Pharmaceutical giant Bayer has come under fire after an Illinois court made the accusations of former FDA commissioner David Kessler, MD, public. Kessler’s expert opinion, filed in a federal court, accuses Bayer of hiding data regarding the safety of two of its birth control pills, Yasmin and Yaz, while conducting extensive off-label promotion in order to drive sales.
“By failing to disclose all thromboembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events,” Kessler concluded in his exhaustive opinion.
Already, there are multiple pending lawsuits over injuries and deaths related to drospirenone/ethinyl (found in Yaz/Yasmin). The double whammy of unethical marketing and hiding data about blood clotting risks associated with the drug may mean big trouble for Bayer.
Kessler’s evaluation became public just days before the FDA’s Reproductive Health Drugs Advisory Committee December 8th meeting which is slated to include discussion of the risks and benefits of oral contraceptives containing drospirenone.
The most damning evidence in Kessler’s opinion came from a review of Bayer’s private materials. Kessler accused Bayer of burying a draft of 2004 white paper that stated Yasmin caused a “several-fold increase” in rates of deep-vein thrombosis and pulmonary embolism compared to three popular birth control pills. The paper also stated that, in general, serious adverse events were 10 times higher for Yasmin than for similar products.
Of course the FDA never received that information. Instead, Bayer submitted a white paper that read: “The spontaneous reporting data do NOT signal a difference in VTE rates for Yasmin and other [oral contraceptive] uses. We see NO signal of a difference.”
Despite the dangers, Bayer also did a significant amount of marketing, “a systematic and extensive campaign,” that portrayed Yasmin and Yaz as aids for premenstrual symptoms and acne, although they had not been approved to treat those symptoms.
Kessler also claimed that Bayer carried out a “systematic and extensive campaign to market Yasmin and Yaz” as a treatment for premenstrual syndrome (PMS) and acne even though the products weren’t approved for those indications. In addition, the company repeatedly overstated the benefits of the pills and downplayed their risks, Kessler said.
Bayer considers these accusations a matter of litigation at this point, and has not commented substantively on the allegations.
Despite this shocking news, the FDA hearing on Thursday will not include a discussion of Kessler’s documents the deadline has passed to submit documents for the advisory committee.
Still, it’s likely that the FDA will take some action against medications that contain drospirenone.
In the FDA reviewers stated in their briefing documents that “review of the epidemiologic studies show certain trends that cannot be ignored,” including that recently approved “combination hormonal contraceptives” appear to have a higher risk for venous thromboembolism, or blood clots.
If Kessler’s allegations, that “Bayer had a duty to present a full and balanced view of all the data and analysis concerning Yasmin to the FDA and healthcare professionals and failed to do so,” what happens in court could be even worse for Bayer.
GJEL is currently investigating potential claims against Bayer because of Yaz and Yasmin. Because of his expertise on the matter, Andrew Gillin, partner at GJEL was recently quoted by US Recall News about the litigation.
Photo Credit: Surija