The Don Quixote of Nutraceuticals

“I’m for research,” says Dr. Stephen L. DeFelice of Westfield, NJ. “Nature holds the greatest promise of medicine.”Photo by Frank C. Dougherty for New York Times 

For Dr. Stephen L. DeFelice, Nature’s Remedies Are the Way to Go. Of Course, Not Everyone Agrees.

New York Times 10/29/95

CRANFORD – As a young endocrinologist at St. Vincent’s Hospital in Greenwich Village, Dr. Stephen L. DeFelice witnessed a minor miracle. Several times a month, women would walk into the clinic suffering from hyperthyroidism, a disease that causes emotional instability, weight loss and, if left untreated, death. On a hunch from a colleague, Dr. DeFelice, who was on a fellowship in clinical pharmacology, tried a new therapy for the thyroid disorder. The treatment, called carnitine, reversed the symptoms in a week — much faster than the traditional thyroid medication, and just as effectively.

That was in 1965, four years after he graduated from Jefferson Medical College in Philadelphia. The next year, while working as a researcher at Pfizer, Dr. DeFelice continued to study carnitine, this time on prisoners. By accident, an inmate with angina pectoris, a heart ailment, got into the regimen. Angina pectoris causes chest pain and shortness of breath. Although Dr. DeFelice was still studying carnitine for its effect on the thyroid, he discovered that it helped ease angina pectoris, too.

“The more I did, the more I saw it working, the more excited I became,” recalled Dr. DeFelice. “Then I hit a tremendous barrier. It’s called economics. It’s called regulations.”

That enormous economic barrier has defined Dr. DeFelice’s career, leading him out of the mainstream of modern medicine and into a controversial field of his own invention called nutraceuticals, in which chicken soup, cranberry juice, calcium and fish oils potentially hold the keys to curing the common cold, bladder infections, osteoporosis and heart disease.

Some in medicine and government see him as a scientific Don Quixote, tilting at regulatory and economic windmills. Still others think his single-minded campaign is misguided, and possibly dangerous, because of its emphasis on pills rather than on a healthy diet. And then there are those who think he’s on to something.

Dr. DeFelice (pronounced dee-fahLEASE), a 59-year-old Westfield resident, works on his cause from a modest office in Cranford a few hundred yards from the Garden State Parkway, where piles of press clippings and articles from medical journals line the perimeters of all the rooms in crooked stacks. Dr. DeFelice’s basic argument is that the Government should make it easier for nutraceuticals to receive official approval for medical use because natural substances, by virtue of their consumption over thousands of years, have a presumption of safety. If it didn’t take 10 years and millions of dollars to get a nutraceutical approved by the Food and Drug Administration, he reasons, then drug companies would be willing to invest in them.

But it does, and they’re not.

For example, the problem Dr. DeFelice encountered 30 years ago was that carnitine is a natural substance. (It is produced in the liver when two amino acids combine.) Had carnitine been an artificial chemical created in the laboratory, it would have been easy for a drug company to patent, giving it exclusive marketing rights for 17 years.

When companies discover promising new drugs, that’s the first thing they do. Then they spend years proving to the Food and Drug Administration that the patented chemical is safe and effective. That process, which involves extensive testing, can cost $250 million. By the time drug approval comes, there are usually about seven years left on the patent — enough time to recoup the expense of developing the drug.

But natural substances like water, salt- and carnitine — can’t be patented. (It is possible, though, to patent the process of extracting, or the composition or the use of natural substances.) And, as Dr. DeFelice quickly learned, if you can’t get the exclusive market on a medicine, it’s pointless to spend a quarter of a billion dollars to see whether it works. Had carnitine been an artificial chemical, created in the laboratory, Dr. DeFelice is convinced that it could be one of the great weapons in the physician’s pharmacopeia. Instead, it has been relegated to the shelves of health food stores.

You might expect Dr. DeFelice to be a big supporter of health food stores, which stock many of the natural cures, like carnitine, that he believes in. But health food stores have long been unregulated; their remedies often bear extravagant claims, and customers set their own doses, rather than receiving guidance from a physician. Even more important, in Dr. DeFelice’s view, the items in health food stores don’t have to go through the rigorous clinical trials used by the pharmaceutical industry. “If you don’t do the research, you don’t know what really works in the health food store,” Dr. DeFelice said.

Most young drug researchers probably would have moved on after discovering that carnitine was a financial dead end. But Dr. DeFelice’s difficulties with carnitine made him even more resolute. “Carnitine taught me that nature’s promise far surpasses that of drugs,” Dr. DeFelice said. “But we don’t have a system to get it to them.”

