When Dr. Novella recently wrote about plausibility in science-based medicine, one of our most assiduous commenters, Daedalus2u, added a very important point. The data are always right, but the explanations may be wrong. The idea of treating ulcers with antibiotics was not incompatible with any of the data about ulcers; it was only incompatible with the idea that ulcers were caused by too much acid. Even scientists tend to think on the level of the explanations rather than on the level of the data that led to those explanations.

A valuable new book elaborates on this concept: Diagnosis, Therapy and Evidence: Conundrums in Modern American Medicine, by medical historian Gerald N. Grob and sociologist Allan V. Horwitz. They point out that 

many claims about the causes of disease, therapeutic practices, and even diagnoses are shaped by beliefs that are unscientific, unproven, or completely wrong.

While we try to be science-based, we are not always as scientific or as logical as we would like to think. We form hypotheses that are compatible with existing data, and then our assumptions guide our thinking and future research and sometimes interfere with our reception of new data. We must recognize those assumptions and constantly re-evaluate them. It’s important that we look the imperfections of science-based medicine squarely in the face if we are going to have any hope of overcoming them.

Of the therapies recommended in a 1927 textbook only 23 were later validated as effective or preventive. The other 211 were subsequently found to be either harmful, useless, of questionable value, or simply symptomatic.

Medical treatment has had a big impact on human health, but there’s more to the story. We developed effective treatments for ulcers, but the incidence of ulcers was already declining before those treatments had any impact. The decline of rheumatic heart disease is probably not due to antibiotics but may be due to decreased virulence of the causal bacteria. We have no idea why the incidence of stomach cancer has decreased in the US, or why it is so high in Japan.

A popular concept today is that cancer is largely a preventable illness linked to diet, environmental carcinogens and behavior. This is rooted largely in belief and hope rather than fact. Smoking is the one notable exception. Genetic factors and the many physiologic changes of aging may contribute more than we would like to think. To some extent, disease is an unavoidable consequence of life: the idea that science can eventually provide perfect health may be a chimera.

In our efforts to prevent heart attacks we are essentially treating risk factors, without a clear understanding of how they relate to pathophysiology. We are treating hypertension, hyperlipidemia and other risk factors rather than directly treating the cause(s) of cardiovascular disease. We offer behavioral prescriptions based on assumptions derived from inadequate epidemiologic evidence, and this kind of thinking can lead us astray. Recommending a low fat diet helped fuel an epidemic of obesity as people replaced the fat in their diet with extra carbohydrates.

Once we have formed a belief we are slow to respond to new evidence that refutes it. The book covers the history of tonsillectomy. Tonsillectomies remained fashionable long after the evidence showed most of them were useless.

The most interesting question they ask is

How do diagnoses come into existence and why do many disappear with the passage of time?

What ever happened to chlorosis and neurasthenia? The same patient presenting with the same symptoms in 1890 and 2010 would get entirely different diagnoses. The ailments that afflict humans don’t change much; our diagnostic categories do.

Autism, CFS and fibromyalgia are all relatively new diagnoses for conditions that undoubtedly existed long before the diagnostic name was coined. “Their pathobiology remains unknown, and there is little agreement on their diagnostic boundaries. Once given a name, however, the numbers given to each diagnosis have expanded exponentially.”

Psychiatric diagnoses are particularly slippery. Where exactly do you draw the line between normal sadness and depression? Disease occurs on a continuum and we try to fit it into discrete boxes. We organize the data differently at different times as influenced by historical circumstances. The Diagnostic and Statistical Manual of Mental Disorders (in its many iterations, now up to DSM-5) changes as it reflects not only new data but cultural, social, and political forces. There is no evidence that the new DSM categories of anxiety have improved the diagnosis, treatment, or understanding of anxiety disorders. The popularity of the diagnosis of post traumatic stress disorder (PTSD) raises issues about the connection between external causes, individual responses, and resulting symptoms. Broadened criteria for PTSD have made it possible for almost everyone to be diagnosed or considered at risk.

We differentiate between science-based medicine and belief-based medicine, but we mustn’t forget that scientists form beliefs too. Our interpretation of the evidence is influenced by our working hypotheses. We must remember to constantly guard against overinterpretation and to concentrate only on what the evidence actually shows. When we use a diagnosis, we must remember that it is not definitive, but only an artificial category we have imposed on nature to help us understand our patients’ symptoms and provide a framework for treatment decisions. When we have an explanation, we must keep re-evaluating the data to make sure another explanation doesn’t fit the data just as well.

Ionannidis showed that most published studies are wrong. Grob and Horwitz show that many of our current diagnoses, treatments, and ideas about disease may be wrong too.

I suggest that we all repeat the mantra: “I could be wrong” and keep asking “Could any other explanation fit the data?”

The core information supporting science-based medicine resides in the scientific literature. There, scientists and physicians publish the results of experiments and clinical trials that seek to understand the biological mechanisms by which the human body functions and through which disease forms and to apply this understanding to test new treatments for diease. Consequently, the quality and integrity of the biomedical literature are topics of utmost importance to supporters of science-based medicine. We’ve discussed problems with the scientific literature before here, ranging from how pseudoscientific “complementary and alternative medicine” journals have insinuated themselves into the medical literature and how drug companies have managed exercise undue influence over clinical trials and journals.

One question that perhaps we have not dealt with so much is the question of the very nature of a good scientific journal, particularly what is suitable material for such a journal. For purposes of this discussion, I will focus mainly on the biomedical literature, which spans a range from basic science journals dealing with biomedical science to clinical journals, which mainly report the results of clinical trials and clinical research. Of these journals, there are in general two types, journals that primarily report original research and those that present reviews of existing research. Most journals do a mix of the two, the majority tending towards a form where most of the articles are reports of orginal research mixed in with a much smaller number of review articles.

There is one journal, however, that is different. It is a journal known as Medical Hypotheses. It is a journal that (or so it claims) exists to present radical scientific ideas, the more radical the better. Here is how the journal is described on its website:

The purpose of Medical Hypotheses is to publish interesting theoretical papers. The journal will consider radical, speculative and non-mainstream scientific ideas provided they are coherently expressed.

Medical Hypotheses is not, however, a journal for publishing workaday reviews of the literature, nor is it a journal for primary data (except when preliminary data is used to lend support to the main hypothesis presented). Many of the articles submitted do not clearly identify the hypothesis and simply read like reviews.

So far, there’s nothing inherently objectionable or anti-scientific in the concept behind MH. I can easily see a role for a journal that publishes speculative biomedical papers. However, there is a problem, and this problem has been brewing for a long time. Last month, apparently, it came to a head, and last week it was reported in Science that the publisher of MH, Elsevier, had issued the editor, Bruce Charlton, an ultimatum:

The editor of the journal Medical Hypotheses–an oddity in the world of scientific publishing because it does not practice peer review–is about to lose his job over the publication last summer of a paper that says HIV does not cause AIDS. Publishing powerhouse Elsevier today told editor Bruce Charlton that it won’t renew his contract, which expires at the end of 2010, and it asked that Charlton resign immediately or implement a series of changes in his editorial policy, including putting a system of peer review in place. Charlton, who teaches evolutionary psychology at the University of Newcastle upon Tyne in the United Kingdom, says he will do neither, and some on the editorial advisory board say they may resign in protest if he is fired.

Elsevier’s move is the latest in an 8-month battle over the journal; it comes after an anonymous panel convened by Elsevier recommended drastic changes to the journal’s course, and five scientists reviewed the controversial paper and unanimously panned it.

Before I go on, let me just say right here that I don’t necessarily disapprove of a journal devoted to highly speculative, even radical hypotheses. Such a journal can play a very important role for airing ideas at the fringes of what is known. Unfortunately. However, as I shall describe shortly, I believe that MH has been a big problem. Specifially, my problem with MH is that it blurred the line between the speculative and apparently confused “speculative” with “making stuff up.” Apparently the reviewers agreed:

Following the advice of an external panel whose membership has not been made public, Elsevier wrote Charlton on 22 January to say that Medical Hypotheses would have to become a peer-reviewed journal. Potentially controversial papers should receive especially careful scrutiny, the publisher said, and some topics–including “hypotheses that could be interpreted as supporting racism” should be off limits.

Elsevier also had its flagship medical journal, The Lancet, organize a formal review by five anonymous experts. The reviews, which have not yet been released publicly but were obtained by Science, were unanimously harsh–especially about the Duesberg paper, indicating that it is riddled with errors and misinterpretations. “It might entertain their friends and relatives on a cold winter evening, but it does not belong in a scientific journal,” one reviewer wrote. On 24 February, Elsevier wrote Duesberg that his paper–which had not yet been printed and had been taken down from the journal’s Web site in August–would be “permanently withdrawn.” Ruggiero received a similar letter 5 days later.

Why did it come to this? The reason is that a journal whose editor valued “radical” ideas far more than actual science has been polluting the medical literature in a manner that was too easily abused by cranks and quacks. Moreover, this was not a new problem; it had been longstanding and known to those of us who pay attention to such matters. Many are the times I have seen a wide variety of cranks cite MH papers as support for their positions. In essence, MH had become a vanity journal that will publish almost anything, no matter how much it goes against established science. For example, Mark Blaxill published pseudoscientific speculation that vaccines cause autism, and the anti-vaccine movement trumpeted Blaxill’s paper for the next several years as “evidence” in a “peer-reviewed journal” that vaccines cause autism. Similarly, MH published Mark and David Geier’s “hypothesis” proposing the use of the powerful anti-sex hormone drug Lupron to treat autism, an utterly ridiculous idea from a scientific standpoint that wasn’t just “radical”; it was demonstrably wrong. In the same vein, MH published a paper by a dream team of anti-vaccine activists proposing the use of spironolactone to treat autism based on its anti-androgen properties. Recently, MH published an article that appeared to echo attempts by the anti-vaccine movement to link mitochondrial diseases to “vaccine injury.”

It worked, too, because most lay people can’t distinguish between a highly speculative scientific article and a scientific report based on sound data from well-designed experiments and/or clinical trials, with solid scientific reasoning leading to its conclusions. Nor do most people–even scientists– have any idea of some of the other amusingly (and not-so-amusingly) wacky “hypotheses” published in MH, such as ideas that masturbation is a treatment for nasal congestion, a paper linking high heeled shoes to schizophrenia, a meditation on the nature of navel fluff, and truly offensive speculations about “mongoloids.” And there was support for the most blatant pseudoscience as well, even above and beyond support of HIV/AIDS denialism. For example, over the years MH has published several articles arguing for the “plausibility” of homeopathy, such as this, this, and this.

Perhaps the worst debacle suffered by MH came to pass last summer, when it published an article by HIV/AIDS denialist Peter Duesberg that was outrageously wrong and even downright racist. So bad was the article, that Elsevier apparently felt compelled to act and in doing so administered one of the worst indignities imaginable to a scientist. It withdrew Duesberg’s article from MH last year. Now I know what happened since then. Elsevier ordered an external review, the results of which were reported in the news article in Science cited above. Given the history of MH publishing anti-vaccine pseudoscience and other highly dubious papers, I was curious why this particular manuscript would have been withdrawn from Medical Hypotheses, given the usual low standards demonstrated by MH and that the article expresses the usual nonsensical “scientific opinions” that HIV isn’t enough to cause AIDS, that HIV doesn’t kill as many in Africa as estimated, and that anti-HIV drugs don’t work. What changed between the time that Medical Hypotheses (MH) accepted this article and decided to withdraw it? Why would this one article be worse than all the other pseudoscience routinely published by MH? Quite frankly, I was puzzled at the time.

My search led me to Ben Goldacre’s column entitled Medical Hypotheses fails the Aids test, which in turn led me to this detailed explanation on AIDSTruth.org entitled Elsevier retracts Duesberg’s AIDS Denialist article. After that, it all became clear. Basically, the slapdown administered to Duesberg and other HIV/AIDS denialists through his article being retracted by MH had its genesis in a study by Pride Chigwedere and coinvestigators at Harvard University, who estimated that delays in providing antiretroviral drugs in South Africa because of state-supported AIDS denialism (in which Duesberg played a prominent role in promoting) had caused over 300,000 deaths. In fact, the article mentioned Duesberg’s role in promoting HIV/AIDS denialism in South Africa. This is what happened:

AIDS denialist Peter Duesberg, whose influence on the disastrous South African government policies was mentioned in Chigwedere’s article, submitted a response to JAIDS that was co-authored by four others including Rasnick. After this article was rejected because of its poor academic quality, Duesberg et al. submitted it to a different journal, Medical Hypotheses. Two days later, the editor accepted the paper. Medical Hypotheses does not practice peer review, a process in which several scientists check a submitted academic paper for quality and suggest needed improvements over a period of weeks or months. The Duesberg et al. paper was accepted without such a review process, after inspection only by the editor of Medical Hypotheses.

This appears to be a relatively common occurrence, with articles rejected by real journals somehow having a way of finding their way into Medical Hypotheses. Duesberg was particularly crass, too, writing in the article:

A precursor of this paper was rejected by the Journal of AIDS, which published the Chigwedere et al. article, with political and ad hominem arguments but without offering even one reference for an incorrect number or statement of our paper (available on request).

Apparently I missed it at the time, but HIV/AIDS denialists were crowing about this, just as anti-vaccinationists crowed about papers by Mark Blaxill and Mark Geier making it into Medical Hypotheses and held them up as “evidence” that their ideas were making it into mainstream scientific journals.

The publication of Duesberg’s HIV/AIDS denialist paper also led an effort by scientists to do something that should have been done a long time ago. For some reason that has always eluded me, ever since I first discovered the land of woo that is Medical Hypotheses, this journal is indexed with MEDLINE and shows up on PubMed searches. It goes against a lot of what MEDLINE claims to be its standards for indexing a journal or even the very functions of MEDLINE. Based on the co-optation of Medical Hypotheses by HIV/AIDS denialists to their cause, a number of academics, authors, and researchers wrote a letter to Donald A. B. Lindberg, M.D. Director, National Library of Medicine Betsy L. Humphreys Deputy Director, National Library of Medicine Sheldon Kotzin Associate Director, Library Operations Library Selection Technical Review Committee calling for Medical Hypotheses to be delisted from MEDLINE.

My guess is that the serious threat of having MH removed from list of journals indexed by MEDLINE is what led Elsevier to act. After all, if a journal isn’t listed in MEDLINE, its articles won’t show up on PUBMED searches, and that is the kiss of death for any biomedical journal that hopes to maintain any sort of reputation at all. But did Elsevier go too far? Although I view Elsevier’s action as a long overdue effort at finally exercising some quality control, there are those who vigorously defend MH and its editor Bruce Charlton. In fact, Charlton published some of these defenses on his blog, and equally unfortunately some of them were quite poorly reasoned, such as this defense by Professors Lola J. Cuddy and Jacalyn M. Duffin:

If it emerges that Duesberg’s paper erred beyond his minority viewpoint to actual errors–be they deliberate or accidental, a signal comparison can be made to two leading medical journals. Medical Hypotheses would have been no less a victim or a wrongdoer than the distinguished entities The Lancet and the New England Journal of Medicine.

Earlier this month, Elsevier’s flagship journal The Lancet withdrew a 1998 paper by Andrew Wakefield et al. that helped foster the now discredited theory linking autism and MMR vaccines. No one has called for the alteration of Lancet. Indeed, the issue has drawn attention to the preeminent leadership role that The Lancet plays in the dissemination of knowledge and ideas.

Similarly, in 2000 the New England Journal of Medicine published a peer-reviewed paper that strongly supported the use of rofecoxib (known as Vioxx®). Later it emerged that the paper had suffered improper industry interference and failed to declare a treatment-related death. The drug was taken off the market in 2004. Considerable discussion surrounded the editorial responsibilites for the 2000 article when the flaws came to light in 2005. But no one called for the New England Journal of Medicine to be altered in any way. Jeffrey Drazen is still its editor-in-chief.

This is, of course, comparing apples and oranges. It’s been well known that fraud is very difficult to detect through a standard peer review of a scientific paper, and most journals do not have good systems in place to detect undisclosed conflicts of interest. In any case, in their defense of MH Cuddy and Duffin are demonstrating extreme ignorance at best or extreme disingenuousness at worst. There is a profound difference between a journal’s peer reviewers missing examples of scientific fraud, which peer review tends to be ill-equipped to detect, and a journal editor just taking any ridiculous “speculative” paper that comes along and calling it science. Although an argument can be made that Wakefield’s paper should never have been accepted for publication because it was such thing gruel, the Vioxx paper at the time it was published looked like a perfectly legitimate and reasonable randomized clinical trial. It took years to discover the problems with both papers. Cuddy and Duffin are in essence invoking the tu quoque fallacy by pointing to failures of peer review as a justification for the failure of MH not only to maintain a reasonable level of quality control but even to exercise any peer review at all. Remember, MH is not peer reviewed. It is, as Charlton has described it, “editorially reviewed,” which means basically that Charlton picks what is published. Unfortunately, he has chosen poorly so often that he finally got burned.

Another issue illustrated by this controversy is the role of editors, their editorial independence, and how far publishers should go in influencing the content of scientific journals that they publish. Editorial independence is indeed very important for preventing external forces, such as advertisers (i.e., drug companies) from having undue influence over editorial decisions over scientific content. Some argue that editorial independence is, for all intents and purposes, paramount. On the other hand, it is the responsibility of the publisher to exercise quality control, and that’s just what Elsevier’s action appears to be in this case. I’ve complained about Elsevier before in the context of its allowing a pharmaceutical company to pay it to publish what was in essence fake medical journal, but in this case it appears to be doing (mostly) the right thing. I say “mostly” because I do agree that one aspect of its actions does make me uncomfortable, specifically the part about saying that some controversial topics should be off-limits. That drifts uncomfortably close to the realm of pre-emptive censorship. Science depends on the unfettered dissemination and discussion of ideas, even ideas that many might find offensive.

Science is also served by fearlessness in discussing radical ideas. Howver, care has to be taken to make sure that there is a clear line between what is speculation and what is not, and it has to be made very clear when such a journal is not peer-reviewed. MH under Charlton’s leadership has failed on both counts. Whatever the value of the concept behind a journal like MH, in the case of MH that value has not only failed to be realized, but has in fact been degraded and brought into serious disrepute. Charlton has, through his carelessness, arrogance, and his ideologically blind refusal to enforce even the most minimal minimal scientific standards on articles submitted to MH, has resulted in embarrassment after embarrassment falling upon his journal, from its abuse by the anti-vaccine movement to the latest debacle. The Peter Duesberg HIV/AIDS denialist paper retracted by Elsevier was merely the last straw. As a result, Elsevier decided that it had little choice but to order Charlton to impose peer review or to resign. By refusing to adhere to even a modicum of scientific rigor, Charlton has destroyed the aspect of MH that he apparently most values.

A journal devoted to cutting edge, even fringe scientific hypotheses might indeed be valuable, but because of his carelessness, Charlton guaranteed that Medical Hypotheses was not that journal and that it never will be. If there is to be a journal devoted to highly speculative scientific articles, it’s clear that Medical Hypotheses isn’t it and can no longer even attempt to be it. Bruce Charlton saw to that. Maybe MH under new editorial leadership can claim that role, or maybe a new journal will arise to fill such a niche. Either way, the old MH had to change or risk being destroyed. “Radical ideas” are all well and good, and bouncing them around may make for a fun drinking game among scientists. However, if these radical ideas are not supported by known facts, sound scientific studies, and strong reasoning, they are nothing more than that and can serve to mislead more than to enlighten.

Get your facts first, and then you can distort them as much as you please. -Mark Twain

There is an educational approach to becoming a doctor.  It involves learning massive amounts of basic science, followed by massive amounts of pathophysiology,  which barely prepares you for the clinical  years of the last half of medical school and   subsequent residency with the massive knowledge dump you have to absorb.  Much of the information is given by experts in the field, usually MD’s or PhD’s (or both),  who lecture formally and informally.  Being considered expert in ID at a teaching hospital, I now spend hours a day yammering on about infections to anyone who will listen, students in all the medical fields who rotate through our hospitals.  I value the facts I have learned in my field and respect those who have worked to provide me with the information.  I greatly value facts and the people who provide them.

Most of the information I get in medicine is from those in the field.  It is rare for people to write about aspects of medicine that I will take seriously.  Yes, there are a lot of people who write on the web about medicine, but given what it takes to achieve even a solid knowledge in medicine, much less develop expertise, I usually can’t take them too seriously.  Call me arrogant, but if you want to be a legitimate source of information there are dues that have to be paid.

The world of anti-vaccination discourse is small. There are few physicians who take an interest in the topic. Most doctors are too busy to care and it is like worrying about defending fresh water and clean air.  I would wager that to most physicians outside the world of pediatrics, the benefit of vaccines is rarely given a thought.

The anti-vaccinationists are an equally small group of people, at last the ones that bother to write on the topic. Sometimes they seem inordinately loud, but that is only because they end up on Oprah.

I often feel that the two sides inhabit different worlds with different approaches to reality.  I live in a world dominated by facts derived from the sciences.  The facts always change, or  better words may be evolve or refined, with time.  But facts matter to me.  There is a world of facts derived from observation of the natural world and in the end my opinion on a topic medicine does not matter.  It is what the facts indicate that should determine my opinions, not the other way around.  Facts can be tricky things, especially in medicine, with nuance and subtlety that makes the facts less clear cut than one would like, especially compared to a hard science like physics or chemistry.

Facts often do not seem to matter to anti-vaccine proponents and other CAM practitioners to the same degree that they do to me.  For example, given the preponderance of information about the worthlessness of homeopathy I cannot see how anyone would ‘practice’ homeopathy. Or acupuncture. Or chiropractic. Or virtually any CAM discussed on this blog.

I have spent half of my life accumulating facts to understand the best way to practice medicine and, as best I can tell these facts, do not matter much to the CAM practitioners or anti-vaccinationists.

And I don’t get it.  Why do the CAM practitioners and anti-vaccine proponents not pay attention to the facts.  It is, as I have said, like we live in two separate cultures.  I have spent some time in other countries whose customs are different from mine: Japan, France, Minnesota.  Before visiting those foreign lands I would read texts by anthropologists and historians on what to expect and how their culture differed from mine.  I would never have survived my three years in Minneapolis if not for “Lake Woebegon.”  But who better to understand a foreign culture than an anthropologist.  What I need is anthropologist to help understand why the facts do not matter.

Ask and you will receive.  I serendipitously came across two articles.  The first is by Leonard Pitts in my local paper.   The other is  ”A Post-modern Pandora’s box: Anti-vaccination misinformation on the internet” by Anna Kata, an anthropologist from Canada.  There are other studies on the beliefs of the anti-vaccinationists, but they are from the perspective of doctors and have underlying belief that if you get the right information to people they will make the right decision.  Doctors believe, in the end, in rational discourse. Others do not.

