SAN DIEGO, June 17, 2008 (PRIME NEWSWIRE) — Skylight Healthcare Systems(r) and Interactive Care Network (ICN) announced today that five leading hospitals are providing their hospital discharge information and planning resource for post-hospital care. Delivered to patients and their families’ right at the bedside, this resource provides comprehensive information on over 165,000 post-hospital services. As the first interactive discharge planning tool of its kind, early-adopting hospitals have shown increases in discharge process improvements and patient satisfaction. “Our ability to engage patients and family members in the hospital discharge process through the Skylight ACCESS System is simplifying communication efforts for hospital staff while empowering patients to get more involved in their own healthcare decisions,” said Andy Figallo, Co-Founder of ICN. With an additional ten hospitals scheduled to “go-live” this year, the hospitals offering this application includes:

   * Banner Estrella Medical Center, Phoenix, AZ  * Aurora Sinai Medical Center, Milwaukee, WI  * Adventist Bolingbrook Medical Center, Bolingbrook, IL  * Dr. P. Phillips Hospital, Orlando, FL  * Mercy San Juan Medical Center, Sacramento, CA 

Skylight and ICN were the first companies to provide an automated discharge resource designed specifically for patients, families, and healthcare professionals. This interactive tool enables all parties the ability to work together to successfully determine the patient’s care options after the hospital stay. The Skylight/ICN offering provides select choices at every level of post-discharge services from inpatient nursing and rehabilitation services to outpatient and home care providers including hospice, mental health, durable medical equipment and transportation services.

“Fundamental to patient satisfaction and loyalty, we believe that our integrated discharge planning tool can help ease the strain on patients and their families as they navigate their care choices when they go home,” said David Schofield, President and CEO of Skylight. “The fact that many of our hospital clients are quickly adopting this unique service is a testament of their commitment to providing their patients a faster and more effective discharge process.”

About Skylight Health Systems

Skylight Healthcare Systems is the industry pioneer in interactive patient care technology. With patient communication as the cornerstone of a safe, comfortable and clinically optimal hospital experience, the Skylight ACCESS(r) Interactive Patient System encourages patient and family to actively participate in their health care, improves communication between staff and patient/family members, and can provide a faster recovery and smoother discharge plan. Skylight’s vision is to provide hospitals with a robust tool which will allow them to greatly enhance interactive communication along the entire patient care continuum. With nearly 12,000 installable locations under contract, leading hospital administrators have confidently selected Skylight Healthcare Systems as the proven choice for their interactive patient care technology. Skylight Healthcare Systems is headquartered in San Diego, California. For more information about Skylight Healthcare Systems, please visit: www.skylight.com.

The Skylight Healthcare Systems logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=4652

About Interactive Care Network

The Interactive Care Network is comprised of health care professionals with more than 75 years of combined experience in the nursing and rehabilitation industry. ICN provides up to date, accurate information for over 165,000 facilities and post hospital care services directly to the patient’s room. Their partnerships have established ICN as the premier interactive resource for extended care needs. Our Mission is to ease the decision making process for hospital patients and families during their transition toward recovery. This is achieved by providing participating hospitals with an interactive search tool of post hospital care providers that is quick, simple, and tailored to meet the patient’s needs. To see an online demo of the integrated solution, please visit http://www.interactivecarenetwork.com/tv-search.html.

This news release was distributed by PrimeNewswire, www.primenewswire.com

 CONTACT:  Skylight Health Systems           Darrell Atkin, Director of Marketing           858.523.3750           [email protected]            Interactive Care Network           Andrew Figallo, Co-founder           614.942.0240           [email protected] 

By Julius A. Karash, The Kansas City Star, Mo.

Jun. 17–A $2.1 million urgent-care center is being built at the I-470 Business and Technology Center in Lee’s Summit.

Emergent Care Plus will be the first venture of an emergency practice formed last year by physicians Anne Morgan, Chad Surrat, Kyla Kutch and Theron Barr. The 7,000-square-foot stand-alone facility is expected to open in October.

Urgent-care physicians typically treat minor illnesses and injuries of a nonemergency nature, such as sprains, minor fractures and upper-respiratory infections.

Morgan said Emergent Care Plus also would treat complex lacerations, administer intravenous medications, and provide radiology and laboratory services. It initially will operate from 8 a.m. to 8 p.m. seven days a week.

“We will function almost to the level of an emergency room,” Morgan said. “However, the co-pay will be at an urgent-care level.”

Patients will not have to make appointments but will be able to go online to alert staff members that they are on the way. Patients also will be able to fill out personal and insurance information electronically before arriving.

The new center initially will be staffed by nine physicians, with most of the care being provided by the four physician partners, Morgan said.

She said the center would not attempt to compete with primary-care doctors but rather would serve as an adjunct to primary-care physician offices when immediate treatment was not available.

“We will be able to communicate electronically with the primary-care physician to outline the treatment we provided,” Morgan said.

The urgent-care center will be the first medical building in the I-470 Business and Technology Center’s business section, near Strother Road and Interstate 470, said Kenneth Wasserman, senior vice president of CEAH Realtors, who brokered the land sale to the four doctors.

“We expect to get several other medical service facilities in the business park,” he said.

To reach Julius A. Karash, call 816-234-4918 or send e-mail to [email protected].

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To see more of The Kansas City Star, or to subscribe to the newspaper, go to http://www.kansascity.com.

Copyright (c) 2008, The Kansas City Star, Mo.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

By Mary Jo Feldstein, St. Louis Post-Dispatch

Jun. 17–As part of an ongoing restructuring, SSM HealthCare-St. Louis on Monday dismissed 75 members of its management team, including all hospital chief operating officers and vice presidents. Another 25 employees in human resources, finance and other administrative functions were let go earlier this year.

A month after coming on board last year, Chief Executive Jim Sanger reorganized the hospital system into north and south geographic regions and by areas of patient care.

As this centralization occurred, top system leaders realized the hospitals needed more consistent practices to improve patient care and efficiency.

SSM hopes eliminating most top management positions at individual hospitals will reduce redundancy and help the transition. Sanger thinks fewer people making decisions will lead to more consistent decision-making.

“Right now, our hospitals compete with each one another and largely do things differently,” Sanger said in a memo to staff, physicians and hospitals’ boards on Monday. “Under this new structure, leaders from across our organization will work closely with staff to identify the best elements of each of our hospitals and then use those best practices to create more consistent, highly effective processes at each hospital.”

The plan will save money through economies of scale, said J. Stuart Bunderson, an associate professor at Washington University’s Olin School of Business.

“It could be a good thing,” Bunderson said. “Think of all you save, not only in terms of salaries but in office space and all that goes with that.”

The question, Bunderson said, is whether the hospitals are too varied to be managed centrally.

Bob Porter, executive vice president for strategy and business development, sees the changes as an opportunity for SSM’s hospitals to work more cooperatively than competitively.

“We had six different entities trying to do the best for that entity,” Porter said, referring to the system’s local hospitals. “We weren’t doing enough to maximize what’s best for the whole.”

This was Sanger’s goal when he announced the reorganization in December but Monday’s announcement refines its implementation.

Here’s how it will be structured: Each region will have a top leader and an executive vice president. In addition to heading up patient care for the respective region, each executive vice president will manage two system-wide segments — which include pharmacy and laboratory. Each also will oversee several smaller functions for the region.

“It sends a very strong message that this is one system, not lots of little fiefdoms,” Bunderson said. “At least in the short term there will be people who have loyalties and investments in the local facility who will be unhappy with that.”

Other changes are still to come. SSM is still working on reorganizing medical services. One possibility would have some hospitals specialize in specific complex conditions while preserving access to more basic treatments at all SSM facilities.

But Porter said he’s cautious about using the industry term “centers of excellence.” He thinks the end result will be less centralized. He sees the goal as hospitals coordinating and collaborating where it makes the most sense clinically and financially.

The systemwide cuts are separate from about 45 jobs cut at St. Mary’s Health Center in Richmond Heights, announced Monday, and 25 positions at DePaul Health Center in Bridgeton that were made earlier this year.

SSM attributed the cuts at those hospitals to lower-than-expected revenue.

[email protected]

314-340-8209

—–

To see more of the St. Louis Post-Dispatch, or to subscribe to the newspaper, go to http://www.stltoday.com.

Copyright (c) 2008, St. Louis Post-Dispatch

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

By Michael Amon, Newsday, Melville, N.Y.

Jun. 17–As lawmakers consider overhauling the state’s doctor discipline system, records show that New York — more than any other state — relies on medical investigations conducted elsewhere to punish physicians.

What’s more, among the 10 states with the most doctors, New York ranks ninth for punishing physicians through its own investigations, sanctioning 2.10 doctors per 1,000 in 2007. Florida, by contrast, disciplined 5.91 doctors per 1,000.

Of the 311 disciplinary actions taken by the New York Board for Professional Medical Conduct in 2007, 173, or 56 percent, did not stem from in-state probes but from “reciprocal actions” — sanctions taken against doctors punished first by other states. Called “piggybacking” by reform groups, these actions require minimal investigation and are rarely challenged by physicians.

“It becomes an issue of productivity,” said Arthur Levin, director of the Center for Medical Consumers in Manhattan. “When we want to look at how proactive New York is, all we know is that they’re very good at finding the bad doctors in other states but not necessarily here.”

Numbers may hinder effort

New York actually punished more doctors than any state but Illinois last year, but those figures include the piggybacked investigations. Patient advocates say the statistics make New York’s physician discipline board look deceptively aggressive and could hurt efforts to change the system, including Gov. David A. Paterson’s proposal now being considered by the legislature.

Claudia Hutton, a state Department of Health spokeswoman, said New York punishes fewer doctors on its own because under state law, investigators must prove at least two instances of negligence or wrongdoing — not one as in many other states. She also said staffing levels were stagnant at the Office of Professional Medical Conduct, which investigates cases for the Board for Professional Medical Conduct.

“We do the best we can with our staffing levels,” Hutton said, noting that OPMC received funding to hire 15 more investigators this year, bringing the total to 84. “I think you will see different numbers over the next few years.”

Hutton added that it’s important for the state to pursue actions against doctors sanctioned elsewhere. “We don’t want that physician returning here to practice,” Hutton said.

Paterson’s plan

Paterson’s bill would encourage more local probes by allowing the Office of Professional Medical Conduct to use malpractice histories to initiate cases. It also would make public the names of doctors charged with wrongdoing and make it easier to go after doctors who refuse to turn over records for probes. The law was proposed following criticism that OPMC and the Department of Health were too lenient with Dr. Harvey Finkelstein, the Long Island doctor accused of reusing syringes.

The proposal’s chances are unclear, legislative aides and advocates say. Legislative leaders and the governor’s representatives today will try to hammer out an agreement.

Taking a closer look

“When New York is touted as the state with the highest numbers, it makes it harder to make the case for reform,” said Blair Horner, legislative director of the New York Public Interest Research Group. “You have to look at the numbers a little harder.”

New York is not alone in pursuing out-of-state cases. Since 2003, when Dallas-based trade group the Federation of State Medical Boards began alerting states to sanctions of doctors with multiple licenses, reciprocal actions have risen 37 percent. The actions are universally praised for preventing bad doctors from jumping from state to state.

“You can’t be against reciprocal actions, they’re a good thing,” said David Swankin, president of the Citizens Advocacy Center in Washington, D.C. “The question is — what are they doing besides reciprocals?”

New York has long piggybacked on the work of other state’s doctor-disciplinary systems. Since 2004, 61 percent of its sanctions have been initiated in other states. From 1990 to 2006, New York, along with Pennsylvania and Hawaii, were the only states to punish more out-of-state doctors than in-state ones, according to the National Practitioners Data Bank.

One explanation: New York’s medical schools train about 15 percent of the nation’s doctors. They often keep a medical license here but practice — and get disciplined — somewhere else.

When a New York-licensed doctor is sanctioned elsewhere, the state moves quickly to restrict their practice here, Hutton said. Three full-time OPMC staff members and one part-timer are assigned to handle reciprocal actions.

Out-of-state probes easier

Disciplinary cases from other states are easier to process, Hutton said. They don’t have to be reinvestigated by New York staff. Instead, the out-of-state action is reviewed to ensure that it constituted misconduct under New York law. The doctor can challenge the findings, but most do not, Hutton said.

As for punishing fewer doctors than other big states, one reason may be that New York places hundreds of physicians with substance abuse problems into a monitoring system that is the nation’s most extensive. The roughly 1,400 doctors now in the system are required to get treatment and to allow doctors chosen by the state to track their progress, Hutton said. In other states, many of those doctors would have been disciplined.

“New York has a more progressive model, and frankly I believe in the long run it provides for better care for more patients,” said Dr. Michael Rosenberg, president of the Medical Society of the State of New York.

Staffing levels an issue

Finally, Hutton blamed staffing levels, saying the number of investigators had remained flat at around 69 for several years, even as complaints surged from 6,275 in 2003 to more than 7,300 in 2005 — second only to Florida. Each complaint, she said, must be investigated, taking an average of 230 days.

Even without the staff increase this year, though, New York had the second-largest investigative team in the country, behind only California.

Other states appear more productive with smaller staffs. The State Medical Board of Ohio regulates 40,000 doctors — half as many as New York. But with 21 investigators, it disciplined 160 physicians in locally generated cases last year, compared with 138 in New York. North Carolina, with 10 investigators, disciplined 129 doctors on its own initiative last year, while cutting in half the number of reciprocal actions it took from 83 in 2006 to 41.

North Carolina Medical Board spokeswoman Jean Fisher Brinkley said questions had been raised about whether reciprocal actions “were the best use of resources.” With more locally generated cases, she said, “the relevance to people in our state was greater.”

BEHIND NEW YORK’S

DOCTOR DISCIPLINE SYSTEM

Much more than other states with a lot of doctors, New York issues sanctions that stem from other states’ investigations — cases known as “reciprocal” or piggyback actions.

Critics say it exaggerates the state’s doctor discipline statistics and hurts chances for toughening the system.

State says it pursues reciprocal actions to keep bad doctors from returning to New York.

State generates fewer in-state doctor-discipline cases than other states. One reason: New York must prove two bad acts by doctors here before punishment kicks in — many other states require just one.

THE PROCESS

The New York physician discipline process can begin several ways.

The Office of Professional Medical Conduct can file charges when it learns that a doctor has been disciplined in another state or convicted of a crime. The charges are reviewed to ensure that they constitute misconduct under the state’s Public Health Law.

Then doctors are offered a settlement agreement but have the right to a hearing before the Board of Professional Medical Conduct. Most waive the hearing and settle, officials said.

Doctors can also be investigated when a complaint is filed by a member of the public. Each complaint is checked by one of 84 investigators.

Most of the more than 7,000 complaints filed each year are dismissed but they can lead to formal charges. After being charged, doctors are offered a chance to settle, or plead guilty. They also have the right to a hearing before a three-member panel made up of two doctors and a non-doctor. The burden of proof is preponderance of the evidence.

HOW THE STATES COMPARE

New York California Texas Florida Michigan

Total actions 311 310 311 281 97

Locally generated actions 138 256 306 251 70

Rate per 1,000 in-state doctors 2.10% 2.64% 6.27% 5.91% 2.52%

Investigators 69 100 26 47 N/A

Doctors 65,644 97,141 48,796 42,503 27,785

Complaints 7,358 7,259 6,923 9,950 N/A

—–

To see more of Newsday, or to subscribe to the newspaper, go to http://www.newsday.com

Copyright (c) 2008, Newsday, Melville, N.Y.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

LSE:SOR,

NORWALK, Conn., June 17 /PRNewswire/ — More than half of people 50 and older are at risk for osteoporosis, the most common bone disease, according to the National Osteoporosis Foundation. It is essential to make bone health a priority because bone loss occurs without symptoms.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080415/NYTUFNS1 )

“Osteoporosis, or the ‘silent disease’ as it is often called, is of particular concern to women, who are more susceptible to it,” said Peggy Fleming, Olympic figure skating champion and HealthSaver spokesperson.

Bones protect the heart, lungs, brain and muscles, and store calcium, an essential nutrient. Without strong bones, the risk of osteoporosis and broken bones increases.

“Luckily it is never too late to prevent or treat osteoporosis,” said Brad Eggleston, vice president of HealthSaver.

Be sure you get enough calcium in your diet and stay physically active. These are two of the most important things you can do to keep both your body and bones at optimal health.

Calcium is Essential

— If you do not consume enough calcium, your body will take the calcium from your bones and use it to maintain healthy nerves, muscles and blood levels. This loss of calcium causes your bone structure to deteriorate and become fragile.

— Since bone is living tissue that constantly renews itself, maintaining strong bones is of utmost importance, especially in our early years. After age 30, bone breakdown exceeds bone formation, causing us to reach our peak bone mass. It is therefore necessary, by age 30, to have accumulated enough calcium in our bones to maintain calcium requirements for both our skeletal structure and our body.

— A study conducted by the U.S. Department of Agriculture found that 78 percent of women and 55 percent of men over the age of 20 do not meet the recommended calcium intake. Adults aged 19 to 50 need 1,000 mg of calcium per day, and adults older than 50 need 1,200 mg.

— Meet your daily calcium requirement with an English muffin and one cup of low-fat fruit yogurt for breakfast; a baked potato with skim mozzarella cheese, a cup of broccoli and a cup of baked beans for lunch; and an orange and a handful of almonds as an afternoon snack. An 8-oz. glass of milk is also a quick way to drink nearly one-third of your day’s calcium requirements.

— You can also enrich your meals with calcium. For pancakes, use milk instead of water. Add non-fat powdered milk to casseroles and soups. Or sprinkle low-fat cheese on salads. And don’t forget about food labels. Aim for foods with at least 10 percent of the Daily Value (DV) of calcium per serving.

Risk Factors

— Factors that increase a person’s risk of developing osteoporosis include age, sex, family history, body size, inadequate calcium intake, lack of physical activity and certain lifestyle choices.

— As you grow older, your body develops bone less quickly. Weak bones, however, are not a natural part of aging.

— People with a family history of fractures tend to have reduced bone mass, according to the U.S. Department of Health. If broken bones are frequent in your family, take extra steps to ensure optimum bone health.

— Excessive alcohol consumption hinders the body’s ability to absorb calcium, resulting in reduced bone mass. Smoking also reduces the body’s ability to use calcium efficiently.

— People who weigh less than 127 pounds may have a higher risk of developing osteoporosis.

Ladies, Take Special Care

— Women are four times more likely to develop osteoporosis than men, due, in part, to menopause. Menopause reduces the production of the female hormone estrogen, which helps keep bones strong and intact. For several years after menopause, women lose bone up to four times faster than they did before. Women also have less bone tissue and lower bone mass than men.

— Women’s risk for hip fractures, the most destructive type of bone fracture, is equal to their risk of breast, ovarian and uterine cancer, according to the National Osteoporosis Foundation.

Use It or Lose It

— When you are physically active, your body receives a signal alerting your bones to become stronger. New cells are then added to strengthen bone. Therefore, if you do not exercise, your bones do not receive the message that they need to be strong.

— The U.S. Department of Health recommends 30 minutes of physical activity each day for adults, and 60 minutes for children.

— Weight-bearing exercises are best for preventing bone loss because bones become denser when called upon to work against gravity. Examples of weight-bearing activities include hiking, tennis and – if you prefer the gym – stair-climbing machines.

Vitamin D and Supplements

— Calcium isn’t the only element needed for healthy bones. Vitamin D is also necessary. Vitamin D helps the body absorb calcium by helping it enter the bloodstream.

— The main source of vitamin D is sunlight. Just 15 minutes per day is all you need. Your diet can also provide vitamin D.

— If you’re not consuming enough vitamin D or calcium, you may want to consider a dietary supplement. The most popular calcium supplements are calcium carbonate and calcium citrate. Look for “USP” on the label to ensure the supplement meets standards established by the U.S. Pharmacopeia.

— To get the most out of your calcium supplement, take in doses no larger than 500 mg. Also be careful not to take with iron supplements, as they may interfere with each other.

Talk to Your Doctor

— People who fracture a bone after the age of 50, and women older than 65, should be routinely screened for osteoporosis.

— Three out of four women age 45 – 75 have never spoken to their physician about osteoporosis, according to the Foundation for Osteoporosis Research & Education. Be proactive with your health. Discuss with your doctor your risk for bone disease, the need for a bone density test, your calcium and vitamin D intake and your medications.

— Your doctor may recommend a bone mineral density test to determine your bone health. This test is quick and painless, and can help determine the rate of bone loss, detect low bone density and confirm a diagnosis.

— Though osteoporosis does not have a cure, certain medications can stop or slow bone loss, and even help build new bone.

Osteoporosis prevention and treatment isn’t just about broken bones. It’s about sustaining a strong skeletal structure, preventing disability in your older years and keeping your body at optimum health.

HealthSaver, an emerging health care discount program, offers savings on prescriptions, vision care, complementary and alternative health care treatments, vitamins and supplements by mail and more than 1,500 fitness clubs nationwide, including select Bally Total Fitness, World Gym and Ladies Workout Express locations.

About HealthSaver

HealthSaver offers discounts of 20 percent on vision care, as well as discounts of 10 to 50 percent on prescriptions at participating pharmacies, 20 percent off complementary and alternative health care treatments and fitness club benefits. HealthSaver also offers discounts of 10 to 35 percent on dental care services at some 42,000 participating provider locations nationwide, including routine cleanings, X-rays, fillings, orthodontics, and even popular cosmetic dentistry procedures such as teeth whitening. Members can also save from 5 to 50 percent off vitamins and supplements by mail. Discounts are based upon reasonable and customary costs or manufacturers suggested retail price (MSRP) and are only available from participating providers. HealthSaver is not an insurance product or service. More information about HealthSaver is available online at http://www.healthsaver.com/ or toll free by calling 1-800-7HEALTH (1-800-743-2584). A one month trial membership in HealthSaver (http://www.healthsaver.com/ or 1-800-743-2584) costs $1 and can be canceled anytime during the trial period. Unless the member calls to cancel during the trial, membership will be extended automatically and billed to a credit card number at the $149.99 annual fee. Members may call toll free to cancel at any time and receive a refund of the unused portion of their current year’s fee. HealthSaver is offered by Affinion Group, a leader in the membership, insurance and loyalty marketing businesses, providing products and services that touch the lives of millions of Americans.

About Affinion Group, Inc.

As a global leader with nearly 35 years of experience, Affinion Group (http://www.affinion.com/) enhances the value of its partners’ customer relationships by developing and marketing valuable loyalty, membership, checking account, insurance and other compelling products and services. Leveraging its expertise in product development and targeted marketing, Affinion helps generate significant incremental revenue for more than 5,300 affinity partners worldwide, including many of the largest and most respected companies in financial services, retail, travel, and Internet commerce. Based in Norwalk, Conn., the company has approximately 3,300 employees throughout the United States and in 10 countries across Europe. Affinion holds the prestigious ISO 27001 certification for the highest information security practices, is PCI compliant and Cybertrust certified.

Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Peggy Fleming https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=57424

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20080415/NYTUFNS1AP Archive: http://photoarchive.ap.org/PRN Photo Desk, [email protected]

HealthSaver

CONTACT: Todd Smith, +1-615-764-2598, +1-615-202-7944 (Mobile), AndreaLindsley, +1-615-780-3315, +1-615-415-8886 (Mobile), for HealthSaver

Web site: http://www.healthsaver.com/

PURCHASE, N.Y., June 17 /PRNewswire-FirstCall/ — Nutrition 21, Inc. , a developer and marketer of nutritional supplements that help consumers manage blood sugar levels, improve cardiovascular health, enhance memory and address chronic joint pain, today introduced Skin Rejuvenation(TM) a new Iceland Health-branded product. Skin Rejuvenation is an Omega-3 formulation with nutrients and anti-oxidants in capsule form designed to reduce, at the cellular level, inflammation that causes facial wrinkles.

“We are pleased to introduce Iceland Health Skin Rejuvenation into our growing product portfolio,” said Mark Stenberg, president of Iceland Health, LLC, a wholly-owned subsidiary of Nutrition 21. “The skin care market is a large and growing opportunity. Iceland Health Skin Rejuvenation is formulated with our pharmaceutical grade Omega-3 and 16 nutrients, anti-oxidants and vitamins that increase skin density, protect the skin’s membranes, build connective tissue, and protect the skin from free radical damage. Skin Rejuvenation will help maintain the collagen that supports the skin and gives it resilience.”

Nutrition 21 will offer Iceland Health Skin Rejuvenation through its direct response marketing channel. The Company will support the product through targeted newspaper print ads in selected markets and will offer the product through the Iceland Health web site at http://www.icelandhealth.com/.

Mr. Stenberg concluded, “We believe this product can be an important part of a comprehensive program of skin care for men and women dedicated to looking their best and living healthier lives. This product continues the Nutrition 21 tradition of combining high quality science with ground-breaking technology to develop superior healthcare products.”

