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Homeopathic industry and its acolytes make poor showing before FDA

Ask your pharmacist if nothing is right for you. (HT @leachkathleen)

Ask your pharmacist if nothing is right for you. (HT @leachkathleen)

On April 21 and 22, the FDA held a public hearing:

to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. . . . FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.

The FTC recently announced that it, too, is wading into the homeopathic waters. The FTC, which regulates advertising of homeopathic products, will hold a public workshop on September 21 in Washington, DC, “to examine advertising for over-the-counter (OTC) homeopathic products.” Like the FDA, it will also accept public comments online.

All of this regulatory buzz caused the FDA Law Blog to take notice. (The blog is hosted by a law firm specializing in food and drug regulation law.) A post titled “Will FTC Kill Homeopathic Products – or Will FDA?” gave this assessment:

Bottom line, if the FTC holds homeopathic products to the same scientific standards that are applied to claims for other OTC products like dietary supplements, as the FTC appears inclined to do . . . few if any homeopathic products will pass the test.

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Posted in: Clinical Trials, Health Fraud, Homeopathy, Legal, Naturopathy, Politics and Regulation

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Legislative Alchemy: Naturopathic licensing and practice expansion 2015

Naturopathic genetics: a new specialty?

Naturopathic genetics: a new specialty?

Naturopathy is chock-full of quackery. No doubt about it. Here at SBM and elsewhere, the seemingly limitless nonsense that can be incorporated into naturopathic practice has been documented time and again: detoxification, food “sensitivities,” anti-vaccination ideology, fake diseases (chronic yeast overgrowth, adrenal fatigue, chronic Lyme disease), bogus tests (also here), homeopathy, chelation therapy, assorted other odd-ball treatments, lack of ethical standards, and just general wackiness.

So, let’s give naturopaths licenses to practice primary care! What a good idea.

This affinity for nonsense is perfectly understandable, given their pseudoscience-filled education and foundation in vitalism. Once the scientific method is chucked in favor of “philosophy,” what’s to stop them from simply making things up? As far as I can tell, nothing. But why inflict this on the public under the guise of promoting health, safety and welfare?

To be fair, naturopaths aren’t the only ones who incorporate quackery into their practices. There are chiropractors, acupuncturists, reiki masters, doctors of Oriental Medicine, and “integrative medicine” practitioners. But what sets naturopaths apart, in my mind, is the sheer range of pseudoscience they will accommodate without the slightest hint of doubt in its efficacy or safety and their unwavering belief in their ability to diagnose and treat patients with the expertise and skill of medical doctors. “Delusional” is not too strong a word to describe their utter lack of awareness of their ignorance or the danger to patients they may pose. (more…)

Posted in: Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Vaccines

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“America’s Quack” strikes back

Wile E. Coyote or Dr. Henry Miller? You be the judge!

Wile E. Coyote or Dr. Henry Miller? You be the judge!

Those of you who read my not-so-super-secret other blog (or who follow the news) familiar with this, but I feel that what happened over the last couple of weeks with respect to a man to whom I like to refer as “America’s Quack” is worth posting right here, in modified form.

Last week, a group of ten doctors led by Dr. Henry Miller, most of whom were affiliated either with the Hoover Institution or the American Council on Science and Health (ACSH)—or both—wrote a letter to Lee Goldman, MD, the Dean of the Faculties of Health Sciences and Medicine at Columbia University complaining that Dr. Mehmet Oz shouldn’t be faculty at Columbia University because of his “disdain for science and for evidence-based medicine, as well as baseless and relentless opposition to the genetic engineering of food crops” and “an egregious lack of integrity by promoting quack treatments and cures in the interest of personal financial gain.” The letter produced a fair amount of media attention a week ago. I originally mildly approved of it, but over the course of a few days after the letter was released, my opinion on it soured. The reasons were several and included a profound distaste for threatening letters sent to a person’s employers, admittedly based in part on my own experiences having been at the receiving end of such intimidation tactics, as well as a concern that the letter had been written with no clear purpose behind it other than as a publicity stunt to embarrass Dr. Oz and Columbia. When I learned that Dr. Oz was planning to answer the letter on his show this week, there were predictions that this particularly bone-headed publicity stunt would backfire spectacularly. And it did.
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Posted in: Herbs & Supplements, Homeopathy, Science and the Media, Traditional Chinese 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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FDA and Homeopathy: Part Two.

