Our Medical Approval System is Flawed
by Walt Cheney

It is said that in the United States we have the best medical system in the world. No doubt we enjoy many of the best treatments, the best medicines, and the best doctors. Yet we have a system that has serious flaws. Flaws that causes us, in some cases, pain and suffering that might otherwise be unnecessary.

We have given the power of approval of drugs to the FDA, the Federal Drug Administration. In order to provide us safe drugs they require well-planned scientific studies involving animals and then humans with some given placebos. Extensive peer review validates the data at all stages of the study including final approval. Specific care is given to identifying side-effects detrimental to the patient. The efficacy of the drug must greatly outweigh the side-effects.

These scientific studies take years and it is said it costs 100's of millions and 12 years to get a drug through the approval process. To compensate, the company that complies with this procedure, secures a patent that gives exclusive rights to manufacture and sell the drug for 17-19 years. For this period the company can command the price the public will bear and after that period other companies make generic drugs that cost the consumer much less.

This approval system is very active with companies scurrying to develop the latest drug or a slight modification of existing drugs to obtain patents and rake in the dough. Pharmaceuticals are said to have profits 15-25% over the typical costs of other industries.

So where are the flaws? Let me give you an example. A friend heard a radio broadcast on January 20th by Paul Harvey who reported that hydrazine sulfate was helpful for individuals with cancer. The Syracuse Research Center with an Internet address of http://www.ngen.com/hs-cancer/ was given as the source of the story. She asked me if I could find information about the substance since her uncle has just been diagnosed with terminal cancer. I logged onto the Internet, found the Center homepage, and a list of articles relative to studies using hydrazine sulfate with cancer patients.

I also found a link on the Center's page to a D.A.Y. Industries located in England where Americans can buy hydrazine sulfate by mail. In the United States, because the FDA has not approve it, physicians cannot prescribe it even though the scientific literature claims it is helpful to cancer patients and has few side-effects. I printed out the data for her but my laser printer was being repaired and used my dot-matrix printer with a worn-out cartridge. The print was light and hardly readable. I told her I would make better copies when my laser printer was fixed. On January 22nd my printer was returned and I revisited the website of the Center and printed out the articles. To my surprise, the link to the D.A.Y. Industries had been removed!! The page had been last modified on January 21st. With a little detective work I resurrected the web address of the D.A.Y. Industries as http://itdl.telecal.co.uk/day/cancer/index.html. Her uncle asked her to order the product.

The question is, "Why was this link removed?" I believe the Center came under pressure from the government. Even though the studies indicate that hydrazine sulfate helps cancer patients -- it cannot be prescribed by physicians in the United States! Why? There isn't a pharmaceutical company that will finance the scientific studies needed to get FDA approval for a substance that is not patentable and results in high profits. Natural occurring substances or those produced in volume cannot get FDA approval. This includes a lot of herbs.

The 1st flaw in our medical approval process is that if the substance can't make a lot of money it is unlikely to be submitted for approval.

Lately, the people of Arizona and California rose up against the Federal Government and the FDA and authorized physicians to prescribe marijuana for patients. The government says marijuana is illegal and no studies have been submitted for its approval. Even though the active ingredient THC has been approved as the drug Marionol and though thousands of individuals, along with many doctors, claim that it helps reduce the pain associated with AIDs and cancer. According to the FDA, their testimony is not scientific. If you say that something makes you feel better it is not acceptable.

The 2nd flaw in our medical approval system is that statements of responsible individuals that claim "it makes them feel better" is insufficient evidence, classified by the FDA as "subjective" and not sceintific -- even though thousands may claim this.

I believe Congress intended to give the FDA the power to protect us from medical providers that would harm us. Because power corrupts, the FDA now exerts the power to make decisions for you, to protect you from yourself -- and this takes away personal freedom. In recent years, the FDA attempted to take control of vitamins, stop you from smoking cigarettes, would like to control herbs, and make other decisions for you. They now want to regulate the cup your children urinate in provided in a home-drug-testing kit. I ask you how far do you want big-brother to control your life?


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