Tuesday, April 10, 2012

Sid Wolfe/Public Citizen Warned about YAZ contraceptive 10 years before FDA added warning: for this he was disqualified from serving on his FDA advisory committee

Today FDA said that YAZ, Yazmine, Beyaz and Safyral  (oral contraceptives made by Bayer) cause a higher than usual increase in blood clots in users.  Blood clots are increased by all contraceptives and other drugs utilizing female hormones.  It is estimated that in the US, 200,000 people die yearly from blood clots that travel to the lungs and obstruct the flow of blood.  In young women, this may be one of the most common causes of death.
Anyway, Public Citizen listed YAZ as one of its "Do Not Use Pills" in 2002.  Sid Wolfe, MD is director of Public Citizen's Health Research Group, which makes up this list.
In December, FDA prohibited him from fully participating in its advisory committee discussion of YAZ, due to an "intellectual conflict of interest."  This was a new spin on the concept of conflict of interest, which is generally accepted to mean a financial conflict of interest.  Wolfe simply had some prior knowledge about YAZ, which led his group to form an opinion about the drug, and other drugs.
In banning Wolfe from participating fully on the committee of which he was a member, FDA made clear that it only wanted people who were uneducated about the drug as to serve as "experts" advising FDA -- in other words, it wanted people who would not see beyond the data FDA presented to them, when offering advice on the drug.
It's about time FDA announced it was adding a warning to the label of these four contraceptives, which share the same progestin, admitting they caused even more blood clots than is usual for oral contraceptives.  This is 10 years after YAZ made PCHRG's list of bad drugs.  What took so long?  And has FDA apologized to Sid?  Or to the young women of America?

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