From athletes in international competition to college and high school athletes to the teenager who simply wants to "bulk up," people of all ages and abilities have found alternatives to replace anabolic steroids.

Regulated by the Drug Enforcement Administration, anabolic steroids were placed in the Controlled Substances Act's Schedule III (which includes some narcotic drugs, stimulants and depressants) by the Anabolic Steroids Act of 1990. Unlawful distribution and possession with the intent to distribute anabolic steroids is a federal crime, punishable by up to five years in prison.

Since the law was enacted, many athletes have avoided anabolic steroids because of the penalties associated with their abuse, says Donald Leggett, a compliance officer in the Food and Drug Administration's Center for Drug Evaluation and Research. "They have looked at other chemicals that perform in a similar fashion but are not technically regulated as or called anabolic steroids."

Those alternatives include prescription, veterinary, investigational, and unapproved drugs, and dietary supplements.

Dietary supplements are regulated as foods. No data has been submitted to FDA to prove bodybuilding claims for these substances, and the short- and long-term effects of their use are unknown.

"Many alternatives are labeled as 'dietary supplements' even though they make anabolic and other athletic enhancement claims. Such attempts to market directly to the public may represent a circumvention of the safety and efficacy provisions required of drugs. Thus, the short- and long-term effects of their use are generally unknown," Leggett says.

When supplement manufacturers make bodybuilding and drug- type claims, FDA can, and often does, issue warning letters to the manufacturer or prosecute for consumer fraud. FDA's Center for Drug Evaluation and Research recently won several court cases involving consumer fraud by supplement manufacturers, Leggett says.

The consumer is defrauded by believing these supplements will build muscles or promote testosterone production, when in fact they do no such thing, he says.

In a study, published in the Aug. 26, 1992, Journal of the American Medical Association, of bodybuilding magazine advertisements, Rossanne M. Philen, M.D., and colleagues, report that they counted 89 supplement brands, 311 products, and 235 ingredients, most of which were unspecified amino acids. More than 22 percent of the products had no ingredients listed in their advertisements.

The study also found that many steroid-type ingredients, called sterols, were being advertised. With the exception of ecdysterone, the sterols were all plant derivatives. Ecdysterone in an insect hormone with no known use in humans.

The abuse of many of these ingredients, as well as prescription, veterinary, investigational, and unapproved drugs, concerns FDA.

Agency investigators have collected more than 3,000 drug samples from the black market over a 10-year period, according to Leggett. Many of those samples, he says, were not steroids but other, potentially more dangerous, prescription drugs.

Some steroid alternatives popular among athletes include the investigational drugs clenbuterol and gamma hydroxybutyric acid, or GHB, and approved prescription drugs such as human growth hormone and erythropoietin, better known as EPO.

Clenbuterol

Athletes use clenbuterol because they think it has the same mass and strength building capability in people as it does in animals.

But clenbuterol also has serious, immediate side effects in humans. In Spain, between March and July 1990, 135 people became ill after eating beef liver that contained clenbuterol residues. Their symptoms included fast heart rate, muscle tremors, headache, dizziness, nausea, fever and chills. Symptoms appeared from 30 minutes to six hours after they ate the liver and lasted for nearly two days.

Like most other steroid alternatives, the long-term effects of clenbuterol are not fully known. But, Leggett says, some serious cardiovascular complications may result from their use.

In many instances, veterinary drugs are used simply because they are easier than human drugs to obtain, Leggett says. "Historically, there are places in this country, particularly in rural areas, where just about anyone could walk in and purchase a veterinary equivalent of a (human) drug that would require a doctor's prescription."

Gamma Hydroxybutyric Acid

GHB is an investigational new drug that powerfully and rapidly induces sleep and depresses the central nervous system in animals and humans, according to Leggett.

The drug has been illegally marketed as a steroid alternative both openly and "in the back room" in gyms, spas, and health food stores and advertised in bodybuilding magazines. Promoters claim it stimulates production of human growth hormone and thus produces muscle mass and weight loss. It has also been promoted as a sleep aid and touted as a street drug.

But GHB is extremely dangerous.
A Duluth, Ga., teenager getting ready for his high school prom on May 11, 1990, drank a concoction of water and Somatomax PM, a powdery substance containing GHB his friend had bought at a health food store. Instead of getting the "high" he had expected, he was in a coma 20 minutes after taking the drink. Fortunately, his parents soon found him, and with emergency treatment he recovered.

There were 80 hospitalizations from GHB use reported through November 1990, according to a national Centers for Disease Control study published in the Nov. 30, 1990, issue of Morbidity and Mortality Weekly Report.

Patients reported that within 15 to 60 minutes of taking one-half to three teaspoons of GHB, they developed symptoms such as vomiting, drowsiness, dizziness, tremors, seizure-like movements, unconsciousness, slowed heartbeat, lowered blood pressure, breathing difficulty, and breathing cessation. Patients recovered, usually with emergency room care in 2 to 96 hours. There have been no reported deaths.

