Craig Klugman, Ph.D.
Have you ever wondered what happens to drugs when a company finds them to lack promise or they prove to be dangerous in animal testing? One might expect that such compounds are shelved or destroyed. But in the case of GW501516 by GlaxoSmithKline (GSK), the compound has become the darling of competitive athletics.
According to Julie Deadorff’s article in the Chicago Tribune, one drug known as GW501516 failed because it caused cancers in lab animals. GSK began looking at the drug in 2005 as a treatment for raising HDL cholesterol to counter metabolic syndrome. By 2006, GKS had ceased research on the drug and made its findings public.
Even though the drug will never be approved for human use, it is one of a number of unregulated chemicals used in research that have been picked up by power athletes such as competitive bodybuilders and cyclists. GW501516 is attractive to these athletes because it activates PPARδ and AMP-activated protein kinase, the same pathways that are activated by physical exercise. In lay language, the drug helps the body to burn fat as energy and increase lean muscle mass. The drug held promise for obesity, diabetes and cardiovascular disease. Recently, the World Anti Doping Agency issued a warning against using GW501516, following up their banning of the substance in 2009. Just this month, a Russian cyclist was suspended after testing positive for the drug.
Because the drug is no longer being developed or considered for clinical trials, it exists in a limbo where it is unregulated. While GSK does not manufacture or sell GW501516, they did publish the chemical compound, enabling any drug manufacturer to produce the drug. Various websites offer advise from long-time users on everything from how much to use and how often to what results one can expect. You can even purchase GW501516 through the online black market for under $100. The websites (and according to Deadorff, the bottle) has a warning “For research purposes only, not for human consumption.”
On the one hand, autonomy suggests that an individual has the ability to make choices about what to put into his or her own body. Thus, a person armed with knowledge of the potential risks and benefits should be free to make a choice. The downside to this way of thinking is what happens if people who have ingested this substance start developing cancers. Their cancer treatment will be paid for out of their insurance, meaning by all of the people who have paid insurance premiums, or by federal and state governments, or charity. In other words, the price to be paid for using the dangerous substance is not just paid by the user, but also by society-at-large. One could also state that any person who willingly ingests such a substance proven to be harmful might lack the very competency and capacity that autonomy presumes.
If these abandoned drugs are dangerous and pose a harm to human beings, then these drugs should be regulated by more than a simple “for research purposes only” label. We may need to develop a national policy to control these substances so that not any person can have research substances delivered to their home or to a random P.O. box. Such policies, however, would create concerns about whether a government is overstepping its bounds and trying to create a “nanny state” where agencies protect people from all sorts of risky behaviors and dangers, including the people themselves.
Of course it could turn out that GW501516 only causes cancers in small lab animals and does not have that effect in humans. The answer might be to locate individuals who have taken the drug and ask them to be part of a research study looking at the effects in humans. This would not be a clinical study, but a study of use of an unregulated drug in nature.
GW501516 is not the first and won’t be the last dangerous drug that athletes use in an untraditional manner. Epo, a drug that increases the oxygen-carrying capacity of blood is a perennial favorite with known dangers. This case shines a penlight on a subculture where any health risk is worthwhile in order to gain a potential edge or shortcut to physical greatness. The problem might not be a system of regulation or policies, but a culture that creates such competitiveness and body image problems that individuals willingly consume carcinogenic agents in hopes of a short term win. This should not be surprising. In the 1980s and 1990s researcher Bob Goldman repeatedly surveyed world-class athletes, asking if they would take a pill that guarantees them a gold medal but would kill them within five years. During each survey, over 50 percent of respondents said they would.