Will 2016 be the year when the FDA and FTC finally crack down on homeopathy?

I like to say that homeopathy is The One Quackery To Rule Them All (although of late I’ve debated whether homeopathy or reiki is the most properly referred to as that). It’s a strange beast, homeopathy. Its two main “Laws” are so clearly pseudoscience that you’d think that no one could ever fall for something that dumb, but, well over 200 years after Samuel Hahnemann pulled those two Laws out of his nether regions, not only is homeopathy still popular in large swaths of the developed world, but there are actual physicians who use it.

Just consider homeopathy’s laws. The first is the Law of Similars, which states that to relieve a symptom you must use a substance that causes that symptom. Not only does this law make no sense on an intuitive level, but there is no biological or medical basis for it. Of course, the Law of Similars doesn’t really matter, because the second law of homeopathy renders it completely irrelevant. That law, the Law of Infinitesimals, states that diluting a remedy makes it stronger. That’s not nearly enough pseudoscience, though. Because of this law, homeopaths often dilute remedies to, in essence, nonexistence. For example, a typical 30C dilution (where C=100) means thirty 100-fold dilutions, which, if you do the math, you’ll find to be a 10-60 dilution. Avogadro’s number is only on the order of 6 x 1023, which means that a 30C dilution is at least 1036-fold higher than a dilution where we’d expect to see a single molecule of the original substance; that is, if you start with what chemists call a mole of starting compound. No wonder homeopathy is considered the king of pseudoscience, and that’s not even considering that some homeopathic remedies (like Oscillococcinum, the infamous homeopathic flu remedy) use starting ingredients like extract of duck liver and heart—and at 200C (10-400), yet!

So it’s been with a great deal of interest that I and other skeptics followed the developments in homeopathy last year, which have now been recapped in an article in the New England Journal of Medicine. Actually, the developments weren’t so much in homeopathy, which basically never changes, other than sometimes in the extravagant imagination of homeopaths trying to justify their quackery with everything from quantum mechanics to “nanoparticles.” Rather, the developments concerned the regulation of homeopathy in the US. Basically, the FDA announced that it would hold hearings on revamping its regulation of homeopathy, which were held in April. Then, in September, the Federal Trade Commission (FTC) held a workshop to consider its regulation of advertising homeopathic products. For the first time in a very long time, it looks as though there might be real change in the way homeopathy is regulated in this country.

It’s really good to see the NEJM publish an article, Regulating Homeopathic Products — A Century of Dilute Interest by Scott H. Podolsky, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H., on the potential for real regulatory reform when it comes to homeopathy. (The only thing that made me sad about the article is that I should have thought of pitching an article on this topic to the NEJM first!) It’s a clear description of how we’ve gotten where we are with respect to homeopathy.

Noting that there have been over a century of missed opportunities to regulate homeopathy, Podolsky and Kesselheim provide a little historical lesson:

Founded by Samuel Hahnemann in Germany around the turn of the 19th century and introduced into the United States shortly thereafter, homeopathy was predicated on such notions as “like cures like” and the “law of infinitesimals,” whereby extraordinarily diluted products that in their original form might have caused symptoms resembling those of the illness in question are administered to patients in a highly individualized fashion.

In the competitive U.S. medical marketplace of the 1830s and 1840s, orthodox physicians took notice and drew attention to the biologic implausibility of homeopathic remedies. The most caustic critique was voiced by Oliver Wendell Holmes, who declared homeopathy a “mingled mass of perverse ingenuity, of tinsel erudition, or imbecile credulity, and of artful misrepresentation,” while noting the potential therapeutic effect on patients of “the strong impression made upon their minds by this novel and marvelous method of treatment.” But Holmes similarly criticized the orthodox “heroic” medicine of his day (which was grounded in bleeding and emetics), and homeopathy continued to attract adherents, including some conventional physicians.

People often ask me: How could homeopathy have ever caught on, even in the 1800s? The reasons are simple. First, Hahnemann thought it up before Avogadro’s number had been deduced. Second, “conventional” medicine of the time was so poor, rife with bleedings, purges, the use of heavy metals like mercury and cadmium, and a lot of treatments that likely did more harm than good in many cases. Given that homeopathy, at its core, is nothing more than either water or ethanol (depending on what was used as the diluent) or sugar pills (homeopaths often put their remedies into sugar pills and dry them out), it’s the equivalent of doing nothing. In the world of 1800s medicine, not infrequently doing nothing with homeopathy and letting a disease run its course, produced better results than “conventional” medicine. As medicine advanced and became more scientific, particularly from the late 1800s on, that changed. Medicine became more and more effective, while homeopathy remained water. Yet for some reason it persisted.

