How the Low T Industry Is Cashing in on Dubious, and Perhaps Dangerous, Science

Sellers of testosterone therapy play -- some say prey -- on men's insecurities.
Sellers of testosterone therapy play -- some say prey -- on men's insecurities.
Illustration by Jeff Drew

Alex Truman didn't think something was wrong until he returned to the gym. Before fathering his two kids, he worked out regularly and even made an early career of exercise. He had two degrees in health and fitness and ran gyms on the East Coast before he moved to Dallas and got into sales. Lean and square-jawed, he knew his body. But in his late 30s, it was betraying him. At 37, he was taking cholesterol medicine. "I didn't have an awful diet," he says, "but I liked beer, I liked pizza." He yearned to feel better.

He headed back to the weights and machines where he'd spent much of his 20s. He'd lift and lift, but something was different. Back in the day, all his effort would produce tangible results: bigger, defined muscles in his arms and legs, more strength and less fat. Now, results like that eluded him. "I'd go five to six days a week," Truman says, "and not see any progress." He'd go running and wear out easily. "It was really pissing me off because I had it before."

Beyond the workouts, he just felt so tired. At 39, he shared a bedtime with his kids, and waking up in the morning was difficult. But Truman says it wasn't normal fatigue, echoing the sentiments of many men in his position. He felt as though he had pushed through an all-nighter for a test in college -- only he felt that way all the time no matter how much he slept.

Many men (and their doctors) would call this aging, but Truman believed something was truly wrong. So did his wife at the time, and she told him so. "Why don't you go get checked for low testosterone?" she asked. "I hear the commercials all the time."

The commercials for the treatment of low testosterone, or "low T," are ubiquitous, even becoming a punch line on The Ticket, the Dallas sports radio station that profits from the low T industry's advertising. All the commercials ask men if they're feeling tired, depressed or just plain run-down, especially in the bedroom; these are the "symptoms" of "low T." Then the commercials offer a possible cure: testosterone therapy. It can be in the form of gels, pills or injections, but the upshot is the same -- taking the hormone can make a man feel younger, healthier or just plain better, almost like he's back in college.

There are many testosterone providers in the Dallas-Fort Worth area -- indeed, men can get it from their regular doctors. By 2017, national sales will reach more than $5 billion, predicts Global Industry Analysts.

No place in North Texas is more prepared to cash in on those sales than the Low T Center, Mike Sisk's metastasizing chain of testosterone replacement clinics. Low T Center has sponsored race days at Texas Motor Speedway and planned to sponsor a high school football stadium, but that deal fell through. (Testosterone supplements are banned from high school athletics.) Sisk aims to have 60 clinics open across the country, one-fourth of those in DFW, by year's end, and he says he'll open another 60 next year.

After Truman's wife mentioned the commercials about two years ago, he headed to the first Low T Center location, in Southlake. A pretty, petite receptionist in black scrubs welcomed him. Signed jerseys hung on the walls. In a waiting area that employees call the "man cave," a flat-screen TV was tuned to ESPN. In a small room, a physician's assistant drew Truman's blood to test how many nanograms of testosterone he had for every deciliter of his blood.

The Low T Center will treat any man age 25 or older with a level of 350 ng/dl or lower, a common practice at testosterone replacement clinics. At the center, the man also has to exhibit "symptoms" of low T, which are outlined in one of the clinics' commercials: being "tired," "run-down" or "irritable." Employees say they turn away anywhere from 30 to 50 percent of the men who come in because they don't meet these criteria.

Truman passed the symptoms test when he told the assistant about his early bedtime and his inability to gain strength no matter how much he lifted. Then he waited for his lab report in the man cave. About a half-hour later, he got the news. "I think my number was like 70, 75," he says, "which is the equivalent to about an 80-year-old man, which is like, 'Wow, that explains a lot.'"

Usually the clinics will perform only one test to verify a man's low testosterone level, but because Truman was so low, he came back the next morning for another test. He was still below 100, he says. He received his first injection of testosterone, which the Low T Center gets from pharmaceutical giant Pfizer, Inc., that day. It seemed simple.

