To some Americans, Canada can feel like an extension of the U.S. But when it comes to human growth hormone (HGH), the boundary between the two countries is a medical brick wall.
In Canada human growth hormone can generally be prescribed for "off-label" uses. That means Canadian doctors can use HGH to treat conditions for which the drug has not been explicitly approved. Thus Dr. Anthony Galea's use of HGH in patients in Canada is not against the law. Bringing HGH into the U.S, however, is illegal, and using HGH to treat athletes without therapeutic-use exemptions violates sports doping rules.
Off-label prescribing of drugs is not uncommon in the U.S.—some blood-pressure medications are prescribed to help headaches, for example—but federal law bans the off-label use of HGH. Oddly, anabolic steroids, which are controlled substances, can be prescribed off-label, while HGH, which is not a federally controlled substance, cannot. According to Rick Collins, a lawyer in Mineola, N.Y., with expertise in steroid law, disgraced Canadian sprinter Ben Johnson is one reason for that bizarre twist of law.
After Johnson's failed drug test at the 1988 Seoul Olympics, Congress held hearings on the use of anabolic steroids and growth hormone in sports. Steroid trafficking was already a crime, but until Congress passed the Anabolic Steroids Control Act in 1990 (thanks to testimony from coaches and doctors about the widespread abuse in sports), possessing steroids was not illegal. HGH was nearly added to the controlled substances list at the same time, but medical experts convinced Congress that HGH should not be "tarred by the same brush used for anabolic steroids," in the testimony of Dr. Louis Underwood, a pediatric endocrinologist. Underwood stated that HGH had not been shown to have as serious side effects as steroids and that making HGH a controlled substance would slow research on the drug.
In an apparent effort to regulate HGH less tightly than steroids, Congress swapped HGH into the trafficking law from which steroids had been removed. But the wording of the regulations got ambiguous. Today, the law effectively limits distribution of HGH to adults to three specific FDA-approved treatments: for AIDS-related wasting, short bowel syndrome and growth hormone deficiency. The law has been interpreted to bar off-label prescribing of HGH, whether or not that was the original intent (and, some doctors argue, regardless of whether potential off-label applications show therapeutic promise).
Interpreting the law has been confusing for many American doctors, and apparently for Galea as well. At a March talk in Vancouver, Galea said off-label use of HGH is allowed in the U.S. and cited Florida orthopedic surgeon Allan Dunn as a pioneer of it. Dunn has treated approximately 1,000 patients with HGH, including athletes; former NFL running back Abdul-Karim al-Jabbar was a patient. Dunn says he found that injecting growth hormone into the joints of mature rabbits regenerated cartilage, and that HGH injected into knees helps the human body to grow cartilage. "This has saved a number of my patients from needing a total knee replacement," says Dunn, adding that off-label use of HGH is "perfectly legal in many states." (Research indicates that many states simply don't have an explicit law regarding off-label use.)
It is unlikely that any Florida agency would take issue with Dunn's prescribing of HGH, but federal agents who monitor HGH issues could pay him a visit if they were so inclined. As some medical marijuana dispensaries in California have learned the hard way, just because a state law does not line up with a federal law does not mean the federal law is moot.
Dr. Thomas Perls of Boston University Medical Center has written articles for medical journals informing doctors that the off-label prescribing of HGH is illegal. Perls has other qualms with Galea's take on HGH as well. In a 2007 e-book Galea called HGH possibly "the one hormone that may actually reverse the aging process." Perls, an expert in the science of aging, calls HGH antiaging claims "the worst kind of quackery and hucksterism." He notes that studies suggest that growth hormone promotes the spread of existing tumors. "If that's true," he says, "then it can really cause great medical harm with no benefit." According to colleagues and patients, Galea has his middle-aged clients tested for tumors before treating them with HGH.