On April 20-21, the Food and Drug Administration (FDA) will hold a public hearing to discuss regulations for homeopathic products. Although the agency was directed in the early 1970s to review the safety and effectiveness of all drugs used in over-the-counter (OTC) medicines, “to date, FDA has not reviewed this class of products for safety and efficacy.” The FDA is charged with “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs [and] biological products . . . .” If the FDA takes this role seriously, it will regulate homeopathy out of existence.
The word “homeopathy” is derived from the Greek words homoios (similar) and pathos (suffering or disease). Homeopathy is a type of complementary and alternative medicine (CAM) that was invented by Samuel Christian Hahnemann (1755-1843), a German physician who had become justifiably distressed with the medicine of his day, which included bloodletting, leeching, and purging. Hahnemann disagreed with these treatments, in part, because he thought they were aimed at “balance[ing] the body’s ‘humors’ by opposite effects.” Effective treatment, according to Hahnemann, utilized the substance that causes a symptom to treat the same symptom in illness (“like-cures-like”). Thus Hahnemann developed his “law of similar” – the notion that symptoms of disease can be cured by extremely small amounts of substances that produce similar symptoms in healthy people when administered in large amounts.
To bolster his theory, Hahnemann and his early followers conducted “provings” in which they administered herbs, minerals, and other substances to healthy people (including themselves) and kept detailed records of what they observed. Hahnemann used these “provings” to determine what a homeopathic remedy contains and how diluted it should be. He compiled these records into lengthy reference books called material medica, which are used to match a patient’s symptoms with a “corresponding” drug.
At first, Hahnemann used small doses of accepted medication. But later he theorized that the smaller the dose, the more powerful the effect – a notion commonly referred to as the “law of infinitesimals.” To lower the dose of a substance, homeopaths repeatedly dilute and agitate the substance in a process known as “potenisation” or “dynamisation.” Homeopathic medicines are prepared by taking a substance (e.g. plants, animal material, or chemical), diluting it in water or alcohol, then forcefully hitting the container against a hand or a surface. If the original substance is soluble, one part is diluted with either nine or ninety-nine parts of distilled water and/or alcohol; if insoluble, it is finely ground and pulverized in similar proportions with powdered lactose (milk sugar). This process is repeated several times until the desired concentration is reached.
Dilutions of 1 to 10 are designated by the Roman numeral X (1X = 1:10; 3X = 1:1,000; 6X = 1:1,000,000). Similarly, dilutions of 1 to 100 are designated by the Roman numeral C (1C = 1:100; 3C = 1:1,000,000; and so on). Most remedies today range from 6X to 30X, but products of 30C or more are marketed to the public. To understand how dilute some of these substances are, consider this: one third of a drop of some original substance diluted into all the water on Earth would produce a remedy with a concentration of about 13C.
To illustrate further, let’s look at a real-world example: a product called Boiron Oscillococcinum. Manufactured by Boiron, Oscillococcinum is a marketed as a drug that “temporarily relieves flu-like symptoms such as body aches, headache, fever, chills and fatigue.” Its “active ingredient” (Anas Barbariae Hepatis et Cordis Extractum) is prepared by incubating small amounts of freshly killed duck’s liver and heart for 40 days. The resultant solution is then filtered, freeze-dried, rehydrated, repeatedly diluted in liter after liter of water (200 times), and inserted into sugar granules. On Oscillococcinum’s packaging, the dose is identified as “200CK.” That sounds strong, certainly stronger than other dilutions of homeopathic products, despite actually being diluted many thousand times more. In fact, if a single molecule of the duck’s liver or heart were to survive in the dilution, its concentration would be 1 in 100 to the 200th power. This is a huge number. It has 400 zeroes.
These principles – “like-cures-like” and “ultra-dilution” – run contrary to modern science. From a theoretical standpoint, there is simply no plausible scientific reason that has been proposed as to why homeopathy should work. The reason is because homeopathy cannot work. If homeopathy did work, major parts of basic science textbooks would need to be rewritten, including physics, chemistry, and biology.
But that shouldn’t be surprising. The “law of similars” is little more than an ancient and common superstition known as “sympathetic magic” – the notion that things have an essence or essential quality that can be transferred. Further, the “law of infinitesimals” conflicts with basic principles of chemistry, pharmacology, and thermodynamics. Homeopathic dilutions are virtually devoid of the original substance; there is not likely to be even a single molecule of the original drug in the final remedy that is given to the patient.
It is, however, more important to know whether a treatment works (its efficacy) than how it works. And when tested clinically, homeopathic products are shown to lack efficacy. So not only should homeopathic products not work, they in fact don’t work. Homeopathy has never been empirically established by controlled trials.
