has been appointed President of HCA’s North Texas Division. The Methodist Healthcare System is a joint venture between HCA and the not-for-profit Methodist Healthcare Ministries of South Texas.

Mr. Scoggin will assume his new position on February 13, 2006. There will be a transition period with William D. Poteet, III, current HCA North Texas Division President, who in November announced his retirement effective the first of May.

“Jim is a very experienced healthcare executive and is well suited to lead HCA in the dynamic North Texas market,” Mr. Hazen said. “Jim has been very instrumental in developing the Methodist Healthcare System as the leading hospital system in San Antonio. We look forward to him doing the same for us in the Dallas/Fort Worth market.”

Mr. Scoggin, who is 47, graduated from Texas A&M University in May 1980 and began his healthcare management career with Humana as a Financial Specialist at Southmore Medical Center in Pasadena, Texas. After seven years with Humana in positions including hospital CFO and COO, he joined Methodist Hospital in San Antonio in 1987 as Chief Operating Officer where he served for eight years until the formation of the Methodist Healthcare System.

In 1995, Mr. Scoggin was appointed CEO of Methodist Hospital and later assumed responsibilities for all hospital operations in the South Texas Medical Center. The center at that time had approximately 1,100 beds and included Methodist Hospital, Methodist Women’s & Children’s Hospital and Methodist Specialty and Transplant Hospital.

In March 2000 Mr. Scoggin was promoted to Executive Vice President of the Methodist Healthcare System. In this role, he had responsibility for consolidated system departments including legal operations, managed care contracting, real estate/MOB development and management, human resources, physician organizations, outpatient businesses, transplant services, marketing and strategic planning, rural market development, and overall network development. He also has worked closely with the Methodist Healthcare CEO in Board/Partner relations and communications.

HCA North Texas

CONTACT: Gary Conwell of HCA North Texas, +1-972-401-8720, or cell,+1-281-387-6986, or [email protected]

NEW YORK (Reuters Health) – Having automated external
defibrillators (AEDs) and coaches trained in cardiopulmonary
resuscitation (CPR) at organized sporting events for children
can save lives, researchers report in The Journal of
Pediatrics.

In the paper, Dr. Neal J. Thomas from Penn State Children’s
Hospital, in Hershey, Pennsylvania and colleagues present the
case of a healthy 13-year-old boy who experienced “commotio
cordis” — a sudden cardiac arrest that leads to death — after
being hit in the chest by a baseball.

Coaches trained in basic life support started CPR,
including chest compressions and mouth-to-mouth resuscitation,
immediately after the boy collapsed at home plate. Paramedics
arrived 6 to 8 minutes later, determined that the boy was in
ventricular fibrillation, and shocked him back into normal
sinus rhythm using an AED.

In ventricular fibrillation or VF, the electrical impulses
controlling the heartbeat become chaotic, causing the heart’s
main pumping chambers (the ventricles) to quiver instead of
contracting normally. Unless VF is corrected by an electrical
shock from an AED, the person can die within minutes.

“We have documented proof,” Thomas told Reuters Health,
that this child was in ventricular fibrillation and that then,
with the cardiac shock provided by the AED, he was converted
back to a normal sinus rhythm.

According to Thomas, most Division 1 college sports and
athletic departments, as well as some high schools already have
AEDs, but not many grade schools do, despite the fact that
commotio cordis almost always happens in children.

“AEDs are available in malls and in most places where a
large number of people gather, but they are not commonly
available in youth sport events, mainly because of the cost,”
Thomas said. The price of an AED, which is very easy to use,
ranges between 2,500 and 4,000 dollars.

“Although only a small group of children can die of sudden
cardiac arrest, there is a whole host of diseases that can
cause sudden cardiac death in young athletes and in
bystanders,” Thomas said. “Having AEDs available may impact not
only the athletes but also the spectators.”

SOURCE: The Journal of Pediatrics, December 2005.

By Alison Neumer Lara, Chicago Tribune, Chicago Tribune

Dec. 21–Head into Walgreens to pick up routine sundries these days and your shopping list could read like this: deodorant, cough drops, vibrator.

Women-oriented sex toys or devices, plus other so-called “pleasure products”–once purchased only in seedy triple-x shops, clandestinely over the Internet or in a handful of women-oriented sex boutiques–are becoming available in mainstream drugstores from major condom manufacturers.

About time, Samantha of “Sex and the City” might sneer. In one notorious episode, the sex-savvy blond rolls her eyes at the male electronics store clerk who refuses to acknowledge her broken vibrator as anything but a high-end back massager. Waiting for the guy to return with a replacement, Samantha works the store, advising women shoppers on which “massagers” yield the best buzz.

In October, Trojan debuted the Elexa brand, a line of sexual aids for women, including a disposable vibrating ring, warming lubricant gel and specialized condoms. In September, Durex began introducing its electronic Play products: three–wink, wink–“personal massagers.” Ansell’s LifeStyles brand also rolled out “4 Play” accessories such as shimmering body lotion and “edible body dust.”

The products are sold at retailers such as Walgreens, CVS and their online counterparts, as well as mainstream e-commerce sites such as Drugstore.com and Amazon.

Coy terminology

Although the big brands still tiptoe around the terminology, the products themselves don’t shy from their objectives: women’s sexual satisfaction and the growing market of eager female consumers who want it.

“There’s a discussion of pleasure in America’s drugstore shelves,” says Laura Berman, a sex therapist and director of the Berman Center, an institute for women’s sexual health in Chicago. “As a culture, we are much more receptive to the idea of women being empowered sexual beings.”

In September the Berman Center introduced its own extensive line of sex toys, including remote-control vibrators, G-spot stimulators and pelvic exercisers (which are available at Drugstore.com and locally at G Boutique in Bucktown, but not at mainstream brick-and-mortar retailers).

The more, the better, says Searah Deysach, owner of Edgewater’s female-oriented sex toy shop Early to Bed. “Any time women’s sexuality and pleasure get more of a foot in the mainstream world, it can’t do anything but help,” she says.

Indeed, since Deysach opened her store four years ago and started selling sex toys with an informed sales staff, the industry has become significantly more female focused. Many more toys now are made of silicone, a safer and healthier choice than the plastics used for the last 40 years, and the packaging is more tasteful. Drugstores and health professionals are helping to normalize the idea of sex toys by dispelling the notion that they’re dirty or wrong.

But this isn’t just a progressive, altruistic gesture from the world’s largest condom manufacturers. As sociosexual mores continue to shift left, the market for sexual health products continues to expand. Over the last two years, CVS more than tripled the shelf space assigned to the category, according to the drugstore. Amazon sells 30,000 sex-related items in its “health and personal care” section.

Not everyone will be able to get their hands on the goods. The sale of sex toys is prohibited in eight states–Alabama, Colorado, Georgia, Kansas, Louisiana, Mississippi, Texas and Virginia–and manufacturers don’t plan to wrangle with the law.

Critics say sex toys shouldn’t be available in any drugstore, regardless of the state.

Commerce is catering to adult convenience at the expense of exposing children to age-inappropriate products, says Janice Crouse, senior fellow at Concerned Women for America’s think tank, the Beverly LaHaye Institute.

Coarse culture

“It’s just another example of the coarsening of our culture,” Crouse says. “How do we keep our children innocent? They are already being exposed to things far beyond what they can absorb for their age.

“It isn’t offensive as much as it is sad that we have reached a point where we are sexualizing everything, even the drugstore.”

Still, the explosion of women’s sexual health products in particular underscores not just the increasingly open attitudes about women’s sexuality but also women’s purchasing power. Women influence 80 percent of all consumer spending in the U.S., which means anywhere from $3.3 trillion to $7 trillion annually, according to researchers.

All four product lines–Elexa, Durex, Lifestyle and the Berman Center–deploy discreet, sophisticated marketing meant to appeal to women. No porn star pictures or big vibrator labels. The Elexa packaging is a sleek black. The Durex and Berman products come with lavender drawstring pouches for storage. The marketing language is about empowerment and taking charge of your sexual well-being.

To ease purchase anxiety even further, the vibrating ring and other Elexa sexual aides are shelved in the feminine care aisle next to tampons and pads.

Times have changed, says Elexa product manager Cassandra Johnson. “We’ve been marginalized for so long because products have been geared to a men’s perspective.”

– – –

Taking stock of the numbers

– 29 percent of women age 25 to 60 currently use sexual aids.

– 23 percent of women say they’ve taken their vibrators along on vacation.

– 60 percent of sexually active women want sex more often.

Sources: Berman Center, Elexa by Trojan, Durex

[email protected]

—–

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NASDAQ-NMS:DSCM, NASDAQ-NMS:EDGW,

CHICAGO _ By the end of the decade, consumers should have another prescription-strength option to treating heartburn that won’t burn a hole in their wallets.

TAP Pharmaceutical Products Inc. has agreed to license rights to its blockbuster heartburn drug Prevacid to health-care giant Novartis AG, which plans to launch an over-the-counter pill once the patent on TAP’s prescription version expires in 2009.

This is expected to be good news for millions of heartburn sufferers who may be looking for a cheaper and just-as-effective option to expensive brand name drugs like prescription strength Prevacid and Nexium _ pills that cost about $4 a pill on average at retail prices. An over-the-counter version is expected to cost less than $1.

Prevacid is the nation’s fourth-best-selling brand name prescription in the United States, trailing heartburn rival Nexium, No. 3, and cholesterol-lowering drugs Zocor and top-seller Lipitor.

Prevacid would be the second of the heartburn treatments in the popular proton-pump inhibitor class to seek over-the-counter status. A 20-milligram version of Prilosec, known as the “purple pill,” went over-the-counter in late 2003 and sells these days for about 80 cents a pill or even less depending on discounts and sales at retail outlets.

Novartis would not say what it will sell Prevacid for but industry observers expect its price to be near that of Prilosec given the two treatments are so similar in efficacy and safety. Novartis plans to make Prevacid “one of the top five OTC products in the United States,” said Larry Allgaier, chief executive officer of Novartis Consumer Health.

“We have the experience and a proven track record in switching drugs from Rx to OTC,” Allgaier said. “We’re excited about making Prevacid _ a brand that people know and trust _ even more accessible to patients in the future.”

All proton-pump inhibitors on the market similarly treat gastroesophageal reflux disease, commonly known as GERD, as well as more serious acid-related disorders. In fact, even studies funded by the drugmakers themselves have shown prescription strength Prilosec, Nexium and Prevacid to be therapeutically equivalent, according to the drugmakers and their studies.

Therefore, a second proton pump inhibitor going over-the-counter might further put a dent in America’s bill for prescription heartburn treatments as well as drugmaker profits.

In 2004 _ the first full year Prilosec OTC was on retail store shelves _ U.S. sales of prescription proton pump inhibitors fell 4 percent to $12.5 billion from $12.9 billion in 2003, according to market research firm IMS Health.

TAP will continue to market and sell prescription Prevacid until at least 2009 when the compound patent expires.

Novartis will take on a “multiyear OTC” development initiative that includes clinical trial design, product development activities such as regulatory submission to the Food and Drug Administration, manufacturing, product launch and distribution, the companies said. Novartis will eventually submit the lowest dosage, a 15-milligram version, of Prevacid to the FDA for approval, TAP said.

Financial terms of the deal were not disclosed but TAP said it will use some of the proceeds from the licensing deal to fund future research and development initiatives.

TAP is hoping to find ways to replace the $2.5 billion in annual net sales Prevacid generates by the time the drug’s patent expires. TAP is a joint venture of North Chicago-based Abbott Laboratories and Japan’s largest drugmaker, Takeda Pharmaceutical Company Ltd.

“This agreement allows TAP to maximize the value of its Prevacid franchise while also focusing on future novel compounds to treat acid related disorders,” said TAP President Alan MacKenzie.

But TAP will likely generate far fewer sales from sales of an over-the-counter Prevacid even if it is as successful as OTC Prilosec. Neither TAP nor Novartis would comment about sales projections for OTC Prevacid.

OTC Prilosec distributor Proctor & Gamble Co. had projected $200 million to $400 million in sales for its first year on the market. It generated $135 million in sales in its first six months on the market and appeared to be on pace to meet or exceed its 2004 goals. Proctor & Gamble would not disclose annual sales figures for that year or whether it met its projections.

P&G bought licensing rights from original Prilosec developer AstraZeneca PLC, which continues to sell Nexium.

___

(c) 2005, Chicago Tribune.

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By Lara Brenckle, The Centre Daily Times, State College, Pa., The Centre Daily Times, State College, Pa.

Dec. 20–BELLEFONTE — Four people charged with helping distribute $1.5 million worth of heroin and cocaine in Centre County pleaded guilty to drug and criminal conspiracy charges Monday.

Prosecutors said the four were charged in connection with an investigation into Taji “Verbal” Lee, who, when he was arrested in January, police called one of the biggest heroin dealers in the county.

Lee, of New Jersey, was arrested on numerous drug charges after an undercover officer arranged to purchase 400 baggies of heroin, worth about $7,500, from him, according to court reports. He remains in Centre County Correctional Facility, awaiting trial.

Prosecutors relied upon testimony from Lee’s co-defendants to build a case against Lee, even convincing one co-defendant, Kenyon A. Ebeling, 36, of Boalsburg, to tape record phone conversations with Lee.

Other co-defendants who pleaded guilty Monday are Bradley J. Arzner, 25, of State College, Nicholas S. Oswald, 25, formerly of State College, and Trista L. Shope, 24, of State College.

Arzner pleaded guilty to one count of delivery of drugs, three counts of possession with intent to deliver and one count of criminal conspiracy. He faces three to six years in prison on those charges.

He also pleaded guilty to charges in an unrelated case, in which he was accused of stabbing Penn State student David Pimentel during a fight on Hiester Street in December 2004. He entered pleas to charges of terroristic threats and aggravated assault in that case.

He faces three to six years in prison on the drug charges, and four to eight years on the stabbing charges, said prosecutor Michael Madeira, senior deputy attorney general and Centre County district attorney-elect.

Ebeling pleaded guilty to two counts of possession with intent to deliver, one count each of criminal conspiracy, criminal use of a communication device and dealing in the proceeds of unlawful actions. She faces 111/2 to 23 months in jail.

Shope pleaded guilty to one count each criminal conspiracy and possession with intent to deliver. She faces one to two years in prison.

All three are scheduled to be sentenced Jan. 16.

Oswald, who was already on probation for an unrelated offense, pleaded guilty to one count of possession with intent to deliver.

His attorney, Stacy Parks Miller, asked Kistler to consider mitigating circumstances — that he has made great strides in keeping off drugs, maintaining and assisting with the prosecution of his co-defendants.

Madeira did not object. Kistler sentenced Oswald to one year’s probation, to be served after his current probationary term ends. He was also fined $200, ordered to pay the cost of his prosecution and probation, and to perform one day of community service.

Lara Brenckle can be reached at 235-3902.

—–

Copyright (c) 2005, The Centre Daily Times, State College, Pa.

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail [email protected].

By Troy Graham, The Philadelphia Inquirer, The Philadelphia Inquirer

Dec. 20–Leonard “Pooh” Paulk had a long run through the Camden drug underworld, prosecutors said, beginning nearly 20 years ago when he was a teenage street dealer and ending last year with his conviction as one of the city’s largest narcotics wholesalers.

Because of that record, the 37-year-old faced a mandatory life term when sentenced in U.S. District Court in Camden yesterday.

Judge Freda Wolfson called that “drastic” but had harsh words for Paulk as well.

“This cycle of drugs and violence has got to stop,” she said. “And if it stops because you have to go to jail and never get out, then that’s the way it is.”

Paulk took his punishment calmly. He shuffled into court smiling broadly and waving to three rows of family and friends in the back of the room. His stepson, Dajuan Wagner, who played three NBA seasons with the Cleveland Cavaliers, sat in front.

Given the chance to speak, Paulk eagerly thanked his supporters and repeatedly professed his love for his family.

“I apologize for putting you through this, but something good is going to come out of this,” he said. “Keep your heads up.”

Paulk is married to Wagner’s mother, Lisa. Wagner, an all-American out of Camden High School, left the courtroom about halfway through the hearing and did not return.

Paulk’s sister, Tomicka Wilson, spoke in her brother’s defense, describing him as a good father and husband.

“You don’t know the good of him,” she said. “When he was arrested, his children’s lives changed. No one has looked at that.”

But prosecutors described Paulk as a drug kingpin and wholesaler of heroin, crack and powder cocaine for an open-air drug organization led by Darnell “Big Lips” Tuten. At times, the organization made more than $100,000 a week, and Paulk bet more than $1.6 million at casinos in three years.

The government said Paulk and Tuten, 32, had ruled with a ruthless style of intimidation and violence. Defense attorneys said Paulk armed himself only to protect his wife and stepson from kidnapping attempts.

Paulk and Tuten were indicted with 11 others, and prosecutors won convictions or guilty pleas from all but one, who was convicted of a separate drug conspiracy. Paulk, convicted in November 2004, was the first to be sentenced.

Paulk’s attorney, Peter Goldberger, told Wolfson that he would offer little argument since federal law mandated a life sentence.

“The idea of a sentence from which there is no hope for release in a drug case is an abomination,” he said. “It is my hope that that law will be repealed and made retroactive.”

Assistant U.S. Attorney Kevin Smith acknowledged that asking for a life sentence was “never easy,” but he reflected on Paulk’s long criminal history.

“This individual led people by fear and directed a massive amount of drugs through this city,” he said. “Mr. Paulk deserves life in jail.”

Contact staff writer Troy Graham at 856-779-3893 or [email protected].

—–

Copyright (c) 2005, The Philadelphia Inquirer

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail [email protected].

By Ibon Villelabeitia

AMMAN (Reuters) – The waiter with dreadlocks and a Bob
Marley T-shirt glides among a group of chic Jordanians sipping
cappuccinos and smoking hookahs, or water pipes.

A call to prayer from a distant mosque is drowned out by
the sound system playing rock band Coldplay and the lively
chatter of young customers: “What’s up? Keefak?,” “Thank you,
habibi.”

The banter is a form of speech that mixes Arabic with
English. It is widely used among Jordan’s Western-educated
elites, drawing ire from language purists and exposing a
widening social and economic gap in the small kingdom.

Dubbed by some “Arabizi” — a slang term for Arabic and
“Inglizi,” or English in Arabic — it is also a means of
expression for many young Jordanians who have been educated
abroad and who do not share Jordan’s conservative values.

“When I came back from university in Canada I realized

that everybody was mixing English and Arabic. It is so
prevalent. It wasn’t like that five years ago,” said Dalia
Alkury, 25, author of an independent documentary called
“Arabizi.”

“It is easier to express yourself in English about topics
that are considered taboo, like sex,” she said. “I can’t speak
about sex with my friends in Arabic. The words are too heavy
and culturally loaded. It all sounds ‘haram’ (sinful). I feel
more free in English. ‘Arabizi’ is a way to escape taboos.”

Linguists blame the growing use of English among young
Jordanians on American pop culture inundating the Arab world.

“Some young people look down on Arabic language. They think
it is old and that English represents life and desires,” said
Haitham Sarhan, a linguist and professor at Jordan University.

“If this trend continues Arabic could be in danger. Young
people think Arabic is boring,” Sarhan said.

He said the trend was an example of an intellectual crisis
in Arab countries, which was outlined in a U.N. Arab Human
Development report published earlier this year.

“HI, KEEFAK, CA VA?”

Mixing Arabic with foreign languages has long been
commonplace among Western-educated elites in Arab countries
such as Lebanon or Algeria.

In cosmopolitan Beirut, young people sometimes greet each
other with a salutation that mixes English, Arabic and French:
“Hi, Keefak, Ca va?”

But in Jordan, a poor desert country, the sudden popularity
of “Arabizi” reflects deep changes in society since the early
1990s, when authorities embarked on economic liberalization

programs.

An influx of white-collar workers and professionals from
Kuwait during the 1991 Gulf War and from Iraq in more recent
years created a more affluent and liberal middle-class.

Pupils at private and public schools study English from a
young age in Jordan, a moderate and pro-Western state ruled by
King Abdullah, who was educated in England and in the United
States.

But elite schools in wealthy neighborhoods in Amman, where
“Arabizi” is spoken at trendy cafes and American-style malls,
teach many of their subjects, like sciences, in English.

In the gritty working-class areas of East Amman or in the
tribal heartland, “Arabizi” is unheard of and few speak
English.

STATUS SYMBOL

Musa Shteiwi, a sociology professor at Jordan University
and director of Jordan’s Center for Social Research, said the
use of English has become a status symbol among middle- and
upper-class Jordanians, many of whom send their children to
universities in the United States.

“It’s an expression of class position and works as a
demarcation of social status. It is a way of putting a cultural
distance between you and the pastoral and Bedouin world of
traditional Jordan,” Shteiwi said.

“It’s a new phenomenon. The lines between the rich and the
poor are becoming more evident as we move toward a class
society. In the past the upper classes belonged to the
government’s bureaucracy. The new class is not shy about
showing off its status and English is just another sign of
status.”

“Arabizi,” the documentary, will be broadcast on state-run
Jordanian television early next year. It tackles the use of
“Arabizi” through a series of interviews, sometimes showing
Arabic-speaking parents sitting next to their
“Arabizi”-speaking children.

Alkury said she speaks Arabic at home with her parents.
Even though she uses English or “Arabizi” most of her day, she
said she is proud of her heritage and of her mother tongue,
Arabic.

“I speak ‘Arabizi’ all day but I feel very Jordanian. If I
was going to write poetry, I could only do it in Arabic.”

By Schroeder, Janice L; Steinke, Elaine E

Necrotizing fasciitis (NF), is a life-threatening bacterial infection that causes rapid necrosis of deep subcutaneous tissue and fascia underlying the skin. French military hospitals and British naval surgeons in the 18th century, nurses in the Crimean war, and Confederate army surgeons all referred to NF in grim detail as hospital gangrene.1-3 In 1952, Bob Wilson, MD, was the first to describe the signs and symptoms of fascial necrosis and proposed the term necrotizing fasciitis. Publicity describing the condition as the “killer bug,””flesh-eating bacteria,” and “galloping gangrene” during the past two decades has piqued public interest in this condition.1,2,4

CASE STUDY

Cassi Moore enjoyed the outdoors and spending weekends with her husband and three children ages 10, eight, and five. One Friday in June 1998 while on a camping trip, Moore sustained a small cut to her left thumb, which she immediately washed and bandaged. She also received a minor blow to her left lateral chest while practicing tae kwon do. On Sunday, Moore started to feel as though she were coming down with the flu.

By Monday afternoon, Moore was markedly worse, experiencing vomiting, diarrhea, fever, and pain on her left side. She went to her primary care physician, who diagnosed her with the flu and a pulled muscle based only on her verbal history. Her flu-like symptoms and left-side pain continued to increase, and Moore returned to her physician the next day complaining of extreme pain in her left side, much more than would be expected based on the appearance of her bruise. Again, based on her verbal report alone, the physician prescribed pain medication and sent her home. By Tuesday evening, the bruise on Moore’s chest was noticeably larger and darker.

Wednesday morning, Moore was very weak, and the medication she was taking did not stop the pain in her side. She was having difficulty breathing and was experiencing visual problems. By 11 AM on Wednesday, the bruise on her left side began to ulcerate and leak fluid and blood. By 1 PM, Moore was too weak to walk without assistance and was taken to the emergency department (ED).

On arrival in the ED, Moore had no detectable blood pressure and was in septic shock. Actions were quickly taken to stabilize her condition with IV fluids and medications. A computed tomography (CT) scan revealed gas in the soft tissues under her skin, which is a sign of necrotizing fasciitis. An infectious disease specialist and surgeon were consulted immediately, and Moore was rushed to the OR for emergency debridement of her left side and a portion of her left breast. Cultures obtained during surgery indicated the presence of group A Streptococcus (GAS). After surgery, Moore remained on a ventilator in the intensive care unit (ICU). Vasoconstricting medications kept blood flowing to her vital organs, and various IV antibiotics were administered in an effort to treat the NF.

Photographs courtesy of Cassi Moore and the National Necrotizing Fasciitis Foundation.

The day after surgery, it became apparent that Moore required hemodialysis, so she was transferred to a larger medical center with dialysis capabilities. At this point, Moore’s prognosis looked grim. She was in severe sepsis, and the effects of the vasoconstricting medications needed to keep her alive, combined with microvascular thrombosis from septic shock, were taking their toll on her hands and feet. Her fingers, toes, and parts of her right foot began to turn purple and black and started to shrivel. She eventually lost portions of all her fingers except her left thumb, which, surprisingly, was the thumb injured during the camping trip. Moore’s right leg was amputated below the knee and approximately one-third of her left foot also was amputated. The initial debridement of her left chest was followed by several smaller debridements in the ICU. After the infection in her side was gone, Moore underwent skin grafting procedures to her side, and later, reconstructive surgery to a portion of her side and left breast.

Approximately six weeks after the first surgery to debride her left side, Moore was strong enough to be transferred to a rehabilitation center for physical therapy, occupational therapy, and continued IV antibiotics. After 77 days in several hospitals and rehabilitation centers, Moore was discharged home.

EPIDEMIOLOGY AND CAUSES OF NF

Necrotizing fasciitis can occur in any area of the body, but commonly occurs in the extremities, abdominal wall, and perineum as a result of a disruption to the skin (eg, insect bite, burn, surgical incision, injection, laceration).2-11 Necrotizing fasciitis also can be associated with varicella, blunt trauma,2,5-8 incarcerated hernias, and renal calculi.2 Nontraumatic hematogenous spread of toxin-producing bacteria, such as Streptococcus pharyngitis, can spread from a distant site of infection.2,7 The specific entry mode or cause of bacteria resulting in NF is not known in about 20% of cases.2,4,9-12

Necrotizing fasciitis can occur in patients of any age. Some preexisting conditions can increase the risk of NF. These include

* alcoholism or IV drug use,

* diabetes mellitus (DM),

* immunocompromise,

* obesity,

* peripheral vascular disease, and

* smoking.2-4,7,11-13

The cause of death from NF frequently is multiple organ system failure resulting from overwhelming sepsis. Morbidity and mortality rates reported in the literature vary from 6% to 80%,27,14 with Fournier’s gangrene, an infective gangrene of the scrotum or vulva, consistently reported as high as 75%.9 Most studies report an overall mortality rate of 28% to 30%.2,7-9 Regardless of the numbers, necrotizing fasciitis is a serious, life-threatening disease that requires prompt diagnosis and intervention.

TYPES OF NF

No single organism is responsible for all types of NF (Table 1). Based on the number and type of organisms present, NF can be divided into three types. Type INF is polymicrobial, involving aerobic gram- negative bacteria, anaerobic gramnegative bacteria, and anaerobic grampositive bacteria.2,5,8,11,15 Type INF usually is preceded by a break in the skin from a penetrating injury or surgical procedure. Patients with DM account for a disproportionately high percentage of people with type INF.5 Pain experienced by patients with type I NF statistically is less severe than in type II NF. This may be due to the neuropathy associated with DM. Patients in an immunocompromised state or who have chronic debilitating diseases also are more likely to exhibit type I NF.2,3,7,8,15

Type II NF is the most common type of NF, with reported cases occurring in all age groups. It usually is community-acquired, although 20% of the cases in an Ontario group A streptococcal study were nosocomial, and 50% had no obvious portal of entry.8 Type II NF occasionally is called streptococcal gangrene, or hemolytic streptococcal gangrene, with the offending organism being GAS alone or in combination with staphylococcus.2,7,8,15

Type III NF involves marine vibrio gram-negative rods. The usual portal of entry is a puncture wound from a fish or a cut or an insect bite that has been exposed to seawater or shellfish. These vibrios synthesize an extracellular toxin that mediates the soft- tissue damage in NF.2,15

PATHOPHYSIOLOGICAL MECHANISMS

The skin provides physical and physiological barriers to infection (ie, a first line of defense). Tight junctions of skin cells, the presence of antibacterial peptides, and the shedding of surface cells make it difficult for bacteria to colonize on intact skin. When the microbes penetrate the skin, physiological protection is activated through the inflammatory response. Chemical mediators are released that secrete pyrogenic endotoxins and exotoxins.16 Secretion of these fever-producing proteins begins a cascade of events that lead to tissue destruction. If the infection is not contained by the body’s neutrophils and platelets, continued release of cytokines damages endothelial cells. Increased vascular permeability of the damaged endothelial lining of vessels allows fluid to leak out into the extravascular spaces, adding to the endothelial cell dysfunction, inflammation, and edema.13 Decreased blood flow causes tissue hypoxemia and necrosis. Vasculitis and thrombosis in adjacent tissues cause further necrosis involving the subcutaneous nerves, which explains the clinical change from severe pain to numbness. Under hypoxic wound conditions, the polymorphonuclear neutrophil phagocytic function typically present early in the inflammatory process is severely hampered, allowing more anaerobic growth, which accelerates the necrotic process.3,9,13,17

TABLE 1

Types of Necrotizing Fasciitis (NF)1-3

Fascial layers beneath the skin are not well supplied with blood vessels. This poor blood supply inhibits the normal infection- fighting ability of the inflammatory re-sponse process and hampers the body’s ability to transmit antibiotics to the affected area. As infection and necrosis spread throughout the fascial layers, vasoconstriction and thrombosis lead to edema and further diminish circulation, resulting in hypoxemia and necrosis of the fascia, skin, soft tissue, and muscles. Progression of soft-tissue necrosis can \be as rapid as one inch per hour.11 The fastest and most effective way to reduce the bacterial load and stop the necrosis is with prompt surgical excision and debridement of all infected tissue.3,5,10,11

CLINICAL MANIFESTATIONS

Necrotizing fasciitis usually begins with flu-like symptoms, such as fever, chills, tachycardia, and aches. The skin becomes erythematous, tender, edematous, and warm, similar to cellulitis, with or without blisters, accompanied by localized pain. A hallmark of NF is pain out of proportion to the physical findings.2,3,5,11,12 Symptoms of pain and fever often are overlooked during initial visits to health care providers because the symptoms are mistaken for the flu, muscle strain, or cellulitis.3,5,11 The subcutaneous tissue may have a hard, almost wooden feel on palpation, extending beyond the obvious area of redness. A complete blood count reveals leukocytosis with a left shift within a few days of presenting symptoms. A left shift is an abnormally high number of bands (ie, immature neutrophils) on the differential count and is indicative of an ongoing bacterial infection.18 This first stage can progress over a matter of hours or may take several days.2,3,11

During stage two, the patient becomes systemically more ill and may exhibit deterioration in sensorium. The infection continues to spread over larger areas in spite of initiation of antibiotic therapy. Septic vasculitis and thrombosis impede antibiotic penetration, making antibiotic therapy only minimally effective. The skin starts changing color from red to a patchy, dusky blue-gray, and blisters may form. Laboratory results may reveal azotemia, hypocalcemia, hyponatremia, hypoproteinemia, thrombocytopenia, hematuria and elevated creatine kinase and sedimentation rates, and metabolic acidosis.3,7,8 Hypoalbuminemia, anemia, and hyperbilirubinemia are common.

If soft-tissue GAS is present, radiological scans may help establish the extent of the infection that cannot be detected by physical examination.2,3,11,13 The absence of soft-tissue GAS on scans does not rule out NF.2

In the third and final stage, bullae, an ominous sign, are seen in about 30% of cases. The bullae become filled with a hemorrhagic, foul-smelling fluid described as “dishwater pus.”2-4,7,11 Large areas of hemorrhagic bullae may cause the patient to become anemic.11,13 Normal appearing skin is undermined with necrosis while muscles remain intact. The large number of aerobic and anaerobic bacteria spreading along the fascial plane causes the vasculature of the skin to become inflamed and thrombosed, resulting in necrotic eschars that appear like deep thermal burns.2 If Enterobacter or Clostridiuni are responsible for the NF, crepitus due to bacterial gas production can be palpated. Nerve destruction replaces the severe pain with numbness.3 As toxins are released into the blood, the patient appears septic with a high fever, high white blood cell count, disorientation, or unconsciousness.2,3,11

PERIOPERATIVE IMPLICATIONS

The key to successful management of NF is early diagnosis and prompt debridement. A comprehensive history and physical examination of the patient presenting with pain that is out of proportion to the physical findings should cause a high degree of suspicion and prompt further investigation into the possibility of NF. Perioperative nurses should understand that initiating administration of broad- spectrum antibiotics and ensuring prompt surgical evaluation are critical for optimal patient outcomes.2,4,5,7,8,10,11

The physician can make a definitive diagnosis in the OR. The surgeon makes a 2-cm to 3-cm incision down to the deep fascial layer of skin where he or she obtains cultures. A lack of bleeding or a thin, brownish, murky fluid exuding from the wound is the first sign of possible NF. The surgeon then performs the “finger test” by gently inserting his or her index finger into the subcutaneous compartment between the fascia and dermis. If the tissues divide and fall apart easily, the finger test is considered positive for NF and prompt surgical debridement is imperative for positive patient outcomes.4,10,19

Perioperative nurses should ensure that surgical supplies specific to emergency NF debridement are immediately available, including

* aerobic and anaerobic culture swabs,

* instrumentation appropriate for the site to be debrided,

* pressure-vacuum irrigation equipment,

* standard set-up packs,

* standard skin preparation supplies,

* sterile specimen containers, and

* the surgeon’s antibiotic of choice for irrigation.

The anesthesia care provider must be prepared to manage septic shock. Prompt access is essential to the surgical team.

The extent of infection often is underestimated on physical examination, so at the time of surgery, the surgeon must determine the extent of debridement needed. The surgeon must excise all necrotic tissue and expose all infection. He or she may determine that a repeat evaluation and further debridement of the area is needed after 24 to 48 hours. If the patient’s condition deteriorates clinically and hemodynamically with the continuing spread of necrosis, the patient should return to the OR sooner than the scheduled 24 to 48 hours. When an extremity is involved, amputation may be required if repeated attempts at debridement do not halt the progression of necrosis.10 During the hospital course, practitioners must perform frequent physical assessments to monitor the affected area for expansion of erythema, edema, pain, skin color changes, presence of bullae, and color and odor of drainage. Dressing changes may be excruciating, requiring premedication or sedation. During sedation, the practitioner thoroughly assesses the surrounding tissue with a sterile gloved hand to determine if the fascia can be separated. If the tissue can be loosened beyond the area of debridement, further surgical debridement may be necessary.10,13 It is common for patients to make multiple trips to the OR for repeat debridement procedures.

Anatomy of the skin

CONTROLLING PAIN

The use of patient-controlled analgesia (eg, morphine sulphate, meperidine, fentanyl) can provide adequate pain control. Assessing pain is important for both ensuring patient comfort and determining disease progression. Nerve necrosis may be developing if a patient reports a change from pain to numbness. Fever greater than 101 F (38.3 C), low hemoglobin and elevated hematocrit and blood urea nitrogen may indicate dehydration and the need for adjustment in fluid resuscitation. Extensive fat necrosis may cause hypocalcemia. Heparin therapy is initiated to decrease the risk and extent of vasculitis and thrombosis.13 Hyperbaric oxygen (HBO^sub 2^) therapy is advocated, particularly if the offending organism is anaerobic.3,5,12,13,20 One retrospective study reported a 35% mortality rate in a group of 33 patients who were treated with the standard antimicrobial and surgical protocol, compared to a 16% mortality rate in 30 patients who received HBO^sub 2^ in addition to the standard protocol.4 The anaerobic properties of bacteroides, Clostridium, Peptococais, and others make HBO^sub 2^ therapy an important adjunct to antimicrobial and surgical interventions. Hyperbaric oxygen is toxic to Clostridium in particular, blocking the production of alpha toxin. Hyperoxemia allows more efficient leukocyte function, increased red cell pliability, and termination of lipid peroxidation. The resulting reduction in edema aids in the preservation of marginally perfused tissue.4,5

PSYCHOSOCIAL CONSIDERATIONS

Psychological consequences of NF result from extreme pain, physical disfigurement, and emotional factors, such as anxiety, fear, worry, anger, and hopelessness. Emotional disharmony (eg, depression, anxiety) can slow the physical and emotional healing process. Appropriate dispensing of psychotropic and pain medications, optimal nutrition, and social services support for patients and their family members will help with the physical and emotional healing.”

DISCUSSION OF THE CASE STUDY

Moore’s experience follows the pattern of type II NF. An otherwise healthy adult, Moore was without the typical preexisting conditions often found in type I NF, such as DM or other debilitating diseases. The causative organism primarily was GAS. Although Moore had a small break in her skin on her left thumb, the site of’ NF was her left chest where she received blunt trauma. Her pain was out of proportion to her presenting symptoms, and she exhibited flu-like symptoms, including fever. Her symptoms progressed rapidly, from flu-like symptoms on Sunday to septic shock by Wednesday. Moore was fortunate that her surgeon did an immediate, thorough debridement, which prevented the need for repeat trips to the OR for further debridement. It was unfortunate that the microthrombotic component of septic shock therapy combined with the vasoconstricting agents needed to maintain vital organ perfusion caused necrosis of her fingers, toes, and right lower leg.

Moore is again playing the guitar and keyboard with the help of finger extensions and is able to drive her car with modifications to the gas pedal that allows her to use her left foot on the gas. She is back at her job as a computer programmer and is again enjoying weekend outings with her family. Special prosthetics allow Moore to do almost everything she did before her ordeal with NF.

