'T' clinics create concerns about care, competition

National Report-One only needs to do a Google search for “testosterone clinic” to realize there’s an explosion of for-profit businesses branded as men’s health establishments, offering what sounds like the fountain of youth to men with “low T” and sexual dysfunction. Unless one of these practices is affiliated with an academic medical center or urology group, there’s a good chance urologists are not part of the picture. In fact, primary care and emergency medicine doctors and even chiropractors might be directing patient care at these clinics.   

Urologists are concerned.

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Dr. KaplanNot only are urologists, who are among those who specialize in treating men with sexual dysfunction and hypogonadism, not leading the men’s health charge, but it also seems these clinics are getting men’s attention, potentially driving business away from traditional medical centers. 

“[Men’s health] is clearly not owned by urology, but urology can have leadership, particularly because many of the issues that drive men into the health care system are urology based,” said Steven A. Kaplan, MD, professor of urology at New York’s Icahn School of Medicine at Mount Sinai and director of benign urologic diseases and the men’s health program at Mount Sinai Health System. “I think we have an opportunity in a field that’s kind of muddled to bring scientific validity, credibility, and more importantly, value to our patients.

“There’s a lot of hocus-pocus out there. They do prey a little on men’s insecurities and promise them they’re going to be 25 years old. I can tell you that no matter what I do, I’m not going to make a 55-year-old man 25.”

Dr. JamesonJason J. Jameson, MD, senior associate consultant in urology at Mayo Clinic in Phoenix, says the approach at Mayo Clinic is that men’s health is much more than male sexual dysfunction and hypogonadism.

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“These issues can be markers of other systemic disease, particularly cardiovascular disease and potentially metabolic syndrome,” Dr. Jameson said.

Next: Care concerns

Care concerns

There is a lack of scientific evidence comparing the care at the so-called “shot clinics” to traditional urology care for the same conditions. The reason, according to Dr. Jameson, could be that it’s hard to study businesses that deal in cash or bypass insurance, which the clinics often do. In fact, it’s difficult to even put a number on U.S.-based clinics that cater to men’s health.

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Dr. HotalingBut there is anecdotal evidence of quality of care problems associated with the shot clinics, as well as some evidence showing concerning care trends among men on testosterone. James M. Hotaling, MD, MS, assistant professor of surgery (urology) and co-director of the Center for Reconstructive Urology and Men’s Health, University of Utah, Salt Lake City, says he and colleagues have presented an abstract based on MarketScan data from the Centers for Disease Control and Prevention, which demonstrates that from 2003 to 2013, the use of testosterone has increased fourfold in men ages 18 to 45.

“That’s a significant concern,” Dr. Hotaling said. “I see one to two patients a week from these clinics who are angry because they have been placed on testosterone, are now azoospermic, and had not been counseled about this likely side effect of the medication.”

The men’s health clinic at University of North Carolina focuses on cardiology, urology, and sexual dysfunction. The for-profit injection clinic in the next town purports to be a men’s health clinic, but only does injection therapy for erections and testosterone supplementation, according to Culley C. Carson III, MD, professor of urology, University of North Carolina, Chapel Hill.

Dr. Carson said he doesn’t think shot clinics like these are safe because most are run by physicians who do not have medical backgrounds in men’s health. Often, there’s no system in place to care for complications that occur. Dr. Carson said he sees patients from the nearby clinic who have been overdosed on testosterone, to where their levels are much higher than most endocrinologists or urologists would accept.

Dr. Karpman“I think with any disease state, you want the specialists who are trained to deal with not only these conditions but also the complications of the treatments,” said Edward Karpman, MD, director of the men’s health center at El Camino Hospital, Los Gatos, CA. “If you’re giving guys testosterone but you don’t know what you’re looking for on a rectal examination or you don’t know of all the pitfalls of testosterone replacement therapy, you shouldn’t be doing it.”

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In fact, even urologists might hesitate to offer some of the services offered at the clinics. One example, according to Dr. Carson, is stem cell treatment for erectile dysfunction, which some clinics are promoting.

“The stem cell treatment that they’re using is approved for orthopedic use. These clinics… are offering it for erectile dysfunction,” Dr. Carson said. “Number one, there’s no data. Number two, it’s not FDA approved for use in erectile dysfunction or in the penis. Number three, there have been some studies done on stem cell injection therapy in the penis for erectile dysfunction and none of those have shown very good results. So to me, it’s the ultimate scam of our male patients.”

Next: Is urology missing the boat?

Is urology missing the boat?

Dr. CarsonThe experts interviewed for this article agree that one of the things that the for-profit clinics are doing a lot of is marketing-something urologists rarely do.

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“They market like crazy. It’s a different kind of marketing-more lifestyle focused. And it often promises a little more than can be delivered,” Dr. Carson said.

Urologists might see lifestyle marketing as unethical or cheesy, Dr. Karpman said. But the reality is that the aggressive marketing has been so effective that many patients are convinced they should go to these clinics, and not doctors’ offices, for their care.

“Patients don’t know that we are the true gatekeepers of these disease states and that many of these patients can get their treatments covered by insurance or at a greatly reduced cost by coming to us. Unknowingly, they go to these shot clinics to get treated and really get taken advantage of,” Dr. Karpman said.

It’s ironic that the heavy marketing has in some ways led patients to seek assistance for what has previously been a taboo topic for many men, according to Dr. Jameson.