About Nutrition 21

Nutrition 21, Inc. , headquartered in Purchase, NY, is a nutritional bioscience company and the maker of chromium picolinate-based and omega-3 fish oil-based supplements with health benefits substantiated by clinical research. Nutrition 21 holds more than 30 patents for nutrition products and uses. Nutrition 21’s portfolio of health and wellness brands include: Chromax(R), Core4Life Advanced Memory Formula(TM), Diabetes Essentials(TM), Iceland Health(R) Maximum Strength Omega-3 and Iceland Health(R) Joint Relief. The company also manufactures private label supplements and ingredients for third parties. Nutrition 21 distributes its products nationally through more than 29,000 major food, drug and super center retailers as well as internationally. For more information please visit http://www.nutrition21.com/.

Safe Harbor Provision

This press release may contain certain forward-looking statements. The words “believe,””expect,””anticipate” and other similar expressions generally identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based largely on the Company’s current expectations and are subject to a number of risks and uncertainties, including without limitation: the effect of the expiration of patents; regulatory issues; uncertainty in the outcomes of clinical trials; changes in external market factors; changes in the Company’s business or growth strategy or an inability to execute its strategy due to changes in its industry or the economy generally; the emergence of new or growing competitors; various other competitive factors; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including its Form 10-K/A for the year ended June 30, 2007. Actual results could differ materially from the results referred to in the forward-looking statements. In light of these risks and uncertainties, there can be no assurance that the results referred to in the forward-looking statements contained in this press release will in fact occur. Additionally, the Company makes no commitment to disclose any revisions to forward-looking statements, or any facts, events or circumstances after the date hereof that may bear upon forward-looking statements.

   Contact: Nutrition 21, Inc.                 For Investor Inquiries:            Mark Stenberg                      Joe Diaz            President - Iceland Health, LLC    Lytham Partners, LLC            914-701-4500                       602-889-9700  

Nutrition 21, Inc.

CONTACT: Mark Stenberg, President of Iceland Health, LLC, +1-914-701-4500; or Joe Diaz of Lytham Partners, LLC, +1-602-889-9700

Web site: http://www.nutrition21.com/http://www.icelandhealth.com/

JERUSALEM and NEEDHAM, Massachusetts, June 17 /PRNewswire-FirstCall/ — Oridion Systems Ltd. – Significant findings from numerous medical research projects demonstrating the clinical benefit of end-tidal CO2 (EtCO2) monitoring using Microstream(R) capnography technology, were recently presented at medical congresses in the United States and Europe.

During Digestive Disease Week (DDW) in San Diego, California, Dr. Vargo, of the Cleveland Clinic, presented a blinded study that analyzed 122 randomized patients and showed that Microstream(R) capnography “significantly reduces the proportion of patients with hypoxemia, major hypoxemia, apnea and oxygen requirements during ERCP (Endoscopic Retrograde Cholangiopancreatography) and EUS (Endoscopic ultrasound).

Other studies describing the clinical value of Microstream(R) EtCO2 monitoring were presented during the European Resuscitation Council (ERC) in Ghent, Belgium and the European Society of Anesthesiology (ESA) in Copenhagen, Denmark. At ERC, two oral presentations were given and a Capnography Symposium took place with three distinguished clinicians and the clinical practice manager from London Ambulance Service. The four presentations showed the value of capnography in pre-hospital care (trauma, intubations, and ROSC). The Symposium was moderated by Prof. Pierre Carli, President Societe Francaise d’Anesthesie et de Reanimation (French Society of Anesthesia and Intensive Care).

Two medical presentations given at European Society of Anesthesia demonstrated the importance of capnography for non-intubated and intubated patients. In a study on the use of continuous non-invasive arterial CO2 estimation in spontaneously breathing patients after craniotomy, Dr. Wolter from France showed a good correlation between capnography and arterial blood gas analysis in sedated patients under regional anesthesia.

“These recent studies continue to confirm that patients are safer when their caregivers use Oridion Microstream(R) capnography technology,” stated Gerry Feldman, President of Oridion Capnography. “The results of these global research projects clearly demonstrate that capnography improves patient safety and should be included in hospital and pre-hospital ventilatory monitoring strategies.”

Oridion is the global leader of innovative capnography monitoring solutions helping to improve patient safety, and its Microstream(R) capnography technology has become the standard of care in ventilation monitoring.

A full list of these medical abstracts can be found on the Oridion website: http://www.oridion.com/global/english/clinical_solutions/overview/research.ht ml.

   Next financial reporting:   August 18, 2008 Results Q2 / Half Year 2008   November 10, 2008 Results Q3 / Nine Months 2008   About Oridion  

Oridion Systems Ltd. (http://www.oridion.com/) is a global medical device company specializing in patient safety monitoring. The Company operates through wholly owned subsidiaries in the United States, Europe, and Israel.

Oridion develops proprietary medical devices and patient interfaces, based on its patented Microstream(R) technologies, for the enhancement of patient safety through the monitoring of the carbon dioxide (CO2) in a patient’s breath. These products provide effective, proven airway management and are used in various clinical environments, including procedural sedation, pain management, operating rooms, critical care units, post-anesthesia care units, emergency medical services, transport, alternate care and other settings where patients’ ventilation may be compromised and at risk.

Certain statements made herein that are not historical are forward-looking. The words “estimate””project””intend””expect””believe” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, among others, our ability to maintain profits, the market demands for our Capnography products, our ability to focus our team on the Capnography business, changes in general economic and business conditions, inability to maintain market acceptance to the Company’s products, inability to timely develop and introduce new technologies, products and applications, rapid changes in the market for the Company’s products, loss of market share and pressure on prices resulting from competition, introduction of competing products by other companies, inability to manage growth and expansion, loss of key OEM partners, factors effecting OEM partners’ position in the market, inability to attract and retain qualified personnel, inability to protect the Company’s proprietary technology.

   For further information please contact:    Alan Adler, Chairman and Chief Executive Officer   Gerry Feldman, President   Walter Tabachnik, Chief Financial Officer   Elena Gerberg, Investor Relations    e-mail: [email protected]   website : http://www.oridion.com/   phone : +972-2-589-9159   address : Oridion Systems Ltd., P.O. Box 45025, 91450 Jerusalem, Israel  

Oridion Systems Ltd.

CONTACT: For further information please contact: Alan Adler, Chairmanand Chief Executive Officer, Gerry Feldman, President, Walter Tabachnik,Chief Financial Officer, Elena Gerberg, Investor Relations, e-mail:[email protected], phone : +972-2-589-9159, address : Oridion SystemsLtd., P.O. Box 45025, 91450 Jerusalem, Israel

By Gupta, Sanjeev

EXECUTIVE SUMMARY Today’s engineer-to-order and other project- based businesses are being tasked to deliver more projects faster but with fewer resources. To perform, they must no longer need to feel stymied by the limitations of traditional “politically correct” processes such as earned value management that hinder projects from being completed on time, within scope, and on budget.

An execution management method, based on the principles of Eliyahu Goldratt’s book, Critical Chain, keeps execution synchronized throughout the organization and allows resources to be concentrated on only a few projects at a time. It also provides a simpler, more effective way to assess the urgency of each task. As a result, managers receive early warning signals so that emerging issues are resolved before they threaten getting things done on time, not after the fact.

Project-based organizations (PBOs) have struggled with the challenge of managing projects and getting them done on time and on budget. Unfortunately, the problem remains unsolved, even after investing billions of dollars in techniques ranging from critical path method/project evaluation and review techniques (CPM/PERT) to earned value management (EVM) and in software ranging from enterprise resource planning (ERP) to project portfolio management (PPM).

EVM embodies all that is wrong with traditional approaches. It is supposed to measure project progress in an objective manner, combining the measurements of technical performance (i.e., accomplishment of planned work), schedule performance (i.e., behind/ ahead of schedule), and cost performance (i.e., under/over budget) within a single integrated method. EVM claims to provide an early warning of performance problems. EVM also promises to improve the definition of project scope, prevent scope creep, communicate objective progress to stakeholders, and keep the project team focused on achieving progress.

In reality, EVM is counterproductive. Although its goal – requiring organizations to provide accurate effort estimates in planning and achieve them in execution – sounds good, that’s about the only good in EVM. If such good planning and execution were the results of EVM, its projects would be on schedule and on budget. However, reality sings a different tune. EVM measurements ignore a simple fact: Projects are full of uncertainties:

* Customer requirements change.

* Technical problems are found.

* Additional work is discovered.

* Vendors do not deliver on time.

* The work materializes slower than expected.

* Approvals do not come in on time.

* Priorities change.

Moreover, as uncertainties multiply, plans go awry. Lacking a secure way to prioritize resources across multiple projects, people are constantly pulled from one project to fix other projects’ problems. Priorities become unclear and people start multitasking. The result is not surprising; delays and firefighting break out all over.

Experienced managers intuitively know the devastating effects of uncertainties and contention for resources. Therefore, they respond by starting their work packets as soon as possible to have any hope of meeting their commitments. Unfortunately, when too much work is in execution, it only increases contention for resources.

Even though this scenario is repeated from project to project on a consistent basis, organizations always seem surprised by the ensuing schedule slips on their present-day projects. Again and again, they shift their focus from that of delivering projects to that of explaining delays.

Safeties can be sins

Add to these uncertainties and resource contentions another reality – the need to hold people accountable. Anybody who has ever managed projects knows that this is the gordian knot of project management, a problem that may be intractable. Nonetheless, traditional methods, such as EVM, assume a perfect world, one where events can be precisely planned and everyone knows exactly when tasks will get done.

Simple, standalone projects can accommodate uncertainties by adding a little safety, a buffer, in each task. However, in more complex projects with resources shared across projects, small uncertainties multiply as delays on one begin to impact others as they contend for the same resources. As a result, the required safeties become immense, forcing many tasks to take way too long. That’s why creating precise schedules for people and tasks is actually a recipe for disaster in multiproject situations. Yet this is what traditional project management methods, such as EVM, are forcing people to do.

Under EVM, if you’re a manager who wants to be on target, you need to add a lot of safety into your estimates. The results? Student syndrome and the law of Parkinson! People will either wait until the last possible moment before starting the task, eating up safeties, or work will be expanded to fill the time available, meaning a lot of time is wasted doing things that just aren’t needed. Bottom line: Projects will take too long and cost too much.

EVM measurements also encourage the execution of easy tasks that do not lie on the critical path, rather than the ones that are critical but difficult. It’s human nature. Prioritize the five most important things you need to do today. If No. 3 is the easiest, don’t you tend to do it first because your next monthly EVM review will shine? In project execution, this tendency to “earn value” also leads to quality disasters because it tempts project participants to do tasks out of sequence.

Over and over, project participants are forced to multitask in order to catch up. People are forced to open and work on new tasks instead of solving problems on their current ones. As these open tasks begin to pile up, managerial and problem-solving bottlenecks begin to form and bog the entire project down. In fact, projects managed using EVM actually “earn value” and show progress comfortably in the beginning. Then, oops, there are no more easy tasks and everything comes to a screeching halt. And there you are again. The project becomes overdue and goes over budget, just like the projects before them and the ones to come.

Nonetheless and with the insanity of the same thing being done over and over with the same bad results, most organizations continue to bow to the “politically and corporately” correct gods of EVM/ ERP, planning, collaboration, communication, and the other management trends of the day.

Management news isn’t all bleak

Adding people and processes to track and report delays without changing the rules of managing execution will not help, nor will making managers more skilled at fighting fires and negotiating resources for their projects. To obtain the required leap in performance, old rules for running projects must be abandoned, including EVM.

The positive news is that effective rules for managing project execution, based on Eliyahu Goldratt’s theory of critical chain, have now been proven in a wide range of environments. Execution management is the process that uses these rules and keeps resources across the entire organization synchronized and focused around a uniform set of task priorities.

Following are the new rules for managing project execution:

1. Don’t start projects as soon as possible. Contrary to conventional thinking, starting all work as soon as possible is counterproductive. It creates bottlenecks, gives rise to confusion about priorities, and induces multitasking. Instead, successful execution begins by acknowledging that the most heavily loaded resources (constraints) determine how many projects can be done. Releasing projects faster than what the constraints can handle is useless.

Limit the number of projects in execution, based on capacity constraints, and sequence and release projects into execution based on the availability of those constraints.

2. Don’t turn task estimates into commitments. Contrary to conventional practice, turning task estimates into commitments only prolongs projects without increasing the chances of delivering them on time. When people are held accountable for task level estimates, they build in safeties to protect themselves against uncertainties. In execution, these safeties get wasted due to multitasking.

Don’t measure people against estimates to condense task-level safeties into strategic buffers that protect the longest path of the project rather than each individual task.

3. Don’t create precise schedules for resources at planning time. Set task priorities in execution based on how much buffer is remaining. Tasks with the lowest buffer ahead of them get the highest priority. Furthermore, if buffers in a project are running too low, managers and executives now have the early warning signals that allow them to intervene when there is still time.

Organizations as varied as aircraft maintenance and repair, new product development, and engineer-to-order manufacturing are using execution management to raise their outputs by 10 percent to 40 percent rather than a miniscule two to four percent that the rest of the players in their industry are targeting. They have become more responsive to customers (leadtimes are shorter) and avoid large investments and expenses (more can be done with less). These organizations are large and small, public and private. It’s been said, “The more complex a problem is, the simpler its solution ought to be.” So it is with execution management, which simply and efficiently helps executives identify constraints, assign buffers where they achieve the most, and drive execution priorities based on relative buffer consumption. By getting updated estimates of time- to-completion from currently active tasks, they can stay on top of how much of the buffer is consumed in an ongoing fashion. As long as there is some predetermined proportion of the buffer remaining. If task variation consumes a buffer by a certain amount, they raise a flag to determine what they might need to do if the situation continues to deteriorate. If it deteriorates past another point in the buffer, they put those plans into effect.

(And, if the customer demands EVM updates, go ahead and provide them. Just keep EVM far from your execution management system!)

EVM embodies all that is wrong with traditional approaches.

After execution management, an aircraft in the repair cycle is ready for use in 80 days less than before execution management efforts.

SYSTEM SERVICE

An execution management system synchronizes your organization’s execution priorities and alerts your management to prospective problems, providing time for them to successfully intervene. It comprises:

* Operational goals and measurements: Goals and measurements communicate the performances and activities that are expected from managers. To assure overall success, operational goals must be line with business goals, and measurements promote synchronized execution and impart timely interventions when early warning signals appear.

* Management policies and processes: Management policies enforce the new rules and management processes translate these rules into decisions and actions that all can readily understand.

* Execution-oriented project plans: Project plans not only capture the dependencies between your tasks and resources, but also encapsulate management decisions. These plans are not so detailed that control becomes difficult but do need to have enough detail to provide good execution priorities.

* Management information: Management information consists of execution priorities, early warning signals, and execution diagnostics. This information should be current and available – on demand – to all managers.

A MODEL PBO

Warner Robbins Air Logistics Center is the largest industrial complex in Georgia, employing more than 25,584 civilian, contractor and military people. Before execution management, the C5 aircraft production line’s turnaround time was 240 days with 13 aircraft in the repair cycle. After execution management, turnaround time is shortened to 160 days with only seven aircraft in the repair cycle.

At the Franz Edelman Award Competition in 2006, Ken Percell, chief operating officer of the center, affirmed, “The increase in C- 5 availability has generated an additional 180 million ton-miles of airlift capability. For our Air Mobility Command operators, that will result in revenue generated of $49.8 million per year.

“While our line required 12 aircraft, global mobility depended on realignment of C-17 aircraft to perform some critical C-5 missions. The additional C-5’s had a replacement cost based on C-17 equivalents of $2.37 billion. This is an immediate realization that has made it easier for the Air Force to discontinue C-17 production early as the C-17’s return to the original missions.”

TIME, NOT MONEY

When managing projects, making efficient use of time is the key to success. This is true from both operational and business perspectives because:

* When projects start running out of time, an organization experiences more than just project delays. There are cost overruns and, all too often, compromises in scope and quality. Even though managers attempt to attack cost overruns by trying to make their resources more efficient, it is well-documented (and common sense) that the longer a project takes, the more resources it will consume. In fact, when pursuing “resource efficiency,” managers actually stretch projects out, increasing costs.

* Once projects fall behind, expediting costs are often incurred.

* For capital-intensive projects, the longer the project takes, the higher the cost of the tied-up money.

* In multiproject organizations, time also equals throughput. The faster that a project gets completed, the faster new capacity becomes available to do the next project.

There is no argument that processes and discipline are essential for ensuring that customer requirements are understood and met and that work gets done with high quality, but these goals are easily compromised when projects come under time pressures. Creating time is vital for following quality processes and discipline.

From the viewpoint of business performance, whether the organization develops new products, constructs infrastructure, overhauls aircraft, or shuts down plants for maintenance, the faster the project gets done, the more value it delivers. As product life cycles continue to shrink, faster time-to-market translates into higher pricing and larger market shares. The faster the infrastructure project gets finished, the faster its benefits start accruing. Faster turnaround in aircraft repair and overhaul equates to higher fleet availability with less aircraft. Faster completion of plant maintenance frees up higher productive capacity.

Project-based businesses that feed into these value chains are able to create competitive advantages for themselves by guaranteeing on-time delivery of their sub-projects. And, if they are on the critical path of overall projects, they can even charge a premium!

Sanjeev Gupta

Sanjeev Gupta is CEO of Realization Technologies, an enterprise software company that specializes in project flow. Recipient of the 2006 Franz Edelman Award and Chief of Staff Team Excellence Award for its work with Warner Robins Air Logistics Center, Realization Technologies has helped organizations increase speed and efficiency in new product development; engineer-to-order manufacturing; construction; maintenance, repair, and overhaul; and other project- based operations, including Hamilton Beach/Proctor-Silex, LSI Logic, Medtronic, and the United States Marine Corps.

Copyright Institute of Industrial Engineers-Publisher May/Jun 2008

(c) 2008 Industrial Management; Norcross. Provided by ProQuest Information and Learning. All rights Reserved.

By Lepsinger, Richard

EXECUTIVE SUMMAR Companies frequently develop vision and mission statements about being at the top of their industry, the great service they provide to customers, and their rewarding work environment. Yet more often than not, these statements are so far from reality that they become joke fodder for customers and employees alike. It doesn’t have to be this way. Your company really can keep its promises- but first you must create a culture of execution.

Creating a culture of execution begins with the knowledge that developing plans and strategic initiatives is just the starting point. The foundation for execution also requires adopting the mindset that a highly skilled and engaged work force – while important – will not ensure effective execution.

Many leaders have a blind spot in this area. Either they believe that their job is setting the direction and execution is the responsibility of lower-level managers or they assume that if they clearly communicate an exciting vision of the future to an engaged work force, everything else will fall into place.

A survey that we conducted at OnPoint Consulting shows how widespread the problem of ineffective execution is. Results show that almost half of those surveyed believe there is a gap between their organization’s ability to develop a vision and strategy and its ability to execute that strategy, and even more – 64 percent to be exact – lack confidence that the gap can be closed. But companies can make a conscious effort to close the execution gap. You simply have to take some tried and true steps to creating a “get it done” culture.

In laying the foundation, recognize that execution starts with a plan. A solid plan can immensely improve the efficiency with which a project is carried out. It facilitates the organization and coordination of related work activities, prevents operational delays and bottlenecks in work processes, helps people avoid duplication of effort, and helps employees set priorities and meet deadlines. It also helps you prepare for potential problems before they happen so that one snag in the system doesn’t throw everyone completely off course. Remember that the best and most useful plans are flexible starting points that can be easily changed to address new needs or challenges as you encounter them.

Ensure plans are aligned and coordinated across the organization. A common snafu at many organizations is that the head of one department will implement a new initiative without considering how it will affect the overall company or specific departments. When a New York-based mutual insurance and financial services company realized it wasn’t going to meet certain financial goals, division heads focused on cutting expenses in their individual departments. Unfortunately, they did not develop operational plans that were compatible across the organization or that helped coordinate the day- to-day activities required to achieve overall business objectives. In fact, these individual cuts made it difficult to maintain support and service to internal customers.

When the CEO became aware of the problem, he worked with his executive team to clarify cross-organizational initiatives that were priorities for the entire company. Then each divisional leader identified the specific cost reduction targets for his or her division that would support the achievement of the corporate objectives and initiatives while not inhibiting the ability of other departments to achieve their goals.

Finally, in setting the tone for execution, clarify and clarify even more. It’s often difficult to get things done because people don’t understand their role, responsibilities, or what exactly is expected of them. One reason employees aren’t always clear on what they should be doing and when is because their manager assumed that they would understand what needed to be done.

Don’t underestimate the importance of taking time to make certain that everyone is on the same page and understands what needs to be done. Clearly communicating roles and responsibilities and checking for understanding is never a wasted effort.

Convene and electrify the team

People work better if they know exactly what’s expected of them. Establish clear expectations. Goals help everyone focus on important activities and responsibilities. They encourage people to find more efficient ways to do the work, and they facilitate constructive performance feedback by ensuring that managers and direct reports or team members have a shared picture of expected outcomes. Setting specific performance goals or task objectives is also an important form of clarifying. Performance improves because specific objectives guide effort toward the most productive activities, and challenging objectives tend to energize a higher level of effort.

Goals should be set even for those things that can’t be easily measured. It’s much easier to measure an improvement in sales than it is to measure an improvement in service quality or customer satisfaction.

Lack of clarity on goals and expectations can have a significant impact on business performance when not put in the context of organizational objectives. For example, in the early 1990s, Sears experienced a rash of complaints about its automotive service business in more than 40 states. The company was accused of misleading customers and selling them unnecessary parts and services. What had happened was that Sears had tried to boost flagging revenue by establishing new goals and incentives for its auto center employees. Minimum work quotas were increased and productivity incentives were introduced for mechanics. The automotive advisors were given product-specific sales quotas and paid a commission based on sales.

Since failure to meet the new goals could lead to a transfer or a reduction in work hours, the pressure on employees to produce was intense and some desperate employees resorted to unethical practices. It appears that management did not anticipate the unintended consequences of the goals they put in place or clarify the line between legitimate preventive maintenance and unnecessary service leaving employees to chart their own course. The total cost of the settlement was estimated at $60 million.

Don’t micromanage your entrepreneurial-minded employees but do monitor them. Your entrepreneurialminded employees – those who take individual initiative and do an effective job without much direction from you – are the gems that make your company special. But just because you feel like you can let them loose with a project or client doesn’t mean that you shouldn’t follow up with them periodically. In fact, when you empower employees in this way, monitoring becomes even more important.

As your employees take on new roles and responsibilities, they are using new skills, working in new arenas, and making and implementing decisions that can have a powerful effect on your organization’s success. You may be concerned they’ll think you’re micromanaging them if you’re keeping an eye on things. Don’t be. When done right, monitoring does not have to feel like micromanaging.

Encourage employees to share bad news openly. Getting information from employees can be easier said than done. If there is a problem, mistake, or delay, they may be hesitant to inform you because they fear your reaction or think it will make them look incompetent. Even an employee who is not responsible for a problem may be reluctant to report it if he or she is concerned about being on the receiving end of an angry outburst. It’s essential to be careful about how you react to information concerning problems.

Strive to always be constructive and non-punitive. When an employee presents bad news, express appreciation for the accurate information, no matter how negative it may be. Respond quickly to the problem with specific actions to deal with it. Help your employees learn from mistakes collectively rather than singling anyone out.

Decisions: deal makers or deal breakers

Balance careful analysis of a problem and decisive action to solve it. Effective leaders move quickly to deal with a threat or problem. Nevertheless, they know they must make an accurate diagnosis of the problem and identify relevant remedies before taking action. Otherwise, they may end up implementing ineffective solutions or solving the wrong problem – both of which can make things worse instead of better.

Carlos Ghosn at Nissan is a leader who is able to balance analysis and decisiveness and has a reputation for being able to get things done. When Ghosn became CEO in 1999, the company was in a state of serious decline and had lost money in all but one of the previous eight years. The problems at Nissan included excessive costs, declining sales, and weak management. By the end of 2000, however, the company was once again profitable and the 2001 earnings for Nissan were at a record high. The rapid turnaround at Nissan was accomplished with a series of decisions and actions that represented a good mix of analysis and decisiveness.

Purchasing costs represent 60 percent of the cost of a vehicle and at Nissan they were excessive. Ghosn formed a cross-functional team with representatives from relevant functions such as engineering and tasked them with finding ways to reduce purchasing costs. One solution was to reduce the number of local suppliers by half and place large orders with a smaller number of global sources. Another solution was to eliminate overly exacting specifications imposed on suppliers by Nissan engineers. These and other changes made it possible to attain Ghosn’s goal of reducing purchasing costs by 20 percent. Production overcapacity was another source of unnecessary costs. The company could manufacture a million more cars than it could sell, but any reduction in production capacity would have to be consistent with plans to increase sales in the future. Ghosn closed five factories in Japan and eliminated more than 21,000 jobs. To simplify production operations at the remaining factories and make them more efficient, Ghosn reduced the number of different car platforms and power train combinations.

Years of declining sales at Nissan were caused by a lack of customer appeal for most of the company’s cars. Designers were taking orders from engineers who focused completely on performance, and there was little effort to determine what types of cars customers really wanted. To increase the appeal of Nissan vehicles to customers, Ghosn encouraged the designers to be more innovative and gave them more authority over design decisions. Several new models were introduced, and for the first time in many years Nissan had cars that excited customers both in Japan and abroad.

