The Food and Drug Administration’s decision to review the case of Avandia, a diabetes drug whose use was restricted because it was found to elevate the risk of heart attack by over 40 percent, has raised questions not only about the drug but about the FDA as well.
The decision has sent shock waves through the health care system. Avandia was declared unsafe three years ago after researchers discovered that thousands of people had heart problems after taking it. It is currently available only to those with advanced diabetes, people so sick that a heart attack is worth the risk.
A Senate inquiry exposed worrisome flaws in FDA oversight eight years after it had ruled Avandia to be safe for general use in the treatment of diabetics. That precipitated a makeover of the regulatory regime, and companies are now required to demonstrate that new drugs do not carry unacceptable cardiac risks.
Now, Dr. Janet Woodcock, the FDA’s top drug official, wants a re-think of the re-think. She called a two-day meeting that begins on Wednesday to clarify questions concerning a clinical trial conducted by the manufacturer, GlaxoSmithKline. Past findings were riddled with questions, she said, and the agency has an obligation to try to answer them.
“I made the decision last time about Avandia, and it’s not that it was an open-and-shut case,” she said. “What we’re trying to do here is resolve that uncertainty as much as we can with all the available data.”
Dr. Steven Nissen, the respected Cleveland Clinic cardiologist who led the battle against Avandia, has been scathing in his reaction to Dr. Woodcock’s decision, accusing her of bad faith.
“The efforts to whitewash this entire affair is really an unacceptable misuse of their regulatory role,” Dr. Nissen said. He added that he would be “horrified” if the panel were to recommend that the restrictions be removed. “The evidence against this drug is overwhelming,” he said.
Indeed, most experts consider it unlikely that the FDA will relax the restrictions, and some wonder aloud what constructive purpose the review this week could serve.
By contrast, Glaxo welcomed the news as a well-deserved shot in the arm for their unfairly maligned product. Glaxo continues to maintain that Avandia is okay. The company cites a Duke University study which, they say, proves that their drug does not significantly imperil the heart.
Unsurprisingly, however, some outside experts have said the Glaxo trial was seriously flawed. The mere fact that the Duke review was paid for by Glaxo inevitably raises suspicions that the search for scientific truth was intermingled with the search for Big Pharma funding. Glaxo insists the Duke researchers were fully independent. The FDA conference will look over that evidence on Wednesday too.
The credibility of the giant pharmaceutical firms like GSK has long been under fire, if not demolished entirely. And we can’t help feeling cynical about GSK’s claims. It is worth noting here that the company pled guilty to criminal misconduct related in part to concealing the hazards of Avandia and paid a $3 billion fine for it, one of the largest in U.S. history.
But what about the FDA? Dr. Nissen sounds as cynical about them as others are about Big Pharma. He suggests that the FDA is “seeking to avoid accountability for its role in the Avandia tragedy… [that FDA and GSK originally] agreed privately to conceal this hazard from patients and practitioners.”
An assessment of the grave charges made by the FDA’s critics of unethical conduct in this and other cases (including Vioxx, Ketek and defective defibrillator leads) is beyond the scope of this editorial.
Is there inefficiency in the FDA? Bureaucracy, thy name is inefficiency. Technical error? Unavoidable in any human undertaking, and particularly in one as vast and complex as evaluating the safety and efficacy of many thousands of new products.
Perhaps to this list of fallibilities we must add poor judgment on the part of Dr. Woodcock in reopening the Avandia case. Even if her intentions are pure, and this is really just expert thinking-out-loud, in pursuit of fine-tuning FDA methods, without any conspiratorial motives, it might have been wiser to leave it alone.
Tov sh’b’rofim l’Gehinnom. Even doctors with the finest skills and the best intentions must often consign their patients to a gehinnom of painful and costly treatments. Worse, the health-care system systematically violates the medical principle of “first, do no harm,” as the 100,000 hospital deaths annually attributed to medical error by the National Institutes of Health demonstrates.
Indeed, the health-care system in America is so fraught with problems — in questions of treatment, insurance, and so on — it is imperative that the government agencies entrusted with protecting the public health be above reproach.
Error, as long as all reasonable precautions are taken to reduce it, can be forgiven. The NIH statistic underlines the hard-won realization in modern times that there is no such thing as an exact science, and that human healing on an assembly line may be a contradiction in terms.
Even incompetence and insensitivity are aspects of the human condition, from which doctors are not immune. There is no way to guarantee that human beings will be at their best, even in so sensitive a field. Shlomo Hamelech long ago put away the Book of Healing, so that we would trust in Hashem, Rofei kol basar, and not in medical techniques and mortal practitioners, even if practical necessity dictates that we go to them for help.
But what cannot be forgiven is bad faith, cover-ups, or corruption. It behooves Dr. Woodcock and the FDA to demonstrate convincingly that those who accuse them of such things are wrong and that the FDA can be trusted to do its vital work, if not perfectly, at least honestly and well.