“While it is great that men are opening up about their health concerns, providers need to have a detailed understanding of the proper diagnosis and treatment of these conditions, and the risks and benefits should be thoroughly discussed with patients and documented,” Dr. Jameson said.

Another big difference between shot clinics and traditional medical practices that focus on men’s health is the clinics are run like cash businesses, free of the regulatory burdens of traditional insurance-based medical practice.

“Most of these companies do not take insurance,” Dr. Hotaling said. “We see many patients [from these centers] who pay $300 or $400 a month, and maybe $3,000 a year in addition to that for their annual ‘physical’ for their testosterone. And that’s in Utah, which has one of the lowest insurance reimbursement rates in the country and a very low cost of living.”

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Men are willing to pay cash for the promise of youth and vitality. Testosterone therapy in particular is big business. It’s so big that Time devoted its Aug. 18, 2014 cover to “Manopause?! Aging, insecurity and the $2 billion testosterone industry.”

Next: Clinics tend to be upscale and don't feel medical

These clinics tend to be upscale and don’t feel medical, Dr. Hotaling said. He described the model as, “You go to the barber shop to go hang out with your buddies, and you just happen to get a testosterone shot.”

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“From a business opportunity, you’re selling a drug that makes everybody feel better and once you go off it, you feel terrible. Almost any man you put on testosterone will feel better,” he said.

The profit margins can be huge, Dr. Hotaling said. These clinics might be charging patients $400 a month for testosterone that actually costs from $20 to $50.

“There’s also the issue of convenience. A lot of urology clinics operate during normal business hours. Also, most clinics in urology are not set up to take cash,” Dr. Hotaling said.

Traditional medical practices within academic centers have the benefit of full access to specialists but are not able to respond to male patients’ demands as quickly. A great example, according to Dr. Hotaling, happened at Utah’s Center for Reconstructive Urology and Men’s Health. The urologists there used to administer testosterone pellets (Testopel). The procedure takes 5 minutes; the pellets last 3 to 4 months and patients love them, he says. But when insurance companies put an end to most of their coverage for the pellets, hundreds of patients who had been going to the center were left having to pay $3,500 to $4,000 per treatment. Many have since turned to cash-pay clinics for compounded testosterone injections.

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“We went to our institution and said, can we compound these testosterone pellets, which is what a lot of these testosterone clinics do, and give it to our patients for let’s say $400 or $500 (a price point that’s reasonable). And our institution said no way,” Dr. Hotaling said. “There’s just a lot more regulation at an academic medical center, which puts a lot of what we do at a disadvantage.”

Next: A case for urology

A case for urology

Dr. Hotaling says urologists are in an ideal position to lead men’s health.

“You have to ask, why are cardiologists running a hormone replacement clinic? That would be like me putting out a shingle that I’m going to start doing echocardiograms. Could I do it? Yes. Would it be optimal? Not necessarily,” he said. “Urologists give more comprehensive care. And I also think a lot of these clinics offer the care in a vacuum, where they don’t want to refer the patients out because they’re afraid of losing their patients.”

More on testosterone: T found beneficial in men 65 years and older

Now is an especially opportune time for urologists to get more involved in male testosterone treatment, given the recent release of data from the Testosterone Trials and other important studies, which should help to allay safety concerns about testosterone therapy among patients and lift the burden about those fears off urologists, Dr. Carson said.

Education about evidence-based men’s health is needed, according to Dr. Jameson.

“With regard to hypogonadism, I think the focus really should be on appropriate diagnosis, testing, and treatment. And that should be the focus whether that is done in a low-T clinic, in a primary care office, or a urology office,” Dr. Jameson said.

There are various guidelines available for hypogonadism, including the consensus statement by the Sexual Medicine Society of North America, released in 2015 (www.smsna.org/V1/about/position-statements).

Read: Groups urge increased focus on men’s health

It appears all providers might need some educating, according to a study examining data from the nation’s largest commercial insurance databases of 61,474 men aged 40 and older (Public Health Rep 2015; 130:143-52). Study patients had received at least one prescription for testosterone therapy from 2001 to 2010. The study’s authors found that a substantial number of men prescribed testosterone therapy did not receive testosterone or PSA testing before or after starting treatment. And nearly one in five of the men treated had baseline serum testosterone values above the threshold defined as normal by the Endocrine Society. Urologists and endocrinologists were more likely than other specialists, including primary care physicians, to treat patients according to the guidelines, the authors found.

Next: Treat men's health department more like cosmetic surgery or an elective specialty

Taking a lead in men’s health could require big changes in thinking for traditional urology and academic medicine, according to Dr. Hotaling. An important step, at least for hospital-based men’s health centers, would be to treat the department more like cosmetic surgery or an elective specialty, enabling more rapid response to market demands.

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Urologists need to tackle the issue of monetizing men’s health, according to Dr. Kaplan.

“You could have a concierge option,” Dr. Kaplan said. “Concierge is going to deal a lot more with things like exercise, nutrition, hormonal health, as well as traditional diagnostic testing and ultrasound. You can do it in a parallel way [with traditional medicine] but not in the same office.”

If urologists don’t provide men’s health care services, including low testosterone and sexual dysfunction therapies, there are plenty of other people who will, according to Dr. Hotaling. Taking steps to better meet male patients’ demands could be an opportunity for urologists to be involved in more male patients’ overall, long-term health care, he said.

“Some of the men going to these clinics, that’s the only medical care that they’re getting,” Dr. Hotaling said.

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