Testosterone has been on the market for decades, approved years ago by the US Food and Drug Administration (FDA) for treatment of hypogonadism, which translates to extremely low testosterone levels in men. Testosterone that is chronically low can be a health risk, and thus any risk/benefit profile associated with testosterone supplements favor men suffering from hypogonadism as the risks associated with chronically low testosterone far outweigh those associated with testosterone supplementation.
However, ever since manufacturers of testosterone sniffed a market in aging men attempting to recapture the fountain of youth (testosterone ebbs naturally as people age), the push has been on to make testosterone therapy a regular component of men’s health.
To that end, manufacturers reportedly have been pushing (and funding) courses designed to educate doctors on the benefits of testosterone amidst allegations that such courses are downplaying the risks associated with testosterone side effects.
According to the Journal Sentinel/MedPage Today, a doctor education course funded by the manufacturer and marketer of AndroGel allegedly communicated to physicians that they could safely prescribe testosterone to men suffering from prostate cancer. There was allegedly no mention in the course that testosterone can actually fuel some forms of prostate cancer. And this, in spite of the fact that treatment guidelines and product labels do indeed warn against prescribing testosterone to men suffering from prostate cancer.
There are various testosterone side effects, including testosterone stroke and testosterone heart attack. One recent plaintiff whose testosterone lawsuit is part of the multidistrict litigation for testosterone products (IN RE TESTOSTERONE REPLACEMENT THERAPY PRODUCTS LIABILITY LITIGATION COORDINATED PRETRIAL PROCEEDINGS NO. 14 C 1748, MDL NO. 2545, US District Court, Northern District of Illinois, Eastern Division) is a 54-year-old resident of Waukesha.
Jeff Goehring filed his testosterone lawsuit this past July claiming health issues allegedly stemming from his use of AndroGel. According to court documents, Goehring went to his doctor complaining of fatigue - an issue grasped by the testosterone manufacturing and marketing community as a key driver of prospective patients to testosterone supplements. A natural drop of testosterone with age - or the ebb and flow of testosterone levels, which can fluctuate throughout the day - can leave an individual feeling fatigued. It’s a natural process of aging, but manufacturers of testosterone supplements appear to have an answer for this. Regardless of the FDA stance on testosterone and the agency’s approval of testosterone supplementation that has little to do with fatigue, manufacturers are alleged to be actively promoting testosterone supplements to doctors by way of courses and speaking engagements by other doctors.
While manufacturers are not allowed to actively promote a drug to doctors for uses not approved by the FDA, doctors nonetheless have sway to prescribe drugs off-label, and manufacturers have found a way around the promotion regulations by funding courses and paying doctors to speak, on their own accord, to colleagues.
Back to Goehring, who was prescribed testosterone supplementation therapy in 2009 after tests showed his levels of testosterone were low. Four days after he began taking AndroGel, Goehring collapsed from a stroke. He has launched a testosterone lawsuit against AbbVie.
This past spring the FDA attempted to clarify the fog surrounding testosterone supplementation by mandating a label change outlining the fact testosterone supplementation is not approved for men with sagging testosterone levels from aging (still, that doesn’t prevent doctors from prescribing it, as physicians have the authority to supersede that of the FDA). Later, this past August the FDA announced that it would require manufacturers of testosterone products to conduct a controlled clinical trial.
There will be much interest in the outcome, but according to noted cardiologist Stephen Nissen of the Cleveland Clinic, results could be years away: such a trial could involve 10,000 participants.
“It’s going to be big and expensive, but these drugs bring in billions of dollars,” Dr. Nissen, the chairman of cardiovascular medicine at the Cleveland Clinic, said in published comments. “The sooner we start, the sooner we answer it.”
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Meanwhile the active marketing of testosterone for the so-called “Low-T” phenomenon continues, seemingly unabated. Given the associations with heart attack and death that could lead to testosterone death, lawsuits are expected to continue. Since 2010, testosterone products have been linked to more than 3,900 serious complications, according to a Journal Sentinel/MedPage Today analysis of reports made to the FDA. Nearly a quarter of those reports cited cardiovascular problems such as heart attacks or blood clots.
The reports include 150 deaths and nearly 2,000 hospitalizations.