Dirty Dancing: Women Learn the Art of Striptease While Getting an Aerobic Workout

By Shannon Pease, The Miami Herald

May 22–Pole dancing is not just for strippers anymore.

The high-energy activity is taking place at clubs and at gyms, appealing to women in all walks of life, from housewifes to high-powered executives.

On Sunday, a group of women, clad in yoga pants and tank tops, learned the basics of pole work at Scores, an Oakland Park strip club, which hosted its first-ever class — taught by three of Scores’ professional dancers.

“Not everybody is cut out to go to the gym,” said Andrea Amenta, director of public relations for Scores. “With this, it’s a little bit more fun.”

Participants who began the class shy and reserved were rotating around the neon poles by the end of the two-hour session, which took place during the club’s off-hours.

“I think it’s intriguing, and it adds a certain level of exotic element to a relationship,” said Darlene Kaufman. “It’s fun and it’s new. It keeps things fresh.”

The 10 students began the class by learning to walk seductively. They then slowly took on the challenge of striptease, slowly peeling off layers of garments worn over their exercise gear.

Those with the upper body strength and stamina decided to follow the lead of the instructor, and took a shot at climbing the pole.

PRIVATE DANCING

Mayrav Bond said Sunday’s class wasn’t the toughest workout she’s ever had; she was in it only for the fun.

“What woman doesn’t want to entice her man?” said the 32-year-old lawyer.

Similar classes are offered at local gyms, and even at home parties.

Crunch Fitness in Miami Beach touts a clothed cardio striptease with focus on upper body and core strengthening, while Mind Body Connection in Cooper City boasts a cardio “strip” aerobics class.

‘I always tell people ‘You’ll have a newfound respect for strippers after you take this class,’ ” said Mind Body Connection owner Eileen Owoc.

“It looks easy, but try to get yourself off the ground one inch — it’s hard,” Owoc said.

NEW TREND

The pole dancing trend was made popular by Sheila Kelley’s S Factor workout. The S Factor offers classes in several states and sells a series of home tutorials.

For those who prefer to practice in the privacy of their own home, A Pole Lot of Fun delivers. The Davie-based business advertises women-only parties that come complete with a pole, music and champagne.

While some of the ladies are toning up, others do it to spice up their private lives, Scores’ Amenta said.

Those who wish to “show off their new talents” will be given an opportunity to perform for their significant others in a private VIP area at the club, Amenta said.

“I think it is an opportunity for female empowerment,” Amenta said. “It’s about building inner strength. Just boosting one’s confidence.”

Owoc agreed.

“When in their life will these women in Cooper City be this close to the pole?”

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Copyright (c) 2006, The Miami Herald

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].

Medco Workers Ratify New Union Contract

By Hubble Smith, Las Vegas Review-Journal

May 25–Nearly 600 workers at the Medco Health Solutions mail-order pharmacy plant in Henderson will return to work Friday after ratification of a new three-year union contract, ending a 49-day lockout by the company.

The new contract provides for a medical and dental plan that cannot be altered or changed during the term of the contract, United Steelworkers spokeswoman Lynne Baker said Wednesday.

Other benefits such as life insurance, accidental dismemberment and disability insurance and 401(K) retirement plans have also been restored, she said. Any changes have to be negotiated.

The ratification comes after pharmacy technicians and support staff represented by USW Local 675 were locked out by Medco on April 5. Workers had refused to give up their right to bargain over benefits and were “illegally” locked out, Baker said.

The three-year contract runs retroactively from Sept. 1, 2005, through Sept. 1, 2008. Workers will receive a lump sum of $2,100, an immediate wage increase of 3.5 percent and similar wage increases each September through 2007. Workers will also get $850 bonuses in 2007 and 2008.

“The labor movement joined together to support our locked-out members,” Baker said. “They wrote to Medco and said they would be changing their business to another (pharmaceutical) provider if the lockout didn’t end. I’m talking to people now who are ready to move their business and we’re telling them everything’s settled, keep going with Medco. We’re steering business back to them as we speak.”

Soraya Balzac, spokeswoman for New Jersey-based Medco, said terms of the contract advance Medco’s imperative to operate efficiently and cost-effectively.

“It’s certainly a fair and equitable agreement,” she said. “We recognize contract negotiations require give and take on both sides. This allows the company to retain our competitive position.”

Negotiations have begun for about 800 workers at Medco’s mail-order pharmacy in Columbus, Ohio, and 300 workers at Medco’s call center in Tampa, Fla.

—–

To see more of the Las Vegas Review-Journal, or to subscribe to the newspaper, go to http://www.lvrj.com.

Copyright (c) 2006, Las Vegas Review-Journal

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].

MHS,

Boot camp for women battles image of Japan’s army

By Isabel Reynolds

OYAMA, Japan (Reuters) – They swapped their floral blouses
for camouflage gear, their running shoes for heavy black boots
and the comforts of home for narrow bunk beds and an early
morning bugle call.

Thirty-two young women got a taste of life in the Japanese
military last week as they took part in the “Miss Parsley”
tour, a public relations event aimed at women in their 20s, who
the polls show to be least interested in defense issues.

“Does it suit me? Does it suit me? I kind of like it,”
giggled Yoko Ito, a 25-year-old Osaka office worker, as she
tried on a sniper’s camouflage suit, complete with leafy
headdress, and brandished a replica gun.

Like others on the two-day stay at the Fuji School, an
officer training center in the scenic foothills of Japan’s most
famous mountain, Ito admitted her knowledge of the armed forces
was hazy.

“I just vaguely wondered what they did,” she said. “At the
time of the Kobe earthquake (in 1995) a lot of houses in my
area fell down, so I saw them on rescue missions. Japan is so
peaceful.”

Japan’s armed forces, known officially as the Self-Defense
Force, exist in legal limbo under a U.S.-drafted pacifist
constitution which bans the maintenance of a military but has
been interpreted as allowing a force for self-defense, and
which renounces the country’s right to go to war.

Due to the tight restrictions on its activities, many
Japanese see the military as glorified firefighters rather than
a highly trained and well-equipped force of 235,000, boasting
an annual budget of 4.8 trillion yen ($43 billion).

“People have an image of the Self-Defense Force as only
involved in disaster relief,” said Lt.-Col. Masaru Kawai, one
of the organizers of the tour.

“But it is our duty to defend the country, so we want them
to see the facilities we have at Fuji School and what they can
do.”

TANKS AND AZALEAS

The women certainly seemed impressed, gasping as elite
Ranger troops abseiled from a 15-yard tower and slid belly-down
along a rope slung between two trees, on a trip that veered
between coddling and military harshness.

“Take care not to fall out, little ones,” a uniformed group
leader called as she helped two visitors clamber into a Type 90
tank for a high-speed ride around a muddy exercise ground.

“Does anyone need the toilet? Just let us know if you don’t
feel well,” other troops chorused.

But amid the hilarity and frequent photo sessions against a
backdrop of pink and white azalea blooms were tastes of real
military life.

The “recruits” tried rock-climbing and rope-crawling,
marched in strict formation and were made to do push-ups when
they failed to obey orders.

The annual event has been held for more than a decade, but
the ruling Liberal Democratic Party’s plans to change the
constitution to clarify the legal position of the armed forces
— and a decision to send a small number of troops to Iraq —
have made defense a political issue in a country often
described as “dazed by peace.”

Tour participants were divided on the need for change.

“Everyone sees Japan as very peaceful at the moment, so
they want to keep the constitution as it is,” said Rie Hosoda,
a 28-year-old systems engineer.

“But if we are attacked, we won’t be in a position to keep
it. It’s not that I want to change it right now, but I think
it’s only natural that it should change along with the
situation.”

SCARY REALITY

Others said they hoped Japan’s military would continue to
devote itself to disaster relief.

“I only really knew about their humanitarian activities,”
said Natsue Yawata, a 23-year-old medical student.

“But talking to everyone here, I realize they are more
focused on defending the country. It’s a bit scary. I don’t
want the world to become the kind of place where the military
has to be more active.”

Named after a cartoon character the defense agency uses to
represent the female contingent of the armed forces, the “Miss
Parsley” tour is not directly intended to boost recruitment,
but several visitors said they were keen to join up.

Women have been recruited as nurses since the military was
reestablished in 1954, and almost all branches of the armed
forces were opened to women in 1993.

The number of female troops has ballooned from 57 in 1955
to nearly 11,000 last year, but only about one in every 100
female applicants for officer-level entry makes the grade.

Another possible side effect of the tour emerged as the
visitors waved a tearful goodbye to their military mentors and
left by bus for the station.

“We want you to become fans of the armed forces,” one tour
supervisor told the women. “Bear in mind that military men make
excellent husbands — they all know how to cook and clean.”

AngloGold fights malaria to boost Ghana efficiency

By Orla Ryan

OBUASI, Ghana (Reuters) – Ghanaian mineworker James Ankoma
knows what it is like to be laid low with malaria.

“Body weakness, painful joints, high temperatures and
chills,” he says, listing the symptoms of a disease which the
World Health Organization (WHO) estimates kills over one
million people a year globally, many of them in sub-Saharan
Africa.

Already this year, Ankoma has taken four days off work at
Ghana’s oldest mine, Obuasi, to recuperate from malaria. And he
isn’t the only one.

Ankoma’s employer, gold giant AngloGold Ashanti, estimates
malaria costs it $4.5 million a year at Obuasi in absenteeism,
lost productivity and treatment costs.

“It brings down the strength of the workers in Obuasi, it
can also affect the income of the worker,” Ankoma said.

Obuasi, which has a 30-year mine life and employs 8,000
people, is AngloGold’s biggest mine in Ghana, Africa’s
second-biggest exporter of gold after South Africa.

AngloGold hopes to reduce its malaria bill with an
aggressive anti-malaria campaign, which aims to halve the
incidence of the disease in Obuasi by 2008.

By August every house in Obuasi will have been sprayed with
insecticide in the first stage of an ongoing program aimed at
killing the mosquitoes which carry the disease.

AngloGold officials said the chemical is not DDT. The
mosquitoes in the Obuasi mine area, as in many other parts of
Ghana and Africa, have become resistant to DDT, which also has
a bad environmental reputation.

Every day 116 sprayers are at work in the ramshackle shanty
towns that make up Obuasi, spraying walls, under tables, beds
and behind pictures and attaching a blue sticker to every
treated home.

Under the program, which will run indefinitely and cost
$1.3 million a year, some bed nets will be given away while
more will be sold at subsidized prices.

SHAFTS LIKE TENTACLES

With its deep underground shafts spread like tentacles
through the town, the AngloGold Ashanti plan targets 250,000
residents in Obuasi as well as the mine employees.

Gold Fields Ltd., AngloGold and Golden Star may link up to
run a similar scheme in Tarkwa, a mining town near which all
three firms have operations, Steve Knowles, manager of the
AngloGold’s Malaria Control Program, said.

“It makes economic sense, you are not just giving money to
the community, that is what you can sell to head offices and
board rooms,” Knowles said.

The pungent smell of the insecticide deters some residents
but the vast majority want to take part.

For Josephine Oduro, so sick with malaria during pregnancy
that she lost her baby at birth, the spraying may free her and
her family from the threat of the disease.

Her two children, Jacob, 6, and Franklin, 3, frequently get
malaria and each hospital treatment sets her back 100,000 cedis
($11), a hefty figure for a market trader.

“We have just been sprayed for the first time, I believe it
will work,” she said.

Water Pipes, Smokeless Tobacco Harmful, WHO Warns

By Laura MacInnis

GENEVA — Water pipes and smokeless tobacco products have gained in popularity among young people worldwide, many of them unaware that they are as harmful as cigarettes, the World Health Organization (WHO) said on Tuesday.

In a warning issued on the eve of World No Tobacco Day, the United Nations agency said those smoking flavored tobacco through water pipes, once predominant in the Middle East and now found in trendy cafes across Europe and North America, inhale dangerous amounts of carbon monoxide, nicotine and tar.

“The idea that bubbling smoke through water is going to somehow reduce the toxins is completely false,” Douglas Bettcher of the WHO’s Tobacco Free Initiative told a news conference.

Water pipes often lack standardized health warnings used for cigarettes, which “may reinforce the assumption of relative safety,” according to a WHO report entitled “Tobacco: Deadly in Any Form or Disguise.”

Yet a growing body of evidence confirmed waterpipe smoking caused lung disease, cardiovascular disease and cancer, it said.

Bettcher also warned that smoke-free products, generally consumed by chewing, sucking or pressing small pieces of tobacco between the gum and cheek, were “no safer than the other smoked tobacco products.”

Most popular in India, Scandinavia and the United States, the WHO said smokeless tobacco was highly addictive, and has been linked to cancers of the head, neck, throat and esophagus as well as serious dental conditions.

The agency noted the popularity of cigarette alternatives has led to worrisome high tobacco consumption rates among girls, particularly in Middle Eastern and other countries where smoking among women is considered uncouth.

While adult men now generally smoke more than women, WHO spokeswoman Marta Seoane said the addiction of a new generation of girls could boost the numbers of those afflicted with disease or dying from tobacco in 15 years’ time.

“The global public health problem is going to be multiplied, because those rates are going to be so much higher for future female smokers,” Seoane said, recommending that countries broaden tobacco control efforts and launch awareness programs geared toward girls.

The WHO launched its Tobacco Free Initiative in 1998 to focus international attention on tobacco, which kills five million people a year.

Some 128 countries have ratified its 2003 tobacco control treaty, which came into force a year ago, and bans advertising, promotion and sponsorship of tobacco products.

Given the wide use of new products, Tobacco Free Initiative Director Yumiko Mochizuki-Kobayashi said the WHO forecast that 10 million people would die from tobacco-related health conditions every year by 2020 was “very, very under-estimated.”

Mochizuki-Kobayashi said countries needed to ensure the full disclosure of the ingredients and health effects of all tobacco products, and not just cigarettes.

Pensioners Seek Paradise in Panama Mountain Idyll

By Mike Power

BOQUETE, Panama — Perched on a volcanic plain in the highlands of western Panama, Casey Koehler’s luxury mansion looks like a slice of prime Florida real-estate beamed down to Central America.

Diamonds flaring in his Rolex watch, the Michigan-born retiree sits on his porch in the resort of Los Molinos and lists reasons for retiring to a country most Americans his age remember best as the scene of a 1989 U.S. invasion.

“It’s 77 to 82 degrees every day, and it’s spectacularly beautiful,” said Koehler, 65, who moved to Panama last year. “This house cost me $230,000. In Florida it would be $1.5 million.”

Politically and economically stable, its turbulent history all but forgotten by visitors, Panama is luring U.S. and European retiree baby-boomers dreaming of a millionaire lifestyle on the cheap.

Eager to follow neighboring Costa Rica as a magnet for wealthy U.S. and European pensioners fleeing high real estate prices at home, Panama, which uses the U.S. dollar as its currency, is offering perks to retirees ranging from tax breaks to discounts on travel, cinema tickets and fast food.

Much of rural Panama is still dirt-poor with a very basic infrastructure, and while the gleaming skyscrapers of the cosmopolitan capital Panama City are only a short flight from Miami, the city is too hot for most newcomers.

Retirees are instead flocking to the area around Boquete, a cool mountain town famous for growing coffee and oranges, where small wooden houses are decked with tropical fruit and flowers year-round and old men play dominoes in the shade.

U.S. and European retirees are transforming it into a chic enclave with bistros, a 24-hour supermarket and delicatessens.

CHEAP AND CHEERFUL

Boquete is a world away from the image of a typical “banana republic” that stuck in the minds of many baby-boomer Americans who watched television images of the 1989 U.S. invasion to remove dictator Manuel Noriega and the rioting that followed.

Gleaming SUVs jostle for parking space in Boquete’s narrow streets. Foreign pensioners scour bistro menus for low-cholesterol dinners while pouring over maps in search of land to buy. With prices rocketing from $10 to $300 per square meter (yard), there’s a gold-rush whiff in the air.

Koehler, a former Central Intelligence Agency worker, said cheaper living partly drew him to Panama. He said that while he spent $5,000 a month in the United States to live in none-too-opulent style, he now spent only $1,200 a month and wanted for nothing.

Others, like Ramona and Charles Holmes, who moved to Boquete from California last year, dote on its slower, peaceful pace and its unspoiled beauty.

“People thought we were crazy,” says Ramona, a 50-year-old former legal clerk. “They thought we’d be kidnapped. That’s just silly. OK, sometimes we find snakes and tarantulas on our property, but it’s so beautiful here you could cry.”

Developer Sam Taliaferro built Valle Escondido, a 200-home gated community for retirees, on a coffee farm in Boquete. Laughing, sun-tanned pensioners scoot around on golf carts in the landscaped environment. “When we wake up, we say, ‘Wow, we’re in paradise,”‘ he enthuses.

Taliaferro says he wants to haul Boquete, and especially the local Ngobe Bugle indigenous group which once relied on sporadic coffee-picking work for a living, into modernity.

“Now there is something more for the Indians to do than pick coffee,” he said. “They are actually waiting on tables, sitting by computers. They’re moving from a third-world to a first-world economy.”

PARADISE AT A PRICE

However, not everyone is thrilled with the new influx.

Some Boquete locals say the boom, which has pushed up demand, is creating imbalances in its economy which are hitting the Ngobe Bugle hardest, such as localized inflation that is putting products like meat out of their reach.

“We eat meat once a week now. Before, we ate it a little more than that,” said Ngobe Bugle coffee-picker Eric Gomez.

Teacher Johnny Zapata said the new arrivals should adapt to their new natural and social environment rather than trying to change it.

“They want to stop our festivals; they say we are too scandalous,” he said. “Also, the climate is changing as they cut down trees.”

Francisco Serracin of Panama’s Specialty Coffee Association, says some gourmet plantations are being cleared for new homes. “It could become a threat to the industry. There will be very few of us left who believe in coffee,” he says.

Nearby, the church in this devout town has placed a sign in the street bearing a caveat: “Boquetean, if you sell your land, it will die. If you don’t, it will live. Think about yourself and your country.”

A four-by-four vehicle roars past the notice, racing up the mountain to where the coffee bushes droop with jasmine-scented flowers as harvest time approaches.

Canadians healthier than Americans – study

By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) – Despite complaints about long waits
for services, Canadians are healthier than their U.S. neighbors
and receive more consistent medical care, according to a report
released on Tuesday.

A telephone survey of more than 8,000 people showed that
even though Americans spend nearly twice as much per capita for
health care, they have more trouble getting care and have more
unmet health needs than Canadians do.

The survey was done by Harvard Medical School researchers
who include members of Physicians for a National Health
Program, which advocates for a national health program in the
United States.

“These findings raise serious questions about what we’re
getting for the $2.1 trillion we’re spending on health care
this year,” said Dr. David Himmelstein, an associate professor
of medicine at Harvard.

“We pay almost twice what Canada does for care, more than
$6,000 for every American, yet Canadians are healthier, and
live two to three years longer,” Himmelstein added in a
statement.

“Canadians had better access to most types of medical care
(with the single exception of pap smears),” Himmelstein and
colleagues wrote in the study, published in the American
Journal of Public Health.

“Canadians were 7 percent more likely to have a regular
doctor and 19 percent less likely to have an unmet health need.
U.S. respondents were almost twice as likely to go without a
needed medicine due to cost (9.9 percent of U.S. respondents
couldn’t afford medicine versus 5.1 percent in Canada),” they
added.

UNMET NEEDS

“After taking into account income, age, sex, race and
immigrant status, Canadians were 33 percent more likely to have
a regular doctor and 27 percent less likely to have an unmet
health need.”

The researchers analyzed data from a telephone survey of
3,505 Canadian and 5,103 U.S. adults.

They wanted to see if there were any differences in health
between Canadians, who have a tax-supported national health
care system, and Americans, whose health care largely depends
on private insurers, employers or the free market, with older
Americans and the very poor cared for by Medicare, Medicaid and
other joint federal-state health insurance plans.

The researchers found that U.S. residents had higher rates
of diabetes, arthritis, chronic lung disease, high blood
pressure and obesity.

“Most of what we hear about the Canadian health care system
is negative; in particular, the long waiting times for medical
procedures,” Dr. Karen Lasser an instructor of medicine at
Harvard who worked on the study, said in a statement.

“But we found that waiting times affect few patients, only
3.5 percent of Canadians versus 0.7 percent of people in the
U.S. No one ever talks about the fact that low-income and
minority patients fare better in Canada,” she added.

“Based on our findings, if I had to choose between the two
systems for my patients, I would choose the Canadian system
hands down.”

The researchers said the study population was
representative of 206 million U.S. adults and 24 million
Canadian adults but noted that only half the Americans
contacted took part in the survey, and 60 percent of the
Canadians.

Doctor’s Unorthodox Treatments Land Him in the `Lyme Wars’

CHARLOTTE, N.C. _ By the time DeAnn Lipe found Dr. Joseph Jemsek, she had been sick for seven years.

It started with pain in her chest and tingling in her toes. Then came pain in her hips and left eye, memory loss and incredible fatigue.

Doctors diagnosed allergies, gallbladder disease and depression. They prescribed steroids, antibiotics and antidepressants. Nothing helped.

Then a nurse friend noticed a rash on Lipe’s arm and referred her to Jemsek, an infectious disease specialist. At his Huntersville, N.C., clinic, Lipe found her answer _ Lyme disease.

That diagnosis put her in the middle of a national medical dispute that has been dubbed the “Lyme Wars.”

At the center of the fight is Jemsek, one of 30 doctors in 10 states to be brought before licensing boards for discipline because of the way they diagnose and treat the tick-borne disease.

Jemsek and other so-called “Lyme-literate” doctors say chronic Lyme disease is rampant, often ignored and needs to be treated with antibiotics, both orally and intravenously, for months or even years.

Mainstream physicians say the approach of aggressive Lyme doctors is dangerous and without scientific merit. Persistent Lyme disease is rare, they say, and there is no evidence to support treatment with antibiotics for such a long time.

In North Carolina, the medical board alleges that Jemsek diagnosed and treated at least 10 patients for Lyme disease when they did not have it.

One of the patients died. Another, Phillip Moore, said he got worse while taking IV antibiotics for more than four months. “He was treating me for something he couldn’t prove I really had.”

Moore expects to testify against Jemsek when the two sides face off at a public hearing in Raleigh on June 14.

Jemsek’s focus on Lyme disease came after years of concentrating on HIV. He diagnosed the first AIDS case in Mecklenburg County, N.C., in 1983, and opened his own AIDS clinic in 2000.

Several months later, he saw a patient who changed his career.

“Do you treat Lyme disease?” she asked.

Of course, Jemsek said.

The patient said many doctors don’t believe Lyme disease exists in the Southeast. Jemsek didn’t balk. He prescribed tetracycline, an antibiotic in a pill.

Soon after, another Lyme patient contacted Jemsek. Then another and another.

They’d heard by word of mouth or over the Internet that he was a Lyme-literate medical doctor, willing to treat their difficult problems.

Their stories were similar: foggy memories, extreme fatigue, unusual pain, fevers, numbness in their limbs. They had been diagnosed with many ailments, including Rocky Mountain spotted fever, depression, multiple sclerosis and chronic fatigue syndrome.

It reminded Jemsek of the early days of AIDS, when few doctors wanted to treat it and patients were desperate. He says he had a feeling: “There’s something here.”

To learn more, Jemsek attended a meeting of the International Lyme and Associated Diseases Society. It was created in 1998 to support doctors who believe mainstream medicine has ignored patients with chronic Lyme disease.

At first, Jemsek thought many of the presentations were strange. “They scared the hell out of me,” he said, and he considered leaving.

But he met a few doctors who impressed him with their knowledge and passion. They compared patients and treatments and talked about the need for more research.

“Essentially it’s been trial and error,” said Dr. Raphael Stricker, a California hematologist and president of the Lyme society. “Patients remain ill after standard therapy, but when you put them on longer treatment, they tend to do very well.”

The two published studies on long-term antibiotic treatment for Lyme disease showed no benefit. But Stricker and Jemsek say the studies were flawed and the treatment didn’t last long enough to be helpful. They point to a third, as yet unpublished study by a Columbia University researcher who found improvement in chronic Lyme patients who received antibiotics for 70 days.

One of Stricker’s most famous patients is best-selling author Amy Tan, whose works include “The Joy Luck Club” and “The Kitchen God’s Wife.” She has written a chapter about her Lyme disease in “The Opposite of Fate,” a book of essays. “I am in this for the long haul,” she wrote, “with treatment that will likely last for years.”

So far Jemsek has evaluated 2,000 patients for Lyme disease from 42 states and as far away as Europe. Today, he is treating about 400 Lyme patients in addition to 1,200 HIV patients.

He says blood tests for Lyme disease aren’t always accurate, and the chronic disease is more prevalent than most doctors believe. “We get so wrapped up in our tests, we forget to talk to the patient. You have to go back to what you see with your eyes.”

If it’s caught early, Lyme disease is easily treated.

The Lyme Wars erupted over what happens when the disease isn’t detected initially.

The U.S. Centers for Disease Control and Prevention advises looking for a tick bite, a classic bull’s-eye rash and symptoms such as joint pain and fever.

Mainstream doctors acknowledge some Lyme patients will have persistent nervous system and heart problems even after treatment. But Allen Steere, the Yale University specialist who first identified an outbreak in Lyme, Conn., in 1976, said those patients will have specific symptoms and test results. They are also rare, Steere said, because doctors are better at diagnosing and treating early disease.

Blood tests aren’t good at detecting early disease, but they are reliable for late-stage disease, said Paul Mead, an epidemiologist for the CDC. If weeks or months have passed since the initial infection, Mead said, antibodies should be present. Someone with Lyme disease should test positive.

Based on recommendations of the Infectious Diseases Society of America, most doctors believe four weeks of oral antibiotics _ or a second four weeks in extreme cases _ is all that research supports. “If there was evidence (for longer treatment), I’d jump on the bandwagon,” said Eugene Shapiro, an infectious disease specialist at Yale.

People who take antibiotics for a long time risk getting an infection in the catheters used to deliver IV medicine, Shapiro said. Also, overuse of the drugs can lead to antibiotic-resistance “superbugs.”

“You have potential adverse effects without any benefit,” he said.

Phillip Moore, a 40-year-old Concord patient who expects to testify for the medical board in June, said Jemsek never explained to him that long-term antibiotic therapy for Lyme disease was not standard practice.

Like many of Jemsek’s patients, Moore had spent more than a year seeing specialists who couldn’t figure out what caused his health problems, including chronic diarrhea. His family doctor referred him to Jemsek, who diagnosed Lyme disease.

“I just wanted to feel better,” Moore said.

He started IV antibiotics in September 2004, and a month later he became so ill he took a leave of absence from work. “I was just weak and pale. It was affecting my personality.” He noticed mood swings, anxiety and angry “road rage” episodes.

After 4 { months, Moore asked Jemsek to take the IV catheter out of his arm. He didn’t feel any better, and he was suspicious of the treatment, which he said cost his insurance company thousands of dollars a month. Two other specialists told him they thought he never had Lyme disease.

While Moore was in treatment, Jemsek was building a new $8 million Huntersville, N.C., office complex, which opened in January.

“It should have a wing dedicated to me,” Moore said.

Jemsek declined comment on Moore’s treatment. In general, the doctor said, “We always tell folks this is a partnership. We never claim to have the answers.”

Another patient cited in the medical board’s allegations is Kathleen Jabkiewicz of Concord, N.C. She was 41, the mother of twin 10-year-old sons, when she died while being treated by Jemsek for Lyme disease. Her husband, Joseph, has sued the doctor, claiming his wife didn’t have the disease and that nearly two years of IV antibiotics contributed to her March 2004 death.

Jabkiewicz was a pediatric intensive care nurse at NorthEast Medical Center when, in 2002, she was referred to Jemsek by her internist. She complained of body aches and migraines, and had seen multiple doctors. Although lab tests were negative, Jemsek diagnosed Lyme disease, the lawsuit says.

As treatment progressed, she began having what appeared to be epileptic seizures, according to the lawsuit. Following a second hospital stay for seizures, Jabkiewicz got a morphine prescription from Jemsek’s nurse practitioner for headache pain.

She took the first dose at home March 6, 2004, and was found dead the next morning.

An autopsy gave the cause of death as morphine poisoning. It said blood levels indicate Jabkiewicz took more than the prescribed amount of morphine, but there was no indication of abuse. It also said she had no evidence of active Lyme disease.

In court filings, Jemsek said Jabkiewicz’ lab tests were contradictory. He denies that he misdiagnosed her or did anything to cause her death.

Largely through patient activism, the Lyme Wars have become public and political.

In Rhode Island, the legislature passed a law several years ago to protect doctors who prescribe open-ended antibiotic therapy. The California Legislature did the same thing, also requiring that doctors explain the different approaches to care.

Rhode Island legislators have also mandated insurance coverage for Lyme disease treatment. Reimbursement varies in other states.

This month, Blue Cross and Blue Shield of North Carolina instituted its first policy on Lyme disease. Previously, the company paid most claims for lab tests and long-term antibiotics. The new policy doesn’t set limits on what the company will pay, but it cites short-term antibiotic therapy as the standard to follow.

If insurance won’t pay, fewer patients could afford months of drug treatment.

It happened to DeAnn Lipe, the 38-year-old nurse from Troutman, N.C., who has been treated by Jemsek since February 2005. After two months of treatment, just as she was beginning to feel better, her insurance company stopped paying claims.

She couldn’t afford the “thousands of dollars a month,” so she stopped the treatment. Ten weeks later, after finding three other doctors who supported Jemsek’s diagnosis, she re-started treatment, again covered by insurance.

After six months of IV antibiotics, Lipe said she began feeling better in March. She vacuumed her carpet for the first time in months. She shopped for groceries without assistance.

Confident that Jemsek’s treatment is working, Lipe worries what will happen to her and other patients if the medical board takes his license.

Dr. Christopher Ohl, an infectious disease specialist at Wake Forest University, shares her concern about the patients.

Unlike Jemsek, he doesn’t believe there’s much Lyme disease in North Carolina. But he agrees that people with chronic, vague complaints aren’t served well by mainstream medicine.

“They’re kind of pushed away, which makes them feel worse,” Ohl said.

“They may not need a year’s worth of antibiotics. What they need is recognition that they don’t feel well (and) that they have symptoms that aren’t well understood. We just don’t have the answers yet.”

___

LYME DISEASE

_Caused by a bacterium spread by the bite of infected deer ticks.

_First recognized in the United States in 1976 in Lyme, Conn.

_Symptoms include fever, headache, fatigue and a characteristic bull’s-eye skin rash. Not all patients will develop the rash or recall a tick bite. If left untreated, infection can spread to joints, the heart and the nervous system.

_Blood tests are helpful in diagnosing later stages of disease. Early Lyme disease is diagnosed based on symptoms and the possibility of exposure to infected ticks.

_Most cases of Lyme disease are treated successfully with a few weeks of oral antibiotics. Some doctors contend that chronic Lyme disease is prevalent and requires long-term antibiotic treatment, but this is controversial.

_Ticks that transmit Lyme disease sometimes transmit other tick-borne diseases as well.

_Reported cases rose 69 percent from 11,700 in 1995 to 19,804 in 2004. Concentrated in the Northeast and Mid-Atlantic states, northern Midwest and Northern California. Reported cases are rare in the Carolinas _ 122 in North Carolina and 22 in South Carolina in 2004.

Source: U.S. Centers for Disease Control and Prevention.

___

FOR INFORMATION

U.S. Centers for Disease Control and Prevention: www.cdc.gov.

Lyme Disease Association: Toll-free (888) 366-6611; www.lymediseaseassociation.org.

Infectious Diseases Society of America: (703) 299-0200; www.idsociety.org.

International Lyme and Associated Diseases Society (ILADS): (301) 263-1080; www.ilads.org.

___

PREVENT TICK-BORNE DISEASE

_Wear light-colored clothing so you can see ticks crawling.

_Tuck pants legs into socks so ticks cannot crawl inside pants legs.

_Apply repellents to discourage tick attachment.

_Conduct a body check upon return from tick-infested areas. Use a hand-held or full-length mirror to view all parts of your body.

_Remove any tick you find.

_Check children for ticks, especially in the hair, when returning from tick-infested areas. Ticks may be carried inside on clothing and pets.

___

DR. JOSEPH JEMSEK

_Born: April 16, 1949, in Mattoon, Ill.

_Married: June 1996 to Kay Jemsek; their children are James, 6, and Jordan, 2. Two children, John, 29, and Joanne, 25, from a previous marriage.

_Education: Graduated University of Illinois in Champaign-Urbana in 1970, University of Illinois medical school in Chicago in 1974.

_Residency: Medical University of South Carolina in Charleston.

_Fellowship: Infectious disease at Baylor College of Medicine, Houston.

_Career: Joined the Nalle Clinic in Charlotte in 1979. Opened Jemsek Clinic in Huntersville in 2000.

___

(c) 2006, The Charlotte Observer (Charlotte, N.C.).

Visit The Charlotte Observer on the World Wide Web at http://www.charlotte.com/

Distributed by Knight Ridder/Tribune Information Services.

_____

PHOTOS (from KRT Photo Service, 202-383-6099): MED-LYMEDISEASE

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Moscow says banned gays because “cleaner” than West

MOSCOW (Reuters) – Moscow’s influential mayor said on
Tuesday the city banned gay activists from holding a parade
because it is morally cleaner than the West, which is caught up
in “mad licentiousness.”

The gay activists tried to hold their protest against
homophobia and discrimination at the weekend despite the ban,
but were detained by police, abused by militant Christians and
attacked by neo-fascists.

They had wanted to lay flowers at the grave of the unknown
warrior, a monument to those who died defeating Nazi Germany,
but police blocked their path.

Mayor Yuri Luzhkov said such an action would have been a
desecration of the sacred monument, and rejected Western
criticism of his ban as prejudiced and homophobic.

“Our way of life, our morals and our tradition — our
morals are cleaner in all ways. The West has something to learn
from us and should not race along in this mad licentiousness,”
he told Moscow radio, according to local news agencies.

“We may have a democratic country, but we live in an
organized country and an organized city.”

The protest on Saturday, which was intended as a Gay Pride
solidarity event as have become common in Western capitals,
degenerated into a scrum with women hurling eggs and fruit at
the activists, while shouting “Moscow is not Sodom.”

Riot police detained several dozen neo-fascist skinheads
who wanted to break up the protest.

Luzhkov, who has run Russia’s capital almost as a private
fiefdom since 1992, said his anticipation of such a public
reaction to the gays’ plans had led him to ban the march to
ensure the safety of all.

“These gays wanted to lay flowers at the grave of the
unknown warrior. This is a provocation. It is desecration of a
sacred place,” he said.

He rejected the gays’ argument that the eternal flame is a
monument to all those oppressed by fascism.

“These gays go there, and openly go up to the monument. It
is a contamination. People burst through and of course they
beat them up,” he said.

