Testimony on the Anabolic Steroid Control Act of 2004

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Statement of Ralph W. Hale M.D.

Chairman of the Board, United States Anti-Doping Agency

Before the House Subcommittee on Crime, Terrorism and Homeland Security of the House Judiciary Committee

Legislative Hearing on H.R. 3866, the "Anabolic Steroid Control Act of 2004."

March 16, 2004

Mr. Chairman, members of the committee, good morning. My name is Dr.

Ralph Hale. Thank you for the opportunity to testify regarding this important health issue. Today, I am here as the Chairman of the Board of Directors of the

United States Anti-Doping Agency. I am also a physician who has been practicing medicine for more than 40 years. USADA has been recognized by Congress as the independent, national anti-doping agency for Olympic and Paralympic sport in the United States. Our mission is to protect and preserve the health of athletes, the integrity of competition, and the well-being of sport through the elimination of doping.

Recently USADA has received increased media attention for its role in the investigation into the existence and use by elite athletes of the designer steroid, THG. Designer steroids are an important concern for USADA. However, USADA is equally concerned about a class of anabolic substances that are readily available in the United States on the shelves of supermarkets and nutrition stores, as well available for order on thousands of internet sites. These products, marketed and sold as allegedly "safe" dietary supplements, contain substances, such as androstenedione and norandrostenedione and are one chemical step away from anabolic steroids. Once ingested these products are converted within the body into anabolic steroids. The availability of these products is a significant public health issue that transcends sport and places American consumers at risk.

The perils of anabolic steroid use are well known. In Olympic sport, the most notable, systematic state-supported program of doping with anabolic steroids was conducted by the East Germans from 1974 until the Berlin Wall fell. One of the anabolic substances developed by the East Germans as part of their doping program was androstenedione. In the body, androstenedione metabolizes into the anabolic steroid, testosterone. The documented side effects of the East German steroid program, particularly for women athletes, were tragic. These side effects include damage to the liver and reproductive system, susceptibility to cancers, and permanent masculinization of women. It is also well known that men who abuse steroids and steroid precursors risk serious health consequences including gynecomastia, baldness, shrunken testicles, infertility and susceptibility to aggressive behavior or rage. For adolescents who use steroids the side effects can include all of the above, as well as a strong likelihood that natural growth will be arrested or otherwise detrimentally affected.

Despite all of these well-known health consequences, for approximately the last eight years, American consumers have been able to walk into their corner nutrition store and buy products containing androstenedione. In 1998, after certain popular professional athletes acknowledged using androstenedione, sales of these supplements in the United States, particularly among teenagers, dramatically increased. The popular demand for androstenedione gave birth to an entire industry. Now the nutrition store shelves, and the internet, are flooded with products containing various steroid precursors. For example, 19-norandrostenedione, which metabolizes in the body into the steroid nandrolone, another controlled substance, is present in hundreds of over-the-counter products.

Last Thursday, the Food and Drug Administration took action against androstenedione and acknowledged that there is a "serious and substantial concern" about the safety of products containing androstenedione. USADA fully supports this important action and encourages the FDA to immediately take action against the remaining steroid precursor products on the market. Currently the introduction of these products is governed by the Dietary Supplement Health and Education Act. Under DSHEA a supplement manufacturer is not required to prove to the government that its precursor product is safe prior to putting it on the shelf. Instead, DSHEA places the burden on the government to take action against unsafe products after they reach the shelves.

The androstenedione example makes clear, that by the time the agencies are able to take action against a specific steroid precursor; unscrupulous manufacturers will already have made minor chemical changes to the product and reintroduced it into the marketplace. For example, while the FDA sent letters to 23 companies selling products containing androstenedione, last week's action does not yet reach the companies that are now selling the more popular next-generation androstenedione products such as 1-AD and 4-Androstenediol. While we hope the FDA will promptly address those other products, legislative action needs to be taken to discourage the continued introduction of new steroid precursor products.

Significantly, steroid precursor manufacturers fully exploit the protection offered by DSHEA and actively tout precursor products as "natural" and "legal" in order to raise the false implication that they offer a safe alternative to controlled anabolic steroids. At the same time, the marketers of these products glorify the muscle-building qualities of these substances and reinforce the association between these products and those very same controlled anabolic steroids. These products are marketed under names that reinforce their connection to anabolic steroids, including "Cycloroid," "Masterbolan," "Anabol-X," "Paradrol," and "Animal Stak." These products are advertised as equal to or better than the "real steroids" and promise the user huge gains in muscle mass.

While I believe these products raise a health concern for all American consumers who are duped into taking them, I am particularly concerned about the susceptibility of adolescents to the advertising message of steroid precursors. In a society where high school athletes can sign multi-million dollar endorsement contracts, we cannot expect teenagers to ignore advertisements claiming that these products are "safe alternatives" to steroids and will make them "ripped," "huge," improve their athletic performance and give them the body of their dreams. The manufacturers certainly have no motivation to reveal the serious health consequences associated with their products to the adolescents who are buying them, and unfortunately, there is no law requiring disclosure ofthose health consequences.

For Olympic athletes, who know to avoid these products, there remains another concern. In increasing numbers, athletes are failing doping tests after taking mislabeled dietary supplements. Studies have shown that an alarmingly high percentage of dietary supplements contain doping substances that are not disclosed on the label. For example, a recent study of 624 dietary supplements by the International Olympic Committee found that 41 percent of the products from American companies contained a steroid precursor or banned substance not disclosed on the label.

USADA believes that the current effectively unregulated availability of products containing steroid precursors in the United States is a health crisis that affects not just elite athletes, but every American teenager who dreams of athletic success, and every consumer who takes one of these products without being informed of the risks. Additionally, because of the risk of contamination, American consumers who believe they are taking perfectly safe nutritional products may unknowingly be ingesting steroid precursors.

There is simply no credible argument supporting the over-the-counter availability of products containing steroid precursors. The time has come to put a stop to the proliferation of these dangerous products. I appreciate this Committee's attention to this problem, as well as the actions of numerous Senators and Congressmen who have joined USADA in the fight to remove these dangerous products from America's stores. On behalf of USADA, I would like to specifically thank Congressmen Sensenbrenner, Conyers, Sweeney, Osborne, and Berman for introducing the Anabolic Steroid Control Act of 2004. I would also like to thank Senators Biden, Hatch, Grassley and Harkin for their attention to this matter and commend their introduction of the Senate version of this bill.

These bills amend the Controlled Substances Act by scheduling the substances I have discussed here today and by making it easier to schedule any anabolic steroid precursors introduced by manufacturers in the future. USADA believes that these bills are the appropriate solution to the steroid precursor problem. We urge full support for these bills and we are hopeful that they will be rapidly passed by Congress.

I would like to thank this Committee for its time and its interest in this important public health issue and for inviting me to share my thoughts on the dangers posed to American consumers by products containing steroid precursors. Thank you.

SOURCE: Hale, R. W. 2004. "U. S. Anti-Doping Agency. Testimony before the House Subcommittee on Crime, Terrorism and Homeland Security of the House Judiciary Hearing on "Anabolic Steroid Control Act of 2004." March 16. [Online information; retrieved 6/17/05.] http:// judiciary.house.gov/HearingTestimony.aspx?ID=69. Reprinted with permission of the United States Anti-Doping Agency.

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