“The Internet plays a large role in disseminating anti-vaccination information. This paper builds upon previous research by analyzing the arguments proffered on anti-vaccination websites, determining the extent of misinformation present, and examining discourses used to support vaccine objections. Arguments around the themes of safety and effectiveness, alternative medicine, civil liberties, conspiracy theories, and morality were found on the majority of websites analyzed; misinformation was also prevalent. The most commonly proposed method of combating this misinformation is through better education, although this has proven ineffective. Education does not consider the discourses supporting vaccine rejection, such as those involving alternative explanatory models of health, interpretation strikes me that this argument is for a freedom without responsibility for the consequences of parental responsibility, and distrust of expertise. Anti-vaccination protestors make post-modern arguments that reject biomedical and scientific “facts” in favour of their own interpretations. Pro-vaccination advocates who focus on correcting misinformation reduce the controversy to merely an “educational” problem; rather, these post-modern discourses must be acknowledged in order to begin a dialogue.”

Note she puts facts in quotes.

What the author did was Google for websites that opposed childhood vaccinations for any reason and she ended up with  9 sites, including the whale, vran.org, vaclib.org, and vaccinationnews.com.  Why so few?  Evidently those seeking health information on the net rarely look past the first 10 search results, so she tried to mirror the results of the average internet user searching for information.  She then analyzed the sites for content relating to Safety and Effectiveness, Alternative Medicine, Civil Liberties and Conspiracy Theories/Search for Truth as well as design attributes of the web sites, emotive appeals and content.  Interestingly,  a search using the terms “immunization OR immunization” failed to find any anti-vaccine sites; anti-vaccinationists do not use the term as “they tend not to believe that vaccine confer immunity.”

The findings will be no surprise to those who frequent anti-vaccine sites, or alt med sites in general.

What 100% of the sites had in common was the assertion that vaccines are dangerous because they contain poisons or cause a variety of illnesses. It was noted that on the sites “pertinent information was not elaborated upon” and gave examples of the amount of ‘toxins’ being too small to cause disease and that the ether in vaccine is the chemical not the anesthetic  not being mentioned on the anti-vaccination sites.

Also common were statements concerning the lack of vaccine immunogenicity, the lack of vaccine efficacy in decreasing childhood diseases (credited to diet, hygiene, etc) and a trivialization of vaccine preventable diseases, failing to mention the past and present morbidity and mortality of the diseases.

What these sites demonstrate is a disregard for facts, which at one time were considered the final arbitrator of reality. If facts do not matter, and can be ignored arbitrarily, then the conversation between the reality based approach to medicine and the alt med practitioners is impossible.

She notes that most sites endorsed the use of alternative medicines and often argued against germ theory.

“Anti-vaccination website tended to reject scientific, clinical and epidemiologic studies demonstrating the safety and efficacy  of vaccines.  Pro-vaccinations studies were criticized as unreliable, conducted by those with vested interests in vaccination.”

Again. Facts ignored or dismissed.

Three quarters of the sites cited the infringement of civil liberties by requiring vaccination. It strikes me that this argument is for a freedom without responsibility for the consequences. It  is an argument for which I have some sympathy, but only as long as those who wish to exercise their freedom not be vaccinated are always at least 30 miles away for me and mine or agree to take all the financial responsibilities for the medical care of anyone they inadvertently infect.  My problem with the civil liberty approach comes from having to take care of for free and my hospital treat for free people in the trauma ICU who preferred the freedom of not wearing seat belts and helmets in defiance of the man and ended up with multiple, very expensive,  traumas.  But we are all biased by our experience.

“The conspiracy theory theme was present on every website analyzed”.  Someone, usually doctors or big pharma,  is covering up of the TRUTH they don’t want us to know (but is somehow widely available) about the sordid truth that vaccination production and promotion is being motivated by solely profit.

Those who speak out against vaccination were considered martyrs to the cause, such as Dr Andrew Wakefield.  I cannot wrap my head around the fact that after all the information that has been released about the conduct in his Lancet paper that people would resort to insisting that the man is out to get him rather than the fact that his study was unethical and the data falsified.  I hate to risk invoking Godwins law, but I am reading the Fall of Berlin at the moment, and one of the many striking aspects of the madness of the Eastern front is how, as the Soviet’s were shelling Berlin and the Soviet troops were entering the city, there were still those who still thought and acted like a German victory was possible.  I have also seen patients who deny remarkable pathology and present with advanced cancer or AIDS. The ability for people to deny even the most compelling evidence is beyond my feeble intellect to comprehend.  I can only shake my head in wonder.

Religious ideology was the least represented reason against vaccination on the sites, although the morality of growing vaccines in aborted fetus or experimenting on children was mentioned, it was only mentioned in about a third of sites.

Not unsurprisingly, misinformation and falsehoods were found on every site.  ”88% made claims unsupported by evidence” and personal testimonials of the harm alleged to caused by vaccines were also common.

Only the Wikipedia was free of taint.

“The open nature (of the Wikipedia) appears to have acted as form of peer-review, keeping the page current, unbiased and properly referenced. There appears to be no self-criticism within the anti-vaccination community; this was demonstrated by most of the analyzed website.”

Free and open debate is least practiced by those who rage against the oppression of the man.  That should have been an Alanis lyric; she would have had less criticism for a lack of understanding of ironic.  Again the pattern: a disinterest in facts as well as no interest in having factual errors corrected.  The attitude evidently being ‘if I want your opinion, I’ll give it to you.’

Interestingly,  25% identified themselves as non-partisan, non-profit or a public education group, giving the impression impartiality, but  all linked to other anti-vaccination sites while only half linked to pro-vaccination sites.

If you spend time in the anti-vaccination world, or alt-med world, none of the above will come as any surprise.  To my mind what was an interesting conclusion of the author.

“A proponent of vaccination would likely wish to counter with “correct” information; indeed, the most commonly proposed intervention to combat vaccine misinformation is education…With acknowledging falsehoods is important, the assumptions behind educational methods must be examined.  Assuming additional information will influence vaccination decisions reduces the issue to one in which the two sides are separated only by a gap in information.”

She further points out that educational attempts only anger those who are corrected (AoA anyone?) and that historically education has not altered the opinion of those who have been against vaccination, whose essential messages have changed little since the 18th century, despite the massive increase in biomedical information to correct vaccine misinformation.

It is not the facts that inform the rejection of vaccines (or, more broadly, modern medicine) but “belief in alternative models of health, promotion of parental authority and responsibility and  suspicions of expertise.”

It is not the facts that guide opinion, but opinion that determines the facts.  She uses the relationship opinion = evidence + values, and as the former approaches zero, the latter predominates.

She also points out how the trend in medicine to patient autonomy and informed choice has had the inadvertent effect of medical consumers extending that autonomy to public health issues and rejecting the premise of vaccines for the overall societal good, noting that “parents may reject epidemiological and population-level risk arguments for vaccinations, for such statistics do not take into account specific experiences, ideologies, and health histories.”

It is both the triumph of medicine that so much benefit can be gained by ignoring specific experiences, ideologies, and health histories, and is medicines current bane.  I know that the data suggests the more we treat all patients the same, the better the outcomes, but no one wants to be another cog in the medical industrial complex.

I am motivated by the facts, and have a trust in the long term validity of the results of medical research.  Ideas wax and wane, but most people in the field are doing good work and are not  dishonest.  They are good people trying to do good work.  Dr. Wakefield is an aberration.   However, to the anti-vaccination crowd, not only is Dr. Wakefield a source of truth, the rest of the results of biomedical research are suspect.  It is the post-modern questioning of the legitimacy of authority and science,   and neither is valued nor trusted. In my world, both are valued and trusted.

So where does that leave science based medicine?  I am not certain.  I value facts, medical and scientific authority, always with the understanding of its somewhat fluid nature.  The ‘other side’ does not value facts or the weight of expert opinion, especially when it contradicts their opinion.   Those who promote anti-vaccination or homeopathy or the numerous non-reality based therapies live in a different world than I, and we do not share a common common view.

What is the proper dialog or is such a dialog even possible?  I suppose the best I can do is plant a seed of doubt here or serve as a source of information for someone who is not committed to the ideas of scams. Maybe Fordor’s needs to have a new guide.

My previous posts have described guest lecturers at my medical school campus, invited by a student interest group in CAM. Those events continue; currently ongoing is an 8-weekend certification course in Ayurveda for the subsidized cost of $1500 (includes “tuition, syllabus, and personal guru”). I could pick on this student group, but what’s the point? There will always be medical students who organize to promote ideas that you or I disagree with, whether it be political, religious, or personal. The fact that Tim Kreider disagrees with a particular student group is not terribly interesting.

The more important issue is how CAM is treated by faculty in the curriculum. Particularly during the preclinical years, medical students are in the habit of transcribing and commiting to memory everything uttered by the professors who grade them. A lack of rigorous skepticism is frankly necessary given how much information we are required to master. Where would CAM fit in among the lectures on anatomy, physiology, and pathology?

This post describes a lecture to the first-year medical students given by a respected faculty member and high-ranking administrator at my university, whom I will call Dr. P. This lecture was a mandatory part of the core curriculum. Dr. P comes across as an intelligent, reasonable, sincere, caring, and competent physician. It just so happens that he reaches some very different conclusions on questions of CAM than do I and my role models on this blog, and these conclusions have led him to become director of CAM programs at my university and a major player in the integrative medicine movement nationally. This post and my next will attempt to summarize how Dr. P presents his message when he has an entire medical school class for an audience.

[A note on my anonymization of Dr. P: my goal in writing for SBM has never been to bring bad publicity to my medical school, which is a terrific institution in most ways that matter to me. Identifying Dr. P would make my university affiliation obvious. I write not to call out a particular professor or program or university but rather to illustrate from a student's perspective a situation that may be increasingly common at US medical schools. Feel free to criticize my decision to keep him anonymous for now, but please honor it by not naming him in the comments, if you know his identity.] 

Dr. P stressed throughout his lecture that he is not trying to advocate specifically for CAM use. In fact, he dislikes the label “alternative” because it implies abandoning “conventional” medicine. Instead he is promoting “integrative medicine” (IM), which he described as “the practice of medicine that reaffirms the importance of relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals, and disciplines to achieve optimal health.” (quoted by him from a consortium of IM programs) This definition by itself sounds eminently reasonable and completely consistent with everything we are taught about compassionate, professional, evidence-based practice. Indeed, after presenting this definition Dr. P said, “it isn’t different from what we do in conventional medicine.” So why do we need IM at all? Do we need a new label and concept for something we agree is already our goal? Dr. P insisted that IM is not simply a re-branding of CAM, as he knows we skeptics suspect, but rather a more open-minded and inclusive approach to care that may or may not involve particular aspects of CAM. My concern with IM, as I will describe, is that Dr. P and I seem to have different thresholds for what kind of evidence is compelling in determining an appropriate therapeutic approach. All the changes in labeling seem to me, in my most cynical moments, to be little more than a savvy marketing strategy.

Part of IM is attention to spirituality, by which Dr. P means not religion but rather values and sources of meaning. Dr. P shared with his audience that he derives personal meaning, for example, from his family and children, and he described how he engages his patients in discussions about what is important to them. Such talks, he told us, can be particularly helpful in establishing a therapeutic relationship and plan in the face of chronic or life-threatening disease. Dr. P spoke eloquently and compellingly here, and these segments of his presentation could easily fit into separate sessions on these topics that we have throughout med school. But what, I wonder, does this have to do with CAM, and why do we need IM in order to promote such discussions? This common conflation of CAM with humanism contributes to my suspicion that physicians who embrace CAM do so not because they reject science—Dr. P is a smart guy who understands statistics and methodology—but rather out of objection to the business aspect of medicine or to problems with its delivery in our current system.

Another confounder, in my opinion, is preventive care. Dr. P is a practicing internist, but both his graduate training and his academic appointments also involve preventive medicine. Part of the appeal of his message about IM is how it is wrapped up in a concern for improving disease prevention and health maintenance in primary care. I agree that this concern is a laudable goal and hopefully an uncontroversial one. What frustrated me was how Dr. P explicitly condemned “conventional medicine” for ignoring preventive care, even to the point of saying that most docs “just talk” about prevention rather than really do it! (I was stunned by this casual dismissal, particularly given that our school has faculty who actively combat lead poisoning, vitamin D deficiency, and low vaccination rates in our community, just to name a few initiatives.) Although it may be that such sentiments on crank websites reflect theoretical disputes over “true cause” of disease, I suspect that the issue for most IM-sympathetic physicians is rather the practical constraints and financial incentives that restrict physician-patient interactions. I am happy to discuss ways that physicians could more effectively promote good nutrition, exercise, and stress management. Can’t these system problems be addressed without using language about “alternative” approaches that opens the door to implausible therapies?

Dr. P introduced CAM using the NCCAM categories: alternative whole medical systems (naturopathy, Ayurveda, TCM); biologically based practices (herbs, supplements); energy therapies (Reiki, Qi Gong, TT); manipulative and body-based practices (chiropractic, massage therapy); and mind-body medicine (Yoga, meditation). His language while describing these categories was most instructive, as he refrained from making specific claims that I might offer for evaluation. He described energy therapies and alternative systems as the categories most “foreign” to our “Western” approach, whereas I would say they represent pre-modern, magical thinking that limits their value. He made the important distinction between modern DO physicians (like MDs) and osteopathic manipulation (like chiropractic), and I noticed at that point that he almost said “allopathic” before correcting himself with “conventional.” (Another deliberate marketing strategy, perhaps?) He warned us about the challenges of quality assurance and unsupported claims that plague the unregulated supplement market, though he seemed more optimistic than I about finding diamonds in that rough. He said that mind-body techniques are the “most integrated” of the CAM modalities, meaning most supported by evidence, and he seemed more impressed by their effects on psychological stress and wellbeing than purported physiological effects. The impression he gave while discussing these general types of CAM was not of an ideological booster but rather of an open-minded investigator, whose only fault might be too much hesitance to conclude that a CAM modality is worthless. He comfortably points out weaknesses and challenges while remaining enthusiastic overall.

Following the categories, Dr. P showed a few photographs of examples of CAM. He reminded us that his goal was not to teach or encourage CAM but rather to make us aware so that we can respond appropriately to patients. Photo and description of acupuncture, of course. At a photo of a child’s back covered in horrible bruises he told us that if we didn’t know about the alternative practices of “cupping” (e.g.) and “coining” (e.g.) we might mistake such marks for child abuse… Again, my interpretation differs: although I agree that knowledge about culturally-specific practices is helpful for interventions, I might argue that injuries without benefit are indeed a form of abuse, no matter how well-intentioned.

Dr. P made one of several valiant attempts at audience participation by soliciting any family or folk remedies that we had encountered at home. Crickets chirped as students kept quiet in front of 180 peers. One brave soul volunteered that his mother swears by Airborne, which got no reaction from Dr. P. (I suspect he was hoping for a remedy not quite so laughable.) Dr. P suggested as an example the common use of prunes for constipation and pointed out that we are unlikely to see anyone fund a randomized, controlled trial (RCT) for that indication. Fair enough. Failing RCT evidence, continued Dr. P, we need to look for other supporting evidence. As an example of such non-RCT evidence, he showed the abstract from a 2000 Chest publication describing an inhibitory effect of chicken soup extract on neutrophil chemotaxis in vitro, as support for grandma’s home flu remedy. While this “chicken soup for the cell” (my snarky phrase, not his) is amusing and perhaps intriguing, I cannot fathom how this level of evidence meaningfully influences clinical decision making, beyond being an excuse to give advice that we might give anyway. While the goal of this presentation was explicitly not to detail the evidential support for any particular CAM, I was disappointed that such a lame example was given. Even if I buy it, though, how does the efficacy of chicken soup for a cold have any relevance to homeopathy? Here is a danger of accepting a garbage pail category like CAM as a coherent discipline, in my opinion.

What followed next was an extended appeal to popularity, not necessarily to claim that CAM is useful per se or that we should embrace it in our practice, but at least to convince us to take it seriously as something our patients may use or want. Dr. P cited the 1993 NEJM survey that reported CAM use by 34% of Americans (see Dr. Crislip on this oft-cited report). Discussing the results of this and later surveys, Dr. P suggested that changes in relative rankings of modalities reflected rational responses to evolving evidence, specifically a fall in the popularity of Echinacea and spinal manipulation for head colds following negative RCT evidence. He showed a New York Times article describing how alternative medicine is popping up in US hospitals, though to my reading the article paints hospitals more as selling out and cashing in than as thoughtfully adopting newly proven practices. For the second time, Dr. P mentioned the consortium of 40+ medical schools with IM programs (including Harvard, you know). He noted 2006 Resolution #306 of the American Medical Association, which recommended promotion of physician awareness of the “benefits, risks, and evidence for efficacy or lack thereof” of CAM (see the students’ initial proposal and then search for the watered down amended version here), as well as practice guidelines for addressing CAM use in lung cancer patients prepared by American College of Chest Physicians.

Dr. P seemed to be familiar with common objections to his support for CAM, and he tried to deflect them by telling us how difficult it is to rely only on solid RCT evidence in practice. He readily admitted that much CAM research has methodological flaws, and he explained that many CAM therapies are too individualized for conventional study methods. Dr. P pointed out that only 20-30% of conventional medicine is based on RCTs, anyway. Although we are “focused on evidence” at this stage in our training, he said, later on we’ll see that physicians have to do the best they can with limited available evidence. I commented in my notes at this point that some of his reflections on the limitations of EBM seemed similar to what I read on SBM… though given the different verdicts reached on CAM, it seems that IM and SBM fall back on different sources of evidence when the RCTs are inconclusive!

Dr. P’s message to us was to be open and non-judgmental to patients who use CAM, which of course is appropriate. He did not counsel us to practice any CAM that we do not first specifically obtain training in, but rather to consider referring patients to qualified CAM providers when necessary. He described doing literature searches to answer patient questions, such as whether acupuncture might help with in vitro fertilization. I am sure that Dr. P is a great physician to have if you are a patient who wants CAM; so long as your desired CAM is not harmful and does not replace proven, needed care, he is willing to work with you. While that attitude may be valuable in a particular context (keep the patient happy in order to ensure she gets “conventional” care along with the CAM), I find myself wishing that Dr. P would admit that some of CAM is frankly nonsense and that not every proposed CAM indication deserves research. At least to us, if not to the patient in his office.

This talked was billed as a general introduction to CAM and IM, given in order to help us be more receptive to patients’ beliefs and practices. The details of or evidence for specific CAM modalities were not discussed, rather the field was painted with a broad brush as probably harmless and sometimes effective and increasingly evidence-based and, by the way, very popular. The presentation also conflated CAM use with compassionate and preventive care; if this is a deliberate tactic to win acceptance, it is a savvy one. The talk seemed like it would be quite attractive, or at least not at all objectionable, to a shruggie. I could not help but notice, however, that although Dr. P did not dwell on the more outlandish CAM modalities (homeopathy, Reiki), he also refrained from saying anything critical of them. He was very careful and seemed quite reasonable, making it difficult for me to offer specific criticisms despite leaving the lecture with a sense that he and I would disagree on much.

My next post will cover Dr. P’s lecture to second-year medical students on CAM, ethics, and the law. That lecture offered a little more insight than this one in how Dr. P thinks differently than some of us do on questions of CAM usefulness.

A question that arises often when discussing the optimal role of science in medicine is the precise role of plausibility, or prior probability. This is, in fact, the central concept that separates (for practical if not philosophical reasons) science-based medicine (SBM) from evidence-based medicine (EBM).

The concept featured prominently in the debate between myself and Dr. Katz at the recent Yale symposium that Kimball Atwood recently discussed. Dr. Katz’s treatment of the topic was fairly typical of CAM proponents, and consisted of a number of straw man derived from a false dichotomy, which I will describe in detail below.

I also recently received (I think by coincidence) the following question from an interested SBM reader:

What would Science Based Medicine do if H. pylori was not known, but a study showed that antibiotics given to patients with stomach ulcers eliminated symptoms? I assume that SBM wouldn’t dismiss it outright saying that it couldn’t possibly be helping because antibiotics don’t reduce stomach acid. I assume a SBM approach would do further studies trying to discover why antibiotics work. But, in the meantime, would a SBM practitioner refuse to give antibiotics to patients because he doesn’t have a scientific explanation as to why it works?

This is the exact type of scenario raised by David Katz during our discussion. He claimed that strict adherence to the principles of SBM would deprive patients of effective treatments, simply because we did not understand how they work. This is a pernicious straw man that significantly misconstrues the nature of plausibility and its relationship to the practice of medicine.

Plausibility

Plausibility is essentially an application of existing basic and clinical science to a new hypothesis, to give us an idea of how likely it is to be true. We are not starting from scratch with each new question – which would foolishly ignore over a century of hard-won biological and medical knowledge. Considering plausibility helps us to interpret the clinical literature, and also to establish research priorities. But plausibility is not the ultimate arbiter of clinical truth – it must be put into context with clinical evidence, just as clinical evidence must be put into the context of scientific plausibility.

One common mistake when considering plausibility is to reduce it to a false dichotomy – a claim is either plausible (which is falsely equated to scientists understanding its precise mechanism of action), or implausible (which is falsely equated to not knowing the mechanism of action). Rather, at least three broad categories need to be considered with regard to plausibility.

The first category are those treatments with a known mechanism or mechanisms of action that should, according to our existing models, produce a certain clinical effect. For example, we know that beta blockers bind and inhibit beta receptors in the heart and on blood vessels and thereby reduce cardiac output and dilate arteries which lowers blood pressure. It is therefore very plausible that beta blockers would have a protective effect against syndromes that result in an excess of catecholamine (adrenalin) production, since catecholamines bind and activate beta receptors.

We may also add to this category treatments for which there is anecdotal or preliminary evidence for efficacy – clinical plausibility.

There is still a range of plausibility within this category, but in such cases there is at least some reason to think that a treatment should work. The core principle of EBM, however, is that even in such situations we still need clinical studies looking at net health effects to show that plausible treatments are safe and effective – plausibility is not enough.

The next broad category is not implausible, but neutral or unknown with respect to plausibility. For such treatments we have no particular reason to think that they should work, but no reason to suspect that they do not or cannot work either. This category would include any pharmacological substance with an unknown mechanism of action, or mechanisms that are not known to interact with the disease or symptom being treated. There is no reason to think that beta blockers would improve memory in dementia, but this is not inherently implausible. Beta blockers are drugs, and may have other effects that have not yet been discovered.

This category applies to the question above – if we had reliable clinical data that showed antibiotics worked for ulcers, even though we had no idea how, we would still accept and even use this treatment (assuming the clinical data was sufficient). This of course would then lead to further investigation – is the beneficial effect due to a pharmacological property of the antibiotic not related to its antibiotic effects, or are some ulcers perhaps caused by or exacerbated by a bacterial infection.

Dr. Katz argued that SBM eliminates the possibility of serendipity – discovering new treatments by accident through clinical observations. But this is simply not true (one of his straw men) – SBM considers all the evidence, clinical and basic science. If clinical evidence is solid, that is enough, and often in the history of medicine lead to discoveries about mechanism and biology.

The arrow of research can go both ways – understanding plausibility can lead to new treatments, but discovering new treatments can lead to discoveries about biology and mechanism. The two play off each other.