Gay activists, who were arrested when they arrived at the
park with flowers, said the mere fact of holding the protest
was a victory.

Arctic ‘Noah’s Ark’ Vault to Protect World’s Seeds

By Alister Doyle, Environment Correspondent

OSLO — A frozen “Noah’s Ark” to safeguard the world’s crop seeds from cataclysms will be built on a remote Arctic island off Norway, the Norwegian government said on Tuesday.

Construction of the Global Seed Vault, in a mountainside on the island of Svalbard 1,000 km (600 miles) from the North Pole, would start in June with completion due in September 2007.

“Norway will by this contribute to the global system for ensuring the diversity of food plants. A Noah’s Ark on Svalbard if you will,” Norwegian Agriculture and Food Minister Terje Riis-Johansen said in a statement.

The doomsday vault would be built near Longyaerbyen, Svalbard’s main village, with space for three million seed varieties. It would store seeds including rice, wheat, and barley as well as fruits and vegetables.

It would be a remote Arctic back-up for scores of other seed banks around the world, which may be more vulnerable to risks ranging from nuclear war to mundane power failures.

“Gene banks can be affected by shutdowns, natural disasters, wars or simply a lack of money,” Riis-Johansen said.

Loss of genetic diversity would mean losing a part of cultural heritage. “We also reduce the ability of agriculture to meet new challenges relating to climate change, population increase, and so on,” he said.

The seeds would be stored at -18 Celsius (-0.40F). If the power failed, the seeds would probably stay frozen.

“The temperature there is around -3C, -4C in the summer but we believe that even if the freezers broke down a suitable temperature would last for months,” said Grethe Helene Evjen, a senior adviser at the Agriculture Ministry.

“This will be primarily a duplicate storage for plant seeds already stored elsewhere,” she told Reuters. Seeds would remain the property of nations making deposits.

Norway would provide 30 million Norwegian crowns ($4.94 million) to build the vault. Prime Minister Jens Stoltenberg would mark the start of construction during a meeting of prime ministers from the Nordic region on the island on June 19.

Norway has long talked of building the Arctic seed vault without previously taking action. For about 15 years some varieties of seed have been stored in a disused Svalbard mine under a plan to see if they can germinate after 100 years.

Norway has worked with the U.N.’s Food and Agriculture Organization on the plans. It would also get financial support from the Global Crop Diversity Trust to help poor countries use the storage.

Fatal Turn: The Lives of Too Many Young Drivers Have Taken A

By Robin Fitzgerald, The Sun Herald, Biloxi, Miss.

May 28–GULFPORT — Teenage drivers in South Mississippi are killing themselves and others in record-breaking numbers.

It’s not that they plan to, but the trend in teen-involved traffic deaths leaves law enforcement officials at a loss as to how to explain why the numbers keep climbing.

Since January, nine crashes involving teenagers have killed 16 area young people. Half the traffic deaths this year involved teen drivers, based on a Sun Herald review of 24 fatal crashes with a total of 32 deaths. Since Christmas Eve, six other youths have died in local or regional crashes, raising the youth death toll to 22 since Dec. 24.

Area coroners said they can’t remember when as many youths have died in crashes.

Could it be teenagers’ lack of experience behind the wheel? The distractions of cell phones, music and friends? National traffic-safety studies have long indicated these as leading factors in teen-involved crashes. A new study covering 10 years of statistics indicates the majority of fatal crashes with teen drivers kill the drivers or their passengers.

With the trend in South Mississippi, one factor could be that life “has turned upside down for everyone” since Hurricane Katrina hit Aug. 29, as State Trooper Johnny Poulos put it.

“Many teen hangouts are gone and teens could be spending more time in vehicles because they don’t have anywhere to go,” Poulos said.

“But I don’t think there’s any one reason. The fatal crashes I haven’t worked, I’ve followed. Speeding contributed to some. Some pulled out in front of another vehicle. Maybe they’re not paying attention, not being focused. We could speculate on it all day long and probably never figure it all out.”

One of several crashes that gnaw at his memory occurred after two teenage boys argued over which CD to play.

“When you give the keys to a teenager, at that age and with that mentality, that’s a lot of power to give,” Poulos said.

Some national safety groups recommend legislation to forbid teen drivers from carrying passengers and to require at least 50 hours of adult-supervised driving during the learner’s permit stage.

Some teenagers are more mature than others, said Poulos, who gave traffic-safety programs at 75 percent of Coast schools in the past year.

“Driver safety needs to begin at home with parents staying on their kids about safety, and setting a good example,” Poulos said, “and the schools need to do more to promote driver education.”

A snap decision can quickly turn tragic, no matter how responsible your teenager appears to be, said April Parker of Wade. Her daughter, Whitlee Lynae Davis, 16, died May 8 when she ran a stop sign on her way to school.

“She was pure. She lived life to its fullest. Decisions were important to her,” Parker said. “She didn’t drink or smoke. She recently wrote an essay on how she wanted to make the right decisions because she didn’t want to ruin her reputation or God’s plan for her life.”

Parker said she believes her daughter’s death was for a purpose.

“It hurts,” Parker said. “But maybe God’s plan for her life was to show others, teenagers and adults, how you can’t be too careful when you drive, how you need to make sure you’re right with God.”

Young drivers are more likely to engage in unsafe driving behaviors such as speeding, tailgating and weaving in and out of traffic, according to the National Highway Traffic Safety Administration.

Drivers aged 15 to 20 make up 6 percent of the driving population, but account for 14 percent of all driver-involved fatal crashes in 2003, one NHTSA study shows.

A new study, by the AAA Foundation for Traffic Safety, shows drivers aged 15 to 17 killed 30,917 people from 1995 through 2004. One-third of those killed were the teen drivers. Another third were their passengers.

South Mississippi’s increase in teen traffic deaths could have something to do with an increase in traffic during hurricane recovery, said Master Sgt. Joe Gazzo, a veteran state trooper.

Also, teens are more likely to have “

‘the Superman syndrome,’ believing ‘it would never happen to me,’

” said Gazzo.

“The hardest part of our job is knocking on that door to tell a parent their kid is dead. A lot of it is kids just making that wrong decision.”

————

Deaths of our children

A Sun Herald review of 24 fatal crashes in South Mississippi since January shows 16 of 32 deaths occurred in nine crashes involving teenage or young-adult drivers. Six more area youths have died in crashes since Dec. 24, raising the youth death toll to 22 since Christmas Eve. A summary of the crashes, by date, with details from law enforcement agencies and county coroners:

— Dec. 24: Dustin Triplett, 17, and Reginald Abrams, 18, both of Gulfport, died in unrelated one-vehicle crashes in Harrison County after the driver lost control. Triplett tried to pass another vehicle on Shaw Road near Stiles Road at 3:48 p.m. when his pickup flipped. Abrams was a passenger in a crash at 7:24 p.m. on Kiln-DeLisle Road. The driver and two others were injured.

In Forrest County, Biloxi resident Brandon Spears, 14, and Biloxi native Zakiya Emil Pringle, 17, died in the Carnes community after delivering Christmas presents to a relative. Their teenage driver swerved to avoid another vehicle and lost control. Spears was an 8th-grader at Biloxi Junior High. Pringle, a former classmate, had moved to Memphis after Hurricane Katrina displaced his family.

— Jan. 2: Christopher Bush, 19, lost control of his vehicle at U.S. 90 near Riley Road in Gautier around 4 p.m. The vehicle flipped several times. The Gautier High graduate was enrolled at the Jackson County campus of Mississippi Gulf Coast Community College.

— Jan. 12: Six college students died and two friends were injured when the extended-cab pickup they were in was struck by a gravel truck on Mississippi 26 near Wiggins around 3:30 a.m. Their vehicle was stationary, facing north, on the foggy east-west highway. The six who died, all graduates of Mercy Cross High in Biloxi, were Brittany Marie Jordan, 18, and her sister, Carley Taryn Jordan, 20, both of Ocean Springs; William “Jerrod” Thompson, Richard G. O’Barr, and Candice Newman, all 20, and Joshua Scott Bozeman, 21, all of Biloxi. Their driver, 21, and another friend, 20, were hospitalized. Friends and family have said the students were together earlier at a nightclub in Bogalusa, La.

— Jan. 14: Michael T. Battle and John S. McGrath, both 18 and of Ocean Springs, died after Battle lost control of his car and it hit a tree off Interstate 10 in Jackson County around 11:45 p.m. Battle was an Ocean Springs High student and McGrath was a recent graduate.

— Jan. 15: Infant Caanaan Sairley, 4 months, died and four people were injured when his mother, Brittany Broome, 18, pulled in front of an 18-wheeler on U.S. 98 near Lucedale in George County at 3:23 p.m. The truck driver’s wife and children were traveling with him.

— Feb. 13: Nicole Olsen, 18, trying to cross U.S. 90, pulled in front of a vehicle in Pascagoula around 7:30 p.m. She was an expectant mother and a Pascagoula High senior. A 15-year-old passenger was injured.

— Feb. 14: James Israel, 14, was joyriding on a four-wheeler on Saracennia Road in Jackson County when he lost control and struck his head.

— Feb. 28: Dane Eubanks, 16, was a passenger in a vehicle in which the driver lost control and the vehicle flipped several times on Old Spanish Trail in Gautier around 2:45 p.m. He and the injured driver, also 16, were returning from a Mardi Gras celebration. Eubanks was a junior at Gautier High.

— April 14: Stepbrothers Donny Sullivan Jr., 20, and Joshua James Premeaux, 17, of Vancleave, were ejected from a Jeep Cherokee and four teenage friends were injured when their vehicle crashed into a pole on Interstate 10 near Interstate 65 in Mobile at 3:30 a.m. None was wearing a seat belt. They were returning from a trip to Panama City, Fla. Premeaux was a junior at Biloxi High. Sullivan played football and baseball in Biloxi and St. Martin.

— April 29: Gabby Henderson, 15, and her best friend, Jasmine Townsend, 16, both of Ocean Springs, died after Townsend pulled in front of another vehicle on U.S. 90 in Gautier around 10:50 p.m. They had just dropped off a friend after a school pageant and were on their way to gas up the car. They were dance-team members and sophomores at Ocean Springs High.

— May 8: Whitlee Lynae Davis, 16, of Wade, was on her way to school as she followed a carload of friends, who authorities said also ran a stop sign at Cedarcrest and Mississippi 614. Davis’ vehicle was struck by a commercial gas truck. She was a junior at East Central High School.

—–

Copyright (c) 2006, The Sun Herald, Biloxi, Miss.

Distributed by Knight Ridder/Tribune Business News.

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Pakistanis try confronting shame of honor killing

By Waheed Khan

KARACHI (Reuters) – Ayesha Baloch was dragged to a field,
her brother-in-law held the 18-year-old down, her husband sat
astride her legs and slit her upper lip and nostril with a
knife.

They call such assaults on women a matter of “honor” in
some Pakistani communities, but for the majority it is a source
of national shame.

Married less than two months ago in Pakistan’s central
district of Dera Ghazi Khan, Baloch was accused of having
sexual relations with another man before marriage.

“First they tortured me and beat me. I started screaming.
Akbar then caught my hands and pulled me to the ground. Essa
sat on my legs and cut my nose and lips,” Baloch mumbled
through her bandages at hospital in the city of Multan.

“I was bleeding and started screaming after they fled on a
motorcycle. People heard me and rescued me and took me to my
mother’s home.”

At least she wasn’t killed.

More than 1,000 women are slain by their husbands or
relatives, and that is just the reported, not actual, number of
“honor killings” in Pakistan each year.

Many killings are planned rather than done in rage, and the
motive often has more to do with money or settling scores.

The same week, a world away from Baloch’s village, social
activists, parliamentarians and community leaders gathered in
the suburban, leafy capital of Islamabad to launch a campaign
— “We Can End Honor Killing.”

Farhana Faruqi Stocker, country director of international
aid agency Oxfam, said some 10,000 people called
“change-makers” had signed up so far.

But Stocker knows two constituencies will be vital to the
campaign’s success.

“The mindset of legislators has to be changed in order for
good legislation to come out,” Stocker told Reuters.

But she is well aware that there are many remote rural
areas of Pakistan where maulvis, or clerics, exert more
influence than local government and federal law.

“In order to bring change, we have to engage with clerics.”

MORE THAN LAWS NEEDED

Pakistan is a country living in many centuries at once.

Its small, Westernised elite embrace the 21st, conservative
clerics preach strict interpretations of Islam from the Middle
Ages, while many of its poor rural communities are governed by
tribal customs going back long before Islam arrived.

Honor killings are known as “karo-kari” killings.

A woman is deemed a “black woman,” a “kari,” once she is
accused of having sex outside of marriage and is liable to be
killed. “Karo” is the male version.

The custom is rooted in tribalism, although a strict
interpretation of Islam’s hudood penal code also rules that
adulterers should be stoned to death.

A former president of Pakistan, Farooq Ahmed Leghari, comes
from Dera Ghazi Khan. He says it will take more than laws to
change society there, or places like it.

“To fight this menace you need social movements involving
people from all segments of society,” Leghari told Reuters
after the launch of the campaign against “honor killings.”

President Pervez Musharraf champions enlightenment, but
critics say he has achieved little due to the influence of
tribal chieftains, feudal lords and religious parties in
parliament.

A law enacted last year set a minimum 10-year jail sentence
for perpetrators of so-called honor killings.

But rights lawyer Rashid Rehman said crimes are more often
covered up by families, and police prefer not to get involved.

“Those arrested are often freed for lack of evidence or
after reconciling with the victims’ families, in most cases
close relatives,” he said.

While police have taken Ayesha Baloch’s assailants into
custody, along with their father who egged them on, she has low
expectations of justice; “They are powerful people with money,
and will get out on bail.”

UPHILL BATTLE

Mukhtaran Mai, an icon for oppressed women and herself the
victim of a gang rape in 2002, said police should enforce the
law without bias, but getting more girls into school was
crucial, too.

“Until women are allowed to get educated … these crimes
will continue,” said Mai, whose rape was ordered by village
elders after her 12-year-old brother was accused of having
sexual relations with a woman of another tribe.

Some 70 percent of Pakistanis live in rural areas where
feudalism and tribalism still thrive and traditional codes
apply.

Burdened by a population of 160 million growing at well
over two percent a year, and with an annual per capita income
of $800, Pakistan is in danger of being swamped by social
problems.

Cities are inundated with migrants from rural areas, who
bring village ways with them.

Police face an uphill battle even to stop an increase in
honor killings, never mind eradicate the crime, according to
Fida Hussain Mastoi, assistant inspector-general of police in
the southern province of Sindh.

Days earlier, Nur Jehan died in Karachi, a month after
being shot four times by relatives who accused her of loose
morals.

They tracked her down in the city, having traveled from a
village in the southwestern province of Baluchistan, then
seized her, shot her and left her for dead in a ditch. She
survived for a month in hospital, until a stomach wound became
infected.

She was 14.

FDA Approves ZOSTAVAX(R), Merck’s New Vaccine for Prevention of Shingles in Adults Age 60 and Older

The U.S. Food and Drug Administration (FDA) has approved Merck’s new vaccine ZOSTAVAX(R) (Zoster Vaccine Live (Oka/Merck)) for prevention of herpes zoster (shingles) in individuals 60 years of age and older.

Shingles is a frequently painful disease marked by a blistering rash. Caused by the reactivation of the virus that causes chickenpox, shingles can lead to severe complications including long-term nerve pain (postherpetic neuralgia), which can last for months or even years. ZOSTAVAX is not a treatment for shingles or postherpetic neuralgia. ZOSTAVAX is given as a single dose by injection.

“ZOSTAVAX is the first and only medical option approved for the prevention of shingles,” said William Schaffner, M.D., professor of preventive medicine, Vanderbilt University School of Medicine, Nashville. “Approval of a vaccine against shingles represents a major public health advance for people 60 and older.”

Anyone who has been infected with chickenpox — that’s more than 90 percent of adults in the United States — is at risk for developing shingles. The incidence and severity of shingles, as well as the frequency and severity of its complications, increase with age. About 40 to 50 percent of the estimated 1 million cases of shingles that occur in the United States each year occur in people age 60 and older. Shingles can be unpredictable and can occur without warning at any time.

“This vaccine is clinically important because it can prevent a disease that may cause pain in some patients,” said Ann Arvin, M.D., professor of pediatrics, infectious diseases and microbiology and immunology, Stanford University School of Medicine, who studied the vaccine. “ZOSTAVAX is unique because in contrast to other vaccines that help prevent a primary infection, ZOSTAVAX helps prevent reactivation of a virus that’s already inside the body.”

Shingles usually starts as an unusual or painful sensation on one side of the body or face, followed by a blistering rash. Pain from shingles can be mild to severe and may occur just prior to the development of the rash, during the eruption of the rash and as long-term nerve pain (postherpetic neuralgia). Postherpetic neuralgia has been described as tender, burning, throbbing, stabbing, shooting and/or sharp pain. Other complications, such as scarring, allodynia (pain from an innocuous stimulus such as the touch of soft clothing or a light breeze), pneumonia, visual impairment and hearing loss also can occur as the result of shingles. Treating shingles and postherpetic neuralgia can be difficult, often requiring a multifaceted approach.

ZOSTAVAX is contraindicated in persons with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine; with a history of primary or acquired immunodeficiency states including leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; with AIDS or other clinical manifestations of infection with human immunodeficiency viruses; and with active untreated tuberculosis. ZOSTAVAX is also contraindicated in persons on immunosuppressive therapy including high-dose corticosteroids and in women who are or may be pregnant.

Vaccination with a live, attenuated vaccine, such as ZOSTAVAX, may result in a more extensive vaccine-associated rash or disseminated disease in individuals who are immunosuppressed. Safety and efficacy of ZOSTAVAX have not been evaluated in individuals on immunosuppressive therapy, nor in individuals receiving daily topical or inhaled corticosteroids or low-dose oral corticosteroids. The use of ZOSTAVAX in individuals with a previous history of shingles has not been studied.

Studies of ZOSTAVAX Included More Than 40,000 People

The approval of ZOSTAVAX is based on studies of more than 40,000 people, more than 21,000 of whom received active vaccine. The efficacy and safety of a single dose of ZOSTAVAX was evaluated in the largest of these studies, the landmark Shingles Prevention Study (SPS) of 38,546 men and women age 60 and over who had no previous history of shingles. This randomized, double-blind, placebo-controlled study was a Department of Veterans Affairs study conducted in collaboration with the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and Merck at 22 U.S. research sites.

In the study, participants were randomized to groups given either ZOSTAVAX (N=19,270) or a placebo (N=19,276) and followed for the development of shingles for a median duration of 3.1 years. All subjects with clinically diagnosed shingles were offered antiviral treatment, as well as standard-of-care treatment for pain, as necessary.

ZOSTAVAX significantly reduced the risk of developing shingles compared with placebo by 51 percent (315 cases (5.4 cases per 1,000 person-years) vs. 642 cases (11.1 cases per 1,000 person-years), respectively; Greater Than or Equal to 0.001) in the SPS. Efficacy of ZOSTAVAX for the prevention of shingles was highest for those 60 to 69 years of age and declined with increasing age.

Overall, the benefit of ZOSTAVAX in the prevention of long-term nerve pain from shingles (postherpetic neuralgia) can be primarily attributed to the vaccine’s effect on the prevention of shingles. Vaccination with ZOSTAVAX reduced the incidence of long-term nerve pain from shingles in individuals 70 years of age and older who were vaccinated with ZOSTAVAX but went on to develop shingles. Following completion of the SPS, a separate analysis was conducted to evaluate the reduction in postherpetic neuralgia in the group of individuals who had been vaccinated with ZOSTAVAX but who had developed shingles. In the analysis, ZOSTAVAX reduced the overall incidence of postherpetic neuralgia by a statistically significant 39 percent compared to the placebo group. A statistically significant reduction in postherpetic neuralgia was seen in individuals aged 70 to 79 (55 percent) and a nonstatistically significant reduction in postherpetic neuralgia was seen in those aged 60 to 69 (5 percent) and 80 and older (26 percent) in the analysis.

Safety Profile of ZOSTAVAX

In the Adverse Event Monitoring Study (AEMS), which included a subgroup of individuals from the SPS, vaccine-related injection site and systemic adverse events seen in the first 42 days after vaccination in 1 percent or greater of the individuals who received ZOSTAVAX (n=3,345) included headache (1.4 percent) and the following injection-site reactions: erythema (33.7 percent), pain/tenderness (33.4 percent), swelling (24.9 percent), hematoma (1.4 percent), pruritus (6.6 percent), and warmth (1.5 percent). Most of these adverse experiences were reported as mild in intensity.

In the overall study population in the SPS, serious adverse experiences (SAEs) occurred at a similar rate (1.4 percent) in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS, the rate of SAEs was increased in the group who received ZOSTAVAX (1.9 percent) as compared to the placebo group (1.3 percent) in the first 42 days after vaccination. Investigator-determined, vaccine-related serious adverse experiences were reported for two subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and three subjects who received placebo (Goodpasture’s syndrome, anaphylactic reaction, and polymyalgia rheumatica).

In the entire SPS study population, the rates of overall cardiovascular events (0.4 percent) including coronary artery disease related conditions (0.2 percent) were similar in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS of the SPS, in the first 42 days after vaccination, the rate of overall cardiovascular events was higher after ZOSTAVAX (0.6 percent) than after placebo (0.4 percent), including the rate of coronary artery disease-related conditions (ZOSTAVAX, 0.3 percent; placebo, 0.2 percent).

Selected Important Information about ZOSTAVAX

ZOSTAVAX is indicated for prevention of herpes zoster (shingles) in individuals 60 years of age and older. ZOSTAVAX is not a treatment for shingles or postherpetic neuralgia. As with any vaccine, vaccination with ZOSTAVAX may not result in protection of all vaccine recipients.

Patients should be informed of the theoretical risk of transmitting the vaccine virus to close contacts (including household contacts) who may be pregnant and have not had chickenpox or been vaccinated against chickenpox, or contacts who have problems with their immune system. The risk of transmitting the attenuated vaccine virus to a susceptible individual should be weighed against the risk of developing natural shingles that could be transmitted to a susceptible individual.

The duration of protection after vaccination with ZOSTAVAX is unknown. In the SPS, protection with ZOSTAVAX was demonstrated through four years of follow-up. The need for revaccination has not been defined. ZOSTAVAX is not a substitute for VARIVAX(R) (Varicella Virus Vaccine Live (Oka/Merck)) and ZOSTAVAX should not be used in children.

Concurrent administration of ZOSTAVAX and antiviral medications known to be effective against the varicella zoster virus has not been evaluated. Concurrent administration of ZOSTAVAX and other vaccines has not been evaluated.

Merck Commitment to Vaccines

“Merck is pleased to introduce the first and only shingles vaccine – the result of nearly two decades of Merck vaccine research,” said Mark Feinberg, M.D., Ph.D., vice president of policy, public health and medical affairs, Merck Vaccines. “The Company is also very pleased to announce that we will make ZOSTAVAX and all of Merck’s other adult vaccines available free of charge through a new patient assistance program for vaccines for low-income individuals for whom the vaccines are medically appropriate.”

Through this new program, Merck will provide free vaccines to adults who are uninsured and who are unable to afford vaccines. Merck’s vaccines will become available through this program in the third quarter of 2006.

Outside the United States, ZOSTAVAX was approved for licensure in the European Union and in Australia earlier this month, and Merck has filed regulatory applications for ZOSTAVAX in other world markets. Merck will begin to commercialize ZOSTAVAX outside of the U.S. in 2007. In addition, the FDA and other regulatory agencies around the world are now reviewing applications for GARDASIL(R) (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine), Merck’s investigational HPV and cervical cancer vaccine. In February, the FDA approved ROTATEQ(R) (rotavirus vaccine, live, oral pentavalent), Merck’s rotavirus vaccine.

Pricing and CPT Code for ZOSTAVAX

ZOSTAVAX, a frozen vaccine, is available for ordering by physicians and Merck expects to begin shipping the vaccine soon. The catalog price of ZOSTAVAX is $145.35 purchased as a 10-pack of single-dose vials of lyophilized vaccine with sterile diluent and $152.50 purchased as a single-dose vial of vaccine with sterile diluent.

The American Medical Association has established the Current Procedural Terminology (CPT*)(R) code “CPT 90736 Zoster (shingles) vaccine, live, for subcutaneous use” for ZOSTAVAX. CPT codes allow for the identification and potential reimbursement of existing common procedures, services and products, new and emerging technologies as well as the collection of data to facilitate performance issues.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Merck Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the cautionary statements in Item 1 of Merck’s Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

* Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association.

Prescribing information and patient product information for ZOSTAVAX is attached.

