FDA and Big Business

In the February 6, 2004 Bonanza there was an article about Mr. Peterson who had been taking Lipitor on his doctor’s advice. Possibly as a result of taking this drug he temporarily lost short-term memory, fine motor skills and his health deteriorated. Only 2,500 people took Lipitor before it went to market. Now millions of people take it. How could anybody possibly know all of the harmful side effects? Isn’t the FDA supposed to be preventing this?

In the 1930’s the Food and Drug Administration was set up. The purpose of the FDA is to protect the American public from unsafe and ineffective drugs. Before 1988 the approval process took two years to determine the safety and effectiveness of a new drug. What happened in the 1980’s was the emergence of a new disease, AIDS. The two years that it took to pass an AIDS drug was a death sentence for most people infected with the HIV virus. The FDA was under staffed to get new drugs through the research process any faster.

There were massive protests outside the FDA building by AIDS activists. They wanted help much faster than it was coming. Many AIDS sufferers sought new drugs “under ground” that were not approved. Congress felt that the best way to fund the FDA was to look to the industry to fund the agency. Congress responded to this demand by passing a bill, called the “Prescription Drug User’s Fee“, which required drug companies to pay $500,000 for each new drug application. This money goes to the FDA to increase its’ staff and man power and speed up the approval process. The current approval process now takes six months.

There was a pro-industry shift after 1988. Now that the FDA receives funding from the drug industry, the objectiveness and independence of the agency has been compromised. An unhealthy relationship between the FDA and the drug industry has developed. The current atmosphere at the FDA is to please the drug industry, avoid conflict and get out as many drugs as possible.

Since 1997 over one dozen approved drugs were taken off of the market because of the harm that they were causing. One drug was Baycol, a cholesterol lowering drug from Bayer, which was approved in 2000. This drug was causing severe muscle destruction. Another drug was Phen Fen or Redux. This drug was marketed as a weight loss drug. It can cause damage to the valves of the heart and fluid to build up in the lungs. Some people needed heart valve replacement to live and some died waiting for heart valve replacement or from fluid in the lungs.

The reporting of the side effects of drugs by medical doctors is voluntary. Less than ten percent of all side effects get reported. The FDA is dependant upon the drug companies to self regulate and to report the side effects. Only three thousand patients have been given a drug before it is released to the market. This is a very small percentage of patients who will take the drug. Therefore, it is still an experiment when a new drug hits the market. Allowing the drug companies to self-regulate is like having Wall Street allow Enron, Worldcom and Tyco to self-regulate. The financial incentives are too tempting for unbiased regulation. He who pays the piper calls the tune.

The purpose of this article is that we need to take one hundred percent responsibility for our health. First, ask you doctor or pharmacist about the side effects of any drug prescribed. Second, take the initiative to look the drug up on the internet BEFORE you start to take the drug. Third, it may be helpful to ask family or friends if they have had any negative reactions and/or have heard of any side effects of the proposed drug. The safety nets which are supposed to protect us are no longer effective. In the end, only you have the power over your health.

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