News for the ‘News’ Category
Yaz lawyers oppose former FDA chief’s testimony
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.
Drug company ‘check lists’ influence patient choice
FDA panel member ‘well utilized’ by Yaz maker
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.
Watchdog group pushes FDA panel to revote on Yaz safety
First Yaz trial will be April 30 if mediation fails
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.
FDA panel members had ties to Yaz maker
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.
Combined birth control pills provide limited PMS pain improvement
FDA advisor warns ‘do not use’ Yaz, Yasmin
When Dr. Sidney Wolfe was asked in 2009 by the Food and Drug Administration (FDA) to join the agency’s Risk Management Advisory Committee for a 4-year term, the head of the Washington, DC-based watchdog group Public Citizen took the task to heart. He championed the removal of the longstanding painkiller Darvocet/Darvon, calling the drug “extremely dangerous” based on reports of more than 2,000 accidental deaths since 1981. He also pushed for stronger warnings on prescription drugs, including the type 2 diabetes drug Avandia, which has been linked to fatal heart attacks.
First Yaz lawsuit ordered to mediation for potential settlement
The first of more than 10,000 lawsuits against Bayer over its birth control pills Yaz and Yasmin won’t go to trial this week as planned because a judge appointed a mediator in hopes of settling the case. The lawsuit accused Bayer of misleading women about the safety risks associated with its oral contraceptives.




