Letter 11: David (grieving families and women’s health experts) vs. Goliath (Bayer)
Bayer was referred to as the “sponsor” – which seemed odd to me, since they should
have been called the defenders. They occupied as much space as the FDA and all its
advisers and were MUCH better-equipped. They included the best physicians money
could buy – doctors who were paid to defend Yaz but pretended to be impartial
medical professionals. Bayer had unlimited time to attack the FDA study. And attack
they did. They used slide after slide to boost their credibility and overwhelm the FDA
Advisory Committee with their confident and arrogant stream of biased information. Only with great reluctance did they admit that Yaz had no proven benefits compared to safer birth control pills. Teenagers have experienced blood clots and also died as you did, Annie.
None of us in the audience, even grief-stricken family members, could ask any questions or add any information. Neither family members nor nationally recognized health experts who had spoken about the risks were asked any questions by the panel. We were not important.
The FDA and their Advisory Committee did not treat us as experts having important information to share, and that made it easier for Bayer’s paid cheerleaders to take over the conversation. It was only after the hearing, for example, that Dr. Zuckerman found out that Bayer neglected to mention that one of their studies only included women who were 35 and older! That was an important point, since birth control pills are known to be more dangerous for women over 35 and so are less likely to be prescribed for that age group.
After all the talking, the FDA finally asked the Advisory Committee a terribly vague question for them to vote on: Do the benefits of Yaz outweigh the risks? They neglected to explain what the panel members should compare Yaz to.
Some Advisory Committee members compared Yaz to pregnancy. They tended to vote yes. The members who compared Yaz to other birth control pills tended to vote no.
The final vote: 13 “Yes” and 11 ”No.”
The 13-11 vote is rare for FDA Advisory Committees: the votes are not usually close. Later we found out that three of the physicians who voted “in favor” of Yaz had financial ties to Bayer. One was part owner of a generic version of Yaz. The only panel member who had previously expressed his concerns about Yaz and Yasmin was not allowed to vote.
You might ask: how was informed concern a conflict of interest, but financial ties to Bayer was not? And why was past prescribing of Yaz, which several Committee members admitted, not a conflict of interest?
The answer is simple: Bayer pressured the FDA to take away the vote that was certain to be against their product. None of the family members had the access to pressure the FDA to remove voting privileges of doctors who had financial ties to Bayer. The vote would have gone the other way if we had had the same ability to negotiate with the FDA that Bayer had.
When stating their reason for their vote, several Committee members admitted that the question confused them and was the wrong question. Of course it did and was. The question implied that there are only two choices for women: a constant state of pregnancy or taking the most dangerous types of birth control pills. The question should have been: Are Yaz and other drosperinone drugs as safe as other birth control pills?
Many of the doctors who voted that Yaz had greater risks than benefits gave the Hippocratic Oath of causing no harm as their reason.
Months later, the FDA announced that drosperinone birth control pills were more dangerous than other birth control, but that they could still be sold. They made that announcement after the media interest had died down. There would be a stronger warning of the risks, but that warning was hidden about midway through a 33-page label that no patients and very, very few doctors are ever going to read.
Annie, your dad and I had and still have many questions about this meeting. We asked our Congressional representatives and Senator to contact the FDA to convey those concerns. Only one did, and then only after much badgering. Even then, in her letter, the Senator expressed no concern of her own – only that a constituent had contacted her. If the FDA ever answered it was never shared with us.