Time for Action: the FDA and Homeopathic Drugs

August 30, 2011

The website of the Center for Drug Evaluation and Research, the division of the Food and Drug Administration (FDA) responsible for evaluating the efficacy of drugs, proudly proclaims that it “promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs are safe and effective.” (bolding in original) Sadly, this is not a true statement. The FDA allows homeopathic drugs to be marketed without requiring the manufacturers to establish that their drugs are effective for their intended use. This free pass to homeopathic junk needs to stop, and that is why CFI and CSI have filed a formal petition asking the FDA to hold homeopathic over-the-counter drugs to the same standards as conventional (i.e., real) medicine.

Before discussing our petition and the FDA’s enforcement policy, here’s a quick primer on homeopathy for those not familiar with this “alternative” medicine. Homeopathic remedies were first developed in the late 1700’s, before the advent of modern medicine. Homeopathic drugs are produced by taking a substance that is believed to cause disease symptoms and then diluting the substance repeatedly until, according to accepted laws of chemistry, there are no molecules left of the original substance. But homeopaths nonetheless insist that—by virtue of some scientifically inexplicable process—their drugs possess therapeutic value. One explanation sometimes advanced is that the vigorous shaking of the solution that occurs during the dilution process imprints a “memory” of the original substance. (No, I’m not making this up.) Essentially, homeopathy is magic posing as science.

So why does the FDA allow this junk to be sold? The reasons are a bit complicated, but the first thing to realize is that FDA’s hands are partially (but only partially) tied. The Federal Food, Drug, and Cosmetic Act of 1938 contained an express provision allowing homoeopathic products to be sold as drugs provided they were clearly labeled as homeopathic drugs and their ingredients were recognized in the Homeopathic Pharmacopoeia of the United States. The emphasis of the 1938 statute was on safety, not effectiveness, and the sense among some legislators was that since homeopathic products didn’t seem to kill anyone outright, it was permissible to market them. (And, of course some legislators actually believed in homeopathy: yes, there were screwballs in Congress in 1938 just as there are today.)

The FDA’s authority to require drug manufacturers to prove their products are effective—in addition to being safe—is largely a result of the Kefauver-Harris Drug Amendments of 1962, which provided that the FDA could direct manufacturers to provide “substantial evidence” of effectiveness based on well-controlled studies. The FDA has imposed this requirement in many instances, for which the American people should be grateful.

But even after 1962, the FDA has not required homeopathic drug manufacturers to submit proof of effectiveness. It plainly has the authority to do so, but it has declined to exercise this authority—usually.  Why? I am not privy to the deliberations of FDA administrators, but I don’t think it’s any deep mystery. The FDA has to establish priorities like any agency with limited funds, and homeopathic drugs have not been deemed a priority.

Interestingly, the FDA has occasionally stepped in and issued warning letters to homeopathic manufacturers and retailers when the FDA believes there is a health emergency. For example, in early 2010, some homeopathic peddlers were warned not to advertise their products as being a treatment for the H1N1 (swine) flu. The FDA’s warning letter admitted that “ordinarily” there are “many homeopathic drug products … manufactured and distributed without FDA approval or authorization,” but the H1N1 epidemic was different. People could die.

So basically the FDA’s approach is this: we can’t be bothered about magic pills unless things get really serious.

It’s not clear this hands-off attitude was ever justified, but given the FDA’s many responsibilities, this approach would at least be understandable were use of homeopathic products rare. But that is no longer true. Homeopathic drugs used to be marketed on a relatively small scale, but their sales have burgeoned in the last couple of decades. In 2009, consumer sales of homeopathic treatments in the United States reached $870 million. The homeopathic industry websites are brimming with enthusiasm about the popularity of their products, and, incredibly, some academically affiliated medical centers have established “integrative medicine” clinics that offer, inter alia, homeopathic drugs. The woo woo is on the rise.

Furthermore, for the sick person who relies to her detriment on homeopathic junk for regular influenza—which can be life-threatening— or some other disease that’s not part of a national health emergency, it’s small comfort to be told that the FDA does do something about homeopathic crap if it thinks enough lives are at stake. A useless drug is a harmful drug, even when there is no raging epidemic, and the FDA should protect consumers from harm.

So it’s time for the FDA to take action. It’s positively shameful that in the 21st century we are allowing magic pills to be sold as medicine.

Let’s be clear, by the way: in its petition, CFI and CSI are not asking the FDA to ban homeopathic drugs. We are simply asking that they be held to the same standards of effectiveness as other drugs. Who knows? Maybe when these drugs are finally subject to rigorous testing, all our known laws of chemistry will be overturned and we’ll discover that solutions do have “memories” of substances that are no longer physically present.

Will the FDA act on our petition? Don’t know. It’s quite possible it will be ignored. Dr. Steven Barrett of Quackwatch filed a somewhat similar petition in 1994 to no avail. (And here’s a big “thank you” to Steve Barrett, Steve Novella, Edzard Ernst, and the many, many others who have worked tirelessly against the acceptance of homeopathic nonsense.) But we’re cautiously optimistic that a different result might obtain this time because homeopathy is no longer a carnival sideshow. It’s become a big deal, with a sizeable chunk of the over-the-counter market—facts not unknown to the FDA. In any event, part of our mission is to limit the influence of pseudoscience. We’re just not going to stand by and let the purveyors of snake oil market their junk unchallenged.

And speaking of the purveyors of snake oil, CFI/CSI filed two additional petitions that specifically target industry giant Boiron. Boiron has a slyly worded web ad for its popular flu remedy, Oscillococcinum (Oscillo), that boasts about how it complies with FDA regulations, thereby implying to those who naively believe the FDA actually requires Ocsillo to be effective that the FDA is satisfied that it works. The FDA should direct Boron to reword its ad.

Furthermore, in its packaging for Oscillo, Boiron uses only Latin to describe its “active” ingredient. We understand homeopaths, like all wizards, prefer the mystifying sounds of Latin, but we believe consumers have a right to know what Boiron is selling in Oscillo, namely extract of duck liver and heart (extremely diluted).

don’t think we’re singling out Boiron because we have some sort of grudge. No, in fact, we have a marketing suggestion for them: ditch the Latin and put a nice, pretty unicorn on the package. Somehow it fits.