For more information on ZOSTAVAX, visit www.ZOSTAVAX.com

                                                               9703300      ZOSTAVAX(R)      (Zoster Vaccine Live (Oka/Merck))      DESCRIPTION      ZOSTAVAX*      is a lyophilized preparation of the Oka/Merck strain of live, attenuated varicella-zoster virus (VZV). The virus was initially obtained from a child with naturally-occurring varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5). The cells, virus seeds, virus bulks and bovine serum used in the manufacturing are all tested to provide assurance that the final product is free of adventitious agents. ZOSTAVAX, when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV when reconstituted and stored at room temperature for up to 30 minutes. Each dose also contains 31.16 mg of sucrose, 15.58 mg of hydrolyzed porcine gelatin, 3.99 mg of sodium chloride, 0.62 mg of monosodium L-glutamate, 0.57 mg of sodium phosphate dibasic, 0.10 mg of potassium phosphate monobasic, 0.10 mg of potassium chloride; residual components of MRC-5 cells including DNA and protein; and trace quantities of neomycin and bovine calf serum. The product contains no preservatives.      CLINICAL PHARMACOLOGY      Background      Herpes zoster (HZ), commonly known as shingles or zoster, is a manifestation of the reactivation of varicella zoster virus (VZV), which, as a primary infection, produces chickenpox (varicella). Following initial infection, the virus remains latent in the dorsal root or cranial sensory ganglia until it reactivates, producing zoster. Zoster is characterized by a unilateral, painful, vesicular cutaneous eruption with a dermatomal distribution.     Although the rash is the most distinctive feature of zoster, the most frequently debilitating symptom is pain. Pain associated with zoster may occur during the prodrome, the acute eruptive phase, and the postherpetic phase of the infection. This later phase is most commonly referred to as postherpetic neuralgia (PHN).     Serious complications, such as scarring, bacterial superinfection, allodynia, cranial and motor neuron palsies, pneumonia, encephalitis, visual impairment, hearing loss, and death can occur as the result of zoster.      Mechanism of Action      The risk of developing zoster appears to be related to a decline in VZV-specific immunity. ZOSTAVAX was shown to boost VZV-specific immunity, which is thought to be the mechanism by which it protects against zoster and its complications. (See Immunogenicity.)      Clinical Studies      Efficacy of ZOSTAVAX was evaluated in the Shingles Prevention Study (SPS),(1)a placebo-controlled, double-blind clinical trial in which 38,546 subjects 60 years of age or older were randomized to receive a single dose of either ZOSTAVAX (n=19,270) or placebo (n=19,276). Subjects were followed for the development of zoster for a median of 3.1 years (range 31 days to 4.90 years). The study excluded people who were immunocompromised or using corticosteroids on a regular basis, anyone with a previous history of HZ, and those with conditions that might interfere with study evaluations, including people with cognitive impairment, severe hearing loss, those who were non-ambulatory and those whose survival was not considered to be at least 5 years. Randomization was stratified by age, 60-69 and Greater Than or Equal to70 years of age. Zoster cases were confirmed by Polymerase Chain Reaction (PCR) (93%), viral culture (1%), or in the absence of viral detection, as determined by the Clinical Evaluation Committee (6%). Individuals in both vaccination groups who developed zoster were given famciclovir, and, as necessary, pain medications. The primary efficacy analysis included all subjects randomized in the study who were followed for at least 30 days postvaccination and did not develop an evaluable case of HZ within the first 30 days postvaccination (Modified Intent-To-Treat (MITT) analysis).     ZOSTAVAX significantly reduced the risk of developing zoster when compared with placebo (Table 1). Vaccine efficacy for the prevention of HZ was highest for those subjects 60-69 years of age and declined with increasing age.                                  Table 1    Efficacy of ZOSTAVAX on HZ Incidence Compared with Placebo in the                       Shingles Prevention Study*                  ZOSTAVAX                Placebo         ------------------------------------------------ Age        #     # HZ  Incidence   #     # HZ  Incidence   Vaccine  group** subjects cases rate of  subjects cases rate of     Efficacy  (yrs.)                 HZ per                  HZ per     (95% CI)                          1000                    1000                         person-                 person-                           yrs.                    yrs. ---------------------------------------------------------------------- Overall   19254   315      5.4    19247   642     11.1  51% (44%, 58%) ----------------------------------------------------------------------   60-69   10370   122      3.9    10356   334     10.8  64% (56%, 71%) ----------------------------------------------------------------------   70-79    7621   156      6.7     7559   261     11.4  41% (28%, 52%) ---------------------------------------------------------------------- Greater  Than or  Equal  to 80     1263    37      9.9     1332    47     12.2 18% (-29%, 48%) ----------------------------------------------------------------------      * The analysis was performed on the Modified Intent-To-Treat (MITT) population that included all subjects randomized in the study who were followed for at least 30 days postvaccination and did not develop an evaluable case of HZ within the first 30 days postvaccination.     ** Age strata at randomization were 60-69 and Greater Than or Equal to70 years of age.     Forty-five subjects were excluded from the MITT analysis (16 in the group of subjects who received ZOSTAVAX and 29 in the group of subjects who received placebo), including 24 subjects with evaluable HZ cases that occurred in the first 30 days postvaccination (6 evaluable HZ cases in the group of subjects who received ZOSTAVAX and 18 evaluable HZ cases in the group of subjects who received placebo).     Suspected HZ cases were followed prospectively for the development of HZ-related complications. Table 2 compares the rates of PHN defined as HZ-associated pain (rated as 3 or greater on a 10-point scale by the study subject and occurring or persisting at least 90 days) following the onset of rash in evaluable cases of HZ.                                  Table 2    Postherpetic Neuralgia (PHN)* in the Shingles Prevention Study**                                                  ZOSTAVAX                                   ------------------------------------ Age group (yrs.) +                   #     # HZ  # PHN Incidence% HZ                                    subjects cases cases rate of  cases                                                         PHN per  with                                                          1,000    PHN                                                         person-                                                           yrs. ---------------------------------------------------------------------- Overall                              19254   315    27      0.5   8.6% ---------------------------------------------------------------------- 60-69                                10370   122     8      0.3   6.6% ---------------------------------------------------------------------- 70-79                                 7621   156    12      0.5   7.7% ---------------------------------------------------------------------- Greater Than or Equal to 80           1263    37     7      1.9  18.9% ----------------------------------------------------------------------                                   Placebo                   ------------------------------------ Age group (yrs.) +   #     # HZ  # PHN Incidence% HZ  Vaccine efficacy                    subjects cases cases rate of  cases against PHN in                                         PHN per  with   subjects who                                          1,000    PHN    develop HZ                                         person-        postvaccination                                           yrs.            (95% CI) ---------------------------------------------------------------------- Overall                                                         39%++                      19247   642    80      1.4  12.5%       (7%, 59%) ----------------------------------------------------------------------                                                                     5% 60-69                10356   334    23      0.7   6.9%    (-107%, 56%) ----------------------------------------------------------------------                                                                    55% 70-79                 7559   261    45      2.0  17.2%      (18%, 76%) ---------------------------------------------------------------------- Greater Than or                                                    26%  Equal to80           1332    47    12      3.1  25.5%     (-69%, 68%) ---------------------------------------------------------------------- *PHN was defined as HZ-associated pain rated as Greater Than or Equal to3 (on a 0-10 scale), persisting or appearing more than 90 days after onset of HZ rash using Zoster Brief Pain Inventory (ZBPI)(2). ** The table is based on the Modified Intent-To-Treat (MITT) population that included all subjects randomized in the study who were followed for at least 30 days postvaccination and did not develop an evaluable case of HZ within the first 30 days postvaccination. + Age strata at randomization were 60-69 and Greater Than or Equal to70 years of age. ++ Age-adjusted estimate based on the age strata (60-69 and Greater Than or Equal to70 years of age) at randomization.      The median duration of clinically significant pain (Greater Than or Equal to3 on a 0-10 point scale) among HZ cases in the group of subjects who received ZOSTAVAX as compared to the group of subjects who received placebo was 20 days vs. 22 days based on the confirmed HZ cases.     Overall, the benefit of ZOSTAVAX in the prevention of PHN can be primarily attributed to the effect of the vaccine on the prevention of herpes zoster. Vaccination with ZOSTAVAX reduced the incidence of PHN in individuals 70 years of age and older who developed zoster postvaccination.     Other prespecified zoster-related complications were reported less frequently in subjects who received ZOSTAVAX compared to subjects who received placebo. Among HZ cases, zoster-related complications were reported at similar rates in both vaccination groups (Table 3).                                   Table 3    Specific complications* of zoster among HZ cases in the Shingles                            Prevention Study    Complication                          ZOSTAVAX           Placebo                                       (N = 19,270)      (N = 19,276) ----------------------------------------------------------------------                                   (n = 321)   % Among  (n = 659)  %                                               Zoster             Among                                                Cases            Zoster                                                                  Cases ----------------------------------------------------------------------   Allodynia                             135       42.1      310  47.0   Bacterial Superinfection                3        0.9        7   1.1   Dissemination                           5        1.6       11   1.7   Impaired Vision                         2        0.6        9   1.4   Ophthalmic Zoster                      35       10.9       69  10.5   Peripheral Nerve Palsies (motor)        5        1.6       12   1.8   Ptosis                                  2        0.6        9   1.4   Scarring                               24        7.5       57   8.6   Sensory Loss                            7        2.2       12   1.8 ---------------------------------------------------------------------- N=number of subjects randomized n=number of zoster cases, including those cases occurring within 30 days postvaccination, with these data available   * Complications reported at a frequency of Greater Than or Equal to1% in at least one vaccination group among subjects with zoster.      Visceral complications reported by fewer than 1% of subjects with zoster included 3 cases of pneumonitis and 1 case of hepatitis in the placebo group, and 1 case of meningoencephalitis in the vaccine group.      Immunogenicity      Immune responses to vaccination were evaluated in a subset of subjects enrolled in the Shingles Prevention Study (N=1395). VZV antibody levels (Geometric Mean Titers, GMT), as measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) 6 weeks postvaccination, were increased 1.7-fold (95% CI: (1.6 to 1.8)) in the group of subjects who received ZOSTAVAX compared to subjects who received placebo; the specific antibody level that correlates with protection from zoster has not been established.      INDICATIONS AND USAGE      ZOSTAVAX is indicated for prevention of herpes zoster (shingles) in individuals 60 years of age and older.      ZOSTAVAX is not indicated for the treatment of zoster or PHN.      CONTRAINDICATIONS      ZOSTAVAX should not be administered to individuals:      --  With a history of anaphylactic/anaphylactoid reaction to         gelatin, neomycin, or any other component of the vaccine (see         WARNINGS).      --  With a history of primary or acquired immunodeficiency states         including leukemia; lymphomas of any type, or other malignant         neoplasms affecting the bone marrow or lymphatic system; or         AIDS or other clinical manifestations of infection with human         immunodeficiency viruses (see WARNINGS).      --  On immunosuppressive therapy, including high-dose         corticosteroids.      --  With active untreated tuberculosis.      --  Who are or may be pregnant (see PRECAUTIONS, Pregnancy).      WARNINGS      Vaccination with a live attenuated vaccine, such as ZOSTAVAX, may result in a more extensive vaccine-associated rash or disseminated disease in individuals who are immunosuppressed. Safety and efficacy of ZOSTAVAX have not been evaluated in individuals on immunosuppressive therapy, nor in individuals receiving daily topical or inhaled corticosteroids or low-dose oral corticosteroids.     Neomycin allergy commonly manifests as a contact dermatitis, which is not a contraindication to receiving this vaccine.(3) Persons with a history of anaphylactic reaction to topically or systemically administered neomycin should not receive ZOSTAVAX (see CONTRAINDICATIONS).      ZOSTAVAX is not a substitute for VARIVAX*      * (Varicella Virus Vaccine Live (Oka/Merck)) and should not be used in children.      PRECAUTIONS      General      As with any vaccine, adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur.    Deferral of vaccination should be considered in acute illness, for example, in the presence of fever Greater Than 38.5(degree)C (Greater Than 101.3(degree)F).     The duration of protection after vaccination with ZOSTAVAX is unknown. In the Shingles Prevention Study (SPS), protection from zoster was demonstrated through 4 years of follow-up. The need for revaccination has not been defined.     As with any vaccine, vaccination with ZOSTAVAX may not result in protection of all vaccine recipients.     The use of ZOSTAVAX in individuals with a previous history of zoster has not been studied (see CLINICAL PHARMACOLOGY, Clinical Studies).      Transmission      In clinical trials with ZOSTAVAX, transmission of the vaccine virus has not been reported. However, post-marketing experience with varicella vaccines suggests that transmission of vaccine virus may occur rarely between vaccinees who develop a varicella-like rash and susceptible contacts. Transmission of vaccine virus from varicella vaccine recipients without a VZV-like rash has been reported but has not been confirmed. The risk of transmitting the attenuated vaccine virus to a susceptible individual should be weighed against the risk of developing natural zoster that could be transmitted to a susceptible individual.      Information for Patients      The health care provider should question the vaccine recipient about reactions to previous vaccines (see CONTRAINDICATIONS). The health care provider should also inform the vaccine recipient of the benefits and risks of ZOSTAVAX. Patients should be provided with a copy of the Patient Information Sheet at the end of this insert, and be given an opportunity to discuss any questions or concerns.     Vaccinees should also be informed of the theoretical risk of transmitting the vaccine virus to varicella-susceptible individuals, including pregnant women who have not had chickenpox. Patients should also be told that pregnancy should be avoided for three months following vaccination.     Patients should be instructed to report any adverse reactions to their health care provider.      Drug Interactions      Concurrent administration of ZOSTAVAX and antiviral medications known to be effective against VZV has not been evaluated. Concurrent administration of ZOSTAVAX and other vaccines has not been evaluated.      Carcinogenesis, Mutagenesis, Impairment of Fertility      ZOSTAVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.      Pregnancy      Pregnancy Category C: Animal reproduction studies have not been conducted with ZOSTAVAX. It is also not known whether ZOSTAVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. However, naturally occurring VZV infection is known to sometimes cause fetal harm. Therefore, ZOSTAVAX should not be administered to pregnant females; furthermore, pregnancy should be avoided for three months following vaccination (see CONTRAINDICATIONS).     Vaccinees and health care providers are encouraged to report any exposure to ZOSTAVAX during pregnancy by calling (800) 986-8999.      Nursing Mothers      Some viruses are excreted in human milk; however, it is not known whether VZV is secreted in human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if ZOSTAVAX is administered to a nursing woman.      Pediatric Use      ZOSTAVAX should not be used in children.      Geriatric Use      The median age of subjects enrolled in the largest (N=38,546) clinical study of ZOSTAVAX was 69 years (range 59-99 years). Of the 19,270 subjects who received ZOSTAVAX, 10,378 were 60-69 years of age, 7,629 were 70-79 years of age, and 1,263 were 80 years of age or older.      ADVERSE REACTIONS      In clinical trials, ZOSTAVAX has been evaluated for safety in approximately 21,000 adults. In the largest of these trials, the Shingles Prevention Study (SPS), subjects received a single dose of either ZOSTAVAX (n=19,270) or placebo (n=19,276). The racial distribution across both vaccination groups was similar: White (95%); Black (2.0%); Hispanic (1.0%) and Other (1.0%) in both vaccination groups. The gender distribution was 59% male and 41% female in both vaccination groups. The age distribution of subjects enrolled, 59-99 years, was similar in both vaccination groups.     The Adverse Event Monitoring Substudy (n=3,345 received ZOSTAVAX and n=3,271 received placebo) used vaccination report cards (VRC) to record adverse events occurring from Days 0 to 42 postvaccination (97% of subjects completed VRC in both vaccination groups). In addition, monthly surveillance for hospitalization was conducted through the end of the study, 2 to 5 years postvaccination.     The remainder of subjects in the SPS (n=15,925 received ZOSTAVAX and n=16,005 received placebo) were actively followed for safety outcomes through Day 42 postvaccination and passively followed for safety after Day 42.     Because clinical trials are conducted under conditions that may not be typical of those observed in clinical practice, the adverse reaction rates presented below may not be reflective of those observed in clinical practice.      Serious Adverse Reactions      In the overall study population, serious adverse experiences (SAEs) occurred at a similar rate (1.4%) in subjects vaccinated with ZOSTAVAX or placebo.     In the AE Monitoring Substudy, the rate of SAEs was increased in the group of subjects who received ZOSTAVAX as compared to the group of subjects who received placebo, from Day 0-42 postvaccination (Table 4).                                  Table 4    Number of Subjects with Greater Than or Equal to 1 Serious Adverse                               Experience      (0-42 Days Postvaccination) in the Shingles Prevention Study   Cohort                             ZOSTAVAX    Placebo  Relative Risk                                       n/N        n/N       (95% CI)                                        %          % ---------------------------------------------------------------------- Overall Study Cohort               255/18671  254/18717          1.01 (all ages)                               1.4%       1.4%  (0.85, 1.20) ----------------------------------------------------------------------    60-69 years old                 113/10100  101/10095          1.12                                          1.1%       1.0%  (0.86, 1.46)    70-79 years old                  115/7351   132/7333          0.87                                          1.6%       1.8%  (0.68, 1.11)    Greater Than or Equal to 80       27/1220    21/1289          1.36     years old                            2.2%       1.6%  (0.78, 2.37) ---------------------------------------------------------------------- AE Monitoring Substudy Cohort        64/3326    41/3249          1.53 (all ages)                               1.9%       1.3%  (1.04, 2.25) ----------------------------------------------------------------------    60-69 years old                   22/1726    18/1709          1.21                                          1.3%       1.1%  (0.66, 2.23)    70-79 years old                   31/1383    19/1367          1.61                                          2.2%       1.4%  (0.92, 2.82)    Greater Than or Equal to 80        11/217      4/173          2.19     years old                            5.1%       2.3%  (0.75, 6.45) ---------------------------------------------------------------------- N =number of subjects in cohort with safety follow-up n=number of subjects reporting an SAE 0-42 Days postvaccination      Table 5 displays selected cardiovascular SAEs occurring in the SPS within 42 days postvaccination.                                  Table 5        Selected Serious Adverse Experiences (SAEs) Reported More Frequently After ZOSTAVAX than After Placebo Days 0-42 Postvaccination                    in the Shingles Prevention Study                                          AE Monitoring   Entire Study                                           Substudy         Cohort                                      ZOSTAVAX Placebo ZOSTAVAX Placebo                                       N = 3326 N = 3249  N =     N =                                                         18671   18717                                        n (%)   n (%)   n (%)   n (%) ---------------------------------------------------------------------- Overall Cardiovascular events by body  system                               20 (0.6)12 (0.4)81 (0.4)72 (0.4)    Coronary Artery Disease-related     conditions*                       10 (0.3) 5 (0.2)45 (0.2)35 (0.2) ---------------------------------------------------------------------- N=number of subjects with safety follow-up n=number of subjects reporting SAE within the category *CAD-related conditions: angina pectoris, coronary artery disease, coronary occlusion, cardiovascular disorder, myocardial ischemia, & myocardial infarction      Rates of hospitalizations were similar among subjects who received ZOSTAVAX and subjects who received placebo in the AE Monitoring Substudy, throughout the entire study.     Investigator-determined, vaccine-related serious adverse experiences were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture's syndrome, anaphylactic reaction, and polymyalgia rheumatica).      Deaths      The overall incidence of death occurring Days 0 to 42 postvaccination was similar between vaccination groups during the Days 0-42 postvaccination period; 14 deaths occurred in the group of subjects who received ZOSTAVAX and 16 deaths occurred in the group of subjects who received placebo. The most common reported cause of death was cardiovascular disease (10 in the group of subjects who received ZOSTAVAX, 8 in the group of subjects who received placebo). The overall incidence of death occurring at any time during the study was similar between vaccination groups: 793 deaths (4.1%) occurred in subjects who received ZOSTAVAX and 795 deaths (4.1%) in subjects who received placebo.      Most Common Adverse Reactions      Adverse Events Reported in the AE Monitoring Substudy of the SPS      Injection-site and systemic adverse experiences reported at an incidence Greater Than or Equal to 1% are shown in Table 6. Most of these adverse experiences were reported as mild in intensity. The overall incidence of vaccine-related injection-site adverse experiences was significantly greater for subjects vaccinated with ZOSTAVAX versus subjects who received placebo (48% for ZOSTAVAX and 17% for placebo).                                  Table 6       Injection-Site and Systemic Adverse Experiences Reported by     Vaccine Report Card in Greater Than or Equal to1% of Adults Who   Received ZOSTAVAX or Placebo (0-42 Days Postvaccination) in the AE          Monitoring Substudy of the Shingles Prevention Study    Adverse Experience               ZOSTAVAX             Placebo                                    (N = 3345)           (N = 3271)                                        %                   % ----------------------------------------------------------------------   Injection Site Erythema+                                    33.7                 6.4 Pain/tenderness+                             33.4                 8.3 Swelling+                                    24.9                 4.3 Hematoma                                      1.4                 1.4 Pruritus                                      6.6                 1.0 Warmth                                        1.5                 0.3 ---------------------------------------------------------------------- Systemic  Headache                                     1.4                 0.8 ----------------------------------------------------------------------  + Designates a solicited adverse experience. Injection-site adverse experiences were solicited only from Days 0-4 postvaccination.      The numbers of subjects with elevated temperature (Greater Than or Equal to38.3(degree)C (Greater Than or Equal to101.0(degree)F)) within 42 days postvaccination were similar in the ZOSTAVAX and the placebo vaccination groups (27 (0.8%) vs. 27 (0.9%), respectively).     The following adverse experiences in the AE Monitoring Substudy of the SPS (Days 0 to 42 postvaccination) were reported at an incidence Greater Than or Equal to1% and greater in subjects who received ZOSTAVAX than in subjects who received placebo, respectively: respiratory infection (65 (1.9%) vs. 55 (1.7%)), fever (59 (1.8%) vs. 53 (1.6%)), flu syndrome (57 (1.7%) vs. 52 (1.6%)), diarrhea (51 (1.5%) vs. 41 (1.3%)), rhinitis (46 (1.4%) vs. 36 (1.1%)), skin disorder (35 (1.1%) vs. 31 (1.0%)), respiratory disorder (35 (1.1%) vs. 27 (0.8%)), asthenia (32 (1.0%) vs. 14 (0.4%)).      Adverse Events Occurring after Day 42 postvaccination      AE Monitoring Substudy subjects in the Shingles Prevention Study were monitored for hospitalizations through monthly automated phone queries and the remainder of subjects were passively monitored for safety in this study from Day 43 postvaccination through study end.     Over the course of the study (4.9 years), 51 individuals (1.5%) receiving ZOSTAVAX were reported to have congestive heart failure (CHF) or pulmonary edema compared to 39 individuals (1.2%) receiving placebo in the AE Monitoring Substudy; 58 individuals (0.3%) receiving ZOSTAVAX were reported to have congestive heart failure (CHF) or pulmonary edema compared to 45 (0.2%) individuals receiving placebo in the overall study.      Clinical Safety with High Potency ZOSTAVAX      In an additional clinical study, high potency ZOSTAVAX (203,000 plaque-forming units (pfu)) administered to 461 subjects was compared to a lower potency ZOSTAVAX (57,000 pfu; similar to potencies studied in the Shingles Prevention Study) administered to 234 subjects. Moderate or severe injection-site reactions were more common in the recipients of the higher potency ZOSTAVAX (17%) as compared to the lower potency recipients (9%). Among recipients of the higher potency ZOSTAVAX, 4 subjects (0.9%) reported SAEs (1 case each of angina pectoris, coronary artery disease, depression and enteritis); 1 subject (0.4%) receiving the lower potency ZOSTAVAX reported an SAE (lung cancer).      VZV rashes following vaccination      Within the 42-day postvaccination reporting period in the SPS, noninjection-site zoster-like rashes were reported by 53 subjects (17 for ZOSTAVAX and 36 for placebo). Of 41 specimens that were adequate for PCR testing, wild-type VZV was detected in 25 (5 for ZOSTAVAX, 20 for placebo) of these specimens. The Oka/Merck strain of VZV was not detected from any of these specimens.     Of reported varicella-like rashes (n=59), 10 had specimens that were available and adequate for PCR testing. VZV was not detected in any of these specimens.     In all other clinical trials in support of ZOSTAVAX, the reported rates of noninjection-site zoster-like and varicella-like rashes within 42 days postvaccination were also low in both zoster vaccine recipients and placebo recipients. Of the 17 reported varicella-like rashes and noninjection-site, zoster-like rashes, 10 specimens were available and adequate for PCR testing. The Oka/Merck strain was identified by PCR analysis from the lesion specimens of two subjects who reported varicella-like rashes (onset on Day 8 and 17).      Reporting Adverse Events      The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967 or report online to www.vaers.hhs.gov.(4)      DOSAGE AND ADMINISTRATION      FOR SUBCUTANEOUS ADMINISTRATION.      Do not inject intravascularly.      ZOSTAVAX is administered as a single dose.      Caution: Use only sterile syringes free of preservatives, antiseptics, and detergents for each injection and/or reconstitution of ZOSTAVAX. Preservatives, antiseptics and detergents may inactivate the vaccine virus.     Reconstitute the vaccine using only the diluent supplied. The supplied diluent is free of preservatives or other antiviral substances which might inactivate the vaccine virus.     Use a separate sterile needle and syringe for reconstituting and administration of ZOSTAVAX to prevent transfer of infectious diseases.     ZOSTAVAX is stored frozen and should be reconstituted immediately upon removal from the freezer. The diluent should be stored separately at room temperature or in the refrigerator.     To reconstitute the vaccine: Withdraw the entire contents of the diluent vial into a syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ZOSTAVAX when reconstituted is a semi-hazy to translucent, off-white to pale yellow liquid.     Inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.     Withdraw the entire contents into a syringe and inject the total volume of reconstituted vaccine subcutaneously; preferably in the upper arm.     THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY.      DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.      DO NOT FREEZE reconstituted vaccine.      Needles should be disposed of properly and should not be recapped.      HOW SUPPLIED      No. 4963-00 -- ZOSTAVAX is supplied as follows: (1) a package of 1 single-dose vial of lyophilized vaccine, NDC 0006-4963-00 (package A); and (2) a separate package of 10 vials of diluent (package B).     No. 4963-41 -- ZOSTAVAX is supplied as follows: (1) a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4963-41 (package A); and (2) a separate package of 10 vials of diluent (package B).      Handling and Storage      During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of -20(degree)C (-4(degree)F) or colder.     ZOSTAVAX SHOULD BE STORED FROZEN at an average temperature of -15(degree)C (+5(degree)F) or colder until it is reconstituted for injection. Any freezer, including frost-free, that has a separate sealed freezer door and reliably maintains an average temperature of -15(degree)C or colder is acceptable for storing ZOSTAVAX.     For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.      Before reconstitution, protect from light.      The diluent should be stored separately at room temperature (20 to 25(degree)C, 68 to 77(degree)F), or in the refrigerator (2 to 8(degree)C, 36 to 46(degree)F).      REFERENCES      1. Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, Arbeit RD, Simberkoff MS, Gershon AA, Davis LE, Weinberg A, Boardman KD, Williams HM, Zhang JH, Peduzzi PN, Beisel CE, Morrison VA, Guatelli JC, Brooks PA, Kauffman CA, Pachucki CT, Neuzil KM, Betts RF, Wright PF, Griffin MR, Brunell P, Soto NE, Marques AR, Keay SK, Goodman RP, Cotton DJ, Gnann JW Jr, Loutit J, Holodniy M, Keitel WA, Crawford GE, Yeh SS, Lobo Z, Toney JF, Greenberg RN, Keller PM, Harbecke R, Hayward AR, Irwin MR, Kyriakides TC, Chan CY, Chan IS, Wang WW, Annunziato PW, Silber JL. A Vaccine to Prevent Herpes Zoster and Postherpetic Neuralgia in Older Adults. NEJM 2005;352:2271-84.     2. Coplan PM, Schmader K, Nikas A, Chan ISF, Choo P, Levin MJ, et al. Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: Adaptation of the brief pain inventory. J Pain 2004;5(6):344-56.     3. Reitschel RL, Bernier R. Neomycin sensitivity and the MMR vaccine. JAMA 1981;245(6):571.     4. Atkinson WL, Pickering LK, Schwartz B, Weniger BG, Iskander JK, Watson JC. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR02):1-36.      Manuf. and Dist. by:      Merck & Co., Inc.,     Whitehouse Station, NJ, 08889, USA      Issued May 2006      Printed in USA      *Registered trademark of Merck & Co., Inc.      Copyright (C) 2006 Merck & Co., Inc.      Whitehouse Station, NJ, USA      All rights reserved      **Registered trademark of Merck & Co., Inc. 

9703300

Patient Information about

ZOSTAVAX(R) (pronounced “ZOS tah vax”)

Generic name: (Zoster Vaccine Live (Oka/Merck))

You should read this summary of information about ZOSTAVAX* before you are vaccinated. If you have any questions about ZOSTAVAX after reading this leaflet, you should ask your health care provider. This information does not take the place of talking about ZOSTAVAX with your doctor, nurse, or other health care provider. Only your health care provider can decide if ZOSTAVAX is right for you.

What is ZOSTAVAX and how does it work?

ZOSTAVAX is a vaccine that is used for adults 60 years of age or older to prevent shingles (also known as zoster).

ZOSTAVAX works by helping your immune system protect you from getting shingles and the associated pain and other serious complications. If you do get shingles even though you have been vaccinated, ZOSTAVAX may help prevent the nerve pain that can follow shingles in some people.

As with any vaccine, ZOSTAVAX may not protect everyone who receives the vaccine.

ZOSTAVAX cannot be used to treat shingles once you have it. If you do get shingles, see your health care provider within the first few days of getting the rash.

What do I need to know about shingles and the virus that causes it?

Shingles is a rash that is usually on one side of the body. The rash begins as a cluster of small red spots that often blister. The rash can be painful. Shingles rashes usually last up to 30 days, and for most people the pain associated with the rash lessens as it heals.

People who have problems with their immune system may have a greater risk of getting more widespread rashes and longer-lasting pain.

Shingles is caused by the same virus that causes chickenpox. Once a person has had chickenpox, the virus can live, but remain inactive, in one or more nerve roots in your body for many years. For reasons that are not fully understood, the virus may become active again. Age and problems with the immune system may increase your risk of getting shingles.

Can I get ZOSTAVAX?

You can receive ZOSTAVAX if you are 60 years of age or older, but only your health care provider can decide if ZOSTAVAX is right for you.

Who should not receive ZOSTAVAX?

You should not receive ZOSTAVAX if you:

— are allergic to any of its ingredients. This includes

allergies to gelatin or neomycin.

— have a disease or condition that causes a weakened immune

system such as an immune deficiency, including leukemia,

lymphoma, HIV/AIDS or are taking high doses of steroids by

injection or by mouth.

— have active TB (tuberculosis) that is not being treated.

— are pregnant or may be pregnant.

*Registered trademark of Merck & Co., Inc.

Copyright (C) 2006 Merck & Co., Inc.

Whitehouse Station, NJ, USA

All rights reserved

What should I tell my health care provider before I receive ZOSTAVAX?

You should tell your health care provider if you:

— have or have had any medical problems.

— are taking any medications, including those that might weaken

your immune system.

— have any allergies, including allergies to neomycin or have

had an allergic reaction to another vaccine.

— become pregnant within 3 months of getting the vaccine.

Vaccine recipients are encouraged to report any exposure to

ZOSTAVAX during pregnancy by calling (800) 986-8999.

— are breast-feeding.

— have had shingles in the past.

— may be in close contact (including household contact) with

someone who may be pregnant and has not had chickenpox or been

vaccinated against chickenpox, or someone who has problems

with their immune system.

How is ZOSTAVAX given?

ZOSTAVAX is given as a single dose by injection under the skin.

What are the possible side effects of ZOSTAVAX?

Redness, pain, swelling, itching, warmth, and bruising at the site where the injection was given, and headache were the most common side effects that people in the clinical studies reported after receiving the vaccine. Talk to your health care provider about other possible side effects.

Call your health care provider right away if any medical condition you have gets worse or you develop any new or unusual symptoms after you receive ZOSTAVAX.

What are the ingredients in ZOSTAVAX?

Active Ingredient: a weakened form of the varicella-zoster virus.

Inactive Ingredients: sucrose, hydrolyzed porcine gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride.

What else should I know about ZOSTAVAX?

This leaflet summarizes information about ZOSTAVAX. If you would like more information, talk to your health care provider or visit the website: www.ZOSTAVAX.com.

Rx Only

Issued May 2006

Manuf. and Dist. by:

Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

Physical Therapy May Promote Resolution of Lymphatic Coding in Breast Cancer Survivors

By Wyrick, Shelly L; Waltke, Leslie J; Ng, Alexander V

ABSTRACT

Background and Purpose: Surgical removal of axillary lymph nodes may cause lymphatic cording that has been reported to resolve in about 3 months. The purpose of this study was to retrospectively investigate the effectiveness of physical therapy as a treatment. We hypothesized that lymphatic cording resolves in less than the expected 3 months with skilled physical therapy. Subjects: Thirty- one lymphatic cording cases were identified. Methods: Information from patient records was collected describing cancer treatment, lymphatic cording, and physical therapy care. Results: The average approximate time to onset was 35.9 weeks. Shoulder abduction range of motion improved, on average, 52 in 4 weeks. The average length of physical therapy care was 10.1 9.5 weeks. For those who attended physical therapy regularly, length of care was 7.3 3.4 weeks. A higher frequency of therapy cancellations was strongly correlated to a longer therapy length of care. Length of care for patients undergoing concurrent cancer treatment was significantly longer (17.0 14.8) compared to of those who were not (6.5 3.3 weeks). Discussion: Our data suggest that physical therapy may shorten cording resolution time and that this recovery time is influenced by other factors such as attendance or concurrent care. Further research is needed. Conclusion: Physical therapy appears to shorten resolution time of lymphatic cording from the expected 3 months without therapy to 10 weeks.

INTRODUCTION

Breast surgery, radiation, and chemotherapy are standards in breast cancer treatment that may contribute to posttreatment morbidities such as pain, decreased range of motion, weakness, swelling, neuropathy, radiation fibrosis, fatigue, and lymphatic cording.1-6 Pain is the most frequently reported symptom after breast cancer treatment.7 Arm symptoms occur in about 80% of women who undergo lumpectomy with axillary dissection and radiation.8 Five years after axillary lymph node dissection, 25% of breast cancer survivors report pain9 which may be caused by fibrotic changes, nerve damage, tissue tightness, swelling, lymphatic cording, or seromas.1-3,10,11 Postoperative deficits following axillary lymph node dissection can become chronic conditions for most breast cancer survivors.12

Lymphatic cording is thought to occur from lymphatic disruption following breast or axillary surgery resulting in a visible and palpable web of tissue that overlays observable cording when the patient abducts her arm.2 This condition has been defined by Moskovitz et al2 as an early postoperative morbidity following surgical removal of lymph nodes.

The pathophysiology of lymphatic cording, or ‘axillary web syndrome’ has been investigated and described by Moskovitz et al.2 Of 4 axillary web syndrome cases that underwent biopsy with light microscopy, a fibrin clot was observed in the superficial vein of 3 cases and the lymphatic vessel of the fourth.2 Following this analysis, several etiologies were proposed.2 First, during axillary lymph node dissection, the tissues in the axilla are retracted and the patient’s arm is positioned to allow the surgeon to work in the axilla; Moskovitz et al proposed this shoulder position sustained during surgery may cause lymphovenous injury.2 secondly, it was proposed that the tissues may release their own hypercoagulability factor following the surgical procedure which then causes the clotting.2 Third, the removal of nodes in the axilla may impede the flow of lymph, thus causing lymphovenous stasis.2

Regardless of origin, signs and symptoms of lymphatic cording include axillary pain radiating down the arm, limited shoulder range of motion, as well as the characteristic “cording.”2 Clinically, it is important to differentiate the cords from the border of the pectoralis major muscle, which will be superior and anterior to the cords. In addition, soft tissue may give a cordlike appearance due to increased tension between the skin of the upper arm and adherence of an axillary scar to underlying fascia.

The study by Moskovitz et al reported that treatment for this condition, including physical therapy, does not shorten or change the course of the syndrome.2 The number of patients receiving physical therapy, description of physical therapy sessions, or home exercise program was not provided. Resolution of this condition occurs within 3 months according to studies by Moskovitz et al2 and Leidenius et al.11

Despite prior reports that physical therapy does not assist in resolution of this condition,2 physical therapy and specific treatment techniques for lymphatic cording have since been described in the literature.” To our knowledge, there are no data or research specifically focused on the effectiveness of physical therapy as a treatment for lymphatic cording. The purpose of this study is to further describe lymphatic cording from a clinical perspective and to investigate the effectiveness of physical therapy treatment through retrospective analysis of patient charts. Our hypothesis is that lymphatic cording resolves in less than 3 months with skilled physical therapy treatment.

METHODS

Procedures

Chart review took place at a private physical therapy clinic whose sole focus is cancer survivor care. This retrospective research project was approved by the sponsoring institutions IRB.

Initially 180 physical therapy medical charts of patients seen between January, 2003 and September, 2004 were screened. Ninety- three percent of patients seen during this time were breast cancer survivors and, of these, 31 (19%) episodes of lymphatic cording were documented. All subsequent data collection was from these 31 charts, ie, n=31. Our definition of the term “breast cancer survivor” is anyone living with the diagnosis during or after cancer treatment.

Data collected from review of these charts included: cancer diagnosis, cancer treatment (surgery, chemotherapy, and radiation), location and severity of lymphatic cording (mild, mild to moderate, moderate, or moderate to severe), and lymphedema. The terms used to describe severity of cording (mild, mild to moderate, moderate, moderate to severe, and severe) were used by the therapist as a subjective description and do not reflect any objective measurements. Other data included range of motion of the shoulder at the time of evaluation and periodically throughout treatment (as measured with a goniometer), physical therapy treatment type, start date of physical therapy care, physical therapy cancellations, and date of discharge from physical therapy. Not all charts included all data sets.

All patients were evaluated by the same therapist. All evaluations, treatments, and discharges from therapy occurred between January, 2003 and September, 2004.

Approximate time to onset of lymphatic cording was calculated as the time elapsed between the most recent surgery and the physical therapy evaluation. The term “time to onset” is used loosely in that chart documentation did not include the date of symptom onset, but rather the date the patient first presented to therapy.

Length of care was calculated as the number of days from the evaluation to the last physical therapy visit. In some cases, the discharge summary was completed at a later date than the last visit. In such cases, the last day of physical therapy was used to calculate length of care. In 2 cases the patient died, and in 4 other cases the patient did not schedule a follow up appointment and therefore was discharged. These 6 cases were excluded from Length of Care calculation. One patient was seen twice during the January 2003 to September 2004 timeframe for initial cording, and later for reoccurrence of cording. Length of care was calculated for each course of therapy.

Statistical Analysis

Because of small sample sizes and differences in variance (ie, SD) between groups, we used more conservative nonparametric, compared to parametric techniques for our data analysis. The Mann Whitney statistic was used for between group unpaired comparisons. Bivariate correlations between length of care and cancellation numbers were performed with Spearman Rho correlation coefficients because a lower limit in one variable was observed in many subjects. The Fisher exact test was used to test for differences in proportionality of cancellations. Results are presented as mean SD with exact p if significant at p

RESULTS

Cancer Diagnosis and Treatment

Concurrent care

Few charts included the type of breast cancer. Twenty-eight of the 31 charts clearly indicated whether or not the patient was undergoing current treatment of cancer (chemotherapy or radiation) during her course of physical therapy. Forty-three percent (n=12) of the patients were undergoing cancer treatment during their course of physical therapy, while the other 57% (n=16) had completed their cancer treatment at the time of the initial evaluation, or were not receiving chemotherapy or radiation as part of their treatment.

Surgical type

All charts included a description of what type of surgical treatment was received (Tablel). One patient was seen twice between January 2003 and September 2004, therefore the total number of surgical procedures done was 30.

Lymphatic Cording

Approximate time to onset

Approximate time \to onset was calculated as the time lapsed between the most recent surgery and physical therapy evaluation. Seven charts either listed a season or no date at all. Nineteen patients gave the exact date of surgery while 5 others reported a month and year. If a month and year was given, the last day of that month was used as the ‘surgery date’ to calculate time to onset. On average 35.9 66.9 weeks elapsed between surgery date and physical therapy evaluation with a range of 14 days to 5.8 years. Seventeen percent of the cases with available data had an approximate time to onset of one year or more.

Two cases included recurrence. In the first chart, only one episode was reviewed because the first onset occurred in 2002. In the second instance, both episodes were reviewed because the patient had 2 occurrences of cording between January, 2003 and September, 2004.

Severity and location

Of the 31 charts reviewed, 30 indicated the severity of the cording. Severity was documented as mild, mild to moderate, moderate, moderate to severe, or severe. This subjective description of the condition took into account pain intensity, loss of range of motion at the shoulder, and reactivity or increase in symptoms during functional activity and gentle stretching. The most common severity of cording was mild (40%) followed by moderate (30%), mild to moderate (13%), and moderate to severe ( 10%). There were no reports of severe lymphatic cording. Although subjective, all ratings were performed by the same therapist (LW).

Table 1.

Twenty-nine charts indicated the areas of cording involvement. Areas involved included one or more of the following: axilla, medial upper arm, antecubital region, volar forearm, and wrist or posterior/ medial hand. Seventeen percent (n=5) of the cases exhibited signs of cording at the axilla alone. Twenty-one (n=6) percent of the cases had no cording at the axilla and instead experienced cording at a more distal site (Figure 1).

Physical Therapy Intervention Treatment

All patients were treated with therapeutic exercise including stretching of the involved region. Home exercise programs typically included 4 supine exercises involving cane-assisted shoulder flexion, active abduction, horizontal abduction, and a trunk rotational stretch with shoulder abduction. In some instances patients or family members were instructed in soft tissue stretching techniques. Treatment may have also included progressive resistance exercises for the involved extremity, and use of the Airdyne (Schwinn Airdyne Nautilus health & Fitness Group, Louisville, CO) bicycle. The Airdyne bicycle exercises both upper and lower extremities and may have been chosen for its upper extremity range of motion benefits, or for treatment of cancer related fatigue as appropriate. Manual therapy, compressive bandaging, and compression pump (Lympha Press, Israel) were used as indicated if the patient also had lymphedema or persistent swelling.

Figure 1. The patient is in the supine position with her right upper extremity in 90 of shoulder flexion. Her left hand is applying distally directed skin stretch over her forearm to reveal lymphatic cording in the antecubital region of her right elbow.

Range of motion

Range of motion was reported in degrees of flexion and abduction measured in the supine position. Analysis was completed on all charts that included more than one numeric documentation of range of motion. Data was excluded if a subjective report was used to describe range of motion, such as ‘within normal limits.’ Data was also excluded if the range of motion at the initial evaluation was 170 or more in shoulder flexion and abduction (n=4), as this may be considered a normal amount of motion. Thirteen charts included numeric data for range of motion at evaluation and at least one other time during the first 4 weeks of care. The average improvement for shoulder flexion in the first 4 weeks of care was 39 20 from an average of 111 19 at evaluation. The average improvement for shoulder abduction was 52 21 in the first 4 weeks, with an average of 84 17 at evaluation.

Length of care

The first and last days of physical therapy were used to calculate length of care. Six charts were excluded from all length of care calculations because these patients died or were discharged after the patient did not follow up with therapy. Of the remaining 25 charts, reasons for discharge included meeting goals, dramatic improvement (ie, “patient reports 95% improvement in pain”), range of motion being within normal limits or equal to the noninvolved arm, patient had returned to preoperative activities, or patient did not feel she needed to return to therapy.

The average length of physical therapy care was 10.1 9.5 weeks. The charts reviewed were then separated into 2 groups. The first group included all patients who attended physical therapy regularly (n=18). Regular attendance was defined as not missing more than 2 consecutive weeks of therapy due to cancellations. The second group included those patients who missed 2 consecutive weeks due to cancellations (n=7). The average length of care for those who attended physical therapy regularly was 7.3 3.4 weeks, those that cancelled or did not show to therapy for more than 2 weeks averaged 18.0 17.1 weeks. This difference was statistically significant (p= 0.012). There was a positive correlation between those patients who cancelled more frequently and length of physical therapy care (r^sub s^=0.54, p = 0.002) (Figure 2a). Because we were concerned about the influence of an apparent outlier on our correlations we also analyzed our data without the single patient who had 25 cancellations and length of care of 53 weeks. Even without this patient the correlation was still significant (r^sub s^ = 0.49, p = 0.007) (Figure 2b).

The average length of care for women who were receiving concurrent cancer treatment and physical therapy averaged 17.0 14.8 weeks of therapy. Those women who had completed their treatment averaged 6.5 3.3 weeks of therapy. This difference was statistically significant (p = 0.009). Patients who presented to therapy more than one year after surgery averaged 3.6 1.04 weeks for physical therapy length of care.

