Health care systems around the world are being pressured to “do more and spend less”, to make healthcare more cost effective. Owing to aging populations and the growing cost of providing health services, there’s more scrutiny than ever on the value of different health treatments, with the goal of reducing the use of treatments that don’t help. The Choosing Wisely initiative was establishing expressly for this purpose. Regrettably, while well-intentioned, Choosing Wisely hasn’t had as much of an effect as you might expect. Medicine can be slow to change, as David Gorski discussed earlier this week. Unless we ruthlessly scrutinize what we do for effectiveness, and are willing to act on what we learn, self-driven change is unlikely. One way that governments (and insurers) can dramatically reduce the use of a health service or treatment is to simply stop offering it, or paying for it. Yet stopping funding is something that is relatively uncommon in health care. It seems to be much more difficult to stop a practice, possibly owing to inertia, a reluctance to change, and the sometimes-vociferous protests that can emerge from patients or physicians that may feel that their preferred therapy is effective. The formidable challenge of stopping health care funding, once it has started, is one reason why this blog has been very critical of the expanding scope of practice being granted to alternative medicine purveyors – the legislative alchemy that is the first step towards insurance coverage. Because once that’s in place, it will be far more difficult to stop it. So it’s essential to understand the evidence. (more…)
The Robert F. Kennedy building in Washington, DC, headquarters of the United States Department of Justice
It is shaping up to be a good year for those of us advocating more effective regulation of supplements and unproven therapies in the US. The Food and Drug Administration (FDA) is reviewing its regulation of homeopathy, and recently also announced it is taking public comment on its regulation of the term “natural.” The Federal Trade Commission (FTC) is also reviewing the claims made by the homeopathy industry, and even gave a nudge to the FDA to fix its regulation.
Now the US Department of Justice (DOJ) is getting in on the fun:
USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.
This action by the DOJ raises the stakes to a new level – criminal charges. While the FDA and FTC do the best they can, they often lack teeth when it comes to supplements. The FDA might issue a polite request and then escalate to a stern warning when companies step out of line. The FTC can issue fines which amount to little more than a slap on the wrist – the cost of doing business. Both agencies are playing whack-a-mole and losing.
FTC vs. homeopathy: Cage match?
Well, I’m back.
OK, returning from London isn’t nearly as epic as Sam Gamgee’s final words in The Lord of the Rings returning to his wife and daughter after having accompanied Frodo, Gandalf, Bilbo, and key elves of Middle-Earth to the Grey Havens, there to say goodbye to them as they boarded a ship to the undying lands. I just love the quote. It says something to me returning home after a long journey, even if it was just a vacation to J.R.R. Tolkien’s native land. It also suggests a bit of the exhaustion after a long day of traveling, complete with a long-delayed flight, a late arrival, and a state of utter exhaustion that accompanied it, plus an unfortunate lower gastrointestinal issue.
All of this is a way of saying that this post might actually be relatively brief for a post by me…no epics this week. [Addendum: Nope. Even lower GI annoyances and exhaustion couldn’t keep me from going over 2,000 words. At least I didn’t hit 3,000.] In its nearly eight year history, I’ve never missed more than one week at SBM, and I don’t intend to start now. Specifically, with the FTC workshop on homeopathy rapidly approaching, one week from today, I couldn’t resist adding my 2 pence to the mix, now that the agenda and list of participants have been announced.
Two institutions duke it out: FTC versus FDA.
Last month, the Society for Science-Based Medicine submitted a comment to the Food and Drug Administration (FDA) in response to its request for public comments on the agency’s current regulation (actually, lack of regulation) of homeopathic drugs. As the SFSBM pointed out, the FDA has, without legal authority, exempted homeopathic drugs from the safety and efficacy requirements applicable to other drugs under the Food, Drug and Cosmetic Act (FD&C Act). Lax regulation has resulted in consumer confusion: consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, and the lack of scientific evidence underlying claims made by homeopathic drug companies.
As it turns out, we were in excellent company. The Federal Trade Commission (FTC), the agency charged with preventing fraudulent and deceptive business practices, submitted its own comment to the FDA, making these same points. (The FTC is holding its own workshop on advertising homeopathic drugs later this month. We’ll get to that shortly.)
