And the story continues on the recent findings of the FDA Advisory Panel that recently ruled that Yaz and Yasmin are safe. Now, lawyers representing Plaintiffs that are suing Bayer over injuries from the contraceptives, are urging U.S. District Judge David Herndon to examine evidence of conflicts of interest at the U.S. Food and Drug Administration.
Lawyers representing the thousands of women injured have asked a federal judge overseeing consolidated litigation to not dismiss key evidence showing conflict-of-interest played a key role in a regulatory decision on the safety of the drugs.
The lawyer heading up the Plaintiffs’ Steering Committee asked Judge David Herndon to include evidence showing that four members of an independent advisory panel to the Food and Drug Administration had received considerable sums of money from Bayer and Barr Pharmaceuticals, manufacturers of Yaz, Yasmin and a generic form of the birth-control pills.
The drug companies are likely to include the recent findings of that advisory panel, which voted to advise the FDA to keep Yaz, Yasmin and other drosperinone-containing drugs on the market, as evidence at trial to show its drugs are safe. What the drugs companies are looking to strike from the record is evidence showing that conflict-of-interest on that advisory panel, specifically the testimony from former Food & Drug Administration (FDA) Commissioner David Kessler, who believes that panel was tainted by drug company money and influence.
Kessler claims conflicts of interest tainted the joint meeting of two advisory committees that decided not to remove Yaz and Yasmin from the public market.
That FDA advisory committee voted 15-11 on the question of whether the benefits of taking Yaz outweighed the risks of suffering life-threatening pulmonary embolism (blood clots) and gall bladder disease. Considering the amount of people on that advisory panel also on the payrolls of these pharmaceutical companies, it’s not a stretch to suggest that money may have had some influence. That panel also voted 21-5 on the matter of the warning labels of these drugs not being strong enough to warn of these side effects.
The agency stands behind the validity of its independent panel is not bound to act as the panel votes but it often does. Had that panel voted to say the risks of Yaz, Yasmin and Ocella did outweigh the benefits, it would have been a boon to the cases of the thousands of women already injured by these contraceptives.
The PSC lead attorney wrote to Herndon that a “person with knowledge of relevant facts could question (those specific panel members’) impartiality,” according to the journal report. Kessler has testified that, in his opinion, “Due to the complex dynamics that are part of the FDA advisory committee meetings, and in light of the fact that a reasonable person with knowledge of the relevant facts could question the above members’ impartiality, it is my opinion that the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such.”
The former Commissioner said that one member of that panel, specifically, was a “huge advocate” of Yaz. Kessler reviewed documents pertaining to backgrounds of Paula Hillard, Anne Burke, Melissa Gilliam, and Julia Johnson.
Herndon plans to start the first of nine trials on April 30, if mediation fails. He had planned to start it on Jan. 9, but canceled it on Dec. 31. He canceled the trial a day after Bayer challenged Kessler’s opinions about the FDA.
Stay tuned for further information concerning this very interesting story!