Human Growth Hormone

Human growth hormone, manufactured using recombinant DNA technology, is identical to the natural hormone. Some athletes believe that HGH promotes muscle growth and muscle strength although researchers have not confirmed these claims.

Lyle Alzado, a former Los Angeles Raiders defensive lineman, said in a July 4, 1991, New York Times article that human growth hormone has become the drug of choice for today's athlete, primarily because it undetectable in drug tests. Alzado died May 14, 1992, from a rare form of brain cancer, central nervous system lymphoma, which he attributed to his prolonged use of steroids and HGH.

Too much human growth hormone, produced by a hyperactive pituitary gland or a tumor, is the cause of acromegaly, a condition characterized by excessive growth of the bones of the hands, feet and face. Acromegaly is ultimately fatal because of resulting heart disease and other metabolic problems.

Erythropoietin

EPO, approved for treating anemias associated with chronic renal failure and zidovudine (AZT) therapy in HIV-infected patients, stimulates bone marrow to produce red blood cells. The hormone appeals to athletes because they tire less easily when taking it and because it is undetectable by tests presently used.

"It (EPO) increases the red blood cell count, and therefore the athlete is able to absorb more oxygen and increase stamina- the oxygen-carrying capacity of the blood system is just unbelievable," Leggett says.

But EPO use is not without risk. As the body's red blood cell count rises and the blood thickens, blood clots, heart attack, or stroke could result.

Abuse of EPO is especially risky among marathoners and long- distance bicyclists. As these athletes compete, Leggett explains, they lose body fluids, including blood fluids. Reducing blood fluids concentrates the already abnormally high red blood cell count, which can lead to polycythemia, an abnormal increase in circulating red blood cells.

"EPO can turn their blood to the consistency of Jell-O," he says.
Severe Penalties
Here are some potential health effects of drugs and other substances-ranging from the mildest to the most severe-used as alternatives to anabolic steroids.

Side effects
• greasy skin
• headache
• severe acne
• premature balding
• bloating associated with water retention
• dizziness
• chills
• drowsiness
• nausea
• vomiting
• muscle tremors
• fever
• fast heart rate
• slowed heart rate
• bloody diarrhea
• seizure-like movements
• lowered blood pressure
• breathing difficulty
• breathing cessation
• blood clots
• cardiovascular problems
• liver disease
• cancer
• heart attack
• stroke
• death

"We consider these things to have the potential for hazard when they're not monitored or taken in accordance with the supervision of a licensed practitioner," Leggett says.

"Many of these people take way above and beyond the directions for use simply because they feel 'the more the better.' That was true of anabolic steroids, too. The people who are taking these drugs are essentially saying, 'If one teaspoon is recommended, I'm going to take five and grow five times as fast.'"

With that philosophy, the potential for an overdose is very high-and so is the potential for death.

FDA is also concerned about the prescription, veterinary, investigational, and unapproved drugs used as steroid alternatives primarily because little is known of the short- and long-term effects these drugs may have on humans, especially when taken in higher-than-recommended doses or in combination with other drugs.

Comparing anabolic steroids to those steroid alternatives, Leggett says, "We approved all of these anabolic steroids for domestic use in treating diseases like anemias, osteoporosis, and certain cancers. We know what to expect from their label dosage and overdoses."

"We have no idea what a normal dosage or overdose is for many of the steroid alternatives or what might be their effect. This is because we've never seen any clinical studies reflecting their use in humans. So, we're completely without a baseline there."

Some short-term reactions from using steroid alternatives are similar to those associated with anabolic steroid abuse. These reactions include: bloody diarrhea, nausea, vomiting, severe acne, premature balding, bloating associated with water retention, and greasy skin.

"Those are all soft effects, which may or may not be very serious," Leggett says. "But if the preliminary effects from using steroid alternatives are similar to those associated with anabolic steroid abuse, then there is the potential for some of the long-term effects, too. Effects long-term steroid abusers experience include cardiovascular problems, liver disease, certain cancers."

Clenbuterol, gamma hydroxybutyric acid, human growth hormone, and erythropoietin, all banned in international competition, are some of the more popular steroid alternatives athletes are now abusing. But, Leggett says, this list is likely to grow as athletes experiment with different and new chemicals.

As athletes strive for bigger, more muscular bodies through chemicals, Leggett, expecting the worst, says, "I'm sure they'll come up with something someday that's even more disastrous than the few (drugs) we've seen in recent years."

Kevin L. Ropp is a staff writer for FDA Consumer. A Reprint From FDA Consumer Magazine Printed July 1993. This article originally appeared in the December 1992 FDA Consumer. Publication No. (FDA) 93-1207 We hope you found this reprint from FDA Consumer magazine useful and informative. FDA Consumer, the magazine of the U.S. Food and Drug Administration, provides a wealth of information on FDA- related health issues: food safety, nutrition, drugs, medical devices, cosmetics, radiation protection, vaccines, blood products, and veterinary medicine. For a sample copy of FDA Consumer and a subscription order form, write to: Food and Drug Administration, HFI-40, Rockville, MD 20857. *U.S. Government Printing Office 1993-342-343-/80027

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