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TIME TO CORRECT THE EPISTEMOLOGIC CHAOS THAT PREVENTS NUTRACEUTICAL CLINICAL DISCOVERY

October 12, 1999

What is Health?
What is Disease?
What is a Health Claim?
What is a Medical Claim?

Stephen L. DeFelice, M.D.

The current nutraceutical (foods, medical foods and dietary supplements) industry is market-driven, but needs to become research-driven. Nutraceutical companies sponsor very little clinical research to evaluate the efficacy and safety of their commercialized products, and few realize that their present and future success requires that they start proving what they are claiming.

Why is this happening? Mainly because current federal laws and regulations have created epistemologic chaos regarding certain nutraceutical definitions. These faulty definitions are applied by the FDA and then serve to limit the freedom of companies to make legitimate medical or health claims. It is, therefore, crucial that we resolve this epistemologic dilemma in order to form a rational foundation for new Congressional laws that will encourage nutraceutical clinical research.

For example, current laws such as DSHEA mistakenly attempt to distinguish the difference between a health and medical claim. If, for example, a nutraceutical dietary supplement lowers cholesterol and a company makes such a claim, it is considered a medical and not a health claim and, therefore, not permitted to be made by the company. The company may be permitted to claim, "it benefits the body's cholesterol" in order to be considered a health claim.

The ultimate result is that the truth - that the product does lower cholesterol - cannot be claimed by a company. A misleading cholesterol claim, however, can be made. This common type of epistemologic chaos borders on sophistry and is clearly unacceptable. It both robs the patient of important truthful information concerning his or her health and also profoundly discourages nutraceutical clinical research, the essential element in medical discovery, be it for the management of a disease or abnormal condition.

There is an urgent need for Congress to pass new laws which contain new, precise language defining such critical terms as health, disease, health claim and medical claim. This will allow and encourage companies to conduct nutraceutical clinical research on products that will help to reduce or eliminate disease, the manifestations of disease or other abnormal conditions, premature death, and yes, health care costs.

The four core questions to be answered are as follows:

1. What is health?
2. What is disease?
3. What is a health claim?
4. What is a medical claim?

In addition to having queried various experts on these questions, I turned to both lay and medical dictionaries for enlightenment. The following are representative definitions which are in harmony with those of the experts:

American Heritage Dictionary:

HEALTH:
1. The state of an organism with respect to functioning, disease and abnormality at any given time.
2. The state of an organism functioning normally without disease or abnormality.
3. Optimal functioning with freedom from disease and abnormality.

Stedman's Medical Dictionary:

HEALTH:
The state of the organism when it functions optimally without evidence of disease or abnormality.

American Heritage Dictionary:

DISEASE:
An abnormal condition of an organism or part, especially as a consequence of infection, inherent weakness, or environmental stress, that impairs normal physiologic function.

Stedman's Medical Dictionary:

DISEASE:
Morbus; illness; sickness; an interruption, cessation, or disorder of body functions, systems, or organs.

In FDA's recent attempt to define "disease", it states that the latter is "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by a characteristic set of one or more signs or symptoms, including laboratory or clinical measurements that are characteristic of a disease."

This definition is an exercise in classic tautology. Basically, it states that a disease is a disease which is not very helpful in clarifying epistemologic chaos. If FDA had added "or abnormality" at the end of the definition after" disease" then it would be in harmony with the experts, lay and medical dictionaries. (To further complicate the issue, it is possible that FDA may be applying this definition of disease to dietary supplements only and not to other categories such as foods.)

What is very encouraging and surprising is the basic commonality and consistency of the perception of the meaning of "health" and "disease". Both make good sense because they reflect the truth of reality.

Regarding the term "health", both dictionary definitions describe two conditions - "disease" and "abnormalities". Neither tries to distinguish the difference between the two. For example, few would call a sore knee after playing tennis or periodic fatigue or PMS diseases. But they are indeed abnormal conditions which often, like disease, require medical management. After all, a problem is a problem no matter what you call it.

Regarding the term "disease", the words "disorder of body functions" and "abnormal condition of an organism or part..... that impairs normal physiologic function" certainly includes a sore knee, periodic fatigue and PMS, none of which is commonly perceived as a disease. Cutting through all the complexities of both medical and lay dictionaries, be it a specific disease or a specific abnormal condition, both types of entities are commonly referred to in general definitions of health and disease. In order to be healthy, we must be free of disease and any other abnormal condition. For complex historical reasons, the simplicity of this self-evident truth has eluded us.

In the final analysis, we must ask ourselves what is important to the patient. This fundamental principle is too often forgotten. If a patient has either PMS or pancreatic cancer, the patient needs medical management. Giving a condition a name and categorizing it with a legal-regulatory label is academic and does not meet the real needs of real people. What is important is whether therapy will benefit the patient and not fruitless epistemologic debates, particularly when such debates powerfully discourage clinical research on nutraceutical discovery.

Considering the aforementioned and using common sense, I would propose the following four definitions:

1. Health is the absence of disease or any other abnormal condition which may generally, but not always, require medical management.

2. Disease is a condition that impairs health and could benefit from medical management.

3. A health claim deals with a substance that has a beneficial clinical effect on a disease or abnormal condition.

4. Similarly, a medical claim deals with a substance that has a beneficial clinical effect on a disease or abnormal condition.

In conclusion, it follows that there is no difference between a health and medical claim.

Congress must act now on FIM's proposal, the NREA (Nutraceutical Research & Education Act), which was introduced in Congress by Representative Frank Pallone (D-NJ) on October 1, 1999. The NREA permits companies to make claims based primarily on the results of the clinical research conducted on the specific product commercialized. If a nutraceutical lowers cholesterol, then the claim should reflect the truth, i.e., it lowers cholesterol. If a nutraceutical decreases insomnia, then the claim should reflect it. No distinction is made between a health or medical claim.

If we are compelled to continue to categorize claims, we should replace the terms "health" and "medical" claims. Instead we should use a new term, "medical-health" claims as the legal and regulatory language of choice.