Fountain of Youth: The Low T Industry Cashes in on Some Dubious Science
Joshua Carr is 54 and in solid shape, with a healthy weight and average build. He'd been feeling a bit tired in the days before he got his blood drawn for his yearly physical, but he didn't volunteer that to his family doctor because he didn't have illusions about his age. He didn't eat as much or work out as hard, but that was just the years adding up.
The doctor told Carr his blood work was fine, but by the way they needed to talk about something. There's a gravity in his voice that gave Carr pause. "You have low T," the doctor said, showing him a chart with corresponding age and testosterone levels. "See, you're at this number, and it should be in this range. Go see a urologist."
Carr, who asked that we not use his real name, was surprised at the diagnosis. Low T. He'd never heard of it before, but there it was, a chart showing that men his age ideally have a total testosterone level of about 600 ng/dl -- nanograms per deciliter -- of blood. His levels were about half that, although, considering that 400 to 800 ng/dl is an acceptable range for the average man, he was only borderline low.
He scheduled an appointment with a Houston urologist, who confirmed he had low testosterone disease and prescribed a cream called Testim. This cure, which he was supposed to rub on his arms and shoulders after he showered in the morning, had the potential to kick his testosterone up to what it was in his teenage years.
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Just be careful not to touch family members, the urologist warned -- a woman comes into contact with it and she could grow a beard. Exposing young boys to too much testosterone will stunt their growth because it tricks their bodies into thinking they're pubescent ahead of time. As for prepubescent girls, he didn't need to go into detail. Testosterone is just no good.
Other than proper application etiquette, they didn't discuss the potential side effects of using Testim, the increased risk for cardiovascular-related disease: strokes, pulmonary embolisms, blood clots, heart attacks and death. So Carr decided to try it.
At first he thought he felt a small energy boost. It wasn't much, but he thought he'd take it. He exercised more and slept less. After a while, he realized he wasn't really sleeping much at all, and it was because he was feeling more anxious than he'd ever felt before in his life. His skin turned an angry, fake-tan red, so instead of applying Testim daily, he cut back to once every two or three days.
Carr used Testim for about a year, from late 2012 to the end of 2013, when he got another checkup and his blood test came back showing testosterone levels of about 2,000 ng/dl -- way too high. His doctor ordered him to stop the treatment immediately. A few months after that, as Carr prepared for bed one night, he was seized with a massive chest pain. He lost feeling in his left arm and nearly passed out.
Heart attack, he thought as he was rushed to the hospital.
Turned out he was right.
American men have tried ways to slow down, even stop, the effects of aging 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 Mexican radio station that blasted country music across the Rio Grande. Near the end of the centry, testosterone therapy -- minus the goats -- had become less invasive but still lacked Food and Drug Administration approval.
That changed in 1995, when the FDA passed off on a skin patch for men with a testosterone deficiency. Unimed Pharmaceuticals put AndroGel, a low T gel, on the market five years later, estimating its consumer base to be four or five million men who have low testosterone. Two years later, Unimed revised its numbers: The market had grown to about 20 million. The FDA estimated that in 2010, 1.3 million men took testosterone. That number has since increased by a million.
At last the floodgates opened for smart salesmen to sell testosterone -- and agelessness -- to the masses.
One injection chain, Dallas businessman Mike Sisk's Low T Center, is the face of the new wave of interest in testosterone therapy. It has more than 50 locations throughout the country, including eight in Houston. The company's flagship branch, the Low T Center in Southlake near Dallas, definitely looks the part of a testosterone oasis. Framed football jerseys hang on the walls between flat-screen TVs tuned to ESPN, while coffee tables in the waiting room are spread with glossy copies of Sports Illustrated and Car and Driver. Making a client feel at home in his "man cave" is customer service 101, Sisk says, but the message on Low T Center's website proposes a challenge that is just a tad adversarial: "Time to man up. Stop by today."
Other testosterone providers in Houston run the gamut from primary care physicians to wellness-spa gurus who tackle low T with a mixture of medicine and meditation. For decades, traditional urologists and endocrinologists have been treating hypogonadism, a real medical condition in which pituitary gland signals from the brain fail to reach the balls.
But the specialists say interest in testosterone therapy has only shot up within the past five years or so, something they attribute to the barrage of advertisements from pharmaceutical companies and the growth of quick-fix clinics acting as testosterone dispensaries. Unlike menopausal women, middle-aged men don't experience a sudden, dramatic drop in hormones, but they might feel tired, depressed, not as aggressive or virile. It's natural, but now more than ever, men are getting the message that they don't have to live with it. By 2017, national sales of low T creams, gels and injections will exceed $5 billion, predicts Global Industry Analysts.
Mike Sisk, founder and CEO of Low T Center, offers testosterone injections to men with low levels. It's a form of testosterone replacement therapy, which replaces men's natural production of the hormone over time.