But there is a third category in the plausibility spectrum – treatments that are inherently implausible. These are treatments that not only lack a known mechanism of action, they violate basic laws of science. Homeopathy violates the law of mass action (a basic principle of chemistry), the laws of thermodynamics (extreme dilutions maintaining the chemical “memory” of other substances), and all of our notions of bioavailability and pharmacokinetics.

Homeopaths therefore substitute any notion of chemical activity with a vague claim about “energy” – but this just puts homeopathy in the category of energy medicine, which is just as implausible. Invoking an unknown fundamental energy of the universe is not a trivial assumption. Centuries of study have failed to discover such an energy, and our models of biology and physiology have made such notions unnecessary, resulting in the discarding of “life energy” as a scientific idea over a century ago.

Essentially any claim that is the functional equivalent to saying “it’s magic” and would, by necessity, require the rewriting not only of our medical texts, but physics, chemistry, and biology, can reasonably be considered, not just unknown, but implausible.

Dr. Katz and others would like us to believe that this category does not exist, based upon the premise that we do no yet understand enough science to make such judgments. They often invoke vague references to quantum mechanics or the counter-intuitive nature of subatomic physics or cosmology to make their point. But this is an anti-intellectual and unscientific approach – it denies existing knowledge.

The alternative (often another false dichotomy and straw man) is not that we know everything – no one claims that. But not knowing everything is not the functional equivalent of knowing nothing. We do know stuff, and it is folly to deny the accumulated knowledge of the last few centuries of organized science.

Having said that – even the most implausible claim can still prove itself with sufficient clinical evidence. If homeopathy actually worked, it could be demonstrated through repeated rigorous clinical studies (something which has never happened). Admittedly, the bar for such evidence would be as high as the prior implausibility of the claim – which is very high – but if it really worked, that bar of evidence should theoretically be reachable. In that very hypothetical situation, the results would be extremely intriguing – clearly there would be something fundamental missing from our understanding of the relevant areas of science – a situation that often results in Nobel prizes.

Conclusion

SBM is ultimately about achieving the optimal relationship between science and the practice of medicine. SBM requires considering all the science, in its proper context, and does not follow any simplistic algorithm as is often suggested by critics. We look at what is known and what is unknown, at basic science and clinical evidence, and we put it all together, making an individual judgment for each individual claim.

We also are students of history – what claims have prospered or failed in the past, and what patterns predict ultimate success or failure? One pattern that should be obvious is that of highly implausible claims (not merely unknown) that can only produce weak and preliminary evidence, where more rigorous evidence tends to be negative, and positive evidence cannot be replicated, followed by special pleading by proponents. That is the pattern of a treatment that does not work.

We have seen this pattern with treatments that are now not controversial in their failure – phrenology, radioactive tonics, animal magnetism, and Abram’s dynomyzer (turned out to be a black box with loose non-functioning parts). We see the same pattern with homeopathy, therapeutic touch, energy medicine, and acupuncture.

We also see the same pattern for highly implausible (what some would consider pathological) fringe sciences outside of medicine – ESP research, ghost hunting, free energy, and cryptozoology, for example. There are also non-controversial historical examples, such as N-rays.

Of course, those who have not learned the lessons of history are doomed to repeat it.

The Main Event: Novella vs. Katz

The remainder of the Symposium comprised two panels. The first was what I had come to see: a Moderated Discussion on Evidence and Plausibility in the Context of CAM Research and Clinical Practice, featuring our Founder, Steve Novella, who is also Assistant Professor of Neurology at Yale; and David Katz, the other speaker who had borne the brunt of the criticism after the 2008 conference (as I wrote in Part I). According to the Symposium syllabus, he is:

David L. Katz, MD, MPH, FACPM, FACP, an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. Katz is the Director and founder (1998) of Yale University’s Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, CT; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. He currently serves as Chair of the Connecticut Chapter of the Partnership to Fight Chronic Disease and represents Yale University on the Steering Committee of the Consortium of Academic Health Centers for Integrative Medicine.

The syllabus had excerpted that statement from a much larger, remarkable document, which I urge you to review.

I will attempt to report the Moderated Discussion as neutrally as possible, as though I were a disinterested journalist (don’t worry: later I’ll rail).

The session began with 10-minute remarks by each of the two panelists. Each was then asked to respond to a few scripted questions posed by the moderator, Dr. Barry Boyd (whose earlier talk I discussed in Part I). The panelists were aware of the questions beforehand.

Dr. Novella went first. He began by suggesting that everyone in the room shares a common ground: wanting to do what’s best for patients, and in particular wanting to offer them things that work. He proceeded to summarize what he means by “science-based medicine.” My notes are scant and illegible, but I’ll try to re-create the points. Steve can fill in any glaring omissions later.

Science-based medicine, said Dr. Novella, is not a list of treatments, procedures, specialties, drugs, diseases, or whatever; rather, it is a methodology. It seeks the best diagnostic and therapeutic options wherever it may find them; it is, like science in general, always open to new directions and willing to scrap existing ones, if the evidence so leads. It is based in the natural sciences, especially biology, but it also applies scientific methods to practical aspects of clinical medicine, such as testing diagnostic and therapeutic hypotheses. It assumes “consilience”: like science itself, it is not “Eastern” or “Western,” but universal.

Science-based medicine doesn’t “cherry-pick”: it starts with a problem and follows the evidence toward or away from potential solutions; it does not first pick a solution and then assemble whatever evidence there may be to support it. It acknowledges numerous sources of bias and error, from our flawed brains to small studies and studies sponsored by advocates (Steve cited drug companies). It recognizes the necessity to consider the “meta-evidence” (I think that was Steve’s term), meaning evidence gleaned from the entire range of potential sources: basic science to clinical trials to clinical realities.

Dr. Katz followed. He began by observing that it isn’t very often that he begins a debate by agreeing with the other debater. This yielded a smattering of appreciative chuckles.  He continued with a series of “bullets,” and once again I’m afraid I don’t have them all in my notes, but here’s my attempt, followed by most of the points that Dr. Katz made in his opening remarks:

• “Plausibility and Pandora”
• “Tail wags Dog”
• (illegible), Serendipity
• Absolute Relationship
• Scylla and Charybdis

Dr. Katz mentioned that according to astrophysicists (or perhaps one in particular that he had read or heard speak), there is more empty space between the elementary particles in each of our bodies than exists in the entire universe. He doesn’t understand it himself, but assuming it is true he wonders, for example, how others can so easily dismiss Therapeutic Touch merely because it isn’t really touch, since what we think of as touch isn’t really touch, either.

He listed a few innovations in the recent history of medicine that were “heresy” when first proposed, suggesting that if plausibility had ruled the day they would never have emerged:

1. H. pylori shown to be the cause of peptic ulcers;
2. Beta-blockers beneficial even for patients prone to congestive heart failure;
3. Rocky Mountain spotted fever established as caused by a bacterium.
4. (Later he mentioned the right heart catheter as an example of something that everyone thought was safe and effective, until a study showed that it wasn’t; but even then it took a long time for MDs to finally stop using it)

He mentioned that the monoamine oxidase inhibitor (MAOI) class of antidepressants had been discovered serendipitously when TB patients taking isoniazid (INH), a related drug, didn’t seem so depressed.

He said, “relative absence of evidence is not absolute evidence of absence.”

Evoking Scylla and Charybdis, he invited the audience to consider this choice: that something “works whether or not it’s plausible”; or that something is “implausible whether or not it works.”

He offered the metaphor of a solid floor and a moving ceiling to represent proven and unproven treatments, and noted that if we insist on using only proven treatments, we will soon get squeezed (he didn’t say it exactly that way, but I think you get the point).

The two participants then sat down and the moderator asked the questions. I can remember only one, but I remember most of the discussion. A large part of it involved how to deal with patients who are suffering, but for whom scientific medicine has no clear solution. Dr. Novella argued that he would never abandon such a patient, and that there are ways to be compassionate and caring without offering implausible treatments. He has also discussed similar points here on SBM. When asked what he would do if a patient asked his opinion about a particular method, he replied that he would be honest. He said that according to surveys, only a small fraction of those who seek “CAM” do so because of having exhausted all “conventional” options. Most do it for other reasons, having more to do with their beliefs.

I must admit that I can’t remember exactly how Dr. Katz responded to that point and to Dr. Novella’s opinions, but it presumably had to do with his floor/ceiling metaphor; his views on the same general topic are available elsewhere.

The scripted question that I distinctly remember went something like this: “what would you do if your hospital decided, in response to a perceived demand in its community, to establish a Therapeutic Touch program?”

Dr. Novella replied that he would oppose it on the grounds that hospitals have made an implicit commitment to offer science-based treatments, and Therapeutic Touch does not meet that standard.

Dr. Katz disagreed, suggesting that we don’t really know that TT doesn’t work; there have been intriguing studies, he said, showing effects on cells in tissue culture that couldn’t possibly be explained by a placebo effect. He suggested that extreme skeptics believe that TT doesn’t work and can’t work, while extreme advocates are certain that it does, and thus the reasonable, moderate position—represented by himself, presumably—would seem to be somewhere in the middle. He made similar comments about homeopathy.

Dr. Katz said that if he were advising the hospital in question and certain physicians were adamantly opposed, he would suggest that the hospital offer Therapeutic Touch to patients but provide them with a disclaimer stating that those (named) physicians were opposed to it.

Dr. Novella, referring to Dr. Katz’s earlier point about the space between elementary particles justifying a tentative plausibility for TT, asserted that counter-intuitive concepts in quantum mechanics and cosmology do not apply to the macroscopic, everyday world of clinical medicine.

There was a brief exchange about plausibility and mechanism. After Dr. Katz asserted that we needn’t know the mechanism to conclude that something works, Dr. Novella replied that “knowing the mechanism” and plausibility are not equivalent.

Dr. Novella asked if “CAM” advocates would ever be willing to say that something doesn’t work; he noted that even among Cochrane Reviews one doesn’t find such conclusions for “CAM” methods. Dr. Katz said that he had concluded that one particular substance (I don’t remember what it was) doesn’t work, but he was not willing to say the same for many others, including homeopathy, TT, and Meyers’ Cocktail, although his own studies of homeopathy and Meyers’ cocktail had not shown benefit. He argued that his studies had been hampered by stipulations from the IRB that made them not applicable to typical use.

………

I’ve witnessed these sorts of debates before. The usual scenario is that the audience is heavily biased in favor of the pro-“CAM” stance, and the skeptic finds himself backpeddling from the outset. The pro-“CAM” participant need merely raise his eyebrows or utter a word such as “reductionistic” to get supportive laughter or applause, whereas the skeptic can barely open his mouth without being hissed and booed. That this did not happen at the Yale Symposium is a tribute to Steve Novella, who is better at being sympathetic to others’ heartfelt beliefs while maintaining his intellectual integrity than anyone I’ve seen in such a spot. It also reflects the civil tone of the meeting as a whole and of the tone presented by the moderator, Barry Boyd. I congratulate them all, even Dr. Katz—although I must admit to a secret suspicion that he was frustrated by not succeeding in making Steve Novella look like a curmudgeon. I could be wrong.

………

The final panel of the day consisted of Drs. Novella, Katz, and a few other Symposium faculty fielding questions from the audience. Most of the questions were directed to the two debaters, who reiterated several of the previous points. Other panelists spoke to an extent; Auguste Fortin, Associate Professor of Medicine and Director of Communication Skills Training for the Yale Primary Care Internal Medicine Residency Program, repeatedly referred to himself and his colleagues as “allopaths.”

Comment

A quick aside to Dr. Fortin: please, for the sake of your residents and of accurate communication skills in medicine, learn the basis for the term “allopath” and cease using it to refer to physicians. (Hint: look here). Modern medicine is “modern medicine.” We are “medical doctors.”

Regarding Dr. Katz’s assertions, particularly amusing to me was the one about H. pylori and plausibility. I usually find wanton self-promotion distasteful, but He Who Debunked the Marshall-and-Warren-as-Galileo Myth was sitting right there in the audience! The short story, for the benefit of John Millet and medical students in general, is that even if clinicians scoffed at the hypothesis when they first heard it, there was no discernible effect on its progress from bench to practice.

Practicing physicians and even academics tend to be conservative (with a small ‘c’) and risk-averse; this is a different issue from that of how scientific medicine as a whole deals with novel hypotheses. (Josephine Briggs also failed to appreciate the distinction when she offered her list of “quirky ideas from outside the mainstream,” reported in Part I). The notion that bacteria might cause an inflammatory lesion was entirely plausible, of course, and even if some physicians were surprised to learn that bacteria can adapt to an acidic environment, bacteriologists were not.

The H. pylori hypothesis became intriguing at the moment that Marshall and Warren reported having successfully cultured the organism. It was rapidly investigated all over the world, and within a few years the old etiologic “paradigm”—ironically, a rather implausible mind-body hypothesis involving stress—was no more. The story of H. pylori is a great triumph of science-based medicine, not a reason to dismiss plausibility arguments.

After the conference I approached Dr. Katz and suggested that the time it took for H. pylori to be accepted as the cause of peptic ulcer disease was entirely reasonable. He replied, “reasonable for whom? What about patients?” I’d meant, of course, “reasonable according to how long it takes to do the work,” which I told him, adding, “so what do you mean about patients? That we should have started treating them with antibiotics before…?” I didn’t finish the obvious question, but what would we have been treating? Marshall and Warren had no idea what the organism was when they first saw it.

In talking with Katz I quickly realized that he is surprisingly naïve for someone who holds himself out as an expert in “integrative medicine.” It hadn’t occurred to him that Therapeutic Touch (like all versions of “energy medicine”) is a form of psychokinesis (PK), nor did he know that PK has been studied for well over 100 years without having yielded any reproducible evidence for its existence. (The notion that it is a recent hypothesis deserving the attention of medical academia is a ruse). In an attempt to offer another example of strange powers that are beyond our understanding, he stumbled when he reported that during his recent vacation, a “mentalist” in a restaurant had come right up to him and effortlessly bent the tines of his fork with merely two fingers of one hand, a task that Katz himself could barely accomplish with both hands. He exclaimed, “I don’t know how he did it, but I know he did it!” I replied, “but you know that it was a trick, don’t you?”

There is no shame in being fooled by a good conjurer—most people are—unless the very field in which you claim expertise requires that you know about such things. Spoon bending (or, in this case, fork bending), is claimed by some of its more illustrious practitioners to be a form of PK. There is a pattern here: Dr. Katz’s counterpart at Harvard, Dr. David Eisenberg, is also innocent of such matters. He is also the co-author of language quoted in Part I of this report, praising chiropractors for “never failing to find a problem.”

Dr. Katz betrayed a naïveté about clinical trials, in spite of his professed expertise in that realm. When Dr. Novella and I asked what he thought the aggregate results of several trials of an ineffective but passionately advocated method are likely to be, he replied that they would certainly hover around the null. We would all like this to be true, but it isn’t. Clinical trials are not physics experiments. Even RCTs are fraught with opportunities for error and bias.

Experience shows that the typical history of clinical research for a “CAM” method is this: early trials, usually small, poorly designed, and performed by advocates, tend to be “positive”; later ones that are larger and better trend toward the null, but it can take years and many trials before it becomes clear that this is their fate—if it happens at all. There will inevitably be sporadic “positive” studies that are trumpeted by advocates, even if they can’t be replicated. The study that Dr. Katz mentioned at the Symposium, purporting to demonstrate Therapeutic Touch exerting an effect on cells in culture, is a perfect example.

It may be formally true that one can’t “prove a negative,” but this is no reason to take seriously every crackpot notion that comes along. To position oneself as “middle of the road” or “balanced” regarding a claim such as homeopathy or Therapeutic Touch is misleading and unscientific. It is the equivalent of asserting the same for long-settled questions such as whether the earth is planar or spheroid, whether or not perpetual motion machines can work, and so on. It is akin to a call to “teach the controversy” of evolution vs. “creation science.”

In the meantime, implausible “CAM” methods continue to be held out as “promising” or at the least not disproven, and more trials are invariably called for—no matter that in many cases existing knowledge is sufficient to refute the hypothesis. This has been the trajectory of research in homeopathy, acupuncture, ‘distant healing,’ the ‘supplements’ discussed by Dr. Briggs at the Symposium, and other “CAM” proposals. (Natural products are not highly implausible, of course, but for a number of reasons are usually moderately implausible). In acupuncture and homeopathy research, such futility has continued for decades. The same is true for the entire field of parapsychology (the investigation of paranormal claims such as PK, ESP, etc.), in spite of highly sophisticated experimental designs over the past 30-40 years—more sophisticated than would be possible for most “CAM” trials.

As several have argued, parapsychology research is an example of pathological science. I suspect that this is the inevitable result of performing trials of any highly implausible claim that has passionate adherents, and that much of “CAM” research is doomed to repeat this history. Just as paranormal claims are an important subset of “CAM,” parapsychology research is an important historical precursor of “CAM” research—even if most medical academics, including those who identify with “integrative medicine,” are unaware of it.

I’ve sparred with Dr. Katz in the past, in print, addressing some of the other points that he made at this Symposium:

• Dr. Katz here; my reply (to his and a ton of other indignant letters) here (included are responses to his right heart catheter argument, a discussion of “mechanism” as it applies to plausibility, a rebuttal to post-modern language devices, and more).
• Dr. Katz’s response to his critics following the 1^st Yale Symposium here; my take on his response: here and here (including comments on the false dichotomy of proven methods vs. “CAM”; his hyping of homeopathy, TT, craniosacral therapy, Myers’ Cocktail, and other bogus treatments; his and others’ casual flouting of well-established medical ethics)

Conclusion

Most of the content of the 2^nd Yale Research Symposium on Complementary and Integrative Medicine, Dr. Katz’s comments being a notable exception, was not “complementary” or “integrative,” but simply medicine. What proponents mean by the term “integrative medicine” seems to vary according to political expediency. To onlookers it is not substantially different from the “holistic medicine” of 30 years ago, described by philosophers Clark Glymour and Douglas Stalker:

Is there another, holistic, conception of medicine distinct from [modern medicine]? Certainly, many people seem to think so…Popular bookstores are filled with works on “holistic medicine,” many edited by medical doctors…[or]…authored by professors at distinguished medal schools… The therapies described and recommended in a typical book of the genre include biofeedback, hypnosis, psychic healing, chiropractic, tai chi, iridology, homeopathy, acupuncture, clairvoyant diagnosis, human auras, and Rolfing…

What ties together [these] diverse practices…? In part, a banal rhetoric about the physician as consoler… In part, familiar and rather useless admonitions about not overlooking the abundance of circumstances that may contribute to one condition or another. Such banalities are often true and no doubt sometimes ignored, with disastrous consequences, but they scarcely amount to a distinctive conception of medicine. Holist therapies can be divided into those that are adaptations of traditional medical practices in other societies—Chinese, Navajo, and so forth—and those that were invented, so to speak, the week before last by some relatively successful crank…

The recent success of the “Integrative Medicine” (IM) movement at medical schools is a curious turn of history. Enthusiasts portray it as “patient-centered,” “healing-oriented,” “preventive health” and more, but the only part of it that can honestly be held out as distinct from modern medicine is a collection of practices that don’t withstand either scientific or ethical scrutiny. To claim otherwise distorts the history of medicine and of what the practice of modern medicine involves. It misrepresents the relation between science and medicine and the extent to which the tools of Evidence-Based Medicine can be brought to bear on highly questionable claims. It distracts from the usefulness of physicians learning a wide range of critical thinking skills. Such skills might be applicable, for example, to evaluating strange powers such as PK and fork-bending, or to the ethics of studying “Lyme-Literate” practitioners. Perhaps most importantly, it constitutes a radical departure from firmly established medical ethics.

Fundamental to the movement is euphemism: accurate terms are replaced by those that seek to reassure and soothe. This obscures, rather than elucidates the phenomenon. It facilitates bait-and-switch ruses both for individual practices and for “CAM” or IM as a whole. One of our fellow bloggers, a Stanford oncologist who has been a student of such matters since the peak years of the Laetrile fraud, wrote a depressingly accurate satire explaining how medical schools have been duped by what amounts to a clever PR campaign. Language distortions have literally changed the standards of care in medicine, and not for the better. The term “integrative medicine” is now central to that change.

Medical students have not been told these things by “integrative medicine” mentors, who themselves are largely innocent of them—just as they tend to be naïve about many of the practices that they find so intriguing, as documented in the two parts of this report.

I hope that this report provides some small impetus for John Millet and other IM enthusiasts at Yale and elsewhere to re-evaluate their thoughts. They are, almost without exception I’m sure, smart, committed, enthusiastic, caring young people who are trying to become the best that they can be in medicine. I certainly developed that opinion of John in the short time that I spoke with him and observed him. He reminded me, in fact, of our very own Tim Kreider. I hope that this report will suggest to John and others that there is more to an honest, comprehensive, and ethical evaluation of IM than its proponents acknowledge.

In addition to this report and the links from it, here is a short template for how medical schools might begin to teach “CAM” in an honest, rigorous way (scroll down to “ ‘CAM’ for Medical Students”). I’m slightly embarrassed to say that we at SBM have been talking for a couple of years about creating a more comprehensive set of materials just for that purpose, perhaps to occupy its own website, but we’ve not yet done it.

For John and other Yalies, of course, there is a much better resource: Dr. Steve Novella himself, who is without a doubt the most knowledgeable skeptic under the age of 80 that I’ve ever met. I’m not kidding, Yale medical students: this guy is the real deal, and you don’t want to miss your brief opportunity to learn from him.

Finally, I’m imagining that some who read this report will wonder whether it really matters: if medical students are learning real medicine anyway, so what? Who cares if a little woo sneaks through the doors of the White Coat Academy? Isn’t it better that IM is calling attention to some things (walnuts, nutrition, exercise, relaxation methods) that tend to be short-changed by medicine even if they shouldn’t be?

Uh, nupe. Those who are interested in walnuts and exercise and relaxation are to be encouraged, but should also be encouraged to repudiate “CAM” or IM precisely because of its pseudoscientific, unethical content. There are all sorts of hazards awaiting those who fail to understand this—we saw a small example in Part I, regarding “Lyme-Literate” practitioners prescribing colloidal silver. (If the Yale IRB is still watching, please scroll down Part I to the comment from ‘rosemary’). There are, of course, larger, almost unbelievable hazards emanating from the very pinnacles of “CAM” research: for starters, look here and here.

Afterword

The philosophers Glymour and Stalker were uncanny in their predictions, made more than 25 years ago:

If holistic-health advocates were content with encouraging sensible preventive medicine or with criticizing the economic organization of American medicine, we might be enthusiastic, but they are not. If the movement were without influence on American life, we would be indifferent, but it is not. Holistic medicine is a pablum of common sense and nonsense offered by cranks and quacks and failed pedants who share an attachment to magic and an animosity toward reason. Too many people seem willing to swallow the rhetoric—even too many medical doctors—and the results will not be benign. At times, physicians may find themselves in sympathy with the holistic movement, because some fragment of the rhetoric rings true, because of certain practices and attitudes they encounter in their daily work with colleagues and patients, or because of dissatisfaction with the economic and social organization of medicine. One hopes they will speak bluntly, but it does no good to join forces with cranks and quacks, magicians and madmen.