Saving the company also required major changes in human resource practices that were strongly embedded aspects of the company culture, such as guaranteed lifetime employment, and pay and promotion based on seniority. These changes would primarily affect managers and other salaried employees. One change was to establish a merit pay plan. Instead of being rewarded for seniority, employees were now expected to earn their promotions and salary increases through effective performance. Areas of accountability were sharply defined so that performance could be measured in relation to goals. New bonuses provided an opportunity to earn up to a third of one’s annual salary based on performance.

To facilitate management development, Ghosn delegated imponant responsibilities and provided opportunities to learn from experience. The changes in human resource practices made it possible to replace weak middle and upper-level managers gradually with more competent successors.

Leaders should always use a systematic, logical analysis to identify the cause of a problem before taking action. Great leaders know when additional information or analysis will only delay action without adding value. To facilitate a rapid, effective response, top performers anticipate potential problems and disruptions and develop contingency plans in advance.

Make decisions as close to the action as possible. The key here is ensuring that decisions are being made where the best information is in order to increase speed and quality of responsiveness. It’s not uncommon for organizations to swing back and forth from centralizing work and processes to decentralizing as they try to deal with a strategic issue or competitive threat.

Organizational redesign is not necessarily the best solution to a competitive or strategic problem. Leaders frequently find that the change just presents a different set of problems and issues. The key is to determine what processes and work would benefit from centralization or decentralization.

Facilitate informal and spontaneous interaction among employees. Your employees’ informal relationships are key in getting things done. The ability to connect with a colleague “in the moment” when you have a problem or new information is essential for effective execution.

When people are in the same location, it’s easier to arrange the work space so that employees can easily interact with one another on work and nonwork topics. Employees in these organizations can meet up in a break room or kitchen area, but more and more frequently organizations have employees who are working all over the place, whether they’re out in the field or working from home. These global organizations use technology – virtual workspaces, video conferencing, instant messaging, electronic social networks – to provide proximity and access to a dispersed group of people.

BMW’s new factory, which opened in Leipzig, Germany, in May 2005, is an example of teamwork enhanced by physical design. Open work spaces cascade over two floors and unfinished car bodies move along a track that runs above offices and an open cafeteria. If the assembly line slows, engineers feel the pulse of the plant change and can quickly investigate the problem. And weekly quality audit meetings in a plaza workers pass on their way to lunch ensure that everyone is quickly aware of production problems. The combination of togetherness and openness sparks impromptu encounters among line workers, logistics, engineers, and quality experts.

Turn your performance management system into a business tool. This system is one of the most important tools leaders have to ensure effective execution. It ensures goals are aligned across levels and work units, helps people know what they need to do and how they need to do it, and allows leaders to monitor progress toward goals. When used effectively, it provides early warning when things are off course and allows time to get back on track. If, however, you view performance management only as an end-of-the-year review along with a form to fill out for human resources, then it isn’t going to help you get things done any more efficiently.

When you put these elements in place at your organization, you’ll see a general improvement in individual, team, and overall organizational ability to execute plans and initiatives. Your employees will start getting things done more easily and consistently, and these regular wins will inspire them to redouble their efforts.

One day you’ll look around and realize your mission statement actually rings true – and that’s one of the best feelings you’ll ever have as a leader.

The best and most useful plans are flexible starting points that can be easily changed to address new needs or challenges as you encounter them.

When done right, monitoring does not have to feel like micromanaging.

Leaders should always use a systematic, logical analysis to identify the cause of a problem before taking action.

Richard Lepsinger

Richard Lepsinger is president of OnPoint Consulting, an organizational and leadership consulting firm that combines practical, research-based tools and business simulations to help clients translate issues into action. Lepsinger has 20 years of experience as a human resources consultant and executive. He was a founder of Manus, a human capital consulting firm, which he grew to more than $4 million in revenue before selling it to Right Management Consultants. Lepsinger is also the co-author of three books including Flexible Leadership: Creating Value by Balancing Multiple Challenges and Choices.

Copyright Institute of Industrial Engineers-Publisher May/Jun 2008

(c) 2008 Industrial Management; Norcross. Provided by ProQuest Information and Learning. All rights Reserved.

PLx Pharma Inc.

President

Ron Zimmerman, 713-842-1249

www.plxpharma.com

PLx Pharma Inc. announced today that it has successfully completed a clinical trial of PL 2100, also known as Aspirin-PC and demonstrated its bioequivalence with regular aspirin. This trial demonstrates PL 2100 Aspirin-PC may bridge to the safety and efficacy of aspirin for prescription (Rx) treatment and prevention of secondary prevention of stroke and myocardial infarction and over- the-counter (OTC) analgesic and fever indications.

This trial is a first step in a clinical development program that will investigate PL 2100 Aspirin-PC as an aspirin formulation that is potentially safer for the gastrointestinal (GI) tract. Unlike other approaches to GI safety, such as enteric coated aspirin products which markedly delay the anti-platelet effects, PL 2100 is being investigated for rapid anti-platelet, analgesic and anti- pyretic efficacy with potentially improved gastrointestinal safety.

Aspirin is a widely used drug available OTC for pain and fever relief and as directed by a physician for treatment and prevention of myocardial infarction and stroke. When used alone or in combination with other nonsteroidal anti-inflammatory drugs (NSAIDs) and other drugs, there is a well documented increased risk for life threatening GI complications, including ulcers and GI bleeding. Recent estimates suggest aspirin may be responsible for nearly 50% of NSAID-induced mortality. PL 2100 Aspirin-PC is a novel formulation of aspirin that combines aspirin with a new gastro- protective agent, phosphatidylcholine (PC).

“Aspirin associated gastrointestinal toxicity poses a significant public health concern,” said Byron Cryer, M.D., with the University of Texas Southwestern Medical School and Dallas Veterans Affairs Medical Center, Texas. “A GI safer aspirin product that provides rapid anti-platelet activity with pharmacokinetics and pharmacodynamics identical to regular aspirin would be a welcome addition for the safer treatment of cardiovascular diseases and pain.”

About PLx Pharma Inc.

PLx Pharma is a privately owned pharmaceutical company developing GI safer NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen, naproxen and aspirin) utilizing its novel proprietary phospholipid based technology. This technology complexes a natural soy derived phosphatidylcholine (PC) with a traditional NSAID to mitigate NSAIDs GI toxicity. PLx’s lead products are GI safer oral complexes with phosphatidylcholine of ibuprofen (PL 1100 and PL 1200 Ibuprofen-PC which are in clinical development), naproxen (PL 3100 Naproxen-PC) and aspirin (PL 2100 Aspirin-PC). Parenteral formulations, additional oral NSAID-PC and other drug-PC combinations are also under development.

(c) 2008 BUSINESS WIRE. Provided by ProQuest Information and Learning. All rights Reserved.

By Chang, Kwok C Leung, Chi C; Yew, Wing W; Lau, Tat Y; Tam, Cheuk M

Rationale: Relatively little is known about the hepatotoxicity of pyrazinamide. Objectives: We compared continuation-phase regimens incorporating pyrazinamide, isoniazid, and/or rifampin with those containing isoniazid and rifampin to evaluate the hepatotoxicity of pyrazinamide.

Methods: Cohort and nested case-control analyseswere conducted on a cohort of 3,007 patients with active tuberculosis (TB) managed at government chest clinics under a TB control programwith treatment started from January 1 through June 30, 2001. Cases included all patients with probable hepatotoxicity from 12 or more weeks after starting treatment. Hepatotoxicity was considered probable when serum alanine transaminase exceeded three times the upper limit of normal. Each case was matched by sex and age with three control subjects selected randomly from the rest of the cohort. Treatment regimens of cases within 4 weeks preceding hepatotoxicity were compared with those of matched control subjects in comparable periods relative to the date of commencing treatment.

Measurements andMain Results:Hepatotoxicity occurredin 150 (5.0%) patients atany time including48(1.6%) cases. From12ormoreweeks after starting treatment, the estimated risk of hepatotoxicity was 2.6% for regimens incorporating pyrazinamide, isoniazid, and/or rifampin, and 0.8% for standard regimens containing isoniazid and rifampin. Multivariable conditional logistic analysis showed a significant association between hepatotoxicity and, respectively, hepatitis B, previous hepatotoxicity, and treatment regimens. The adjusted odds ratio (95% confidence interval) of hepatotoxicity for regimens incorporating pyrazinamide, isoniazid, and/or rifampin relative to standard regimens was 2.8 (1.4-5.9).

Conclusions: Adding pyrazinamide to isoniazidand rifampinincreases the risk of hepatotoxicity appreciably.

Keywords: hepatotoxicity; pyrazinamide; tuberculosis

The introduction of pyrazinamide in the initial phase has further reduced the duration of rifampin-containing anti-tuberculosis (anti- TB) regimens from 9 months to 6 months (1). It has been shown that pyrazinamide acts predominantly in the initial 2 months in the modern regimen (2) due to need of an acidic microenvironment for killing tubercle bacilli (3). However, pyrazinamide may still be useful for containing treatment failure in case of a complicated continuation phase (4, 5). Clinical scenarios that may indicate the use of pyrazinamide in the continuation phase include the unavailability of drug susceptibility test results (6), intolerance of other first-line anti-TB drugs, initial resistance to isoniazid (2, 7, 8), and multidrug-resistant TB.

Despite the important role of pyrazinamide, relatively little is known about its hepatotoxicity. The hepatotoxicity of pyrazinamide is both dose dependent (9) and idiosyncratic (10, 11). Initial use of pyrazinamide at a dosage of 3 g daily with isoniazid showed a high risk of hepatitis in comparison with isoniazid and para- aminosalicylic acid (12). Previous controlled trials that suggested nonsignificant hepatotoxicity for pyrazinamide at dosages of 1.5 to 2 g daily were neither designed nor sufficiently powered for evaluating hepatotoxicity (2, 13).

Concern about the hepatotoxicity of pyrazinamide has recently been rekindled by studies on treatment of latent TB infection involving pyrazinamide and, respectively, rifampin (11), ofloxacin (14), levofloxacin (15), and ethambutol (16). A retrospective cohort study involving 430 patients has suggested that pyrazinamide is more hepatotoxic than isoniazid and rifampin (17), but their findings may be difficult to conclude due to important methodologic issues (18- 20).

The only pragmatic approach to address the hepatotoxicity of pyrazinamide may be by comparing pyrazinamide-containing regimens with standard regimens that do not contain pyrazinamide in comparable periods either in the initial or continuation phase. Because pyrazinamide would often be given in the initial phase unless the patient is at risk of hepatitis, it would be more difficult to identify comparable control subjects in the initial phase than it would be in the continuation phase. Thus, we conducted a case-control study nested in a cohort of patients with TB treated at government chest clinics in Hong Kong in 2001 to examine the hepatotoxicity of pyrazinamide given in the continuation phase. The case definition of TB was a clinically compatible illness confirmed by bacteriologic evidence or, in the absence of bacteriologic evidence, a case with compatible clinical, radiologic, and/or histologic findings, and showing appropriate response to treatment. In 2001, the number of TB notifications in Hong Kong was 7,262 (21). The proportions of pulmonary TB (with or without coexisting extrapulmonary TB) and extrapulmonary TB were 88% and 14.8%, respectively (21). Approximately 62%of cases with pulmonary TB were culture positive (21).

This study was possible because it had been relatively common in Hong Kong to continue pyrazinamide with isoniazid and rifampin in the continuation phase for some patients with drug-susceptible and relatively extensive TB to reduce the risk of treatment failure; to give rifampin, ethambutol, and pyrazinamide in the continuation phase for patients with initial resistance to isoniazid (21); and to give pyrazinamide with isoniazid and ethambutol or levofloxacin for patients with drug-susceptible TB and intolerance of rifampin. Pyrazinamide might also be given in the continuation phase for patients with multidrug-resistant TB, which constituted about 1% of all patients.

METHODS

To evaluate the hepatotoxicity of pyrazinamide, cohort and nested casecontrol analyses were conducted on a cohort of 3,007 patients with active TB managed at government chest clinics under a TB control program with treatment started from January 1 through June 30, 2001. Cases included all patients with probable hepatotoxicity after starting treatment for 12 or more weeks. Hepatotoxicity was considered probable when serum alanine transaminase (ALT) exceeded three times the upper limit of normal (ULN) in the absence of alternative clinical diagnoses (21, 22). In case of multiple episodes of hepatotoxicity, only the first episode after starting treatment for 12 or more weeks was selected for comparison.

Each case was compared with three sex- and age-matched control subjects selected at random from the rest of the cohort. Treatment regimens received by each case within 4 weeks preceding hepatotoxicity were compared with those of matched control subjects within a comparable 4-week period relative to the date of commencing treatment. To improve comparability of regimens, control subjects were included only if they had received at least 3 weeks of treatment within the comparable 4-week period. Treatment regimens were classified into the following groups based on the predominance (>50% in that period) of any of the different combinations of isoniazid, rifampin, and pyrazinamide, with or without streptomycin, ethambutol, ofloxacin, or levofloxacin, and regardless of dosing frequency: (1) standard continuation-phase regimens comprising isoniazid and rifampin; (2) pyrazinamide-containing regimens comprising isoniazid and/or rifampin; (3) others.

Cohort Analysis

The risk of hepatotoxicity among patients given a particular regimen was calculated by dividing the number of cases given that regimen by the total number of patients given the same regimen within the entire cohort, which was estimated through the nested sample using sampling fractions. Ordinary logistic regression analysis was used to examine the association between hepatotoxicity from 12 or more weeks after starting treatment and, respectively, sex and age. A two-tailed P value of 0.05 or less was taken as statistically significant.

Nested Case-Control Analysis

Univariate and multivariable conditional logistic regression analyses were used to compare the hepatotoxicity of pyrazinamide- containing regimens with standard continuation-phase regimens. A two- tailed P value of 0.05 or less was taken as statistically significant. In addition to treatment regimens, the following explanatory variables were included in univariate analysis: previous hepatotoxicity, smoking, habitual drinking, opiate abuse, past health including hepatitis B and hepatitis C, previous anti-TB treatment, and disease characteristics. For multivariable analysis, treatment regimens and previous hepatotoxicity were included by default, whereas explanatory variables with P values less than 0.2 by univariate analysis were included by forward stepwise selection using P values of 0.05 and 0.1 as cutoff values for entry and removal, respectively. Sensitivity analysis was performed after excluding patients with previous hepatotoxicity. An alternative analysis using a more stringent definition for hepatotoxicity (serum ALT exceeding either five times the ULN or, in the presence of hepatitis symptoms, three times the ULN) was also considered.

SPSS version 10 (SPSS, Inc., Chicago, IL) was used for statistical analysis. Approval was obtained from the institutional review board of the Department of Health of Hong Kong for conducting the study. Patient consent was not necessary because our study was an observational study.

RESULTS

Descriptive From a cohort of 3,007 patients who commenced treatment from January 1 to June 30, 2001, hepatotoxicity occurred in 150 (5.0%) patients at any time including the 48 (1.6%) cases. Table 1 summarizes the demographic characteristics.

The 48 cases comprised 10 females and 38 males. The time distribution of hepatotoxicity was positively skewed with a median of 20.6 weeks, an interquartile range from 15.6 to 28.6 weeks, and a range from 12.1 to 40.0 weeks. ALT levels were distributed as follows: more than three times and up to five times the ULN in 22 cases (of whom 10 had hepatitis symptoms); more than five times and up to 10 times the ULN in 14 cases; and more than 10 times the ULN in 12 cases. Total bilirubin levels were elevated more than two times the ULN in seven cases, of whom six had serum ALT that was elevated more than five times the ULN. Two out of 12 cases with ALT exceeding 10 times theULN died of liver failure, whereas all of the 36 cases with lower ALT survived. One fatal case was a 67-year-old Chinese male with chronic hepatitis B and hepatotoxicity preceded by treatment with pyrazinamide, isoniazid, and rifampin. The other fatal case was a 75-year-old Chinese male with unknown status for chronic hepatitis B and C and hepatotoxicity preceded by treatment with isoniazid and rifampin.

A total of 16 cases received regimens containing predominantly pyrazinamide, isoniazid, and/or rifampin. The status of hepatitis symptoms was unknown for one case with serum ALT less than 10 times the ULN. Assuming this case was symptomatic, hepatitis symptoms were present in all (100%) of six cases with serum ALT exceeding 10 times the ULN, and only 2 (20%) of 10 cases with lower serum ALT. Treatment was suspended in all except two cases who continued treatment nonstop but without pyrazinamide. One male patient resumed treatment with the same pyrazinamide-containing regimen, whereas 12 cases resumed treatment without pyrazinamide. A total of three cases experienced hepatotoxicity again, all with ALT exceeding five times the ULN: two with chronic hepatitis B after resuming treatment without pyrazinamide, and one with unknown status for chronic hepatitis B and C after resuming treatment with the same pyrazinamide-containing regimen.

Cohort Analysis

Of 3,007 patients in the entire cohort, the estimated numbers of patients who received standard continuation-phase regimens, pyrazinamide-containing regimens, and other regimens from 12 or more weeks after starting treatment were 2,327 (77.4%), 617 (20.5%), and 63 (2.1%), respectively. The risks of hepatotoxicity for standard continuation-phase regimens comprising isoniazid and rifampin were 0.8%, 0.9%, and 0%among females younger than 35 years, from 35 to 49 years, and older than 49 years, respectively. The corresponding risks for standard continuation-phase regimens among males were 0.9%, 0.9%, and 0.8%. The corresponding risks for pyrazinamide- containing continuation-phase regimens were 0%, 0%, and 0.6% among females, and 0%, 3.2%, and 5.0% among males (P = 0.24 for chi^sup 2^ test of trend). The overall risks of hepatotoxicity were 0.8% for standard regimens and 2.6% for pyrazinamide-containing regimens.

The case fatality rate of hepatotoxicity from 12 or more weeks after starting treatment was 1 (0.16%) out of 617 patients taking pyrazinamide, isoniazid, and/or rifampin, and 1 (0.04%) out of 2,327 patients taking isoniazid and rifampin. Both fatal cases were males older than 49 years. Restricting the analysis to males older than 49, the corresponding risks were 0.42% and 0.12%. Neither difference was significant statistically.

Ordinary logistic regression analysis showed that hepatotoxicity from 12 or more weeks after starting treatment was significantly associated with males but not with age. The adjusted odds ratios (95% confidence interval) were 1.00 (0.98-1.01) for age and 2.1 (1.0- 4.4) for sex.

Nested Case-Control Study

After excluding an 18-year-old male for whom matched control subjects were unavailable, each of 47 cases was compared with three sex- and age-matched control subjects. By univariate analysis (see Table 2), there was a significant association between hepatotoxicity from 12 or more weeks after starting treatment and, respectively, pyrazinamide-containing and other regimens, previous hepatotoxicity, hepatitis B, history of smoking, and extent of pulmonary disease exceeding the equivalent of right upper lobe. Multivariable conditional logistic regression analysis showed a significant association between hepatotoxicity and, respectively, pyrazinamide- containing regimens, other regimens, previous hepatotoxicity, and hepatitis B (see Table 3). Sensitivity analysis restricted to 33 cases and 96 matched control subjects with no previous hepatotoxicity showed similar findings (see Table 4). In addition, a significant association was found between hepatotoxicity and hepatitis C. An alternative analysis of hepatotoxicity using a more stringent definition for hepatotoxicity (serum ALT exceeding either five times the ULN or, in the presence of hepatitis symptoms, three times the ULN) also showed a significant association between hepatotoxicity and pyrazinamidecontaining regimens (see Table 5).

DISCUSSION

This is probably the first case-control study that has evaluated hepatotoxicity of pyrazinamide by comparing continuationphase regimens containing pyrazinamide, isoniazid, and/or rifampin, with standard continuation-phase regimens comprising isoniazid and rifampin. By examining a large cohort of 3,007 subjects in a nested case-control design in the continuation phase, the estimated risk of hepatotoxicity from 12 or more weeks after starting treatment was 2.6% for pyrazinamidecontaining regime\ns with an adjusted best- estimated odds of hepatotoxicity about 2.5 to 2.8 times that of standard continuation-phase regimens. By using incidence proportion instead of incidence rate, and pyrazinamide-containing regimens instead of arbitrary apportioning of risk to pyrazinamide in a multidrug regimen, our findings have corroborated the hepatotoxicity of pyrazinamide demonstrated by a cohort study (17) but without committing two major methodologic pitfalls that might overestimate the toxicity of pyrazinamide (18-20).

It might be argued that hepatotoxicity of pyrazinamide from 12 or more weeks after starting treatment might not be extrapolated to the initial phase. This argument may not stand if the premise is confounding due to timing, which has already been addressed by examining treatment in comparable periods with reference to the date of starting treatment. Thus, not only do our findings have clinical implications for the management of some patients for whom pyrazinamide may be indicated in the continuation phase, but they may also explain the predominance of hepatotoxicity in the initial phase (17), when pyrazinamide is used much more frequently. This reinforces the need for prudence in rechallenging patients with pyrazinamide in the wake of severe drug-induced hepatitis (23).

A potential problem with the interpretation of the results of any observational study that compares treatment regimens is the clinician’s selection bias. Although clinicians would continue to prescribe pyrazinamide in the continuation phase in some patients for various reasons as described in the introduction, they would probably have done so more frequently among patients without previous hepatotoxicity, which might also trigger a search for other potential risk factors, such as hepatitis B and history of habitual drinking. Thus, the clinician’s selection bias could cause an imbalanced distribution of potential risk factors of hepatotoxicity across patients receiving different continuation-phase regimens, and negatively confound the association between pyrazinamide-containing regimens and hepatotoxicity. This could be adjusted by either including previous hepatotoxicity as a covariate in regression analysis or excluding subjects with previous hepatotoxicity. Consistent findings by both approaches have substantiated the hepatotoxicity of pyrazinamide.

The definition of hepatotoxicity is arbitrary and different definitions have been used (24). The British Thoracic Society and the American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America have recommended that potentially hepatotoxic medications be stopped if serum ALT exceeds either five times the ULN (with or without symptoms) (6, 23) or three times the ULN with jaundice and/or hepatitis symptoms (23). Close monitoring of liver function is recommended when ALT is two or more times greater than normal (6). We defined hepatotoxicity by ALT elevation exceeding three times the ULN with no reference to symptoms, partly because symptoms would often be insensitive and nonspecific, and partly because of the importance of early identification of hepatotoxicity (22). More stringent definitions for hepatotoxicity should attenuate the strength of association between hepatotoxicity and pyrazinamide, but we still found appreciable odds of hepatotoxicity for pyrazinamide.

Although we showed a significant association between hepatotoxicity and, respectively, chronic hepatitis B and C, the low testing rates plus possible diagnostic suspicion bias necessitated caution in interpretation. The unadjusted odds of hepatotoxicity among our study patients with hepatitis B relative to hepatitis B virus noncarriers were comparable with the strength of association found by another local study (25), which demonstrated a significantly higher incidence of liver dysfunction during anti-TB treatment among patients with hepatitis B in comparison with those without (34.9% vs. 9.4%, P

The association between hepatotoxicity and sex is contentious. Although several reports suggested an increased risk of hepatotoxicity among females (29-32), a number of studies showed no significant sex difference for hepatotoxicity (17, 28, 33, 34). We found the odds of hepatotoxicity among males were 2.1 times that of females after adjusting for age. This was corroborated by a considerable difference in the unadjusted risk of hepatotoxicity for pyrazinamide-containing regimens between males and females (3.2% vs. 0% among subjects aged 35-49 yr, and 5.0% vs. 0.6% among subjects > 49 yr, respectively).

Human immunodeficiency virus infection, which was not included in the analysis, was unlikely to be a confounding factor because unlinked anonymous screening showed a low incidence of below 0.5% among patients receiving anti-TB treatment in Hong Kong (21).

It was impossible for our study to examine the effect of dosing schedules on the hepatotoxicity of pyrazinamide-containing continuation-phase regimens because almost all study subjects received pyrazinamide-containing regimens daily.Arandomized controlled trial, which involved intermittent and daily regimens with identical dosages of pyrazinamide, showed that initial-phase intermittent regimens containing isoniazid, rifampin, and pyrazinamide were significantly less hepatotoxic than their daily counterparts (35). It is uncertain whether intermittent regimens with substandard dosages of pyrazinamide may be less hepatotoxic at the possible expense of treatment efficacy.

Death in 2 out of 12 cases with serum ALT exceeding 10 times the ULN contrasted with the absence of case fatalities among 36 cases with lower serum ALT. Furthermore, both fatal cases were older than 65 years and one had chronic hepatitis B treated with pyrazinamide- containing regimens preceding hepatotoxicity. Despite small numbers and lack of statistical significance, our findings may suggest caution against delay in the diagnosis of hepatotoxicity. If early diagnosis of hepatotoxicity may reduce the case fatality rate, and the sensitivity of hepatitis symptoms is in the order of only 20% for serum ALT below 10 times the ULN, treatment with pyrazinamide may necessitate periodic monitoring of liver biochemistry in the presence of other risk factors such as chronic hepatitis B or C, and possibly advanced age and male sex.

In conclusion, adding pyrazinamide to isoniazid and rifampin increases the risk of hepatotoxicity appreciably.

Conflict of Interest Statement: None of the authors has a financial relationship with a commercial entity that has an interest in the subject of this manuscript.

