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.
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:
• 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.
"I stuck to the 500 calories, and the weight started dropping," Schmitt said. "I absolutely urge people
on a daily basis to do it."
Another HCG user, Kathleen Loehrig, 48, of Boynton Beach, said she lost 20 pounds and remains an enthusiast even after gaining seven back. Physicians say it is common to regain weight quickly after coming off extreme low-calorie diets, and that such weight-loss programs can lead to serious side effects ranging from hair loss to heart trouble.
A growing market
Weight-loss plans are big business in the United States, where nearly 36 percent of adults are too heavy, according to the National Center for Health Statistics. The growth in Americans' waistlines has driven the demand for quick-fix remedies, and HCG appears to have become the hottest fad.
It's impossible to measure precisely the growth of the industry in Florida because neither the state nor the federal government keeps tabs on HCG prescriptions. But since 2010, Florida has seen the arrival of more than two dozen HCG-only companies, state records show. Dozens of other clinics began dispensing the hormone about the same time, doctors say.
Advertisements in magazines now circulating in Broward and Palm Beach counties tout HCG diet programs and HCG clinics. "No hunger! No exercise!" one Davie clinic recently proclaimed. "OUTSTANDING WEIGHT LOSS RESULTS in just 28 days" claimed another.
A varied cast of entrepreneurs and businesses have mobilized to meet the demand.
At least 19 of the 52 weight-loss clinics or HCG providers the Sun Sentinel reviewed have medical personnel who previously faced state disciplinary sanctions or whose insurers paid out malpractice claims, or both. A Pembroke Pines physician who advertises HCG spent a year in prison after his conviction on federal charges of defrauding Medicare in 1987, according to news reports at that time and a state administrative complaint.
The founder of one statewide weight-loss center chain was suspended by Florida's Board of Nursing in 1995 for writing and dispensing weight-loss prescriptions without a doctor present. A nurse practitioner at a North Palm Beach clinic was sanctioned in 2007 for using pre-signed prescription forms to dispense controlled substances.
Two medical spas in Broward County that advertise HCG treatments employ physicians disciplined for botched plastic surgery procedures.
Other clinics were founded or are operated by entrepreneurs without medical licenses or degrees, which is permitted by state law. The HCG Cure Diet in Delray Beach is co-owned by George Tobin, former manager for 1980s rock star Tiffany (best known for the song "I Think We're Alone Now").
No doctor visits
The Sun Sentinel reviewed two complaints to state authorities concerning HCG weight-loss clinics in Broward County that allegedly provided the hormone without a face-to-face meeting with a physician, as required by Florida law.
In one of the cases, a 54-year-old woman from Davie told the Florida Attorney General's Office she got HCG and syringes from the Hollywood clinic HCG Results last year after paying $399. She said she did not have an examination by a doctor.
The clinic owner, Gary Levine, disputed the woman's account. Before receiving HCG, Levine told the Sun Sentinel, every patient is examined by an on-site physician.
Levine, who runs a second company that supplies rock for hobbyist aquariums out of the same offices, said patients who do not carefully follow the HCG diet plan will not lose weight and may become disappointed in HCG. Levine, who is neither a licensed dietitian nor a doctor, said it was his nutritional counseling that constituted the backbone of his program.
"I have hundreds and hundreds of files that say it works," he said.
The clinic's physician, Dr. Ronald Heromin, was arrested in a federal pain-pill bust in October 2011 and is awaiting a January trial on a federal conspiracy charge. He has entered a not-guilty plea. In the past, he faced state disciplinary action, which included more than $10,000 in fines and costs, for operating on the wrong knee of a patient.
In a September 2011 complaint filed with the Florida Attorney General's Office, Dr. Louis Zall, a physician, reported that his then 29-year-old daughter paid $695 to join an HCG weight-loss program at Physicians Weight Loss Centers in Coral Springs. Zall wrote in his letter that his daughter received HCG on her first visit to the clinic but did not see a doctor until the second visit. Zall's daughter, Geri, died in September. The autopsy report noted no connection to HCG use.
Kasey Matthews-Krugman, district manager for the facility, said in an email that her records show Geri Zall saw a physician named Dr. Carol Rudolph and received HCG on her second visit. She could not explain why the prescription label detailed in Zall's letter reported a different doctor's name.
The Attorney General's Office did not investigate either facility mentioned in the complaints, according to press secretary John Lucas. Officials from the office wrote back to the complainants advising them that they could take their concerns
to other state agencies. Neither clinic has faced any action, representatives at both said.
Some local physicians told the Sun Sentinel that HCG can be obtained online easily without a prescription. Last month, Dr. Kenneth Woliner, of Boca Raton, said he placed an order through the website of a Tampa Bay-area company for a 28-day HCG injection kit. He paid $146.94, according to an online receipt he provided. He said he did not see or speak to any doctor.
A few days later, Woliner said, he received a package containing a vial of HCG, which he also showed to the newspaper.
"This," he said, "is illegal."
The Sun Sentinel found some provisions of Florida's Commercial Weight-Loss Practices Act, which regulates weight-loss providers in the state, were being ignored by weight-loss centers.
In random visits to more than 10 such clinics in Broward and Miami-Dade counties, the newspaper found none had the "Weight-Loss Consumer Bill of Rights" visibly posted in its patient registration area, as required by law. The Bill of Rights requires weight-loss businesses provide the name, address and qualifications of the licensed dietitian who approved their programs on request, but some clinics contacted by the Sun Sentinel were unable to do that or gave the name of someone other than a licensed dietitian.
Florida's Department of Agriculture and Consumer Services is empowered to bring civil suits against clinics that violate the act, but a spokesperson said the agency has received no consumer complaints in recent years.
"We believe this is an area of state law that Floridians simply aren't fully aware of yet — that complaints should be filed with our office," said Sterling Ivey, the department's press secretary.
Most HCG and weight-loss clinics are exempt from the scrutiny of Florida's Agency for Healthcare Administration, which oversees, inspects and provides background screening to medical clinics in the state. The agency interprets the state's 9-year-old Health Care Clinic Act as not applying to facilities that do not bill insurance companies, and most weight-loss providers don't.
Rich Cleland, the assistant director of the U.S. Federal Trade Commission's division of advertising practice, said Florida regulators should more closely scrutinize clinics and physicians dispensing HCG.
"We're talking about products being marketed by licensed healthcare professionals," Cleland said. "If that is something outside the boundaries of professional conduct, it's something worth looking at."
Gershenbaum, HCG Waist Management's owner, acknowleged there are improper practices in the industry, including online sales of HCG by companies that don't require buyers to see a physician.
"That is illegal and immoral and beyond inappropriate," he said.
Gershenbaum himself was disciplined by the Florida Department of Health in 2000 for writing prescriptions for people who filled out online questionnaires, and he was ordered to pay more than $8,000 in fines and costs. Gershenbaum defended his actions at the time by noting that laws on Internet medicine were still being formulated and all but one of the substances he prescribed are now available over the counter.
He urged critics of HCG to speak to people who have had success with it. Their success stories, he said, outweigh the lack of clinical evidence.
"There are certain ways to lose weight, and certain ways get to be considered controversial," he said. "For those that don't promote or recognize HCG, what do they promote?"
Many other doctors said the surest way to shed pounds remains eating less and exercising more. HCG, they say, has no place in any dieter's regimen.
"It is not an unproven treatment; it is a disproven treatment," said Woliner, who gave a presentation entitled "The HCG Hoax" to the Broward County Dietetic Association last year. "It doesn't work."