UNDERSTANDING NF

Necrotizing fasciitis is a rare, fast-spreading, life- threatening infection of the soft tissues underlying the skin. Early symptoms often are mistaken for cellulitis or other infections. The hallmark symptom of NF is pain that is out of proportion to presenting symptoms. Appropriate antibiotic therapy along with early and thorough debridement improves patient outcomes compared to delayed surgical debridement. Understanding the signs and symptoms, risk factors, and pathophysiologic process of NF increases the perioperative nurse’s a\bility to anticipate the surgical needs of the patient and facilitate a quick diagnosis and prompt treatment.

Editor’s note: The authors thank Cassi Moore for sharing her photographs and personal experience with necrotizing fasciitis. Readers can learn more about Moore’s experience by visiting the National Necrotizing Fasciitis Foundation web site at http:// www.nnff.org and clicking on “Survivor’s Stories.”

ABSTRACT

* NECROTIZING FASCIITIS (NF) is a potentially life-threatening bacterial infection of the skin, deep subcutaneous tissue, and fascia. Early symptoms may be misdiagnosed as cellulitis. A hallmark symptom that distinguishes NF from cellulitis is severe local pain that is out of proportion to the size and type of the wound present.

* EARLY DIAGNOSIS AND TREATMENT of NF is imperative for a patient’s survival. This article describes the pathophysiologic mechanisms, clinical manifestations, and treatment of NF, as well as implications for perioperative nursing. AORN J 82 (December 2005) 1031-1040.

The cause of death from necrotizing fasciitis frequently is multiple organ system failure resulting from overwhelming sepsis. Reported morbidity and mortality rates vary from 6% to 80%.

A hallmark of necrotizing fasciitis (NF) is pain that is out of proportion with the physical findings; NF usually begins with flu- like symptoms.

SIDEBAR

Common Definitions Used in Describing Necrotizing Fasciitis

Cytokines function as the messengers of the immune response by providing communication among macrophages and lymphocytes.1 They are divided into four major groups: interleukins, interferons, tumor necrosis factors, and transformation growth factors.2

Endotoxins are contained in the cell walls of gram-negative bacteria and are released during bacterial destruction.1 Endotoxin bacteria also are called pyrogenic bacteria because they activate the inflammatory process and produce fever. Endotoxins provoke the production of cytokines.3

Exotoxins are proteins released during bacterial growth.1 Very small quantities of exotoxin can be fatal.3

Fournier’s gangrene is an infective gangrene of the scrotum or vulva caused by anaerobic hemolytic strain of Streptococcus.1

Necrotizing fasciitis is a life-threatening bacterial infection that causes rapid necrosis of deep subcutaneous tissue and fascia underlying the skin.

Polymorphonuclear neutrophil is a predominant phagocytic cell in the early inflammatory response to injury.1

A pyrogenic substance or agent tends to cause a rise in body temperature, such as some bacterial toxins.

Thrombosis is an abnormal condition in which a clot (ie, thrombus) develops within a blood vessel.

Vasculitis is an inflammation of the blood vessels. It may be caused by a systemic disease or an allergic reaction.

1. S E Huether, K L McCance, Pathophysiology: The Biologic Basis of Disease in Adults & Children (St Louis: Mosby, 2002) 197-226.

2. B Bullock, R Henze, Focus on Pathophysiology (Philadelphia: Lippincott, 2002) 271-291.

3. B Bullock, R Henze, Focus on Pathophysiology (Philadelphia: Lippincott, 2002) 223-251.

NOTES

1. I Loudon, “Before our time: Necrotizing fasciitis, hospital gangrene, and phagedema,” Lancet 344 (Nov 19, 1994) 1416-1419.

2. R J Green, D C Dafoe, T A Raffin, “Necrotixing fasciitis,” Chest 110 (July 1996) 219-227.

3. S D Fritzsche, “Soft-tissue infection: Necrotizing fasciitis,” Plastic Surgical Nursing 23 (Winter 2003) 155-139.

4. T J Andreasen, S D Green, B J Childres, “Massive infectious soft-tissue injury: Diagnosis and management of necrotizing fasciitis and purpura fulminans,” Plastic and Reconstructs Surgery 107 (April 2001) 1025-1035.

5. W Guo, S Steinberg, “Infections of skin, muscle, and soft tissue,” in Textbook far Critical Care, fifth ed, J M Vincent et al, eds (Philadelphia: Elsevier Saunders, 2005) 1309-1312.

6. S Nseir et al, “Fatal streptococcal necrotizing fasciitis as a complication of axillary brachial plexus block,” British journal of Anesthesia 92 (March 2004) 427-429.

7. D Purnell, T Hazlett, S L Alexander, “A new weapon against severe sepsis related to necrotizing fasciitis,” Dimensions of Critical Care Nursing 23 (January/February 2004) 18-23.

8. D Stevens, “Necrotizing infections of the skin and fascia,” Up to date, htty://www .nptodate.com (accessed 1 Jan 2005).

9. M Maynor, “Necrotizing fasciitis,” eMedicme,http:// www.emedicine.com/emerg /topic332.htm (accessed 6 Oct 2005).

10. B Oelschlager, E P Dellinger, “Necrotizing soft-tissue infections,” Contemporary Surgery 57 suppl (August 2001) S26-S31.

11. L A Sekeres, “Necrotizing fasciitis: A perioperative case study,” Critical Care Nursing Clinics of North America 12 (June 2000) 181-186.

12. B W Walker, “Putting the breaks on necrotizing fasciitis,” Nursing 34 (October 2004) 40-41.

13. A Fink, G DeLuca, “Necrotizing fasciitis: Pathophysiology and treatment,” Dermatology Nursing 14 (October 2002) 324-327.

14. L Braun et al, “A sepsis review: Epidemiology, economics, and disease characteristics,” Dimensions of Critical Care Nursing 22 (May/June 2003) 117-124.

15. J Blanchard, “Necrotizing fasciitis; cleaning hospital toys; disinfecting noncritical items; clinical practice patterns; barrier protection,” AORN Journal 81 (March 2005) 608.

16. B Bullock, R Henze, Focus on Patliophysiology (Philadelphia: Lippincott, 2002) 223-251.

17. S E Huether, K L McCance, Pathophysiology: The Biologic Basis of Disease in Adults & Children (St Louis: Mosby, 2002) 197-226.

18. K D Pagana, R J Pagana, Mosby’s Diagnostic and Laboratory Test Reference, 7th ed (St Louis: Elsevier Mosby, 2005).

19. L Tierney et al, 2005 Current Medical Diagnosis and Treatment (New York: McGraw-Hill, 2005) 1350-1392.

20. D Levy, “Medical encyclopedia: Necrotizing soft tissue infection,” MedlinePlus, http://ipuno.nlm.nih.gov/med lineplus/ency/ article/001443.htm (accessed 18 Oct 2005).

Janice L. Schroeder, RN; Elaine E. Steinke, RN

Janice L. Schroeder, RN, BSN, CNOR, CRNFA, is a private first assistant at Hutchinson Medical Center, Hutchinson, Kan.

Elaine E. Steinke, RN, PhD, ARNP, is a professor at Wichita State University, School of Nursing, Wichita, Kan.

Copyright Association of Operating Room Nurses, Inc. Dec 2005

By Celestini, M; Marchese, A; Serenelli, A; Graziani, G

Aim. Spinal instability is often disregarded as a cause of chronic low back pain and until now there has been no agreement as to its definition and on its nosologic importance or as to a conservative therapeutic protocol. The authors aim to verify whether possible symptomatological characteristics are reflected in radiological findings and, although there is no univocal opinion on the utilization of orthoses of containment for unstable segments, they also aim to verify their efficacy on pain control and neuromotor performance when employed in isolation or in association with the most reliable rehabilitation techniques.

Methods. Forty-eight patients between the ages of 30 and 50 were entered in the study, selected with special exclusion criteria and appropriately randomized to a group following kinesitherapy (KT) and orthoses (O) (O+KT group) and to a control group (orthoses [O] group); the symptomatological and instrumental characteristics were studied at time intervals 0 (to), 3 months (t3), 6 months (to), and 12 months (12t).

Results. The samples examined present homogeneous characteristics. Lumbar instability pain is related to the presence of shift and not to hypermobility, when the latter is guided by efficient neuromotor feedback. In the O+KT group, treatment achieves the two-fold results of reducing shift and increasing mobility in the absence of pain. Both groups tend to increase the utilization of a brace over time. Furthermore, in the O+KT group, a marked reduction in the use of medicine is noticed.

Conclusion. Following treatment both groups report a decrease in pain even though the results of neuromotor performance prove to be better in the group following KT.

Key words: Low back pain * Exercise therapy * Pain.

For many decades backache was considered to have a postural or a degenerative origin. Only recently a new nosographic entity, segmentary lumbar instability, has been discussed, which due to its symptomatological and instrumental characteristics, has not attracted many followers. In fact, more often in the rehabilitation sector, the identification of this pathology, due to its atypical manifestations, can be controversial in the best of hypotheses when not denied altogether. The attitude of its detractors seems justified by the examination of findings in part attributable to systemic and segmentary hypermobility and in part to rigidity in general. In its initial phases, in fact, instability is characterized by hypermobility due to the presence of abnormal oblique forces during trunk flexion. In the more advanced phases of the degenerative forms, the narrowing of the intervertebral discs and the development of osteophytes can determine a reduction in mobility.1

According to a definition by Panjabi.- instability “is a mechanical condition in which there is loss of spinal segment rigidity because the optimal equilibrium in which it should exist, by means of stabilizing elements, is lost due to acute or chronic degenerative laxity or damage; this situation can generate such pain and functional limitations that it paves the way for the progression of the ailment itself”. Among the definitions present in medical literature we find: low back pain condition with variable clinical symptomatology, appearance of symptoms of inconstant intensity, varying from moderate to severe, in response to minimum strain.s-4 loss of vertebral disc structural rigidity,5 accentuated anteroposterior translation, presence of combined pathological motions, increase in the neutral zone, pathological instantaneous rotation center.6 With instability we are in the presence of the loss of capacity to resist forces applied in physiological conditions on the part of the unit of spinal motion.7 It manifests itself with the appearance of an abnormal intersegmentary movement both in a quantitative way with hypermobility and/or shift and qualitatively with a pattern of altered motions.6

Many authors now agree with the existence of an osteoligamentous instability and a neuromuscular one,1, 8-10 the former can be helped with neuromuscular aid which, if not achieved, obliges us to intervene surgically; the latter, instead, almost always needs only conservative treatment.

O’Sullivan etal.n have tried to correlate the characteristics of the pain symptomatology with the observable clinical signs examined objectively and with diagnostic instrumental findings, but, without finding a close correspondence.

For a long time radiological diagnosis of instability has been controversial. Nonetheless, the dynamic radiographie examination in flexo-extension has generally been accepted as a sufficiently reliable method for the diagnosis of instability. The correlation between particular symptoms and specific types of instability is rather scarce.12 Initially, according to the criteria defined, there had to be the presence of at least a 3 mm shift on the radiographie image in lateral projection and at least a 10 inclination on the image in anteroposterior projection.

Indirect signs of instability consist of marginal osteophytosis, by traction, asymmetric collapse of the intervertebral disc during flexo-extension, vertebral disalignment on the frontal plane, fracturing of the annulus.13,14 A study conducted by Sihvonen et al.15 on patients with chronic low back pain, who underwent a radiographie examination using dynamic evaluation of the lumbar tract and a needle electromyography of the paravertebral muscles, pointed out the following elements: retrolisthesis was considered a rather rare form of instability. However, in patients not presenting degenerative damage, this state was slightly more frequent compared to anterolisthesis. This difference might suggest that retrolisthesis, in comparison to anterolisthesis, represents a primitive lesion or can be considered an early sign of degeneration and loss of mechanical functional abilities. A3 far as the association with the symptomatology of irradiated pain is concerned, when retrolisthesis occurs there is a posterior protrusion of the fibrous ring with narrowing of the intervertebral space.

The stabilization of the spinal segment is assured by 3 subsystems: the passive stabilizing system is represented by the vertebrae, the intervertebral rings and the ligaments; the active elements consist of muscles and tendons, and the neural control system, which monitors proprioceptive information. On the other hand, the overall dysfunction of the 3 subsystems can cause damage, which results in the appearance of painful symptoms. Cholewicki et al.16 have demonstrated that lumbar stability is kept viable by an increase in segmentai muscular tone, underlining the importance of motor control in coordinating muscular recruitment during the motion stages between the muscles with greater extension, which are the more superficial agents mainly for the more massive movements, and the small muscles, which are responsible for finer adjustments. The presence of 2 types of active muscles in stabilizing the spine has been pointed out by Bergmaark:17 1) the extrinsic muscle system, consisting of long lever muscles, like the ileocostal, 2) the intrinsic muscle system, represented by muscles which insert themselves directly on the lumbar vertebrae and have the task of stabilizing the segments and directly controlling their movement. Several authors 8-10 have attributed the responsibility for instability not only to the incapacity of adequately activating (preactivization) the transverse abdominus but to the incapacity on the part of the paravertebral, particularly of the multifidus, muscles to stabilize and coordinate the reciprocal movement of single vertebra in relation to their contiguous elements during the movements of the trunk as well. Specific dysfunctions of the multifidus and the low abdominal muscles, examined in patients suffering from chronic low back pain, are mainly represented by the alterallons of the synergic and coordinated activation pattern, which are often activated in order to give greater stability to spinal segments where osteoligamentous lesions from chronic strain or trauma has occurred. In these conditions muscular hyperactivation occurs. 18 This behavior has been interpreted both as a predisposing factor towards the lesions and as a result of soft tissue damage, which has necessarily caused the development of a different strategy toward neuromuscular control in order to improve stability in the damaged tract. This theory has already been put forward by Magnusson and Wilder.19,20

Obviously there is an objective difficulty in the assessment of instability when its cause Ls the alteration of the neuromuscular stabilizing system. Many studies published in recent years have emphasized the necessity for utilizing rehabilitative techniques to improve neuromuscular control. The methodologies, already elaborated by Knott21 and then by Bobath,22 which had their origin in works pertaining to neurologic pathology such as marrow lesions and strokes, developed back stabilization exercises, in which both facilitation and inhibition were inserted in the sequences of neuromotor development used by the authors themselves, instead of simple repetition of strengthening exercises,7, 23-25 or the denervation of paraspinal muscles in the presence of retrolisthesis.” Takin\g the cue from recent discoveries in the biomechanical field, all these works tend to insist on the primary need to re-educate the proprioceptive capabilities with particular regard not only to the anticipatory phase of the exertion and the control of the movement itself but to the reactions of equilibrium in the extension of the muscles in order to eliminate the contractures of the unstable segment as well, and finally, on the need to condition the transverse abdominus and multifidus as well as the small oblique and quadratus lumborum muscles in particular, integrating the proprioceptive capabilities with the global neuromotor action.

It must be remembered that while the long spinal extensor muscles perform the extensional component, the multifidus muscle behaves as a transducer of forces both due to its high content of spindle muscles and its nearness to the center of rotation, and as a highly efficient center of postural feedback as well, while the quadratus lumborum performs a stabilizing action during flexo-extensional movements of the lumbar spine. On the other hand, the internal oblique muscles, if activated in co-contraction transform themselves from rotatory spinal muscles to stabilizing ones; but the muscle with the best stabilizing characteristics on the lumbar vertebrae is undoubtedly the transverse abdominus. As Hodges et al.w have demonstrated, it anticipates all the movements of the trunk and limbs with its contraction. We are indebted to O’Sullivan ” for demonstrating that transverse abdominus’ activity occurs in antagonism to that of the rectus abdominus muscles. Furthermore, the former’s conditioning must be pursued without increasing the strength of the latter.

Lindgren etal.26 recommend performing stretching exercises for the muscles connecting the waist with the lower limbs in particular for the ileopsoas, the gluteals, and the ischiocrurals. They often noticed a retraction on the part of these muscles, which is explainable with the attempt of part of the body somehow to stabilize the waist and thus facilitate the achievement of postural stability. These exercises must obviously be practiced without overburdening the lumbar structures.

Previous studies support the orientations toward more suitable choices of rehabilitative techniques.

Through similar training lasting 4 weeks (3 sessions a week) Sung -” has assessed by means of the Oswestry score test and by electromyography that the variation in the contractability of the multifidus was statistically significant in male subjects, while in female subjects it was likely to take a longer period of time to achieve the same results. Arokoski et al.28 have reached similar conclusions, nonetheless underlining the greater ability of women to activate the stabilization of the trunk’s extrinsic muscle masses.

To this type of treatment McGiIl et al.29 add endurance exercises, when the patients’ reduced capacity in this component is demonstrated. The length of time of endurance in training flexors, extensors and lateroflexors as well as their relationships can represent a valid tool in assessing improvement and establishing training programs.

In postdiscectomy instability Yilmaz et al.30 have demonstrated statistically that the utilization of stabilization exercises are more effective than home exercises and those of the control group, assessing the following parameters: pain, functional disability, Shober, Pile Test, and endurance test of the trunk.

Unfortunately, there are no studies comparing the various techniques, if we exclude the disappointing results obtained with exercises whose sole intent was to strengthen the muscles.31-33

The authors intend to verify whether eventual symptomatological characteristics are reflected radiologically and, although there is no univocal opinion on the utilization of orthoses of containment for the unstable segments, they also intend to verify their efficacy on pain control and neuromotor performance when employed in isolation or in association with the most reliable rehabilitation techniques.

Materials and methods

Population

Fortyeight patients were enlisted according to the following criteria. Inclusion criteria were: females, relapse of chronic low back pain, age between 30 and 50, positive to the systemic laxity test (systemic laxity evaluation by means of search for articular laxity pertaining to the following 9 districts: II and V finger in both left and right hands, elbow and knee bilaterally, back lumbar spine),34 at least one positive radiograph, medical history diagnosing at least 5 positive signs of instability among: history of recurrent low back pain instigated by minimum stress, central lumbar pain in standing position, protracted with application of strain, temporary relief from pain after manipulative treatment, improvement of symptoms through utilization of orthopaedic braces, prior traumas,35 and positive objective examination showing at least one sign of diagnosis of instability (a visible or palpable presence of a step at the level of the spinous apophysis level of the lumbar tract, and the so called “instability catch” represented by abnormal movements observed during active range of motion [ROM] evaluation 4). The exclusion criteria were: practice of high impact sports, menopause, endocrine metabolic disturbances, osteoporosis and/or vertebral collapse, prior emilaminectomy, specific or unspecific inflammations of the lumbar spine. The estimate of the size of the sample was based on a study of the vagueness of the Backill questionnaire regarding the Italian population, and with the choice of precision within 5%. The minimum number had to be at least 18 members per group, to which we added a 30% dropout average. We thus reached a total of 48 units.

Assessments

After giving their informed consent, all the female patients had to answer a questionnaire (historical assessment), administered by a sole interviewer, which included the following: the date of first manifestation of pain, the way in which it appeared, the duration and the event that triggered the single episode, the number of episodes in a year, the number of episodes in the last 90 days, the appearance of symptoms in the intermediate levels of flexion- extension (the modifications of the neutral zone appeared to be more sensitive than those of the ROM in the corresponding segment; this therefore seems to be an important clinical measure of vertebral stability),36 lessening of the symptoms with an orthesis, the presence of central lumbar pain in standing position, accentuated pain from strain, relief with manipulative therapy, prior traumas, relation between pain and sloping position, irradiation of pain to the lower limbs, possible use of brace and medicine in presence of pain. The Backill scale 37 was given to all patients to assess their disability. The clinical assessment included classic clinical items such as the Dandi (test to assess the extensor efficiency pertaining to the toe), Lasegue, Wasserman, Vallelix osseo-tendinous reflexes (ROT), the strength of the lower limbs, tenderness, piriform test,38 Wolkman test (to test the endangering of the sacroiliac articulations, performed in lateral decubitus by an operator who applied pressure perpendicularly to the iliac crests), assessment of pain and rigidity according to Maigne;3? furthermore, there were clinically orientated items (these items were considered orientational since some of them had been described by the authors below and had been considered so by the clinical experience of the authors themselves), described as positivity to pince-roul,39 trigger and tender point,38-40 Delitala (stimulation of sciatic nerve at sacrum emergence), strength of abdominal muscles and spinal erectors, spinalgia, Shoeberg test,22 systemic laxity test,34 clinical step, abnormal motions in the active ROM according to Paris,4 guided straightening (the individual’s passage from a spinal flexed position to a standing position using the lower limbs as a pylon for straightening up), the disturbance test.18 Regarding this, Radebold etal. studied the activation pattern of 6 couples of spinal muscles in individuals suffering from chronic low back pain, who underwent sudden stress on their spinal chord in flexion, extension and lateroflexion, and compared this pattern with that of healthy individuals.18 In applying the disturbance, consisting in sudden removal of an obstacle against which the individuals had to exert pressure with their trunk, the healthy individuals reacted by, in quick sequence, disactivating the agonist muscles and activating the antagonist ones, while the patients showed a lesser tendency to disactivate the agonist muscles, which remained contracted even during the activation of the antagonist ones (co-contraction). Furthermore, their muscle recruitment was quantitatively inferior in comparison with that of the healthy individuals in the course of all the trials performed. Between the 2 groups examined there were also differences in the reaction times to the applied stimuli: the patients’ latency times in the appearance of muscular response both in disactivating the agonist and activating the antagonist muscles were greater than in the healthy ones. The following were examined in standard standing, dynamic and oblique X-rays: the presence of lyses or isthmic scleroses, spondylolisthesis, retrolisthesis, forward shift greater than 3 mm in dynamic radiographies, facette syndrome,41 the level and measurement of the discosomatic angle (parameter created by the authors, which represents the sum of the angles of the hypermobile interdise space in maximum flexion and extension). All these parameters have been the material of a specific correlational study of clinical observation and of repeatability about to be published.

The assessments were made at the beginning of the study (t0), at 3, 6, and 12 months (respectively t3, to, and t12). In particu\lar, all the assessments were made at tO, the anamnestic, clinical and radiological ones at to, and only the anamnestic ones at t3 and t!2.

Therapy

The female patients selected were randomized on the basis of a sampling chart subdivided into 2 age classes (30-40 years and 40-50 years), into 2 therapeutic groups: orthoses only (O group); stabilizing kinesitherapy and orthoses (O+KT group). The O utilized was a cloth band with splints of the CAMP brand, prescribed for 90 days of continuous use to both groups without discrimination. The KT protocol was standardized beforehand in 12 applications, 3 times weekly for 4 weeks, consisting in diaphragm breathing exercises, proprioceptive trunk exercises, with particular attention given to the achievement and maintenance of the neutral zone at the level of lumbar lordosis, gluteal and ischiocrural stretching exercises performed in an unloaded way, contraction exercises of the lumbar stabilizing muscles (in particular of the transverse abdominus) both singly and in association with the other trunk muscles, gradually adding control during the motion of the limbs and reconditioning of endurance, exercises for trunk stabilizing on ever more reduced supporting surfaces and finally on unstable surfaces, selective strengthening exercises of the lower limbs and postural and occupational counselling/guidance.

Statistical analysis

Parametrical and non-parametrical tests(t-Student with two- tailed independent data, Levene’s test, χ^sup 2^ test by degrees) were utilized, preceding verification of the data distribution and statistical tests of correlation between variables. Significant differences were considered those with P

Results

The groups studied proved to be homogeneous for the first display of events, for the characteristics of pathology, for the traditional clinical tests, as well as for those identified as specific by the authors, except for the spinalgia and straightening tests. Even for the radiological examinations, including discosomatic excursion between the maximum flexion and extension and for the Backill scale, the results show no significant differences between the groups. The characteristics of the patients who dropped out in both groups are furnished in Table I. Anamnestic, clinical and radiological items were monitored longitudinally in each group, of which the most interesting clinical results are set out in Table II. Table III, and Table IV.

The number of episodes of back pain (assessed by the patient in the last 90 days preceding the control) decreases progressively. At the first control 78% of the O+KT group affirmed having 6 acute episodes in the last 3 months; 6 months later the number of episodes had remarkably decreased, in fact, the percentage of patients affirming they had more than 6 episodes in the preceding 90 days had decreased to 27%. In the same group at to, 55% affirmed they had a complete remission of pain symptoms (Table II).

TABLE I.-Characteristics of dropout patients and moment of leaving. t0: start of study; t3: follow-up at 3 months; t6! follow- up at 6 months; t12: follow-up at 12 months.

TABLE II.-Anamnestic results. t0: start of study; t6: follow-up at 6 months; 112: follow-up at 12 months.

TABLE III.-Clinical data. t0: start of study; t6: follow-up at 6 months; t12: follow-up at 12 months.

TABLE IV.-Radiological findings. t0: start of study; t6:follow- up at 6 months; 112: follow-up at 12 months.

The O group finds relief in manipulative therapy (47% at t0) even if in later checks nobody is follows this kind of therapy (P

Backill’s functional and pain scale did not manifest a statistically significant modification trend either in time or in association with other parameters except for the pain alarm item in the O group, where the perception of pain perceived as “relatively severe” was reported in 63% of the population at tO, while it disappeared in subsequent checks, and was perceived exclusively as “light” as set out in Table II.

It is obvious that the use of a brace brings immediate relief to patients suffering from instability especially in the O group. Furthermore, we believe a positive response to its use can help a doctor formulate the right diagnosis. Both groups report a reduction in pain through exercise in the period preceding therapy, while at the end of the trial group O, conditioned by the use of a brace, they seem to look for stability through the absence of movement and rest to avoid pain. Instead, group O+KT finds relief and stability through muscular activation, by repeating the motions learned during treatment. While group O continues to take medicine, almost the whole of group O+KT tends not to take it anymore (77%) at to.

As regards the radiographie findings, the only important variations concern the O+KT group, in respect to the articular discosomatic excursion parameters superior or equal to 15 (the number of positive individuals increased) and shift superior to 3 mm (the number of positive individuals decreased). As regards both parameters a significant difference was also reported between groups. As to the use of medicine in the 2 groups at to, 77% of the O+KT group patients are remarkably orientated towards not taking medicine compared to 8% of the O group (PO.01 ).

The practice of self performed kinesitherapy was compared between the 2 groups and it turned out that 86% of the O+KT group did exercises at home when experiencing pain against 14% of the group utilizing only ortheses with P

Discussion

Both therapies are efficient in pain control, as demonstrated by the anamnestic findings; VAS or other similar scales were not used because they were not considered valid for assessing a symptom with inconstant and unrepeatable characteristics-, even the Backill scale does not appear to be an adequate tool for assessing pain which Ls discontinuous or caused by behavior typical of instability since it does not highlight any significant variation in time, possibly also due to the smallness of the sample.

Between 40 and 50 years of age no individual appears to suffer from functional radiologie laxity. This is probably due to the occurrence of rigidity on a degenerative basis, which establishes itself in response to the repeated mechanical stress sustained by the structures of the mobile segment; from this it is possible to deduce that the pain symptom and hypermobility have preceded this phase.

A positive Lasegue is not a pathological indicator of clinical and radiologie positiveness of instability because there is no correlation between it and all the items considered significant for the diagnosis of instability.

The statistical investigation demonstrated a high index of correlation between the discosomatic delta and the other typical clinical parameters of instability when the difference passes 15. In particular, the discosomatic delta >15 is closely correlated to retrolisthesis (which in medical literature Ls pointed out as one of the initial signs of instability). Thus it can be deduced that this indication can be taken as a limit value for the radiologie diagnosis of lumbar segmentary instability (personal data).

Both therapies produce an increase in the discosomatic angle, in other words they remove the latent constitutional laxity together with the reduction of rigidity and pain connected to the contracture.

However, the differing results between the 2 therapies is displayed in the reduction of shift, which is achieved solely in patients who have undergone kinesitherapy treatment. What distinguishes the result between the 2 proposed therapies is not the reduction of pain or of contracture, but the quality of movement on the level of the unstable mobile segment. From the analysis comparing the trend of the data on shift and on the discosomatic delta in the O+KT group, and keeping in mind the literature on lumbar instability,23-25 it is possible to hypothesize: a) the body reacts to strain by protecting the hypermobile tract with a quantitative increase of rigidity by activating the contraction of the intrinsic paravertebral muscles, which pass bridge-like on the segment itself; b) the bracing aims to and achieves the result of containing the hypermobile tract, however, without supporting the local circuit in contracture; c) the KT treatment implements the capacities of neuromuscular activation, achieving active protection; consequently, it removes the latency of hypermobility (increase of delta) consenting a quantitative and qualitative increase in mobility (lessening of shift). In fact, by improving neuromuscular control, the KT treatment is capable of rendering the movement more harmonious, by reducing disturbances at the mobile segment level, which trigger the typical ailments of instability and the contractured response of the paravertebral muscles. Therefore, instability and rigidity are not in absolute contradiction and this renders the clinical diagnosis difficult as every pain stimulus at the segmentary level is expressed in a reflex circuit, whose final expression is contracture. Obviously even hypermobility and harmonious movement are not contradictory if the neuromuscular system, adequately stimulated, succeeds in controlling the motion even in a wider range and with less restraint on the part of the mechanical structures; all this confirms Panjabi’s “neutral zone” theory.7

Conclusions

Both groups found the experimentation helpful, the association of KT produces better effects on the symptomatology, neuromotor performance and life style, which is displayed in the tendency not only to take less medicine and use supports less, but to resort to home therapeutic exercises replacing bed re.st in case of recurrence of pain as well.

The results remain constant a year after treatment.

This study’s most original finding appears to be the discovery of the 15 limit as the summation of the \discosomatic angles of the hypermobile vertebral segment in establishing a correct clinical diagnosis of instability and, furthermore, the finding that the passing of this limit is closely correlated to retrolisthesis.

Because of the complexity and variability of behavior in this study, further randomized controlled trials are surely to be hoped for.

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M. CELESTINI. A. MARCHESE, A. SERENELLI. G. GRAZIANI

Department of Pb vsical Medicine and Rehabilitation RM/A-RM/E, S. Spirito in Sassia Hospital, Rome, Italy

Submitted for publication January 28. 2005.

Accepted July 3. 2005.

Address reprint requests to: Dr. A. Serenelli. Dipartimento di Medicina Fisica e Riabilituzione. Ospedale S. Spirito in Sassiu. Uingo Tevere in Sassia 1. 00193 Roma. E-mail: [email protected]

Copyright Edizioni Minerva Medica Sep 2005

By Storey, Mark

[T]He traditional subject, particularly the masculine subject, is in the throes of an identity crisis. Moreover, this crisis is a particularly radical one. […] [I]t is not simply a matter of discovering or choosing for oneself a single, unified, coherent identity from a range of cultural possibilities. [. . .] Rather, the current crisis threatens to transform or even overthrow the whole concept of identity. This is the point of convergence of fears of late capitalism, fears of feminism, fears of any swerving from the path of “straight” sexuality: the fears that, together, constitute what I want to call “pomophobia.”

-Thomas B. Byers, “Terminating the Postmodern: Masculinity and Pomophobia” 7 (emphasis in original)

Thomas Byers is one critic whose approach to the crisis of masculinity seems to push the issue further than most: Whereas others have focused so often on the implications of the crisis for constructions of masculine identity, Byers sees it as such a radical event that even the concept of identity is in the process of redefinition. Contemporary life, what we might call “the postmodern era,” has witnessed so profound a shift in how we see ourselves that all the old frameworks of the self have come crashing down; some embrace this, but some, as Byers argues, see the change as a threat to the order in which they are safely established-this fear of things “falling apart” is what Byers means by pomophobia. His hope is that the old ideas of an essential masculinity may fall away and new constructions of sexuality and gender will replace them. Postmodernity’s relentless dismantling of established orders and its deconstruction of the old hegemonic discourses strikes fear into the normative masculinity that relies so heavily on them. From the rubble that remains after its destruction, a new sexual order can be established free of the previous era’s patriarchal hierarchy.

It is no big leap to see Byers’s pomophobia at work in much contemporary fiction written by and about men; indeed, that well may be where pomophobia achieves its most sophisticated expression. Few male-authored novels about men, in recent-or in any-times, have caused as much controversy as American Psycho. To call Bret Easton Ellis’s third novel difficult seems a desperate case of understatement: Its lingering, horribly detailed descriptions of torture and murder, as well as the explicit sexual content, caused a moral panic when the book first appeared, a furor now well documented elsewhere.1 One puzzle that has also fueled the novel’s cult status is whether the “action” actually takes place or is a sustained, nightmarish fantasy. Most critics either think of American Psycho as the stylish confession of a yuppie serial killer, a not-so-subtle satire of 1980s consumer greed, or a long, increasingly insane rant, a malign chimera conjured by the disturbed mind of Patrick Bateman.

Now that the notoriety has quietened, those approaches now seem strangely simplistic. It turns the novel into a 400-page puzzle, a kind of ontological whodunnit that one can “work out” by following the clues. Except Ellis is a better novelist than that, and American Psycho a vastly more complex novel. The question is not whether the “action” really takes place-a careful reading reveals that was never the point-but what the “action” tells us about the person who recounts it. The narrative is life through the prism of Patrick Bateman’s psyche, but closer inspection reveals his psyche is nonexistent. Instead, Ellis gives us a central identity created by external forces, a fictional world encased in the language of the society that created it and told through the voice of a man who in real terms is not actually there. The narrative is deeply mired in the “crisis of masculinity,” exploring the creation of an identity in a postmodern world in which the concept of identity has changed. In the impossibility of that postmodern creation, Ellis shows us the monstrous heart of masculinity at the outer limits, a frenzied pomophobia that, instead of re-establishing Bateman’s identity and sense of order, serves to draw him further into the realm of chaotic unreality.

It is important to establish from the beginning the “unreal” qualities of Patrick Bateman. Criticism of the novel has often allowed a curious and damaging contradiction to creep into analyses of Bateman’s account: In the same breath as they proclaim him to be an embodiment of pure evil, critics have credited the narrative-his narrative, remember-with a startling amount of reliability and coherence. We may reasonably conclude that literary critics are happy to place their trust in psychopaths. James Annesley, for example, claims that “in the terms laid down by Ellis, Patrick Bateman’s murders are crimes for which an increasingly commercial and materialistic society must take ultimate responsibility” (13); although with a more specific example in mind, Ruth Helyer discusses the scene in which Bateman returns to the apartment of Paul Owen (an early “victim”) and “finds the real estate agent there, intent on covering up the carnage, for the sake of reletting the property” (729). Both credit Bateman with a level of reliability that does not hold. To discuss his “crimes” in terms that make them real, or to attempt to understand his motivation in that way, places trust in the subjective nature of what we are told, crediting Bateman’s “I” with a stable sense of self. To believe the events are true, or even to react to them in ways that suggest that they are the product of our narrator’s imagination, creates a Patrick Bateman who is unmistakably there, who exists, lives, and breathes among us. Read beyond these rather trivial choices, however, and it is possible to see Bateman as not there at all, a representation of representations in which he is in the center as the negative space. Elizabeth Young recognizes the impossibility of analyzing Bateman:

Patrick is a cipher; a sign in language and it is in language that he disintegrates, slips out of our grasp [. . .]. He is a textual impossibility, written out, elided until there is no “Patrick” other than the sign or signifier that sets in motion the process that must destroy him and thus at the end of the book must go back to its beginnings and start again [. . .]. Patrick becomes, in effect, feminized, excluded from “existing” in language. (“The Beast in the Jungle” 119, emphasis in original)

When reading American Psycho, it becomes clear that the novel is as much about the dilemma of Patrick Bateman’s identity as it is a satire on 1980s consumerism. Ellis explores the dilemma through language, the system through which normative masculinity has traditionally located and perpetuated itself: By creating a male protagonist who exists only as an exemplar of traditionally male language systems (violence, pornography, the media, fashion, commerce) taken to their extremes, he undermines the stability of those language systems and shows the impossibility of their attempts to adapt to postmodernity. “Patrick Bateman” is not a single coherent identity that comes from within, but a pliable, artificial identity that is formed entirely by the culture that surrounds him. In almost all aspects of the novel, Ellis constantly undermines Bateman’s subjectivity by having his account of the world be an uneasy collage of the different spheres of masculine language that create him. Having said this, it is too easy to make out that there is no “reality” within American Psycho; to consign every word to the box marked “fantasy” is as overly simplistic as taking it at face value. Ellis increasingly blurs the line between reality and unreality as the novel progresses, to the point where neither Bateman nor the reader knows what is or is not “real.”

Young recognizes the range of voices that creates American Psycho, noting that the novel “is written largely in brochure- speak, ad-speak, in the mindless, soporific commentary of the catwalk or the soapy soft-sell of the market place” (“Beast” 101); we might add that these are all modes of patriarchal language, traditionally written or spoken by men. That Bateman should recount his story in exactly this language is no accident-he is, after all, the epitome of a certain type of masculinity. Physically perfect, financially successful, popular with women, and surrounded by every conceivable luxury, he is the ultimate clich of the 1980s male. But Ellis’s novel runs deeper: Bateman conceives of the world in a purely clichd, masculine way. The things he buys, the friends he keeps, the sex he has, and the violence he perpetrates are all told through a male vernacular particular to the 1980s that he inhabits. Rather than reinforcing our sense of Bateman’s reliability, the form of the novel suggests that the central character is merely an illustration of a particular identity type.

