Panel members had financial ties to Yaz maker
Why are the birth control pills Yaz and Yasmin still on the market when studies show they are more dangerous than other oral contraceptives?
Why are the birth control pills Yaz and Yasmin still on the market when studies show they are more dangerous than other oral contraceptives?
Watson Pharmaceuticals has launched Vestura, a generic version of Bayer’s blockbuster birth control pill Yaz. Like their brand-name counterpart, these pills will also carry a safety announcement on their packaging, warning users that studies suggest the drospirenone-containing pills may put users at greater risk for developing life threatening blood clots.
Drug giant Bayer is not at all happy that a former Food and Drug Administration (FDA) chief has been tapped to testify against the drug company in a multidistrict litigation (MDL) focusing on the safety of Bayer’s top-selling birth control pills, Yaz. Former FDA commissioner Dr. David Kessler recently submitted an expert report claiming that an FDA advisory committee vote on the pills was tainted because some members of the panel were paid consultants for Bayer and posed an obvious conflict of interest.
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.
If mediation fails between Bayer and lawyers for the defendant, the first Yaz/Yasmin trial against the drug company will start on April 30. U.S. District Judge David Herndon ordered the mediation earlier this month in an attempt to settle the mounting lawsuits. But in a Jan. 10th clarification of a Dec. 31st order, he warned that if Bayer and plaintiffs don’t act in good faith, he would remand cases to districts where they began.
Last month, an advisory panel for the Food and Drug Administration (FDA) pored over data that showed women who took birth control pills containing the hormone drospirenone were at greater risk of developing blood clots than women on older generation birth control pills. Yet, panel members refused to ban the drug, instead recommending that the FDA put stronger warnings on the pills’ labels. Why would the panel have such lax standards when it comes to the safety of American women? One watchdog group is suggesting that the panel, which included four advisers with ties to companies that make drospirenone-containing drugs, may have been unfairly slanted.