In 2001, the Food and Drug Administration (FDA) approved the oral contraceptive Yasmin for use. A similar contraceptive, Yaz, was approved in 2006. Both drugs are manufactured by Bayer, a pharmaceutical company. As early as 2004, Bayer scientists reported that Yasmin carries a “‘several-fold increase’ in reporting rates for blood clots compared to three other oral contraceptives, and that Yasmin’s rate of all serious adverse events was ’10 fold higher’ than that of other products.” Despite this, the FDA approved Yaz two years later, though it contained the same hormone that caused the blood clots in Yasmin. A 2009 study found that this hormone, drospirenone, increased a user’s risk of venous thromboembolism by a factor of 6.3.
Yaz and Yasmin have been linked to 100 deaths, and over 10,000 lawsuits have been filed against Bayer claiming that consumers have been harmed by taking the contraceptives. In December 2011, the FDA reexamined Yaz and Yasmin. A panel voted to include the risk of blood clots on labels, though it declined to require Bayer to indicate that the risk was any greater than that for other contraceptives, despite a study published in the British Medical Journal that indicated that the risk of blood clots were twice as high for users of Yaz and Yasmin than for other contraceptives. The FDA panel voted 15-11 to allow the contraceptives to remain on the market, finding that their benefits to consumers outweighed their risks. Scientists and consumer advocates soon observed, however, that four (possibly five) members of the FDA panel had financial ties to Bayer, and all four voted to keep the drugs on the market. They each had disclosed these conflicts of interest to the FDA, and the FDA allowed them to vote on the panel anyway. In February 2013, Bayer faced roughly 13,600 lawsuits in the United States regarding the contraceptives, excluding claims already settled. Further, as of February 2013, Bayer had also “reached agreements, without admission of liability, to settle the claims of approximately 4,800 claimants in the U.S. for [about $1 billion.]” Yaz and Yasmin are still on the market, and Bayer profited $1.42 billion from them in 2012.
This incident is only the latest of several in recent years that have caused many to question the FDA’s transparency and bias in its review and approval processes. Conflict of interest within FDA advisory committees has been discussed before, but several new regulations have loosened FDA conflict of interest requirements, and recent events such as the Bayer incident raise questions as to whether the current regulations are effective. Further examination of these issues is in order. This Note explores the depths of financial conflicts of interest in these processes, how they are regulated, and how they should be regulated. Part II discusses current conflict of interest regulations imposed upon the FDA. Part III examines the arguments for loosening regulations. Part IV addresses the argument for tightening regulations, including a more in-depth discussion of the Yaz/Yasmin incident as well as other drug scandals that implicate the integrity of the FDA. Part V assesses the legitimacy of these arguments and makes a recommendation for avoiding conflicts of interest on advisory committees that jeopardize public safety.