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.
Some of these products contain no medicine at all.
Retail pharmacies have a sugar pill problem. Homeopathic “remedies” may look like conventional medicine when they’re stocked on pharmacy shelves, like the photo above. But unlike conventional medicine, homeopathic products don’t contain any “medicine” at all. They are effectively sugar pills – placebos. Not surprisingly, there is convincing evidence to show that homeopathy is useless as a medical treatment, and fundamentally incompatible with a scientific understanding of medicine, biochemistry and even physics. Questions have been raised about the ethics of selling homeopathy in pharmacies to consumers who may not realize what they’re buying. This growing practice is attracting sharp criticism from other health professions. So why do pharmacies sell them? And what will it take for pharmacies to change? (more…)
There can be no doubt that, when it comes to medicine, The Atlantic has an enormous blind spot. Under the guise of being seemingly “skeptical,” the magazine has, over the last few years, published some truly atrocious articles about medicine. I first noticed this during the H1N1 pandemic, when The Atlantic published an article lionizing flu vaccine “skeptic” Tom Jefferson, who, unfortunately, happens to be head of the Vaccines Field at the Cochrane Collaboration, entitled “Does the Vaccine Matter?” It was so bad that Mark Crislip did a paragraph-by-paragraph fisking of the article, while Revere also explained just where the article went so very, very wrong. Over at a blog known to many here, the question was asked whether The Atlantic (among other things) matters. It didn’t take The Atlantic long to cement its lack of judgment over medical stories by publishing, for example, a misguided defense of chelation therapy, a rather poor article by Megan McArdle on the relationship between health insurance status and mortality, and an article in which John Ioannidis’ work was represented as meaning we can’t believe anything in science-based medicine. Topping it all off was the most notorious article of all, the most blatant apologetics for alternative medicine in general and quackademic medicine in particular that Steve Novella or I have seen in a long time. The article was even entitled “The Triumph of New Age Medicine.”
Now The Atlantic has published an article that is, in essence, The Triumph of New Age Medicine, Part Deux. In this case, the article is by Jennie Rothenberg Gritz, a senior editor at The Atlantic, and entitled “The Evolution of Alternative Medicine.” It is, in essence, pure propaganda for the paired phenomena of “integrative” medicine and quackademic medicine, without which integrative medicine would likely not exist. The central message? It’s the same central (and false) message that advocates of quackademic medicine have been promoting for at least 25 years: “Hey, this stuff isn’t quackery any more! We’re scientific, ma-an!” You can even tell that’s going to be the central message from the tag line under the title:
When it comes to treating pain and chronic disease, many doctors are turning to treatments like acupuncture and meditation—but using them as part of a larger, integrative approach to health.
Today the UK Parliament will have a vote for the chair of the Health Select Committee. The two choices could not be more starkly different, so much so that this vote might be seen as a referendum on two world views, one that respects science and another that confuses pseudoscience and spirituality for medicine.
On one side we have Sarah Wollaston, the previous chair, who is a former general practitioner and has taken a solid stand against pseudoscience in medicine. She has previously tweeted, for example, “Homeopathy can also have serious harms when masquerading as a ‘vaccine’.”
Tredinnick, on the other hand, has previously argued that the NHS should incorporate astrology into the healthcare system. I have previously argued that homeopathy is the most absurd and easily debunked major form of alternative medicine. Astrology, however, is arguably more absurd, I had just never heard it offered as a basis for healthcare. Tredinnick has at least accomplished setting a new low bar for alternative medicine nonsense.
Tredinnick appears to be a true-believer, fully steeped in the propaganda that is CAM (so-called complementary and alternative medicine). He has said:
Ninety per cent of pregnant French women use homeopathy. Astrology is a useful diagnostic tool enabling us to see strengths and weaknesses via the birth chart.
And, yes, I have helped fellow MPs. I do foresee that one day astrology will have a role to play in healthcare.