AbbVie’s AndroGel Testosterone Hit By Heart Study
Maybe a little ‘Low T’ is something men can live with. How so? For the past several years, elixirs for boosting testosterone levels have been widely touted for curing low sex drives amid controversy over their benefits and research suggesting the malady is less common that advertising suggests. Now, though, a new study finds that the drugs raised the risk of a heart attack, stroke or death by 29 percent.
Last year, AbbVie’s (ABBV) AndroGel sales totaled nearly $1.2 billion, a 32 percent rise, making the gel the second-biggest seller for the drugmaker behind the Humira rheumatoid arthritis treatment, which had sales of more than $9 billion. AbbVie stock is up about 40% year-to-date, since being spun off by Abbott (ABT).
The study, which was published in the Journal of the American Medical Association, reviewed data from more than 8,700 men who underwent an angiography at one of 76 cardiac catheterization labs in the US Veterans Affairs health system between 2005 and 2011. Their average was in the early 60’s and many had underlying illnesses, including prior heart attacks, diabetes and high blood pressure.
Nearly 26 percent of the men using a testosterone gel, patch or injection had an adverse outcome within three years, compared with nearly 20 percent of those who did not use testosterone. It was unclear, though, how testosterone may increase heart risks, but possibilities include evidence that testosterone may affect blood platelets and lead to clots, atherosclerosis or coronary plaque.
The findings come amid years of aggressive promotion of testosterone. The study noted that annual prescriptions for testosterone increased by more than 5-fold from 2000 to 2011, reaching 5.3 million prescriptions and generated sales of $1.6 billion in 2011. In addition, professional society guidelines recommend testosterone therapy for patients with symptomatic testosterone deficiency.
This age group “represent a sizable group of testosterone users, and there is only anecdotal evidence that testosterone is safe for these men,” wrote Anne Cappola, a hormone expert at University of Pennsylvania and an associate editor at JAMA in an editorial. “In light of the high volume of prescriptions and aggressive marketing by testosterone manufacturers, prescribers and patients should be wary." The findings warrant "both cautious testosterone prescribing and additional investigation.",
The marketing for the drugs has been controversial. Two years ago, for instance, a group lodged a formal complaint with the independent Pharmaceutical Advertising Advisory Board in Canada over a promotional campaign for the AndroGel testosterone gel that was sold at the time by Abbott Laboratories (ABT). Since then, Abbott spun off a unit now called AbbVie, which sells the product.
They charged that Abbott was promoting AndroGel for unapproved uses, exaggerating implied effectiveness, potentially harming public health due to cardiovascular side effects associated with the gel and violated Canadian law by failing to disclose that the drugmaker was sponsoring various ads and communications aimed at consumers and physicians (back story here).
Three years ago, a study in The New England Journal of Medicine found that only 2 percent of men aged 40 to 80 suffered from the condition, which is also called male menopause, andropause or late-onset hypogonadism. The researchers measured testosterone levels in 3,369 men between those ages and then correlated their levels with different symptoms.
Meanwhile, the ‘Low-T’ web site run by Abbott at the time (and now by Abbvie) was criticized for its overstating the extent to which men develop low testosterone. The site claimed more than 13 million men in the US over the age of 45 develop low levels and a spokesman pointed to a pair of studies used to bolster the notion that low testosterone will increase substantially with age, including in men well past 65 years old (see earlier Pharma news).
To read the remainder of this article, go to Pharmalot.
Ed Silverman, a contributing editor of YCharts, is the founder and editor of Pharmalot. He previously reported on the pharmaceutical industry and other business topics for the Star-Ledger of New Jersey, New York Newsday and Investor’s Business Daily. He can be reached at firstname.lastname@example.org. Read the RIABiz profile of YCharts. You can also request a demonstration of YCharts Platinum.
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