*****

 

Mike Sisk is a University of Tennessee alum and, now, a big booster.
Mike Sisk is a University of Tennessee alum and, now, a big booster.
Sebron Snyder

"You as a patient, I own you until the door closes [to the examining room]," Mike Sisk says. He's sitting inside his flagship Low T Center in Southlake in his office, which is only a couple of turns from the main entrance because he likes to be close to his customers. He outgrew his first central clinic, where Truman received his initial injection, about a year and a half ago and moved down the street to this location.

In a light-gray suit and University of Tennessee orange tie, usually with the jacket off, Sisk is not an imposing figure. Average height and medium build, with a balding pate, the body of the man who considers himself "patient zero" in the low T industry is not the greatest selling point of his low T empire - until he speaks.

His words spill out in the rapid-fire patter of a born salesman, as if he's trying to get his entire pitch in before the door closes in his face. The cadence increases when he talks customer service. That salesmanship, how he distinguishes his clinics from doctor's offices, how he gets men to look forward to their appointments instead of dread them, is his major contribution to the industry.

"The docs own you inside that room, and then as soon as the door opens, I own you again."

Not too long ago, Sisk didn't own much of anything. "I was just a country kid from Tennessee," he says. During his time at the University of Tennessee, he loaded boxes onto airplanes at night for FedEx. After he graduated, the company offered him a sales position, and he moved to Dallas. Here, he met his wife, a second-grade teacher in Oak Cliff. He then got a job at Ernst & Young, one of the world's largest audit firms, and put his MBA in finance to use. "I never really was a corporate guy," Sisk, who now runs a growing corporation, says. "I didn't fit in there, but I learned a lot, wouldn't take anything for those days."

Sisk moved back to Tennessee to care for his ailing father, who owned 7-Elevens. Despite his foray into the corporate sphere, he considered himself a one-man crew. "My dad was an entrepreneur," he says, and "I was always just that serial entrepreneur." About 10 years ago, he returned to Dallas and started his own finance company.

Then "I turned 40," he says, "and it was like somebody had turned the light switch off."

Sisk didn't know what had happened, why he was feeling so blue, so he visited his doctor. "He was doing various tests and said, 'You're just getting older and you're depressed. We're going to give you some Zoloft.'"

Instead, Sisk says he "found a guy who was willing to do some other tests, and he said I have low testosterone. He sent me home with testosterone shots."

For Sisk, the injections seemed too good to be true. "I was like, 'There's no way this shot makes me feel this good and something bad not happen.' I got to talking to doctors, and there's two schools of thought: There's guys that hate it, and there's guys that love it, so I really had to do my homework to understand what was happening there. Doctor Google was very helpful. I did a lot of stuff on Google."

American men have tried ways to slow down, even stop, aging's effects for generations. John R. Brinkley, the "Goat Gland Man," became a Texas legend for transplanting slivers of goat glands into men's testicles in the 1920s and '30s, a piece of quackery he advertised on an unregulated 500-kilowatt Mexican radio station that blasted country music from across the Rio Grande. Near the end of the century, testosterone therapy -- minus the goats -- had become less invasive but still was not approved by the Food and Drug Administration.

That changed in 1995, when the FDA approved a testosterone skin patch for men with a testosterone deficiency. AndroGel, a testosterone gel produced by Unimed Pharmaceuticals Inc., joined it on the market five years later.

The FDA's approvals opened the door for smart salesmen to sell testosterone and the idea of having low T to the masses. Sisk's wife had been injecting him in their kitchen, but he realized that wasn't the "best clinical answer." He got the idea for clinics dressed up as lounges, places that didn't resemble boring and sterile doctor's offices. He found a doctor to be his medical director and left his finance company to open his first Low T Center in Southlake in 2010.

From there, the business bloomed. Sisk says his average clinic sees about 75 men a day, and he's adding new ones almost weekly. Listening to him, Sisk's continued rise seems inevitable.

"Never in our lifetime has there been more 40- to 60-year-old men," he says. "Really, for the first time, men have really looked for ways to be healthy, and testosterone is just a part of that. The education of testosterone is, hey, if you have a lack of energy, gaining weight, losing muscle and you have low libido, you need to have your testosterone checked because that could be the culprit."

For some, the injections, which Sisk believes are safer than gels or pills, are covered by insurance. "It's just like going to your primary care doctor," he says. "If you don't have insurance or you have a high deductible, it's $395 a month."