Photo by Sebron Snyder
Sisk is a smart salesman. He's also quick to clarify he's not a doctor. Sitting in the office of his Southlake center, he explains the genius of his contribution to the industry in the rapid-fire patter of a born salesman.
Low T Center makes testosterone replacement therapy easy. It will treat any man aged 25 or older with a testosterone level of 350 ng/dl or lower. The center also requires that clients exhibit symptoms of low T: fatigue, irritation, waning sex drive. An intitial consultation and one on-site blood test are enough to confirm eligibility for Pfizer testosterone injections.
But the key to his success is attention to detail, Sisk says. In addition to great doctors, he's put real heart into the centers' lively lounge atmosphere, the smiling receptionist, the element of comfort and convenience.
"Never in our lifetime has there been more 40- to 60-year-old men," he says. "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."
Listening to him, Sisk's continued rise seems inevitable. But it wasn't too long ago that he didn't own much of anything. 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. There he met his wife and got a job at Ernst & Young, one of the world's largest audit firms.
He returned to Tennessee for a time to care for his ailing father, but about ten years ago he moved back to Dallas to start his own finance company. Then he turned 40, and suddenly "it was like somebody had turned the light switch off," Sisk says.
Sisk didn't know what had happened and why he was feeling so blue. He went to the doctor, who prescribed Zoloft. Depression couldn't be the answer, he decided, so he got a second opinion -- and 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."
His wife started off injecting him in their kitchen, but then Sisk got the idea of packaging that service in a swankier outfit. He found a doctor to be his medical director and left his finance company to open the first Low T Center in 2010.
From there, the business bloomed. Sisk says his average clinic sees about 75 men a day, and he's constantly signing on new clients. For some, the weekly injections, which Sisk says are safer than gels or pills, are covered by insurance. Without insurance, the cost comes to $395 a month.
Sisk is all about testosterone replacement therapy, which sounds like a general term for low T treatment but actually touches on only one aspect of a diverse array of options for men looking to increase their levels.
Testosterone replacement implies replacing natural hormones with synthetic ones produced by drug companies. Extended use -- which in some cases could be as short as two weeks -- results in inevitable testicular shrinkage because the chemicals tell the body it has an ample supply of testosterone and natural production ceases. The testes become smaller and softer.
Dr. Russel Williams, a urologist at Houston's Male Reproductive Clinic, says injection clinics have done a tremendous job of raising awareness for low testosterone, but they educate men about only one side of the story. The other treatment option is testosterone enhancement, which aims to increase the body's natural production of male hormones through exercise, dieting, and cutting out alcohol and recreational drugs, in addition to some medication.
Some men say they've never exercised a day in their lives so they must have the shots, but they're putting their testicular function at risk. Williams says 5-10 percent of his patients might experience some kind of complication -- blood thickening, liver inflammation, prostate enlargement -- that requires halting treatment. When that happens, their levels will tank and they'll feel horrible.
"There are guys that say, 'Enough is enough of these synthetics; I wanna have a baby.' Well, we've got a problem. Or, 'Enough of synthetics; I wanna make my own testosterone.' We've got a problem," Williams says. Every so often, a patient seeks him out to fix problems that come with long-term synthetic testosterone use.
The advantage replacement therapy has over enhancement is in its easily marketable and deliverable product. Low T one-stop shops can give men that sudden rush of feel-good that would take more time and effort with a total well-being approach. The choice is left to the individual, but Williams fears that the men who drop by injection clinics may think a shot is their only option.
Specialty physicians like urologists and endocrinologists with knowledge of the whole spectrum of testosterone therapy are usually not overseeing high-volume injection clinics, he says.
Dr. Russel Williams is a Houston urologist working at Male Reproductive Clinic. He has been treating low testosterone in men for years and recommends a testosterone enhancement approach that balances supplements with dieting and exercise.
Photo by Susan Du
There are ways to minimize testicular shrinkage, such as by supplementing testosterone with certain female hormones, like HCG, produced in a portion of the placenta, or the ovulation drug Clomid. Dr. Larry Lipshultz, who runs a urology practice in the Texas Medical Center in Houston, says he regularly cycles his patients on and off testosterone to monitor their natural levels, something the testosterone dispensaries don't do.
"They've seen the advertisements, they have the symptoms and all of a sudden they're going to the market and they're going to the shoemaker and they see a sign that says 'Testosterone!' So they go and they get a shot," Lipshultz says. "The main problem we're up against is how accurate is the diagnosis, how closely do they listen to the patients' symptoms. How personally do they tailor the treatment? These low T centers just are not watching out for them the way physicians watch out for them."
