17 novembre 2005 13:19

FDA women are waiting- The FDA is out to lunch and more news

Pharmaceutical Drugs Found in U.S. Water Supplies -

Prescription and over-the-counter medications can harm your health even if you don't take them--through you local water supply.

http://www.mercola.com/2005/nov/17/pharmaceutical_drugs_found_in_us_water_supplies.htm

At FDA, Graham is still the whistle-blower

By Rita Rubin, USA TODAY

OLNEY, Md. — As David Graham sipped a large decaf skim mocha — hold the foam and whipped cream — at a suburban Washington, D.C., coffee shop last week, a fellow customer, a stranger, walked over and wished him well.

FDA whistle-blower David Graham isn't satisfied with the agency's progress on drug safety.

It was a year ago Friday that Graham made headlines by blowing the whistle on the Food and Drug Administration at a Senate committee hearing. But he's still sometimes recognized by fans. (Related story:Graham's least-favored drugs)

They'll be happy to know that he's still associate director for science and medicine in the FDA's Office of Drug Safety, which — much to his dismay — is still part of the FDA center that reviews and approves new drugs.

But they may not be thrilled to hear what he has to say about what has changed — or, more accurately, what has not changed — since he told the Senate Finance Committee the FDA is "virtually defenseless" against another "terrible tragedy and a profound regulatory failure" like Vioxx. Merck pulled the blockbuster arthritis drug off the market in September 2004 because it raises heart attack and stroke risk.

"Today, the United States of America is worse off when it comes to drug safety than it was a year ago when I testified," Graham says. That's because the FDA's recent drug safety initiatives serve only as window dressing, diverting attention away from real solutions, such as an independent Office of Drug Safety, Graham says.

Take the Drug Safety Oversight Board established by the FDA in February to oversee management of drug safety issues. "A kangaroo court," Graham says, noting that several of the 15 members are FDA employees who work for the center that reviews and approves new drugs.

Or take the ongoing Institute of Medicine study of drug safety requested by the FDA. Graham says he doubts the study will make much of a difference, because it's based largely on information supplied by the FDA.

Senate Finance Committee chair Chuck Grassley, R-Iowa, who convened the November 2004 hearing, says Graham should not be discouraged. "Dr. Graham and people like him make a big difference," Grassley says.

Because of Graham's coming forward, Grassley says, his staff talks to several FDA whistle-blowers — some new, some not — every week.

Neither Acting FDA Commissioner Andrew von Eschenbach nor Steven Galson, director of the FDA's Center for Drug Evaluation and Research, agreed to be interviewed for this story.

Instead, Susan Bro, senior communications adviser in the FDA commissioner's office, responded via e-mail:

"Who's the 'we' behind the FDA? Thousands of cutting-edge scientists, physicians, pharmacists and public health experts who consult with their colleagues and outside experts to make sound medical decisions and recommendations each and every day. To characterize the work being done here as anything less than substantial, forward-looking and ambitious is simply not accurate."

An article in this week's Journal of the American Medical Association supports Graham's assessment of the FDA. Especially in the past five years, writes Howard Markel, a University of Michigan pediatrician and history of medicine professor, the FDA has been heading downward "from a sterling — albeit very human — regulatory agency into one much more tarnished, politicized, and increasingly disputed by the very people it was designed to protect."

http://www.usatoday.com/news/health/2005-11-16-fda_x.htm