ANDRO ANGST

Should the U.S. regulate over the-counter sports supplements as anabolic
steroids?

The cloud that hovered briefly over Mark McGwire's sunny march to baseball
immortality this past summer was the revelation that he was taking
androstenedione, a hormonally based supplement reputed to help weight
lifters add muscle. Writers wagged their fingers and raised questions about
whether performances achieved with the substance are somehow tarnished or
less valid. (Major League Baseball and some other athletic organizations
permit its use; most others ban it.) But the editorial sputtering did
little to elucidate the central question: Are such compounds merely dietary
supplements, as the U.S. Food and Drug Administration classifies them, or
are they just another form of musclebuilding (anabolic) steroid?

Many endocrinologists insist that the differences between supplements like
androstenedione and traditional anabolic steroids (which are legal only for
certain medical conditions) are trivial. "They are all steroid hormones,"
says Charles E. Yesalis, professor of health and human development at
Pennsylvania State University. "The only debate is whether they are
anabolic or not."

Moreover, though it was somehow overlooked in the hundreds of articles
written about androstenedione in the wake of the McGwire admission,
4androstenedione, as it is technically known, is just one of a growing
family of over-the-counter steroids. In fact, many fitness buffs do not
even consider androstenedione to be particularly potent. "4-androstenedione
has really been left in the dust," says Timothy N. Ziegenfuss, an assistant
professor of physiology at Eastern Michigan University who is researching
several of the steroid compounds. The five newer products that are now
available are 5-androstenedione, 4-androstenediol, 5-androstenediol,
19-4-norandrostenedione and 19-5-norandrostenediol. (The Merck Index
classifies 5-androstenediol and 19-5 norandrostenediol as anabolic steroids.)

The argument about whether such nonprescription steroids are anabolic or
not is more than an academic curiosity because, should the U.S. ever
officially decide that they are---as most other countries have already
done--- they would fall under the Anabolic Steroids Control Act of 1990,
which directed the government to restrict the substances the same way it
regulates marijuana. Currently over-the-counter steroids are not regulated
by the FDA, because their makers "don't claim to treat, cure, mitigate,
diagnose or prevent a disease," notes Judith Foulke, an FDA spokesperson.

Traditional anabolic steroids have long been recognized as giving athletes
an unfair advantage, especially in sprinting, shot-putting and other
activities demanding short bursts of power. All of them are basically
either esters of testosterone or synthetic versions of testosterone that
have been altered to enhance certain physiological effects and to minimize
others. (Testosterone is the primary male sex hormone and has many
functions in the body, including muscle-building.)

According to Ziegenfuss, the over-the-counter steroids work in a different
way. The substances, which are supposed to be taken orally and typically in
100-milligram doses, make it into the liver, which destroys all but a few
percent of the amount ingested. The few milligrams that survive, however,
combine with various enzymes there and temporarily boost testosterone
levels. But whether they do so significantly enough to make a difference
for musclebuilding (anabolism) or athletics is now hotly disputed.

Scientific research on the extent to which the substances boost
testosterone levels is scant and conflicting. In a 1962 study some women
showed a 300 percent testosterone increase an hour after taking
androstenedione. But Ziegenfuss's initial research with 4androstenediol,
the results of which were to be presented at a meeting in November, showed
only a meager 45 percent testosterone increase 90 minutes after ingestion.
A different mode of administration, though, which he would not identify,
resulted in a 100 percent increase in blood testosterone levels.

"Whether it's large enough to impact performance, we don't really know,"
Ziegenfuss cautions. He also notes that no studies have evaluated the
efficacy and physiological effects of taking more than one sterold
supplement at once, as many bodybuilders are now doing. Anecdotal evidence
suggests that "stacking" certain supplements in this manner can be more
effective than taking a single one.

Although the physiological mechanisms underlying over-the-counter steroids
may not be exactly the same as those of traditional anabolic steroids, the
differences do not impress some experts. "I want them taken off the
market," remarks Yesalis, the author of two books on performance-enhancing
drugs.

Derek W. Cornelius, whose company, Syntrax Innovations, manufactures and
markets all of the steroid supplements, insists that "the abuse potential
of these supplements is low," noting that they are all intended to be taken
orally and that much of the product is therefore destroyed in the liver.
For comparison, some traditional anabolic steroids are injected
intravenously or taken through the skin via a patch.

Ziegenfuss, however, notes that "many of the deleterious effects you see
from [anabolic steroids] are related to the use of some synthetic oral
compounds, which have harmful effects on the liver." He adds that "although
there's no reason at this point to expect androstenedione or androstenediol
to have toxic effects on the liver, I wouldn't call these compounds
abuse-proof." ---Glenn Zorpette