New Steroids Sold Over Counter
Law From 1990 Doesn't Bar Then-Unknown Substances
William Llewellyn of Molecular Nutrition: "Our goal is . . . making the most effective products we can make within the constraints of the law." (Helayne Seidman For The Washington Post)
By Amy Shipley
Washington Post Staff Writer
Friday, December 6, 2002; Page A01
Two new steroids that are not readily detectable by current drug-testing methods have angered sports and government officials, who say the companies marketing them are skirting the law to sell dangerous drugs over the counter as dietary supplements.
Congress banned all known steroids in 1990 after hearing testimony about their health effects and rampant abuse in sport. However, the two new steroids -- called 1-testosterone and 4-hydroxy-testosterone -- escaped mention in the legislation because they were virtually unknown. Because their manufacturers can claim they are natural substances, the steroids have been marketed as dietary supplements that increase strength and build muscle.
Dozens of products containing these full-blown steroids, which have been dubbed "pro-steroids" by their manufacturers, have proliferated on nutrition store shelves and the Internet in recent months. They are sold in a variety of forms but not as injectable steroids (considered the most potent means of administering steroids).
"People just do not know what is going on in the dietary supplement market," said James Tolliver, a pharmacologist in the drug and chemical evaluation section of the Drug Enforcement Administration's Office of Diversion Control. The new drugs "are anabolic steroids that can produce very significant adverse effects in humans. On top of that, they are available to anyone."
Because tests have not been developed to detect these drugs, even athletes in sports that ban steroids might be able to use them without getting caught. The International Olympic Committee, National Football League and National Collegiate Athletic Association ban steroids and test their athletes. The National Hockey League and Major League Baseball do not.
Since the mid-1990s, supplement manufacturers have exploited a legal loophole to sell another type of over-the-counter steroid product known as "steroid precursors." Steroid precursors convert to illegal steroids only after they are ingested. The two new steroids are considered more potent than precursors because they do not require such a conversion in the body. They were recently discovered by two U.S. scientists who are considered leaders in the dietary supplement industry.
Don Catlin, head of the IOC-accredited laboratory at UCLA in Los Angeles, said he has recently become aware of 1-testosterone and 4-hydroxy-testosterone and considers them the equivalent of "designer steroids." There are no tests for either substance, although Catlin and U.S. Anti-Doping Agency Senior Manager Director Larry Bowers said 1-testosterone may share metabolites with some known steroids, which could aid in its identification. Catlin said he has begun the process of trying to develop formal tests for both.
The first of the new steroids was discovered and dubbed 1-testosterone -- its chemical name is 1delta-dihydrostestosterone -- by Patrick Arnold of LPJ Research and ErgoPharm in Seymour, Ill., just over a year ago. Arnold marketed the steroid only in its precursor form in a product called 1-AD. It is claimed to be seven times more anabolic -- in other words, more potent -- than testosterone, and has since been sold as a pro-steroid by many other companies. The other new steroid, 4-hydroxy-testosterone, was discovered by William Llewellyn of Molecular Nutrition in Jupiter, Fla. It will be released in a few weeks by Llewellyn in a product called Hydroxytest; the company Promatrix already is selling it in a slightly modified form in a supplement named Testabol Ether.
"There's a multitude of products; you can't keep track of all of them," Arnold said. "It's an industry full of people trying to get an edge on everyone else."
Though pro-steroids didn't exist a year ago, there are now more than a dozen such products sold under names such as 1-Test, 1-Test Ether, Atomic T-Bol, One, T-100, TestXtreme, Androgen-1, Test-100, Test-250, Testosterol XP, TestXtreme and Mag10. While most manufacturers shy away from references to anabolic steroids in their advertising, other companies are more bold.
"We have entered the final leg to making supplements equally effective to steroids," states an Internet advertisement for 1-Test Ether, made by Higher Power Nutrition. "Let's not kid ourselves, some may wish to deny it, but 1-Test is an actual steroid."
A Search for Strength
In the 1930s, scientists synthesized the first anabolic steroids for medical purposes. Steroids were originally used to treat males whose testes failed to produce sufficient natural testosterone for normal growth, and later for cancer, AIDS, organ transplantation and impotence. In early tests, scientists found that anabolic steroids, when given to laboratory animals, produced significant muscle development. That discovery led to their widespread use by bodybuilders and athletes in a variety of sports by the 1960s.
Studies have shown that anabolic steroids, when taken for muscle-enhancing effects, may have harmful side effects that include aggressive behavior, liver damage, hair loss, testicular atrophy and stunted growth if taken by adolescents.
When steroids were banned in the United States, some athletes turned to the black market. Others sought out legal strength-building products. To meet the growing demand, some chemists began searching through old research papers and textbooks to find age-old steroid recipes that were not on the banned list in 1990 and thus, by virtue of their obscurity, remained legal.
In his promotion of the product 1-AD, the 1-testosterone precursor that was later sold as a pro-steroid, Arnold cited research from the pharmaceutical company G.D. Searle from the 1960s. Llewellyn, too, said he relied upon decades-old research to find 4-hydroxy-testosterone.
Elm Valle, a 29-year-old bodybuilder and certified personal trainer in Cleveland, Tenn., said the legal steroid products are an invaluable piece of his training regimen. He said he takes protein supplements daily along with a "stack" of supplements from Molecular Nutrition: 1-T Ethergels (1-testosterone pro-steroid), Boldione (boldenone precursor) and 3-Alpha (dihydrotestosterone precursor). Valle said the only side effect he has experienced while using the products has been occasional grumpiness. Valle, who is not paid to promote any company's supplements, said he put on 12 pounds of muscle in four weeks using the stack -- in tandem with a strict diet and an intense workout plan. He finished third in the most recent Mr. Tennessee championships.
