An effort to rein in a weight-loss fad that the FDA calls risky ran into a wall Thursday night at a Florida Board of Medicine hearing in Deerfield Beach.
Assistant Attorney General Ed Tellechea, the board’s general counsel, told members that state boards and agencies are no longer allowed to enact rules that could be costly to small businesses. HCG weight-loss clinics meet that definition.
All the board can do is build a case and ask the Legislature to act, Tellechea said. The deadline for bill filing has passed for the current session, so the matter would have to wait for 2015, he said.
“I am 99 percent positive if you pass a rule doing this, it’s going to require legislative ratification,” he said.
The fad in question is the “hCG diet,” which involves restriction on calories plus injections of manufactured versions of human chorionic gonadotropin, a hormone produced in pregnancy. HCG is appropriate for use in certain infertility treatments, the FDA and mainstream medical groups say, but weight-loss clinics and some body-builders use it for off-label purposes.
Doctors on the medical board say they’ve noticed that some entrepreneurs who used to run pain-pill clinics before the state cracked down on them have gravitated to the hCG weight loss business. There’s a good reason for that, says Henry “Skip” Lenz of Boca Raton, who holds a doctorate in pharmacy.
It’s a lucrative business, he said in a letter to the board. Compounding pharmacies buy raw HCG powder from a wholesaler, then make up sterile injectable vials that they can sell wholesale to diet clinics, which in turn sell them at a markup to patients.
“Let me be clear, there is a scientific consensus that hCG is of no use in the treatment of obesity or weight control and implying otherwise is a misleading, deceptive or fraudulent misrepresentation of fact,” Lenz wrote.
Boca Raton family physician Ken Woliner, the one who asked the board to crack down on HCG weight-loss clinics, cited reports of cardiac arrhythmias, hair loss and other medical problems linked to the HCG diet plan. He said he has filed complaints about more than 100 of the clinics to the Department of Health, without result.
DOH is supposed to investigate and bring action against the licenses of physicians who practice below the standard of care. But Woliner said DOH “tanks” the cases because it doesn’t consider them important.
Alison Dudley, executive director for the board, said the problem is often that DOH personnel can’t get cooperation from patients, who use HCG because they believe it makes them thin or builds their muscles.
Indeed, some of hCG’s fans showed up at the Thursday night hearing. One was Dr. Sasson Moulavi of Boca Raton, who said he has been successfully using hCG injections in his obesity practice for many years without seeing dangerous side-effects. The hormone prevents the loss of muscle mass during rapid weight loss diets, he said.
Moulavi said the health problems occurred in patients who were using the drug while taking in only 500 calories a day.
One man who testified, Earl Bass, said the hCG shots and low-calorie diet have helped him lose 130 pounds. Before finding the weight-loss regimen, he said, “I was headed for an early grave.”
Michael Lowe, attorney for a chain of clinics that use the drug, said there was “no actual evidence it has harmed people.”
He added, “Dr. Woliner is asking you to regulate a product. That is not within the power of the board.”