The FTC’s advertising substantiation policy requires that health-related efficacy claims be supported by competent and reliable scientific evidence. The FDA, despite federal law, does not require evidence of efficacy for homeopathic drugs prior to their being marketed. This creates a potential conflict between the two regulatory schemes, resulting in homeopathic over-the-counter (OTC) “drugs” on the market that both comply with FDA’s policy and violate FTC’s policy. This, says the FTC, can be harmful to consumers and create confusion for advertisers. The FTC “recommends that the FDA reconsider its regulatory framework for homeopathic medicines” and tells the FDA what it can do to remedy the situation. (more…)
Just say no to homeopathic cough syrup! Actually, avoid all cough syrups.
On the pages of SBM we frequently discuss homeopathy, and rightfully so considering its position as one of the most pervasive yet dumbest forms of alternative medicine. Just yesterday our own Scott Gavura, who is neither pervasive nor dumb, wrote an excellent review of some recent improvements in the regulation of these ridiculous remedies in Canada, and I encourage readers to check that out. Sadly, despite numerous high profile setbacks for the practice, including a thorough trouncing by the Australian National Health and Medical Research Council in March, proponents of what is essentially the belief in sympathetic magic continue to clutter the pubmeds and interwebs with worthless studies. (more…)
Do you believe in magic? It might surprise you to learn that some people believe sugar pills have healing properties. This belief system, called homeopathy, is a multi-billion dollar industry worldwide, and it’s growing. While there is no convincing evidence to demonstrate that homeopathic treatments are more effective than a placebo, many consumers and even some health professionals accept homeopathy as a legitimate health treatment, and its providers as legitimate health professionals. Responding to the perceived consumer demand for these products, government regulators have had a difficult decision to make: They could ignore homeopathy as a health practice, treating it like we might think of astrology: firmly outside of medicine. Or they could choose some form of regulation, targeting the providers (homeopaths) or the product (homeopathy), possibly with the goal of managing its use, or perhaps limiting harms to consumers. The risk of regulating nonsense, as has been described before, is the perceived legitimacy that recognition and regulation implies. Regrettably, regulation in many countries has had that exact effect. What’s worse, regulation often seems to have prioritized the commercial interests of homeopaths over the public interest, leaving consumers with little understanding that homeopathy lacks scientific credibility as a health practice. Consequently, homeopathy has attracted regular criticism from SBM’s bloggers, science and health journalists, and other science advocates over the years. It appears this advocacy is finally having an effect. Regular readers will recall several posts over the past few weeks, describing the possibility of new regulation of homeopathy by the US Food and Drug Administration (FDA). And just recently, Health Canada announced two important changes to its homeopathy regulation, which may signal a new direction. Are we witnessing the beginning of more sensible regulation of this prescientific practice? (more…)
Author’s note: The FDA has asked for public comments on the regulation of homeopathic products. The Society for Science-Based Medicine’s Comment follows, modified for this format. The Comment is based in part on two previous posts, “How should the FDA regulate homeopathic remedies?” and “Homeopathic industry and its acolytes make poor showing before the FDA.” The comment period closes August 21, 2015.
Society for Science-Based Medicine
Comment: Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century
All homeopathic products on the U.S. market today, whether over-the-counter (OTC) or prescription, fall within the definition of “drug” in the Food, Drug & Cosmetic Act of 1938. The overwhelming scientific consensus is that homeopathy is highly implausible, unsupported by scientific evidence, ineffective in treating illness and, when relied upon instead of actual medicine, dangerous and even deadly. Yet the FDA has, without statutory authority, exempted homeopathic drugs from the regulatory scheme mandated by federal law. In accordance with its consumer protection mandate, the FDA should take immediate action to remedy this by requiring that all homeopathic drugs comply with the same statutes and regulations as all other OTC and prescription drugs. (more…)
Homeopathy is full of crap! Click to embiggen.
Borrowed with loving attribution from Hell’s News Stand. Go to He…go there!
“A gentle ethical defence of homeopathy” by Levy et al. was recently published in an ethics journal. A full-text preprint is available online. They say:
Utilitarian critiques of homeopathy that are founded on unsophisticated notions of evidence, that adopt narrow perspectives on healthcare assessment, and that overstate the personal, social and ontological harms of homeopathy, add little to our understanding of the epistemology of medicine. But when they are used to denounce the ethics of homeopathy – they are not only ill-considered and counterproductive, but philosophically and socially perverse.
