Ed McCabe Testifies in DC at NIH On The Efficacy of O3 - National Institute of Health Office of Unconventional Medical Practices.

On June 18, 1992, in government building C in Bethesda Maryland, a radical change occured in health care in this country.

It was a bell tolling a bright new future for health care in this country and in some ways a death toll for the abusive practices that federal and state agencies have had towards alternative health care providers, dietary supplement manufacturers and retailers as a whole.

This came about as a result of Senator Harkin of Iowa having appropriated two million dollars to the National Insitute of Health to set up, through their office of Science Policy and Legislation, an Office of Unconventional Medical Practices.
The new office convened a meeting of ninety spokesmen for unconventional therapies who were invited to present their treatments to an adhoc panel convened by the National Institute of Health. Ed McCabe spoke on behalf of the oxygen and ozone doctors nationwide.

NIH's invitation to these practitioners of alternative medicine was in itself validating to these sciences. Among those who attended were practitioners of acupuncture, homeopathy, ayurvedic medicine, naturopathy, biofeedback, oxygen therapies, chinese herbs, hands on healing, meditation, visualization, intravenous use of vitamin C, and holistic dentistry, to name a few.

The director of this NIH office of Uncoventional Medical Practices is Steven Groft, 47. The efforts of his office are a part a monumental shift in the emphasis of health care in this country with a mind towards integrating traditional and modern uncoventional medical therapies into the mainstream practices of this country.

The thrust of their activities are centered around putting together a game plan for reviewing, evaluating, researching and implementing alternative therapies in a way that is consistent, scientific, fair and unencumbering to the uniqueness of the individual modalities.

A major impediment to the acceptance of alternative therapies in this country has been that they do not lend themselves to the traditional avenues of inquiry.
For example, how do you go about setting up an animal study to evaluate the mind/body connection? The new NIH office needs to come to a better understanding of alternative therapies in order to determine the adequacy of observational and experiential research.

They also need to set standards for peer review and create avenues for applications of those interested in doing research into these areas to get grants or other funding. It is a monumental task, something akin to wrapping Jello in rubber bands, that is as challenging as it is overdue.

In addition to the NIH Office of Uncoventional Medical Practices, there are two other very exciting things that are taking place in Washington. One of them is also under the auspices of the NIH. It is the National Cancer Institutes evaluation of the status of unconventional cancer treatments, that also includes uncoventional aids treatments.

These are known as UCT's. They are preparing a set of "best case series" on the UCT's as well as conducting pilot clinical trials using uncoventional cancer therapies.
The National Cancer Institute has been criticized for not pursuing the evaluation of UCT's more vigorously. To address this situation, the NCI has prepared a document to provide guidance to those individuals who wish to develop data which would support further research into their approach. There are two ways that can be used in generating appropriate clinical data.

One straightforward way is identifying patients who have benefited from treatment by presenting records of patients who have responded favorably to alternative treatments in such a way as to give a general idea of what can be expected by a patient receiving these therapies.

This is known as a "best case series". Since a best case series is a retrospective review, essential data is frequently unavailable. Often it is far better to pursue an alternative strategy which involves conducting a relative small clinical trial in which key factors of the UCT may be identified and steps taken to insure that essential data is collected. Critics of this approach claim that it is opening a Pandora's box that would lead to chaos and quackery in the health care community.

Proponents point out that all Doctors are subject to malpractice at all times and that it is illegal to make false claims. All the NCI's new methodology would do is put the spirit of innovation and experimentation back into an area that has become beauracratized and legislated to a point where the possibility of a low cost solution is nil.

The NCI's investigational drug branch as it is known, is attempting to be unbiased and balanced toward these UCT's, and they point out that it must be recognized, that it is extremely easy for proponents of a therapy to make claims regarding its efficacy.

The scientific method has always placed the initial burden of proof on the investigator to support their claims, not on others to refute them. It would be a misuse of their resources to bear the responsibility for generating proof of the efficacy of a UCT.

Also taking place in Washington is the introduction of the Health Freedom Act of 1992, into the senate by Senator Orrin Hatch. The purpose of the Health Freedom Act of 1992 is to help assure that consumers who wish to purchase dietary supplements, such as vitamins, minerals, and herbs, may do so in a way that allows consumers the maximum amount of choice in the market place, while retaining a proper level of public health safeguards.

There is a growing body of research that indicates that dietary supplements can help promote health and prevent certain diseases. In our free market system, consumers should be able to purchase dietary supplements and companies should be free to sell them as long as the labeling and advertising is truthful, non misleading, and there exists a reasonable scientific basis for the product claims.