It's a fantastic business model. Once a man begins replacing his testosterone, his natural ability to produce the hormone is dampened, so Sisk's patients come to his clinics every seven to 10 days for their shots.

Once he gets men in the door, Sisk has a captive audience, but he believes it's the little things, such as stereotypically male magazines and the clinics' decor, that bring men to him and the Low T Center, instead of GPs and other Dallas clinics that claim to boost testosterone.

"This is a non-sterile doctor's office, right?" Sisk asks. "The only place you've ever read Time was in a doctor's office. I got Sports Illustrated. I got Men's Health & Fitness. I got Car and Driver. I got magazines out there that are relevant to men, and they're current. I was in a dentist's office about six months ago reading about the St. Louis Rams winning the Super Bowl. Those were the magazines that they had out there. They just don't bother [with] the simple things. It's customer service 101."

Again, the cadence increases.

"If you look at health care, where health care really has screwed up, it isn't what happens inside that [examining] room," he says. "Rarely does a guy talk to his doctor and he has a bad experience. It's everything else that makes it a bad experience. It's the pissed-off front-desk girl. It's the terrible nurse. It's the poor building. It's all that process. That's what we are really good at. My docs are great docs, but the process is what makes this thing work so well."

*****

 

While Sisk owns his customers outside the examining room, his national medical director, Dr. William Reilly, owns them inside. He's a small, lithe, white-haired man. A joint surgeon for 22 years in Midland before he joined the center's staff, Reilly had grown weary of replacing old men's knees and hips. "With traditional medicine," he says, "you can talk your head off, give the guy a prescription: 'Here's your blood pressure medicine.' He doesn't get it filled, comes back six months later and he's worse. [I'm thinking,] Why did I talk to this guy?"

Reilly wanted to change his version of medicine. Instead of treating ailments, he thought, why couldn't he prevent them? This realization happened to coincide with a decline in his active lifestyle. "I've always played sports. I've always worked out," he says. "Then, when I turned 63, I started to hit a brick wall. I noticed my energy level was going down. My ability to concentrate was affected. I'm lifting weights, and I'm losing muscle."

He attended a meeting hosted by Cenegenics, another player in the low T industry. With the company's training, he opened a testosterone therapy clinic -- an "age-management" clinic in his parlance -- in Midland, "and before I knew it, I had 55 patients." He also began injecting himself with testosterone.

"I went from 23 percent body fat to 16 percent body fat in six weeks," he says. "I'm down to 9 percent body fat right now. I just turned 67. I bench over 200 pounds. I work out with the trainer three days a week. My energy level's like it was in college."

As a salesman, Reilly is as good as, if not better than, Sisk. His low T story, even if he hit the proverbial wall later in life, echoes those of many other men. They all fit the pattern of the industry's commercials to a T.

Reilly began working part-time at the Low T Center, and Sisk must have realized his potential: "Mike said what would it take to have you come full-time, and I put a number on the table. He said can you start tomorrow." That was more than a year ago, and it's been his job to maintain the clinics' medical standards for the men who walk through the door.

But what gets them to the door? For many, it starts with a simple quiz. It was designed to determine whether a man should talk to his doctor. The quiz, available on isitlowt.com, surely describes the life experiences of many middle-aged to older men: "Do you have a lack of energy?" "Have you noticed a decrease in your enjoyment of life?" "Have you noticed a recent deterioration in your ability to play sports?" "Are you falling asleep after dinner?" Most of these questions, or their variants, are recycled in industry commercials.

Though the quiz is widely used, it's hardly a foolproof indication of a low testosterone level. In 2013, The New York Times revealed that Dr. John Morley of the St. Louis University School of Medicine had drafted the low T quiz on toilet paper in about 20 minutes in a bathroom. He was paid by a company that produced testosterone. "I have no problem calling it a crappy questionnaire," Morley told the Times.