So in 1976, Dr. DeFelice decided to change the system. He started the Foundation for Innovation in Medicine, a nonprofit group dedicated to advancing natural therapies. Dr. Kava said. “There are many things that occur in the natural world that can be quite dangerous if they’re purified and given in high dose.”

Dr. DeFelice doesn’t mind going against the crowd. As for going directly to the mass media with his cause, he has no apologies. “I’m for research. Who can be against research?” he said. “Nature holds the greatest promise of medicine. I had to do it. I hate disease.”

In the last several years, however, the political winds have been blowing in Dr. DeFelice’s favor. A frequent critic of the F.D.A., Dr. DeFelice suddenly found plenty of company when the Republicans swept Congress. The House Speaker, Newt Gingrich, among others, is a dedicated foe of the F.D.A. Just last year, some of the Washington lobbyists who regularly attend meetings sponsored by Dr. DeFelice successfully pushed Congress to pass the Dietary Supplement Health and Education Act. That law explicitly allows makers of vitamins and herbal cures to make health claims, and it could be the regulatory springboard for the nutraceutical industry.

Although Dr. DeFelice worries that the new law might open the door to charlatans, it’s also the break he’s been waiting for all these years. He believes the potential market for nutraceuticals is $250 billion — half the size of the American food market — and has just formed a for-profit company, Intra-Cellular Health, which would help other companies patent, test and market nutraceuticals. He is also a consultant to Applied Microbiology, a food technology and biotech company in Tarrytown, N.Y., which plans to release Cardia Salt Alternative, a reducedsodium salt substitute, next spring. Cardia, which contains magnesium and potassium, has been clinically shown to lower blood pressure, the company says.

The dietary supplement act may even hold the answer for carnitine. Thirty years after Dr. DeFelice discovering it, his enthusiasm has not waned. Its most promising medical application, he believes, would be to be used with a cancer drug called adriamycin. A potent tumor-reducer, adriamycin is used sparingly because it damages the heart, Dr. DeFelice said. But carnitine could prevent the damage and allow the drug to be used in higher doses.

Dr. DeFelice holds a use patent on carnitine for treating heart problems. Now, he thinks, it might just be worth something.



I’ll Have the Fish Oil, With a Side of Licorice

There are some foods that almost all experts agree improve health: milk has calcium that builds stronger bones; fresh fruits and vegetables have fiber that fights cancer and heart disease; orange juice contains folic acid, which prevents neural tube defects in unborn babies.

Many other remedies from nature’s medicine cabinet are more suspect. Does garlic really prevent cancer, fight infections and lower blood pressure? Jean Carper, author of “The Food Pharmacy” (Bantam, 1988), says garlic does live up to the folklore. Your doctor may disagree.

What follows are some foods, or ingredients in foods, that may hold promise for fighting illness. Dr. Stephen L. DeFelice, a leader of the nutraceutical movement, takes vitamins E and C, carnitine and magnesium chloride daily.

Warning: even scientists disagree. Some think nature’s best medicine is a healthy diet; others, like Dr. DeFelice, say only concentrated dietary supplements deliver the benefit.

APPLES Apples contain pectin, which lowers cholesterol, helping to keep the cardiologist away. Some researchers also think apples fight infections.

CRUCIFEROUS VEGETABLES Cabbage, broccoli and brussels sprouts are thought to prevent cancer by ridding the body of toxins.

GREEN TEA The hot beverage of choice in much of the Far East, green tea has also been shown to reduce skin cancers in laboratory rats.

LICORICE You’d need far more than the amount in your average stick of candy, but some scientists believe the antioxidants contained in licorice can slow down cancers that are beginning to form. It may also prevent tooth decay.

YOGURT The lactobacilli bacteria it contains are credited with promoting helpful microorganisms in the intestine and warding off yeast infections in women. Popular folklore also holds that eating it regularly will help you live a long life.

BETA CAROTENE An antioxidant found in carrots, beta carotene has long been touted as a cancer-preventing agent, and is available in pills and added to food. But a major study in Finland last year found that heavy smokers who took it actually had more lung cancers. The study set off a ferocious debate in nutrition circles.

FISH OILS Low rates of heart disease among Eskimos led investigators to look at the cardio-friendly properties of fish. The omega-3 fatty acids found in fish oils are widely credited with preventing heart disease by thinning the blood and lowering cholesterol.

CHILI PEPPERS Anybody who’s ever eaten one can attest to their power in clearing nasal passages. Chili peppers also contain capsaicin, an agent that blocks pain.

CHAMOMILE Widely available in herbal tea, it’s what Peter Rabbit was given after his adventure in Mr. McGregor’s garden. In humans, it’s useful for indigestion and headaches.