Physical therapy cancellations

Of patients receiving concurrent cancer treatment (n=12), 8 missed more than 2 weeks of physical therapy due to cancellations. The proportion of those who missed more than 2weeks of physical therapy was significantly greater in patients currently undergoing treatment than those patients not receiving concurrent cancer treatment (n = 16), where only one missed more than 2 weeks of therapy due to cancellations (p = 0.001, Fisher exact).

DISCUSSION

Our data suggests that physical therapy promotes resolution of lymphatic cording in less than 3 months in contrast to prior reports.2,11 Additionally, our data suggest that that lymphatic cording may be more chronic than has been described.2,11

Cancer Diagnosis and Treatment Concurrent care

Forty-three percent of the women being seen in therapy were undergoing their cancer treatment at the same time. This high percentage suggests that physical therapists treating this patient population should be familiar with acute cancer treatment side effects and contraindications to therapy. For example, low white blood cell or red blood cell counts may limit the type of activity the patient can tolerate. Likewise radiation treatment and possible burns should be taken into consideration when doing any direct hands on manual therapy.

Concurrent cancer treatment should affect the physical therapists’ prognosis and estimation of length of care. In our study, women receiving concurrent cancer treatment required over 8 more weeks of treatment than those who had completed their cancer regiment prior to physical therapy evaluation and treatment. We cannot conclude that these women should wait until after cancer treatment to start physical therapy. Prospective research is needed to compare subjects receiving concurrent cancer care and physical therapy to those who are undergoing cancer treatment without physical therapy, rather than compare subjects receiving concurrent care to those who have completed their cancer treatment.

Lymphatic Cording Approximate time to onset

Lymphatic cording has been described in the literature as an early postoperative morbidity, with symptoms developing within the first 8 weeks postoperatively in 95% of the population.2,11 The term “time to onset” was used loosely in our study to define the time between the most recent surgery and first physical therapy visit. The average approximate time to onset in our patient population was 35.9 weeks. This substantial difference from what previous studies suggest may in part be due to the delay between when a patient visits her physician and her physical therapy evaluation. Additionally, a patient may only become concerned when the symptoms do not dissipate on their own. Those women who experience resolution of symptoms within 2 months of surgery may be less likely to complain of symptoms or seek out treatment for the problem. As the problem lingers on, a woman may be more likely to mention it to a health care provider. Even with these considerations, the average time to onset seen in our study suggests that lymphatic cording may be more than an acute, self-resolving problem in many cases. Given the 35.9 average time to onset, one can postulate that either the condition did not occur within the first 8 weeks after surgery, or the condition did not resolve in 3 months.

Figure 2A.

Figure 2B.

We are not aware of any published cases that describe lymphatic cording as a recurring condition. Two cases in our study involved recurrences. While this is equivalent to only 6% of the reviewed cases, it again suggests that lymphatic cording can be more complex than an acute, self-resolving condition.

Severity and location

The evaluatingtherapist in this study used a subjective rating of mild to severe to describe the involvement of cording. Our data most commonly documents the condition as mild. While to our knowledge there is no, as yet, validated severity scale for lymphatic cording, our subjective description of the condition took into account pain intensity, loss of range of motion at the shoulder and reactivity or increase in symptoms during functional activity and gentle stretching.

The majority of subjects in this study (79%) had symptoms that were not limited to the axilla. Additionally, many subjects did not have any symptoms at the axilla. Both lymphatic “cording”14 and “Axillary Web Syndrome”2 have been used in the literature to describe this condition. We propose that the term “lymphatic cording” is a more accurate description of the condition, as compared to “axillary web syndrome” in that the condition is not limited to the axilla, and may occur outside the axilla all together.

Physical Therapy Intervention Treatment

The physical therapy used in this study included treatment for more than lymphatic cording alone. Because of the retrospective nature of this study, patients may have been treated for tissue tightness, lymphedeina, fatigue, and muscle weakness as consequences of cancer treatment, but not related to lymphatic cording. Therefore, it is difficult to differentiate the single best treatment for lymphatic cording. Ideally, future research in this area should include women presenting with lymphatic cording alone, without other conditions.

Range of Motion

The data in this study reveals an average of 84 of abduction at the time of evaluation with an average 52 improvement in shoulder abduction within 4 weeks of physical therapy care. The significance of this number may be questioned because there is no control group for comparison and other literature2″ has not reported how much improvement is made without physical therapy within the first month. Regardless, a 52 increase in shoulder abduction from 84 is functionally significant and would give a person sufficient range of motion to complete most activities of daily living.

Length of care

Both Moskovitz2 and Leidenius11 studies suggest that the condition usually is self-resolving within 3 months. The average length of physical therapy care in this study was 10.1 weeks, or 2.5 months. In cases where the patient came to therapy consistently (as defined by not missing more than two weeks due to cancellations) the physical therapy length of care average dropped to less than 2 months (7.3 weeks) and range of motion improved within 4 weeks. Once again, because of the retrospective nature of this study, patients may have been treated for tissue tightness, lymphedema, fatigue, and muscle weakness as consequences of cancer treatment, but not related to lymphatic cording. These other deficits may have increased the required length of care, or underestimate the effects of physical therapy on lymphatic cording alone. The strong positive correlation between frequency of cancellations and physical therapy length of care suggests that physical therapy may have a positive effect on the lymphatic cording resolution or just that the patients who cancelled were sick or still undergoing treatment.

The data used to describe length of care did not include cases in which the patient was discharged due to a lack of follow up. In these cases, the status of the patient and the lymphatic cording is unknown. The remaining data may therefore be skewed because the patients not following up with therapy may have experienced less success with the treatment. On the other hand, patients may not return for therapy if they feel they have made enough progress to manage on their own.

Seventeen percent of the patients with appropriate data presented to therapy more than one year post operatively and were on average treated with a short (3.6 weeks) course of therapy. These patients with ‘late onset’ lymphatic cording must have experienced either an onset over 8 weeks postoperatively, or self-resolution of the condition did not occur in 3 months. The short length of care suggests that physical therapy promoted resolution of the condition.

Physical therapy cancellations

The retrospective nature of this study has allowed for a unique analysis of the patients who cancelled appointments more frequently. In prospective research, a subject who misses more than 2 weeks of interventions is often considered a ‘drop out.’ However, it is crucially important to know why this subject group, who may have overwhelming medical demands, discontinue physical therapy treatments, and what is their functional outcome. In this study, those who missed physical therapy were much more likely to be undergoing concurrent care. Additionally, those who missed therapy more frequently required a longer length of care. Physical therapists should take this into account when developing a plan of care. In future prospective research, survivors who miss intervention should perhaps be considered as a separate subject group, rather than a group that has dropped out of the study.

This study suggests that lymphatic cording can be resolved with skilled physical therapy in less than 3 months. If the patient is not receiving concurrent cancer care, the resolution may occur in a much shorter time span of about 6 weeks or less.

SUMMARY

Lymphatic cording has been described as an acute, self-resolving problem occurring after axillary dissection. Our data suggest that the condition may be more complex with the possibility of a late onset or with lack of resolution in 3 months from surgery.

Those women receiving concurrent cancer care required a longer length of care and cancelled appointments more frequently. As a physical therapist determines the plan of care and prognosis, it may be helpful to consider those who have completed their cancer treatment as a separate patient population to those who are concurrently receiving cancer treatment.

Finally, physical therapy may promote resolution of lymphatic cording on average faster than without physical therapy (as based on prior reports of resolution without treatment). On average, patients gained 52 of abduction from 84 of average abduction at evaluation with 4 weeks of therapy. Prior studies have suggested that treatment does not improve the resolution of the condition and that resolution occurs within 3 months of surgery. The improvement of 52 of abduction in 4 weeks may suggest that therapy can improve resolution. Prospective research is needed to investigate specific physical therapy treatment techniques and their effectiveness in lymphatic cording resolution.

REFERENCES

1. Johansson S, Svensson H, Denekamp J. Dose response and latency for radiation-induced fibrosis, edema and neuropathy in breast cancer patients. Int J Rad Onc. 2002;52:1207-1219.

2. Moskovitz AH, Anderson BO, Yeung RS, et al. Axillary web syndrome after axillary dissection. Am J Surg. 2001;181:434-439.

3. Kwekkeboom K. Postmastectomy pain syndrome. Canc Nur. 1996;19:37-43.

4. Rietman JS, Dijkstra PU, Geertzen JHB, et al. Short-term morbidity of the upper limb after sentinel lymph node biopsy or axillary lymph node dissection for stage I or II breast carcinoma. Cancer. 2003;98:690-696.

5. Schrenk P, Rieger R, Shamiyeh A, Wayand W. Morbidity following sentinel lymph node biopsy versus axillary lymph node dissection for patients with breast carcinoma. Cancer. 2000;88:608-614.

6. Morrow GR, Andrews PLR, Hickok JT, Roscoe JA, Matteson S. Fatigue associated with cancer and its treatment. Support Care Cancer. 2002;10:389-398.

7. Rietman JS, Dijkstra PU, Hoekstra HJ, et al. Late morbidity after treatment of breast cancer in relation to daily activities and quality of life: a systematic review. EJSO. 2003;29:229-238.

8. Yap KP, McCready DR, Narod S, et al. Factors influencing arm and axillary symptoms after treatment for node negative breast carcinoma. Cancer. 2003;97:1369-1375.

9. Earnst MF, Voogd AC, Balder W, et al. Early and late morbidity associated with axillary levels I-III dissection in breast cancer. J Surg Oncol. 2002;79:151-155.

10. Blunt C, Schmiedel A. Some cases of severe post-mastectomy pain syndrome may be caused by an axillary haematoma. Pain. 2004;108:294-296.

11. Leidenius M, Leppanen E, Krogerus L, von Smitten K. Motion restriction and axillary web syndrome after sentinel node biopsy and axillary clearance in breast cancer. Am J Surg. 2003;185:127-130.

12. Hack TF, Cohen L, Katz J, et al. Physical and psychological morbidity after axillary lymph node dissection for breast cancer. J Clin Onc. 1999;17:143-149.

13. Kepics JM. Physical therapy treatment of axillary web syndrome. Rehab Onc. 2004;22:21-22.

14. Young AE. The surgical management of early breast cancer. IJCP. 2001;55:603-608.

Shelly L. Wyrick, PT;1 Leslie J. Waltke, PT;1 Alexander V. Ng, PhD2

1 Cancer Rehabilitation Specialists, a division of SPORT Clinic of Greater Milwaukee

2 Program in Exercise Science, Department of Physical Therapy, Marquette University

Copyright Rehabilitation in Oncology 2006

(c) 2006 Rehabilitation Oncology. Provided by ProQuest Information and Learning. All rights Reserved.

New Drug May Hold Promise for Stutterers

By Toni Clarke

BOSTON (Reuters) – When Dr. Gerald Maguire was a child, he resolved every New Year’s Eve to stop stuttering. The resolution usually lasted less than two hours.

Now Maguire is helping investigate an experimental new drug that he believes could offer hope to the more than 3 million Americans who suffer from the speech disorder.

The drug, pagoclone, is being developed by Indevus Pharmaceuticals Inc. Results of a 132-patient trial released on Wednesday showed that 55 percent of patients taking pagoclone showed a significant improvement in symptoms compared to 36 percent who took a placebo.

Shares of Lexington, Massachusetts-based Indevus rose as much as 10 percent on Wednesday on the news.

Maguire, who is an associate professor of psychiatry at the University of California Irvine School of Medicine, said pagoclone, if approved, would be the first drug specifically designed to treat stuttering.

Today, patients are either not treated, or are treated with drugs that are not approved for the disorder such as the benzodiazepine class of anti-anxiety drugs or antipsychotics such as Zyprexa and Risperdal.

Maguire believes pagoclone may help stutterers without causing the kind of dependence linked to benzodiazepines or the weight gain often associated with the newer antipsychotics.

Pagoclone is designed to heighten activity of the brain chemical GABA, which is thought in turn to block the chemical dopamine. Dopamine, which is responsible for motion and movement, is often too high in people who stutter, Maguire said.

“Stuttering is a neurological disorder that has psychological consequences,” he said.

For four years, Maguire did not talk on the phone, as his anxiety overwhelmed his ability to speak. He said the antipsychotic Zyprexa helps.

The disorder, which affects about 1 percent of the adult population, normally begins in childhood. About half of children who develop it grow out of it.

That could be because an area of the brain called the striatum, which acts as the timer and initiator of speech, does not fully develop until later in life. Pagoclone is designed to enhance the functioning of the striatum, Maguire said.

The drug, which was tested in patients for eight weeks, was not associated with any serious complications, Indevus said.

Indevus said it will meet with the U.S. Food and Drug Administration to discuss the findings and plans for further development. By mid-afternoon trading, the company’s shares were up 3.8 percent at $4.61 on Nasdaq.

(Additional reporting by Julie Steenhuysen in Chicago)

Cymbalta does not cause sexual side effects

NEW YORK (Reuters Health) – Among men with depression,
treatment with the antidepressant Cymbalta (duloxetine) does
not worsen sexual functioning, as is common for most
antidepressants, investigators reported this week at the
American Psychiatric Association 2006 annual meeting in
Toronto.

“When we take surveys of patients who take their
antidepressants only intermittently or discontinue them
altogether, about two-thirds of patients will say it is because
of side effects, of which the most common are sexual side
effects,” presenter Dr. Anita Clayton told Reuters Health.
Failure to take the antidepressant as prescribed is likely to
result in relapse, she added.

Clayton and her colleagues at the University of Virginia in
Charlottesville randomly assigned 684 patients with depression
to 60 milligrams per day of Cymbalta, or to 10 milligrams per
day of Lexapro (another antidepressant), or to placebo for 8
weeks. The patients completed the “Changes in Sexual
Functioning Questionnaire” at regular intervals.

Approximately 42 percent of patients on Cymbalta had an
antidepressant response, versus 35 percent of those treated
with Lexapro, with onset as early as 2 weeks and sustained
throughout the study.

At 4 and 8 weeks, Lexapro was associated with significant
worsening of sexual functioning compared with placebo. In
contrast, the effect of Cymbalta was similar to that of
placebo.

At 8 weeks, responses to the sexual functioning
questionnaire showed that 37 percent of men treated with
Cymbalta, 49 percent of those taking placebo, and 59 percent
among those taking Lexapro had worsening sexual functioning.
Among women, the rates of worse sexual dysfunction were similar
between the two drugs (36 percent and 38 percent, versus 26
percent for placebo).

The initial 8-week phase of the trial was followed by a
6-month, flexible dosing extension phase in which patients took
Cymbalta 60 to 120 mg daily or Lexapro 10 to 20 mg per day.
Those who discontinued placebo pills because of lack of
efficacy were randomly assigned to one of the two drugs.

By the end of the 8 months, there were no significant
differences between the two drugs in terms of their effect on
sexual function.

“We know that among people with sexual dysfunction
associated with SSRI (antidepressants), 5 percent to 10 percent
get over it. They become acclimated to it, but it takes about 4
to 6 months,” Clayton noted. The reported sexual side effects
in this study were also affected by attrition and dosing
flexibility, she added.

When asked if medications like sildenafil (Viagra) could
help reduce the sexual side effects, she answered, “Sildenafil
may be helpful in men with erectile dysfunction or arousal
problems related to antidepressant medication, but it has no
effect on reduced sexual desire or orgasmic dysfunction.”

This study was funded by Eli Lilly and Company.

Not Enough Sleep Associated with Weight Gain

By Megan Rauscher

NEW YORK — Women who fail to get enough shut-eye each night risk gaining weight, a Cleveland-based researcher reported at a medical conference in San Diego today.

In a long-term study of middle-aged women, those who slept 5 hours or less each night were 32 percent more likely to gain a significant amount of weight (adding 33 pounds or more) and 15 percent more likely to become obese during 16 years of follow-up than women who slept 7 hours each night.

This level of weight gain — 15 kg, or 33 pounds — is “very clinically significant in terms of risk of diabetes and heart disease,” Dr. Sanjay Patel of Case Western Reserve University told Reuters Health.

Women who slept 6 hours nightly were 12 percent more likely to experience major weight gain and 6 percent more likely to become obese compared with those who slept 7 hours each night.

The 68,183 women in the study provided information in 1986 on their typical night’s sleep and reported their weight every 2 years for 16 years. The findings were presented at the American Thoracic Society’s International Conference.

Women who said they slept for 5 hours or less each night, on average, weighed 5.4 pounds more at the beginning of the study than those sleeping 7 hours.

After accounting for the influence of age and weight at the beginning of the study, women who slept 5 hours or less each night gained about 2.3 pounds more during follow-up than those who slept 7 hours nightly. Women who got 6 hours of shut-eye each night gained 1.5 pounds more than those who slept 7 hours nightly.

The researchers analyzed the diets and physical activity levels of the women, but failed to find any differences that could explain why women who slept less weighed more. “We actually found that women who slept less, ate less,” Patel said.

“In terms of exercise, we saw a small difference in that women who slept less exercised slightly less than women who slept more but it didn’t explain the magnitude of our findings,” Patel said.

All in all, it seems that diet and exercise are not accounting for the weight gain in women who sleep less, Patel concluded.

It’s possible that sleeping less may affect changes in a person’s basal metabolic rate — the number of calories burned when at rest, Patel said.

Another possible contributor to weight regulation that’s come to light recently is called “non-exercise associated thermogenesis” or NEAT, which refers to involuntary activity such as fidgeting or standing instead of sitting. It may be, Patel said, that if people who sleep less, also move around or “fidget” less.

Gambia retrains “bumsters” to shake sex tourism tag

By Rose Skelton

FAJARA, Gambia (Reuters) – The young Gambian man in the
yellow string vest calls out to a European woman walking along
a wide golden beach shrouded in a fine sea mist.

“Hey nice lady! Nice lady, I want to talk to you,” he
yells. She keeps walking.

“It’s nice to be nice,” he grumbles as he returns to his
friends, his matted hair escaping from his cap.

The young man is one of Gambia’s “bumsters,” youths who
offer to walk with tourists as they visit markets and beaches
in this tiny West African nation and who fend off the
attentions of rivals for a small fee.

What is left unsaid but understood is the possibility of a
more intimate relationship, that could be a ticket, however
temporary, out of poverty.

A week-long relationship could mean three hot meals a day
for the Gambian man and a luxury hotel bed to sleep in, plus
money for beer or cigarettes.

“I experienced one time when there was a young boy who was
trying to get me to his house for ‘the real Gambian Experience’
as they call it,” said Wilma, 35, from the Netherlands.

“It was very hard to get rid of him. Yes, he was trying to
sell himself,” said Wilma, who did not want to give her
surname.

In many African countries, it is common to see older white
men with young local black women, but Gambia, along with some
resorts in neighboring Senegal, has earned a name as a place
for older European women to meet young African men.

Now a British hotel manager is working to get the bumsters
off the beaches and into legitimate jobs in order to improve
Gambia’s image.

OLDER WOMEN

Precise numbers for the sex tourism industry are hard to
get. A 2003 report by UNICEF said 60-70 percent of visitors to
one of the main tourist areas near the capital Banjul were
there for “sun relaxation and cheap sex.”

Flights from Britain regularly arrive with a high
proportion of women traveling alone, often visiting younger
Gambian men they met on previous visits.

A lasting relationship can mean continued financial support
— invaluable in a country ranked as one of the 25 poorest in
the world — and, if all goes well, a visa to live in Europe.

For European women, it is a chance to have a young and
potentially attractive holiday companion.

But for those not interested in a liaison with a local man,
being approached in this way can be unpleasant — and that was
what spurred British hotelier Geri Mitchell to create jobs for
the men annoying her guests.

Mitchell, 52, who manages The Safari Garden Hotel, a leafy
oasis in the Fajara beach area near Banjul, selected a group of
young men and sent them to train as tourist guides.

They now charge tourists a set rate of 30 Dalasi ($1) an
hour or 50 Dalasi ($1.75) for a one-off trip. The hotel offers
them a formal introduction to the guests.

The project, which built on a previous government
initiative to train reformed bumsters as guides, has provided
much needed financial relief to Lamine Bojang, a guide in his
mid-20s.

Bojang’s father died when he was young and so he is the
family’s chief earner, and he has to pay his siblings’ school
fees.

“In my family, I play a big role,” he said.

Before becoming guides, Bojang and his friends used to
collect firewood in the forest and sell it to make ends meet.

Now, they say, they are able to make a basic living and
they have earned the respect of the hotel and its guests.

SETTING AN EXAMPLE

Part of the guides’ training involves learning how to
recognize and report sex tourism involving an underage person.

The majority of prostitutes in the tourist area near Banjul
where the guides work, are underage, with some as young as 12,
according to the UNICEF report.

The U.N. agency has also said it is concerned the former
British colony is increasingly becoming a destination for sex
tourists as countries in southeast Asia take steps to shake off
their image as havens for pedophiles.

Mitchell said the tourist guides also help monitor sex
tourism.

“That’s a message that we really want to get out to sex
tourists: Don’t come, because everybody is out there and taking
responsibility for what’s going on,” she said.

Rachel, 25, traveled alone from Britain to Gambia for a
vacation and praised efforts to deal with the bumsters.

“I just think the worst thing about the Gambia is that you
can’t step outside of your hotel for a minute without being
hassled. I think the Gambia would be a much better place
without that. I think official tour guides are probably the
best way of doing that,” she said.

Colonoscopy may not benefit the very elderly

NEW YORK (Reuters Health) – For people in their 80s and
90s, the risks of colonoscopy appear to outweigh the benefits,
investigators report in the Journal of the American Medical
Association. The slow development of colorectal cancer means
that these patients are more likely to die of other causes,
even if cancer is identified.

Meanwhile, for average-risk individuals, the decreased risk
of developing colorectal cancer after a normal result on an
initial colonoscopy remains lower than that of the general
population for more than 10 years, according to a second study
published in JAMA.

Current guidelines do not include an age at which
colorectal cancer screening with colonoscopy should be stopped,
Dr. Otto S. Lin and his associates note, even though the
procedure is associated with higher complication rates among
the very elderly.

Physicians need to consider whether the risk and cost of
screening colonoscopy can be justified by potential benefits in
very elderly patients, Lin’s team notes.

The investigators evaluated data for 1,034 symptom-free
individuals, 50 to 54 years of age, 147 between 75 and 79 years
of age, and 63 who were at least 80 years of age. The subjects
all underwent colonoscopy at Virginia Mason Medical Center in
Seattle between 2002 and 2005.

The rate of tumors increased with age, from 3.2 percent
among the youngest group to 14 percent among the oldest group.
However, screening colonoscopy added little to the lifespan of
the older patients, just 0.13 years.

These findings should help doctors and patients “decide
whether screening colonoscopy should be performed and help
avoid its use in patients who are unlikely to benefit
substantively,” Lin and his associates conclude.

In the second paper, a group led by Dr. Harminder Singh
points out that the interval for screening colonoscopy that has
been widely adopted is based on the estimated time required for
a polyp to transform into cancer. However, the average duration
of lowered risk of colorectal cancer risk after a normal
colonoscopy is not known.

To estimate this risk over time, Singh and colleagues at
the University of Manitoba in Winnipeg evaluated cancer
diagnoses and cancer-related deaths reported in the Manitoba
Cancer Registry and the Manitoba Health Population Registry.
This included 32,203 individuals with normal colonoscopy
results and who had been followed for more than 6 months.

The results showed that even after 10 years, people with
normal colonoscopy results had a lower cancer risk than people
in the general population. This suggests that a screening
interval of longer than 10 years may be appropriate.

In a related editorial, Dr. Timothy R. Church, from the
University of Minnesota School of Public Health in Minneapolis,
reminds readers that the benefits of screening were originally
based on trials of stool blood testing, rather than on much
more expensive strategies.

He estimates that at a cost of $500 per colonoscopy,
screening 10 percent of individuals 50 years or older in the US
every year would cost more than $4 billion annually.

SOURCE: Journal of the American Medical Association, May
24/31, 2006.

New Data Show Overactive Bladder Therapy Enablex(R) Does Not Impair Memory Function Compared to Frequently Used Alternative

ATLANTA, May 23 /PRNewswire/ — Data from a head-to-head clinical study looking at the effects of two prescription medications used to treat overactive bladder (OAB) showed that treatment with Enablex(R) (darifenacin) did not result in impaired memory function in healthy adults age 60 and older. In contrast, treatment with Ditropan XL(R)(i) (oxybutynin extended-release or ER), the other medication evaluated in the study, caused significant memory deterioration. Importantly, the individuals receiving oxybutynin ER failed to notice the change in their memory function. These findings were presented today during the 2006 Annual Meeting of the American Urological Association (AUA).

Enablex and Ditropan XL are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Both therapies are antimuscarinic agents, meaning they act on muscarinic receptors in the body associated with bladder control.

“Beyond balancing efficacy, tolerability and safety, selecting an appropriate overactive bladder treatment requires consideration of possible cognitive effects. These data indicate that Enablex may be a good treatment option for the older population,” stated Gary Kay, PhD, Washington Neuropsychological Institute and lead study investigator. “Clinical studies have demonstrated increased sensitivity of older subjects to antimuscarinics, including effects on memory; prompting us to conduct this clinical trial.”

These data are analyses of results from a multi-center, randomized, double-blind, placebo-controlled, parallel-group, three-week study involving 150 healthy older adults (male and female greater than or equal to 60). Results at three weeks suggest that Enablex (15mg) had no significant effect on memory function and was comparable to placebo, as measured by delayed recall accuracy on the Name-Face Association Test (a standardized, computer- administered test in which subjects try to recall the names of 14 people 30 minutes after being introduced to them). This was the primary endpoint for this study. Other standardized memory function tests used in this study evaluated delayed recall of first-last name associations and object locations.

“As the population grows older, the need for safe and effective overactive bladder treatments continues to increase,” said Senior Medical Director Anthony DelConte, M.D., Novartis Pharmaceuticals Corporation. “We are pleased this study provides reassurance that Enablex is a viable treatment option for older adults.”

About the study

Following a two-week screening period, subjects were randomized (1:1:1 ratio) to receive once-daily treatment in accordance with U.S. prescribing information with oxybutynin ER, Enablex and placebo. Cognitive function was assessed through the Psychologix/CogScreen battery of computerized cognitive function tests performed during clinic visits at baseline and following each week of treatment.

Subjective memory loss was assessed as a tertiary endpoint, using a validated self-reporting instrument, the Memory Assessment Clinics Self Rating Scale (MAC-S). In contrast with the objective memory tests, there was no significant difference between groups in self-rated memory scores, which suggests that changes in memory went unnoticed by subjects.

In this study, the most common adverse events (dry mouth: 26.5% Enablex, 40% oxybutynin ER; constipation: 20.4% Enablex, 4% oxybutynin ER) resulted in low rates of discontinuation.

More on overactive bladder

Overactive bladder, a condition that affects more than 33 million Americans, is caused by the untimely contraction of the bladder muscle.(2) At least 16 percent of the population over the age of 40 suffers from the chronic and troublesome symptoms of overactive bladder.(3) Although prevalence increases with age, the problem affects people of all ages. People with overactive bladder often limit travel, social and even work activities to avoid potentially embarrassing episodes that can occur with this condition.

About Enablex

Enablex is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Enablex is a potent muscarinic receptor antagonist that helps reduce incontinence episodes, increases the amount of urine that the bladder can hold, and decreases the pressure or urgency associated with the urge to urinate. It offers a unique M3 selectivity profile with sustained efficacy and low rates of central nervous system and cardiovascular side effects. Enablex works by preferentially blocking the M3 receptor that is primarily responsible for bladder muscle contraction.

Enablex has been studied in more than 98 clinical trials with a combined total of more than 10,500 people. In clinical trials, the most frequently reported adverse events with Enablex were dry mouth, constipation, dyspepsia and abdominal pain; however, patient discontinuation rates due to these events were low. The majority of adverse events in Enablex-treated subjects were mild or moderate and mostly occurred during the first two weeks of treatment. As with other overactive bladder medications, Enablex is contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow- angle glaucoma and in patients who are at risk for these conditions. Enablex is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.

Novartis Pharmaceuticals Corporation and Procter & Gamble Pharmaceuticals, Inc. (P&GP), a division of The Procter & Gamble Company, are collaborating on the co-promotion and further development of Enablex(R) (darifenacin) extended release tablets for the treatment of overactive bladder in the United States.

The foregoing release contains forward-looking statements that can be identified by terminology such as “further development,” or similar expressions or by express or implied discussions regarding potential new indications or labeling for Enablex or regarding potential future sales of Enablex. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Enablex to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Enablex will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Enablex sales will reach any particular levels. In particular, management’s expectations regarding Enablex could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data and new clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government, industry, and general public pricing pressures; and other risks and factors referred to in the Novartis AG’s current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG — a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com/.

Abstract 1271: Effects of Enablex and Extended-Release Oxybutynin on Memory in Older Subjects. Gary G. Kay, PhD, May 23, 2006 1:00-4:00 pm EDT

   Editor's Note: Full prescribing information available at http://www.enablex.com/.    Contact    Karen Sutherland   Novartis Pharmaceuticals Corporation   Tel: 862-778-0323   Cell: 917-330-5981   [email protected]     (1) Kay, Gary G., et al. "Effects of Darifenacin and Extended-Release       Oxybutynin on Memory in Older Subjects"       Abstract 1271, American Urological Association Annual Meeting 2006.    (2) Increasing Awareness and Improving the Care of Urinary Incontinence:       Highlights from the World Health Organization 2nd International       Consultation on Incontinence. Reviews in Urology. 2003; Vol 5, No 1:       22-25.    (3) National Association For Continence.  About Incontinence: Urge/OAB.       Prevalence. http://www.nafc.org/. [Last accessed, 5/4/06]     (i) Ditropan XL is a registered trademark of Alza Corporation, a       subsidiary of Johnson & Johnson  

Novartis Pharmaceuticals Corporation

CONTACT: Karen Sutherland of Novartis Pharmaceuticals Corporation,+1-862-778-0323, cell, +1-917-330-5981, [email protected]

Web site: http://www.pharma.novartis.com/http://www.enablex.com/

Hot flashes worse after surgery-induced menopause

NEW YORK (Reuters Health) – Women who undergo surgical
removal of both ovaries, a procedure called bilateral
oophorectomy — and who do not received hormone replacement
therapy – have a significantly increased risk of experiencing
moderate to severe hot flashes compared with women who have
natural menopause, according to new report published in the
journal Fertility and Sterility.

Dr. Jodi A. Flaws, of the University of Maryland,
Baltimore, and colleagues examined the association between type
of menopause and hot flashes after accounting for patterns of
hormone replacement therapy use. Three types of menopause were
considered: natural menopause, hysterectomy (removal of the
uterus), and hysterectomy with bilateral oophorectomy.

Four hundred seventy-five postmenopausal women between the
ages of 40 and 60 years completed a mailed survey on their
history of hot flashes and use of hormone replacement therapy.
Two hundred sixty-three women (55 percent) had natural
menopause, 142 (30 percent) had a hysterectomy with at least
one ovary left intact, and 70 (15 percent) had bilateral
oophorectomy.

Hormone replacement therapy use was more common among women
who underwent bilateral oophorectomy than among those who
underwent only hysterectomy or natural menopause. Women who
underwent bilateral oophorectomy were also more likely to have
used hormone replacement therapy for longer periods of time.

Women who had either type of surgical menopause had a lower
risk of experiencing any hot flashes.

However, among the women who did not receive hormone
replacement therapy, those who underwent bilateral oophorectomy
had an increased risk of moderate or severe hot flashes
compared with women who had natural menopause.

“Researchers have hypothesized that the increase in risk of
hot flashes among women who undergo bilateral oophorectomy
compared with postmenopausal women who do not undergo bilateral
oophorectomy is caused by the abrupt decline in the gonadal
hormone levels, including the estrogens that have been shown to
be negatively associated with hot flashes in midlife women,”
Dr. Flaws and colleagues explain.

Those who experience natural menopausal or who undergo
hysterectomy only have lower estrogen levels than premenopausal
women. However, the “conservation of one or both ovaries
provides some level of estrogen production and, therefore, a
lower likelihood of experiencing hot flashes,” the researchers
conclude.

SOURCE: Fertility and Sterility, May 2006.

Linoleic Acid Supplements Change Fat Distribution

By Martha Kerr

LOS ANGELES (Reuters Health) – A study presented here at Digestive Disease Week 2006 shows that conjugated linoleic acid supplements induce a change in body fat distribution, with the greatest fat reductions occurring in the abdomen and legs. Meanwhile, body weight and body mass index are essentially unaffected.

Conjugated linoleic acid is found in fats from ruminant animals, such as cows or sheep, and from dairy products, Dr. Alexandra Einerhand of the Lipid Nutrition Center in Loders Croklaan, Wormerveer, the Netherlands, and colleagues in Norway explain in their meeting abstract. The body normally stores low levels of conjugated linoleic acid, ranging from 150 mg to 400 mg, the Dutch researcher noted.

Einerhand’s team randomly assigned 105 overweight or obese adults to 3.4 grams per day of conjugated linoleic acid or to a placebo, consisting of olive oil, for 6 months.

There was a significant 5.6 percent drop in body fat mass in participants given the conjugated linoleic acid supplement compared with those given placebo at the end of the 6-month study period, the researchers report.

Reductions in fat mass were already detectable after 3 months. In women, reductions occurred in both the abdomen and legs, while in men, reductions were only seen in the abdomen. The conjugated linoleic acid supplements did not affect tissue composition in the arms.

Waist circumference dropped by 3.1 cm, while waist-to-hip ratio fell 0.024. Body weight was reduced by 1.5 kg and BMI was 0.6 lower, although Dr. Einerhand said these changes were not statistically significant.

Individuals with the highest BMIs at baseline showed the greatest response to conjugated linoleic acid supplementation.

“These changes were independent of diet and exercise,” she added.

Einerhand told Reuters Health that there appeared to be no toxicity with conjugated linoleic acid supplements and a number of other parameters the investigators measured were unaffected.

Insulin sensitivity, HDL (“good” cholesterol) and LDL (“bad cholesterol) levels, and biological markers of inflammation were also unchanged, she commented. “It may be that the changes are too modest to be seen at this time,” Einerhand suggested.

Venezuela ‘revolution’ gets a hip-hop beat

By Greg Brosnan

CARACAS, Venezuela (Reuters) – Among the shabby high-rise
tenements overlooking Venezuela’s capital, hip-hop beats rather
than the usual gunfire kept the Caracas neighborhood of Pinto
Salinas awake one night recently.

Bass notes echoed from a small stage as teen-agers in baggy
sports clothes and fat sneakers, many of them black youths
descended from African slaves, listened avidly to an instructor
before themselves rapping in Spanish over a thundering sound
system.