The most obvious starting point for realizing this is the violence, the source of the novel’s notoriety. Once our initial squirming is over, an almost too obvious question occurs to us: How can Bateman maintain so detailed a description of what he is doing when it is in the present tense? This cannot be a written confession; anything ot\her than past-tense narration makes no sense. This may seem a questionable point, even a facetious one, but as an unavoidable facet of the narrative it surely short-circuits any attempt to read Bateman too trustingly. We can reach only one conclusion: He got the details from elsewhere. When Bateman at one point mentions Ed Gein,2 one of his associates comments, “You’ve always been interested in stuff like that, Bateman” (92), and a conversation at the Yale Club turns once again to serial killers:

“But you [Patrick] always bring them up,” McDermott complains. “And always in this casual, educational sort of way. I mean, I don’t want to know anything about Son of Sam or the fucking hillside strangler or Ted Bundy or Featherhead, for god [sic] sake.”

[. . .] “He means Leatherface,” I say, teeth tightly clenched. “Leatherface. He was part of the Texas Chainsaw Massacre.” (153, emphasis in original)

Just as Ellis blurs the line between reality and unreality (and we may take this scene, tentatively, as one of the more “real”), so do Bateman and associates. Philip Simpson notes that “Bateman talks about notorious real-life serial killers and fictional ones with no apparent discernment between them” (150). Bateman’s viewing choices also seem extreme: He mentions watching The Toolbox Murders (278), a film notorious for its graphic scene of someone being murdered with a nail-gun; he has watched his favorite film, Body Double? thirty- seven times and tells the counter assistant at the video store that his favorite part is when “the woman . . . gets drilled by the . . . power driller” (113; ellipses in original). The scenes in which he is apparently committing “real” violence subsequently take on a different tone: They are so over the top, so filmic, even comic- book in the details that we are given (including one murder using a nail-gun and another using a power driller) that it seems like something he has taken from a book or a film. The state of Bateman’s apartment on the morning after a particularly horrific night (290- 91) is typical: The smell emanating from the mangled corpses (he opens Venetian blinds covered with the fat of electrocuted breasts), would be hard to cover up. As he seems never to do any cleaning, we can only presume that his maid, whom he mentions more than once, does it for him. Would she stay silent about finding a decapitated head wearing sunglasses on the kitchen work surface? Or were there no remains to find because the murders never took place? Or perhaps there is no maid? The evidence of the novel alerts us to Bateman’s unreliability, but the language that describes his atrocious acts sets off alarm bells on a deeper level; life for Bateman, it seems, is one long film.

This blurring between a coherent idea of Bateman’s interiority and the language in which his identity is immersed extends into every part of the novel. He cannot decide on a restaurant without consulting his trusty Zagat guide (310), and he cannot offer an opinion on something without first having read a review of it (he tries to remember a line from New York magazine to describe a painting by David Onica [99]). The constant listing of brands, makes, and models is unmistakably evocative of catalogue-speak or a consumer guide. Even his political comments are contradictory, nonsensical, and above all utterly trite; his assessment of the way forward for America ( 15) is a string of campaign sound bites.

His real-life sexual acts become intertwined with the pornography he freely admits to watching,4 to the extent that in his own narrative the line between the two is obliterated. Relatively early in the novel, he tells us he rented Inside Lydia ‘s Ass (97-98) and describes a scene from it in exactly the same uninflected, cool prose in which he later describes the “real” sex. As a result, the sex, like the violence, becomes less realistic; for the most pari, it reads like a certain type of male fantasy, and at one point Bateman even describes a threesome as a “hardcore montage” (303).

The chapters on music-Genesis, Whitney Houston, Huey Lewis and the News-are all analyzed in language so mind-numbingly banal that “one is tempted to read them as further evidence for the non- reality, the not-thereness of Patrick” (Young, “Beast” 112). The language is that of second-rate music journalism,5 not an independent intellectual process but a turgid conglomeration of other, male-authored, sources.

Each area of Bateman’s life may have an element of “truth” when he tells it, an aspect taken from his own lived experiences, but in the telling it mutates into something else. Ellis’s destabilizing Bateman’s identity comes when he injects the more frenzied moments and the “real” becomes unreal, or even surreal. Ellis creates a central character who represents a certain type of masculinity, and then he takes that identity to extremes. This is masculinity with the volume turned up, an identity created not from internal, subjective coherence but from an uneasy chorus of voices, each one representing elements of a dominant masculinity. John Sutherland, in a tireless piece of literary detective work, has worked out that Bateman’s fictional address,6 if it existed, would be “in the Impressionist Gallery of the Metropolitan Museum of Art” (142). When we consider how Ellis creates Bateman’s character, this seems an astonishing piece of coincidence if unintentional. Bateman’s identity, apparently coherent from afar, loses definition when examined close-up.

Rather than have Bateman unaware of his own nonexistence, Ellis offers us flashes of peculiar self-awareness. The novel is littered with such moments: To a doorman, Bateman feels he is a “ghost,””something not quite tangible” (71); while having lunch with Bethany, he admits that “I’m really dreaming all this” (231) and later says that “I am […] used to imagining everything happening the way it occurs in movies” (265). If we are still not convinced, Bateman gives it to us straight:

[T]here is an idea of a Patrick Bateman, some kind of abstraction, but there is no real me, only an entity, something illusory, and though I can hide my cold gaze and you can shake my hand and feel flesh gripping yours and maybe sense our lifestyles are probably comparable: I am simply not there. (376-77, emphasis in original)

The narrative seems to be working on two levels: the unreal, fantasy world of male vernacular, and behind it a “real” Patrick Bateman living in a “real” New York City. The moments in which Bateman displays an astute, if paradoxical, self-awareness (awareness that there is no self) are the fissures in the narrative when one level slips into the other. At one level, the level Bateman wants to present, his identity is serf-fashioned out of clichd masculine language, but the inevitable cracks that appear in such an artificial identity allow us to peer into the void beneath.

This dual structuring may explain how Ellis creates his central character (if we can use such a term in this case), but it does not totally explain why. Again, we might usefully attempt to deal with form and content separately; on the level of form, as I have explained, the language that Bateman uses, language that belongs to a specific, male group of society, creates his subjectivity. Effectively, we are dealing with social constructionism: Vivien Burr, summarizing the influential theories of Harr, argues that “the structure of the language we are born into determines the kinds of beliefs about personhood we acquire” (126). Further explanation reveals the relevance of this theory to our reading of American Psycho:

“Beliefs” here […] refer to the fundamental structuring of our thinking that is achieved by our use of language. In other words, the structure of our language decrees (or at least very strongly suggests) that we adopt particular fundamental assumptions (i.e., beliefs) about human nature, and live them out in our daily interactions with each other. (Burr 126)

Bateman’s beliefs about life are totally determined by the structure of the language he adopts. In his fantasy world, he lives out those beliefs, actions determined not by an essential internal identity, but by the assumptions that his language structure makes about the world. If Ellis constructs Bateman out of deliberately clichd and extreme language, a particular language that belongs to the masculinity Bateman represents, then the novel exists to expose and satirize the beliefs that masculine language has about human nature: The murderous insanity of Bateman is merely the ultimate realization of normative masculinity’s internal logic.

We go back to Byers: Bateman is not a “single, unified, coherent identity [chosen] from a range of cultural possibilities,” but an artificially created persona. In Byers’s terms, overthrowing the concept of identity comes down to the challenges that postmodernity offers to “straight” masculinity. The question may be, In what way is Patrick Bateman possibly threatened? I have already mentioned that he becomes a representation of normative masculinity taken to its extremes, the ultimate (in the proper sense of the word) figure of 1980s commercial success.

Except, of course, we are reading Bateman with the reliability that has already been criticized in others. What must be acknowledged is that within this argument there are fundamental assumptions that actually pose problems for its own conveyance: Reading Bateman as a textual figure is an attempt to move away from the simplistic interpretations highlighted earlier, but in doing that, I have had to re-import a language of positivism that then seems self-contradictory. In an essay that argues against the reification of Bateman and sees him instead as a discursive formation, the argument must rely on the mimetic language it is trying to repudiate. In the end, this is a paradox that is unavoidable both here and in the novel itself: There can be discussion \of “him” and “his reactions” as long as one always bears in mind that Ellis has created his subjectivity as a way to explore the implications of masculine language.

Ellis himself seems consciously to recognize this difficulty and expresses it within the novel. Bateman’s narrative becomes an intense case of masculine self-fashioning, a narrative edited by the teller to give the impression of a certain type of man-editing that occasionally goes awry when dangerous levels of self-awareness creep in. The use of first-person narration extends the idea of social constructionism: “The simple existence of the word T allows us to foster the belief that we are autonomous individuals [… and] that this self contains mechanisms and processes [. . .] that are responsible for our actions” (Burr 126). The subjective narrative position, then, works two ways in the novel: For Bateman, imagining the world from the position of “I” allows him to unite the otherwise unconnected strains of masculine language in an attempt to create the impression of a unified self. Ellis, however, can undermine the reader’s expectation of a monological narration and emphasize how the chorus of masculine discourses that create Bateman lead to a chaotic and fractured sense of self.

The spatial figuration within the novel provides a framework in which the narrative voice can operate; yet, it alerts the astute reader to the impossibility of treating the narrative as a coherent structure. Bateman’s identity may be a case of masculine vernaculars piled on top of each other, but the reason that Ellis creates someone to represent these vernaculars-the motivation that drives the purpose of the novel-lies in Byers’s pomophobia. Bateman’s world is one in which his position is increasingly unstable, in which the form of masculinity he so desperately tries to portray as being his own is undergoing a swift and irreversible erosion.

In its most explicit form, Bateman’s fear of his own subjugation expresses itself through the violence he enacts on “others”; this loaded term is important here, as what Bateman sees as “other” is linked to the position of normative masculinity in the postmodern era. Women in particular, but also homosexuals, blacks, and other ethnic minorities, all suffer his wrath at some point; we have already established the unreality of these murders, so we can presume that Bateman singles these people out in his mind for a reason. From a quick glance at the list, it is obvious why: These are the groups who, in a postmodern society, find their place in the margins being brought into the center. To Bateman, the rise of the marginalized threatens his central position as hegemonic male; to protect that position, he lashes out, attempting to eliminate the threat. Zygmunt Bauman sees this kind of reaction as having a completely rational design: “Each order has its own disorders; each model of purity has its own dirt that needs to be swept away” (11). In Bateman’s order, that of normative masculinity, the people he hates are the “dirt” that threaten the “purity” of his own (albeit imagined) existence. His project becomes an extreme example of pomophobia, a reaction not built on irrationality, but something stemming from a deeply conservative mindset:

In the modern world, notoriously unstable and constant solely in its hostility to everything constant, the temptation […] to bring the perpetual change to a halt, to install an order secure against all further challenges, becomes overwhelming and very difficult to resist. (Bauman 11)

Bateman, in the face of “perpetual change,” imagines a world in which his masculine superiority can bring it to a halt. His wish, the wish of the language systems that created him, is to install an order that perpetuates their existence. As the threat to that existence increases, so, too, must the fight against it become more extreme: “[!Increased intensities of reaction in matters of the politics of gender and sexualities […] represent a set of deep and persistent fears on the part of a formerly dominant order that has begun to recognise that it is becoming residual” (Byers 6). There can be no more extreme and intense reaction to that change than the life imagined by Patrick Bateman.

Certain episodes that ElHs inserts into the narrative illustrate Bateman’s insecurity about his position in society. The novel’s opening chapter neatly compresses many of the themes that follow: In a taxi with Tim Price, Bateman observes a plethora of different people in the streets outside-beggars, transvestites, “some crazy fucking homeless nigger” (Ellis 6), and homosexuals. The casual racism, homophobia, and prejudice toward anyone who strays from the line of normative masculinity become a feature of the novel. Suzanne Hatty sees this distancing between the self and “other,” the viewer and the viewed, as a way for the self to project its own insecurities:

[T]he duality between self and Other reflects a hierarchical structure in which the self is valued over the Other [. . .] and in which the latter may be viewed as the repository of all that is negative, threatening, or devalued in modern Western society. (11)

Bateman’s world is one in which the “other” increasingly penetrates his sphere of existence; therefore, his reaction toward them needs to become increasingly hostile to maintain the distance. For Bateman to remain coherent, his unstable sense of self requires a particularly savage attack on the “other” and a clear idea of who they are. Everyone he “murders” presents some kind of challenge to his position of patriarchal supremacy.

The one group who presents the biggest threat to normative masculinity in the postmodern era, and the group toward whom Bateman concentrates much of his hostility, is women. Perhaps the defining aspect of the type of masculinity that Bateman represents is the subjugation of femininity, whether that femininity is embodied in women or, more disturbingly for those men, in themselves. Helyer has noted that Bateman’s carefully orchestrated grooming procedure “seems an incredibly ‘feminine’ pastime” (736), and on a more complex level, the relentless obsession with his own appearance reveals a deeply narcissistic side to him. A Freudian analysis of Bateman may be interesting in itself, and in terms of his narcissism, it poses a question often raised about the novel. Bateman’s relation to homosexuality is more complex than that-too complex, in fact, to elucidate in the confines of this essay. What these details perhaps show is Ellis’s desire to complicate Bateman’s misogyny by layering an unconscious femininity into his narrative.

Bateman’s relationships with women are all characterized by indifference, and at times hostility; he also assumes that all women are instantly attracted to him, even in love with him. When anything threatens to unsettle this prejudiced and arrogant view of women, his objectification of them is also shaken. Consider his reaction when he is shunned by an unimpressed barmaid with whom he attempts to flirt at a nightclub: “You are a fucking ugly bitch I want to stab to death and play around with your blood,” he says (or at least thinks) when her back is turned (59). At a dinner, Evelyn talks about marriage (123-26): The days when women were seen and not heard are gone, and Bateman once again threatens (actually or not) an outburst of violence. The presence of Bethany, an old girlfriend from university, and the news that not only is she extremely successful but she also has a platinum American Express card means “[v]iolent convulsions seem close at hand” (242). A couple of pages later, she becomes a “victim.” Moments in which his carefully groomed masculinity is ignored, or at least is made to take a passive, feminine position, fracture his deluded belief in the patriarchal ideology, and he lashes out. The self-fashioning of Bateman to which American Psycho is a testament is done in the unquestioning belief in hegemonic masculinity; its dismantling is also Patrick Bateman’s. His attempt to mold his secretary Jean into the image of cliched male fantasy (he tells her to wear a skirt and high heels [66-67]) reveals the extent to which he attempts to create his world to fit a masculine template.

Bateman’s associates also seem to hold a staggeringly chauvinistic opinion of women, obsessed with “hardbodies”-women with “blond hair and big tits”-and relating to them only in terms of their superficial attractiveness. Indeed, Bateman’s suggestion that a personality may matter is met with derision by Reeves: “A good personality [. . .] consists of a chick who has a little hardbody and who will satisfy all sexual demands without being too slutty about things and who will essentially keep her dumb fucking mouth shut” (91, emphasis in original). This attitude reveals a fundamental aspect of the way that the normative masculinity represented by Bateman and friends view women: a wish to objectify women in purely aesthetic terms and to deny them any interiority or autonomy that might threaten masculine superiority.

This denial of female interiority and insistence on their objedification leads to a consideration of the murky line that the novel treads between sex and death. Tim Price’s peculiar theory of sexually transmitted disease is particularly illuminating:

“Diseases!” he exclaims, his face tense with pain. “There’s this theory out now that if you can catch the AIDS virus through having sex with someone who is infected then you can catch anything, whether it’s a virus per se or not-Alzheimer’s, muscular dystrophy, hemophilia, leukemia, anorexia, diabetes, cancer, multiple sclerosis, cystic fibrosis, cerebral palsy, dyslexia, for Christ sakes-you can get dyslexia from pussy-” (5, emphasis in original)

Penetration, sex, compromises the integrity of the self, and in the modern era sex becomes the source of death-the biggest danger to the safety of men’s health become\s “pussy.” Women’s bodies are, therefore, the ultimate threat to men, the location of their downfall. For Bateman, the fear of sex equates women with death and legitimizes his destruction of women through violence. Women’s interiority in a metaphorical sense threatens men’s position as the dominant sex; their interiority in a literal sense, their bodies, threatens the existence of men. This explains Bateman’s determination to butcher their bodies; he does not simply murder women; he obliterates them, cuts them open, carves them up, eats their brains, makes nipples into necklaces, ties ribbons around vaginas. Normative masculinity’s objedification and fear of women’s bodies achieves its ultimate expression in Bateman’s fantasy of turning them into meat. In an analysis of the Marquis de Sade, Angela Carter expresses the primal reasoning that lies at the heart of this normative masculine instinct: “[T]he strong abuse, exploit and meatify the weak [. . .] the primal condition of man cannot be modified in any way; it is, eat or be eaten” (138).

We might usefully turn to another novel that deals with similar ground as American Psycho, albeit from a very different angle: Dennis Cooper’s Frisk. Like Ellis, who explores the challenges that postmodernity offers to the formation of normative masculine identity, Cooper, too, begins to explore the implications of the period for a different kind of male identity. The places to which he takes his fiction-to the forbidden boundaries of desire, death, and linguistic expression-probe the same territory as American Psycho.7 At first glance, however, Cooper’s work seems fundamentally different from Ellis’s: It deals exclusively with homosexual men, who, rather than being “victims” of postmodernity’s change, might feel emancipated by their mainstream acceptance and demarginalization. Except that presumes that Cooper’s primary concern is the politics of sexuality; in fact, he is more interested in maintaining an individuality that has nothing to do with any notion of a collective “gay identity.” The idea of becoming mainstream is exactly what Cooper seems to reject, and the lives that he portrays in his novels are as affected by pomophobia as are Ellis’s. Instead of a fear of becoming residual, they fear the assimilation of their often deviant individuality into the politically correct realm of postmodern society. Cooper has commented that he sees the traditional position of homosexual men as outsiders as a potentially positive thing: “[IJt’s stupid to think you’re ever going to be allowed into the main structure of anything. So there is a kind of freedom there” (qtd. in Nicolini). Completely unexpectedly and totally against the critical presumptions made about it, Cooper’s work becomes conservative: He resists the postmodern move toward normalizing all sexual practices and welcoming with open arms all previous outsiders into the happy new family of postmodern society. Cooper “does not feel the least bit ‘gay’ (in both senses of the word) [. . . his] emphasis is on being ‘queer'” (Nicolini); he wants to remain outside, on the periphery, a place in which his individuality can remain fundamentally “different.”

The plot is as fractured and blurred as one would expect from Cooper: We follow thirty years in the life of Dennis (who changes momentarily to Spit in his early twenties), from an impressionable thirteen-year-old coming to terms with his homosexuality and discovering the boundaries of his identity, through an explorative twenties, into an uncertain thirties. Throughout this time, a series of sexually violent photographs that he saw as a youngster haunt his actions and sexual proclivities and draw him farther and farther into the outer limits of society. A fascination with sexual death seems to manifest itself in a series of grizzly murders, recounted in a nineteen-page letter to his best friend Julian. It transpires, however, that the letter was fictitious, and we end where we began, with the photographs. Not so much a circle as a spiral; downward or upward is uncertain, but Cooper never flinches from showing us this murky world.

Thematically, the novel bears some remarkable similarities to American Psycho. As Bateman tore apart his female victims to reduce them to their constituent elements-blood and guts-so Frisk contains a similar element of male bodily fascination. The photographs that open the novel appear to show a young man stripped and tied to a bed, murdered, with his anus horribly mutilated. The narrator, Dennis we presume, finds the photos fascinating, not just for what they show, but for the tantalizing thing that they almost show. The obliterated anus seems to be a passage into an inner world: “At its center’s a pit, or a small tunnel entrance, too out-of-focus to actually explore with one’s eyes, but too mysterious not to want to try” (Frisk 4). Cooper captures the essence of his novel in one sentence: Life becomes “too out-of-focus” for Dennis, a spaced-out, semi-dream world in which reality and fantasy merge imperceptibly. In the places that this allows him to go, however, and the new areas of depravity that gradually open before him, he finds a freedom that no longer exists in his contemporary society. Cooper’s prose is awkward: full of et ceteras and ums and ers, sentences constantly drifting off into ellipses, a smudged and grubby style that reminds us that this new world is somehow incommunicable, existing outside of the capacity of language, and therefore requiring other ways of expressing its core truth. Elizabeth Young recognizes both the reasons for which and the place at which that core truth is sought:

It is as if stunned by years of postmodernism and all the endlessly circulating codes and signs and signifiers there is a sense of the body being the last frontier, an actuality that no amount of theory can disperse. (“Death in Disneyland” 238)

There is not the kicking out against the flow of change as there is for Ellis’s threatened males; the disaffected take flight for the margins and return to the only stable and constant source left to them, the human body. Byers’s belief that only the “traditional subject” is undergoing an identity crisis seems to be complicated by Cooper’s work: As gay men, Cooper’s characters already exist in contradistinction to the normative masculine subject-Bateman et al.- who are supposed to be the ones in crisis. Frisk shows that the cultural shift of postmodernity destabilizes all identities that oppose the changes that are taking place. The celebration of difference that we find at the center of postmodernity means that those who wish to remain different find then” place in the darkness being dragged into the light. When the center collapses (and collapse it does, as normative masculinity knows), the edges become the center. To deliberately exist outside the mainstream, one must cultivate new extremities of behavior. Cooper’s return to the body is the first step.

The response is not merely sexual exploration, however, but a need to understand the makeup of the body on a more profound level. Searching for something purer and more “real” than the flux of postmodern life, Dennis travels down the “small tunnel entrance” that he sees in the photograph into a world of such extremity that it ceases to be understandable through conventional logic. He claims to have “gotten totally removed from almost everyone now” (32); when explaining what his “type” is like, he reveals how and why that is:

My perfect type tends to be distant, like me. I don’t mean matter- of-fact, I mean shut tight. Like he’s protecting himself from other people or pain or both by excising himself from the world in every way, apart from obvius physical stuff you need to get by such as walk, talk, eat, etc. (36-37)

Dennis tries to be “shut tight” as a way of removing himself from the world-not the “physical stuff,” but the fear of postmodernity’s barrage of “codes and signs and signifiers.” The “etc.” in his list of physical stuff may well include sex and, therefore, the body; through them, Dennis tries to find his sense of the real. Cooper, however, realizes that although the expression of these “real” experiences can be made only through language, it is in language that their reality is lost. Expressing the truth of the body through language is impossible, making the body the source of something inexpressible. Dennis searches for a sense of individual identity in his obsession with the body, but ultimately the body cannot offer him that sense because its truths remain elusive. Explaining to another lover, Pierre, that he wants him to save his shit and piss in the toilet because “it’s [. . .] information” leads to a conversation about the photographs (69). Dennis tells of his reaction when he first saw them, saying he felt “enlightened”:

“Or maybe it wasn’t feeling at all, but shock or numbness or […]! don’t know. I think of it as religious. Like insane people say they’ve seen God. I saw God in those pictures, and when I imagine dissecting you, say, I begin to feel that way again.” (70)

The obsession with the body takes on pseudoreligious overtones, a search for the spiritual in the everyday. Dennis finds his desire to dissect and enter the human body almost impossible to articulate or understand, as if it exists in an otherworldly or spiritual dimension. Instead, Frisk suggests that those desires can be articulated only through fiction, that only in the unreal can the unspeakable be given a fixity that goes some way toward making it real. Bateman’s project is the same: His narrative has to be a fantasy to play out the extremities that he requires; only in the imagination can the project of normative masculinity achieve its ultimate realization-except it does not, because in these poststructuralist times the sign no longer equates with the signified. The meticulously crafted verisimilitude of the life that Bateman imagi\nes is the attempt to bring his fantasy into the realm of the real through language. It does not work, cannot work, and so causes Bateman to become trapped in the linguistic world of his own making-the famous “ABANDON ALL HOPE YE WHO ENTER HERE/THIS IS NOT AN EXIT” opening and closing lines. Dennis’s narrative attempts the same thing: He admits that the third part of the novel (“Torn”) is interspersed with fragments of an “artsy murder-mystery novel” that he has written, motivated by his “interest in sexual death” (40). This detail never allows us to place our faith in the details, forcing a conscious fictionality into our reading and emphasizing the impossibility of gaining access to the truth. Later, Dennis’s long letter describing the rape, torture, and murder of several young boys takes this a step further; he seems to have lived out the ultimate expression of his inner desires, except none of it is real and it turns out to be pure fantasy. When asked why he wrote it, his answer gestures at the same perpetual elusiveness we see in American Psycho:

“[B]asically I realized at some point that I couldn’t and wouldn’t kill anyone, no matter how persuasive the fantasy. And theorizing about it, wondering why, never helped at all. Writing it down was and still is exciting in a pornographic way. But I couldn’t see how it would fit into anything as legitimate as a novel or whatever.” (Cooper 123)

“Theorizing about it” is dismissed because it would reduce the experience to the rational, seeking to understand it through an inadequate language; however, Dennis’s admission that “writing it down” is “exciting in a pornographic way” shows that through language he has come closest to capturing the essence of the experience. He realizes, however, that this is not quite enough, and in a neat metafictional twist, he rejects the idea that it could all cohere into a novel. Cooper forces us to see Frisk as a work of ostensible pornography, causing us to ponder on the gap that such representation places between depiction and reality. Pornography plays a significant role in the novel: Gypsy Pete’s shop at which the young Dennis’s sexual awakening takes place, Pierre the porn star, and, of course, the pornographic photographs that frame the narrative. Pornography not only throws us back again to American Psycho, but it also points to Cooper’s central theme of the incapacity of language. Angela Carter says that pornography “involves an abstraction of human intercourse in which the self is reduced to its formal elements” (4): Dennis’s fantasies of opening up people, of turning them inside out, of consuming them (coprophilia makes an appearance, as does cannibalism) take Carter’s pornographic aesthetic to the next level: It abstracts the humanity of the people and turns them into meat, as Bateman did to his female victims. Dennis admits that he hoped that the letter would provoke someone to visit him, which would give him the courage to “actually kill somebody” (123). But it doesn’t. Instead, when Julian and his brother visit Dennis after reading the letter, they have sex with a boy called Chretien; when Julian asks Dennis if he is “maintaining,” meaning holding back the urge to kill, he replies, “Sure. Absolutely. But in my fantasies. . .” (120). The ellipses run off into a world that is indescribable, the more-real-than-real of pornographic dreams, and the world Dennis tried to articulate in his letter. And that’s the closest he’ll get: Language places a gap between the actual experience and its expression, abstracts it, and reduces it to its formal elements-and so never allows Dennis to get any closer.

The final chapter confirms this. The photographs that open the novel reappear, only this time the images are obviously fake: The body is “too tensed to be dead”; the boy’s expression “suggests an inexperienced actor trying to communicate shock”; and finally, the wound is “actually a glop of paint, ink, makeup, tape, cotton, tissue and papier-mch” (127-28). Images that introduced Dennis to a world that seemed commensurate with his aberrant desires are ultimately fake, mere pornographic constructions, the falseness of which undermines the belief in them that is needed for their power to remain. “[Y]ou can see the fingerprints of the person or persons who made it,” the novel concludes (128). The truth of the body, the key to a deviance that would allow Dennis to remain in the margins, turns out to be a lie. Cooper seems to suggest that postmodern society is so pervasive, so final in its assimilation of individualism, even the body has lost its integrity. The body becomes another simulacrom, untrustworthy and untenable as a location of reality. Dennis remains trapped (both the opening and closing chapters are titled “The symbol for Eternity”), spiraling in a world in which the signs of deviance point ever increasingly to the signifieds of normality. As individual masculinity seeks the unspoken areas outside the mainstream, the old reliable locations slip increasingly into a postmodern mainstream in which those margins are becoming narrower. Perhaps the only place left is the realm beyond expression, those margins in which language cannot hope to capture the experience-the darkness after the ellipses. Postmodernism leaves only those areas for deviance to exist, and yet individuals who wish to reside there are faced with the dilemma that their existence is incommunicable within our humanist world of reliable language.

We return full circle to Byers’s central point: The crisis of masculinity is so radical that our conventional ways of constructing identity are no longer relevant, and we arrive at a place in which gender and sexuality have to find new ways to conceptualize themselves. Ellis shows how traditional masculinity is as utterly constructed, as “pumped up by ideological steroids,” as Byers claims (27). In the nightmare world of American Psycho, Ellis critiques traditional masculinity in the most intense way possible, creating a character who, in his chaotic, hysterical perception of the world, lives out the final expression of a masculinity in its death throes.

Cooper offers us something a little less straightforward. As a gay writer writing about gay men, we might think that he would celebrate postmodernity; what we must always remember is that Cooper is a transgressive artist. Through his complex exploration of language, he takes us to the outer circle, the taboo, the hinterlands at the edge of the city; and there he wrestles with the difficulties of his transgression in the postmodern era. The postmodern move to fragmentation and instability means the redefinition of previous binary terms: abnormal becomes normal; disobedience becomes obedience. It destabilizes language and creates the paradox of Cooper needing to be conservative to remain transgressive; he expresses those dilemmas in his fiction.

Ellis opens his novel with an epigraph that comes, by way of W. B. Yeats, from a Talking Heads song: “And as things fell apart / Nobody paid much attention.” How apt that now seems to what Ellis and Cooper are attempting to do. They have written novels that pay attention to the difficulty of male identity formation at the end of the twentieth century, showing how the instabilities of language and the fear of things “falling apart”-pomophobia-both affect and redefine different types of masculine identity, whether those who represent an old order or those who are presumed to represent the new. Both see that new constructions of gender and sexuality are inherent in the changes that postmodernity brings and that men found (and are still finding) that the center can no longer hold. It becomes clear that in any “crisis of masculinity” that emerges because of these changes, fiction may still be the only arena in which the new complexities and ambiguities can most thoroughly be played out.

UNIVERSITY OF MANCHESTER

MANCHESTER, ENGLAND

NOTES

1. Customarily, any discussion of American Psycho seems to open with an account of the novel’s troubled publication. A good summation of those events can be found in Murphet.

2. Ed Gein was a notorious serial killer and cannibal discovered in Plainfield, Wisconsin, in 1957. The story has served as the loose basis for such films as Psycho (1960) and The Texas Chainsaw Massacre (1974) and inspired Thomas Harris’s The Silence of the Lambs (1989).

3. Directed by Brian De Palma (1984), the film is partly an homage to Alfred Hitchcock, as is American Psycho. Even Bateman’s name evokes the Norman Bates of Psycho.

4. Bateman mentions the titles of at least half a dozen porn films and admits to phoning a sex line (219).

5. Ellis knew about the clichs of music journalism; at Bennington, he wrote a regular music review column for the college magazine.

6. Bateman reveals his address to Detective Kimball as “Fifty- five West Eighty-first Street” (270).

7. Despite being as, if not more, disturbingly violent than American Psycho, Frisk barely raised an eyebrow on publication. Both authors have pointed out that violence by men against men seems more acceptable than violence by men against women.

WORKS CITED

Annesley, James. Blank Fictions: Consumerism, Culture and the Contemporary American Novel. London: Pluto, 1998.

Bauman, Zygmunt. “The Dream of Purity.” Postmodernity and its Discontents. Cambridge: Polity, 1997. 5-16.

Burr, Vivien. An Introduction to Social Constructionism. London: Routledge, 1995.

Byers, Thomas B. ‘Terminating the Postmodern: Masculinity and Pomophobia.” Modem Fiction Studies 41.1 (1995): 5-33.

Carter, Angela. The Sadeian Woman: An Exercise in Cultural History. 1979. London: Virago, 2000.

Caveney, Graham, and Elizabeth Young, eds. Shopping in Space: Essays on “Blank Generation ” American Fiction. London: Serpent’s Tail, 1992.

Cooper, Dennis. Frisk. London: Serpent’s Tail, 1991.

Ellis, Bret Easton. American Psycho. London: Picador, 1991.

Hatty, Suzanne E. Mascul\inities, Violence, and Culture. London: Sage, 2000.

Helyer, Ruth. “Parodied to Death: The Postmodern Gothic of American Psycho.” Modern Fiction Studies. 46.3 (2000): 725^6.

Murphet, Julian. Bret Easton Ellis’s American Psycho. London: Continuum, 2002.

Nicolini, Kirn. “Dennis Cooper’s Monster in the Margins.” Bad Subjects: Political Education in Everyday Life. 7 Apr. 2004. <>.

Simpson, Philip L. Psycho Paths: Tracing the Serial Killer Through Contemporary American Film and Fiction. Carbondale: Southern Illinois UP, 2000.

Sutherland, John. “Why Does Patrick Bateman Wear Two Ties?” Where Was Rebecca Shot? Puzzles, Curiosities and Conundrums in Modern Fiction. London: Phoenix, 1998. 138-44.

Young, Elizabeth. “The Beast in the Jungle, the Figure in the Carpet.” Caveney and Young 85-122.

_____. “Death in Disneyland.” Caveney and Young 235-63.

Copyright HELDREF PUBLICATIONS Fall 2005

By Storey, Mark

[T]He traditional subject, particularly the masculine subject, is in the throes of an identity crisis. Moreover, this crisis is a particularly radical one. […] [I]t is not simply a matter of discovering or choosing for oneself a single, unified, coherent identity from a range of cultural possibilities. [. . .] Rather, the current crisis threatens to transform or even overthrow the whole concept of identity. This is the point of convergence of fears of late capitalism, fears of feminism, fears of any swerving from the path of “straight” sexuality: the fears that, together, constitute what I want to call “pomophobia.”

-Thomas B. Byers, “Terminating the Postmodern: Masculinity and Pomophobia” 7 (emphasis in original)

Thomas Byers is one critic whose approach to the crisis of masculinity seems to push the issue further than most: Whereas others have focused so often on the implications of the crisis for constructions of masculine identity, Byers sees it as such a radical event that even the concept of identity is in the process of redefinition. Contemporary life, what we might call “the postmodern era,” has witnessed so profound a shift in how we see ourselves that all the old frameworks of the self have come crashing down; some embrace this, but some, as Byers argues, see the change as a threat to the order in which they are safely established-this fear of things “falling apart” is what Byers means by pomophobia. His hope is that the old ideas of an essential masculinity may fall away and new constructions of sexuality and gender will replace them. Postmodernity’s relentless dismantling of established orders and its deconstruction of the old hegemonic discourses strikes fear into the normative masculinity that relies so heavily on them. From the rubble that remains after its destruction, a new sexual order can be established free of the previous era’s patriarchal hierarchy.

It is no big leap to see Byers’s pomophobia at work in much contemporary fiction written by and about men; indeed, that well may be where pomophobia achieves its most sophisticated expression. Few male-authored novels about men, in recent-or in any-times, have caused as much controversy as American Psycho. To call Bret Easton Ellis’s third novel difficult seems a desperate case of understatement: Its lingering, horribly detailed descriptions of torture and murder, as well as the explicit sexual content, caused a moral panic when the book first appeared, a furor now well documented elsewhere.1 One puzzle that has also fueled the novel’s cult status is whether the “action” actually takes place or is a sustained, nightmarish fantasy. Most critics either think of American Psycho as the stylish confession of a yuppie serial killer, a not-so-subtle satire of 1980s consumer greed, or a long, increasingly insane rant, a malign chimera conjured by the disturbed mind of Patrick Bateman.

Now that the notoriety has quietened, those approaches now seem strangely simplistic. It turns the novel into a 400-page puzzle, a kind of ontological whodunnit that one can “work out” by following the clues. Except Ellis is a better novelist than that, and American Psycho a vastly more complex novel. The question is not whether the “action” really takes place-a careful reading reveals that was never the point-but what the “action” tells us about the person who recounts it. The narrative is life through the prism of Patrick Bateman’s psyche, but closer inspection reveals his psyche is nonexistent. Instead, Ellis gives us a central identity created by external forces, a fictional world encased in the language of the society that created it and told through the voice of a man who in real terms is not actually there. The narrative is deeply mired in the “crisis of masculinity,” exploring the creation of an identity in a postmodern world in which the concept of identity has changed. In the impossibility of that postmodern creation, Ellis shows us the monstrous heart of masculinity at the outer limits, a frenzied pomophobia that, instead of re-establishing Bateman’s identity and sense of order, serves to draw him further into the realm of chaotic unreality.

