Pharmaceutical companies and clinics spent years pushing testosterone therapy as a cure-all for aging men. That's all over now. Maybe.
Over the past decade, men with low energy, waning libidos, sour moods, and other vague symptoms of aging have been offered a convenient biological scapegoat for what ails them (at least the ones not purposefully trying to lower their sex drive). Aggressive drug marketing campaigns, under-regulated medical clinics, and willing doctors have offered, encouraged, and rewarded low testosterone diagnoses and self-diagnoses. The “Low-T” market, crowded with over-the-counter and off-the-shelf medications like Ageless Men’s Health, New Vitality, and 25 Again, has made a lot of money for those ready to promise men rock hard abs, diamond-cutter erections, and vitality. Whether or not it has truly remade men is another matter entirely.
The pharmaceutical industry started pushing testosterone treatments in the early 2000s, ramping up to a flurry of misleading marketing a decade later as the massive potential market came into view. One commercial for 25 Again (formerly known as Body Shapes Medical) aired in 2012 featured a be-stethoscoped doctor in a lab coat warning that men stop producing testosterone at 35. The good news, the doctor added, was that he could identify optimum levels and help men replenish them with self-administered butt injections. This would have been very exciting if the TV doctor had been telling the truth. But he wasn’t. Men gradually start to lose testosterone at age 35, but that’s not a problem and it’s not low testosterone. The treatment and the problem had been consciously uncoupled by advertisers.
Prior to the major marketing campaigns, testosterone therapy was a treatment for hypogonadism, a condition that occurs in only about 2.1% of men in which the testicles or pituitary glands fail to work because of cancer, congenital abnormalities, or the mumps. This didn’t stop pharmaceutical companies from pushing off-label uses, suggesting their new products could address a wide range of issues including low energy, decreased libido and sexual stamina, poor mood, and almost every other hazy symptom of male aging. The idea that andropause, the term for the male equivalent of menopause, could be cured had marketing legs even if that nomenclature lacked mass appeal. Low-T became a commonly treated medical disorder without becoming a common medical disorder because demand could be manufactured faster than lab workers could stuff pills and serums into hypermasculine packaging.
Someone was bound to get hurt. Lots of people, actually.
On September 29, 2015, David Lester, who sought treatment at a 25 Again clinic after seeing one of the company’s ubiquitous commercials, died of a massive heart attack reportedly caused by excess hormones. Testosterone levels have to be below 300 nanograms per deciliter to qualify as low. Lester’s were well in the 500 range when he was pronounced dead, according to court documents. Lester’s widow named 25 Again Medical Director Dr. Elizabeth Bates in a wrongful death lawsuit against the clinic, which remains litigation awaiting a trial date. Bates is no longer legally allowed to administer hormone treatments, but there’s plenty of reason to believe that clinicians around the country are still passing out testosterone treatments like Halloween candy.
A recently departed employee of an independent testosterone clinic operating in Ohio who declined to be named for fear of legal reprisal told Fatherly that the only doctor working with their team was under investigation for prescription fraud. “We weren’t allowed to talk about it at work… it was very hush-hush,” they stated, adding that the business’s co-owners didn’t seem to care so long as they had access to the product. “The two owners were definitely in this business to be able to get this stuff at cost. There were tongue in cheek references made to them not having to get their testosterone on the street.”
It took some time and money for testosterone to become a catchall cure for men who are not as manly as they used to be. In 1889, French physiologist Charles-Édouard Brown-Séquard injected himself with “juice extracted from a testicle, crushed immediately after it has been taken from a dog or a guinea-pig” and claimed in the pages of The Lancet that doing so increased his physical stamina, mental acuity, and the power of his urine stream. He was roundly mocked. In 1927, a team of scientists from the University of Chicago scientists discovered they could re-masculate castrated animals using isolates derived from bovine testicles and by the 1940s several groups had successfully synthesized testosterone. Still, it wasn’t until then the US Food and Drug Administration approved the first testosterone patch in 1995 that testosterone even had the potential to become a popular drug.
Testosterone prescriptions increased 12-fold from 2000 to 2011. At the height of the testosterone boom the addressable market size for Low-T treatments was understood by researchers to be between 5.6% and 76.8%, the massive spread representing the absurdly broad range of criteria for diagnosis. From patches to creams to injections, major pharma companies including Eli Lilly and Abbvie pushed treatments including AndroGel (made famous by baseball doping scandals), Fortesta, Testim, Axiron, and Androderm. They were well rewarded for their investment. Sales increased exponentially from $324 million in 2002 to $2 billion in 2012 as direct-to-consumer advertisements spiked interest in consumers and clinics alike. Around 2009, a testosterone marketing push in the Southeast and Great Lakes region resulted in men reporting exposure to up to 200 cumulative advertisements for Low-T treatments from 2009 to 2013. These men started showing up at clinics.
“Men 18 to 40, they don’t go to the doctor,” Dr. Stanton Honig, a urologist and the director of the Yale Medicine Male Reproductive Health and Sexual Medicine Program, explains. “They’re tired, running around with their kids, there are all these activities. They’re not sleeping, and not eating right, and not exercising, and gaining weight, and their libidos and energy are low. They’re looking for a quick fix.”
