HERBAL OVERDOSE

The death of Baltimore Orioles pitcher Steve Bechler last month, while
taking the weight-loss product ephedra, sparked a heated debate regarding
the role of the federal government in regulating dietary supplements. In the
wake of Bechler's death, Tommy Thompson, secretary of Health and Human
Services, went so far as to say that he would never use ephedra himself or
recommend it to family or friends.

Now, the Food and Drug Administration has moved to impose new rules and
regulations governing manufacturing practices and content labels for dietary
supplements that include not only ephedra but other herbs like ginko biloba,
used to boost cognition, and St. John's Wort, taken for depression. With
millions of Americans consuming these supplements daily, it's a matter of
"buyer beware," according to FDA Commissioner Mark McClellan.

Unfortunately, a simple caveat emptor isn't good enough. The FDA has stopped
short of putting these supplements in the category of pharmaceuticals and
thus has failed to fulfill its charge to assure that the health products we
consume are both safe and effective.

In navigating the current controversy, we would do well to summon the
history of the last century that led to the initial regulation of food and
drugs , and draw on the equipoise of its most determined sponsor, President
Theodore Roosevelt, who sought to sustain the initiative and competition
inherent in capitalism while protecting the health and welfare of Americans.

There are striking similarities between today's herbal and dietary
supplement markets and the production and sale of food and drugs in the late
19th and early 20th centuries. Back then, there was scant government
oversight into the quality of food preparation and the composition and
manufacturing of medications. Moreover, the border between food and drugs
was blurred. Many "natural elixirs" with putative healing powers were either
completely ineffective or remarkably dangerous.

A massive industry had grown in America around so called "patent" medicines.
They were termed so because of their secret and proprietary components.
Physicians at the time, of course, had little in their therapeutic
armamentarium, lacking drugs like antibiotics that today we take for
granted. If patent medicines had merely been harmless placebos, then the
argument for their regulation would have been weakened to that of Dr.
McClellan's caveat emptor. But concoctions like Lydia Pinkham's Vegetable
Compound were potentially toxic elixirs laced with large amounts of alcohol
and opium.

Roosevelt was keenly interested in nature, and knew that she was not always
a benevolent goddess. Many herbs and plants are poisonous, particularly when
ingested in large amounts. They also serve as the sources of potent
medications, like digitalis, which comes from foxglove. Roosevelt had also
struggled with ill health as a child and young man, afflicted with
debilitating asthma and a frail body. His solution to his medical problems
was to pursue a robust life of good diet and ample exercise, in essence,
exerting his considerable willpower to try to overcome his maladies and
rebuild himself.

It is, therefore, a fair assumption that Roosevelt would be particularly
aghast at the proliferation of products that Americans are currently taking
to substitute for willpower, like ephedra. And he would be similarly
disappointed at the failure of federal regulators to forcefully intervene
and require manufactures to provide detailed information to consumers about
both the dangers and the degree of efficacy of their products.

We can also posit Roosevelt's familiarity with the forces that may be
inhibiting the Bush administration from taking the full and needed step to
classify herbs and dietary supplements as medicines. Similar forces were
arrayed against Roosevelt when he pursued the pure food and drug acts of
1902 and 1906. At the time, much of the nascent American advertising
industry and the revenues of newspapers pivoted on the promotion of
unregulated products like Lydia Pinkham's Vegetable Compound. Congress was
persistently and potently lobbied by representatives of these industries to
water down any proposed regulations. The lobbyists argued that for
capitalism to flourish it could not be shackled by onerous federal
intervention, and that Americans should be free to choose what they wanted
to take for their health.

Roosevelt believed deeply in the forward moving currents of competition and
innovation in the flow of commerce. He also was a great believer in science,
a polymath who wanted the facts in clear and concrete terms before making a
considered judgment. Roosevelt, then, was a person not only of the head but
of the heart. His "compassionate conservatism" meant protecting the
vulnerable from the manipulation of the corrupt and promoting choice when
that choice was rationally and fully informed.

Nonetheless, the legislation that Roosevelt initiated, and the many
amendments that have passed through the Congress over the last century, have
proven imperfect in regulating the plethora of dietary and herbal products
that flood our society. It is scandalous that only after the death of a
young athlete would good manufacturing practices be mandated and bottle
labels have to accurately note contents.

Keep in mind that we are not talking about severe life-threatening diseases
like cancer or AIDS, where excess FDA regulation could slow the development
and distribution of key drugs . We are talking about herbal supplements like
ephedra, which is considered "natural" yet contains a potent chemical that
can mimic the effects of amphetamines, causing heart attack, stroke, and
arrhythmia. Recently, both ginko and St. John's Wort were shown to be no
better than placebo. Merely knowing what is in the bottle does not inform
consumers of the scientific evidence supporting claims about the product or
the risks they run in taking it. That would be true caveat emptor.

Theodore Roosevelt has been said to serve as a model for President Bush in
terms of bold action and moral clarity. Our president would do well to apply
Roosevelt's appreciation for science and his pursuit of honest commerce in
bringing to heel an industry that is out of control and a threat to the
health of Americans.

Dr. Groopman is a Harvard Medical School professor and chief of experimental
medicine at Beth Israel Deaconess Medical Center in Boston.