The best way to evaluate the efficacy of different treatments and distinguish them from placebos is through randomly controlled clinical trials. Most homeopathic products have never been tested; proponents simply rely on “provings” to tell them what should work. But even for products that have been tested, these studies suffer from a critical problem: because many homeopathic remedies contain no detectable amount of the active ingredient, it is often impossible to test whether they contain what their label says.
The studies that have been conducted lead to one inescapable conclusion: homeopathic remedies are not, and cannot be, effective. In 2013, the Australian National Health and Medical Research Council (NHMRC) published a report after reviewing the clinical evidence behind homeopathy. The report identified more than 1,800 studies, of which only 225 were of sufficient size and rigor to have any scientific merit. The NHMRC concluded that there exist “no good quality, well-designed studies with enough participants to support the idea that homeopathy works better than a placebo, or causes health improvements equal to those of another treatment.” The NHMRC acknowledged that “some studies did report that homeopathy was effective,” but noted that these studies were assessed as “being small and/or of poor quality.”
The NHMRC was not the first to review the evidence or come to this conclusion. In 2010, the UK House of Commons Science and Technology committee published its own report, concluding:
In our view, the systematic reviews and meta-analysis conclusively demonstrate that homeopathic products perform no better than placebos. The Government shares our interpretation of the evidence. We asked the Minister, Mike O’brien, whether the Government had any credible evidence that homeopathy works beyond the placebo effect and he responded: “the straight answer is no.”
Of the systematic reviews of homeopathy research, there is but one outlier, the 2011 Swiss report, which requires further explanation. The 2011 Swiss review looked at the exact same research as the UK and Australian reports, but came to an entirely different conclusion: that homeopathic treatment is effective and should be covered by insurance companies. How could this be? Part of the problem is that the Swiss review board was packed with homeopaths with obvious conflicts of interest. But the bigger issue, and the primary reason for the reviews anomalistic conclusion, was that the Swiss authors changed the rules of evidence.
Supporters of homeopathy often argue that randomly controlled trials are not an appropriate way to test homeopathy because “they are far less suitable when studying the overall effects of a holistic therapy in a complex organism with multiple problems.” Rather, homeopaths insist that homeopathic remedies should be tested based on “real-world effectiveness.” This is precisely what the authors of the 2011 Swiss report attempted to do. The Swiss authors, in fact, devoted an entire chapter of their report to attacking the validity of randomly controlled trials. And then they pulled a sleight of hand:
If homeopathy is highly likely to be effective but this cannot be consistently proven in clinical trials, the question arises of what conditions are needed for homeopathy to show its effectiveness and realize its potential, and what conditions threaten to obscure this?
This statement is clear evidence of bias. The Swiss authors started with a desired conclusion – that homeopathy is “highly likely to be effective” – and then sought to find the kind of evidence (“real-world effectiveness”) that would fit their pre-determined conclusion and help them to promote homeopathy. This is CAM newspeak for “poorly controlled studies.” But if homeopathic products – or any medicinal product – are more than placebos, and all other elements of the “holistic” care packages are the same (controlled), it should be possible to see differential results between the test substance and the placebo.
Proponents of homeopathy want our government to continue to ignore the lack of evidence surrounding their beliefs. In the words of Steven Novella, they “would have the world believe that one man, Samuel Hahnemann, stumbled upon a fantastic secret two centuries ago . . . that defy scientific explanation, have been ignored by 200 years of scientific progress, and yet to this day would turn our scientific understanding of the world.” But on April 20-20, the FDA has an opportunity to do what reason demands. It’s about time.
Homeopathic products clearly fall within the definition of “drug” under the Food, Drug and Cosmetics Act. Why, then, does the FDA not require that homeopathic drugs be proven safe and effective prior to marketing? Why has the FDA, in the words of one federal district judge,
largely abdicated any role it may have had in creating standards for homeopathic OTC [over-the-counter] drugs, and has instead attempted to delegate this authority to the non-governmental organization that determines whether homeopathic substances should be included in the HPUS. In addition, the FDA explicitly states that it makes no guarantee about the safety or efficacy of homeopathic OTC drugs even if they meet the unknown standards for inclusion in the HPUS.
The FDA has never recognized any homeopathic remedy as safe and effective for any medical purpose. If the FDA required homeopathic remedies to be proven effective to remain marketable – the standard it applies to other categories of drugs – homeopathy would face extinction in the United States. That is precisely what should happen. The FDA should not permit worthless products to be marketed with claims that they are effective. Homeopathy is witchcraft and quackery, and it should be expelled from modern medical care.