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Suit challenges makers of muscle pills

As baseball great Mark McGwire was hitting 70 home runs in a single season _ a feat that dazzled the nation in 1998 _ the capsules in his locker became a national obsession.

Did McGwire owe his record-breaking season to androstenedione, an over-the-counter nutritional supplement, or to his power and skill? Was andro, as it's called, a dangerous steroid or a harmless, modern-day snake oil?

Four years later, the debate rages, even as the industry has grown to a $100-million-a-year business. Though the supplement has been banned by the International Olympic Committee, the National Football League and the National Collegiate Athletic Association, the government still allows its purchase without a prescription.

Now attorneys are entering the fray. On Thursday, Tampa lawyers filed a class-action lawsuit in Florida and five other states that accuses a dozen manufacturers of andro and other "prohormones" of false marketing.

The lawsuit says there is no medical proof to back up company claims that prohormones increase strength.

In fact, the lawsuit states, prohormones have been shown in medical studies to enhance estrogen levels, the hormone responsible for female sex characteristics.

That's a tough case to make to those who swear by the supplements.

"People are screaming this stuff works," says attorney Vincent Lynch, whose Trenam, Kemker law firm filed the suit. "It shows how effective the marketing is."

The lawyers want their clients, including three in Florida, awarded refunds for the supplements they purchased. They estimate thousands of people have taken the products, and want the companies stopped from engaging in "deceptive and unlawful trade practices."

A half-dozen manufacturers named in the lawsuit did not return phone calls Thursday seeking comment.

At the very least, the suit against them underscores the fissures that exist within the sports and medical communities about what prohormones are, what they do, and what, if anything, should be done about them.

Consumers, meanwhile, are free to draw their own conclusions. And swallow as much as they want.

Androstenedione was a communist invention. Doctors in the former East Germany created it to give their athletes an edge in the 1988 Olympic Games in Seoul.

Prohormones such as andro are a synthetic form of steroids that the body naturally manufactures. Taken orally, they are broken down by enzymes and converted into hormones. Testosterone is the hormone that promotes muscle growth.

The big question is whether andro and other supplements spike testosterone enough to affect strength, or if they are destroyed by the body's conversion process before having a measurable impact.

Reliable medical studies on prohormones are few. The study most often cited was commissioned in 2000 by Major League Baseball and the players association. Two Harvard University researchers found that 300 milligrams of andro taken daily for seven days modestly increased testosterone levels.

But the study, published in the Journal of the American Medical Association, did not examine whether andro had an impact on muscle mass.

"There hasn't been a single study yet that proves (prohormones) increase muscle growth function," says Conrad Earnest, director of exercise physiology at the Cooper Institute in Dallas.

But there is a vocal chorus of doctors who say prohormones are just as harmful as illegal steroids.

"It will feminize a male," says Gary Wadler, a New York physician and lead author of the book, Drugs and the Athlete. "I don't think this is an issue for a lawsuit. I think it's an issue for a change in federal law."

In 1994, at the urging of U.S. Sen. Orrin Hatch of Utah, the U.S. Food and Drug Administration stopped regulating claims made by supplement makers. Dr. Lewis Maharam, president of the New York chapter of the American College of Sports Medicine in New York City, is convinced the pills deliver on their promises.

"It works, it works," he says. But Maharam says he has seen disturbing changes in teenagers who use prohormones.

"You see (enhanced) breast tissue, and the only way that goes away is with a mastectomy," he says. "There's male pattern baldness, 3 to 4 inches off their height. Their cholesterol profiles are becoming all wacky and they're probably getting early coronary disease," Maharam said.

"Their testicles," he says, "are now little marbles."

Prohormones meet the government's criteria for illegal steroids in all areas but one: promoting muscle growth.

"That seems to be the missing ingredient that they can't seem to tag right now," says Earnest.

Lynch says that leaves prohormone manufacturers in a Catch-22.

"One, it doesn't work, and if they take the position that it does work, it's an illegal steroid," Lynch says. "And if they do agree that it doesn't work, it's false advertising."

In 1999, the Federal Trade Commission cited two manufacturers who claimed their prohormones promoted muscle growth with minimal or no bad side effects. The FTC argued that science didn't back up the claims.

As a result, AST Nutritional Concepts & Research and Met-Rx USA agreed to change their promotions and warnings. Still, both were named in the class-action suit filed Thursday.

The lawyers say other manufacturers need to change their claims, too, including vitamin giant General Nutrition Companies, as well as Muscletech and Nutraceutics Corp. All were named in the suit.

Prohormones aren't cheap. Some sell for $70 or more a bottle. Often, labels recommend that users "stack," or take, several types of prohormones at once.

"Gain lean mass and strength faster and more efficiently by raising your testosterone levels safely!" boasts Twinlab, which makes Nor Andro Fuel Stack and is being sued.

Paul Thanasides, co-counsel for the lawsuit, said, "What we're doing is exposing how highly fraudulent it is."

In addition to Florida, the lawsuit was filed in California, New York, New Jersey, Pennsylvania and Colorado. There are a total of nine named plaintiffs.

But a critical question remains: What do consumers make of the products?

Brian Cadigan has swallowed prohormones for days at a time, on and off for years. The ads promised he would get bigger, and at his South Tampa gym, Metroflex, bigger is always better.

Cadigan spent $20 or more per bottle, and he did get stronger. But he was never entirely sure whether the extra bulk was due to the prohormones, or to the fact that he was lifting more weights.

"I saw a difference, but I was trying harder, too," says Cadigan, 41.

_ Times researcher John Martin contributed to this report. Kathryn Wexler can be reached at wexlersptimes.com or (813) 226-3383.

Prohormones

MAJOR PROHORMONES: Androstenedione, nordione, 1-Testosterone, DHEA.

MAJOR MANUFACTURERS: AST Sports Science Inc., Nutraceutics Corp., Bodyonics Ltd., General Nutrition Cos., Muscletech Inc., Twin Laboratories Inc.

BANNED BY: The International Olympic Committee, the National Football League and the National Collegiate Athletic Association.

PRICES:

A bottle of 60 capsules of 4-Diol 250 from AST Sports Science costs $39.16 on their Web site.

A bottle of 112 capsules of Nortesten by Muscletech sells locally for $69.99.

COMPANIES' CLAIMS: Builds lean muscle, increases strength, causes fat loss, improves libido and enhances sexual functioning.

WHAT SOME MEDICAL STUDIES SUGGEST: Can raise levels of estrogen; can result in enlarged breasts, shrunken testicles and fat deposits.

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