On the topic of birth control, this blog has focused much of its attention on the NuvaRing, whose links to deep vein thrombosis, pulmonary embolism, and death (among other side effects) resulted in a $100 million settlement spread over 700 plaintiffs. Were every patient to accept this offer, each would see a payout of about $60,000. Though studies have suggested the NuvaRing is a dangerous medical device, another method of birth control–a pill marketed under the names Yaz and Yasmin (which includes a synthetic hormone called drospirenone)–has led to the filing of thousands of lawsuits against its manufacturer Bayer since its introduction in 2006. This drug, by the way, was prescribed to over 13 million women in 2010 alone.
The current issue of the Bayer Stockholder Newsletter (from the second quarter of 2014) notes, “As of July 9, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 8,900 claimants in the U.S. for a total amount of about US$1.8 billion.” On average, this is a payout of more than $202,000 per case. The author of the newsletter goes on to write, “Bayer has only been settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case-specific analysis of medical records on a rolling basis.”
These initial complaints alleged that Bayer did not provide adequate warnings of potential side effects, which include those similar to NuvaRing: blood clot, seizure, gallbladder disease, heart attack, and stroke. The newsletter adds that about 2,400 of the remaining 5,000 unresolved Yaz/Yasmin claims include venous clot injuries, “some of them fatal,” and that Bayer is also involved in cases that include generic versions of these drugs, marketed as Ocella and Gianvi.
When the issue of reviewing the safety of these drugs was up for debate by an FDA-appointed advisory committee, the group decided in a 15-to-11 vote not to approve warning labels that would include language about the possibility of developing blood clots. While this may seem like a legitimate and reasonable decision based upon empirical, scientific research, the non-profit and non-partisan Project On Government Oversight (POGO) found that four of the members of the FDA’s advisory committee (including its chairperson) had financial connections with Bayer. Unsurprisingly, all four of these individuals voted “yes” on whether the drug’s benefits outweigh its risks. Drugwatch adds, “None of the committee members had disclosed any conflicts of interest at the meeting.” Another doctor who sat on the panel said that he voted no because “there are plenty of other alternatives that do not show any increased risk. One of the main things [in medicine] is do not harm. And even a small excess of risk is no–we shouldn’t take that lightly.”
Not only do these facts effectively invalidate the committee’s decision not to market the drugs with sterner warning labels, it is also emblematic of the FDA’s lax oversight process. All too often, decisions about the safety of various products and devices are left up to those who stand to profit from their viability in the market. Were these four individuals not on the advisory committee, perhaps stricter warnings would have been adopted, but for now, we anxiously await a response from the FDA to the plea POGO makes at the end of its letter: “Please inform us how the FDA plans to deal with these problems.”