Raids trigger debate on growth hormone anti-aging therapy - East Valley Tribune: News

Raids trigger debate on growth hormone anti-aging therapy

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Posted: Sunday, August 5, 2007 1:01 am | Updated: 7:14 pm, Fri Oct 7, 2011.

Dr. Eli Hammer was talking with a patient in the conference room of his north Scottsdale office when seven federal drug agents wearing bulletproof vests walked in and handed him a search warrant.

For information on both sides of the growth hormone debate, go to http://www.antiagingquackery.com/ and www.hammerinstitute.com

Ten hours later, they left with Hammer’s patient files, copies of computer hard drives, 19 stacks of documents and about 200 vials of human growth hormone.

“They picked the wrong office,” Hammer said. “The DEA investigation was completely off base.” The May 1 Drug Enforcement Administration raid sparked an investigation by the Arizona Medical Board that threatens Hammer’s medical career and intensifies debate about the lucrative anti-aging industry and its legions of well-heeled baby boomers willing to do whatever it takes to look and feel younger.

The doctor agreed to talk about his case and the debate over the medical use of growth hormone in an exclusive interview with the Tribune.

At issue is whether growth hormone does more harm than good, when it should be legal to prescribe for aging adults and who should decide.

“It gives me energy and clarity of mind,” said Jim Dougherty, the 65-year-old founder of PetSmart. “I feel great.”

Diagnosed years ago at the Mayo Clinic with hypogonadism, or abnormally low levels of testosterone, he said it wasn’t until he started seeing Hammer five years ago that he found the right chemical balance.

Dougherty injects himself six times a week with growth hormone and once a week with testosterone, plus takes vitamin supplements. Hammer checks his blood every three months and adjusts dosages as needed.

Sales of growth hormone reportedly top $600 million a year in the U.S. and an estimated 30,000 Americans have taken the drug, including celebrities like Sylvester Stallone and Nick Nolte.

So there’s much at stake as it comes under increasing scrutiny from federal and state law enforcement, with arrests this year of more than 20 people in connection with prescribing and dispensing growth hormone, including doctors and pharmacists in Florida, New York and Texas.

“We’re not looking at the users,” said Ramona Sanchez, special agent with the DEA in Phoenix. “We’re looking at those doctors that distribute and dispense it absent (certain) medical conditions.”

Sanchez won’t say why Hammer’s growth hormone prescribing practices were targeted or whether his case is connected to recent local search warrants that linked Mesa, Chandler and Phoenix police and firefighters to steroid use. No arrests have been made.

“We’re scratching the surface right now,” she said. “We’ll let the evidence take this wherever it goes.”

Growth hormone is illegal under federal law except to treat childhood growth disorders, AIDS wasting, pituitary tumors and adult hormone deficiency, typically due to a pituitary tumor or trauma. Unlike most drugs, the law forbids prescribing it “off-label” to counter the effects of advancing age or improve athletic performance.

Studies, including the 1990 research that spawned hundreds of anti-aging clinics, show dramatic cosmetic improvements in subjects treated with high doses over relatively short periods.

But they’ve also shown troubling side effects, including edema, diabetes, joint pain and abnormal growth of bones or internal organs.

“There’s absolutely no proof that giving growth hormone helps anybody in any way,” said Dr. Thomas Perls, associate professor of geriatrics at Boston University School of Medicine who runs the Web site www.antiagingquackery.com. “I think anybody who is selling growth hormone for anti-aging is a quack,” Perls said.

But Hammer and others, led by two Chicago osteopathic physicians who started an anti-aging academy that now claims some 17,000 members, believe a blood test can diagnose older men and women as being hormone deficient and thus legal candidates for treatment.

“There’s no law saying I can’t treat them for adult growth hormone deficiency, and that’s what I do,” Hammer said. “I don’t see how the government should get involved with a doctor-patient relationship.”

The Arizona Medical Board suspended Hammer’s license last month because he refused to submit to a board-ordered substance abuse evaluation, but a judge suspended the board’s action pending an administrative hearing.

