“The FDA dropped the ball.” This revelation from Rep. Henry Waxman (D – California), the chair of a Congressional oversight committee that heard testimony last week about another dangerous drug, Avandia, manufactured by North Carolina’s own GlaxoSmithKline, should be so shocking that it would be fodder for a Pulitzer prize winning novel. But it’s not.
The story of Avandia is the latest of many, many stories over the last decade where the governmental agency whose mission is to insure that dangeorus drugs don’t make their way into the marketplace failed us, once again.
Avandia, a diabetes drug, has now been shown to increase by more than 43% the risk of a cardiovascular event in those patients taking the medication. GSX, who sold more than $2 billion of the drug in 2006, had studies that showed adverse cardiac events in patients taking the medication, yet did not modify their warning label to disclose that risk to doctors and their patients. Dr. Steven Nissen of the Cleveland Clinic found these studies performing nothing more elaborate than a Google search. The FDA, at the time that it approved Avandia more than eight years ago, required that GSX perform a long-term study as a condition of approval, but did not follow up with GSX to determine the results of the study. Obviously, GSX did not voluntarily disclose the information, or voluntarily change its label Now, the FDA has ordered it to, but only after light was shed on the failures of this agency to protect the public.
What’s even more disturbing is the disclosure that GSX pressured (and threatened legal action against) a nationally respected physician, Dr. John Buse at UNC-Chapel Hill, to terminate his criticism of the drug after he raised concerns about the medicine’s heart risks at a medical conference. Dr. Buse testified last week before Congress that after his revealed his concerns, he received threatening phone calls in which he was characterized as a liar and accused of being for sale. GSX had, to that point, provided grants to Dr. Buse to perform valuable research, but since his criticism, he has received none.
The FDA is not doing its job. Lawyers and doctors are forced to reveal information in order to insure that the truth is told and lives are saved. Legislation is presently pending before Congress that would establish a potentially dramatic remaking of drug regulation, something that the drug manufacturers are vigorously opposing. This time, a simple rebuke of the FDA and drug manufacturers is not enough. This time, legislation must be adopted.
Notify your congressmen that you care.
If you or a loved one took Avandia and suffered a cardiac event, please call our office (800.762.1990) so that we can discuss your legal rights.