www.pharmalot.com states that Ruth Macklin, a professor of Biomedical Ethics at the Albert Einstein School of Medicine, a member of the World Health Organization's Ethical Review Committee and, until recently, chair of the Ethics Subcommittee of the Advisory Committee to the Centers for Disease Control and Prevention's director, has written a letter to FDA commish Margaret citing "accumulating evidence of the increased dangers of Avandia compared with Actos and in comparison to older, standard oral treatments for diabetes; and advice by the American Diabetes Association and the European Diabetes Association, based on unanimous consensus group findings, that Avandia not be used....the agency should publicize the details of this trial, along with an explanation of why it is considered ethically justified in light of the known and predictable harm rosiglitazone causes. Better yet, stop the trial now and explain later."
Meanwhile, the FDA July 13, 2010 advisory meeting will give the FDA a chance to get an idea of scientific and ethical opinions on comparative safety trials in which one product is tied to a higher mortality risk. A former top staffer to House Energy & Commerce Chairman Waxman is doing an internal study of agency post-marketing safety procedures to assure Capitol Hill the FDA takes the issue seriously.
We handle Avandia cases and are still accepting new cases. If you or a family member took Avandia and you believe may have suffered a heart attack or death, please contact the head of the pharmaceutical practice area, Todd Hageman.