A not-benign result that even Glymour and Stalker may not have predicted is the epidemic of commercialism and self-promotion that would have been unthinkable only a few years ago. It is abundantly evident on Dr. Katz’s website and on “integrative medicine” websites elsewhere. If the mood of society has changed so much that this does not strike today’s medical students as profoundly unprofessional (as it would have struck us in the 1970s), I hope that at least they will consider the conflicting interests of practitioners whose patients presume will offer untainted advice. It is self-evident that we should strive to immunize ourselves, our patients, and our institutions against sales pressures from Big Pharm, no? Why should this, which by virtue of its infatuation with magical thinking is even more likely to lead us astray, be any different?

A few months ago, I wrote about a particularly nasty form of cancer quackery known as the “German New Medicine” or Die Germanische Neue Medizin in German. As you may recall, the German New Medicine is based on the nonsensical idea that cancer arises from an internal emotional conflict. This conflict then results in what is called the “Dirk Hamer Syndrome” (DHS) or “Dirk Hamer focus” in the brain, named after Dr. Ryke Geerd Hamer’s son Dirk, who was tragically shot in his sleep by Vittorio Emanuel, the last crown prince of Italy. After a prolonged course requiring multiple operations, Dirk succumbed to his wounds and died. Three years later, Dr. Hamer developed testicular cancer, and, in a perfect case of post hoc ergo propter hoc, Hamer decided that it was the psychic shock of his son’s death that had caused his cancer. Thus was born Die Germanische Neue Medizin, which, according to Hamer, promises a 95% or more chance of curing any cancer, no matter how advanced. Never mind that Hamer apparently underwent a combination of surgery and other “conventional therapies for his testicular cancer. Also never mind that these “Dirk Hamer Focus” to which Hamer pointed on CT scans of the brain appeared, more than anything else, to be artifacts of the imaging process and nothing real.

As I described in my previous post in October, the German New Medicine is a seriously dangerous form of cancer quackery that is not only worthless but in many cases blames the patient for having developed cancer, as evidenced in this video, where a proponent of German New Medicine gives as examples of psychic stress a “cancer blow” that comes from menopause, in which loss of estrogen supposedly leads women to feel that they “aren’t the woman they used to be” and that that conflict is manifest in the bone or an athlete’s anger because of an injury that screws up his ability to perform leading to an osteosarcoma of extremity.

Unfortunately, cancer quackery frequently evolves under the selective pressure of competition with other cancer quackeries and based on the unique environments in which various forms of quackery come to land. Since I first wrote my post about Die Germanische Neue Medizin, I’ve been meaning to address one of its offshoots. The particular offshoot that I plan to address is, in essence, the French cousin of Die Germanische Neue Medizin, and it’s called Biologie Totale, or Total Biology (Claude Sabbah’s official site is here, but it’s all in French). I first became aware of Biologie Totale about a year and a half ago through this news story:

A new therapy that claims to cure cancer and other diseases but has been blamed for dozens of deaths in Europe is gaining popularity in Canada, according to a Radio-Canada investigation.

“Total biology” is a therapeutic approach that claims illness is caused by psychological conflicts in the brain.

The approach, also known as new medicine or bio-psycho-genealogy, professes to heal all disease, including AIDS and advanced forms of cancer.

The method is gaining traction in Quebec where patients are often told to ignore their cancer, or stop medical treatment altogether, according to an investigation by CBC’s French-language service.

The similarity of Biologie Totale to German New Medicine should be apparent just from the description above, but Biologie Totale, while resembling German New Medicine, appears to be on the way to “speciating,” so to speak from its precursor, except that Dr. Claude Sabbah appears to have been able to do something that I thought impossible: To make German New Medicine even more ridiculous. It always cracks me up to see such a name, too: Total Biology. Not New Biology (like German New Medicine). Total Biology. Apparently Sabbah thinks that he’s discovered a way of understanding the complete and total biology of the human organism. It would be nice if he did, but he doesn’t, as is demonstrated here:

The Total Biology of Living Beings is a concept that was developed by Claude Sabbah, the fruit of over 35 years of experience. In addition to his medical training (as a specialist in oncology, emergency medicine, sports and hyperbaric medicine and psychotherapy), Claude Sabbah is a researcher, NLP practitioner and a teacher and speaker of world renown. Total Biology integrates the knowledge drawn from several areas of medical specialization, recognized scientific research and various observations on the plant, animal and human realms. The concept sheds light and understanding on the normal functioning of a living creature, how it becomes ill and how it is possible for it to regain health and well being.

NLP, by the way, is neurolinguistic programming, a form of psychotherapy based on the concept that success can be achieved by simply modeling the language, behavior, and thought patterns of successful people. This concept in and of itself sounds very seductive and even fairly reasonable on the surface, but, as our fearless leader Steve Novella pointed out three years ago, research has shown it to be wrong. Steve used the example of an episode of Spongebob Squarepants in which Spongebob’s friend Patrick, envious because Spongebob has won lots of awards and he hasn’t, decides to mimick Spongebob’s every move. As Steve put it, Patrick is an affable loafer, lazy and not too bright, and he is no smarter or any less lazy due to simply mimicking Spongebob’s behavior. However, one can see how someone enamored of NLP might find Hamer’s concepts in German New Medicine to be seductive. Not surprisingly, Dr. Sabbah cites his inspiration as being from Dr. Hamer. Then he, like so many purveyors of pseudoscience, claims to have taken Dr. Hamer’s woo and gone much further:

Claude Sabbah has applied these findings from 1985. Since then, with his years of medical practice, his own findings, with the cooperation with many other researchers and scientists… Claude Sabbah has set the concept of Total Biology which integrates: Dr Hamer’s New Medicine, Modern Western and Asian Medicine, Observation of the Biological Laws of the Fauna & Flora, Biological Cellular Memorized Cycles, NLP, the concept of the mini-Maxi Schizophrenia, Biogenealogy, personal researches, and many more…

Is there any quackery Dr. Sabbah hasn’t mined for his Biologie Totale? More importantly, what, exactly, do Dr. Sabbah and his acolytes spreading like a–if you’ll excuse me–cancer throughout Quebec and Canada tell their patients to do to try to fix the results of these “psychic traumas”? In 2008 Radio Canada journaists went undercover to find out. It isn’t pretty. In fact, it’s an unholy combination of seemingly faith healing and German New Medicine:

He [Sabbah] teaches his approach in six-day seminars offered in France and Canada. He tells students that cancer and other diseases are formed in the brain first, and must be deprogrammed.

During the investigation, Radio-Canada journalists went undercover with hidden cameras seeking medical advice about fictitious diseases.

One of the journalists claimed to have breast cancer. She visited several total biology practitioners who told her that her life was not in danger, and the lump in her breast was the result of a maternal conflict.

She was recommended to stop chemotherapy altogether. During another visit a practitioner told her to drink champagne and relax.

Another undercover journalist who claimed he had prostate cancer was told his ailment was caused by a conflict between his parents at the time of his conception.

He was given orders to recite a prayer 15 times a day.

A CBC television news report can be viewed here. Oddly enough, it notes that Claude Sabbah had suffered a stroke and was recovering, which was why he missed a seminar in Quebec that he had been scheduled to do. Apparently Totale Biologie didn’t save him from that. In any case, the story of the woman with breast cancer sounds very familiar, doesn’t it? Do you remember a woman named Michaela Jakubczyk-Eckert? She had breast cancer, and she listened to Dr. Hamer. She ended up dying a horrible, painful death. It’s a good thing it was just reporters pretending to have breast cancer this time, as any real woman with breast cancer who listened to this nonsense risks suffering the same fate.

It’s also pretty amazing that anyone could think a malignant tumor is the result of a “maternal conflict.” But, as mentioned above, it’s not just this life we have to worry about. According to this quackery, a psychological conflict at conception can result in cancer later in life. But it goes even further than that. Indeed, Biologie Totale is a cornucopia of woo that goes into the past before conception and continues to differentiate into different flavors of Hamer’s concepts. I hadn’t had any idea, but after looking into it I found that it’s somehow become attached to a form of pseudoscience known as Memorized Biological Cellular Cycles and Biodecoding. If you want to get a load of how far this quackery goes by expanding on German New Medicine, read and be amazed at Psycho-biogenealogy & Transgenerational, which gets all lumped together with neurolinguqitic programming in a manner that is hard to believe. Even more amazing, it is now postulated that it’s not just this life we have to worry about. You can apparently have as close to a perfectly “conflict-free” life as there is, but if your parents or grandparents or ancestors even further back had “conflicts,” well, you’re out of luck. These can give you cancer:

Through Dr Hamer’s theories, we understand that diseases, emotional impacts associated with them and memories of traumas can be transmitted to future generations via genes. It seems logical that in some cases the primary programming cause of illness can be found on previous generations.

The modern face of the biogenealogy was mainly developed by Anne Ancelin-Schutzenberger, Doctor in psychology and researcher, who has conducted numerous research programs in Europe, Canada and the US. Her interest in spychogenealogy started when one day, she was concerned by a remark of her daughter who said : ” Do you realize, Mom, you are the elder of 2 children among which the second is dead. Dad is the elder of two children among which the second is dead. You know when uncle Jean-Paul died, I was afraid that my brother dies [...] ” Until the day the brother passed away…

Completed by Bert Hellinger’s works on the transgenerational and family constellations, biogenealogy explains the family dynamic and the way of transmission of ancestral memories of traumas. It brings a brand new understanding on how biological, behavioral and psychological patterns are transmitted, and offers amazing technics to deprogram them on the family alienation level. Working on those ancestral memories helps to free ourselves from them as well as the whole lineage from our ancestors to our descendants.

Cancer patients just can’t catch a break, can they? If their developing cancer isn’t their fault for thinking bad thoughts or being unable to overcome “psychic trauma” on their own, then it’s the fault of their family and previous generations! Never mind that there sort of idea is inconsistent with modern biology. In fact, it’s downright Lamarckian! I wonder if Dr. Sabbah is a creationist, too.

So what evidence does Dr. Sabbah and the panoply of other “blame-the-victim” quacks who draw inspiration from Hamer have to back up their claims that Biologie Totale or the many variants of the German New Medicine can cure cancer and pretty much every other disease just through psychotherapy to erase “psychic conflicts”? Do you even have to ask? It’s testimonials all the way down, of course, including these testimonials on various Biologie Totale websites. One testimonial in particular comes from a naturopath (of course) named Olivier Comoy, who claims that he’s seen many people recover from various illnesses but doesn’t specify the illnesses. I’m guessing, however, that Comoy didn’t see a single case of cancer or a non-self-limited disease that was cured by his ministrations. Either that, or he treated diseases with a waxing and waning course, saw the patient during the waning phase of his illness, declared a “cure,” and then sent the patient on his way, never to see the waxing phase return. Certainly there’s nothing like any sort of clinical trials, of even crappy quality, to support it. Unfortunately, there are more and more like him. Worse, it’s metastasizing to the United States, as these testimonials demonstrate.

There are few things I detest more than quacks like these believers in German New Medicine and Biologie Totale preying on the desperation of seriously ill patients. Not only can they not cure any patients, but they actively hurt them by telling them that the means to cure themselves is within them, not caring that the flip side of that message is that if they are not healed by tis quackery it must be their fault for not wanting it enough or not being able to work through some psychic trauma.

But why do people believe in this stuff?

Ever since I first discovered Hamer’s German New Medicine, Sabbah’s Biologie Totale, and the various flavors of this sort of quackery that have proliferated like cockroaches over the last decade, I’ve asked myself why people believe such obvious nonsense. As for a lot of cancer quackery, there is the desperation of patients who are faced with a life-threatening disease like cancer or AIDS or a debilitating chronic disease like multiple sclerosis. But that in and of itself doesn’t strike me as enough. I think part of the answer can be found in passages like this:

In the concept of Total Biology of Living Beings, dis-ease constitutes a perfect solution of the brain to ensure, in the short term, the survival of the organism. The dis-ease is a very precise transpose of an unresolved conflict, conscious or not, into the body.

Dis-eases, health problems and even behavioural problems appear when our conscious thought (our sixth sense) is unable to find a solution to a conflict which is either very intense or long-lasting and which, due to this, generates a stress which affects the whole body collectively. By means of these stresses, from minor to the more severe, the brain will direct the threatening stress to a particular body part or function of the body that is in correspondence with the conflict.

The conflict, once resolved, results in the absence of the dis-ease. However, if there is no solution, the brain will take charge to dispatch into the body and order a mutation of cells which will produce a state of dis-ease. This is the conversion into the biology of an unresolved stress affecting a precise area of the brain.

First, note how “disease” is spelled “dis-ease.” This is a common way of spelling the word on a wide variety of “alternative” medicine sites, and Hamerian woo fits very well into this thinking. For instance, at About.com’s Holistic Healing site, the reason for this spelling is explained thusly:

The term “dis-ease” is used as a substitute for the the word disease by individuals and healing communities who are aligned with wellness. In doing this it is their intent to place emphasis on the natural state of “ease” being imbalanced or disrupted, desiring not to give too much focus to a particular ailment.

Hamerian woo like German New Medicine and Biologie Totale go beyond even this by postulating that diseases afflicting humans aren’t really diseases at all, but rather the body behaving appropriately. But it goes even further by implicitly equating the word “ease” with emotional and psychological ease, with “dis-ease” being due to a buried psychological traumas. Moreover, German New Medicine and Biologie Totale are not unique in this respect of claiming that diseases like cancer and infections are not really diseases at all. Robert O. Young, for instance, postulates that cancer is not a disease as well. In fact, he claims that cancer is an acid liquid of “spoiled cells” and that cancerous tumors are nothing more than the body’s reaction to these “spoiled cells” to protect the rest of the body by encapsulating the cells. He claims the same thing about viruses, characterizing them as “molecular liquids or gases (venom) that can be created by chemical imbalances in humans.” Young even claims that sepsis is not caused by bacterial infection, terming it an “out-fection” which he characterizes as the “cell breaking down from the inside out from an emotional or physical stress or disturbance giving rise to increased acidity.” Amazing how so many of the various forms of woo circle around to blaming psychological trauma for physical diseases, isn’t it? Of course, Young takes an entirely different approach where alkalinization is his answer to everything, but there are echoes of Hamerian woo in a wide variety of “alternative” medicine.

Another example is a “healer” named Andreas Moritz. He’s been mentioned before on SBM for his book on “liver cleanses,” but his woo goes much farther than just that. Most recently, he was the subject of a bit of a blog storm for his having tried to shut down a blog critical of his quackery. What brought on the criticism was an article on his website entitled Cancer Is Not A Disease – It’s a Survival Mechanism. It’s all there: The claim that cancer is not really a disease but is in fact a normal response either to extreme “toxic” insult or to this:

After having seen thousands of cancer patients over a period of three decades, I began to recognize a certain pattern of thinking, believing and feeling that was common to most of them. To be more specific, I have yet to meet a cancer patient who does not feel burdened by some poor self-image, unresolved conflict and worries, or past emotional trauma that still lingers in his/her subconscious. Cancer, the physical disease, cannot occur unless there is a strong undercurrent of emotional uneasiness and deep-seated frustration.

Cancer patients typically suffer from lack of self-respect or worthiness, and often have what I call an “unfinished business” in their life. Cancer can actually be a way of revealing the source of such inner conflict. Furthermore, cancer can help them come to terms with such a conflict, and even heal it altogether. The way to take out weeds is to pull them out along with their roots. This is how we must treat cancer; otherwise, it may recur eventually.

“Poor self image”? Emotional traumas? Is that how mice and other animals develop cancer, too?

Basically, Moritz appears to take concepts from the quackery that is German New Medicine and Biologie Totale but doesn’t limit himself to them given that he clearly believes that exposure to large amounts of “toxic” carcinogens can lead to a collapse of the body’s defenses. More importantly, like Robert Young, he views cancer as a “survival mechanism.” In fact, Moritz calls cancer the “wisdom of the body.” Indeed, he goes so far as to rationalize how tumors can hijack normal physiological processes like angiogenesis (the ingrowth of new blood vessels) as “evidence” that the body doesn’t view cancer as a threat and actually goes out of its way to supply it with blood, oxygen, and nutrients. It never occurs to him that tumors actually trick the body into helping them grow.

Why does so much “alt-med” claim that cancer is actually not a disease but rather an example of the body’s “wisdom” or that cancer is due to unresolved psychological conflicts, past emotional trauma, or poor self-image? I’ve speculated multiple times about why there is this tendency to “blame the victim” in “alt-med,” an undercurrent of “The Secret“-like thought, sometimes implied sometimes explicity, that tells people that they have control over reality if they just want it badly enough. As far as Hamerian woo goes, I think there’s also an undercurrent of a view of nature and the human body that views nature as perfect, where disease (or “dis-ease”) is not because the body malfunctions but because it does what it is designed to do. While there is a germ of truth in this idea, as evidenced by our knowledge of how chronic inflammation can lead to cancer and vascular disease for example, Hamerian woo, like much of alt-med, takes this germ of a reasonable science-based idea and runs off the cliff with it to deny that bacteria can cause sepsis, that HIV can cause AIDS, or that viruses can cause disease.

But it goes even beyond that when it comes to cancer. Cancer is a set of diseases where the body’s own cells turn on it, ignoring the “ease” and “balance” so beloved of “alt-med” believers that normally control cellular proliferation. Cells grow out of control, damaging organs, hijacking the body’s own blood vessels, and parasitizing the body’s nutrient supply. How can that happen if the body is so perfect? There must be a secret “trauma” that leads the body to cause such a reaction to wall off the psychic trauma, of course! Or, if you don’t subscribe to Hamerian woo, then it must be external “toxins,” almost always unnatural human-made evil chemicals that disrupt the happy paradise of the body and must be purged. Come to think of it, it’s not unlike the story of Adam and Eve in the Garden of Eden, with science, including science-based medicine with its chemotherapy, surgery, and drugs playing the role of the fruit of the tree of knowledge of good and evil. Add a whole lot of wishful, magical thinking à la The Secret, creating a world in which either wishing makes it so or overcoming subconscious psychic truamas, and you have a recipe for a belief system that bears far more resemblence to religion than to science.

One (dark and stormy?) night in 1882, a critically ill 70 year old woman was at the verge of death at her daughter’s home, suffering from fever, crippling pain, nausea, and an inflamed abdominal mass. At 2 AM, a courageous surgeon put her on the kitchen table and performed the first known operation to remove gallstones. The patient recovered uneventfully. The patient was the surgeon’s own mother.

This compelling story is the beginning of an excellent new biography of William Halsted, the father of modern surgery, Genius on the Edge: The Bizarre Double Life of Dr. William Stewart Halsted, by Gerald Imber, MD.

When Halsted went to medical school, surgeons still operated in street clothes, with bare hands, and major surgical procedures carried a mortality rate of nearly 50 percent. Suppuration of wounds was called laudable pus. Lister had recently introduced carbolic acid dips and sprays (that were irritating and toxic), but hand washing was discouraged because it was thought to force germs into skin crevices.

Halsted was responsible for the first use of sterile gloves in the operating room, although his initial reason for introducing them was to relieve the skin irritation of the scrub nurse who later became his wife. He collected statistics to prove that gloves reduced the infection rate, although he wasn’t always consistent: he once removed his gloves to better palpate a lesion and the patient got infected and died. In addition to the first gallstone removal, he developed the radical mastectomy (radically improving the survival of breast cancer patients), the first successful hernia repair and aneurysm repair, and many techniques that improved the outcomes of surgery. He established an animal lab to teach surgery to students and to try out new procedures. He kept refining his knowledge of anatomy, used meticulous surgical technique and fine silk sutures to minimize tissue damage (thereby reducing the chance of infection), insisted on hand washing and sterile technique, and kept careful records of outcomes to determine which procedures were best.

With his equally renowned colleagues internist William Osler, pathologist William Welch, and gynecologist Howard Kelly, he helped revolutionize the training of doctors by creating the first modern medical school at Johns Hopkins. Previously, medical schools were little more than for-profit trade schools. There was no laboratory or clinical work and students often did not see patients at all. The course lasted 3 years and had no entry requirements. At Johns Hopkins, an undergraduate degree was required for admission, the program lasted 4 years, there was extensive training in science, bedside teaching rounds were instituted, and there was a hierarchy of post-graduate training with interns and residents.

They even admitted women on the same basis as men. I thought it was hilarious how that came about. After building the hospital they had run out of money and were desperately seeking an endowment to establish a medical school. A committee of women offered to raise the money if the board would agree to admit women students. The board didn’t want to admit women, but they thought it would be safe to agree because they were confident the women would never be able to raise the necessary amount. The women promptly raised more than enough and forced the board to honor its promise! Incidentally, Gertrude Stein was an early medical student there, but instead of sticking around to graduate she went to Paris to write poetry and become famous.

The students Halsted trained (including Harvey Cushing, the father of neurosurgery) developed into a new generation of leaders and teachers: science-based surgeons who were responsible for many of the subsequent advances in surgery. They went on to teach another generation, and many of today’s most prominent surgeons and researchers can trace the line of their teachers’ teachers directly back to Halsted.

Yet this man who accomplished so much for science was a drug addict for 40 years. He was given morphine to help him withdraw from cocaine and ended up hooked on both drugs for the rest of his life. He only worked part of each year. He would disappear for months at a time, apparently to binge on cocaine in privacy. He was sometimes observed by colleagues to be suffering drug effects or withdrawal symptoms. Sometimes he would leave in the middle of an operation, saying he had a headache, leaving his residents to finish the procedure.

He was an odd duck in many ways. He was abrasive, abrupt, inconsiderate, forgetful, and apparently unfeeling: his personality quirks constantly antagonized his students and colleagues. His marriage was apparently sexless and his wife was also addicted to morphine.

His story is interesting in more ways than one. It provides insight into a crucial time in history when medicine was transitioning from superstition to science, when scientific surgery and modern medical education were being born. It is also fascinating to realize that this flawed man was able to maintain an incredibly productive scientific career for 4 decades despite his addictions. I can’t help but wonder what would happen to such a man today.

I get all sorts of mail. I get mail from whining Scientologists, suffering patients, angry quacks—and I get lots of promotional material. I get letters from publishers wanting me to review books, letters from pseudo-bloggers wanting me to plug their advertiblog—really, just about anything you can imagine.

Most of the time I just hit “delete”; it’s obvious that they’ve never read my blog and they’re just casting a wide net for some link love. But a recent email from a PR firm piqued my interest: (it’s a long letter, and I won’t be offended if you simply reference it rather than read the whole thing now):

Hi Dr. Lipson,

My name is N. and I am reaching out to you on behalf of Dr. Jon Kaiser, an esteemed HIV/AIDS and nutrition specialist who specializes in supporting immune system function with nutrition.

I recently read your blog post titled “Will Congress Finally Reform Supplement Laws” and thought you might be interested in Dr. Jon Kaiser’s perspective on the role of nutritional supplementation in medicine.

