Related Stories
FDA May Be More Transparent
Key Excerpts from Article on Website of New York Times
Posted: June 8th, 2009
http://www.nytimes.com/2009/06/02/health/policy/02fda.html
For years, the Food and Drug Administration has withheld information about drugs and medical devices from the public when their makers cite trade secrecy even in cases where the agency suspects that the products are causing serious illness or death. Now the new leadership at the F.D.A. may change that. The Obama administration ... is setting up a task force within the agency to recommend ways to reveal more information about F.D.A. decisions, possibly including the disclosure of now secret data about drugs and devices under study. The goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers. Many people have been harmed over the last decade because the F.D.A. has treated clinical trial results of drugs and devices as trade secrets, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has campaigned for the release of such information. In 2007, Dr. Nissen published a study showing that Avandia, a popular diabetes medicine made by GlaxoSmithKline, increased the risk of heart attack by 42 percent. The data Dr. Nissen used was made public because of a lawsuit, but the agency had known of the possible risk for nearly two years. Repeated scandals led the Bush administration in 2005 to promise to make public its product safety investigations more quickly, but it did not recommend changing the laws and regulations that govern the release of trade secrets and agency records.
Note: For a powerful summary of corrupt practices by government and corporations in the pharmaceutical industry, click here.
Related Stories
Latest News
Key News Articles from Years Past
