Piecing Together Safety of Homeopathic Medicine: Researcher, Clinician, and Manufacturer Perspectives

By Mark Land, M.S., RAC-US, AAHP President

In this issue we examine the safety of homeopathic medicines for the perspective of researchers, clinicians, and manufacturers.

In general, evaluating the safety of medications is complex and fraught with the potential for misinterpretation. Manufacturers marketing drugs in the United States and other developed countries are required by regulation and ethical considerations to carefully record and analyze reports of adverse effects. This is true for homeopathic medicine as well. The discipline of recording, analyzing and reacting to adverse event reports is known as pharmacovigilance. Manufacturers and marketers of OTC drugs including homeopathic OTC medicines have been required to report serious adverse events to FDA since 2007. Some homeopathic manufacturers have safety databases dating back 35 years or more.

Pharmacovigilance is only one of several factors necessary to understand the consumer or patient experience with marketed products. It is probably safe to say that most homeopathic manufacturers receive proportionally very few adverse event reports. What is at debate is what percentage of consumers report adverse events to the manufacturer or to FDA. Although pharmacovigilance is the gold standard for post marketing safety surveillance, alone it is an incomplete measurement of safety. Adverse event reports taken in the clinical setting are also highly valuable to the drug sponsor. The additive power of adverse effects from clinical research reporting and pharmacovigilance surveillance is an important combination of information that not only adds to the safety database but also informs the design of the surveillance program for a given product.

Clinicians record not only therapeutic effects but adverse effects as well. Adverse effect reports in clinical research are extremely valuable. Their value derives from the setting in that reports are taken by healthcare providers in a systematic way. Study subjects are encouraged to report adverse effects, meaning that the rate of reports in clinical trials is likely to be closer to real world rates. Doctor Dossett reports on rates of adverse effects reported in clinical trials published and analyzed in medical literature.

In homeopathy, treatment is symptom dependent. Physicians and practitioners interview patients vigorously to develop a symptom picture. Cataloging changes in symptoms both positive and adverse following administration of a homeopathic medicine is fundamental to the homeopathic therapeutic setting. Homeopathic medicines are often diluted and not considered a risk for direct chemical adverse effects. Clinicians, however, warn us that that doesn’t mean that there are no adverse effects in practice. Evaluating the safety of drugs is multifaceted and complicated by dose, dosage form, route of administration, frequency of administration and even the sensitivity of the consumer/patient among other things. In his article Dr. Shevin reports on the adverse effects known as aggravations. It is generally characterized by a brief worsening of symptoms after administration of a homeopathic medicine. These effects are often minor and transient and may not be reported by the physician.

So how do manufacturers minimize risks to consumers and patients? In his article Dr. Hoover discusses at length dose response in relationship to homeopathic dilutions. It is commonly held that for most substances any toxic effects are diminished as the exposure is reduced. For example, a 1X homeopathic dilution is more concentrated than a 3X and to the extent that the starting material was capable of toxic effects the 3X would be less toxic than the 1X. Following this theory there is a point beyond which we do not expect any risk of adverse effects.

The Homeopathic Pharmacopoeia of the United States (HPUS) evaluates each homeopathic substance to determine the dilution at which it is safe to administer with wide margins of safety for both consumers and patients. The HPUS considers a reasonable container size of the finished product when evaluating safe dilutions. These calculations can be overwhelmed if the container size and dosage instructions exceed these reasonable limits, however.

This brings us back to my point: Evaluating the safety of drugs— even homeopathic medicines—is complicated. I hope your journey through this issue sheds a little more light onto the mosaic of thought that accompanies the design, development and surveillance of marketed homeopathic medicines.