Doctors Use Obesity Treatment Debunked by FDA

More than a decade after a controversial hormone injection was widely shown to be useless in treating obesity, the treatment is still being given to many overweight Southern Californians as part of weight-reduction programs.

When the federal Food and Drug Administration concluded in December, 1974, that the hormone, called human chorionic gonadotropin (HCG), was worthless for weight loss, it ordered a warning printed in capital letters to be added to the packaging information that said the drug “has no known effect on fat mobilization, appetite or sense of hunger, or body-fat distribution.”

But a Times reporter who randomly telephoned 40 medical weight-loss programs that advertise in Los Angeles County yellow pages found 19 that offer HCG shots, including the Lindora Medical Clinic, one of Southern California’s largest chains of weight-loss clinics.

Dr. Antony Gualtieri, the chief medical consultant for the state Board of Medical Quality Assurance, expressed surprise when informed of the findings. He said the state licensing agency had last officially disciplined a doctor for such use of HCG in 1981.

“Weight clinics seldom come to our attention,” added Herschel I. Elkins, chief of the consumer law section of the state attorney general’s office in Los Angeles. “If people don’t lose weight, they blame themselves; if they do, it is because of (the program).”

Lack of Complaints

The lack of complaints may help explain why HCG continues to be widely used. “I don’t know if patients know what they are getting,” Gualtieri said. “We have to react to complaints. We have no statutory right to go into a doctor’s office and review their medical practice.”

Gualtieri added, “HCG is absolutely without value and totally inappropriate for use in weight reduction.” He said it is “unprofessional conduct at its worst” for a doctor to represent HCG as effective to a patient.

But some physicians prescribing HCG defend the shots, saying HCG motivates patients to follow low-calorie diets and sometimes succeeds where other approaches have failed.

“It is probably the safest medication ever used,” said Dr. Richard E. Zinkan of Tustin, who said he has treated more than 500,000 patients with the “effective” medication since 1967. Zinkan said he now treats about 40 patients a day with the hormone at each of his four clinics.

At Lindora medical clinics, the patient information booklet states that HCG works by “mobilizing your abnormal fat into the blood stream as nutrients. This permits you to accept a very low caloric intake so that you can lose weight rapidly, feel well and not be overly hungry.”

The FDA’s warning directly contradicts those assertions.

Lindora’s clinic in Long Beach was the site of a 64-case hepatitis outbreak in 1985. State and federal health officials linked the epidemic to hepatitis B virus contamination of a “jet gun” injector--a conclusion disputed by Lindora officials. It turned out that the jet gun was primarily used to give patients at the clinic daily injections of HCG.

While Lindora no longer uses jet gun inoculators, the hormone shots remain a mainstay of therapy at the chain’s 29 weight-reduction clinics.

‘Beyond Placebo Effect’

“Most of the patients that come through the clinic use (HCG),” Dr. Marshall B. Stamper, Lindora’s founder and owner, said in a telephone interview.

“They prefer it to other methods,” Stamper said, adding that he uses the shots himself on occasion for arthritis of his fingers, another condition for which the FDA has not approved HCG. “We tell the patients point-blank that it doesn’t cause weight loss, but that they will feel better on it. I feel the patients have definitely benefited. I feel it goes beyond the placebo effect.”

HCG shots have been condemned by the American Medical Assn., the California Medical Assn. and the Federal Trade Commission on the basis of studies in the Journal of the American Medical Assn. and elsewhere in the mid-1970s that concluded the shots were no more effective than salt-water placebo injections or diet alone.

“HCG is a good gimmick,” said Dr. George A. Bray, chief of diabetes and clinical nutrition at the USC School of Medicine and an author of one of these studies. “If (you want to be) a lucrative ‘fat doctor,’ an injection program has merit because it gets people back on a regular basis.”

HCG, which is obtained from the urine of pregnant women, is approved by the FDA for treating undescended testicles in boys and in some infertility cases. The dosage of medication used in weight-loss programs is very low. It usually does not cause side effects, such as headache, swelling of body tissues, fatigue or breast enlargement, that have been associated with higher doses.

HCG for weight loss was first advocated in a 1954 article in the Lancet medical journal by Dr. A. T. W. Simeons of the Salvator Mundi International Hospital in Rome. The so-called “Simeons method” subsequently became popular throughout the world.

