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Monday, September 25, 2023


FDA should cut business ties

The Food and Drug Administration should be one of the most trusted organizations. Because they regulate what we put into our bodies, it is hoped the FDA keeps track of what medicines are harmful and what foods should be removed from shelves. The FDA was created to stop quacks from offering snake oils to cure illnesses and to regulate dangerous meatpacking factories. The reality is very different from the idea we have of this bureaucracy that colludes with pharmaceutical corporations.

For example, Vioxx is a drug used for arthritis that was pulled off the market after it was linked to 27,000 heart attacks and deaths. This may seem like a tragic mistake on the surface, but a study linking Vioxx to heart attacks proves otherwise. Dr. David Graham, an FDA scientist, conducted the study and was instructed to downplay the fatal side effects. The deputy director of the FDA’s Office of Drug Safety told Graham to warn Merck, the pharmaceutical company responsible for Vioxx, of the research before the public found out first. Only when the media found out was Graham able to publish the findings, which demonstrated that as high as 139,000 people have had heart attacks as a result of taking Vioxx.

The Union of Concerned Scientists conducted a survey of FDA scientists, asking questions involving the influence of pharmaceutical companies on the research done. Nearly one-fifth reported they had to change or eliminate their findings for non-scientific reasons. Forty percent said they were afraid of reprisals. Nearly 60 percent reported political interference with FDA decisions. The UCS called for accountability, protection from altering research and whistleblower protection to help alleviate the problems in the FDA.

In 1991, Dan Quayle headed the Council on Competitiveness, which gathered representatives from pharmaceutical and biotech companies for advice to help the U.S.compete in the global market. Suggestions included speeding up the drug approval process, using private companies to screen drugs instead of the FDA and bringing genetically modified food to the market. There are numerous problems with these proposals. Although expediting the approval process for life-saving drugs can be beneficial, this would apply to even minor drugs with side effects that can outweigh the affliction being treated itself. Also, private companies would be prone to the same corruption as the FDA, but with less accountability, and genetically modified foods would not be tested for their safety but immediately sold without labels warning consumers of the product.†

Perhaps the most insidious result of the Council on Competitiveness was the passing of the Prescription Drug User Fee Act. This gave the FDA’s budget a boost, but from the money of pharmaceutical companies. This effectively turns drug companies into clients and the FDA into a pseudo-corporation that’s accountability is not to the public. In order to make more money, the market is flooded with new drugs when current drugs do the same thing. Safety is not an issue. In Great Britain, a national system is used to keep track of the consumers’ side effects, a stark contrast to the companies having to report the side effects – if they do at all.

The FDA itself realizes it is fallible, as illustrated by Raymond Woosley’s comments – every American who takes medicine is essentially conducting the experiments that the FDA or the companies never properly performed. Over 100,000 people die every year from the medicines that are supposed to treat them. This does not have to happen. The FDA once engaged in ethical practices – the best example being Frances Kelsey standing up to the Merrell Company for a potentially dangerous medicine being prescribed to pregnant women. This, however, has changed. As long as the FDA is literally in the pockets of "big pharma," we will not be completely safe from the predatory practices of immoral companies.

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