by Stephen L. DeFelice, M.D.
Chairman
The Foundation for Innovation in Medicine (FIM)
(See press release below related to this report)
National Consumption, Confusion and Concern
Poll after poll indicates that the U.S. population is consuming nutraceuticals, dietary supplements along with special foods and diets, in rapidly increasing numbers. The polls also report that paralleling this phenomenon is a growing and pervasive confusion and concern regarding the safety and effectiveness of the products consumed. The confusion and concern, however, have not decreased the rate of consumption placing millions of people at risk. This is a disturbing phenomenon that must be addressed ñ on a national level.
We should not forget, however, that the health — medical promise of dietary supplements and special foods is enormous. The problem is that many people, relying on self-care, have been misled about the value of the specific products that they consume primarily due to massive promotion which is largely characterized by unsubstantiated and /or false claims regarding health and medical benefits. They are bombarded with health messages such as This will boost your immune system or This will give you more energy. To compound the problem, many of these same people are also taking pharmaceuticals along with the nutraceuticals, which can often interact with each other either to the benefit or detriment of the patient.
This phenomenon, unfortunately, has turned off many professionals, particularly physicians, to the true health ñmedical nutraceutical promise.
Clinical Safety Instead of Effectiveness is Currently the Major National Concern: A Hidden Danger
Issues of safety are now dominating the national public policy agenda. The recent reports of the potential and real dangers of St. John’s Wort have convinced physicians as well as others that there is a significant problem with certain of these products which can be serious. Unlike the past, physicians will now consider dietary supplements, special fortified foods and diets as a possible cause when a patient develops a medical problem. With this new physician awareness, we can expect increased detection of toxicity and adverse effects within the very near future which will powerfully fuel the national concern with safety.
Recently the GAO issued a report calling for more studies on the safety of dietary supplements, the Center for Science in the Public Interest warned of the dangers of foods fortified with botanicals or herbal products, and the FDA held hearings on the toxicity of ephedra — all events dealing with safety. There is little doubt that the safety issue is here to stay and is likely to dominate the national health agenda.
Safety Alone Must Not Be The National Concern — It Must Be Combined With Clinical Effectiveness
Let’s not forget what this movement is all about. Just ask the people that are consuming nutraceuticals. Healthy people are taking them primarily to stay healthy. That usually means they are trying to prevent diseases such as cancer, Alzheimer’s, arthritis, diabetes and heart attacks from arriving at their doorsteps. On the other had, patients who already have been stricken by disease or some other condition that requires medical management want to get rid of what ails them or at least diminish the impact.
Nutraceuticals can help both the healthy and the sick attain their goals. Governmental action should, therefore, take both effectiveness and safety together as issues to be addressed. One aspect must not dominate the other.
How Can We Know That Nutraceuticals Are Both Safe And Effective And Can Help People?
For reasons that are puzzling, I have rarely heard this fundamental question asked! Laws and regulations should logically be structured on the answer to this question. And, the answer is quite simple. Any individual nutraceutical product consumed associated with a medical-health claim should be evaluated in people that have the condition for which they are taking the specific nutraceutical in order to justify the claim. This, in medical circles, is called clinical research. We know that pharmaceuticals such as aspirin, insulin, penicillin and beta-blockers are both effective and acceptably safe because these substances were evaluated in clinical studies or trials. Why shouldn’t the same principle hold true for nutraceuticals?
Why do women take folic acid to prevent neural tube defects in their newborn babies and why are AIDS patients avoiding taking St. John’s Wort while taking life-saving drugs such as protease inhibitors? The answer is that clinical studies have shown the benefit of the former and the risk of the latter.
The FDA Cannot Solve The Problem And A Law That Reacts Primarily to Safety Concerns Could Make Matters Worse!
