A new report says Bayer AG may have considered marketing the Yaz birth control pills for off-label uses. According to a report from Bloomberg, company documents uncovered in the course of Yaz and Yasmin lawsuits also indicate Bayer may have misled women about the serious risks posed by Yaz’s precursor, Yasmin.
Internal Bayer emails provided to lawyers representing plaintiffs in Yaz and Yasmin lawsuits show company officials discussed promoting Yaz as a treatment for all forms of premenstrual syndrome, or PMS, even though Yaz is only approved for the most severe form of the disorder, called premenstrual dysphoric disorder, or PMDD. According to Bloomberg, in one case, salespeople for Bayer unit Berlex Laboratories Inc., acquired in the 2006 purchase of Schering AG, received an e-mail that year from a company official citing a Woman’s Day magazine article about Yaz:
“This article is a nice way of using YAZ for PMS treatment instead of just focusing on the specific” class of women with PDD, the email, from Matt Sample, a Berlex sales consultant, states.
In the same email, Sample urges sales reps to ask doctors “what percentage of your patient population suffers from” symptoms common to PMS, versus the more severe form of the disorder, and to seek information on “what they think the impact of Yaz will be.”
According to Bloomberg, plaintiffs lawyers involved in Yaz and Yasmin litigation contend Sample’s email amounts to an effort to have Yaz promoted for a use not approved by the U.S. Food & Drug Administration (FDA). Under U.S. law, drug makers are legally barred from marketing drugs based on off-label used, though doctors are able to use approved drugs in anyway they see fit.
In another email from 2002, then-Berlex executive Kimberly Schillace discusses a contract with Dr. Judith Reichman, a Los Angeles-based gynecologist who writes a blog about women’s health issues, and was a regular contributor on NBC’s “Today” show as a contributor on women’s health. “She definitely will mention the off-label benefits of our products,” Schillace writes.
It does appear that Schillace was correct about Reichman’s endorsement of off-label uses of Yasmin, which was only approved by the FDA for birth control. According to Bloomberg, Reichman noted Yasmin could be helpful with PMS-like symptoms in a 2003 MSNBC article. She also wrote that Yasmin may help women with PMS-related symptoms and depression in her 2005 book, “Slow Your Clock Down.â€
Bayer has also had problems with U.S. regulators for the way its marketed Yaz. According to Bloomberg, in 2008, the FDA cited Bayer for Yaz TV commercials that downplayed the drug’s serious risks, and forced it to spend millions on a corrective advertising campaign.
Documents provided by plaintiffs’ lawyers to Bloomberg also show that Juergen Dinger, lead author of the European Active Surveillance Study, which purportedly showed no increased risk of blood clots associated with Yasmin, was involved in the drug’s development when he was a Schering vice president. Yasmin and Yaz plaintiffs claim that study downplayed the serious risks associated with drospirenone, the synthetic progestin contained in Yaz. Dinger’s tenure at Schering and his involvement with the Yasmin birth-control pills weren’t disclosed in the study when the final results were published in the medical journal Contraception in 2007, Bloomberg said. Maureen Cronin, a Schering executive, said in a 2005 e-mail that she met with Dinger and “reached agreement on the future reporting on EURAS” study results.
“One major reason for providing only tables and a synopsis is that we do not want to imply that we have a VTE (venous thomboembolisms)problem but emphasize the fact that the study results indicate that Yasmin’s VTE/ATE (arterial blood clot) is comparable to other” contraceptives, Cronin wrote, according to a copy of the e-mail.
Dinger told Bloomberg the email in question was taken out of context, while Cronin could not be reached for comment.
Bayer currently faces more than 10,000 product liability lawsuits involving Yaz and Yasmin. Thousands of those lawsuits have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.
A growing body of research has pointed to an increased risk of dangerous blood clots associated with the use of Yaz, Yasmin, and other drospirenone containing contraceptives. In fact, just last month, the FDA warned that a study it funded found that compared women using birth control pills made with an older form of progestin, women taking pills with drospirenone had a 75 percent greater chance of experiencing VTEs. The FDA is currently reviewing the safety of such drugs, and has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for December 8 to discuss the safety of drospirenone birth control pills.
