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Andro ban is a 'first step'

The muscle-building supplement can still be found in gyms and on the Internet. The FDA is evaluating more enforcement action.

March 22, 2004|Martin Miller | Times Staff Writer

The Food and Drug Administration may have demanded recently that nearly two dozen companies stop selling the muscle-building supplement androstenedione, but that doesn't mean such products will no longer be available.

The order to halt production and marketing of the popular supplement, a steroid precursor commonly known as andro, doesn't affect other companies that may be selling the formula. Nor will it affect chemical cousins that also claim to increase bulk and athletic performance.

"The andro ban is a good first step," said Dr. Gary Wadler, an associate professor of clinical medicine at New York University who helped write sports anti-doping laws. "But there are still some enormous loopholes."

The FDA acknowledges that other andro products are available at gyms, health stores and over the Internet, but said it's still evaluating whether to pursue enforcement action against those manufacturers and distributors.

In its recent move, the FDA warned 23 companies, which the agency says are the country's major suppliers, that they would face possible product seizure and fines if they failed to comply immediately with the order.

As a steroid "precursor," the synthetic form of andro acts much like a muscle-building anabolic steroid, which is a controlled substance and illegal without a prescription. Precursors, usually in pill form, are converted into a steroid after absorption into the body. Androstenedione itself is produced in small amounts in the adrenal glands, ovaries and testicles and turned into testosterone, a steroid.

Andro supplements were made famous by former baseball slugger Mark McGwire, who has acknowledged using the product in 1998, the same year he broke a major league record for home runs.

Some athletes -- including an unknown number in Major League Baseball -- take the supplement to boost strength and improve performance. (The major leagues are under pressure to ban andro, as the National Football League and the National Collegiate Athletic Assn. have done.) About 2% of high school sophomores use andro products, according to the latest government figures.

The FDA action came as a result of safety concerns raised by consumers and researchers. In boys and men, excessive doses of the supplement can lead to enlarged breasts; the product also has been linked to testicular atrophy and impotence.

In girls and women, large doses can cause male pattern baldness, excessive facial hair and deepened voices. The supplement also has been associated with abnormal menstruation, blood clots and an increased risk of breast and endometrial cancer.

When taken by children and adolescents, andro can stunt growth and cause the premature onset of puberty.

Companies that manufacture or sell andro could still sue to block enforcement of the FDA's recent order. One company targeted by the FDA, New York-based TwinLab Corp., said in a news release earlier this month that its andro products are "safe and effective if used as directed" and is preparing "an appropriate response" to the government's decision. TwinLab officials declined to comment further.

Robert Pandina, director of the Center of Alcohol Studies at Rutgers University in Piscataway, N.J., says companies can easily develop steroid precursors or tamper with old formulations to generate new products that don't violate the letter of the law.

"The ability to modify these drugs is so great and there's so much potential profit that they will be able to either avoid detection or simply claim they aren't using a chemical compound that is on the officially banned list," said Pandina, who has studied performance-enhancing drugs in sports for decades.

A Senate bill, co-sponsored by Sens. Joe Biden (D-Del.) and Orrin Hatch (R-Utah), would strengthen the government's ability to keep steroid precursors off merchandisers' shelves. The Anabolic Steroid Control Act would reclassify andro supplements as controlled substances, which means that they would be subject to the same restrictions as prescription drugs. The bill also would give the government the flexibility to shut down manufacturers that slightly modify products to skirt the law.

"Just because you changed a molecule, if the effect is the same, you're still in the ballpark," said Biden at a news conference earlier this month making a case for his bill. "It's still criminal behavior."

The Senate has not scheduled a vote yet for the bill, but with the publicity generated from the FDA ban, and recent revelations from the sports world that top athletes have been using performance-enhancing substances, the two senators expect the bill to get a hearing soon.

Other critics say the demand for performance-enhancing supplements won't diminish until professional sports leagues begin punishing athletes for abusing them. Kids of both sexes look up to these athletes as role models, and if the pros are using them, so will they, said Carleton Kendrick, a Boston-based psychotherapist who has counseled adolescents about steroid use.

"A lifetime ban would make the risk of getting caught unacceptable," Pandina said. "But if they're going to give players four, five, six chances before they do anything serious, where's the deterrent in that?"

Other critics take a different view. Although conceding that steroid precursors probably aren't very healthy, Tracy Olrich, an assistant professor of physical education and sports at Central Michigan University in Mount Pleasant, Mich., said the controversy surrounding them is overblown.

"I'm not justifying steroid use and not saying they should be legal," said Olrich, who has conducted several small studies on athletes and steroid use. "But alcohol and tobacco use are by far much more of an issue than steroids will ever be. The hysterics has been unbelievable."

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