Bayer Does It Again: More Regrettable Human Error

By Bob Schwarz

The worldwide drug giant Bayer did it again.  About three years ago, Bayer was caught hiding scientific studies regarding Trasylol from the Food and Drug Administration (FDA), physicians and patients.  Bayer casually downplayed the significance of that criminal act by attributing it to “regrettable human error.”  Now, and only because of the litigation over one of Bayer’s Yas and Yasmin birth control drugs causing serious blood clot injuries and deaths, it has been discovered that Bayer again withheld important safety information from the FDA.

Two recently published scientific studies found that women taking birth control pills like Yas and Yasmin that contain drospirenone are more likely to develop blood clots than those who take birth control medication that doesn’t contain it.  Evidently, Bayer neglected to disclose this increased risk to the FDA during the approval process for Yas and Yasmin.

In the federal court multidistrict litigation (MDL) case in Illinois, former FDA Commissioner David Kessler wrote an expert report wherein he stated that “Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from premarketing to the present.”

Commissioner Kessler further stated that Bayer engaged in extensive off-label promotion of Yasmin and Yas for unapproved uses to increase sales in violation of FDA regulations. That off-label promotion unnecessarily increases the risk of thromboembolic events in patients because there are better, safer FDA-approved alternatives for those unapproved uses.

Here is a summary of what happened.  Based on adverse event reports received by the FDA in 2003, which included six deaths, the FDA told Bayer then that a labeling change for venous thromboembolisms, or blood clots, was being considered. Commissioner Kessler determined that Bayer omitted data from a post-marketing surveillance study that was submitted to the FDA in 2004, and later failed to disclose blood clot risk to the FDA, doctors and the public in 2008 and 2010.

Commissioner Kessler wrote in his report that serious adverse events observed in a clinical study should have been reported to the FDA prior to approval of Yasmin, but that Bayer chose not to do so. The FDA requested a proposed change to the warning label to indicate an increased risk, but Bayer did not provide the FDA with any proposed changesBayer knew based on its own analysis that Yasmin had an increase in the U.S. reporting rate of various side effects, notably blood clots, compared to other contraceptives, but the drug maker omitted this information from its analysis that it presented to the FDA. Commissioner Kessler stated that, “In my opinion, had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin’s NDA could be made. These facts would impact the Agency’s risk-benefit equation about the drug and whether it could be approved.”

Bayer not only withheld this information from the FDA, but has fought hard to keep it a secret from doctors and patients.  The sheer gravity of Bayer’s conduct requires that Bayer be held accountable for the countless serious injuries and deaths caused by its corporate greed.  You see, if doctors and patients knew of this increased risk, the doctors would write fewer prescriptions and Bayer would not make as much money.  Bayer likely justified its 2003 actions with the fact that there were only six reported deaths and all drugs have side effects.

As with all pharmaceutical litigation, the question is what did Bayer know and when did Bayer know it.  Full and complete disclosure of all known risks associated with a drug is absolutely required in the approval process.  Once approved and on the market, Yas and Yasmin’s labels and warnings have to be updated when any new information is received regarding an increased risk of serious injury or death.  Withholding information from the FDA during or after the approval process is not an error, and it is not simply human error.  It is an intentional act that is based in Bayer’s corporate culture of putting profits over people.

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