March 16, 2004
“Anabolic Steroid Control Act of 2004”
Chairman Coble, Congressman Scott, and distinguished members of the Subcommittee, I appreciate your invitation to testify today on the importance of fighting the growing abuse of steroids in this country.
The issue of steroid trafficking and abuse has recently received national attention in the context of professional sports. But the importance of stopping steroid abuse extends far beyond our national pastimes; the importance is to give our children a healthy future. Abuse of anabolic steroids among young Americans has reached dangerous levels, and it puts our kids at increased risk of heart disease, liver cancer, depression, stunted growth, and eating disorders, not to mention increased episodes of hostility and aggression.
Anabolic androgenic steroids are synthetic chemicals based on the structure and pharmacology of testosterone originally developed in the 1930s to help rebuild body tissue and prevent breakdown of tissue in individuals suffering from debilitating diseases. They promote the growth of skeletal muscle and the development of male sexual characteristics, in addition to other effects. Their popularity with athletes exists due to the muscle development and physical performance enhancements they provide. Unfortunately, this popularity has filtered down to our nation’s teenagers and young adults, who are lured by easy shortcuts to greater athletic prowess and more muscular physiques.
The Dangerous Impact of Steroids on Teens and Athletes
Steroid use among young Americans has already passed the danger zone. The 2003 Monitoring the Future Study conducted by the University of Michigan indicates that approximately 3.5 percent of American high school students have used illegal anabolic steroids at least once by grade 12. In that same study, an incredible 45 percent of all 12th graders did not believe taking steroids posed a great risk.
This report came on the heels of earlier studies, including the National Institute of Drug Abuse (NIDA) report of 1999, which stated that more than a half million 8th and 10th grade students where using anabolic steroids. A Youth Risk Behavior Surveillance Survey conducted by The Centers for Disease Control and Prevention (CDC) indicated that in 2001, five percent of all high school students reported use of steroids pills/injections without a physician prescription during their lifetimes.
Compounding the dangerous perception among young people that steroid use is harmless is the high-profile use of steroids among professional athletes. And because sports figures are prominent role models for our younger citizens, the President has focused on doping and cheating in sports.
The negative effects of long term anabolic steroid use are well documented. They include damage to the liver, kidney, heart, and sexual organs. Their use can also prevent children from reaching their full height. Moreover, abuse often elevates cholesterol and causes cardiovascular weakening, combined with hypertension. And because steroids are commonly injected, needle sharing can transmit blood born diseases such as HIV and AIDS. Steroids use can also cause uncontrolled outbursts of anger, frustration or combativeness resulting in wanton acts of violence. These outbursts are commonly referred to as “roid rage.”
The Need for Additional Legislation
Despite these clear health risks, the rapid evolution of new steroids has made it difficult for law enforcement to keep up, because each specific chemical formulation is required to be considered as a separate drug. In its initial attempt to regulate steroid abuse, Congress passed the Anabolic Steroid Control Act of 1990 (ASCA), which scheduled anabolic steroids as a class of drugs, and specifically listed 27 as controlled substances. In addition, Congress anticipated that future steroids would ultimately infiltrate the anabolic steroid black-market, and crafted a four-part definition that the DEA could use to administratively classify new steroids as Schedule III anabolic steroids. All four of the following questions needed to be answered:
The four-part test was first considered by the DEA in 1999, when it determined that the substance androstenedione met the first three criteria required under the 1990 legislation, but has been unable to make a finding regarding the fourth criteria, due to a lack of accepted methodology available to validate the final requirement for muscle growth. This meant that Congress had provided the DEA with the blueprint for scheduling steroids, but the scientific community had yet to develop a study that accurately quantified the promotion of muscle growth. This major stumbling block provided a legal loophole for traffickers of anabolic steroids to continue marketing their dangerous drugs as dietary supplements.
Consequently, the DEA has had to initiate and fund studies to develop animal models that could quantify the effects of steroids on muscle. For example, the DEA is currently co-sponsoring a three year study in New York City using the guinea pig to evaluate the effects of steroids on skeletal muscle growth. Other participating agencies include the Office of National Drug Control Policy (ONDCP), the National Institute on Drug Abuse (NIDA), and several branches of the National Institutes of Health. The first phase has been completed and the second phase is scheduled for completion in September 2004. This model will then be used to evaluate the effects of skeletal muscular growth from two substances: testosterone precursors and nandrolone precursors. Both of these steroids are now openly sold in dietary supplement products. The DEA is also funding a study in Seattle, Washington, using an immature rat as a model. In conjunction with the New York study, the development of skeletal muscular growth using steroids currently sold in dietary supplements is being examined. We anticipate this study will be completed by October 2004.