But that hasn't stopped men nationwide from seeking out testosterone therapy based on a vague set of questions. And according to the industry, the number of eligible men keeps climbing. When it first petitioned the FDA in 1999, Unimed estimated the market for AndroGel at one million men. But by 2000, when the drug was available, the number of men with low T, according to Unimed, was four or five million. Two years later, Unimed revised its numbers again: The market had grown to about 20 million. More recently, Dr. Joseph Perkinson, who used to be Low T Center's medical director, went on "Good Morning Texas" and said, "An estimated 30 percent of men between the ages of 40 and 79 have low testosterone. That's almost one in three." The FDA estimated that about 1.3 million men took testosterone in 2010; three years later, that number had increased by a million.

It's all a show, write doctors Lisa Schwartz and Steven Woloshin, medical professors at Dartmouth, in a 2013 article in the internal medicine edition of The Journal of the American Medical Association. "The Low T campaign," they write, "uses three basic strategies: lower the bar for diagnosis (turning ordinary life experiences into conditions that require medical diagnosis), raise the stakes so that people want to get tested, and spin the evidence about drug benefits and harms."

It's not clear what exactly constitutes a low level of testosterone. The consensus seems to be that, for a man 18 or older, a normal level is between 300 and 800 ng/dl. Some put the low end of normal at 200; others put the high end of normal at 1,000. One man's normal is another man's high or low. Schwartz and Woloshin note that for a clinic to use a low level of 230 means only 7 percent of men 50 or older nationwide would be eligible for treatment; using 350, as most providers including the Low T Center do, increases the number to 26 percent.

"Ideally," Schwartz and Woloshin write, "lines would be drawn to maximize benefit and minimize harm. Unfortunately, lines are often drawn not because of evidence but to expand the market. Whether the campaign is motivated by a sincere desire to help men or simply by greed, we should recognize it for what it is: a mass, uncontrolled experiment that invites men to expose themselves to the harms of treatment unlikely to fix problems that may be wholly unrelated to testosterone levels."

*****

 

Another fact that muddies the water is that having "low T" is an actual medical condition. It's called "hypogonadism," and there are two kinds. Secondary hypogonadism is when a man's testicles are fine but the part of his pituitary gland, which tells them to create testosterone, has stopped sending signals, says Dr. Bradley Jones, an internist in the Baylor Health Care System. In primary hypogonadism the testicles are getting plenty of signals, but they just aren't creating testosterone.

It's vaguely analogous to menopause. When women's ovaries shut down, the pituitary gland's signals can't be consummated. This has led some to compare the life-altering experience of menopause, which all women go through, to what possibly very few men experience, with the terms "male menopause" and "andropause" even being thrown around.

Research, though, suggests true hypogonadism is rare. A 2002 study in the European Journal of Endocrinology estimated that only 7 percent of men younger than 60 were hypogonadal. The number increased to 20 percent for men 60 plus. A more recent study from the Endocrine Society put it at about 6 percent in middle-aged to older men, and it "increased with age, waist circumference and poor self-reported health status."

Also, Schwartz says, men should seek testosterone replacement therapy only if they have hypogonadism and have defective testicles. This could mean a man's testicles didn't descend or they were damaged.

Otherwise, men lose their testosterone slowly and naturally. According to that 2002 Journal of Endocrinology study, testosterone levels begin to decrease about 1 percent per year after a man turns 50. (Reilly says it's 1 percent once a man hits 30; Sisk, who makes it clear he's not a doctor and only a salesman, says it begins to decline once a man hits 18.) Jones, who prescribes testosterone therapy to men if they understand the risks first, says he sees men's levels begin to noticeably decline around age 60 or 70. In short, the change is not dramatic.

Other factors might apply to a man having a low level, which can vary from day to day and throughout the day. One study suggests that testosterone can decrease when a man has kids. Another study suggests a man's favorite sports team can affect his levels: If the Cowboys go down on Sunday, a fan's testosterone could drop.

On top of that, the benefits of testosterone replacement, if there are any, are not clear. Natural testosterone, essentially, makes a man a man, helping him operate sexually and giving him his shape. But the benefits of replacing the hormone have never been measured in any meaningful way, says Schwartz, and the FDA has approved the drug only for use in men who truly do have a clinical testosterone disorder. Industry commercials imply that testosterone can make men, among other things, lose weight and increase energy, but "we don't know whether the promises are really true," Schwartz says. On the other hand, the risks of having too much testosterone, such as increased aggression and irritability, are proven.