There are six major points to what is known as S-2835, or the Health Freedom Act of 1992. The first one is the definition of a dietary supplement. The bill provides a definition of a class of products to which it applies. It would define dietary supplements as articles that include anything that you would want to supplement your diet with, such as a vitamin, mineral, herb, or other nutritional substance.

The second point under the bill is that dietary supplements are not drugs, and a dietary supplement shall not be considered a drug solely because of the potency of a substance in the supplement. It also provides that a dietary supplement shall not be deemed a drug soley because the labeling or advertising for the supplement provides information concerning the potency of the substance.

The third point in the bill is that dietary supplements are not food additives. A food additive is something like a preservative, emulsifier, solvent, or other technical or functional agent.

The FDA should not be allowed to assert that a food additive requirement would prevent consumers from obtaining a safe vitamin, mineral, herb or other similar food substance that they knowingly want to consume or add to their diets by means of a dietary supplement.

For example, in the past FDA has asserted that compounds of Chromium are unapproved food additives, and thus illegal when added to dietary supplements. This action took place despite the fact that it is clear that chromium is an essential mineral, that is extremely safe and even has a recommended daily allowance.
It is important to note that preventing the FDA from regulating food substances in dietary supplements as food additives does not deprive the FDA of ample authority to protect consumers from unsafe products.

There are sections in the law that prohibit a food from bearing or containing any poisonous or deleterious substance which may render it injurious to health. However, it is up to the FDA to prove that a food substance is poisonous or deleterious and may render the product injurious to health before the agency can deprive consumers of that food.

A fourth section of the bill provides that labeling or advertising about a dietary supplement may include claims or other information about the substance provided that such claims or other information are truthful, not misleading, and that there is scientific evidence, either published or unpublished, that provides a reasonable basis for such claims or other information.

This will enable retailers greater flexibility in marketing their products and also permit the public to have access to necessary information in selecting the appropriate dietary supplement for their needs.

A fifth section of the bill deals with prior restraints by the FDA on truthful labeling or advertising. It states that the FDA shall not establish any requirement that disease or health related claims or other information concerning a dietary supplement must be approved by or conform to a regulation issued by FDA before they may be used in labeling or advertising.

This section of the bill is very important in that it reverses a significant portion of the National Labeling and Education Act of 1991, that requires FDA pre-approval of health claims where dietary supplements are concerned.

The new bill states that if a labeling claim is made that is false or misleading or there is otherwise no reasonable basis for the claim, FDA has and would continue to have ample authority to take action against the subject product as a misbranded food.
This would be a boon to consumers and retailers alike in that it would allow an appropriate flow of information in the marketplace. The historical and scientific references supporting dietary supplements are legion and have been restrained to date by regulation and legislation.

The sixth point in the bill would provide a right to judicial review of FDA warning letters. Presently, when the FDA issues a warning letter concerning a dietary supplement claim asserting that the disease or health related claim is false or misleading or there is insufficient scientific evidence to support the claim, retailers and manufacturers are unable to submit the claim to a review of the validity of the agencies allegations in a court of law.

The new law would make it clear that judicial review is available in any case where the FDA issues a warning letter.

The Health Freedom Act of 1992, which again is Senate Bill 2835, is one of the most helpful and promising pieces of legislation to be introduced in many years. It undoes many injustices of the past. Every health minded American should contact his or her senator encouraging expeditious passing of this piece of legislation and immediate enforcement of it thereafter.

In contrast to the promise offered by the Health Freedom Act of 1992, the NIH Office of Unconventional Medical Practices and the National Cancer Institutes UCT's (uncoventional cancer therapies) guide are the shenanigans revolving around House Bill 3642 - the Food Drug Device and Cosmetic Act, the raid on Dr. Jonathan Wright's medical office in Kent, Washington by the FDA.

The harassment of long time ozone practitioners, such as Dr. William Tursca and Dr. John Pittman as well as the Basil Wainwright case and the incarceration of Dr. Shandl, calls to mind the Charles Dickens novel, A Tale of Two Cities, that begins, "It was the best of times, it was the worst of times..."

It is important to point out that the winds of change that are blowing have been brought about as a result of the way our democratic system works. The positive events described above came about as a result of our objections to the excesses of authority and our legislators response to them.

It is a testimony to the American system and a testimony to the rule of reason. The important thing to keep in mind is that never was it more important for health minded Americans to become involved, voice their opinion, organize, and contact their legislators regarding these matters.

Health Care in this country is a pivotal issue this year because it is one of the supporting girders that defines our quality of life and our degree of freedom. The present system is in a horrible state of dissaray because special interests have been aasserting themselves and the people have not.

Indeed, the winds of change our blowing. We need to open our sails and take maximum advantage of them. In other words, we need each of us as individuals to participate in the process to the extent that they are able, so that we can maximize our freedom of choice by amplifying our collective voice.