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1023 2011

The 1023 campaign is a UK based organization whose purpose is to raise awareness of the actual claims of homeopathy. The name is a reference to Avogadro’s number (6.02214179×10^23), which is the number of atoms or molecules of a substance in one unit called a mole. This is an important basic concept in chemistry, for it means that there are a finite number of bits of a substance in any solution, which further means that solutions cannot be infinitely diluted. You cannot have fractions of a molecule of any substance. There is therefore a dilutional limit – a point beyond which if you further dilute a solution you are increasingly likely to have removed all of the original substance.

Homeopathic preparations frequently use serial dilutions that vastly exceed this dilutional limit. This is a central fallacy of homeopathy (what homeopaths call a “law” of homeopathy). Samuel Hahnemann, who invented the fiction of homeopathy, knew about the dilutional limit but believed that substances gave their magical essence to water when diluted. Modern homeopaths believe this too, but in order to make their nonsense more marketable to a 21st century culture a tad more used to science (or at least scientific jargon) than Hahnemann’s, they have desperately tried to wrap “magical essence” in sciencey technobabble.

The 1023 campaign’s main purpose is public awareness. It appears that the best tool defenders of science-based medicine have against homeopathy is simply to make the public aware of what it actually is. I have not found any good surveys that quantify public beliefs on the subject (sounds like a good project) but it is my subjective experience (and that of many of my colleagues) from talking to countless patients and acquaintances that many if not most people are simply not aware of what homeopathy actually is. The term is often conflated with herbal or “natural” remedies. Shock and disbelief is a common reaction to explanations of what homeopaths actually claim.

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Mothering magazine: Peddling dangerous health misinformation to new mothers

Last week, the British Medical Journal (BMJ) published an expose by investigative journalist Brian Deer that enumerated in detail the specifics of how a British gastroenterologist turned hero of the anti-vaccine movement had committed scientific fraud by falsifying key aspects of case reports that he used as the basis of his now infamous 1998 Lancet article suggesting a link between the MMR vaccine and a syndrome consisting of regressive autism and enterocolitis. Indeed, Deer even went so far as to describe Wakefield’s fraud as “Piltdown medicine,” comparing it explicitly to the infamous “Piltdown man” hoax, and in an accompanying editorial the editors of the BMJ agreed. These revelations were not by any means new. Scientists had suspected that something wasn’t quite right about Wakefield’s work almost as soon as it had been published, and by 2004 Brian Deer had uncovered clear evidence of major undisclosed conflicts of interest on Wakefield’s part. Unfortunately, by that time the proverbial cat was out of the proverbial bag, and Wakefield’s fraudulent research, aided and abetted by his flair for self-promotion in the media and some truly execrable, credulous, and sensationalistic coverage by the British press, had ignited a major scare over the MMR vaccine. MMR uptake rates plummeted below levels necessary for herd immunity, and measles came roaring back with a vengeance in the U.K. By the time the British General Medical Council finally ruled about a year ago that Wakefield had committed research fraud and violated research ethics in the work reported in his 1998 Lancet article and recommended that he be “struck off” (i.e., have his license to practice medicine in the U.K. revoked), the damage had been done.

As important as Wakefield is to the genesis of the modern anti-vaccine movement, however, there is another force that acts far more “where the rubber hits the road,” so to speak. This force comes in the form of publications and online discussion forums that cater to new mothers, offering all manner of advice and support. Some of these are very good, but all too many of them are hotbeds of anti-vaccine pseudoscience, confidently proclaimed by “elder statesman” members of these forums and included in articles published in glossy, attractive magazines. As a rather ironic coincidence, just as news of Andrew Wakefield’s latest humiliation was finding its way out into multiple news outlets last week, the first issue of 2011 of just such a glossy publication hit the shelves. I’m referring to Mothering, whose tagline is “Inspiring Natural Families Since 1976.” In reality, it should read: “Inspiring quackery and anti-vaccine views since 1976.” Of course, in the world of “alt-med,” the two often go hand-in-hand. In any case, one of our readers sent me a link to the latest issue of Mothering. Unfortunately, I can’t supply you with that link, because it’s for subscribers. I will, however, describe and quote articles and passages that demonstrate just what a wretched hive of scum and quackery Mothering is, particularly with respect to vaccines but not limited to vaccines. Taking into account its large and vigorous online forums, Mothering is major force for the promotion of anti-vaccine views and quackery among new mothers.
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Posted in: Health Fraud, Homeopathy, Science and the Media, Vaccines

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Of SBM and EBM Redux. Part III: Parapsychology is the Role Model for “CAM” Research

This is the third post in this series*; please see Part II for a review. Part II offered several arguments against the assertion that it is a good idea to perform efficacy trials of medical claims that have been refuted by basic science or by other, pre-trial evidence. This post will add to those arguments, continuing to identify the inadequacies of the tools of Evidence-Based Medicine (EBM) as applied to such claims.

Prof. Simon Replies

Prior to the posting of Part II, statistician Steve Simon, whose views had been the impetus for this series, posted another article on his blog, responding to Part I of this series. He agreed with some of what both Dr. Gorski and I had written:

The blog post by Dr. Atwood points out a critical distinction between “biologically implausible” and “no known mechanism of action” and I must concede this point. There are certain therapies in CAM that take the claim of biological plausibility to an extreme. It’s not as if those therapies are just implausible. It is that those therapies must posit a mechanism that “would necessarily violate scientific principles that rest on far more solid ground than any number of equivocal, bias-and-error-prone clinical trials could hope to overturn.” Examples of such therapies are homeopathy, energy medicine, chiropractic subluxations, craniosacral rhythms, and coffee enemas.

The Science Based Medicine site would argue that randomized trials for these therapies are never justified. And it bothers Dr. Atwood when a systematic review from the Cochrane Collaboration states that no conclusions can be drawn about homeopathy as a treatment for asthma because of a lack of evidence from well conducted clinical trials. There’s plenty of evidence from basic physics and chemistry that can allow you to draw strong conclusions about whether homeopathy is an effective treatment for asthma. So the Cochrane Collaboration is ignoring this evidence, and worse still, is implicitly (and sometimes explicitly) calling for more research in this area.

On the other hand:

There are a host of issues worth discussing here, but let me limit myself for now to one very basic issue. Is any research justified for a therapy like homeopathy when basic physics and chemistry will provide more than enough evidence by itself to suggest that such research is futile(?) Worse still, the randomized trial is subject to numerous biases that can lead to erroneous conclusions.

I disagree for a variety of reasons.

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Posted in: Acupuncture, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Herbs & Supplements, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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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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