Court Docs: FDA Yaz Panelists Had Ties to Bayer
If you were wondering why the FDA advisory panel on Yaz blood clot risks still refuses to recall the controversial oral contraceptive from the market, you may be interested to know that it was recently discovered that at least four of the panelists that reviewed the drug had previous financial ties to the drug’s manufacturer.
According to court documents, which were reviewed by the BMJ and Washington Monthly, four of the advisers that had conducted the research for Bayer and the other makers of pills containing drospirenone (a synthetic progestin) were financially tied to the drug company in that they were being paid by Bayer to render opinions, conduct research, to act as consultants and/or speak on behalf of the company and its drospirenone-based pills. While all of the panelists claim to have disclosed their ties to Bayer to the FDA beforehand, the conflict of interest remains obvious to the rest of us. For its part, the FDA refuses to release the advisers’ “financial conflict of interest forms” because they claim that the information is confidential. However, the FDA’s spokeswoman, Morgan Liscinsky, has said that no waivers had been issued.
Julia Johnson, who is the acting chairperson of the FDA and a professor of obstetrics and gynaecology at the University of Massachusetts Medical School, has said in an email, “The FDA is very vigilant on examining potential conflicts of interest.” She declined to be interviewed by claiming that she can’t speak about the meeting.
When the panel met to discuss the potential dangers of Yaz, they voted 15 to 11 that the benefits of using Yaz outweighed the risks. This new information could cause many Yaz lawsuit plaintiffs to claim include the conflict of interest in their filings. When this potential conflict of interest arose, it appeared in the form of a court filing by the FDA's former commissioner, David Kessler, who found the payments from Bayer by sifting through internal documents that aren’t available to the public.
