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Quality Care Close To Home |
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The Clinical View by P.E. Hoffsten, M.D. 31 OCTOBER 2002 DID YOU KNOW? The list of drugs available through your local pharmacy includes thousands of medications. A three thousand page book called the Physicians Desk Reference is published every year listing all the medications made by commercial drug companies in the United States. This book lists the chemical composition, the uses of, the side effects from, the expected results, and how the drugs are eliminated from the body for all the different medications listed in the book. Each one of these medications requires a prescription from a healthcare provider in order to be legally purchased at the pharmacy. There are strict regulations for the drug company to demonstrate the effectiveness of their medication and the chemical purity of the product. The drug manufacturer must have adequate trails in humans demonstrating the safety of the drug before it can ever be approved by the Food & Drug Administration for sale to the public. Drug companies spend virtually millions of dollars carrying out clinical studies to determine all of the above. After the drug has been on the market for a brief period of time, the drug company is required to carry out "post marketing surveillance" to ensure that the drug provided for the public is not causing adverse side effects. And still problems occur. Several years ago, that wonderful "Fen-Phen" was found to be associated with hardening and distortion of the heart valves in a very few people. The product was removed from the market even though one of these drugs had been on the market for 22 years with no detected sided effects. The product Rezulin (troglitazone) was the first drug on the market that reversed the basic abnormality in patients with diabetes. Unfortunately, it was associated with liver damage in a very few people and it was removed from the market after only three years of use. Most recently, Baycol (cerivastatin) was removed from the market when it was found that people who used this drug in combination with Lopid (gemfibrozil) had muscle abnormalities that resulted in severe damage in a few people. Cerivastatin was removed from the market even though it was as safe and effective as the other statin drugs if used alone. But because many physicians used this drug in combination with Lopid, the company felt the liability was too great and Baycol (cerivastatin) was removed from the market. In 1994, the United States Congress passed the Dietary Supplement and Health & Education Act. By this Congressional Act, Congress permitted the continued sale of any dietary supplement, vitamin, mineral, amino acid, enzyme, organ tissue, or metabolite that was being sold at that time. The manufacturer of any of these products was allowed to make a health claim for the product provided they also had a disclaimer stating that the product was "not intended to diagnosis, treat, cure, or prevent any disease". And thus our "health food stores" now market an awesome array of products consumed by our population in quantity equal to more than all of the prescription drugs combined. As expensive as our prescription medications are, the 35% of the American public spends three billion dollars on non- prescription medications and there is no insurance coverage on these products. But now comes the most incredible point of all. The manufacturers and sellers of dietary supplements are not required to certify the purity or composition of their product. If somebody uses one of these products and has an adverse reaction, there is no requirement that it be reported to any given government agency. If one of these products is found to be mislabeled or adulterated, it can be removed from the vendors shelves, but the burden of proof showing that the product is adulterated or mislabeled rests with the government itself, not with the manufacturer. Now think about this. Here we have situation where the Chief Executive Officers of several of our major corporations have committed fraudulent acts costing both the public and their own employees billions of dollars. As long as these people get a dollar in their pocket, they don't care how it gets there. And we are trusting them to provide us with a nutritional supplement that they claim makes our muscles stronger, our cholesterol go down, provides use with resistance to colds, stops our arthritis, makes us sleep better and prevents all manner of disease. By Congressional Act in 1994, these corporations that make these products are not required to demonstrate effectiveness, purity, or safety of their product. Sometimes the acts of our government are nowhere near as understandable as Alice in Wonderland. And yet some of the nutritional products really do seem to have a beneficial effect. One that I recommend is glucosamine /chondroitin-sulfate. I have been using this myself for several years and am personally convinced that the aching joints and stiffness I used to experience is much improved. Yet when our National Institute of Health (NIH) carried out a study to see how effective this product was, they could not find a commercial product in the health food stores that had adequate purity to carry out the NIH study. The National Institute of Health had to make their own glucosamine/chondroitin-sulfate with demonstrated purity in order to carry out their study. When the study was done, it indeed did show that this product was effective in decreasing joint inflammation and stiffness. But the products available to the NIH over the counter did not have adequate uniformity and purity to be used in the National Institute of Health study. Several other products such as "Mr. Woos Little Liver Pills", Kava, and Echinacea, have been found to cause liver or kidney failure with some fatalities. The product "PC Spes" used for prostate health has been found to be contaminated with Coumadin, Xanax, Estrogen, and Indocin. Never has the adage, "buyer beware" been more
appropriately applied than in the area of the nutritional supplement market.
Do you really know what you are buying? Under the present law, the answer
to that question is no. |
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