Asbury Park Press, Sunday June 24, 1984
By Erlinda Villamor
Press Staff Writer
Is Chicken Soup a food, a nutrient or a drug?
How effective is garlic or onion in alleviating hypertension?
Can certain Chinese herbs prevent cancer, and can one stave off heart disease by quaffing cod-liver oil, or gorging on cabbage, broccoli or cauliflower?
If a group of researchers has its way, consumers could one day hop to the corner health food store for “natural-drugs” to help treat acne, bladder infection, heart problems and even certain types of cancer.
Far from it, Dr. Stephen DeFelice, a former chief of clinical pharmacology at Walter Reed Army Institute of Research, told a symposium on “Food-Drug Dilemma,” held Wednesday at the University of Medicine and Dentistry, Newark.
The symposium was sponsored by the Foundation for Innovation in Medicine, a non-profit research organization based in Cranford. DeFelice is in the forefront of a move to step up development of natural medicinal products.
The foundation he heads is holding symposiums in various parts of the country to drum up interest in the subject.
That nature is a cornucupia of medicinal substances is not the issue, DeFelice stressed.
“Nature’s medical track record is unsurpassed. The mere survival of living things as individuals and as species is the greatest testament to the success of nature,” he said.
THE ISSUE, panel members agreed, is “definitions.”
Move over Noah Webster. “The current definitions of what’s nutrition, what’s a drug and what’s food no longer apply, DeFelice said.
Panelists engaged the audience, made up of doctors, researchers, nutritionists and representatives from the pharmaceutical industry, in a hair-splitting exercise in semantics. What they had to say about nutrition, food and drug could well be food for thought for the regulators.
Dr. Richard S. Rivlin, chief of Nutritional Service, Memorial Sloan-Kettering Cancer Center underscored the implications of the lack of consensus on the words’ meanings.
“We even have hamburgers containing vitamin C, and they call them ‘health burgers.’ But how therapeutic these hamburgers are, we cannot say.”
“Definitions are important because our legal system prevents research into these subjects (natural substances), DeFelice declared.
“When a nutrient stops being a nutrient and becomes a drug – that’s the most important economic question of the next decade,” he added.
Food and natural substances have long intrigued humankind for their purported curative and therapeutic value.
During the past few decades especially, interest in the medical use of natural substances in this country has spawned a booming health food industry, although little scientific support exists for the substances’ vaunted benefits.
But federal regulations, said DeFelice, are making make it extremely difficult for today’s Americans to reap the time-proven benefits of certain natural foods and nutrients. He contends the government is using “its strong regulatory powers” to lock substances into categories, without providing for “certain gray areas.”
“WE NEED an entirely new regulatory system for naturally occurring substances,” said Dr. Donald B. Louria, professor and chairman of UMDNJ’s Department of Preventative Medicine & Community Health.
The panelists think that by changing the legal definitions of food, nutrients and drugs, they have a good shot at having the regulations changed to cover the gray areas.
Research and development on natural substances has been relatively limited, and consumers are the worse for it, he said.
“There is a relative lack of natural substances approved by the Food
and Drug Administration (FDA) for medical uses,” but “an ever-increasing number of approved, unnatural drugs.”
According to Louria, researchers have no economic incentive to invest large sums of money in studying natural products for their health and medicinal benefits.
Drug development entails costly, risky and time-consuming clinical research. Its manufacture and sale are rigidly regulated. “This can cost millions and millions of dollars,” according to DeFelice.
A “natural-drug” necessarily involves natural products. As such, it is not protected by patent, which enables the researcher and developer to recoup their investment.
CONGRESS, in drawing up food and drug regulations, considered products of nature as God’s gift to mankind, and freed them from patent protection, unless “a particular, unobvious use, a process of production or a novel composition of a natural substance” is involved. (Interferon, a human protein being developed as a possible cure for certain cancers, is a good example.)
DeFelice: “If you want to develop a natural substance and sell it as being good for the heart, you have to spend a lot of time and money on research. But what doctor would do that if, after he makes his claim (for a drug), the product can be bought at any health food store?”
DeFelice predicted a therapeutic role for carnitine, which, like insulin, is a substance naturally found in tissues. He spent 20 years on his research. Carnitine, he says has proven to be helpful in treating muscular and heart weakness, renal disorders, convulsions and other conditions caused by a lack of the substance.
An Italian pharmaceutical company has developed and marketed carnitine, and DeFelice said he has applied for an FDA approval for the product.
“The World Health Organization said a mouthful when it defined a drug as ‘any substance or product that is used or intended to be used to modify or explore physiological systems or pathological states for the benefit of the recipient,’ ” said Dr. Rivlin, who also is professor of medicine at the Cornell University Medical College.
Going by that definition “any substance ingested, including water and alcohol, is a drug. And any natural substance can be called a drug.”
RIVLIN CITED an alphabet soup of vitamins that are made naturally by the body and that have definite therapeutic and medical value.
That’s why, it is not necessary to take all the vitamins, he said.
Vitamin K is manufactured by intestinal microorganisms, although it can be rendered useless if a person is taking an antibiotic, Rivlin said.
Niacin is another essential nutrient that the body produces. So is Vitamin D, which can be made by the skin and is important for healthy bones, skin and hair, Rivlin said.
Vitamin A is attracting a lot of attention because of its potential for treating certain forms of cancer and acne, according to Rivlin. Nearly every dermatologist now prescribes Vitamin A for cystic acne, he said. In addition, Vitamin A “would be entirely safe and probably has no toxicity.” Vitamin A, however, tends to accumulate in the liver with toxic effects. “The problem is how to get it out of the liver.”
Carrots abound in carotene, I which is rich in Vitamin A.
Vitamin C or ascorbic acid is obtained from natural foods in normal diets and is known to prevent scurvy. Are these vitamins drugs or nutritional supplements?
WILL VITAMIN C someday be regulated as a drug because experiments have shown it inhibits the formation of nitrosamine, a suspected carcinogen?
“Even nutrients can be toxic if they are not handled properly by the cells,” said Dr. John Pinto, associate, Sloan Kettering Institute, and professor of Nutrition in Medicine, Cornell University.
If that’s the case, asked DeFelice, “when does a nutrient stop being a nutrient and becomes a drug which can be toxic?”
“The daily practice of medicine has allowed us to use vitamins and natural substances in therapeutic ways,” said UMDNJ’s Louria.
Whether these substances are food, drug or nutrient seems to be beside the point, he indicated. “Should garlic and onion be regulated as drugs if they are taken for hypertension? I defy anyone to point up the difference between (sic) food, nutrient and drug,” Dr. Louria said.
Lawyers on the panel agreed a redefinition of terms is in order. William J. Curran, a Harvard Medical School professor of legal medicine, said what is needed is not so much precision in the definitions as a consensus between scientists and the regulatory agencies on the terms. “Their definitions should be as close as possible ‘ he said.
“The FDA has a very simplistic definition of drug; if you talk of disease, it’s a drug ‘ said Stephen H. McNamara, a Washington, D.C. lawyer specializing in food and drug law. “In these days of sophisticated medicine, things are no longer that simple”