For regulatory and logistical reasons the FDA has little capacity to adequately regulate the promotion of false and unsubstantiated claims and significantly increase nutraceutical clinical research. It is certainly possible that future court decisions will give the FDA more regulatory power to regulate claims but, even if this does occur, it is doubtful whether it will be adequate.
If safety issues continue to arise and have national visibility, Congress will probably take action and pass new legislation. Such legislation would grant the FDA more regulatory power on restricting unsubstantiated or false claims and clarifying truthful ones. But one must ask the question, “How is it possible to know the truth about the effectiveness and safety of a product — and thereby regulate the claim — unless it is tested in clinical studies?” And we should also remind ourselves that, new laws and regulations or no new laws and regulations, people will continue to consume these products placing themselves at substantial risk losing the important opportunity to take nutraceutical products that can significantly improve their health.
The NREA As The Solution To The Problem: It Will Create a Clinical Research Driven Nutraceutical Health Sector
The NREA or Nutraceutical Research and Education Act was proposed by FIM (TheFoundation for Innovation in Medicine) in 1989. Ten years later it was introduced in Congress on October 1, 1999 by Representative Frank Pallone(D-NJ). It is primarily based on the successful Orphan Drug Act. The intent of the latter was to stimulate clinical research on rare diseases where there were few economic incentives to invest in such research. The primary section of the Act grants the sponsor of clinical research conducted on the specific product the exclusive right to make the claim for a period of seven years, provided, of course, the FDA approves the claim. It is similar to a use patent.
The Act has been highly successful in creating a clinical research driven Orphan Drug industry that has greatly benefited those afflicted with rare diseases. Before the Act was passed by Congress in 1983, there were a handful of orphan drugs approved by the FDA. Since then, close to 200 have been approved.
The NREA similarly offers exclusivity for the claim to the sponsor of the clinical research on the nutraceutical product evaluated. It, however, extends the exclusivity claim to a period of 10 years.
Additional Comments
As with the Orphan Drug Act, the NREA will bring physicians into the nutraceutical health care sectorwhich is essential for proper health care. By, based on the results of clinical research, enlightening them about the value of such products, they could accurately advise their patients on the best use of nutraceutical products to optimize their health. This is the way it should be.
What does one do in the meantime? The best solution is to inform one’s physician of the nutraceutical products that are being consumed. If any significant change occurs such as an unexpected improvement or worsening of the patient’s condition, the physician can then relate these changes to the nutraceuticals as possible causes.
Conclusion
If the NREA or a similar act which will encourage clinical research is not enacted by Congress, then we must live with and accept the following conditions:
We will lose a great and almost immediate opportunity to significantly increase nutraceutical medical discovery that will minimize the impact of both mental and physical disease and other conditions that ail us.
We will continue to expose ourselves to a substantial degree of toxicity and adverse effects.
Remember we are all in the same boat when it comes to disease and the accompanying tribulations of life. We must all ask ourselves, “Do we want to continue on this senseless and destructive path or, by one single Congressional Act, significantly diminish the impact of mental and physical disease on our lives beginning within a relatively short period of time?”
Stephen L. DeFelice, M.D.
September 27, 2000
Press Release
The Dietary Supplements, Special Foods and DietsDilemma — What Should We Do?
The bubble is about to burst in the dietary supplement, food and special diets industries. All surveys report that people are becoming increasingly confused and concerned about the particular products being consumed. St. John’s Wort has alerted the medical community about the general potential dangers of these products and more will soon be discovered.
Congress will understandably step in and enact new legislation to address the problem. The impact of such safety-only based legislation will further reduce the paucity of nutraceutical clinical research that is presently being conducted. Clinical research is essential to demonstrate the effectiveness and safety of the specific products sold. The result of safety-only based legislation would be an indefinite postponement of the delivery of the important medical — health benefits of nutraceuticals.
FIM, The Foundation for Innovation in Medicine, has proposed a solution to this problem which will create a favorable environment for companies to conduct nutraceutical clinical research.
Stephen L. DeFelice, M.D.