REALL News - Vol 05 No 11 - 1997

Magazine Overview

The REALL News, Volume 5, Issue 11, published in November 1997, features an article titled "Homeopathy - The Ultimate Fake" by Stephen Barrett, M.D. The issue includes a quote from James Randi stating, "It's a very dangerous thing to believe in nonsense."

Homeopathy - The Ultimate Fake by Stephen Barrett, M.D.

This article critically examines homeopathy, asserting it is a category of "quack products" legally marketed as drugs in the United States. This unique status is attributed to two factors: the 1938 Federal Food, Drug, and Cosmetic Act, which recognized substances in the Homeopathic Pharmacopeia of the United States as drugs, and the FDA's failure to apply the same rigorous standards to homeopathic products as to other drugs.

Basic Misbeliefs

Homeopathy originated in the late 1700s with German physician Samuel Hahnemann (1755-1843). Distressed by the harsh medical practices of his era, such as bloodletting and purging, Hahnemann developed the "law of similars." This principle suggests that diseases can be cured by minute amounts of substances that cause similar symptoms in healthy individuals when given in larger doses. The term "homeopathy" itself comes from the Greek words for "similar" and "suffering."

Hahnemann and his followers conducted "provings" by administering substances to healthy people and meticulously recording the observed symptoms. These records were compiled into "materia medica" to match patient symptoms with specific remedies. Hahnemann believed diseases were disturbances in the body's self-healing ability and that a small stimulus could initiate healing. He also theorized that chronic diseases stemmed from a "suppressed itch" or "evil spirit." Initially using small doses of accepted medications, he later embraced "enormous dilutions" and the "law of infinitesimals," positing that smaller doses yield greater effects—a concept directly contrary to the dose-response relationship established by pharmacology.

The inclusion of substances in the Homeopathic Pharmacopeia is based on historical "provings" from the 1800s and early 1900s, not modern scientific testing. The current edition lists over a thousand substances but does not specify their uses; this is left to practitioners. The article emphasizes that legal recognition as "drugs" does not equate to FDA endorsement of their effectiveness.

Historical Context and Decline

In the late 19th century, homeopathy was relatively popular, with about 14,000 practitioners and 22 schools in the U.S. However, as medical science advanced, homeopathy's popularity declined, and its schools either closed or adopted modern methods, with the last pure homeopathic school shutting down in the 1920s.

Constitutional Types and "Remedies"

Many homeopaths believe individuals have a "constitutional remedy" that addresses their specific type. These "constitutional types" are described with characteristics resembling astrological profiles (e.g., "Ignatia Type" for nervous individuals, "Pulsatilla" for gentle, emotional women, "Nux Vomica" for aggressive types). The article questions the rationality of this diagnostic approach.

The "Remedies" Are Placebos

Homeopathic products are derived from minerals, botanicals, and other sources. The preparation involves serial dilution and "succussion" (vigorous shaking). Dilutions are denoted by Roman numerals: X (1:10) and C (1:100). Common remedies are 6X to 30X, but 30C or higher are also marketed.

A 30X dilution means the original substance has been diluted 10^30 times. The article illustrates the extreme nature of this dilution by comparing it to dispersing a drop of dye in water that would fill a container over 50 times the size of the Earth. Robert L. Park, Ph.D., noted that a 30C solution would require a container larger than the Earth to contain even one molecule of the original substance.

Occillococcinum, a 200C product for cold and flu symptoms, is highlighted as an example of extreme dilution. Its "active ingredient" is derived from a duck's liver and heart, diluted to an extent that the article calculates would require a container vastly larger than the universe to contain a single molecule. Despite this, the product had significant sales, earning it the nickname "the $20-million duck."

The article explains that chemical laws dictate a limit to dilution, known as Avogadro's number, corresponding to potencies of 12C or 24X. Hahnemann himself acknowledged the improbability of any original molecule remaining after extreme dilutions, but he believed a "spirit-like" essence imprinted by shaking and dilution could exert medicinal effects.