A

Edward De Vere.  Sort-of.

Friends, FDA, countrymen, lend me your ears;

I come to bury Homeopathy, not to praise it.

The evil that homeopaths do lives after them;

The good is oft interred with their bones;

So let it be with Homeopathy. The noble Ullman

Hath told you homeopathy was effective:

If it were so, it was a grievous fault,

And grievously hath Homeopathy answer’d it.

Here, under leave of Ullman and the rest–

For Ullman is an honourable man;

So are they all, all honourable men–

Come I to speak in Homeopathy’s funeral.

It was my nostrum, faithless and worthless to me:

But Ullman says it was effective;

And Ullman is an honourable man.

He hath brought many provings home to HPUS

Whose prescriptions did the general coffers fill:

Did this in Homeopathy seem effective?

When that the ill have died, Homeopathy hath wept:

Efficacy should be made of sterner stuff:

Yet Ullman says it was effective;

And Ullman is an honourable man.

You all did see that on the Cochrane

I thrice presented Homeopathy a meta-analysis,

Which he did thrice refuse: was this efficacy?

Yet Ullman says it was effective;

And, sure, he is an honourable man.

I speak not to disprove what Ullman spoke,

But here I am to speak what I do know.

Edward De Vere, 17th Earl of Oxford. Sort of.

We only have a vague idea as to what other bloggers are going to write about. Yesterday Jann wrote on the same topic (and Scott the week before), which I will read tomorrow after my post goes up. Why would I want my post to be informed by another’s well-reasoned and thoughtful essay? I have a reputation after all. So here is my response to the FDA. (more…)

Posted in: Homeopathy, Legal

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How should the FDA regulate homeopathic remedies?

Hyland's "4 Kids Complete Allergy" homeopathic preparation (not for use with food allergies)

Hyland’s “4 Kids Complete Allergy” homeopathic preparation (not for use with food allergies), one of many unregulated, unproven over-the-counter preparations sold in the United States

The FDA announced recently that it is holding a public hearing on April 21 and 22,

to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.

It’s about time. We know that homeopathic remedies are not, and cannot be, effective. I will not plough that ground again here. Unfortunately, the FDA does not have any authority to bar these fraudulent products from sale altogether. Only Congress can do that.

In this post, I review the current regulatory framework for homeopathic products. I then explore the possibilities, given the opportunities for regulatory change presented by the FDA at this time. In doing so, I answer some of the questions posed by the FDA in its formal notice of the hearing, printed in the Federal Register.

I argue that the FDA has no statutory authority for the manner in which it currently regulates (or, actually, doesn’t regulate) homeopathic drugs. I further argue this system, largely controlled by the homeopathic industry, must be abandoned, and that there is no reason why homeopathic drugs should not be regulated just like any other OTC or prescription drug.

(Note to those wanting to submit written comments or attend the hearing: there are deadlines and other requirements for participation. You can read those in the Federal Register.)
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Posted in: Clinical Trials, Homeopathy, Legal, Politics and Regulation

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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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Another Review Finds Homeopathy Worthless

homeopathy T

Just say “NO” to homeopathy. Available at skeptoid.com.

It is long past time to close the door on homeopathy. After thousands of studies, homeopaths are still unable to produce convincing evidence that homeopathy works for any indication. Multiple reviews of the evidence have come to this conclusion, and now we have one more to add to the pile – the Australian National Health and Medical Research Council (NHMRC) just published their report after reviewing the clinical evidence and have concluded that homeopathy doesn’t work for anything.

Homeopathy is a prescientific medical philosophy based upon the fanciful notions that like cures like (which is really an expression of sympathetic magic) and that extreme dilutions of a substance can retain the magical essence of the substance. These ideas were silly two centuries ago when they were invented. The scientific advances we have made since them have only deepened this conclusion. Homeopathy should have been tossed onto the scrap heap of history along with phrenology, humoral theory, mesmerism, and other quaint ideas. Its persistence is testimony to the power of cultural inertia.

