Letter 19: A Mixture of Facts and Pathos

Dear Annie,

 

Interviewing bereft parents, researchers, lawyers, even former Bayer employees in

both the U.S .and in Europe, the documentary focuses on how Bayer has reacted

to the accumulating evidence that Yasmin, Yaz and other drospirenone drugs are

unsafe.

 

Sabo reports that Denmark has a unique medical records system found nowhere else.  Every drug prescription, every medical diagnosis, and every death are recorded.  Even more important, the information can be linked together. In 2008, Professor Lidegaard of Copenhagen, Denmark conducted a study showing that a woman on drospirenone birth control was 60% more likely to develop deep vein thrombosis (called DVT – a type of blood clot) than the same woman taking most older (second generation) birth control pills. Bayer criticized Lidegaard’s method of data collection and insisted that their own company’s study found no such differences.

 

But Sabo notes that Bayer has used Danish data bases in the past.  So their defense seems hypocritical, doesn’t it?

 

Professor Lidegaard was persistent, and in 2011 he conducted a new study that showed the risk of DVT blood clots was twice as high with drospirenone drugs. This time Bayer countered that the study was invalid because he hadn’t statistically controlled for BMI (body mass index).  

 

But Sabo found several previous safety studies on all types of birth control pills that indicated that BMI did not affect DVT blood clots. He points out that there are now a dozen independent studies that have shown that the hormone drospirenone is more dangerous than the older hormones it replaced. The only studies showing that there is no risk of drosperinone are the ones paid for by Bayer.

 

In New York, Sabo interviewed Marie Foegh, a retired scientist who played a leading role in the development of drospirenone. She said that Bayer’s claims that Yasmin will keep you slim and happy were not substantiated, and that the marketing department tried to make Yasmin into something that it was not. According to her, Yasmin was proven to be an effective contraceptive, but nothing more.

 

When Sabo was in Hawaii interviewing your Dad and me, he confided that one of the apparently healthy young women included in the Yasmin clinical study died and that information was not reported to the FDA as soon as it should have been. Sabo had hoped to get a comment from Foegh about this situation, but he was unable to.

 

Bayer has never been held accountable for this deception. Perhaps if that information had been given to our FDA in a timely manner, Yasmin and your killer -- Yaz -- would not have been approved in the U.S. and we would be talking about this in person.

 

Love,

Mom

National Center for Health Research

1001 Connecticut Avenue NW, Suite 1100

Washington, DC 20036

(202) 223-4000

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