As we reported in a previous blog, tomorrow the FDA will be considering safety findings on Yasmin and Yaz, but will not be armed with some alarming data Bayer apparently withheld from U.S. regulators.
The former head of the FDA, David Kessler, stated in a document unsealed yesterday by the MDL court in Illinois, that Bayer withheld findings of its own company researchers that demonstrated an increased rate of blood clots in users of its birth control pills. This data, along with other information concerning increased rates compared to other oral contraceptives, was left out of the data Bayer presented to the FDA in 2004. The presentation was a review of Yasmin’s safety.
Because Kessler’s report (along with four other expert opinions) was sealed until yesterday, it was not made available to the FDA in time for tomorrow’s hearing. The deadline for submission, according to Kalyani Bhatt of the FDA’s Division of Advisory Committee and Consultant Management, was November 23. While we at The Levensten Law Firm are disappointed the FDA will not have a chance to review these documents in tomorrow’s hearing, the unsealing of these expert opinions nonetheless help provide more information regarding the knowledge Bayer withheld concerning the safety of Yasmin contraceptives.
Kessler’s report stated that in a draft of an internal report, Bayer employees wrote that Yasmin has a “several fold increase in the reporting rates for DVT (deep venous thrombosis), PE (pulmonary embolism), ATE (arterial thromboembolism) and confirmed VTE (venous thromboembolism)s” compared to three other oral contraceptives.
The report of John Abramson, a Harvard medical school professor, was another of the unsealed documents yesterday. According to the document, Bayer’s Berlex unit paid a well-known gynecologist in LA, Judith Reichman, $450,000.00 to support her book tour. Berlex officials in an email said the money would be compensation for the doctor’s pushing of off-label benefits of Bayer products. Yasmin has only been approved as a contraceptive, but these documents provide further support that Bayer has actively pursued public mentions of possible off-label uses, including paying an author/doctor hundreds of thousands of dollars, to avoid the FDA restrictions on marketing.