South Florida's latest weight-loss craze and the booming business it's spawned are based on a pricey hormone that many doctors say is useless as a diet aid and may carry serious health risks.
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The U.S. government has refused for decades to approve the substance known as HCG for weight loss, and two states ban its prescription for that purpose. But a Sun Sentinel investigation found South Florida clinics charging hundreds of dollars for diet plans that employ the hormone produced by pregnant women, and facing virtually no regulation, inspection or oversight.
In its probe of 50 Florida clinics and HCG providers, more than two dozen of which are in Broward, Palm Beach and Miami-Dade counties, the Sun Sentinel found:
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• Physicians and counselors say HCG will help patients obtain dramatic weight-loss results without side effects, hunger pangs or the need for exercise, claims that the U.S. Food and Drug Administration and a significant body of medical research dispute.
• Many of the facilities are run or staffed by entrepreneurs with no medical training, doctors or medical assistants disciplined by state medical boards, or self-described "nutrition counselors" without medical licenses.
• In random visits to more than 10 of the clinics, the Sun Sentinel found none fully complied with Florida's patient protection laws. The newspaper also found three people who reported obtaining HCG without seeing a doctor first, which is illegal.
Though HCG has been around since the 1950s, South Florida doctors and health professionals said, there has been a recent surge in demand due in large part to use by celebrities, residents' obsession with physical appearance, and the state's lax laws and oversight. One Florida-based clinical compounding pharmacist estimated the market for HCG may have tripled in the past two years.
"There are things people do without any evidence, without any support, but which are not illegal — I would put HCG in that category," said Dr. Olveen Carrasquillo, associate professor of medicine and chief of the Division of General Internal Medicine at the University of Miami Health System. "For HCG, you have pretty good evidence that it doesn't work. Some states are better at regulating, trying to outlaw this thing, than Florida is. It's much more a state that believes the less regulation, the better."
If patients do lose weight, say doctors who oppose the use of HCG, it has nothing to do with the hormone that may cost up to $700 as part of a monthlong weight-loss plan, and everything to do with the drastic diets prescribed along with it. HCG dieters are supposed to limit themselves to the caloric equivalent of about one Big Mac sandwich a day. More liberal plans allow the equivalent of 1 1/2 Big Macs daily.
"People lose weight because they're not eating," said Dr. Hillel Z. Harris, an emergency room physician in Boca Raton. "That's what it medically comes down to."
'A roaring lion'
The FDA is so adamant that HCG (full name: human chorionic gonadotropin) is ineffective for dieters that its prescription label is required to state that "there is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or 'normal' distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets."
Yet many Florida doctors make precisely those claims as they offer HCG injections or liquid drops administered under the tongue as elements of weight-loss plans that require patients to consume only 500 to 800 calories daily. Some of their websites and advertisements carry disclaimers saying results will vary; some also note the FDA has not approved the drug for weight loss.
Advocates of the hormone say it decreases appetite and tricks the body — female and male alike — into thinking it is pregnant, thereby causing it to tap into fat stores rather than muscle.
"HCG has been around for 50 years," said Dr. Bart Gershenbaum, founder and owner of HCG Waist Management in Davie. He called use of the substance, plus the accompanying reduction in caloric intake, "the best diet plan I've ever seen."
"Why it's not FDA-approved, I can't answer. In the two years I've been associated with this office, I've seen unbelievable results with an unbelievable safety profile," Gershenbaum said.
Results reported by South Floridians vary widely.
Barby Chirino paid a Fort Lauderdale clinic $300 for a 30-day supply of HCG and lost 22 pounds. However, the Miami woman said she regained all of that weight, plus 18 additional pounds, right after she came off the diet.
"As soon as I stopped, it was almost like I regressed," Chirino said. "My appetite came back like a roaring lion."
But one of Gershenbaum's patients, Angela Schmitt, 27, of Hollywood, said she tried and failed to lose weight for years before shedding 78 pounds in two months last year.
