Reforms needed at FDA after Vioxx recall

The manner in which approval of Vioxx and the events leading up to Vioxx's recall by Merck was handled by the FDA has not been appreciated by anyone. Several experts have called for another watchdog group while others have suggested a complete overhaul. Many doctors are concerned that if the world loses faith in the FDA, it will have disastrous consequences.

It is well known that pharmaceutical firms literally control everything that happens at the FDA. Not only do they spend millions of dollars in campaign contributions (mostly on Republican candidates who favor a totally relaxed approach to the drug industry and have blocked most efforts by poor Americans to import drugs from Canada), they also lobby the FDA. Many FDA staffers are essentially drug industry insiders and many senior level people in the current administration have strong ties to the drug industry. (Related article: Vioxx recall shows that FDA has been hijacked by the drug industry)

Another startling fact that an average American does not know is that the FDA relies on the drug industry to tell the truth, which as the Vioxx case has shown, does not happen. There is tremendous incentive for drug industry to either cook up data or at least not share data that may be detrimental to its commercial interests. This loophole allowed Merck to keep the drug on the market (and kill tens of thousands of Americans) even though a lot of data was coming up that showed that Vioxx had serious complications.

Guerry Thornton, an attorney in Atlanta, will soon be lobbying Washington for new drug approval laws that do a better job of protecting American lives. "The system places too much emphasis on perceived benefits and not enough on the risks. The Vioxx review should have found that heart risks outweighed the drug's benefits. Surely 80,000+ deaths was too great a risk. The FDA relies on drug company safety data, and this needs to change," says Thornton.

"Certain Senators favor protection for FDA approved drugs. Such laws should not provide a safe haven for negligent drug companies," Thornton continues. What he is referring to are efforts by lawmakers to make it almost impossible for Americans to sue drug companies when they are injured by their products. We already have a very lenient drug approval process and if Congress passes law that makes drug companies not liable for their defective products, Americans will lose complete faith in the American drug approval system. The pharmaceutical industry, in a recent Gallup poll, was almost at the bottom of the list in approval by American people, in the company of oil and gas companies.

Related article: FDA favors Merck over American lives