File this under ‘a study in contrasts.’
Within 24 hours, two regulatory agencies took notably different positions on the virtues of low testosterone medications. Although widely touted for boosting male sex drive, moods and energy, they have also been controversial because some studies found the medicines may pose cardiovascular risks.
Yesterday, Health Canada asked drug makers to update product labeling after a review “found a growing body of evidence from published literature and case reports… for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate.”
This morning, the FDA reserved judgment. In response to a Citizen’s Petition from a consumer advocacy group, the agency rejected the idea of adding a so-called Black Box warning – which is placed on product labeling for the most serious health risks – and also requiring drug makers to send notices to physicians and upgrade patient medication guides to include information about cardiovascular risks.
The FDA believes “publication of these studies warrants further exploration of a possible safety signal regarding testosterone and cardiovascular risk. Our current evaluation remains ongoing,” wrote Public Citizen Health Research Group, which petitioned the agency earlier this year for upgraded warnings. The FDA “will continue to evaluate the cardiovascular risks of testosterone, and, if warranted, will take appropriate regulatory action to protect the public health when its evaluation” is complete.
This is not to say the FDA has ruled out issuing the same sort of warnings as Health Canada. In fact, the agency maintained that the concerns raised by the advocacy group “were all known to the agency” before the petition was filed. But the FDA argues “there is insufficient evidence of a causal link” between testosterone medicines and cardiovascular risks to support the added warnings.
There have been dueling studies over the virtues of testosterone treatments.
A study published earlier this year in PLOS One found the risk doubled during the first three months after starting therapy in men younger than 65 years old who had a history of heart disease. And the risk doubled for all men older than 65 – with or without heart disease – shortly after beginning treatment. The study relied on patient records of nearly 56,000 men, including more than 48,000 under age 65.
And last fall, a study in the Journal of the American Medical Association found the medicines increased the risk of heart attack, stroke and other cardiovascular events in men who had a history of heart disease. The study examined records of more than 8,700 men with low testosterone in the Veterans Administration health system, and was one of two studies that prompted the FDA to begin its review.
However, the JAMA study was attacked over methodology. Critics say the study included more than 100 women among the 1,132 subjects studied. And more than two dozen international groups have demanded that JAMA retract the article, although the journal has declined to do so.
Meanwhile, earlier this month, a study of 24,000 Medicare patients found that testosterone treatments did not increase the risk of a heart attack and may even have lowered the risk by about 30 percent in the group of men who were judged most likely to have one based on other factors. The study was published in the Annals of Pharmacotherapy.
Nonetheless, Public Citizen Health Research Group’s Sid Wolfe, a senior advisor, offered a tart response for the differing regulatory reactions and argued that the FDA “needs new, more public health-oriented leadership.”
In a statement, he wrote that, either “Canadian men are more sensitive to the cardiovascular risks of testosterone than American men, thus justifying new warnings in that country, but none, at this time, in the U.S., or the FDA is more sensitive to pressure from doctors dispensing more than 7 million prescriptions of testosterone in the past year and from the companies selling billions of dollars of testosterone products during the past year than Canadian regulators.”