Archive for the ‘drug trials bribery’ Category

Drug Trials, Bribery, and Probably Fraud

Saturday, August 21st, 2010

Are you surprised to learn that more than 80 percent of the drugs approved for sale in 2008 involved trials in foreign countries, and 78 percent of all people who participated in clinical trials were enrolled at foreign sites? This, according to a recent investigation the inspector general of the Department of Health and Human Services. Medical authorities, especially ethicists, have long worried that many of these trials are in countries that federal auditors rarely visit and where research controls are questionable.According to the New York Times, at least a dozen major drug and device makers are under investigation by federal prosecutors in a broadening bribery inquiry into whether the companies made illegal payments to doctors and health officials in foreign countries.

Last month, a federal drug official reported repeated instances in a foreign clinical trial of Avandia, a controversial diabetes medicine, in which patients appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events. This “landmark” study is a main reason that Avandia remains on the market in the United States. So far Government officials have not accused GlaxoSmithKline, the trial’s sponsor, of fraud.