I found their arguments unconvincing. (more…)
The cover of Georgetown Medicine Spring/Summer 2015 issue. This image will drive Mark Crislip crazy, as it features yet another acupuncturist not using gloves while sticking needles into people. Dr. Gorski loves watching Dr. Crislip’s reactions to such photos.
We frequently discuss a disturbing phenomenon known as quackademic medicine. Basically, quackademic medicine is a phenomenon that has taken hold over the last two decades in medical academia in which once ostensibly science-based medical schools and academic medical centers embrace quackery. This embrace was once called “complementary and alternative medicine” (CAM) but among quackademics the preferred term is now “integrative medicine.” Of course, when looked at objectively, integrative medicine is far more a brand than a specialty. Specifically, it’s a combination of rebranding some science-based modalities, such as nutrition and exercise, as somehow being “alternative” or “integrative” with the integration of outright quackery, such as reiki and “energy healing,” acupuncture, and naturopathy, into conventional medicine. As my good bud and fellow Science-Based Medicine (SBM) blogger Mark Crislip put it, mixing cow pie with apple pie does not make the cow pie better, but we seem to be “integrating” the cow pie of quackery with the apple pie of science-based medicine thinking that somehow it will improve the smell, taste, and texture of the cow pie.
I remember how, when I first discovered how prevalent outright pseudoscience and quackery had become in medical academia (which was before I became one of the founding SBM bloggers), I was in denial. I couldn’t believe it. Then I tracked this phenomenon with something I called the Academic Woo Aggregator. It turned out to be a hopeless endeavor because, as I soon discovered, the phenomenon was so pervasive that it was really hard to keep the Aggregator up to date. Since then, I’ve generally only focused on particularly egregious examples, naming names when institutions like my alma mater embrace anthroposophic medicine; “respectable” journals publish “integrative medicine” guidelines for breast cancer patients; cancer organizations include “integrative oncology” in their professional meetings; NCI-designated comprehensive cancer centers promote reiki to pediatric cancer patients or offer high dose unproven vitamin C treatment to patients; or respected academic institutions embrace traditional Chinese medicine (TCM) and the quackery that is function medicine. You get the idea. It’s depressing just how far medical academia has fallen in terms of being “open-minded” to the point of brains falling out when it comes to medical pseudoscience.
Anyone who reads Science-Based Medicine on even a semi-regular basis will know our collective opinion of homeopathy. Basically, at its core, homeopathy is pure quackery.
I don’t care if it’s repetitive to say this yet again because it can’t be emphasized enough times that homeopathy is The One Quackery To Rule Them All. OK, there are others that compete for that title, such as reiki and other magical “energy therapies” like therapeutic touch, both of which, unfortunately, can be found in many academic medical centers where the faculty really should know better. Any “medicine” whose very precepts break multiple laws of physics and chemistry, laws that would have to be proven not just wrong but spectacularly wrong for homeopathy to work, deserves only ridicule.
The “laws” of homeopathy
Think of it this way. There are two “laws” of homeopathy, neither of which has any basis in reality. First, there is the law that states “like cures like” and asserts that, to relieve a symptom, you need to use a substance that causes that same symptom in healthy adults. There is, of course, no evidence that this is a general principle of medicine. For instance, we don’t generally treat fever by administering something that causes fever or treat vomiting with something that causes vomiting. The second law, however, is the one that’s completely ridiculous. Basically, it’s the law of infinitesimals. This law states that a homeopathic remedy is made stronger with dilution, specifically serial dilutions with vigorous shaking between each dilution step to “potentize” the remedy. That’s ridiculous enough, but homeopaths, never satisfied with the merely ridiculous have to turn the ridiculous up to 11 and beyond by using this principle to assert that dilutions far beyond the point where there is likely even to be a single molecule of the original remedy left are effective and become more so with more dilution. For instance, a 30C dilution is 30 one hundred-fold dilutions (C=100, get it?), or a 1060 dilution. Avogadro’s number is only on the order of 6 x 1023, or more than 1036-fold less than the dilution. The simple mathematics of homeopathy just doesn’t work, although this doesn’t stop homeopaths from coming up with some truly spectacular flights of pseudoscience (like the “memory of water”) to try to “explain” how it can work.