How Close is Too Close
Posted by
Greg OwenNovember 30, 2007 2:55 PMIt has long been believed by many that the Food and Drug Administration (FDA) is much too close to drug companies, which clearly causes a conflict in terms of regulating those companies. To see the extent of the problem, we only need to take a look at Merck's Vioxx catastrophe, were it was revealed by one scientist that he had actually received vailed threats from the FDA regarding the release of his findings, findings which were less than favorable to Merck/Vioxx.
There is a lot more evidence than the issues with Vioxx, not that any more is needed. Take Wyeth and their disastrous drug fen-phen. Wyeth eventually withdrew fen-phen from the market. Although, by the time they did that, eight million prescriptions had been written and the drugs had been linked to thousands with severe heart and lung damage and even some deaths. Where Vioxx and the fen-phen were concerned, there is no doubt that both involved negligence on the part of not only the drug companies but also the FDA. In fact, when lawsuits were filed by consumers of the drugs Pondimin and Redux, thousands of documents became public. Those documents showed that the FDA knew about the health problems related to these drugs, when they knew and that they resisted taking action until they could resist no more. Criticism of the FDA does not end there. The FDA's handling of many other drugs have come under scrutiny i.e., Avandia , which is still on the market; cholesterol drug Baycol; pain reliever Bextra; and the Guidant heart defibrillator. Without a doubt, the reaction time of the FDA and drug companies alike are at a snails pace.
Recently, Congress passed a drug-safety bill in order to promote tracking of drugs and possible adverse reaction. Although, many see that as nothing more than a public-relations move. One other disturbing fact worth noting, is the fact that the office that promotes drug approvals is double the size of the office that deals with drug safety issues, obviously that is a major weakness in the system.
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