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Alternative Medicine

First Published: February 2000
Last Update: April 2002
Author: Computer Partners

There has been concern on the alternative medicine front about the potential power of the FDA in closing down Web sites that specialize in alternative medicine.

This fear was fuelled by an announcement in December by the Clinton administration that this year's budget would include a proposal of $10 million to back an FDA effort to crack down on online pharmacies and alternative medicine websites.

The December 28 press release from the office of the press secretary of the White House said that the money will be used, "to develop a rapid response team and upgrade FDA's computer technology to identify, investigate, and prosecute websites selling such items as: prescription drugs without a valid prescription, unapproved new drugs, counterfeit drugs, and expired or illegally diverted pharmaceuticals. This initiative will also help crack down on the marketing of products based on fraudulent health claims."

The last line of this quote is what has got those in the alternative medicine field concerned. Although the statement sounds legitimate enough, it does raise concerns when you take into account the history of the FDA.

In the past the FDA has attacked alternative medicine providers for making what the FDA believed were fraudulent health care claims.

For instance, last January Durk Pearson & Sandy Shaw won a landmark decision against the FDA.

An article by the Laissez Faire City Times reported that the District of Columbia Circuit ruled 3-0 against the FDA on all issues before the Court. The FDA's health claim approval process was also ruled unconstitutional.

In the article, Shaw and Pearson said that the FDA had refused to permit four claims that they had made. For example the FDA had refused `the claim that "antioxidant vitamins may reduce the risk of certain cancers" by claiming that there was not "significant scientific agreement" (which they would not define) and would not permit us to qualify...'

One significant aspect of the court ruling in that case was that the Court had agreed with Shaw and Pearson's argument that the FDA hadn't established a "significant scientific standard" for health claims. The Court ruled that the FDA had established no standard since the FDA had refused to define what "significant scientific agreement" meant. It was considered a statutory violation because Congress required in the DSHEA (the Dietary Supplement Health and Education Act of 1994) that the FDA establish a procedure and standard for accepting health claims.

In the article Shaw and Pearson made reference to a book they had written in 1993 that `explained what a disastrous effect upon the public health the FDA was having in drastically slowing the flow of truthful health information concerning dietary supplements, such as antioxidant vitamins. One of our examples was low-dose aspirin; in the "Physician's Health Study" published in 1989 [1], it was reported that in previously healthy men over 50, an aspirin every other day reduced the risk of a first heart attack by about 44 percent.'

Ten years after that fact first came to light, the FDA was still prohibiting aspirin companies from communicating the information to the public. During that period, Shaw and Pearson said that hundreds of thousands of people had died of a heart attack unnecessarily.

In an article on Smart Basics IntelliScope, Shaw and Pearson said, "the FDA ... did not permit health claims for supplements because they didn't think that any health claim was truthful, other than one claiming that a nutrient supplement could eliminate a deficiency of that nutrient (where "adequate" levels are defined by the RDA).

As a result of the Shaw and Pearson case, the FDA has been forced to make changes to its definition. On January 5 of this year, the FDA finalized rules for claims on dietary supplement saying "under DSHEA, dietary supplements may bear "structure/function" claims -- claims that the products affect the structure or function of the body-- without prior FDA review. They may not, without prior FDA review, bear a claim that they can prevent, treat, cure, mitigate or diagnose disease...."

In their FDA talk paper, the FDA points out that "express disease claims" would be saying something like, "prevent osteoporosis" and "implied disease claims" would be saying, "prevents bone fragility in post-menopausal women".

The paper goes on to say,"... While this rule should not affect the availability of dietary supplement products or consumer access to them, it may affect whether certain claims can be made under DSHEA...."

The rule was published in the Jan. 6, 2000 Federal Register. It becomes effective 30 days after it is published in the register. It is still too early to see what the results of this new ruling will be.

John Hammell, president of The International Advocates for Health Freedom said that "the bureaucrats at FDA have a long history of acting in the capacity of a trade association to protect the financial interests of the pharmaceutical industry due to a revolving door between the FDA and the pharmaceutical industry."

