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Society for Science-Based Medicine: Comment to FDA on homeopathic drug regulation

Sisyphus

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…)

Posted in: Announcements, Health Fraud, Homeopathy, Legal, Politics and Regulation

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Is Homeopathy Unethical?

Homeopathy is full of crap!  Click to embiggen.

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…)

Posted in: Homeopathy, Medical Ethics

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Bastions of quackademic medicine: Georgetown University

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.

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.
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Posted in: Acupuncture, Basic Science, Energy Medicine, Homeopathy, Medical Academia

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Should physicians and managed care organizations offer homeopathy?

Homeopathy is water

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.
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Posted in: Homeopathy

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It’s time for pharmacies to stop selling sugar pills

Some of these products contain no medicine at all.

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…)

Posted in: Ethics, Homeopathy, Politics and Regulation, Public Health

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NCCIH and the true evolution of integrative medicine

NCCIH and the true evolution of integrative medicine

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.

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Posted in: Acupuncture, History, Medical Academia, Naturopathy, Science and the Media

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David Tredinnick – Quack Candidate for Health Select Committee Chair

DAVID-TREDINICK-large570Today 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.

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Posted in: Politics and Regulation, Science and Medicine

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Integrative medicine, naturopathy, and David Katz’s “more fluid concept of evidence”

The Integrative Medicine Wheel

The Integrative Medicine Wheel

Dr. David Katz is undoubtedly a heavy hitter in the brave new world of “integrative medicine,” a specialty that seeks to “integrate” pseudoscience with science, nonsense, with sense, and quackery with real medicine. In fairness, that’s not the way physicians like Dr. Katz see it. Rather, they see it as “integrating” the “best of both worlds” to the benefit of patients. However, as we’ve documented extensively here, on our personal blogs, and even in the biomedical literature (plug, plug), what “integrative” medicine means in practice is indeed what I characterized, the infiltration of woo into medicine. This infiltration seems to have started mainly in academia—hence the term “quackademic medicine” and “quackademia”—with the steady infiltration of nonsense into medical schools and academic medical centers, but has since metastasized to the world of community hospitals. This “integration” (or, as I like to refer to it, “infiltration”) has become so pronounced that a few years ago The Atlantic published an article entitled “The Triumph of New Age Medicine“, and just last December the Journal of the National Cancer Institute (JNCI) published a monograph full of articles touting “integrative oncology,” including guidelines recommended by the Society of Integrative Oncology (SIO) for the “integrative” treatment of breast cancer symptoms.

I mention Dr. Katz for two reasons. First, he’s taken another broadside at us at Science-Based Medicine in blog entry at The Huffington Postwhere else?—entitled “Holism, Holes and Poles” that I’ve been meaning to address for a while. But before I address Dr. Katz’s most recent complaint against science-based medicine (SBM), it’s necessary to step back and look at some history.
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Posted in: Clinical Trials, Homeopathy, Medical Academia, Naturopathy

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Should the FDA crack down on homeopathic “remedies”?

In the category of potentially dangerous complementary or alternative medicine, I can think of few products worse than ones claimed to relieve asthma, yet don’t actually contain any medicine. Yet these products exist and are widely sold. Just over a year ago I described what might be the most irresponsible homeopathic treatment ever: A homeopathic asthma spray. If there was ever a complementary or alternative product that could cause serious harm, this is it:

oral-asthma-spray

Photo Credit Ryan Meylon

Among the different treatments and remedies that are considered “alternative” medicine, homeopathy is the most implausible of all. Homeopathy is an elaborate placebo system, where the “remedies” lack any actual medicine. Based on the idea that “like cures like” (which is sympathetic magic, not science), proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: cancer, boar testicles, crude oil, oxygen, and skim milk are all homeopathic “remedies”. (I think Berlin Wall may be my favorite, though vacuum cleaner dust is a runner-up). The dilution in the case of homeopathy is so significant that there’s mathematically no possibility of even a trace of the original ingredient in the typical remedy – they are chemically indistinguishable from a placebo. To homeopaths, this is a good thing, as dilution is claimed to make the medicine-free “remedy” more potent, not less. As would be expected with inert products, rigorous clinical trials confirm what basic science (and math) predicts: homeopathy’s effects are placebo effects. Recently Steven Novella blogged about the Australian Government’s National Health and Medical Research Council’s (NHMRC) comprehensive report on homeopathy which concluded the following: (more…)

Posted in: Homeopathy, Politics and Regulation

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A brief bit of shameless self-promotion…The Prince of Wales edition

PrinceCharles-590x350

In an effort to expand the Gorski empire almost to the level of the Crislip empire and to try to make it to somewhere within two or three orders of magnitude of the Novella empire, I’ve published an article on Slate.com about Prince Charles’ visit to our fine country entitled “Prince of Pseudoscience“. Consider this the mandatory shameless self-promotion that all SBM bloggers take advantage of from time to time to publicize their activities elsewhere.

Enjoy! (I hope.)

I’m told that Dana Ullman has made an appearance in the comments. I might have to head on over after work tonight…

Posted in: Announcements, Homeopathy, Politics and Regulation, Science and the Media

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