Booming anti-aging business relies on risky mix of steroids, growth hormone

'Strong at Any Cost' is a three-part Star-Ledger special report on the secret world of steroid use by law enforcement officers and firefighters

Henry Balzani, 63, boasts he can leg-press 720 pounds. He’s got the photo on his cell phone to prove it.

He says he has the energy and mental acuity of a man in his 20s. In just one year, he adds, he shed 30 pounds of fat and put on 10 pounds of muscle.

Balzani, a gynecologist, credits his physical turnaround to diet, exercise, vitamin supplementation and the restorative power of hormones.

He takes testosterone, human growth hormone and TA-65, an unregulated substance that fights the aging process at the chromosomal level, its manufacturers claim.

Impressed with the results and with his own research, Balzani and a partner last fall opened Total Life Rejuvenation, a Clifton anti-aging clinic that specializes in hormone replacement therapy, a treatment that boosts the body’s naturally declining hormones to youthful levels.

“There’s a big movement for this,” Balzani said, citing testosterone advertisements, celebrity endorsements and the fictional Samantha Jones, the libidinous huntress who plugs hormones in this year’s “Sex and the City 2.” “It’s becoming mainstream.”

By all accounts, the anti-aging business is booming, a trend fed by an eager public’s timeless thirst for elixirs and pills to flatten bellies, increase vigor and improve sexual potency.

And with every new patient and every new prescription, the medical establishment grows more alarmed.

Critics say anti-aging practitioners, operating in a gray area of both medicine and the law, too often cross the line by peddling powerful and potentially dangerous substances on the basis of medically faulty diagnoses.

“It’s a total ruse,” said Thomas Perls, an associate professor of medicine and geriatrics at Boston University Medical School and one of the anti-aging movement’s more outspoken foes.

“The population generally equates hormones with youth, and therefore for gullible or narcissistic individuals, it becomes an easy sell,” Perls said. “Any claims that this stuff works for anti-aging is absolute nonsense. It’s quackery.”

In recent years, prosecutors across the nation have charged dozens of doctors, pharmacists and clinic owners with illegally dispensing anabolic steroids and growth hormone to patients under the guise of anti-aging medicine.

Yet critics say most physicians who flout the law continue to get away with it, the result of lax state medical boards, weak federal oversight and the secrecy inherent in the doctor-patient relationship.

“Nobody’s watching,” said Alan D. Rogol, a University of Virginia professor and pediatric endocrinologist who has written extensively about the abuse of steroids and growth hormone. “Each patient sees his doctor, and his doctor has a doctor-patient relationship, and if he’s diagnosed as deficient — however that’s done — then a legitimate prescription is written.”

The U.S. Food and Drug Administration approves drugs for specific uses but doesn’t monitor physicians or the practice of medicine. That’s left to the states.

The agency that oversees doctors in New Jersey, the State Board of Medical Examiners, has taken disciplinary action against just three physicians for improperly prescribing steroids or growth hormone in the past five years, a spokesman said. In two of the cases, the physicians were first sanctioned by other states.

Moreover, New Jersey is one of just 16 states without a prescription drug monitoring program, which law enforcement officials call a cost-effective layer of protection against abuse and fraud.
Under the programs, pharmacies are required to enter into a database information about every prescription they fill for controlled dangerous substances, a category that includes opiates like OxyContin and anabolic steroids like testosterone. Regulators would therefore have a snapshot of every doctor’s prescribing habits.

The federal government gave New Jersey a $350,000 grant six years ago to start a monitoring program. Nearly three years ago, Gov. Jon Corzine signed legislation that would put the money to work.

Today, the cash remains in a bank account, untouched.

“If 34 other states are doing this, why aren’t we?” asked former Assemblyman Fred Scalera (D-Essex), who held a hearing on the topic before the Assembly consumer affairs committee in September. Scalera, who gave up his seat for a private-sector job last month, said the grant expires in April, though the state could seek an extension.

“The purpose of the hearing was to put people on notice that this program needs to get done,” he said.

Thomas Calcagni, acting director of the state Division of Consumer Affairs, which oversees the Board of Medical Examiners, said state officials are committed to the monitoring program and are “moving with alacrity” to put it in place.

“Failure is not an option,” said Calcagni, a former federal prosecutor who took the consumer affairs post in May.

A request for proposals to find a software vendor for the database is now under review at the state Treasury Department, he said, and consumer affairs employees already have reached out to pharmacies to alert them to the new reporting requirements.

“Everyone’s in agreement that this can be a critical tool for us,” Calcagni said. “Right now we’re dependent on information coming to us somewhat sporadically, when there’s a complaint filed or an arrest made, so we’re more reactive. This will provide us with a steady stream of information we can monitor and take proactive steps when red flags are raised and troubling trends emerge.”

Calcagni added that the rise of anti-aging medicine, with its emphasis on tightly regulated hormones, also bears watching more closely.

