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Bayer AG’s Yasmin — Still All That Yaz

11/21/2011
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Increase your possibility for blood clots – take Yaz birth control.

That would be bare truth in advertising were Bayer AG willing to be honest about its block buster contraceptive medication that generated over $1.5 billion in sales last year.

Another truth in advertising for the Yaz drug maker? We were just kidding when we claimed that Yaz was good for clearing up acne and treating all forms of PMS symptoms. We said it, but we did not mean it and, oh yeah, Yaz was never approved for those uses.

In an email discovered during the litigation that has been filed against Bayer, a company official encouraged sales representatives to propose that doctors prescribe Yaz for unapproved, off-label use:

“…what percentage of your patient population suffers from” symptoms common to PMS, versus the more severe form of the disorder, and to seek information on “what they think the impact of Yaz will be.”

Yasmin and Yaz were never approved for treatment of common PMS symptoms.

In another email, a sales representative suggests that a noted gynecologist: “…definitely will mention the off-label benefits of our products.”

We have been writing since early 2009 about Bayer’s less than responsible commercials that used attractive, successful appearing women to promote its drugs Yaz, Yasmin and Ocella while using glitzy advertising to obfuscate the lack of FDA approval for some of its uses and to hide its sometimes lethal side effects.

An upcoming meeting at the FDA, on December 8, 2011, is designed to discuss the fate of oral contraceptives and the studies that have been conducted about them. At least one of the leading studies, conducted by Juergen Dinger then director of the Center for Epidemiology and Health Research, has come under scrutiny. Dr. Dinger is a former employee of the company initially marketing the Yasmin line of oral contraceptives and there have been emails discovered that cast some questionable light on the independence of the study. For example an executive at the company sent a 2005 email talking about the risk of “VTE” and “ATE” (referring to clots in users):

“One major reason for providing only tables and a synopsis is that we do not want to imply that we have a VTE problem but emphasize the fact that the study results indicate that Yasmin’s VTE/ATE is comparable to other” contraceptives.

Like buying “ghost writers”, some companies have sponsored “studies” of their products with the sole goal of supporting the safety of the product, rather than discovering independent, objective findings about their products.

Sadly, $1.5 billion buys a great deal of favorable opinions and provides more than enough motivation for companies to discover supportive findings in any study they conduct.

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