FDA panel member ‘well utilized’ by Yaz maker
January 27th, 2012 by Jennifer Walker-Journey
A Food and Drug Administration (FDA) panel member who voted to keep the birth control pills Yaz and Yasmin on the market despite studies that showed the pills put women at greater risk for deadly blood clots was praised by the drugs’ maker Bayer in a 2008 report saying, “She will be well utilized.” The adviser, Paula Hillard, M.D., with Stanford’s School of Medicine, is listed on the medical school’s website as a paid consultant receiving $5,000 or more annually from a division of Bayer.
Hillard’s apparent conflict of interest on the federal agency panel was noted by former FDA Commissioner Dr. David Kessler, who recently offered expert witness testimony as part of an ongoing class-action lawsuit against the pharmaceutical company claiming that Bayer over-promoted the benefits and understated the risks of Yaz. Kessler also said that Bayer had plans to talk with Hillard about the risk of blood clots.
Hillard was also featured in a 2010 Bayer Tactical Brief video designed “to illustrate patient counseling techniques on the safety of Yaz.”
Blood clots are potentially deadly medical problems that can lead to strokes, heart attacks or pulmonary embolism. All birth control pills carry a slight risk for blood clots, which is noted on the drugs’ safety packaging. However, recent studies show that pills containing the hormone drospirenone put women at greater risk for developing blood clots. Bayer’s Yaz and Yasmin contain drospirenone. Bayer also makes versions of the pills with folic acid, known by the brand names Beyaz and Sayfral. Generic versions are also available.
The recent studies prompted the FDA to undergo a review of the safety of drospirenone-containing pills. The agency’s advisory panel voted to recommend that stronger warnings be put on the pills’ packages. Hilliard and at least three other members of the 26-member panel were later found to have research or financial ties to Bayer or companies that make generic versions of the pills.
In light of panel members’ possible conflict of interest in the Yaz case, citizen watchdog group POGO (Project On Government Oversight) is calling for a revote.
Source: California Watch