In a twist in Venezuelan President Hugo Chavez’s
self-styled socialist revolution, his government, which has
long pumped proceeds from oil sales into health and education
for the poor, is paying for rap-crazy youths to prime their
rhymes as an escape route from drugs and violence in some of
Caracas’ toughest neighborhoods.

“We’re used to seeing corpses, used to seeing people kill
each other every day in shootouts,” said Alfred Garcia, a
20-year-old rapper from Pinto Salinas who helped organize the
workshop on hip-hop culture.

“Shooting can break out at any time … but not tonight,”
he said. “I know the bad guys … I spoke to them and told them
this event was going on. They said they wouldn’t bother us if
we didn’t bother them.”

Held in poor neighborhoods across Caracas, rap workshops
are run with government funds by Tiuna el Fuerte, a collective
of young artists and musicians born out of a failed April 2002
coup against Chavez.

MEAN STREETS

“This is a turntable, this is a mixer,” a 21-year-old
instructor in combat pants who called himself MC klopedia told
wide-eyed children who clambered onto the stage at Pinto
Salinas for a class on hip-hop basics. Some could barely walk.

“There is gangster rap, there is hardcore rap … Hey pay
attention!” he snapped as two toddlers scuffled.

Older brothers, some wearing dark glasses and headscarves
and holding pitbull terriers on chains, looked on approvingly
at the rap class.

After oil production soared under 1950s dictator Marcos
Perez Jimenez, Venezuela began building scores of high-rise
apartment complexes across Caracas known as ‘superblocks’ aimed
at providing healthy spaces for urban living.

But overflowing with rural migrants and virtually
unpoliced, many hillside complexes like Pinto Salinas are now
as prone to drug violence as the chaotic shantytowns that have
sprung up around them.

As marijuana smoke mixed with the solvent stench of
graffiti artists’ spray paint, the budding rappers at Pinto
Salinas described their daily reality in neighborhoods known as
“barrios” a world away from the plush malls and guarded
condominiums of wealthier parts of the city.

“Come to my barrio, to see I am not lying, where the
bullets are a concert of pure death, not salsa,” one rapper
chimed. A friend puffed a “beatbox” rhythm into a microphone
with his mouth while another “scratched” vinyl records.

MUSIC WITH A MESSAGE

The project was born out of the political upheaval that has
characterized Venezuela in recent years.

Leaving a rehearsal at their university in 2002, members of
a band mixing salsa with hip-hop from a Caracas neighborhood
similar to Pinto Salinas bumped into a march by Chavez
opponents that was part of a coup that briefly toppled him.

After joining thousands of other Chavez supporters in the
streets to help restore his power, some of the band members
vowed to support the former paratrooper’s “revolution” using
music and art.

The government put the young musicians on the payroll, gave
them transport, a sound system and a plot of concrete-covered
land in the shadow of a “superblock” complex as a base.

Covered in creative graffiti, much of it critical of
Chavez’s sworn enemy President Bush, the spot overlooking a
busy highway is a hangout, concert venue and school for
everything from sound-engineering to circus skills.

“We are armed and fighting,” said one of the collective’s
founders, 32-year-old Piki Figueroa. “Our bullets are music,
dance, painting, poetry, video and images.”

Critics denounce Chavez’s neighborhood programs as wasteful
populist measures aimed at currying favor among the masses.

Members of the collective say they support the government
with reservations because they worry about corruption. Tiuna
says it had little grasp of the reality of barrio youth
culture, something they want to help change.

Proudly watching her son perform, rapper Garcia’s mother
Egle Mijares said she was hopeful the project could limit the
number of bullets flying around Pinto Salinas on most other
nights.

“They’re getting rid of all that adrenaline they have,” she
said of the budding street poets. “They’ve fallen in love with
rap so much that they’ve given up crime.”

Russian romances blossom in Norwegian Arctic town

By Alister Doyle

KIRKENES, Norway (Reuters) – In a blossoming of post-Cold
War romance on the Arctic tip of Europe, one in four marriages
in the Norwegian port of Kirkenes involves a Russian.

The signs of cross-border closeness are everywhere: Street
signs in Kirkenes are in both Norwegian and Russian and around
a dozen Russian trawlers are tied up in the port for repairs.

“We’re getting back to normal,” said Jarle Forbod, managing
director of the Norwegian-Russian Chamber of Commerce.

The ties between Russia and Norway date back to Viking
times but during the Cold War relations collapsed, changing
lives in this remote area which is further east than Istanbul
and where snow covers the hills in May.

A century ago, the Arctic was a hub for trade — Russians
bought fish from Norway and exported goods including furs and
timber. The nearby town of Hammerfest had six foreign
consulates and was the first in northern Europe to have street
lights.

All that changed after the 1917 Bolshevik Revolution and
following World War Two, NATO troops and Russia’s communists
shivered through the Cold War along this frontier, although no
shot was ever fired in anger.

“The impression of Russia here is positive,” said Rune
Rafaelsen, general secretary of the Norwegian Barents
Secretariat which promotes better ties in northern Europe.

Russians are popular in northern Norway partly because the
Red Army drove Hitler’s Nazis out at the end of World War Two
— and then withdrew.

PERSON TO PERSON

“The most successful thing is that we’ve established person
to person contacts, and between businesses and institutions,”
Rafaelsen said.

Problems include how to manage a region with one of the
biggest wealth gaps in the world — Norwegian per capita
incomes are among the highest at $36,680 in 2004 against just
$9,680 for Russians, according to World Bank data.

“My wages are maybe 10 times more here than in Russia,”
said Ljudmila Kristian, a Russian doctor working at the
hospital in Kirkenes. “We get a lot of Russian patients.”

One in four marriages in the Kirkenes area, which has about
9,400 people, is a mixed Norwegian-Russian alliance. Most are
Russian women marrying Norwegian men.

The Barents Secretariat, which groups Nordic nations and
Russia, has channeled about 4 billion crowns ($660 million) to
projects in northwest Russia, mainly to help dismantle aging
nuclear submarines.

Hopes of deepening these links are now pinned on joint oil
and gas exploration in the Barents Sea, where Russia’s Shtokman
is one of the world’s biggest offshore gas fields and could
provide jobs on both sides of the border.

Rafaelsen said a former U.S. ambassador had visited the
Kirkenes region seven times, seeing it as a future center for
oil and gas.

“Seen from Washington, this is the center of Norway,” he
quoted the ambassador as saying.

TRADE SLUGGISH

Despite the closer ties, businesses on both sides still
face some challenges in breaking into neighboring markets.

Operating with far higher costs, few Norwegian companies
have managed to attract Russian business.

“We can’t beat a Russian yard on price but we can beat them
on quality and delivery time,” said Greger Mannsverk, head of
the Kimek shipyard in Kirkenes. The yard has months-worth of
bookings for repairs to Russian trawlers.

Mannsverk said there were also differences between doing
business Russian-style, with its tradition of strong leaders,
and the Norwegian business ethos, with its emphasis on
grassroots democracy.

“If you’re on the strong side of an argument you can say,
‘we’ll do it like this’ and the Russians will accept your
decision,” he said.

“Maybe in Norway we’ve gone too far the other way, it’s
more difficult to make decisions. You almost have to call a
mass meeting to decide small things.”

Trade with Russia still lags commerce with other Nordic
nations. Exports to Russia from Norway totaled 5.3 billion
crowns ($874 million) last year, mostly fish, while imports
were 8.3 billion crowns, mainly metals.

Bodil Emanuelsen, 43, who runs an arts shop in Kirkenes,
said that negative stories, such as prostitutes crossing the
border from Russia, often grabbed local headlines.

“But it’s not all negative. It’s much easier to travel now
— there are many good arts festivals in Russia,” she said.

Veronica Zubairova, 22, moved to Norway when she was 9 but
would like to move back across the border to nearby Nikel to
study.

“I feel I’m Norwegian but there’s Russian in my blood,” she
said in fluent Norwegian at the counter of a Kirkenes kiosk.

New Studies Examine SEROQUEL(R) in Combination With Antidepressant Therapy in Patients With Depression

WILMINGTON, Del., May 22 /PRNewswire-FirstCall/ — AstraZeneca today announced results of two clinical studies that examined SEROQUEL(R) (quetiapine fumarate) in combination with antidepressant therapy in patients with depression. One study evaluated the use of SEROQUEL in combination with antidepressant therapies (SSRI/SNRI medications(+)) to improve residual depressive and anxiety symptoms in patients with major depressive disorder.(1) Another study examined the benefit of SEROQUEL when added to SSRI/SNRI therapies in patients with treatment-resistant depression.(2) These two studies were presented at the annual meeting of the American Psychiatric Association (APA).

SEROQUEL is approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia. On December 30, 2005, AstraZeneca submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) to seek approval for SEROQUEL in the treatment of patients with depressive episodes associated with bipolar disorder. SEROQUEL is currently being investigated for the treatment of major depressive disorder.

“There is growing evidence that augmentation of antidepressant therapy with atypical antipsychotics may help improve symptoms of depression,” said Greg Mattingly, M.D., Associate Clinical Professor, Department of Psychiatry, Washington University School of Medicine. “These studies are encouraging and warrant further investigation of the potential of SEROQUEL(R) (quetiapine fumarate), both as a monotherapeutic agent as well as in the augmentation of SSRI/SNRI therapy, in patients with major depressive disorder.”

ABOUT THE STUDIES

One study was a double-blind, randomized placebo-controlled trial designed to evaluate SEROQUEL augmentation of SSRIs/SNRIs in patients with residual depressive and prominent anxiety symptoms associated with major depression. In this study, patients (n=58) with residual symptoms following at least six weeks of SSRI/SNRI treatment received SEROQUEL (50-600mg/day; mean dose=202 mg/day) or placebo for eight weeks.(1)

The study found significant reduction (SEROQUEL vs. placebo) in several rating scales as early as week 1 (p less than or equal to 0.01) and continuing through week 8 (p less than or equal to 0.01). HAM-D(++) results for SEROQUEL at week 1 and week 8 vs. placebo at week 1 and week 8 were -6.5 and -11.2 vs – 2.9 and -5.5; HAM-A (S) (-7.4, -12.5 vs -3.4, -5.9); CGI-Severity** (-0.45, -1.5 vs -0.07, -0.6).(1)

The second trial, also a randomized, double-blind, placebo-controlled trial (n=39), examined augmentation of SEROQUEL (200-400 mg/day; mean dose=268 mg/day) to SSRI/SNRI therapy in treatment-resistant depression. At the end of the eight-week trial, patients receiving SEROQUEL(R) (quetiapine fumarate) had significantly lower HAM-D17 scores versus placebo (8.3 vs. 14.7, respectively, p

The most common adverse events observed in these trials include sedation, somnolence, lethargy, dry mouth, weight gain, dizziness, headache, similar to previous clinical trials of SEROQUEL.(1,2)

“AstraZeneca recognizes the difficulties in treating depression and is dedicated to finding new therapies and regimens for patients who suffer from this disorder,” adds Wayne Macfadden, M.D., US Medical Director for SEROQUEL. “The results of these analyses reinforce the importance of additional investigation of the potential role of SEROQUEL in managing symptoms associated with depression.”

The studies were conducted by A. McIntyre and associates at the Department of Psychiatry of Penticton Regional Hospital in Penticton, British Columbia, Canada and Gregory W. Mattingly and associates at Washington University School of Medicine. Both studies were supported by AstraZeneca Pharmaceuticals.

SEROQUEL is the #1 prescribed atypical antipsychotic in the United States.(3) With a well-established safety and efficacy profile, SEROQUEL has had more than 16 million patient exposures worldwide since its launch in 1997. In 2005, global sales for SEROQUEL reached $2.8 billion.

IMPORTANT SAFETY INFORMATION

SEROQUEL(R) (quetiapine fumarate) is indicated for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy with lithium or divalproex, and the treatment of schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment. It is recommended SEROQUEL be taken twice daily in divided doses. SEROQUEL is not currently approved for the treatment of major depressive disorder or the depressive phase of bipolar disorder.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL is not approved for the treatment of patients with dementia-related psychosis.

Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including SEROQUEL.

Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including SEROQUEL. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Precautions include the risk of seizures, orthostatic hypotension, and cataract development.

The most commonly observed adverse events associated with the use of SEROQUEL in clinical trials for schizophrenia and bipolar mania were somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, SGPT increase, dyspepsia, and weight gain.

For full Prescribing Information for SEROQUEL, please visit the Web site http://www.seroquel.com/.

ABOUT ASTRAZENECA

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com/

This press release contains forward-looking statements with respect to AstraZeneca’s business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company’s Annual Report/Form 20-F for 2005.

   +         Selective serotonin reuptake inhibitors (SSRIs) act             specifically on the neurotransmitter serotonin. These             medications include fluoxetine (Prozac), sertraline (Zoloft),             paroxetine (Paxil), citalopram (Celexa) and escitalopram             (Lexapro). Serotonin and norepinephrine reuptake inhibitors             (SNRIs) are useful as first-line treatments in people taking an             antidepressant for the first time and for people who have not             responded to other medications. These medications include             Venlafaxine (Effexor).(4)   ++        Hamilton Depression Rating (HAM-D) Scale: This scale is used to             assess the severity of depression in patients already diagnosed             with an affective disorder. There are two versions of the scale             using either 21 or 17 items (HAM-D21 and HAM-D17); the 17-item             scale uses the first 17 questions on the full scale. Items are             scored from 0 to 4, the higher the score, the more severe the             depression. Questions are related to symptoms such as depressed             mood, guilty feelings, suicide, sleep disturbances, anxiety             levels and weight loss.(5)   S         Hamilton Anxiety Rating (HAM-A) Scale: This scale consists of             14 items, each defined by a series of symptoms. The HAM-A was             one of the first rating scales developed to measure the             severity of anxiety symptomatology. The scale measures the             severity of symptoms such as anxiety, tension, depressed mood,             palpitations, breathing difficulties, sleep disturbances,             restlessness and other physical symptoms. Items are scored from             0 to 4, the higher the score, the more severe the symptoms.   **        Clinical Global Impression (CGI) Scale: The CGI scale refers to             the global impression of the patient and requires clinical             experience with the syndrome under assessment. The CGI             improvement scale can be completed only following or during             treatment. The concept of improvement refers to the clinical             distance between the individual's current condition and that             prior to the start of treatment. The scale has a single item             measured on a 7 point scale from 1 ('normal', not ill) to 7             (extremely ill).    (1)       A. McIntyre, A. Gendron, A. McIntyre.  Quetiapine reduces             residual depressive and prominent anxiety symptoms in partial             responders to selective serotonin reuptake inhibitors (SSRIs)             or serotonin norepinephrine reuptake inhibitors (SNRIs) with             major depression: an 8-week, double-blind, randomised, placebo-             controlled study.  Annual Meeting of the American Psychiatric             Association, 2006, Toronto, Canada, research poster board             NR254.   (2)       G. Mattingly, H. Ilivicky, J. Canale, R. Anderson.  Quetiapine             Combination for Treatment-Resistant Depression.  Annual Meeting             of the American Psychiatric Association, 2006, Toronto, Canada,             research poster board NR250.   (3)       All atypical prescriptions:  Total prescriptions Jan 06 to Mar             06.  IMS Health.  National Prescription Audit.   (4)       Frank, Ellen.  Major Depression.  NAMI.  May 2003.  Available             at:             http://www.nami.org/Template.cfm?Section=By_Illness&Template=/T             aggedPage/TaggedPageDisplay.cfm&TPLID=54&ContentID=23039&lstid=             326.  Accessed on May 1, 2006.   (5)       Lundbeck Institute. Psychiatric Rating Scales. PDF available             at:             http://www.brainexplorer.org/factsheets/Psychiatry%20Rating%20S             cales.pdf. Accessed on May 1, 2006.  

AstraZeneca

CONTACT: Lynn Gionta of AstraZeneca, +1-302-885-5672,[email protected], or Jim Minnick of AstraZeneca, +1-302-886-5135,[email protected]

Web site: http://www.astrazeneca-us.com/

Company News On-Call: http://www.prnewswire.com/comp/985887.html

Verdict due for Ethiopia’s ex-dictator Mengistu

By Tsegaye Tadesse

ADDIS ABABA (Reuters) – Mengistu Haile Mariam, accused of a
17-year reign of terror in Ethiopia, faces a long-awaited
genocide verdict on Tuesday in a sign of Africa’s new resolve
to bring ex-leaders to account for past abuses.

The former Marxist ruler, now nearing 70 and living in
comfortable exile in Zimbabwe, is accused of killing tens of
thousands of people after toppling Emperor Haile Selassie in
1974.

In the most notorious purge, the Red Terror, thousands of
suspected opponents were rounded up, executed by garrotting or
shooting, then tossed into the streets.

Mengistu fled to Zimbabwe in 1991 but has been the subject
of a 12-year trial in absentia in Addis Ababa.

The prosecution blames the lengthy case on the complexity
of the proceedings but Ethiopians hoping to close the door on a
painful era indicated they weren’t troubled by the delay.

“I know that even if Mengistu and all his supporters are
sentenced to death, there is no way I will get my son back,”
said Abebe Girma, 60, a pensioner whose son was accused of
being an opposition supporter and executed in the 1977-78 Red
Terror.

“Just the same, I want justice to be done.”

Most of Africa’s many former strongman rulers in the
decades since independence have avoided facing legal charges.
But activists believe the continent is finally strengthening
its resolve to tackle a litany of past abuses.

Liberian warlord-turned-president Charles Taylor became the
first African leader last month to stand before an
international court in Sierra Leone, where he awaits trial on
11 counts of war crimes and crimes against humanity.

And in June, an African Union summit is to decide whether
to extradite former Chad President Hissene Habre to Belgium to
face charges of mass murder and torture during his 1982-1990
rule.

The International Criminal Court is also probing war crimes
in Uganda and the Democratic Republic of Congo.

“Things have changed hugely since the bipolar (Cold War)
world when the only people who could deliver any justice were
the people there,” said Richard Dowden, head of the UK-based
Royal African Society, referring to Africa’s coup-laden past.

WHISKY DURING FAMINE

Some 40 members of Mengistu’s “Dergue” junta — ousted in
1991 by guerrilla forces led by now Prime Minister Meles Zenawi
— have also been tried and will appear at the Supreme Court.

Twenty more, like him, are being tried in absentia.

They could face the death penalty if found guilty of crimes
against humanity and genocide, which Ethiopian law defines as
intent to wipe out political and not just ethnic groups.

Evidence against Mengistu has included signed execution
orders, videos of torture sessions and personal testimonies.

Despite calls for his extradition, Zimbabwe’s President
Robert Mugabe is unlikely to hand over Mengistu in the event of
a guilty verdict. Rights campaigners hope, however, that a
post-Mugabe government may take that step.

“I simply cannot believe a new government in Zimbabwe would
want to protect him and I can’t think of anyone else who would
take him,” Dowden said.

Mengistu, whose army helped train Mugabe’s guerrillas in
their 1970’s struggle for independence from white rule, lives a
lavish but reclusive life in Zimbabwe.

Officially, Mengistu and his family live in a government
villa in a wealthy district of Harare, behind a high security
wall and guarded round the clock.

But diplomats believe he moves around a number of “safe”
houses and owns some properties including farms.

Many Ethiopians want him back now.

MURDER, FAMINE

“If Mengistu is found guilty, there’s no reason for
Zimbabwe to give sanctuary to a murderer. Mengistu must be
returned home and face the verdict,” said engineer Shimles
Hailu.

Emperor Selassie, dethroned in 1974, was his most prominent
victim. He was allegedly strangled in bed a year after the
revolution that ended centuries of feudal rule.

Selassie was secretly buried under a latrine in the palace.
About 70 of his senior officials were shot by firing squads and
dumped in a mass grave.

When famine struck in 1984, aid workers recalled how
Mengistu flew in planeloads of whisky to celebrate the
revolution anniversary while denying there was starvation.

Up to 1 million people died from hunger in the famine that
provoked “Live Aid,” the world’s most famous aid mobilisation.

“It is hoped the verdict will show the world Mengistu’s and
his regime’s brutality, and will bring peace of mind to all
those who lost loved ones in his hands,” said an Ethiopian
lawyer, who asked not to be named.

Although proceedings against Mengistu and his henchmen
began in 1992, the trial formally started in 1994.

The co-accused include former prime minister Fikre Selassie
Wogderesse, former vice-president Fissiha Desta and others who
have been in prison awaiting verdict since 1992.

Ablation better than drugs for arrhythmia: trial

BOSTON (Reuters) – A technique to treat irregular heart
beats using a method known as ablation was substantially more
effective than anti-arrhythmic drugs in a clinical trial.

A 12-month trial of 112 patients showed the ablation
technique had a 75 percent success rate in preventing
arrhythmias in patients who had failed at least one drug
regimen, compared with a success rate of just 6 percent for
patients who received drug therapy alone, according to data
presented on Saturday at a meeting of the Heart Rhythm Society
in Boston.

During ablation, a doctor inserts a catheter, or thin,
flexible tube, into the heart. A special machine delivers
energy through the catheter to areas of the heart muscle that
cause abnormal heart rhythm and disconnects that pathway.

Initially, about half the patients in the trial received
drugs alone and half received ablation. But 37 patients in the
drug group joined the ablation group because the drugs were not
adequately controlling their arrhythmia, according to Dr.
Pierre Jais, a cardiologist at Haut-Leveque Hospital in France,
who led the trial.

Of the millions of patients who suffer from atrial
fibrillation, only about 30,000 a year are treated using
ablation, Jais said. That could change with trials such as this
one, he said.

“If you speak to people who are performing ablation, all
will tell you that ablation works better than drugs, but these
people are a minority of cardiologists,” he said. “Most
cardiologists are not convinced.”

While ablation has been performed for more than a decade,
it has only matured within the last few years. As its success
rate has risen, so has interest in the procedure, Jais said.

The next step is to conduct a trial to see whether people
who are treated with ablation live longer than those who just
take drugs.

The latest trial followed patients for a year, but Jais
said he feels confident the benefit likely extends out as far
as a decade or more.

“My feeling is that if you don’t have a recurrence a year
after the process the risk of getting one after that is
extremely limited,” he said.

Baltimore’s New Bait: The City is About to Unveil a New Slogan, ‘Get In On It,’ Meant to Intrigue Visitors

By Doug Donovan, The Baltimore Sun

May 20–Nine months and half a million dollars later, Baltimore has a new slogan.

Drumroll, please: “Baltimore – Get In On It.”

The preposition-rich slogan is set to be announced next week as the centerpiece of Charm City’s new effort to sell itself to tourists and visitors, according to sources familiar with the lengthy and secretive process.

“Get in on what?” asked Baltimore City Councilwoman Rochelle “Rikki” Spector, after repeating it aloud three times.

“I’ve seen some dumb ones in the past, but this is the dumbest,” said former Mayor/former Gov./Comptroller William Donald Schaefer through his spokesman.

(As mayor, Schaefer once presided over “Pink Positive Day” when curbs were painted pink, television anchors were encouraged to wear pink, and the city’s collective spirit was supposed to be improved through color after losing the Colts.)

Filmmaker John Waters said, “It’s not catchy. I keep having to ask what it is again because I forget. That’s OK. I don’t hate it.

“I get what they’re saying,” Waters said. “What they’re saying is, come celebrate real estate porn. You know, when people talk about how much their house cost at parties.”

One branding expert, Eric Swartz, founder of TaglineGuru.com, said Baltimore has come up with a winning slogan.

“Get In On It sounds provocative, inviting, sounds like there’s something to discover” in Baltimore, Swartz said. “It’s vague enough to have an appeal to people who are not familiar with Baltimore. It’s an invitation.”

City officials refused yesterday to confirm the winning motto. But the Baltimore Area Convention and Visitors Association has submitted four applications to the U.S. Patent and Trademark Office to secure use of the phrase.

Luckily for Baltimore, the trademark no longer belongs to Marshalls Inc., the Massachusetts-based discount retailer that first registered it a decade ago.

Nancy Hinds, a BACVA spokeswoman, said the slogan will be unveiled during a ceremony scheduled for Wednesday at the Hippodrome Theatre. She said the slogan was just one element of the city’s overall new branding campaign.

“Whatever the tagline is, is only half the story,” Hinds said. “It’s far more than just a slogan.”

Former Mayor Kurt L. Schmoke was more diplomatic yesterday than his predecessor, Schaefer.

“Some will like it, and for others it will be an acquired taste,” he said. “It’s an appeal to a young, hip generation, or something like that, I’m assuming.”

Swartz, the branding specialist, declared that some of Baltimore’s previous slogan attempts – “The City That Reads,””The Greatest City in America” and “Charm City” – are among the nation’s worst.

There has been a string of other nicknames along the way: Digital Harbor, Mobtown and Crab City. Then there are the less image-friendly labels: The Heroin Capital and The Murder Capital.

The convention and visitors association has kept a tight lid on the finalists for weeks and has made sure other booster groups do the same.Kirby Fowler, president of the Downtown Partnership, “has been sworn to double secrecy,” said his spokesman, Mike Evitts. So, too, have BACVA board members.

But sources who have been briefed on the finalists said “Get In On It” was judged to be far better than the other finalists that the city’s consultant, Landor Associates, was paid $500,000 to produce over the past nine months.

Here are some of the finalists, according to sources who requested anonymity because of the secrecy:

“The City You Savor”

“Breeze Into Baltimore”

“All City, No Hurry”

“Enjoy The Pace”

Swartz said the city should be prepared for an initial backlash.

“Projects of this magnitude are usually accompanied by a fair amount of anguish and nagging doubts, especially when detractors start chomping at the bit. After all, a city’s pride and reputation are at stake,” Swartz wrote in an article, “Jumping on the Brandwagon,” on his Web site.

The branding strategy aims to create a positive perception that attracts tourists and conventions, which, in turn, can boost the local economy.

Experts consider Las Vegas’ slogan “What Happens Here Stays Here” to be among the most successful. An earlier attempt by Sin City to brand itself as a family-friendly destination led to a demonstrable drop-off in business.

“A slogan is a valuable ambassador,” Swartz wrote.

The city picked a respected and experienced brand-builder in Landor. The San Francisco-based firm has come up with slogans for such locations as Madrid, Spain; Florida; and Hong Kong, as well as brands such as Gatorade, Altoids and Kentucky Fried Chicken.

In November, Landor’s director of brand strategy, Susan Palombo, told the Baltimore City Council and Mayor Martin O’Malley that “the perception [of Baltimore] is very bad.”

Her company’s survey found that David Simon’s television dramas about crime and drugs in Baltimore – The Wire, The Corner and Homicide: Life on the Street – were culprits for fostering the city’s bad image. Simon declined to comment yesterday.

Palombo also said at the time that Baltimore did not rank among travelers surveyed as a “dream destination.” When Baltimore was presented as an option in a Landor survey, travelers ranked it in the top 10 – behind New York, Washington, Boston, Atlantic City and Philadelphia.

In a Landor survey in which Baltimore was not mentioned, travelers did not volunteer the city as a place they wanted to visit.

Palombo said at the time that Baltimore had to build on the city’s unique character and should not try to “out-Disney” Orlando, “out-monument” Washington or “out-Broadway” New York.

Baltimore union leader Ron DeJuliis said he thought “Get In On It” is “catchy.”

“I like that,” he said.

Spector, the council’s longest-serving member, questioned whether “Get In On It” will do the trick.

“I don’t know; it doesn’t have a Baltimore ring to it,” Spector said. She said she knows the slogan is supposed to appeal to visitors and not longtime residents such as her.

Even so, she said, “I don’t associate anything Baltimore to it.”

—–

Copyright (c) 2006, The Baltimore Sun

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ABHR Gel in the Treatment of Nausea and Vomiting in the Hospice Patient

By Moon, Richard B

Abstract

Hospice patients at the end stages of life often suffer nausea and vomiting, distressing symptoms that are either side effects of medications or direct effects of the underlying disease state. Such symptoms can greatly diminish the hospice patient’s quality of life. Effective pharmacotherapy is available, but in many cases traditional dosage forms are incompatible with the patient’s physical condition, cause discomfort, or are difficult for family members to administer. In such cases, a compounded preparation containing lorazepam, diphenhydramine, haloperidol, and metoclopramide-commonly referred to as ABHR gel-has proven highly effective. A number of case reports are presented to illustrate the effectiveness of ABHR gel in relieving the symptoms of nausea and vomiting in hospice patients. Also discussed are the causes of vomiting and the mechanisms of each of the medications contained in the ABHR gel.

Lorazepam, diphenhydramine, haloperidol, and metoclopramide are the drugs contained in the compounded gel commonly referred to as ABHR. The gel was named after the brand names Ativan, Benadiyl, Haldol, and Reglan, under which these drugs were originally marketed. This gel is an option that has proven highly effective for relieving the symptoms of nausea and vomiting for terminally ill hospice patients. This combination of drugs works to block each physical pathway that is responsible for nausea and vomiting. Case reports are provided to illustrate ABHR gel’s effectiveness in relieving these symptoms.

Pathophysiology and Overview of Nausea and Vomiting

Boomsma published an excellent review of the mechanisms involved in nausea and vomiting and the medications used in the treatment of these symptoms in hospice patients.1 There are three distinct stages of vomiting (Table 1). The body’s vomiting center (VC) is the final pathway that controls all vomiting. The VC does not respond directly to chemical stimuli but is triggered by four different mechanisms, as follows:

* Chemoreceptor trigger zone (CTZ): The CTZ incorporates various receptors (serotonin, dopamine, and opiate) that mediate the emetic effects of blood toxins and drugs. The CTZ is unable to induce vomiting without an intact VC.2,3

* Afferent impulses from the periphery: Stimulation of the VC from outside the central nervous system occurs when chemical stimulation and physical factors cause afferent impulses from the periphery. Serotonin, dopamine, and opiate receptors are the mediators of emesis.2,4

* Vestibular apparatus: The vestibular apparatus is located near the VC. Motion induces stress, which transmits an impulse to the vestibular apparatus. Norepinephrine and acetylcholine are the receptors in the vestibular apparatus.2,5,6

* Conical structures: Cortical structures are areas in the higher brain stem that are able to initiate vomiting. Impulses (sight, smell, taste, or unpleasant memories) sent to the cortex of the VC may stimulate this pathway.2,4

The ABHR gel treatment works by blocking each of the pathways that trigger nausea and/or vomiting.

Table 1. Stages of Vomiting.

Obstacles in the Treatment of Nausea and Vomiting

Obstacles to treating nausea and vomiting in the hospice population are as follows:

* Traditional single-agent therapy is not always effective.

* The delivery of medication to a patient via the oral route can be problematic in a nauseous patient.

* Some patients lose their ability to swallow.

* Caregivers, who are often elderly, may be uncomfortable dosing with injections and suppositories.

Attempts to solve these problems have led to the use of compounded transdermal combinations of medications, including the frequently used ABHR gel. This and similar combinations are used clinically for chemotherapy patients, although often with an injectable route of administration. The two most commonly used topical doses are lorazepam 2 mg/diphenhydramine 50 mg/haloperidol 2 mg/metoclopramide 40 mg per milliliter and lorazepam 4 mg/ diphenhydramine 100 mg/haloperidol 4 mg/metoclopramide 80 mg per milliliter. The common dosage is 0.25 mL applied to the inner wrist four times a day. Table 2 summarizes the drug classes, nausea and vomiting pathways affected, therapeutic effects, and side effects of the drugs that constitute ABHR gel.

Table 2. ABHR Gel: Components and Actions on Nausea and Vomiting Pathways.

An additional factor in the choice of these agents and use of the transdermal route of administration is the cost of the preparation weighed against the costs of continued nausea or vomiting and administering the agents separately. The convenience of the topical gel is another factor to consider, as it minimizes the confusion created when dosing with multiple medications or when an antiemetic regimen changes frequently.

Dispensing Review and Case Reports

Over a period of 366 days (March 1, 2003 to February 29, 2004), 55 of our hospice patients received at least one prescription for a 2-week supply of ABHR gel. Of these 55 patients, 28 refilled their prescription at least once, while 27 received a single dispensing. The 27 patients who received only one prescription unfortunately died before they could refill their prescription. Among the 55 patients, no treatment failures were reported by the nursing staff; however, treatment was reported by the attending physician as being unsuccessful in one case. The nurses reported that the only dosing problems they experienced were with patients who had bowel obstruction.

Case Reports

Patient 1: 72-year-old woman

Diagnosis: Malignant neoplasm in the bronchi and lungs

Treatment: The patient received 14 prescriptions (13 refills) of ABHR gel on a regular basis, beginning with her admission into hospice and continuing until she died 7 months later. Prochlorperazine suppositories were added to her regimen as needed to treat new symptoms.

Treatment results: The compound worked well for the patient. As she came to the preterminal stage of her disease, about 2 weeks before she died, she started reporting increased pain and nausea, and began vomiting more frequently. Prochlorperazine suppositories were added to her regimen as needed to treat the nausea and vomiting. The suppositories seemed to alleviate some of her discomfort.10

Patient 2: 60-year-old man

Diagnosis: Secondary malignant neoplasm of the liver

Treatment: The patient was in hospice care for only 2 months before he died. During that time he received four prescriptions (three refills) of ABHR gel. In addition to ABHR gel, he received haloperidol 1-mg tablets, prochlorperazine suppositories, and ondansetron tablets for nausea.

Treatment results: The patient stated that he experienced nausea and/or vomiting when he missed a dose of the ABHR gel.

Patient 3: 81-year-old woman

Diagnosis: Malignant neoplasm of the ovary

Treatment: The patient was in hospice care for approximately 1 month before she died. In that short time, she received five prescriptions (four refills) of ABHR gel to treat her escalating discomfort.

Treatment results: A few days after receiving her first dosage of ABHR gel, the patient experienced hallucinations, which her family attributed to the ABHR gel. It should be noted that this symptom occurred as her disease state advanced, and there was no way to relate it directly to the ABHR gel. The hospice team continued to order the medication with no further hallucinatory episodes noted.

Patient 4: 88-year-old man

Diagnosis: Malignant neoplasm of the prostate

Treatment: Over the 3-month period the patient was enrolled in hospice care, was dispensed the ABHR gel a total of five times, all within the last 6 weeks of his life.

Treatment results: A couple of weeks after initiating the ABHR gel, the patient stated that he was not experiencing any nausea or vomiting. His symptoms were well controlled on his medication regimen.

Patient 5: 93-year-old woman

Diagnosis: Adult failure to thrive

Treatment: The patient had been in hospice for close to 2 years. She received 14 prescriptions (13 refills) of ABHR gel over a 6- month period.

Treatment results: The patient related nausea with pain, and shortly after starting the ABHR gel therapy her pain diminished. A couple of months later she again reported abdominal pain. Her physician believed that this pain was nausea; therefore, he increased the ABHR gel dose and her pain disappeared.