These two studies have already proven both costly and time consuming. By contrast, the amount of research and time required to introduce a new steroid into the dietary supplement market is minimal. The logical result has been an increase in the number of steroids available in dietary supplement products. Again, the ongoing requirement that the DEA must first scientifically validate muscle growth is a genuine impediment to effective regulatory oversight of these steroids. This means they continue to enter the dietary supplement market and continue to be legally purchased by America’s youth, athletes, bodybuilders and other ill informed individuals who abuse anabolic steroids.
To counter this trafficking trend, the DEA believes the fourth requirement of the ASCA, the quantification of muscle growth, should be dropped from the definition for anabolic steroids. This is a cornerstone of the legislation sponsored by Chairman Sensenbrenner, H.R. 3866. The legislation also specifically adds several steroids & precursors to the list of controlled substances considered anabolic steroids. In short, the bill will directly declare certain steroids and steroid precursors as dangerous drugs, and give us new tools to more quickly and effectively classify new steroids as controlled substances.
For example, one listed steroid precursor is androstenedione. Last week, Department of Health and Human Services Secretary Tommy G. Thompson announced that the Food and Drug Administration (FDA) concluded there is inadequate information to establish that a dietary supplement containing androstenedione can reasonably be expected to be safe. Therefore, the FDA sent 23 warning letters to companies that manufacture, market, and distribute dietary supplement products containing androstenedione informing them that failure to cease distribution of these products could result in enforcement action.
The legislation this subcommittee is considering gives DEA two important tools for shutting down the illegal steroid trade:
First, it would give us clear authority to conduct law enforcement operations against the trafficking of steroid precursors, as well as other steroids, including the designer steroid, THG. Until now, these steroids have masqueraded as harmless dietary supplements. This bill would finally call these steroids what they are—dangerous drugs.
Second, and as noted above, this legislation would remove an enormous legal stumbling block to taking these steroids off the shelf by eliminating the requirement to prove muscle growth to schedule a new steroid. Despite years of testing costing hundreds of thousands of dollars, we have not yet been able to schedule a single steroid under that requirement.
Trafficking of Illegal Steroids into Our Country and DEA Enforcement Operations
Anabolic steroids are not controlled in most countries. This translates into a virtually unlimited supply of steroids world-wide.
Outside our borders, anabolic steroids are frequently smuggled into the United States from Mexico by U.S. citizens who travel there to purchase them without a prescription. In addition, criminal groups of Russian, Romanian, and Greek nationals are significant traffickers of steroids, and are responsible for substantial shipments of steroids entering the United States. Domestically, illicit steroids are often sold at gymnasiums and bodybuilding/weightlifting competitions, where sellers obtained them through theft and fraudulent prescriptions.
Overall, the DEA has increased its enforcement effort of anabolic steroids. In 2001, we initiated 52 steroid cases. Last year, 87 investigations were launched. In one example, in October 2002 the DEA arrested eight individuals involved in the largest ketamine manufacturing and trafficking organization in North America. Included in the arrests were the owner of Ttokkyo Laboratorios and their sole Mexican distributor arrested in Panama. At the time, Ttokkyo was the largest manufacturer of anabolic steroids in Mexico and supplier to major U.S. distributors. This international ketamine and anabolic steroid trafficking organization in Mexico smuggled thousands of vials of ketamine and steroids to California, New York, New Jersey, and Florida. Among the Schedule III steroids being smuggled were methandienone, nandrolone, testerone, and oxandrolone.
The DEA has one mission: to protect the public from dangerous drugs. However, the current law regarding steroids causes regulatory delay, especially with respect to steroids that we know are hormonally, chemically, or pharmacologically related to testosterone. Because DEA authority extends only to controlled substances, steroids that are not classified as controlled substances continue to fall outside our jurisdiction.
H.R. 3866 will correct this problem. Manufacturers of steroids designated or scheduled as controlled substances will need to register with the DEA and strict accountability will be required for the sale, prescription, and dispensing of steroids. These products will no longer be legally purchased through ads in fitness magazines or over the Internet, but only pursuant to a prescription obtained by a licensed medical practitioner.
Mr. Chairman, thank you for your recognition of these important issues and the opportunity to testify here today. I will be happy to answer any questions you may have.