The recent FDA Advisory Committee meeting on testosterone exposed the darker side of a drug that was originally created to help those suffering with a rare disorder, called hypogonadism. Since 2006, however, sales of prescription testosterone therapies have doubled and are expected to triple by 2017. The highest grossing of these products is AndroGel®. According to the manufacturer, AbbVie, sales of the drug topped $1 billion in 2013 alone, resulting in the use of the product by over two million Americans a year.
So how did an industry for a relatively unknown disorder grow at such an enormous rate in such a short time? Brandon Bogle, a lawyer handling the Testosterone litigation at Levin, Papantonio, filled me in on it all. It seems that the answer to that question is partially revealed by the FDA Advisory Committee’s findings concerning prescription testosterone labeling. In its decision, the FDA’s 21-member panel elected to “tighten labels for the drugs to reconfirm that they are not prescribed to men simply for men who are looking to relieve symptoms associated with aging.”
Why Both Testosterone Users And Non-Users Should Care About This Finding
From the outside, just reading that statement, this finding – along with an earlier communication which promised to study the effect of these drugs more deeply – seems like a slap on the wrist to the manufacturers of prescription testosterone therapies.
To understand its significance, we have to explore why the committee meeting was ordered by the FDA in the first place and why the FDA is investigating the link between these drugs and serious cardiovascular injuries. The answer is that in recent years, with the introduction of easier to use gels, the pharmaceutical industry seized on an opportunity to expand its reach – and build a new audience and generate more profit – with testosterone drugs, not on the basis of clinical evidence, but rather on potential market share.
An Industry Built Of Innuendo
At the committee meeting, an FDA representative stated that the agency has issued warning letters to sponsors of these products over “inappropriate and misleading promotions”, referring to one ad specifically which claims that patients who had taken a testosterone drug “would start chasing their wives around the room a little bit – they just feel like guys again”. The FDA concluded that such a statement “suggests that the product could be used successfully to treat sexual dysfunction”. Yet as early as 2004, in one of several reports, the Institute of Medicine found that “a systematic review of the medical literature on testosterone therapy…demonstrated that there is not clear evidence of benefit for any health outcomes examined.” Importantly, one of the outcomes measured by the Institute of Medicine was the effect of testosterone on sexual desire and performance.
The inescapable conclusion is that for over 10 years, a significant, reliable stream of data has concluded that prescription testosterone drugs have no significant effect on the ‘aging effects’ – the youthful vigor, libido and lean muscle mass of our youth – of users. During this time, the pharmaceutical testosterone industry has only increased its marketing efforts and more than doubled its profits.
Dangers And Risks That Testosterone Users Can Face
It is an industry built largely on the dubious promise of a fountain of youth for men. What’s more disturbing, however, is that this treatment is no harmless placebo. In fact, there is a wealth of data to connect testosterone usage to an array of harmful side effects. They can worsen the symptoms of prostate and breast cancer, and carry black box warnings – the most serious of all cautions reserved for conditions of injury or death – related to injuries that can be suffered by women and children who are secondarily exposed to testosterone.
For users, a growing body of evidence links use of these products to an increased risk of catastrophic events such as heart attacks, strokes, and even death. The journal PLOS ONE, found a two-fold increase in the risk of heart attack in men 65 or older within 90 days of the start of their testosterone therapy. Users under the age of 65 with a history of heart disease had a two-to-three fold increased risk of heart attack.
The dilemma faced here is a perfect example of the dangerous dance between marketing and pharmaceutical drug manufacturing. In this case, testosterone manufacturers transformed a drug that is useful to a very small subset of patients with serious medical conditions and gave it a marketing makeover in order to dramatically increase sales. Here, testosterone manufacturers offered the fountain of youth seeking to seize on the desire for baby boomer males to feel more youthful and vibrant. The problem is that these manufacturers offered this benefit without any legitimate evidence of a connection between testosterone use and the rejuvenation of these youthful traits.
Quite simply, there is little to no evidence that the natural decline of testosterone with aging is even a bad thing. Thus the makers of these products have relied on the ‘power of suggestion’. By packaging and rebranding the natural symptoms of aging – giving it a clever catch-phrase, and wrapping it in a multi-million dollar campaign built of innuendo – pharmaceutical companies have created a ‘consumer need’. In response to these aggressive and deceptive marketing practices, consumers have reached out to their doctors and so the cycle – and a multi-billion dollar industry – received its jumpstart.
Ellen Barnett is a writer and contributor to Ring of Fire.