The Food and Drug Administration (FDA) should disregard a joint advisory committee’s support of a controversial birth control pill because four members of the panel had ties to either the contraceptive maker or the maker of a generic version, the Project On Government Oversight (POGO) said Wednesday in a letter to the FDA.
In POGO’s letter to FDA Commissioner Margaret Hamburg, the watchdog group questioned why members with ties to Bayer HealthCare Pharmaceuticals were allowed, in essence, to endorse the company’s second-best-selling franchise without announcing their ties during the meeting.
“It’s troubling that the FDA was well aware of the potential conflicts of interest, without discussing the ties at a public forum,” POGO Executive Director Danielle Brian said. “The American public must be able to trust that the FDA and its advisory committees are making decisions based on science not industry influence.”
The FDA joint advisory committee met Dec. 8 to consider whether the benefits of the oral contraceptives Yaz and Yasmin outweighed the risks of the drugs, which have been linked to fatal blood clots in some women who have taken the pills. The joint committee voted 15-11 in favor of the contraceptive. One member, Pharma watchdog Dr. Sidney Wolfe of Public Citizen, was not allowed to vote because of his previous advocacy against Yaz/Yasmin.
FDA officials were aware of the ties but neither agency officials nor the four members publicly disclosed these ties during the Dec. 8 meeting joint committee meeting. Dr. Paula Hillard of Stanford School of Medicine, Dr. Julia V. Johnson of the University of Massachusetts Medical School and Dr. Anne E. Burke of The John Hopkins Bayview Medical Center had all received past funding from Bayer. The fourth, Dr. Elizabeth Raymond of the Gynuity Health Projects in New York had received research funds from a company which has a licensing agreement with Bayer for generic versions of Yaz.
POGO is asking the FDA to:
- Set aside the December vote and convene a new advisory committee to reevaluate the safety of Yaz and Yasmin;
- Ensure that ethics guidelines currently under consideration include stronger requirements for public disclosure of conflicts; and
- Post the financial disclosure forms filed by advisory board members online.
“How many more times will the FDA have to answer questions about potential conflicts of interest before it finally raises it standards?” Brian said.
Follow the link to read POGO’s letter to the FDA.