Death by Prescription

I am a person of Faith, but not blind faith. When it comes to anything except God, I ask a lot of questions before I entrust myself to someone or something. Particularly when it comes to prescription drugs, I find myself asking more and more questions. The answers I find continue to shake my confidence in the drug industry and the FDA. Most people assume that the p

On September 30, 2004, Merck withdrew their very popular Cox-2 inhibitor and arthritis medication Vioxx from the market. After years of building controversy and concerns over safety, Vioxx was pulled from the market because of solid evidence that the risk of heart attack and stroke doubled in patients who were taking Vioxx long-term. This set off an immediate flurry of concern within the media and medical community about the safety of other similar drugs like Celebrex, Bextra, and Mobic. Hearings were started by the US Senate chaired by Senator Charles Grassley from Iowa.

Immediately, the concerns spread to other drugs like the use of the anti-depressant drug Prozac in children, which increases the risk of suicide, and the use of the cholesterol-lowering drug Crestor, which increases the risk of muscle and liver damage. The question everyone is asking is this: "If the FDA is supposedly doing its job, why are so many drugs being taken off the market after being approved?"

The Great Clinical Trial--You

When the FDA first approves a medication for use by the public, they know less than half of the serious adverse drug reactions of that drug. That is a fact. They know less than half of the adverse drug reactions of a particular medication at the time that the drug is approved. The clinical trials that are done by the pharmaceutical industry prior to approval are relatively small and short-term. Once a drug is released onto the market, millions of scripts may be written and less frequent; however, maybe even more serious side effects may occur. There is no way these pre-clinical trials can elicit all the potential problems that a drug may have. How do they find out the other half of these adverse drug reactions? The answer is very simple--YOU! You are the "Great Clinical Trial." You are the "human guinea pigs" they use to discover adverse reactions of the new drugs that are put on the market.

Once a new drug is released to the public, there is a voluntary reporting system back to the FDA. If a doctor, observes an adverse drug reaction in a patient, they are not required to report this to the FDA. It is strictly voluntary. It's not surprising that less than 1% of the adverse drug reactions are ever reported back to the FDA. Even when adverse drug reactions are reported back to the FDA, they are given to a department that has absolutely no authority except to gather the data. Once enough red flags are raised about the potential new risk of a drug that is already on the market, they refer their concern back to the committee that originally approved the drug. Normally, the only thing that happens is a new warning added to the package insert or drug label. But it gets worse: In order to put new warnings on a drug, the FDA must get permission from the company that makes the drug! In the case of Vioxx, the FDA had wanted stronger warnings added to the drug label two years before this drug was pulled from the market. However, this change to the drug label was never accomplished because Merck did not approve of this action.

This is a serious and obvious problem. Voluntary reporting and inefficient bureaucracy keep dangerous drugs on the market too long, and many drugs that do stay on the market do so with warnings that don't reflect the risks that have been discovered as the drugs have been tested on you.

Kevin McNabb http://tinyurl.com/38eoo7

How to start taking responsibility for your own health. Find out what true optimal health really means. http://tinyurl.com/38eoo7

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Dedicated to helping open up the communicationb between the medical community, the nutritional industry and the general public.