A recent report from the Journal of the American Medical Association (JAMA) stated many of the published scientific studies used to establish the effectiveness and safety of Vioxx, a painkiller taken by millions of Americans, was “ghostwritten” by the manufacturer. The report not only shakes the public’s confidence in the pharmaceutical industry’s science, it also alerts them to the even greater threat posed by the Bush administration’s recent attempts to cease the litigation that uncovered the secret documents.
Much of the science federal agencies, like the Food and Drug Administration, rely on to determine the safety of consumer products is sponsored by regulated companies. Now it is coming out that the scientific reports are not just funded by the companies, they are being written by them as well. These companies are bending science to their advantage. The regulators who are supposed to be protecting American consumers are not doing their jobs. The FDA officials who were reviewing the studies to decide whether or not to approve Vioxx did not realize that the purported authors had little to do with studies themselves.
The origin of the Vioxx studies is now known because the authors of the JAMA article had access to internal company documents that were uncovered in the lawsuits filed by the alleged victims of Vioxx. These lawsuits, however, are the very kind corporate lobbyists are trying to make impossible and would not have been filed if the Bush administration’s attempts to shield the pharmaceutical industry from responsibility had been in place at the time. These lawsuits serve the useful purpose of revealing corporate faults. The Supreme Court has already ruled that certain product liability claims directed at medical devices are pre-empted by federal law. Later this year, the Court will decide whether FDA-approved are pre-empted as well. If companies succeed in getting FDA-approved products pre-empted, consumers injured by the products will no longer have their day in court. http://www.dallasnews.com/sharedcontent/dws/dn/opinion/viewpoints/stories/mcgarity_09edi.e4c6b09f.html