Dr. Kaiser is well-known in the global AIDS/HIV community.  In the 1980’s, Kaiser pioneered the use of nutritional supplements in HIV/AIDS patients to help them build stronger immune systems; his research showed that conventional drug treatments were more effective if the patient’s immune system were strong.  Today, many AIDS and HIV patients around the world follow this treatment paradigm.

As a physician, Dr. Kaiser is well-known in the global AIDS/HIV community.  In the 1980’s, Kaiser pioneered the use of nutritional supplements in HIV/AIDS patients to help them build stronger immune systems; his research showed that conventional drug treatments were more effective if the patient’s immune system were strong.  Today, many AIDS and HIV patients around the world follow this treatment paradigm.  Building upon his success in HIV patients, Dr. Kaiser is applying the lessons learnt in HIV to patients with cancer, Chronic Fatigue Syndrome and other chronic diseases, general health and the elderly.

Dr. Kaiser is very passionate about advocating nutritional supplementation and views it integral to successful disease and general health management.   He would more than like to share and engage in a discussion about the supplements and the impact of the proposed reforms to supplement laws.

I’ve included more information on Dr. Kaiser and K-PAX and I have pasted links to a 2001 double-blind, placebo-controlled study funded by Bristol-Myers Squibb that demonstrated an increase in the number of CD4 lymphocytes in HIV-infected patients who were taking Dr. Kaiser’s natural immune support formula compared to patients taking a placebo (in addition to standard HIV medications). This formula has been refined over 15 years and is now in clinical trials with the goal of receiving FDA approval.  If successful, Dr. Kaiser will be one of the first nutritional suppliers to gain FDA approval for  the use of a nutritional supplement as an adjunctive therapy for disease management.

I’ve never heard of Kaiser, and the only K-PAX is know is home to Prot. So I looked it all up.

Before I assume anything about a doctor, I always check to make sure they’re really a doctor.  Jon Kaiser is an M.D. in northern California. He graduated from a real medical school where he apparently performed well.  According to the state medical board, his license is current and he has no official actions against him. He has reported to the state board that he is not board certified in any specialty, but claims non-boarded specialty status in internal medicine and infectious disease. He reported to the board and listed on his CV that he has one year of post-graduate training.  I’m not sure how one can claim to be an internist without specialty training, but he does.

To specialize in internal medicine requires three years post-graduate training, and to specialize in infectious diseases generally requires an additional 1-3 years of post-graduate training. It’s not unheard of for older HIV specialists to not have formal infectious disease training—many of them were internists who invented the field of HIV medicine out of necessity when the epidemic first appeared. But to practice internal medicine or infectious disease with only one year of post-graduate training (an internship probably) is very, very unusual.  My state currently requires completion of two years of post-graduate training in a certified program, although since two year programs are vanishingly rare, most licensed physicians will have at least three years.   In the old days, a doctor could finish an internship and hang up a shingle as a family doc.   But even back in the 80s, internal medicine had become far too complex to rely on just an internship.  Hell, my dad graduated from medical school in 1949 and even then internists were expected to compete a full residency program.

This doesn’t mean Kaiser isn’t a good doctor, but it raises the bar on any claims he makes.  If I know that someone is a boarded internist and infectious disease specialist, and is published in her fields of specialty, I’m likely to require a bit less as far as proving his or her credibility. Someone who completed a brief course of post-graduate training and declares themselves to be an expert will require a lot more to convince me of their expert status.

Most HIV specialists are infectious disease specialists first, and if they belong to a professional organization it is usually the IDSA or the HIVMA. His CV lists him as a member of the American Academy of HIV Medicine.  I’m not familiar with their work, but their website has some useful information. Included is a verification engine to see if a doctor is a member: Kaiser  is not listed on their verification site. He lists himself as being on multiple boards, so I’m assuming this is a glitch in the system.  He also lists himself as a founding member of the California Academy of HIV Medicine, an organization I cannot yet find on the web.  I asked his publicist about this and this was Dr. Kaiser’s response:

As a founding member of the American Academy of HIV Medicine, I was intimately involved in setting policy objectives for the organization in its early development phase beginning in 2000. I formed the Academy’s Reimbursement Committee in 2000, and was quoted in the attached AAHIVM newsletter (see middle column, paragraph #2). I have also been certified as an HIV Specialist by the organization on two separate occasions (see attached). It appears my membership to the national organization and California chapter inadvertently lapsed when I moved offices. This has been corrected and my membership is now currently active.

Well, I guess that explains the discrepancy between his CV and the professional organization he claims membership and leadership experience in.  Unfortunately they didn’t find me a link to the CAAHIVM.  Perhaps they don’t have a website.

Anyway, I was curious about the publicist’s claim that Kaiser is a major player in the HIV community, so I did a PubMed search. It turned up three references.  I guess one can be a respected HIV clinician rather than a researcher, and that would certainly not show up in PubMed.  But that leads to another problem.

Kaiser bills himself as “combining the best of natural and standard therapies” for HIV disease.  I have no reason to doubt this, but since his approach is unorthodox and he isn’t an active researcher I’m not sure how he knows that his treatment is so good.  He does claim some pretty spectacular results:

Though long term stability in my patients has always been the rule, I can now definitely say that the progression of HIV disease in my practice is an extremely rare event. This experience, which has encompassed the care of over 500 HIV(+) patients during the past five years, allows me to make the following statements: Not one patient who has come to me during the past six years with a CD4 count of greater than 300 cells/mm3 has progressed to below that level. Not one patient who has come to me during the past six years with a CD4 count of greater than 50 cells/mm3 has become seriously ill or died from an HIV-related illness. This extraordinary level of good health and stability does not come without hard work. My patients follow an aggressive program of natural therapies to support their immune systems. They have also benefited tremendously from the new drugs, lab tests, and other recently released treatment options. What a difference a few years has made!

That seems pretty impressive to me, for a few reasons. In many circumstances, someone who has gathered this much favorable data would have published it.  Without seeing the data in a peer-reviewed journal, there’s no way to verify the validity of these claims, or the reason for them.  If the data are accurate, perhaps he attracts a very medically-adherent population.  At many of the HIV centers I’m familiar with, patients often have financial, social, and psychiatric barriers to care, and results aren’t so rosy.  So what’s this guy’s secret?  Does he have a really, really compliant set of patients, or is he doing something different, something not yet well-represented in the HIV literature?

According to him, the secret is his “comprehensive” approach:

I define a comprehensive approach as one which adds a program of aggressive natural therapies and emotional healing techniques to the standard medical treatment of an illness or condition. An aggressive natural therapies program includes a combination of diet therapy, vitamins, herbs, exercise, and stress reduction. Emotional healing encompasses a proactive program of psychological healing techniques that ideally includes a spiritually-oriented practice (prayer, meditation, yoga, etc.) combined with a significant level of social support.

That’s a bold statement.  He claims extraordinary results, and claims that a raft of disproved therapies are the answer. If, as he claims, this approach is especially beneficial to those who cannot tolerate proven therapy with anti-retroviral drugs, he really should be working off data, data that show that his approach is safe and effective.
And that brings us back to the original letter from his publicist.  In the letter, they claim that K-PAX (the supplement, not the planet) significantly increased CD4 counts compared to placebo in patients taking usual therapy.
Whether CD4 cell count is a useful measure in this setting is debatable.  Viral load is an important measure of HIV activity, and CD4 count varies from moment to moment.  Also, above a certain level, it’s not clear that CD4 cell count is a marker of clinical risk.  Important outcomes other than CD4 cell count and viral load include prevention of opportunistic infection.
In Kaiser’s study, published as a “rapid communication”, he measured many parameters in addition to CD4 count.  This was a very small study (40 patients) with a very brief follow up period (12 weeks).  In the results section, the author notes that there were differences in the characteristics between the test and control groups, and that these differences were not statistically significant:

(1) the micronutrient group had a lower CD4 count at baseline when compared with the placebo group (CD4: 357 ± 154 cells/?L vs. 467 ± 262 cells/?L, P = 0.13), (2) the participants in the micronutrient treatment group reported a greater number of months of neuropathy symptoms preceding enrollment than those in the control group (means: 21.4 months vs. 12.2 months, P = 0.14; medians: 14.2 months vs. 2.5 months), and (3) the micronutrient treatment group contained 3 patients with diabetes mellitus compared with zero in the placebo group (P = 0.09).

It is technically correct that most of these differences were not statistically significant, but, look at the results:

The mean absolute CD4 count increased significantly by an average of 65 cells in the micronutrient group versus a 6-cell decline in the placebo group at 12 weeks (P = 0.029)

CD4 counts vary quite a bit, and are an imperfect measure of disease activity and immune function.  As we can see from his groups, there was a very large range of CD4 counts in each group at the start.  An average change in CD4 count of 65 seems anemic at best. Kaiser is more optimistic:

This study demonstrates that a micronutrient supplement administered to HIV-infected patients taking stable HAART significantly enhances CD4 lymphocyte reconstitution. Our findings support the potential for a broad-spectrum micronutrient supplement to be used as adjuvant therapy in combination with HAART to provide patients with a more robust CD4 cell rebound after initiating antiretroviral treatment.

I find the data from this pilot study entirely unconvincing.  His conclusions are hyperbolic and premature.  That’s not unusual, though.  Researchers sometimes get a bit excited about their work, and as an inexperienced author, perhaps he can be forgiven for a little unrestrained enthusiasm.
But it gets a bit more interesting that that.  In a letter to the editor, a careful reader noted something unusual. A patient showed him a brochure claiming that K-PAX could raise CD4 counts by 26%.  K-PAX, it seems, is the same product used in Kaiser’s study. The writer was concerned:

Most disturbingly, the first author on the paper, Jon D. Kaiser, MD, seems to be the same person mentioned in the brochure as the developer of K-Pax Vitamins.

[...]

Given the recent controversies at other medical journals about the failure of authors to disclose potential conflicts of interest, I am sure that this article would not have been published without disclosure (or at all) if the Editors had been aware of the conflicts of interest in this case.

There is a long, sordid history of conflicts of interest in published research.  Some drug companies have gone so far as to print their own faux-journals containing only favorable studies.  That is why most journals have strict disclosure rules for conflicts of interest. A study being sponsored by a drug manufacturer does not invalidate it, but failure to disclose this connection is unethical and problematic on many levels.
Kaiser was (correctly) allowed to respond:

After reporting the improved immune reconstitution of patients taking the micronutrients plus highly active antiretroviral therapy (HAART) to the Bristol-Myers Squibb team, I anticipated that they would show interest in pursuing the development of a therapy that had the potential to act as a safe and beneficial immune modulator.

On learning that they had no interest in pursuing the development of this compound, I chose to form a company, K-PAX, Inc., to keep the micronutrient supplement in production and make it available for sale while I worked to get the study results published.

I neglected to inform the Editors of this journal of this conflict of interest and any potential bias that existed during the paper’s submission and publication process. Nor did I inform the other authors on the paper of my financial interest in the company. They received no personal compensation for their efforts.

In other words, he is the guy who makes and sells K-PAX, and he owned up to failing to disclose this profound conflict of interest. I asked Kaiser through his publicist about this. His response was less conciliatory:

This research study was performed before there ever was a company or financial interest in a product (2001-2003). The data were analyzed by an independent Data Analysis Firm selected by Bristol-Myers Squibb in 2001. The JAIDS editorial board performed a thorough evaluation after Dr. Smith raised his concerns and found no evidence that either the data analysis or study conclusions were inaccurate.

I’m unimpressed by this response.
As I’ve said many times in this space, being wrong is not a moral failing—being deceptive is.  Many doctors who offer unproven therapies are genuine in their beliefs that they are doing good.  This doesn’t change the fact that promoting unproved treatments is a bad thing.  A doctor should know better than to use hyperbolic language to convince HIV patients that he somehow has the answer to their disease, an answer that no other specialist has.  Of course, most doctors have a lot more formal training that Dr. Kaiser, so perhaps he can be forgiven for his hyperbolic promotion of a single pilot study as a major breakthrough in HIV treatment.
Right?

Children aren’t supposed to die.  That so many of us accept this statement without a blink is remarkable and wonderful, but it is also a very recent development in human history.  Modern sanitation, adequate nutrition, and vaccination have largely banished most of the leading killers of children to the history books.  Just look at the current leading causes of childhood death in developing countries to see how far these relatively simple interventions have taken us.

As we have systematically removed the leading infectious killers of children from prominence, other organisms have naturally risen to the top of the list.  This has lead some to the fatalistic (and mistaken) conclusion that we are simply opening up niches to be inevitably filled by other virulent organisms.  This assumes that there is some mandated quota of say, meningitis, that children must suffer every year, and if one organism doesn’t meet this quota then another will fill it.  Were this the case, after vaccination we’d expect to see a shift in the causes of meningitis, but at best a transient drop in the total number of cases per year as other bugs step in to pick up the slack of their fallen, virulent, meningitis-inducing brethren.  Such is not the case.

Though new organisms are now the leading causes of invasive bacterial infections in children, and we have indeed seen some increases in non-vaccine targeted strains, as I’ll discuss below, the total number of such infections has dropped precipitously.  It’s fair to say that the vaccination program has done a remarkable job improving a child’s chance of surviving to adulthood in good health.  However, no one in their right mind would argue that the current state of affairs, as good as it is, is good enough, and so we have shifted our sights to the current leading cause of invasive bacterial infections in children, Streptococcus pneumoniae (S. pneumo, or pneumococcus).

The Need for a Pneumococcal Vaccine

S. pneumo is a challenging bug to prevent and treat.  Its 90 different serotypes together cause a variety of infections, from the relatively mild such as otitis media (ear infection) and sinusitis, to the far more serious including pneumonia, sepsis, meningitis, and osteomyelitis. Much of this versatility and the primary factor determining each strain’s virulence comes from the polysaccharide capsule surrounding S. pneumo.  This gel-like substance hides many of its antigens from exposure, and is itself a poor target for the immune system.

Increasing antibiotic resistance in some strains of S. pneumo certainly doesn’t help the matter, but neither is it the primary cause of S. pneumo’s current position of infamy.  The majority of strains are susceptible to good old penicillin, and even resistant strains are susceptible to other classes of drugs.  The problem is that in a small minority of cases the infection spreads so aggressively that children die or suffer complications in spite of rapid medical care and appropriate antibiotics.

This is why in children prior to 2000, and in spite of modern medical care, S. pneumo caused around 13,000 cases of bacteremia, 2500 cases of pneumonia, 700 cases of meningitis, and 200 deaths (not to mention 5,000,000 cases of otitis media).  As always, prevention would be better than treatment, and in 2000 the first vaccine against S. pneumo for children under the age of 2 was licensed in the US (an earlier vaccine, PCV-23, existed for adults but was incapable of generating a good response in children).  PCV-7 (Prevnar) targeted only 7 of the more than 80 known serotypes, but the seven were well selected, accounting for 80-85% of the cases of invasive disease and a majority of penicillin resistant strains.

Coverage Gaps and Moving Targets

The subsequent 10 years have been almost exactly what you would hope for from the vaccine.  Invasive pneumococcal disease in children has dropped by 76% (including non-targeted serotypes), and disease from targeted serotypes, which recall made up 80% of all invasive disease before the vaccine, dropped 99%.   We’ve even seen a modest but significant decrease in the incidence of S. pneumo disease in the elderly, which is most consistent with the effect of herd immunity.  This is an outstanding success.

Though PCV-7 is effective, it’s also far from perfect.  Predictably, the strains not targeted by PCV-7 have persisted in the population and become more common.  Some of these strains are less pathogenic, but a few have shown themselves capable of virulence, and so in the last decade we’ve seen a shift in the behavior of infections caused by S. pneumo.  One such example of this may be seen in the increased rate of empyema.

Occasionally during a pneumonia bacteria can also infect the space between the lung and the wall of the chest, causing an accumulation of pus that is difficult to treat with antibiotics alone, and usually requires some form of drainage. Typically this is done with a tube inserted between the ribs or thorascopic surgery, and usually includes a prolonged hospital stay.  Needless to say, an empyema is undesirable, and the rate of this complication from pneumonia seems to be increasing.

This concerning trend has been most recently demonstrated by an article appearing in Pediatrics.  Between 1997 (3 years pre-PCV-7 licensure) 2006, the authors found an approximate 50% drop in invasive pneumococcal disease in general, pneumonia, meningitis, and bacteremia, consistent with the existing literature confirming the general efficacy of PCV-7.  However, they also were able to demonstrate a subtle increase in the rates if empyema during the same amount of time.  This means that with a near halving in the total number of pneumonias, but an increase in a complication of pneumonia, the risk of developing an empyema during a pneumococcal pneumonia has roughly doubled in the last decade.

Now comes the hard part: Why?  Well, frankly, we don’t yet know.  This study doesn’t establish the causative mechanism behind the increased incidence of empyema; it simply establishes that it has increased in spite of pneumococcal vaccination. The increase could be part of a previously occurring trend, after all, the incidence of empyema was already increasing before the vaccination was implemented.  It could be from a shift toward serotypes that are more prone to cause empyema, but aren’t targeted by the vaccine.  Unfortunately this particular study isn’t designed to look at involved serotypes, and the other literature to support this hypothesis is currently mixed.  I find it compelling to note that this very study also demonstrates a nearly identical increase in the rate of empyema associated with Staphylococcal pneumonia, suggesting an unidentified common factor between the two.

We Can Do Better

We know that PCV-7 is effective at controlling most infections from targeted serotypes, that non-targeted serotypes are beginning to thrive, and the increased rate of empyema has not been curtailed by the current vaccine.  The next logical step is to broaden our coverage to include the non-targeted pathologic strains within the vaccine.

This is precisely what has been done.  Several vaccines with a broader scope have been in development, and on February 24th the FDA licensed the first of this next generation of pneumococcal vaccines. PCV-13 targets all seven prior serotypes and includes an additional six that together comprise the most common and pathological serotypes currently in circulation (serotypes 1, 3, 4, 5, 6A and B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).  It is slated to replace the current PCV-7, will follow the same 4-shot 2, 4, 6, and 12-15 month schedule, and can be used to complete a series of PCV-7 vaccinations.

This vaccine, like every other one, has undergone extensive testing for both safety and efficacy.  It is built on the identical technology as PCV-7 that has a decade’s worth of excellent safety, and will, as with all other vaccines, undergo even more rigorous post-release surveillance.

Based on PCV-7’s success, we have every reason to expect an even greater reduction in the burden of serious infections suffered by our children. If we’re lucky, we’ll soon have to declare a new bug the leading cause of invasive bacterial infections in children, not because of its success, but because of S. pneumo’s fall.

March 4, 2010

Today I went to the one-day, 2^nd Yale Research Symposium on Complementary and Integrative Medicine. Many of you will recall that the first version of this conference occurred in April, 2008. According to Yale’s Continuing Medical Education website, the first conference “featured presentations from experts in CAM/IM from Yale and other leading medical institutions and drew national and international attention.” That is true: some of the national attention can be reviewed here, here, here, and here; the international attention is here. (Sorry about the flippancy; it was irresistible)

I’ve not been to a conference promising similar content since about 2001, and in general I’ve no particular wish to do so. This one was different: Steve Novella, in his day job a Yale neurologist, had been invited to be part of a Moderated Discussion on Evidence and Plausibility in the Context of CAM Research and Clinical Practice. This was not to be missed.

I arrived early enough to take a relatively inconspicuous seat near the back. My plan was to respect the Prime Directive, at least until late in the day when Steve was to speak. Alas, ‘twas not to be. Not long after I’d lodged myself there, the young man who had organized the conference came right up to me and said “welcome, Dr. Atwood.” He is 2nd year Yale medical student John Millet, an enthusiastic kid who had clearly worked hard on this task and who later gave a nice talk. He said that he recognized me from the picture on my blog, by which I guess he meant SBM (which, he said, he reads faithfully). Except that there is no picture of me on SBM, so clearly he is an empath!

For a “CAM” Conference, there wasn’t much “CAM”

The welcoming comments were offered by our John and by Deputy Dean of Education Richard Belitsky, one of two speakers who had borne the brunt of the criticism following the 2008 conference. I criticized him at the time for his “obsequious welcoming statement,” which “betrayed either an ignorance of science and critical thinking or an ignorance of ‘CAM’.” I am happy to report that it seems to have been the latter, both because he apparently had something to do with inviting Dr. Novella to the conference and because his welcoming statement today was more measured than the last. In particular, he said something to the effect (my pen had run out of ink at that point) that “this is the Yale University School of Medicine, and we consider it very important that all conference material be presented with the utmost scientific rigor.”

The agenda seemed to reflect that theme. The 2008 conference had included talks on Therapeutic Touch, Reiki, chiropractic, Qi Gong, “integrating mind, body, and spirit,” David Katz’s infamous “invitation to think more fluidly about evidence,” and, well, Bernie Siegel. This conference, in contrast, had hardly any “CAM” talks at all. Below is the schedule. For the talks that I attended (in the early afternoon there were two options), I’ve indicated which ones were about “CAM” and which were not; among those that I missed were a couple on “mindfulness meditation” for stress reduction and one on hypnosis to reduce anxiety, which are hardly “CAM.” Another that I missed was “auricular acupuncture,” which I assume was “CAM”:

Yale Research Symposium on Complementary and Integrative Medicine

Welcome and Opening Remarks

John Millet YSM 2012 and Richard Belitsky MD

Plenary Session: An Integrative Approach to Cancer: The Biology of Lifestyle Interventions and Cancer Survival

D. Barry Boyd MD, MS (Not CAM)

Keynote Lecture:  Progress in Research in Complementary and Alternative Medicine

Josephine P. Briggs MD (Mostly Not CAM )

Concurrent Sessions:

Traditional Chinese Medicine, Nutrition, and Research Methods Track

Auricular Acupuncture as a Treatment for Pregnant Women Who Have Low Back and Posterior Pelvic Pain: A Pilot Study

Shu-Ming Wang MD, Lac (CAM)

Globalization of Chinese Medicine:  A Case Study of PHY906, A Traditional Chinese Medicine Formula as Adjuvant Chemotherapy for Cancer Treatment

Yung-Chi “Tommy” Cheng PhD (Mostly Not CAM)

N-Acetylcysteine for Pediatric Trichotillomania

Michael H. Bloch MD (Not CAM)

Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes: A Randomized, Controlled, Crossover Trial

John Millet YSM 2012 (Not CAM)

Patient Experiences and CAM Use in Chronic Lyme Disease: A Qualitative Study

Ather Ali ND, MPH and Lawrence A. Vitulano PhD

(CAM, but not quite as bad as it looks)

The Impact of Dietary Protein on Calcium Absorption and Kinetic Measures of Bone Turnover in Women

Karl L. Insogna MD (Not CAM)

Psychological Stress and Sudden Cardiac Death: The Downside of the Mind-Body Connection

Rachel Lampert MD (Not CAM)

Piloting a Mindfulness Based Stress Reduction Curriculum for Internal Medicine Residents

Auguste H. Fortin VI MD, MPH

Development and Initial Psychometric Testing of the Determinants of Meditation Practice Inventory

Anna-leila Williams PA, MPH, PhD(c)

Mindfulness Training as Treatment and Mechanistic Probe for Addictions

Judson Brewer MD, PhD

How Does Stress Increase Alcoholism Relapse and Affect Chronic Disease Risk?

