WHAT'S WRONG WITH AMERICA'S HEALTHCARE SYSTEM

The FDA tries to control more than it needs to. It claims regulatory authority over drugs, but defines a drug as anything that affects the body. Carried to the logical extreme, prune juice could be considered a drug, since it definitely affects the body. A 1997 study by Tufts University found that the cost of getting FDA approval for a new drug costs upwards of $200,000,000 and may take ten years or longer. In May, 2000, an article in the New England Journal of Medicine stated that getting a new drug approved could cost between $300 and 600 million. The pharmaceutical industry is the richest in the world - yes, richer than the oil industry. However, given such rules, even the richest drug company cannot afford to introduce a new medicine without patent protection. Consequently, more than ever before we live in the era of Patent Medicine, once not a very complimentary term.

Securing FDA approval allows a manufacturer to advertise what the approved product will do - i.e., to make health claims, which are forbidden without FDA approval. For instance, it is well established through clinical studies that the saw palmetto herb is more effective - and safer - at shrinking a swollen male prostate gland than the "approved" brands whose advertisements are everywhere (Health and Healing, June 1999). If a manufacturer of saw palmetto wished to state this known truth on its label, the FDA would haul that manufacturer into court in short order for having committed the sin of making health claims. The fact that they might be true is beside the point, for the FDA has arrogated unto itself the right to censor them. In a nation which finds it cannot censor pornography under the free speech right of the First Amendment, the FDA finds it can censor a manufacturer and prevent it from telling the public the truth about a product. On January 15, 1999, the U.S. District of Columbia Circuit Court of Appeals held that the FDA had violated the First Amendment of the Constitution by denying four health claims conveying information; the Court also held that the FDA cannot constitutionally deny a health claim conveying information. Paying no attention to the Constitution or the Court, on November 30, 1999, the FDA denied a health claim concerning the herb saw palmetto's ability to reduce a swollen prostate, stating that it considered the claim to be one requiring the filing of a new drug application. Congressman Peter DeFazio wrote the FDA a stern letter protesting its unconstitutional acts. For the FDA, if you want to make health claims, the solution is simple: get in line, spend your $200,000,000 +, and in ten years or so perhaps you can do so. Since the saw palmetto herb cannot be patented, the American male consumer is out of luck at learning about that effective, harmless, and far cheaper product, unless someone can persuade the FDA to obey the Court of Appeals.

In many countries, people think that if they want the best medicine in the world, they need to come to the United States. This is certainly the case for catastrophic injuries. If you're broken to pieces, you've got a much better chance of being put back together properly in the U.S. However, most Americans do not die of accidents but of degenerative diseases. One American dies of cancer every minute, 1,500 a day, 10,000 a week, 500,000 a year. This is the equivalent of three fully loaded 747's crashing and killing everyone aboard every day, all year long. An American Cancer Society study of cancer mortality rates in 46 countries shows the U.S. as #25, just a little below the middle.

Pretty regularly, someone makes an appeal for more money for medical research. But what about the effective, non-toxic therapies already discovered which have been suppressed, discouraged, outlawed or driven out of the U.S. by Official Medicine? This book deals with those medicines, all non-toxic and mostly not available - not because they didn't work, but for political reasons. But if something is non-toxic, why should the government (FDA) need to "protect" us from it? Or is the protection for companies who do not want competition from inexpensive, effective, non-toxic therapies? The FDA spent eight years of effort and untold millions trying to jail Dr. Burzynski (Chapter 11), discoverer of an effective and NON-toxic cancer therapy.