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Wednesday, 08 August 2007 02:52

Martha Rosenberg: Avandia decision shows FDA progression from watchdog to lapdog; drug is "safe" -- from pharma regulators

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by Martha Rosenberg

They're just dropping like Chinese imports -- prescription drugs that turn out to be deadly after FDA approval.

Not just Vioxx -- recently found to cause kidney problems on top of the heart attacks for which it was pulled -- but its seven deadly sisters named by the FDA's Dr. David Graham before Congress in 2004: Crestor, Meridia, Serevent, Lotronex, Arava, Accutane, and Bextra.

After a post-Vioxx damage control campaign -- "FDA has confidence in the safety and efficacy of Crestor" read AstraZeneca ads that the FDA pulled; it wasn't that confident -- the cholesterol drug Crestor was found in the heart journal Circulation to be eight times more likely to cause rhabdomyolysis, kidney failure, or spillage of protein in the urine than other cholesterol drugs.

Thirty users of Meridia, Abbott Laboratories' weight-loss drug, died of cardiovascular problems from 1997 to 2003 and 224 other experienced nonfatal strokes, heart attacks, and other cardiovascular ailments, according to FDA reports.

And Accutane manufacturer Hoffman-La Roche Inc. goes to trial this October in Madison County, Illinois -- where the first Vioxx trial occurred -- to defend charges that its acne drug caused Jason Peipert's inflammatory bowel disease, which ruined the young soccer star's career.

Then there's Sanofi-Aventis' notorious antibiotic Ketek -- blamed in the deaths of four and liver injury or failure of 37 since 2004 -- whose primary clinical trials doctor, Anne Kirkman Campbell, is in federal prison in Lexington, Kentucky for forging data for money. (Test subjects included her entire staff and members of her family.)

Another doctor, upon whose clinical data Ketek was approved, conducted trials while his medical license was on probation and was arrested soon after for cocaine and gun possession.

And the atypical anti-psychotics whose marketing was also "atypical" with 29 percent of AstraZeneca's Seroquel sales coming from off-label Alzheimer use, though studies say it worsens the condition and Eli Lilly settling 29,000 lawsuits from inadequate warnings about Zyprexa's diabetes, weight gain, and pancreas infection side effects.

Finally there's GlaxoSmithKline's Avandia prescribed for 1 million Americans for type 2 diabetes and now known to increase the risk of heart attack by 43 percent and cardiovascular death by 64 percent.

Avandia is more expensive and dangerous than older drugs and NOT more effective, said Dr. Graham to a joint panel of experts convened to consider the drug in July -- a charge he could also level against the other suspect drugs and Big Pharma itself.

But instead of pulling the questionable drugs, the FDA just adds warnings and subtracts uses. (see antidepressants; HRT). Ketek is no longer recommended for sinus infections; just community acquired pneumonia. Meridia is only recommended for people who have to lose 30 pounds or more who don't have poorly controlled hypertension, a history of heart disease, stroke, or severe liver or kidney disease. And Accutane users are clearly warned about suicidal behavior, birth defects, and inflammatory bowel disease risks to the drug on the label.

Because pulling the drugs not only affects sales, company image, and stock price, but it also feeds lawsuits. ("The drug was so unsafe they PULLED IT FROM THE MARKET.")

Thanks to fast tracking and 6-month approvals, no one knows if a drug is dangerous until a critical mass of human guinea pigs takes/tests it. Only 3,000 clinical trials are usually conducted premarket and what if the drug harms one in every 3,001? Did you really think lethal tests on beagles and other mammals keep you safe? Talk about dying in vain.

Pulling a drug after approval just casts light on the approval process itself, which is teeming with conflicts of interest. In the last decade, 92 percent of FDA advisory meetings included a member with financial ties to drug companies, according to USA Today -- the FDA calls them sponsors -- and federal law against using experts with financial conflicts of interest was waived 800 times.

Too bad THAT can't be on the warning label.


Martha Rosenberg is a Staff Cartoonist for the Evanston Roundtable.