It is important to establish from the beginning the “unreal” qualities of Patrick Bateman. Criticism of the novel has often allowed a curious and damaging contradiction to creep into analyses of Bateman’s account: In the same breath as they proclaim him to be an embodiment of pure evil, critics have credited the narrative-his narrative, remember-with a startling amount of reliability and coherence. We may reasonably conclude that literary critics are happy to place their trust in psychopaths. James Annesley, for example, claims that “in the terms laid down by Ellis, Patrick Bateman’s murders are crimes for which an increasingly commercial and materialistic society must take ultimate responsibility” (13); although with a more specific example in mind, Ruth Helyer discusses the scene in which Bateman returns to the apartment of Paul Owen (an early “victim”) and “finds the real estate agent there, intent on covering up the carnage, for the sake of reletting the property” (729). Both credit Bateman with a level of reliability that does not hold. To discuss his “crimes” in terms that make them real, or to attempt to understand his motivation in that way, places trust in the subjective nature of what we are told, crediting Bateman’s “I” with a stable sense of self. To believe the events are true, or even to react to them in ways that suggest that they are the product of our narrator’s imagination, creates a Patrick Bateman who is unmistakably there, who exists, lives, and breathes among us. Read beyond these rather trivial choices, however, and it is possible to see Bateman as not there at all, a representation of representations in which he is in the center as the negative space. Elizabeth Young recognizes the impossibility of analyzing Bateman:

Patrick is a cipher; a sign in language and it is in language that he disintegrates, slips out of our grasp [. . .]. He is a textual impossibility, written out, elided until there is no “Patrick” other than the sign or signifier that sets in motion the process that must destroy him and thus at the end of the book must go back to its beginnings and start again [. . .]. Patrick becomes, in effect, feminized, excluded from “existing” in language. (“The Beast in the Jungle” 119, emphasis in original)

When reading American Psycho, it becomes clear that the novel is as much about the dilemma of Patrick Bateman’s identity as it is a satire on 1980s consumerism. Ellis explores the dilemma through language, the system through which normative masculinity has traditionally located and perpetuated itself: By creating a male protagonist who exists only as an exemplar of traditionally male language systems (violence, pornography, the media, fashion, commerce) taken to their extremes, he undermines the stability of those language systems and shows the impossibility of their attempts to adapt to postmodernity. “Patrick Bateman” is not a single coherent identity that comes from within, but a pliable, artificial identity that is formed entirely by the culture that surrounds him. In almost all aspects of the novel, Ellis constantly undermines Bateman’s subjectivity by having his account of the world be an uneasy collage of the different spheres of masculine language that create him. Having said this, it is too easy to make out that there is no “reality” within American Psycho; to consign every word to the box marked “fantasy” is as overly simplistic as taking it at face value. Ellis increasingly blurs the line between reality and unreality as the novel progresses, to the point where neither Bateman nor the reader knows what is or is not “real.”

Young recognizes the range of voices that creates American Psycho, noting that the novel “is written largely in brochure- speak, ad-speak, in the mindless, soporific commentary of the catwalk or the soapy soft-sell of the market place” (“Beast” 101); we might add that these are all modes of patriarchal language, traditionally written or spoken by men. That Bateman should recount his story in exactly this language is no accident-he is, after all, the epitome of a certain type of masculinity. Physically perfect, financially successful, popular with women, and surrounded by every conceivable luxury, he is the ultimate clich of the 1980s male. But Ellis’s novel runs deeper: Bateman conceives of the world in a purely clichd, masculine way. The things he buys, the friends he keeps, the sex he has, and the violence he perpetrates are all told through a male vernacular particular to the 1980s that he inhabits. Rather than reinforcing our sense of Bateman’s reliability, the form of the novel suggests that the central character is merely an illustration of a particular identity type.

The most obvious starting point for realizing this is the violence, the source of the novel’s notoriety. Once our initial squirming is over, an almost too obvious question occurs to us: How can Bateman maintain so detailed a description of what he is doing when it is in the present tense? This cannot be a written confession; anything ot\her than past-tense narration makes no sense. This may seem a questionable point, even a facetious one, but as an unavoidable facet of the narrative it surely short-circuits any attempt to read Bateman too trustingly. We can reach only one conclusion: He got the details from elsewhere. When Bateman at one point mentions Ed Gein,2 one of his associates comments, “You’ve always been interested in stuff like that, Bateman” (92), and a conversation at the Yale Club turns once again to serial killers:

“But you [Patrick] always bring them up,” McDermott complains. “And always in this casual, educational sort of way. I mean, I don’t want to know anything about Son of Sam or the fucking hillside strangler or Ted Bundy or Featherhead, for god [sic] sake.”

[. . .] “He means Leatherface,” I say, teeth tightly clenched. “Leatherface. He was part of the Texas Chainsaw Massacre.” (153, emphasis in original)

Just as Ellis blurs the line between reality and unreality (and we may take this scene, tentatively, as one of the more “real”), so do Bateman and associates. Philip Simpson notes that “Bateman talks about notorious real-life serial killers and fictional ones with no apparent discernment between them” (150). Bateman’s viewing choices also seem extreme: He mentions watching The Toolbox Murders (278), a film notorious for its graphic scene of someone being murdered with a nail-gun; he has watched his favorite film, Body Double? thirty- seven times and tells the counter assistant at the video store that his favorite part is when “the woman . . . gets drilled by the . . . power driller” (113; ellipses in original). The scenes in which he is apparently committing “real” violence subsequently take on a different tone: They are so over the top, so filmic, even comic- book in the details that we are given (including one murder using a nail-gun and another using a power driller) that it seems like something he has taken from a book or a film. The state of Bateman’s apartment on the morning after a particularly horrific night (290- 91) is typical: The smell emanating from the mangled corpses (he opens Venetian blinds covered with the fat of electrocuted breasts), would be hard to cover up. As he seems never to do any cleaning, we can only presume that his maid, whom he mentions more than once, does it for him. Would she stay silent about finding a decapitated head wearing sunglasses on the kitchen work surface? Or were there no remains to find because the murders never took place? Or perhaps there is no maid? The evidence of the novel alerts us to Bateman’s unreliability, but the language that describes his atrocious acts sets off alarm bells on a deeper level; life for Bateman, it seems, is one long film.

This blurring between a coherent idea of Bateman’s interiority and the language in which his identity is immersed extends into every part of the novel. He cannot decide on a restaurant without consulting his trusty Zagat guide (310), and he cannot offer an opinion on something without first having read a review of it (he tries to remember a line from New York magazine to describe a painting by David Onica [99]). The constant listing of brands, makes, and models is unmistakably evocative of catalogue-speak or a consumer guide. Even his political comments are contradictory, nonsensical, and above all utterly trite; his assessment of the way forward for America ( 15) is a string of campaign sound bites.

His real-life sexual acts become intertwined with the pornography he freely admits to watching,4 to the extent that in his own narrative the line between the two is obliterated. Relatively early in the novel, he tells us he rented Inside Lydia ‘s Ass (97-98) and describes a scene from it in exactly the same uninflected, cool prose in which he later describes the “real” sex. As a result, the sex, like the violence, becomes less realistic; for the most pari, it reads like a certain type of male fantasy, and at one point Bateman even describes a threesome as a “hardcore montage” (303).

The chapters on music-Genesis, Whitney Houston, Huey Lewis and the News-are all analyzed in language so mind-numbingly banal that “one is tempted to read them as further evidence for the non- reality, the not-thereness of Patrick” (Young, “Beast” 112). The language is that of second-rate music journalism,5 not an independent intellectual process but a turgid conglomeration of other, male-authored, sources.

Each area of Bateman’s life may have an element of “truth” when he tells it, an aspect taken from his own lived experiences, but in the telling it mutates into something else. Ellis’s destabilizing Bateman’s identity comes when he injects the more frenzied moments and the “real” becomes unreal, or even surreal. Ellis creates a central character who represents a certain type of masculinity, and then he takes that identity to extremes. This is masculinity with the volume turned up, an identity created not from internal, subjective coherence but from an uneasy chorus of voices, each one representing elements of a dominant masculinity. John Sutherland, in a tireless piece of literary detective work, has worked out that Bateman’s fictional address,6 if it existed, would be “in the Impressionist Gallery of the Metropolitan Museum of Art” (142). When we consider how Ellis creates Bateman’s character, this seems an astonishing piece of coincidence if unintentional. Bateman’s identity, apparently coherent from afar, loses definition when examined close-up.

Rather than have Bateman unaware of his own nonexistence, Ellis offers us flashes of peculiar self-awareness. The novel is littered with such moments: To a doorman, Bateman feels he is a “ghost,””something not quite tangible” (71); while having lunch with Bethany, he admits that “I’m really dreaming all this” (231) and later says that “I am […] used to imagining everything happening the way it occurs in movies” (265). If we are still not convinced, Bateman gives it to us straight:

[T]here is an idea of a Patrick Bateman, some kind of abstraction, but there is no real me, only an entity, something illusory, and though I can hide my cold gaze and you can shake my hand and feel flesh gripping yours and maybe sense our lifestyles are probably comparable: I am simply not there. (376-77, emphasis in original)

The narrative seems to be working on two levels: the unreal, fantasy world of male vernacular, and behind it a “real” Patrick Bateman living in a “real” New York City. The moments in which Bateman displays an astute, if paradoxical, self-awareness (awareness that there is no self) are the fissures in the narrative when one level slips into the other. At one level, the level Bateman wants to present, his identity is serf-fashioned out of clichd masculine language, but the inevitable cracks that appear in such an artificial identity allow us to peer into the void beneath.

This dual structuring may explain how Ellis creates his central character (if we can use such a term in this case), but it does not totally explain why. Again, we might usefully attempt to deal with form and content separately; on the level of form, as I have explained, the language that Bateman uses, language that belongs to a specific, male group of society, creates his subjectivity. Effectively, we are dealing with social constructionism: Vivien Burr, summarizing the influential theories of Harr, argues that “the structure of the language we are born into determines the kinds of beliefs about personhood we acquire” (126). Further explanation reveals the relevance of this theory to our reading of American Psycho:

“Beliefs” here […] refer to the fundamental structuring of our thinking that is achieved by our use of language. In other words, the structure of our language decrees (or at least very strongly suggests) that we adopt particular fundamental assumptions (i.e., beliefs) about human nature, and live them out in our daily interactions with each other. (Burr 126)

Bateman’s beliefs about life are totally determined by the structure of the language he adopts. In his fantasy world, he lives out those beliefs, actions determined not by an essential internal identity, but by the assumptions that his language structure makes about the world. If Ellis constructs Bateman out of deliberately clichd and extreme language, a particular language that belongs to the masculinity Bateman represents, then the novel exists to expose and satirize the beliefs that masculine language has about human nature: The murderous insanity of Bateman is merely the ultimate realization of normative masculinity’s internal logic.

We go back to Byers: Bateman is not a “single, unified, coherent identity [chosen] from a range of cultural possibilities,” but an artificially created persona. In Byers’s terms, overthrowing the concept of identity comes down to the challenges that postmodernity offers to “straight” masculinity. The question may be, In what way is Patrick Bateman possibly threatened? I have already mentioned that he becomes a representation of normative masculinity taken to its extremes, the ultimate (in the proper sense of the word) figure of 1980s commercial success.

Except, of course, we are reading Bateman with the reliability that has already been criticized in others. What must be acknowledged is that within this argument there are fundamental assumptions that actually pose problems for its own conveyance: Reading Bateman as a textual figure is an attempt to move away from the simplistic interpretations highlighted earlier, but in doing that, I have had to re-import a language of positivism that then seems self-contradictory. In an essay that argues against the reification of Bateman and sees him instead as a discursive formation, the argument must rely on the mimetic language it is trying to repudiate. In the end, this is a paradox that is unavoidable both here and in the novel itself: There can be discussion \of “him” and “his reactions” as long as one always bears in mind that Ellis has created his subjectivity as a way to explore the implications of masculine language.

Ellis himself seems consciously to recognize this difficulty and expresses it within the novel. Bateman’s narrative becomes an intense case of masculine self-fashioning, a narrative edited by the teller to give the impression of a certain type of man-editing that occasionally goes awry when dangerous levels of self-awareness creep in. The use of first-person narration extends the idea of social constructionism: “The simple existence of the word T allows us to foster the belief that we are autonomous individuals [… and] that this self contains mechanisms and processes [. . .] that are responsible for our actions” (Burr 126). The subjective narrative position, then, works two ways in the novel: For Bateman, imagining the world from the position of “I” allows him to unite the otherwise unconnected strains of masculine language in an attempt to create the impression of a unified self. Ellis, however, can undermine the reader’s expectation of a monological narration and emphasize how the chorus of masculine discourses that create Bateman lead to a chaotic and fractured sense of self.

The spatial figuration within the novel provides a framework in which the narrative voice can operate; yet, it alerts the astute reader to the impossibility of treating the narrative as a coherent structure. Bateman’s identity may be a case of masculine vernaculars piled on top of each other, but the reason that Ellis creates someone to represent these vernaculars-the motivation that drives the purpose of the novel-lies in Byers’s pomophobia. Bateman’s world is one in which his position is increasingly unstable, in which the form of masculinity he so desperately tries to portray as being his own is undergoing a swift and irreversible erosion.

In its most explicit form, Bateman’s fear of his own subjugation expresses itself through the violence he enacts on “others”; this loaded term is important here, as what Bateman sees as “other” is linked to the position of normative masculinity in the postmodern era. Women in particular, but also homosexuals, blacks, and other ethnic minorities, all suffer his wrath at some point; we have already established the unreality of these murders, so we can presume that Bateman singles these people out in his mind for a reason. From a quick glance at the list, it is obvious why: These are the groups who, in a postmodern society, find their place in the margins being brought into the center. To Bateman, the rise of the marginalized threatens his central position as hegemonic male; to protect that position, he lashes out, attempting to eliminate the threat. Zygmunt Bauman sees this kind of reaction as having a completely rational design: “Each order has its own disorders; each model of purity has its own dirt that needs to be swept away” (11). In Bateman’s order, that of normative masculinity, the people he hates are the “dirt” that threaten the “purity” of his own (albeit imagined) existence. His project becomes an extreme example of pomophobia, a reaction not built on irrationality, but something stemming from a deeply conservative mindset:

In the modern world, notoriously unstable and constant solely in its hostility to everything constant, the temptation […] to bring the perpetual change to a halt, to install an order secure against all further challenges, becomes overwhelming and very difficult to resist. (Bauman 11)

Bateman, in the face of “perpetual change,” imagines a world in which his masculine superiority can bring it to a halt. His wish, the wish of the language systems that created him, is to install an order that perpetuates their existence. As the threat to that existence increases, so, too, must the fight against it become more extreme: “[!Increased intensities of reaction in matters of the politics of gender and sexualities […] represent a set of deep and persistent fears on the part of a formerly dominant order that has begun to recognise that it is becoming residual” (Byers 6). There can be no more extreme and intense reaction to that change than the life imagined by Patrick Bateman.

Certain episodes that ElHs inserts into the narrative illustrate Bateman’s insecurity about his position in society. The novel’s opening chapter neatly compresses many of the themes that follow: In a taxi with Tim Price, Bateman observes a plethora of different people in the streets outside-beggars, transvestites, “some crazy fucking homeless nigger” (Ellis 6), and homosexuals. The casual racism, homophobia, and prejudice toward anyone who strays from the line of normative masculinity become a feature of the novel. Suzanne Hatty sees this distancing between the self and “other,” the viewer and the viewed, as a way for the self to project its own insecurities:

[T]he duality between self and Other reflects a hierarchical structure in which the self is valued over the Other [. . .] and in which the latter may be viewed as the repository of all that is negative, threatening, or devalued in modern Western society. (11)

Bateman’s world is one in which the “other” increasingly penetrates his sphere of existence; therefore, his reaction toward them needs to become increasingly hostile to maintain the distance. For Bateman to remain coherent, his unstable sense of self requires a particularly savage attack on the “other” and a clear idea of who they are. Everyone he “murders” presents some kind of challenge to his position of patriarchal supremacy.

The one group who presents the biggest threat to normative masculinity in the postmodern era, and the group toward whom Bateman concentrates much of his hostility, is women. Perhaps the defining aspect of the type of masculinity that Bateman represents is the subjugation of femininity, whether that femininity is embodied in women or, more disturbingly for those men, in themselves. Helyer has noted that Bateman’s carefully orchestrated grooming procedure “seems an incredibly ‘feminine’ pastime” (736), and on a more complex level, the relentless obsession with his own appearance reveals a deeply narcissistic side to him. A Freudian analysis of Bateman may be interesting in itself, and in terms of his narcissism, it poses a question often raised about the novel. Bateman’s relation to homosexuality is more complex than that-too complex, in fact, to elucidate in the confines of this essay. What these details perhaps show is Ellis’s desire to complicate Bateman’s misogyny by layering an unconscious femininity into his narrative.

Bateman’s relationships with women are all characterized by indifference, and at times hostility; he also assumes that all women are instantly attracted to him, even in love with him. When anything threatens to unsettle this prejudiced and arrogant view of women, his objectification of them is also shaken. Consider his reaction when he is shunned by an unimpressed barmaid with whom he attempts to flirt at a nightclub: “You are a fucking ugly bitch I want to stab to death and play around with your blood,” he says (or at least thinks) when her back is turned (59). At a dinner, Evelyn talks about marriage (123-26): The days when women were seen and not heard are gone, and Bateman once again threatens (actually or not) an outburst of violence. The presence of Bethany, an old girlfriend from university, and the news that not only is she extremely successful but she also has a platinum American Express card means “[v]iolent convulsions seem close at hand” (242). A couple of pages later, she becomes a “victim.” Moments in which his carefully groomed masculinity is ignored, or at least is made to take a passive, feminine position, fracture his deluded belief in the patriarchal ideology, and he lashes out. The self-fashioning of Bateman to which American Psycho is a testament is done in the unquestioning belief in hegemonic masculinity; its dismantling is also Patrick Bateman’s. His attempt to mold his secretary Jean into the image of cliched male fantasy (he tells her to wear a skirt and high heels [66-67]) reveals the extent to which he attempts to create his world to fit a masculine template.

Bateman’s associates also seem to hold a staggeringly chauvinistic opinion of women, obsessed with “hardbodies”-women with “blond hair and big tits”-and relating to them only in terms of their superficial attractiveness. Indeed, Bateman’s suggestion that a personality may matter is met with derision by Reeves: “A good personality [. . .] consists of a chick who has a little hardbody and who will satisfy all sexual demands without being too slutty about things and who will essentially keep her dumb fucking mouth shut” (91, emphasis in original). This attitude reveals a fundamental aspect of the way that the normative masculinity represented by Bateman and friends view women: a wish to objectify women in purely aesthetic terms and to deny them any interiority or autonomy that might threaten masculine superiority.

This denial of female interiority and insistence on their objedification leads to a consideration of the murky line that the novel treads between sex and death. Tim Price’s peculiar theory of sexually transmitted disease is particularly illuminating:

“Diseases!” he exclaims, his face tense with pain. “There’s this theory out now that if you can catch the AIDS virus through having sex with someone who is infected then you can catch anything, whether it’s a virus per se or not-Alzheimer’s, muscular dystrophy, hemophilia, leukemia, anorexia, diabetes, cancer, multiple sclerosis, cystic fibrosis, cerebral palsy, dyslexia, for Christ sakes-you can get dyslexia from pussy-” (5, emphasis in original)

Penetration, sex, compromises the integrity of the self, and in the modern era sex becomes the source of death-the biggest danger to the safety of men’s health become\s “pussy.” Women’s bodies are, therefore, the ultimate threat to men, the location of their downfall. For Bateman, the fear of sex equates women with death and legitimizes his destruction of women through violence. Women’s interiority in a metaphorical sense threatens men’s position as the dominant sex; their interiority in a literal sense, their bodies, threatens the existence of men. This explains Bateman’s determination to butcher their bodies; he does not simply murder women; he obliterates them, cuts them open, carves them up, eats their brains, makes nipples into necklaces, ties ribbons around vaginas. Normative masculinity’s objedification and fear of women’s bodies achieves its ultimate expression in Bateman’s fantasy of turning them into meat. In an analysis of the Marquis de Sade, Angela Carter expresses the primal reasoning that lies at the heart of this normative masculine instinct: “[T]he strong abuse, exploit and meatify the weak [. . .] the primal condition of man cannot be modified in any way; it is, eat or be eaten” (138).

We might usefully turn to another novel that deals with similar ground as American Psycho, albeit from a very different angle: Dennis Cooper’s Frisk. Like Ellis, who explores the challenges that postmodernity offers to the formation of normative masculine identity, Cooper, too, begins to explore the implications of the period for a different kind of male identity. The places to which he takes his fiction-to the forbidden boundaries of desire, death, and linguistic expression-probe the same territory as American Psycho.7 At first glance, however, Cooper’s work seems fundamentally different from Ellis’s: It deals exclusively with homosexual men, who, rather than being “victims” of postmodernity’s change, might feel emancipated by their mainstream acceptance and demarginalization. Except that presumes that Cooper’s primary concern is the politics of sexuality; in fact, he is more interested in maintaining an individuality that has nothing to do with any notion of a collective “gay identity.” The idea of becoming mainstream is exactly what Cooper seems to reject, and the lives that he portrays in his novels are as affected by pomophobia as are Ellis’s. Instead of a fear of becoming residual, they fear the assimilation of their often deviant individuality into the politically correct realm of postmodern society. Cooper has commented that he sees the traditional position of homosexual men as outsiders as a potentially positive thing: “[IJt’s stupid to think you’re ever going to be allowed into the main structure of anything. So there is a kind of freedom there” (qtd. in Nicolini). Completely unexpectedly and totally against the critical presumptions made about it, Cooper’s work becomes conservative: He resists the postmodern move toward normalizing all sexual practices and welcoming with open arms all previous outsiders into the happy new family of postmodern society. Cooper “does not feel the least bit ‘gay’ (in both senses of the word) [. . . his] emphasis is on being ‘queer'” (Nicolini); he wants to remain outside, on the periphery, a place in which his individuality can remain fundamentally “different.”

The plot is as fractured and blurred as one would expect from Cooper: We follow thirty years in the life of Dennis (who changes momentarily to Spit in his early twenties), from an impressionable thirteen-year-old coming to terms with his homosexuality and discovering the boundaries of his identity, through an explorative twenties, into an uncertain thirties. Throughout this time, a series of sexually violent photographs that he saw as a youngster haunt his actions and sexual proclivities and draw him farther and farther into the outer limits of society. A fascination with sexual death seems to manifest itself in a series of grizzly murders, recounted in a nineteen-page letter to his best friend Julian. It transpires, however, that the letter was fictitious, and we end where we began, with the photographs. Not so much a circle as a spiral; downward or upward is uncertain, but Cooper never flinches from showing us this murky world.

Thematically, the novel bears some remarkable similarities to American Psycho. As Bateman tore apart his female victims to reduce them to their constituent elements-blood and guts-so Frisk contains a similar element of male bodily fascination. The photographs that open the novel appear to show a young man stripped and tied to a bed, murdered, with his anus horribly mutilated. The narrator, Dennis we presume, finds the photos fascinating, not just for what they show, but for the tantalizing thing that they almost show. The obliterated anus seems to be a passage into an inner world: “At its center’s a pit, or a small tunnel entrance, too out-of-focus to actually explore with one’s eyes, but too mysterious not to want to try” (Frisk 4). Cooper captures the essence of his novel in one sentence: Life becomes “too out-of-focus” for Dennis, a spaced-out, semi-dream world in which reality and fantasy merge imperceptibly. In the places that this allows him to go, however, and the new areas of depravity that gradually open before him, he finds a freedom that no longer exists in his contemporary society. Cooper’s prose is awkward: full of et ceteras and ums and ers, sentences constantly drifting off into ellipses, a smudged and grubby style that reminds us that this new world is somehow incommunicable, existing outside of the capacity of language, and therefore requiring other ways of expressing its core truth. Elizabeth Young recognizes both the reasons for which and the place at which that core truth is sought:

It is as if stunned by years of postmodernism and all the endlessly circulating codes and signs and signifiers there is a sense of the body being the last frontier, an actuality that no amount of theory can disperse. (“Death in Disneyland” 238)

There is not the kicking out against the flow of change as there is for Ellis’s threatened males; the disaffected take flight for the margins and return to the only stable and constant source left to them, the human body. Byers’s belief that only the “traditional subject” is undergoing an identity crisis seems to be complicated by Cooper’s work: As gay men, Cooper’s characters already exist in contradistinction to the normative masculine subject-Bateman et al.- who are supposed to be the ones in crisis. Frisk shows that the cultural shift of postmodernity destabilizes all identities that oppose the changes that are taking place. The celebration of difference that we find at the center of postmodernity means that those who wish to remain different find then” place in the darkness being dragged into the light. When the center collapses (and collapse it does, as normative masculinity knows), the edges become the center. To deliberately exist outside the mainstream, one must cultivate new extremities of behavior. Cooper’s return to the body is the first step.

The response is not merely sexual exploration, however, but a need to understand the makeup of the body on a more profound level. Searching for something purer and more “real” than the flux of postmodern life, Dennis travels down the “small tunnel entrance” that he sees in the photograph into a world of such extremity that it ceases to be understandable through conventional logic. He claims to have “gotten totally removed from almost everyone now” (32); when explaining what his “type” is like, he reveals how and why that is:

My perfect type tends to be distant, like me. I don’t mean matter- of-fact, I mean shut tight. Like he’s protecting himself from other people or pain or both by excising himself from the world in every way, apart from obvius physical stuff you need to get by such as walk, talk, eat, etc. (36-37)

Dennis tries to be “shut tight” as a way of removing himself from the world-not the “physical stuff,” but the fear of postmodernity’s barrage of “codes and signs and signifiers.” The “etc.” in his list of physical stuff may well include sex and, therefore, the body; through them, Dennis tries to find his sense of the real. Cooper, however, realizes that although the expression of these “real” experiences can be made only through language, it is in language that their reality is lost. Expressing the truth of the body through language is impossible, making the body the source of something inexpressible. Dennis searches for a sense of individual identity in his obsession with the body, but ultimately the body cannot offer him that sense because its truths remain elusive. Explaining to another lover, Pierre, that he wants him to save his shit and piss in the toilet because “it’s [. . .] information” leads to a conversation about the photographs (69). Dennis tells of his reaction when he first saw them, saying he felt “enlightened”:

“Or maybe it wasn’t feeling at all, but shock or numbness or […]! don’t know. I think of it as religious. Like insane people say they’ve seen God. I saw God in those pictures, and when I imagine dissecting you, say, I begin to feel that way again.” (70)

The obsession with the body takes on pseudoreligious overtones, a search for the spiritual in the everyday. Dennis finds his desire to dissect and enter the human body almost impossible to articulate or understand, as if it exists in an otherworldly or spiritual dimension. Instead, Frisk suggests that those desires can be articulated only through fiction, that only in the unreal can the unspeakable be given a fixity that goes some way toward making it real. Bateman’s project is the same: His narrative has to be a fantasy to play out the extremities that he requires; only in the imagination can the project of normative masculinity achieve its ultimate realization-except it does not, because in these poststructuralist times the sign no longer equates with the signified. The meticulously crafted verisimilitude of the life that Bateman imagi\nes is the attempt to bring his fantasy into the realm of the real through language. It does not work, cannot work, and so causes Bateman to become trapped in the linguistic world of his own making-the famous “ABANDON ALL HOPE YE WHO ENTER HERE/THIS IS NOT AN EXIT” opening and closing lines. Dennis’s narrative attempts the same thing: He admits that the third part of the novel (“Torn”) is interspersed with fragments of an “artsy murder-mystery novel” that he has written, motivated by his “interest in sexual death” (40). This detail never allows us to place our faith in the details, forcing a conscious fictionality into our reading and emphasizing the impossibility of gaining access to the truth. Later, Dennis’s long letter describing the rape, torture, and murder of several young boys takes this a step further; he seems to have lived out the ultimate expression of his inner desires, except none of it is real and it turns out to be pure fantasy. When asked why he wrote it, his answer gestures at the same perpetual elusiveness we see in American Psycho:

“[B]asically I realized at some point that I couldn’t and wouldn’t kill anyone, no matter how persuasive the fantasy. And theorizing about it, wondering why, never helped at all. Writing it down was and still is exciting in a pornographic way. But I couldn’t see how it would fit into anything as legitimate as a novel or whatever.” (Cooper 123)

“Theorizing about it” is dismissed because it would reduce the experience to the rational, seeking to understand it through an inadequate language; however, Dennis’s admission that “writing it down” is “exciting in a pornographic way” shows that through language he has come closest to capturing the essence of the experience. He realizes, however, that this is not quite enough, and in a neat metafictional twist, he rejects the idea that it could all cohere into a novel. Cooper forces us to see Frisk as a work of ostensible pornography, causing us to ponder on the gap that such representation places between depiction and reality. Pornography plays a significant role in the novel: Gypsy Pete’s shop at which the young Dennis’s sexual awakening takes place, Pierre the porn star, and, of course, the pornographic photographs that frame the narrative. Pornography not only throws us back again to American Psycho, but it also points to Cooper’s central theme of the incapacity of language. Angela Carter says that pornography “involves an abstraction of human intercourse in which the self is reduced to its formal elements” (4): Dennis’s fantasies of opening up people, of turning them inside out, of consuming them (coprophilia makes an appearance, as does cannibalism) take Carter’s pornographic aesthetic to the next level: It abstracts the humanity of the people and turns them into meat, as Bateman did to his female victims. Dennis admits that he hoped that the letter would provoke someone to visit him, which would give him the courage to “actually kill somebody” (123). But it doesn’t. Instead, when Julian and his brother visit Dennis after reading the letter, they have sex with a boy called Chretien; when Julian asks Dennis if he is “maintaining,” meaning holding back the urge to kill, he replies, “Sure. Absolutely. But in my fantasies. . .” (120). The ellipses run off into a world that is indescribable, the more-real-than-real of pornographic dreams, and the world Dennis tried to articulate in his letter. And that’s the closest he’ll get: Language places a gap between the actual experience and its expression, abstracts it, and reduces it to its formal elements-and so never allows Dennis to get any closer.

The final chapter confirms this. The photographs that open the novel reappear, only this time the images are obviously fake: The body is “too tensed to be dead”; the boy’s expression “suggests an inexperienced actor trying to communicate shock”; and finally, the wound is “actually a glop of paint, ink, makeup, tape, cotton, tissue and papier-mch” (127-28). Images that introduced Dennis to a world that seemed commensurate with his aberrant desires are ultimately fake, mere pornographic constructions, the falseness of which undermines the belief in them that is needed for their power to remain. “[Y]ou can see the fingerprints of the person or persons who made it,” the novel concludes (128). The truth of the body, the key to a deviance that would allow Dennis to remain in the margins, turns out to be a lie. Cooper seems to suggest that postmodern society is so pervasive, so final in its assimilation of individualism, even the body has lost its integrity. The body becomes another simulacrom, untrustworthy and untenable as a location of reality. Dennis remains trapped (both the opening and closing chapters are titled “The symbol for Eternity”), spiraling in a world in which the signs of deviance point ever increasingly to the signifieds of normality. As individual masculinity seeks the unspoken areas outside the mainstream, the old reliable locations slip increasingly into a postmodern mainstream in which those margins are becoming narrower. Perhaps the only place left is the realm beyond expression, those margins in which language cannot hope to capture the experience-the darkness after the ellipses. Postmodernism leaves only those areas for deviance to exist, and yet individuals who wish to reside there are faced with the dilemma that their existence is incommunicable within our humanist world of reliable language.

We return full circle to Byers’s central point: The crisis of masculinity is so radical that our conventional ways of constructing identity are no longer relevant, and we arrive at a place in which gender and sexuality have to find new ways to conceptualize themselves. Ellis shows how traditional masculinity is as utterly constructed, as “pumped up by ideological steroids,” as Byers claims (27). In the nightmare world of American Psycho, Ellis critiques traditional masculinity in the most intense way possible, creating a character who, in his chaotic, hysterical perception of the world, lives out the final expression of a masculinity in its death throes.

Cooper offers us something a little less straightforward. As a gay writer writing about gay men, we might think that he would celebrate postmodernity; what we must always remember is that Cooper is a transgressive artist. Through his complex exploration of language, he takes us to the outer circle, the taboo, the hinterlands at the edge of the city; and there he wrestles with the difficulties of his transgression in the postmodern era. The postmodern move to fragmentation and instability means the redefinition of previous binary terms: abnormal becomes normal; disobedience becomes obedience. It destabilizes language and creates the paradox of Cooper needing to be conservative to remain transgressive; he expresses those dilemmas in his fiction.

Ellis opens his novel with an epigraph that comes, by way of W. B. Yeats, from a Talking Heads song: “And as things fell apart / Nobody paid much attention.” How apt that now seems to what Ellis and Cooper are attempting to do. They have written novels that pay attention to the difficulty of male identity formation at the end of the twentieth century, showing how the instabilities of language and the fear of things “falling apart”-pomophobia-both affect and redefine different types of masculine identity, whether those who represent an old order or those who are presumed to represent the new. Both see that new constructions of gender and sexuality are inherent in the changes that postmodernity brings and that men found (and are still finding) that the center can no longer hold. It becomes clear that in any “crisis of masculinity” that emerges because of these changes, fiction may still be the only arena in which the new complexities and ambiguities can most thoroughly be played out.

UNIVERSITY OF MANCHESTER

MANCHESTER, ENGLAND

NOTES

1. Customarily, any discussion of American Psycho seems to open with an account of the novel’s troubled publication. A good summation of those events can be found in Murphet.

2. Ed Gein was a notorious serial killer and cannibal discovered in Plainfield, Wisconsin, in 1957. The story has served as the loose basis for such films as Psycho (1960) and The Texas Chainsaw Massacre (1974) and inspired Thomas Harris’s The Silence of the Lambs (1989).

3. Directed by Brian De Palma (1984), the film is partly an homage to Alfred Hitchcock, as is American Psycho. Even Bateman’s name evokes the Norman Bates of Psycho.

4. Bateman mentions the titles of at least half a dozen porn films and admits to phoning a sex line (219).

5. Ellis knew about the clichs of music journalism; at Bennington, he wrote a regular music review column for the college magazine.

6. Bateman reveals his address to Detective Kimball as “Fifty- five West Eighty-first Street” (270).

7. Despite being as, if not more, disturbingly violent than American Psycho, Frisk barely raised an eyebrow on publication. Both authors have pointed out that violence by men against men seems more acceptable than violence by men against women.

WORKS CITED

Annesley, James. Blank Fictions: Consumerism, Culture and the Contemporary American Novel. London: Pluto, 1998.

Bauman, Zygmunt. “The Dream of Purity.” Postmodernity and its Discontents. Cambridge: Polity, 1997. 5-16.

Burr, Vivien. An Introduction to Social Constructionism. London: Routledge, 1995.

Byers, Thomas B. ‘Terminating the Postmodern: Masculinity and Pomophobia.” Modem Fiction Studies 41.1 (1995): 5-33.

Carter, Angela. The Sadeian Woman: An Exercise in Cultural History. 1979. London: Virago, 2000.

Caveney, Graham, and Elizabeth Young, eds. Shopping in Space: Essays on “Blank Generation ” American Fiction. London: Serpent’s Tail, 1992.

Cooper, Dennis. Frisk. London: Serpent’s Tail, 1991.

Ellis, Bret Easton. American Psycho. London: Picador, 1991.

Hatty, Suzanne E. Mascul\inities, Violence, and Culture. London: Sage, 2000.

Helyer, Ruth. “Parodied to Death: The Postmodern Gothic of American Psycho.” Modern Fiction Studies. 46.3 (2000): 725^6.

Murphet, Julian. Bret Easton Ellis’s American Psycho. London: Continuum, 2002.

Nicolini, Kirn. “Dennis Cooper’s Monster in the Margins.” Bad Subjects: Political Education in Everyday Life. 7 Apr. 2004. <>.

Simpson, Philip L. Psycho Paths: Tracing the Serial Killer Through Contemporary American Film and Fiction. Carbondale: Southern Illinois UP, 2000.

Sutherland, John. “Why Does Patrick Bateman Wear Two Ties?” Where Was Rebecca Shot? Puzzles, Curiosities and Conundrums in Modern Fiction. London: Phoenix, 1998. 138-44.

Young, Elizabeth. “The Beast in the Jungle, the Figure in the Carpet.” Caveney and Young 85-122.

_____. “Death in Disneyland.” Caveney and Young 235-63.

Copyright HELDREF PUBLICATIONS Fall 2005

NEW YORK (Reuters Health) – For overweight individuals known to secrete high levels of insulin, a diet low in sugar leads to greater weight loss than a diet high in sugar, investigators in Boston report. However, dietary sugar load or “glycemic load” makes no difference when insulin secretion is relatively low, according to the team.

These findings, the investigators note, “offer the first evidence that simple indexes of insulin secretion may help enhance weight loss success in overweight individuals through the use of targeted dietary recommendations specific for insulin secretion status.”

With insulin resistance, the body does not use the normal amount of insulin secreted by the pancreas properly, causing the pancreas to secrete more insulin.

Because both resistance to insulin and insulin secretion are involved in the regulation of body weight, Dr. Anastassios G. Pittas, from Tufts-New England Medical Center, and associates theorized that dietary glycemic (sugar) load could influence the effect of a diet designed to lose weight.

To test their theory, they assigned 32 healthy overweight adults to a high-glycemic load diet (glycemic load 116 g/1000 kcal) or a low-glycemic load diet (glycemic load 45 g/1000 kcal). Calories were restricted 30 percent compared with baseline individual energy needs for 6 months.

For those with high insulin secretion, the low glycemic load diet was associated with significantly greater weight loss than the alternative diet. Although the opposite pattern was observed among those with low insulin secretion, the results did not reach statistical significance.

The authors note that there are probably a number of mechanisms that could explain these results. High-glycemic load diets increase post-meal “hyperinsulinemia, which favors fatty acid uptake, inhibition of lipolysis, and energy storage leading to weight gain,” they note.

They also suggest that a high glycemic load may also increase hunger and thus increase eating during the postabsorptive period.