Acknowledgment: The authors would like to thank all colleagues in the Hong Kong Tuberculosis and Chest Service (Hong Kong, China) for their contribution to the computerized tuberculosis registry.

AT A GLANCE COMMENTARY

Scientific Knowledge on the Subject

Relatively little is known about the hepatotoxicity of pyrazinamide. Previous controlled trials that suggested nonsignificant hepatotoxicity for pyrazinamide were neither designed nor sufficiently powered for evaluating hepatotoxicity.

What This Study Adds to the Field

Adding pyrazinamide to isoniazid and rifampin increases the risk of hepatotoxicity appreciably.

References

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12. Matthews JH. Pyrazinamide and isoniazid used in the treatment of pulmonary tuberculosis. Am Rev Respir Dis 1960;81:348-351.

13. British Thoracic Association. A controlled trial of 6-months chemotherapy in pulmonary tuberculosis: first report: results during chemotherapy. Br J Dis Chest 1981;75:141-153.

14. Ridzon R, Meador J, Maxwell R, Higgins K, Weismuller P, Onorato IM. Asymptomatic hepatitis in persons who received alternative preventive therapy with pyrazinamide and ofloxacin. Clin Infect Dis 1997;24: 1264-1265.

15. Papastavros T, Dolovich LR, Holbrook A, Whitehead L, Loeb M. Adverse events associated with pyrazinamide and levofloxacin in the treatment of latent multidrug-resistant tuberculosis. CMAJ 2002;167: 131-136.

16. Younossian AB, Rochat T, Ketterer JP, Wacker J, Janssens JP. High hepatotoxicity of pyrazinamide and ethambutol for treatment of latent tuberculosis. Eur Respir J 2005;26:462-464.

17. Yee D, Valiquette C, Pelletier M, Parisien I, Rocher I, Menzies D. Incidence of serious side effects from first-line antituberculosis drugs among patients treated for active tuberculosis. Am J Respir Crit Care Med 2003;167:1472-1477.

18. Chaisson RE. Tuberculosis chemotherapy: still a double-edged sword. Am J Respir Crit Care Med 2003;167:1461-1462.

19. Resi D, Gagliotti C, Moro ML. Side effects of antituberculosis therapy. Am J Respir Crit Care Med 2004;169:542.

20. Leung CC, Chan CK, Yew WW. Side effects of antituberculosis therapy. Am J Respir Crit Care Med 2004;169:1168-1169.

21. Hong Kong Tuberculosis and Chest Service. Annual report. Department of Health: Hong Kong SAR, China; 2001.

22. Thompson NP, Caplin ME, Hamilton MI, Gillespie SH, Clarke SW, Burroughs AK, McIntyre N. Anti-tuberculosis medication and the liver: dangers and recommendations inmanagement. Eur Respir J 1995; 8:1384-1388.

23. Blumberg HM, Burman WJ, Chaisson RE, Daley CL, Etkind SC, Friedman LN, Fujiwara P, Grzemska M, Hopewell PC, Iseman MD, et al.; American Thoracic Society; Centers for Disease Control and Prevention; Infectious Diseases Society. American Thoracic Society/ Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med 2003;167:603-662.

24. Saukkonen JJ, Cohn DL, Jasmer RM, Schenker S, Jereb JA, Nolan CM, Peloquin CA, Gordin FM, Nunes D, Strader DB, et al.; American Thoracic Society Hepatotoxicity of Antituberculosis Therapy Subcommittee. An official ATS statement: hepatotoxicity of antituberculosis therapy. Am J Respir Crit Care Med 2006;174: 935- 952.

25. Wong WM, Wu PC, Yuen MF, Cheng C, Yew W, Wong P, Tam C, Leung C, Lai C. Antituberculosis drug-related liver dysfunction in chronic hepatitis B infection. Hepatology 2000;31:201-206.

26. Ungo JR, Jones D, Ashkin D, Hollender E, Bernstein D, Albanese A, Pitchenik A. Antituberculosis drug-induced hepatotoxicity: the role of hepatitis C virus and the human immunodeficiency virus. Am J Respir Crit Care Med 1998;157:1871- 1876.

27. Huang YS, Chern HD, Su WJ, Wu JC, Lai SL, Yang SY, Chang FY, Lee SD. Polymorphism of the N-acetyltransferase 2 gene as a susceptibility risk factor for antituberculosis drug-induced hepatitis. Hepatology 2002;35:883-889.

28. Hwang SJ,Wu JC, LeeCN, Yen FS, Lu CL, Lin TP, Lee SD.Aprospective clinical study of isoniazid-rifampin-pyrazinamide- induced liver injury in an area endemic for hepatitis B. J Gastroenterol Hepatol 1997;12: 87-91.

29. Teleman MD, Chee CB, Earnest A, Wang YT. Hepatotoxicity of tuberculosis chemotherapy under general programme conditions in Singapore. Int J Tuberc Lung Dis 2002;6:699-705.

30. Dossing M, Wilcke JT, Askgaard DS, Nybo B. Liver injury during antituberculosis treatment: an 11-year study. Tuber Lung Dis 1996;77: 335-340.

31. Ormerod LP, Horsfield N. Frequency and type of reactions to antituberculosis drugs: observations in routine treatment. Tuber Lung Dis 1996;77:37-42. 32. Devoto FM, Gonzalez C, Iannantuono R, Serra HA, Gonzalez CD, Saenz C. Risk factors for hepatotoxicity induced by antituberculosis drugs. Acta Physiol Pharmacol Ther Latinoam 1997;47:197-202.

33. Gulbay BE, Gurkan OU, Yildiz OA, Onen ZP, Erkekol FO, Baccioglu A, Acican T. Side effects due to primary antituberculosis drugs during the initial phase of therapy in 1149 hospitalized patients for tuberculosis. Respir Med 2006;100:1834-1842.

34. Schaberg T, Rebhan K, Lode H. Risk factors for side-effects of isoniazid, rifampin and pyrazinamide in patients hospitalized for pulmonary tuberculosis. Eur Respir J 1996;9:2026-2030.

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Kwok C. Chang1, Chi C. Leung1, Wing W. Yew2, Tat Y. Lau1, and Cheuk M. Tam1

1Tuberculosis and Chest Service, Centre for Health Protection, Department of Health, Hong Kong, China; and 2Tuberculosis and Chest Unit, Grantham Hospital, Hospital Authority, Hong Kong, China

(Received in original form February 28, 2008; accepted in final form April 2, 2008)

Correspondence and requests for reprints should be addressed to Dr. Kwok Chiu Chang, M.B., M.Sc., Wanchai Chest Clinic, 1st Floor, Wanchai Polyclinic, 99 Kennedy Road, Wanchai, Hong Kong, China. E- mail: [email protected]

Am J Respir Crit Care Med Vol 177. pp 1391-1396, 2008

Originally Published in Press as DOI: 10.1164/rccm.200802-355OC on April 3, 2008

Internet address: www.atsjournals.org

Copyright American Thoracic Society Jun 15, 2008

(c) 2008 American Journal of Respiratory and Critical Care Medicine. Provided by ProQuest Information and Learning. All rights Reserved.

Caring isn’t a big part of Carla’s life; it IS her life.

The 18-year-old, from Devonport, looks after her mother Dot, who has had a stroke, her eight-year-old brother Brogan, who has global development delay, and is studying childcare at Torpoint Community College.

It means doing the housework, shopping and cooking in the home and looking after her brother, even feeding him.

“Brogan needs help with nearly everything,” she explained. “He needs 24-hour care.

“It can be difficult but I take it on my shoulders; there are people far worse off than me.

“Because of his condition, something could happen to him any day, but if anything did I’d be lost without him.

“I was surprised to be named one of the Young Carers of the Year, as all the other children do so much as well.”

Mother Dot, who uses a wheelchair or walking aids, said: “I had a stroke nine months ago.

“Carla was looking after her brother on her own when I was in hospital”, she said. “I couldn’t cope without her.”

Handing Carla her award, Natalie Cornah said: “She does a fantastic job; she should get some recognition.”

(c) 2008 Plymouth Evening Herald, The. Provided by ProQuest Information and Learning. All rights Reserved.

By Michael Schaffer, The Oskaloosa Herald, Iowa

Jun. 16–OSKALOOSA — The most common words uttered Saturday afternoon by people touring the Oskaloosa Care Center at 605 Highway 432 was “awesome,””wow,””beautiful,””fantastic.”

And rightfully so, as the center open house gave visitors an up close look at all the facilities — from the Alzheimer’s wing to living quarters to the physical therapy room.

“We’re very unique because we have two Alzheimer’s pods,” Oskaloosa Care Center owner and member of the board of directors Ron Reitmeier said. “We can take care of 20 Alzheimer’s people at a time. And it’s very separate and it doesn’t co-mingle with everyone else.”

The pods offer several skylights, lighted memory cases at each bedroom door, several tables with chairs, an entertainment area with television, a large shower and bathing area with a whirlpool and access to an outdoor exercise area.

Reitmeier said after three years, it felt good to be finally open.

“After three years it seems like a long road but its all been worthwhile,” Reitmeier said. “The people of Oskaloosa have just been wonderful. We’ve gotten all kinds of cooperation.”

The 69-bed center has been accepting patients since May 19, said Oskaloosa Care Center Administrator Tina Steffen, whose job it is to oversee daily operations.

“I’ll tell you what, I could not have got any better education from any college than what I got with the experience that they gave me,” Steffen said. “Starting from the ground up, getting a building ready to go, was a knowledge that I’ll never ever get again. It was a wonderful opportunity.”

Once the center is operating at full capacity, they could employ up to 75 full- and/or part-time employees. The center will hire more employees as more patients are admitted.

“We’ve got enough employees to take care of up to 30,” Steffen said. “And then we’ll take on more employees again.”

Reitmeier said the center was in the process of applying for Medicare, which should be granted shortly. The center is licensed to take care of Alzheimer’s patients.

“And last week we had the state survey and we received a deficiency free and so now we can accept not only private pay but Title XIX, which we could not accept before,” Reitmeier said.

The center offers long-term care but Steffen said they offer short-term rehabilitative care with the goal of getting the patient going back home as soon as possible.

“Yes, we’re long-term care for those who are unfortunate and unable to get back home,” she said. “But we are able to rehab and get them back home, and that’s our goal. I mean, we want everyone to be able to live in their own home. But in the event they cannot, we’re here for them. And that’s our job.”

Herald City Editor Michael Schaffer can be reached by email at [email protected]

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Copyright (c) 2008, The Oskaloosa Herald, Iowa

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By Alexis Garrobo, The Beaufort Gazette, S.C.

Jun. 16–If you want to shatter the illusion of safety, visit a hospital emergency room.

It’s there that medical professionals come across the worst cases.

But two emergency room nurses at Beaufort Memorial Hospital have been trained to work with sexual assault victims and make their ordeals as bearable as possible.

“I think that (treating sexual assault victims) has really enlightened me because we think we live in a community where everybody is safe,” said Beaufort Memorial nurse Ashley Goldman. “When you see these patients, you realize it happens.”

Five nurses at various hospitals throughout the Lowcountry are trained as Sexual Assault Nurse Examiners and are prepared to treat sexual assault victims that come through emergency room doors in less time and with more familiarity in sexual assault cases.

SANE is a national program that familiarizes nurses with rape kits, legal processes and the needs of sexual assault victims. Nurses complete a 40-hour workshop that includes a police ride-along, participation in a Hope Haven of the Lowcountry team meeting, clinicals and shadowing a sexual assault response team. Nurses also undergo a three-year training period before taking a national qualifying exam.

SANE, which links patients to Hope Haven for long-term treatment, began in the 1990s and started about a year ago at Beaufort Memorial, said Shauw Chin Capps, director of Hope Haven, a nonprofit children’s advocacy and rape crisis center.

Last year there were 375 sexual assault victims in Beaufort, Colleton, Hampton, Jasper and Allendale counties, according to Hope Haven’s records. Of those, 249 occurred in Beaufort County.

“(The patients) feel victimized by the system because they aren’t treated immediately,” said Capps “With the SANE nurses they are … more attuned to the needs, preserve the forensics and know time is of the essence.”

For patients seen by a SANE nurse, the wait times are shorter, there is less of an emotional strain and forensic evidence is more likely to be intact, said Goldman.

In hospitals with SANE nurses, patients generally wait an hour compared with much longer waits at hospitals where sexual assault patients are not considered urgent cases, said Capps.

The SANE nurses also make a huge difference in the victim’s healing journey, she said. When a victim comes into the emergency room, a SANE nurse stays with the patient though treatment.

The extra training reinforces a nurse’s duty for the patient and also for forensic evidence should charges be filed. When collected by a SANE nurse, 92 percent of the kits compared with 15 percent of those collected by non-SANE nurses contained an extra vial of blood for alcohol or drug analysis, according to a study by the National Electronic Network on Violence Against Women. The same article found the blood stain card was property prepared in 100 percent of the kits collected by SANE nurses and 81 percent of the other cases.

And the attention to detail is critical when it comes to prosecuting sexual offenders.

“I couldn’t stand the thought that someone committed a crime and wouldn’t be held accountable because of something a nurse didn’t know,” Goldman said.

—–

To see more of The Beaufort Gazette or to subscribe to the newspaper, go to http://www.beaufortgazette.com.

Copyright (c) 2008, The Beaufort Gazette, S.C.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

The U.S. Food and Drug Administration says it is ordering manufacturers of conventional antipsychotic drugs to include boxed warnings on the products.

The FDA said it will require pharmaceutical companies to make safety-related changes to prescribing information and labeling to warn about an increased risk of death associated with the off-label use of the drugs when used to treat behavioral problems in older people with dementia.

In 2005, the FDA announced similar labeling changes for atypical or newer antipsychotic drugs. The warning will now cover older types of conventional antipsychotics.

The warning for both classes of drugs will say clinical studies indicate antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients being treated for dementia-related psychosis.

The drugs are FDA-approved primarily for the treatment of symptoms associated with schizophrenia. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is called off-label use and falls within the practice of medicine.

The new action includes such drugs as Compazine, Haldol, Loxitane, Mellaril, Moban, Prolixin, Thorazine and Trilafon.

By Cheryl E. Moose, The News Herald, Morganton, N.C.

Jun. 13–VALDESE — David Rakestraw at the Penny Patch knows exactly where the tomatoes he sells come from.

So do Juanita Carswell at Eighteen Produce in Morganton and Sexton Digh and Boyce Crowe at the Burke County Farmers Market in Valdese.

The U.S. Food and Drug Administration doesn’t yet know where tomatoes containing salmonella came from. However, it’s said tomatoes grown in North and South Carolina are safe.

Salmonella in tomatoes made 228 people sick in 23 states since June 1. Farms in Mexico and parts of central Florida, two chief tomato suppliers, are still on the suspect list.

“Folks started calling Monday asking about our tomatoes,” Rakestraw said. “They love them and are looking for them.”

On Friday, Rakestraw, Carswell and Digh sold tomatoes from the Carolinas (including the much-anticipated Lincoln County fruit.)

The Penny Patch and Eighteen Produce buy some tomatoes from a Florida wholesaler, but the FDA said the tomatoes aren’t from central Florida.

Neither Rakestraw nor Carswell buy tomatoes from Mexico, they said.

Carswell said one customer drove from Lenoir on Friday to buy Lincoln County tomatoes.

“Our sales have increased,” she continued. “People know they can come here and get a good tomato.”

Places you can’t get tomatoes include fast-food restaurants. Signs on McDonalds’ doors say they aren’t selling them. Taco Bell isn’t either. Neither is LongHorn Steakhouse in Hickory, Gwen Deal said Friday at the Valdese farmers market.

She said, “I come here every week for tomatoes and beets.”

She was out of luck on the tomatoes in Valdese. David McKinney and his wife, Alda, bought the last ones.

The McKinneys craved cheeseburgers for supper and knew they probably couldn’t get them like they like them — with tomatoes — at a restaurant. They ate at home Friday night with the assurance their tomatoes were safe.

They bought the tomatoes from Digh, who sold produce out of his van on Friday.

Digh doesn’t grow his own produce anymore — his arthritis is too bad.

He bought his tomatoes for Friday from a South Carolina farmer and sold all 20 in the first hour of business.

On the FDA’s do-not-eat list are raw red plum, red Roma and red round tomatoes grown outside specific states or countries the FDA cleared because they were not harvesting when the outbreak began or were not selling their tomatoes in places where people got sick.

Grape tomatoes, cherry tomatoes and tomatoes sold with the vine still attached are safe. That is not because there is anything biologically safer about those with a vine, but because the sick people assured investigators those aren’t the kinds of tomato they ate.

While folks who planted their own tomatoes at home ?like the McKinneys and Crowe ? wait for the fruit to ripen for plucking, they can rely on produce stores and stands that know where their tomatoes were grown.

If you do not go to the store armed with a list of safe sources, or if a store or restaurant manager cannot assure you their tomatoes came from safe regions, the FDA’s food safety chief, Dr. David Acheson has this advice: “If you don’t know, don’t take the risk.”

The Associated Press contributed to this story.

The FDA is directing consumers to its Web site — www.fda.gov — for updated lists of the safe regions.

—–

To see more of The News Herald or to subscribe to the newspaper, go to http://www.morganton.com/.

Copyright (c) 2008, The News Herald, Morganton, N.C.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

MINNEAPOLIS, June 16 /PRNewswire/ — Metropolitan Health Plan (MHP(R)), the HMO of Hennepin County, announced staffing changes related to the retirement of David Edwards, Chief Financial Officer and David R. Johnson, Executive Director.

David Johnson served MHP for 23 years and Hennepin County for over 35 years. During his tenure at MHP, the plan has grown from serving members of Minnesota Prepaid Medical Assistance, to a plan that offers 10 government sponsored plans to over 20,000 enrollees.

Sue Zuidema has been appointed the interim Executive Director of MHP. Ms. Zuidema has served in Hennepin County for 30 years in a variety of positions, including Director of the Community Health Department and most recently an Area Director in the Human Services and Public Health Department. She has a Master’s Degree from the Humphrey Institute in health policy.

Cynthia MacDonald has been appointed as the MHP Chief Operating Officer. Prior to her promotion, Ms. MacDonald was the MHP Director of Government Programs. Ms. MacDonald has 25 years of experience in health care and an extensive background in Medicaid and Medicare as the Director of Government Programs with Blue Cross Blue Shield of Minnesota and as the managed care contracting division manager at the Minnesota Department of Human Services. She also worked for several years at the American Association of Retired Persons in Washington, D.C. Ms. MacDonald holds a Bachelor of Arts degree from The George Washington University and a law degree from William Mitchell College of Law.

Tim Schulz has been appointed interim Chief Financial Offer. Mr. Schulz has over 20 years experience working in the healthcare industry. Most recently he was the Vice President of Finance for Blue Cross and Blue Shield of Minnesota and Treasurer for Blue Plus. Mr. Schulz is a CPA and has a Bachelors degree with an emphasis in accounting from the University of North Dakota and a Masters of Business Taxation degree from the University of Minnesota’s Carlson School of Management.

Metropolitan Health Plan (MHP(R)) is a not-for-profit, state-certified Health Maintenance Organization (HMO) and an enterprise initiative of Hennepin County. MHP serves people enrolled in Minnesota Health Care Programs (Medical Assistance, General Assistance Medical Care, Minnesota Senior Health Options, Minnesota Senior Care Plus, and MinnesotaCare) in Anoka, Carver, Hennepin, Mower, Polk, and Scott counties. It also serves Medicare Advantage members in 22 Minnesota counties through four plan choices. MHP provides services to members through a network of providers and community clinics.

Metropolitan Health Plan

CONTACT: Bonnie Hays, +1-612-543-3338, fax, +1-612-904-4264,[email protected], for Metropolitan Health Plan

Web site: http://www.mhp4life.org/

By Cheryl Powell, The Akron Beacon Journal, Ohio

Jun. 16–A dedicated father-and-son duo are the backbone of orthopedics in Akron.

If you’re seeking care at a hospital in town for bone or joint problems, there’s a two-in-three chance that Dr. Dennis Weiner or his son Scott is in charge of the program.

Dr. Dennis Weiner, 69, became chair of orthopedics at Akron Children’s Hospital 28 years ago.

A couple decades later, Dr. Scott Weiner, 48, an orthopedic oncology specialist, took over as head of orthopedics at Summa Health System in 2004.

The elder Dr. Weiner used to bring his teenage son into the operating room to watch surgeries.

Now the two sit together at medical meetings as peers.

And when a young patient has possible bone cancer, the veteran Dr. Weiner is quick to refer the child to his son for care.

“It’s a sense of pride,” the father said. “I’ve sent patients to him because I think he’s the best to handle their care. I think it’s a sense of pride that he’s not only my son but he’s an outstanding oncologist.”

A survey of doctors released last year by national physician search and consulting firm Merritt Hawkins & Associates found that the majority (57 percent) wouldn’t recommend medicine as a career to their children.

But unlike the growing number of dissatisfied doctors, the elder Dr. Weiner always wanted his kids to follow in his footsteps. Three of Dennis Weiner’s seven grown children have pursued careers in medicine.

Another son, Brad, became an orthopedic surgeon and works as a spine specialist and researcher in Houston. Like Scott, he completed his orthopedic residency at Summa.

“They’re graduates of the program that Scott now runs,” his dad is quick to point out.

Likewise, daughter Kris recently earned her nursing degree and soon will start working in the geriatric program at Summa.

Nevertheless, he said, he was careful never to push them into the demanding, time-consuming career.

“They saw the lifestyle,” he said. “It impressed me that they still wanted to do it.”

“I never felt any pressure or anything,” his son agreed.

In recent years, the Weiners have been a driving force behind an effort to put Akron on the map as an orthopedic research powerhouse.

The two spend time conducting research together at Northeastern Ohio Universities Colleges of Medicine and Pharmacy (NEOUCOM).

Then they started talking — first with each other, then with other doctors and researchers — about encouraging more joint projects in the region.

The result has been making plans to bring together Summa, Children’s, Akron General Health System, NEOUCOM and the University of Akron to create an Orthopaedic Research Institute of Northeastern Ohio.

The initiative recently got a major boost from the state, which agreed to provide $8.6 million to recruit top researchers for two endowed research positions.

“The thing got bigger and bigger,” Dennis Weiner said.

These days, family gatherings often turn into an informal physician grand rounds of sorts.

“It drives our wives crazy,” Scott said with a laugh, “because when doctors get together, we talk about doctor stuff.”

If Dennis Weiner has his way, there will be at least two Dr. Weiners in town for many more years.

“I’m 69, and I want to work as long as I can stand up,” he said.

Will more Weiners be joining the practice?

Dennis Weiner sees potential doctors among his 11 grandchildren, including Scott’s four children: Ben, Brian, Julie and Nick.

“I love going to work every day, and I think they see that,” Scott said. “We’re all encouraging them.”

“Keep your fingers crossed,” his father added.

Cheryl Powell can be reached at 330-996-3902 or [email protected].

—–

To see more of the Akron Beacon Journal, or to subscribe to the newspaper, go to http://www.ohio.com.

Copyright (c) 2008, The Akron Beacon Journal, Ohio

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

PARSIPPANY, N.J., June 16 /PRNewswire/ — Fontus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on nephrology and endocrinology, announced today that it has acquired ROCALTROL(R) (calcitriol) from Roche Laboratories Inc. ROCALTROL is a vitamin D analog prescribed by nephrologists for the management of hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (CRF) and by endocrinologists for the management of hypocalcemia in patients with post-surgical hypoparathyroidism, idiopathic hypoparathyroidism and pseudohypoparathyroidism.

About ROCALTROL(R) (calcitriol)

ROCALTROL, available as capsules and as an oral solution, is the most potent metabolite of vitamin D available and is active in regulating the absorption of calcium from the gastrointestinal tract and its utilization in the body. The calcitriol in ROCALTROL is believed to be the active hormone which exerts vitamin D activity in the body. ROCALTROL improves calcium absorption in patients who have severe vitamin D deficiencies commonly associated with CRF, chronic kidney disease (CKD), end-stage renal disease (ESRD) or primary hypothyroidism.

ROCALTROL therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of serum calcium. In order to avoid hypercalcemia and related conditions, the optimal daily dose of ROCALTROL must be carefully determined for each patient. The safety and effectiveness of ROCALTROL in pediatric predialysis patients is based on evidence from adequate and well controlled studies of ROCALTROL in adults with predialysis chronic renal failure and additional supportive data from non-placebo controlled studies in pediatric patients. Specific doses of ROCALTROL are recommended for pediatric predialysis patients. These and other precautions and warnings may be found in the package insert for ROCALTROL.

About Fontus Pharmaceuticals

Fontus Pharmaceuticals, Inc. (“Fontus”) is a specialty pharmaceutical company distinguished by its strategy to acquire and market FDA-approved products used in the fields of nephrology and endocrinology. Fontus focuses on mature products with widely accepted clinical value and brand loyalty. Fontus re-invigorates promotion and in some cases reformulates products to optimize clinical benefit. Fontus is the second new specialty pharmaceutical company to be formed with an investment from the private equity fund, Konanda Pharma Fund I, L.P. For more information, please visit http://www.fontuspharma.com/.

About Konanda Pharma Fund I, L.P.

