Drug-safety ‘advocates’

Earlier this week, a joint session of two Food and Drug Administration advisory committees recommended that Avandia, one of two drugs that reduce insulin resistance, stay on the market with added information about which patients should avoid taking the medicine in order to reduce the risk of heart attacks. The recommendation, based on a careful evaluation of a massive amount of data, focused on whether it was possible to tailor the use of Avandia, which has helped people with diabetes stave off blindness, leg amputations and kidney failure, to groups of patients that might be a higher risk for heart problems.

It remains to be seen whether the measured recommendation puts to rest both the controversy and hysteria surrounding Avandia and the FDA. Dr. Steven Nissen simultaneously released his “study” about Avandia’s supposed heart-attack risk and told ABC’s “Nightline” that Avandia would kill more people than the September 11 terrorists. Dr. Nissen also shared his data with congressional Democrats and timed his study to come out in advance of the FDA’s ongoing review of Avandia, which ultimately proved to be more rigorous, more detailed and more useful in making a decision about clinical use, a decision that ironically mirrors how the drug is being used already.

The fact is, Dr. Nissen and some drug-safety officials at the FDA did nothing to make medicines safer. Rather, their effort is designed to foment fear, politicize science and most immediately gain control over FDA in concert with politicians such as Rep. Henry Waxman and Sen. Charles Grassley. With Avandia, the gimmick was to hype the danger by claiming that meta-analysis, a statistical technique used to cherry-pick and then combine a number of short-term studies, should be the new gold standard for yanking drugs from the market. Such short-term studies were rejected by self-styled FDA whistleblower David Graham and the claims about heart problems associated with Vioxx. Dr. Graham’s effort to bolster claims that Avandia could be pulled off the market with safety data on a completely different drug that had not been peer reviewed angered the committee members and exposed Dr. Graham as someone willing to suborn sound science for the sake of power.

It is time to investigate whether these self-proclaimed drug-safety advocates are acting in our best interest.

Nearly 75 percent of diabetes specialists report that their patients on Avandia are concerned, want to go off or have taken themselves off the drug. Many doctors have stopped prescribing or are afraid to prescribe Avandia because of lawsuit concerns. Tort lawyers are using media reports and the Nissen article to build their case against Avandia, though the FDA committee voted to keep it on the market.

Much has been said about the FDA being broken. In truth, those who want to usurp its power have vandalized it. They have undermined the public health and the integrity of medical science. Perhaps the FDA advisory action on Avandia will restore both.