Tainted FDA Advisory Panel Votes for Big Business and Disregards Women’s Safety

By Rheingold Giuffra Ruffo & Plotkin LLP

Safety issues stemming from the use of birth control pills containing drospirenone, such as Yaz and Yasmin, have been a concern for years. Studies conducted on the drugs have shown that users have an increased risk of dangerous blood clots and other side effects including deep vein thrombosis, stroke, pulmonary embolism and gallbladder disease. Cases of injury and death have also been linked to using the drugs. In fact, ongoing litigation is pending in federal court, Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100), which is a consolidation of federal injury lawsuits against drospirenone birth control pill manufacturers.

In the mist of lawsuits against the makers of Yaz, Yasmin and other oral contraceptives containing the synthetic progestin, drospirenone, the Food and Drug Administration (FDA) held an advisory committee panel to determine if the benefits of the drug outweigh the risks. The advisory panel voted on the matter (15-11) December 8, 2011 and concluded that the benefits did in fact outweigh the risks of injury. However, since the panel’s decision, information has become known that some panel members who endorsed the drug’s safety had financial ties to the drug’s maker, Bayer, as reported by NewsInferno.

FDA advisory panel members are supposed to be impartial and are required to disclose any financial connections with a related drug maker, according to a Wall Street Journal Report. Safety advocates believe that the panelists’ connection to Bayer is a conflict-of-interest and any decision made by the committee members should be disregarded. As a result, a new safety advisory panel hearing has been called for by safety advocates upon learning that members of the last advisory panel had ties to the makers of the very products they were evaluating.

The Project on Government Oversight has called for a new panel without conflict-of-interest or impartiality concerns to determine the safety of Yaz and Yasmin. The panel findings are not only biased and tainted but also outrageous. Members voted in favor of big business instead of safety, which should be the point of the panel. Consequently, women using these dangerous drugs will suffer risks of serious injuries as large drug manufacturers, like Bayer, continue to sell their product to consumers and line their pockets at the expense of safety.

At present, the FDA is standing behind the advisory panels vote and it is unclear whether safety advocates demands for a new panel will be satisfied. However, evidence of the regulatory committee’s conflict-of-interest may come into play in the ongoing consolidated Yasmin and Yaz litigation, of which the first trial is scheduled to begin April 30, 2012.

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