Konanda Pharma Fund I, L.P. is a private equity fund that founds and invests in portfolio companies that acquire mature prescription drug brands that offer important therapeutic benefits. For more information, please visit http://www.konanda.com/.

Fontus Pharmaceuticals, Inc.

CONTACT: Marilyn Seiger of Kovak-Likly Communications, +1-203-762-8833,[email protected], for Fontus Pharmaceuticals, Inc.

Web site: http://www.fontuspharma.com/http://www.konanda.com/

BALTIMORE, June 16 /PRNewswire/ — Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the U.S. Food and Drug Administration (USFDA).

Lupin’s Escitalopram tablets are the AB-rated generic equivalent of Forest Laboratories’ Lexapro(R) tablets, indicated for the treatment of major depressive disorder. The brand product had annual sales of approximately $2.6 billion for the twelve months ended March 2008, based on IMS Health sales data.

Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, “We are pleased to receive this tentative approval and look forward to bringing Escitalopram tablets to the US market as an affordable generic alternative post patent expiry.”

The product will be introduced in the market through LPI’s strong network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen Lupin’s presence in the Selective Serotonin Reuptake Inhibitor (SSRI) segment.

About Lupin

Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world. The Company has secured global leadership position in Anti-TB and Cephalosporins and has a significant presence in the areas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs.

The Company’s R&D endeavors have resulted in significant progress in its NCE program. The Company’s foray into New Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.

For the financial year ended March 2008, the Lupin’s Revenues and Profit after Tax were Rs.27,730 million (US$ 694 million) and Rs.4,083 million (US$ 102 million) respectively. Please visit http://www.lupinworld.com/ for more information about Lupin Ltd.

Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top six Pharmaceutical companies in India. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com/.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management’s expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.

   *Lexapro(R) is a registered trademark of Forest Laboratories, Inc.    For more information:   Contact: Edith St-Hilaire            Senior Marketing Manager            410-576-2000 Ext. 207  

Lupin Pharmaceuticals, Inc.

CONTACT: Edith St-Hilaire, Senior Marketing Manager of LupinPharmaceuticals, Inc., +1-410-576-2000, ext. 207

Web site: http://www.lupinpharmaceuticals.com/http://www.lupinworld.com/

By Bridget Scrimenti, The Sun, Lowell, Mass.

Jun. 16–CONCORD — Doctors thought Birger Nost would lose his leg.

The 77-year-old broke bones in three places, while gangrene ate away at wounds that wouldn’t heal.

After his toe was amputated, Nost decided to seek treatment at Emerson Hospital’s Center for Wound Care and Hyperbaric Medicine.

He was their first patient.

“I thought to myself, “This man’s going to lose his leg and there’s no way we’re going to heal this,'” said Wendy Slabodnick, R.N., Director of the Center for Wound Care and Hyperbaric Medicine.

For six months, Nost spent close to four hours a week in a glass chamber.

The high concentration of hyperbaric oxygen speeds up the body’s healing process, helping to create new cells to heal tissue,

Slabodnick said. The oxygen level is similar to being at 33 feet below sea level.

When Nost’s leg healed, he walked out of the center without having to use a cane or walker.

“It felt great — it was a pleasure to be able to walk on my own,” Nost said. “I felt like I was free.”

The majority of patients who are treated with hyperbaric oxygen have non-healing wounds caused by diabetes or radiation treatments for cancer.

“The radiation treatments over time can often damage bone or soft tissue,” Slabodnick said.

The center, which opened in September, treats about 30 patients a month.

Inside the tubular glass chamber, patients can nap or watch a plasma flat-screen TV, while a technician never leaves the room.

“It looks scarier than it is and the patient is never alone,” Slabodnick said.

On a bulletin board in the center’s hallway, there are pictures of patients who have healed, including Nost.

“That becomes their (patients’) goal, to get their face on that board,” Slabodnick said.

“He (Nost) walked out with his leg and I have never seen someone so happy — he was crying, the staff was crying.”

—–

To see more of The Sun, or to subscribe to the newspaper, go to http://www.lowellsun.com.

Copyright (c) 2008, The Sun, Lowell, Mass.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

(Honor grads in bold)

Anastasia Applegate

Kyle Caldwell

Kelsey Cates

Kellie Clark

Drew Dyson

Kristhianne Franca

Sarah Lane

Christopher Martin

Nicholas Preziotti

Maximilian Ritz

Chanmoly Seng

Aleksandr Sergiyenko

Alaina Williams

Nichole Williams

valedictorian

Name Kellie Amanda Clark

Age 17

GPA: 4.07

Parents: Roger A. Clark Jr. and Jennifer M. Pittard

College: Old Dominion University

Major: Health Sciences

Most likely to be playing on my iPod: I am almost always listening to Trans-Siberian Orchestra (no matter what time of year).

Favorite online social network: There are two that I have in mind … – Facebook – to keep in contact with friends, and the Shadow of the Ghost forum – to keep up with an awesome book.

In 10 years I’ll be . . . Most likely still in school studying to be a multiple sclerosis research technician, well on my way to help find a cure.

Besides making valedictorian, of what one achievement are you most proud? Receiving a scholarship from the National Multiple Sclerosis Society. It may not seem like a terribly big achievement, but it meant a lot to me.

One thing about home you will miss most when you go off to college? Spending time with my family and friends around here. Granted, I will still keep in touch with everyone; it is definitely going to be a tough transition.

What annoying habit of yours will your college roommate have to deal with? I am not the most tidy of roommates. I will probably hear a lot of complaining when my half of the room is so messy.

What one special item will you take from home to college? If I could take all of the pictures and mementos I have taped to my bedroom wall over the years, I would definitely take those, but I will probably take a few photo albums and such with me to remember some great times.

Biggest challenge faced by your generation? Probably something I am working towards changing – so many people in today’s society have health issues that need to be taken care of . . . part of the reason why I aspire to become involved with MS research.

(c) 2008 Virginian – Pilot. Provided by ProQuest Information and Learning. All rights Reserved.

At Dr. Riggins My MASC (Medical Aesthetic Skin Care) in Northwest Washington, DC, owners and founders Doctors Rovenia Brock and Murray Riggins have taken skin care to another level with services that include nutrition counseling, state-of-the-art skin care treatments, and non-invasive medical procedures.

The multi-disciplined husband and wife team opened MASC to give clients “a safe, comprehensive alternative to skin care.” After years of working in emergency rooms, Dr. Riggins has seen far too many facial procedures gone wrong. “Instead of seeing patients after they’ve had bad outcomes, I want to use my experience and training to ensure positive safe results,” emphasizes Riggins. Dr. Brock, who is nationally known as “Dr. Ro,” author of Dr. Ro’s “Ten Secrets to Livin’ Healthy,” rounds out the practice with her line of skin care products and her training as a nationally renowned nutritionist and health coach. “The skin is the largest organ of the body. It just makes sense to treat it holistically. At MASC, we teach people how to take care of their skin from the inside out.” In addition to nutrition and health coaching, MASC services include a variety of body and facial treatments, chemical peels, laser skin treatments, laser hair removal, and dermal wrinkle fillers and injectables.

About MASC and Its Founders

Located at 1205 Fern Street in Northwest Washington, DC, My MASC provides a comprehensive alternative to skin care from education and treatment, to maintenance. In addition to being a noted author, Dr. Rovenia Brock is a nutritional contributor to ABC’s Today Show and NPR, and was recently named one of the nation’s top five nutritionists by More Magazine. Dr. Riggins is the medical director of MASC. He is a 25-year veteran emergency medical physician, and has trained extensively in medical skin care esthetics with top dermatologists and facial plastic surgeons. His professional memberships include the National and American Medical Associations, the American College of Emergency Physicians, and the American Association of Cosmetic Physicians. For more information on services, counseling, and treatment approaches, call 202.391.0295 or visit the web site at www.mymasc.com.

 CONTACT: Rovenia Brock 301-469-3491  

SOURCE: My MASC

By Garden Variety CURTIS SMITH For the Journal

Q: I have an overgrown Spanish broom and I want to cut it down, but I want it to come back up again. When is the best time to do this? — E. J.

A: The best time to rejuvenate the Spanish broom would be late winter or early spring. In this type of pruning remove all stems to within a few inches of the ground.

But you also can use renewal pruning in which you cut part of the plant. This is safer, and if necessary you can do it now. A healthy, vigorous Spanish broom plant can be cut to the ground every few years and regrow with no permanent ill effects. However, a weaker plant may not regrow.

If you choose to prune more severely, do it now. A healthy plant may survive. But even a healthy one will be more severely injured by drastic pruning during the summer.

If you choose to be less drastic, you can remove onethird of the oldest stems and allow new growth to develop from the base even during the summer. Don’t wait until the end of the summer, or the growth may not mature enough to produce flower buds for next year.

Both methods will avoid the accumulation of unsightly dead wood in the plant’s center.

Q: My lawn has some brown streaks. These streaks run parallel across the lawn. What could cause such a straight-line pattern of dead grass?

A: The most common cause is overlapping when applying fertilizer. The brown streaks develop in areas where the grass was burned when it received a double dose of fertilizer.

In a few months, the grass may regrow in the burned areas if the crown of the grass plant wasn’t killed. Then you may have excessively green stripes where the brown stripes were. Adequate water to keep the soil uniformly moist will help speed the recovery of the grass. But don’t overuse this precious resource.

Garden calendar

Saturdays to Aug. 30, 10-10:45 a.m. Santa Fe Greenhouses summer tours. Expert gardeners will lead tours through a half-acre Xeriscape Demonstration Garden and Western Cottage Garden. Free. Call (505) 473-2700 or go to www. santafegreenhouses.com.

June 29, 1-4 p.m.

Albuquerque Daylily Society presents Daylilies Around the World. View these flowers and photographs and buy bare-root day lilies. This annual show and sale will be at the Albuquerque Garden Center, 10120 Lomas NE. Free. Go to www. albuquerquegardencenter. org for more info.

June 30, 8:30 a.m.-4:30 p.m. Bosque Education Guide for Teachers, Rio Grande Nature Center State Park, 2901 Candelaria NW. Curriculum includes valley geology, groundwater and demands on the river. Participants receive the curriculum and other teaching materials. Bring a lunch, hat, water and sunscreen. $3 state park fee.

The Sandoval County Extension Service Master Gardeners hot line is open Mondays, Wednesdays and Fridays from 9 a.m. to noon, and Tuesdays and Thursdays from 1:30 to 4:30 p.m. Call 867-2582.

Valencia County gardeners can call the Valencia County Extension Service office at 565-3002 from 8 a.m.-4:30 p.m. weekdays or leave a message.

Send questions to Garden Variety, Attn: Dr. Curtis Smith, NMSU Cooperative Extension Service, 9301 Indian School NE, Suite 112, Albuquerque, NM 87112. Phone, 275-2576; fax, 292-9815; e-mail [email protected].

(c) 2008 Albuquerque Journal. Provided by ProQuest Information and Learning. All rights Reserved.

By Annie Getsinger, Herald & Review, Decatur, Ill.

Jun. 16–DECATUR — Some of the men dressed in their Sunday best for a Father’s Day banquet at Main Street Church of the Living God proudly wore a little something extra. Light blue lapel pins in the shape of tiny ribbons signified prostate cancer awareness, the focus of the weekend’s Healthy Father, Healthy Family celebration.

The weekend started off with a barbecue on Saturday with free prostate cancer screenings, family fun events and a health fair organized by Main Street’s pastor, the Rev. Thomas Walker’s son, Shalen Walker.

“He’s not only supporting my endeavor,” Walker said of his son, “but he’s also heading the campaign.”

Walker emphasized the importance of getting checked for African-American men.

“We stand at more risk, and so where there’s more risk, there’s more requirement,” he said. “And the requirement is that we be tested regularly.”

Walker said Father’s Day is a time to recognize strong men, but it is also a time to remind them to care for themselves and lead healthy lifestyles.

“We want people to enjoy today, enjoy life, enjoy your father, but we also want to say we want to enjoy another year,” Walker said. “And some of us will not be around another year if we don’t get checked for prostate cancer.”

His own father, Roger Walker Sr., died from prostate cancer in 1999 at the age of 70.

“So as much as it brought awareness to my family, I want to make it aware to other families,” Walker said. “I am the shepherd of this ministry. I am the pastor of this ministry, so I want to spread it throughout my congregation, and then move from the congregation to our community.”

Sunday’s banquet honored senior pastors and male community role models with Outstanding Man Awards. Church trustee Tommie Love, 64, was honored at the event. Five years ago, he survived a prostate cancer scare. He had an infection at the age of 30, and by age 59, his doctor was almost certain that his enlarged prostate was cancer. Love asked his doctor to hold off on surgery for 30 days.

“I wanted to pray on it 30 days,” Love said.

Love had the operation, and when he woke up in the recovery room, he found out that tissue samples showed he did not have cancer. He fully believes that the power of prayer and faith brought him through that dark time. Now he gets checked every year and urged all men in the community to be tested regularly.

“You pray that God will take care of you, but you’ve got to take the first step yourself,” Love said. “And the first step is to go get tested. If there is a problem, you’ll know it, and you’ll know to do something about it. If there is not a problem, you just keep praying that there won’t be.”

Annie Getsinger can be reached at 421-6968 or [email protected].

—–

To see more of Herald & Review, or to subscribe to the newspaper, go to http://www.herald-review.com

Copyright (c) 2008, Herald & Review, Decatur, Ill.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

The majority of newly diagnosed patients who are prescribed medications for obsessive-compulsive disorder (OCD) receive inadequate dose and/or duration of drug treatment, according to a study conducted by BioMedEcon, a leading provider of health economics and outcomes research.

The study, which was supported by Jazz Pharmaceuticals, Inc., was based on a nine-year retrospective claims analysis that assessed the adequacy of medication treatment among Medicaid-enrolled adults who were newly diagnosed with OCD, a mental disorder that is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Findings were presented at the 161st annual meeting of the American Psychiatric Association (APA) on May 3-7, in Washington, D.C.

The analysis was prompted by recently published APA clinical practice guidelines for OCD that provide specific recommendations for appropriate medication selection, dosing and treatment duration. BioMedEcon applied these recommendations to assess the adequacy of drug therapy among Medicaid-enrolled adults newly diagnosed with OCD.

Among 2,960,421 adult Medicaid enrollees, 987 (0.03 percent) were diagnosed with OCD during the nine-year period and received an appropriate medication. Of these patients, the majority (67 percent) received either medication doses that fell below the minimum guideline-recommended range, or treatment duration that was shorter than the minimum guideline-recommended period.

“The burden of OCD is substantial,” said Dr. Jeffrey Dunn, Formulary and Contract Manager for Select Health and co-investigator of the study. “We previously reported that the health care costs for Medicaid enrollees with OCD were significantly higher than health care costs for patients with depression. We now wonder whether this is a function of quality of care. We are currently investigating whether improved quality of OCD care results in superior patient outcomes and reduced health system burden. I believe that this will be the case.”

Dr. Cheryl Hankin, principal investigator of the study and President and Chief Scientific Officer of BioMedEcon agrees, “Physicians who prescribe drug therapy for OCD must be knowledgeable of guideline-recommended behavioral and drug treatment options, as well as appropriate drug dosing and duration regimens. Improved quality of care for OCD will likely result in enhanced patient functioning and greater patient well-being.”

Along with Hankin and Dunn, research co-investigators are John Knispel, M.D., Medical Director from Humana, Arthur Levin, M.D. from Health Plus, and Amy Bronstone, Ph.D. and Zhaohui Wang, M.S., from BioMedEcon.

About BioMedEcon

BioMedEcon applies rigorous scientific methods to create coherent, objective and practical formulary decision models, pharmaceutical and drug delivery market entry strategies, and healthcare policy recommendations to pharmaceutical and biotech companies, managed care organizations and advocacy groups. For more information, call 650.563.9475 or visit http://biomedecon.com.

CareMedic Systems, Inc., a leader in proactive financial management for hospitals and providers, today announced that the University of Maryland Medical System (UMMS) has recently completed several successful go lives on the company’s electronic Financial Record(TM) (eFR(R)). The solution is now installed in three of UMMS’ four central business offices (CBOs) to help the institution gain an affordable, easy-to-use, enterprise-wide business intelligence tool while simultaneously enhancing operational efficiencies to improve financial performance.

The successful implementations place CareMedic’s unique, overarching revenue cycle management technology in the following healthcare facilities: Shore Health System (Easton, Md.); Maryland General Hospital (Baltimore, Md.); and Baltimore Washington Medical Center (Glen Burnie, Md.). The final entity, University of Maryland Medical Center (Baltimore, Md.), has begun implementation and expects to be fully implemented by the end of the summer. The implementations also involved front- and back-office imaging solutions from CareMedic.

CareMedic’s eFR solution stores and extracts information from disparate financial systems in a common patient folder, which is updated as staff makes changes in any of the systems that feed the eFR. All of the data — insurance, eligibility, coverage information, referral information, physicians, department encounters — is associated directly to the patient account, tying “pockets” of information together.

By implementing the eFR, UMMS is effectively tying together its disparate hospital information systems (HIS) to gain aggregated, enterprise-wide reporting to help manage and improve financial operations — and avoid the costly endeavor of replacing HIS systems to gain a consistent technology platform.

“We chose the eFR solution because we were seeking an approach that could give us better data and better tracking across our system,” said Hank Franey, senior vice president of finance, University of Maryland Medical System. “Instead of investing years and multiple millions of dollars to standardize our patient accounting systems, we’ve implemented the eFR solution in one year for a fraction of the cost to achieve our objective. The solution will ultimately give us access to a customizable and easy-to-use dashboard report, plus it promises to enhance our management of accounts receivable.”

According to Christine Fontaine, director of the CBO at Shore Health System, which went live on the eFR in November 2007, the eFR workflow capabilities already are a big win with staff. “Our people found the system very easy to use and there is no comparison now with our workflow efficiencies,” she said. “You can actually write rules so that staff only see those specific accounts that they truly need to work on that day versus a significant amount of accounts that aren’t a priority. They can slice and dice the data to resolve accounts effectively and efficiently. They’ve taken to it like fish to water and in a short time, become savvy users.”

“We are delighted to be able to partner with the University of Maryland Medical System as it endeavors to develop a comprehensive view of its revenue cycle activity to meet financial performance goals,” said Sheila Schweitzer, Chairperson and Chief Executive Officer of CareMedic. “By choosing our eFR, they are clearly committed to employing smart choices in information technology to drive operational improvement and efficiencies.”

About the University of Maryland Medical System

The University of Maryland Medical System is a 1,746-bed, private, not-for-profit teaching hospital system that provides a complete range of inpatient and outpatient services to more than 500,000 people each year. Member hospitals include: the University of Maryland Medical Center (which includes the University of Maryland Hospital, the Greenebaum Cancer Center, the R Adams Cowley Shock Trauma Center and the University of Maryland Hospital for Children), University Specialty Hospital, Kernan Hospital, Maryland General Hospital, Shore Health System (which includes The Memorial Hospital at Easton and Dorchester Hospital), Baltimore Washington Medical Center and the Mt. Washington Pediatric Hospital. The medical system, which has 11,500 full-time equivalent employees, also has primary and specialty care sites throughout Central Maryland.

About CareMedic Systems

Founded in 1997, CareMedic Systems provides enabling technologies and outsourced services that move and manage critical data through the healthcare revenue cycle, ultimately improving cash flow and margins while reducing operational expenses. The company’s fully integrated data management and workflow tools address revenue cycle activity from inception through claims resolution, and require manual intervention only when necessary. CareMedic is committed to consistently delivering results to its customers. For additional information, visit www.caremedic.com.

CHARLOTTE, N.C., June 16 /PRNewswire-FirstCall/ — MedCath Corporation , a healthcare provider focused on high acuity healthcare services, predominately the diagnosis and treatment of cardiovascular disease, and its physician partners today announced their plans to expand Bakersfield Heart Hospital located in Bakersfield, California.

The expansion, which is subject to the approval of California’s Office of Statewide Health Planning and Development (“OSHPD”), will include the addition of 72 inpatient beds to the hospital’s existing 47 inpatient beds and expansion of the hospital’s emergency department by 16 beds. The expansion will allow Bakersfield Heart Hospital to expand its current services, which include cardiac, vascular, GI (gastrointestinal), general surgery and internal medicine. In addition, upon completion of the expansion Bakersfield Heart Hospital anticipates providing new surgical services in joint replacement, gynecological, ENT and bariatric. Project cost is anticipated to total between $50 million and $60 million, of which $2.5 million to $3.0 million represents cost associated with the completion of architecture and engineering work that is included in the OSHPD application.

“Through this expansion, we and our physician partners will be able to add to our successful, diversified hospital with a strong heart emphasis and maintain our commitment to providing the healthcare needs of the high-growth Bakersfield community”, said O. Edwin French, MedCath’s President and Chief Executive Officer. “The diversification of services is an important part of MedCath’s strategy to expand our service offering in certain of our communities. Bakersfield Heart Hospital is a pre-eminent heart facility that already derives approximately 40% of its admissions from diversified lines.”

MedCath anticipates submitting its application to OSHPD within 6 months, and believes that construction will take approximately two years following OSHPD approval. Based on this, MedCath anticipates that the hospital’s expansion will be completed in late fiscal 2012.

MedCath Corporation, headquartered in Charlotte, N.C., is a healthcare provider focused on high acuity services with the diagnosis and treatment of cardiovascular disease being a primary service offering. MedCath owns an interest in and operates nine hospitals with a total of 616 licensed beds, located in Arizona, Arkansas, California, Louisiana, New Mexico, South Dakota, and Texas. MedCath is in the process of developing its tenth hospital, which is anticipated to open in fall 2009, in Kingman, Ariz. In addition, MedCath and its subsidiary MedCath Partners provide services in diagnostic and therapeutic facilities in various states.

Parts of this announcement contain forward-looking statements that involve risks and uncertainties. Although management believes that these forward- looking statements are based on reasonable assumptions, these assumptions are inherently subject to significant economic, regulatory and competitive uncertainties and contingencies that are difficult or impossible to predict accurately and are beyond our control. Actual results could differ materially from those projected in these forward-looking statements. We do not assume any obligation to update these statements in a news release or otherwise should material facts or circumstances change in ways that would affect their accuracy.

These various risks and uncertainties are described in detail in “Risk Factors” in MedCath’s Form 10-K filed with the Securities and Exchange Commission on December 14, 2007, a copy of which is available on the internet site of the Securities and Exchange Commission at http://www.sec.gov/.

MedCath Corporation

CONTACT: O. Edwin French, President & Chief Executive Officer, or ArtParker, Interim Chief Financial Officer, both of MedCath Corporation,+1-704-708-6600

Web site: http://www.medcath.com/

EyeGate Pharma, a privately held, specialty pharmaceutical company using iontophoresis technology to safely and non-invasively deliver therapeutics into the front and back of the eye to treat serious ocular diseases, today announced the appointment of Ms. Amy Cohen as Vice President, Clinical Operations.

Stephen From, President and Chief Executive Officer of EyeGate, commented on the appointment, “Amy brings a great deal of clinical operations experience to EyeGate. She has been centrally involved in bringing early clinical programs through to late stage development. Amy will play a key role managing clinical development of EyeGate’s lead clinical compound, EGP-437, delivered via the EyeGate(R) II Ocular Delivery System. Our lead program, in anterior uveitis, is scheduled to enter into Phase I/II clinical development in the near future, followed by dry eye later in 2008.”

Recently, EyeGate initiated a voluntary Phase I clinical study designed to assess the safety and tolerability of the non-invasive EyeGate(R) II Drug Delivery System in up to 95 healthy adult volunteers. This GCP Phase I study was designed to establish the maximum tolerated current that can be employed with the EyeGate(R) II. This information will help shape future clinical trials and support future regulatory requirements.

Amy Cohen brings more than 20 years of clinical development and healthcare experience to EyeGate. Most recently she was Director, Clinical Operations at Javelin Pharmaceuticals. At Javelin, she provided overall clinical operations management and planning for Phase I through Phase 3 clinical studies for two of the three clinical candidates for acute pain (Dyloject(TM) and Rylomine(TM)). Previously, Ms. Cohen was Program Manager, Clinical Trials/Medical Affairs at Becton, Dickinson and Company, where she oversaw all clinical trials within the ophthalmic surgery program. She has also held clinical operations leadership positions at Boston Scientific and Biogen Idec.

She holds a M.S. in Health Policy & Management from Harvard University School of Public Health and B.A. from Wellesley College.

About EyeGate Pharma

EyeGate Pharma has recently initiated a Phase I clinical study designed to assess the safety and tolerability of the non-invasive EyeGate(R) II Ocular Drug Delivery System and plans to initiate Phase 2 clinical trials in 2008 in uveitis and dry eye. EyeGate was founded in 1999 with technology licensed from Bascom Palmer Eye Institute at the University of Miami. EyeGate’s transscleral (white membrane of the eye) iontophoresis delivery platform, the EyeGate(R) II Delivery System, was developed to safely deliver a wide range of therapeutics to both the anterior (front) and posterior (back) chambers of the eye. For more information please visit www.eyegatepharma.com.

