Campaign to Defend Homeopathy
Overview and Campaign Components
Last update 6/4/2018 12:00 pm
Historical Context
Naturopathy is deeply rooted in Western medicine. As far back as history is recorded, humans approached healing from a holistic perspective. Both causes and cures were sought among elements of the patient’s physical environment, diet, and social health – what we would call holistic care today. At the same time, some medical
philosophers sought understanding by describing the body as a machine which may have missing or broken parts and pieces that could be identified and replaced. For millennia, these two systems cooperated side by side, each yielding clues to mysterious maladies and ways to treat them. The advent of dissection, anatomy, and microscopes favored the dominance of the mechanistic view. The ideological attraction of technological advances made with machines, hydraulics, and complicated communication networks during the industrial revolution overwhelmed the holistic paradigm. Antibiotics and the germ theory of disease closed the door entirely. Within a few virtually all the homeopathic schools and practitioners were gone, replaced by AMA trained physicians.
Yet, naturopathy and the discipline of homeopathy survive. What today’s American Medical Association won’t admit is that at the time homeopathy was researched, tested and proven, its standard of care was bloodletting, arsenic injections, and strychnine-laced potions. Taking the Hippocratic Oath to heart, homeopathy sought to help people survive and heal from disease without causing them greater harm that the new medicines were causing.
The rigorous and detailed path of scientific discovery undertaken by Dr. Hahnemann has been preserved down to every stroke of his pen. As a pioneering pharmacist searching the flora of the world for potential curative value, he documented how natural quinine, an early traditional prophylactic against malaria, would produce similar disease symptoms when ingested by healthy people. From there he posited a theory that if a large amount of a material could cause a disease, then a small amount of the same material could trigger the body’s self-regulation systems to respond to it. To this end, the first vaccinations were, in fact, homeopathic preparations of small amounts of pathogens derived from the blood and sputum of gravely ill patients. Homeopathy’s detractors called these tiny doses nonsense, then proceeded to give their patients large doses of live pathogens, killing hundreds.
The homeopathic hospital was a place of rest and safety. Clean water, careful hygiene, proper nutrition, sunlight and fresh air were the first requirements, at a time when regular clinics dismissed sunlight, sanitation and nutrition as superfluous. During flu outbreaks, most patients treated homeopathically survived. Others, cloistered in closed wards, experience amplified effects of the disease. Still today, homeopathic physicians question carefully the patient’s situation at home, at work, and in their family, and their diet, exercise, and spiritual routine, in addition to physical symptoms captured by their feces, urine, skin, tongue, eyes, hair, etc., over time. It all is related to the genesis and maintenance of the health condition, and thus the treatment.
All these patient attributes were noted in great detail during the “provings”, a curious word that describes the process of generating symptoms from increasing amounts of a particular material. These observations were codified into a set of complicated diagnostic paradigms. The timing, severity, resolution and co-presence of symptoms for each patient could lead to a very different decision about which homeopathic remedies to administer, how to give them, and when. No one symptom was held out as important; the most obvious symptom was often discounted and the least obvious was often of most interest. During its heyday, homeopathic experience with diagnosis and treatment was accumulated and shared widely through schools and individual contact. Like in many traditional societies, great wise healers were sought out for their insight and expertise.
Pursued today, the provings would be called clinical research: what happens to a set of patients when a medicine is given to them in increasing amounts over time? Within the allopathic approach, theories are developed about how a particular symptom might be caused by a certain problem with a particular metabolic pathway, body structure or function. A single chemical molecule is proposed to patch the problem, regardless of any other influences on the patient. When given potent modern medicines, some patients get better, some get worse, some have no change, some die, and others develop complications long into the future. Of course, the placebo and Hawthorne effects are present in both homeopathic and pharmaceutical testing. Just by being observed as part of a trial, patients may experience a resolution of their condition, whether they received the real drug or not.
Rather than short-circuiting or replacing any part of the body’s structure and function, homeopathy seeks to trigger the whole body’s response to a condition that it has not effectively recognized and addressed. Homeopathic preparations by definition are not dangerous or toxic. In some cases, the original potent drug material itself is no longer present in the drop, salve or pill given to the patient, but its presence is recognized by the body. While this may seem mysterious, it helps to remember that the full method of action of many (if not all) pharmaceuticals is admittedly unknown. Every study proposes a theory about how the single substance affects the full functioning of the body, but always admits the complexity of the body is too great to know all the effects (good and bad) the drug may or may not have. Similarly, it’s helpful to remember that the thyroid secretes one molecule at a time, which circulates in the blood stream triggering thousands of cascading metabolic responses without being degraded. This dilution is greater than anything found in homeopathy. The cure is not always quantity. Our understanding of viruses and diseases like cancer are still rudimentary after trillions of dollars of research. And with the failure of our most potent antibiotics to counter novel pathogen, a healthy body’s immune response has again become our primary defense.
Current Regulatory Framework
Homeopathy was given special protected status when the Food and Drug Administration was formed by Congress in 1938. Homeopathy was then widely used; a sitting senator held degrees in medicine and homeopathy. He insisted that both the US Pharmacopeia and the Homeopathic Pharmacopeia be recognized as legitimate sources of drug treatments. This détente held until the 1970’s and 80’s, when certain constituencies sought to marginalize homeopathics and dietary supplements as ineffective, dangerous and unnecessary. A broad and vocal coalition sought to protect access to dietary supplements, which resulted in the 1990 Dietary Supplement Health and Education Act passing into law.
In 1988, the FDA addressed how it would regulate homeopathic drugs under a Compliance Policy Guidance referred to as Section 400.400 which can be found here:
https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm
CPG 400.400 acknowledged the longstanding safety record of homeopathics and recognized their traditional use by consumers to treat many self-limiting diseases. It also established labeling requirements and highlighted fraud prevention.
FDA Proposed New Guidelines – 2017
Under the Obama administration, pharma industry interests and regulators reinforced the narrative that homeopathics were useless quackery which resulted in people wasting their money or being harmed by putting off conventional drug treatments. Typically, people do not spend money on products that don’t work, and there is no known case on record of anyone using homeopathy in place of urgent medical care. Nevertheless, the FDA proceeded with a “Homeopathy Working Group” that presented its findings during two days of recorded testimony in 2015. Typical of regulatory theater, the evidence presented by the working group was not incorporated into the resulting Compliance Policy Guidance that the FDA proposes will replace Section 400.400.
The proposed CPG presents itself as a risk-based enforcement framework based on manufacturing practices, adulteration, ineffective treatment, and avoidance of conventional treatment. No matter how the drafters have hidden it, the new guidance is designed to undermine protections for homeopathic remedies and access to them by consumers. As noted in the attached comments submitted to the FDA by the Natural Products Association, homeopathic drugs have almost no adverse events reported, while pharmaceutical drugs average over 1 million per year. If this were truly risk-based enforcement, the FDA would not focus on homeopathic remedies at all. FDA Docket
The FDA opened a federal docket to receive comments on the proposed CPG. Several thousand comments were submitted, most of them by consumers who depend on homeopathy and want it protected, as it has been, under Section 400.00. A minority of anti-naturopathy pro-pharma quack busters chimed in, but no one presented evidence of actual risk. Two comments supported homeopathy with incisiveness. The Alliance for Natural Health, a consumer health advocacy group with 650,000 members, painstakingly laid out the legal challenges to the proposal. The Natural Products Association, led by a man who worked for the FDA for many years and is sympathetic to the Trump administration, submitted a comment with succinct talking points that appeal the anti-government sentiments. Between the two, most of the regulatory issues were covered. Both comments are attached.