Rajita Sinha PhD

Pre-Operative Hypnosis: A Bio-behavioral Model for Reduction of Anxiety in Surgical Patients

Haleh Saadat MD

Moderated Discussion on Evidence and Plausibility in the Context of CAM Research and Clinical Practice

Moderator: D. Barry Boyd MD, MS

Panel:  David Katz MD, MPH

and Steven Novella MD

Open Forum Discussion with Expert Panel

Moderator:  Lawrence A. Vitulano PhD

Panel:  D. Barry Boyd MD, MS, David Katz MD, MPH, Steven Novella MD

In this post I will discuss the conference up to the point at which Dr. Novella became involved (oh no, you’re thinking: that’s the best part!), but I’ll try to follow with the second part within a day or so.

The Morning: Drs. Boyd and Briggs

Most of the “Not CAM” talks were reasonably presented and, well, reasonable. Two that are worth mentioning in a bit of detail were those by oncologist Barry Boyd, on “An Integrative Approach to Cancer: The Biology of Lifestyle Interventions and Cancer Survival,” and the talk by Josephine Briggs, the Director of the NCCAM since 2008. Dr. Boyd’s talk, in spite of a title promising everything from “visualize your immunocytes” to “antineoplastons,” was mainly about one thing: diet/exercise and cancer progression (and to a lesser extent cancer formation). It boiled down to some intriguing evidence from animal studies, biochemistry, and epidemiology suggesting that purposeful, modest weight loss may improve cancer prognosis in patients who are still in relatively good shape. The physiology is essentially the physiology of the “metabolic syndrome,” involving insulin resistance, up-regulation of insulin and insulin-like growth factor 1 (IGF-1, which probably acts as a tumor growth factor), and a systemic inflammatory state (which, by leading to epithelial cell proliferation, provides more opportunity for carcinogenesis).

If you’re interested, Dr. Boyd has an article available online covering similar material. I talked to him several times during the course of the day: he seemed completely scientific in his outlook, and excited about new possibilities in the way that smart people in academic medicine can be. He correctly called the Gonzo regimen “nonsense.” In his talk he showed a slide with a small box labeled chemotherapy-radiation therapy-surgery-biological; it was contained within a “the bigger box” labeled lifestyle changes-dietary interventions-exercise-stress reduction (hormonal was kind of on the surface of the little box). Beyond the bigger box, which was labeled Non-Conventional Medicine, was the real “CAM”: TCM, Ayurvedic, Energy Healing, Homeopathy, Botanical.

I agree with him: diet and exercise, other than pseudoscientific drivel, are not “CAM.”  At one point I asked him why he even thought of himself as “integrative.” He replied that he did not! Why, then, does he identify himself with the woo crowd? Why does he tout Michael Lerner, who defends boundless nonsense including Gerson (whose regimen is similar to Gonzo’s)? Why does he tout Ralph Moss, who championed Gonzo? Why does he tout James Gordon, who pushed at least one hapless patient into the hell that was the Gonzo trial? Doesn’t he know how the politics of quackery works? In spite of those issues, I had a good time talking with him and I hope to do it again sometime.

Josephine Briggs, the NCCAM Director, talked mostly about “supplements” studies sponsored by the Center. Surprise: they’ve all been disconfirming. Hoodathunk? Well, she did present evidence for something that I’ll admit I’d poo-poo’d in the past. It turns out that there was a large-enough-to-be-noticeable diminution in public demand for echinacea and glucosamine-chondroitin sulfate beginning not long after each NCCAM-sponsored trial had been publicized; the same is now expected, not only by Dr. Briggs but according to a trade magazine that she cited, for ginkgo biloba. Not that this justifies such trials at taxpayers’ expense, of course.

Dr. Briggs identified “areas of promise in natural products research,” naming “insight into molecular targets of dietary small molecules [etc.]” Hmmm: that sounds suspiciously like “lend[ing] a drug development aspect to an otherwise ‘herbal’ application.” Later I asked her if, in fact, the NCCAM had changed its previous attitude about refusing to fund studies proposing to look for active molecules in natural products, and she said “yes.”

Dr. Briggs herself seems to have a rational, scientific way of looking at things. No surprise: she was, for decades, a renal physiologist. She betrayed her own nerdiness with a slide titled “Quirky ideas from outside the mainstream,” which purported to show examples of, well, quirky ideas whose time eventually arrived: physical resistance training for people recovering from physical trauma (Pilates 1915); breathing techniques to help with labor pains (Lamaze 1940); breast feeding better than formula for babies (Froelich 1950s); dying patients would be better off with fewer medical interventions and more palliative support (Saunders, etc. 1960s); mindfulness-based stress reduction can help with pain management (no author or date). No arguments there, except that those ideas were never “quirky,” unless the term is defined by what the preponderance of practicing physicians was NOT doing or recommending at the time. How do those histories justify investigating implausible claims?

They don’t, but listening to Dr. Briggs one would think that the future of the NCCAM will stay away from the highly implausible. Rather, it will involve rational natural products research, investigations of reasonable physical techniques (“yoga and Tai chi for balance and avoiding falls in elderly people”), uncontroversial (i.e., not psychokinesis) mind-body techniques to help with symptoms, mainly pain, and research into the nature of the placebo effect. (She listed acupuncture as a “mind-body practice.” Did she really mean that? Was she acknowledging that it is a placebo?) If that were the extent of it, I could think of better things to do than spend my time criticizing the Center.

Alas, it won’t be, because Dr. Briggs must walk on a tightrope being shaken by Senator Harkin at one end and Senator Hatch at the other, with Congressman Burton making sure that there is no safety net underneath. And there will remain such sticky problems as the NCCAM putting the cart before the horse by funding “integrative medicine centers”; by continuing to wear its blindfold regarding the ongoing, largest and most expensive NCCAM trial yet funded, that should have long ago been terminated because of scientific and ethical misconduct and unnecessary risks to human subjects; and by continuing to offer misleading information to the public, right on the NCCAM website.

Dr. Briggs seemed unaware of the last point (I don’t recall her mentioning the other two). She was quite pleased with the website and recommended it more than once. Lover of irony that I am, I offer an example of misinformation attributed to the NCCAM website that unwittingly insults some the Center’s own ‘stakeholders,’ and is printed right in the 2010 Yale Research Symposium syllabus:

In homeopathic medicine, there is a belief that “like cures like,” meaning that small, highly diluted quantities of medicinal substances are given to cure symptoms…”

Ouch! That’s, er, the opposite of homeopathy. To wit:

The curative power of medicines, therefore, depends on their symptoms, similar to the disease but superior to it in strength, so that each individual case of disease is most surely, radically, rapidly and permanently annihilated and removed only by a medicine capable of producing (in the human system) in the most similar and complete manner the totality of its symptoms, which at the same time are stronger than the disease.

It is the despised “allopathy” that seeks merely to cure the symptoms:

Whenever it can, it employs, in order to keep in favour with its patient, remedies that immediately suppress and hide the morbid symptoms by opposition (contraria contrariis) for a short time (palliatives), but that leave the disposition to these symptoms (the disease itself) strengthened and aggravated.

That language is the historical basis for homeopaths (and related sects) claiming to cure “the underlying cause of the disease, not just the symptoms.” (I wonder if Dr. Briggs knows that she might get into trouble if she spends too much effort advocating for studies of methods that offer “contributions to symptom management”). Most of the misinformation on the NCCAM website, of course, serves not to diminish “CAM” practices but to embellish them.

The Afternoon

There is little to say about the talks that I attended; most of them were straightforward and uncontroversial, as their titles suggest (I don’t consider studying walnut consumption as a source of polyunsaturated fatty acids to be “CAM”). Each of the small efficacy trials showed some evidence of benefit. OCD expert Michael Bloch reported that N-acetylcysteine, a drug already used for other purposes, shows promise in the treatment of trichotillomania, an obsessive-compulsive disorder in which the individual pulls out her hair to the point of being severely disfigured, and for which there is currently no good pharmacologic treatment. I don’t know why this topic was even presented at a “CAM” conference, except perhaps that the drug is sold as a “supplement.”

Walnuts appear to improve endothelium-dependent vasodilatation in type II diabetics; impaired vasodilatation is correlated with cardiovascular disease, so perhaps walnuts are useful for this high-risk group. John Millet, the medical student who had “outed” me at the beginning of the day, gave that talk in a most competent fashion and is one of the authors of the published article.

Dietary protein appears to increase calcium absorption from the gut in post-menopausal women, according to Karl Insogna, an endocrinologist who is Director of the Yale Bone Center. He gave a great talk; look for the results of his Spoon study (Supplemental Protein to Offset Osteoporosis Now) within a couple of years.

The talk on “CAM use in Chronic Lyme Disease” deserves mention. The speaker was Ather Ali, a very deferential and soft-spoken young man whose background appears to include a large dollop of pseudoscience (Bastyr University) followed by a sprinkling of science at the Yale School of Public Health, folded into a ribbon cake of mixed messages at David Katz’s Integrative Medicine Center. Why the talk was not quite as bad as it looks is that the speaker mostly backed away from “Chronic Lyme Disease” (CLD) as a formal label, deferring to “medically unexplained symptoms.” These, he noted, might also be labeled chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivity, and more. The choice of the term “Chronic Lyme Disease” is an operational one: the ongoing qualitative study that he discussed asks questions of subjects who “self-identify or (have been) diagnosed with CLD” and “providers who diagnose and/or treat patients with CLD.”

Some of the preliminary results reveal problems with this purely qualitative study—both interpretational and ethical. The questions that the subjects are asked are many, ranging from cultural influences and “narratives” to laboratory values. One of the “salient insights” that Ali presented was this statement from a patient:

On finally obtaining a diagnosis:

It felt really good. That’s actually an understatement. It felt like for as sick as I was, and as awful as I felt that day, it just felt like I had a ray of hope for the first time in I don’t know how long.

This is no surprise; we don’t need a study to find this out. What we probably won’t find from this study, because of self-selection of subjects, are any who do not feel so good when given this “diagnosis.” Some may be scared out of their wits; others may recognize the scam and walk right out the door. In any event they have all been told a lie. What is the message here? I’m reminded of another such foray by naïve academic “CAM” enthusiasts (immortalized in the very first W^5), who unwittingly gave a perfect description of quackery when they wrote:

Chiropractors never have to put a patient’s pain in the category of the “mind.” They never fail to find a problem. By rooting pain in a clear physical cause, chiropractic validates the patient’s experience.

Are we to conclude that real physicians should be so dishonest?

The ethical problem with this survey arises because the investigators will inevitably stumble upon practitioners who are pushing dangerous treatments; that’s the nature of the beast known as “Lyme Literate.” The preliminary results have already identified an example, colloidal silver, which appeared on one of Ali’s slides (without his commenting, as I recall). In the question period I made that point and asked if either the IRB or the investigators had addressed it. He replied that the IRB had not, that he hadn’t seen anyone injured, and that he felt that it wasn’t an issue because this is merely an observational, not an interventional, study. I was tempted to ask, “what are you going to do, wait until someone turns gray?”—but I held my tongue.

I was confident, when I asked that question, that the IRB had not considered the issue. IRBs, like most people and most physicians, have no idea what dangers lurk under rocks dignified with labels such as “holistic,” “integrative,” “functional,” and the like. IRBs and investigators, however, are responsible for protecting human subjects, even in purely observational studies. There are numerous ethical and legal bases for this assertion, but for now consider this quotation:

…the lack of treatment was not contrived by the USPHS but was an established fact of which they proposed to take advantage.

That statement is found in the minutes of a meeting at the CDC, April 5, 1965. It was an attempt by an apologist to excuse the (still extant) Tuskegee Syphilis Study on the grounds that it was merely “observational.” The Yale IRB need only replace “lack of treatment” with “mistreatment,” and “USPHS” with “Yale investigators,” to understand the point. The IRB might also consider that the mere presence of “experts” from Yale will be interpreted by subjects as tacit (at least) approval of the practices and the practitioners.

It is, nevertheless, possible that the qualitative CLD study will yield useful information. More likely, however, is that it will be understood and presented by its authors in a “non-judgmental” way or as sympathetic to the practitioners (see above re: chiropractors), and thus it will be up to those with more savvy to read between the lines.

End of Part I

I just thought I’d make a brief announcement that I’m currently in St. Louis attending the annual meeting of the Society of Surgical Oncology. If any of our St. Louis readers are attending the meeting, look me up. I’d be tickled to death to know whether any of my colleagues here are even aware of SBM, much less regular readers. (If no one is aware, though, I’ll be disappointed.) Heck, if you show me your mad skillz at writing and that you share our philosophy, maybe you can even join us as another blogger here!

Also, if anyone’s interested in attempting a meetup, let me know. I’ll be in St. Louis until Sunday morning. It may or may not be possible, given that the SSO meeting fills each day quite nicely and most evenings have something booked, including meeting up with a former postdoc of mine who happens to be at Washington University now, but you never know until you ask. Unfortunately, Saturday night probably out, unless it’s before 7 PM or after 10 PM. My mentor, Dr. Mitch Posner, is the incoming president of the SSO; so I want to go to the Presidential Banquet that evening.

I spent 43 years in private practice as a “science-based” chiropractor and a critic of the chiropractic vertebral subluxation theory. I am often asked how I justified practicing as a chiropractor while renouncing the basic tenets of chiropractic. My answer has always been: I was able to offer manipulation in combination with physical therapy modalities as a treatment for mechanical-type back pain—a service that was not readily available in physiotherapy or in any other sub-specialty of medicine.

If I had it to do over again, however, I would study physical therapy rather than chiropractic. Considering the controversy that continues to surround the practice of chiropractic, I would not recommend that anyone spend the time, effort, and money required to earn a degree in chiropractic. Physical therapy, which is now beginning to include spinal manipulation in its treatment armamentarium, may offer better opportunity for those interested in manual therapy. Properly-limited, science-based chiropractors are now essentially competing with physical therapists who use manual therapy. Unfortunately, only a few chiropractors have renounced the vertebral subluxation theory, making it difficult to find a “good chiropractor.” I consider physical therapy to be more progressive and more evidence based. For this reason, I generally recommend the manipulative services of a physical therapist rather than a chiropractor.

There are some science-based chiropractors who use manipulation appropriately, but until the chiropractic profession abandons the implausible vertebral subluxation theory and is defined according to standards dictated by anatomy, physiology, and neurology, I would not describe it as a science-based profession.

Heretics and Science-Based Chiropractors

After my second year in chiropractic college, I came to the conclusion that the chiropractic subluxation theory was not a credible construct. In an effort to separate the good from the bad in the use of manipulation by chiropractors, I published my book Bonesetting, Chiropractic, and Cultism in 1963, renouncing the chiropractic vertebral subluxation theory and suggesting that chiropractors should limit their use of spinal manipulation to treatment of back pain. Over the years, I wrote many articles critical of chiropractic, always suggesting that the definition of chiropractic be changed in chiropractic colleges and state laws so that the next generation of chiropractors would be properly limited. Science-based chiropractors could be separated from their subluxation-based counterparts under a new degree, such as a “Doctor of Chiropractic Therapy” (DCT) or a “Chiropractic Manual Therapist” (CMT). I suggested that it would not be necessary for chiropractors to practice as “doctors”—they could practice as therapists offering non-surgical, drug-free treatment for back pain and related musculoskeletal problems, a new specialty combining use of manipulation with physical therapy modalities. Needless to say, this change never occurred and I was labeled a “chiropractic heretic”—or worse—by my colleagues.

Today, the educational requirements for obtaining a degree in chiropractic have improved. Most chiropractic college applicants now have undergraduate degrees. But the basic definition of chiropractic has not changed. As currently defined by the North American Association of Chiropractic Colleges, “Chiropractic is concerned with the preservation and restoration of health, and focuses particular attention on the subluxation,” indicating that the majority of chiropractors may still adhere to a basic version of the subluxation theory. Few chiropractic college graduates may be able or willing to abandon a belief system they must depend upon for an income.

Filling a Need for Manual Therapy

At the present time, spinal manipulation is still not as readily available in medical practice as it should be, leaving an opening for the services of a good?albeit rare?science-based chiropractor who combines manipulation with physical therapy modalities. But it would be necessary for such a chiropractor to openly renounce the chiropractic vertebral subluxation theory (more of a belief than a theory) and publicly state that his or her practice is limited to care of musculoskeletal problems. Unfortunately, as indicated by the paradigm of the North American Association of Chiropractic Colleges, such chiropractors may be in the minority, even among recent graduates?at least in the United States.

High-velocity, low-amplitude (thrust type) spinal manipulation is not yet commonly used by physical therapists. For this reason, orthopedists and neurologists who are familiar with manual medicine are often willing to refer back-pain patients to a good chiropractor for manipulation as well as to steer patients away from subluxation-based chiropractors. Physicians can often locate good chiropractors by reading their office notes and by talking with their patients.

Most cases of back pain are self limiting, and spinal manipulation is not often more effective than other physical treatment modalities in affecting the final outcome. But in many cases, appropriate spinal manipulation may provide more immediate symptomatic relief than other forms of therapy. And in special cases, thrust-type manipulation may be the best way to restore mobility in spines stiffened by post-traumatic adhesions or locked by muscle spasm and binding vertebral joints. For this reason, benefit may outweigh risk when manipulation is used appropriately in the treatment of carefully selected cases of mechanical-type back pain. But there is no evidence to indicate that upper neck manipulation provides more benefit than risk, considering the risk of damage to vertebrobasilar arteries.

Use of manipulation combined with instruction, massage, physical therapy, and rehabilitation may be the best way to relieve mechanical back pain and keep the patient mobile until recovery is complete—provided, of course, that treatment is based on a correct diagnosis. A science-based chiropractor who works in concert with a patient’s physician can often provide such a treatment regimen—as opposed to solo subluxation-based chiropractors whose primary concerns are locating and correcting vertebral subluxations.

Separating the Good from the Bad

Since the vertebral subluxation theory continues to form the foundation of chiropractic, it seems unlikely that the chiropractic profession will ever abandon the belief that adjusting spinal joints will restore and maintain health. Many chiropractors who say that they reject D.D. Palmer’s subluxation theory simply come up with new terminology that identifies some kind of vertebral joint “dysfunction” that allegedly affects the nervous system, thus interfering with the body’s ability to heal itself. Failure of chiropractic colleges to reject such views and make the changes needed to develop chiropractic into a musculoskeletal back-pain specialty (with commensurate changes in state laws) may simply allow chiropractic to continue as an alternative healing method, such as homeopathy or acupuncture, permitting its practitioners to treat the gamut of human ailments as “primary care providers.” It may then be necessary to depend primarily upon physical therapists for appropriate use of manipulation based on credible research. Chiropractors who can no longer tolerate the controversy associated with chiropractic can retrain as physical therapists, making good use of their training in the use of manipulation. Forty-three states now grant physical therapists direct access to patients; that is, referral from a physician is not needed.

Although I am a critic of chiropractic, I would not hesitate to offer support to a good science-based chiropractor who has separated himself or herself from the herd by expressing views that oppose the implausible treatment methods that are so prevalent among chiropractors. When I was in practice as a chiropractor, I felt an obligation to speak out so that friends, patients, and health-care professionals would not assume that my approach represented chiropractic in general. I worried that a patient who was pleased with my services might assume that treatment by any other chiropractor would be the same. Unfortunately, chiropractic treatment based on the implausible vertebral subluxation theory may be so inconsistent that treatment for any condition may range from an atlas adjustment to a sacral adjustment, all purported to be effective in improving health by removing “nerve interference.” So far, apparently reluctant to bite the hand that feeds them, chiropractic associations in the United States have failed to publicly renounce the vertebral subluxation theory or to condemn the multitude of dubious treatment methods based on subluxation theory.

Today, chiropractic treatment in America is like Forrest Gump’s box of chocolates: “You never know what you’re gonna get.”

Why the Chiropractic Vertebral Subluxation Theory Is Implausible

Scientific consensus does not support the theory that nerve interference caused by vertebral misalignment is a cause of organic disease. Spinal nerves primarily supply musculoskeletal structures. Organ function is governed by the autonomic nervous system in concert with psychic, chemical, hormonal, and circulatory factors.

The vagus nerve is an autonomic (parasympathetic) cranial nerve that originates in the brain stem and passes down through the neck and thorax to the abdomen to supply organs along its path. Preganglionic autonomic fibers, which pass through spinal segments from T1 thru L2, terminate in sympathetic trunk and splanchnic ganglia located outside the spinal column. Autonomic cranial and sacral nerves pass through solid bony openings.

The vagus nerve along with autonomic ganglia and nerve plexuses provide overlapping sympathetic and parasympathetic nerve supply from many directions to assure continued function of the body’s organs, independent of spinal nerves. This is why a transverse spinal cord injury at the C4 or C5 level can paralyze musculoskeletal structures from the neck down while involuntary functions of organs continue. With this fail-safe mechanism in place, I don’t know of any reason to believe that slight misalignment of a single vertebra or an undetectable “vertebral subluxation complex” can be a cause of organic disease as suggested by the chiropractic vertebral subluxation theory.

Spinal nerves are commonly compressed by bony spurs and herniated discs. Even the most severe compression of a spinal nerve, which may cripple the supplied musculoskeletal structures, does not cause organic disease. The sphincter muscles involved in voluntary control of bladder and bowel functions are supplied primarily by spinal nerves and sympathetic fibers that are well protected in their passage through the solid bony openings that form the sacral foramina.

When there is disc protrusion into the spinal canal, or when there is a space-occupying mass in the spinal canal compressing cauda equina spinal nerves that travel down (from the conus medullaris at the lower border of the 2nd lumbar vertebra where the spinal cord ends) to exit lumbar and sacral foramina, loss of voluntary control of bladder and bowel muscles (most commonly urinary retention) signals a medical emergency that requires the immediate attention of a neurosurgeon.

Implausible Theory Fosters Implausible Treatment Methods

The implausibility of the chiropractic vertebral subluxation theory does not provide a foundation for a consistent, replicable treatment method. As a result, vertebral subluxation theory has fostered the development of a great variety of antithetical chiropractic treatment methods designed to “remove nerve interference,” many of which do not involve use of hands-on manipulation—such as healing touch or use of a spring-loaded stylus to tap vertebrae into alignment. Such treatment methods are unrelated to legitimate use of manual manipulation in the treatment of back pain and related musculoskeletal problems.

The chiropractic (undetectable) “vertebral subluxation complex” is not the same as a true vertebral misalignment, a true vertebral subluxation, or any one of a number of joint problems that cause mechanical-type symptoms (which can often be relieved by manipulating the spine) but are not alleged to be a cause of visceral disease.

Proper treatment hinges on a proper diagnosis, which, in my opinion, is never a “vertebral subluxation complex.”