Simeons based his theory on beneficial effects that he had observed when treating boys with HCG who suffered from both obesity and abnormally low levels of sex hormones. In 1974, the FDA dismissed his studies, concluding, “Simeons’ sweeping claims were based almost entirely upon uncontrolled collections of case reports.”

In weight-loss programs that use the hormone, a patient is typically prescribed a 500-calorie-a-day diet, compared to a normal adult intake of more than 1,800 calories daily, and HCG shots five times a week for six weeks. The cost for such a program may be $300 to $500.

Pills Favored Over Shots

Typically, each time an injection is given, a patient is encouraged by a nurse to stick to the diet. Vitamins may also be given, either as a pill or by injection, although there is no evidence that vitamins contribute to weight loss, according to most academic physicians who specialize in nutrition. These experts also feel that any vitamin supplements should be given as pills, which are safer and much less expensive than shots.

People who follow such a 500-calorie, supervised diet for four to six weeks--without taking additional medicines--may lose 15 to 25 pounds or more, although some of the weight can be quickly regained when the diet ends. Nevertheless, there is a tendency for patients who take HCG to credit the hormone with causing the weight loss.

“I pulled out the Physicians’ Desk Reference, and I knew there was no scientific proof that HCG would make you lose weight,” one former Lindora nurse said. She went on the HCG program soon after she began to work for the chain in 1985 and quickly lost 40 pounds. “However, they seem to have gotten excellent results for 15 years.”

Physicians have the discretion to prescribe licensed drugs for unapproved uses, although it is generally considered good medical practice to inform patients about FDA warnings, such as the one for HCG, and obtain their consent.

But misrepresenting the effectiveness of a drug, on the other hand, may be “negligent” and may constitute “unprofessional conduct,” said Gualtieri of the Board of Medical Quality Assurance. “We have to rely on the the physician’s expertise and judgment in using medication,” he said. “We cannot prohibit them from using (licensed drugs), but we can hold them to appropriate use.”

One former Lindora patient who asserted that the clinic did not tell him about the FDA warning is James Olson, 54, a former patient at the Long Beach clinic and a hepatitis victim. “They spoke very highly of the injections. No way did they tell me anything about (the FDA’s warning).”

Took Shots

Olson, a civilian employee at the Long Beach Naval Shipyard, dieted and was given HCG shots for about 15 weeks in late 1984 and early 1985, going from 276 pounds to 190 pounds. After developing hepatitis, a form of liver inflammation, his weight increased to 255 pounds. He has filed a lawsuit against Lindora alleging that negligence and substandard care led to his case of hepatitis.

“I paid a big price,” said another former patient at Lindora’s Long Beach clinic who was hospitalized for hepatitis and also has a lawsuit pending against Lindora related to the development of liver disease. “On 500 calories a day, you are going to lose weight no matter what. What the purpose of the HCG is you will never know.”

About 32 million adults--28% of all adults in America--are overweight, and 11.7 million are seriously overweight, the federal Health and Human Services and Agriculture departments said recently. But weight-loss advice for such individuals remains controversial.

Most academic physicians who specialize in nutrition emphasize that a gradual approach is the best way for most people to lose weight--and to maintain that loss. This usually involves combining a balanced diet low in fat and high in carbohydrates with an exercise program and behavioral changes to eliminate the factors that led to overeating in the first place.

Advice Is to Avoid Fads

These experts usually counsel patients to avoid fad diets and medicines such as thyroid hormone or diet pills. Surgery and newer treatments--such as a “gastric bubble” that is inserted into the stomach through the mouth--are expensive, have side effects and may not result in long-term weight loss. Such procedures are usually reserved for the severely overweight, who often suffer as well from life-threatening medical conditions.

Several physicians who use HCG in their practices were asked how they discuss the advantages and disadvantages of the medication with patients. “I tell them the truth,” Dr. Milton H. Gotlib of Los Angeles said. “I don’t make claims it curbs the appetite.”

“I don’t cite the Physicians’ Desk Reference, but I do say that a great many physicians consider (HCG shots) useless,” said Dr. Walter F. Jekot of Los Angeles, who said he uses the hormone for fewer than 10% of his weight-loss patients. “But you have to understand that (many patients) have seen their friends lose weight taking the shots.”

Jekot emphasized that despite the stigma associated with the shots, the end result is the important issue. “You can’t look at the situation as black and white. There are shades of gray.”