Out-of-state doctors treating patients by Webcam
Two physicians affiliated with an Arizona-based company have been prescribing or recommending risky and unproven weight-loss drugs and near-starvation diets to “patients” all over the country via telephone and Internet.
Novus OP, based in Mesa, AZ, says on its website that it can help people lose weight with a 500-calorie-per-day diet combined with doses of HCG, a hormone injection intended for fertility treatments.
Novus lists two doctors on its website as “lead weight loss specialists”: Jerry Guanciale, D.O., and chiropractor Ronald Willis.
Guanciale, who is described as a general and cosmetic surgeon, practices in South Carolina. He consults with patients over a web camera and prescribes injection kits for $299 per 26-day treatment, said Whitney Ethington, a manager of Prescription HCG Diet Direct. Guanciale has prescribed injections to “several patients” in Florida since the company started the long-distance consults in February, she said.
Willis, who practices in Arizona, talks to patients by phone and sends them homeopathic tongue drops, which cost $154.95 for 26 days and do not require a prescription, Ethington said. A press release from Willis calls Florida one of the top five states for sales of the HCG Diet.
Neither Guanciale nor Willis holds a Florida license, and therefore cannot legally treat patients in the state, according to the Florida Department of Health. However, there isn’t much Florida can do to stop them.
Ethington said the physicians can treat patients in other states as long as the doctors don’t solicit the patients.
“The patients have to choose us,” she said.
Greg Billings, executive director at the Center for Telehealth and E-Health Law, says regulations vary by state. Doctors who treat patients outside the state in which they are licensed must meet the requirements of the patients' home states, he said.
Florida regulations require that any doctor providing a patient with professional advice or treatment be fully licensed in the state, whether or not the doctor is prescribing medications.
Doctors who practice in-state may treat patients via Internet only if the doctor has first completed a documented patient evaluation, including a medical history and physical examination, according to an executive summary from the Florida Board of Medicine.
Guanciale appears to be flouting regulations in his own state, as well. The South Carolina Board of Medicine bans doctors from prescribing drugs to individuals the physician has never personally examined.
Because Willis is advising patients but not prescribing, it is unclear whether he is breaking the law in his home state of Arizona.
Guanciale and Willis did not return phone calls from a Health News Florida reporter.
Arizona corporate records show that Lauren Ethington, Clint Ethington and Seth Hassell hold various president, CEO and principal shareholder positions at the companies that own Novus OP. They could not be reached for comment; the relationship among the various Ethingtons is unclear.
HCG, which jump-starts estrogen and testosterone production, is approved only for fertility treatments and not for weight loss, said Federal Drug Administration spokeswoman Shelly Burgess.
She said adverse events are not uncommon. FDA received a recent complaint about a patient who was taking HCG for weight loss, who suffered a pulmonary embolism -- a blockage of a main artery or vein that usually results from a blood clot.
Despite risks, doctors can prescribe the drug for weight loss as long as they tell patients that it has not been found to help patients lose weight, Burgess said.
Several studies have shown HCG to be dangerous and ineffective for weight loss, said Arizona Dr. Craig Primack of the American Society of Bariatric Physicians. If patients on the HCG diet are losing weight, it's probably because of the 500-calorie diet they are placed on, he said.
“HCG is nothing more than a placebo,” he said. “And it could cause an increased risk of breast cancer, blood clots, ovarian cancer and for men it could increase the risk of prostate cancer.”
If doctors insist on prescribing HCG for weight loss, he said, they should verify the patient’s medical history, take blood pressure and blood tests and, for women, administer a pregnancy test.
Ethington, the Prescription HCG Diet Direct manager, said patients fill out a questionnaire of their medical background, but she did not know how doctors verify patients’ medical records and check their vitals.
Greg Billings, at the Center for Telehealth and E-Health law, said that two-thirds of the states require that a physician conduct an in-person physical examination of the patient before prescribing.
A few states allow for the examination to take place electronically, but typically a simple Webcam examination or an online questionnaire does not meet the standard of care required for state medical boards, he said.
Yet there’s a lot of confusion regarding what the law deems to be an appropriate physical examination and as a result, some physicians break the law unintentionally.
The situation with Novus OP highlights many of the concerns legislators face as more entrepreneurs look to set up electronic medical practices, he said.
“What if something goes wrong with the patient and that person needs follow-up care? What if a patient is allergic to something in the medication? Even if it’s an over-the-counter medication that a doctor recommends, the doctor can still be held responsible,” Billings said.
Dr. Nabil El Sanadi, a member of the Florida Board of Medicine, said that regulations are lagging behind technology, and there are no rules to address every situation.
When similar cases have come up, he said, the Board could not penalize doctors in other states. It could only notify the authorities in the state where the physician is licensed and hope they took action.
--Reporter Brittany Davis can be reached at 954-239-8968 or Brittany.Davis@HealthNewsFlorida.org.