On December 8, 2011, an FDA advisory committee held hearings on the safety of Yaz and Yasmin. After nearly a full day of testimony, the committee voted 21-5 that the information about the risks of Yaz provided to doctors and patients were inadequate. The panel voted narrowly, however, that the benefits outweigh the risks overall, and therefore voted not to remove Yaz from the market. The second vote was 15-11.
In the weeks following the votes described above, some disturbing details have come to light about the members of the expert panel that is advising the FDA.
- Five members of the committee, including the committee chair, have financial ties to Bayer
- A sixth member was stripped of his voting rights for an “intellectual conflict of interest” because he had the foresight to question the safety of Yaz a few years ago.
- A detailed report on the safety of Yaz, authored by former FDA Commissioner David M. Kessler, M.D., was not considered by the committee. The report was submitted in the Yaz litigation under seal, and although the Judge ordered it released to the public, the order did not come out until after the deadline for submitting materials to the advisory committee. The FDA declined to make an exception in this case.
Simple maths suggests that if the committee members with financial ties to Bayer were not permitted to vote, and if the sixth expert who was disqualified at the last minute was allowed to vote, then the committee might have decided, 12-10 to recommend removing Yaz and Yasmin from the market.
In addition, Lopez McHugh has reviewed the transcript of the vote and found that several of the experts who voted to keep Yaz on the market had significant concerns about the safety of the drug. For example:
- Dr. Clark voted to keep Yaz on the market, but thought there was a “modest increase in absolute risk.” (Transcript, p. 109).
- Dr. Johnson, the chairperson of the committee, explained that she does not think “there is one advantage for this pill over any other,” and if an additional study found an increased risk, would vote to remove Yaz from the market. (Transcript, p. 110).
- Dr. Morrato explained that the absolute risk was low, but if she were making a comparative assessment, she would vote no. (Transcript, p. 110).
- Dr. Hennessy explained that “it was a difficult vote,” and that the drug “out to be rarely used”. (Transcript, p. 112).
- Dr. Burke believed that Yaz had a “moderate increased risk,” but didn’t believe it was necessary to take off the market “at this point.” (Transcript, p. 112).
- Dr. Espey compared the risk of blood clots on Yaz to the risk of blood clots while pregnant, apparently ignoring the fact that there are other methods of birth control with lower risk. (Transcript, p. 109).
- Several other experts appeared to follow the same logic as Dr. Epsey, and compared Yaz to the risk of getting pregnant rather than comparing Yaz to other forms of birth control (Dr. Hoeger, Dr. Tepper, and Dr. Rice, p. 110; Dr. Wild, p. 111; and Dr. Raymond, p. 112).
The experts who voted to remove Yaz from the market expressed additional concerns. For example:
- Dr. Orzsa explained that there was no benefit from Yaz over any other drug, and pointed out that even a “small” increase in risk could cause thousands of unnecessary [life-threatening] blood clots. (Transcript, p. 110).
- Dr. Woods saw no clear benefit and a modest, but “potentially catastrophic risk.” (Transcript, p. 110).
- Dr. Kaboli saw no clear benefit, so no reason to subject women to even a small increase risk. He stated that he wouldn’t recommend it to his patients and wouldn’t have his daughter take it. (Transcript, p. 111).
- Dr. Winterstein took issue with how the question was worded–weighing overall risk against overall benefit (prevention of pregnancy), rather than comparing to potentially safer drugs on the market. (Transcript, p. 111).
- Dr. Suarez-Almazor explained that she did not believe there was clear evidence of benefits over other oral contraceptives. Further, she was “disturbed” by the fact that every independent study showed an increased risk while only the industry-sponsored studies showed no increased risk. (Transcript, p. 111).
As the above examples demonstrate, even if the FDA decides to keep Yaz on the market, a panel of experts had serious concerns about the risks versus the benefits of Yaz.
The non-profit group Project on Government Oversight has written an open letter to the FDA, calling for it to put aside the committee vote and hold new hearings, this time with experts that do not have ties to Bayer. Whether the FDA addresses the Project’s concerns remains to be seen. Updates will be posted here.
If you suffered blood clots, pulmonary embolism, or stroke while on Yaz, Yasmin, Ocella, or Beyaz, then you should consider calling for a free case evaluation. You can contact Lopez McHugh using the form on the right, or by clicking here.