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Bayer hides critical documents from FDA

Big Pharma privacy trumps women’s health

On December 8th, the FDA will be holding a meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. On the agenda? An examination of the risk of blood clots that comes along with the use of birth control pills that contain drospirenone.

Among those pills are Yaz and Yasmin, both drugs made by pharmaceutical giant Bayer.

Recently, the FDA released a report showing that women taking these types of pills were 74 percent more likely to experience clots than women who take low-estrogen birth control pills. A separate study backed up those results showing women taking drospirenone were six times more likely to develop dangerous venous thromboembolisms.

So the FDA has access to any studies or other documentation that could shed light on the dangers of these drugs so that they can make some kind of informed decision come December 8th right?

Yeah, you’d think that…

But when a lawyer associated with one of the 7,000 pending lawsuits over alleged injuries and deaths possibly related to Yaz and Yasmin and generics containing the same ingredients (they say Bayer didn’t disclose the serious risks associated with the drugs) asked a federal court to force Bayer to release confidential documents to the FDA, she hit a major roadblock.

She thought that the 50 sealed documents (including clinical trials, case studies, and documents that could reveal conflicts of interest among panel members) would help the FDA panel conduct a comprehensive review of the risks associated with the drugs. But maybe Bayer was afraid that the review would be TOO comprehensive.

Sealing documents is a common practice in settlements between drug manufacturers and plaintiffs in lawsuits. The companies say it’s about guarding trade secrets. But what happens when those sealed documents contain information that could impact public health?

Well, what happens is, those documents stay sealed.

Sure, Bayer relented on a few of the documents, releasing 10 of them–but they maintained that giving the FDA the other documents would put their trade secrets in jeopardy. Which is ridiculous, really, since the manufacturing methods for these drugs are actually available online through the U.S. Patent Office.

So what are the Bayer-execs hiding as the December 8th meeting approaches?

Could these 40 documents contain information on how the drugs are hurting women? Perhaps they contain information on how to convince doctors to prescribe the drugs? Or maybe they provide details on how to capture potential new patients through slick marketing campaigns?

The truth is these documents could have information in them that may save lives (and lead to some hard questions for Bayer) if they were released. But it’s apparently more important to protect the interests of Bayer than it is to protect women’s health.

A U.S. District Court judge supported Bayer’s claims that they must protect their precious research as well as their confidential marketing materials. He denied the attempt to bring the Yaz- and Yasmin-related documents to light and expressed his concern that releasing the documents could “prove economically advantageous to [their] competitors.”

Oh sure, we certainly can’t go trying to save women’s lives when there could be corporate spies lurking in FDA panel meetings.

Sources:
“Bayer Keeps Confidential Documents Under Wraps,” Pharmalot (pharmalot.com)

“Bayer, The FDA & Confidential Yaz Documents,” Pharmalot (pharmalot.com)