SOURCE: EyeGate Pharma

WALTHAM, Mass., June 16 /PRNewswire/ — Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that Centocor/Schering-Plough/Mitsubishi Tanabe/Janssen’s golimumab and Roche/Chugai’s Actemra will be two of the most successful emerging novel agents in the rheumatoid arthritis drug market over the next decade in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

The new Pharmacor report entitled Rheumatoid Arthritis finds that the novel TNF-alpha inhibitor golimumab will be one of the most commercially successful emerging agents for rheumatoid arthritis, due to its more- convenient intravenous and subcutaneous dosing formulations, compared with the formulations of other current and emerging TNF-alpha inhibitors. Additionally, due to its novel mechanism of action, the interleukin-6 inhibitor Actemra will successfully compete with Bristol-Myers Squibb’s Orencia and Biogen Idec/Genentech/Chugai/Zenyaku Kogyo’s Rituxan / Roche’s MabThera in the treatment of rheumatoid arthritis patients who respond inadequately to TNF-alpha inhibitors.

The report also finds that Amgen/Wyeth/Takeda’s Enbrel and Abbott/Eisai’s Humira — both currently marketed TNF-alpha inhibitors — will continue to dominate the rheumatoid arthritis market. Driven by their continued uptake as first-line treatments among biological agents, sales of Enbrel and Humira for rheumatoid arthritis will be close to $4 billion for each drug by 2017.

“Most of the sales growth over the next 10 years will occur through 2012, driven by continued uptake of currently marketed drugs and the launch of several novel biological agents,” said Dancella Fernandes, Ph.D., analyst at Decision Resources. “From 2012 to 2017, annual market growth will slow due to fewer new product launches, restrictions imposed by third-party payers that will prevent expansion of biological therapy into earlier lines of treatment, biogeneric erosion and smaller increases in the rates of diagnosis and drug treatment.”

About Decision Resources

Decision Resources (http://www.decisionresources.com/) is a world leader in market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.

   All company, brand, or product names contained in this document may be      trademarks or registered trademarks of their respective holders.    For more information, contact:    Elizabeth Marshall   Decision Resources, Inc.   781-296-2563   [email protected]  

Decision Resources

CONTACT: Elizabeth Marshall of Decision Resources, Inc.,+1-781-296-2563, [email protected]

Web site: http://www.decisionresources.com/

Forget the cloying scents and chemical additives of air fresheners or scented candles. Freshen up your surroundings with naturally made sachets instead. You can go the easy route and purchase ready-made sachets, or you can make them yourself.

Event planner Debi Lilly of Chicago’s A Perfect Event likes to make sachets using vintage handkerchiefs she picks up at flea markets. “We lay the handkerchief out, iron it, scoop a handful of dried flowers, herbs or spices into the center, and then pull all the corners to a point on top,” Lilly says. “Last, we tie the sachet with vintage ribbons and trims.”

Sachets long have been used to freshen up clothing inside closets and drawers. Here are some more unexpected ways to use the aromatic pouches.

1. In the car. Tuck a sachet beneath the driver’s seat to freshen the car interior and revive and relax the driver. Botura, a new sachet scent from Hillhouse Naturals ($2.80, hillhousenaturals.com) contains vetiver (a perennial grass), orange and geranium.

2. In the laundry hamper. “Fresh, airy scents would be great at the bottom of a laundry hamper,” says Peggy Batts, Hillhouse Naturals’ founder. Batts likes the uplifting notes of citrus for this purpose, or their own Fresh Linen sachet ($2.80), which contains bergamot, lemon and orange.

3. In the fireplace. In a twist on the traditional sachet, Lilly ties together cinnamon sticks and dried lavender in small bundles and tosses them into the fire.

4. At the office. Both Lilly and Batts love the idea of lavender in a desk drawer. “I’m a lavender-a-holic, in general, but it’s a good one for public spaces,” Lilly says. “Jasmine is a good one here as well,” Batts adds. “It is said to be as relaxing as lavender, and good for combating exhaustion too.”

5. In the gym bag. For those in-between periods when your shorts and socks must sit in the bag a day or two before you’re able to take them home: Toss in a packet of something fresh and clean, such as lemon.

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(c) 2008, Chicago Tribune.

Visit the Chicago Tribune on the Internet at http://www.chicago.tribune.com/

Distributed by McClatchy-Tribune Information Services.

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For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

US WorldMeds, a Kentucky-based specialty pharmaceutical company, today announced that a recently completed Phase III clinical trial investigating the use of lofexidine hydrochloride (Lofexidine) for the treatment of opiate withdrawal symptoms in patients undergoing opiate detoxification has shown that opiate-dependent patients taking the drug experienced a significant reduction in withdrawal symptoms at the anticipated peak of withdrawal and stayed longer in detoxification treatment as compared to patients taking placebo.

“The debilitating withdrawal symptoms associated with opiate detoxification are a major reason people struggling with heroin or prescription drug addiction avoid or leave treatment,” said Paul Breckinridge “Breck” Jones, CEO of US WorldMeds. “These trial results are impressive and confirm our expectations for Lofexidine. Lofexidine promises to be an important new tool for treating opiate addiction here in the US.”

Lofexidine is being developed as a non-addictive, non-narcotic treatment for relieving withdrawal symptoms associated with opiate detoxification. Opiates include the illicit drug heroin and prescription drugs such as oxycodone (e.g. OxyContin(R)) and hydrocodone (e.g. Vicodin(R)). Typical opiate withdrawal symptoms include vomiting, sweating, stomach cramps, diarrhea, and muscle pain.

If approved by the US Food and Drug Administration (FDA), Lofexidine would be the first non-addictive, non-narcotic treatment approved in the United States for relieving withdrawal symptoms associated with opiate detoxification. Currently, the only FDA-approved treatment options for opiate detoxification are medications such as methadone and buprenorphine, which are opiate derivatives and have addictive properties.

US WorldMeds initiated the randomized, double-blind Phase III clinical trial for Lofexidine in June 2006 as a collaborative effort between the company, the National Institute on Drug Abuse (NIDA) and the Department of Veterans Affairs (VA) Cooperative Studies Program Coordinating Center in Perry Point, MD. The trial was designed to evaluate the effectiveness of Lofexidine in reducing withdrawal symptoms in subjects undergoing opioid detoxification. Additionally, the trial sought to assess whether Lofexidine increased the number of patients who completed detoxification treatment, whether the drug was safe, and other secondary objectives.

The Phase III trial for Lofexidine involved 264 adult patients – 200 male and 64 female – who had a proven dependence on an opioid such as heroin, morphine, or oxycodone. Study subjects were admitted to one of 15 clinical trial sites throughout the United States for this eight-day, inpatient study. As a primary measure of effectiveness, the severity of the subjects’ withdrawal symptoms was evaluated using the Short Opiate Withdrawal Scale (SOWS-Gossop), a subjective assessment in which patients rate their individual withdrawal experiences. Study subjects were free to withdraw from the study at any time.

The statistical analysis of the primary efficacy endpoints of the Phase III trial is now complete. The initial results demonstrate Lofexidine’s statistical significance versus placebo in reducing withdrawal symptoms associated with opiate detoxification on the third day of treatment, which is the expected peak point for withdrawal symptoms. Also, patients taking Lofexidine in the trial stayed in detoxification treatment longer than patients taking placebo.

“This trial has shown that Lofexidine can both reduce peak withdrawal symptoms associated with opiate detoxification and help people remain in an opiate detoxification program such as the one studied,” said Dr. Charles Gorodetzky, Medical Director of US WorldMeds. “These benefits, combined with the fact that Lofexidine would be the first non-addictive, non-narcotic medication of its kind on the US market, make it a potentially important new tool in managing patients during the critical opiate withdrawal period.”

NIDA estimates that drug and alcohol addiction costs the United States greater than $500 billion each year in lost earnings, healthcare expenditures, and costs associated with accidents and crime. Opioid addiction, which includes the use of illegal drugs such as heroin and the non-medical use of medications such as methadone, morphine, oxycodone (e.g. OxyContin(R)) and hydrocodone (e.g. Vicodin(R)), impacts millions of American families annually. In the September 2007 National Survey on Drug Use and Health, the US Substance Abuse and Mental Health Services Administration (SAMHSA) reported that nearly 3.8 million Americans have used heroin in their lifetimes and that approximately 560,000 used the drug in 2006. The survey also showed that more than 4 million Americans have illicitly used OxyContin(R) in their lifetimes and that 1.3 million illicitly used the prescription medication in 2006.

Lofexidine, an alpha-2-adrenergic agonist, has been studied in six prior clinical trials in the United States. Lofexidine therapy is associated with common side effects including hypotension, bradycardia, dry mouth, and sedation.

Lofexidine has been approved for use for 15 years in the United Kingdom (UK) to manage the often debilitating withdrawal symptoms that occur during opiate detoxification. It is marketed in the UK by Britannia Pharmaceuticals as BritLofex(R). US WorldMeds acquired a license for Lofexidine from Britannia in 2003.

Given the encouraging initial results of the Phase III clinical trial, US WorldMeds intends to submit a new drug application (NDA) for Lofexidine with the FDA for US approval. The NDA will be filed after the complete dataset from the trial, including additional efficacy and safety measures, is analyzed, and additional required studies are completed.

The following medical facilities were involved in the Phase III Lofexidine trial:

— Alexian Brother Behavioral Health Hospital, Hoffman Estates, IL

— Atlanta Center for Medical Research, Atlanta, GA

— Aurora Psychiatric Hospital, Wauwatosa, WI

— CNS Psychiatric Institute of Washington, Washington, D.C.

— Lake Charles Clinical Trials, LLC, Lake Charles, LA

— North Miami Research, Inc, North Miami, FL

— Providence VA Medical Center/ Ocean State Research Institute, Providence, RI

— Research Across America, Dallas, TX

— St. Vincent Catholic Medical Center & Richmond University Medical Center, Staten Island, NY

— University of Kentucky Center for Human Behavioral Science, Lexington, KY

— University of Texas Health Science Center, San Antonio, TX

— Vanderbilt Psychiatric Hospital, Nashville, TN

— VA Puget Sound Health Care System/ The Seattle Institute for Biomedical and Clinical Research, Seattle, WA

— VA Salt Lake City Healthcare System/ Western Institute of Biomedical Research, Salt Lake City, UT

— Wayne State Addiction Research Institute, Detroit, MI

About US WorldMeds

US WorldMeds is a closely held specialty pharmaceutical company based in Louisville, Kentucky. Founded in 2001, US WorldMeds is focused on identifying, developing and commercializing therapeutic treatments for niche patient populations. For more information, please visit http://www.usworldmeds.com.

RICHMOND, Virginia, ROSH HA’AYIN, Israel, June 16 /PRNewswire/ — EnzySurge Ltd. (EnzySurge), a provider of innovative solutions for advanced chronic wound management, recently announced the formation of its Scientific Advisory Board (SAB) comprised of world-renowned scientists, researchers and practitioners with diversified expertise in chronic wounds. The Company named David Armstrong, DPM PhD, Rob Kirsner, MD, PhD, Diane L. Krasner, PhD RN, FAAN, Joseph L. Mills, MD, PhD and Itzhak (Tzaki) Siev-Ner, MD as members of the SAB. David Armstrong will chair the Advisory Board. The SAB will meet regularly to provide EnzySurge with scientific and clinical guidance for its research, regulatory and commercialization activities.

“We are delighted with the caliber of scientists and practitioners who have decided to join our SAB said Amir Shiner, CEO of EnzySurge. “They are not only key opinion leaders in the various areas relevant to our field, but they also all bring industry experience, which will be instrumental as we move toward commercializing our products. The individual and collective expertise of our Scientific Advisory Board in diabetic foot, venous and pressure ulcers, biotechnology, clinical development and wound care standards of care, will no doubt accelerate our research and development and will ensure we address the most vital needs of our target market.”

EnzySurge’s DermaStream(TM) product line is based on its proprietary Continuous Streaming Therapy (CST(TM)) technology. The comprehensive system continuously streams a fresh supply of active solutions to a controlled wound environment. EnzySurge has developed a series of bio-active therapeutic solutions to facilitate safe and effective healing of chronic wounds, from debridement, through regeneration to closure. The DermaStream family of products is designed to treat all forms of chronic wounds including diabetic ulcers, venous ulcers and pressure ulcers. DermaStream touch-free treatments result in faster, more effective and painless wound healing in the hospital, clinics, nursing homes and at home.

The members of EnzySurge’s Scientific Advisory Board include:

Chairman, David G. Armstrong DPM, MD, PhD is Professor of Surgery and Associate Dean at the Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science in Chicago. Armstrong is Director of the Center for Lower Extremity Ambulatory Research (CLEAR). He has produced more than 230 peer-reviewed research papers in more than two dozen scholarly medical journals as well as over two dozen book chapters and is co-Editor of the American Diabetes Association (ADA)’s Clinical Care of the Diabetic Foot. Armstrong was selected as one of the first six International Wound Care Ambassadors and is the recipient of numerous awards by national and international medical organizations. He is past Chair of Scientific Sessions for the ADA’s Foot Care Council, and a past member of the National Board of Directors of the ADA. Armstrong is the founder and co-chair of the International Diabetic Foot Conference (DF-Con), the largest annual international symposium on the diabetic foot in the world.

Rob Kirsner MD, PhD is a Professor and Vice Chairman of the School of Medicine, University of Miami, School of Dermatology and Cutaneous Surgery. Dr. Kirsner received certifications from the National Board of Medical Examiners, American Board of Dermatology and American Academy of Wound Management. Dr. Kirsner’s clinical interests are in wound healing, leg ulcers, skin cancer, medical dermatology and cutaneous surgery. He is active in research in wound healing, health care policy, dermatoepidemiology, inpatient dermatology and cancer control and prevention.

Diane L. Krasner, PhD, RN, FAAN is a Wound & Skin Care Consultant based in York, Pennsylvania. She works part-time as the WOCN / Special Projects Nurse at Rest Haven – York. She has been the lead co-editor of Chronic Wound Care: A Clinical Source Book for Healthcare Professionals since the first edition was published in 1991. Dr. Krasner is on the editorial boards of Wounds, The International Journal of Wound Care and World Wide Wounds. Dr. Krasner is a Board Certified Legal Nurse Consultant and she serves as an expert witness in legal cases involving wound and skin care.

Joseph L. Mills, MD, PhD serves as Chief of the Division of Vascular Surgery, Professor of Surgery, and Director of the Vascular Surgery Training Program at the University of Arizona Health Sciences Center, Tucson, Arizona. Dr. Mills is certified by the American Board of Surgery with Special Qualifications in Vascular Surgery. His areas of active research interest include open and endovascular treatment of aortic aneurysms, noninvasive evaluation of peripheral vascular disease, hemodialysis access, treatment of carotid and vertebral artery disease to prevent stroke, diabetic foot problems, limb salvage using endovascular techniques and leg bypass surgery, and treatment and prevention of graft stenosis. Dr. Mills has published over 130 manuscripts, produced five films of complex operative techniques, and edited three major textbooks.

Itzhak (Tzaki) Siev-Ner, MD is the Chairman of the Israeli Diabetic Foot Society. Siev-Ner serves as the Director of the Orthopedic Rehabilitation department in the Sheba Medical Center, Tel-Hashomer, Israel. He is Board certified both in Orthopedic Surgery and Physical and Rehabilitation Medicine. His main practice is prevention and treatment (conservative and surgical) of Diabetic Foot Ulcers, chronic wounds, amputations and the rehabilitation of these conditions. He is involved in research of different aspects of wound healing.

About EnzySurge

EnzySurge Ltd. is a developer and provider of innovative solutions for the treatment and management of chronic wounds. EnzySurge’s flagship DermaStream(TM) platform based on the proprietary Continuous Streaming Therapy (CST(TM)) offers a new and unique wound treatment modality by continuously streaming a fresh supply of advanced bio-active therapeutic solutions to a controlled wound environment. DermaStream(TM) is designed to deliver effective, affordable and easy-to-use wound treatment throughout all phases of chronic wound treatment cycle from debridement, through regeneration to wound closure. DermaStream(TM) was designed for use in hospitals, clinics, nursing homes and for home care.

EnzySurge is committed to the development and delivery of innovative solutions that improve the quality of life of chronic-wound patients by shortening healing time, preventing hospitalization and reducing treatment costs. visit http://www.dermastream.com/

   PR Contacts:    Boaz Gruener, Director of Marketing and Business Development   [email protected]   +972-54-4563608  

EnzySurge Ltd

CONTACT: PR Contacts: Boaz Gruener, Director of Marketing and BusinessDevelopment, [email protected], +972-54-4563608

PHILADELPHIA, TOKYO and WOBURN, Mass, June 16 /PRNewswire/ — Fox Chase Cancer Center and VisEn Medical today announced a partnership to advance Phase I clinical trials of one of VisEn Medical’s “smart” fluorescence activatable imaging agents to enable physicians to identify and characterize early stage disease in oncology patients. Olympus Medical Systems Corp. will provide paired fluorescence laparoscopic imaging systems to enable the detection and evaluation of ProSense highlighted tumors in patients in the trials. The clinical trials will initially focus on ovarian cancer and are planned to begin in 2009 at Fox Chase Cancer Center.

Under terms of the program, VisEn will develop and submit an Investigational New Drug (IND) application on a clinical analog of its proprietary fluorescence molecular imaging agent, ProSense(R), which highlights certain enzymatic processes associated with early stage cancer development in vivo. In addition to conducting the clinical trials, Fox Chase Cancer Center will invest in the ProSense clinical program through VisEn and will receive certain rights, equity and royalties on future sales.

“These clinical molecular imaging technologies should provide the foundations for earlier and more accurate disease detection, and more importantly, enhanced functional imaging capabilities that will eventually help guide therapeutic interventions,” said Michael V. Seiden, MD, Ph.D., President and CEO of Fox Chase Cancer Center. “Promoting advances in diagnosis that may lead to improved cancer treatments is a key part of Fox Chase’s approach to solving the cancer problem, and we are pleased to be working with two of the leaders in molecular imaging to help bring these new approaches into clinical medicine.”

“We are gratified for the opportunity to work jointly with Fox Chase Cancer Center and Olympus Corporation to develop the first clinical applications of our fluorescence molecular imaging technology platforms,” said Kirtland Poss, President and CEO of VisEn Medical. “This program is a major step forward in VisEn Medical’s central mission, which is to lead the development and commercialization of fluorescence in vivo imaging technologies in a range of translational applications from research through clinical medicine, enabling substantial benefits for researchers, pharmaceutical companies, doctors and patients.”

Both Dr. Seiden and Mr. Poss noted the contributions to the project by Olympus Medical Systems Corp. “We are pleased to receive the system support from Olympus Medical Systems Corp. through their provision of these novel fluorescence imaging systems into the program,” said Mr. Poss. “These advances will help open up new opportunities for more effective and efficient cancer detection, surgery and treatment.”

The ProSense(R) Activatable Imaging Agent platform was developed to provide in vivo readouts of some of the key protease activities known to underlie disease states in oncology, inflammation, and cardiovascular disease. A pre-clinical version of ProSense is currently being used by leading academic institutions and pharmaceutical customers worldwide to image disease-related in vivo protease profiles in pre-clinical research and drug development. The IND program and the planned Phase I clinical trials are designed to translate the benefits of ProSense into humans, as well as to further develop the multi-channel white light and near infrared fluorescence laparoscopic imaging systems used in collecting and analyzing fused images in real time in the operating room. The planned trial is also designed to gather safety and imaging data for the agent, which will be administered systemically, and to collect preliminary pharmacokinetic information on the metabolism of the agent to support expanded Phase II clinical trials.

About Fox Chase Cancer Center

Fox Chase Cancer Center is one of the leading cancer research and treatments centers in the United States. Founded in 1904 in Philadelphia as the nation’s first cancer hospital, Fox Chase became one of the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, treatment, and community outreach.

About Olympus

Established in 1919, Olympus Corporation, Tokyo, Japan, manufactures and sells precision machinery and instruments for medical and healthcare, imaging and information, and industrial applications, whose core competency is opto-digital technology. With a focus on innovation and quality, Olympus Corporation is improving medical and healthcare services by developing molecular imaging system technology with Olympus Medical Systems Corp. for early detection and treatment of oncological diseases to better serve our customers’ needs. Olympus Medical Systems Corp., a wholly owned subsidiary of Olympus Corporation, develops a wide range of medical equipment, including gastrointestinal endoscopes, minimally invasive surgical endoscopes, endoscope disposal equipment, ultrasonic endoscopes and other endotherapy products.

About VisEn Medical

VisEn Medical, Inc. was founded in 2000 based on fluorescence in vivo imaging technologies initially developed by industry-leading researchers and clinicians at the Massachusetts General Hospital and Harvard Medical School. VisEn develops and commercializes the industry’s highest performing fluorescence in vivo imaging technology platforms, from research through medicine. The Company also works with large pharmaceutical partners to design ranges of tailored molecular imaging agents and applications that are targeted to their specific pre-clinical and clinical research areas. Privately-held VisEn is headquartered in Woburn, Massachusetts and has been financed by leading venture firms including Flagship Ventures, Merck Capital Ventures and The Bollard Group. For further information please visit http://www.visenmedical.com/.

VisEn Medical, Inc.

CONTACT: Kirtland G. Poss, President and CEO of VisEn Medical, Inc.,+1-781-932-6875, ext. 301; or Franklin Hoke of Fox Chase Cancer Center,+1-215-728-2700, [email protected]

Web site: http://www.visenmedical.com/

Maximus, a business unit of leading infusion therapy firm Medegen Inc., will exhibit at the Association for Professionals in Infection Control and Epidemiology (APIC) annual scientific conference, June 15-17 in Denver, Colorado. The exhibit will feature the new MaxPlus(R) Clear, the first and only clear positive displacement connector for use in patient care, as well as two award-winning clinical research posters.

The first, an abstract authored by Victor Lange, ICP, CRC entitled “Needleless Valves/Connectors: Infection Prevention” is the first place winner of the Clinical Innovations/Practice Abstract Presentation awarded by the Infusion Nursing Society Conference held May 3-8, 2008 in Phoenix, Ariz. In this study, the latest FDA requirements for microbial ingress testing of a needleless access device were performed on three different devices. Results confirmed that the MaxPlus connector with Tru-Swab(TM) technology is clinically superior to the two additional products tested in terms of microbial barrier properties when using common disinfection protocol and worst case clinical simulation.

Maximus is the only needleless access device manufacturer to test their needleless access device against these new, more rigorous FDA standards and publish the results. In 2007, Maximus received 510K clearance for the claim of “meets and exceeds latest FDA guidance for microbial ingress testing.”

Maximus will also display the first place winner of the 2008 Infusion Nurses Society Scientific Poster Contest for Clinical Research, authored by Andre’ Schotte, RN, PhD, entitled “Luer Activated Device (LAD) Performance”. In this study, clinical data was collected to compare the MaxPlus positive displacement connector to an alternative “neutral” connector for number of catheter occlusions over a seven week period. During this period, the MaxPlus connector experienced only one withdrawal occlusion and no total occlusions, whereas the alternate device experienced 11 withdrawal occlusions and nine total occlusions. To determine why there was such a discrepancy, the author conducted independent laboratory testing and discovered that out of nine different connectors tested, only the MaxPlus connector exhibited positive displacement which reduces the occurrence of blood reflux into the catheter at disconnect. The eight other connectors all exhibited negative reflux, including the connectors that claim to be neutral. Negative displacement connectors permit reflux of blood into the catheter when the syringe or administration set is removed from the connector. As evidenced in the clinical research, this can lead to occlusions.

“The results of these two meaningful research efforts illustrate the clinical impact of the MaxPlus device,” said Jeff Goble, President of Medegen. “The annual meeting is a great way for nurses and infection control practitioners to see how the MaxPlus Clear Connector promotes best practice by allowing for thorough disinfection and flushing.”

MaxPlus Clear is the first and only clear positive displacement connector shown to enhance patient care by lowering bloodstream infection and occlusion rates.

For more information on the conference, visit http://conference.apic.org//AM/Template.cfm?Section=Home3

About Medegen Inc.

Medegen is a leading innovator in infusion therapy, focused on helping hospitals drive greater clinical performance for improved patient care. The growing company provides clinically superior medical products and reliable, cost-effective manufacturing services to the medical community through its three operating units: Manufacturing Services, Maximus and KippMed. Manufacturing Services provides cost-effective contract manufacturing solutions to medical device, drug delivery and pharmaceutical companies. KippMed manufactures and markets IV therapy components for the OEM market, drawing from a 25-year history in IV component supply. Maximus develops, manufactures and markets needleless intravenous therapy products for the acute care market. The Maximus line of medical products features patent-protected technologies which improve patient outcomes and greatly reduce bloodstream infection rates. Medegen is headquartered in Ontario, Calif. with executive offices in Scottsdale, Ariz. and operations in Tijuana, Mexico. For more visit http://www.medegen.com/.

EXACT Sciences Corporation (NASDAQ: EXAS) today announced that a major gastroenterology journal has accepted for publication a multi-center, prospective study of EXACT’s Version 2 technology for early colorectal cancer detection using stool-based DNA testing. The study, conducted by Steven H. Itzkowitz, M.D, Professor of Medicine, Mount Sinai School of Medicine and his collaborators, was also recently presented in abstract form at Digestive Disease Week (DDW) in San Diego, California. With respect to the earliest cancer stages, Dukes’ A and B, the abstract data from DDW reported sensitivity above 85 percent on average, with specificity above 80 percent. Sensitivity in asymptomatic screening patients and symptomatic patients was similar. Early stage detection of colorectal cancer is critical, as five-year survival rates can exceed 95 percent among those whose colorectal cancers are detected at the earliest, most treatable, stages.

