Over the past decade, according to the New York Times, testosterone replacement therapy (a form of hormone replacement) has quadrupled among men aged 40 and older. By 2011, about one in 25 men in their 60s was on a testosterone replacement plan. While this figure is staggering, this treatment initially offered a promising solution for out-of-shape men looking to strengthen their bodies more quickly than would otherwise be possible. Other benefits promoted by various pharmaceutical companies included increased energy, higher libido, and alleviated depression. Unfortunately, a study in Boston about ten years ago suggested those men taking supplemental testosterone also suffered “nearly five times the number of cardiovascular problems, including heart attacks and strokes,” which resulted in the trial being cancelled before it was completed.
Less than one year ago, this blog posted an article about risks associated with hormone replacement therapy for women–specifically estrogen and progesterone–and explained that those taking such supplements faced a higher chance of developing heart disease, blood clots (including potentially deadly pulmonary embolism), breast cancer, dementia, incontinence, and stroke. Now, similar threats are facing men: new studies have established that men over 65 stand a greater cardiovascular risk and increased chance of blood clots. A University of Washington professor is realistic about expectations, claiming that for people with very low testosterone levels “the benefits outweigh the risks.” But, he goes on to admit, “[F]or millions of others, it’s in the same category as snake oil.”
Several studies have concluded that testosterone therapy is risky, and these have been accompanied by a number of lawsuits, five of which (as of February) have been brought against Abbott Labs, manufacturers of AndroGel. Of these five men, three claim to have had heart attacks and two are claiming to have had strokes. One complaint argues that Abbott Labs “deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes while downplaying known adverse and serious health risks.”
Critics point to the fact that long-term data about these treatments simply do not exist yet. Says a Dartmouth professor: “We’re giving people hormones that we don’t know they need for a disease that we don’t know they have, and we don’t know if it’ll help them or harm them.” However, harm may be occurring even while these trials are happening. A Hunter College professor adds, “It’s in the pharmaceutical companies’ interest to have a trial going on for 10 years. In that time, they can continue to sell testosterone.”
Though AndroGel has been most prominent in the news, other testosterone supplements like AndroDerm, Testim, and Axiron have been embroiled as well. In light of these health scares, the FDA has finally agreed to launch an investigation into the potential correlation between cardiovascular health and testosterone treatments. As we have previously stated in these blog posts, it is unreasonable to expect pharmaceutical companies to police the safety of their own products. Consequently, the civil justice system remains the only tried and true bulwark standing between corporations worth billions of dollars and individual consumers who have been injured through no fault of their own.