Studies are popping up that highlight safety risks associated with testosterone drug use, and the FDA said last month it would reassess the issue after two years of monitoring. But so far, the agency hasn't drawn any conclusions on whether testosterone treatments increase the risk of stroke, heart attack or death--and so a public advocacy group is taking matters into its own hands.
Public Citizen spoke out on the issue Tuesday, petitioning the FDA to immediately add its most serious warning to every testosterone-containing drug sold in the U.S. The demand for black box warnings follows 14 studies that show a significant increase in cardiovascular risk increase, the group says.
It's a move that could have some big implications for Big Pharma. IMS Health expects the market to hit $5 billion by 2017, with Eli Lilly ($LLY) and AbbVie ($ABBV) among the beneficiaries.
Public Citizen's Health Research Group founder and senior adviser, Sidney Wolfe, criticized the FDA's current stance on the drugs, labeling it "reckless" and "a betrayal" in the face of mounting evidence. "It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks," he said in a statement.
While the FDA takes its time making up its mind, drugmakers will continue plowing ad dollars into marketing. And while the agency approved the drugs for low testosterone caused by medical problems, critics have said advertising is steering men toward using the drugs as lifestyle treatments. Axiron maker Eli Lilly, AndroGel maker AbbVie and former Testim partners Auxilium ($AUXL) and GlaxoSmithKline ($GSK) helped grow the testosterone market by 90% in 5 years to hit $1.9 billion in 2011.
If a November study in Journal of the American Medical Association holds any weight, drugmakers may have something to worry about. Published last year, the study found that using testosterone increased the risk of death from heart attack or stroke by 29% in men with or without a history of heart disease. And last month, the FDA itself said another study had found an increased risk of death among men with preexisting heart disease, regardless of age.
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Editor's note: This story was changed to changed to reflect the fact that GlaxoSmithKline no longer markets Testim with Auxilium.