Op-Ed article from The SanFrancisco Chronicle

Sunday, June 4, 2000

Stephen L. DeFelice

Are you confused about the safety and health benefits of dietary supplements? If not, you should be.

More Americans than ever are using a wide range of dietary supplements and special diets — which I call nutraceuticals — yet most physicians are not well-educated about these products due to a lack of clinical research.

Most of the information available about dietary supplements is generated by market-driven companies making claims that are often excessive and even untrue. There is almost no clinical research data available to guide consumers and their doctors on the safety and efficacy of specific nutraceuticals.

The fact is that many nutraceuticals offer tremendous medical and health promise. Only a medical Luddite would question their enormous potential to prevent and treat the diseases and ailments that plague us. Who can doubt, for instance, the value of folic acid supplementation in preventing defects in the newborn, of carnitine supplementation in saving the lives of the children born with insufficient levels of this naturally occurring substance in the heart, or the extremely promising potential of niacin in reducing heart attacks and strokes? And don’t forget that plant-derived products, such as quinine for malaria, aspirin for pain and digitalis for heart failure, are dramatic examples of nutraceuticals that were developed as drugs by the pharmaceutical industry.

But how can consumers separate the wheat from the chaff? The answer is that manufacturers must be given incentives to undertake clinical research on the nutraceutical products they sell. Only by testing products in well-conducted human studies can we know whether they are safe and effective.

What kinds of incentives are needed? Specifically, companies need to be granted the exclusive right to make health claims about their products. Under current laws and regulations, even if a company sponsored a clinical study that showed that a mixture of herbs reduced the toxicity of highly damaging anti-cancer drugs, it could not make this claim; manufacturers are prohibited from make health claims about their products unless they conduct research according to time-consuming and prohibitively expensive guidelines demanded by the Food and Drug Administration.

The Nutraceutical Research and Education Act (NREA), which I first proposed in 1989, would change current laws and allow manufacturers to make health claims about their products. The NREA is based on the principles of the Waxman-Hatch Act (also known as the Orphan Drug Act), legislation aimed specifically at developing cures for extremely rare diseases. This law ultimately led to the manufacture and use of both natural and artificial products that have saved the lives of thousands of patients.

Congressman Frank Pallone Jr., D-N.J., after assessing the nutraceutical situation and evaluating the importance of clinical research, took the bold step of introducing the NREA in Congress on Oct. 1, 1999.

There it presently sits, lacking advocates.

In an attempt to address safety concerns, Congress may soon pass new legislation affecting dietary supplements. Historically, congressional action that deals primarily with safety issues has had a negative impact on clinical research, primarily by making it too expensive and time-consuming for all but those with the deepest pockets.

The NREA, by contrast, would greatly increase clinical research and thereby dramatically increase medical discovery. The heavily research-oriented pharmaceutical and biotechnology industries would unquestionably and rapidly make substantial investments to discover the benefits of nutraceuticals.

As with the Orphan Drug Act, the NREA would bring physicians into the nutraceutical health care sector. By enlightening them about the value of such products, they would be able to accurately advise their patients in determining the best use of nutraceutical products.

Currently, reliable information about nutraceuticals doesn’t exist, and physicians tend to shy away from the subject. In addition, many patients don’t talk to their doctors about dietary supplements, which poses a potential for harm in cases where nutraceuticals could adversely react with pharmaceutical medications.

For example, St. John’s wort has been heavily promoted in the media as an alternative treatment for mild-to-moderate depression, based on limited, but positive, clinical studies. This level of depression is often found in patients with major illnesses, such as AIDS, or in those facing a serious medical intervention, such as an organ transplant. But how many patients

— or their physicians — know that research has shown that St. John’s wort can reduce the blood levels of the life-saving pharmaceutical drugs used in these circumstances? This nutraceutical herbal remedy can also interfere with the action of other important medications.

Recently, the Institute of Medicine, a branch of the National Academy of Sciences, issued a report questioning the commonly accepted benefits of high doses of vitamins C and E and other antioxidants. Another major new study cast serious doubt on the long-held belief in the value of a high-fiber diet in helping to reduce the incidence of colon cancer.

Can you be sure that more bad news concerning nutraceuticals is not on the way? The American public has embarked upon a great uncontrolled experiment involving both special diets and dietary supplements in an attempt to manage its health. There is simply not enough clinical evidence to demonstrate that these products are good for you.

These studies are spawning a counterrevolution to the almost blind acceptance of the health and medical benefits of nutraceuticals. It is finally beginning to dawn on us that millions of people — both healthy and sick — have wagered their health by consuming nutraceutical products that are either not helpful or are even harmful.

It is time to bring an end to our irrational nutraceutical exuberance concerning this segment of the self-care movement and bring nutraceuticals into the medical mainstream. Companies need to be encouraged to provide reliable research data that will help consumers and their physicians make health care decisions based not on fictions or fantasies, but on facts.

©2000 San Francisco Chronicle