SOURCE: Diabetes Care December 2005.

By Nichola Groom

LOS ANGELES (Reuters) – Everything old is new again for
many of the best known U.S. brands.

From Walt Disney Co. to Anheuser-Busch Cos Inc. to Burger
King Corp., corporations are resurrecting decades-old mascots,
logos and slogans in a bid to cash in on consumer nostalgia for
the “good old days” and the craze for anything classic, vintage
or retro.

“People like to bring back the old stuff,” said Jack Trout,
president of marketing strategy firm Trout & Partners. “These
are all classic brands so they have a history … it is sort of
reintroducing the brand to a new generation, using the old
symbols.”

In the last year alone, Anheuser-Busch launched a series of
retro Budweiser cans, Yum Brands Inc. unit KFC revitalized the
name “Kentucky Fried Chicken,” and General Mills Inc. brought
back the Jolly Green Giant from a decade-long hibernation.

Kellogg Co. put vintage packaging designs on a new line of
cereal bowls, Peanuts characters like Snoopy and Charlie Brown
turned up on high-end T-shirts, and McDonald’s Corp. will
launch a vintage-inspired clothing line for young adults next
year featuring the chain’s old advertising themes and
characters.

Playboy Enterprises Inc. has tapped into the swinging
history of its adult magazine by putting retro images of its
bunny logo on items from clothing to martini shakers. In
Britain, a photo exhibit of Playboy images from the past 50
years is also tied in with luxury department store Harvey
Nichols, which will sell T-shirts featuring vintage Playboy
magazine covers.

Classic images of Mickey Mouse and other Disney characters
have also undergone a renaissance after the company in 2003
struck a deal to sell retro-Mickey T-shirts and other clothing
at the Los Angeles celebrity shopping haven Fred Segal.

RETRO-MICKEY

Since then, couture designers like Dolce & Gabbana have
also latched on to retro-Mickey, helping add $200 million to
the $1 billion in sales growth of Mickey products since 2003,
said Dennis Green, Disney Consumer Products’ creative head.

The aim of the revitalization, Green said, is twofold.

“Number one is to get Disney and the brand and its
characters cool, and the number two hope is that the mass
market will jump on it,” he said in an interview, adding that
nearly three years after appearing at Fred Segal, retro Mickey
products are now being sold at Wal-Mart Stores Inc.

Reinforcing a brand’s history and tradition is useful,
according to Trout, because it gives corporations a way to
stand out from the crowd at a time when the market is being
bombarded with cheaper, healthier or newfangled alternatives.

“These things stick in people’s minds,” Trout said.
“Heritage in a category is a very powerful differentiator.”

Levi Strauss & Co., where vintage details have been sewn
into everything from $500 premium denim to its more modest $39
518 jeans, is banking on just that.

“You see a lot of people coming to brands like ours for
nostalgic reasons, for simplification,” said Amy Jasmer, a
spokeswoman for privately held Levi. “There is so much in the
market, they don’t know which brand to choose.”

Budweiser’s limited edition series of three retro cans and
one bottle served a similar purpose.

“It reinforced the incredible heritage and quality that
only Budweiser can own,” Anheuser-Bush’s vice president of
brand management, Marlene Coulis, said in a statement.

The idea of heritage and tradition has also been key to
revitalizing the sales of some struggling brands, including
hamburger chain Burger King.

As part of a broad turnaround of the No. 2 burger chain,
Burger King in 2004 brought back its “Have it Your Way” slogan
30 years after it debuted.

“Even though billions of dollars have been spent on other
ad slogans, somehow ‘Have it Your Way’ continued to shine
through as one of the more indelible ad campaigns we ever
introduced,” said Russ Klein, Burger King’s chief global
marketing officer.

(Additional reporting by Alexandria Sage)

By Anthony Spangler, Fort Worth Star-Telegram, Texas, Fort Worth Star-Telegram, Texas

Dec. 18–The Tarrant County Medical Society says the JPS Health Network is shifting its mission from charity care to becoming the “hospital of choice” for insured patients, creating a two-tiered system that could leave many of the county’s poorest patients without care.

In a recent letter to JPS Chief Executive David Cecero, the society said the taxpayer-supported hospital has refused to accept some transfer patients from local hospitals and discourages treatment of the poor and uninsured by using a complicated application process.

“The safety net facility must behave like a safety net,” Dr. Gary Floyd, president of the medical society, wrote in the letter to Cecero. The letter is posted on the society’s Web site and is printed in the November issue of the society’s Tarrant County Physician magazine.

The letter was also signed by Dr. James L. Norman, who is chairman of a medical society task force on indigent care. Many of the concerns were raised by JPS physicians, Floyd said.

“No one expects JPS to take care of all of our charity care,” Floyd said in a recent interview. “The other nonprofit hospitals share that responsibility. But for our public hospital to deflect even a portion of their share is wrong.”

JPS is trying to attract more patients with insurance or the ability to pay to offset the rising cost of charity care, officials said. The network is increasing its patient admissions, emergency care and clinic appointments, and has posted more than $80 million in surpluses in the past two years.

JPS has used the cash to expand clinics and school-based programs, buy an Arlington hospital, and begin expansion of its Fort Worth hospital.

“Let me assure you that our mission and vision has not shifted, nor will it,” Cecero wrote in a response published last week in the society’s December magazine. “We understand our mission and we are proud of our role in the Tarrant County community.”

Harold Samuels, chairman of the JPS board, said a majority of the hospital board has supported Cecero’s efforts to increase the number of paying patients or those with insurance.

“We are never going to have enough money to serve all the people who need medical care,” Samuels said. “So if we can generate some dollars from paying patients, then we can provide more care to the indigent.”

Samuels said he wants to know about problems so they can be fixed.

“I understand those concerns were brought by our physicians and, perhaps, they felt like our administration wasn’t responding quickly enough to those concerns,” he said. “I would prefer that we learn about these things and address them before they are made public. But I don’t have a problem with the way we learned about these problems.”

Tarrant County commissioners, who appoint JPS board members and approve the network’s tax rate and budget, voiced support for the hospital district’s financial well-being and the services it provides to the community.

But at least one commissioner urged JPS to improve its working relationship with physicians. “A hospital can’t always be run like a business,” Commissioner Glen Whitley said. “Cecero still has to get better acquainted with a public hospital role and build a better relationship with physicians and other hospital chief executives.”

Seeking treatment

JPS patients qualify for the network’s free or subsidized health care, known as the Connection program, if they are legal residents of Tarrant County, do not have health insurance, are not already covered under a government program such as Medicaid, and have an income below 200 percent of the federal poverty level. Poverty criteria are affected by the number of family members.

JPS officials said they could not immediately provide the Star-Telegram with the number of Connection patients treated in the past year, but they released figures showing that 35,175 Connection patients were served during the 2004-05 fiscal year. About 27 percent of JPS patients are in the Connection program.

About 432,000 people in the Fort Worth-Arlington metropolitan statistical area lack health insurance, according to a report by the Texas comptroller’s office in April. The agency also reported that about 567,000 in the area fall below 200 percent of the federal poverty level.

Numbers were not available on how many people in Tarrant County qualify as both poor and uninsured.

“JPS Health system was established as our county’s public hospital and is charged with caring for patients without resources,” Floyd wrote in the letter from the doctors group. “But the number of patients enrolled in JPS Connection should be more representative of the eligible population. The system should be somewhat biased in favor of these patients.”

In the past year, the number of JPS’s poorest patients — those on Medicaid and in the Connection program — have declined 10.5 percent, while the number of patients with insurance rose 1.2 percent.

Medical society officials say JPS would reach more people if the application process were simpler.

JPS officials say the process can be daunting, but it is necessary because one application is used for Connection, as well for as state and federal programs. They say the process protects taxpayers by ensuring applicants are truly in need.

Patient Lucile Harmon was not overwhelmed by the necessary paperwork but said questions about how she spends her money were intrusive.

“It was easy,” said Harmon, 53, of Fort Worth. “But they want to know how you spend every dollar on food or this or that. “It seemed like they wanted me to prove that I really needed help. It was already difficult on my pride to go to the county hospital.”

Many indigent patients do not seek care until they have an emergency, pushing up the cost, JPS officials said. About 85 percent of patients admitted to the network’s John Peter Smith Hospital are first seen in the emergency room, officials said.

“If we could get more people enrolled in the system and get them treated at clinics, we wouldn’t have as many people seeing a doctor for the first time in the ER,” said Robert Earley, JPS senior vice president.

Some emergency patients are asked for cash deposits if they have not yet applied for the Connection program. The inability to pay does not delay emergency treatment, officials said.

“Unless it’s urgent, they will have to make an appointment,” said Gale Pileggi, JPS chief financial officer. “Patients should never be told they have to be screened before they receive services.”

The medical society letter also criticizes the network’s response to other hospitals that handle Connection patients, saying JPS has refused to accept transfer of some patients who have received initial treatment elsewhere.

The network is also slow in providing medical records of those patients who have been denied transfer, according to the letter.

JPS records show that the network accepts about 94 percent of transfer requests from area health facilities, with about half of the denials based on a lack of bed space.

“We have tried to find more rooms, but the demand just keeps growing,” said Ron Stutes, JPS chief operating officer. “Most of the time, we are at 105 [percent] to 108 percent capacity.”

When JPS does deny the transfer of a Connection patient, it can take up to two weeks for the treating hospital to obtain a copy of the patient’s medical records. JPS averages about 15 days to share patient medical records, in line with state standards, officials said.

“The problem has been that when JPS won’t take the patient back, they need to get the patient records to the other hospitals quicker,” Floyd said. “It would save money if you didn’t have to duplicate tests that might have already been performed at JPS.”

The network is in the process of developing a medical records hot line for other health care providers to request JPS patient records, JPS Chief Medical Officer Jay Haynes said. It is unclear when that system will be available.

Covering costs

The Connection program is not the only charity care provided by JPS. Most self-pay patients, who make up nearly 15 percent of the network’s caseload, are eventually written off as charity care as well, officials said.

“We collect only 1 [percent] to 2 percent of the charges from the uninsured, self-paying patients,” Pileggi said. “That is virtually no compensation, which we count toward charity care.”

The cost of uncompensated care provided at JPS during the 2004-05 fiscal year, which ended Sept. 30, was estimated at $271 million. The hospital district received $211 million from property taxes during that time.

The network’s financial data show that other public money offsets much of that shortfall. JPS received $72 million in federal funds for the 2004-05 year. That money — known as dispro funding — is given to hospitals that provide a disproportionate amount of care to low-income patients.

JPS, like other nonprofit health care providers, is exempt from paying property taxes and can receive charitable grants.

“I think it is disingenuous of JPS to portray charity care as a money-losing prospect since they receive property tax money and get dispro funds,” said Floyd.

JPS officials say paying patients help offset charity costs, because insurance companies reimburse for charges at a higher rate than governmental programs such as Medicare and Medicaid.

“With more insured patients, there is a reimbursement above cost for your services, with the extra cash intended for capital investment,” Pileggi said.

Thomas Marks, interim chief financial officer for the nonprofit University of Michigan Hospital in Ann Arbor, said insured patients are critical for the survival of public hospitals.

“Although most are not-for-profit, that doesn’t mean they don’t need to make money,” he said. “A hospital is a very capital-intensive business. It takes a large amount of money to afford new technology.”

Operating a hospital at peak capacity is key to keeping costs down, he said. “It is more efficient to keep your beds full,” Marks said. “And since the majority of U.S. citizens have health care through private insurance, it only makes sense to have a good mix.”

Airing concerns

Top executives at JPS admit the concerns raised by the medical society have merit, but they say better communication within the medical community could have prevented the issues from being overstated.

JPS has asked the medical society to create a position on its board for a JPS executive. “We don’t think publicizing their concerns was the best way to work these issues out,” Earley said.

Others praised the physicians for speaking up.

“The doctors who sent that letter to Cecero are very conservative and well-respected within the medical community,” said Dr. Wayne Williams, former head of community medicine at JPS.

“For them to air things publicly speaks volumes,” he said. “When doctors think their patients are being treated poorly, they speak up as patient advocates.”

Anthony Spangler, (817) 390-7420 [email protected]

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By Gardner, Marcia R

Germinal matrix-intraventricular hemorrhage, periventricular hemorrhagic infarction, and periventricular leukomalacia are common brain injuries in preterm infants that can have significant long- term influences on children’s development, physical skills, and cognitive functioning. Characteristics of preterm infants, including immature cerebrovascular autoregulation, fragility of blood vessels, and the presence of the germinal matrix, increase their vulnerability to neurologic injury. Grades I-II germinal matrix- intraventricular hemorrhage tends to have little-to-moderate long- term impact on cognitive and neuromotor development after the neonatal period, while more severe hemorrhage is associated with less optimistic developmental prognoses. Periventricular leukomalacia and ventriculomegaly in the neonate are associated with severe cognitive disabilities as well as with cerebral palsy. Neurodevelopmental strategies emerging from both the neonatal developmental care and early intervention models may have a place in the post-acute care of newborns who experienced these insults. Vigilant developmental screening and early developmental intervention are essential components of the follow-up nursing care for children whose medical histories include neonatal brain injury.

Children who experience non-transient neurological insults during the perinatal and neonatal period constitute an important group in pediatric nursing because they have significant health needs and consume many health and educational resources (Chan et al., 2001; Hack et al., 1994). The majority of children who experience perinatal/neonatal neurologic insults are born preterm (Volpe, 2001), and many are extremely low birth weight, extremely preterm infants (Fanaroff et al., 1995). See Table 1 for definitions commonly associated with gestational age and birthweight. A range of chronic and disabling conditions, including cognitive impairment, learning disabilities, psychiatric disorders, functional disabilities, sensory impairment, and mobility disorders are associated with the particular neonatal neurologic insults of intraventricular hemorrhage, ventriculomegaly, and periventricular parenchymal damage (Aziz et al., 1995; Hack et al., 1994; Jakobson, Frisk, Knight, Downie, & Whyte, 2001; Resnick et al., 1998; Volpe, 1998). As neonatal intensive care units continue to expand the boundaries of gestational age and birth weight survival (McCormick, 1997), nurses and other health care professionals may be caring for larger numbers of children with this history and with similar complex health conditions.

Physiologic Context for Outcomes

Childhood outcomes vary according to the severity and type of neonatal brain injury. These are briefly reviewed below to provide context for understanding outcomes in children who experience intracranial hemorrhage and/or brain parenchymal injury.

Intracranial hemorrhage. Intracranial hemorrhage (ICH) occurs in both term and preterm infants, although causative factors in these neonatal groups differ. ICH in the term infant is primarily a function of birth trauma, while ICH in the preterm infant can be trauma-related but is often a function of neurological and vascular immaturity. The majority of cases of neonatal ICH are seen in the preterm population, primarily because of obstetrical and neonatal clinical advances that have minimized birth trauma in term infants and have improved survival rates of low birth weight and preterm infants (Vohr et al., 2000; Volpe, 1998, 2001). Germinal matrix intracranial hemorrhage (GM-IVH) is both the most frequent neonatal ICH and the hallmark ICH of the preterm infant. Bleeding is believed to be a result of blood vessel fragility in the germinal matrix in combination with poor cerebral autoregulation, and the risk for GM- IVH decreases significantly after 32 weeks of gestation (Annibale & Hall, 2003).

The severity of intraventricular-periventricular hemorrhage (IVH- PVH) is determined by the presence of blood in the germinal matrix and ventricles demonstrated by cranial ultrasound scan. Table 2 summarizes the classic ultrasound grading scheme for IVH-PVH (Annibale & Hill, 2003; Papile, Burstein, Burstein, & Koffler, 1978; Perlman & Rollins, 2000). Grade IV hemorrhage is most severe and reflects hemorrhage into the brain parenchyma.

ICH rates are somewhat variable among neonatal centers, and are related to birth weight and gestational age of infants, as well as to population characteristics and treatment modes (Clark, Dykes, Bachman, & Ashurst, 1996; Synnes et al., 2001). A 1995 study found that about 34% of very low birthweight infants between 501 and 1,500 grams had experienced any ICH, and up to 18% had ICH findings of grade III and higher (Fanaroff et al., 1995); a recent review estimated the incidence of GM-IVH in very low birthweight infants to be around 20% (Roland & Hill, 2003). Smaller and less mature infants consistently demonstrate higher rates and severity of ICH (Vohr et al., 2000). Approximately 5 to 10% of infants with ICH will develop hydrocephalus, potentially resulting in further neuron degeneration, and in the need for surgical intervention and potential pulmonary, infection, and other complications (Chumas, Tyagi, & Livingston, 2001; Heep, Engelskirchen, Holschneider, & Groneck, 2001). Neurodevelopmental outcomes of infants needing surgical interventions, such as ventriculostomy and placement of ventricular shunts, are related to the severity of hemorrhage and resultant brain injury rather than to shunting or complications of surgery (Reinprecht et al., 2001). Ventriculomegaly without increased intracranial pressure is also associated with ICH. especially in infants with grades III and IV IVH-PVH, and ventriculomegaly is also a predictor of impaired developmental progress (Ment et al., 1999).

Table 1. Definitions Related to Birthweight and Age Used in Cited Neonatal Outcomes Studies

Strategies to prevent ICH. Prophylactic medications have shown promise for the prevention of grades III and IV hemorrhage in low birth weight, preterm infants. Both antenatal steroid administration and postnatal indomethacin administration have been evaluated (Fowlie, 1996: Ment et al., 1994; Ment et al., 1995). The mechanism by which these medications act to prevent IVH-PVH is unclear, although both agents appear to have blood vessel maturing and stabilizing effects (Ment et al., 1994; Ment et al., 1995), and indomethacin is known to mediate cerebral blood flow and prostaglandin function (Volpe, 1994). However, although a protective effect of indomethacin has been shown, studies are equivocal regarding its relationship to long-term neurodevelopmental functioning in these infants (Ment et al., 1994: Ment et al., 2004; Schmidt et al., 2001). Antenatal steroids have also demonstrated consistent effects for preventing IVH-PVH (Sehdev et al., 2004; Volpe, 2001). Yet, the main strategy for prevention of IVH-PVH continues to be atraumatic delivery of the infant and effective post- delivery regulation of physiologic status, especially oxygen and fluid status, in an effort to minimize deleterious changes in cerebral perfusion, vessel pressures, and oxygenation (Annibale & Hill. 2003).

Periventricular parenchymal damage. Periventricular hemorrhagic infarction (PHI) and periventricular leukomalacia (PVL) are the most common and potentially disabling brain parenchymal disorders in newborns. Periventricular leukomalacia occurs more frequently in preterm than in term infants, and periventricular hemorrhagic infarction is seen almost exclusively in preterm infants (Volpe, 1998, 2001). In the preterm population, PHI is seen in association with GM-IVH, and is characterized by hemorrhagic and necrotic damage to cerebral white matter (Volpe, 1998).

PVL in the preterm infant is associated with several perinatal and neonatal risk factors, including premature rupture of membranes, maternal chorioamnionitis, asphyxia, and GM-IVH (De Felice et al., 2001; Wu & Colford, 2000). PVL is characterized by severe focal and less severe diffuse cerebral white matter injury, including destruction of neurons in the periventricular white matter, diffuse destruction of oligodendrocytes, impaired myelination, decreased total cerebral white matter, and ventriculomegaly (Volpe, 2001). Over time, damaged areas of the brain evolve as cysts visible on ultrasound scan (Pierrat et al., 2001). Cystic PVL is a predictor of cerebral palsy (CP) (Dunin-Wasowics et al., 2000; Pinto-Martin et al., 1995: Wu & Colford. 2000).

Post-insult Outcomes

GM-IVH in the preterm neonate can result in damage to the neural precursor cells residing in the fetal germinal matrix, so long-term effects of ICH may be related to both immediate damage as well as inhibition of appropriate functioning of neural cells derived from the germinal matrix (Raz et al., 1994). Periventricular hemorrhagic infarction and periventricular leukomalacia involve both local and more diffuse permanent cerebral white matter injury (Volpe, 1998, 2001). Such neurologic insults can both profoundly and subtly influence children’s developmental trajectories and functioning over time. How and when the clinical manifestations of these insults become apparent depends on the severity and type of brain injury.

Early Developme\ntal Outcomes

Infants through preschoolers. Extremely low birthweight, extremely premature infants represent the population at greatest risk for GM-IVH and PVL (Volpe, 1998, 2001). Within this sub- population of preterm infants, one study found that approximately half of the sample had a neuromotor disability, and 10 to 20% manifested a severe developmental or other disability associated with neonatal brain injury by 30 months corrected age (Wood, Marlow, Costeloe, Gibson, & Wilkinson, 2000). In this population, complex parenchymal brain injury involving PHI and PVL is recognized as a significant predictor of severe developmental delay (Volpe 1998, 2001), commonly measured with standard infant developmental scales such as the Bayley Scales of Infant Development Mental Development Index (BSID-AADI) (Bayley, 1969), the Wechsler Intelligence Scales for Children (WISC) (Wechsler, 1991), and the Vineland Adaptive Behavior Scales (VABS) (Sparrow, Balla, & Cicchetti, 1984), among others.

Early developmental outcomes associated with less severe injury are more reassuring. In one study, developmental outcomes of LBW preterm infants with transient, low-grade (I-II) ICH ultrasound findings were similar to outcomes in infants without a history of any brain injury at age 1 year (Whitaker et al.,1990).

Hack et al. (2000) found 53% of a sample of 221 ELBW infants with Grade III or higher IVH had severe developmental delays at age 20 months, and 69% had some form of developmental impairment, defined as any cognitive, motor, or sensory problem. In this same study, 56% of infants with ventriculomegaly had severe delays, and 71% had any impairment; 63% of infants with PVL had severe delays, and 75% overall had an impairment. Additional studies have shown similar significant relationships among the lowest birthweights, lowest gestational ages, and complex brain injury, and between complex brain injury and significant neurodevelopmental impairments including cognitive and motor delays as well as cerebral palsy manifesting from infancy through preschool ages (Ment et al., 1999; Pierrat, 2001).

Specifically, in one of these studies, 74% of infants with PVL associated with small, localized cystic changes had signs of cerebral palsy by 24 months corrected age. Of the infants with extensive cystic PVL who survived past 40 weeks corrected age, 96% had signs of cerebral palsy by 24 months corrected age, and of these, less than 1% could walk independently by age 5 years (Pierrat, 2001). Table 3 summarizes additional details of studies of developmental outcomes from infancy through preschool age.

Later Developmental Outcomes

School-aged children. Developmental outcomes for school-aged children who experienced severe IVH in the neonatal period are similar to those for younger children with severe IVH – the more severe the IVH, the more severe the developmental impact and the higher the risk for severe mental retardation and cerebral palsy. The most sensitive predictors of sensory, cognitive, language, psychomotor, and academic functioning in early school-aged children, as in younger children, are birth weight and gestational age combined with cranial ultrasound findings (Hack et al., 1994).

Table 3. Developmental Outcomes in Infants, Toddlers, and Preschoolers

A study of 685 low birthweight 6-year-olds found that children whose cranial ultrasound scans in the neonatal period showed ventricular enlargement or parenchymal lesions had significantly higher risks of mental retardation and borderline intelligence than those without these lesions. Children whose ultrasound scans showed GM-IVH only were also at some increased risk for mental retardation and borderline intelligence (Whitaker et al., 1996). The group of children who had neonatal cranial ultrasound findings consistent with ventricular enlargement or parenchymal damage had a significantly higher prevalence of attention deficit-hyperactivity disorder (ADHD), tic disorder, and all psychiatric disorders than those without cranial ultrasound abnormalities or with only GM-IVH. Children with no cranial ultrasound abnormalities and those with a history of GM-IVH only did not differ relative to the prevalence of psychiatric disorders (Whitaker et al., 1997).

In this same sample, children of normal intelligence with ventricular enlargement or parenchymal lesions demonstrated poorer visual perceptual organization than did a comparison group without ultrasound abnormalities (Whitaker et al., 1996). Jakobson et al. (2001) also documented the relationship between the severity of IVH and/or PVL and increased visual perceptual deficits in a group of 6- year-olds born preterm with ELBW. Table 4 summarizes details of studies of developmental outcomes in school-aged children.

Overall, the presence of IVH on cranial ultrasound is a strong predictor of utilization of special education services (Resnick et al., 1998). Approximately 30% of children with any IVH have eligibility for special education services and demonstrate poorer school achievement than children without these Findings (Boyce, Smith, & Casto, 1999). Furthermore, in a recent study of adolescents born at 32 weeks gestation or younger, IVH-PVH was also strongly predictive of poor school performance and use of special education services (van de Bor & den Ouden, 2004). Overall, the severity of IVH is consistently related to greater developmental delay at preschool and school-age time points (Bendersky & Lewis, 1995; Boyce et al., 1999).

Table 4. Developmental Outcomes in School-aged and Adolescent Children

Summary of Clinical Outcomes

Extremely low birth weight, extremely preterm infants are at the greatest risk of all neonates for GMIVH, PHI, and PVL insults that can result in severely impaired neurodevelopment and cognitive functioning (Volpe, 1998). Children who had simple GM-IVH (grades I- II) tend to have less severe impairments than those who developed parenchymal lesions or ventriculomegaly as neonates (Hack et al., 2000; Whitaker et al., 1996). Some children who had GM-IVH have little or no developmental sequelae during infancy and early childhood (Whitaker et al., 1990), although it is possible that some developmental outcomes of grades I-H GM-IVH are so subtle that they are not identified on standard scales. In addition, other studies suggest that a variety of related impairments emerge later in the developmental trajectory (Boyce et al., 1999; Whitaker et al., 1996), and that cognitive problems persist at least through early adolescence. Children who as infants were found to have more extensive IVH (grade III or higher) are likely to demonstrate severe developmental delays during infancy and early childhood, and to demonstrate severe cognitive and perceptual disorders later.

Ventriculomegaly and PVL correlates found on cranial ultrasound in neonates are associated with severe developmental and motor delays, including disorders of muscle tone and clinically diagnosed cerebral palsy (Hack et al., 2000; Ment et al., 1999; Pinto-Martin et al., 1995; Whitaker et al., 1996). Increasing severity of PVL is associated with more severe neurologic abnormalities (Pierrat et al., 2001). Parenchymal brain injury is also associated with behaviors consistent with attention deficit-hyperactivity disorder and with other psychiatric syndromes in young school-aged children (Whitaker et al., 1997).

Nursing Issues for Mediating The Impact of Neonatal Brain Injury

The profound long-term effects of severe neonatal brain injury include cognitive, physical, and behavioral disabilities that ultimately stress parent, family, educational, and societal resources. If risks for neonatal neurologic injuries can be minimized, long-term outcomes should be reduced in frequency and severity as well. For infants who have already experienced neurologic insults, nurses can incorporate strategies for developmental enhancement and early detection of disabilities into assessment and care.

Developmental enhancement. Targeted developmental strategies that decrease environmental stressors and increase environmental supports (for example, “developmental care”) have been effective for improving physiological stability, increasing the rate of weight gain, and improving neurobehavioral outcomes in low-risk preterm infants without medical complications (Als et al., 1994; Buehler, Als, Duffy, McAnulty, & Liederman, 1995; Westrup, Kleberg, von Eichwald, Stjernqvist, & Lagercrantz, 2000). In addition, structured multisensory interventions, including auditory stimulation with a female voice, eye contact, stroking, and rocking, improved alertness in stable preterm infants with PVL, and improved oral nipple feedings promoted faster progression to discharge in preterm infants with IVH and/or PVL (White-Traut et al., 1999; White-Traut et al., 2002). Multisensory stimulation continuing to 2 months of age (corrected) resulted in a trend toward better neurodevelopmental status at one year of age, although infants with PVL had significantly worse mental development scores overall than those with simpler injury (Nelson et al., 2001). There is limited additional data on the use of developmental strategies specifically with brain-injured neonates during the convalescent period.

Interdisciplinary care. An interdisciplinary approach to care during hospital convalescence is essential for ensuring that functional status is maximized and for promoting the best possible discharge status for the infant. Nursing participation in the development and implementation of the interdisciplinary strategies and plan of care will ensure that all relevant information about infant status is incorporated, and that recommended interventions are implemented consistently. Parents should be educated about common behaviors and developmental needs of preterm infants and can be assisted to learn developmental care strategies, such as targeted stimulation, positioning, interaction, and fee\ding skills based on individual infant characteristics. Also, nurses are instrumental in reinforcing parents’ use of other therapeutic strategies recommended by the interdisciplinary team, and in helping them appreciate the progress that their infants have made. Families should be referred as appropriate to community-based resources including early intervention and home care programs.

Childhood screening. After the neonatal period, children who have experienced severe IVH or who have ventriculomegaly or periventricular leukomalacia will present with significant developmental delays during infancy. In addition to providing information and empathetic support, nurses can help families by referring these infants, even before disabilities are obvious, for developmental follow-up and multidisciplinary interventional therapies including community early intervention programs. Children who have medical histories that include simple GM-IVH should be screened carefully for subtle developmental, behavioral, or perceptual problems, as their impairments may manifest later and may not be as clear-cut or as obvious as those with more severe brain injuries. It is important to continue intensive developmental screening throughout childhood, as a range of perceptual, auditory, learning, or behavioral-psychiatric disabilities may develop later, even when infant and toddler developmental screens appear essentially normal. These more subtle disabilities can have a very significant effect on children’s social and school functioning. Children with these subtle challenges generally require special educational services and multi-disciplinary supports as well (Flanagan, Jackson, & Hill, 2003; Specht, 2004).

Outcomes research on infants who experienced neurologic insults at or after birth illustrates the vulnerability of the brain to injury and the lasting impact of this injury on function, behavior, and learning. These infants and children, especially those with the most severe sequelae of ICH and periventricular parenchymal damage, require large and potentially costly investments of time and resources in health care and education settings, as well as emotional investment from parents, caregivers, educators, and health professionals; the “costs” of these psychological investments are much more difficult to calculate. Any interventions that can reduce the degree of disability affecting these infants as they grow theoretically also should reduce burdens on families and society. Many of these infants will receive developmental interventions post- discharge through community early intervention programs, but it is unclear what role the consistent initiation of targeted developmental care prior to hospital discharge plays in reducing long-term disability and enhancing long-term cognitive, motor, and functional performance. In the short term, multisensory stimulation can promote behaviors necessary for functional adaptation in brain- injured preterm infants and can reduce the costs of neonatal care through earlier discharge to home (White-Traut, et al., 2002). More research in this area of nursing care is needed.

Conclusion

Children who previously received developmentally supportive care along the developmental care model (Als et al., 1994) during the neonatal period are reaching the ages for long-term developmental follow-up. Data should begin to be available to evaluate whether this model of care influences dimensions of childhood development in low-risk preterm infants. Extending this model by evaluating the long-term impact of basic developmental interventions on infants with IVH, PVL, and other neonatal brain injuries will provide additional information about the influence of predischarge nursing care on later developmental functioning. The use of an interdisciplinary approach to care, vigilant screening of children with a history of neonatal brain injury, parent education, and referral to appropriate services are important nursing strategies for identifying problems and initiating comprehensive programs of intervention.

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Marcia R. Gardner, MA, RN, CPNP, CPN, is Assistant Professor of Nursing, Drexel University, and doctoral candidate, University of Pennsylvania School of Nursing, both in Philadelphia, PA.

Acknowledgment: Part of this work was funded by NIH Grant 5T32NR07100-04: Research on Vulnerable Women, Children, and Families.

Copyright Anthony J. Jannetti, Inc. Nov/Dec 2005

By Ewing, Whitney Merrill; Allen, Patricia Jackson

Cow milk protein intolerance (CMPI) affects 3% of infants under the age of 12 months and is often misdiagnosed as GERD or colic, risking dangerous exposure to antigens. Most infants out grow CMPI by 12 months; however, those with IgE-mediated reactions usually continue to be intolerant to cow’s milk proteins and also develop other allergens including environmental allergens that cause asthmatic symptoms. Clinical manifestations of CMPI include diarrhea, bloody stools, vomiting, feeding refusal, eczema, atopic dermatitis, urticaria, angioedema, allergic rhinitis, coughing, wheezing, failure to thrive, and anaphylaxis. The research and literature showed that CMPI is easily missed in the primary care setting and needs to be considered as a cause of infant distress and clinical symptoms. This article focuses on correctly diagnosing CMPI and managing it in the primary care setting.

The advent of pasteurization and improved hygiene in farming over the last 100 years has led to the dramatic increase in consumption of cow milk-based products by infants and breast-feeding mothers (Brown, 2002). Despite the numerous health benefits of milk, there are potential detrimental effects, such as gastrointestinal complaints, colic, eczema, rhinitis, asthma, and anaphylaxis (Lake, 2001; Nocerino & Guandalini, 2003). The health risks are no surprise since cow’s milk was not intended for human infants. Two conditions that explain these symptoms are cow milk protein intolerance (CMPl) and cow milk allergy (CMA). Both involve the body’s inability to digest the cow milk protein (CMP), but they are differentiated by the body’s immune response. The literature cites CMPI occurring in 2 to 15% of infants with CMA, accounting for 53 to 64% of these cases (Anderson, 1997; Nocerino & Guandalini, 2003; Vanto et al., 2004). Actual occurrence of CMPI in developed countries is likely around 3% of infants under a year of age (Salvatore & Vandenplas, 2002).

Due to the varied clinical symptoms, there is often a delay in diagnosis, and symptoms can progress to bloody diarrhea, anemia, dehydration, poor growth, and failure to thrive (Lake, 2001). CMPI is responsible for 50 to 80% of gastrointestinal symptoms in children under one year of age (Nocerino & Guandalini, 2003). There is evidence that CMA is a precursor for childhood and adult diagnoses of asthma, environmental and food allergies, and reflux disease (Brown, 2002; Hill, Heine et al., 2000; lacono, 1996). Knowing this, it is imperative that pediatric nurse practitioners know how to recognize and treat CMPI so that symptom progression and failure to thrive are prevented, and the source of future allergies is stunted (Isolauri & Turjanmaa, 1996).

CMA is differentiated from CMPl by elevated levels of IgE specific antibodies (Heine, Elsayed, Hosking, & Hill, 2002). Non- IgE mediated CMPI may cause elevated T-cell levels, and does not have the same long-term adverse effects of CMA. Clinically, it is impossible to diagnose CMPI versus CMA, and they are often discussed and treated without differentiation since the immunologic basis of the involved mechanism often is not determined (Salvatore & Vandenplas, 2002). For the purpose of this article, the term CMPI will be used to refer to both conditions unless CMA is specifically mentioned.

Pathophysiology

A useful framework for understanding CMPI is the body’s immunologic response to cow milk protein (CMP) as described by Brown (2002). Brown diagrams how each system of the body is in contact with ingested CMP through the blood and extracellular fluids ( see Figure 1). Based on this, it is not surprising that CMPI manifests in several body systems. It is therefore important to treat CMPI and not just specific symptoms.

Immunologic Response. The protein in cow’s milkbased formulas acts as an antigen in the sensitized infant’s body, and in the case of CMA, stimulates the production of IgE antibodies. CMPI occurs when large molecules, such as intact CMP, pass thru the infant’s permeable gastrointestinal (GI) tract and are absorbed rather than broken down (Cirgin Ellett, 2003). As the infant’s GI tract matures, the lining also matures, and fewer proteins get through, resolving the CMPI symptoms and reducing the production of IgE.

Pathophysiology. The difference between CMPI and CMA lies in the antibodies. CMA reactions are mediated by immunoglobulin E antibodies (IgE). CMPI reactions are similar but have no IgE component. When an allergic infant is exposed to milk protein, either prenatally or post natally. his or her body makes more IgE antibodies to the cow milk protein than a nonallergic infant. These IgE antibodies connect with mast cells in the skin, the gastrointestinal tract, and the sinopulmonary tract (Burks. 2003; Sicherer, 2003). With continued exposure, the affected mast cells release mediators that cause the signs and symptoms of an allergic reaction (Brown. 2002; Hill, Heine, Cameron, Francis. & Bines. 1999; lsolauri & Turjanmaa. 1996; Lake. 2001; Odze, Wershil, Leichtner, & Antonioli. 1995). IgE food reactions are usually caused by milk, eggs, peanuts, tree nuts, soy, wheat, and seafood (Sicherer. 2003). Providers recommend to parents to avoid these foods in the first year and some foods until after the second year because of their potentially highly allergic status. However, milk proteins are in all of the first line formulas and may be in the pregnant/breast- feeding mother’s diet therefore, they are harder to avoid completely. Clinical tolerance to milk, eggs, wheat, and soy usually develops within a few years of diagnosis, despite continuing presence of IgE antibodies to the allergenic foods (Anderson. 1997).

Figure 1. Effect of CMP on Sensitized Infants

Stages of CMPI. Researchers have categorized three stages of CMPI associated with severity of reaction; and immediate, intermediate, and late stage reactions to CMP (Heine et al.. 2002). Within 30 minutes, the immediate stage shows signs of urticaria (skin rashes, perioral erythema), angioedema of the face, and or anaphylaxis. accompanied by CMP IgE antibodies (Dupont & de Boissieu. 2003: Heine et al., 2002). The intermediate stage is a non IgF sensitized reaction, and gastrointestinal symptoms develop within hours post contact/consumption of CMP (Dupont & de Boissieu, 2003; Heine et al., 2002). The late stage reaction has gastrointestinal symptoms with or without respiratory or cutaneous symptoms, and develops one to five days post contact or consumption (Dupont & de Boissieu. 2003; Heine et al., 2002). IgE involvement in the late stage is uncertain.

