Shedding Light in the Darkness

Homeopathy Update, FDA and the Australian Review


In April the FDA issued a safety warning – “warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter,” as “these products have not been evaluated by the FDA for safety and effectiveness.”

The same month the FDA held two days of hearings on homeopathy. The hearings focused on FDA regulations regarding labeling requirements for OTC, over-the-counter homeopathic products.

The hearings were jumped on by skeptics like Science-Based Medicine, with one member angrily declaring, “finally (I hope), the FDA has apparently realized that they are completely neglecting their mandate to protect the public from harmful or worthless medical products when it comes to homeopathy. If I would guess, I think the FDA understands that homeopathic products are utterly worthless pseudoscientific nonsense. They can’t possibly work, and when studied they don’t work.”

Well, as it turns out, the majority of speakers supported the practice of homeopathy and the existing FDA regulations for homeopathic remedies.

The sessions closed with testimony by Dr. Peter Fisher, head of the Royal London Hospital for Integrated Medicine, and physician to Queen Elizabeth II. Fisher cited overwhelming positive patient responses to homeopathic treatment.

Among the few detractors, Adriane Fugh-Berman, a pharmacology professor at Georgetown University Medical Center, suggested: “The evidence for homeopathy’s effectiveness is between scant and nil.” Fugh-Berman cited the recent Australian report that concluded there is no reliable evidence homeopathy is effective.

The dismissive review, published in March, by the Australian National Health and Medical Research Council prompted headlines like “Australia officially debunks homeopathy” and “No evidence homeopathy is any better than a placebo” (The Washington Post).

The review was triggered in part by campaigning by the Friends of Science in Medicine lobby group which demands that all alternative and complementary medicines should be banned in Australia unless proven by rigorous scientific inquiry. (A FSM member was on the report panel)

Among the report’s failings, it only reviewed 225 research papers (which they deemed credible) and only looked at studies with more than 150 participants. That leaves out hundreds, maybe thousands of studies that could have demonstrated positive outcomes. And it excluded all non-English language studies. The majority of studies in homeopathy are generated from European or South American research and many studies are in languages other than English.

It also specifically excluded research into the use of homeopathy in preventative health care.

The Cuban government, for example, now relies on homeopathy to manage its regular leptospirosis epidemics, which had typically high mortality and morbidity rates prior to this innovation. In 2007 around 2.5 million people were treated with a homeopathic nosode. Only 10 cases were reported instead of the usual several thousand cases of leptospirosis and there were no deaths. The financial cost to the Cuban government for this successful health campaign was only $200,000 compared with the $2 million that would have been incurred for conventional vaccination and antibiotics.

Some positive outcomes were dismissed in the review because of what they suggested was flawed methodology. While some studies quoted in the review showed favorable outcomes e.g. “Mathie et al (2012) reported one outcome from the Level II study conducted by Casanova and Gerard (1988). The mean difference between the homeopathic Anas barbariae and placebo groups on that outcome significantly favoured homeopathy.”

And – “The effectiveness of homeopathy for the treatment of patients with postoperative ileus.” – “A meta-analysis of all six included studies revealed a statistically significant effect in favour of homeopathy for time to first flatus. This effect remained even with the exclusion of the two low quality studies.”

And – “Two Level II studies (Jacobs, 2000; Jacobs, 1994) reported significant effects in favour of homeopathy.”
Jacobs – Randomized double-blind trial took place in two clinics in poor districts of Nicaragua, a country where diarrhea is the primary cause of mortality during the first year of life and accounts for 19% of all outpatient consultations in children aged from one to four years. The homeopathic treatment group had a statistically significant decrease in duration of diarrhea.

Before closing I’d like to draw attention to how homeopathy helped the Spanish flu epidemic of 1918 in the US. The mortality rate of people treated with traditional medicine and drugs was 30%. Those treated by homeopathic physicians the mortality rate was 1.05%. Of the 1500 cases reported at the Homeopathic Medical Society of the District of Columbia there were only 15 deaths. While Ohio reported 24,000 cases of flu treated allopathically with a mortality rate of 28.2%, while 26,000 cases of flu treated homeopathically had a mortality rate of 1.05% .

Finally I quote from the web site of the Beth Israel Deaconess Medical Center, Harvard Medical School: “Some studies have found evidence that homeopathic remedies do, in fact, relieve symptoms of illness. Many of these were double-blind, placebo-controlled studies. This presents a conundrum to impartial scientists.”


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