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Ososillyococcinum and other Flu bits.

Osillococcinum

I keep half an eye on the medicine displays in stores when I shop, and this year is the first time I have seen Oscillococcinum being sold.  Airborne as been a standard for years, but Airborne has been joined by Oscillococcinum on the shelves.  Dumb and dumber.    It may be a bad case of confirmation bias, but it seems I am seeing more  iocane powder, I mean oscillococcinum, at the stores.

On a recent podcast I was listening to one of the hosts suggested a homeopathic remedy for flu symptoms, and then specifically suggested osillococcinum.  This is a technology podcast, the 404, and the hosts are certainly bright, educated people.  Why would he suggest osillococcinum?  Probably because he unaware of how oh so silly the product is.

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Posted in: Homeopathy, Pharmaceuticals, Vaccines

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CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1
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Posted in: Homeopathy, Legal, Science and Medicine

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Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

Review

This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”

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Posted in: Chiropractic, Clinical Trials, Energy Medicine, Health Fraud, History, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

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What’s with the new cough and cold products?

One of my earliest lessons as a pharmacist working in the “real world” was that customers didn’t always act the way I expected. Parents of sick children frequently fell into this category — and the typical vignette went like this for me:

  1. Parent has determined that their child is sick, and needs some sort of over-the-counter medicine.
  2. Parent asks pharmacist for advice selecting a product from the dozens on the shelves.
  3. Pharmacist uses the opportunity to provide science-based advice, and assures parent that no drug therapy is necessary.
  4. Parent directly questions the validity of this advice, and may ask about the merits of a specific product they have already identified.
  5. Pharmacist explains efficacy and risk of the product, and provides general non-drug symptom management suggestions.
  6. Parent thanks pharmacist, selects product despite advice, and walks to the front of the store to pay.

In many ways, a pharmacy purchase mirrors the patient-physician interaction that ends with a prescription being written — it’s what feels like the logical end to the consultation, and without it, feels incomplete. It’s something that I’m observing more and more frequently when advising parents about cough and cold products for children.

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Posted in: Homeopathy, Legal, Science and Medicine

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Nosodes Redux: “I hate those meeces to pieces!”

Life and medicine generate facts and experiences that require conceptual frameworks that aid in understanding.  It is no good have a pile of facts if they cannot be understood within a broader understanding.

The practice of Infectious Diseases, while certainly aided by understanding anatomy, physiology, microbiology, chemistry and the other sciences that form the core of medicine (referred to in Medical School as the basic sciences), gains a broader  appreciation from the concepts of evolution.  Infectious Diseases, at its most fundamental level, is applied evolution, and understanding evolution often adds greater insight into infectious diseases.  Me find bug, me kill bug, me go home may be my motto, but it is meant in jest.

There have been papers or books that have added conceptual frameworks to my understanding of the natural world and medicine.  Besides evolution, there was Observations on Spiraling Empiricism a classic that all health care providers should read, as it outlines the cognitive errors we all make in prescribing medications; I have discussed this article before.

There is  The Drunkard’s Walk: How Randomness Rules Our Lives by Leonard Mlodinow.  So often the explanation of why something  happens is a shrug of the shoulders; feces occurs. The book formalized my understanding that much of what happens is random and without cause.  The challenge in medicine is trying  find a pattern in the randomness of life upon which to base a diagnosis. It is equally important to recognize when patterns are not there. All too often what is seen as a pattern is our imposing structure on what are random events.  Or maybe that really is a bunny in the clouds.  Clinical study results often occur by chance and having a significant ‘P’ value may still be due to randomness if the study is measuring nonsense.

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Homeopathy and the Selling of Nonspecific Effects

One of the core features of science (and therefore science-based medicine) is to precisely identify and control for variables, so that we know what, exactly, is exerting an effect. The classic example of this principle at work is the Hawthorne effect. The term refers to a series of studies performed between 1924 and 1932 at the Hawthorne Works. The studies examined whether or not workers would be more productive in different lighting conditions. So they increased the light levels, observed the workers, and found that their productivity increased. Then they lowered the light levels, observed the workers, and found that their productivity increased. No matter what they did, the workers improved their productivity relative to baseline. Eventually it was figured out that observing the workers caused them to work harder, no matter what was done to the lighting.

This “observer effect” – an artifact of the process of observation – is now part of standard study design (at least well-designed studies). In medical studies it is one of the many placebo effects that need to be controlled for, in order to properly isolate the variable of interest.

There are many non-specific effects – effects that result from the act of treating or evaluating patients rather than a physiological response to a specific treatment. In addition to observer effects, for example, there is also the “chearleader” effect from encouraging patients to perform better. There are training effects from retesting. And there are long-recognized non-specific therapeutic effects just from getting compassionate attention from a practitioner. It is a standard part of medical scientific reasoning that before we ascribe a specific effect to a particular intervention, that all non-specific effects are controlled for and eliminated.

