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Stephen L. DeFelice, MD


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The Patient Always
Gets Screwed


Promising Ovarian Cancer Therapy Blocked

Carnitine-Ovarian Cancer Promise and a Failed Attempt at a Clinical Study


When Was The Last Cure?


Translational Science - How Doctornauts Can Help


Senator Tom Harkin (D-IA) has been one of the leaders in Congress on Translational Science.


Doctornauts Barry Marshall and Lukas Wartman: Living Proof of the Urgent Need for the Doctornaut Act



View the Discussion Draft of the Doctornaut Act Prepared by Former Senator Bill Frist.




A Special Message for Congressman Frank Pallone

DSHEA Versus NREA (The Nutraceutical Research and Education Act) and the Three Nutraceutical Objectives

by Stephen L. DeFelice, M.D.

It's time to revisit the Dietary Supplement Health Education Act (DSHEA). Any new legislation and subsequent regulations, however, must be based on a solid, rational foundation to accomplish well-defined objectives. Unfortunately, this was not sufficiently done when the current law and regulations were written over a decade ago.

Both healthy individuals and those who are ill take their dietary supplements primarily for the prevention and treatment of diseases particularly the major ones such as cardiovascular, cancer and Alzheimer's. This self- evident fact has been confirmed by a number of surveys. Of course, dietary supplements are also used for other health conditions that are not recognized as diseases such as fatigue and aging skin. These uses, however, are clearly of secondary importance. To put it simply, people take supplements to get rid of their diseases, if they have them, or to prevent them if they don't. When Americans are asked what they want to know about the products they consume, the results of surveys are wisely in harmony with what physicians and other health care professionals agree upon.

They want to know the following:

1. Are the dietary supplements effective for the reasons consumed?
2. Are they acceptably safe?

3. And is the information available to them truthful?

The critical question then is, "How can we deliver these THREE NUTRACEUTICAL OBJECTIVES?" The unequivocal answer is by conducting clinical studies on the particular products sold. We can only know that penicillin works against bacterial lobar pneumonia; that insulin reverses diabetic coma; that niacin lowers blood lipids and that cranberry juice reduces the severity of urinary tract infections in women — and that all are acceptably safe - from data generated by clinical studies.

What does DSHEA do? Just the opposite! It effectively discourages clinical research which results in the following: People do not know whether the supplements they take are effective. They do not know if they are acceptably safe. They are denied access to truthful information regarding the effectiveness and safety of products.

The construct of DSHEA was an attempt to accommodate many players in the very complicated dietary supplement sector. In a real sense, it was a breakthrough milestone in our health sector because, for the first time, the government permitted companies to legally make claims about dietary supplements concerning bodily function. One well-intended objective was to reduce the rampant practice of making unsubstantiated and false claims regarding the beneficial impact of supplements on many diseases. The Congress handed the FDA a very difficult assignment and, for reasons too complicated to discuss here, an impossible task to carry out.

The major FDA attempt was to establish two types of claims categories — "health" and "disease" related. Companies are prevented from making the latter ignoring the fact that good ìhealthî largely depends on the prevention and treatment of disease. As an example of this epistemological chaos, if a company sponsors a well-controlled clinical study on a mixture of dietary supplements that shows that the product lowers cholesterol, the company cannot state the truth, namely, that it ìlowers cholesterolî because FDA considers this to be a ìdiseaseî claim. The company can, however, claim, "That it benefits the body's cholesterol" or "Can contribute to a healthy heart" which not only confuses the consumer but deprives him or her of the truth.

If, in a follow-up clinical study, the product is administered along with a cholesterol-lowering pharmaceutical which work together to significantly reduce the size of coronary artery plaques more than the pharmaceutical alone, and the company wants to make this claim, it cannot for two reasons. First, it is considered a disease claim. Second, simply by the fact that it is given along with a pharmaceutical, it also falls in the disease category.

Given the restrictive ground rules regarding claiming, what company would make a substantial investment to sponsor clinical studies on its products when it is not allowed to educate the public, let alone physicians and other health care professionals, about the truth but, instead, it is pushed into making misleading and/or confusing claims? The company will, instead, like water, take the path of least resistance to the marketplace.

Over 15 years ago, FIM proposed the NREA, or Nutraceutical Research and Education Act, as way to accomplish the aforementioned critical THREE NUTRACEUTICAL OBJECTIVES. <(1) A nutraceutical is a food or part of a food that has a health benefit including the prevention and treatment of disease. It includes dietary supplements, foods, and functional foods which are really dietary supplements in food dosage forms. The core principle of the proposed NREA is to offer attractive economic incentives for companies to sponsor clinical research or studies on their specific nutraceuticals that are marketed.

I came up with the concept of the NREA as a result of my long and extensive experience with carnitine, which is legally both a pharmaceutical and nutraceutical. My work with carnitine has taken me deep into virtually all aspects of innovation in our medical system. For example, there was evidence that this natural substance was effective in the treatment of the rare condition, carnitine deficiency, which is a debilitating and oftentimes fatal disease in children. But the high cost of obtaining an NDA or FDA approval of the drug, coupled with the very, very small market size, discouraged any company from pursing its development. After the Orphan Drug Act was approved, however, my colleague and proprietor of Sigma Tau, S.pA., Dr. Claudio Cavazza, invested the time and money to successfully obtain FDA approval for carnitine though no profit would come of it.

