FDA Conflict of Interest in Avandia Panel
The Food and Drug Administration has completed its investigation of a potential conflict of interest regarding the advisory committee that decided on new labeling requirements for the dangerous drug Avandia.
Despite proven links between Avandia and heart disease, the FDA has left Avandia on the market with a black box warning informing consumers that Avandia increases their risk for heart attack, heart failure, and death.
However, this decision was not unanimous. Three committee members voted against the new labeling requirements, essentially giving Avandia manufacturer GlaxoSmithKline a free pass despite mounting evidence against the drug.
One of these three, endocrinologist David Capuzzi, has been under investigation for a conflict of interest involving his work as a paid speaker for GlaxoSmithKline. While Capuzzi did not directly promote Avandia, he was paid by GSK to promote its dietary supplement Lovaza.
The FDA is not legally allowed to release Capuzzi’s financial disclosure form, so it is currently unclear whether these paid speaking engagements were disclosed prior to his work on the Avandia advisory panel. FDA completed its investigation and referred the matter to the Office of the Inspector General for the Department of Health and Human Services a few weeks ago in August.
Conflicts of interest remain an ongoing problem within the FDA. In fact, advisory panel member Abraham Thomas revealed that he had previously done paid speaking engagements for Takeda Pharmaceuticals, which makes Avandia’s largest rival diabetes drug Actos, which has also been linked to similar heart problems.
However, Thomas ended his professional relationship with Takeda in 2008 and FDA rules only require panel members to report financial relationships within the last year. Thomas actually voted for Avandia to be recalled, which would have been a boon to Takeda.
Dangerous and defective drugs are a serious problem nationwide, and some industry watchdog groups suspect that the pharmaceutical industry intentionally uses this type of paid speaking engagement to influence future or current FDA panel members without breaking the law.
This type of legalized bribery could potentially lead to more defective drug injuries and even wrongful death in states like Missouri, Arkansas, Illinois, Indiana, Kansas, Wisconsin, Iowa, and nationwide.
If you or a family member has been injured by a prescription drug, over-the-counter drug, or dietary supplement, please contact the drug injury attorneys of Schlichter, Bogard & Denton today for a free evaluation of your case.