The majority of the testosterone prescriptions written during the 2000s were scribbled out on the pads of family practitioners, not urologists or endocrinologists. And many came at the request of patients. Up to a quarter of them were handed out without the requisite blood tests needed to ensure that testosterone treatments, which thicken blood, wouldn’t increase stroke risk. Despite evidence that these treatments might make men more prone to heart attacks and prostate cancer, the prescriptions kept coming.
The medical fallout for users was real, though hard to observe.
The real danger posed by testosterone treatments, according to Honig, is that they disincentivize men from addressing the underlying health issues that lower testosterone. Obesity lowers men’s testosterone levels (when obese men lost an average of 17 pounds saw their testosterone increased by 15%). Opiates lower men’s testosterone levels. Depression and other mental health problems are misdiagnosed as a manifestation of low testosterone. The treatments confuse and conflate real issues.
For men not struggling with obesity, drug addiction, or psychological problems, the biggest risk testosterone treatments pose is to their fertility. The problem is most keenly felt by new fathers interested in having more children. A natural testosterone decline occurs in early fatherhood, leading to some potential issues related to mood and sexuality. But testosterone treatments can take a toll of sperm production. When men use synthetic testosterone, their testicles stop working to produce both the hormone and sperm.
“They thought they were going to feel great and be rejuvenated, and then they found their sperm count was down to zero,” Honig says, noting that he sees up to two patients with fertility problems as a result of testosterone treatment a week. “Most of the time that’s reversible, but not all of the time.”
And, for many men, the results of treatments didn’t and don’t meet sky-high expectations. Steve, who declined to share his last name for medical privacy, was first diagnosed with Low-T by his GP in 2012 at the height of the testosterone boom when his testosterone started to naturally decline at age 51. At the time, his levels were at 170 ng/dL (270-1070 is the normal range) and he was apprehensive about the potential side effects. His doctor finally convinced him that the risks such low testosterone posed to his health were much greater than the risks the medication did — warning him he could get osteoporosis, break a hip, or have a heart attack.
Scared straight, Steve opted to take the testosterone in gel form. Since then, the problem has not been the side effects, but the overall cost. Like many testosterone consumers, he currently drives several hours to a compounding pharmacy to obtain an off-brand testosterone gel at a compounding pharmacy, per his doctor’s recommendation. Over the past seven years of taking it, his levels have increased to 300 ng/dL, but has only noticed modest improvements to his mood and energy, and credits increased bone density to taking calcium and vitamin D supplements rather than testosterone. He hopes to eventually cease treatments and the long expensive drives to obtain his testosterone gel but is not sure if he made the right choice.
“There are some medicines you have to weigh the pluses and minuses,” Steve says. “My story is not written and I don’t know what this will mean in the future. Nobody used to test for this, so nobody really knows.”
He’s not wrong.
The FDA started cracking down on pharmaceutical testosterone in 2015 after passing rules against the prescription of testosterone products for men experiencing natural declines due to aging — exactly what clinics and pharmaceutical companies had profited off for over a decade. Manufacturers were required to put warnings on labels. Since then, drug manufacturers have faced over 7,000 lawsuits with AbbVie alone facing some 4,600 over AndroGel. Many experts are projecting negative growth for the testosterone replacement therapy market until 2024 as a result of increased consumer concerns.
But demand doesn’t diminish quite so quickly. Disinvestment by pharmaceutical companies has opened the door for the proliferation of testosterone supplements not regulated by the FDA. Many of these supplements don’t do anything at all, but some supplements marketed as “all-natural” contain hidden pharmaceuticals that interact with other medications. New direct to consumer male-enhancement brands like Roman and Hims, which deliver Sildenafil (the active ingredient in Viagra), Sertraline (the active ingredient in Zoloft), and anesthetic penis wipes to stop premature ejaculation right to men’s doors, are moving into this confusing space — or, arguably, the confusing space right next door — as supplement companies begin to settle the same sort of cases that cost drug companies big money a decade ago.
“There’s a lot of money to be made selling supplements that sound too good to be true, and testosterone boosting seems to be one that’s in vogue right now,” says Robert Freund, an attorney who’s handled several supplement-related lawsuits. “There’s no admission of liability when they settled, so we don’t really know what would’ve happened if they went to trial.”
The advertised potential benefits of testosterone remain much more commonly understood and well known than the potential pitfalls.
Honig recognizes that testosterone can be important for a small number of men who need it, but hopes for a future where it’s deployed more responsibility. As much as we’ve come a long way from grounding up cow balls, there’s plenty of room for improvement when it comes to testosterone treatment. For men who not done having children, lifestyle changes like sleep, diet, and exercise along with medication options like Clomid, another off-label medication to treat male infertility, can increase men’s testosterone and sperm count at the same time, instead of sacrificing one for the other. The aftermath is still playing out, but if concerns about hormones can motivate men to see reputable doctors and specialists rather than clinics advertised on TV, it’s possible that the testosterone boom and bust might have helped men’s health overall. Though that’s a fairly optimistic narrative.
In the meantime, clinics that prioritized profits over patients might be on the path to accountability as more drug companies and doctors face legal consequences. Whether operators will bow out of the business gracefully or make a last grab for profits will depend on personal motivations. But it’s inevitable that more men will find themselves facing the consequences of buying into the Low-T hype.
“I suggest people do a lot of research before they choose a doctor for their hormone replacement therapy,” the former clinic employee told Fatherly. “We were often told at meetings that we were in it for the money.”
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