A watchdog group is calling on the Food and Drug Administration to throw out a joint committee's vote in support of a controversial oral contraceptive because four members of the committee – including a Stanford University professor of obstetrics and gynecology – had ties to the maker of the birth control pill that were not disclosed to the public during the meeting.
Two FDA committees met Dec. 8 to discuss the benefits and risks of the oral contraceptives Yaz and Yasmin and related contraceptives containing the drug drospirenone.
The meeting came amid mounting evidence that drospirenone-containing birth control pills, including bestseller Yaz, have a higher risk of causing potentially dangerous blood clots.
The committee discussed and compared the results of 10 epidemiologic studies of women taking oral contraceptives. Ultimately, the members voted [PDF] 15 to 11 that the benefits of drospirenone-containing oral contraceptives outweighed the risks.
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But four of the members who cast crucial votes in support of the contraceptives had ties to Bayer HealthCare Pharmaceuticals Inc., the manufacturer of Yaz and Yasmin, according to public documents unearthed by the Project On Government Oversight and detailed in its Jan. 11 letter to the FDA.
That included Dr. Paula Hillard of Stanford’s School of Medicine. Hillard is listed on the medical school’s website as a paid consultant receiving $5,000 or more annually from a division of Bayer in 2010. Hillard was selected as a temporary voting member for the FDA committee in 2011.
In addition, former FDA Commissioner Dr. David A. Kessler described Hillard as a Yasmin advocate with a long relationship with Bayer in a Dec. 26 expert witness report he filed as part of an ongoing class-action lawsuit against the pharmaceutical company claiming that Bayer over-promoted Yaz's efficacy.
In 2008, Kessler noted, a Bayer Corporate Account Update announced: “New west coast speaker … Paula Hillard, MD recently relocated from Cincinnati, OH to Stanford – this enables us to now have another huge Mirena and Yasmin advocate here in Nor Cal – she will be well utilized!”
Kessler also said Bayer’s plan involved talking to Hillard about the risk of venous thromboembolism, the potentially lethal disorder in which clots that form abnormally in veins may dislodge suddenly and travel to the lungs, where they can cause serious injury or death.
A Bayer Tactical Brief from January 2010 describes a video shoot with Hillard to “illustrate patient counseling techniques on the safety of YAZ.”
Nick Schwellenbach, director of investigations for the Project On Government Oversight, said Hillard clearly had a conflict of interest.
“We believe, given her very specific work on drospirenone with Yaz and Yasmin for Bayer up until November 2010, we think that constitutes a conflict of interest, and she should have been barred from being a voting member on that committee,” he said.
In a written response, Stanford spokeswoman Margarita Gallardo wrote that Hillard had “fully disclosed to the best of her recollection all required information regarding potential conflicts of interest to the FDA.”
In her disclosure, Gallardo said, Hillard told the FDA that she attended two Bayer meetings in 2010. The first, in October, discussed a range of oral contraceptives that contain drospirenone. A second meeting in November was related to the use of the levonorgestrel intrauterine system, a device not under consideration by the panel.
Gallardo said Hillard's reimbursements from Bayer for consulting in 2010 were less than $10,000. She said Hillard did not consult for Bayer in 2011.
The Project On Government Oversight is pushing the FDA for greater public disclosure of committee members’ financial arrangements in general. The agency requires committee members to fill out a form that gives specific information about current and past financial arrangements, said Ned Feder, staff scientist for the Project On Government Oversight. But the forms are not public documents.
If the FDA decides that something on a member’s form poses a possible conflict of interest, the agency can allow the person to participate in a meeting by granting a waiver. The conflict-of-interest waiver document makes public the person’s financial arrangements.
But in the case of Hillard and three other reviewers on the joint committee studying contraceptives, the FDA did not issue any such waivers.
“The whole issue could be taken care of if the FDA simply took the information it got from reviewers and made it public,” Feder said.