An interview with Stephen L. DeFelice, M.D. on The Neutraceutical Revolution and the hidden medical miracles in everyday food.
The Neutraceutical Revolution: the hidden medical miracles in everyday food.
From the pages of the newspaper to your grocer's aisles, neutraceuticals are everywhere you turn: eggs enriched with omega-3, margarine that claims to lower cholesterol, and breakfast cereals packaged as multivitamins. In addition, there are supplements — a dizzying bevy of pills, tinctures, oils and teas that claim to eradicate pain, boost energy, make us smarter and ward off cancer.
The Neutraceutical Revolution: A panacea or Pandora's Box? The promises are alluring, but the claims are unsubstantiated, the industry is underregulated, and the consequences of unchecked use can be alarming. Ephedra, or ma huang, a stimulant found in nonprescription herbal weight-loss supplements, has been associated with heart failure, stroke and psychosis. A popular and well-documented remedy for depression, St. John's wort inhibits the effectiveness of antiviral drugs such as protease inhibitors, which are prescribed in the treatment of HIV and AIDS. For even the most savvy consumers, the neutraceutical kingdom is a jungle, rife with contradictory evidence.
Stephen L. DeFelice, M.D., founder and chairman of the Foundation for Innovation in Medicine (FIM), is both a long-time advocate of neutraceuticals and a critic of the industry. His interest in medical research and discovery stems from his study of carnitine, a substance that occurs naturally in the human body and can be found in meat and dairy, as well as on the shelves of any health food store. As DeFelice attempted to acquire corporate sponsorship for the study, he found that corporations were loath to back natural substances, preferring instead to finance the development of synthetic drugs that could be patented.
In 1991, DeFelice drafted the Neutraceutical Research and Development Act (NREA) to promote the research of neutraceuticals. The NREA would allow companies that invest in clinical research to make health claims and obtain exclusivity on those products. At present, under the Dietary Supplement Health and Education Act of 1994, supplements may bear claims that the products affect the structure or function of the body. They may not, without Federal Drug Administration (FDA) review, claim to prevent, mitigate, cure, treat or diagnose disease. DeFelice's hopes for the Neutraceutical Research and Development Act (NREA) are based on the success of the Orphan Drug Act, which provides incentives to the manufacturers of drugs for rare diseases. Rep. Frank Pallone (D-N.J.) introduced the NREA into Congress October 1, 1999.
Monica J. Smith for MOTHER: First of all, could you define neutraceutical?
Dr.DeFelice: It's a dietary supplement or a food that has health and medical benefits, including the prevention and treatment of disease. For example, it would include an orange, which is a food, for the treatment of scurvy. It would also include a pill, which is a dietary supplement, for the treatment of scurvy. There's no difference between a dietary supplement and a food as long as it works.
You are considered the grandfather of neutraceuticals. In fact, you coined the term, which just made it into the pages of Webster's Dictionary this year. How did you come up with it?
I coined the term "neutraceutical" in 1989. I was in the Piazza Navona, a very famous piazza in Rome. I said, "Look, we have to give an identity to all these names out there, because they have thousands of names." Well, I was drinking that night. I was eating, I was celebrating and I was drinking grappa, and I came up with "neutraceutical." I wrote the article, and bang, it took off like gangbusters.
Do neutraceuticals include the products sold as "functional foods," such as calcium-laced orange juice or ginseng-spiked sports bars?
No. No one has really defined "functional food." Functional food is a term created by marketers that is sup posed to make the consumer believe they are getting something extra. For example, is an orange a functional food When you have scurvy, you eat an orange and the scurvy goes away. It's quite functional. And so, they're putting these tricks in herbal teas. They're putting in ginseng and ginkgo biloba, then they're saying, "This is functional. It has added value."
How do we distinguish between products wrapped in false promises and those foods and supplements that can actually affect our health?
That's why I coined the term neutraceuticals. We have many terms out there, and nobody knows what they mean — even "dietary supplement" hasn't been defined. All the other marketing terms out there, like photochemical and hypernutritious foods and functional foods and farmer foods, these are terms that don't exist. They're just marketing terms. Ninety-nine percent of the products out there have never been tested clinically to show that they actually work in people. So how do you know something's good for you? Right now, you have to look to the pharmaceutical market. They do clinical studies, and that's how you know that aspirin or penicillin or insulin is good for you.
What are some examples of plant-derived products that were developed as drugs by the pharmaceutical industry?
Oh . . . Digitalis for the heart, quinine for malaria . . . aspirin. This list is very long.