Additional Case Report Findings

Seven other case reports published between 2000 and 2002 in the RxTriad newsletter of the International Journal of Pharmaceutical Compounding relate the successful use of ABHR gel and other combination drug therapies in hospice patients.10-16

One notable case report described a 78-year-old woman who had stomach cancer. The patient’s chief complaint was nausea, and the prescribed trimethobenzamide suppositories were not effectively treating this symptom. As an alternative, ABH gel (ABHR without metoclopramide) was suggested, but the patient still experienced some nausea. Metoclopramide was then added to the gel, and after two doses of the second preparation, the patient’s nausea was relieved. She followed the ABHR gel protocol and experienced relief from nausea for over a year until her death.11

A second case report described a 74-year-old woman who suffered from canc\er of the liver and bone. Prochlorperazine maleate capsules were providing little or no relief, and alternative routes of administration were being explored. The patient’s physician prescribed ABHR gel with instructions to apply 0.5 mL to the wrist every 4 to 6 hours as needed. With this formula and dose, the patient experienced relief from nausea and diminished anxiety as her life ended.12

In another case, ABHR gel was effective in the treatment of opioid-related nausea in a patient receiving both extended-release and immediate-release forms of oxycodone to control pain. Administration of ABHR gel helped to relieve the patient’s nausea and improve her quality of life.11

Similar combinations of the four drugs involved with ABHR gel therapy may be used in intravenous form or, in appropriate cases, in an ambulatory infusion manager pump.12 Variations of the ABHR gel protocol may include the use of phenothiazines such as prochlorperazine, or butyrophenones such as droperidol; one or more ingredients may be omitted to suit each patient’s unique needs.13,14

Conclusion

Nausea and vomiting are great concerns to hospice patients, who are generally in the preterminal stages of their life. ABHR gel is one of the combination drug therapies that have demonstrated clinical effectiveness for a wide variety of hospice patients suffering from symptoms of nausea or vomiting. ABHR gel is easily administered, causes little or no discomfort to the patient, can be a cost-effective tool in the management of nausea and vomiting, and for many patients enhances quality of life as life nears its end.

Suggested Resources

* Cowan JD. The dying patient. Curr Oncol Rep 2000; 2(4): 331- 337.

* Kemp C, Stepp L. Palliative care for patients with acquired immunodeficiency syndrome. Am J Hasp Palliat Care 1995; 12(6): 14, 17-27.

* Lichter I, Hunt E. The last 48 hours of life. J Palliat Care 1990; 6(4): 7-15.

* Lindley-Davis B. Process of dying. Defining characteristics. Cancer Nurs 1991; 14(6): 328-333.

* Peralta A Jr. Symptom management in hospice and palliative care. Tex Med 2001; 97(8): 42-51.

References

1. Boomsma D. Nausea and vomiting in hospice patients. IJPC 2000; 4(4): 250-251.

2. Young LY, Koda-Kimble MA, eds. Applied Therapeutics: The Clinical Use of Drugs. 6th ed. Vancouver, WA: Applied Therapeutics; 1995: 105.1-105.10.

3. Seigel LJ, Longo DL. The control of chemotherapy-induced emesis. Ann Intern Med 1981; 95(3): 352-359.

4. [No author listed.] Lexicom. Latest Drugs. [Lexicom Website] November 2004. Available at: www.lexi.com. Accessed November 2004.

5. Borison HL. Physiology and pharmacology of vomiting. Pharmacol Rev 1953; 5(2): 193-230.

6. Wood C, Graybiel A. A theory of motion sickness based on pharmacological reactions. Clin Pharmacol Ther 1970; 11:621-629.

7. Malik IA, Khan WA, Qazilbash M et al. Clinical efficacy of lorazepam in prophylaxis of anticipatory, acute, and delayed nausea and vomiting induced by high doses of cisplatin. A prospective randomized trial. Am J Clin Oncol 1995; 18(2): 170-175.

8. Dipiros JT, Talbert RL, Yee GC et al. Pharmacotherapy: A Pathophysiologic Approach. 5th ed. New York, NY: McGraw-Hill; 2002.

9. Rousseau P. Antiemetic therapy in adults with terminal disease: A brief review. Am J Hosp Palliat Care 1995; 12(1): 13-18.

10. Herr J. Case report: Ibuprofen and prednisone rectal suppositories for the relief of metastatic cancer pain. IJPC RxTriad December 2002: 1-2.

11. Herr J, Farkus J. Case report: Ativan, benadryl, and haldol (ABH) gel and Ativan, Benadryl, Haldol, and metoclopramide (ABHM) gel in the treatment of nausea. IJPC RxTriad Match 2001:1.

12. Petrin R. Case report: ABHR gel in Pluronic lecithin organogel. IJPC RxTriad September 2000:1-2.

13. Simonetti D. Case report: Treatment of opioid-related nausea in a terminal cancer patient. IJPC RxTriad May 2000:2.

14. Karolchyk S, Covalesky B, Molhatra V. Case report: Multiple therapy for a dying patient. IJPC RxTriad May 2001:2.

15. Sherman J. Case report: Droperidol 10 mg/mL in Pluronic lecithin organogel for the treatment of severe nausea and vomiting. IJFC RxTriad September 2000:1.

16. Simonetti D, Faulkner K. Case report: Prochlorperazine and metoclopramide in a PLO for analgesia in a patient with terminal colon cancer. IJPC RxTriad November 2000:1-2.

Richard B. Moon, PharmD, RPh, FIACP

Pharmacy Innovations

Jamestown, New York

Address correspondence to Richard B. Moon, PharmD, RPb, FIACP, Pharmacy Innovations, 863 Fairmount Avenue, Jamestown, NY 14701. E- mail: [email protected]

Copyright International Journal of Pharmaceutical Compounding Mar/ Apr 2006

(c) 2006 International Journal of Pharmaceutical Compounding. Provided by ProQuest Information and Learning. All rights Reserved.

Sanofi, FDA in Talks on Ketek Label after Concerns

WASHINGTON (Reuters) – French drug maker Sanofi-Aventis and U.S. regulators are discussing potential revisions to prescribing instructions on antibiotic Ketek after safety reviewers said a strong warning may be needed about cases of liver failure, the Food and Drug Administration said on Friday.

The company and the FDA confirmed the talks after the Wall Street Journal cited an internal FDA report linking Ketek to 12 cases of liver failure, including four deaths.

FDA spokeswoman Susan Bro said the report was a confidential memo from reviewers in the FDA’s Office of Drug Safety and the agency would not release it publicly.

But she confirmed that the report called for new information on Ketek’s label about liver injury reports. One possibility the reviewers raised was adding a “black box,” the strongest warning possible for a prescription drug, Bro said.

The report “recommends labeling revisions be considered but not product withdrawal,” Bro said.

Bro said she could not say how many reports of liver damage in Ketek patients had been received because data were still being reviewed.

Ketek, which was approved in 2004 to treat respiratory infections, drew renewed scrutiny in January when researchers reported that three patients using the drug developed severe liver damage and one died.

The FDA had rejected the drug in 2001 and 2003, asking for more safety information.

U.S. lawmakers have questioned the FDA’s approval of the drug amid charges of faulty data from one of the company’s studies.

The safety reviewers noted that “while the numerical risk appears higher in the Ketek database, they are not able to conclude greater risk for liver injury in patients receiving Ketek than other drugs in the category,” Bro said.

“This will be carefully considered along with all other sources of expert review in the agency’s assessment of Ketek’s safety profile,” she added.

A Sanofi spokesman in Paris said the company “continues to believe that Ketek is safe and effective.”

“We are in talks with the FDA to evaluate secondary effects on the liver and as we are in discussions we are not going to start commenting on these figures,” the spokesman added, when asked about the alleged cases.

He said all secondary effects were reported to the FDA and talks on labeling had been going on for several months. He said the company did not have a copy of the safety reviewers’ memo.

Sanofi shares fell 24 cents, or 0.5 percent, to $46.67 in afternoon trading on the New York Stock Exchange.

(Additional reporting by Noelle Mennella in Paris and Kenneth Li in New York)

CONSUMERS, CHARACTERS, AND PRODUCTS: A Balance Model of Sitcom Product Placement Effects

By Russell, Cristel Antonia; Stern, Barbara B

ABSTRACT:

This study examines the influence of product placements in television serial comedies on consumer attitudes toward the products. Proposing a “Balance Model of Sitcom Product Placement Effects,” the study integrates genre theory to analyze character- product associations in sitcoms, parasocial theory to consider consumer-character referential relations, and balance theory to address the main research issue of the way that characters’ relations to placed products and consumers’ relations to the characters affect consumers’ attitudes to the products. The model is based on balance theory, in which attitude alignment is the explanation for links between a triad composed of the consumer, the sitcom character, and the placed product. The influence of two consumer-character variables (attitude and parasocial attachment) and two character-product variables (valence and strength of association) are tested in a real-world situation. The methodology uses real televised sitcoms as stimuli, real viewers as respondents, and a real-time on-line survey to measure the relationship among the variables. Study findings support the predictions that consumers align their attitudes toward products with the characters’ attitudes to products and that this process is driven by the consumers’ attachment to the characters.

The purpose of this paper is to examine the influence of product placements in television serial comedies on consumer attitudes toward the products. The justification for investigating placements, defined as a marketing practice in which a firm pays for inclusion of its branded products in films and television programs (Balasubramanian 1994), is that they have become so ubiquitous that in 2005 they are expected to be used in 75% of prime-time network shows (Consoli 2004). The strategy has become part of the marketing mix of over 1,000 U.S. brands (Marshall and Ayers 1998), including large Fortune 100 companies, such as Procter & Gamble, PepsiCo, and Anheuser-Busch (Vranica 2004). With 41% of U.S. homes expected to be equipped with digital video recorders that allow consumers to skip through advertising messages by 2008, product placements threaten to eclipse traditional advertising messages (Piccalo 2004). The placement industry is now a $3.46 billion industry, with $1.88 billion spent on television placements alone in 2004 (PQ Media 2005).

The reason for an increase in placements is that they are associated with an increase in sales, which is especially notable when products appear in sitcoms, a program type that provides strong evidence of the strategy’s effectiveness across product categories. For example, in the apparel category, a 35% rise in sales of Nick & Nora pajamas occurred between 1995 and 1998 when Ally McBeal (the main character in the Ally McBeal show) wore them as lounging outfits (Carter 2000; Stanley 1998). Similarly, in the nonalcoholic beverage category, the 1990s growth in coffee bars such as Starbucks and New World Coffee has been attributed to their importance in urban sitcoms such as Frasier and Friends (Tueth 2000); in the alcoholic beverage category, the popularity of the Cosmopolitan martini is often linked to its popularity among the women in Sex and the City.

Even though the phenomenon of placements was only named and identified a decade ago (Balasubramanian 1994), advertising and consumer researchers have already begun to study its impact on memory (Babin and Carder 1996; Gupta and Lord 1998; Nelson 2002; Russell, Norman, and Heckler 2004), attitudes (d’Astous and Seguin 1999; Russell 2002), and behavior (Auty and Lewis 2004; Russell and Puto 1999). Early studies of sitcoms focused primarily on a placed product’s connectedness to the plot, defined as events in a media vehicle (Russell 2002). Findings indicate that a product’s connection to the plot is a significant source of influence on viewers’ attention to and attitudes toward products (d’Astous and Seguin 1999; Russell 2002). More recent studies indicate that the degree of viewers’ parasocial relationships with the characters (Russell, Norman, and Heckler 2004) is another significant source of influence, offering the notion of attachment to characters as an explanatory factor. However, there is still little research on the relationship between a placement’s role in a specific media vehicle and the process whereby it affects viewers’ attitudes toward the product. That is, neither the characters’ intraprogram relations to placed products nor the consumers’ extraprogram relations to the products have been fully examined.

FIGURE 1

Balance Model of Product Placement Effects

To enrich our understanding of the way that placements work, we propose investigating both relations in terms of the central role of sitcom characters, considered “the most crucial element” (Wolff 1988, p. 14) in the genre, itself called “character comedy” (Feuer 1992, p. 154). The characters function in a tripartite influence process in which stage one is the inside-program character-product relation, stage two is the outside-program consumer-character relation, and stage three is the interaction between inside and outside influences in the consumer-product attitude. From this perspective, the question of interest is, How do characters’ relations to placed products and consumers’ relations to the characters affect consumers’ attitudes to the products?

To address this question, we turn to multidisciplinary theory, using literary criticism as the source of information about characters and products in the sitcom genre, parasocial theory as the source of information about consumers and fictional characters, and balance theory as the source of information about the triadic relationship forming the “Balance Model of Sitcom Product Placement Effects.” Figure 1 depicts the balance between three components of the triadthe consumer, the character, and the product-and presents the theoretical roots underlying the character-product dyad and the consumer-character dyad that allow us to predict attitudinal effects for the third dyad: the consumer-product relation (i.e., the consumer’s attitude toward the placed product). The model extends prior research by integrating two key factors that affect consumers’ attitudes toward placed products, that is, the extent to which products are associated with the characters in the program (d’Astous and Seguin 1999; Russell 2002) and the relationships viewers have with the program characters (Russell, Norman, and Heckler 2004). We begin with an overview of the theoretical foundation that underlies the model, turning first to genre theory, which provides information about the formal and structural attributes of sitcoms that determine the centrality of characters and products; next we address parasocial theory, which provides information about consumer- character relations; and last we examine balance theory, which offers the explanation of the interaction between both of the preceding theories and drives our hypotheses.

THEORETICAL OVERVIEW

Genre Theory: Characters and Products

Genre theory is the branch of literary criticism aimed at classifying texts in accordance with attributes specific to one genre but not others (Fowler 1982). We draw from it to identify within-program characteristics of sitcoms, a species of comedie work in which the dramatic elements of character, plot, props, settings, and so forth form a unique pattern (Feuer 1992). Sitcoms are particularly genre-bound (Fiske 1987), for they are the “signature” program type (Feuer 1992) invented and mass-produced for television (Neale and Krutnik 1990). Mass production rests on formulaic construction, which enables the program to be created in conformance to conventions that dictate the deployment of dramatic elements (Cawelti 1970), including, for the first time, products as part of the pattern (Neale and Krutnik 1990). Production of cookiecutter programs allows for increased industry profits owing to low research and development costs, economies of scale, and high volume. Standardized entertainment programs also systematize the decoding of meanings and ensure that viewers “are influenced, even manipulated, by the genres they [the programs] are fitted into” (Fiske 1987, p. 111; cf. Feuer 1992). Standardization thus results in high profits for producers and ease of construction of meaning for audiences (Fiske 1987) presumed to possess genre knowledge by dint of long exposure to similar works.

Serialization of sitcoms also guides viewer expectations of potentially long relationships with characters, for longevity is a built-in feature that goes hand in hand with standardization in impacting both profitability and viewer-constructed meanings. Just as manufacturing efficiency is increased when the same product is produced year after year, so too are viewer perceptions of meaning reinforced by repeated viewing of ongoing dramas (Esslin 1976). Each episode in a serial contains the same characters, designed to be familiar, recognizable, and stereotypical. Sitcom popularity since the 1950s (starting with shows like I Love Lucy and The Honeymooners) is attributed to the presentation o\f types of people whom viewers recognize and with whom they become familiar over time. Familiarity allows viewers to experience a “comforting feeling of security” in the presence of characters who behave predictably, for they are stereotypes or stock characters (Frye {1957} 1973) unlikely to behave in a threatening or disturbing fashion (Brown 1992). These comedic types are embedded in the sitcoms’ literary heritage, traceable to the Old Comedy of Athens (Levin 1987) traditionally populated by stock characters such as lechers, sluts, fools, and liars. The same types reappear in contemporary sitcoms: Joey in Friends is lecherous; Samantha in Sex and the City is promiscuous; Jack in Will and Grace is a fool; and George in Seinfeld is a liar. The formula also locates characters within a group-the focus of “ensemble playlets” (Brown 1992, p. 511) representing a lifestyle community held together by shared values such as friendship, emotional interdependency, loyalty, and, since the 1970s, liberalism (Eaton 1978/79). Most recently, domestic groups are composed of friends functioning as a surrogate family, a response to cultural changes in the nature of family composition that now include unmarried singles living together, gay partners, live-at-home adult children, and single-parent households, all of which appear in programs such as Sex and the City, Friends, and Will and Grace.

The presence of products is perhaps the most defining element of the lifestyle community, with products serving as significant objects in the consumption scenarios that pervade the genre. Prior research (Hirschman, Scott, and Wells 1998; Solomon and Greenberg 1993) on character-product associations indicates that products serve as “psychocultural” cues to the audience’s construction of meanings about characters and groups (Sherry 1995). The genre depends on a carefully drawn sociocultural scenario filled with characters interacting with products, and thus providing information about them. Insofar as sitcoms are “popular when their conventions bear a close relationship to the dominant ideology of the time” (Fiske 1987, p. 112), the prominence of consumption is reflected in the importance of products such as clothing, makeup, home furnishings, food, and beverages to the characters (Cornwell and Keillor 1996). Characters associated with products communicate meaning about consumption (Fiske 1987; Wolff 1988) to audiences accustomed to the generic sitcom pattern that routinely depicts an embedded consumption scenario (Hirschman, Scott, and Wells 1998; Solomon and Greenberg 1993). Thus, genre theory sheds light on character-product relationships specific to a media vehicle, with sitcoms containing stereotypical types in familiar settings replete with everyday products.

Our model takes into account the fact that sitcom characters’ attitudes toward products in situation comedies vary along two main dimensions: valence (from negative to positive) and association strength (from weak to strong). Sitcom characters’ statements about preferences vary in valence, for characters cannot automatically be assumed to be favorably inclined toward products seen and discussed (Butler 2001). That is, they may display positive or negative attitudes. In Will and Grace, for example, the main characters make fun of their boring friends who want to eat at Olive Garden, a mass- market chain restaurant (Chang and Roth 2000) instead of a more upscale innovative place. Similarly, in Fraster, Frasier (the main character) and his brother Niles, both affluent food and wine snobs, mock their father’s simple food preferences for beer, beef jerky, and surf ‘n” turf dinners (Chang and Roth 2000). In addition to valence, character-product associations vary in intensity, from weak to strong. Weak associations refer to products that are merely placed in a character’s home to enhance the realism of the set-a form of “reality engineering” that is more implicit than product use or discussion (Solomon and Englis 1994). Classic examples of backgrounding a product as something that is “just there” are abundant in Friends, where the characters’ apartments contained items ranging from Heineken beer to Barilla spaghetti sauce. In contrast, strong associations refer to products used more explicitly to convey ideological information about a character (Hirschman 1988) that enriches his or her depiction (Holbrook and Grayson 1986). In this situation, the product contributes to the character’s identity and/or strongly reflects a character’s values (Hirschman 1988) and the character-product association may be relatively strong (DeLorme and Reid 1999; Russell 2002). In the last season of Sex and the City, for instance, Miranda, a New York lawyer, was defined by her pregnancy and motherhood, and products related to that experience were strongly associated with this life transition and with her upperclass lifestyle, from the Bellini accessories and Kiehls baby lotions she purchased for the newborn to her Weight Watchers’ experience to shed baby weight. Both dimensions of valence and association strength are included in the model to characterize the character-product dyad (see Figure 1).

Parasocial Theory: Consumers and Characters

Examination of the consumer-character dyad draws from parasocial theory, which explains viewers’ inclinations to be attached to or distanced from fictional characters conceived of as real (Horton and Wohl 1956; Levy 1962). A tradition of research of viewer-character relationships in the television context spans the fields of communications (Fiske 1987; Jenkins 1992; von Feilitzen and Linne 1975), psychology (Horton and Wohl 1956; Maccoby and Wilson 1957), and marketing (Churchill and Moschis 1979; Kozinets 2001; Lavin 1995; McCracken 1986; Russell, Norman, and Heckler 2004). This research informs the processes whereby attitudes and relationships develop between viewers and television characters. Following a single episode, viewers are likely to develop attitudes toward characters that reflect the overall attitude of the characters. Over the course of watching multiple episodes of a television series, however, viewers can become actively vested in the characters whose lives they closely follow and care about, and sometimes begin to interact with them as if they were real, in a parasocial way. Thus, long-term viewing is essential to the attachment process over time, a process in which viewers develop attitudes toward the characters, get to know them, experience feelings of intimacy with them, and engage in vicarious participation in their lives (Maccoby and Wilson 1957). The process resembles the developmental progression of “real” relationships (Kozinets 2001), during which communication with the other (Tulloch and Jenkins 1995) and understanding of him or her increases in tandem with familiarity.

Note that attitude and attachment are different constructs, with attitude referring to a viewer’s feelings of positive (negative) inclinations toward a character, and attachment referring to a viewer’s feelings of closeness (distance) to a character. Attachment emphasizes the strength of the interpersonal relationship, representing the degree to which the character is viewed as a meaningful referent other. This distinction is common in the psychology of interpersonal relations and social influence literature in which the concept of attachment is similar to Heider’s “similarity, proximity, common fate” (1958, p. 177), or French and Raven’s “feeling of oneness” (1959, p. 161), a trigger of normative influences flowing from an agent (the character) to a target (the consumer). Thus, our model (see Figure 1) integrates the two distinct dimensions of the consumer-character dyad: attitude (from negative to positive) and parasocial attachment (from weak to strong).

Parasocial relationships are expected to be especially important in situation comedies because of the genre’s attributes of serialization, standardization, and stereotypes (Newcomb and Hirsch 1983). The temporal longevity of sitcoms over a number of seasons (equivalent to years)-for example, Friends lasted for nine seasons, and Frasier for eleven-makes them especially suitable as loci of parasocial attachments in that viewers can get to know the characters and vicariously participate in their lives (Russell, Norman, and Heckler 2004). Media researchers have identified the potential for television characters and celebrities to serve as behavioral models (McCracken 1986) and have found that referential influences occur via parasocial interactions (Russell, Norman, and Heckler 2004). That is, the more consumers feel parasocially attached to television characters, the more these characters become referent others, resulting in their greater influence on viewers (Bandura 1976). In placement terms, as viewers become closer to characters, they tend to identify with them (von Feilitzen and Linn 1975; Levy 1962), accept them as models of correct product decisions, and even model personal consumption on characters’ product use (Russell and Puto 1999). Thus, based on the extant parasocial theory literature, parasocial attachment is expected to play an important role in the influence viewers receive from sitcom characters.

Balance Theory: Consumers, Characters, and Products

To construct the model depicted in Figure 1 and address the research question-“What are the interactive effects of characters’ relations to products and consumers’ relations with characters on consumers’ attitudes to products?”-we draw from Heider’s balance theory in social psychology (1946, 1958). Balance theory explains an individual’s desire to maintain consistency among a triad of linked attitudes. The premise is that when an individual perceives a set of elements as linked, the perceiver (person 1) strives for balance in his or her attitude toward another person (person 2) and with an object associated with person 2 (Osgood andTannenbaum 1955). In this situation, person 1 will align his or her attitude toward the object with that of person 2 such that cognitive consistency is achieved. When the theory was applied to celebrity endorsers in advertisements, person 1 = a consumer; person 2 = a celebrity; and the object = an endorsed product. Thus, if a consumer likes a celebrity and a celebrity likes a product, then the consumer will also like the product. We adapt the theory to product placements by reconceiving the elements such that person 1 remains the consumer, but person 2 = fictional sitcom character, and an object = a product associated with the character. The adaptation underlies our proposal that consumers will be inclined to achieve balance by aligning their feelings toward the character with the character’s attitude to a product. The attitude alignment process is facilitated by the consumer-character relationships and affected by the nature of the character-product relationship.

We integrate into our balance model both the notion of attitude valence (liking/disliking) and that of association (strength/ weakness) between components of the triad. The distinction between valence and association strength was present in Heider’s original articulation of the theory (1958) and later in Osgood and Tannenbaum’s extension of the theory (1955), with attitude valence referring to a person’s degree of positive or negative evaluation of something or someone distinct from association, referring to the strength of connection between a person and another person or object. Recent research suggests that person Is attitude alignment with that of person 2 is especially strong if the attitude object is central to person 2 and if the relationship between persons 1 and 2 is strong (Davis and Rusbult 2001). Analogously, in the context of placements, the consumer’s attitude toward the product will be a function not only of the valence of the character’s attitude toward the product and consumer-character relationships but also of their respective levels or strengths.

HYPOTHESES

Our hypotheses specify the linkages between consumer-character variables (attitude and parasocial attachment) and character- product variables (valence and strength of association). Per Heider’s balance theory, attitudes toward the placed product will be a function of all four variables: consumers will align their attitude toward the product (ConsAttProd) with attitude toward the character (ConsAttChar) and parasocial attachment with the character (ConsParaChar) based on the valence of the character’s attitude toward the product (CharAttProd) and the strength of the character association with the product (CharAssocProd).

Heider’s balance theory and its extensions stipulate that people prefer balanced triadic attitudinal structures. This theory has direct consequences on predicting the evaluation of products associated with a character in a program. In the context of our proposed consumer-character-product triad, balance exists when all three relations among elements are positive, or when two relations are negative and one is positive. When consumers are exposed to a product placement associated with a character, their drive to establish attitudinal balance implies that their evaluation of the placed product will be directly affected by the dimensions of the relationship they have with the character (attitude and attachment) and the dimensions of the relationship that exists between the character and the product (attitude and association).

Hypotheses Ia and Ib follow from Heider’s balance theory to predict that if the character’s attitude toward the product is positive (CharAttProd > O), a balanced interattitudinal state will occur in which ConsAttProd will be positively related to ConsAttChar and ConsParaChar. Conversely, if the character’s attitude toward the product is negative (CharAttProd

H1a: If CharAttProd > O, ConsAttProd is positively related to ConsAttChar and ConsParaChar.

H1b: If CharAttProd

Hypothesis 2 treats character-product associations, which vary not only in valence but also in strength. Existing research has shown that the strength of the association affects the need for attitude alignment such that a stronger relation will result in a greater need for attitudinal balance and thus greater alignment (Davis and Rusbult 2001). Therefore, H2 predicts that the strength of the character-product association (CharAssocProd) will moderate the relationship between ConsAttProd and the character variables ConsAttChar and ConsParaChar.

H2: The effects of ConsAttChar and ConsParaChar on ConsAttProd are moderated by CharAssocProd.

Hypothesis 3 predicts that the consumer-character variables- attitude and parasocial attachment-will affect consumers’ attitudes toward products to differing degrees. Indeed, the extant literature suggests that attachment, which captures the television character’s influence as a referent other, and thus his or her referent power (French and Raven 1959), will be more predictive of normative influences on viewers than mere liking of the character (Bandura 1976). As viewers interact with television characters parasocially and develop attachments to them, the characters become referent others comparable to real-life others able to influence viewers’ norms, attitudes, motivations, and behaviors (Churchill and Moschis 1979; Russell, Norman, and Heckler 2004). The stronger the attachment, the more committed a viewer is to reexperience the emotional reward of relationships with characters and the cognitive reward of increased information about what the characters are up to this time (Pfister 1991, p. 99). Research on attitude alignment also supports this prediction, as data showed that the stronger the relationships between two individuals, the greater the tendency to modify one’s attitude to match the other person’s (Davis and Rusbult 2001; Newcomb 1959). We thus expect that parasocial attachment levels (ConsParaChar) will be better predictors of attitudinal balance, and thus ConsAttProd, than the more general attitude of the character (ConsAttChar).

H3: ConsParaChar will have a stronger effect on ConsAttProd than ConsAttChar.

THE STUDY

To maximize external validity, the model was tested in a “live” study using actual episodes of situation comedies as stimuli. The stimuli were actual sitcom episodes-the season premieres of Will and Grace, Friends, Everybody Loves Raymond, and Frasier-watched in real- time by “real” viewers (see program descriptions in Appendix 1). A professional on-line survey Web site (surveymonkey.com) was used to program the research instrument and collect the data.

Sample

Recruitment of the sample was conducted in several waves via e- mail, and participants were screened on their television viewing habits so that only respondents who were regular viewers of at least one series and could watch a particular episode live were selected. In the selection process, potential respondents were asked if they were willing to watch the season’s finale episode of the series, and later on that evening log on to a secure site to complete a questionnaire about their viewing experience. After watching the episode, selected participants received an e-mail message with the link to the survey Web site. The time when each respondent logged on and the amount of time it took to complete the self-paced questionnaire were recorded. These recruitment procedures had been pretested on a small sample of student viewers to ensure the soundness of this novel methodology. In the pretest, the recruiting methodology achieved a 70% response rate, and the data supported using real programs as stimuli, real viewers as respondents, and same-day recall.

A national sample of viewers was recruited in three waves of e- mails using a multistep permission-based process (Tezinde, Smith, and Murphy 2002). First, e-mail contact was initiated with 45,833 U.S. consumers listed in a purchased national database, and the consumers were asked to participate in a general survey on television viewing. This survey was used to screen participants. Among those who responded to the first survey (n = 10,329), those who indicated that they regularly watched one of the four sitcoms (n = 1,628) were contacted and invited to participate in the study. During the selection process, the respondents were told that they would have to watch the first episode of a series, and then later on that evening log on to a secure Web site to complete a questionnaire about their viewing experience. A total of 690 respondents agreed to participate, and the same professional on-line survey Web site was used to program the survey, record the time when each respondent logged on, record the amount of time it took to complete the self- paced questionnaire, and collect the data. A total of 261 respondents completed the questionnaire within two hours of the episode’s end (n ^sub Everybody Loves Raymond^ = 76, n^sub Frasier^ = 32, n^sub Will and Grace^ = 33, and n^sub friends^ = 123). This represents a 37.8% response rate from the group of agreed participants in the study (or 16% of the original group contacted), a rate considered high for a Web-based study (Bachmann, Elfrink, and Vazzana 1999). Respondents’ ages ranged from 16 to 84, and the majority were female (79.5%). Nonresponse bias was addressed by comparing the demographics of participants in the final study to those of individuals contacted at each phase of recruitment. No substantial differences emerged between participants and nonparticipants in terms of gender and age distribution or education levels.

Research Instrument

The questionnaire included three parts. Part 1 contained a three- item semantic differential measure of the respondents’ at\titude toward the series, with each item consisting of a sevenpoint attitude toward the show measure (I like it/I dislike it, good/bad, unpleasant/pleasant). The television connectedness scale, a 16-item multifactor instrument, was also administered to measure the intensity of the relationship between the respondent and the program and its characters (Russell, Norman, and Heckler 2004).

After the respondents completed Part 1, Part 2 began with an explanation that “in the show, sometimes people are seen interacting with certain products or services (eating certain foods, drinking certain things, using certain modes of transportation, traveling to certain places, shopping at certain places, consuming certain forms of entertainment, using certain types of services, etc).” In Part 2, the respondents were asked to remember up to five instances of similar consumption-related events, and for each instance they were asked to type in the product or service and complete three, seven- point attitude items about the consumption event (ConsAttProd: I liked it/I disliked it, good/bad, unpleasant/pleasant). Then they were asked to fill in open-ended comments about why they thought the product was there, what they thought it contributed to the show, and which character(s) it was most closely associated with and why. An additional three-item scale measured the strength of the character- product association (CharAssocProd: The [product] was strongly associated with this character; the character interacted with [the product]; the character expressed like/dislike for [the product]). Finally, the respondent indicated the valence of the character’s attitude toward the product (CharAttProd: The association between [the product] and the character was positive/negative). The procedure was repeated for each instance mentioned.

Part 3 contained scales measuring responses to the characters the respondents had listed. The first scale was a threeitem seven-point attitude to the character measure (ConsAttChar: Ilike him or her/I dislike him or her, she/he is good/bad, she/he is pleasant/ unpleasant), and the second was the nine-item parasocial attachment scale (ConsParaChar; Rubin, Perse, and Powell 1985; see Appendix 2). The scales were followed by an open-ended question asking the respondent to describe the character in as much detail as possible (What is she/he like? What does she/he enjoy, and so forth). The procedure was repeated for each character listed in Part 2. At the end of Part 3, demographic information was collected.

Data Analysis

Overview of Data

Attitudes toward each episode (mean on all three attitude items, α = .94) were strongly positive and did not significantly differ by series, M^sub Raymond^ = 6.81, M^sub Frasier^ = 6.73, M^sub Friends^ = 6.78, and M^sub Will and Grace^ = 6.84, F(3, 257) = .252, p > .05. The connectedness levels (mean on all 16 items, α = .89) did not significantly differ either, M^sub Raymond^ =3.10. M^sub Frasier^ = 3.02, M^sub Friends^ = 3.26, and M^sub Will and Grace^ = 3.02, F(3, 260) = 3.197, p = .02. On average, respondents listed 2.97 (SD = 1.64) products or services, with the number of products significantly lower for Friends (M = 2.52) than for the other programs, M^sub Raymond^ = 3.22, M^sub Frasjer^ = 3.69, and M^sub Will and Grace^ = 3.40; F(3, 250) = 6.497,p

TABLE I

Character-Product Associations by Program

To take into account the differing number of products listed by each respondent, the analyses used only data from the first product listed by each respondent and only those products mentioned by at least 10% of the respondents. These first-listed products and the characters associated with them (n = 226) are depicted in Table 2.

Across all products listed, character-product relations varied in both valence and association strength. Association strength (CharAssocProd; mean across the three items, α = .84) varied from 1.0 to 5.0, with a grand mean of 3.84. The valence (CharAttProd) also reflected variance in characters’ attitudes toward products, with a grand mean of 3.88. Because the valence variable was a Likert scale from negative to positive, the observations were divided based on the midscale point: for the first product listed, 31.8 % of the ratings for first-listed products were at or below the mid-scale point, and across the total of 914 products listed, 36.9% were at or below the mid-scale point.

Consumers’ attitudes toward individual characters (ConsAttChar) were generally positive (grand mean on all three attitude items = 6.43, on seven-point scale, α = .92) and did not differ significantly by series, F(3, 237) = 1.396, p > .05. With an overall mean of 3.68, reported levels of parasocial attachment with each character (ConsParaChar; five-point scale, α = .89) varied from weak (1.00) to strong (5.00), and were not significantly different by program, F(3,239) = .464, p > .05. To demonstrate that the attitude and parasocial attachment constructs are distinct, we computed the correlation coefficient between ConsAttChar and ConsParaChar, which was .221 (p

Model Testing

To test the model, we conducted a series of regressions of ConsAttProd as the dependent variable on the different predictor variables. Hypotheses Ia and Ib predict that in a state of balance, ConsAttChar and ConsParaChar will be positively associated with ConsAttProd if the character’s attitude toward the product (CharAttProd) is positive (H1a), and negatively associated with ConsAttProd if the character’s attitude toward the product (CharAttProd) is negative (HIb). Hypothesis 2 predicts that the strength of the character-product association (CharAssocProd) will moderate these effects.

