Editor's Memo: FDA Removes Homeopathic HCG; Helps Legitimate Use In Pain Treatment
Early last month, the FDA took action against seven companies marketing over-the-counter human chorionic gonadotropin (HCG) products that were labeled “homeopathic” for weight loss.1 As most physicians know, HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions. The FDA took its action in order to keep non-approved formulations of HCG from being marketed online and in retail outlets.
The fraudulent claim that was cited by the FDA in its action was that homeopathic HCG, when combined with a 500-calorie diet, produces weight loss. The FDA and the Federal Trade Commission contend this is fraudulent advertising, because there is no proof that HCG independent of a low-calorie diet produces weight loss. The action taken by the FDA was supported by the American Society of Bariatric Physicians, the national weight loss society of physicians.
I support this action by the FDA because pharmaceutical-grade HCG fills a needed adjunctive role in pain management. Fraudulent claims about weight loss hurt legitimate medical practice. In pain management, our menu of therapeutic agents is short, and we need natural hormones to assist in some special clinical situations.
The use of HCG has great value in chronic pain management because of its basic physiologic properties. It is called “human chorionic gonadotropin” because it was originally believed to be produced only in the placenta during pregnancy. The public consequently often believes that it is only a “fertility drug.” Science has discovered, however, that HCG is produced in the pituitary of men and women of all ages.2,3
Chemically, it is made up of two amino acid subunits labeled a and b. One unit contains amino acid sequences that are identical to follicle-stimulating hormone, luteinizing hormone, and thyroid-stimulating hormone.2,3 Consequently, HCG stimulates the gonads, adrenal glands, and thyroid to secrete a number of hormones, including testosterone. The other subunit of HCG is an anabolic agent. It increases cyclic adenosine monophosphate (cAMP) and nitric oxide (NO).4 cAMP is known to be a critical element in tissue production, and NO is known to increase blood flow. There are HCG receptors throughout the body, including in the central nervous system (CNS).5,6 Animal studies show that it has considerable neurogenic properties.7
Pain practitioners will find HCG particularly useful in patients with central pain, as these patients develop significant hormonal deficiencies and have a need to regenerate CNS tissue. In my practice, I use HCG as an adjunct to standard pain management that is accompanied by hormonal testing for pituitary-adrenal-gonadal deficiencies; physician supervision is recommended when prescribed.
Below are key points that summarize HCG’s use in pain practice, which clearly separates its use from that advertised by the makers of homeopathic HCG.
- No claims of pain cure are made. HCG in pain practice is an adjunct to standard therapy when hormonal deficiencies are apparent.
- Unquantifiable dosages such as “homeopathic” are not acceptable, as we must know the precise dosages of every medication we prescribe. After all, a patient with chronic pain may be concomitantly taking multiple agents (eg, opioids, neuropathic compounds, and anti-inflammatory drugs), and we must constantly monitor for effectiveness, side effects, and interactions.
- As a highly active hormonal substance, HCG must be prescribed and monitored by a physician and not sold for self-help purposes.
- A 500-calorie diet is inappropriate in the vast majority of patients with chronic pain, as some are malnourished and even in a catabolic state because of poor dietary habits.
- One of the labeled indications for HCG is hypogonadism. Low serum testosterone levels are common in male and female pain patients who take opioids and other agents. Unfortunately, severe pain, per se, as well as many of our pharmaceutical agents cause pituitary insufficiencies and require hormonal replacement.
- Any physician can use a marketed pharmaceutical off-label as long as he or she does not make any public claim or advertise about off-label use. Advising the patient that the pharmaceutical is being used in an off-label manner is recommended. Be it clearly stated here that there is no claim of pain cure for HCG or that it is a substitute for standard pain treatment measures.