You've been working with Congressman Prank Pallone (D-N.J.) to pass the Neutraceutical Research and Education Act [NREA], which was brought before Congress October 1, 1999. What is the act all about?
I'm an advocate of neutraceuticals. I'm the strongest advocate out there and the most rational one. But, the problem is, nobody does the research to show that they work. The NREA would change current laws and allow manufacturers to make health claims about their products. Our point is that we need to pass an act that doesn't force every neutraceutical company to spend $500 million on research like the pharmaceutical companies do. For instance, one study is enough to make the connection between drinking cranberry juice and the treatment of urinary tract infections because you don't have to worry about the safety of cranberry juice. We want to encourage companies to do the research by giving them the right to say what the results of the clinical trials are. And this is the essence of the bill-we will give each company or person the exclusive right to make that claim. And I know that the legal formula is going to work, based on the history of a piece of legislation called the Orphan Drug Act. Orphan disease is a rare disease nobody was researching because the research cost far more than any potential income from the drug. So Senator Orrin Hatch (R-UT) and Representative Henry Waxman (D-CA) got together and passed the Orphan Drug Act, which says that for rare diseases you don't have to do as much clinical research [as you would] with a more common disease. Before the Orphan Drug Act in 1983, there were very few drugs approved, maybe 30 in the previous 30 years. Since the Orphan Drug Act, there [have been] approximately 200 approved. It worked.
How did you become the crusader for this difficult issue?
Well, I'm the guy who brought carnitine into the United States. As a young doctor, I started to study the drug, and people said "You're crazy. [Carnitine]'s a natural substance, available in the health food stores. Why would you be spending all that money developing it as a drug?" But then the Orphan Drug Act passed, and I got a company to invest money to pass carnitine for approval as a drug for a rare disease, a carnitine deficiency, that kills kids. Congress is proud of that act. The exact same principles apply to neutraceuticals, and it's the only legal avenue out there that makes any sense.
The Council for Responsible Nutrition and some other industry groups petitioned the FDA four years ago to set up industry wide standards of quality for the manufacturing of supplements. Not much has happened. Why is the FDA so slow to act?
First of all, the food and health food industries are not research-oriented. Never have been. So, DSHEA [the Dietary Supplement Health and Education Act of 1994, which I thought would create a clinical research oriented industry, did not. It created a promotion-driven industry with all these false and unsubstantiated claims. But now, with the often dangerous side effects of St. John's wort and ephedra in the papers, Congress is taking a look at what's going on. The FDA is powerless under DSHEA. It has some power, but not that much. When more [cases of] toxicity hit the fan, Congress will pass new laws because people want herbal remedies . . . and those people vote.
We've come across many references to findings published in well-respected medical journals like The Lancet, the Journal of the American Medical Association and The New England Journal of Medicine. How much research needs to be carried out on a neutraceutical before credibility can really be established?
It's relative. For example, take a drug — insulin for a diabetic coma. If it was just discovered today, the FDA would rush out approval right away. You only need one patient to show insulin works. Let's say again, cranberry juice. People have been using this for years for urinary tract infections. It was published in JAMA. But, if you have a Tibetan herb just introduced in the United States, that's a different story. You might want it to have two or three trials to see whether it works. And then you might want to have a long-term safety trial to make sure it's safe. If there's a Tibetan herb that's good for Alzheimer's, you would take it, unless they found some toxicity associated with it. Even then, you might accept the toxicity risk because Alzheimer's is so devastating. But if you have a skin rash, you won't accept that same risk. Everything depends on risk benefit.
In the meantime, until the industry is held to a level of standards that protect the well-being of the individual, what can people do to protect themselves?
There's only one thing you can do until the NREA gets passed: Identify the good products and the good products will drive out the bad. Of course, you're not going to shut down the dietary supplement system because it's too political. But the NREA will create good products and the doctors will become involved. And eventually you push out the bad drugs. In the meantime, if you really want to get a handle on what you're taking, tell your doctor. About 50 percent of people are telling doctors about their dietary supplements, but they tend to talk just about calcium and things like that that are not controversial.
In recent years, consumer sales of supplements have exploded, growing from $9.8 billion in 1994 to about $14.7 billion in 1999, and it's expected to keep growing. Why has self-care, self-diagnosis and self-treatment become so popular?
There are multiple factors. One, you have the baby boomers, who have always been concerned about their health. Two, the media has been highly attracted by medical issues, and it educates both the consumer and the physician, so there is massive health awareness. Also, doctors aren't available to handle all the problems of people who are concerned about every little thing. Consequently, when they don't get sufficient attention from the medical community, they are forced to teach themselves what they want to know. And there are a lot of resources — papers and television and now the Internet.
