Copyright 2000 The Chronicle Publishing Co.
The San
Francisco Chronicle
JUNE 4, 2000, SUNDAY, SUNDAY EDITION
SECTION: SUNDAY CHRONICLE; Pg. 4/Z1
LENGTH: 1080 words
HEADLINE:
Congress Needs to Sweeten the Deal on Health Claims
BYLINE: Stephen L. DeFelice
BODY:
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.
Stephen L. DeFelice is a physician and chairman of
the Foundation forInnovation in Medicine and former chief of clinical
pharmacology at the WalterReed Army Institute of Research.
LOAD-DATE: June 5, 2000 
