PAY PUBLIC MEDICAL SCHOOLS TO TEST HERBAL REMEDIES

RECENTLY, the New England Journal of Medicine published six reports warning
that about a dozen people have gotten seriously sick by treating their own
illnesses with pills and powders sold as dietary supplements. These articles
and letters described disorders including lead poisoning, impotence,
lethargy, diarrhea and abnormal heart rhythms that were linked to various
supplements. Some of these "all natural" products turned out to contain
toxic contaminants or potent drugs or hormones, according to the reports.

"Alternative treatments should be subject to scientific testing no less
vigorous than that required for conventional treatments," the NEJM strongly
argued in an editorial accompanying the reports.

The reports highlight two problems: that physicians need further education
and awareness of these alternative therapies; and that research is needed in
this area to verify safety and effectiveness. The articles also pointed out
the need to protect patients from poor packaging, manufacturing and
advertising practices and recommended further federal regulation.

We agree about the need for rigorous testing of alternative drugs and
treatments. Unfortunately, the editorial didn't say how to pay for such
testing -- a complex problem. We think we have a solution for that. But
first some background.

Unlike prescription drugs, herbs and other substances marketed as dietary
supplements currently don't have to be proved safe and effective. Formerly
these supplements weren't permitted to make health claims, but Congress
eased that prohibition with the Dietary Supplement Health Act of 1994. After
that, sales of supplements including such popular ones as saw palmetto
(touted for improving prostate health), ginkgo biloba (said to improve
memory), ginseng (promoted as increasing energy) and St. John's wort
(celebrated as an anti-depressant) soared from $8 billion a year in 1994 to
$12 billion last year.

Certainly it makes sense for somebody to research the safety and
effectiveness of these and other herbal treatments. After all, the use of
so-called botanicals as drugs is as old as medicine itself. In the 1700s,
the English physician William Withering described the use of digitalis,
derived from the foxglove plant, to treat "dropsy," now known as congestive
heart failure. Recently, researchers isolated the drug Taxol, which seems to
combat certain forms of breast cancer, from the bark of the Pacific yew
tree. As we write, pharmaceutical companies are scouring the world's rain
forests and oceans for more products that may become new drugs.

Such pharmaceutical prospecting is an expensive process: In order for a
company to risk its money to find, develop and test a new drug, there must
be a good chance that the search will result in a patentable and salable
product. The patent is crucial. It allows just one drug company to control
the license to produce a new drug for a period of seven years. During this
time, a company recoups the money spent on developing the drug and sometimes
gains windfall profits.

Why, you might ask, don't drug companies -- or supplement companies -- test
the hundreds of herbal medicines that are already available, some of which
have been widely used as folk medicines for hundreds or even thousands of
years?

The answer is that these substances and their uses are considered already
known. For that reason they are unpatentable. But without a patent, any firm
which lays out millions in research dollars to prove an herb effective would
be at a huge competitive disadvantage. Every rival company could sell the
product more cheaply, not having to recover the buckets of cash spent on
research.

So who could research such natural products, and who could pay for it?

Publicly owned medical schools seem an appropriate site for the research
work, as a part of their mission to enhance public health. As for paying for
it, a small surcharge of 25 cents or 50 cents a package could be collected
for each alternative remedy sold. The money should go to the already
existing but cash-starved federal Office of Alternative Medicine, initially
earmarked for research on the herb or supplement for which it was collected.
Although the National Institutes of Health established the OAM about five
years ago to begin studying alternative therapy, funding for this office has
been slow in coming, as has the development of a research community
interested in this area and the willingness of mainline medical journals to
publish this research.

As we envision it, OAM could distribute the money to researchers in a way
similar to how the NIH apportions its research grants. As the fund balance
grows, OAM also could assume responsibility for developing a system of
quality control. In this way, the costs of research and testing could be
funded entirely by the users of alternative remedies. And they also would be
the first to benefit from it.

Sierpina, a medical doctor, is clinical associate professor of family
medicine at the University of Texas Medical Branch at Galveston. Williams is
a professor of pharmacology at UTMB.

Checked-by: Don Beck