And what a day it was. The Avandia congressional hearing was no snoozefest. FDA commish Andy von Eschenbach couldn't find a warning in the Avandia label because it was buried in the fine print. A doctor testified he was threatened with a $4 billion lawsuit for questioning Avandia heart attack risks. Glaxo's chief scientist pooh-poohed the threats because they were made by a "passionate" executive. And various congressman implied Steve Nissen was primarly interested in promoting his career.
This was nothing to celebrate. Beyond the debate over Nissen's analysis of Avandia risks, the larger issue is the sorry state of drug safety. If the system worked better, data would be accessible for analysis, the FDA would conduct timely reviews and issue appropriate decisions, and - voila! - hearings wouldn't be needed. But that would be a perfect world. What we have, instead, is a system that sags under the weight of commercial and political pressures. That's not surprising. And not reassuring, either.
Today's hearing should serve as a reminder that improving public health is the endpoint. Unfortunately, this isn't the first safety scandal; there have been plenty over the past decade. But making accusations and excuses is easy, and so anyone can do it, and some do. Unless the hard work begins, there will be more such hearings. And just like some medications in question, the viewing experience can be enough to give you a heart attack.
Meanwhile, there are other compelling stories to digest. Here are a few....
Military Sets New Rules For Dispensing Psychotropic Meds (The Hartford Courant)
Pfizer Loses Court Ruling Over Norvasc Patent (TheStreet.com)
Glaxo's Strategy To Promote Avandia To Minorities In A Quagmire (The New York Times)
Abbott and Thailand Face Off Over Patent Dispute (The Boston Herald)
Bristol-Myers Squibb Hires Lobbyist For Generics Issues (Yahoo/AP)
Gilead Says Viread Meets Goal In Hepatitis B Trial (Yahoo/Reuters)
2 Comments
"Beyond the debate over Nissen’s analysis of Avandia risks, the larger issue is the sorry state of drug safety. If the system worked better, data would be accessible for analysis, the FDA would conduct timely reviews and issue appropriate decisions, and - voila! - hearings wouldn’t be needed"
LOL!!! I just posted basically the same thing as a comment on the other story. So while the "powers" fight...the public is still left in the dark..
In addition to hopeless understaffing and red tape at the FDA, they are in a nearly unwinnable position. If they move too quickly on something and make an error, there are countless lawyers ready to file suit. If they move too slowly on something (often because the decisions are so weighty that the deliberations/analyses must be so thorough in order to stand up in court later), there's entirely different army of lawyers ready to sue. Bottom line: Avandia and Actos should be reserved for control of blood glucose in patients without any evidence of heart disease, and only in those who have failed other therapy. This would significantly curtail their use, as the vast majority of patients with diabetes already have some detectable form of heart disease, and the fact that diabetes itself is considered a CHD risk equivalent. The FDA shpuld settle this as soon as possible, and GSK and Lilly/Takeda must prove in a completed randomized controlled clinical trial that these drugs are safe from a CV perspective before they can be used again widely. Concomitantly, the FDA needs to also immediately turn its attention to Abbott's Tricor.