Insofar as the hypotheses predict different effects depending on the valence of the character’s attitude toward the product, separate regression analyses were conducted on the dataset split between the negative (n = 90) and the positive (n = 135) character’s attitudes. For each dataset, a first regression was conducted, including simple main effects only (attitude toward the character [ConsAttChar] and parasocial attachment with the character [ConsParaChar}). The second regression model included these main effects as well as the two-way interaction terms with the dichotomized association strength variable (ConsAttChar CharAssocProd and ConsPara Char CharAssocProd) to test H2. The association variable was operationalized as weak (CharAssocProd = O) or strong (CharAssocProd =1) based on the mean on the three-item character-product association measure.

The regression results appear in Table 3. Together, these regression analyses show that parasocial attachment affects consumers’ attitudes toward products, but that the effects differ depending on both the strength and valence of the product-character associations, lending support to our hypotheses. As predicted by H3, parasocial attachment is the only character variable that consistently affects consumers’ attitudes to placed products. Specifically, the results for positive character-product associations show that parasocial attachment is positively related to attitude toward the placed product (supporting HIa) regardless of the strength of the character-product association (no moderating effect of CharAssocProd). The results for negative character- product associations show that parasocial attachment is negatively related to attitude toward the placed product (supporting H1b), but only when the association is strong (moderating effect of CharAssocProd, partial support for H2).

TABLE 2

Products Selected for Analysis

TABLE 3

Parameter Estimates for Regression Models

DISCUSSION

The findings support the model’s depiction of parasocial attachment between consumers and sitcom characters. When the character’s attitude toward the product is negative, ConsParaChar significantly affects ConsAttProd if the character-product association is strong-that is, if consumers perceive a strong connection between the character and the product, then ConsParaChar affects ConsAttProd negatively. When the character’s attitude toward the product is positive, ConsParaChar affects ConsAttProd regardless of the strength of the character-product association-that is, if consumers perceive a positive connection between the character and the product, then ConsParaChar affects ConsAttProd positively. Consistent with H3, parasocial attachment was a stronger predictor of attitude toward the product than attitude toward the character. The only significant effect of ConsAttChar on ConsAttProd was found for strong negative character-product associations.

The study findings reveal support for the model of integrated influences from television referent others, and the genre implications of character-product associations. In accordance with the proposed balance model of product placement effects, consumers align their attitudes toward products with the inside-program characters’ attitudes to products, and this alignment process is driven by the consumers’ extraprogram attachment to the characters. In this way, the model contributes to a richer understanding of product placement effects, describing the importance of a character’s effect on viewers’ attitudes toward placed products, particularly when characters’ attitudes toward products are positive. However, when characters’ attitudes toward products are negative, characters influence viewer attitudes only if they are strongly associated with the product. Support is also found for the superior pre- ‘ dictive ability of parasocial attachment over attitude toward a character.

By integrating the infl\uence of viewers’ parasocial attachment to television characters and that of genre attributes on product- character associations, the balance model contributes to a richer understanding of product placement effects. Findings support the balance model of an attitude alignment process in which a consumer’s attitude toward the product is a function of the valence and strength of the character-product association in the program and the valence and strength of the consumer-character attachment. This study represents the first attempt at integrating balance theory into the study of product placement effects, and provides support for plot connection (Russell 2002) and character-product associations (Chang and Roth 2000) as important predictors of placement effects; it also provides support for the crucial role of consumer-character attachment in the attitude alignment process. Balance theory predictions previously tested in real-life interpersonal relationships (Davis and Rusbult 2001) also hold in a media context, proving that television characters with whom consumers experience a strong parasocial relationship can also contribute to the formation and change of consumers’ attitudes toward consumption. In addition, the study corroborates previous researchers’ reports of the abundance of consumption information in sitcoms (Fiske 1987; WoIfF 1988).

Limitations

The present study has the general methodological limitation typical of prior placement research, which is characterized by a necessary compromise between internal and external validity (Campbell and Stanley 1966). We chose to “confront rather than evade external validity” (Wells 2001, p. 496) in two ways. First, we selected a methodology that allows for collection of real-world data from nonstudent samples; and second, we used real television programs to gain the benefits of externally valid stimuli and naturalistic settings. Consequently, the methodology contributes to product placement research by overcoming the limitations on external validity found in recent controlled experiments (Russell 2002). In so doing, however, we forewent the experimental manipulation of internal elements such as different levels of association between characters in a made-for-research stimulus, which would have enabled us to control the stimulus and placement effects (Babin and Carder 1996), the inclusion of more branded products as opposed to generic ones, or the collection of premeasures of consumer attitudes, which would allow assessment of attitude change (Russell 2002).

In addition, the study’s focus on one genre in one medium and one culture gives rise to the limitation of lack of generalizability across other program genres, media, and cultures. That is, even though the study provides support for the influence of characters and character-product associations on attitudes to placed products in American television sitcoms, we do not claim that its findings apply across other formats such as soap operas or crime dramas, other media such as books or music videos, or media vehicles popular in other cultures or subcultures.

Future Research

Nonetheless, the generalizability issue can be looked at as an opportunity for future researchers to extend product placement research to other media contexts (Esslin 1976) in which product- character associations and parasocial relationships occur. Among the many contexts are placements in books (e.g., Fay Weldon’s The Bulgari Connection and Lauren Weisberger’s The Devil Wears Prada); hip-hop music videos and songs (e.g., Busta Rhymes’ songs “Pass the Courvoisier” and “Pass the Courvoisier 2,” and Ludicris’s “Southern Hospitality,” which mentions Cadillac repeatedly); on-line video games (e.g., The Sims Online); and Broadway shows (e.g., Baz Luhrmann’s La Bohme). Precisely because placement research is so new, unexamined media vehicles provide fertile ground for the study of the nature and function of placements in one rather than another medium, such that greater understanding of specific media-related consumer effects can be achieved. For example, future research issues include the purpose of media placements in context, the means whereby they are introduced into the vehicle, the consumer- character relationship, and the anticipated attitude changes (Hirschman and Thompson 1997).

Just as the media contexts require future research, so too do the program genres within a single medium, notably television. Here, even though the history of placements in sitcoms, soap operas, and game shows is as long as that of television itself (Lavin 1995), new program types such as mob dramas (e.g., The Sopranos) and reality shows (e.g., Joe Millionaire, American Idol) tend to crop up with increasing rapidity. Indeed, the burgeoning of reality shows has been considered the fuel that powers “the apotheosis of recent product placements” (Carter 2001, p. Al), with such shows occupying 15 of the 18 half-hour time periods on Monday, Tuesday, and Wednesday nights, and half of the slots on other nights in 2003 (as projected in Carter 2003). Careful study of the reality shows’ particular attributes is needed, for they differ fundamentally from any other television program genre. Unlike other television serials that are scripted and populated by professional actors playing the characters, reality shows are unscripted and populated by real people playing themselves in artificial situations that represent “mutations made possible by reality TV” (Thompson 2001, p. 23). Furthermore, the participants appear for only a limited time period (8 to 10 weeks) and then vanish completely. These special characteristics are likely to affect parasocial relationships, but until further research is conducted, little is known about placement effects in this new genre.

Similarly, the ethnicity of respondents in American subcultures and other cultures is well worth investigating (Gould, Gupta, and Grabner-Krauter 2000). Spanish-language television in the United States features sponsor-owned shows in which the product is central to the characters and plot, comparable to products in radio soaps (Lavin 1995). For example, Budweiser sponsors Kiosko Budweiser, a sitcom made for Puerto Rican television in which a Bud kiosk functions much as the Cheers bar did (Hundley 1995). The kiosk is the central meeting place for the characters (Davila 1998), and Budweiser placements on the kiosk are a permanent part of the set. Placement effects cannot be extrapolated from general American audience responses, however, for a survey of Puerto Rican viewers revealed that most tended to “dismiss {the company’s} involvement in the ptogtam on the grounds that real kiosks [are] always decorated with beer advertisements” (Davila 1998, p. 463). The likelihood of ethnic response differences in terms of program language, viewer race, and country of origin suggests that the study of other racial and ethnic groups is necessary to ascertain the effects of placements in different cultural environments.

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Cristel Antonia Russell (Ph.D., University of Arizona) is an associate professor of marketing, HEC School of Management.

Barbara B. Stern (Ph.D., City University of New York) is a professor of marketing, Rutgers, The State University of New Jersey.

This research was funded by grants received by the first author from San Diego State University and NIH (R21 AA014897-01A1).

APPENDIX 1

Series and Episode Analyses

Raymond-Series description

Characters

The Barone family

Robert Ray’s brother, a policeman, lives with his parents.

Ray Robert’s brother, a sportswriter for Newsday (Long Island daily paper).

Debra Ray’s wife, housewife; she and Ray live across the street from Marie and Frank. They have three children-AIi is six or seven, twin boys are three.

Marie Ray and Robert’s mother.

Frank Ray and Robert’s father.

Setting Long Island suburbs.

Situation The group is the Barone family, middle-class Italian, where men work and women stay at home. Conflict between Debra, who is a terrible housekeeper and cook, and Marie, who is a critical mother-in-law.

Episode description: “The Cult”

Ray is eating PICKLES, and talking to Debra about them, as they are eating dinner and drinking GINGER ALE. Robert, who is depressed and eating TUMS in bed, gets up and goes across the street to visit Ray and Debra. He enters wearing a HAWAIIAN SHIRT, and says that he is distraught about an ongoing feud between Marie and Debra, and that he has decided to join a support group called “Inner Path” for therapy that will enable him to achieve inner peace. The family thinks that it is a cult, but Ray accepts Robert’s invitation to go to the next meeting. Ray disapproves of the group, but says that he is depressed by the unending feud between Marie and Debra. Ray wants to get Robert away from the group, and Robert’s partner, Judy, suggests an intervention. Robert is invited to come over to Ray’s house for some CAKE, and the whole family is there. Robert tries to resist their intervention, but the family tries to express their feelings about Robert: Ray expresses his love for Robert; Marie wants to feed everyone some CAKE; and Frank calls Robert a “lughead” for not understanding how his father feels. Debra and Marie are so worried about Robert that they decide to make up. Afterward, Robert says that he and Ray planned the support group “therapy” to get Marie and Debra to make up.

Episode description: “Counseling”

The second episode is also based on therapy, but this time for Debra and Ray. It begins with an argument when she asks him to help her clean the house before a dinner party, and he refuses to help because he “spent the whole day with the kids” and wants to relax. He is watching TELEVISION, eating CHIPS and drinking GINGER ALE, while Debra is trying to VACUUM up the crumbs; she eventua\lly vacuums up the remote. At the dinner party, their friends talk about the help they’ve gotten from their therapist, Pamela, who has enabled them to discover the root of their arguments. Debra is fascinated, but Ray is not, and that night, they have an argument about starting therapy. Debra wins, and they make an appointment with Pamela. At the therapy session, Debra cries, explaining that she works hard at home and feels “unappreciated”; Ray’s strategy is to agree with Debra, admitting that he’s been selfish and calling her a “saint” for putting up with him. Pamela applauds his honesty, and Debra is furious because Ray tried to manipulate Pamela. When they return home, his parents are there, and they all discuss his failure to help Debra clean the house. Frank tells Ray to help out a little, and Marie says that Debra needs all the help she can get because she is a terrible housekeeper. Ray admits that he really wants to be taken care of, and agrees that he would rather have a mother than a wife. At this, Robert laughs; Marie smiles. When Robert comes over the next day to apologize for laughing at Ray, he brings a gift: a life-size cardboard figure of Marie in her wedding dress.

Note: The season premiere of Everybody Loves Raymond consisted of two back-to-back episodes.

Frasier-Series description

Characters

Frasier Niles’s brother, psychiatrist, host of a radio talk show, snob.

Niles Frasier’s brother, psychiatrist, divorced, also a snob. ‘

Martin Niles and Frasier’s father, ex-cop, disabled (walks with a cane), dislikes his sons’ snobbery.

Daphne Martin’s caretaker, a physical therapist. Martin and Daphne live with Frasier.

Roz The producer of Frasier’s radio talk show, and a personal friend of Frasier and Daphne.

Setting Seattle, Frasier’s apartment-very deluxe, with a view of Seattle, expensive art and furniture, full wine rack.

Situation Family group-Niles and Frasier are brother psychiatrists, whose snobbishness irritates their father, Martin, an ex-policeman. Daphne is Martin’s physical therapist, and they both live with Frasier.

Episode description: “The Ring Cycle”

The episode is about Niles and Daphne’s three successive weddings, complete with complications. The first takes place in Reno at the Lucky 7 chapel, where Niles has forgotten to buy a WEDDING RING. Roz, the producer of Frasier’s show, calls and Niles’s CELL PHONE rings; Niles and Daphne then realize that they can’t say that they eloped because Frasier would be hurt at not being invited. They decide to get married again the next day at City Hall; en route to the wedding, Frasier investigates Martin’s lunch bag (prepared in Daphne’s absence) and finds CHIPS and PUDDING CUPS. When Daphne’s mother gets to City Hall, she says that no daughter of hers can get married without a minister, and she walks out. But the newlyweds get married again, and Daphne’s mother comes to Frasier’s apartment to apologize for demanding that a minister be present. Frasier brings in a bottle of WINE, and Niles and Daphne tell her that they will go back to City Hall to get married again (wedding number 3). ‘ j

Friends-Series description

Characters In their late 20s/early 30s, white.

Joey Actor in Days of Our Lives (soap opera), Italian, a womanizer.

Monica Ross’s sister, wealthy background, Jewish, married to Chandler, works as a chef, is food-obsessed, neurotic, and controlling.

Phoebe Massage therapist, New Age hippie, nurturing, loves animals.

Rachel Monica’s high-school best friend, works at Ralph Lauren, on and off romance with Ross, has just had his baby.

Ross Monica’s brother, wealthy background, Jewish, works as a paleontologist, university professor, married three times, one child.

Chandler Married to Monica, works at unknown job in finance, Ross’s college roommate.

Setting All the characters live in New York-the West village-and hang out at “Central Perk,” an upscale coffee house.

Situation A “pack of pals” show, comparable to Cheers, in which six close friends get together at each others’ apartments or at Central Perk to discuss jobs, relationships, clothing, and other issues.

Episode description: “The One Where No One Proposes”

“Who-proposed-exactly-what-to-Rachel” showdown. All of the friends gather in Rachel’s hospital room, which is filled with BALLOONS and FLOWERS, to celebrate her giving birth to Ross’s baby. Joey, who is now in love with Rachel, finds an ENGAGEMENT RING that has fallen out of Ross’s coat. When he bends down to retrieve it, Rachel thinks that he is proposing to her, and she accepts. Joey realizes that Ross was about to propose, and Phoebe leaves the room to get her GAME BOY back from a child to whom she lent it. Monica and Chandler come to visit next, and since they are trying to have a baby, when she announces that she is ovulating they duck into a closet to have sex, unfortunately interrupted by Mr. Geller (Rachel’s father), who gives them advice on the best positions for conceiving. Back in Rachel’s room, Phoebe congratulates Ross on his engagement, and Ross, who is eating a SANDWICH outside, is confused; he mentions that Joey ate a piece of PLASTIC FRUIT earlier. When Ross returns to Rachel’s room, he thinks that Rachel is hallucinating until Phoebe points out her RING. Joey explains that he didn’t propose; he tells Rachel that the ring is Ross’s. Ross explains that he was not going to propose- he was carrying the ring because his mother had just given it to him. However, he tells Rachel that he wants to start dating again.

Will and Grace-Series description

Characters Thirty-something, white.

Will Gay lawyer, has two-bedroom apartment (Lincoln Towers on the Upper West Side-155 West End Avenue), not currently in a relationship.

Grace Jewish, lives with Will, single interior designer who dated Will at Columbia,

Education Pioneer Lindamood Dies at 83: The Arroyo Grande Resident Co-Founded the Lindamood-Bell Learning Processes

By Leslie Griffy, The Tribune, San Luis Obispo, Calif.

May 18–Say “cat.” Take away the “c.””At” is what is left.

The developer of such simple but powerful lessons used to teach thousands of children to read died Saturday in her Arroyo Grande home.

Patricia Lindamood, 83, was co-founder of the private education firm Lindamood-Bell Learning Processes of San Luis Obispo, one of the biggest educational firms in the nation. She was named a Cuesta College Woman of Distinction in 2004.

As a language and speech pathologist, Lindamood used research and created detailed lessons to help students better understand the relationships between sounds and the written word.

“She was one of the pioneers when it comes to developing tests and materials,” said Mark Sadoski, a Texas A&M College of Education professor and researcher.

The company that Lindamood helped found in the 1970s with reading specialist Nanci Bell distributes lessons and trains educators from here to Australia.

The firm’s programs get results — kids learn. In a five-year study of a Lindamood-Bell program implemented in a Pueblo, Colo., school district, Sadoski said the results were clear.

Before the district’s teachers had been trained in the program, the school’s reading scores were below the state average. Five years later, 83 percent of the students tested scored at or above Colorado state standards, a jump of 16 percentage points.

“One of the things that the Lindamood-Bell people did was that they spent a good deal of time working to get buy-in from the teachers, staff and the community,” Sadoski said.

While working as a trained pathologist, Lindamood was also substitute teaching.

She noticed that some children struggling to read weren’t getting extra attention.

So she eventually persuaded parents to let her work with some students. Nine months later, students communicated better.

She continued working with children out of her home and began doing research.

Bell came to work for her and the two then founded the company, which began as a nonprofit. Their work soon expanded to training teachers and developing lessons to be used in schools.

“She had an absolute commitment to helping children,” said county schools Superintendent Julian Crocker. “She did a lot to advance education.”

Her detailed teaching and student materials gave specific instruction for children on how to make certain sounds, Sadoski said.

A “T” is a “tongue tapper,” because you tap your tongue on your mouth. Those instructions “helped a lot of children read more effectively,” Crocker said.

“How much more could you ask for?”

Reach Leslie Griffy at 781-7931.

—–

Copyright (c) 2006, The Tribune, San Luis Obispo, Calif.

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].

Tattooed Mummy Unlocks Peru’s Moche Culture

By Ines Guzman

HUACA CAO VIEJO, Peru — Archeologists probing Peru’s lifeless northern desert discovered a 1,500-year-old mummy that may unlock secrets of the Moche, one of the mysterious civilizations that once ruled the Andean nation.

Baptized the Lady of Cao by researchers after it was found by a ceremonial pyramid near the Pacific Ocean, the tattooed mummy is the first female Moche leader ever discovered. It could debunk theories that the culture, known for its pottery and human sacrifices, was governed only by men.

Unveiling the mummy this week, U.S. and Peruvian archeologists said the woman, who probably died during childbirth at age 25, had religious and magical figures of spiders and snakes tattooed on her arms, much to the surprise of the investigating experts.

“The conservation of her body is exceptional. We found her buried with mercury sulfide that helped eliminate microorganisms and help the preservation,” said Regulo Franco, one of the archeologists who has spent 16 years excavating the Huaca Cao Viejo pyramid with funding from a Peruvian bank.

The Lady of Cao was found with two ceremonial war clubs and 23 spear throwers — sticks that propel spears — puzzling archeologists who say such items have previously only been found in male Moche graves.

The woman was also buried with three other mummies, including a teenage girl found alongside her who was probably strangled as a sacrifice to the Moche leader.

Those mummies will be unwrapped over the next few months. Archeologists, backed by Peruvian bank and government funding and by the U.S.-based National Geographic Society, hope to extract DNA to see if they are the bodies of relatives.

The culture of the Moche, who constructed the largest adobe pyramid in the Americas, the Moche Sun Pyramid, developed along Peru’s northern coast near what is now the country’s third-largest city Trujillo. It flourished in the river valley oases from 100 A.D. to 800 A.D. The Lady of Cao dates to 450

A.D.

The Moche were later conquered by the Chimus, who were known for elaborate irrigation systems and built Chan Chan, one of the world’s largest adobe cities.

They in turn were conquered by the Incas, who built a civilization that stretched from the Equator to the Pacific coast of Chile and are best known for the Machu Picchu citadel in southern Peru.

Their rule came to an abrupt end in the 1530s when they were subjugated by the Spanish Conquistadors.

The Moche’s Huaca Cao Viejo pyramid is covered in reliefs that suggest prisoners were sacrificed to the gods by a warrior-priest. It was abandoned for centuries.

Moche pottery has been the main way that experts had interpreted their culture. The ceramics showed the Moche had well-developed weaving techniques, but because of rainstorms every few decades, most of their textiles have been destroyed.

El Salvador Tropical Coffee Forests Threatened

SAN SALVADOR (Reuters) – Tropical forests that house El Salvador’s famed coffee plantations and provide habitat for migrating birds are being depleted at an alarming rate, scientists warned on Tuesday.

Between 2001 and 2004, the country lost 21,025 hectares of forest-covered coffee farms, Mario Acosta, president of El Salvador’s Foundation for Coffee Research (Procafe), said.

El Salvador last year planted around 161,000 hectares of coffee, the vast majority of it grown on wooded plantations.

With the greatest population density and smallest land size in Central America, El Salvador was long ago cleared of virtually all its native forest. Coffee farms, where bourbon variety coffee trees flourish under a thick shade canopy, provide 75 percent of El Salvador’s remaining forest cover.

“Just in the period between 2001 and 2004, we lost 21,025 hectares with the accompanying environmental degradation, with the problems this means for watersheds and all the problems of unemployment in the countryside,” Acosta told reporters at the opening of a regional conference on the role of the coffee industry in the environment.

The dramatic losses took place during a sustained period of record-low coffee prices which led many farmers to abandon their land, in some cases ceding it to encroaching urban expansion.

In recent years, environmental groups have embraced El Salvador’s coffee industry, noting the role it plays providing habitat for migrating birds and other wildlife.

A recent joint study by Procafe and Washington-based research group Resources for the Future, presented at the conference, found that 13 percent of El Salvador’s so-called coffee forests were lost in the 1990s.

The report blamed coffee forest depletion on urban expansion, a lack of investment and renewal of coffee trees, farmer indebtedness, migration and weak regulatory oversight of land-use changes.

The El Salvadoran coffee industry shed some 70,000 jobs during the period of low prices and now employs about 90,000 people directly.

The country exported 1.3 million 60-kg bags of coffee in the 2004/05 coffee year, generating income of $164.5 million.

Despite being the country’s the main agricultural export, coffee income is a fraction of the over $2 billion the country receives annually from the estimated 25 percent of its population that lives abroad, mainly in the United States.

New MRI Machine Can Handle Larger Patients

By Rob Robertson, The Commercial Appeal, Memphis, Tenn.

May 15–Anyone yearning to know how a pimento must feel when it’s being stuffed inside an olive might ask a heavy person about the last time he had to get an MRI.

An MRI (magnetic resonance imaging) device looks something like a giant doughnut with a tongue depressor sticking out of the hole.

It is essentially a giant magnet wrapped around a sliding operating table that doctors use to take high-resolution pictures of patients’ innards.

“People who are large or claustrophobic may often be scared of getting an MRI because sometimes there’s very little room between the patient and the machine,” said Janet Hickman, COO of Diagnostic Imaging, PC. “Now that doesn’t have to be the case.”

Diagnostic Imaging is an outpatient imaging services provider that recently became the first imaging center in the Mid-South to use a new, state-of-the-art MRI that aims to make scanning a lot easier for patients of all sizes.

Diagnostic’s new Magnetom Espree MRI, built by Siemens, uses a more powerful 1.5 Tesla magnet to provide doctors with clearer images, even for the obese, and a larger “hole” that’s more comfortable for bigger patients or those who get anxious or claustrophobic.

Cindy Wilcox, one of the technicians who operate the machine, said patients who might have been afraid of getting an MRI are relieved when they see the new device.

“There’s a lot less anxiety when they actually see how much space they have,” Wilcox said. “With the old magnet we had to smush people down to get them in the machine sometimes.

“We’ve handled people up to 420 pounds already with this and they had plenty of room.”

Diagnostic Imaging provides MRI and CT (computed tomography) services, including lung screening, ultrasound, nuclear imaging, mammography, general radiography and fluoroscopy.

The 20-year-old business recently relocated its offices to the PennMarc Center in East Memphis, where an outer wall had to be knocked out in order to move the new $1.8 million MRI, which is about the size of a small car, into place.

“We basically had to build the office around the MRI and CT rooms,” Hickman said.

The new MRI replaced two magnets, a closed tunnel-type and an open system.

“We felt the new device met our needs in both areas,” Hickman said.

Accommodating larger patients was a factor in the decision to purchase the new machine, but claustrophobes — people with a fear of enclosed places — were more of a concern, Hickman said.

“We’re already seeing patients that thought they’d have problem with an MRI, but when they saw it thought, ‘Oh, well this won’t be a problem at all,'” Hickman said.

Siemens spokeswoman Anne Sheehan said the Espree’s improved technology makes the MRI experience easier for doctors too.

“Obese or claustrophobic patients prefer the open bore system, but open bores typically used weaker magnets that produced poorer images,” Sheehan said. “This is a new choice; it has the strength of the old closed units but is roomier for larger people.”

MRIs and CTs have been used by hospitals and, more recently, diagnostic imaging centers, for more than 20 years.

CTs, which use X-rays to produce images, are typically less bulky and more open than MRIs, as well as being faster at imaging — making them preferable in trauma cases.

MRIs were originally used mainly for brain and spinal conditions, but technology has advanced so that MRIs can be used for any manner of ailments.

“There’s virtually nowhere in the body that can’t be imaged,” Sheehan said, “and it’s done without X-rays or the risk of radiation, which makes a difference to patients.”

The Espree is being used equally between hospitals and independent imaging centers now, gradually replacing older magnets, Sheehan said.

Imaging centers like Diagnostic Imaging, however, offer more efficient service for non-critical cases.

In Memphis, the sixth-fattest city in America according to Men’s Health magazine, it makes sense for health-care providers to have medical equipment that can comfortably accommodate people of all sizes — not only for patients, but also for doctors looking for better technology to treat those patients, Hickman said.

“For the patients it’s a lot more comfortable now,” Hickman said. “And it’s easier on the doctors because the images are clearer, giving doctors more options when diagnosing their patients.

“Everybody wins.”

—–

To see more of The Commercial Appeal, or to subscribe to the newspaper, go to http://www.commercialappeal.com.

Copyright (c) 2006, The Commercial Appeal, Memphis, Tenn.

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 Scientific finds battery problem in some devices

By Susan Kelly

CHICAGO (Reuters) – Boston Scientific Corp. on Monday said
it had notified doctors that some of its implantable cardiac
devices, which it acquired as part of its purchase of Guidant
Corp. last month, could be at risk for early battery depletion.

Boston Scientific, whose shares fell 1 percent, said the
problem occurred in a single lot of 996 implantable
cardioverter defibrillators and cardiac resynchronization
therapy defibrillator devices that had been implanted in
patients globally. No deaths or injuries were reported.

Implantable cardiac devices, or ICDs, are used to jolt a
dangerously racing heartbeat back to a normal rhythm. Several
models of the life-saving devices have been the subject of
recalls or safety alerts by Guidant and other manufacturers in
recent years.

Boston Scientific said 30 of its Guidant devices had been
returned by May 8, and it had received an additional 46 reports
of devices that remained implanted but showed signs of
premature battery depletion.

The devices, which contain a faulty component from the
single manufacturing batch, are in the Vitality DS, Vitality
AVT and Vitality 2 ICD lines and the Contak Renewal 3, Contak
Renewal 4 and Contak Renewal 4AVF lines of CRT-Ds.

In information posted on its Web site, Boston Scientific
advised doctors to schedule follow-up appointments as soon as
possible with patients who had received the devices and contact
the company for instructions to determine remaining battery
life of the devices.

The battery problem came to light after an overall review
of Guidant’s product lines, Boston Scientific said.

Boston Scientific swooped in to buy Guidant for about $27
billion after Guidant initiated a series of device recalls and
was stung by criticism over its failure to promptly notify
physicians and the public about life-threatening defects.

“We understand and acknowledge we have to do a better job
of communicating, and this is a step in that direction,” Boston
Scientific spokesman Paul Donovan said.

Boston Scientific also advised doctors of two device
malfunctions linked with implantation of Guidant defibrillators
in an unusual position.

Planting one of these devices below the chest muscle,
rather than below the skin, can result in mechanical stress to
an area of the titanium case that can cause the product to
malfunction, the company said. The uncommon technique could
affect devices in the Renewal 3, Renewal 4 and Vitality HE
product lines.

The two patients whose devices malfunctioned underwent
successful replacement procedures, Boston Scientific said.

Morgan Stanley analyst Glenn Reicin said the product
notifications stem from an approach adopted by Guidant last
year to update physicians regularly about performance issues.

“Investors should view these communications as normal
course of business,” Reicin said in a note to clients.

Boston Scientific is currently working to resolve a warning
letter from the U.S. Food and Drug Administration over quality
control issues. The Guidant division also faces its own FDA
warning letter over its ICDs.

Boston Scientific shares were down 21 cents at $20.49 in
midday New York Stock Exchange trading after initially dipping
almost 3 percent.

Tuna firms don’t have to warn of mercury: judge

SAN FRANCISCO (Reuters) – Tuna companies do not have to put
labels on their cans warning the fish contains mercury, a San
Francisco judge ruled in rebuffing a lawsuit brought by
California’s attorney general.

In a Thursday decision publicized on Friday, San Francisco
Superior Court Judge Robert Dondero ruled against state
Attorney General Bill Lockyer, who in 2004 sought to ban the
sale of canned tuna without mercury warnings.

Lockyer sued Del Monte Foods, maker of StarKist tuna;
Bumble Bee Seafoods, a unit of Connors Brothers Income Fund of
Canada, maker of Bumble Bee tuna; and Tri-Union Seafoods, maker
of Chicken of the Sea tuna.

The complaint alleged the firms violated state Proposition
65, an initiative approved by voters in 1986 to require firms
to issue warnings before exposing people to “known carcinogens
or reproductive toxins.”

Scientists have found that nearly all fish contain trace
amounts of mercury but some species, including tuna and
swordfish, can have higher levels.

“The judge has made a common-sense ruling based on
nutrition and science,” tuna industry lawyer Forrest
Hainlinesaid in a statement. “It’s easy to see that canned tuna
has always been an extremely healthy and important food source
despite extremists’ attempts to raise irrelevant and misleading
arguments.”

At Duke, Echoes of St. John’s Case

By Karla Schuster, Newsday, Melville, N.Y.

May 14–A thick stack of aging newspaper clippings are buried somewhere in his garage, but Theodore Lynch has never been able to bury his feelings about what happened 15 years ago, when after seven days as the lone holdout for conviction, he gave in and voted to acquit three white St. John’s University lacrosse players from Long Island accused of sexually assaulting a black classmate.

“I should have stayed firm. I should have caused a mistrial and every day it haunts me,” said Lynch, a computer analyst from Cambria Heights, who had originally wanted to convict two of the three players.

Lynch, like many connected to the St. John’s case, has watched the scandal involving Duke University lacrosse players, including one from Garden City, unfold with the keen interest and unique perspective of someone who had a front-row seat for a similar story of race, class and the culture of college sports.

“I have an awful lot of sadness – that ‘here we go again’ feeling,” said Christine Rider, an economics professor at St. John’s for 29 years who retired last year.

It was March 1990 when a black St. John’s student said she accepted a ride with a classmate that ended with her being sexually assaulted by six white students, including five lacrosse players, in an off-campus house nicknamed “Trump Plaza” and notorious for raucous behavior.

The six young men, four of whom were from Bethpage, were accused of orally sodomizing the woman, who said she had one drink and lost consciousness, and forcing her to perform oral sex on several of them. They were indicted on a variety of charges, including sodomy, sexual misconduct, sexual abuse and unlawful imprisonment.

The case touched a raw nerve in a city still struggling to recover from a series of racially explosive incidents – from Tawana Brawley, a black teenager who accused white cops of assault in 1987 (charges that were eventually determined to be fabricated), to the boycott by blacks of a Korean deli in Brooklyn in 1990. As protesters picketed the Long Island City Courthouse where the trial unfolded, the case generated a crushing amount of media coverage long before cable news stations, blogs and Web sites made such attention routine.

“The racial and cultural issues that existed [at the time] were never far from the surface,” said attorney Peter Bongiorno of Garden City, who represented Adam Gerber, one of the six students charged in the St. John’s case. Gerber pleaded guilty to second-degree sexual abuse, a misdemeanor, and was sentenced to probation and community service.

Yet what Rider remembers is how little of that public debate roiling across the city seemed to seep into the daily life of the Fresh Meadows campus or its working-class commuter students.

“I don’t remember any discussion of it among faculty in any kind of formal setting,” Rider said, “or any attempt to formally discuss how to talk about this in classes or integrate it as a ‘lessons learned’ sort of thing.”

At the time, the university offered special counseling for those who sought it, but officials said few did. The school also instituted special, required sensitivity training for athletes, but the only public forum on the case was a liturgy devoted to the topic of “respect.”

At Duke, the allegations that lacrosse players raped a black woman hired as a stripper to dance at an off-campus house in Durham have sparked prayer vigils, protests both in the city and on campus, as well as five university task forces to study issues raised by the case and determine the future of the lacrosse team.

The woman says she was raped in March by three white lacrosse players, including at least one from Long Island, at an off-campus house.

Race and class issues

The Duke allegations have laid bare the history of fractured town-gown relations, which center on race and class (Durham is a racially mixed, middle-class city while Duke’s students are mostly white, from out-of-state and pay annual tuition and housing costs equal to the city’s annual median income).

Duke has canceled the remainder of its lacrosse season and will decide shortly whether to continue the program at all. The lacrosse team at St. John’s continued to play as the case made its way through the courts, but within five years, the school disbanded the program, citing economics and pressure to comply with Title 9, the federal law requiring a balance between men’s and women’s sports.

Brooklyn Councilman and former state Sen. Vincent Gentile was a young prosecutor in the Queens district attorney’s office, just a few years out of law school, when he and Assistant District Attorney Peter Reese tried the three St. John’s players.

The case remains the highest profile prosecution of Gentile’s career. It was, Gentile said, the first acquaintance rape case to go to trial in the state. Every day during the seven-week trial, as the protesters supporting the victim marched in front of 100-year-old Long Island City Courthouse, the cadre of high-powered defense attorneys inside employed a strategy that hinged on a grueling cross-examination of the woman.

The jury’s reaction to the young woman’s testimony during cross-examination – she verbally sparred with defense lawyers in a way that many jurors found arrogant and unsympathetic – stayed with Gentile.

After that, Gentile said, “it was always a fear of mine that a defense attorney would get to the point of pressing someone so hard that they would snap under cross … to the point where the jury may misinterpret things.”

Defense strategies

Like the St. John’s case, the defense lawyers representing the Duke lacrosse players have targeted inconsistencies in the alleged victim’s story and timeline. Stephen Scaring, the Garden City defense attorney who represented Walter Gabrinowitz, one of the three St. John’s players who was acquitted, said such cases revolve less around broad social issues than with basic legal strategies.

