Yaz MDL Judge called upon to consider FDA links to Bayer

A potential conflict of interest is causing an outcry of concern, and U.S. District Judge David Herndon has been called upon to examine what is really going on in the FDA.

As mentioned in our previous blog, four of the FDA voters that made up a portion of the panel making decisions on Yaz are financially linked to the birth control’s maker, Bayer. Currently, Yaz, Yasmin, Ocella and their generics are the only birth control pills on the market that contain the hormone drospirenone.

The FDA panel convened on December 8th to determine the following:

1. If the benefits of taking drospirenone-containing pills outweigh the risks. The main benefit of taking Yaz is pregnancy prevention, while risks include an increased risk of blood clots, stroke and pulmonary embolism, among others.

Committee members (including the four that are paid by Bayer) voted 15-11 that the benefits outweigh the risks.

2. If current labeling on the drugs adequately reflect the increased risk benefit profile for the product.

Only five panelists believed that the increased risks are clearly outlined in the drugs’ warning label,while 21 voted that they did not.

While the finding that the warning for these drugs is inadequate is an important victory, the question still remains: How would the votes to keep the drug on the market have changed had 15% of the members not been paid the drug manufacturer in question? Would this dangerous drug, which has been determined to have an increased risk of clots and other complications, finally be pulled from the market?

That is why both watchdog groups and women injured while taking Yaz birth control have asked the Judge to investigate the relationships within the Committee, most recently in the form of an opposition to a motion to exclude from the Yaz Multi-District Litigation the opinions of former FDA commissioner David Kessler that there is a conflict of interest within the FDA. Specifically, the impartiality of FDA panelists Paula Hillard, Anne Burke, Melissa Gilliam and Julia Johnson should be questioned after their backgrounds showed a strong financial tie to Bayer.

Kessler was also quoted as saying that one of the FDA members linked to Bayer is a “huge advocate” for Yaz and a “Bayer-trained speaker.” The former FDA commissioner also stated:

"Due to the complex dynamics that are part of the FDA advisory committee meetings, and in light of the fact that a reasonable person with knowledge of the relevant facts could question the above members' impartiality, it is my opinion that the FDA advisory committee was not independent of Bayer, and its recommendations and votes need to be viewed as such."

For more information on the Yaz birth control litigation, or for answers to questions about blood clots, stroke or pulmonary embolisms while taking Yaz, contact us toll-free at 888.841.9623, email us at Anneke@ToledoLaw.com or visit www.ZKBLaw.com.