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PROFNET WIRE: HEALTH & MEDICINE: FDA Drug Approval

Posted on: Thursday, 23 March 2006, 15:00 CST

ROUND-UPS FDA Drug Approval (5 experts) Mad Cow Disease (continued, 1 expert) LEADS 1. Alternative Health: Medicinal Herbs Can Be Useful Feature in Your Garden 2. Health: Prevention is the Best Treatment for DVT 3. Health: New Approaches to Targeting Asthma and Allergies 4. Mental Health: Battling March Madness Stress 5. Nutrition: Cutting Carbs isn't the Answer 6. Pediatrics: Sleep Apnea in Children Can Be Debilitating 7. Public Health: On the Scent for Safer Drivers 8. Sports Medicine: Sports Injuries Now Viewed as Occupational Injuries ROUND-UP: FDA DRUG APPROVAL

Following are experts who can comment on the FDA's plan to streamline the drug-approval process, making it more predictable and less expensive:

1. GREGORY V. PAGE, Ph.D., FDA life sciences practice leader at DELOITTE ENTERPRISE RISK SERVICES: "The FDA should develop a dual-track review process: Track 1 would cover pharma products offering only limited medical gains; these products must be almost risk-free. Track 2 would be for products offering significant therapeutic advances in which some degree of risk is not only acceptable, but also almost expected. Until such a system is available, the drug-approval process will continue to plod along as it has for the past 20 years. FDA and pharma manufacturers need to develop public education programs about the drug risk/benefit decision-making process. Congress should limit manufacturers' liability exposure when people take an FDA-approved drug." News Contact: Rebecca Schultz, rschultz@nuvox.net Phone: +1-859-342- 9133 (3/23/06)

2. PETER PITTS, director of the CENTER FOR MEDICINE IN THE PUBLIC INTEREST, is a former FDA associate commissioner: "Although pharmaceutical companies poured a record amount of money into drug development in 2005, the FDA approved only 20 new drugs, down from 36 in 2004. The agency needs to be more future-oriented and science-based and apply advanced engineering to the approval process so failure -- or success -- can be identified faster in the tricky area of medicine. Not only could there be enormous savings in costs, but helpful drug discoveries could be moved more quickly from bench to bedside so they actually help the patients who so desperately need them." News Contact: Kelly Torrance, kelly@keywire.biz Phone: +1-202-471-4250 (3/23/06)

3. DARREN MCDANIEL, CEO and managing officer of COAST IRB LLC, a provider of central IRB services for Phase I-IV pharmaceutical, medical device and repository trials in the U.S. and Puerto Rico: "The FDA isn't streamlining the process, they're harming it and not protecting human participants. FDA regulations are 30 years out of date and were written in a research environment 100 percent different than the one that exists today. The FDA issues 'guidances' (as opposed to laws) that are voluntary and unenforceable. The best way to improve the FDA drug-approval process is to insist upon data safety monitoring boards." McDaniel is a featured speaker globally, published in prestigious peer-reviewed journals, and is currently working on a book to improve human subject protections in research. News Contact: Melinda Mullin, melinda@msco.com Phone: +1-914-251-1500, ext. 14 Web site: http://www.coastirb.com/ (3/23/06)

4. MICHAEL PARANZINO, president of PSORIASIS CURE NOW: "Patients with incurable diseases like psoriasis have a strong interest in an FDA that promptly makes potentially helpful treatments available to patients. No treatment is without risks, but with diseases like psoriasis, where no treatment works for everyone, patients need many treatment options. And in close cases, it is patients (working with their physicians) who should make the call about whether a particular risk-benefit ratio makes sense for them." Paranzino: mike@framersinstitute.org Phone: +1-301-571-2393 (3/23/06)

5. GARY C. MESSPLAY, Esq., is partner at HUNTON & WILLIAMS, which focuses on the regulation of drugs, biologics, medical devices, food and cosmetics by the FDA, the Drug Enforcement Agency (DEA), the Department of Agriculture (USDA) and other federal and state agencies. Messplay's practice includes regulatory and administrative law matters, litigation and transactional work related to FDA and USDA-regulated products. Prior to joining the firm, Messplay was in-house counsel at Eli Lilly and Company, where he had global legal and regulatory responsibility for the company's top-selling pharmaceutical product, with annual sales exceeding $3 billion. He is head of the Hunton & Williams' food and drug practice. News Contact: Keenan M. Hughes, keenan@blisspr.com Phone: +1-212-840-1661 (3/23/06)

ROUND-UP: MAD COW DISEASE (continued)

ProfNet added the following to items posted previously at http://profnet.prnewswire.com/organik/orbital/thewire/lst_leads.jsp?iLRTopicI D=1949

1. DR. NOLAN HARTWIG, DVM, professor of veterinary diagnostic and production animal medicine and extension veterinarian at the IOWA STATE UNIVERSITY COLLEGE of Veterinary Medicine: "What is the source of the infection of this cow in Alabama? We don't have any way of knowing for sure without a rigorous traceback. If the cow consumed contaminated feed before the U.S. instituted the ban in 1997, we don't know where that contamination came from. We have the technology to identify any animal from conception to consumption. We need to do that to protect the consumer and the industry. There are federal proposals out there and programs in place, but they're all voluntary. Although there are many questions that need answered about a national ID system, we need to get cracking on it." News Contact: Teddi Barron, tbarron@iastate.edu Phone: +1-515-294-4778 (3/23/06)

