Weight loss hormone banned but still popular

The bald, pot-bellied man walked into the Revive Weight Loss Clinic and asked a female employee wearing scrubs whether he and his wife could get on the HCG weight loss diet advertised on the clinic's Web site.

Not only did the employee say the man and his wife could do so at the clinic, located directly across from MountainView Hospital, she pointed out that her svelte figure and those of her colleagues were a result of the HCG diet.

"It really works."

Forty weeks of a daily regimen of HCG would cost around $550, she said; 26 weeks, about $300.

"It will be up to the doctor to determine how much you need," she said, giving the man who appeared to be a potential client a brochure while explaining how HCG works in conjunction with a 500-calorie-a-day diet.

Since the 2007 publication of controversial infomercial king Kevin Trudeau's best-selling book on HCG, "The Weight Loss Cure 'They' Don't Want You To Know About," it hasn't been difficult to find doctors and clinics cross the United States selling the diet.

HCG stands for Human Chorionic Gonadotropin, a pregnancy hormone made by the developing embryo soon after conception and later by a part of the placenta.

More than a half century ago, a British researcher, Dr. Albert B. Simeons, argued that injections of HCG would allow dieters to exist comfortably on a 500-calorie daily diet, a claim later largely discredited by a series of studies by scientists worldwide.

Last year, the hormone piqued the interest of sports fans when Los Angeles Dodgers' star outfield Manny Ramirez was suspended for 50 games for having taken HCG for an entirely different reason.

It turns out HCG is popular among steroid users because it can lessen the side effects of steroid use, which can include low sperm count and shrunken testicles.

That the HCG weight loss diet is available in Nevada may seem strange when this fact is considered: It is illegal in the Silver State for a physician to prescribe HCG for weight loss.

Yet Las Vegas doctors and clinics advertise what is a synthetic version of the hormone as a way to lose up to 30 pounds in a month.

HCG is legal in many other states.

Las Vegas plastic surgeon Terry Higgins touts the diet in the latest edition of the glossy "Las Vegas Woman" magazine, writing that the "regimen has continually shown a weight loss of between 1-2 pounds a day."

The Review-Journal has run weight loss ads from a company that, while not mentioning HCG in the ad, still touts it on its Web site.

Douglas Cooper, interim executive director of the State Board of Medical Examiners, said Nevada physicians who prescribe HCG for weight loss risk losing their licenses.

"It probably would just be a (warning) letter at first," Cooper said. "But we have a law against using HCG this way."

In 1979, Cooper said, the medical board made it illegal for physicians to prescribe HCG for weight loss because of a perceived threat to public safety.

The Nevada State Board of Osteopathic Medicine passed a similar regulation soon afterward, arguing that HCG constitutes "experimental medicine."

But on March 5, the State Board of Medical Examiners will entertain a petition brought by two Las Vegas physicians, Drs. Ivan Goldsmith and James Tate, to remove HCG from a list of substances banned for the control of weight loss.

Goldman said it makes no sense that Nevadans simply can cross state lines into Utah, Arizona and California and legally obtain HCG.

"It is a diet that should be done under a doctor's supervision, though," he said. "You have to make sure things like blood pressure stay in line."

Spokesmen for medical boards in Arizona, California and Utah contacted recently by the Review-Journal say they have had no complaints from people about the safety of the HCG diet.

"I'm tired of doctors in Nevada having to do surreptitiously what is done everywhere else legally," said Goldsmith, who runs the TrimCare diet program in Las Vegas. "Literally millions of people across the nation are using HCG. The law is hopelessly outdated. There is no real evidence that HCG has hurt anybody, but we know obesity is hurting Americans to the point where the majority of our health problems are caused because of it. We need HCG as a tool to help control an epidemic. There are no easy answers, but HCG does work for some people."

Goldsmith said he does not prescribe HCG for weight loss because of his concern about legal sanctions. Goldsmith said he does prescribe it to women who have lost muscle mass and to men with low testosterone levels.

Tate was unavailable for comment.

"It's hard to believe the HCG diet is not legal," said Las Vegas real estate agent Lynn Wilcox, who said she lost 26 pounds in six weeks on the diet and has kept it off.

Wilcox said she was taught by a clinician how to give herself injections in her buttocks.

"I'm normally very scared of needles, but this is a very thin one, like diabetics use, and really doesn't hurt," she said.

Wilcox didn't want to name her medical practitioner for fear of getting him in trouble with the Nevada medical board.

HCG HISTORY

The Food and Drug Administration has given its stamp of approval to the use of HCG, but only as part of fertility treatments for both men and women.

In the 1970s, the FDA and Federal Trade Commission took steps against HCG injections for weight loss, then the nation's most popular method of obesity control.

Three scientific studies, one in Israel and two in the United States, had found that a placebo was as effective as HCG in curbing hunger pangs and other physical distress that resulted from a 500-calorie daily diet.

Consumer activists had long argued that the drug's popularity was pushed by doctors who wanted patients returning regularly for injections

Since 1975, HCG labels note that it is not approved by the FDA for weight loss. But that doesn't stop physicians throughout the United States from prescribing it for that purpose.