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Homeopathy for fibromyalgia: The Huffington Post bombs again

Over the weekend, my wife and I happened to be in the pharmacy section of our local Target store. We happened to be looking for one of our favorite cold remedies, because both of us have been suffering from rather annoying colds, which have plagued both of us for the last week or two. As we perused the Cold and Flu section of the pharmacy, we were struck at how much shelf space was taken up by Airborne (which was “invented by a schoolteacher“). Nearly three years ago Airborne had to settle a case brought against it alleging false advertising to the tune of $23 million. Despite that, Airborne is still being sold, and there are even a whole bunch of knock-off products copying it. Then, as we continued to look for our favored cold remedy, we noted that, sitting right next to the extensive shelf space devoted to the various flavors and types of Airborne supplements, I saw Boiron’s homeopathic remedy for colds containing oscillococcinum, which is derived from duck liver and heart and diluted to 200C (a 10400-fold dilution).

Yes, I was a bit depressed after that. Now I know what my skeptical friends in the U.K. go through every time they walk into a Boots pharmacy.
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Posted in: History, Homeopathy

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Homeopathic Vaccines.

It is probably of no surprise to anyone who has read my blog entries, I am a proponent of vaccines.  They give the most bang for the infection prevention buck, and many of the childhood illnesses covered by the vaccine are now so rare that many physicians, even in Infectious Diseases, have never taken care of cases of measles or mumps or German measles, etc.  It is  a remarkable triumph of modern medicine.  Of course, the decline of infectious diseases is always multifactorial: good nutrition, understanding of diseases epidemiology, and good hygiene all have contributed to the decline of many diseases, vaccine preventable or not,  The application of science has resulted in an almost inconceivable decline in contagions that have killed and injured millions.

It is always better to prevent an illness than to have to treat it.  An ounce of prevention is worth a pound of cure.  Even those who erroneously believe that standard vaccines are not effective and/or dangerous understand that it is better to prevent illness with some sort vaccine.  But rather than use an effective vaccine, they choose, instead, other options.  Like homeopathic vaccines. (more…)

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Vaccine Wars: the NCCAM Drops the Ball

If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an invitation from Dr. Briggs. We differed from her in our opinion of the website: one of our suggestions was that the NCCAM could do a better job providing American citizens with useful and accurate information about “CAM.”

We cited, among several examples, the website offering little response to the dangerous problem of widespread misinformation about childhood immunizations. As Dr. Novella subsequently reported, it seemed that we’d scored a point on that one:

…Dr. Briggs did agree that anti-vaccine sentiments are common in the world of CAM and that the NCCAM can do more to combat this. Information countering anti-vaccine propaganda would be a welcome addition to the NCCAM site.

In anticipation of SBM’s Vaccine Awareness Week, I decided to find out whether such a welcome addition has come to fruition. The short answer: nope.

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Uff Da! The Mayo Clinic Shills for Snake Oil

A couple of weeks ago, in a review of the Mayo Clinic Book of Home Remedies, Harriet Hall expressed relief that she hadn’t found any “questionable recommendations for complementary & alternative medicine (CAM) treatments” in that book:

Since “quackademic” medicine is infiltrating our best institutions and organizations, I wasn’t sure I could trust even the prestigious Mayo Clinic.

The Home Remedies book may be free of woo, but Dr. Hall was right to wonder if she could trust the Mayo Clinic. About a year ago I was asked to comment on an article in the American Journal of Hematology (AJH), in which investigators from the Mayo Clinic reported that among a cohort of lymphoma patients who were “CAM” users,

There was a general lack of knowledge about forms of CAM, and about potential risks associated with specific types of CAM…

This suggests the need to improve access to evidence-based information regarding CAM to all patients with lymphoma.

No surprise, that, but I couldn’t help calling attention to the paradox of one hand of the Mayo Clinic having issued that report even as the other was contributing to such ignorance:

The Mayo Clinic Book of Alternative Medicine details dozens of natural therapies that have worked safely for many patients in treating 20 top health issues. You may be surprised that Mayo Clinic now urges you and your doctor to consider yoga, garlic, acupuncture, dietary supplements and other natural therapies. Yet the record is clear. Many of these alternative therapies can help you achieve reduced arthritis pain, healthier coronary arteries, improved diabetes management, better memory function and more.

Mayo Clinic cover

Nor could such a paradox be explained by the right hand not having known what the left was doing: Brent Bauer, MD, the Director of the Mayo Clinic Complementary and Integrative Medicine Program, is both the medical editor of the Book of Alternative Medicine (MCBAM) and a co-author of the article in the AJH.

As chance would have it, I had picked up a copy of the latest (2011) edition of the MCBAM only a couple of days before Dr. Hall’s post. Does it live up to its promises? Do its “straight answers from the world’s leading medical experts” respond to “the need to improve access to evidence-based information regarding CAM?” Let’s find out. In some cases I’ll state the implied questions and provide the straight answers.

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Posted in: Acupuncture, Book & movie reviews, Chiropractic, Energy Medicine, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Science and Medicine, Science and the Media

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