"In a matter of months, my strength exploded," said Valle, who stands 5 feet 3 and went from 128 to 140 pounds. The products "polish you. They help you gain the extra muscle. There is only so much you can gain by eating the right foods. The rest you have to supplement. Any competitive bodybuilder will tell you that."
Valle said he believes only those who recklessly consume too much of the substances are in danger of becoming sick or experiencing serious side effects. He did, however, acknowledge that pro-steroids and precursors can be risky when adolescents get their hands on them. "That is a problem," he said. "They're making choices without being educated about it -- teens, especially. They are easily swayed to take these and, unfortunately, they don't make mature decisions."
DEA officials are outraged over the emergence of these products and the blatancy of some of the advertising, but they say they are powerless to prevent their distribution unless the steroids they contain are added to the Anabolic Steroids Control Act of 1990. Because of the relative anonymity of the new steroids and the lack of medical data on their effects, DEA officials say it could take months, or even years, for that to happen.
The Food and Drug Administration says its hands are similarly tied. Under the 1994 Dietary Supplement Health Education Act (DSHEA), it must prove a supplement is a health hazard before removing it from the market. Though extensive research shows that anabolic steroids can have a multitude of troubling side effects, because the new steroids have not specifically been studied, the same body of evidence does not exist for them.
"What we don't have is a lot of science to help us understand if there is a safety issue," said Christine Taylor, director of the FDA's Office of Nutritional Products, Labeling and Dietary Supplements. "We are concerned and monitoring the situation."
Precursors Came First
Pro-steroids are the latest bane to government officials and Olympic drug-testing administrators, but all say they also remain troubled by steroid precursors, which came into the existence soon after the passage of the DSHEA. In 1996, Arnold, the chemist considered responsible for the most revolutionary developments in the industry, developed the first and most famous of the precursors: androstenedione. "Andro," which gained fame after baseball slugger Mark McGwire admitted using it, metabolizes into the illegal steroid testosterone.
Andro, though, is old news to Arnold and other industry insiders, who say newer products are more potent and have fewer negative side effects. Arnold and Llewellyn say there is a limit on the number of natural steroids available that can be sold legally as dietary supplements. Because of that apparent ceiling, many supplement producers are attempting to maximize the effects of the current pro-steroids and precursors by tinkering with modes of administration. Even giants in the dietary supplement industry -- which is filled with copycats and fierce competition -- are divided over some of the advances.
Some industry leaders believe their *****s have gone too far with over-the-top advertising or products that too closely resemble illegal drugs. But they are united on this front: All want to stay in business. They claim their products promote no major, harmful side effects if taken in recommended doses. They say government and anti-doping officials have used inappropriate scare tactics to try to convince the public that over-the-counter steroids are filled with danger.
"Where is the societal damage?" said Syntrax Innovations' Derek Cornelius, who discovered the first nandrolone precursor. "If there was a health problem, the FDA has plenty of recourse it could take in the market. We're all up in arms about something that causes acne and maybe 10,000 people use it? . . . They would have a point if people were having bad side effects, if people were dying in hospitals, but it's not happening. It's like making an issue out of something that's not."
Llewellyn, credited with discovering the first boldenone and dihydrotestosterone precursors, says athletes who wish to use steroids to enhance their physiques should not face legal barriers that are not present for those who have plastic surgery or breast enhancement. He says that athletes and bodybuilders who want to build muscle will turn to the black market if pro-steroids and precursors are banned. Furthermore, he says, despite the increasing potency of the products, supplement manufacturers cannot mimic the actions of illegal drugs that are taken by injection.
"You take 18-year-old kids [who want to bulk up], they're going to go to the steroids . . . you're not going to avoid it," said Llewellyn, the author of "Anabolics 2002: Anabolic Steroid Reference Manual." "At least now they have a legal option, a safer option. . . . Our goal is not holding back in making the most effective products we can make within the constraints of the law."
Government officials say they are wrangling with a mushrooming problem, adding that the absence of documentation on obscure drugs does not prove they are safe or fit to be sold over-the-counter. U.S. Anti-Doping Agency Chief Terry Madden says leaders in the supplement industry are preying upon young people who want to succeed in athletics. Madden and others say pro-steroids and precursors are essentially targeted to minors given their easy availability, the desire of teen athletes to muscle up and the lack of regulation over the industry.
"What 16-year-old doesn't want to knock the ball out of the park?" said Rep. John E. Sweeney (R-N.Y.). "The marketing of these drugs to young athletes is obvious. What is equally horrifying is their availability. These drugs are obtained too easily by youngsters."
Tolliver said recommended dosage levels on many of the supplements have increased such that they far exceed what would be considered "ethical" in legitimate medical studies of the products. He also condemned the plethora of advertisements in which supplement companies pitch "stacks" of pro-steroids and steroid precursors, such as used by the bodybuilder Valle, or individual products that contain a host of steroid precursors and pro-steroids.
"Stacking steroids is not something that would typically be done in legitimate medicine," Tolliver said. "They are mimicking the steroid-abusing population."
The issue likely will be a hot topic in the coming months. On Oct. 9, Sweeney and Rep. Tom Osborne (R-Neb.) introduced a bill that would amend the Controlled Substances Act to allow steroid precursors to be listed as controlled substances and vowed to address the issue in congressional hearings.
Rick Collins, an expert in steroid law and the author of "Legal Muscle: Anabolics in America," said the increasingly sophisticated products in the industry should be judged individually, not lumped into one law and banned across the board.
"You need to be distinguishing between products that are anabolic steroids," he said. "You need to draw the line somewhere. The question is, where are you going to draw the line? Which side of 1-testosterone are you going to draw it?"
© 2002 The Washington Post Company