Manufacturing and Plausibility

Stan Polanski, a physician assistant, points out the impossibility of isolating a single "active" compound in homeopathic dilutions amidst the countless molecules of airborne dust and microcontaminants present in manufacturing facilities. He questions how a specific preparation could "know" which substance is intended to be the "Potent One" among thousands of chemical compounds.

The article argues that until a plausible, non-magical mechanism for "potentiation" through dilution is provided, it's impossible to accept that homeopathic products correctly identify active ingredients. Any study claiming effectiveness must list all substances present at significant concentrations and justify why they are not considered active.

Provings and Symptom Matching

The process of "proving," used to match remedies to symptoms, is also criticized. It involved administering substances and recording any resulting symptoms, assuming these were caused by the substance and that dilute doses would be effective treatments. The article suggests that the symptoms reported were likely due to the placebo effect or spontaneous remission.

Unimpressive "Research"

Since most homeopathic remedies lack detectable active ingredients, testing their contents is difficult. Unlike conventional drugs, they have not been proven effective through double-blind clinical testing, and the vast majority have never been tested at all.

A 1990 review in "Review of Epidemiology" analyzed 40 randomized trials comparing homeopathy to standard treatment or placebo. The authors found that only three trials were well-designed, and only one reported a positive result. They concluded there was no evidence that homeopathy is more effective than a placebo. "Prescrire International" reached similar conclusions in 1995.

A 1994 "Pediatrics" article claimed homeopathy was effective for mild childhood diarrhea in Nicaragua. However, reviewers Sampson and London identified numerous flaws, including unreliable diagnostics, lack of safeguards against adulteration, arbitrary treatment selection, data errors, questionable clinical significance, and the fact that adequate fluid intake was the actual remedy for dehydration.

A 1995 "Prescrire International" literature review concluded that while homeopathic treatments might show an effect in some patients due to their placebo-responsiveness, there is no evidence they are more effective than placebo therapy.

A December 1996 report by the Homeopathic Medicines Research Group (HMRG), evaluating 184 controlled trials, concluded that only 17 were well-designed. While some showed a greater effect than placebo, the small number of participants prevented drawing firm conclusions. The report stated that most homeopathic research is worthless, and no product has been proven effective.

Placebo Effect and Spontaneous Remission

The article acknowledges that placebo effects can be powerful but argues that the potential benefit should be weighed against the harm of relying on ineffective products and wasting money. Spontaneous remission is also cited as a reason for homeopathy's perceived popularity, suggesting many patients would have recovered regardless of treatment.

Homeopaths' Lobbying Efforts and Claims

Homeopaths are seeking coverage under national health insurance, promoting their services as safer, gentler, "natural," and less expensive than conventional care, with an emphasis on prevention. However, the article counters that homeopathic treatments prevent nothing and that many leaders oppose immunization. A report from the National Center for Homeopathy's 1997 Conference mentioned a homeopathic physician suggesting homeopathic products as alternatives to aspirin or cholesterol-lowering drugs for coronary artery disease.

Greater Regulation Is Needed

The article argues that if the FDA required homeopathic remedies to prove effectiveness, homeopathy would likely face extinction in the U.S. The FDA currently considers homeopathy relatively benign compared to treatments for cancer and AIDS, prioritizing other enforcement issues. The article suggests that vigorous FDA action could lead proponents to seek congressional protection.

Despite these risks, the FDA should not permit worthless products to be marketed with claims of effectiveness. In August 1994, critics petitioned the FDA to require over-the-counter homeopathic drugs to meet the same safety and effectiveness standards as nonhomeopathic OTC drugs and to issue a public warning that the FDA does not recognize them as effective.

References

The article lists several references, including works on homeopathy in America, reviews of randomized trials, and analyses of homeopathic treatment for childhood diarrhea and coronary artery disease.

Recurring Themes and Editorial Stance

The recurring theme is the critique of homeopathy as a pseudoscientific practice lacking scientific evidence of efficacy beyond the placebo effect. The editorial stance is clearly against homeopathy, viewing it as a form of quackery that exploits consumers and potentially delays or replaces effective medical treatments. The article advocates for stricter regulation by the FDA to ensure that homeopathic products are held to the same standards of proof as conventional medicines.