“No one gets a free ride,” Scaring said. “If you’re going to allege someone committed a serious crime, your credibility will be questioned.”

Of the six young men charged in the St. John’s case, three, Matthew Grandinetti, Andrew Draghi and Gabrinowitz – all of of whom grew up together in Bethpage – were acquitted at trial but eventually expelled from the university. The university said a campus disciplinary committee had found that each of the three had been guilty of “conduct adversely affecting his suitability as a member of the academic community of St. John’s.”

Two others, Michael Calandrillo, also of Bethpage, and Joseph Reilly, of Rockland County, pleaded guilty to misdemeanors, including sexual misconduct, unlawful imprisonment and second-degree sexual abuse. They were sentenced to probation and community service.

“It made me wonder then, and wonder today as I look at what is happening in North Carolina, how overwhelming does the evidence need to be in able to convince a jury?” said civil rights activist the Rev. Herbert Daughtry, who served as a spokesman for the St. John’s victim, a 21-year-old business major from the Caribbean. “These things continue to play out. Some things are different, but how much different?”

On the campus of St. John’s University, quite a bit has changed. It is also no longer exclusively a commuter school – since 1999, six dorms have been built on-campus that house more than 2,000 students, so that off-campus apartments are no longer the only option.

Once a predominantly white institution – 73 percent of its students were white and 9 percent black in 1990 – the university is far more diverse now. The enrollment is 47 percent white, 15 percent Hispanic, 14 percent black and 13 percent Asian, according to the 2005 Barron’s Profiles of American Colleges.

And the lacrosse team, after a 10-year absence, is back, with the only black coach in the sport for Division I.

Special treatment?

Programs dealing with the temptations facing students and student athletes are “so far advanced and more complex and ingrained than what was done 20 or 25 years ago,” said St. John’s athletic director Christopher Monasch.

Yet, the perception remains that athletes get special treatment from the system – a notion that still troubles Lynch, the St. John’s case juror. His memories remain vivid of how tensions in the jury room began to boil over.

“I was definitely frustrated and I got tired and I guess I wanted to go home and get it over with,” he said of his decision to change his vote. “You realize that when you get 12 people in a jury room … sometimes it’s about who has the strongest wills.”

For Bongiorno, the defense attorney, the legacy of the St. John’s case is simple: “Any allegation of a sex offense outrages our sense of morality – the very nature of the charge is offensive and when the allegations are adamantly denied, it sets the stage for the adversarial process.”

—–

Copyright (c) 2006, Newsday, Melville, N.Y.

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].

Texas Teenager Dies of Rabies from Bat Bite

HOUSTON — A Texas teenager who was bitten by a bat while he slept in his home has died of rabies, the Houston hospital that treated him said in a statement.

Zachary Jones, 16, died on Friday, a week after he became ill from the bat bite he received about a month before.

According to U.S. Centers for Disease Control statistics, only 10 other people have died of rabies in the United States since 1998.

“Rabies, which causes devastating neurological damage, is almost always fatal once symptoms appear, as was the case with this child,” Texas Children’s Hospital said in a statement.

A 15-year-old girl from Wisconsin who contracted rabies in 2004 survived after the onset of symptoms, which can take weeks to develop.

Doctors at Texas Children’s were trying the same treatment on Jones that saved the girl, but a spokeswoman told the Houston Chronicle the boy’s illness was more advanced and he had a different strain of rabies.

A bat apparently flew through an open window into Jones’ room while he was napping. He felt the bat brush against him, but did not know he had been bitten, health officials said.

The bat was captured with a towel and thrown out the window so it was never examined for rabies, they said.

Bats are common in Texas in spring as they migrate north after spending the winter in Mexico. Wildlife experts say they consume insects and help pollinate useful plants.

Tearful Metallica singer recounts drugs battle

By Dean Goodman

LOS ANGELES (Reuters) – Metallica frontman James Hetfield
fought back tears on Friday as he recounted his public battle
with addiction, and labeled the sex, drugs and rock’ n’ roll
ethos as a “horrible myth.”

The 42-year-old singer/guitarist was being honored at a
Hollywood fundraiser for the MusiCares MAP Fund, which provides
access to addiction recovery for members of the music
community.

The event, which also honored concert promoter Bill Silva,
culminated in a three-song set by Hetfield and Metallica
bassist Robert Trujillo, along with Alice in Chains guitarist
Jerry Cantrell and drummer Sean Kinney. They dusted off the
Alice in Chains songs “Would?” and “Them Bones,” and finished
with the Metallica ballad “Nothing Else Matters.”

Other performers included Tom Waits, Velvet Revolver, Jason
Mraz and Black Rebel Motorcycle Club.

Guests included Ozzy and Sharon Osbourne, Motorhead
frontman Lemmy, Metallica drummer Lars Ulrich and guitarist
Kirk Hammett, and Red Hot Chili Peppers singer Anthony Kiedis.
They reclined on couches scattered throughout the Music Box @
Fonda and imbibed alcohol-free refreshments, thus avoiding the
risk of any public relapses.

Hetfield began his speech asking for a moment of silence
“for the people who didn’t make it, that aren’t with us, who
could be and I think should be.”

He recounted the old saw that “dying is easy, living is
hard,” and offered his own recovery as proof that addiction is
survivable.

Five years ago, things were different, he recalled,
expressing gratitude to the award-winning documentary “Some
Kind of Monster,” which depicted Metallica’s virtual
dissolution as Hetfield began a lengthy rehabilitation to treat
drug and alcohol abuse.

“I think that movie helped some people, and it took the
black veil away, it took the mystique and the mystery out of
the rock myth ‘sex, drugs and rock ‘n’ roll,”‘ he said.

“What a horrible statement, to me. It is a myth. And to
have those things attached to music, which is the best drug in
the whole f—–‘ world, moves me like no other. And I thank
God that I discovered that gift early on.”

He alluded to his constant daily struggle, connecting with
real emotions such as fear and love.

He also paid tribute to his bandmates and producer Bob Rock
for saving his life daily, as well as wife Francesca and their
three children, 7-year-old daughter Cali, 5-year-old son
Castor, and especially 4-year-old daughter Marcella, whom he
tearfully described as the glue that kept the family together
during his darkest days.

Other performers chimed in with bons mots during the
evening. Waits congratulated Hetfield, saying “getting sober’s
not for sissies.”

And Velvet Revolver singer Scott Weiland dedicated the
band’s acoustic cover of Pink Floyd’s “Wish You Were Here” to
“everyone from Gram Parsons to Kurt Cobain.”

The event raised about $300,000 for MAP MusiCares, which is
part of the National Academy of Recordings Arts and Sciences,
the group that organizes the Grammy Awards.

Reuters/VNU

Poultry Farms Ramp Up Against Bird Flu

CUMMING, Ga. — Going to the Milford family chicken farm is like trying to infiltrate a high-security medical lab.

After the car’s wheels are sprayed down with disinfectant, visitors are outfitted with blue biohazard suits, clear boot coveralls, tight latex gloves and lunch-lady hairnets. Then, before entering the chicken coop, guests must immerse their feet in a soupy but powerful iodine cleanser.

Like other poultry farmers across the country, the Milfords are taking extreme precautions to prevent their livelihood from getting infected with the deadly avian flu virus, which has devastated chicken markets in Europe, Asia and Africa but has yet to be detected in the Western Hemisphere.

As chicken producers for Tyson Foods, they are required by the company to ban non-essential visitors from the farm and test selected chickens before they’re sent to the slaughter – one of 15,000 tests the company conducts each week for bird flu, which is five times the number of tests it did last year.

The tightened visitor restrictions and increased testing are the company’s “code yellow” precautions, which have been in place for about three months as the virus spreads throughout the world.

Health officials worry that the virus could potentially spark a pandemic if it mutates into a new strain that could be easily transmitted between people.

If the avian flu strain ever does reach the U.S., chicken growers are confident it likely won’t ever reach their isolated chickens, let alone humans. They will, however, likely have to handle widespread fear from consumers.

And the staggering U.S. industry, which produces more than 35 billion pounds of poultry a year, is why farmers in Georgia, the nation’s leading poultry producing state, and elsewhere are taking extreme precautions.

If news from abroad is any indicator, their fears are well placed. France’s poultry industry, Europe’s largest, reported losing $48 million in monthly sales as countries scale back their chicken imports. In Italy, consumer fears of the virus have forced the industry to lay off some 30,000 workers.

Fear of a bird flu backlash in the U.S. has major producers such as Tyson Foods and Gold Kist, and family farmers alike ramping up their efforts to keep consumers at ease.

Poultry growers are quick to point out that none of the 205 cases of avian flu confirmed by the World Health Organization resulted from eating poultry – although one case in Vietnam was contracted after a victim drank raw duck’s blood. Of those cases, 113 people have died.

They add that cooking poultry at normal temperatures would kill H5N1, the deadly strain of avian flu that’s spread across Asia to Europe and Africa.

Just for good measure, KFC plans on tacking red white and blue stickers that say “rigorously inspected, thoroughly cooked, quality assured” on the lid of every bucket of fried chicken it sells in the U.S.

Neither Atlanta-based Chick-fil-A nor Oak Brook, Ill.-based McDonald’s Corp. (MCD) have plans to add a food-safety messages to the packaging of their chicken products.

Most chicken producers, including Little Rock, Ark.-based Tyson and Atlanta-based Gold Kist, favor an “all in, all out” process that rids coops of all chickens before each new group is brought in to insure any disease can’t be carried over.

“We’re lucky. The way our industry is set up is with enclosed housing,” said Wayne Lord, a Gold Kist vice president. “Our commercial poultry are all housed inside chicken houses so the chance for encounter with wild birds is extremely remote. It’s very insulated and very strictly monitored.”

To the Milfords, who have been in the chicken business for generations, the precautions are a sign of the times.

“Years ago, I don’t remember Papa having signs on the door saying: ‘Restricted – No Admittance,'” said Troy Milford, who runs the farm with the help of his father, Dempsey. “But everyone is more aware now.”

Another sign of the times: As he walks around his 13-acre plot, which houses four coops that grow 78,000 chicks at a time, Milford can check his cell phone for messages and e-mail alerts from the company with bird flu news.

The tight controls needed to protect chickens from disease come naturally to modern chicken coops, Milford said. At his coops, shutters automatically clamp down after cooling fans cut off and sensitive sensors connect to a computer to regulate the building’s temperature.

Entering one of them is like entering a dark wind tunnel, tinged with the stench of 20,000 clucking five-week-old chicks.

It’s a far cry from the days when the family first entered the chicken business in the 1930s, when Dempsey’s grandmother bought 80 acres in the north Georgia foothills.

Since then, plots have been handed down from generation to generation as the region has emerged as one of the nation’s leading poultry centers. Nearby Gainesville, just across the county line, calls itself the “Poultry Capital of the World” and Cumming boasts dozens of poultry farms, including three run by Dempsey’s siblings around the corner for a road named after the family.

While avian flu might lead to a host of new restrictions, it’s just the latest challenge the industry must mount, said Dempsey, an ever-smiling 66-year-old in blue overalls.

“You wouldn’t have thought about it ’til 10 years ago,” said Dempsey. “It’s a good thing, though. When you go to all the grocery stores, you don’t worry.”

On the Net:

World Health Organization: http://www.who.int/csr/disease/avian_influenza/en/

Copper, magnesium, zinc levels tied to mortality

NEW YORK (Reuters Health) – French researchers have
identified links between levels of three metals in the body and
the risk of death from cancer or heart disease.

Dr. Nathalie Leone of the Lille Pasteur Institute and
colleagues found men with high copper levels had an increased
risk of dying over an 18-year period, while high magnesium
levels were associated with reduced mortality risk. Low zinc
levels seem to add to the effect of the other two elements.

However, the researchers note, it remains unclear whether
these metals are actually responsible for these effects or
simply markers for cancer or heart disease.

Zinc, copper and magnesium play a number of key roles in
the body, for example in the immune response, inflammation and
oxidative stress, Leone and her colleagues write in the
research journal Epidemiology. To investigate the relationship
between body levels of these elements and mortality, the
researchers followed 4,035 men aged 30 to 60 for 18 years.
During follow-up, 339 men died, including 176 from cancer and
56 from heart disease.

Men with the highest copper levels at the study’s outset
had a 50 percent increased risk of death from any cause, and a
40 percent greater risk of dying from cancer, compared to men
with the lowest levels.

On the other hand, those with the highest magnesium levels
had a 40 percent to 50 percent reduced risk of death compared
to those with the lowest levels.

Low zinc levels along with high copper levels boosted
mortality risk further; men with this combination were 2.6
times more likely to die during the follow-up period than those
with low levels of both zinc and copper. Low zinc values
combined with low magnesium levels contributed to an increased
mortality risk.

High copper levels were tied to older age, smoking and high
cholesterol, Leone and her team note, while lower magnesium
levels were linked to older age, high blood pressure and
diabetes.

Copper can contribute to the formation of damaging free
radicals in the body, the researchers note, while low magnesium
may also contribute to inflammation. Low zinc levels may impair
immune function, while zinc also shields the body from free
radicals.

“In this way, decreased zinc and either increased copper or
decreased magnesium might synergistically enhance oxidative
damage and the inflammatory response,” Leone and her team
write.

“Further studies are needed to confirm the interactions
between serum zinc and serum copper or serum magnesium and
their potential contribution to the prediction of all-cause,
cancer and cardiovascular disease mortality in clinical
practice,” they conclude.

SOURCE: Epidemiology, May 2006.

US Farm Fights Bird Flu One Visitor at a Time

By Bob Burgdorfer

MT. JACKSON, Virginia — Visitors to the Koontz chicken farm in northern Virginia must suit up in battle gear — shower caps, overalls, latex gloves and disinfected boots.

The safety measures are all part of the ongoing battle to keep bird flu out of the U.S. chicken flock.

The deadly H5N1 strain of the flu has been in headlines around the world, but so far it remains overseas. However, the father and son team of John and Kenneth Koontz, along with thousands of other U.S. poultry farmers, are worried that one day it will arrive here.

At the Koontz farm, tucked between the Allegheny and Blue Ridge Mountains, cars and trucks must park 50 feet away from the four enclosed chicken houses which hold 80,000 birds, to prevent germs from migrating from the vehicles to the flocks.

“We are taking measures to fight against it. It’s almost like fighting something that you don’t know what you are fighting,” said John Koontz.

The H5N1 avian influenza is in the spotlight because that particular strain is dangerous to people. Since 2003, it has killed 115 people in Africa, Asia and Europe. Milder forms of the flu have also affected birds.

The H5N1 strain has never been found in the United States, but government and industry officials are worried that migratory birds could bring it here, possibly this year.

Overseas, the disease has spread to people who have been in close contact with infected birds. But what is really worrying scientists is the possibility that the strain could mutate to a form that could easily pass from person to person. A bird flu pandemic could fly around the world in weeks or months, killing tens of millions.

RISKS ARE HIGH FOR CHICKEN INDUSTRY

In the United States, chickens are raised in houses and protected from outside carriers of flu, such as migratory birds.

The H5N1 strain is dangerous to chickens and can quickly wipe out entire flocks. That would cause economic hardship for the producer as well as his neighbors, because the host flock as well as surrounding ones would have to be destroyed, poultry industry officials said.

As a result, farmers here are vigilant in fighting a disease that is not here yet.

In addition to the trays of disinfectants outside the chicken houses, cans of Lysol disinfectant are in the Koontz house and in farm vehicles to spray shoes and clothes when the two men return from off-farm errands.

“If you lost a house of birds you would not get paid,” said John Koontz. “You would end up losing everything you had in it.”

Koontz’s farm raises chickens for Pilgrim’s Pride Corp., the second-largest U.S. chicken producer. The farm produces about 400,000 chickens a year, which are processed into meat for restaurants, supermarkets, and export.

The farm also has beef cattle and crops, but the chickens are “the backbone of the operation,” said Koontz.

BIOSECURITY HAS BEEN PRACTICED FOR YEARS

Biosecurity measures have been in place on U.S. poultry farms for years because mild strains of bird flu have occurred here.

“Even with low-pathogenic (flu), we would put all four houses down” or destroy all the chickens on the farm, said Jeff Bushong, Pilgrim’s Pride’s production manager for Virginia, referring to the Koontz operation.

Then there is the downtime.

“You would have to clean and disinfect to our and the government’s standards. Then the government would come in and make a final inspection. It is usually six to eight weeks,” said Bushong.

An outbreak of H5N1 would also likely hurt chicken exports, an important revenue-producer for the industry.

The United States exports about 15 percent of its chicken meat, nearly all dark-meat portions, such as leg quarters and wings which are popular overseas. An outbreak of the dangerous flu would likely prompt export customers to ban chicken from the infected region.

Industry sources are seeking to reassure consumers that should a case occur here, cooking chicken will kill the virus.

However, in response to the H5N1 outbreaks overseas, the National Chicken Council implemented a plan in which all U.S. chicken flocks will be tested for the flu.

“We started it in January. It is in full swing. You cannot send the birds to the processor without a clean test,” said Richard Lobb, NCC spokesman. “We already had the testing, but we knew we had to do something more serious.”

Bookish Britain overtakes America as top publisher

By Jeffrey Goldfarb

LONDON (Reuters) – Readers on both sides of the Atlantic
Ocean made bestsellers last year of “The Da Vinci Code” and the
latest Harry Potter adventure, but British publishers for only
the second time in 20 years churned out more new book choices
than their American counterparts.

U.S. output dropped for the first time since 1999 while the
number of British titles surged 28 percent, according to new
data from research firm Bowker.

Britain, with one-fifth the population of the United
States, has long been the world’s largest publisher of new
books per capita in any language, but a steep decline in U.S.
publication of general adult fiction and children’s books
helped boost the UK’s total volume to the top English-language
spot.

UK publishers issued 206,000 new books in 2005 compared
with 172,000 in the United States, which saw an 18 percent drop
in production, according to the New Providence, New
Jersey-based firm’s preliminary figures.

The volume of new books has been steadily increasing since
the mid-1980s as the popularity of superstores required more
titles to fill their shelves, and then later the advent of
online retailers made greater choice even easier to supply.

The number of annual new titles from U.S. publishers has
increased 51 percent since 1995, but the growth may have hit a
peak.

“Common sense will tell you that when you produce 200,000
new products — more than any other industry — the market
can’t digest all of them,” Andrew Grabois, a Bowker consultant
who compiled the data, said on Wednesday.

“It’s not because it’s physically too many, but how do
people become aware of all of them?”

Bowker expects that American publishers will remain
cautious this year, as well.

“The price of paper has already gone up twice this year,
and publishers, especially the small ones, will have to think
very carefully about what to publish,” Bowker’s chief operating
officer Gary Aiello said.

The United States previously had published more books than
Britain every year for the past 20 years, except in 2001,
Grabois said.

“The question is, will British publishers face a similar
market correction, or have they figured out how fewer
publishers can publish more books for even fewer readers?” he
said.

The U.S. output last year was the country’s second highest
total, after the record set in 2004. It was the 10th downturn
in the last 50 years, Bowker said.

Bowker’s Books in Print data base represents figures from
83,000 U.S. publishers. Grabois said he obtained the UK data
from Nielsen BookScan.

Sontra Medical Introduces Generation 2.0 SonoPrep(R) Skin Permeation Device

FRANKLIN, Mass., May 9 /PRNewswire-FirstCall/ — Sontra Medical Corporation announced today that it has introduced its 2nd Generation SonoPrep(R) skin permeation device for continuous transdermal glucose monitoring and topical lidocaine delivery. The 2nd Generation SonoPrep device incorporates several new features suggested by current SonoPrep customers. It is more portable and ergonomically friendly with improved features to provide clinician ease of use and patient comfort. New to the 2nd Generation system is a digital display that monitors system and patient treatment status. Also new is a removable battery that allows customers to recharge backup batteries for heavy use conditions. “We are pleased to launch the new SonoPrep device following a rigorous process of design, development and validation,” stated Scott Kellogg, V.P. of Research and Development. “Based on input we have received, we designed a more robust device that is simpler to use and less expensive to manufacture.”

The SonoPrep ultrasonic skin permeation employs low frequency ultrasound to penetrate the skin’s outermost layer, the stratum corneum. This simple and fast (average 15 second) treatment creates an imperceptible window through the skin that enables molecules to pass through with 100 times greater efficiency than intact skin. The SonoPrep ultrasonic skin permeation device makes the skin permeable for up to twenty four hours for continuous non invasive diagnostics such as glucose monitoring and transdermal drug delivery.

About Sontra Medical Corporation (http://www.sontra.com/)

Sontra Medical Corporation is a technology leader in transdermal science. Sontra’s SonoPrep ultrasound-mediated skin permeation technology combined with technical competencies in transdermal drug formulation, delivery systems and biosensors is creating a new paradigm in transdermal drug delivery and diagnosis. The SonoPrep technology is being developed for several billion dollar market opportunities, including continuous glucose monitoring and the transdermal delivery of large molecule drugs and vaccines. Sontra is currently marketing the SonoPrep device and procedure tray for use with topical lidocaine to achieve rapid (within five minutes) skin anesthesia.

   Contact:    Sean Moran, Sontra Medical CFO    508-530-0334   

SonoPrep is a registered trademark of Sontra Medical Corporation. All other company, product or service names mentioned herein are the trademarks or registered trademarks of their respective owners.

This press release contains forward-looking statements, which address a variety of subjects including, for example, the expected technological advances and availability of the second-generation SonoPrep device, the expected benefits and efficacy of the SonoPrep device in connection with diagnostics, vaccine delivery, glucose monitoring and transdermal drug delivery, Sontra’s expected ability to develop, market and sell products based on its technology; the expected market opportunities, distribution and market acceptance of the SonoPrep device and technology, and Sontra’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. Such statements are based on our current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The following important factors and uncertainties, among others, could cause actual results to differ materially from those described in these forward-looking statements: our technology is new and we may experience adverse results in research and development efforts, product development, clinical trials, product evaluations, commercialization efforts, product distribution and market acceptance; markets for our products may develop slower than expected, or not at all; our sales cycle is lengthy and we are still developing sales and marketing strategies which may or may not prove effective; the SonoPrep device may not prove effective in connection with diagnostics, vaccine delivery, glucose monitoring and/or transdermal drug delivery; we may experience difficulties or delays in obtaining regulatory approvals to market products resulting from development efforts or difficulties or delays associated with sources of regulatory-approved transdermal drugs and vaccines; failure to obtain and maintain patent protection for discoveries or commercial limitations imposed by patents owned or controlled by third parties would have an adverse effect on us; we depend upon strategic partners and third-party distributors to develop, commercialize, market and sell products based on our work; and we require substantial additional funding to conduct research and development and to expand commercialization, distribution and marketing activities. For detailed information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to Sontra’s filings with the Securities and Exchange Commission, including Sontra’s most recent Quarterly Report on Form 10-QSB. Forward-looking statements represent management’s current expectations and are inherently uncertain. We do not undertake any obligation to update forward-looking statements made by us.

Sontra Medical Corporation

CONTACT: Sean Moran, CFO of Sontra Medical, +1-508-530-0334

Web site: http://www.sontra.com/

West Siphons Nurses from Third World to Meet Shortage

By Andrew Stern

CHICAGO — The Filipino teachers who trained Fe Sunga to be a nurse fined her $1 each time she was caught speaking her native tongue rather than English.

The Tagalog speaker needed to master English because she and her classmates were destined for better-paying jobs in the United States. They were part of the initial wave in a flood of foreign-educated nurses emigrating to meet an acute nursing shortage in the West that promises to worsen as populations age.

Sunga, a registered nurse who came to the United States from Manila in 1972, took part in a rally marking “nurses week” in Chicago recently. After three decades, she would not consider returning to her native country. “No way. The salaries there are so cheap, maybe $200 a month,” she said.

Nurses have become an essential import in what the World Health Organization and other critics have called an insidious “brain drain” of health care workers from developing nations to wealthier countries, where nursing jobs go unfilled because of an aging workforce and a shortage of nursing school graduates.

“Around the world the nurse is becoming a commodity to be traded among nations, and firms are lining up to become part of the profit that occurs in this exchange,” said Peter Bruehaus of Vanderbilt University School of Nursing in Nashville, Tennessee.

A global industry of nurse recruiters and nursing schools has emerged in developing countries to fill the job openings in the West, though some have unsavory reputations, experts said.

A less-publicized undercurrent in the U.S. debate over immigration is whether to expand or lift caps on prospective immigrants with special in-demand skills such as nurses and computer engineers.

In general, foreign-trained nurses who meet skills and language criteria bypass the years-long backlog faced by most hopeful immigrants because of the U.S.-declared nursing shortage.

Bruehaus estimated the current U.S. nurse vacancy rate at 9 percent, among more than 2 million nursing jobs, and U.S. projections anticipate a shortage of 800,000 nurses by 2050.

In the Philippines, thousands of doctors train to become nurses to qualify for openings in the West; South Korea recently pledged 10,000 nurses over the next five years to bolster New York hospital staffs; and African and Caribbean countries with precarious health care systems have seen their nurses leave for the United States, Europe and Australia.

The Philippines long ago became a government-supported nurses training ground, and expatriate Filipino health workers remit nearly $11 billion a year back home.

Meanwhile, many poor outside of Manila die without seeing a health care worker, and health care crises plague the poor in India, China, African and Caribbean nations that lose nurses to wealthier countries.

AFRICA SUFFERS

Africa has one-quarter of the world’s burden of diseases, but just 3 percent of the world’s health care workers, WHO says. In Ethiopia, for instance, there are 21 nurses per 100,000 people compared to 900 nurses per 100,000 Americans.

Beth Delarama, another nurse trained in the Philippines who immigrated in 1980 and lives in the Chicago area, said salaries are not the only factor. “It’s not the money, it’s the conditions. The quality of care here is much better,” she said.

Newcomers from Thailand, South Korea, India, Nigeria, Jamaica and elsewhere rarely say they plan to return to apply their nursing skills at home, nurses said in interviews.

At Advocate Christ Hospital in Chicago, keeping and recruiting nurses is a priority, executives said.

“We are right now in the process of working with a group of nurses from the Philippines,” said chief nursing executive Darcie Brazel.

“It’s not something I’m particularly crazy about doing because I feel like, boy, it’s not being a good global community citizen. Those countries need their nurses as well. But a lot of (hospitals) are looking at overseas recruiting.”

During past nursing shortages, Bruehaus said a few thousand foreign-trained nurses would fill U.S. job openings in a given year, but 2001 saw a spike to 40,000 nurses from overseas that set a trend that shows few signs of abating.

“The future of the labor market in nursing is more older nurses and more foreign-born nurses. Those are the two groups growing the fastest at an annual rate of about 15 percent each — with the exception of 2005,” Bruehaus said.

The number of foreign-educated nurses dropped unexpectedly last year, though other experts traced it to a temporary crackdown on work visas.

Over the past two years, the number of working American-trained nurses declined, which may signal the anticipated retirement — some for the second time — of an aging generation of nurses. The 2.2 million working U.S. nurses average 47 years old.

Tens of thousands of older nurses returned to the profession in the 1990s as pay and prestige were restored after a period when their ranks shrank due to hospital layoffs related to managed care, coupled with poor working conditions, poor pay and a perceived lack of respect.

Meanwhile, the aging faculty at U.S. nursing schools and a shortage of space have thinned the nurses pipeline, with schools rejecting as many as 150,000 qualified candidates.

Starting yearly salaries at Advocate Christ Hospital now start at more than $51,000, with some nurses earning $100,000 or more.

Statin therapy sub par in stroke patients: study

NEW YORK (Reuters Health) – Only about half of individuals
who suffer a stroke and have elevated levels of harmful LDL
cholesterol are prescribed a statin, and among those who are
taking a statin, fewer than half meet recommended lipid goals,
according to results of a recent study.

Dr. Bruce Ovbiagele, from the University of California Los
Angeles School of Medicine, and colleagues evaluated data from
769 patients who had experienced an ischemic stroke — the type
of stroke caused by a blood clot in the brain that cuts off the
oxygen supply. These patients, whose average age was 69 years,
were deemed to be at high risk of heart disease in the future.

According to current guidelines, an LDL cholesterol level
of 130 mg/dL or higher should trigger initiation of statin
therapy. The goal of statin therapy is a LDL level of 100 mg/dL
or lower.

At baseline, 262 (34 percent) of high-risk stroke patients
had LDL cholesterol of 130 mg/dL or higher. Of these, 47
percent were not on statin therapy.

Among those who were on statin therapy, only 42 percent met
the treatment goal of LDL less than 100 mg/dL.

Writing in the journal Neurology, Ovbiagele and colleagues
say their data suggest that adherence to guidelines for statin
therapy “remains inadequate.”

“This is of concern,” they write, “since patients at high
risk for initial or recurrent coronary heart disease events
constitute the population most likely to benefit from
comprehensive risk factor management.”

SOURCE: Neurology, April 25, 2006.

Tap Water May Raise Bladder Cancer Risk: Study

NEW YORK (Reuters Health) – Pooled data from six case-control studies suggest that higher consumption of tap water-based drinks may slightly increase the risk of bladder cancer among men.

The increased risk of bladder cancer with tap water consumption was “consistently found in all six studies, making chance an unlikely explanation,” write investigators in the International Journal of Cancer.

They caution, however, that for now, the study finding that tap water “is associated with a slight increased risk of bladder cancer” does not readily translate into public health recommendations.

The results are based on 2,749 bladder cancer cases and 5,150 cancer-free controls. Most of the subjects resided in the US, Canada or Finland, with data from subjects in France and Italy also included.

The investigators observed that the risk of bladder cancer was 50 percent higher in men who drank more than 2.0 liters of tap water per day compared with those who drank 0.5 liters or less of tap water per day. Results among women were less consistent.

Coffee made up, on average, about one third of the tap water intake and heavy coffee consumption, defined as more than 5 cups per day, increased bladder cancer risk, especially among men who smoked.

However, consumption of tap water excluding coffee was also associated with an increased risk of bladder cancer.

Drinking fluids other than tap water was not associated with bladder cancer risk, reports the study team led by Dr. Christina M. Villanueva from Institut Municipal d’Investigacio Medica in Barcelona, Spain.

The association between bladder cancer and tap water consumption, but not with non-tap water fluids, suggest to investigators that the increased risk may be related to the cancer-causing contaminants in tap water, such as disinfection by-products.

Disinfection by-products are chemicals generated through reactions of disinfectants (such as chlorine) with organic matter naturally occurring in water. Trihalomethanes are usually the most prevalent by-products of chlorination.

However, in the current study, the increased risk of bladder cancer among those who drink large amounts of tap water was independent of trihalomethane exposure.

SOURCE: International Journal of Cancer, April 15, 2006.

PCA3Plus(TM) the Next Generation Genetic Test for Prostate Cancer Risk: Exclusively From Bostwick Laboratories, Inc.

RICHMOND, Va., May 4 /PRNewswire/ — Bostwick Laboratories, Inc. announces the immediate availability of PCA3Plus(TM), a urine-based genetic test for prostate cancer risk, exclusively from Bostwick Laboratories, Inc.

PCA3Plus(TM) detects PCA3, a specific gene that is highly expressed in prostate cancer. No other human tissues express PCA3.

“We are pleased to be the first to provide the innovative PCA3Plus(TM) test for men at risk for prostate cancer. This test is the second generation of the hugely successful uPM3(TM) test, the first genetic test for prostate cancer risk available exclusively by Bostwick Laboratories, Inc. since 2004. PCA3Plus(TM) uses technology that provides even greater reproducibility than uPM3(TM),” said David G. Bostwick, MD, MBA, Chief Executive Officer and Chief Medical Officer.

PCA3Plus(TM) tests for prostate cancer cells that are shed into the urine. The urine sample is sent to Bostwick Laboratories, Inc. to be tested for genetic expression of the PCA3 gene. If the sample is positive for PCA3, then the patient has a very high likelihood of having prostatic cancer.

PCA3Plus(TM), validated by Bostwick Laboratories, Inc., predicts prostate cancer with a sensitivity of 91%.

Bostwick Laboratories, Inc. is an international reference laboratory that specializes in state-of-the-art testing. It focuses on urologic diseases such as prostate cancer.

PCA3Plus(TM) has not been cleared or approved by the FDA, and is based upon reagents manufactured by Gen-Probe (San Diego, California). PCA3Plus(TM) is a trademark of Bostwick Laboratories, Inc. uPM3(TM) is a trademark of DiagnoCure (Quebec City, Quebec, Canada).

    For More Information, Contact:    Holly Moloney, Marketing Specialist    Bostwick Laboratories, Inc.    804-967-9225 (voice)    804-545-9751 (fax)    [email protected]  

Bostwick Laboratories, Inc.

CONTACT: Holly Moloney, Marketing Specialist of Bostwick Laboratories,Inc., +1-804-967-9225, fax: +1-804-545-9751, [email protected]

Web site: http://www.bostwicklaboratories.com/

Bile build-up in pregnancy may harm baby’s lungs

By Will Boggs, MD

NEW YORK (Reuters Health) – Pregnant women who develop a
build-up of bile in the liver, a condition called intrahepatic
cholestasis of pregnancy (ICP), have babies with an increased
risk of developing respiratory distress syndrome, a potentially
fatal disease that occurs when the tiny air sacs of the lungs
collapse, according to a report in the journal Pediatrics.

ICP, the result of liver malfunction during pregnancy,
causes severe itching and, in some cases, jaundice. The
condition typically resolves after delivery, but it usually
recurs in any subsequent pregnancies.

“Neonatologists should give particular attention during the
first hours of life to these babies, monitoring respiratory
function if they are delivered before term or near term (even
at 37 – 38 weeks of gestation),” Dr. Enrico Zecca from Catholic
University of the Sacred Heart, Rome, told Reuters Health.

Zecca and colleagues investigated the rate of neonatal
respiratory distress syndrome after pregnancies complicated by
ICP and measured bile levels in the affected mothers and their
infants.

The rate of respiratory distress syndrome was about twice
as high in infants of mothers with ICP — 29 percent — as in
infants of mothers without ICP — 14 percent, the authors
report. Male gender was also significantly associated with the
occurrence of respiratory distress syndrome, the results
indicate.

Bile levels of mothers with ICP who delivered healthy
infants did not differ significantly from those of mothers who
delivered infants that developed respiratory distress syndrome,
the researchers note. Similarly, infants with respiratory
distress syndrome had bile levels that were similar to those of
healthy infants.

“Babies from mothers with ICP have a higher risk to develop
neonatal respiratory distress syndrome,” Zecca concluded.
“Obstetricians should take this into account when planning a
preterm delivery in ICP pregnancies, and neonatologists should
have particular clinical attention during the first hours of
life.”

SOURCE: Pediatrics, May 2006.