“We were very pleased to see that a simplified DNA marker panel could reliably detect such a large percentage of early stage colorectal cancers in a highly reproducible way,” commented Steven Itzkowitz, M.D., Professor of Medicine and Principal Investigator of the study. “It is also very gratifying to learn that this important study has been accepted for publication at a time when more attention is being focused on stool-based DNA detection for the millions of people who resist more invasive procedures.”

“Demonstrating that certain advances in molecular diagnostics that we discovered in my lab and licensed to EXACT Sciences can directly contribute to early cancer detection, and can be delivered in a non-invasive way, is a very exciting prospect for the health of our nation,” commented Sanford Markowitz, MD, PhD, of Case Western Reserve University Department of Medicine. “From my standpoint, working with DNA and stool-based detection offers exciting avenues for ongoing research, even exploring non-invasive detection of pre-cancerous lesions, the important precursors to colon cancer.”

“Ever since the first studies on the utility of stool-based DNA for colorectal cancer detection appeared, we have seen regular improvement in test performance, efficiency, and simplicity,” commented Jeffrey R. Luber, President and Chief Executive Officer of EXACT Sciences Corporation. “Acceptance for publication of this latest study on our Version 2 technology underscores the rapid advancement in this area and the importance that the scientific and clinical community place on stool-based DNA detection of colorectal cancer.”

About Colorectal Cancer

Colorectal cancer is the most deadly cancer among non-smoking men and women in the United States, and the second most deadly cancer overall. The American Cancer Society estimates that nearly 150,000 cases will be diagnosed and 50,000 deaths are anticipated in 2008 due to this disease. Despite the availability of colorectal cancer screening and diagnostic tests for more than 20 years, the rate of early detection of colorectal cancer remains low, and deaths remain high. It is estimated that roughly one-third of colorectal cancer-related deaths could be saved if more people underwent regular screening. Early diagnosis results in a greater than 90 percent, five-year survival rate.

EXACT Sciences Corporation

EXACT Sciences Corporation uses applied genomics to develop patient-friendly screening technologies for use in the detection of cancer. EXACT maintains an exclusive license agreement with Laboratory Corporation of America(R) Holdings (LabCorp(R)) relating to the Company’s intellectual property. EXACT Sciences’ stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer (a group comprised of representatives from the American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy), and the American College of Radiology. EXACT Sciences is based in Marlborough, Mass.

Certain statements made in this press release that are not based on historical information are express or implied forward-looking statements relating to, among other things, EXACT Sciences’ expectations concerning the efficacy of its colorectal cancer screening technology, the publication of the clinical study on its Version 2 technology and management’s plans, objectives and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond EXACT Sciences’ control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, the clinical performance and market acceptance of its technologies; the reproducibility of its research results in subsequent studies and in clinical practice; sufficient investment in the sales and marketing of EXACT Sciences’ technologies; the success of its strategic relationship with LabCorp; EXACT Sciences’ ability to license certain technologies or obtain raw materials for its technologies; the ability to convince Medicare and other third-party payors to provide adequate reimbursement for EXACT Sciences’ technologies; the ability to convince medical practitioners to order tests using EXACT Sciences’ technologies; the ability to increase the performance of our technologies; the ability of EXACT Sciences or LabCorp to lower the cost of stool-based DNA screening technologies through automating and simplifying key operational processes; the number of people who decide to be screened for colorectal cancer using EXACT Sciences’ technologies; competition; the ability to protect EXACT Sciences’ intellectual property and the cost of enforcing or defending EXACT Sciences in litigation relating to intellectual property rights; the possibility that other companies will develop and market novel or improved methods for detecting colorectal cancer; and the ability to raise additional capital on acceptable terms. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. EXACT Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by EXACT Sciences, see the disclosure contained in EXACT Sciences’ public filings with the Securities and Exchange Commission including, without limitation, its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC.

By Don Nelson, Athens Banner-Herald, Ga.

Jun. 15–Pat Nielsen’s personal and professional life has been preparing the Athens nurse for the birth of her own small business, which she plans to open Saturday on Gaines School Road.

Full Bloom Pregnancy & Early Parenting Center will open as a community resource for young moms and dads and is a support center combined with a retail shop for expecting and new parents, Nielsen said.

The business will offer holistic childbirth and early parenting classes; breastfeeding and postpartum support; and referrals for doulas — someone who provides physical, emotional and educational support in prenatal care, during childbirth and during the postpartum period. Other classes will cover how to wear baby carriers and slings.

Full Bloom’s services will include prenatal massage, prenatal yoga, discussion groups and book clubs for parents, and Nielsen hopes the center will serve as a gathering place for people to relax and enjoy the company of other parents and children.

The retail side of the center will sell labor and birth products, breastfeeding supplies and clothing, cloth diapers and accessories, glass and bisphenyl-A free bottles, nursing bras, slings and baby carriers, skin-care products, books, magazines, journals, music and more.

Full Bloom won’t be selling cribs and mattress sets, and the majority of merchandise for sale represents items people currently are purchasing through the Internet, which means parents can’t try it on or feel it before buying it, Nielsen said. Internet purchases also often mean the items can’t be found locally.

“I’m selling things parents can’t get locally easily,” she said.

One room in the center will serve as a reference room with books and magazines available for customers to browse and study and purchase if they want them at home.

Nielsen is no stranger to the joy and challenges presented by parenthood.

She and her husband, Roger, have two children (now 28 and 23) of their own.

But she also has spent more than 25 years as a registered nurse working with pregnant women and providing support and education to young parents.

“Those early days of being a parent and making decisions can be really daunting, and sometimes you need a place to get holistic help, where you’re looking at the whole person and their needs and wants,” Nielsen said.

For the past 11 years, Nielsen has provided childbirth and young parenting education at Athens Regional Medical Center, she said. She left that job in December to pursue this dream she nurtured of giving even more support and advice to mothers and fathers.

“This is a huge leap of faith, because I had a job I loved,” Nielsen said.

“Leaving (ARMC) and taking this on took a lot of thought, but it’s something I think is really, really important.” The classes Nielsen taught at ARMC couldn’t cover all the ground she felt was essential to new parents, and there is a strong need for extra information and resources as well as support, she said.

Many young couples don’t have families close by or are transient, so they don’t have a network of people to help them with questions and problems they might face as new parents, she said.

“Full Bloom will provide a place where support is available, and there will always be a trained, professional person there, if not me someone else,” Nielsen said. “They also need someone just to kind of hold their hand and say they’re doing a great job.” Besides being a registered nurse, Nielsen is a birth and postpartum doula, lactation counselor, birth photographer and certified childbirth educator.

Nielsen earned a journalism degree and obtained her master’s in health education from Kent State in Ohio. She completed her associate degree in nursing through North Central Technical College in Mansfield, Ohio, and spent a year on a medical surgical team at Samaritan Hospital in Ashland, Ohio, before moving to maternal-child nursing at Samaritan. She spent about 10 years working in maternal-child nursing at a time when nurses covered a broader spectrum of duties in that field.

“I got my feet wet in that environment,” Nielsen said. “Now everything is divided up into labor and delivery, postpartum care and more.” Nielsen moved to Athens in 1992 with her family and began working with Athens Regional Medical Center’s labor and delivery unit, where she spent about a year. She moved to ARMC’s nurse midwives unit for three years and then began working in ARMC’s health education division with a focus on pregnancy.

A number of friends and parents whom Nielsen has helped in the past, have helped Nielsen renovate the former bridal shop on Gaines School Road and get Full Bloom ready to open. One of those friends, artist Angie Reuter, painted a variety of murals that provide a colorful and whimsical touch to the center.

“I don’ t have a partner, but feel like I have a lot of partners,” she said.

She hopes this new resource and retail center for young parents also will help establish lifelong friendships for the people who use it.

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To see more of the Athens Banner-Herald, or to subscribe to the newspaper, go to http://www.onlineathens.com.

Copyright (c) 2008, Athens Banner-Herald, Ga.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

GlaxoSmithKline has announced the FDA approval of Requip XL in the US for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

GlaxoSmithKline’s Requip XL is said to be the first and only oral once-daily non-ergot dopamine agonist indicated for Parkinson’s disease. The product should be available in pharmacies in mid-July 2008.

Requip XL is an extended-release, once-daily tablet formulation that uses SkyePharma’s patented Geomatrix technology. This innovative tri-layer formulation allows for continuous delivery of ropinirole over 24 hours to provide smooth blood levels.

According to the company, Requip XL offers physicians and patients a simple titration regimen; it also offers a convenient, once-daily dosing schedule compared to other oral dopamine agonists, which are dosed multiple times a day.

By Patricia Anstett, Detroit Free Press

Jun. 16–The Michigan Bariatric Surgery Collaborative will have more complete information within the next year about a promising new bariatric option, sleeve gastrectomy.

The operation, through which tiny surgical tools are inserted through keyhole-sized incisions, removes 85% of the stomach, creating a banana-shaped or sleeve-like organ.

To date, there is only one-year follow-up data on 10 patients in the registry who had the operation — too little to be statistically valid. But as the procedure grows — 14 surgeons at eight Michigan hospitals offer it — more people are asking about it because of the promise it holds for the most morbidly obese people.

It might cause fewer complications and may not create lifelong vitamin deficiency and food absorption problems associated with other gastric bypass operations, some doctors say.

Dr. John Birkmeyer, director of bariatric surgery at the University of Michigan Health System in Ann Arbor said it is too early to know whether people will sustain weight loss achieved in the first year after sleeve gastrectomy surgery.

“The durability of weight loss over time is still a very open question,” Birkmeyer said, who prefers minimally invasive gastric bypass surgery for now, at least.

Over time, the reconstructed, smaller stomach may stretch and lose its effectiveness, Birkmeyer said. He also wants more data to demonstrate the procedure is safer than others.

Dr. Abe Hawasli, a St. John Hospital and Medical Center bariatric surgeon who has offered sleeve gastrectomy since 2004, said his statistics show the operation is safe and lasting.

“The results are excellent,” Hawasli said. “There are virtually no side effects. There’s no foreign body, no band that will slip or erode in the future.”

The operation suppresses a hormone that generates hunger sensations and helps patients achieve more weight loss than with other procedures, he said.

Hawasli also offers a so-called reversal procedure to perform sleeve gastrectomy in people who had other bariatric procedures that failed to produce significant weight loss, he said.

“It works much better than Lap-Band and other procedures,” Hawasli said.

For now, reimbursement for the surgery, which costs $23,000 to $30,000, varies.

Blue Cross Blue Shield of Michigan pays for it only as part of a multistage procedure for morbidly obese people, high-risk patients with a body mass index of 50 of more.

Carey Bartosiewicz, 34, of Clinton Township, one of Hawasli’s patients, has been turned down twice by Aetna Inc. for a sleeve gastrectomy procedure.

Now she’s trying to make the case with Aetna to have a Lap-Band procedure. She’s joined a health club, tries to restrict herself to a modest 2,000-calories-a-day diet and goes to a doctor regularly, as Aetna requires, to monitor her weight-loss progress.

“At this point, I’ll do anything,” said Bartosiewicz, who weighs 405 pounds and has many health problems: high blood pressure, sleep apnea, edema, shortness of breath, arthritis and depression and anxiety, all common among severely overweight people.

Another of Hawasli’s patients, Robert Haas, 55, of Southfield, considers himself fortunate that Blue Cross paid for his sleeve procedure in June 2007. He now weighs 196 pounds, down from 360 pounds.

“I’ve never felt better,” said Haas, a teacher at the Michigan Department of Corrections.

—–

To see more of the Detroit Free Press, or to subscribe to the newspaper, go to http://www.freep.com

Copyright (c) 2008, Detroit Free Press

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

NYSE:AET,

PARSIPPANY, N.J., June 16 /PRNewswire/ — A new study published in the current Journal of the American Society of Hypertension demonstrates that the hypertension treatment olmesartan medoxomil was effective in reversing the narrowing of the arteries that occurs in patients with hypertension. The study, titled VIOS (Vascular Improvement with Olmesartan medoxomil Study) was a one-year, exploratory study that evaluated the effects of an angiotensin receptor blocker (olmesartan medoxomil) vs. a beta-blocker (atenolol) on vascular function and structure in patients with Stage 1 hypertension, independent of the blood pressure lowering effects of these agents.(1)

In the VIOS trial, olmesartan medoxomil, through early blockade of angiotensin II, improved the structure abnormalities of resistance arteries in patients with hypertension as measured by arterial wall to lumen ratio (W/L), returning arterial architecture to normal levels after one year of treatment. This protective effect was not seen with the comparator agent in the study, atenolol.(2) Olmesartan medoxomil is marketed in the United States by Daiichi Sankyo, Inc., as BENICAR(R). BENICAR and BENICAR HCT(R) (olmesartan medoxomil/hydrochlorothiazide) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. BENICAR HCT is not indicated for initial therapy. BENICAR and BENICAR HCT have not been FDA approved for other indications such as end organ disease or other hypertension related morbidity.

“We believe the VIOS data add to the growing evidence for the role of angiotensin receptor blockers in preventing or reversing vascular damage at many stages during this disease process,” said Carlos M. Ferrario, M.D., one of the study’s lead investigators and Professor and Director of Hypertension and Vascular Research Center, Wake Forest University School of Medicine.

Angiotensin II has been linked to vascular dysfunction and end-organ damage, including cardiac hypertrophy and renal injury.(3,4,5) Previous studies have demonstrated a beneficial effect of ACE inhibitors or other angiotension II receptor blockers (ARBs) in the reversal of vascular hypertrophy in hypertensive subjects.(6,7,8,9,10,11,12)

Hypertension is one of the most prevalent conditions in the United States, affecting one in three Americans.(13) Long-standing, uncontrolled hypertension can damage the brain, the eyes, the heart and the kidney.(14) Antihypertensive agents that inhibit the renin-angiotensin system, such as angiotensin-converting enzyme inhibitors or ARBs, have demonstrated substantially greater effects on end-organ repair in the kidney and the heart.(15,16,17,18)

VIOS Study Design

The study was a randomized, controlled, open-label, one-year study. The primary endpoint of this study was the change in the morphological characteristics of resistance arteries as determined by differences in the wall (media)/lumen (W/L) ratio. This parameter was measured using a pressurized myograph procedure on arteriole biopsy samples obtained from a sub-group of 49 patients receiving treatment (27 were on olmesartan and 22 were on atenolol) and from 11 normotensive control subjects.(19)

Non-diabetic patients with Stage 1 hypertension (61% male; age 38 to 67 years) were randomized after a 4-week washout period to olmesartan medoximil 20 to 40 mg or atenolol 50 to 100 mg plus additional agents (hydrochlorothiazide 12.5-25 mg, amlodipine 5-10 mg, or hydralazine 50-100 mg twice daily) as needed for a goal BP of

VIOS Study Results

The arteriolar dimensions (W/L Ratios) in the olmesartan medoxomil and atenolol-based treatment groups were similar prior to drug treatment (14.9% and 16% respectively) whereas arteries from the normotensive subjects had significantly smaller W/L ratios (11%). At the end of the study the W/L ratio in the olmesartan medoxomil-based treatment group was significantly reduced (from 14.9% to a mean of 11.1%; P

This study was supported through an unrestricted grant from Daiichi Sankyo, Inc.

Ongoing Studies with Olmesartan Medoxomil

Olmestartan medoxomil is currently being reviewed in several outcomes trials, including the landmark “Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention Study” or ROADMAP trial. This is a Phase IV multinational clinical study to investigate the drug’s effectiveness in preventing early stage kidney disease in patients with type 2 diabetes. The trial is being conducted at 200 sites in 20 countries involving 4,400 patients. Another study, titled “Olmesartan Reducing Incidence of End stage renal stage in diabetic Nephropathy Trial,” or ORIENT, targeting Japanese and Hong Kong Chinese patients, is investigating the suppressive effects of the drug against the progression of diabetic nephropathy.

About BENICAR and BENICAR HCT

Angiotensin II is a hormone that interacts with a receptor on arterial blood vessels, which results in constriction and increasing blood pressure. In addition, angiotensin II stimulates the release of another hormone that causes enhanced sodium and chloride (salt) retention, with a resultant increase in vascular water retention and blood volume that also contributes to an elevation in blood pressure. BENICAR is a member of the ARB class of antihypertensive medications that help lower blood pressure by blocking the angiotensin II receptor on the blood vessels and antagonizing the release of the hormone which causes salt retention and increased blood volume. BENICAR HCT combines BENICAR with the diuretic hydrochlorothiazide.

BENICAR and BENICAR HCT are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. BENICAR HCT is not indicated for initial therapy.

   Important Safety Information    USE IN PREGNANCY  

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, BENICAR or BENICAR HCT should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality in the prescribing information.

Hypotension in Volume- or Salt-Depleted Patients

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with BENICAR. Treatment should start under close medical supervision. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.

The prescribing information for BENICAR HCT also includes the following warnings regarding its hydrochlorothiazide component:

BENICAR HCT is not recommended in patients with severe renal impairment and is contraindicated in patients with anuria or hypersensitivity to other sulfonamide derived drugs.

Fetal/Neonatal Morbidity and Mortality

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Hepatic Impairment

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hypersensitivity Reaction

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

Systemic Lupus Erythematosus

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

   Lithium Interaction   Lithium generally should not be given with thiazides.    Adverse Events   -- The withdrawal rates due to adverse events (AEs) were similar with      BENICAR and BENICAR HCT to placebo: BENICAR (2.4% vs 2.7%); BENICAR HCT      (2.0% vs 2.0%)   -- The incidence of AEs with BENICAR and BENICAR HCT was similar to      placebo   -- The only AE that occurred in > 1% of patients treated with BENICAR and      more frequently than placebo was dizziness (3% vs 1%)   -- AEs reported in > 2% of patients taking BENICAR HCT and more frequently      than placebo included nausea (3% vs 0%), hyperuricemia (4% vs 2%),      dizziness (9% vs 2%), and upper respiratory tract infection (7% vs 0%)     Dosing and Administration   -- No initial dosage adjustments are recommended with BENICAR in elderly      or in moderate to marked renal impairment*/hepatic dysfunction   -- In patients with possible depletion of intravascular volume (eg,      patients on diuretics, particularly with impaired renal function),      BENICAR should be initiated under close medical supervision and      consideration given to use of a lower starting dose   -- For BENICAR HCT, dose selection for an elderly patient should be      cautious, usually starting at the low end of the dosage range     *Creatinine clearance 
 Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd., Japan's second largest pharmaceutical company and a global leader in pharmaceutical innovation since 1899. The company is dedicated to the discovery, development and commercialization of innovative medicines that improve the lives of patients throughout the world. 
 The primary focus of Daiichi Sankyo's research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. The company is also pursuing the discovery of new medicines in the areas of glucose metabolic disorders, infectious diseases, cancer, bone and joint diseases, and immune disorders. For more information, please visit http://www.dsus.com/. 
   1.  Smith, Ronalde et al. "Reversal of vascular hypertrophy in       hypertensive patients through blockade of angiotensin II receptors.       J Am Soc Hypertension 2008;2(3);165-172   2.  Smith, Ronalde et al. "Reversal of vascular hypertrophy in       hypertensive patients through blockade of angiotensin II receptors.       J Am Soc Hypertension 2008;2(3);165-172   3.  Intengan, HD et al. Resistance Artery Mechanics, Structure, and       Extracellular Components in Spontaneously Hypertensive Rats: Effects       of Angiotensin Receptor Antagonism and Converting Enzyme Inhibition.       Circulation 1999;100;2267-75   4.  Schiffrin EL, Park JB, Intengan HD, Touyz RM. Correction of arterial       structure and endothelial dysfunction in human essential hypertension       by the angiotensin receptor antagonist losartan. Circulation       2000;101:1653-9.   5.  Schiffrin EL. Vascular and cardiac benefits of angiotensin receptor       blockers. Am J Med 2002;113:409-18.   6.  Schiffrin EL, Park JB, Intengan HD, Touyz RM. Correction of arterial       structure and endothelial dysfunction in human essential hypertension       by the angiotensin receptor antagonist losartan. Circulation 2000;101:       1653-9.   7.  Mulvany MJ. Effects of angiotensin-converting enzyme inhibition on       vascular remodeling of resistance vessels in hypertensive patients.       Metabolism 1998;47(12 suppl1):S20-3   8.  Schiffrin EL, Park JB, Pu Q. Effect of crossing over hypertensive       patients from a beta-blocker to an angiotensin receptor antagonist on       resistance artery structure and on endothelial function. J Hypertens       2002;20:71-8   9.  Thybo NK, Stephens N, Cooper A, Aalkjaer C, Heagerty AM, Mulvany MJ.       Effect of antihypertensive treatment on small arteries of patients       with previously untreated essential hypertension. Hypertension 1995;       25:474-81   10. Schiffrin EL, Deng LY, Larochelle P. Effects of a beta-blocker or a       converting enzyme inhibitor on resistance arteries in essential       hypertension. Hypertension 1994;23:83-91   11. Schiffrin EL, Deng LY. Structure and function of resistance arteries       of hypertensive patients treated with a beta-blocker or a calcium       channel antagonist. J Hypertens 1996;14:1247-55   12. Schiffrin EL. Remodeling of resistance arteries in essential       hypertension and effects of antihypertensive       treatment. Am J Hypertens 2004;17:1192-200   13. http://www.americanheart.org/presenter.jhtml?identifier=4621 Site       accessed 4/18/2008   14. High Blood Pressure; Why Should I Care.       http://www.americanheart.org/presenter.jhtml?identifier=2129 Site       accessed 6/3/2008   15. Lewis, EJ. The Role of Angiotensin II Receptor Blockers in Preventing       the Progression of Renal Disease in Patients with Type 2 Diabetes. Am       J Hypertension 2002;15;123S-8S   16. Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal       and cardiovascular outcomes in patients with type 2 diabetes and       nephropathy. N Engl J Med 2001;345:861-9.   17. Dahlof B, Pennert K, Hansson L. Reversal of left ventricular       hypertrophy in hypertensive patients. A metaanalysis of 109 treatment       studies. Am J Hypertens 1992;5:95-110.   18. Dahlof B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity       and mortality in the Losartan Intervention For Endpoint Reduction in       Hypertension Study (LIFE): a randomized trial against atenolol. Lancet       2002;359:995-1003.   19. Smith, Ronalde et al. "Reversal of vascular hypertrophy in       hypertensive patients through blockade of angiotensin II receptors.       J Am Soc Hypertension 2008;2(3);165-172   20. Smith, Ronalde et al. "Reversal of vascular hypertrophy in       hypertensive patients through blockade of angiotensin II receptors.       J Am Soc Hypertension 2008;2(3);165-172   21. JNC 7 = The Seventh Report of the Joint National Committee on       Prevention, Detection, Evaluation and Treatment of High Blood Pressure       (JNC 7), which issued new guidelines in 2003 for hypertension       prevention and management.   22. Smith, Ronalde et al. "Reversal of vascular hypertrophy in       hypertensive patients through blockade of angiotensin II receptors.       J Am Soc Hypertension 2008;2(3);165-172     For more information, please contact:    Kimberly Wix                                       Rich Salem   Daiichi Sankyo, Inc.                               Daiichi Sankyo, Inc.   Office: 973 695 8338                               Office: 973 695 8330   Cell: 908 656 5447                                 Cell: 973 563 1086   [email protected]                                      [email protected]  
 Daiichi Sankyo, Inc. 
 CONTACT:  Kimberly Wix, Office, +1-973-695-8338, Cell, +1-908-656-5447,[email protected]; or Rich Salem, Office, +1-973-695-8330, Cell, +1-973-563-1086,[email protected], both of Daiichi Sankyo, Inc. 
 Web site:  http://www.dsus.com/

BOSTON, June 16 /PRNewswire-FirstCall/ — Experts from PAREXEL International Corporation , a leading global biopharmaceutical services organization, will present in more than 20 sessions at the Drug Information Association (DIA) 44th Annual Meeting. The meeting will be held June 22 — 26, 2008 at the Boston Convention and Exhibition Center in Boston, Massachusetts, home to PAREXEL’s global headquarters office. PAREXEL experts will address key industry topics including global regulatory and drug development strategy, multinational clinical studies, and data-driven patient recruitment, as well as biosimilars, gene therapy regulations, genomics study methods, early-stage biotechnology product development, nanotechnology, and medical imaging biomarkers.

For more than 25 years clients have relied on PAREXEL to provide in-depth expertise in integrated clinical development, medical communications, and regulatory affairs, as well as advanced technologies that help clients expedite time-to-market and peak-market penetration. Attendees at the DIA Annual Meeting can visit PAREXEL experts at Booth #803 in the exhibit hall. Demonstrations of the Company’s technologies, including the market-leading Clinical Trial Management System IMPACT(R) technology, will be provided by PAREXEL’s technology subsidiary, Perceptive Informatics.