Urticaria and angioedema are immediate reactions to CMP: atopic dermatitis, infantile colic, gastroesophageal reflux, esophagitis, infantile proctocolitis, food-protein enterocolitis. and constipation are all intermediate and late-onset reactions (Dupont & de Boissieu, 2003). The literature does not mention whether infants can progress from one stage to the next, but it does indicate that early atopy can progress to asthma later in life.

Clinical Manifestations

Symptomatically, there is no difference in the way CMPI and CMA present, and it is important to refer to allergy or gastroenterology for diagnostic testing if symptoms are severe (Brown. 2002: Heine et al., 2002; Klish et al., 1998; Lake, 2001; Odze et al., 1995; Salvatore & Vandenplas, 2002). Providers need to be aware that infants with CMPI may present with gastrointestinal symptoms only, cutaneous symptoms only, respiratory symptoms only, or anaphylaxis in the rare case, and any combination of all four systems. CMPI symptoms usually begin by one month of age or within one week of starting a CMP based formula (Dupont & de Boissie. 2003), up to 42% of infants with CMPl are symptomatic within 7 days of starting a cow’s milk-based formula (Nocerino & Guandalini, 2003). For a full list of potential symptoms, see Table 1.

Symptoms suggestive of CMH in breast-fed babies are similar to those seen in formula-fed babies (Brown, 2002). Because there is less CMP in breast-milk than regular formula, if the breast-fed baby is symptomatic, it has a high degree of sensitivity, increased likelihood of CMA, and greater potential for long-term sequelae (Brown, 2002).

Table 1. Common Symptoms of CMPI

Gastrointestinal Manifestations. Gastrointestinal (QI) symptoms are the most common symptom of CMPI, presenting clinically 58 to 80% of the time (Dupont & de Boissieu, 2003; Nocerino & Guandalini, 2003). GI symptoms commonly present alone (Nocerino & Guandalini, 2003). Diarrhea, bloody stools, nausea, vomiting, constipation, and feeding refusal make up the GI symptoms associated with CMPI (Heine et al., 2002; Hill, Heine et al., 2000; Iacono, 1996; lacono et al., 1998; Nocerino & Guandalini, 2003; Salvatore & Vandenplas, 2002; Sicherer, Eigenmann, & Sampson, 1998; Vanderhoof et al., 1997). With CMPI, nausea and vomiting typically occur within minutes or hours after food ingestion, followed by diarrhea. Left untreated, diarrhea can progress to bloody diarrhea. CMPI is the most common cause of bloody stools in infants.

Cutaneous Manifestations. Eczema and atopic dermatitis, urticaria, pruritus, and angioedema are the main skin reactions associated with CMPI and occurin 50 to 60% of infants with CMPI (Burks, 2003; de Boissieu & Dupont, 2000; Heine et al., 2002; Hill, Sporik, Thorburn, & Hosking, 2000; Isolauri & Turjanmaa, 1996; Salvatore & Vandenplas, 2002). Eczema describes a generic inflammatory skin condition characterized by erythematous, itchy, potentially infected skin lesions. It may or may not have an allergic cause. Atopic dermatitis, also known as atopic allergy, describes eczema caused by an allergen. It is one of the symptoms of atopy, an allergic, hereditary disorder characterized by hay fever, asthma, chronic urticaria, and atopic dermatitis. Differentiation between eczema and atopic dermatitis is done with radioallergosorbent testing.

Eczema before the age of 4 months has been found to be associated with allergy to several foods (de Boissieu & Dupont, 2000). “Eczema or urticaria on contact with spilt milk is a clear indication that milk is the cause, but this is rare” (Brown, 2002).

Table 2. Differential Diagnosis for CMPI in the Infant

Respiratory Manifestations. CMPI-associated respiratory symptoms occur in 20 to 30% of sensitive infants, usually develop after infancy, and are considered a sign of further IgE sensitization (Brown, 2002). Allergic rhinitis symptoms are indicative of upper airway involvement, and asthma is indicative of lower airway involvement (Anderson, 1997). A cough or wheeze that develops while on a cow’s milk-containing diet, or after rechallenge with cow’s milk, are considered allergy-related respiratory symptoms (Heine et al., 2002).

General Manifestations. General symptoms of CMPI . are anaphylaxis and failure to thrive. Anaphylaxis related to CMP is very rare (Anderson, 1997; Heine et al., 2002; Salvatore & Vandenplas, 2002; Taubman, 1988). When anaphylaxis occurs, the child becomes pale, cool, and perspires; and has urticaria and angioedema progressing to shock within minutes (ISocerino & Guandalini, 2003). Anaphylaxis happens within minutes of ingesting CMP.

Failure to thrive (FTT) can result from serious, untreated CMPl (Brown, 2002; Field, 2002; Hill et al., 1999; Isolauri, Siitas, Salo, Isosomppi, & Kaila, 1998; Isolauri, Tahvanainen, Peltola, & Arvola, 1999; Salvatore & Vandenplas, 2002; Wyllie, 1996). As infants refuse food, absorb fewer nutrients, and have prolonged vomiting and diarrhea, their height and weight may drop down several growth percentiles.

Differential Diagnosis

Gastroesophageal reflux disease (GERD) and colic are the main differentials of CMPI in infants less than 12 months old (Anderson, 1997; Lucassen et al., 1998; Nocerino & Guandalini, 2003; Sicherer, 2003). CMPl, GERD, and colic present similarly and are often misdiagnosed. Other less likely differentials are included in Table 2.

Gastroesophageal Reflux. The research reveals that CMPI is found in up to 50% of infants diagnosed with gastroesophageal reflux (GER) (Salvatore & Vandenplas, 2002). GER is defined as the involuntary passage of gastric contents into the esophagus and is classified as either primary physiologic, primary pathologic, or secondary GER (Salvatore & Vandenplas, 2002). usually, there are clinical manifestations in only one system of the body (GI) with primary GER. If more than one system is involved (GI, cutaneous, or respiratory), it is more suspicious of primary CMPI. Secondary GER is known in the literature as GER disease (GERD), and CMPI is often its causative agent (Salvatore & Vandenplas, 2002). Vomiting and irritability seen in CMPI is sometimes mistaken for the vomiting and irritability often seen with GERD. However, the infant will have relief of symptoms when CMP is removed from the diet. CMPI often precedes gastrointestinal problems and should be ruled out as the underlying pathology of GERD (Staiano et al., 1995). Table 3 lists the symptoms of GERD, CMPI, and their overlap. As with CMPI, GERD improves with age; 98% of infants with GERD have no symptoms by two years of age (Salvatore & Vandenplas, 2002).

Figure 2. CMPI Tolerance Development in Infants

Intestinal permeability tests, β-lactoglobulin antibody presence, and pH tracings can help with GERD-CMPI diagnosis, but they are costly, time-consuming, and have variable reliability. Clinical response to an elimination diet is the safest and most frequent diagnostic clue for CMPI-associated GERD. If symptoms persist, then treatment directed at GERD is indicated (Salvatore & Vandenplas, 2002).

Colic. About 20% of infants have colic in the first four months of life. Of these, 10 to 35% are caused by CMPI (Anderson, 1997: Cirgin Ellett, 2003). Colic is defined as irritability lasting for a total of more than three hours a day and happening more than three days per week for three weeks in an otherwise healthy infant. Along with persistent crying, infants with colic are less able to be soothed and are restless. According to the literature, there are at least five possible causes of colic: CMPI and soy protein allergy/ intolerance: immature gastrointestinal system; immature central nervous system; difficult infant temperament; and parent-infant interaction problems (Cirgin Ellett, 2003). Unless there are other symptoms consistent with CMPI, it is difficult to clinically determine CMPI involvement in colic. Cirgin Ellett (2003) found 10 to 35% of infants studied with colic improved after cow’s milk or soy protein was removed from the infant or breast-feeding mother’s diet. The only way to conclude CMPI is the cause of colic in an infant is through a trial CMP elimination diet. If the infant improves, CMPI is the likely cause of colic.

Prognosis

CMPI affects infants from birth to one year, and those at greatest risk have a history of CMPI or atopic disease in their family (Klish et al., 1998). When a child develops tolerance to cow’s milk depends on the severity of the initial reaction. Children whose initial reaction is limited to cutaneous symptoms, such as contact urticaria around the mouth or simple hives, usually develop tolerance to CMP earlier than children who initially react with anaphylaxis (Anderson, 1997). CMPI usually spontaneously resolves by one to three years of age (Brown. 2002). Reports vary, but between 15 to 50% of CMPI infants are tolerant of cow’s milk protein by one year, and 90% by three years of age (Vanto et al., 2004). When GI symptoms present alone, total resolution of CMPI can be expected (see Figure 2) (Dupont & de Boissieu, 2003).

Once sensitized to CMP, even through breast feeding, an elimination diet does not reverse sensitization that has developed into allergic disease (Isolauri & Arvola, 2000). Early IgE antibodies to CMP is an indicator for possible other food allergies persisting into childhood and adult life, as well as developing asthma and rhinoconjunctivitis (Dupont & de Boissieu, 2003). About 10% of infants with CMA go on to have CMA in their adult life (Dupont & de Boissieu, 2003).

In infants thought to have CMA, low-allergen solids (for example, rice cereal, apples, pears, potatoes, and pumpkins) are usually well tolerated at six months of age, but highly allergic foods (such as eggs, milk, peanuts, soy) should be delayed until the second year of life (Heine et al., 2002).

Diagnostic Testing

The main reason to determine allergy verses intolerance is so that parents and providers can have epinephrine on hand in the event of an anaphylactic reaction to an accidental exposure (Anderson, 1997). Differentiating will also help predict infants who will outgrow the intolerance and those who will go on to develop further allergies. Because it is less costly and time consuming to simply switch the infant formula and wait to see if the infant becomes tolerant at one year of age. testing is often delayed until one year of age.

It is the allergic gene that gets passed on, not specific allergies, so it is important to discover if there are any allergies in the family to food, the environment, or medications. This and the infant feeding history are helpful in diagnosis (Brown, 2002). Families with multiple food allergies are more likely to have infants with CMPI, and atopy in the family is a strong predictor for CMA (Anderson, 1997; Brown, 2002; Sicherer, 2003).

Diagnostic testing for CMPI and CMA should be done by an allergist if the infant has significant symptoms, does not respond to treatment, or has a strong family history of allergies. If CMPI is suspected, a referral should be made to a local allergy clinic. Tests likely to be done include radioallergosorbent testing (RAST), skin prick testing (SPT), atopy patch testing (APT), and double- blind placebo controlled food challenge (DBPCFC).

The definitive test for CMPI is the double-blind placebo controlled food challenge (DBPCFC) that must be done in a provider’s office or hospital over several hours (Heine et al., 2002). It is very costly, takes a lot of time, and places the infant at risk for further sensitizing and anaphylaxis. For these reasons, it is not used very often in infants. The other options for diagnostic testing include screening for specific serum IgE antibodies (RAST), SPT, and AFT. These tests have limited value on their own and are used in combination to diagnose CMPI and CMA.

Clinically, diagnosis is made when symptoms improve with a CMP- free diet, and two or more challenge tests reproduce the symptoms. If atopic disease develops, along with proctitis and proctocolitis, further testing for IgE antibody involvement is indicated (Sicherer, 2003). In the presence of suspected CMP-related anaphylaxis, a presumptive diagnosis of CMA is generally preferred to testing that will further expose and sensitize the infant, but an allergy referral is needed regardless (Anderson, 1997). This diagnosis can be made based on a consistent history of food anaphylaxis and a positive RAST test for allergen-specific IgE antibodies (Heine et al., 2002).

Table 3. CMPI and GERD Manifestations Compared

Tests not normally used but that are occasionally helpfulinclude fecal leukocyte testing, upper endoscopy, colonoscopy, and colon biopsy. If fecal eosinophils are found, they are a diagnostic clue for allergic colitis (Nocerino & Guandalini, 2003). upper endoscopy is helpful in the diagnostic work up of esophagitis and in children presenting with symptoms of enteropathy. If the child has lower GI bleeding (colitis, proctitis), a colonoscopy is helpful. If CMP is the cause, the test will show linear erosions and mucosal edema (Nocerino & Guandalini, 2003). Biopsy can also help determine the cause of GI signs and symptoms.

Management

The specific treatment approach used is modeled after a clinical care pathway (Brown, 2002; Currie & Harveyk, 1998; Rohrbach, 1999). The clinical care pathway is useful in this situation because it combines multidisciplinary interventions aimed at agreed upon goals for the child. Pediatric care has been divided into many sub- specialties and it is important to follow a uniform approach. The clinical management issues will be supported by the research evidence and the critical pathway model (Rohrbach, 1999). The nurse practitioner (NP) coordinates care with an allergist, and possibly nutritionist, gastroenterologist, and dermatologist.

The primary treatment for CMPI is restricting milk and milk products from the diet (Anderson, 1997). Avoiding CMP is important because it allows the intestinal lining to heal and prevents further CMP antigen absorption through the gut (Dupont & de Boissieu, 2003). This is done by either breast-feeding mothers restricting milk and milk products from their diet while breast-feeding, or replacing the cow’s milk based formula with soy-based formula, extensively hydrolyzed formula (eHF), or amino acid formula (AAF). Symptoms should resolve within 2 to 4 weeks. In infants with CMPI, it is best to also avoid eggs, milk, peanuts, tree nuts, fish, and shellfish for the first two years of life. This includes exclusion from the breast-feeding mother’s diet (Nocerino & Guandalini, 2003; Sampson, 2003). The infant’s presenting symptoms as well as breast-feeding status must be taken into consideration when determining which formula to use in the elimination diet.

Breast-feeding. Breast-fed infants are not immune to CMPI. CMPI in exclusively breast-fed infants has a prevalence of 0.37% (de Boissieu, Matarazzo, & Dupont, 1997). Exclusively breast-fed infants are sensitized to CMP through dietary antigens in the breast milk from the mother’s diet (Isolauri & Arvola, 2000). It is rare because there are so few CMP antigens present in breast milk. Though rare, the incidence of CMPI in breast-fed babies has increased in the past two decades coinciding with increased numbers of breast-fed infants (Isolauri et al., 1999). A recent study showed that children with persistent CMPI past the age of four years were breast-fed longer than those who became tolerant, regardless of atopic family history (Vanto et al., 2004). It was suggested that there are cellular, cytokine, or other components in breast milk that increase the persistence of CMPI. There are no other reports of this and further study is needed.

Breast-feeding remains the best source of nutrition for infants and should be encouraged. The only treatment as the child continues to breast-feed is complete avoidance of CMP in the mother’s diet. Infants are most likely to be allergic to cow’s milk; however, egg and peanut allergies also begin in infancy with less frequency. It is therefore best for the mother to seek allergist and nutritionist counseling concurrent with a structured elimination diet to avoid depleting important nutrition during lactation (Isolauri & Arvola, 2000).

When determining if an infant should continue to be breast-fed, four factors must be considered: infant growth, nutrition, clinical symptoms, and the mother’s perceived benefit and ability to maintain the elimination diet. A study conducted by Isolauri et al (1999) determined that breast-fed allergic infants’ growth with an unrestricted diet was slower, first in length and then weight, compared to expected growth for breast-fed infants at the same age. Infants breast-fed during CMP-elimination diets showed similar growth restrictions, as well as general nutritional inadequacy. The study measured the levels of albumin, prealbumin, urea, zinc, and alkaline phosphatase during breast-feeding and after. The levels improved with cessation of breast-feeding, correlating with resolution of atopic eczema and improved growth. In fact, the longer the infants were breast-fed while symptomatic, the more significant their decreased growth and nutrition. The study also found that more mothers considered the elimination diet (either of a single food, milk, and milk products only; or milk, milk products, and cereals) more difficult and demanding than it was helpful to their infant. The study concluded that if allergic symptoms and normal growth cannot be achieved while breast-feeding on an elimination diet, it is not recommended to continue breast-feeding (Isolauri et al., 1999). Another study found that breast-fed infants with GI and cutaneous symptoms did not have symptom resolution with the mother’s CMP elimination diet (Lake, 2001). For these reasons, it is important to consult with an allergist and nutritionist when putting a breast-feeding mother on a CMP-elimination diet.

Formula. There are three categories of formula used for infants with CMPI: soy-based formula, eHF, and AAF. Clinical presentation often indicates which formula should be used. The standard formulas used (Similac, Enfami, Good Start, and store brands) use cow’s milk protein, casein, or whey, which cannot be part of an elimination diet (Morrow, 2004). Extensively hydrolyzed formula (eHF) and AAF are the only formulas that meet hypoallergenicity standards (Salvatore & Vandenplas, 2002).

Soy-based formula. Soy-based formulas (including Enfamil Prosobee, Similac Isomil, and Good Start Soy) are the first-line treatment for CMPI infants (Morrow, 2004). According to one study, soy-based formula is better tasting and less expensive than eHF (Anderson, 1997). Soy-based formula is well tolerated in most CMPI infants. However, it is not tolerated by all infants with CMPI. In the general population, soy intolerance occurs in about 1.1% of all infants (Salvatore & Vandenplas, 2002). Among infants with CMPI, soy- based formula intolerance ranges from 10 to 35% (Dupont & de Boissieu, 2003; Salvatore & Vandenplas, 2002). The American Academy of Pediatrics (AAP) finds that soy intolerance increases up to 60% if the infant has CMP-induced enterocolitis (for example, bloody diarrhea, ulcerations, and evidence of inflammatory bowel disease) (American Academy of Pediatrics [AAP], 1998). A study done in 2003 states it is more common for CMPI infants without IgE involvement to be intolerant of soy (Dupont & de Boissieu, 2003). Infants with IgE involvement (CMA) are likely to tolerate soy-based formula. Age is a contributing factor; infants less than six months are less likely to tolerate soy formula, while infants with CMA who are older than six months are more likely to tolerate soy formula (Salvatore & Vandenplas, 2002).

Soy intolerance is more likely if the infant is younger than six months, has a family history of atopic disease (for example, asthma, allergic rhinitis, or eczema), presents with severe GI symptoms (including bloody diarrhea), and/or has non-IgE associated CMPI (Dupont & de Boissieu, 2003; Lake, 2001; Salvatore & Vandenplas, 2002). The pediatric nurse practitioner (PNP) must decide whether or not to use soy formula based on the incidence of soy intolerance in the literature, infant age, clinical presentation, and likelihood that immunologic differences between CMPI and CMA have not yet been determined.

Table 4. Web Sites for Family Referral

Extensively hydrolyzed formula. The second-line formulas for treating CMPI are extensively hydrolyzed formulas (eHF). eHFs such as Nutramigen, Progestimil, and Alimentum are made with casein, a CMP that has been processed to become “hypoallergenic” (Morrow, 2004). eHF is tolerated by about 90% of infants with CMPI (CMA included) (Salvatore & Vandenplas, 2002). Conversely, it is estimated that about 10 to 19% of infants with CMPI are also sensitive to eHF (D de Boissieu et al., 1997; Heine et al., 2002). Infants who do not tolerate eHFs are more likely to have several other food allergies and tolerance of CMP develops later than one year of age (Dupont & de Boissieu, 2003). Infants unresponsive to eHF are treated with AAF.

Amino-acid based formula. Those with severe CMPI will probably respond best to AAF (Anderson, 1997; Dupont & de Boissieu, 2003; Lucassen et al., 1998). A study by de Boissier et al. (1997), showed that infants who are put on an eHF (such as Nutramigen, Progestimil and Alimentum) and are still experiencing symptoms like irritability, vomiting, diarrhea, eczema, and failure to thrive (FTT), had relief of symptoms when on an AAF, which is safe to use in infants up to 30 months of age (D de Boissieu et al., 1997: Dupont & de Boissieu, 2003). The difficulty is that AAFs are extremely costly and available by prescription only. Neocate and Ross’s Elecare are the only formulas available in this class (Morrow, 2004). Both are approved for use in infants less than one year of age. Neocate has a similar fatty acid profile to that of breast milk and is well tolerated by infants with CMPI (Isolauri et al., 1999). If an infant does not respond to AAF or eHF, the diagnosis of CMPI may be in error and referral for additional testing is warranted. Infants requiring an AAF diet can expect to take longer than one year of age to develop tolerance to CMP (de Boissieu & Dupont, 2000).

Anaphylaxis. Infants who have severe or immediate reactions to CMP may need an emergency medication. Epinephrine (Epipen Jr.) is prescribed for infants/children who have had a sever\e immediate reaction to CMP, or any reaction affecting their ability to breathe. This should be carried with the infant at all times in case of an accidental exposure.

When to Refer. Most allergists would like to see all infants suspected of having CMPI for diagnostic testing. However, most infants with CMPI can be managed in primary care. An allergy referral is necessary if symptoms are severe, unresponsive to an elimination diet, or persist past 12 months of age. Clinical symptoms should guide referrals to gastroenterology or dermatology.

Family Education

A family history of atopy is a significant predictor for allergy. According to the literature, incidence of CMA without atopy in the family is about 12% (Salvatore & Vandenplas, 2002). Incidence rises to 20% if there is 1 atopic parent, to 32% if a sibling is atopic, 43% if both parents are atopic, and up to 72% if the parents have matching types of atopic disease (for example, both have eczema or hives) (Salvatore & Vandenplas, 2002). In families with known allergies, it is wise to counsel the mother if she intends to breast- feed to avoid the most highly allergic foods (milk, eggs, peanuts, and occasionally fish) in her own diet during the third trimester and while breast-feeding (Nocerino & Guandalini, 2003). Regardless of whether breast-fed or formula-fed, in these families, introduction of solids should wait until the child is six months of age with a slow progression of new foods.

It is important for families to know that CMPI usually resolves, sometimes as soon as one year of age and in most children by four years of age (Nocerino & Guandalini, 2003). The literature varies, but between 13 to 49% of children with CMPI are still intolerant at age three; these are usually the children who have immediate reactions to CMP (Vanto et al., 2004). Children with a delayed reaction to CMP will usually develop tolerance more quickly than children who have an immediate reaction.

Family Support. It is important for parents to have support from their primary care provider and other parents experiencing similar situations with CMPl. This can be done informally in a provider’s office and on the Internet. Table 4 contains Web sites have been reviewed for accuracy and are appropriate for family referral. Pediatric providers should be aware of the multiple strains on the family; emotional stress as they try to comfort their fussy, crying baby; financial strains of costly formula; and relational stress of welcoming a new baby into the family.

Further Research

For infants who do not outgrow CMPI, immunotherapy may be considered. It is uncertain if this would prevent future allergies, and there is inconclusive evidence that food allergen immunotherapy works (Anderson, 1997). This research is in the experimental stages and may provide a long-term answer for CMPI. Further research also needs to be conducted to determine if avoiding CMP in atopic families from infancy through the first two years prevents developing asthma or other allergic symptoms later in life. Knowing this will add weight to the importance of diagnosing CMPI early in infancy.

Conclusion

CMPI is present in approximately 3% of infants. A small percentage has IgE-mediated reactions known as cow’s milk allergy. CMPI manifests in the gastrointestinal system, cutaneous system, and respiratory system. Very few CMPI infants have anaphylactic reactions. CMPI must be differentiated from GERD and colic in the primary care setting. Elimination of CMP in the diet of the breast- feeding mother or a change in infant formula to a non-CMP formula usually eliminates symptoms. Referral to allergy is necessary if symptoms are severe or if they persist past 12 months of age. The long-term consequences of early IgE stimulation with CMA are unknown. Pediatric providers must offer education and support to families with CMPI infants.

References

American Academy of Pediatrics (AAP). (1998). Soy protein-based formulas: recommendations for use in feeding. Pediatrics, 101(1), 148-153.

Anderson, J.A. (1997). Milk, eggs, and peanuts: Food allergies in children. American Family Physician, 56(5), 1365-1374.

Brown, H.M. (2002). The spectrum of milk intolerance syndromes. Journal of Nutritional & Environmental Medicine. 12(3), 153-175.

Burks, W. (2003). Skin manifestations of food allergy. Pediatrics, 111(6), 1617-1624.

Cirgin Ellett, M. (2003). What is known about infant colic? Gastroenterology Nurses, 26(2), 60-65.

Currie, L., & Harveyk, G. (1998). Care pathways development and implementation. Nursing Standard, 12(30), 35-38.

de Boissieu, D., & Dupont, C. (2000). Time course of allergy to extensively hydrolyzed cow’s milk proteins in infants. The Journal of Pediatrics. 736(1), 119-120.

de Boissieu, D., Matarazzo, P., & Dupont, C. (1997). Allergy to extensively hydrolyzed cow milk proteins in infants: identification and treatment with an amino acid-based formula. The Journal of Pediatrics, 131(5), 744-747.

Dupont, C., & de Boissieu, D. (2003). Formula feeding during cow’s milk allergy. Minerva Pediatrica, 55(3), 209-216.

Field, T. (2002). Milk soy protein intolerance: A mother’s perspective. Nebraska Nurse, 35(2), 8.

Heine, R.G., Elsayed, S., Hosking, C.S., & Hill, D.J. (2002). Cow’s milk allergy in infancy. Current Opinion in Allergy and Clinical Immunology. 2, 217-225.

Hill, D.J., Heine, R.G., Cameron, D., Francis, D., & Bines, J. (1999). The natural history of intolerance to soy and extensively hydrolyzed formula in infants with multiple food protein intolerance. The Journal of Pediatrics, 135(1), 118-121.

Hill, D.J., Heine, R.G., Cameron, D.J.S., Catto-Smith, A.G., Chow, C.W., Francis, D.E.M., et al. (2000). Role of food protein intolerance in infants with persistent distress attributed to reflux esophagitis. Journal of Pediatrics. 136(5), 641-647.

Hill, D.J., Sporik, R., Thorburn, J., & Hosking, C.S. (2000). The association of atopic dermatitis in infancy with immunoglobulin E food sensitization. The Journal of Pediatrics, 137(4), 475-479.

Iacono, G. (1996). Gastroesophageal reflux and cow’s milk allergy in infants: A prospective study. The Journal of Allergy & Clinical Immunology, 97(3), 822-827.

Iacono, G., Cavataio, F., Montalto, G., Florena, A., Tumminello, M., Soresi, M., et al. (1998). Intolerance of cow’s milk and chronic constipation in children. New England Journal of Medicine, 339(16), 1100-1104.

Isolauri, E., & Arvola, T. (2000). IgE cross-reactivity between human and cow’s milk proteins in atopic breast-fed infants. The Journal of Pediatrics. 136(3), 422-423.

Isolauri, E., Siitas, Y., Salo, M.K., Isosomppi, R., & Kaila, M. (1998). Elimination diet in cow’s milk allergy: Risk for impaired growth in young children. The Journal of Pediatrics, 132(6), 1004- 1009.

Isolauri, E., Tahvanainen, A., Peltola, T, & Arvola, T. (1999). Breast-feeding of allergic infarts. The Journal of Pediatrics, 134(1), 27-32.

Isolauri, E., & Turjanmaa, K. (1996). Combined skin prick and patch testing enhances identification of food allergy in infants with atopic dermatitis. The Journal of Allergy & Clinical Immunology, 97(1), 9-15.

Klish, W.J., Baker, S.S., Cochran, W.J., Flores, C.A., Georgieff, M.K., Jacobson, M.S., et al. (1998). Soy protein-based formulas: Recommendations for using in infant feeding. Pediatrics, 101(1), 148- 153.

Lake, A.M. (2001). Dietary protein enterocolitis. Current Allergy Reports, 1, 76-79.

Lucassen, P., Assendelft, W., Gubbels, J., van Eijk, J., van Geldrop, W., & Neven, A.K. (1998). Effectiveness of treatments for infantile colic: Systematic review. British Medical Journal, 376(7144), 1563-1569.

Morrow, A.L. (2004). Choosing and Infant or Pediatric Formula. Journal of Pediatric Health Care, 18(1), 49-52.

Nocerino, A., & Guandalini, S. (2003, April 3, 2003). Protein intolerance. Retrieved January 15, 2004, from www.eMedicine.com

Odze, R.D., Wershil, B.K., Leichtner, A., & Antonioli, D. (1995). Allergic colitis in infants. The Journal of Pediatrics. 126(2), 163- 170.

Rohrbach, J.I. (1999). Critical pathways as an essential part of a disease management program. Journal of Nursing Care Quality, 14(1), 11-15.

Salvatore, S., & Vandenplas, Y. (2002). Gastroesophageal reflux and cow milk allergy: Is there a link? Pediatrics, 110(5), 972-985.

Sampson, H.A. (2003). Food allergy. Journal of Allergy Clinical Immunology, 111(2), 540-547.

Sicherer, S. (2003). Clinical aspects of gastrointestinal food allergy in childhood. Pediatrics, 111(6), 1609-1616.

Sicherer, S., Eigenmann, P., & Sampson, H. (1998). Clinical features of food protein-induced enterocolitis syndrome. The Journal of Pediatrics, 133(2), 214-219.

Staiano, A., Troncone, R., Simeone, D., Mayer, M., Finelli, E., CeIIa, A., et al. (1995). Differentiation of cow’s milk intolerance and gastro-oesophageal reflux. Archives of Disease in Childhood, 73(5), 439-442.

Taubman, B. (1988). Parental counseling compared with elimination of cow’s milk or soy milk protein for the treatment of infant colic syndrome: A randomized trial. Pediatrics, 87(6), 756-761.

Vanderhoof, J., Murray, N., Kaufman, S., Mack, D., Antonson, D., Corkins, M., et al. (1997). Intolerance to protein hydrolysate infant formulas: An underrecognized cause of gastrointestinal symptoms in infants. The Journal of Pediatrics, 131(5), 741-744.

Vanto, T., Helppila, S., Juntunen-Backman, K., Kalimo, K., Klemola, T., Korpela, R., et al. (2004). Prediction of the development of tolerance to milk in children with cow’s milk hypersensitivity. The Journal of Pediatrics, 144(2), 218-222.

Wyllie, R. (1996). Cow’s milk protein allergy and hypoallergenic formulas. Clinical Pediatrics, 35(10), 497-500.

Whitney Merrill Ewing, RN, MSN, PNP, is Pediatric Nurse Practitioner, Advance Pediatrics, Advance, NC.

Patricia Jackson Allen, RN, MS, PNP, FAAN, is Professor and Director, Pediatric Nurse Practitioner Specialty, Yale University School of Nursing, New Haven, CT.

The Primary Care Approaches section f\ocuses on physical and developmental assessment and other topics specific to children and their families. If you are interested in author guidelines and/or assistance, contact Patricia L. Jackson Allen at [email protected].

Copyright Anthony J. Jannetti, Inc. Nov/Dec 2005

By Pope, James E; Hudson, Laurel R; Orr, Patty M

Disease management has been defined as a system of coordinated health care interventions and communications for populations with conditions in which patient self-care efforts are significant (Disease Management Association of America, 2005). The purpose of this article is to provide an overview of the diabetes disease management program offered by American Healthways (AMHC) and highlight recently reported results of this program (Villagra, 2004a; Espinet et al., 2005).

INTRODUCTION

For many years there has been escalating concern over the substantial difference between how health care should be delivered to achieve the best possible outcomes and how it is actually delivered. The magnitude of this variance in care has become increasingly apparent as the body of empirical evidence documenting the problem continues to grow (Schuster, 1998; Institute of Medicine, 2001; Fisher and Wennberg, 2003; McGlynn et al., 2003). These gaps in care are so large that a panel of experts convened by the Institute of Medicine (2001) called it a quality chasm. There is also recognition that resolving this problem will require changes at multiple levels in the health care delivery system. One response to this problem has been to develop disease management programs to assist individuals with chronic conditions.

Since the inception of these programs, there has been an evolving understanding of the challenges to evaluating the effectiveness of the programs, which has driven a corresponding evolution in the methodology used for program assessment. Practical methods of evaluation have relative strengths and weaknesses. Potential threats to validity in reporting results have been reviewed with the types of bias for which to be cognizant and the method of evidence for which to evaluate (Linden, Adams, and Roberts, 2004).

AMHC

For more than 20 years, AMHC has been working with hospitals, physicians, health plans, and patients to improve health, enhance the fundamental care experience, and reduce the cost of care.

The focus of AMHCs disease management programs is to promote recognized standards of care through member and physician care- support interventions, and to assure program effectiveness in delivering health status improvement and cost reduction outcomes (Table 1). AMHC has demonstrated clinical health status outcomes and cost savings in several studies for patients with heart disease, heart failure, and diabetes (VHlagra, 2004a; Espinet et al., 2005; Villagra, 2004b; Rubin, Dietrich, and Hawke, 1998; Clarke, Crawford, and Nash, 2002; Gold and Kongstvedt, 2003; Ahmed, 2004).

These programs, which predominantly target people with chronic diseases, currently reach more than 1.5 million individuals in all 50 States, Puerto Rico, Guam, and the District of Columbia with a highly personalized, patient-centric approach. Programs are designed to closely monitor patients’ conditions, educate them to become more effective self-managers, and support them in effecting healthful behavior changes. Program implementation and execution include significant effort to attain local market cultural competency through careful attention to factors such as prevalent language, local diet considerations, community values, and other cultural and social norms. While providing services to all individuals in the program, those with the greatest risk for future medical complications are identified with a predictive modeling tool and targeted to receive additional interventions designed to reduce the risk of avoidable costly events in the future (Baker, 2002; Ash et al., 2001).

Table 1

American Healthways’ (AMHC’s) Disease Management Programs Summary Information

AMHC’s programs achieve savings not by restricting access to care, but rather lower costs by bridging gaps in care and helping participants better adhere to their physician’s plan of care and evidencebased standards of care pertinent to their disease (s). This approach leads to improved health and delayed onset of complications and comorbidities, resulting in less demand on the system and lower cost. Improved beneficiary health status is achieved by assisting beneficiaries to better self-manage their chronic conditions, through continuous education and support, setting of attainable goals, telephone and remote monitoring and, when warranted, by intensive coordination of services.

PROGRAM ORIENTATION

Initially AMHC, like other early disease management organizations, focused on a single disease. As various disease management programs began to mature, it was recognized that many patients with the index condition had important comorbidities (Villagra, 2004b). Critics of these early programs raised concerns about neglect of comorbidities and fragmentation of care, especially when different disease management programs were offered by separate entities (Anderson, 2002). Over the subsequent years, AMHC has added other targeted diseases and transitioned from a disease-centric to a patient-centric approach. As such, common comorbidities are addressed even when AMHC is contracted to provide only a single targeted disease program.

These programs are designed to promote patients’ understanding of their diseases, educate them to become more effective self- managers, and to support them in creating and sustaining the behavior changes that result in better health. Education and coaching are accomplished by nurses through telephone outreach that includes a focus on positive lifestyle changes, goal setting for behavior change, and development of patient self-care skills that promote greater patient control and graduated autonomy. While the patient recognizes this as a trusted and accessible source of education and support, the relationship is designed to avoid the creation of a new dependency on the health care system. Eighty- eight percent of randomly surveyed members reported being very satisfied with “…how well the program helps you be in control of your health care…” and 86 percent reported being very satisfied with “…how well the information supplied by the program helps you to manage your condition…” (American Healthways, 2004).

AM HCs programs are also designed to help the patient assist in, and coordinate, their medical care in a highly fragmented health care system. Patients are encouraged to maintain personal health and medication/allergy summaries that improve the efficiency and effectiveness of information flow between physicians in the absence of a common medical record. The informed patient is more likely to ask the right questions of their physicians, demonstrate improved adherence to care plans and make changes in behaviors that impede the course of their chronic disease (Maljanian et al., 2005).

Outcomes are only partially driven by the clinical or medical issues that a patient faces. Psychosocial and other life issues are important drivers of inappropriate utilization of medical services (ten Brinke et al., 2001; Simpson, Carlson, and Trew, 2001; Keenan, Marshall, and Eve, 2002). Our nurses are trained to listen carefully to what a patient says about his life circumstances and recognize how these issues might affect a patient’s health. In addition, our nurses are trained to help recognize depression in patients, allowing for earlier detection and treatment in a disease management population (Badamgarav et al., 2003).

The tool by AMHC that makes nurse interaction efficient, consistent, and scalable is a proprietary Microsoft Windowsbased client-server clinical information application called Population WorksSM (PopWorks). PopWorks incorporates clinical logic to guide the nurse’s interaction with the patient. The logic incorporated into this system is based on the concepts of the practice of evidence-based medicine. The practice of evidence-based medicine means “…integrating individual clinical expertise with the best available external clinical evidence from systematic research…” (Sackett, 1996). Clinical expertise includes “…thoughtful identification and compassionate use of individual patients’ predicaments, rights, and preferences in making clinical decisions about their care…” (Sackett, 1996). Part of the distinction is that purely creating logic built around standards of care for single diseases can create recommendations or interventions that are contraindicated in the presence of another disease or are unlikely to be followed considering social or cultural factors.

As the nurse is speaking with a patient, data are entered into PopWorks. A unique set of interventions consisting of scripted talking points and possible goals to be considered are dynamically created and prioritized for that individual in real time. These interventions can be tailored to a specific cultural and/or social environment.

