House votes to bar over-the-counter sales of steroid precursors
■ Physicians and consumer advocates applaud the new legislation but seek further steps to regulate dietary supplements.
By Joel B. Finkelstein — Posted June 21, 2004
Washington -- Anabolic steroid precursors soon could join the federal list of controlled substances that are unavailable without a physician's prescription.
Anabolic steroids, which convert to testosterone once they are in the body, are barred from over-the-counter sales, but their precursors, such as androstenedione, known as andro, are sold as dietary supplements. They are popular with some professional and young athletes for enhancing performance and building muscle mass.
As dietary supplements, the pills are covered by the Dietary Supplement Health and Education Act, which gives the federal government very little leeway in regulating them.
But legislation passed June 3 by the House, with a 403-3 vote, would reclassify most steroid precursors as controlled substances, making them illegal to sell without a prescription.
"It's sort of a quantum leap from being considered basically a food supplement all the way to a controlled substance," said Gary Wadler, MD, PhD, professor of clinical medicine at New York University.
The legislation also would invoke harsher sentences for anyone caught selling the banned substances in or near sports facilities.
"The goal of this legislation is clear: We do not want these harmful substances around our gyms, baseball stadiums, football fields or our running tracks," said Rep. F. James Sensenbrenner Jr. (R, Wis.), who introduced the measure.
The American Medical Association applauded the bill's passage. "The action by the House is encouraging, and we hope that the Senate will pass similar legislation so that we can remove these dangerous products from the marketplace," said AMA Trustee Ron Davis, MD.
"Increasing numbers of Americans, particularly young athletes, are placing themselves at risk for serious health problems from the use of anabolic steroids and their precursors, particularly through use of over-the-counter dietary supplements," Dr. Davis said. "These health risks can have irreversible, toxic effects."
The supplements have been linked to some of the risks seen with anabolic steroids, such as clotting disorders, liver damage, premature heart attacks and strokes, elevated LDL cholesterol levels and decreased HDL levels, and weakened tendons.
The difference between the effects and risks of anabolic steroids and their precursors is largely a matter of dosage, said Dr. Wadler, who is also a member of the World Antidoping Agency. Once metabolized, they all produce testosterone.
"We know from abuse of anabolic steroids, you can't go by the amount written on the label or in the capsule," he said. "Typically people take multiples, large multiples, of whatever the bottle may say."
The information provided by the supplement makers is often of questionable value as well, because the labels are more likely to be written by people on "Madison Avenue, not the science community," he said.
Should have gone further
Consumer advocates also supported the banning of steroid precursors, but some experts questioned the decision to make an exception for dehydroepiandrosterone, or DHEA, which also has been linked to similar risks as other steroid precursors.
"We fail to see the reasoning behind the exclusion of this potentially dangerous supplement from the legislation," said Janell Mayo Duncan, legislative and regulatory counsel with Consumers Union, publisher of Consumer Reports.
Physiologically speaking, there is no difference between DHEA and the other steroid precursors, Dr. Wadler said.
So far, marketing of DHEA has largely targeted seniors because of research that shows levels of the hormone decrease with age. But if the bill becomes law, that could change.
"I would not be surprised to see the industry respond by enhancing the marketing of DHEA," Dr. Wadler said. "After ephedra was banned by the FDA, you saw the industry respond by promoting synephrine."
Synephrine is often marketed as a relative of ephedra and has many similar stimulant effects. Ephedra was banned by the FDA last year, almost seven years after the medical community first raised concerns about adverse health events linked to use of the compound.
Like ephedra, steroid precursors are being viewed as evidence that the FDA should be given greater power than allowed under current law to crack down on the sale and marketing of potentially dangerous dietary supplements.
"We don't want to repeat another ephedra incident, where it takes consumers dying to get the government to remove dangerous supplements from the market," Mayo Duncan said.
At a recent Senate hearing on dietary supplement regulation, Dr. Davis testified that, based on the experience first with ephedra and now with anabolic steroid precursors, the AMA is recommending that the law be modified so that supplement manufacturers must show that their products are safe and effective before they are released into the market.
"That would put the burden of proof where it should be -- on the manufacturers -- which is how prescription and over-the-counter medications are handled," Dr. Davis said after the House vote.
"That would allow us to identify dangerous dietary supplements before thousands or millions of Americans are exposed to them."