“Somebody should step up here,” he said. “With this becoming an emerging area, it certainly merits the attention of the Board of Medical Examiners.”

At the federal level, the misuse of steroids and growth hormone falls under the purview of the U.S. Drug Enforcement Administration, but the agency has typically focused less on physicians and more on underground operations, including illegal steroid labs and criminal rings that sell or smuggle the substances.

“We’re not turning a blind eye to it, but we don’t tell doctors how to be doctors,” said Special Agent Doug Collier, a spokesman for the DEA’s Newark office. “It’s not our mission to stand guard at every doctor’s door to make sure they do their due diligence. That’s where the Hippocratic Oath comes in.”

Measuring Deficiency

For decades, women have taken hormones to ease the symptoms of menopause, though use of the drugs tailed off after a landmark study in 2002 found they increased the risk of heart attack, stroke and breast cancer.

More recently, anti-aging physicians have found a lucrative and rapidly expanding market in men. Thousands of websites, along with magazine and television ads, promote testosterone as the answer to sluggishness, irritability, weight gain, hair loss, depression and erectile dysfunction.

Andropause, otherwise known as male menopause, has become the movement’s hottest buzzword despite continuing debate among physicians about whether the condition really exists and, if it does, how prevalent it is.

A study published in the New England Journal of Medicine in June suggested just 2 percent of men between the ages of 40 and 80 show the constellation of symptoms consistent with andropause. To many doctors, the term is just another word for the body’s natural aging process.

Where anti-aging practitioners have gone astray, the critics say, is in stretching the definition of what it means to be hormone-deficient. A 40-year-old man might have normal levels of testosterone and growth hormone relative to other 40-year-old men, but the levels are likely to be well below those of a 20-year-old man.

To many anti-aging physicians, that’s a deficiency.

Rogol, the University of Virginia professor, has another name for it: bad medicine.
“It’s a dangerous thing to put someone on testosterone unless you have a real diagnosis for a testosterone deficiency,” he said.

Testosterone, the primary male sex hormone, enhances strength, muscle mass and virility, but it has also been shown to cause heart problems, prostate enlargement, sleep apnea and an increase in red blood cells, which in turn raises the risk for stroke. In some cases, researchers say, testosterone and other steroids can also lead to recklessness, moments of confusion and increased aggression.

Growth hormone, too, has its benefits and dangers. Research shows it can boost muscle size, mainly through water retention, and burn body fat, but it also puts users at an increased risk of diabetes and can lead to joint pain and carpal tunnel syndrome.

In addition, longtime users are at risk of developing acromegaly, a potentially fatal condition that enlarges the internal organs and, in some cases, literally morphs a person’s facial features, creating a more prominent brow and jutting jawline.

Prescribed primarily for abnormally short children, growth hormone is regulated even more tightly than testosterone.

“There are seven or eight kiddie indications, three or four adult indications, and everything else is a felony,” said Rogol, who polices the use of HGH for the World Anti-Doping Agency, the group that monitors Olympic athletes for performance-enhancing drugs.

In adults, legitimate growth hormone deficiency affects just one in 100,000 people annually, according to the American Association of Clinical Endocrinologists. Yet anti-aging physicians use the diagnosis to justify prescribing HGH to patients across the country.

Rogol said he doubts many of those doctors and clinics could back up their HGH prescriptions with proper test results if pressed to do so.

“In a word, it’s bull,” he said.

Despite such criticism, sales of both growth hormone and testosterone continue to soar.
Between 2005 and 2009, spending on various testosterone gels and liquids in the United States more than doubled, to just over $1 billion, according to IMS Health, a firm that provides market research to the pharmaceutical and health care industries. This year, doctors are projected to write more than 4 million prescriptions for the drug.

In the same time period, spending on growth hormone jumped 32.7 percent, to $1.3 billion, and the number of prescriptions climbed to 431,000, IMS Health found.

The explosive growth hasn’t been lost on doctors. Across America, chiropractors, orthopedists, pain-management physicians, internists, plastic surgeons and gynecologists like Balzani are reinventing themselves as anti-aging specialists who hawk hormones on their websites.

The movement has been helped along by an aggressive marketing campaign and by the likes of Suzanne Somers, the '70s sitcom coquette turned estrogen entrepreneur. Somers, 64, has pushed hormones on “The Oprah Winfrey Show,” among other television programs, and in several best-selling books.

In October, she suggested on the TV show “Access Hollywood” that hormone therapy might have prevented the aortic aneurysm that killed John Ritter, her “Three’s Company” co-star, and the Alzheimer’s disease that afflicted former President Ronald Reagan in his final years.

Perls calls Somers’ statements “absolutely irresponsible and harmful.” Rogol said the actress “doesn’t have a clue what she’s talking about.”

