With the September 17th recommendations from a panel of Food and Drug Administration advisors that the agency impose strict new limitations on the multi-billion dollar testosterone drug industry, the secret behind the marketing of these products, like AndroGel®, has been revealed. The smoke and mirrors pitch that these drugs will help the average male feel more alive, more energetic, and more youthful has been sufficiently debunked.
In its decision, the FDA’s 21-member panel elected to tighten labels for the drugs to reconfirm that they are not indicated for men who are simply looking to relieve symptoms associated with aging.
The Meaning Behind These Findings
How did it get to this point? And why would the FDA have to convene a panel of its external experts and hand down a formal opinion on the use of testosterone to doctors as well as consumers?
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.
What Users of Testosterone-Related Drugs Should Know
The FDA has issued warning letters to sponsors of these products over “inappropriate and misleading promotions”, referring in its presentation at the Advisory Committee meeting to one ad specifically that 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”, with the implication that the product could be used successfully to treat sexual dysfunction. Yet as early as 2004, substantial data proved otherwise. That was the year the Institute of Medicine issued a report that found “a systematic review of the medical literature on testosterone therapy … demonstrated that there is not clear evidence of benefit for any health outcomes examined.”.
What is critical for users of prescriptive testosterone products to know is the alarming risks testosterone creates for both users and those who are secondarily exposed to the product. In January 2014, the FDA issued a drug safety communication indicating that it is “currently investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.”. This review was promoted by several studies that have linked testosterone use to these serious side effects. The FDA noted it would communicate its final conclusions and recommendations after the evaluation is complete.
Meanwhile, the evidence of dangerous side effects of these drugs continues to mount. There is a strong association between the use of these drugs and the worsening symptoms of prostate and breast cancer. . There is also a black box warning on these drugs related to serious injuries that can be suffered by women and children who are secondarily exposed to testosterone. [4,5].
Further, there is ample evidence linking use of these products to an increased risk of catastrophic events such as heart attacks, strokes, and even death. A study published in 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. Those under the age of 65 with a history of heart disease had a two-to-three fold increased risk of heart attack. Given the robust and ever-growing body of evidence linking testosterone use to serious cardiovascular injuries, there is a deep need for manufacturers to warn doctors properly and alert the public of these dangers.
Taking The Lead –
Levin, Papantonio’s Testosterone Lawsuit
At Levin, Papantonio, we were among the first law firms in the country to file a lawsuit on behalf of those who had suffered cardiovascular injuries as a result of testosterone use. With the troubling information that we are discovering, we are glad to take the lead in pursuing justice for these men. Recently, the federal court in Illinois handling the nationwide testosterone litigation appointed Levin Papantonio lawyers to the prestigious executive committee handling this litigation on behalf of those injured.
The marketing that has built the billion dollar industry for prescription testosterone drugs and the spin that has followed when manufacturers are forced to answer questions about their serious, and sometimes deadly, side effects defies the trust that the public has given to those who make and market prescription drugs. We at Levin, Papantonio await the results of the FDA investigation into cardiovascular injuries linked to testosterone use and continue to soldier forward for those who have fallen prey to this spin.
1Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy: Testosterone and Aging Clinical Research Directions. Washington: The National Academies Press (2004).
2 Testosterone Products: FDA Drug Safety Communication, January 31, 2014.
3 Shalender Bhasin et al., Testosterone Therapy in Men with Androgen Deficiency Syndromes: An Endrocrine Society Clinical Practice Guideline, 95(6): J Clin Endrocrinol Metab. 2536-2559, 2546 (2010).
4See e.g., Androgel 1% Prescribing Information, Revised 5/2013
5 A black box warning is the most serious type of warning utilized by drug manufacturers and the FDA. It is reserved for conditions which can cause serious injury and/or death.