What kind of drawbacks do you see to this kind of self-treatment?
Because people perceive them to be safe, they take supplements with impunity and they're taking more and more combos. It's not unusual for people to take 20, 30 pills a day. That sort of tells me that overall, dietary supplements and special foods are safer than drugs, otherwise you would see a lot of toxic reactions. If you made pharmaceuticals available for purchase in health food stores, half of America would be dead in six months because [pharmaceutical drugs] are very toxic. On the other hand, I knew there was toxicity out there, but we couldn't pick it up because we didn't know what to look for. If you came to me with yellow jaundice I would think of a tumor. I would think of hepatitis or a rare allergic reaction to a drug, but I wouldn't think of a dietary supplement. It wouldn't even enter my realm of thinking. So, with all the things the doctor sees, they never ask the questions, "What are you taking? What kinds of foods are you eating?"
. . . and a patient might neglect to tell their doctor because it doesn't occur to them or because they're uncomfortable mentioning it. What is the situation with St. John's wort?
St. John's wort is supposedly an antidepressant. But this substance affects the metabolism of the liver, which affects the metabolism of other drugs. It interferes with lots of drugs - heart drugs and the protease inhibitors for HIV virus or the AIDS virus. God knows how many people have died because of that. This hit big time in the medical community. Now, when you come in with jaundice or any other problem, doctors are going to be much more prone to ask, "What kind of dietary supplements are you taking? What kind of special diets are you on?" They're going to ask, and they might detect a drug toxicity problem.
What sort of risks do people face when they don't come clean to their physician about neutraceuticals they're taking?
Two or three things can happen. Most people who see doctors, of course, are taking pharmaceuticals, so they have to consider the pharmaceutical-neutraceutical interface. St. John's wort decreases the activity of a pharmaceutical. Benecol, on the other hand, is a natural substance that Johnson and Johnson sells to lower cholesterol. If you take a cholesterol-lowering drug, Benecol adds to the effect of the drug. So, neutraceuticals either help, hurt or do nothing at all. Let's say you go to your doctor with high blood pressure. Suddenly, you get worse . . . or you get remarkably better. He or she needs all the information they can get at that point. The only thing you can do now is tell your doctor what you're taking.
Some big-name drug companies like Smith Klein-Beechum and American Home Products are packaging popular supplements like ginseng and valerian. Some pharmacists say that because large drug companies are set up for highly regulated, processed drugs, this trend could improve the standards and quality of natural products. Others have a more cynical view of it. They think that because regulations on supplements are light compared to those on pharmaceuticals, the companies won't have any motive to invest money in further research. Would you like to comment on that?
Yes, but now you've got to be careful. You can talk about quality control. If I say there's so much ginseng in something, there is so much ginseng. Certainly, if the big companies say there's 100 milligrams of anything in there, it's in there. They may standardize the quality, but that doesn't mean the products will work for you. They won't do the preliminary research to prove they work unless they can make their claim on a finished product. This difference between quality standardization and effectiveness has the potential to mislead consumers.
Will this surge of interest in neutraceuticals have an ecological or environmental impact beyond the immediate commercial or health issues? For example, shark cartilage has been promoted as protection against cancer. But some types of sharks are endangered. Will the drive for neutraceuticals put too much pressure on threatened resources?
I don't see it. I know companies that are looking all over the world for right environments to plant trees and plants to grow this stuff. And now, with biotechnology coming about, a lot of this stuff, be it animal or plant, can be produced in the laboratory. You can grow shark cartilage. I don't see it as an ecological problem. I imagine that could occur now and then, but it's not a pervasive national problem, and it won't be.
What do you see as the future for neutraceuticals, if you can put that in a nutshell?
Once Congress passes laws to stimulate clinical research, the neutraceutical industry will have a major impact [on the] preventive treatment of disease. The tragedy is that the promise is here now. They're out there on the shelves, and no one is looking at them. There's no industry like the pharmaceutical industry doing clinical research — Congress and the companies don't do it. I'm the only one. I'm the voice in the world, this kid you're talking to. I'm John the Baptist [laughs]. And they're starting to listen now. Companies don't want to do the research because they're making a lot of money, but the media's concentrating on safety now and the amazing amount of false claims, and I think Congress will finally react. I think the future is so marvelous. It doesn't take 10 years to do research on neutraceuticals like it does with pharmaceuticals. And the baby boomers — I'm trying to get to them to tell them about this. At least, they're starting to listen.