A less controversial argument on behalf of hormones comes from Rick Collins, a Long Island lawyer who has defended doctors and clinic owners charged with illegally dispensing the substances.

Collins, who has written extensively on steroid law and lectured at anti-aging conferences, questions why a mature man shouldn’t be legally permitted to choose hormone therapy if he’s weighed the benefits against the risks.

To make his point, he cites the theoretical case of an aging uncle who feels lousy but whose testosterone level is not clinically low. Testosterone therapy might make him feel better, but taking it could put him and his doctor at risk of prosecution, Collins said.

“Do we as a society want to prohibit that?” he asked. “It’s one thing for us to try to talk people out of decisions that involve risk, and it’s another to arrest them for it or to arrest the doctors who facilitate it. No one’s arresting the doctor who puts porn-star implants into a woman.

“We allow all sorts of choices to be made in this country based on the idea that personal autonomy over one’s body is of the highest value,” Collins said. “That’s what liberty is all about. That’s fundamentally American.”

Outspoken Advocate

In his Route 46 office in Clifton, Balzani has his own strong opinions about the law and the medical establishment, which he contends stifles innovation and favors treatment over prevention.
“The law is usually behind, as is Western medicine,” he said.

By replacing hormones as they decline, Balzani said, people can stave off heart disease, high blood pressure, mental deterioration and the decrepitude of old age, living fuller, more productive lives.

The grandfather of five said he has no doubt about the effectiveness of the substances he prescribes. He said he’s benefitted from them himself.

By 2005, he said, he’d had three surgeries to deal with heart problems, and he’d ballooned to 260 pounds. Three years ago, at age 60, Balzani began a hormone regimen through Cenegenics, a Las Vegas company.

At the time, his testosterone level stood at 346, just above the normal range for a man between the ages of 50 and 60, he said. Now, Balzani said, his testosterone level is about 1,000, the very top of the range for a healthy man between 20 and 30.

“If I’m at a range that’s okay for a 60-year-old, how is that good for me?” he said. “That’s not good for me. I’m functioning less and less then. When I’m 90 years old, I want to be able to get up on my own without pushing on two handles.”

To the critics who dismiss his brand of medicine as quackery, Balzani counters that medical and scientific breakthroughs have often been met with skepticism or derision. That doesn’t make the critics right, he said.

“They said penicillin was quackery,” Balzani said. “They said the same thing about the airplane. What about a car? That was quackery.”

Were today’s society not so litigious, he added, doctors would be more willing to embrace new treatments, controversial or not.

“They are afraid, pure and simple,” he said. “To get physicians to think innovatively is very difficult because everyone is afraid of lawsuits.”

Certain of his convictions, Balzani said he has no such fear.

He opened Total Life Rejuvenation in November 2009 with Victor Biancamano, 36, the former office manager for a now-deceased Jersey City doctor, Joseph Colao.

On Sunday, The Star-Ledger reported Colao often prescribed steroids and growth hormone when they weren’t medically necessary and that at least 248 New Jersey law enforcement officers and firefighters obtained steroids from him in just over a one-year period.

Biancamano, who left Colao’s practice shortly before the doctor’s death in August 2007, has since split with Balzani. Two months ago, Biancamano said, he began working with a group of anti-aging doctors he declined to name.

As the registered officer of Total Life Rejuvenation in the firm’s incorporation papers, Biancamano took the name with him. The website now lists locations across New Jersey, New York and Florida.

Balzani continues to practice anti-aging medicine under his own name in Clifton.
In June, when The Star-Ledger interviewed both men in the Clifton office, Biancamano said he had no knowledge Colao was breaking the law and that he and Balzani fully comply with all regulations.

“My clinic is totally on the up and up,” Biancamano said at the time. “Do you think we would still be in business if we were doing something wrong?”

Both he and Balzani said they turn away bodybuilders, athletes and anyone under 35. In addition, they said, they take full medical histories from patients and run blood tests to determine if hormones are warranted.

“We don’t blindly prescribe anything,” Biancamano said. “We know every little thing about our patients.”

Balzani said he has a blunt discussion with each of those patients about the addictive nature of steroids and other hormones, along with their risks. Growth hormone, for instance, is not known to cause cancer on its own, but it’s believed to make existing cancers spread more quickly.

“You acknowledge that to people, get a family history,” Balzani said. “But people want to live their life healthier, and it’s their life to decide.”

Those who go through with the therapy pay out of their own pockets to avoid conflicts with insurance companies, he said. Human growth hormone, though cheaper than it was even a few years ago, still runs between $6,000 and $12,000 per year, and insurers increasingly flag its use for possible fraud.

At a time when many of his colleagues are winding down, Balzani sees his growing anti-aging practice as a refreshing new phase, one he expects will last many more years. And hormones, he contends, have helped him get there.

“People say, ‘You’re crazy. You should be retiring,’ ” Balzani said. “I’m starting a new life at 63. I believe in it.”