LEADS

1. ALTERNATIVE HEALTH: MEDICINAL HERBS CAN BE USEFUL FEATURE IN YOUR GARDEN. CHRIS HAFNER, associate clinical faculty member at NORTHWESTERN HEALTH SCIENCES UNIVERSITY in Bloomington, Minn.: "People are growing medicinal herbs now more for pleasure, kind of like growing vegetables. People find pleasure in picking an herb from the earth and using it to make a tea for themselves or for their children as a medicine. Some medicinal herbs that can be easily grown and maintained in the Midwest are echinacea, yarrow and catnip." News Contact: Jaime Hunt, jhunt@nwhealth.edu Phone: +1-952-888- 4777, ext. 172 (3/23/06)

2. HEALTH: PREVENTION IS THE BEST TREATMENT FOR DVT. MARSHALL E. BENJAMIN, M.D, chairman of surgery and vascular surgeon at the BALTIMORE WASHINGTON MEDICAL CENTER and associate professor of surgery at the UNIVERSITY OF MARYLAND MEDICAL CENTER: "Prevention is the best treatment for Deep Vein Thrombosis, a medical condition that affects more than 2 million Americans each year. If you are traveling, stand up and walk around every hour if possible. Stay hydrated, and wear loose-fitting clothing. Avoid crossing your legs or extended awkward hip or knee positions while you're seated. Exercises like flexing and extending your ankles every 15 minutes while seated can also help keep the blood moving. Other preventive steps include stopping smoking and losing weight." News Contact: Allison Eatough, aeatough@bwmc.umms.org Phone: +1-410-787-4375

3. HEALTH: NEW APPROACHES TO TARGETING ASTHMA AND ALLERGIES. BETH CORN, M.D., assistant professor of medicine at the MOUNT SINAI SCHOOL OF MEDICINE, is an asthma and allergy specialist who can discuss new approaches to targeting allergies and asthma: "Recent medical advances in the treatment of allergic asthma have led to the development of a medication designed to target the root cause of the condition -- the IgE antibody -- by preventing symptoms before they can begin." Corn is the president of the New York Asthma and Allergy Society, as well as an advisor to the Asthma and Allergy Foundation of America. News Contact: Jordan Woodard, jwoodard@ccapr.com Phone: +1-212-229-8437 (3/23/06)

4. MENTAL HEALTH: BATTLING MARCH MADNESS STRESS. RACHEL AGNEW, registered dietitian at PHARMAVITE LLC, is available to offer tips on deflating high stress levels and lifting low moods associated with tax season, deadlines and final exams: "Since stress can have major impacts on emotional and physical health, it's vital that people take better care of themselves during demanding times. Nutrients such as omega-3 fatty acids, B vitamins and naturally occurring compounds like SAM-e can help lift low moods during stressful times." News Contact: Grace Kim, gracek@carryonpr.com Phone: +1- 323-988-4663 (3/23/06)

5. NUTRITION: CUTTING CARBS ISN'T THE ANSWER. JEFF NOVICK, director of nutrition for the PRITIKIN LONGEVITY CENTER & SPA: "Contrary to some opinions, merely cutting carbs is not the way to go. People who eat a high- protein, low-carb diet are digging their grave one forkful at a time. There is a large body of scientific research that shows high-protein diets can increase your risk of heart disease, osteoporosis and cancer. In fact, the top three causes of death in America are directly attributed to the high-fat, high-protein meals most people consume. People are better off with diets rich in fruits, whole grains, vegetables, seafood, and some non-fat dairy and lean meat." News Contact: Ronn Torossian, ronn@5wpr.com Phone: +1-212-999-5585 (3/23/06)

6. PEDIATRICS: SLEEP APNEA IN CHILDREN CAN BE DEBILITATING. DR. CAROLE MARCUS, M.B. B.CH., director of the Sleep Center at the CHILDREN'S HOSPITAL OF PHILADELPHIA, UNIVERSITY OF PENNSYLVANIA: "As many as 90 percent of the 18 million Americans who suffer from obstructive sleep apnea remain undiagnosed. Children may suffer from this debilitating condition as well. If sleep apnea is left untreated in children, consequences can include failure to thrive, continued bed-wetting, attention deficit disorder, behavioral problems and poor academic performance. It is often more difficult to recognize and diagnose sleep apnea in children." News Contact: Christianne Johnson, cjohnson@schwartz-pr.com Phone: +1-781-684-6637 (3/23/06)

7. PUBLIC HEALTH: ON THE SCENT FOR SAFER DRIVERS. BRYAN RAUDENBUSH, assistant professor of psychology at WHEELING JESUIT UNIVERSITY: "The scent of peppermint or cinnamon may keep you more alert and decrease your frustration when you're behind the wheel." Raudenbush recently completed research that confirms that the presentation of peppermint or cinnamon odor while driving may produce a more alert and conscientious driver and minimize the fatigue associated with prolonged driving. News Contact: Steven Infanti, sinfanti@nttc.edu Phone: +1-304-243-2308 (3/23/06)

8. SPORTS MEDICINE: SPORTS INJURIES ARE NOW BEING VIEWED AS OCCUPATIONAL INJURIES. DR. RICHARD HINTON, pediatric orthopaedic surgeon, is working with the Ripken Foundation and studying the mechanisms of youth baseball injuries: "From the public health perspective, sports medicine injuries are now being more effectively viewed in the same model as occupational injuries, motor vehicular injuries and infectious disease. Out of an understanding of the risk factors comes the development of preventive programs which may be primary, secondary or tertiary." News Contact: Debra Schindler, debra.schindler@medstar.net Phone: +1-410-512-3646 (3/23/06)

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Source: PRNewswire

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