Lieff Cabraser Heimann & Bernstein, LLP

FDA Commissioner Called Upon to Convene New Advisory Panel To Review Safety Of Yaz Birth Control

Millions of American women have been prescribed Yaz, Yazmin, and other birth control products containing the synthetic hormone drospirenone, or DRSP, amid thousands of reported cases of blood clots and other problems.

Last December, a U.S. Food and Drug Administration advisory panel reviewed the safety of DRSP oral contraceptives. Three studies funded by Bayer, the manufacturer of Yaz and Yasmin, had come to the conclusion that the risks were no higher for the pills, known as Yaz and Yasmin, than for other contraceptives that do not contain DRSP. But seven separate, independently-funded studies came to the opposite conclusion. Some of these studies rated the risk of Yaz and Yasmin roughly double that of non-DRSP birth control pills.

At the hearing, Joan Cummins was one of the parents and patients to provide emotional testimony. She spoke of the death of her 18-year-old daughter, Michelle Pfleger, in 2010 while being prescribed Yaz. Ms. Pfleger, a freshman at Elon University in North Carolina, collapsed and died of cardiac arrest from a blood clot in her lung.

Nevertheless, the FDA advisory panel voted 15-11 that the benefits of its oral contraceptives outweighed the risks of blood clots developing in women.

However, as noted by Adam Zagorin of the Project on Government Oversight,

[T]he FDA panel did not consider an internal Bayer document that was recently introduced as evidence in a federal court proceeding against the company. That document, dating from 2004, features Bayer's own experts describing its Yasmin contraceptive as having a reported rate of serious 'adverse events' that was '10 fold higher' than other contraceptives. The 'adverse events' typically involved blood clots, which could become life-threatening if they moved to the lungs or heart.

Furthermore, this week the Wall Street Journal reported that three doctors who served on the FDA advisory panel had served as consultants, speakers or researchers for Bayer, which was not disclosed to the public. All three of the doctors with ties to Bayer voted with the majority in finding the benefits of Yaz and Yasmin outweighed their risks.

The conflict of interest these three doctors have was detailed in a report filed by plaintiffs' expert David A. Kessler, a former FDA commissioner, in the Yaz and Yasmin lawsuits against Bayer in federal court. Dr. Kessler wrote, "It is my opinion that certain members of the advisory committee did have conflicts of interest such that a reasonable person with knowledge of the relevant facts could question the member's impartiality."

Dr. Kessler's contended that all three members' relationships are evidence that "the FDA advisory committee was not independent of Bayer and its recommendations and votes need to be viewed as such."

Today, the Project on Government Oversight (POGO), an independent, non-partisan investigative organization, sent a letter to FDA Commissioner Margaret Hamburg detailing the conflicts of interest among members of the FDA advisory committee, and called for a new, fully independent advisory committee to be convened to review the safety of Yaz and Yasmin.

The POGO's letter to the FDA concludes:

"We are troubled by the industry ties of some of the FDA joint committee members who reviewed the safety of Yaz and Yasmin on December 8, 2011. Because of the industry ties of these members, the joint committee's conclusion—which amounted to an endorsement of the safety of these oral contraceptives—should be disregarded. A new advisory committee—without questionable impartiality or any conflicts of interest—should re-evaluate the safety of Yaz and Yasmin."

Learn more about Yaz lawsuits.