Patient Identification and Segmentation

Patients eligible for disease management programs have one or more of the defined conditions or diseases and have health service benefits provided by either a government-sponsored or private health insurance plan that has contracted for AMHC services. Specific individuals are identified using disease-specific algorithms which employ ICD-9-CM (Centers for Disease Control and Prevention, 2005) coding, Current Procedural Terminology (CPT) (American Medical Association, 2005) coding, and when available, pharmacy data. These algorithms are set to minimize false positives an\d maximize sensitivity.

Analytical techniques with predictive modeling are then used to help further segment the population and identify those individuals at increased risk of medical complications (Figure 1). This enables the provision of targeted preventive interactions with the goal of greatly reducing, or altogether avoiding, costly health-care episodes. Technically, predictive modeling identifies individuals at risk of adverse health events and outcomes by applying analytical techniques such as linear or logistic regression analyses, classification/decision trees, or neural networks (Lacson and OhnoMachado, 2000; Snow et al., 2001). AMHC uses neural network techniques, which are derived from theories of human cognition and employ non-statistical algorithms to explain or predict variations in data. This technique provides high predictive power based on the capacity for incorporating complex categorical data and non-linear continuous data (Crawford et al., 2005).

The key to creating significant beneficial population outcomes is to engage a large enough number of individuals with the targeted disease (s) irrespective of their personal motivation to engage in self-care. In our experience, this goal is achieved through an engagement process, in which every identified patient is automatically included in the program. We contact all patients. They can opt-out of the program or limit the type of contact to mail or telephone calls only. Typically, only 4 to 7 percent opt-out or limit the type of program interactions, and patients are not excluded from the program, regardless of severity of disease or number of comorbidities The patient is engaged by leveraging effective behavioral health approaches to behavior change such as Prochaska et al. (1992) trans-theoretical model. By undergoing comprehensive training on Prochaska’s stages of change, AMHC’s clinicians are prepared to appropriately classify how amenable a person is to making a positive lifestyle change at a particular point in time. As a result, interventions are more specifically tailored to a person’s personal preferences, thus increasing the likelihood that an individual will be successful in enacting behavior changes.

Figure 1

Population Identification, Stratification, and Pathway to Outcomes

Integrated Medical Management

The program is designed to be integrated into the customer health plan’s medical management program. The flexibility and scalability of the program allows for integration with a wide variety of management options such as case management, utilization management, and/or precertification functions to provide a comprehensive and fully integrated medical management program for the population. In addition to integrating with existing internal programs, relationships with outside vendors such as pharmacy and behavioral health companies are also established.

Disease Management as a Total Population Management Tool

AMHC’s program is a management tool as opposed to an extra benefit. A benefit approach often equates to a voluntary or enrollment model for participation. Reliance on an enrollment model imposes the burden on the patient, resulting in very low participation and leaving the non-enrolled without the benefit of disease management support. Paradoxically, those with the greatest need are most likely to be those who are least likely to enroll in care management services or seek disease related information specific to personal conditions (Elliott, 1995; Garay-Sevilla et al., 1999).

An engagement approach is a total population approach that captures the diagnosed-but-currently-healthy patients in addition to the very ill patients. Utilizing a total population approach improves member health status in the short term and delays or prevents the onset of complications in the medium and long term.

Prevention Among the Chronically 111

All forms of prevention are incorporated into the program- primary, secondary and tertiary. Age- and sex-appropriate primary prevention is taught and encouraged through an online risk assessment tool available to the diseased population as well as a payer’s total population. Risk factor modifications for the index disease, as well as common comorbidities of that disease are also addressed. Appropriate treatment to limit event recurrence and disease progression, such as use of lipid-lowering agents, are encouraged by educating the patient regarding benefits of treatment while alerting the physician when such gaps in care are suspected.

PHYSICIAN PARTICIPATION

Prior to engaging patients in the disease management program, we establish a local or regional Physician Advisory Council made up of local physician-opinion leaders. After Physician Advisory Council members are introduced to the disease management program, they continue to meet quarterly to review local activities and outcomes, and provide suggestions and feedback to improve the program.

On commencement of the program, physicians are notified which of their patients will participate. They also are provided sample patient materials so they will be aware of the information their patients receive. Historically, these materials are well accepted by physicians as they conform to widely published and accepted clinical guidelines. Based on a randomly administered satisfaction survey to participating physician providers, 75 percent stated they were very satisfied with “…the program’s impact on your patient’s knowledge about the disease…” (American Healthways, 2004).

In addition, we foster physician participation by providing nurses within the community to visit physicians to explain how the program may help address or support a specific patient’s needs. These nurses also are trained to provide academic detailing regarding evidence-based medical care. The absence of an ulterior motive of selling products, such as pharmaceuticals, allows for the development of a trusting relationship with the physician.

AMHC provides tools and information to physicians in a non- intrusive manner, respecting their individual desire to participate at whatever level they choose. Once informed about the programs, our goal is for physicians to view our services as a resource, and not as additional work. We feel we are achieving this goal, as 74 percent of physicians surveyed marked very satisfied with “…the overall benefit of this program to your patients…” (American Healthways, 2004) on the randomly administered satisfaction survey for providers. Interactions with physicians include mailings (introductory letters, quarterly newsletters, standards of care flow sheets and patient reports) and telephone conferences regarding patient-specific issues. These issues may include a significant change in symptoms, possible medication errors or urgent/emergent conditions. AMHC Web-based tool (e-Resident) also is used to give physicians secure access to information about individual patients. This is presented in a format that was designed by practicing physicians.

Physician’s Payment

AMHCs programs do not provide direct financial compensation for physicians. Any change in the physician payment methodology or fee schedule is handled by the health plan.

It is recognized that there are important physician activities surrounding coordination of care that would further amplify the effectiveness of disease management programs. A criticism of disease management is that there may not be appropriate compensation for the doctor’s participation in disease management activities. Some payers are experimenting with physician incentives to achieve better alignment with goals of the disease management programs. For example, physician incentives can be linked to greater participation with our program and to achieving specific clinical performance targets.

PROGRAM RESULTS

The current disease management literature has defined standard parameters for designing a disease management product and for measuring the outcomes from these products. (Linden et al., 2004; Disease Management Association of America, 2005). AMHC references these standards as their products are enhanced, deployed, and outcome results measured. Linden et al. (2004) provides an excellent roadmap for disease management organizations in providing the tools to accurately assess effectiveness and to minimize threats to validity of program outcomes. Potential threats to validity in reporting results are listed with the types of bias for which to be cognizant and the method of evidence for which to evaluate. AMHC uses these methods and those proposed by the DMAA 2004 Consensus Guidelines on Measurement to accurately report outcomes. AMHC will use a prospective random controlled trial (RCT) design as defined by Medicare to evaluate outcomes with the 2005 Medicare pilot project. The CMS chronic care improvement projects will be the first truly random controlled studies of the outcomes for disease management programs, assuring validity and generalization of the results. AMHC will participate in two of the chronic care improvement project pilots starting in August and September 2005. These Medicare RCT pilots will contribute to the disease management community’s body of knowledge regarding the advancement and dissemination of disease management best practice for a Medicare fee-for-service (FFS) population.

Several different measurement methodologies have been used to assess the effectiveness of disease management programs. Three primary metrics are:

* Quality of Care-How many patients are receiving exams and tests as outlined in the standards of care for their diseases/conditions? Does disease management have an impact on patient compliance?

* Proxies for Health Outcomes-A report on hospital and emergency room utilization rates as proxies for unwanted health outcomes (i.e. decreased bed days, emergency room visits, length of stay, lab values).

* Cost Measures-Have the programs lowered the total health-care costs of the p\opulation?

AMHC uses a total population approach that includes all patients in a population with the targeted diseases or conditions into the denominator when calculating cost and quality measurements. Such a measurement methodology focuses on the total health and cost of the population while reducing bias that can be introduced by measuring subgroups of a population. Reported outcomes consist of clinical metrics reflecting adherence to evidencebased standards of care, financial improvement, and program satisfaction from the perspective of the patient and the physician.

In addition, financial officers in payer organizations commonly review AMHCs program outcomes. For that reason we have submitted our results for independent third-parties audits by firms such as Ernst & Young (Hoffman, 2001).

MEASURING OUTCOMES

In the absence of a RCT, the preferred method by which to measure and report the impacts of a disease management program remains controversial. Common methods involve a pre-post or parallel group methodology.

The pre-post design compares populations of individuals with a specific disease at different points in time. With this approach, it is necessary to correct for inflation in medical cost and utilization over time. This can, however, introduce biases. Additionally, bias is introduced by the natural tendency for high- cost patients in the base period to have lower cost in the followup period, and vice versa. This phenomenon has been previously described as regression to the mean (Welch, 1985). While the study of parallel groups can address both of these problems, it must be corrected for variances in demographics and comorbid disease frequency in different populations. Despite the existence of the regression to the mean phenomenon in disease management research, studies that have compensated for this continue to find a decrease in health care costs in chronic disease management (Tinkleman, 2004).

Of particular interest is the article by Villagra and Ahmed (2004), where these two different methods for calculating dis ease management program effectiveness were compared across 10 urban centers engaged in AMHC programs. A staggered implementation of disease management over a 3-year period created natural experiments that allowed a comparison of dis ease management versus no-disease management site pairs, matched by regional proximity and dates. Standard statistical correction for case mix, shuts in demographics, and comorbidities were made before analysis.

In the pre-post comparison, the average cost of the 10 sites during the intervention period was 8.1 percent less than in the baseline period (p

Quality outcome indicators showed higher scores in the intervention group compared to control sites and baseline period. Differences reached statistical significance for dilated retinal exam, microalbumin testing, lipid screening, and tobacco use. A positive trend was observed in HbAIc testing and prescriptions for angiotensin converting enzyme inhibitors or angiotensin receptor blockers.

In summary, analysis of both the prepost and the parallel group designs demonstrated positive clinical and financial results of the AMHC disease management program.

In the retrospective study conducted by Espinet et al. (2005), the impact of disease management programs on diabetes-related Health Plan Employer Data and Information Set (HEDIS) quality indicators from 20 health plans was examined. (In this multistate study, AMHC disease management programs were purchased for only a segment of the population (the health plan’s fully insured members and those selfinsured employers electing the disease management program). These health plans, seeking National Committee for Quality Assurance (2001) (NCQA) accreditation, collected, and subsequently reported HEDIS 2002 results using standard NCQA methodology. The six diabetes- related HEDIS measures analyzed were: (1) HbAIc Testing Rate, (2) HbAIc Control Rate, (3) LDL-C Screening Rate, (4) LDL-C Level Rate, (5) Eye Exams Rate, and (6) Nephropathy Monitoring Rate. Patient records were selected randomly for detailed review without regard to participation in the disease management program. Of the 7,993 members reviewed, 61.8 percent were full participants in the disease management program, 28.5 percent were non-participants, and the remaining 9.7 percent were classified as partial participants. Full participants were defined as participating in the disease management program for more than 6 months, while partial participants were engaged 6 months or less.

HEDIS metrics were then examined with respect to each patient’s participation in the disease management program. The overall national compliance rate across all six HEDIS quality measures for diabetes was statistically higher among full participants than non- participants (p

In summary, this analysis demonstrates that AMHC disease management programs are associated with significantly better HEDIS quality metrics as assessed by a random sample of members. It also demonstrates that involvement in the program for longer than the initial 6 months is associated with incremental improvements in these quality indicators.

COMlNUED EVOLUTION OF DISEASE MANAGEMENT PROGRAMS

Although the two reports discussed here demonstrated innovative ways in which to validate the effectiveness of a disease management program, these approaches are not practical methods by which purchasers of disease management can assess their individual experiences. Traditional methods in use are widely recognized to be susceptible to biases such as asymmetric cost distributions and regression to, and progression from, the mean phenomenon. Determination of medicalcost trend also remains controversial. To address these issues, researchers at Johns Hopkins University are working on an updated methodology that will extend the Hopkins Standard Outcomes Metrics and Evaluation Methodology published in 2003 (American Healthways, 2003).

In addition, AMHC will be participating in a prospective RCT study as design by CMS to evaluate outcomes with the 2005 Medicare Health Support program. The results of these studies will contribute to the disease management community’s body of knowledge regarding the advancement and dissemination of best practice for a Medicare FFS population.

Further evolution in the delivery of dis ease management services is likely in the foreseeable future. Research examining the impact of a patient’s receptivity to dis ease management health care messaging is underway. This analysis will likely provide greater insight into which components of a disease management program are most effective at creating positive behavior change in various types of individuals. Future disease management programs may tailor the interventions for each patient based on that individual’s health care messaging archetype.

Finally, other changes will target enhancing the physician practice-disease management information exchange and care plan integration. Pilot projects are underway examining novel ways in which disease management programs can have more impact at the point of care. Involvement by the disease management program at this point in the care delivery system affords the greatest opportunity to transfer information in a timely and effective manner while assuring that the program is fully aware of how it can best support and amplify components of the physician’s care plan.

REFERENCES

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American Healthways: American Healthways Member and Provider Satisfaction Survey Results for 2004. Commissioned Survey by Data Management and Research Corporation. Unpublished Report. 2004.

American Healthways: Standard Outcome Metrics and Evaluation Methodology for Disease Management Programs. American Healthways and Johns Hopkins Consensus Conference. Disease Management 6(3): 121- 138, Fall 2003.

American Medical Association: CPT(Current Procedural Terminology). Internet address: http://www.ama-assn.org/ama/pub/ category/3113.html (Accessed 2005.)

Anderson, G.: Testimony Before the Subcommittee on Health of the House Committee on Ways and Means. Hearing on Promoting Disease Management on Medicare, April 16,2002. Internet address: http:// waysandmeans.house.gov/legacy. asp?file=legacy/health/107cong/4-16- 02/107-80final.htm (Accessed 2005.)

Ash, AS., Zhao, Y., Ellis, R.P., et al.: Finding Future High- Cost cases: Comparing Prior Cost Versus Diagnosis-Based Methods. Health Services Research 36(6): Part II: 194-206, December 2001.

Badamgarav, E., Weingarten, S.R., Henning, J.M., et al.: Effectiveness of Disease Management Programs in Depression: A Systematic Review. American Journal of Psychiatry 160(12): 2080- 2090, December 2003.

Baker, G.B.: Integrating Technology and Disease Management-The Challenges. Healthplan Magazine 43(5):60-62, 64-66, September- October, 2002.

Centers for Disease Control and Prevention: (ICD-9-CM). Internet address: http://www.cdc.gov/nchs /about/otheract/icd9/abticd9.htm (Accessed 2005.)

Clarke, J., Crawford, A., and Nash, D.B.: Evaluation of a C\omprehensive Diabetes Disease Management Program: Progress in the Struggle for Sustained Behavior Change. Disease Management 5(2):77- 86, 2002.

Crawford, A., Fuhr, J.P., Clarke, J., et al.: The Comparative Effectiveness of Total Population Versus Disease Specific Neural Network Models in Predicting Medical Costs. Disease Management; Manuscript has been accepted for publication (no further revisions necessary) in October 2005 issue.

Disease Management Association of America: Definition of Disease Management. Internet address: http://www.dmaa.org/definition.html (Accessed 2005.)

Elliott, H.: Community Nutrition Education for People with Coronary Heart Disease-Who Attends? Australian Journal of Public Health 19(2):205-10,April 1995.

Espinet, LM., Osmick, MJ., Ahmed, T., et al.: A Cohort Study of the Impact of a National Disease Management Program on HEDIS Diabetes Outcomes. Disease Management 8(2):86-92, 2005.

Fisher, E. S. and Wennberg, D.E.: The Implications of Regional Variations in Medicare Spending. Part 1: The Content, Quality, and Accessibility of Care. Annals of Internal Medicine 138(4):273-287, February 2003.

Garay-Sevilla, M.E., Malacara, J.M., Gutierrez-Roa, A., et al.: Denial of Disease in Type 2 Diabetes Mellitus: Its Influence on Metabolic Control and Associated Factors. Diabetic Medicine 16(3):238-244, March 1999.

Gold, WR. and Kongstvedt, P.: How Broadening DM’s Focus Helped Shrink One Plan’s Costs. Managed Care 12(11):33-39, November 2003.

Huffman, J.: Broad Disease Management Intervention Reducing Health Care Costs for Plan Members with Congestive Heart Failure. Unpublished Report 2001.

Institute of Medicine: Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC. National Academy Press. 2001.

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Lacson, R.C. and Ohno-Machado, L: Major Complications After Angioplasty in Patients with Chronic Renal Failure: A Comparison of Predictive Models. Proceedings of AMIA Annual Symposium 91 (Supplement 8): 457-461, 2000.

Linden, A., Adams, J.L., and Roberts, N.: Evaluation Methods in Disease Management: Determining Program Effectiveness. Commissioned by the Disease Management Association of America. 2004. Internet Address: http://www.dmaa.org/PDFs/Evaluation_Methods_in_DM.pdf. (Accessed 2005.)

Maljanian, R., Grey, N., Staff, L, et al.: Intensive Telephone Follow-Up to a Hospital-Based Disease Management Model for Patients with Diabetes Mellitus. Disease Management 8(1):15-25, February 2005.

McGlynn, EA, Asch, S.M., Adams, J., et al.: The Quality of Health Care Delivered to Adults in the United States. New England Journal of Medicine 348(26):2635-245, June 26, 2003.

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Rubin, RJ., Dietrich, KA, and Hawk, A.D.: Clinical and Economic Impact of Implementing a Comprehensive Diabetes Management Program in Managed Care. Journal of Clinical Endocrinology and Metabolism 83(8):2635-2642, August 1998.

Sackett, D.: Evidence Based Medicine: What It Is and What It Isn’t. British Medical Journal 312:71-72, January 13,1996.

Schuster, MA, McGlynn, EA, and Brook, R.H.: How Good Is the Quality of Health Care in the United States? The Milbank Quarterly 76(4):517-563, December 1998.

Simpson, J.SA, Carlson, L.E., and Trew, M.E.: Effect of Group Therapy for Breast Cancer on Healthcare Utilization. Cancer Practice 9(1):19-26, 28, January 2001.

Snow, P.B., Kerr, DJ., Brandt, J.M., et al.: Neural Network and Regression Predictions of 5-Year Survival After Colon Carcinoma Treatment Cancer 91 (Supplement 8): 1673-1678, April 15, 2001.

ten Brinke, A, Ouwerkerk, M.E., Zwinderman, A.H., et al.: Psychopathology in Patients with Severe Asthma Is Associated with Increased Health Care Utilization. American Journal of Respiratory Critical Care Medicine 163(5):1093-1096, April 2001.

Tinkelman, D., and Wilson, S.: Asthma Disease Management: Regression to the Mean or Better? Amencan Journal of Managed Care 10:948-954, December 2004.

Villagra, V.G. and Ahmed, T: Effectiveness of a Disease Management Program for Patients with Diabetes. Health Affairs 23(4):255-266, July/August 2004a.

Villagra, V.G.: Strategies to Control Cost and Quality: A Focus on Outcomes Research for Disease Management. Medical Care 42(4):Suppl:III-24-111-30, April 2004b.

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James E. Pope, M.D., Laurel R. Hudson, M.S.N., R.N., and Patty M. Orr, M.S.N., Ed.D., RN.

The authors are with American Healthways. The statements expressed in this article are those of the authors and do not necessarily reflect the view or policies of American Healthways or the Centers for Medicare & Medicaid Services (CMS).

Reprint Requests: James E. Pope, M.D., 3841 Green Hills Village Drive, Nashville, TN 37215. E-mail: jim.pope@amhealth wavs.com

Copyright Superintendent of Documents Fall 2005

By Lee, Stacey I; Keltner, Norman L

“You know I used to become unglued whenever the neighborhood kids would ride their bikes through my lawn. Since I’ve been taking Prozac I just don’t give a shit. Tell the little bastards to come on. I tell you, Prozac is great.”

65-year-old neighbor in 2003

This paper will explore the phenomenon of antidepressant apathy syndrome (AAS). Included in this discussion will be efforts to (i) differentiate depression and apathy, (ii) explore relevant case reports, (iii) look at the relationship between apathy and violent behaviors in adolescents, (iv) discuss apathy as a desired effect, (v) suggest possible mechanisms causing AAS, and (vi) explore treatment strategies.

Introduction

Selective serotonin reuptake inhibitors (SSRIs) have been reported to induce an amotivational or apathy syndrome in both children and adults being treated for panic disorder, obsessive- compulsive disorder (OCD), and depression (Garland & Baerg, 2001; Hoehn-Saric, Lipsey, & McLeod, 1990; Hoehn-Saric, Harris, Pearlson, Cox, Machlin & Camargo, 1991). The presentation of apathy in the absence of depression associated with long-term SSRI therapy has been referred to as antidepressant apathy syndrome (AAS) and proposed as a unique syndrome distinct from depression (Marangell, Johnson, Kertz, Zboyan, & Martinez, 2002). Antidepressant apathy syndrome is considered a late-occurring event, dose related, and reversible (Hoehn-Saric et al., 1990, 1991). Despite detrimental social and financial consequences, AAS often goes unreported and undetected (Barnhart, Makela, & Latocha, 2004). Recognition of this phenomenon is the first critical step toward intervention.

Depression or Apathy?

Apathy, from the Greek word pathos for passion, literally means a lack of passion for life. Apathy is defined as a syndrome in which there are lack of motivation, indifference, disinhibition, and poor attention not attributable to cognitive impairment, emotional distress, or diminished level of consciousness (Marin, 1990). Depression involves emotional distress, sadness, anxiety, agitation, and feelings of worthlessness and hopelessness (American Psychiatric Association, 2000). Other common symptoms experienced in depression are physical inactivity, social inactivity, and diminished interest (Table 1). These latter symptoms overlap with apathy and cause diagnostic confusion (Levy et al., 1998). Marin (1990) points out a key diagnostic point: although externally inactive, depressed patients may be in great internal emotional distress. Levy et al. (1998) also suggest that much of the overlap between apathy and depression is compounded by the use of depression scales containing apathy items.

Levy et al. (1998) and Marin (1990) have made great strides to distinguish depression and apathy as two unique disorders. There is increasing evidence suggesting that apathy may also be a late- occurring complication of SSRI treatment separate from the original diagnosis (Garland & Baerg, 2001; Hoehn-Saric, et al., 1990,1991). Hoehn-Saric et al. (1990) initially reported SSRI-induced apathy in a case report of patients with depression and anxiety disorder. More recently, Garland and Baerg (2001) reported five cases of AAS among young people. It is important to note that before clinicians were aware that SSRIs could potentially induce apathy, it was rarely reported (Walkup & Labellarte, 2001). Furthermore, patients fighting anxiety or depression may ignore the insidious onset of apathy until most of their original symptoms are gone. At this late stage in treatment, apathy may be misdiagnosed as a relapse of the primary condition or considered treatment “poop out” (i.e., loss of efficacy). Distinguishing AAS from relapse and “poop out” has clinical implications regarding treatment and management strategies (Barnhart et al., 2004; Marangell et al., 2002).

Case Reports

Hoehn-Saric etal. (1990) reported five patients receiving fluvoxamine or fluoxetine who developed lack of motivation, indifference, disinhibition, and poor attention without concurrent sedation. The cases included two patients with panic disorder prescribed fluvoxamine, and three patients with major depression taking fluoxetine. The manifestation of apathy appeared to be dose related and reversible, depending on the drug’s half-life.

Case 1

A 55-year-old male engineer began fluvoxamine titrated to 300 mg/ day for panic disorder. At this dose, he experienced the side effects of increased perspiration, tiredness, and difficulty maintaining an erection. His dose was decreased to 150 mg/day, which was sufficient to control his panic attacks. However, the patient reported becoming indifferent towards the fulfillment of his duties. He stopped paying his utility bills for 3 months and was consistently late for work. Gradually, the patient realized the extent of his neglect but failed to get upset about it. Fluvoxamine was decreased to 100 mg/day. The feeling of apathy dissipated, and he returned to his normal work habits.

Case 2

A 35-year-old female executive developed panic attacks at the age of 30, which later evolved into agoraphobia. She was eventually placed on fluvoxamine and titrated to a dose of 400 mg/day over a 3- month period. At this dose she became free of panic attacks but began to experience apathy, indifference, and disinhibition. She reported neglecting her children and losing interest in her work. Although in a stimulating environment, she became disinhibited and impulsive. Her medication was reduced to 150 mg/day and her condition normalized in 3 days.

Case 3

A 39-year-old female graduate student presented with symptoms of major depression. She was placed on fluoxetine 20 mg every other day for 4 days, followed by 20 mg/day. Within 8 weeks her initial depressive symptoms resolved, but she complained of a new sense of apathy regarding her professional career. She stated this feeling was completely different from a sense of sedation and was unlike the lack of motivation she had experienced during her depression. As a result of these new symptoms, she was switched to the monoamine oxidase inhibitor, tranylcypromine.

Case 4

A 37-year-old female psychotherapist was seen for symptoms of chronic major depression. She was given a trial of fluoxetine 20 mg/ day. After 6 weeks of treatment she was euthymic. At 6 months she reported a slowly growing sense of lack of motivation and apathy. She reported talking with friends less often, not paying bills on time, and found it difficult to care about anything. She also stated that these feelings bore no relationship to depression. She was switched to amitriptyline, preferring to be sedated over being apathetic and unmotivated.

Case 5

A 50-year-old female illustrator was seen for recurrent major depressive episodes. She was started on fluoxetine 20 mg/day and later decreased to 20 mg every other day because of nausea. Five weeks into treatment she complained of a sense of apathy and a lack of motivation. She felt this was unlike prior side effects or previous symptoms of depression. The dose of fluoxetine was increased to 20 mg/day then eventually to 40 mg/day. The patient’s symptoms of depression were fully resolved, but she continued to complain of apathy, especially with respect to her work. She stated “this is what a frontal lobotomy must be like” (p. 345). Her fluoxetine was slowly tapered down with a partial improvement in her apathy.

These cases presented by Hoehn-Saric et al. (1990) are all similar in that the apathetic symptoms developed gradually, were not associated with sedation, and were not identified as abnormal until they caused social and financial repercussions.

Garland and Baerg (2001) reported similar symptoms of apathy in children and adolescents treated with paroxetine and fluoxetine for depression, anxiety, and obsessive-compulsive disorder. Symptoms were late in onset, dose related, and reversible. The five cases illustrate the detrimental impact AAS can have on development related to schoolwork, social relationships, and sports involvement. In all cases, the patients were unaware of their apathetic state and reported feeling “fine” despite their parent’s concerns. In four out of the five cases, management consisted of dose reduction. In the fifth case, bupropion was added in addition to reducing the SSRI dose.

Are Adolescent Violent Behaviors Related to Apathy?

Suicide

February 2004: Kara Jayne-Anne Otter, 12, taking Paxil for depression, killed herself. Her mother, Shannon Baker, blames the SSRI. Time, February 9, 2004 (Lemonick, 2004).

Murder and Suicide

March 2005: Jeff Weise, 16 years old, opened fire on faculty and students at Red Lake High School, killing nine. His family wondered if his medication (Prozac) might have contributed to his loss of control. Minneapolis Star Tribune, March 23, 2005 (Meryhew, Haga, Padilla, & Oakes, 2005).

Table 1. Differentiating Apathy and Depression

Murder

February 2005: A 15-year-old boy in Charleston, SC killed his grandparents. He claimed the antidepressant Zoloft drove him to it. Birmingham News, February 16, 2005 (Smith, 2005).

Antidepressants are known to increase suicide risk. Traditionally, this upswing in suicidal behaviors was explained away as an increase in psychic energy created by the very tools being used to treat depression-antidepressants. In other words, it was thought that anti\depressants, early on in treatment, posed a risk of giving “legs” to ideations formerly devoid of energy. However, a spike in energy does not convincingly explain the kind of SSRI- linked behaviors that have made headlines in recent years. While this conclusion is not novel, not many are suggesting that the apathy caused by SSRIs may prove to be a viable explanation. The powerful examples noted previously and numerous others drove the FDA to issue black box warnings on antidepressants related to their potential to cause these behaviors in young people.

Apathy as a Desired Effect

As suggested in the opening scenario, a number of anecdotal reports indicate some people appreciate the apathy associated with SSRIs. The 65-year-old neighbor practically rejoices in not caring anymore about what the neighborhood kids do to his yard. At first glance, this might appear to be growth in the Eriksonian sense, but is it? An equally viable explanation is SSRI-induced indifference. Another example is the older man in an unhappy marriage, who confided to the authors that he likes “not hurting” anymore. He also offers the added benefit of a decreased sex drive with the SSRI he is prescribed because “My sex life is nonexistent but I don’t believe in divorce.”

These and other clinical reports suggest that, for some individuals at least, SSRIs provide a way of avoiding their problems. Although not an approach clinicians can comfortably endorse, this is actually the biggest plus for some patients.

Possible Mechanisms of AAS

SSRIs increase serotonin in the brain and serotonin is primarily an inhibitory neurotransmitter. Of course, the person experiencing apathy looks very inhibited. Emotions, motivation, interest, and normal inhibition are inhibited, causing disinhibition. Serotonergic extensions projecting from the raphe nuclei of the brainstem pervasively connect to cortical neurons, including those in the frontal lobe. According to Cowen (1991), each serotonergic neuron makes 500,000 synaptic connections in the cortex or limbic areas. How this revving up of the serotonin system may contribute to apathy is not clear; however, Barnhart et al., (2004), Hoehn-Saric et al. (1990, 1991), Levy, et al. (1998), and Marangell et al. (2002) suggest two possible explanations for AAS.

Direct Effect

Serotonin directly affects frontal lobe projections that modulate initiative, curiosity, inhibition, and ability to focus. According to this view, as serotonin receptors are bombarded with increasing amounts of serotonin, these frontal lobe functions devolve into lack of motivation, disinterest, disinhibition, and poor attention.

Indirect Effect

SSRIs indirectly modulate frontal lobe activity by inhibiting the release of dopamine. It is this knowledge (i.e., serotonin inhibits dopamine) that has led to the development of atypical antipsychotic drugs. Because negative and cognitive symptoms of schizophrenia are thought to be related to hypodopaminergia in the mesocortical tract by blocking serotonergic influence on dopamine neurons, these symptoms can be treated. All atypical antipsychotics work by inhibiting a particular serotonin receptor, 5HT^sub 2A^. Hence, according to the second explanation, by increasing serotonin in the frontal cortex, SSRIs are diminishing dopamine there and causing apathy. It must be noted as well that apathy is considered a negative symptom of schizophrenia.

Treatment Strategies

As stated earlier, distinguishing SSRI-induced apathy from “poop- out” or relapse has clinical implications regarding treatment and management protocols (Barnhart et al., 2004; Marangell et al., 2002). Once AAS has been identified, there are three primary treatment strategies: (i) decrease SSRI dose until apathy subsides, (ii) augment SSRI with a stimulant or with an antidepressant with noradrenergic or dopaminergic activity, and (iii) switch to a different class of antidepressants (Barnhart et al., 2004; Garland & Baerg, 2001; Walkup & Labellarte, 2001). If it is impossible to decrease the SSRI dose low enough to resolve the apathy while maintaining anxiety or depression control, then adding a stimulant, norepinephrine enhancing antidepressant (e.g., secondary amine TCA), or dopamine enhancing antidepressant (e.g., bupropion) may prove beneficial. Should that approach fail, strategy iii may be necessary (Barnhart et al., 2004; Walkup & Labellarte, 2001). It is important to note that AAS has been observed with all SSRIs but not with monoamine oxidase inhibitors or tricyclic antidepressants (Garland & Baerg, 2001; Hoehn-Saric et al., 1990).

What if a differential diagnosis cannot be made? In this situation it is recommended to first increase the dose, knowing fully well that apathy is likely to increase at a higher dose (Walkup & Labellarte, 2001). This is the most logical choice because lack of motivation, indifference, disinhibition, and poor attention will worsen if it is apathy. At that time, the dose can safely be decreased until apathy dissipates. Conversely, if AAS is incorrectly assumed, initially lowering the dose puts the patient at risk for relapse. This strategy is only recommended when a differential diagnosis cannot be made based on clinical signs and symptoms.

Recently, a trial was conducted to determine if adding olanzapine to ongoing SSRI treatment would abate the symptoms of AAS (Marangell et al., 2002). The rationale for this study was based on the observation that apathy associated with frontal lobe injury responds to medications that increase dopamine in the mesocortical tracts. Olanzapine has been shown to enhance dopamine in the frontal cortex by blocking serotonin-induced inhibition of dopamine release. Also, AAS shows some resemblance to the negative symptoms of schizophrenia, which readily responds to atypical antipsychotic medications like olanzapine. This research demonstrated significant improvement in apathy, therefore offering another possible treatment strategy (Marangell et al., 2002).

Conclusion

AAS is becoming a common occurrence in treatment with SSRIs. At times, AAS cannot be distinguished from depression, thus confounding treatment. At other times, AAS may be welcomed by patients because they can hide from pain and misery inside the apathy. And, at still other times, some violence linked to SSRJs may well turn out to be a variant of apathy-“nothing matters-why not!” Nurses are encouraged to assess for signs of AAS and to help the patient make good decisions when it is recognized.

References

American Psychiatric Association (2000). Diagnostic and statistical manual, IV TR. Washington, DC: The Author.

Barnhart, W.J., Makela, E.H., & Latocha, J. (2004). Selective serotonin reuptake inhibitor induced apathy syndrome: A clinical review. Journal of Psychiatric Practice, 10(3), 196-199.

Cowen, P.T. (1991). Serotonin receptor subtypes: Implications for psychopharmacology. British Journal of Psychiatry, 259(Suppl 12), 7- 14.

Garland, E.J., & Baerg, E.A. (2001). Amotivational syndrome associated with selective serotonin reuptake inhibitors in children and adolescents. Journal of Child and Adolescent Psychopharmacology, 21(2), 181-186.

Hoehn-Saric, R., Harris, G.J., Pearlson, G.D., Cox, C.S., Machlin, S.R., & Camargo, E.E. (1991). A fluoxetine-induced frontal lobe syndrome in an obsessive compulsive patient. Journal of Clinical Psychiatry, 52,131-133.

Hoehn-Saric, R., Lipsey, J.R, & McLeod, D.R. (1990). Apathy and indifference in patients on fluvoxamine and fluoxetine. Journal of Clinical Psychopharmacology, 10(5), 343-345.

Lemonick, M.D. (2004, February 9). Prescription for suicide? Time, pp. 59-60.

Levy, M.L., Cummings, J.L., Fairbanks, L.A., Masterman, D., Miller, B.L., Craig, A.H., Paulsen, J.S., & Lirvan, I. (1998). Apathy is not depression. Journal of Neuropsychiatry and Clinical Neurosciences, 20,314-319.

Marangell, L.B., Johnson, C.R., Kertz, β., Zboyan, B.A., & Martinez, J.M. (2002). Olanzapine in the treatment of apathy in previously depressed participants maintained with selective serotonin reuptake inhibitors: An open-label, flexible dose study. Journal of Clinical Psychiatry, 63, 391-395.

Marin, R.S. (1990). Differential diagnosis and classification of apathy. American Journal of Psychiatry, 147, 22-30.

Meryhew, R., Haga, C., Padilla, H., & Oakes, L. (2005, March 23). Rampage at Red Lake High School: 10 dead, 12 wounded. Minneapolis Star Tribune, p. IA.

Smith, B. (2005, February 16). Teen taking Zoloft guilty of murder. Birmingham News, p. 6A.

Walkup, J., & Labellarte, M. (2001). Complications of selective serotonin reuptake inhibitor treatment. Journal of Child and Adolescent Psychopharmacology, 11(1), 1-4.

Stacey I. Lee, BS, SN, and Norman L. Keltner, EdD, RN

Stacey I. Lee, BS, SN is a student

Norman L. Keltner, EdD, RN is professor of psychiatric nursing at the University of Alabama at Birmingham, School of Nursing

Author contact: [email protected], with a copy to the Editor: [email protected]

Copyright Nursecom, Inc. Oct-Dec 2005

By Jeremiah Mcwilliams, The Virginian-Pilot, Norfolk, Va., The Virginian-Pilot, Norfolk, Va.

Dec. 17–NORFOLK — Stephen Zedd, the lead auctioneer in several high-profile auctions for Norfolk-based Zedd Auctioneers Ltd., has been jailed on felony drug charges.

Zedd, 33, was arrested Sunday in Norfolk on two counts of felony drug possession with intent to manufacture, sell, give or distribute. The drugs were heroin and powder cocaine, said Brent Johnson, senior assistant commonwealth’s attorney.

On Friday, he appeared in General District Court for scheduling of a preliminary hearing, set for April 11. At that time, a judge will determine whether there is enough evidence to send the case to a grand jury, which could issue formal charges.

Zedd is being held at Norfolk City Jail without bail.

“We are exploring some possibilities for treatment for Mr. Zedd,” said defense attorney Andrew M. Sacks, who said he is trying to have Zedd released into a treatment program before the April hearing. “He is a wonderful son and a wonderful businessman. But it would appear that he is struggling with a personal battle with substance abuse.”

Zedd was charged in 1997 with felony possession of heroin and cocaine and pled guilty in Norfolk Circuit Court, according to court records. In 1998, he was arrested again on six felony drug counts, and subsequently pled guilty in Virginia Beach Circuit Court, according to records.

