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Call for crackdown on docs who peddle HGH

/ Source: msnbc.com contributor

In March of last year, when Jeff Beacher, then 33 and headlining his own Las Vegas variety show, was looking for ways to shave some of the bulk off his 350-pound frame, he followed a friend’s advice and turned to Dr. Ivan Goldsmith’s TrimCare weight-loss clinic.

According to Beacher, Goldsmith prescribed an impressive cocktail of drugs including human growth hormone, testosterone, phentermine (a weight-loss drug), Glucophage (used to control diabetes) and Arimidex (a drug intended for post-menopausal women with breast cancer), a combo that, he says, turned his life upside down, nearly ruined his business, and sent him looking for psychiatric help.

This is precisely the sort of result that has led Dr. Thomas Perls, a Boston University Medical School professor and expert in aging, to mount something of a crusade against the inappropriate provision of growth hormone and other hormones. In a commentary appearing in Wednesday's Journal of the American Medical Association, Perls and S. Jay Olshansky, a professor of public health at the University of Illinois at Chicago, argue that the medical community and legislators should join the battle and that laws regulating growth hormone should be toughened.

The public is being victimized at a rising rate by the rampant prescription of such drugs, Perls says. In fact, while it may seem odd that a doctor would prescribe a drug intended for older female cancer victims to a young man, it’s standard operating procedure in some of the nation’s anti-aging and weight-loss clinics. Testosterone can be converted to estrogen inside the body, leading to unwanted side effects like bigger breasts (gynecomastia) and smaller testicles in men. Arimidex, an estrogen inhibitor, is prescribed to combat those side effects.

When Perls, who also serves as a consultant on growth hormone and steroids to the U.S. Department of Justice, reviews medical records for the Drug Enforcement Administration, he sees such exotic combinations routinely. He calls it “the worst kind of medicine.”

While the headlines have focused on star athletes such as Roger Clemens accused of using growth hormone as a performance-booster, much more common are doctors peddling the substance to patients looking to shed pounds or forestall signs of aging.

In a brochure from TrimCare, Goldsmith states that human growth hormone is a valuable weight-loss tool because it “has been shown to enhance lean body mass and increase exercise endurance. … There were no significant effects on quality of life. Most adults are concerned about the effects of age, and this is state of the art.” This notion dates from the 1990s when one experiment showed that when older men injected growth hormone, their lean muscle mass increased.

In fact, as Perls and Olshansky point out, “the documented adverse effects include soft-tissue edema, arthralgias [joint pain], carpal tunnel-like syndrome, gynecomastia and insulin resistance with an elevated risk of developing diabetes.” Not only has growth hormone not been approved for weight loss, or for anti-aging, but it has not been proved to increase human performance.

So why prescribe it? Perls believes the money is too hard to resist.

For example, write Perls and Olshansky, one “investigation revealed that the pharmacy would purchase 25 [grams] of imported hGH for $75,000, convert each gram into 3,000 IUs [international units] of hGH, then sell the drug for $6 to $18 per IU, netting a profit of $450,000 to $1.35 million.”

Patients often pay hundreds to thousands of dollars out of pocket each month for the hormones.

From feeling perfect to paranoid

Beacher just wanted to lose weight, and at first, the drugs seemed to work. “Everything felt great. I felt like Superman. You’re working out, losing weight, I was falling asleep great at night, everything was perfect.” But within a few months, Beacher says, “I was becoming paranoid and delusional.”

Perls and other experts say that when any patient is given hormones such as growth hormone or testosterone, constant monitoring should be done to check for blood levels and for possible side effects like diabetes.

But throughout this period, says Beacher (who is planning legal action against Goldmsith), he was given two blood tests, one at the beginning of his treatment and one six months later. “They told me everything was fine.”

When Beacher wearied of the regimen, he claims he contacted Goldsmith who suggested asthma drugs, though Beacher did not have asthma. Then Beacher began having what he calls “massive panic attacks.” Goldsmith prescribed Xanax, an anti-anxiety drug, Beacher says. “I took it. It didn’t help.”

Meanwhile, his life was falling apart. “It destroyed my business and my social life. I was dating an amazing girl but she never got to experience the real me. She saw a psychotic. I was crying every day for two months.”

Beacher’s situation was exacerbated by his own actions. In January, he stopped taking the drugs cold turkey. But because he had been getting so much growth hormone and testosterone in the form of drugs, his body had stopped making its own, so his levels of those hormones crashed.

“So initially he felt completely wiped out, then had severe depression from multiple factors,” reports Dr. Todd Schlifstein of New York University, with whom Beacher consulted. “He was also nauseous, tired, fatigued, cold, sweaty. And he had paranoid thoughts, which is not that surprising going from super levels of testosterone to a subnormal level.”

“I was concerned,” Schlifstein says. “He was on a complicated regimen without any real monitoring of how it was working aside from weight loss which is one of the last things I would worry about with that regimen.”

Little oversight

Lax oversight, and the near-sacred notion of the doctor-patient relationship may be partly to blame for experiences like Beacher’s.

Goldsmith is a board-certified internist and he has had no disciplinary actions entered against him in Nevada, though he has shown a penchant for unorthodox medicine. He has worked in fields like anti-aging, cosmetic procedures, and he markets dietary supplements. In 2007 he signed a deal with a company called NeoStem (mentioned in Msnbc.com’s recent anti-aging package) to bank patients’ blood stem cells even though most physicians and stem cell scientists argue that such banking is usually a waste of money.

Msnbc.com attempted to reach Goldsmith to discuss Beacher, the doctor’s weight-loss practices and related prescribing, and the government’s accusations. Msnbc.com was then contacted by Goldsmith’s lawyer, E. Brent Bryson, who issued a statement: “I greatly appreciate you giving my client and myself an opportunity to respond to your questions. Unfortunately, I have not been able to communicate with my client further regarding the issues we discussed. Thus, I do not believe it is appropriate at this time to elaborate further on any matters that we discussed other than to state that my client has always maintained the highest of standards and ethics in serving his patients.”

Unorthodoxy is tolerated in American medicine because sometimes unorthodox doctors are correct and government has been loath to step into the doctor-patient relationship. Plus, many drugs are routinely prescribed off-label for any number of legitimate reasons. So while the government may go after a doctor it suspects of fraud, it is unlikely to pursue one for unorthodox prescribing unless some medical mishap occurs or an outrageous pattern emerges.

Crackdown urged

But Perls favors modifying this tradition. He endorses new legislation making growth hormone a schedule III drug, which would require distributors and prescribers to register with the DEA. Currently, growth hormone is not a controlled substance, though it is regulated under a 1990 law making its distribution illegal “for any use … other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services … and pursuant to the order of a physician.” Some doctors get around this restriction by diagnosing “growth hormone deficiency” which they often define as simply having less of it than when somebody was 20 years old. But under a schedule III classification, that loophole would be narrowed and writing a prescription for a use such as weight loss, or a natural decline in the hormone, would be prohibited.

Beacher, who still lives in Las Vegas and who says his business is recovering, is living proof one doesn’t need a complicated drug recipe to lose weight. His body functions have now returned to normal and he claims he doesn’t take any weight-loss drugs. Yet he has continued to lose weight, and is now down to 225 pounds. His new regimen? “I do the treadmill twice a day and I eat healthy.”

Brian Alexander, a frequent contributor to msnbc.com, is the author of "Rapture: A Raucous Tour of Cloning, Transhumanism, and the New Era of Immortality" and “America Unzipped: In Search of Sex and Satisfaction."