Timothy Miller, executive director of the board, which regulates Arizona physicians, said its investigation stemmed from the DEA raid on Hammer’s office and took another turn after the doctor tested positive for the anti-anxiety drug Xanax and lacked a prescription for it.

Hammer and his attorneys say he took the drug before an international flight and was not impaired. The board’s action was unwarranted, they say, and has done irreparable damage to his medical practice.

Regarding the growth hormone allegations, Miller wouldn’t say whether the board has access to patient files seized by the DEA. But, typically, those charts would be reviewed to see if prescriptions fit patient diagnoses, and how the diagnoses were made.

“It’s really an issue of looking at a particular case and seeing if it was appropriate for that patient,” Miller said. “It’s not always black and white.”

Since growth hormone naturally declines with aging, and levels vary widely throughout the day, Perls and other doctors argue that it’s impossible to diagnose hormone deficiency with just a blood test.

Dr. S. Mitchell Harman, director and president of the Kronos Longevity Research Institute in Phoenix, said potential side effects of anti-aging growth hormone use outweigh any short-term benefit.

Harman co-authored a 2002 follow-up to the 1990 anti-aging study, giving Milwaukee veterans high levels of growth hormone over a six-month period to see if there were functional improvements.

Just like the subjects in 1990, they lost body fat and gained lean muscle mass, even without exercise or changes in their diet. But nearly half of them suffered serious side effects: diabetes, swollen tissue and aching joints.

Anti-aging practitioners argue that lowering the dosage will solve those problems. But Harman says the evidence just isn’t there to say the stuff is safe, much less effective.

“These doctors who are out there prescribing growth hormone for otherwise healthy people, they don’t have a scientific leg to stand on,” he said.

He calls the American Academy of Anti-Aging Medicine “a bunch of fakes” and its members “physicians who have opted out of mainstream medical practice.”

“I think some of them are quite sincere. We tend to believe things that are in our own self-interest,” Harman said. “I think there’s an element of self-delusion.”

The academy’s certificate hangs on the wall in Hammer’s office. Though it’s not recognized as a specialty by the American Medical Association and Hammer distances himself from the group’s controversial founders, he’s proud to say that he walked away from mainstream medicine because it only allowed him to dispense pills, not practice prevention.

Tall, fit and trim, Hammer sits behind a teak desk in his office and talks about discovering growth hormone as an overweight, unhappy family physician.

It changed his life. He abandoned his practice and started the Hammer Institute for Anti-Aging Medicine in 2000, where he recommends a regimen of diet, exercise, vitamin supplements and growth hormone.

Hammer says it was a fluke that he had 200 vials of growth hormone in his office the day DEA burst in. Food and Drug Administration pressure on compounding pharmacies squeezed local supply. The Mesa pharmacy he had been using ran out, so he ordered from a Southern California pharmacy that shipped it to his office.

For the most part, growth hormone investigations have involved athletes, bodybuilders and illegal Internet trafficking, where doctors write prescriptions without even seeing the patient.

“My assumption is the DEA will say, ‘You’re not what we were looking for. This is not the practice we’re looking for.’”

What is growth hormone?

Growth hormone is produced in the pituitary — a tiny gland at the base of the brain — and stimulates growth and cell reproduction. Growth hormone production slows as you age, beginning in your 40s.

Human growth hormone is made synthetically through recombinant DNA technology, in which bacteria or animal cells are given the gene that directs them to make growth hormone.

FDA-approved uses

• Hormonal deficiency that causes short stature in children

• Long-term treatment of short stature associated with Turner syndrome

• Adult short bowel syndrome

• Muscle-wasting disease associated with HIV/AIDS

• Adult hormone deficiency due to pituitary disease, surgery, radiation or trauma

Growth hormone shots can:

• Increase bone density

• Increase muscle mass

• Decrease body fat

• Improve mood, motivation and libido

• Increase exercise capacity

Side effects can include:

• Swelling in arms and legs

• Arthritis-like symptoms

• Carpal tunnel syndrome

• Muscle pain

• Headaches

• Bloating

• Diabetes

• Abnormal growth of bones and internal organs

• High blood pressure

Source: www.mayoclinic.com

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