The US Food and Drug Administration (FDA) continues to draw flak over the drugs it approves but
which turn out to be dangerous for one reason or another. Activists suspect some nexus between
the drug industry and the federal agency.
The list of bad news for the FDA seems pretty long. First Vioxx was pulled from the market after
the painkiller was found cause heart attack too. It could also cause kidney problems too, it was
Dr. David Graham, with more than 20 years of service with the Food and Drug Administration, in a
senate hearing on Vioxx three years ago, had also termed unsafe the anti-cholesterol drug
Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne
drug Accutane, all of which had been approved by his bosses.
Dr.David Graham lashed out at the drug regulators as being "virtually incapable of protecting
America" and said they were far too likely to surrender to demands of drug makers.
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 death of four and liver
injury or failure of 37 since 2004.
Anne Kirkman Campbell, a family practice doctor in Gadsden, Alabama, apparently viewed a clinical
trial for the Ketek antibiotic as one big piggy bank. She signed up 400 patients, more than any
other doctor in the country and, when one patient backed out, she even forged the consent form
and faked the data.
What's more, Campbell enrolled her entire staff and several family members in the study. Patient
consent forms had been signed every few minutes and, at times, when the office was closed.
A subsequent audit, which was initiated by the firm running the trial, uncovered the fraud. The
FDA's Office of Criminal Investigation began looking into it, but the FDA's drug review division
recommended approval anyway, over the objections of a medical reviewer who subsequently disclosed
the agency's behind-the-scenes decision-making.
Campbell, 49, pleaded guilty to one count of mail fraud and was sentenced to 57 months in prison.
In a phone interview from a federal prison, Campbell blamed the drugmaker for fast-tracking the
trial. "They seemed to want to rush you through everything," said Campbell, who had performed a
half-dozen clinical trials for other drugmakers. "They didn't care how you did it. They wanted
the trial over so they could get the data to the FDA."
Another doctor upon whose clinical data Ketek was approved conducted trials while his medical
license was on probation and was arrested for cocaine and gun possession soon after.
And consider the atypical anti-psychotics whose marketing was also "atypical," with 29 percent of
AstraZeneca's Seroquel sales coming from off-label Alzheimer use, even though studies say it
worsens the condition. Or 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
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. But instead of pulling the
drugs, the FDA just adds warnings and subtracts uses.
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.
Thanks to fast-tracking and six-month approvals, no one knows if a drug is dangerous anyway until
a critical mass of human guinea pigs takes/tests it.
Pulling a drug after approval just casts light on the approval process itself, which is teeming
with conflicts of interest. Ninety-two percent of FDA advisory meetings in the last decade
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, as cheekily comments Martha Rosenberg, an activist.
Graham himself had remarked acidly, "The organizational structure within the FDA's Centre for
Drug Evaluation and Research (CDER) is entirely geared towards the review and approval of
new drugs. When a CDER new drug reviewing division approves a new drug, it is also saying the
drug is "safe and effective." When a serious safety issue arises post-marketing, their immediate
reaction is almost always one of denial, rejection and heat. They approved the drug so there
can't possibly be anything wrong with it. The same group that approved the drug is also
responsible for taking regulatory action against it post-marketing. This is an inherent conflict
of interest. At the same time, the Office of Drug Safety has no regulatory power and must first
convince the new drug reviewing division that a problem exists before anything beneficial to the
public can be done. Often, the new drug reviewing division is the single greatest obstacle to
effectively protecting the public against drug safety risks."
The situation does not seem to have improved much, Rosenberg and others regret.