 Sleep that knits up the ravelled sleeve of care
The death of each day’s life, sore labour’s bath
Balm of hurt minds, great nature’s second course,
Chief nourisher in life’s feast.    -William Shakespeare, Macbeth

The company that makes the Zeo Personal Sleep Coach  kindly sent me one of their devices to try out. It’s a nifty little gadget, and if you are a techno geek, you would probably love it. It’s a fascinating toy; but for insomnia, there’s no evidence that it provides any benefit over standard treatment with sleep logs and sleep hygiene advice.

Polysomnography is done overnight in a sleep lab and costs around $1000. It records multiple parameters: EEG, EKG, EMG, breathing, O2, CO2, and limb movements. It is most commonly used to diagnose obstructive sleep apnea (OSA), a serious condition that is linked to hypertension, heart disease, diabetes, metabolic syndrome, stroke, and increased mortality. OSA can be effectively treated with CPAP and other measures. About 50% of snorers have sleep apnea. We typically think of it as a disease of obese, loudly snoring older men, but even young children can have it: snoring is probably never normal in children and should be investigated.

The Zeo is the first sleep monitor available for consumers to use at home. It doesn’t pretend to do what polysomnography does. It can’t diagnose sleep apnea. It is billed as an educational and motivational tool, not intended for the diagnosis or treatment of sleep disorders. A unit that looks sort of like an alarm clock sits on your bedside table and communicates wirelessly with a comfortable soft elastic headband that positions embedded sensors over your forehead to pick up your brain waves.

It provides a graph of the entire night showing when you were awake, in light sleep, deep sleep and REM sleep. It gives a readout of how many minutes you were in each stage and how that compares to your average readings. Most importantly, it gives a ZQ score: a single number that adds the “good sleep” numbers and subtracts the awakenings to provide a single score that you can use to compare your sleep quality from night to night and to compare your sleep to that of the average person of your age.

The information can be uploaded to the Internet and viewed on the company’s website. It is then used to provide individualized coaching. 6 months of coaching is included in the purchase price of $399, and it can be extended for another 6 months for $99.

Normal sleep architecture:

• We should not fall asleep the moment our head hits the pillow: that indicates a sleep deficit. It normally takes 20 minutes or so to get to sleep.
• REM (Rapid Eye Movement): 20-25% of total sleep time. Normally absent during the first 90 minutes of sleep and then occurs about every 90 minutes. Was thought to be the stage where dreams occur, but now we know dreams occur in every stage of sleep.
• NREM (Non-Rapid Eye Movement): 75-80% of total sleep time. Includes light sleep and deep sleep.
• Awakenings during the night are normal and more common as we age. We don’t remember awakenings that last less than a minute. The Zeo registers awakenings that last at least 2 minutes.

According to the manufacturer, two scientifically controlled studies have compared the Zeo’s sleep stage readings to polysomnography readings and found them valid. But how useful is it to know this information? We don’t know what the optimal time in each stage is, and we don’t yet know how to increase REM sleep even if we wanted to. One uncontrolled pre-marketing study found that home users reported significant improvements in the quality of their sleep and better functioning in the daytime, but with no control group these results are uninterpretable.

The ZQ score is an arbitrarily constructed score that has not been validated. If your score goes up 10 points are you really sleeping better? Is it a useful measurement? It is handy in one sense: my husband used to ask me if I slept well, and I would answer “yes” or “no” or “fairly well I guess.” Now I can tell him “68” or “93.” I can see a downside: it would be easy to become psychologically dependent on these numbers and obsess if your score went down. I lent my machine to a friend to try, and immediately found myself missing it. I had come to look forward to seeing my ZQ report every morning.

I chose not to try the online sleep coaching because I thought I could do my own coaching. It’s not hard to read about sleep hygiene measures and apply them, to notice whether the ZQ score goes down if you drink coffee in the evening, etc.

Zeo offers another intriguing service. You can set the alarm and ask it to wake you up to half an hour earlier, picking a time that you are in the stage of sleep that is easiest to awaken from, so you are not violently jolted awake from a deep sleep. I don’t use an alarm (I’m retired and have the luxury of sleeping until I wake naturally) so I didn’t get to try this function out. I don’t know if the benefits of gentle awakening would outweigh the harm of being awakened up to half an hour early and having total sleep time reduced.

Insomnia is a common problem and sleeping pills are not the answer. Insomnia can be treated effectively by cognitive behavioral therapy (CBT): it works to some extent in almost all patients, and has long-term success. It involves counseling in sleep hygiene, cognitive therapy and stimulus control therapy, and when necessary, sleep restriction therapy. It corrects misunderstandings about normal sleep, establishes realistic expectations, and uses simple relaxation techniques and measures like establishing regular sleep hours and a quiet 30-to-60 minute pre-bedtime routine, avoiding caffeine and alcohol, getting out of bed when you can’t sleep, using the bed only for sleep and sex, exercising during the day but not close to bedtime, keeping the bedroom quiet and at a comfortable temperature, banishing pets from the bedroom, addressing stress issues. Patients are instructed to keep a sleep diary, recording how long they slept, how often they woke up during the night, how refreshed they felt in the morning, whether any factors disturbed their sleep, when they exercised, when they drank coffee or alcohol, etc. It’s hard to see how the Zeo could add anything important to this approach except as a crutch to help motivate patients who are not initially cooperative. What I would like to see is a controlled study comparing optimum sleep hygiene and cognitive behavioral therapy to the use of a Zeo and online sleep coaching. One problem would be picking a reliable measure of sleep improvement to assess outcomes.

The Zeo program might turn out to be the best initial approach to insomnia, since it is less expensive than multiple office visits with a provider for CBT. But I wonder if a web-based program providing the same information about sleep hygiene and giving feedback and encouragement might be just as effective without the device. Pending controlled studies, I will have to assume that it is just a gimmick to enlist patients in doing what they should be doing anyway.

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Note: My source for the information about normal sleep, sleep apnea, and treatment of insomnia was a CME course on sleep disorders that I attended in Seattle on Feb. 20, 2010, sponsored by the AAFP in conjunction with the American College of Chest Physicians and presented by a panel of experts in sleep disorders.

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One of the basic principles of science-based medicine is that a single study rarely tells us much about any complex topic. Reliable conclusions are derived from an assessment of basic science (i.e prior probability or plausibility) and a pattern of effects across multiple clinical trials. However the mainstream media generally report each study as if it is a breakthrough or the definitive answer to the question at hand. If the many e-mails I receive asking me about such studies are representative, the general public takes a similar approach, perhaps due in part to the media coverage.

I generally do not plan to report on each study that comes out as that would be an endless and ultimately pointless exercise. But occasionally focusing on a specific study is educational, especially if that study is garnering a significant amount of media attention. And so I turn my attention this week to a recent study looking at acupuncture in major depression during pregnancy. The study concludes:

The short acupuncture protocol demonstrated symptom reduction and a response rate comparable to those observed in standard depression treatments of similar length and could be a viable treatment option for depression during pregnancy.

Plausibility

The study compared acupuncture designed specifically to treat depression, and in fact tailored to the individual patient, according to principles of Traditional Chinese Medicine (TCM). This was compared to two control groups – a control acupuncture that was not specific to depression and massage. The comparison to massage was obviously not blinded and therefore, in my opinion, of very little value as depression is highly susceptible to non-specific therapeutic effects and both interventions – acupuncture and massage – would be likely to create such non-specific effects.

The interesting aspect of this study is the comparison between treatment acupuncture (targeted for depression) and control acupuncture (not targeted for depression). The purpose of the study was to control, as much as possible, for any other variables so as to determine if the underlying TCM principles have any validity – does it matter where the needles are placed?

We can really only put this study into context if we first consider the prior probability of this claim. I would argue that there is already a large body of acupuncture research that collectively shows needle placement as a variable has no effect on clinical outcome. This one study does little to alter the balance of that evidence.

Further, from a basic science point of view, the TCM principles have essentially no plausibility. The underlying theory is that there is an undetected life force (chi) that is partly responsible for health and illness, that acupuncture needles placed in specific acupuncture points alters the flow and strength of this energy, resulting in a clinical outcome. Chi has no existence in science, however. Vitalistic philosophies such as chi were discarded over a century ago as both unnecessary and without any empirical foundation.

Any modern attempts to explain acupuncture effects with known physiological phenomena might explain non-specific needling effects, but cannot explain any differences due to needle placement, and do not provide any explanation for the location of alleged acupuncture points.

Therefore, given the extremely low prior probability of the claims of this study, nothing short of a large rigorous and replicated study would alter our assessment of validity of acupuncture as a specific intervention.

The Current Study

This new study, published in the Obstetrics and Gynecology, is not of sufficient quality to justify the conclusions of the authors. The authors did do a decent job of trying to rigorously control the comparison between the two acupuncture groups. Subjects were blinded to which group they were in, as were those evaluating the outcome. Standard depressions scales were used. They even made a reasonable attempt to blind the acupuncturists, using a novel method (to my knowledge).

They had experienced acupuncturists design a treatment and control acupuncture regimen for each subject, and then had a “junior acupuncturist” (less than two years experience) perform the treatment without being told which one they were giving.

This, in my opinion, in the crux of the methodology – were the treating acupuncturists properly blinded. The study authors took the very useful step of assessing the degree of blinding of the acupuncturists and the subjects. Unfortunately for the validity of the study, they found that the treating acupuncturists were significantly more likely to have positive expectations for the treatment group than the control group – so their blinding methods failed with respect to the treating acupuncturists. The study was therefore, at best, single blinded. Test subjects did not have any significant difference in expectations.

Because depression is so amenable to non-specific therapeutic effects, the expectations of the treating acupuncturist can plausibly have had a significant effect on the final outcomes. This is the primary weakness of the study – but there are other worth mentioning.

The author also, for some reason, did not stratify the test subject according to race, and there turned out to be significantly more African Americans in the control acupuncture group than the treatment group. Cultural beliefs can have a significant effect on responses to different kinds of placebos, particularly needles. This is therefore a potential, if unknown, confounder.

The results were also not impressive. The study used the Hamilton Rating Scale for depression:

Interpretation of Hamilton Rating Scale for Depression scores is as follows: less than 7, nondepressed; 8–13, mild depression; 14–18, moderate depression; 19–22, severe depression; more than 23, very severe depression.

At 8 weeks the control acupuncture groups has about a 9 point drop in the scale, while the treatment acupuncture group dropped 11.5 points. On this scale that is a modest clinical effect. There was also no difference in remission rates among the three groups. In addition this was a relatively small study (141 treated in total, divided among the three groups) with a 23% drop out rate.

Conclusion

Therefore we have a small and improperly blinded and randomized study showing a modest clinical effect. This does not significantly alter the low prior probability of a treatment effect from needle placement.

This study should also be considered in the context of other trials looking at acupuncture and depression. This very recent Cochrane review concluded:

We found insufficient evidence to recommend the use of acupuncture for people with depression. The results are limited by the high risk of bias in the majority of trials meeting inclusion criteria.

Specifically – there was no difference between verum acupuncture and sham acupuncture in the clinical trials reviewed.

Given the low plausibility and overall negative character of the clinical evidence, it is reasonable to conclude that no further research into acupuncture for any indication is warranted. However, acupuncture is a modality with dedicated practitioners (acupuncturists) and proponents (by contrast, for example, there is no medical specialty dedicated to a particular drug – there are no penicillinists). And therefore it is likely that further research will be conducted.

In that event, given existing research, it would be useful to conduct only highly rigorous trials, using sham and/or placebo acupuncture (where the needle or fake needle does not penetrate the skin) with adequate blinding. Such trials would need to be large with consistent replicated positive results in order to have sufficient weight to overturn the current mass of basic and clinical evidence.

When one of the worst natural disasters in history hit Haiti earlier this year I worried what sorts of  alternative medicine “help” the Haitians might have thrust upon them.  From around the world, health care workers with expertise in trauma and disaster relief offered their skills, realizing that anyone who came to Haiti must bring with them a lot of value—taking up valuable space, food, and water without providing significant benefit will hurt far more than help.

But others have used this disaster to benefit themselves and their own quasi-medical cults.   There have been many reports of the Church of Scientology’s faith healers walking around in yellow t-shirts trying to “assist” people’s nervous systems.  Homeopaths, the folks who sell water panaceas, have been offering to “help” as well.

Poor and less-industrialized countries are a target-rich environment for alternative medicine cults, but may conversely be a tough nut to crack.  Since many alternative medicines don’t require an industrial base, they can be made readily available anywhere.  Homeopathy is just water;  if a homeopath can simply provide a water remedy that contains fewer fecal coliforms than the local water, they can get away with quite a bit before people realize they’ve been duped.  In fact, unless a population has had exposure to real medicine, the altmed folks can fool people for a very long time. But hungry people can also be very pragmatic, and they know that eating grass will only give a false satiety.  The same may be true of medical help.

When face with an immediate threat to life and limb,  most people find out rather quickly the difference between real and fake medicine.  In rich countries such as the U.S., people have the luxury of indulging in alternative remedies.  We have good public sanitation and vaccination and so suffer more from diseases of excess rather than those of desperate poverty.  If you have access to food and clean water, so much that you even consume to excess, then you may have time to explore fake cures.  But when the feces hits the rotating blades…

From our friends to the north (and my email from Dr. Gorski) I learned about a naturopath’s struggle to provide help to Hatitians post-quake.  Canada seems to have a serious naturopath problem.  Naturopaths in Canada tried to co-opt the flu pandemic with a worse-than-misleading educational campaign, and have made in-roads into getting the same rights as real doctors (without the concomitant responsibilities—we real doctors have to have at least some evidence on our side).

So it was with no small amount of Schadenfreude that I read about a naturopath’s failure in Haiti (but also sadness for the Haitian people for being subjected to him).  Denis Marier, a naturopath practicing not far from me, took his altruistic impulse and a whole lot of fantasy and boarded a plane for Hispanola.  His particular medical fantasy seems to be centered around vitamin C.

I’m also trying something new this mission – intravenous vitamin C injections to assist with tissue and wound healing. I don’t have access to refrigeration, but should be able to keep the vitamin C, calcium, magnesium, selenium and zinc stable for a few days. I’ve brought enough from my clinic to give approximately 100 treatments of 5 grams of vitamin C plus support minerals.

Well, I’m sure that vitamin C will fix up those traumatic amputations just fine.  And with neonatal tetanus, it sure couldn’t hurt, right?

The elderly lady with the maggots in her sinus cavity from an earthquake injury went to surgery today – she’s expected to recover well. I’m hoping the IVC administered over the last several days, as well as the homeopathic (Pyrogenium) have contributed to her positive prognosis.

You can hope all you want, but unless devitalized tissue is debrided, no amount of magic water will help.   In an unsanitary environment like a disaster zone, any extra skin punctures simply add to the risk of infection, so rather than being simply useless, Mr. Marier’s medicines are likely to cause additional harm.  The Haitians seem none too impressed with Mr. Marier anyway:

Unfortuantely, as I’ve experienced on previous missions, the local community is arriving at a free “medical clinic” expecting medications, not homeopathic remedies to help with post-traumatic stress from the original disaster.

Those pesky Haitians!  Coming to a medical clinic expecting medical help!  You’d think centuries of crushing poverty would have sucked the hope out of them by now, but apparently they still expect medical clinics to practice medicine.  According to the Globe and Mail report:

After he saw two patients the lineup just melted away, he told me, frustrated, towards the end of his final day. Before he [Marier] left, he disposed of the leftover injectable Vitamin C he brought with him from Canada (it’s a new-ish remedy, apparently, to stimulate tissue healing) because he was worried that, in his absence, it would be used improperly. When I left him, he was also contemplating disposing of a huge load of traumeel, a homeopathic anti-inflammatory.

Yeah, let’s hope all that magic water doesn’t fall into the wrong hands.

I understand the altruistic impulse; it’s largely responsible for my decision to go into medicine.  But an altruistic impulse directed improperly can cause great harm.  Marier sounds like a nice guy who has his heart in the right place.  Maybe he and people like him can refocus his efforts on providing real help, such as raising cash for MSF or PIH, organizations with a track record of providing real help.

It’s been a rather eventful week here at Science-Based Medicine. I apologize that I don’t have one of my usual 4,000 word epics ready for this week. I was occupied all day Saturday at a conference at which I had to give a talk, and Dr. Tuteur’s departure produced another issue that I had to deal with. Fortunately, because Dr. Lipson is scheduled to do an extra post today, I feel less guilty about not producing my usual logorrhea. Who knows? Maybe it will be a relief to our readers too.

This confluence of events makes this a good time to take a break to take care of some blog business and make formal what I alluded to on Thursday in the comments after I announced Dr. Tuteur’s departure, namely that it’s time for us at SBM to start recruiting. Our purpose in recruiting will be to make this blog even better than it is already. We have an absolutely fantastic group of bloggers here, and it is due to their hard work and talent that SBM has become a force to be reckoned with in the medical blogosphere. Our traffic continues to grow, and reporters and even on occasion governmental officials have taken notice. That’s why Dr. Tuteur’s departure makes this a perfect opportunity to build on that record and make SBM even better and a more essential as a source of medical commentary than it is already. To accomplish this goal, it’s clear that any recruitment cannot be simply to fill in a gap in our posting schedule. I would much rather have a weekday go without a post every now and then than to recruit the wrong person to take over Dr. Tuteur’s spot. As a result, I hope to make this recruitment more strategic and to do it in a more formal manner than we have perhaps done in the past. We also plan on taking our time and therefore ask your patience.

To this end, I’m going to ask for nominations, either self-nominations or nominations of others, as suggested bloggers for SBM. Please also include a link to the nominee’s blog or, if the nominee is not a blogger or otherwise known for skeptical writings regarding medicine elsewhere (such as R. Barker Bausell), samples of his or her writing about topics relevant to SBM. I will compile the list over the next couple of weeks; our bloggers will discuss and vet the candidates; and we will decide whom we want to try to persuade to join us, either as a regular weekly blogger (currently Harriet Hall, Steve Novella, and me), an every-other-week blogger (currently Peter Lipson, Mark Crislip, Val Jones, and Joe Albietz), a monthly blogger (currently Kim Atwood), or an occasional contributor (currently Wally Sampson, David Ramey, John Snyder, Tim Kreider, and David Kroll). Finally, if you’re nominating yourself, please specify how often you are interested in contributing and tell us a bit about yourself and your background. Also realize that we do require our bloggers to write under their own names. No pseudonyms will be permitted, at least not on this blog.

So where do we need the most help? A number of you, as well as a number of SBM bloggers, came up with excellent suggestions for priority areas where our readers what to see more material or where we are weak here at SBM. These areas include, in no particular order:

• OB/GYN, including childbirth, pregnancy, and general women’s health issues.
• Nutrition. We could really use a good, science-based nutritionist.
• Psychology and/or psychiatry. As has been pointed out to us, there’s a lot of woo in the world of mental health.
• Statistics. We could use a good statistician to analyze research methodology.
• Epidemiology. As has also been pointed out to us, there is a lot of abuse of epidemiology out there.
• Nursing. There’s a lot of woo in nursing, unfortunately, be it “therapeutic touch” or other woo.
• Medical-legal. Although only one person suggested this, I think this is an excellent idea. What are the medical-legal implications of CAM? Why can’t state medical boards shut down quacks? What does the DSHEA really mean?
• Medical ethics. There are profound ethical implications involved in CAM, in particular whether or not truly “informed” consent is even possible for CAM trials.

If you, dear readers, have any other suggestions, please let us have them. Either leave them in the comments or e-mail me directly at gorskon@gmail.com. Please do not e-mail me at work. I keep my work and blog business as separate as possible, which is why in general I do not respond to blog-related e-mails sent to me at work.

Finally, be aware that SBM is about more than this blog. As you may recall, we’ve arranged one symposium at TAM7, and we plan on doing two workshops at TAM8. We frequently consult with each other on issues of SBM. Sometimes we argue, and this is good. We aren’t looking for clones of one or more of us; we are looking for unique viewpoints who can defend and discuss science-based medicine while writing cogently and entertainingly about it. If you want to do more than that, such as giving talks, participating in workshops, and in general agitating to increase the role of science in medicine, and, as was laid out in the very first post on this blog, here’s why:

The philosophy of this blog, at its core, is simple: Safe and effective health care is critical to to everyone’s quality of life; so much so that it is generally considered a basic human right. The best method for determining which interventions and health products are safe and effective is, without question, good science. Therefore it is in everyone’s best interest for health care to be systematically evaluated by the best science available.

And:

This is why the authors of this blog strongly advocate for science based medicine – the use of the best scientific evidence available, in the light of our cumulative scientific knowledge from all relevant disciplines, in evaluating health claims, practices, and products. The authors are all medically trained and have spent years writing for the public about science and medicine, tirelessly advocating for high scientific standards in health care. Together, and with contributions from other medical science writers, they will turn a critical eye toward all issues relating to science and medicine. They hope to make the Science Based Medicine blog a vital resource for consumers, providers, regulators, the media, and anyone interested in quality health care.

Although our visibility and number of SBM bloggers have increased greatly in the two years since those words were written, our vision and purpose have not. We’re just looking for new people who share that vision and purpose to help us realize them. This time we are asking for your help.

“Conversation about the weather is the last refuge of the unimaginative.” – Oscar Wilde

I will state my bias up front.  I am convinced by the preponderance of data in favor of man made global warming.  At the most simplistic level, I can’t see how converting humongous tons of fossil fuel into CO2 and dumping it into the the atmosphere cannot have effects on the climate.  To my mind its like determining vaccine efficacy or evolution.  Plausible mechanism(s), good basic science, multiple studies using different lines of evidence that all come to the same conclusion.  There are lots of fine points and nuances to be worked out, but the basic truth is reasonable and well defined. Infectious diseases lend some validation to the concept that the world is warming, since with global warming comes a variety of infectious diseases.

It is one big IF:THEN statement.  IF global warming, THEN infections.  Of course  if the IF is not true, then the THEN doesn’t follow.

There is the weather, which the Action Channel News never seems to get right, and I will spare you the Mark Twain quote even though I think he is our best writer ever,  and there is the climate, the summation of weather over time.

Interestingly, infections have probably altered climate for short periods of times.  Through history humans burned trees releasing CO2, chopped down forests for agriculture and raised animals, releasing methane.  As humans populations increased, both CO2 from burning and methane from animals increased as well.  Every now and then large numbers of people have died off.  It happen when Columbus et. al. brought infections to the New World and when plague came to the Old.  People died.  Maybe 90% in the Americas (estimates vary widely) and 2/3’s of Europe died.  As a result, burning fuel and agriculture decreased, decreasing emissions and forests grew back, sequestering CO2.  And temperature rise slowed or decreased.

“Abrupt reversals of the slow CO2 rise caused by deforestation correlate with bubonic plague and other pandemics near 200-600, 1300-1400 and 1500-1700 A.D. Historical records show that high mortality rates caused by plague led to massive abandonment of farms. Forest re-growth on the untended farms pulled CO2 out of the atmosphere and caused CO2 levels to fall. In time, the plagues abated, the farms were reoccupied, and the newly re-grown forests were cut, returning the CO2 to the atmosphere…Moreover, if plague caused most of the 10-ppm CO2 drops… it must also have been a major factor in the climatic cooling that led from the relative warmth of 1000 years ago to the cooler temperatures of the Little Ice Age.”

