Agency injects uncertainty into clinic

A dark cloud hovers above the opening of NuMale Medical Center's first Florida-based testosterone replacement therapy center in Tampa — courtesy of the FDA.

The Food and Drug Administration issued a warning last week against testosterone treatments from patients suffering from no more than old age, the primary demographic NuMale serves. But Dr. Christopher Asandra, the founder of NuMale, tells Coffee Talk the FDA is suffering from “premature equivocation.”

“They're basing all of it on two or three flawed studies over the last couple years that don't represent what true testosterone replacement therapy is,” he says. “They're jumping to conclusions before they even get all the facts.”

The FDA fears those improperly using testosterone treatments face higher risks of heart attack, stroke or even death. But it's the fly-by-night testosterone centers that are giving everyone else the bad name, Asandra says, instead of clinics that individualize treatment based on regular testosterone level tests.

Many of the problems, NuMale President Brad Palubicki says, come from seeing patients who are given far too much testosterone. That type of hormonal overuse would certainly create serious medical problems down the road.

“We have seen patients who say they just gave themselves an injection from another doctor three days ago, but their levels” are twice what they should be, Palubicki says. “The overuse and abuse of testosterone is what will most likely lead to consequences.”