"Once a product is approved by FDA, a physician can use that product for off-label uses if he/she feels it is clinically appropriate and has a scientific basis for its use," said FDA spokeswoman Elaine Gansz Bobo. "Of course the physician assumes the risk and liability and could be subject to legal action for using the product in an off-label manner if negative health outcomes occur."

An estimated 20 percent of all prescriptions in the country are for off-label uses.

Bobo said she could find no FDA action taken against doctors or clinics as a result of HCG causing injury or illness to a diet patient. She said the fact that Nevada does not let physicians prescribe HCG has nothing to do with the FDA.

"What Nevada state law allows is a state practice of medicine issue," Bobo said. "FDA does not regulate the practice of medicine."

Both Goldsmith and Higgins have examined what Simeons first released in 1954 in the British medical journal, Lancet.

"Basically, the HCG diet programs used today are run the same way he did back then," Goldsmith said.

Over a 20-year period, Simeons placed 500 patients on a strict weight loss regimen for 40 days: two daily meals consisting of lean meat, leafy vegetables, and fruit for a total of 500 calories a day, along with a daily shot of HCG.

Simeons reported that patients who followed the diet for 40 days lost 20 to 30 pounds, and that 70 percent of them maintained their weight loss after stopping the diet. A kind of behavioral modification occurred during the diet period, he suggested.

Simeons said the HCG hormone enabled his patients to remain on the diet without feeling overly hungry, dizzy or weak.

In decades since, researchers have continued to study the diet. In 1995, researchers from the Netherlands reviewed the results of 24 studies. But only 12 of the studies were well designed, the Dutch team found, and 11 of those reported that HCG was ineffective in treating obesity.

Not until the release of Trudeau's book and subsequent infomercials in 2007 did the diet regain popularity.

Though initially fined millions and banned from the airwaves by a federal judge because of how he marketed the diet, the ruling was overturned by an appellate court in 2009 and sent back to a lower court for a new remedy, including possible criminal sanctions.

No recent major double-blind scientific studies have been done to support the efficacy of the diet.

Goldsmith concedes that many recent studies of HCG that support the diet regimen do not meet the high standards of the scientific community.

He said that because clinicians around the county can largely use HCG off label as a diet treatment, there is no rush by diet doctors to spend millions on a study.

Writing in the current edition of "Las Vegas Woman" about the effectiveness of the diet, Higgins cites studies "which have supported a significantly greater weight loss in HCG-treated patients than in those treated with placebo."

Though HCG is also now available in drops and nasal spray, Goldsmith said studies have not shown whether those modes of delivery are as effective as injections.

Cooper said the board is requesting information on HCG from experts across the country before the March 5 meeting.

"We will do what's best for Nevadans, not doctors," Cooper said.

Though reports of health problems resulting from the HCG diet have not been reported by the FDA, some doctors warn that a 500-calorie-a-day diet may not sustain the body's vital organs.

There is also an increased risk of blood clots, restlessness, depression and headaches.

It can also cause a potentially life-threatening condition known as ovarian hyperstimulation syndrome.

Dr. Christine Gerbstadt, an American Dietetic Association spokeswoman who is both a medical doctor and dietician, won't be upset if Nevada continues to make it illegal for doctors to prescribe HCG for weight loss.

"I have a friend who was on it in the '70s who's now 320 pounds," Gerbstadt said in a telephone call from Florida. "Of course, you're going to lose weight if you only eat 500 calories a day. But (if) you eat that little, you can have heart and blood pressure trouble.

"No matter what they say, you're losing muscle mass, not just fat. When you do a crash diet like that, the fat's going to come back again if you haven't changed you're eating habits. ... That friend of mine who's now 320 pounds? She also got multiple sclerosis after being on that diet. I have no way to prove that the diet did it, of course. But when you try to get by on 500 calories for an extended period of time, things can happen."

LAS VEGAS AVAILABILITY

Although ads show many Las Vegas medical practitioners appear to make the HCG diet available, some seem leery about discussing their involvement with it.

Dr. William R. Maranon and naturopathic doctor Rachel Azoulay, who run the Revive clinic at 2911 N. Tenaya Way, did not return repeated phone calls to talk about the HCG diet injections their staff recommended to the "bald pot-bellied man," who actually was a Review-Journal reporter.

Their Web site not only advertises the diet, it has video testimonials touting the diet by purported satisfied clients, including a man who refers to himself as a police officer. The site says "injections for weight loss are administered using a very fine needle and are relatively painless."

Plastic surgeon Higgins spoke enthusiastically in a phone interview for 15 minutes about how he used HCG with patients. When the legality of the diet in Nevada was brought up, Higgins said he and his lawyers hadn't found a problem.

Five minutes later, Higgins called back to say he had never used HCG on patients, just his office staff. One staffer had lost 39 pounds, he said.

Goldsmith and Tate were so worried that the medical board might discipline them for trying to get HCG legalized in Nevada that they recently went before a District Court judge and tried to get a temporary injunction preventing the board from taking action against them.

After Judge Stephanie Miley could find no basis for an injunction, Cooper, who was at the hearing, shook his head.

"This was totally unnecessary," he said. "We're not going after anyone. The doctors will have their proper forum on March 5. We'll determine then if this diet is in the best interests of Nevadans."

Contact reporter Paul Harasim at pharasim@reviewjournal.com or 702-387-2908.