Despite the fact that homeopathic potions have essentially zero scientific plausibility (as close to zero as we can get in science), a great deal of resources have been wasted testing homeopathy clinically. The recent NHMRC review identified more than 1,800 studies, of which 225 were of sufficient size and rigor to include in the review. They report:

The review found no good quality, well-designed studies with enough participants to support the idea that homeopathy works better than a placebo, or causes health improvements equal to those of another treatment.

Although some studies did report that homeopathy was effective, the quality of those studies was assessed as being small and/or of poor quality. These studies had either too few participants, poor design, poor conduct and or [sic] reporting to allow reliable conclusions to be drawn on the effectiveness of homeopathy.

According to CEO Professor Warwick Anderson, “All medical treatments and interventions should be underpinned by reliable evidence. NHMRC’s review shows that there is no good quality evidence to support the claim that homeopathy works better than a placebo.”

In 2013 the NHMRC published a review of the clinical evidence for homeopathy, and they broke this down by medical condition. Of the 68 medical conditions they examined, for 7 of them there was no quality evidence from which to draw any conclusions. For 61 of the conditions there was evidence for lack of efficacy – not just a lack of evidence showing that homeopathy works, but evidence showing that homeopathy does not work. (more…)

Posted in: Homeopathy

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Clinical trials of homeopathy versus “respect for science”

Trojan Rabbit

A few months ago, Steve Novella and I published an article in Trends in Molecular Medicine entitled “Clinical trials of integrative medicine: testing whether magic works?” It was our first foray together into publishing commentary about science-based medicine versus evidence-based medicine, using a topic that we’ve both written extensively about over the years on this blog and our respective personal blogs. Specifically, we discussed whether it is worthwhile to do randomized clinical trials (RCTs) testing highly improbable treatments, such as reiki and homeopathy, both of which have no physical basis to believe that they do anything whatsoever. As I’ve said many times before, reiki is simply faith healing in which Eastern mysticism is substituted for Christian beliefs, and homeopathy, as we’ve discussed many times here on SBM, is vitalistic sympathetic magic with no evidence to support its two laws.

To our surprise, that article generated a fair amount of press (for example this), with accounts of it showing up in the media in various places and Steven and I being asked to do a fair number of interviews. Part of the reason, I suspect, is that the editor made the article available for free for a month after its initial publication. (Unfortunately it’s back behind the pay wall again.) Part of the reason is that, intuitively, it makes sense to people not to waste money testing what is, at its core, magic. When I followed up that publication with an article criticizing “integrative oncology” in Nature Reviews Cancer entitled “Integrative oncology: Really the best of both worlds?“, the target was well and truly on my back. Indeed, let’s just say that the Society for Integrative Oncology and the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM) are quite unhappy with me. When both their letters to the editor are published (right now, only one is), I might even blog about them.

In the meantime, I want to deal with criticism published in an unexpected place, albeit not by unexpected critics. The reason is that this criticism relies on a common straw man caricature of what we are saying when we advocate science-based medicine (SBM) that considers prior plausibility in determining what modalities to test in clinical trials and understands Bayesian thinking in which prior plausibility affects posterior plausibility that a “significant” result is not a false positive in contrast to the current evidence-based medicine (EBM) paradigm, which relegates basic science knowledge, even well-established principles of science that show that something like, say, homeopathy or reiki is impossible under the current understanding of physics, chemistry and biology, to the lowest rung on the EBM pyramid. It’s also a criticism that comes up frequently enough that, even though it’s been addressed before in various ways by various SBM bloggers, it’s worth revisiting from time to time. In this case, that’s particularly so because one of the two critics taking Steve and me to task is currently embroiled in a controversy about testing homeopathy for attention deficit hyperactivity disorder (ADHD) at the University of Toronto (more details on that later). Let’s just say, the criticism of Steve and me gives me an “in” to address a story that I thought had passed me by, and I intend to take it.
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Posted in: Clinical Trials, Energy Medicine, Homeopathy

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