Source: San Jose Mercury News (CA) Contact: http://www.sjmercury.com/ Pubdate: Thu, 27 Aug 1998 Author: Lisa M. Krieger, Mercury News Staff Writer MCGWIRE SETS OFF A SALES BOOM Legal hormone used by Cardinals' basher has unproven value, possible risks, experts warn Amateur athletes and bodybuilders are responding to the disclosure that St. Louis Cardinals slugger Mark McGwire uses androstenedione by boosting sales at health food stores -- when they can find it. ``We've been selling a lot. We can't keep it on the shelves,'' said Jamie Laubacher of Great Earth Vitamin Store at the Oakridge Mall in San Jose. ``I sold 20 boxes in two days -- and would have sold more, if I had it.'' But so far, the only people it's proven to help are the ones who sell it. Medical experts say no studies have been done to validate claims for the legal steroid hormone -- and warn that long-term use could be dangerous. Wary of possible harm, some stores like health-product giant General Nutrition Centers have resisted the temptation to carry it. ``We took a close look at the product and determined that the current level of research, we were not comfortable with it,'' according to Greg Miller, a representative of the 3,700-store Pennsylvania-based chain. Sold over the counter at $30 to $50 a box under names such as ``EAS Andro-Blend'' and ``AST Andro-Plex 700,'' androstenedione is unregulated by government authorities. It is purported to provide a natural and legal way to build muscles and boost sex drive by raising levels of testosterone, the male sex hormone. The 6-foot-5-inch, 250-pound McGwire, who is in the spotlight as he chases baseball's single-season home run record, acknowledged Sunday that he regularly takes androstenedione (pronounced an-dro-STEEN-di-own). Because of growing concerns over players' health, baseball commissioner Bud Selig and players association executive director Donald Fehr have decided to take a closer look at Major League Baseball's own policy, which allows use of the substance. The two called Tuesday for the joint medical representatives of the league and the union ``to gather the relevant scientific and medical data and to consult with other experts on the general use of nutritional supplements by major league players.'' That could be a challenge. Good medical data doesn't exist, said Dr. Gary Wadler, associate professor of clinical medicine at the New York University School of Medicine and 1993 recipient of the International Olympic Committee's President's Prize. ``I've looked for research but come up short. What's out there are just claims made by those with a vested interest in the product,'' said Wadler, the author of ``Drugs and the Athlete'' -- the bible on performance-enhancing drugs. Both men and women produce androstenedione in their adrenal glands, which sit atop the kidneys. In men, it is converted to testosterone, which floods their bodies during early adulthood and dwindles as they age. Studies of the hormone have been done in animals -- one of the most credible in a small bird called the zebra finch. Researchers found that the hormone caused female finches to abandon their delicate songs and start singing like males. But there have no controlled, peer-reviewed and published studies in humans. The only available data is found in the product's East German patent application, which claims that androstenedione almost doubled normal testosterone levels. But anything can be written in a patent filing without documentation, said exercise physiologist David M. Lightsey of Bakersfield, who heads the Ergonomic Task Force of the National Council for Reliable Health Information, a group of medical professionals who monitor allegations of health fraud. Nor has the 25-year-old East German data been duplicated by other researchers, he noted. Even without the research, androstenedione can be sold over the counter under terms of the Dietary Supplement Health and Education Act of 1994, which permits the sale of hormones such as androstenedione and creatine, another purported performance enhancer taken by McGwire, as long as the substances do not make therapeutic claims. The act essentially removed the products from oversight by the U.S. Food and Drug Administration. ``We cannot disallow it,'' an FDA official said of androstenedione. ``We don't review the product before it is put on the market. . . . The responsibility is put on the manufacturer to ensure it is safe and labeled properly. We take action if there are reports of illness or injuries or complaints by the public.'' Despite the lack of federal restrictions, scientists familiar with the hormone caution against its use in healthy people. Androstenedione should be taken only under a doctor's supervision by men who do not produce their own testosterone, said Peter Hornsby, associate professor of cell biology at Baylor College of Medicine, who studies the body's hormone-making cells. ``It is extremely dangerous . . . because a normal male doesn't need any more testosterone. If you are a male without it, see a doctor. If you're a female, don't take it because it will have a masculinizing effect,'' said Hornsby. Doctors worry that increased levels of testosterone could cause an otherwise dormant prostate tumor to grow, or could cause prostate enlargement. Other complications could include breast enlargement, personality change and liver or heart problems. Trying to isolate male hormones in the 1950s, scientists first obtained androstenedione by distilling 25,000 liters of male police officers' urine. Synthesis quickly followed, enabling production of larger quantities. Androstenedione was routinely used in nasal-spray form by East German scientists in the mid-1960s and 1970s to boost testosterone levels in both male and female athletes, according to the online magazine Muscle Media 2000. Androstenedione was rediscovered about a year ago when the owner of a supplement company stumbled onto the German patent and realized it would be a legal over-the-counter product. Those who back the product say there's little need for regulation because it is ``natural,'' converting to testosterone in the body. ``I think its more B.S. to write about,'' said Oakland A's first baseman Jason Giambi, who also uses androstenedione. ``The stuff is not illegal. It's not an anabolic steroid. . . . It's kind of sad that someone is trying to mar someone else's (McGwire's) accomplishments.'' According to A's head trainer Larry Davis: ``If they (the players) are going to use it, they're going to use it. It's best that we know about it. We don't disallow you from bringing it into the clubhouse, because it's over the counter. . . . We don't supply it, we don't endorse it, but we don't ban it.'' But testimonials by sports heroes like McGwuire could be persuasive to youths, who may be most at risk, said physiologist Lightsey. ``It sets a terrible example to the kids on the block. Athletes are naive. They aren't out to scam anybody. But they don't have a formal scientific background and buy it all, hook, line and sinker,'' said Lightsey. Mercury News Staff Writer Howard Bryant contributed to this report. 1997 - 1998 Mercury Center. - --- Checked-by: Pat Dolan