He said that, "If they (the FDA) are given 10 million to crack down on websites, we feel that it is inevitable that they'll end up grossly abusing this power by targeting some alternative medical and vitamin company websites, regardless of what they SAY the money is going to be used for."

Hammell said that one of the reasons he is suspicious, is because of an article that appeared in the British Medical Journal which attacked Matthias Rath, MD. Rath is an orthomolecular physician who has a website that the FDA criticized.

"In the BMJ article they made a very strong recommendation that cyberspace be much more tightly regulated so as to stop people like Rath from making statements about his nutritional products and protocols that they don't happen to agree with because they go against the accepted mainstream dogma for such diseases as cardiovascular disease. "

Dr. Rath worked with the late Dr. Linus Pauling, and together they discovered the solution to human cardiovascular disease, the world's number one killer. Hammel said that their nutritional protocols are being massively suppressed because the largest sector of pharmaceutical sales lies in the sale of heart drugs. The "last thing the drug cartel needs is a paradigm shift in the direction of prevention and nutrition because it would put many drug companies out of business."

Other past victims of the FDA have been Saul Kent and Bill Faloon of the Life Extension Foundation (LEF), who Hammel said were indicted on trumped up charges following an illegal FDA raid years ago and were forced to fight in the courts for about 9 years before they were completely exonerated of any wrong doing.

Bill Faloon currently has an article on the LEF website that voices his concerns about this possible FDA funding. In it he said that, "if the FDA convinces Congress to give it the power and money to do this, American consumers will be denied access to innovative therapies, and will be forced to pay a good deal more for the nutrient and drug therapies the FDA allows them to buy over the Internet."

Faloon also points out that the "FDA wants the power to issue subpoenas without first obtaining a court order, a totalitarian tactic the American public revolted against when the agency proposed it in 1990. "

The White House press release specifically states that it is proposing new legislation that will provide the "...FDA with administrative subpoena authority when investigating potentially illegal Internet drug sales. Administrative subpoenas would be issued in accordance with standards established by the Administration's draft privacy regulations."

Granting the FDA this kind of legal power is a legitimate concern.

Faloon raises another important issue. He said that one of the arguments that the FDA uses in its crackdown on online pharmacies is the fact that someone had died by purchasing Viagra online without a prescription.

Faloon reports, "as of November 1998, at least 130 Americans died from taking Viagra legally prescribed by their doctors. (The total number of Viagra-related deaths for 1999 has not yet been calculated.) The FDA approved Viagra as being safe, even though many Americans have died when the drug has been legally prescribed. The FDA failed to detect this lethal side effect of Viagra..." This fact supports what Hammell claimed earlier that the FDA is in fact in alliance with pharmaceutical companies.

In an article in Natural Health, Karin Horgan Sullivan reported that one of every three Americans has tried alternative Medicine and 84% said they would try it again.

She also reported that medical doctors were beginning to see the benefit with workshops, seminars and lectures on alternative medicine being held at medical conferences. She said that, "spurred on by doctors from the University of Maryland at Baltimore, Harvard Medical School in Boston and Columbia University School of Medicine in New York, many conventional MDs are beginning to assimilate alternative treatments into their practices as "integrated" or complementary medicine."

E-marketer reported on April 12, 1999 that about 43% of Internet users go online to gather health care data and to get answers on health care issues. Specifically they look for information on specific disease conditions, educational services, medications, physical fitness and alternative medicine.

The article said, "Consumers are dabbling into the Internet because of a lack of information available from traditional resources, the study reports. More than two-thirds of patients do not receive information about their condition, in literature form, while at their physician's office."

If these figures are accurate and there is every indication that they are, then the public will not be pleased with a crack down on Internet access to health care information. This proposed funding and changes to FDA authority could not only spell trouble for online pharmacies and alternative medicine related sites, but for the general public who has grown accustomed to this new source of medical care.

Here are some online alternative medicine sites that you may find interesting.

Vitamin Lab
Smallflower.com

Great American Products

Color Therapy

Supplement Watch

Herbs.org

Alternative Medicines

Prevention.com

Online Pharmacy

Viagra User

Alternative Medicine from Naturodoc -- Natural health articles, nutritional supplements, fitness tools. Personal consultations with naturopathic doctors.

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