Carr says he wasn't told of other options. Skeptical of testosterone cream at first, he remembers going to the pharmacist with the prescription for Testim in hand and asking if the stuff works. It's very popular, the pharmacist assured him.
Maybe there are men out there with extremely low levels for whom testosterone replacement therapy would do wonders, but for those who are borderline, as Carr was, supposed cures could be dangerous, he says.
"This is one big racket that's going on," Carr says. "I think that the pharmaceutical companies have created this low T disease that doesn't really exist. In reality, I think the doctors should have told me, 'You're in your fifties; you need to exercise more and that's it.'"
Carr believes Testim caused his heart attack, so he lawyered up and sued Auxilium, the company behind the cream. He's not the only one -- as replacement therapy gains traction nationwide, lawsuits against the drug giants behind the scenes have carved out a brand-new area of litigation.
It didn't take effort much on Carr's part to connect the dots. He has no family history of heart attacks, and he'd never felt worse than he did on Testim.
Once he recovered from his heart attack, Carr took to the Internet to research Auxilium and to find someone to sue the company. On its website, he saw the company had won an award for best interactive initiative for consumers for accomplishments in marketing. He was furious.
"Certain pharmaceutical companies have put profits ahead of research," Carr says. "Instead of talking about safety and research, they're boasting that they're the best at medical marketing. Is creativity more important than actual health care?"
Carr signed on with Houston-based personal injury lawyers at Perdue & Kidd, where he discovered other men around the city were echoing his complaints about low testosterone drugs.
Brian Winegar, Carr's attorney, says most of his clients are in their fifties or early sixties, men who at some point in life were feeling sluggish and losing their libido. They're seeing ads on TV or hearing them on the radio for a miracle drug that will make them feel younger, more active and more virile, so they go to their doctors and ask for it.
"Quite often they're not even going to a specialty doctor. They're just going to their family doctor," Winegar says. "Some of them get tested for low testosterone and some of them don't."
All of Perdue & Kidd's lawsuits are against pharmaceutical companies, whom they're accusing of failure to warn physicians about potential side effects. In September of this year, an FDA panel of doctors voted 20-1 to refine the language used on the labels of testosterone drugs. They determined that the products must indicate they are to be used in men who have low testosterone resulting from an underlying medical condition or injury to the testes, but not for age-related low T.
The message doesn't quite fit with some low T clinics' promotional message of eternal youth. What attracts many clients to injection centers is a simple quiz designed to jump-start conversation between a man and his doctor. The quiz, available on isitlowt.com, describes universal symtoms of aging: "Do you have a lack of energy?" "Have you noticed a recent deterioration in your ability to play sports?" Most of these questions, or their variants, are recycled in industry commercials.
Though the quiz is still widely used, in 2013 The New York Times revealed that Dr. John Morley of the St. Louis University School of Medicine had drafted it 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.
Low T Center's Sisk is aware the FDA could crack down, 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." He says he turns away about 50 percent of the men who come looking for testosterone because their levels aren't low enough.
"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," Sisk says. "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."
Studies show that the most dangerous side effect of using testosterone is heart attacks, and after that it's prostate cancer. Despite research published in The Journal of the American Medical Association linking low T drugs to significant health risks, pharmaceutical companies have big money to hire experts to cast doubt on science that reflects poorly on their products, Winegar says.
"The industry is in this very difficult position," he says. "They're in the best position to do these kinds of safety studies because they're the ones with the best data, but they've got this drug that's making an awful lot of money. They don't want to do anything."
And so the lawsuits accrued. In 2008, Alabama's Joseph Sellers started injecting himself with testosterone. 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 and his wife, Melody, filed a wrongful death suit against Pfizer, the producer of the testosterone.
Ohio's Jackie Lay used the same Pfizer-produced injections Sellers had. He also started in 2008, but after four years of use, one day Lay was rushed to the hospital complaining of chest pain, shortness of breath and nausea. 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 the shots must be safe. He suffered congestive heart failure and died in May of this year. His wife, Gail, filed a wrongful death suit against Pfizer the same day.
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.
Carr knows he's up against large pharmaceutical companies in his bid for personal injury damages, but he says he's confident he'll win his case. He thinks it's obvious the companies are crooks and he never had so-called low testosterone disease.
Men like him get sold on the notion that with simple injections or roll-on medication, they can reclaim the physical prowess of their youth, but he left the hospital earlier this year with a stent in his heart that promises to have him in and out of the doctor's office for the rest of his life.
Looking back, he suspects that if he hadn't made the decision to cut back on using Testim daily as prescribed, he might be dead by now. What minor energy boost he experienced early on might have been a placebo effect, Carr says. As far as he's concerned, there was no benefit to the treatment.
"The cream didn't make me feel better. The cream was supposed to increase my testosterone, but what it did was increase it to an extremely dangerous level," he says. "I felt like a human lab rat."
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