Merck Vioxx News and Press Releases - News Menu

December 26, 2004 - WHEN THE departing secretary of health and human services, Tommy Thompson, endorsed creation of a new independent agency to review prescription drugs after they are on the market, he helped save the proposal from getting buried under pharmaceutical industry opposition. The Senate should press Thompson's proposed successor,Mike Leavitt, on the issue in his confirmation hearings. Still, creation of such an office is just one of many steps needed to protect the public from dangers like the cardiovascular problems linked to long-term use of two popular painkillers.

The scandal involving Vioxx and Celebrex and the suppression of evidence by drug companies and the Food and Drug Administration that antidepressants could increase suicidal thinking among adolescents have highlighted serious shortcomings in the way drugs are approved by the FDA, presented to doctors and the public, and monitored once they are on the market. That monitoring is now done by an office within the FDA that lacks sufficient funding.

Its staffers also know that any decision they take to demand tougher label warnings or even suspend drugs is an implied criticism of colleagues who approved them.Whether a new, strengthened drug review office is set up inside or outside of the FDA, adequate funding from Congress will be crucial. Over the years, the review office has seen its staffing actually decrease even as more and more drugs came on the market. This is the result both of Congress's stinginess and a 1992 agreement with drug companies that shifted more government and industry money into speeding approvals of new drugs for diseases like AIDS and cancer.

By all means, life-saving drugs should not be kept off the market because the FDA's new drugs office lacks staffers. But even that of- fice, which is well funded, should reexamine procedures that let a non-life-saving drug like Vioxx on the market after safety testing that was not rigorous enough to reveal its longerterm effects on the cardiovascular system.

The slowness with which the FDA addressed the issue of antidepressants demonstrates another problem. Studies that pointed to problems with the drugs were often suppressed by the drug companies that sponsored them. More-positive results, of course, quickly found their way to the pages of the leading medical journals, a chief source of information for doctors, and into the hands of drug company sales people, another major source of doctors' information.

Between drug makers and patients are phalanxes of professionals who should ensure the safety and effectiveness of medications: researchers, FDA reviewers, medical journal editors, and doctors. All of them depend on impartial, fully transparent information to do their jobs right. In any changes Congress makes, that goal should be foremost.

Toronto Star Says O24 is 'IN' for 2005; Celebrex, Naproxen Out

TAMPA, Fla., Jan. 4, 2005 (PRIMEZONE) -- Toronto Star health editor Judy Gerstel announced arthritis drugs Vioxx(r), Celebrex(r) and naproxen are out. What's IN for 2005? Exercise, weight loss and topical pain relievers, she noted. Wrote Gerstel in her December 31st health column, "Among the products: O24 essential oil pain reliever, from Toronto-based Swiss Medica (OTCBB:SWME)." Gerstel noted that topical pain relief products are "being heavily promoted now that the high-profile drugs are losing their luster."

Since Merck & Co's voluntary worldwide recall of its Vioxx(r) arthritis medicine, Swiss Medica's O24(tm) has become one of Canada's most popular pain relief products. Prior to the US Food & Drug Administration cautions on Celebrex(r) and naproxen, Swiss Medica began test marketing the US-patented O24(tm) at the Happy Harry's Discount Drugstore chain in Delaware. Canadian and US sales of the O24(tm) pain relief product have been robust and encouraging as Swiss Medica plans to continue its North American rollout of its flagship product during 2005.

Recently, the O24(tm) product got a boost after the FDA recommended physicians consider alternatives to Pfizer's popular arthritis medication, Celebrex(r). Noted Florida surgeon Allan N. Fields began recommending O24 as a "selective replacement for Celebrex(r) and Bextra(r) in certain cases." Former surgeon to boxing legend Muhammad Ali, Dr. Fields was named "Physician of the Year" in early November by the AAPRP and awarded the Key to the City of Miami Beach.

In late December, Swiss Medica announced a randomized double blind clinical trial, using the O24(tm) pain relief product on patients suffering from fibromyalgia, had been completed. A final report is expected in January after the Institute of Clinical Evaluative Studies (ICES) in Toronto completes its analysis of the results.

Widely popular in Europe, the O24(tm) product has been used by Olympic athletes and former heavyweight champion Larry Holmes, recommended by the Toronto Maple Leaf's athletic trainer, medically and hospital-tested under emergency room conditions, and is currently enjoying a grassroots groundswell in both the United States and Canada because it reportedly can be used for "pains associated with arthritis" and not interfere with a patient's prescription medications. Also available online at www.024zone.com

For details about Swiss Medica, Inc.: www.swissmedica.com

CONTACT: Blue Skye, Inc.
Sky Wallen
(813) 732-6869
blueskyeinc@yahoo.com
www.blueskyeinc.com

Other Resources
Drug Stores
Medical Classifieds
Legal Search Engine
Top Mesothelioma Sites
Phone Cards

Vioxx-Search-Engine.com
7141 Oak Pointe Curve
Minneapolis, MN 55438 USA

©Copyright
Nielsen Technical Services
All Rights Reserved Worldwide