The Orphan Drug Act basically does two fundamentally positive things; 1) it grants a company the exclusive right for seven years to make a disease claim ñ sort of a methods patent — based on the results of the clinical studies; and <(2) it substantially reduces the amount of clinical data and total cost required to obtain FDA approval. These two provisions effectively spurred companies to invest in clinical research, and the Orphan Drug Act has been a gratifying success.

It is both puzzling and disturbing to note that the general message of the critical importance of encouraging clinical research, clearly demonstrated by the Orphan Drug Act, has escaped notice by Congress and the pharmaceutical and nutraceutical sectors where the difficulties of conducting clinical studies continue to inexorably rise retarding medical discovery. But, unfortunately, it is not surprising.

In 1976, I formed and funded FIM with the sole objective of educating the public and the key players in the health sector, concerning the importance of encouraging clinical research. I relied heavily on the mass media to carry this message forward. FIM held numerous high-level conferences, made proposals, spent large sums on public relations firms and other parties to spread the message. The result? Virtually a zero response except for modest coverage from the industry media. The mass media was nowhere to be seen. We have a definite, almost unbudgeable cultural blind spot when it comes to clinical research. In fact, our society views it with suspicion.

The FIM NREA proposal is based on the same principles of the successful Orphan Drug Act. If a company sponsors clinical studies on its product and FDA approves it, that company will have a seven-year claims exclusivity period. I was mistakenly convinced that, because of our nation's "exuberant enthusiasm" about nutrition, the key players in the health sector arena, particularly the mass media, would want to learn about and accept the general clinical research message necessary to deliver the promise of nutraceuticals to the people. FIM's educational effort, once more, did not resonate in any quarter.

It has always puzzled me why the business health sector that can market nutraceuticals has powerfully resisted changes when the changes involve delivering to the customers what they want as confirmed by multiple surveys. In addition, they are blind to the fact that the potential nutraceutical OTC market is far larger and more profitable than the current health food one coupled with much lower costs to market nutraceuticals. The marketing approach is unique and substantially different than the classic OTC industry. <(2) Over ten years ago I was fortunate enough to meet Representative Frank Pallone (D-NJ) who is quite knowledgeable about the promise and problems of the nutraceutical sector. We discussed the importance of clinical research in achieving the THREE NUTRACEUTICAL OBJECTIVES. He became highly interested and we had a few more meetings. At one of our FIM conferences he, as a speaker, announced he would introduce the Nutraceutical Research and Education Act in Congress. And so he did on October 1, 1999. <(3) The result? Very little interest or support, and, because of this, the Act was temporarily laid to rest.

The following are a few points that should be considered in any new legislation.

The issue of safety: Justifiable concerns with safety played a major role in DSHEA and will also if it is revisited. Dietary supplements, when compared to pharmaceuticals, are vastly safer. For example, if all FDA approved pharmaceuticals were made freely available as dietary supplements, a large percentage of Americans would be deathly ill or no longer with us within a very short period of time! This is not to say that dietary supplements are without risks, but they do not compare to pharmaceuticals.

National placebo: To the skeptics who do not believe that dietary supplements, themselves, offer much promise, there is another important and little appreciated side of the coin. Nutraceuticals are our nation's freely available placebos. Up to 50% of millions of Americans who suffer from a broad variety of conditions experience significant placebo improvement when taking them. We now know that something definitely happens to the brain's machinery during a placebo response which somehow, through a natural mechanism in the body, leads to a beneficial response in these millions.

Cost reduction: And here's another little appreciated but definite benefit: Those millions whose conditions improve find no need to visit a doctor's office to receive a prescription for expensive pharmaceutical drugs and/or undergo costly medical tests. Though not yet sufficiently quantitated, there is little doubt that this results in an enormous reduction in health care costs.

In the final analysis, whether DSHEA is revisited or not, the enactment of the NREA not only compensates for some of the major deficiencies of DHSEA, but also presents a wonderful opportunity for Congress and the nutraceutical industry to deliver the promise of nutraceuticals to Americans—soon. To repeat, the NREA will lead to clinical trials that clinically demonstrate the effectiveness and safety of nutraceuticals related to disease and other conditions. Physicians and other healthcare professionals respect clinical data as the gold standard of acceptability and will recommend products that meet these standards to their patients. As a result, the NREA generated proven nutraceuticals largely will replace DSHEA's unsubstantiated clinically unproven ones.

Regarding the NREA's impact on the future nutraceutical industry, it will divide it into two general sectors similar to the ethical and generic pharmaceutical industries, but with important differences. The former, similar to the NREA industry, because of the exclusivity given to the claim, develops proprietary, high profit margin products which generate sufficient funds to sponsor clinical research while the latter, similar to the DSHEA industry, is a commodity, nonproprietary industry with low profit margins with little incentives to invest in clinical research.

Recently, Congressman Pallone has been appointed as Chairman of the Energy and Commerce Subcommittee on Health. For this reason and the reasons supporting the NREA, FIM urges Congressman Pallone to reintroduce his NREA. After all, Congress should be comfortable with the concept behind this proposal because it is the same as with the successful Orphan Drug Act that it enacted.

References:

1. <http://fimdefelice.org/archives/arc.researchact.html FIM Rationale and Proposed Guidelines for the Nutraceutical Research & Education Act - NREA. <http://www.fimdefelice.org/nrea.html

2. Clinical Research and Nutraceutical Brand names and Trademarks.
<Clinical Research & Nutraceutical Trademarks
December 20, 1999 commentary by Stephen L. DeFelice, M.D.

3. "Bill H.R.3001 - The Nutraceutical Research and Education Act. <http://www.fimdefelice.org/nrea.html