Seated around a U-shaped configuration of tables sat the 26 member FDA Advisory Committee — all scientists or physicians gathered to discuss the risks of birth control pills containing DRSP. They focused on the risks as described in recent studies, including the FDA’s own study that looked at over 800,000 women during a six year time period. The results of the FDA study concluded that new users of Yasmin may be twice as likely to experience a blood clot as users of other birth control pills containing the progestin Levonorgestrel.
During the first two hours of the hearing, an FDA representative presented an overview of the studies Bayer conducted after Yasmin was introduced to the market. The Bayer studies suggested that Yaz posed little additional risk. Then an FDA-paid scientist presented the results of the study that she conducted, showing a greater risk. But rather than bolstering her results with the six independent studies also showing a greater risk, the FDA-paid scientist gave those other studies – including those done by Drs. Jick of the U.S., Parkin of the U.K. ,Vlieg from the Netherlands and Lidegaard of Denmark– short shrift. Rather she focused on trying to explain away the conflicting results between the FDA’s own study and the Bayer-sponsored studies. Possible explanations she offered: FDA study design weaknesses and channeling. (Channeling is the selective prescribing of Yasmin to high-risk patients such as women with polycystic ovary syndrome.)
The FDA teed up nicely the topics for more than two hours of presentations by the German- owned Bayer representatives. Flanked by more than thirty Bayer suits seated neatly in five rows, Bayer’s vice president of US Medical Affairs, Leo Pouffle, with his stunted German accent led the charge. A regimen of six head-set tethered technicians each peering over his or her laptop supplied Dr. Poufle and other Bayer speakers with plenty of power-point ammunition. Bayer’s well-rehearsed battalion calmly, courteously and methodically casted doubt on the FDA study.
Members of the public were then allowed to speak. Each was limited to three minutes. Family members of Yaz victims described how Bayer robbed them of their young, fit, active healthy daughters who died after suffering a pulmonary embolism – caused by taking Yasmin or Yaz. Members of other women’s health organizations spoke up about the unnecessary health risks posed by DRSP. Two scientists testified, including Bert Gerstman, an epidemiologist who criticized the design of Bayer’s studies. Unfortunately, the public comment had little effect on today’s outcome.
After two more hours of questions and answers about the studies, the FDA advisory committee decided that Bayer’s current labels do not adequately reflect the risk/benefit profile for these products. That was expected, since the results of the FDAs own study are not described in the current warnings. But to the disappointment of consumer advocates, the committee did not push for black box or even tougher warnings. The members merely recommended that the FDA draft simpler warnings with an updated summary of recent conflicting study results.
One FDA committee member pressed Bayer’s vice president of US Medical Affairs on whether Yasmin and Yaz are more effective than other oral contraceptives at preventing pregnancy. If the drug was more effective, that might justify their higher level of risk. Dr. Plouffe deflected the question twice. But when the committee asked a third time, he admitted that Yasmin and Yaz are no more effective that other combination oral contraceptives.
Nonetheless, the committee voted 15 to 11 that the benefits of Bayer’s DRSP-containing oral contraceptives outweigh their risks. Apparently, some committee members, mostly clinicians, needed no evidence that Yasmin and Yaz are more effective than other oral contraceptives to come to that conclusion. They were satisfied that Yasmin and Yaz are as effective as other oral contraceptives at preventing birth and refused to accept reported results that Yasmin and Yaz pose greater risks of VTE than other birth control pills. More sympathetic to the consumer’s plight, the scientist and epidemiologists on the committee were dissatisfied with Bayer’s studies and offered their opinions that Yaz and Yasmin posed risks that were simply unacceptable.