Regulating Medical Practice

INTRODUCTIONThe Department of Health has attempted to punish a doctor of naturopathic medicine for his off-label prescription of human chorionic gonadotropin (“hCG”) despite the fact that such practices are accepted form of medical treatment recognized by the FDA and federal courts. Nor can the Department allege any patient harm due to that doctor’s treatment.The statement of charges alleges that Dr. R prescribed hCG for weight loss between 2008 and 2010. The Department asserts that hCG is not approved for weight loss and thus it is a violation of the community standards for care to prescribe it for such. Health care providers with prescriptive authority routinely prescribe drugs for uses that have not been approved by the FDA.This is referred to as “off-label” use, and is standard practice in providing health care nationally as well as in the State of Washington. The statement of charges does not allege that any patient suffered harm through the prescription of such drugs. Nor does it contest that the use of hCG for weight loss is without therapeutic value.Dr. R’S PRACTICE HAS EVOLVED OVER THE DECADES TO BETTER SERVE HIS CLIENTS.Dr. R has been practicing naturopathic medicine for over 27 years, and has significant experience in assessing, evaluating, and treating all aspects of his patients’ signs and symptoms in line with the mission of naturopathic medicine. He is an important provider to the community in his area.Dr. R works in a remote area of Washington state. His patients either cannot appear at his office or find it very inconvenient to. As a result of that fact, Dr. Marschall has developed a process of remotely evaluating patients. He uses a comprehensive questionnaire, reviews available records, conducts an intake over the phone, and then orders whatever tests he believes are necessary before he begins treatment for weight loss. hCG is also but one of many tools Dr. R uses to treat obesity.CHARGESIn 2012 Dr. R was charged by the Department of Health. The allegations read as follows: In 2008 Respondent prescribed hCG for Patient A for weight loss. At no time did Respondent meet Patient A in his office or elsewhere. Respondent’s contact with Patient A was by telephone. Respondent had given Patient A the option of coming to his clinic or having a telephone consultation. Patient A chose the telephone consultation. On the telephone, Respondent asked Patient A questions about her medical history and asked her what medications she was currently taking.In 2008, 2009, and 2010, Respondent prescribed hCG for weight loss for approximately one hundred seventy (170) patients who reside outside of Washington State and whom Respondent did not see in person before or after prescribing hCG.The Department has indicated that it is most concerned with Dr. R’s use of hCG and practice of “telemedicine.” The Department proposes to revoke Dr. R’s license for a period of five years and impose tens of thousands of dollars in fines upon him.The issue of “telemedicine” is beyond the scope of this article, except to note that it is the remote provision of medical care to patients via the internet, phone, or audio-visually (through services such as “skype). Telemedicine has been hailed as allowing doctors to triage, diagnose and monitor medical cases remotely. Nationwide systems exist for the provision of this type of care through such companies as callmd.OFF-LABEL DRUG USE AND THE LAWOff-label drug use is an accepted part of medical treatment. The FDA generally does not regulate how physicians use approved drugs. Once FDA-approved, prescription drugs can be prescribed by doctors for both FDA-approved and –unapproved uses. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001); accord United States v. Caronia, 703 F.3d 149, 153-54 (2d Cir. 2012) citing with approval John E. Osborn, Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information, 10 Yale J. Health Pol’y L. & Ethics 299, 303 (2010) (“Physicians may prescribe FDA – Approved drugs … for any therapeutic use that is appropriate in their medical judgment.”). Indeed, courts and the FDA have recognized the propriety and potential public value of unapproved or off-label drug use. See Buckman, 531 U.S. at 350 (Off-label use is an “accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”); see also In re Zypresxa Products Liability Litigation, 671 F.Supp.2d 397 (E.D.N.Y.2009) (“doctors may voluntarily prescribe FDA-approved medicines for approved and unapproved uses as they belief appropriate in the exercise of their own professional judgment.”). FDA approved indications are not intended to limit or interfere with the practice of medicine nor to preclude physicians from using their best judgment in the interest of the patient. Caronia, 703 F.3d at 153, citing with approval U.S. Food and Drug Administration, Draft Guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices 3 (2009). The FDA itself has observed:Once a drug has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patent populations that are not included in approved labeling. Such “unapproved” or, more precisely, “unlabeled” uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature.U.S. Food and Drug Administration, FDA Drug Bulletin, 12 FDA Drug Bull. 1, 5 (1982). In fact, off-label uses of prescription drugs are a “mainstay of the industry…” In re Zypresxa Products Liability Litigation, 671 F.Supp.2d at 415.A SECOND OPINIONDr. R had one physician and two naturopathic doctors review his treatment protocol. The Reviewing doctor wrote:I have reviewed Dr. R’s instructional booklet on the HCG diet, his patient intake forms, and the medical literature on the HCG diet. I have questioned Dr. R about his medical practices and protocols, including his weight loss telemedicine clinic (serving approximately 10% of his patients).My assessment of the HCG diet as practiced by Dr. R, based on Dr. Simeon’s original protocols is the following:His HCG protocol of 150-200 IU subcutaneous each day for a maximum of 40 days combined with a very low calorie diet of 500 calories is very likely to cause significant weight loss if patients are compliant with the instructions, though there is little scientific evidence to show that the HCG acts independently of the severe calorie restriction. Possible unproven (according to peer-reviewed medical literature) effects of HCG injections include appetite suppression and preferential fat burning in low calorie situations. These are effects anecdotally and clinically observed by medical doctors and naturopaths who prescribe the HCG diet.The dose of HCG used in this diet is 25-50 times lower than the doses typically used in ovulation induction and is very likely to cause little harm other than a theoretical risk of increased blood clots, worsening gallstones, worsening hormonally sensitive pre-existing cancers, and interfering with normal hormonal development of prepubescent children. There are also injection related potential side effects such as abscesses, folliculitis, and bruising/hematoma.Dr. R takes care to protect his patients from these side effects by taking a careful history, ordering medical records when relevant, sending them to a local provider for a physical exam when indicated, ordering lab tests when clinically indicated, never prescribing the diet to prepubescent children, monitoring the patients for side effects, teaching them proper injection techniques, and not prescribing the HCG for more than 40 days at a time. He also screens patients for hormonal and psychiatric reasons for weight gain and takes care to reverse these conditions before prescribing the HCG diet.While the HCG diet as prescribed by Dr. R is not considered standard medical practice in weight loss clinics staffed by medical doctors, and is a controversial method of helping patients achieve weight loss (primarily because medical doctors typically don’t prescribe calorie restriction below 1200 calories and are not used to using HCG for off-label weight loss purposes), there is no indication that his weight loss program constitutes medical malpractice, and much anecdotal evidence (through happy patient testimonials), that he is helping patients.The evaluations by the two naturopathic doctors are even more supportive.THE DEPARTMENT IS UNMOVEDIn conclusion, the Department of Health is determined to both prevent the use of hCG for the treatment of obesity and to curtail telemedicine. It is this writer’s understanding that the Department has brought charges against other doctors for the off-label use of hCG. The Department is thus attempting to regulate doctors in their treatment of patients, something that the courts and the FDA believe is inappropriate. Further, the future of health care increasingly involves telemedicine. Companies now exist to provide this service nationwide and several prominent hospitals in Washington State also offer that service. The Department is thus on the wrong side of technological advance in its stance. While history will likely vindicate the practices of Dr. R, in the short term he may well have his licensed revoked.