Yaz News - January 11, 2012
January, 2012 Wall Street Journal article states certain FDA advisors had undisclosed ties to Bayer surrounding Yaz December Safety Committee Recommendations.
The January 11, 2012 Wall Street Journal reports that certain FDA advisors reviewing Bayer birth control pills Yaz, Yasmin, Beyaz and Safyral, who were members of a December 2011 FDA safety committee to document and make recommendations concerning the safety of Yaz, Yasmin, Beyaz and Sayfral concluding there is no excess danger based on Bayer's studies did not disclose to the FDA they had ties with Bayer (the manufacturer of Yaz / Yasmin) serving as consultants, speakers or paid researchers.
At the December committee meeting the committee voted 15-11 that the benefits of Yaz / Yasmin outweighed the risks. These three doctors who had a conflict but did not disclose it voted with the majority.
FDA advisory committees are designed to give the agency independent judgment on medical issues. "The FDA says members of the advisory committees must declare any financial relationships to the relevant drug maker in order to ensure "transparency."
One frequent FDA panel member stated that if panelists have significant financial ties to a pharmaceutical manufacturer whose product is under review it can bias the proceedings.
"Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process," states Steven Nissen,Cleveland Clinic Cardiologist.
At the present time thousands of Yaz and Yasmin victims have filed lawsuits which have now been consolidated in an MDL in the federal district court in East St. Louis, IL. Injuries range from death to deep vein thrombosis, pulmonary embolisms, lung clots and gall bladder removal.
