When we first covered the alleged link between testosterone drug therapy and cardiovascular problems–particularly in older men–last June, there were about 50 such cases pending across the country. Now there are at least 1,500, and that number is growing every week. Reports do not vary much from individual to individual; complaints of heart attack, stroke, pulmonary embolism, and deep vein thrombosis are most prevalent, though some deaths have been linked with the therapy as well.
A new angle on these cases is beginning to gain traction in both legal circles and in medical publications: an accusation of “disease mongering.” In March, the editorial board of the Journal of the American Geriatrics Society ran a piece in its publication claiming that so-called “Low T” is not an actual medical condition. One of its authors writes, “With advertising directed primarily at baby boomers, age-related complaints such as ‘slowing down’ and low libido are attributed to catchy medicalized-sounding syndromes like ‘Low T’ and ‘andropause.’ These symptoms are likened to menopause, which is a false and misleading analogy because middle-aged men do not experience any universal or sharp decline in serum testosterone.”
While testosterone replacement therapy is a completely acceptable and viable treatment for men suffering from hypogonadism (which causes abnormally low testosterone levels in the blood), critics claim that the drugs are being pushed on men who do not know any better. While a blood test is required to properly diagnose hypogonadism, many Low T patients have been prescribed testosterone supplements without having to submit to one. One attorney alleges that Low T “was made up in marketing departments of drug companies. I’ve never seen this level of disease mongering.”
This accusation may find some support when we take a look at drug companies’ spending accompanying its testosterone drugs. According to Forbes, Endo, manufacturer of Fortesta, spent $13 million marketing it in 2013, over $9 million of which went to educating doctors about Low T. Similarly, AbbVie, makers of AndroGel, spent nearly $76 million marketing its product directly to consumers through television and print ads.
Now that medical journals have begun to publish articles detailing the correlation between testosterone drugs and cardiovascular problems, the FDA has gotten involved. It now requires warnings about cardiovascular health on all testosterone supplements, and it has “urged doctors not to prescribe testosterone to patients who had not been confirmed as having hypogonadism through serum testosterone blood tests.”
One testosterone therapy patient, who endured a spinal stroke after being diagnosed with Low T at age 46, is now confined to a wheelchair: “I guess everyone wants to be better, but I was pretty good [without testosterone treatment]. If there’s a possibility someone could end up paralyzed the rest of their life or dead, the risk should only be taken by people who desperately need testosterone to live an ordinary life. I hope changes are made so this doesn’t happen to someone like me in the future.”
The first Low T drug cases, against AbbVie, are scheduled to start in October 2016.