When an FDA advisory committee met in December 2011 to discuss the safety of birth control pills that contain drospirenone, such as Yaz and Yasmin, they voted 15-11 that the benefit of the pills outweighs the risk of dangerous side effects of drospirenone, which include blood clots that can lead to heart attack, stroke, pulmonary embolism and death.
The FDA held the meeting in December amid growing criticism that drospirenone, a new type of synthetic progestin in a new class of birth control pills, is dangerous and should be recalled. The actual increased risk is small — roughly 10 per 10,000 women taking drospirenone develop blood clots or other thromboembolic events, compared to 6 per 10,000 women taking levonorgestrel, an older synthetic progestin. But because millions of women take a birth control pill, this relatively small increase translates to tens of thousands more women developing blood clots that can lead to death. Dozens of women have died as a direct result of the pills. Bayer now faces thousands of Yaz lawsuits and Yasmin lawsuits.
The links between the FDA committee and Bayer were uncovered by a joint investigation by the BMJ and Washington Monthly. They found that the panel’s chairwoman, Julia V. Johnson, MD, received money from Bayer and conducted a clinical study of drospirenone.
A second panelist was a paid consultant for Bayer, and had received between $5,000-10,000 in 2010 and attended meetings at Bayer. The individual also worked for a laboratory that had a licensing agreement to produce generic Yaz.
A third panelist received research funding from Bayer, as well as another laboratory that had a licensing agreement to produce generic Yaz and Yasmin.
Officials at the FDA determined that these three panelists had no “conflict of interest,” though they were receiving money from the drug company responsible for the drugs under scrutiny. However, a doctor and author of the popular consumer guide Best Pills / Worst Pills was not allowed at the meeting due to a conflict of interest. Sidney Wolfe, MD, is the author of Best Pills / Worst Pills, and is also the director of health research and consumer advocacy at Public Citizen. He had previously warned consumers to avoid drospirenone “due to the increased risk of blood clots.”
There is also criticism that the FDA panel never reviewed a report from former FDA commissioner David Kessler, MD, which accused Bayer of hiding safety information about the heightened risk of blood clots and engaging in “off-label” promotion of their products to increase sales. This study was not included in the documents reviewed by the FDA panel because it was not submitted before a deadline.
This news of a possible financial conflict of interest in the FDA panel comes amid signs that the government will soon require drug companies to disclose payments they make to doctors. It is common practice for drug companies to pay doctors thousands of dollars for research, advice, lectures, travel, and other perks. Consumer advocates are concerned that this amounts to bribery, and may lead to a conflict of interest for the doctors and their patients. Patients assume that a doctor is acting in their best interests alone — not the best interests of a drug company.