   PAREXEL experts will present or chair the following sessions:    Sunday, June 22    -- A Device Primer: IDEs, 510(k)s, PMAs, and Beyond -- Barry Sall,      Principal Consultant, PAREXEL Consulting (8:30 a.m. -- 12:00 p.m.)     Monday, June 23    -- Regulatory Strategy as a Key Component of the Global Multidisciplinary      Drug Development Strategy: Regulatory Intelligence as a Foundation for      Business Success -- Paul Bridges, Vice President, PAREXEL Consulting      (10:30 a.m. -- 12:00 p.m.)    -- Generic Biologics:  Fact or Fiction? The Next Generation of Biosimilars      -- Cecil Nick, MS, Vice President, Biotechnology, PAREXEL Consulting      (1:30 p.m. -- 3:00 p.m.)    -- Hot Topics in Biotechnology: Algorithm for Cell Bank Characterization      -- Ralf Dieter Hess, PhD, MSc, Principal Consultant, PAREXEL Consulting      (3:30 p.m. -- 5:00 p.m.)     Tuesday, June 24    -- Negotiating IT Contracts: Speeding Up the Process and Finding Common      Ground: CRO Perspective -- Cynthia Grubbs, Vice President of Worldwide      Procurement, PAREXEL (8:00 a.m. -- 9:30 a.m.)    -- Doing the Project Planning for Large Multinational Clinical Trials: Key      Aspects to Be Considered when Planning and Executing Global Clinical      Trials -- Session Chair and Speaker: Diego Martin Glancszpigel, MEd,      Vice President of Latin American Operations, Clinical Research      Services, PAREXEL (8:00 a.m. -- 9:30 a.m.)    -- The European Regulatory Landscape for Gene Therapy Clinical Trials      -- Beate Roder, PharmD, PhD, Senior Consultant, PAREXEL Consulting      (10:00 a.m. -- 11:30 a.m.)    -- Gene Therapy Regulations for EU Clinical Trials: Navigating the Maze      -- Session Chair: Cecil Nick, MS, Vice President, Biotechnology,      PAREXEL Consulting, UK (10:00 a.m. -- 11:30 a.m.)    -- Building a Strong EDC Foundation through the Power of Partnership      Trials -- Drew Garty, Senior Director, Worldwide EDC Solutions,      Clinical Research Services, PAREXEL (10:00 a.m. -- 11:30 a.m.)    -- Deal Makers and Deal Breakers: What Venture Capital Firms Look for in      Drug Development Plans -- Session Chair: Alberto Grignolo, PhD,      Corporate Vice President and General Manager, PAREXEL Consulting      (10:00 a.m. -- 11:30 a.m.)    -- Data-driven Patient Recruitment: Tools for Early Planning and      Predictive Management: Approaches to Data-driven Site Selection and LPI      Planning -- Session Chair and Speaker: Joshua Schultz, MS, Vice      President, Clinical Research Services, PAREXEL (2:00 p.m. -- 3:30 p.m.)    -- Innovative Medicines and the EMEA: Strategizing for Success in the EU      -- Session Chair and Speaker: Cecil Nick, MS, Vice President,      Biotechnology, PAREXEL Consulting (2:00 p.m. -- 3:30 p.m.)    -- Evolving Natural Health Products Market Size and Its Development.      Cosmeceuticals: Marketing Topical Products without Making Licensable      Medicinal Claims in Europe -- Peter Lassoff, PharmD, Vice President,      PAREXEL Consulting (4:00 p.m. -- 5:30 p.m.)     Wednesday, June 25    -- Imaging Biomarker Data Management: Qualification and Validation of      Imaging Biomarkers -- George Q. Mills, MD, Vice President, Medical      Imaging Consulting, Perceptive Informatics (8:30 a.m. -- 10:00 a.m.)    -- Biosimilars/Follow-on Biologics: Unique Aspects of the Development of      Follow-On Biologics Products -- Session Chair and Speaker: Bruce      Babbitt, PhD, Principal Consultant, PAREXEL Consulting     (8:30 a.m. -- 10:00 a.m.)    -- The Expanding Use of Genomics Studies Methods, Regulatory      Considerations and the Impact on Evidence-Based Medicine -- Session      Chair: Nayan Nanavati, MS, MT, Vice President Peri Approval, Americas,      PAREXEL; Speaker: Ramita Tandon, Director, Project Management, Clinical      Research Services, PAREXEL (8:30 a.m. -- 10:00 a.m.)    -- Opportunities and Challenges of Globalizing Clinical Research: Adding      Value to Early-stage Biotechnology Product Development -- Matthias      Grossmann, MD, PhD, Vice President and Principal Consultant, Clinical      Pharmacology, PAREXEL (10:30 a.m.-- 12:00 p.m.)    -- Understanding the Regulation of Advanced Therapy Medicinal Products in      Europe, Introduction to the New Regulations on Advanced Therapy      Medicinal Products -- Session Chair and Speaker: Ralf Dieter Hess, PhD,      MSc, Principal Consultant, PAREXEL Consulting (1:30 p.m. -- 3:00 p.m.)    -- Outsourcing in China: Opportunities and Challenges Decision Models and      Case Study -- Session Chair and Speaker: Simon Wang, MBA, MSc, Manager,      PAREXEL APEX International (1:30 p.m. -- 3:00 p.m.)    -- Nanotechnology Task Force: Regulating Nanotechnology Products, FDA's      Exploratory IND Guidance: Transitioning Nanotechnology Drugs/Biologics      -- Session Chair and Speaker: George Q. Mills, MD, Vice President,      Medical Imaging Consulting, Perceptive Informatics     (3:30 p.m. -- 5:00 p.m.)    -- Leveraging Technology to Build an IT Infrastructure for Global Clinical      Trials, Scaling EDC Solutions to Meet the Needs of Large-Scale Global      Trials -- Ian Sparks, Consultant, Worldwide EDC Solutions Group,      Clinical Research Services, PAREXEL (3:30 p.m. -- 5:00 p.m.)    

The DIA Annual Meeting attracts approximately 8,000 attendees, bringing together professionals from the biopharmaceutical and related industries. This year’s meeting will feature nearly 360 sessions across 26 tracks and will cover several hot topics including adaptive trials and methods, patient recruitment and retention, multinational clinical trials, clinical and regulatory considerations for personalized medicine, and various biotechnology related topics.

For more information about PAREXEL visit http://www.parexel.com/ or Booth #803 at the DIA Annual Meeting.

About PAREXEL International

PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 63 locations throughout 52 countries around the world, and has more than 7,600 employees. For more information about PAREXEL International visit http://www.parexel.com/.

This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,””anticipates,””plans,””expects,””intends,””appears,””estimates,””projects,””targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2008 as filed with the SEC on May 9, 2008, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.

PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of their respective business and are hereby acknowledged.

   Contacts:   Jennifer Baird, Senior Director of Public Relations   PAREXEL International   Tel: +781-434-5033   Email: [email protected]    Rebecca Passo   SHIFT Communications   Tel: +617-779-1817   Email: [email protected]  

PAREXEL International Corporation

CONTACT: Jennifer Baird, Senior Director of Public Relations, of PAREXELInternational Corporation, +1-781-434-5033, [email protected]; orRebecca Passo of SHIFT Communications, +1-617-779-1817, [email protected]

Web site: http://www.parexel.com/

By Jim Hall, The Free Lance-Star, Fredericksburg, Va.

Jun. 16–An urgent-care clinic opens today, and more are on the way.

MediCorp Health System enters the market with a walk-in center off State Route 3 in the Harrison Crossing shopping center in Spotsylvania County.

The parent company of Mary Washington Hospital also plans two more of these clinics in Stafford County.

They’ll be joined this summer by three MinuteClinics inside CVS pharmacies, and in September, by another Prime Care center in Spotsylvania County.

The region has at least nine urgent-care centers, from North Stafford to Ladysmith to the Spotsylvania Courthouse.

All feature evening and weekend hours, accept most insurances and don’t require appointments. Many have lab and X-ray capability, and now boast electronic record-keeping.

The clinics are staffed by doctors or nurse practitioners, who specialize in the treatment of minor illnesses and injuries. Parents also use them for sports or school physicals for their children. Employers purchase drug screening for their employees.

Many times the clinics also become the medical home for patients with chronic problems, such as high blood pressure or diabetes.

“Patient like the convenience,” said Dr. Clif Sheets, one of the owners of Prime Care. “They like the ability that they can walk in when they’re sick and be seen when they’re sick.”

MediCorp will operate its clinics in partnership with NextCare Urgent Care.

The Harrison Crossing center is NextCare’s first in Virginia and 31st overall. The company is based in Arizona, with other clinics in Colorado, Georgia, Texas and North Carolina.

MediCorp will be 80 percent owner of the Fredericksburg-area clinics, said Dr. John Shufeldt, Next-Care’s chief executive officer.

“Without MediCorp, we wouldn’t be here,” he added.

Dr. Sebastian Sicari will be medical director for the three Fredericksburg centers.

For the last nine years, Sicari has worked with Dr. Phil Bustin at the Medical Center of Stafford on Garrisonville Road.

He is board certified in family practice and a resident of Spotsylvania County.

MediCorp’s two other walk-in centers are expected to open late this year and early next year. They will be built on White Oak Road and Warrenton Road, both in southern Stafford.

Prime Care is owned by local physicians. Its original clinic is on Salem Church Road. A second is under construction at the intersection of Courthouse and Smith Station roads.

Sheets said he does not fear market saturation since the area continues to grow.

“Right now, my attitude is the water’s warm, come on in,” he said.

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To see more of The Free Lance-Star or to subscribe to the newspaper, go to http://fredericksburg.com/flshome.

Copyright (c) 2008, The Free Lance-Star, Fredericksburg, Va.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

Bombay:524794,

By Frank Sojak, Tribune-Democrat, Johnstown, Pa.

Jun. 16–Sheena Endress is a fancy dresser.

When it comes to dressing a wound, nothing washes away the pain better than a colorful bandage dotted with cartoon characters, she says.

For nearly a dozen years, Endress has been collecting cartoon bandages to donate to hospitals for use on children.

Endress’ project, called the Cartoon Band-Aid Drive, has attracted many others to assist her in her cause. The total number of bandages that Endress and the others have donated to hospitals the past 11 years is more than 220,000.

Recently, she donated 4,000 cartoon Band-Aid bandages to Memorial Medical Center. She has another 5,000 that she soon will deliver to Windber Medical Center.

“To see a little child smile when they get a Cartoon Band-Aid is great,” Endress said. “It makes their whole day.”

It is more soothing for children with an injury to have a cartoon bandage covering their wound because the bandages contain the images of cartoon characters that are familiar to them, she said.

“Plus they look cool,” she said. “I still wear them.”

Endress, a 2007 graduate of Windber Area High School, came up with the idea of donating bandages 11 years ago while battling von WilleBrand’s disease, an illness that affects the blood’s ability to clot properly.

During frequent visits to Children’s Hospital in Pittsburgh to fight the disease, Endress asked the nurses why they used plain brown bandages and not cartoon bandages when they were finished taking blood from her.

She was told that fancy bandages were not in the hospital’s budget.

Endress, 8 years old at the time, then came up with a plan to donate cartoon bandages to the hospital.

Living in Fishertown at the time and a member of the Girl Scouts, she asked her mother, Susan, her troop’s leader, if they could start a project to collect cartoon bandages for the hospital.

Endress received permission and the first year her troop, with the help of several neighboring troops, collected 5,000 bandages for Children’s Hospital.

The program has become a tradition in Fishertown with Girl Scouts collecting about 200,000 bandages in 11 years.

The troops offer badges to girls for their efforts. The badge is dedicated to Endress and to the late Kay Lynn Lohr, a Girl Scout leader who was instrumental in the project.

Although Endress moved to Windber four years ago, the Girls Scouts in Fishertown continue to collect bandages, donating them to UPMC Bedford Memorial and Children’s Hospital.

“I’m very glad that they are still doing so,” she said. “That shows how much they care about others.”

Endress now collects them on her own with her mother and sister, Lindsey, donating them to Memorial and Windber medical centers and West Penn Hospital in Pittsburgh.

They collected 13,000 this year.

She said the donations through the years have come from people in the community who drop boxes of bandages off at containers placed at businesses and workplaces.

Endress, who will graduate in August from IUP’s Culinary School in Punxsutawney, has landed a position as a chef at a Colorado resort. She plans to continue the project there.

For her efforts, Endress is the Person of the Week.

Amy Bradley, a spokeswoman for Memorial Medical Center, said they are impressed with Endress’ commitment and generosity.

“She presented a wide variety of fun Band-Aids that our young patients will really enjoy.”

Dr. Daniel Wehner, chairman of Memorial’s emergency department, said it’s wonderful that Endress has been able to use her experience to help children.

“The cartoon Band-Aids are definitely a great way to help put children at ease during a difficult and sometimes painful situation, so we’ll definitely make good use of them in our emergency room.”

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To see more of The Tribune-Democrat or to subscribe to the newspaper, go to http://www.tribune-democrat.com.

Copyright (c) 2008, Tribune-Democrat, Johnstown, Pa.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

By Sharon K. Wolfe, The Pantagraph, Bloomington, Ill.

Jun. 16–BLOOMINGTON — The 90th annual meeting of the McLean County Association for Home and Community Education and the University of Illinois Extension-McLean County is July 8. It begins with registration at 8:30 a.m. and ends at 3:30 p.m.

The event is sort of trip down memory lane with displays dating from 90 years where homemaking was the focus. While that is still important, the current HCA sends packages to overseas troops and has lessons such as “Blues, Blahs and Bouncing Back.”

Displays will include old sewing items, kitchen utensils, aprons and old-time laundry methods. The style show will include a variety of vintage clothing and more current styles.

“To me, it’s like adult 4-H,” said Pat Pulokas, longtime member. “It’s like continuing education for life.”

“If I didn’t have fun — I wouldn’t be in this,” she said. She noted, however, with so many women in the workforce, the numbers are less. “I just wish more people could experience it.”

Tickets of $20 a person cover the entire day. Deadline for reservations and money is June 20. Tickets are available by calling (309) 452-9154, (309) 473-2283 or (309) 963-5552.

——

GO!

What: 90th annual meeting, McLean County Association for Home and Community Education

When: July 8; business meeting 9:30 a.m., memorial service 11:15 a.m., lunch 11:45 a.m., style show 1 p.m., displays 8:30 a.m. to 3 p.m.

Where: Interstate Center, 2301 W. Market St., Bloomington

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To see more of The Pantagraph, or to subscribe to the newspaper, go to http://www.pantagraph.com.

Copyright (c) 2008, The Pantagraph, Bloomington, Ill.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

Mechelen, Belgium; 16 June 2008 – Galapagos NV (Euronext: GLPG) announced today that it has reached two new milestones in its multi-year drug discovery alliance with GlaxoSmithKline

in osteoarthritis, triggering a payment of EUR 0.8 million from GSK.

In June 2006, GSK’s Center of Excellence for External Drug Discovery (CEEDD) and Galapagos initiated a program to deliver disease-modifying drugs with clinical Proof of Concept to GSK’s global research and development organization. The aim of this agreement is for Galapagos to expand its portfolio of novel targets in the field of osteoarthritis, to conduct compound screening, identify tractable hits, pursue a number of hit-to-lead programs, and develop the resulting leads into candidate selection compounds through to a successful Proof of Concept in clinical research Phase IIa. GSK has exclusive options to further develop and commercialize these compounds on a worldwide basis. Galapagos will have the right to further develop and commercialize compounds for which GSK does not exercise its option. In July 2007, GSK made a EUR 4.4 million equity investment in Galapagos and the alliance was expanded to include up to two selected GSK targets. Now part of GSK’s Immunoinflammation Center of Excellence for Drug Discovery alliance portfolio, the expanded alliance is worth up to EUR 186 million in milestones for two marketable products to Galapagos, plus royalties on global product sales.

Today’s announcement marks the fifth milestone payment made to Galapagos since the start of the osteoarthritis alliance. To date, Galapagos has received a total of EUR 15.9 million in access fees and milestone payments from GSK under the alliance.

“We are pleased that the osteoarthritis alliance with GSK is progressing as planned, in line with our expectation to deliver a pre-clinical candidate this year,” said Onno van de Stolpe, Chief Executive Officer of Galapagos. “Our successful track record in risk-sharing alliances demonstrates that this model is a viable strategy to progress a number of drug discovery programs while retaining the upside.”

Commenting on the collaboration, Jose Carlos Gutierrez-Ramos, Ph.D., Senior Vice President and head of the Immuno-Inflammation Center of Excellence for Drug Discovery at GSK noted “Galapagos is proving to be a partner which consistently delivers results. We are confident that our alliance will continue to advance GSK’s pipeline in osteoarthritis.”

About osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis, typically affecting people aged 45 and older. It is a degenerative disease characterized by joint destruction and loss of articular cartilage. Cartilage is the slippery tissue that covers the ends of bones in a joint. Healthy cartilage allows bones to glide over one another. It also absorbs energy from the shock of physical movement. In OA, the surface layer of cartilage breaks down and wears away. This allows bones under the cartilage to rub together, causing pain, swelling, and loss of motion of the joint. Over time, the joint may lose its normal shape. Also, bone spurs – small growths called osteophytes – may grow on the edges of the joint. Bits of bone or cartilage can break off and float inside the joint space. This causes more pain and damage. No currently available treatments prevent OA or even reverse or block the disease process. Treatment of OA involves pain control, weight control, and exercise. Many OA patients have pain that persists despite these measures. Most of these patients use non-steroidal anti-inflammatory drugs (NSAIDs) that relieve the symptoms without changing the course of the underlying disease. Healthcare providers are concerned about long-term NSAID use due to serious possible side effects. It is expected that with the ageing of the population, more individuals will be prone to develop OA. As mobility of seniors is of high importance to maintaining a high quality of life, preventing the severity of OA is seen as an immense clinical need over the next decade. The market potential of a disease-modifying drug could exceed $8 billion annually[1], based on the current market and the absence of disease-modifying treatment.

Galapagos’ osteoarthritis program

Galapagos focuses its osteoarthritis research programs on chondrocytes, the main cell types in cartilage. These programs will be the basis of the alliance with GSK. Galapagos has identified a number of novel targets that have been validated in cellular disease models and has progressed these into drug discovery. Modulation of these targets in human chondrocytes should lead to a net production of stable cartilage and should therefore be able to prevent and repair damage to this cartilage in patients.

In February 2008, Galapagos announced achievement of a Proof of Principle (reduction of a disease marker) and Proof of Concept (reduction of targeted symptoms) in pre-clinical models in its osteoarthritis (OA) program. Galapagos compounds block cartilage degradation in diseased cartilage explants, while diseased mouse joints treated with this compound also showed reduced cartilage destruction. Galapagos’ osteoarthritis program has progressed from validated targets to a Proof of Principle in 18 months, in this challenging area where there are currently no marketed disease-modifying drugs. The data generated thus far encourage Galapagos to aim for delivery of a pre-clinical candidate in OA by end 2008.

About Galapagos

Galapagos (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA; OTC: GLPYY) is a drug discovery company with pre-clinical programs in bone and joint diseases and bone metastasis. Its division BioFocus DPI offers a full suite of target-to-drug discovery products and services to pharmaceutical and biotech companies, encompassing target discovery and validation, screening and drug discovery through to delivery of pre-clinical candidates. BioFocus DPI also provides adenoviral reagents for rapid identification and validation of novel drug targets, compound libraries for drug screening as well as chemogenomics and ADMET database products to select targets and compounds. Galapagos currently employs 460 people and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More information about Galapagos and BioFocus DPI can be found at www.glpg.com and www.biofocusdpi.com.

About GlaxoSmithKline

GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For information about GlaxoSmithKline visit the company website at www.GSK.com.

About the Immuno-Inflammation Center of Excellence for Drug Discovery (II-CEDD)

GlaxoSmithKLine’s Immuno-Inflammation Centre of Excellence for Drug Discovery is dedicated to discovering therapies for inflammatory diseases. It is designed to integrate and better coordinate the progression of inflammatory disease medicines from therapeutic hypothesis to clinical proof of concept. It focuses on building an innovative pipeline through both internal efforts and external alliances with other companies and research institutions and will focus on ‘virtualising’ a portion of the inflammatory diseases pipeline by forming multiple risk-sharing/reward-sharing alliances.

 CONTACT Galapagos NV Onno van de Stolpe, CEO Tel: +31 6 2909 8028 [email protected] 

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[1] Galapagos estimates based on Datamonitor Market Research, “Global Overview Arthritis,” January 2004

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SOURCE: Galapagos NV

 FDA APPROVES REQUIP(R) XL(TM), THE FIRST AND ONLY ORAL ONCE-DAILY  NON-ERGOT DOPAMINE AGONIST FOR PARKINSON'S DISEASE Extended-Release Formulation Improved Symptoms in Patients Not Optimally Controlled with Levodopa and Reduced Patients'"Off" Time by Nearly Two Hours Per Day LONDON, UK, 16 June 2008 -- SkyePharma PLC (LSE: SKP) today announces that the United States Food and Drug Administration (FDA) has approved GlaxoSmithKline's (NYSE: GSK) Requip(R) XL(TM) (ropinirole  extended-release tablets).  Requip(R) XL(TM) is the first and only  once-daily oral non-ergot dopamine agonist indicated for Parkinson's disease. The product is expected to be available in U.S. pharmacies in mid-July 2008. The new Requip(R) XL(TM) formulation uses SkyePharma's patented  Geomatrix(TM) technology. This innovative tri-layer formulation allows for continuous delivery of ropinirole over 24 hours to provide smooth blood levels. Extended-release ropinirole offers physicians and patients a simple titration regimen; it also offers a convenient, once- daily dosing schedule compared to other oral dopamine agonists, which are dosed multiple times a day. Requip(R) XL(TM) is currently approved in 23 countries in Europe for  the treatment of Parkinson's disease. SkyePharma will receive low-mid single digit royalties on sales. The pivotal study showed that adding Requip(R) XL(TM) to patients' existing levodopa ("L-dopa") therapy reduced the amount of "off" time experienced by patients with Parkinson's disease by more than two hours per day on average, compared with baseline.  "Off" time is experienced by patients with Parkinson's disease when their medication wears off and their symptoms return. "Many patients require multiple doses of one or more medications to control their Parkinson's symptoms, which makes taking their medicines correctly and at the right times challenging. In addition, patients with Parkinson's disease may have trouble completing routine activities of daily living and self-care," said clinical investigator Rajesh Pahwa, M.D., professor of Neurology and director of the Parkinson's Disease and Movement Disorder Centre at the University of Kansas Medical Centre in Kansas City. "Requip(R) XL(TM) provides continuous delivery of ropinirole over 24 hours to provide smoother blood levels without the peaks and troughs that multiple daily doses typically deliver. It is an important once-daily treatment option for patients with Parkinson's disease." Frank Condella, Chief Executive Officer of SkyePharma added: "We are delighted by today's FDA approval of Requip(R) XL(TM) which uses our unique Geomatrix(TM) technology. This represents yet another successful collaboration between SkyePharma and GSK and demonstrates the clinical value of our drug delivery technologies." FDA approval was based primarily on results from the EASE-PD (Efficacy And Safety Evaluation in Parkinson Disease) Adjunct Study, a multi-centre, double-blind, placebo-controlled study conducted in patients with idiopathic Parkinson's disease not adequately controlled with L-dopa. A total of 393 patients in the study were randomized to receive either extended-release ropinirole (n=202) or placebo (n=191) once daily for 24 weeks, in addition to L-dopa. The study's primary endpoint was the mean change from baseline at week 24 in awake time spent "off", which was measured via patient diaries. Results from the study showed that extended-release ropinirole significantly reduced  "off" time by an average of 2.1 hours per day from baseline, compared with a reduction of 0.4 hours per day for placebo.  Once-daily use of extended-release ropinirole was generally well tolerated in the study. The withdrawal rate due to adverse reactions was low and similar between groups (6 percent extended-release ropinirole vs. 5 percent placebo). The most common adverse reactions reported in patients taking extended-release ropinirole compared with placebo were dyskinesia (13 percent vs. 3 percent), nausea (11 percent vs. 4 percent), dizziness (8 percent vs. 3 percent), hallucination (7 percent vs. 3 percent), somnolence (7 percent vs. 4 percent), abdominal pain/discomfort (6 percent vs. 3 percent) and orthostatic hypotension (5 percent vs. 1 percent).  For further information please contact:  SkyePharma PLC                    Frank Condella    +44 20 7491 1777  During office hours               Ken Cunningham                                   Peter Grant Financial Dynamics (UK Enquiries) David Yates       +44 20 7831 3113 Outside office hours              Deborah Scott Trout Group (US Enquiries)        Christine Labaree +1 617 583 1308                                   Seth Lewis About SkyePharma PLC Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products to provide a clinical advantage and life-cycle extension. The Company has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com. About GlaxoSmithKline Requip(R) XL(TM) was developed and is marketed by GlaxoSmithKline, one of the world's leading research-based pharmaceutical and healthcare companies. For more information regarding Requip(R) XL(TM), please see the Complete Prescribing Information available at www.gsk.com. More information on GlaxoSmithKline is available at the company's website at www.gsk.com.                       This information is provided by RNS           The company news service from the London Stock Exchange END 

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SOURCE: Skyepharma PLC