Professor questions FDA mandate on performance enhancer andro
April 20, 2004
Questions concerning the health implications of Androstenedione, or andro, and whether it affected Mark McGwire’s 70-home run season in 1998 have trickled down to athletes and weightlifters.
Andro is a chemical naturally produced in the body. The supplement is marketed to increase testosterone levels in the blood, thus building muscles.
On March 11, the Food and Drug Administration mandated companies discontinue manufacturing, marketing and distributing products with andro.
Doug King, professor of health and human performance, said the FDA cites adverse side effects from too much testosterone. However, there is no evidence andro increases testosterone levels.
There are side effects from too much testosterone, but andro does not increase testosterone, he said.
An FDA official, Kimberly Rawlings, said the administration stopped allowing companies to manufacture or market andro because it felt it didn’t have adequate information about it.
“Based on the limited studies of andro and existing studies of steroids, we believe that the supplement may increase the risk of serious health problems because of the conversion in the body to active hormones,” Rawlings said.
In 1998, King and six others conducted a study in which some participants took doses of andro and others took a placebo. Both groups were put on the same eight-week training program.
Increased testosterone levels were not found in either group, but increased estrogen levels were found in those taking andro. A reduction of HDL-C, or good cholesterol, was found, as well as a strong placebo effect, King said. A placebo effect occurs when users experience benefits from a drug that has no actual effects.
By banning andro, the FDA is implying it works, which may increase usage among younger people, especially because they are not worried so much about long-term effects, King said.
Rawlings said the FDA usually does not do its own testing, but looks at supporting literature or studies of particular products and bases its decision on information from the scientific community.
Another factor in the ban on andro was that it was marketed after Oct. 15, 1994, making it, by FDA rules, a new supplement. FDA regulations require a new supplement to be submitted by a company to the FDA so it can evaluate its safety before the supplement is allowed on the market, Rawlings said. Since no company has submitted this drug to date, it is not allowed on the market.
As with any weightlifting supplement, andro affects each user differently. Though some believe it has nothing but a placebo effect, others believe andro provides a positive physical benefit.
James Fritz, member of the ISU Weight Club, said he experimented with andro once but discontinued usage after only two doses.
“It made my energy level go through the roof,” he said. “I felt like I was in a room with 500 kids screaming.”
He said he remembers being extremely tired, as if he had worn himself out. Fritz said he doesn’t think andro has a placebo effect.
“In my personal opinion, I don’t think a pill changes your state of mind,” he said.
Jason Nicholson, junior in mechanical engineering, learned about andro by working at GNC in Valley West Mall in West Des Moines.
“I’ve stayed away from [andro] because I’ve found that hormones are not something you want to play with — especially when you’re young, and especially testosterone,” Nicholson said.
He said he has known others who used andro to experience aggression and acne and develop breasts.