Conflict of Interest Claims Against Yaz Panel has Advocacy Group Calling for New Hearing
Now that the FDA advisory panel hearing about Yaz side effects has been marred by controversy, a public advocacy group is trying to get the regulators to host a new advisory panel hearing to discuss the blood clot risks associated with Yaz.
The drospirenone-based pills have long been linked to various adverse side effects, including blood clots. This is what caused the original advisory panel to convene on December 8, 2011 to discuss the matter. The problem with that hearing was that some of the panel members, it was later discovered, had financial ties to the manufacturers of Yaz and Yasmin. This naturally led many to criticize the panel’s original findings (in a vote of 15-11) that Yaz, Yasmin and other drospirenone-based pills’ benefits outweighed the risks.
Of the questionable panelists, three of them (who voted in favor of Bayer’s drugs) were directly tied to Bayer. Another panelist, it has been reported, had ties to Barr Labs, which makes a generic version of Yaz. This news created an obvious conflict of interest in the matter that forced the advocacy group to write a letter to FDA Commissioner Margaret Hamburg. In this letter, the group says: “Because of the industry ties of these members, the joint committee’s conclusion — which amounted to an endorsement of the safety of these oral contraceptives — should be disregarded. A new advisory committee — without questionable impartiality or any conflicts of interest — should re-evaluate the safety of Yaz and Yasmin.”
The letter continues to point out that “if a reasonable person would have questions about the impartiality of any member of an advisory committee regarding a matter before the committee, the FDA should not allow that member to participate in the matter and should make public the relevant information about that committee member.”
So far, it is not known if the FDA plans on convening a new panel hearing, but it is clear that many people disagree with the original panel’s findings because of this controversy over the impartiality.
