FDA's political approach in Vioxx controversy hurts Americans

It is now becoming increasingly apparent that the American victims of Vioxx are pretty much on their own and they can not only expect the FDA and the administration to shield Merck due to the close ties between Merck and almost everyone who matters in the current administration. (Related article: Vioxx related deaths higher than Iraq War and 9/11 but Americans do not seem to be outraged)

Dr. Bryan A. Liang, professor and executive director of California Western School of Law’s Institute of Health Law Studies, says that with more resources and less politics, the FDA would be more resilient—and better positioned to help protect Americans. “The FDA is not supposed to be a political organization,” he says. “They are taking a health-policy issue that reveals a weakness in the system and turning it into a political issue.” He maintains that the FDA did try to do the right thing in approving Vioxx in the first place. “But preliminary studies often don’t have enough info to make conclusions about side effects,” he says. (Related article: FDA defends its role in handling of Vioxx recall)

Merck is reported to have known for about four years that there were problems with Vioxx. It is also becoming obvious that FDA did not do it job in the meantime. During this time, however, Merck was raising money for reelection of President Bush and other Republicans. CEO Gilmartin contributed thousands of dollars to reelection campaigns. (Related article: Merck response on Vioxx recall)

“The FDA's primary mission is to protect the public health. The front-line people at the FDA--the scientists, the researchers, and others--are committed to that mission. But when politics gets involved, we have a problem. The fact that Vioxx, and the warnings about the cardiovascular problems with the drug, were late coming to the consciousness of policymakers and significantly delayed action was a symptom that there is a tremendous gap in the regulatory methodology for drug safety at the FDA. Remember, it was Merck--not the FDA--that acted to withdraw the drug voluntarily from the market. So the FDA, Congress, and the President have an obligation to look to the drug safety system to determine how this can be avoided so that another ‘Vioxx’ doesn't occur.