Like all good scientists, he notes the problems with his conclusions

“A more complete assessment of the role of plague- driven CO2 changes in climate change during the last millennium would require a narrowing of uncertainties in both the spatial and temporal occurrence of plague and in the amount of farm abandonment (and reforestation), as well as a resolution of the inconsistencies among the CO2 trends from different Antarctic ice cores.”

An Earth Abides die off of humans is not the correction for global warming I would suggest,  but it is a fascinating association between infectious human deaths and climate change.

As the weather changes, for a week, a season, or over a  longer period of time, the incidence and distributions of  infections change.  Infections could increase or decrease due to something as simple as temperature or humidity.

Or it could be more complex.  Increased rainfall could lead to more food, which could lead to a boom in the rodent population, leading to more interactions of humans and mice, and the next thing you know you have bubonic plague in India or a Hanta virus outbreak in the four corners of the US.

The daily weather makes a difference in infection risk.  My favorite example is Legionella pneumonia, which increases shortly after thundershowers and humid weather.  It may explains why we do not have a lot of Legionella in the NW despite all the rain; it is rarely hot and humid.

In Philadelphia,  Legionella

“Cases occurred with striking summertime seasonality. Occurrence of cases was associated with monthly average temperature (incidence rate ratio [IRR] per degree Celsius, 1.07 [95% confidence interval [CI], 1.05-1.09]) and relative humidity (IRR per 1% increase in relative humidity, 1.09 [95% CI, 1.06-1.12]) by Poisson regression analysis. However, case-crossover analysis identified an acute association with precipitation (odds ratio [OR], 2.48 [95% CI, 1.30-3.12]) and increased humidity (OR per 1% increase in relative humidity, 1.08 [95% CI, 1.05-1.11]) 6-10 days before occurrence of cases.”

There was a recent study that showed increases in Legionella in roadside puddles after a rain.  I ask the housestaff to look for Legionella after thundershowers and I usually get a case or two, although it may just be due to increased diagnostic testing.  The last case of Legionella had spent the day mucking about in his backyard puddles after a thundershower.

Can you catch a cold when the weather is cold? Maybe.  It has been a topic of interest since the dawn of the medical literature.

“The average outdoor temperature decreased during the preceding three days of the onset of any RTIs, URTI, LRTI or common cold. The temperature for the preceding 14 days also showed a linear decrease for any RTI, URTI or common cold.”

More interesting are the infections associated with El Nino oscillations, where the ocean temperatures vary on a 3 to seven to year cycle, leading to alternating wet and dry weather.  As a result

“In North America, El Niño creates warmer-than-average winters in the upper Midwest states and the Northwest, thus reduced snowfall than average during winter. Meanwhile, central and southern California, northwest Mexico and the southwestern U.S. become significantly wetter while the northern Gulf of Mexico states and Southeast states (including Tidewater and northeast Mexico) are wetter and cooler than average during the El Niño phase of the oscillation. Summer is wetter in the intermountain regions of the U.S. The Pacific Northwest states, on the other hand, tend to experience dry, mild but foggy winters and warm, sunny and early springs.”

Changes due to the El Nino lead to changes in the incidence of a huge variety of infections: an example, I think, from WHO. This picture is in my files without reference.

Climate change will affect the distribution of disease vectors such as insects and snails.  Vectors may thrive with increased temperatures or they may die off, but more likely the vectors, like mosquitos, will move.  It has been estimated that half of everyone who has ever died has died from a mosquito borne illness (I admit I heard this numerous times at ID lectures but do not have reference, at least there is a solution).  As it gets warmer, mosquitos can either go up in elevation or North.  It seems that they are doing both.

Dengue has appeared at higher altitudes than previously reported in Costa Rica (at 1,250m),and in Colombia and India (at 2,200m).The previous range was temperature limited to approximately 1,000 metres above sea level.

In Mexico, the dengue vector (Aedes aegypti) has been detected at 1,600 metres; transmission of dengue was unknown above 1,200m before 1986. There have been cases of dengue near or above the altitude or latitude limit of transmission and would be vulnerable to the small increases in temperature that have occurred across these regions.

Dengue has, by serology, infected 40% of the populations of Brownsville Texas, as the disease slowly moves north.

“In the fall of 2004, during a period of endemic dengue transmission, a cross-sectional survey was conducted in these two cities,4 and dengue incidence and prevalence were measured. In Brownsville, the incidence was 2%, which, if extrapolated to the 2005 population of the city (using the 95% confidence interval), projected between 837 and 5,862 recent infections. Similarly, the prevalence was 40%, with a range from 56,948 to 75,372; these values are relatively similar to those obtained from Brownsville in 2005. “

Other examples of climate-related changes in the prevalence or distribution of pathogens and their vectors include the resurgence of Mediterranean spotted fever in Spain and Italy, the recent epizootic of African horse sickness in Iberia,the resurgence of plague in parts of southern Africa,increased incidence and geographic spread of algal blooms, outbreaks of opportunistic infections among seals,and the spread and establishment of pathogens and vectors in Switzerland. More than mosquito born illnesses are changing in prevalence.

Hanta is increasing in Belgium.  There has been an increase in the average temperature which has lead to increased broadleaf trees, with increased seeds, with increased voles, which carry Hanta, which infected humans to cause renal failure .

Oceans are getting warmer and supporting infections.  Vibrio was not found in Alaskan oysters as the water was too cold.  The water temperature was always less than 15 C.  No longer.  The mean temperature has increased each year since 1997  and now supports the growth of V. parahaemolyticus with resultant outbreaks.  Other oceanic infectious diseases are increasing as well.

However, not all is doom and gloom.  Some infections may fade with global warming. For example, RSV may be disappearing as England warmsm.

“The seasons associated with laboratory isolation of respiratory syncytial virus (RSV) (for 1981–2004) and RSV?related emergency department admissions (for 1990–2004) ended 3.1 and 2.5 weeks earlier, respectively, per 1°C increase in annual central England temperature ( and .043, respectively). Climate change may be shortening the RSV season.”

Diseases that may increase in the US or become endemic again include malaria, dengue, and Leishmaniasis.  A 4 degree rise in temperature could allow dengue to exist as far north as Winnipeg and malaria to be in all of Europe. Seems to be a good trade off to me: more dengue and malaria, less RSV.

Good times for an infectious disease doctor.

These studies are representative of the literature (such a better phrase than cherry picking), not a comprehensive review of the topic.  Personally, I find this adjunctive data compelling  support of global warming, at least over recent times (deliberately worded to not commit to the meaning of recent.)  This does not include all the other potential interactions between human behaviors and changes in the weather that result in an increase in infectious diseases.  Even simple local changes can lead to the unexpected increase in the risk of diseases.

“Adjustable rate mortgages and the downturn in the California housing market caused a 300% increase in notices of delinquency in Bakersfield, Kern County. This led to large numbers of neglected swimming pools, which were associated with a 276% increase in the number of human West Nile virus cases during the summer of 2007.”

All the neglected pools became mosquito breeding grounds, and the disease spread was exacerbated in part by a drought that altered bird populations from resistant finches to susceptible sparrows that were not immune to West Nile, allowing the disease to spread.  The result, I suppose, of failed flock immunity.

Imagine how war, human migration, starvation will interact with climate change to increase or alter the spread of malaria, Tb and some infection that no one can predict.  If H1N1  and SARS proved anything, it is whatever new infection will sweep  across the world , it will not be the infection we predict. Who would have thought in 1989 that the next decade would see West Nile virus, never seen the the US, arrive to the continent in a migrating goose and become endemic. When I started medical school in 1979, there was no AIDS.

Maybe its just the weather, the season, and not climate change that is causing the change in the epidemiology of infections.  I do not think so.  I think these infectious disease associations lend credence to climate change. Another line of converging evidence in support of global warming.

Since it is getting warmer, maybe I will finish with a little Twain after all.

“When a person is accustomed to 138 in the shade, his ideas about cold weather are not valuable….In India, “cold weather” is merely a conventional phrase and has come into use through the necessity of having some way to distinguish between weather which will melt a brass door-knob and weather which will only make it mushy.”  - Following the Equator

The House of Commons Science and Technology Committee (STC) has released a report, Evidence Check 2: Homeopathy, in which they recommend that the NHS stop funding homeopathy. The report is a rare commodity – a thoroughly science-based political document.

The committee went beyond simply stating that homeopathy does not work, and revealed impressive insight into the ethical, practical, and scientific problems caused by NHS support for an implausible and ineffective pseudoscience.

The STC formed in October of 2009, and this is their second report. The goals of the STC itself are significant step forward:

The purpose of Evidence Check is to examine how the Government uses evidence to formulate and review its policies.

We certainly can use more of that.

What Is Homeopathy

The report is impressive in its accuracy and insight, starting with its definition of homeopathy. It states that homeopathy is:

based on two principles: “like-cures-like” whereby a substance that causes a symptom is used in diluted form to treat the same symptom in illness and “ultra-dilution” whereby the more dilute a substance the more potent it is…

That is essentially correct. “Like cures like” is another way of stating the ancient superstition of sympathetic magic – the kind of magical thinking that led some ancient cultures to believe that rhino horn is a cure for impotence because of its superficial resemblance to the erect male organ. This is a pre-scientific notion, based upon vitalism or essentialism – that substances contain an essence that can be transferred separate from their physical substance. These notions remain core to homeopathy today.

The report is also careful to state that homeopathic remedies are not the same thing as herbal remedies (a common misconception), even though sometimes they are made from herbs (which are then diluted out of existence).

Ultra-dilutions refers to the homeopathic practice of diluting substances to the point where there is no original substance left – just the water in which it is diluted. This water is then given as a remedy, either by itself or placed on a sugar pill. Dilutions of 30C, or a 1/100 dilution 30 times, or 10^60 dilution are common in homeopathy.

Some Basic Principles

The report then lays out its most basic premise, referring to the National Health Service (NHS):

You have the right to expect local decisions on funding of [...] drugs and treatments to be made rationally following a proper consideration of the evidence.

This may seem like stating the obvious, but it is this very notion – basing medical decisions on reason and evidence – that is being challenged by the so-called alternative medicine culture.

The report also addresses the issue of plausibility – something very important to science-based medicine:

Our expectation of an explanation for a mechanism of action is that it is both scientifically plausible and demonstrable.

But then they add the caveat;

Historically, some medical interventions were demonstrably effective before anyone understood their modes of action. For example, after 150 years of use, there is still debate about precisely how anaesthetics work. It is more important to know whether a treatment works—its efficacy—than how it works.

I would characterize these statements as true  but incomplete. It is not necessary to know exactly how a treatment works in order to be confident that it does work – but these two things are not isolated from each other. They are both part of the overall scientific evidence needed to conclude whether or not a treatment works, and this is relevant to homeopathy. Not knowing how a treatment works in not equivalent to knowing that a treatment is highly improbable (as is the case with homeopathy). Extreme implausibility should affect where we place the threshold of clinical evidence for efficacy.

The report gives an excellent overview of the nature of clinical evidence and the pitfalls of “cherry picking” data to support a biased conclusion. They justify their reliance on meta-analysis of systematic reviews of the best randomized controlled trials.

They follow this up with a discussion of the placebo effect, and how to distinguish placebo medicine from physiologically active medicine. They give a reasonable definition of placebo:

we are attracted to the definition produced by Dr Howard Brody, Director of the Institute of Medical Humanities at the University of Texas Medical Branch, who defined the placebo effect as “a change in a patient’s illness attributable to the symbolic import of a treatment rather than a specific pharmacologic or physiologic property”. According to this definition, the placebo effect does not necessarily require a dummy treatment. It is important to remember that when patients receive an efficacious treatment, they may benefit from a placebo (non-specific) effect as well as the specific effect of the treatment. Brody’s definition also allows for a wider range of non-specific effects, such as the doctor patient relationship, to be relevant to the placebo effect.

They also address the issue of placebo medicine, quoting Edzard Ernst (an outstanding critic of unscientific medicine whose influence on the findings of the committee is clearly seen).

I would argue it is unnecessary, unreliable and unethical to prescribe placebos through the NHS; unnecessary because if you do it well then an active treatment will also generate a placebo effect. If I give my patient an aspirin for his or her headache and I do it with empathy, time and understanding this patient will benefit from the pharmacological effect of the aspirin and she will also benefit from the placebo effect through the encounter with her clinician. It is unreliable and there is lots of data to show that placebo effects are notoriously unreliable; somebody who responds today may not respond tomorrow; responses are not large in effect size and they are not usually long-lasting. Foremost, it is unethical.

Does Homeopathy Work?

At the risk, of being anti-climactic – the simple conclusion the committee comes to is -no. But they do go through their reasoning in detail. They begin with plausibility, first addressing the principle of likes-cures-like. They correctly dismiss the analogy offered by some homeopaths that like-cures-like is similar to the toxicological principle of hormesis – which essentially states that some substances which are toxic at high doses may be benign and even beneficial at low doses.

However, there are significant problems with the hormesis justification. First, it represents over-extrapolation – just because some substances may display hormesis, that does not mean that most or all substances do. And second, hormesis may apply to low doses, but that is not analogous to the ultra-dilute (essentially non-existent) doses of homeopathic remedies – low dose is not no dose. Hormesis also is not analogous to the homeopathic claim that substances behave differently in well and sick individuals.

They conclude:

We conclude that the principle of like-cures-like is theoretically weak. It fails to provide a credible physiological mode of action for homeopathic products. We note that this is the settled view of medical science.

Next they dismantle the notion that ultra-dilutions can still carry the essence of what was diluted in the substance. This notion has been so thoroughly discredited on this and other scientific sites, I will just jump to their conclusion:

We consider the notion that ultra-dilutions can maintain an imprint of substances previously dissolved in them to be scientifically implausible.

And next we get to the real meat of the report – evidence for efficacy. The committee listened to proponents and critics, and found that homeopathy proponents cherry picked out-dated and fatally flawed studies to support their position, including a lecture series that wasn’t even a systematic review.

Meanwhile, the best reviews of the best evidence clearly show that homeopathy is no better than placebo – which means it doesn’t work. They conclude:

In our view, the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos. The Government shares our interpretation of the evidence. We asked the Minister, Mike O’Brien, whether the Government had any credible evidence that homeopathy works beyond the placebo effect and he responded: “the straight answer is no”.

And then here is the zinger:

We regret that advocates of homeopathy, including in their submissions to our inquiry, choose to rely on, and promulgate, selective approaches to the treatment of the evidence base as this risks confusing or misleading the public, the media and policymakers.

That in our criticism of unscientific medicine in a nutshell. SBM is primarily about methodology, not a set of beliefs or conclusions. SBM is the application of fair and rigorous scientific methods to assessing treatments and medical interventions. The only “alternative” to SBM is not fairly and rigorously applying scientific methods. This includes the kind of biased cherry picking for which the STC now criticizes homeopaths.

More Research?

Many of us on SBM have pointed out before that the common ploy of alternative medicine proponents is to take a weak study, or a study that was clearly negative, and then conclude that even though the study was negative, it shows promise, and therefore we need to fund more research. This creates an endless succession of weak or negative research, calling for more research. The purpose seems to be to use the fact that a modality is being researched as a marketing tool, without ever discarding a modality due to negative research.

At some point, however, it must be reasonable to cross a threshold where we can conclude that there has been enough research and the medical community, with its limited research money, should simply move on. With homeopathy we have a highly implausible treatment that should not work, and the evidence shows convincingly that it in fact does not work. Homeopaths have had 200 years to make their scientific case, and they have completely failed. It is time to move on.

The STC agrees:

There has been enough testing of homeopathy and plenty of evidence showing that it is not efficacious. Competition for research funding is fierce and we cannot see how further research on the efficacy of homeopathy is justified in the face of competing priorities.

In fact, they go further to say that it is unethical to enroll patients into a research study of a treatment that we already know does not work.

Policy Recommendations

Given the soundly negative evaluation of the plausibility and efficacy of homeopathy, and the rejection of placebo medicine, it is no surprise that the STC recommended that the NHS stop funding homeopathy completely. This would include closing, or at least withdrawing funding for, the four homeopathic hospitals in the UK. They further recommend withdrawing licensing by the MHRA (the UK equivalent of the FDA):

We conclude that the MHRA should seek evidence of efficacy to the same standard for all the products examined for licensing which make medical claims and we recommend that the MHRA remove all references to homeopathic provings from its guidance other than to make it clear that they are not evidence of efficacy.

Imagine that – applying a single consistent scientific standard to all claims of efficacy.

The NHS spends about 4 million pounds a year on homeopathy (this is direct costs, and does not include maintenance costs for homeopathic hospitals). This is not much, but any money spent on nonsense is a waste of tax money citizens place in the trust of their government.

The implications of these recommendations go beyond the NHS. They further recommend that EU countries who support homeopathy, such as Germany and France, reconsider their own support for this dubious pseudoscience. It is also quite possible that the withdrawal of official government approval of homeopathy will have a ripple effect, leading major pharmacies to stop carrying homeopathic products.

The STC correctly observes that when the government supports a specific treatment, by either paying for it or for research, this becomes a tacit endorsement of the product or service in the eyes of the public. Therefore, they have a responsibility to get the science right.

Homeopathic Response

Defenders of homeopathy are, of course, not happy with the findings of the STC. I find it amusing that in various news article defenders respond to the accusation that homeopathy supporters use deception and misdirection, by using deception and misdirection. For example, in the Times Online:

Robert Wilson, chairman of Nelsons, Britain’s largest manufacturer of natural healthcare products, said: “There is good evidence that homeopathy works beyond placebo, for example in animals and babies.”

The assumption here is that any effect in a baby or animal cannot be due to the placebo effect, because placebo effects are dependent upon the expectation of benefit. This is a gross misconception, however. Placebo effects can result from the attention of the caregiver or other non-specific effects. Or they can simply be an artifact of observation – the person observing for an effect in the animal or baby may be the one responding to the placebo.

The above statement is simply false – there is no good evidence for the effectively of any homeopathic remedy in any population.

Prince Charles is a big supporter of homeopathy, and representative of his foundation to promote alternative medicine were quoted by the New Scientist:

“For patients suffering from long term disease, where no scientific, evidence based medicine can offer effective treatment, it does not matter how it works,” says the foundation, in a response to the committee’s report. “What matters to them is whether they get better, whether pain and other symptoms are alleviated.”

Michael Dixon, medical director of the foundation adds: “Science is a vital tool in healthcare, but so are compassion and caring and treating patients with dignity. It is not clear that the Committee took that into account.”

The report addressed and dismissed the notion of placebo medicine quite well. But we also see here some common ploys. The first sentence justifies using implausible and ineffective treatments simply because there may not be another alternative – but this is no justification. Resorting to an ineffective treatment will not help someone suffering from an untreatable ailment – it will simply add insult to injury. The statement also begs the question – assuming that patients “get better.” However, it is only through rigorous scientific research that we can know if anyone does benefit from a treatment – and the evidence clearly shows that there is no benefit from homeopathy.

The second statement by Michael Dixon is a despicable bit of bad logic, but also not uncommon. It is primarily a non sequitur – treating patients with compassion and dignity does not alter the scientific evidence. It is also a false dichotomy – as if you cannot have science-based medicine and compassionate medicine at the same time.

Further, I would argue that the most compassionate, caring, and dignified treatment a physician can give a patient is to give them proper informed consent and to prescribe treatments which are actually safe and effective. Using ineffective and implausible treatments is the most uncaring thing a physician can do, and prescribing placebos as if they were real medicine is an assault on the dignity of a patient.

Conclusion

The STC report is an impressive document defending many of the core principles of science-based medicine and rational regulation of medical practice and products. If the document were crafted by the authors of SBM itself I do not think we could have improved much upon it.

It remains to be seen what impact it will have – we can only hope that it is extensive and immediate.

It is heartening that a political body can thoroughly review the evidence, receiving testimony offering differing opinions, and come to a so thoroughly science-based conclusion. Its condemnation of homeopathy and the behavior of homeopaths is accurate and devastating.

I would like to see the recommendations replicated in the US and elsewhere. The FDA, for example, should withdraw its automatic approval of the homeopathic pharmacopoeia.

But perhaps even more important than its potential effect on homeopathy specifically, is the potential for this type of analysis, and the basic principles expressed in the report, to be applied to all of medicine. The committee’s report is a devastating condemnation of the foundations of so-called complementary and alternative medicine, smashing many of its pillars.

Perhaps the looming health care crisis and the attention that rising health care costs is currently receiving will make this kind of no-nonsense rigorous scientific assessment fashionable in Western politics. Removing worthless modalities from the health care system is certainly in the interests of efficiency and cost-effectiveness.

As the STC also points out – for the public to have faith in government regulation of health care, and for that trust not to be abused, government has a responsibility to be rigorously evidence-based. They conclude:

By providing homeopathy on the NHS and allowing MHRA licensing of products which subsequently appear on pharmacy shelves, the Government runs the risk of endorsing homeopathy as an efficacious system of medicine. To maintain patient trust, choice and safety, the Government should not endorse the use of placebo treatments, including homeopathy. Homeopathy should not be funded on the NHS and the MHRA should stop licensing homeopathic products.

I admit that the title of this post is a little inflammatory, but it’s frustrating when reporters call for input and then proceed to write unbalanced accounts of pseudoscientific practices. A case in point – my last post described a conversation I had with a reporter about energy medicine. My interviewee was very nice and seemed to “track” with me on what I was saying. I did my level best to be compelling, empathic, and fair – but in the final analysis, not a single word of what I said made it into her article. For fun, I thought you’d like to compare what I said, with the final product.

Here’s an excerpt from the article:

Disease has always been with us, but modern, Western medicine is only a few hundred years old.

Before germ theory and pharmaceutical research, the human race devised countless strategies to relieve pain, banish illness and prolong life. Southern Marylanders are keeping a few of these ancient disciplines alive, insisting they have much to teach us, even in a scientific age.

The rest of the piece is full of the usual pseudoscientific arguments: anecdotal evidence, mistrust of scientific methods, a call to “open-mindedness,” an emphasis on “natural” as being synonymous with “safe and effective,” and an “everybody’s doing it, even academic medical centers” rationale for adoption. There was no dissenting opinion – just an unquestioning acceptance of energy medicine.

Now to be fair, the reporter told me that she had included a quote from me in her submission, but that the newspaper editors had cut it out of the online version.

Nonetheless, my take home message from the experience is that blogs like Science Based Medicine seem to offer the only guarantee of unedited rational thought on matters of health and medicine. Thank goodness we’re no longer beholden to mainstream media for all our health news and commentary. It is a shame that most consumers get their news from TV and other outlets that don’t seem to maintain a journalistic quality filter.

This is why our work here is so important… because without scientists and healthcare professionals providing a counterpoint to the endless onslaught of superficial and misleading information, our patients won’t stand a chance of discerning the truth. We need more critical thinkers to join the cause, and I hope that more of us will step up to the plate and contribute to outlets like SBM or Better Health. Waiting for reporters to include us in the discourse could take a very long time…