The benefits that Sisk's clients claim they experience might be a placebo effect. Men might feel better after taking testosterone, but that might be caused by something else, Schwartz says. The Low T Center's Reilly disagrees.

"It's not a placebo," he says. "This is not a placebo." He flexes, his right bicep stretching the sleeve of his black scrubs. "This is a 67-year-old guy who has 9 percent body fat." He slaps his chest.

As any good sports fan knows, many professional athletes, from Major League baseball players to Olympic sprinters, have used testosterone to grow muscle, much the same way they've used HGH and anabolic steroids. Those caught have been suspended for cheating, but their bodies' transformations seem to show the effect testosterone injections can have.

Even if a man isn't trying to hit 500-foot home runs regularly, Reilly thinks testosterone has a place in a healthy, active lifestyle. He acknowledges that a decline in your testosterone levels is part of the natural aging process, but he doesn't believe it has to be.

"You're going to grow old," Reilly says, "but you don't need to age as fast as you chronologically grow old. And you do that by replacing your hormones. What happens is guys are getting in that range where they're losing enough testosterone, [and] they start to experience some of the hypogonadal effects. If we're going to live longer and you have this quality of life dropping, why not live up here at the peak? Testosterone and exercise and diet can keep you up there so you're active and enjoy life. People grow old chronologically, but do they need to experience all the effects of aging? No. We can replace their hormones. We can get them back to feeling pretty doggone good."

Some men, though, after taking testosterone, haven't felt good at all.

*****

 

Larry Hines seems to have noticed a change, or thought he noticed a change, in middle age. He didn't have the energy he once had, and things weren't working as they once had in the bedroom. He noticed the commercials about how low testosterone might be to blame. Maybe it's not just age, he figured. He drove from his Dallas home to his doctor, and his doctor wrote him a prescription. Later, he suffered a heart attack. He was one of the lucky ones. He survived.

Testosterone can cause a man's veins to constrict and his blood to clot. If the arteries in his lungs get blocked, that's a pulmonary embolism; if the supply of blood to his brain is interrupted, it's a stroke. Testosterone can cause the number of red blood cells to increase, sludging his arteries. Because of this, doctors recommend testosterone replacement patients give blood every three months. Testosterone can also exacerbate sleep apnea and prostate cancer. In fact, if a man has prostate cancer, he's given androgen blockers that suppress his male hormones so his cancer doesn't worsen.

Other than prostate cancer, the most dangerous side effect of using testosterone is heart attacks. In late 2013, JAMA researchers compared a large group of men on testosterone therapy with a group not using the therapy. The researchers found the using group increased their risk of heart attack by 30 percent. In February, the watchdog group Public Citizen called on the FDA to put a black box warning on testosterone products cautioning about the risk of heart attacks. The petition was denied, but it's hard to ignore what happened next.

Northern Alabama's Joseph Sellers started injecting himself with testosterone in 2008. He had hit a wall, and from what he could tell, the injections were safe. For the next three years, it worked as advertised, but then blood clots formed in his legs. His heart gave out on him, and he had surgery to implant heart stents that were meant to correct blocked arteries. In late 2012, Sellers died. In September his wife, Melody, filed a wrongful death suit against Pfizer, the testosterone producer.

Ohio's Jackie Lay used the same Pfizer-produced injections Sellers had. In 2008, he took his first injection. After four years of use, one day Lay was rushed to the hospital, complaining of chest pain, shortness of breath and nausea. The doctors soon realized it was a heart attack. He then slipped into cardiac arrest and lost consciousness. Doctors worked to stabilize him. Almost two years later, Lay died from the episode. He left behind adult children and a wife, Michele, who couldn't afford a funeral. She filed a wrongful death suit against Pfizer in September.

Maine's George Allegar took Pfizer's testosterone injections for the first time in 2011. The label didn't say anything about the possibility of heart attacks, so Allegar figured it must be safe. He suffered congestive heart failure and died in May. His wife, Gail, filed a wrongful death suit against Pfizer the same day.

Several others have died from complications stemming from their testosterone use. In May, Dallas' Hines joined the parade of plaintiffs, more than 300 and counting. All the lawsuits against Pfizer and AbbVie, another testosterone producer, are in U.S. District Judge Matthew Kennelly's court in Illinois.