“I think everyone agrees that he has a drug habit — I don’t think anyone is contesting that,” Johnson said.

Stephen Zedd officially joined Zedd Auctioneers Ltd. as a teenager and has taken increased responsibility for running auctions for the company founded by his father, Calvin Zedd.

He has called a variety of auctions, including the $2 million sale in June of the Lafayette Motor Hotel on Granby Street in Norfolk.

“This is a fine young man at the core,” Sacks said. “We should be supportive of him in this battle.”

Reach Jeremiah McWilliams at (757) 446-2344 or [email protected].

—–

Copyright (c) 2005, The Virginian-Pilot, Norfolk, Va.

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail [email protected].

By Suzanne Hoholik, The Columbus Dispatch, Ohio

Dec. 15–At a spiritual leadership retreat in September, three Mount Carmel Health System executives were among a group of employees who swapped clothes and then showed colleagues, a hospital source said.

They might have been decompressing, relaxing or having fun during a long day of training with co-workers, but it prompted an anonymous complaint two weeks ago to the system’s parent company, Trinity Health System.

After a weeklong review by the Michigan-based Catholic company, the incident was deemed “inappropriate and inconsistent with the values of Mount Carmel and Trinity Health.” So on Tuesday, Joseph Calvaruso, Mount Carmel’s president and chief executive; Julie Snyder, the system’s senior vice president of people services; and Kirk Hummer, chief operating officer at Mount Carmel St. Ann’s hospital, resigned from their jobs.

“We hold all of our management to the same standards, no matter what,” said Stephen M. Shivinsky, Trinity spokesman. “We learned something happened and took action.” Calvaruso could not be reached, and Snyder declined to comment. Hummer did not return calls yesterday, but said last week, “I would love to talk to you about it, but I can’t.” Trinity officials arrived in Columbus Tuesday and met with Calvaruso, Snyder and Hummer. Shivinsky said Mount Carmel employees were notified yesterday morning of the resignations.

Ronald E. Whiteside, chief operating officer at Mount Carmel East hospital, was named interim chief executive last week and remains in charge of the hospital system. Other appointments will be announced soon to fill the vacant spots, officials said.

The leadership retreat was part of the hospital system’s Higher Ground program — a management philosophy introduced by Calvaruso in 1999. Higher Ground was created by Canadian Lance Secretan who said the “heart of the message is that we should love each other and tell the truth.” According to Mount Carmel’s Web site, all three former executives were involved in Higher Ground and were vocal advocates of its principles.

Part of the program that September day focused on having empathy for co-workers and knowing what it’s like to be in their shoes.

Secretan wasn’t at the retreat but spoke with Calvaruso yesterday. The incident in question isn’t part of his international leadership curriculum, but he said he understood how it could happen.

“You can say that they exchanged clothes, and you can make it seem inappropriate, or you can make it sound silly,” Secretan said of them swapping items of clothing. “That’s what happened.

“These are colleagues, people who you work with every day. When they’re playful and joyful and act like human beings and not robots, they’re fired, and that’s a shame.” As part of Higher Ground, employees discuss issues in “wisdom circles” where the person holding a stone is the only one to speak. There are relaxation rooms where they listen to new-age music. Some wear matching jackets that say “love, honor, serve,” and they all aspire to be better leaders.

The Web site says that Higher Ground has helped reduce the hospital system’s employee-turnover rate and create an atmosphere in which people like to work.

A St. Ann’s employee, who didn’t want her name used, said she went through Higher Ground and said the program took the selfishness out of the workplace, and helped people be happier and more productive.

The hospital’s Web site once contained profiles of Calvaruso, Hummer and Snyder describing what they liked about their jobs, their inspirations and destiny. The profiles were removed yesterday.

Calvaruso had written his role at Mount Carmel is “CEO (chief enthusiasm officer),” his cause was to “inspire people to live big” and his “color energies” were red, “followed by yellow and green with trace amounts of blue.” Shivinsky said that though Trinity might “retool” parts of Higher Ground, it will stay at Mount Carmel because it’s effective and employees like it.

“We believe in Higher Ground,” he said. “The Higher Ground principles are laudable and consistent with the values of our Catholic company.” Secretan called it a “sad day” for Mount Carmel and said the three former executives are gifted, talented people.

“I don’t know what Trinity is thinking,” he said. “This is trivial.”

—–

To see more of The Columbus Dispatch, or to subscribe to the newspaper, go to http://www.columbusdispatch.com.

Copyright (c) 2005, The Columbus Dispatch, Ohio

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail [email protected].

BOSTON, Dec. 15 /PRNewswire/ — The U.S. subsidiary, SERONO LABORATORIES, INC., of Swiss Corporation SERONO, S.A., pleaded guilty and was sentenced today in federal court on criminal charges in connection with several illegal schemes to promote, market and sell its drug, Serostim, used to treat AIDS wasting, a condition involving profound involuntary weight loss in AIDS patients.

In October, SERONO, S.A., together with its U.S. subsidiaries, SERONO, INC., SERONO HOLDING, INC., SERONO LABORATORIES, INC. and related entities (“SERONO”) reached a global resolution with the United States in which it agreed to pay a total of $704,000,000 to resolve the criminal charges and civil liabilities in connection with the several illegal schemes to promote, market and sell Serostim. This global resolution is the third largest health care fraud recovery by the United States.

Attorney General Alberto Gonzales; Assistant Attorney General for the Department of Justice’s Civil Division Peter D. Keisler; United States Attorney for the District of Massachusetts Michael J. Sullivan; United States Attorney for the District of Maryland Rod J. Rosenstein; and United States Attorney for the District of Connecticut Kevin J. O’Connor, announced today that SERONO LABS entered its guilty plea before U.S. District Judge Reginald C. Lindsay. After accepting the plea, Judge Lindsay immediately sentenced the company and ordered SERONO LABS to pay a $136,935,000 criminal fine. As part of its agreement with the government, SERONO will also pay a total of $567,065,000 to settle civil liabilities. This global resolution ensures that the federal Medicaid program and each of the State Medicaid agencies who paid any claims for Serostim during the time frame of the investigation, 1996 through 2004, will recoup every dollar paid.

At today’s plea hearing, SERONO LABORATORIES, INC. (“SERONO LABS”) pleaded guilty to two counts of criminal conspiracy. As a result of its criminal conviction, SERONO LABS will be excluded from all federal health care programs for at least five years. SERONO, INC. and all other U.S. subsidiaries of SERONO, S.A., will also be subject to a stringent Corporate Integrity Agreement for the next five years.

In 1996, the FDA granted accelerated approval for SERONO’s drug Serostim solely for use in treating AIDS wasting, which at the time was the leading cause of death among AIDS patients. Serostim came on the market at the same time as protease inhibitor drugs. These drugs, when used in combination with one another as an “AIDS cocktail,” dramatically curtailed the proliferation of the AIDS virus. As a result, the incidence and prevalence of AIDS wasting began to markedly decline among those AIDS patients taking the AIDS cocktail drugs. In turn, the demand for Serostim began to drop significantly immediately following its launch in the Fall of 1996. SERONO LABS then began engaging in a multifaceted marketing and sales campaign to redefine AIDS wasting and create a market for Serostim.

The first Conspiracy count to which SERONO LABS pleaded guilty charged that, from as early as September 1996, through at least January 2002, SERONO LABS conspired with medical device manufacturer RJL Sciences, Inc., (“RJL”) to introduce on the market bioelectrical impedance analysis (“BIA”) computer software packages for use in calculating body cell mass and diagnosing AIDS wasting. The software devices were adulterated in that approval from the FDA had not been obtained for these uses before the software was disseminated. SERONO LABS conspired with RJL to increase the market for the body cell mass calculation devices/software, which in turn, would increase the market for Serostim. Additionally, SERONO LABS employees directly administered BIA tests to patients to induce doctors to prescribe Serostim and to get Medicaid agencies and other payors to reimburse for the drug. RJL and its president, Rudolph J. Liedtke, pled guilty to their roles in the conspiracy in April 2005 and are scheduled to be sentenced in 2006.

SERONO LABS pleaded guilty to a second Conspiracy count charging that, from March 1999, through December 1999, SERONO LABS conspired to pay illegal remuneration to physicians to induce them to prescribe Serostim for which payments were made by the Medicaid program. In March and April 1999, in an attempt to reverse the severe shortfall in sales of Serostim, SERONO LABS offered physicians an all expenses paid trip to a medical conference in Cannes, France in return for the physicians writing up to 30 new prescriptions of Serostim. The sales strategy was part of a campaign referred to as the “$6m-6 Day Plan.” Each prescription encompassed a twelve week course of therapy that cost $21,000, thus the value of 30 scripts to be written by each doctor was $630,000. The SERONO LABS marketing department announced within the company that 10 physicians were “U.S. Invitees” to the Cannes conference with all expenses paid for them and a guest to attend. The 30 prescriptions each doctor was expected to write meant a total value of approximately $6.3 million in sales.

As part of the plea agreement, the Court required, and SERONO has agreed, to notify physicians who prescribe Serostim and known AIDS advocacy groups of the guilty plea and the global resolution of this case.

In December 2004, the Regional Director for Sales in New York pleaded guilty to his role in the marketing Conspiracy. He is scheduled to be sentenced in March 2006. In April 2005, four SERONO LABS sales and marketing executives were indicted on charges of Conspiracy and Offering to Pay Illegal Remunerations. These charges are still pending.

Under its agreement to settle its federal civil False Claims Act liabilities, SERONO will pay $305,077,000, plus interest, to the United States in civil damages for losses suffered by the federal portion of the Medicaid program, the Veteran’s Administration, the Department of Defense and the Federal Employees Health Benefits program as a result of SERONO LABS’ fraudulent drug promotion and marketing misconduct. SERONO will also pay a total of $261,988,000, plus interest, to settle its civil liabilities to the fifty states and the District of Columbia for losses the state Medicaid programs suffered.

The civil settlement resolves allegations that SERONO knowingly caused the submission of false and/or fraudulent claims for Serostim that were not eligible for reimbursement. These included claims, (1) based on testing using the unapproved BIA software devices; (2) for treating supposed loss of body cell mass; and (3) for treating lipodystrophy, a separate condition involving weight gain in the mid-section and weight loss in the extremities. The civil settlement also resolves allegations that SERONO knowingly caused the submission of false and/or fraudulent claims by inducing pharmacies to sell Serostim by paying rebates and discounts to those pharmacies. Finally, the civil settlement resolves allegations that SERONO knowingly caused the submission of false and/or fraudulent claims to federal programs for Serostim by inducing physicians to prescribe the drug by giving them free BIA devices and software, free trips to Cannes, France and other kickbacks.

The investigation leading to the global resolution was commenced in the District of Massachusetts in 2001 after a former SERONO LABS employee filed a civil False Claims Act (“FCA”) suit as a result of her concerns about the illegal marketing practices of the company. Four other employees with similar concerns filed civil suits in Maryland and Connecticut. The civil FCA provides that the Government is entitled to recover up to treble damages on any fraudulent claims filed. The FCA also provides that private individuals who file whistleblower suits can share in recoveries of any successful resolution of their claims. As a part of this resolution, the five whistleblowers will share in approximately 17% of the civil recovery, or approximately $51.86 million.

The investigation was conducted by the Federal Bureau of Investigation; the Food and Drug Administration’s Office of Criminal Investigations; the Department of Health and Human Services’ Office of Inspector General, Office of Investigations; the Department of Labor’s Employee Benefits Security Administration, Boston Regional Office; and the U.S. Postal Service’s Office of Inspector General. Assistance in the investigation was also provided by Patrick Lupinetti, Director of the New York State Attorney General’s Special Projects and Medicaid Fraud Control Unit who coordinated the National Medicaid Fraud Units; Mark Thomas, Chief Deputy Attorney General and David Lewis, Senior Deputy Attorney General of the Medicaid Fraud Control Unit in Florida’s Attorney General’s Office, John Krayniak, Supervising Deputy Attorney General and Chief of the Medicaid Fraud Section of the New Jersey Attorney General’s Office; and Suzanne Giorgi, Deputy Attorney General in the California Department of Justice. The investigation and settlement were handled by Assistant U.S. Attorneys Mary Elizabeth Carmody, Jennifer Boal and Patricia Connolly of the District of Massachusetts, and Department of Justice Trial Attorneys Sondra Mills and Suzette Smikle in the Office for Consumer Litigation and Carol Wallack in the Fraud Section of the Civil Division. Assistant U.S. Attorneys Roann Nichols of the District of Maryland and Richard Molot of the District of Connecticut also assisted in the investigation. The Corporate Integrity Agreement was negotiated by Senior Counsel Mary Riordon in the Office of General Counsel in the Department of Health and Human Services, Office of Inspector General.

U.S. Attorney

CONTACT: Samantha Martin of the U.S. Attorney’s Office, +1-617-748-3139

By Will Boggs, MD

NEW YORK (Reuters Health) – Temporomandibular joint (TMJ)
arthritis in patients with juvenile arthritis can be relieved
with corticosteroid injection, investigators report.

Many TMJ-related symptoms are caused by the effects of
physical and emotional stress on the structures around the
joint, including the muscles of the jaw, face and neck. Along
with arthritis, other symptoms may include popping sounds in
the jaw, inability to fully open the mouth, headaches and other
types of facial pain.

“TMJ arthritis can be active even when children are being
treated with methotrexate and tumor necrosis factor inhibitors,
so corticosteroid injection should be strongly considered when
TMJ arthritis is diagnosed in children with chronic arthritis,”
Dr. Randy Q. Cron told Reuters Health.

Cron from Children’s Hospital of Philadelphia, Pennsylvania
and colleagues investigated the safety and effectiveness of TMJ
corticosteroid injections in 23 children between 4 and 16 years
old with juvenile idiopathic arthritis.

“TMJ arthritis is very common and often asymptomatic,” Cron
pointed out. “If you do not screen for it by MRI (the current
gold standard and most sensitive modality), you will likely
miss it.”

Ten of 13 children with jaw pain before treatment
experienced complete resolution of pain with chewing and jaw
exertion after the corticosteroid injection, the team reports
in the journal Arthritis & Rheumatism. Corticosteroid injection
also improved jaw locking in two of the three children who had
it.

Maximal opening of the jaw increased by at least 0.5
centimeter in 43 percent of the children after corticosteroid
injection, the report indicates, with younger patients showing
the best response.

TMJ-related swelling resolved in 48 percent of children,
the researchers note, but there were no significant changes in
bone abnormalities.

Corticosteroid injection resulted in short-term facial
swelling in two patients, the results indicate, but no skin
inflammation, infection or atrophy beneath the skin occurred.

“We are currently screening children with chronic arthritis
at disease onset for TMJ arthritis,” Cron said. “We are also
trying to find markers that predict TMJ arthritis. Although
preliminary, our results suggest that most all children have
evidence of TMJ arthritis at disease onset.”

Cron recommends treating these children “as early as
possible” — as soon as it is detected.

SOURCE: Arthritis and Rheumatism, November 2005.

By DATUK DR ABDUL HAMID ABDUL KADIR

TO understand the background to the debate on complementary and

alternative treatments, one has to look at the Medical Act 1971.

Section 34(1) of the Act, in the sub-section “Malay, Chinese, Indian or

other native methods of therapeutics”, states:

“Subject to the provisions of sub-section (2) and regulations made

under this Act, nothing in this Act shall be deemed to affect the right

of any person – not being a person taking or using any name, title,

addition or description calculated to induce any person to believe that

he is qualified to practise medicine or surgery according to modern

scientific methods – to practise systems of therapeutics according to

purely Malay, Chinese, Indian or other native methods, and to demand and

recover reasonable charges in respect of such practice.”

The Act does not restrict any person from practising

native/traditional/complementary medicine, so long as the person is not a

medical practitioner registered under the provisions of the Medical Act

1971.

Whether complementary and/or traditional medicine is included by

definition in the “system of therapeutics according to purely Malay,

Chinese, Indian or other native methods” is open to interpretation.

However, it is common knowledge that those practising non- Western

complementary system of therapeutics normally use herbs and additionally

some allopathic medications.

The use of allopathic medications by such practitioners is, in most

instances, for diseases and indications not usually or conventionally

employed in the practice of evidence-based medicine.

Some clarifications on chelation therapy: It is a series of intravenous

infusions containing EDTA (disodium ethylene-diamine-tetraacetic acid),

an organic chemical (amino acid), which may be used to treat iron- load

from multiple blood transfusions, lead poisoning and other heavy metal

poisoning.

EDTA, or its sodium salt, is a chelating agent, forming co- ordination

compounds with most metal ions, such as calcium, magnesium or copper. In

medical and laboratory practice, EDTA is used as an anti- coagulant

additive. When blood is taken for tests, EDTA is added to prevent the

blood sample from clotting, by scavenging the calcium from the sample.

After EDTA was found effective in chelating and removing toxic metals,

like lead, from the blood, some scientists postulated that hardened

arteries could be softened if the calcium in their walls was removed.

This formed the basis for claims that chelation therapy is effective

against atherosclerosis, coronary heart disease and peripheral vascular

disease.

Its supposed benefits include increased collateral blood circulation,

decreased blood viscosity, improved cell membrane function, decreased

arterial vasospasm, decreased free radical formation, inhibition of the

aging process, reversal of atherosclerosis, decrease in angina, reversal

of gangrene, improvement of skin colour and healing of diabetic ulcers.

It is claimed chelation is effective against arthritis, multiple

sclerosis, Parkinson’s disease, psoriasis, Alzheimer’s disease, and

problems with vision, hearing, smell, muscle co-ordination and sexual

potency.

These claims have never been tested by scientific methods or found

effective in the treatment of such a multitude of diseases.

There are instances to show that there indeed are early and late

complications with chelation therapy, like the heavy loss in the urine of

trace metals like zinc, which has an important role in strengthening the

body’s immune function. Loss of large amounts of calcium through

chelation is also believed to create loss of calcium from bones.

Registered medical practitioners, on the other hand, practise

evidence-based medicine. The system of treatment of their patients is

based on well-established and sound scientific studies and principles of

therapeutics, and their efficacy to control, treat or modify diseases.

The system of therapeutics so advocated can be and is being practised

safely universally with predictable results in the vast majority of

patients.

The medications used by allopathic doctors are very specific for

well-defined disease conditions, and the composition, use and adverse

reactions are monitored by authorities established for such specific

purposes. In Malaysia, we have the Drug Control Authority.

Chelation therapy with EDTA would come under the category of

complementary medicine because its widespread use by some registered

medical practitioners is not how it had been used originally on

evidence-based therapeutic criterion.

By prescribing various supplements like large amounts of Vitamin C and

several B vitamins during chelation therapy for treatment of diseases

where there has been no scientific evidence adduced for their

effectiveness and efficacy in such diseases, registered medical

practitioners are, in fact, practising complementary medicine.

The onus to prove that chelation therapy, and other similar

complementary me- dical practices, is a sound, repeatable system of

therapeutics rests heavily on the proponents of complementary medicine.

Anecdotal testimony from patients is not enough.

Medical practitioners who treat their patients with chelation therapy

would have to show scientific evidence that their patients have improved,

not in the short term but more importantly, in the long term.

They have to produce documented case reports with long-term follow-up,

and data from autopsies of former patients. Doctors practising chelation

therapy have published no such data.

The few well-designed studies that have addressed the efficacy of

chelation for atherosclerotic diseases have been carried out by medical

scientists in the US Food and Drug Administration, the American Heart

Association, American Medical Association, American College of Physicians

and the University of Calgary, to name a few. Without exception, these

studies found no evidence chelation worked. There are many patients in

Malaysia who claim to have benefited from chelation therapy and some have

written testimonials and have volunteered to give evidence in person.

Many others who have not benefited remain silent sufferers.

The Medical Act 1971 has no jurisdiction over non-registered or

non-medical persons who practise complementary medicine or native

medicine or traditional medicine. But registered medical practitioners

who practise such medicine would clearly be misleading the public; and

presenting themselves as trained, registered and certified to practise

all systems of therapeutics, thereby adding credibility to their

practice.

There may be a place in the future for “integrative medicine”, but let

us not ignore the fact that even in advanced countries where such

practice is finding a niche, there is widespread opposition which cannot

be dismissed simply as a professional turf war.

The Ministry of Health is “keeping an open mind” about the practice of

complementary and traditional medicine in Malaysia.

It is a fact that the ministry and the universities are looking into

ways and means of regulating traditional and herbal medicine practice by

analysing the hundreds of such medications being sold openly in this

country.

Members of the public have the right to choose whatever system of

treatment they prefer for whatever reason.

But it is also the mandated right of the ministry to set the standards

of health care, and to demonstrate its duty and responsibility to point

out to the public the various pitfalls in any system and the unpleasant

consequences.

DATUK DR ABDUL HAMID ABDUL KADIR

Ethics Committee chairman Malaysian Medical Council Ministry of Health

NEW YORK — The number of older adults participating in sports activities increases after hip replacement but declines after knee replacement for osteoarthritis, research suggests.

Osteoarthritis or OA is a common age-related disease marked by degradation of joint cartilage. OA of the hip and knee can be particularly disabling because of related pain and functional impairment.

The restoration of function and reduction of pain afforded by joint replacement (arthroplasty) should allow a return to sports activities, but little is known about sports activities actually performed by people who undergo total joint replacement.

To investigate, Dr. Klaus Huch from University of Ulm, Germany and colleagues compared lifetime sports activities, preoperative sports activities, and sports activities five years after arthroplasty in 809 patients who underwent total joint replacement due to advanced OA of the hip or knee. They report their research in the Annals of the Rheumatic Diseases.

More than 90 percent of patients had performed sports activities during their life, the authors report, but only 36 percent of patients with hip OA and 42 percent of patients with knee OA maintained those activities at the time of surgery.

Five years after surgery, 52 percent of patients with hip OA were performing sports activities, the report indicates, but only 34 percent of patients with knee OA were performing sports activities.

Pain in the replaced joint as a reason for reduced sports activities was cited twice as often after knee arthroplasty as after hip arthroplasty, the researchers note, whereas precaution as a reason for reduced sports activities was cited more commonly after hip arthroplasty than after knee arthroplasty.

“In general, total joint replacement allows a significant increase of sports activities at a five-year follow-up,” the authors conclude. But they advise against a return to certain sports activities.

“At the moment we generally suggest moderate activity, but we advise against high-impact sports activities (with often uncontrolled and physically powerful joint movements — for example, soccer, downhill skiing, tennis) after total joint replacement.”

SOURCE: Annals of Rheumatic Diseases, December 2005.

NEW YORK — Pregnant women who work the night shift may be more likely than those with traditional work hours to deliver prematurely, study findings suggest.

On the other hand — and contrary to some past research — the study also found that physical demands on the job – including standing for most of the day or lifting heavy objects – were not related to premature delivery or having a smaller-than-normal baby.

Dr. Lisa A. Pompeii and colleagues at the University of North Carolina, Chapel Hill report the findings in the journal Obstetrics & Gynecology.

Previous studies into the pregnancy effects of on-the-job exertion have yielded conflicting results, according to the researchers. One reason, they note, may rest in differences in the ways the studies have defined and measured “exertion.”

For their study, Pompeii and her colleagues used data on more than 1,900 pregnant women in North Carolina who were interviewed about their work conditions through the seventh month of pregnancy.

The women reported, among other things, how many hours per day they spent standing, and how many times per day they lifted an object that weighed 25 pounds or more.

The researchers found that women who spent many hours on their feet — more than 30 per week — were no more likely than their peers to have a premature delivery or a smaller-than-average newborn. The same was true of women who repeatedly lifted heavy objects, even in excess of 13 times per week.

Relatively few women regularly performed heavy lifting — 10 percent during the first trimester, and about 6 percent later in pregnancy. About one-quarter spent most of the day standing while they were in the first trimester, and roughly 20 percent did so during the second trimester and seventh month.

But while physical exertion did not appear to promote early delivery, working the night shift did. Women who, at any point in pregnancy, worked between the hours of 10 p.m. and 7 a.m. were more likely than daytime workers to have a premature infant.

Those who worked the night shift during the first trimester, for example, were 50 percent more likely to deliver prematurely than their peers who worked day jobs.

The reason for the link is unclear, and the researchers stress that because relatively few women in the study worked the night shift — particularly in the seventh month of pregnancy — “it is necessary to interpret these findings with caution.”

There is some evidence that during pregnancy, activity in the uterus changes at night. It’s possible, the study authors speculate, that because night work disrupts the body “clock,” it affects normal activity of the uterus.

Other studies, the researchers note, have found that night work may suppress the hormone melatonin, which helps regulate the body’s normal functional rhythms. More research, they conclude, is needed to see whether melatonin is important in uterine activity during pregnancy, and whether changes in melatonin due to shift work affect pregnancy outcomes.

SOURCE: Obstetrics & Gynecology, December 2005.

By Amy Norton

NEW YORK (Reuters Health) – People who have an alcoholic
drink or two a day may have a lower risk of becoming obese than
either teetotalers or heavy drinkers, a study published Monday
suggests.

Researchers found that among more than 8,200 U.S. adults,
those who said they enjoyed a drink every day were 54 percent
less likely than non-drinkers to be obese. Similarly, those who
drank a little more (two drinks per day) or a little less (a
few drinks per week) had a lower risk of obesity than
teetotalers did.

Heavy drinking, on the other hand, raised the odds of
obesity. People who downed four or more drinks a day were 46
percent more likely to be obese than non-drinkers were. Binge
drinkers also showed a greater prevalence of obesity.

The findings are published online in the journal BMC Public
Health.

Many studies have linked moderate drinking to better heart
health, but only a few have looked at the relationship between
drinking and body weight.

“It’s a fairly new line of research,” said study co-author
James E. Rohrer, a professor of health services research at the
Mayo Clinic in Rochester, Minnesota.

It’s possible, he told Reuters Health, that the lower
prevalence of obesity among moderate drinkers helps explain the
lower risk of heart disease.

However, Rohrer stressed that the findings do not imply
that overweight people should take up drinking for the sake of
their waistlines. Alcohol is high in calories, and it’s not yet
clear why moderate drinking is related to lesser odds of
obesity.

Given that, Rohrer said, drinking should not be viewed as a
“weight-loss strategy.”

The study findings are based on data from a national health
survey of Americans age 18 and older, conducted between 1988
and 1994. The researchers focused their analysis on 8,236
participants who had never smoked.

Overall, half of current drinkers were in the normal weight
range, versus only about one-quarter of non-drinkers. Why this
is so is unclear, but, Rohrer noted, he and colleague Dr. Ahmed
Arif factored in the “usual suspects” in heart disease risk —
such as age, exercise levels, education and income — and
moderate drinking was still related to lower odds of obesity.

Though he cautioned against taking up drinking to trim the
waistline, Rohrer also said the findings suggest that
completely cutting out alcohol might backfire as a weight-loss
plan.

SOURCE: BMC Public Health, online December 5, 2005.

By John Reid Blackwell

Drug maker Merck & Co. will keep its Elkton plant open.

The New Jersey-based company said this week that it will close or sell five of its 31 plants as it restructures. The Rockingham County plant, which employs about 800 Virginians, will see no immediate impact on jobs, its human resources director said.

On Monday, Merck said it would reduce operations at other sites, laying off 7,000 people in three years.

The company said Wednesday that it will shut down some operations in Japan and eliminate jobs in England and New Jersey. Workers at plants in Albany, Ga., and Riverside, Pa., were notified that those facilities will be closed or sold. In addition, 235 jobs will be cut at Merck Frosst Canada.

The Virginia plant produces pharmaceuticals and chemical intermediates. In February, Merck announced a $40 million expansion of the plant to produce a vaccine the company is developing. That expansion is under way, and the company expects the new operation to begin in 2007, said Frank Burks, human resources director at the plant.

Although Merck’s Web site lists a Glen Allen site, the company has provided no information about it. Phone numbers listed for that office have been disconnected.

By PETER GOTT, M.D. Newspaper Enterprise Association

Dear Dr. Gott: I’ve been diagnosed with abnormal protein. I’m told there is no treatment for this condition. I’ve been treated for arthritis for years, and my doctor tells me it may be the protein causing the pain in my joints. This protein also makes my thyroid show up overactive in all blood tests. Can you tell me what part this condition plays in my overall health picture?

Dear Reader:: I’m not sure what you mean by abnormal protein because there are many medical conditions associated with excess or abnormal proteins in the body. For example, multiple myeloma, a form of blood cell cancer, causes elevated blood proteins that can plug up the kidneys, leading to renal failure.

Also, chronic illness can lead to production of an abnormal protein, called amyloid, that may cause organ damage. Finally, most autoimmune disorders, such as lupus and rheumatoid arthritis, are marked by unusual proteins in the blood.

From your brief description, I’d say you probably have an autoimmune disease that is affecting your joints and your thyroid gland. This could be a combination of diseases, such as rheumatoid arthritis and hyperthyroidism, or it might be a single malfunction of protein synthesis affecting many organs. Using selective blood tests, your doctor should be able to clarify your problem.

Obviously, your health will be affected by any protein abnormality; therefore, it’s important for the physician to establish a diagnosis that is more specific than “abnormal protein.” Once the abnormality has been suitably categorized, you can receive appropriate treatment.

For instance, therapy for rheumatoid arthritis includes anti- inflammatory drugs; treatment of hyperthyroidism requires anti- thyroid medication (or radioactive iodine), and management of lupus often necessitates cortisone. Usually, once the underlying disorder is brought under control, the consequences of the abnormal proteins improve and patients return to relatively good health.

I suggest you discuss these issues with your physician, who will explain your disease and recommend treatment.

Dear Dr. Gott: I’m scheduled to have a bunionectomy shortly, and I have a tendency to develop keloids. What, if any, complications could the keloids cause to impede the healing process?

Dear Reader:: Keloids are excessive scar formation. Their cause is unknown. Keloids can follow injury or surgery, but the extent of keloid formation is impossible to predict. In my experience, keloids rarely appear on the feet. Therefore, it’s probably safe to have your bunion operation.

Remember that keloids, being scars, do not interfere with healing: They’re actually part of the healing process. When a keloid causes symptoms (such as pain or skin irritation), it can be surgically removed.

Write Dr. Gott c/o United Media, 200 Madison Ave. 4th floor, New York, NY 10016

NEW YORK — Two reports highlight the emergence of a new, highly toxic strain of the bacterium Clostridium difficile that is resistant to fluoroquinolone antibiotics, such as Cipro (ciprofloxacin) and Levaquin (levofloxacin), and is causing geographically dispersed outbreaks.

The reports were released early by The New England Journal of Medicine to coincide with this week’s report by the Centers for Disease Control and Prevention C. difficile infections in low-risk patients.

C. difficile is a microbe that can be a member of the normal bacterial colonies that live in the intestines. Problems occur, however, when neighboring bacteria are disturbed allowing an overgrowth of C. difficile, which typically results in a foul-smelling watery diarrhea. Overuse of certain antibiotics is one common cause of such disturbances.

The CDC has received an increased number of reports from health care facilities of cases of severe C. difficile-associated disease, according to one of the papers. Dr. L. Clifford McDonald, from the CDC in Atlanta, and colleagues say this suggests the emergence of an epidemic strain with increased virulence, antibiotic resistance, or both.

To test this hypothesis, the research team collected 187 C. difficile samples from outbreaks since 2001 in eight health care facilities in six states, and compared their characteristics with those of 6000 samples obtained between 1984 and 1990.

More than half of the recent samples were of one strain, termed BI/NAP1. Testing showed that this strain was particularly resistant to fluoroquinolone antibiotics.

By contrast, just 14 of the 6000 isolates obtained in the past were of this strain, the report indicates.

“If this epidemic strain continues to spread and to contribute to increased (disease and death), it will be important either to reconsider the use of fluoroquinolones or to develop other innovative measures for controlling C. difficile-associated disease,” McDonald’s group writes.

They stress the need for strict infection-control measures. Because alcohol does not kill C. difficile spores, they recommend that health care workers wash their hands with soap and water instead of using alcohol-based hand sanitizers during outbreaks.

According to a second report, Canadian researchers, led by Dr. Vivian G. Loo from McGill University Health Center in Montreal, identified 1719 episodes of C. difficile-associated diarrhea at 12 Quebec hospitals between January and June of 2004.

From 1997 to 2004, the rate of infections increased from 6 to 22.5 cases per 1000 admissions. Moreover, in 2004, nearly 7 percent of patients with this infection died within 30 days compared with 1.5 percent in 1997.

The predominant strain was similar to that observed by McDonald’s group and was resistant to ciprofloxacin, moxifloxacin, gatifloxacin and levofloxacin.

Loo’s team conducted a study comparing 237 patients with C. difficile-associated diarrhea with 237 patients outcome this problem. They found that treatment with cephalosporin antibiotics or fluoroquinolones increased the risk of this diarrhea by nearly fourfold each.

In an editorial accompanying the two papers, Drs. John G. Bartlett and Trish M. Perl, from Johns Hopkins University School of Medicine in Baltimore, point out that standard stool tests will not identify this epidemic strain.

They therefore advise that “physicians and infection-control personnel need to monitor for an increasing (rate) of C. difficile-associated disease on the basis of some classic features” in patients who have recently been treated with antibiotics.

SOURCE: The New England Journal of Medicine, December 8, 2005.

ARAMARK (NYSE:RMK), a world leader in managed services, announced today that ARAMARK Education – Facility Services has been awarded a 5-year, $60 million contract to provide custodial, maintenance and ground services to the Providence School Department in Providence, Rhode Island.

ARAMARK will manage facility services, custodial, grounds, and maintenance in all 53 elementary, middle and high schools in the Providence School Department. The Providence Schools have an enrollment of more than 26,000 students.

“The City of Providence is pleased to partner with ARAMARK as they begin providing custodial and maintenance services to our public schools,” said Providence Mayor David N. Cicilline. “The ARAMARK team has already become an important partner in our efforts to provide a quality educational experience for our children.”

“We are proud to support the Providence School Department’s vision of schools as active, vibrant communities that foster a love for learning,” said Frank Mendicino, President, ARAMARK Education – Facility Services. “ARAMARK’s goal is to progressively partner with the City of Providence to demonstrably improve the quality of its school buildings and positively contribute to the educational experience of its students, faculty and staff. We are confident that our action plans, created in partnership with Providence Schools, will achieve this goal.”

ARAMARK Education provides a complete range of food, facility, uniform and other support services to more than 650 K-12 school districts in the U.S. It offers public and private education institutions a family of dining and facility services including: on-site and off-site breakfast and lunch meal programs, after-school snacks, summer and adult feeding, catering, nutrition education, retail design and operations, maintenance, custodial, grounds, energy management, construction management and building commissioning. For more information on ARAMARK Education please visit www.aramarkschools.com.

About ARAMARK

ARAMARK Corporation is a world leader in providing award-winning food and facilities management services to health care institutions, universities and school districts, stadiums and arenas, and corporations, as well as providing uniform and career apparel. ARAMARK was ranked number one in its industry in the 2005 FORTUNE 500 survey and was also named one of “America’s Most Admired Companies” by FORTUNE magazine in 2005, consistently ranking since 1998 as one of the top three most admired companies in its industry as evaluated by peers. Headquartered in Philadelphia, ARAMARK has approximately 242,500 employees serving clients in 20 countries. Learn more at the company’s Web site, www.aramark.com.

Forward-Looking Statements

Forward-looking statements speak only as of the date made. We undertake no obligation to update any forward-looking statements, including prior forward-looking statements, to reflect the events or circumstances arising after the date as of which they were made. As a result of these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements included herein or that may be made elsewhere from time to time by, or on behalf of, us.

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect our current views as to future events and financial performance with respect to our operations. These statements can be identified by the fact that they do not relate strictly to historical or current facts. They use words such as “aim,””anticipate,””are confident,””estimate,””expect,””will be,””will continue,””will likely result,””project,””intend,””plan,””believe,””look to” and other words and terms of similar meaning in conjunction with a discussion of future operating or financial performance.

These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements. Factors that might cause such a difference include: unfavorable economic conditions, ramifications of any future terrorist attacks or increased security alert levels; increased operating costs, including labor-related and energy costs; shortages of qualified personnel or increases in labor costs; costs and possible effects of union organizing activities; currency risks and other risks associated with international markets; risks associated with acquisitions, including acquisition integration costs; our ability to integrate and derive the expected benefits from recent acquisitions; competition; decline in attendance at client facilities; unpredictability of sales and expenses due to contract terms and terminations; the risk that clients may become insolvent; the contract intensive nature of our business, which may lead to client disputes; high leverage; claims relating to the provision of food services; costs of compliance with governmental regulations and government investigations; liability associated with non-compliance with governmental regulations, including regulations pertaining to food service, the environment, Federal and state employment laws and wage and hour laws; import and export controls and customs laws; dram shop litigation; inability to retain current clients and renew existing client contracts; determination by customers to reduce outsourcing and use of preferred vendors; seasonality; and other risks that are set forth in the “Risk Factors,””Legal Proceedings” and “Management Discussion and Analysis of Results of Operations and Financial Condition” sections of and elsewhere in ARAMARK’s SEC filings, copies of which may be obtained by contacting ARAMARK’s investor relations department via its website www.aramark.com.