The first missed opportunity to regulate homeopathy was, of course, the Pure Food and Drug Act of 1906. This regulation largely didn’t happen:

The Pure Food and Drug Act of 1906, which had endowed the agency with its initial regulatory power and mandated that drug products actually contain the ingredients on their labels, governed drugs recognized in the U.S. Pharmacopeia and the National Formulary, as well as any product intended to cure, mitigate, or prevent disease. This scope would clearly have covered homeopathic remedies, which were largely administered by clinicians at the time, but regulators had been focused on stemming the tide of truly dangerous quack products containing cocaine, heroin, and chloroform, among other harmful substances.

The next missed opportunity came in 1938, when in the wake of the 1937 elixir sulfanilamide tragedy resulted in at least 100 deaths due to the use of diethylene glycol as a solvent for the medicine, the 1938 Food, Drug, and Cosmetic Act was passed. The act mandated pre-market review of the safety of all new drugs, banned false therapeutic claims, and authorized factory inspections. What it did not do is to regulate homeopathy in any meaningful way:

The next major piece of legislation that could have restricted homeopathic products was the 1938 Food, Drug, and Cosmetic Act. That law, however, focused on the safety, rather than efficacy, of new drugs, and remedies listed in the Homeopathic Pharmacopeia were considered to have met the new quality standards. The inclusion in the Act of a reference to the Homeopathic Pharmacopoeia appears to have resulted not only from the efforts of Senator Royal Copeland (D-NY), a homeopathic practitioner and sponsor of the bill, to differentiate homeopathy from quackery, but also from the belief among such prominent leaders of academic medicine as Morris Fishbein (editor of JAMA) that the distinctions between conventional medicine and homeopathy would continue to dissolve in the crucible of scientific investigation.

The Homeopathic Pharmacopeia still determines what homeopathic products can and can’t be sold in the US today. In essence, homeopathic remedies are not regulated in any meaningful way in the US.

The last missed opportunity was over 50 years ago, when in the wake of the thalidomide tragedy, Congress passed the 1962 Kefauver–Harris Amendments, which I’ve discussed on multiple occasions. The big difference that these amendments made is that for the first time they mandated that the FDA not only perform pre-market assessment of new drugs and medical devices for safety but that it also assess them for efficacy. Yet somehow homeopathic products fell through the cracks again:

When the 1962 Kefauver–Harris Amendments mandated that the efficacy of conventional drugs be proven through “well-controlled investigations,” homeopathic remedies remained under the regulatory radar, protected by the amendments’ failure to change the status of products in the Homeopathic Pharmacopeia. Moreover, both the subsequent Drug Efficacy Study Implementation (DESI) process, by which all drugs approved between 1938 and 1962 were retrospectively evaluated, and the FDA’s review of over-the-counter remedies, excluded homeopathic products, in the latter case with the intention that they would be reviewed “at a later time” (they weren’t).

Same as it ever was—and is. At least, I hope, same as it ever was and is until now. Noting drolly that unlike dietary supplements “homeopathic products can actually be substantially regulated by the FDA, since the Food, Drug, and Cosmetic Act allows them to be sold as ‘therapeutic,'” Podolsky and Kesselheim note that perhaps now is the time that the end of homeopathic remedies’ century-long evasion of regulatory scrutiny is at an end. I certainly hope so, but practical and political considerations might limit what can be done:

We believe that, at minimum, regulators should reconsider the way homeopathic drugs are marketed, so that consumers who are seeking conventional medicines at pharmacies don’t become confused. In August, the FTC submitted comments to the FDA recommending that the agencies better harmonize their approaches to regulating homeopathic products and their advertising. Reconsidering the over-the-counter sale of homeopathic remedies entirely would be an even more drastic step and would require the FDA to take on the entire industry for propagating remedies that don’t meet the same standards of scientific proof applied to conventional medicines.

This is exactly what the FDA should do, but I have little faith that it will. Homeopathy is pure quackery, one of the purest quackeries that exist. It is water. (Really, how many times does this need to be said?) The history of its regulation in the US has been a sordid one. Particularly disappointing is how for nearly 80 years the FDA has been hamstrung from applying the same sort of regulatory framework to homeopathy as it does to any other drugs. One could understand how, even if Sen. Copeland hadn’t sabotaged the 1938 revision of the Pure Food and Drug Act, that law only mandated that the FDA review safety. Since most homeopathic remedies are, in essence, water, most of them would have had no problem meeting that standard.

However, after 1962, there is less of an excuse. Even despite Copeland’s sabotage of the FDA’s regulatory authority through carving out an exception for homeopathic remedies, there is no reason the FDA couldn’t have regulated homeopathic remedies based on the Kefauver–Harris Amendments, given that homeopathic remedies make therapeutic claims. Yet for 50 years the FDA did nothing or, at best, very little. That’s why, even as I hope that this time the FDA and FTC are finally going to do something to substantively regulate homeopathic remedies, even if only to require manufacturers to let consumers know that remedies more dilute than 12C almost certainly have nothing in them, I can’t help but counter my hopefulness with my knowledge of history.