The lawsuits allege the industry's low T campaign sold natural elements of aging as symptoms of a disease and that it drove men to seek out unneeded and risky "remedies." The lawsuits also allege that the testosterone producers misrepresented the safety of their products.

In response to the burgeoning number of lawsuits, the Low T Center put out a press release in February arguing the lawsuits didn't apply to its clinics, not even indirectly. "They don't really relate to the medicine we practice at Low T Center," Reilly is quoted as saying.

Injections, he says, are safer than gels and pills. But this ignores the fact that many of the men suing were taking injections. Reilly also says that the clinics' controlled environment, in which men meet with doctors and their health is monitored, is safer than men indiscriminately injecting themselves at home. The lawsuits don't mention whether the men using injections went to clinics, but it's not like these men were using back-alley hormones.

Sisk, the head of Low T Center, doesn't expect the lawsuits to hamper his business. In fact, at times he sounds rather flippant about the possibility of being sued.

"I had a guy try to sue me one time for not treating him. I was all excited," Sisk says. "You know you have a great product that people really want when they threaten to sue you because you won't give it to them."

If the lawsuits don't scare testosterone providers, the FDA might. In September, a panel of advisers voted 20 to 1 to refine language on the labels of testosterone treatments. The labels should make clear, the panel decided, that testosterone cannot make a man feel as if he's back on a college campus. In essence, a diminished libido, a loss of definition in your arms and a fatigued feeling are natural, the signs of living a long life. The FDA isn't required to follow the panel's decision, but the agency usually does.

Sisk is aware of what the FDA could do, but, again, he feels he's already on the right side of the equation. "The FDA has come out and said all these guys getting testosterone should not be getting testosterone," he says, "and I agree with them 100 percent because 50 percent of the men who come in and get tested here in the Low T Center aren't treatable. They don't have low testosterone, or they have some underlying health condition. If you read that FDA study, and I see this every day, about 60 percent of the guys who are getting testosterone aren't even having lab work done. You come in; they just give you testosterone. That's wrong.

"So we said, even when I started the company years ago, was if you looked at the pain-management industry, it's exactly what's going to happen to the low testosterone industry. You're going to have guys like me getting in who do it medically correct, and even then everyone gets in for a quick buck. Those guys are going to get whacked by the FDA and only the people doing this medically correct are going to survive. I'm that guy."

*****

Alex Truman noticed a change almost immediately. About a month after he started getting testosterone injections at the Low T Center, he says, his body responded. He'd go to the gym, lift and see that all his effort was paying off. His arms became bigger, more defined. His strength increased. His endurance returned, and he was able to run farther, longer. It was as if he'd turned back the clock, to his 20s, to before his kids arrived.

He also noticed changes in other areas of his life. Instead of falling asleep pretty much after dinner, he could stay up till 1 a.m. and be up by 5. He says he was able to stop using his cholesterol medicine because of the injections. His mind had been foggy before, but now it was clear. He was sharper at work. Why had he not done this sooner?

"I couldn't imagine being in that little circle of hell," Truman says, "because it's a miserable feeling. It translates into everything. It translates into your emotional well-being, too, if you're used to being a certain way physically and then you can't do things. Just picking up your kids, you get tired from holding them after five minutes when you should be able to throw them both on your back and carry them around for an hour."

Now 41, with a body other men his age would be envious of, he's been on the injections for about two years. He divorced the wife who suggested he check out the Low T Center and is now seeing someone else. The vitality he thought he'd lost has returned. He's an unabashed advocate for the clinic and testosterone replacement. When he hears a buddy tell a story similar to his, he suggests the Low T Center.

He's aware of the lawsuits and studies that say testosterone, the kind he's on, causes heart attacks, in some cases an early death. But it doesn't scare him. Problems with the heart, he believes, don't apply to him. "I think you have a predisposition to stroke or heart attack," he says.

Nevertheless, Truman and men like him have plunged headfirst into testosterone, seemingly content to take the scientifically unproven benefits over the proven risks. "The male ego is a fragile thing," Truman says, "and I think that's why these centers are so prevalent, because it's filling a need. I'm just glad I'm not living in that little cloud anymore."

Contact the author at sky.chadde@dallasobserver.com


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