I realize that the New England Journal of Medicine (NEJM) review of acupuncture has already been covered by Drs. Gorski and Novella. But my ego knows no bounds; so I thought I would add my two cents, especially since this review, more than any paper I have read, generates a deep sense on betrayal.

There was a time when I believed my betters. Then the Annals of Internal Medicine had their absolutely ghastly series on SCAMS, the publication of which was partly responsible for interest in the topic. Since that series of articles, I have doubt whenever I read an Annals article. When a previously respected journal panders completely to woo, they lose all respectability. Sure, the editors that were responsible for that travesty are long gone, but the taint remains. I tell my kids that once a trust has been violated, it is difficult to get it back. The Annals has permanently lost my trust, I am afraid.

But we will always have Paris. I mean the NEJM. The NEJM is the premier medical journal. Just because an article is published in the NEJM doesn’t mean it’s right; the results of clinical trials are always being superseded by new information. But the article has supposedly been rigorously peer reviewed. Its like Harvard and… Oops, Bad example. Harvard, as we have seen, has feet of clay, and so, evidently, does the The New England Journal of Medicine.

Goodness, gracious, great balls of fire, the editors of the NEJM have fallen into the depths of nonsense with this one.

Let’s go through it, shall we.

First up, the authors:

Brian M. Berman, M.D., Helene H. Langevin, M.D., Claudia M. Witt, M.D., M.B.A., and Ronald Dubner, D.D.S., Ph.D.

From the Center for Integrative Medicine, University of Maryland School of Medicine (B.M.B.), and the University of Maryland Dental School (R.D.) — both in Baltimore; the Department of Neurology and the Program in Integrative Health, University of Vermont College of Medicine, Burlington (H.H.L.); and the Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin (C.M.W.).

You always want acknowledged experts in a field to write your review. If you want a review of Lyme disease, you ask a Lyme expert (The Connecticut Attorney General not withstanding), and if you want a review of heart attacks, you ask a cardiologist.

So in that spirit, if you want a review of prescientific magic, you want someone well-versed in the practice of prescientific magic. Fortunately, these authors seem well qualified. Dr. Berman founded the Center for Integrative Medicine at University of Maryland and has a long history of research into acupuncture. The center has on its staff a reflexologist/reiki master. Really. And the center offers:

Physician Consultations, Acupuncture, Nutrition, Massage, Homeopathy, Mindfulness-based Stress Reduction, Shiatsu, Reflexology, Yoga, Qi Gong, Tai Chi, Osteopathic Manipulation.

The University of Maryland proudly offer both acupuncture and reiki to their trauma patients.

Reiki is a Japanese technique of relaxation that works similarly to acupuncture, in that you are releasing and moving energy,” explains Donna Audia, R.N., a nurse on Shock Trauma’s pain management team and a certified Reiki master. “By using Reiki with trauma patients, we are not only helping them to relax, we’re also making them active participants in their own healing, and that can be very empowering.

Reaction from trauma patients has been positive, with most requesting follow-up treatments. In fact, many family members ask to be a part of the Reiki session. A group of volunteers trained in Reiki now visits Shock Trauma regularly. The University of Maryland Medical Center is the only facility in the country offering Reiki to trauma patients, although it has also been used to treat people with cancer and other illnesses.

Seriously. Your body has been shattered in a car accident and your health care providers think they can improve your condition by moving and releasing your energy by waving their hands over you.

If, god forbid, you have trauma in Maryland, get transferred. Fast.

Dr. Berman has published extensively on acupuncture and Dr. Witt has published multiple articles on homeopathy, including one using homeopathy for low back pain.

So two of the authors are well grounded in magical thinking: who better to write a NEJM review on acupuncture? They found a Dumbledore, a Gandalf, to write the article, which explains the content as the editors of the NEJM were evidently hit with the confundus charm. As I think about it, that is not the best metaphor, since in the fantasy world, magic is real, but in the real world, magic is fantasy, as well as a review article in the NEJM.

The authors start with a case of chronic low back pain with mild degenerative disease but no anatomical or physiologic reason for the pain. The vignette ends with:

The patient wonders whether acupuncture would be beneficial and asks for a referral to a licensed acupuncturist.

Nope. Simple enough. Acupuncture is nonsense. Oh wait. There’s more.

They review the epidemiology, physiology and anatomy of chronic low back pain and note that the understanding of the disease is a long way from satisfactory and conclude with:

In addition, psychological and behavioral factors, including fear of movement, appear to play an important role in patients with chronic low back pain. Such patients have been shown to have altered brain-activation patterns at subcortical and cortical sites associated with emotion and postural control. Studies comparing psychosocial variables with anatomical findings have shown the former to have greater predictive value than the latter.

In other words, with low back pain there is a big psychological overlay. It is the psychological overlay of pain that makes it difficult to determine the effectiveness of a therapy meant to decrease the pain. When treating a condition in medicine, most interventions attempt to alter the underlying pathophysiology: block a receptor with a drug, alter anatomy with a procedure as examples. If the intervention has no effect on the underlying pathophysiology, then there is little reason to expect benefit beyond a placebo effect, which is almost no effect.

Then they jump into acupuncture.

Acupuncture is a therapeutic intervention…

It is an intervention, yes, but therapeutic? Therapeutic means relating to healing of disease. So they are front loading the language, saying at the beginning that acupuncture is effective rather than proving the case. I would have used ‘useless magical’ instead of ‘therapeutic,’ but that’s me.

Although a number of different techniques or schools of acupuncture practice have arisen, the approach used in traditional Chinese medicine appears to be the most widely practiced in the United States.

Why? Is Chinese acupuncture better? Or is popularity the criteria we use for determining appropriate medical care? There is Chinese and Japanese and tongue and foot and ear and the German head acupuncture. Is there any justification offered for using one over the other? Which is the correct style? As I have said before, it is a trick question, like asking which is the real astrology: European, Indian or Mayan. It makes no difference.

Then they delve into real nonsense.

Traditional Chinese medicine espouses an ancient physiological system (not based on Western scientific empiricism) in which health is seen as the result of harmony among bodily functions and between body and nature. Internal disharmony is believed to cause blockage of the body’s vital energy, known as qi, which flows along 12 primary and 8 secondary meridians. Blockage of qi is thought to be manifested as tenderness on palpation. The insertion of acupuncture needles at specific points along the meridians is supposed to restore the proper flow of qi.

I hate to point out that the physiologic system I use, based on so-called “Western scientific empiricism,” is also based on anatomy, chemistry, biochemistry, histology etc. All based on physical structures that can be isolated and examined.

Meridians and qi blockage is based on what? Nothing. Meridians and qi do not exist. Here is the NEJM offering up, complete with a picture, the idea of meridians and qi as if they are a meaningful construct. Next up in the NEJM will be:

Traditional European medicine espouses an ancient physiological system (not based on Western scientific empiricism) in which health is seen as the result of harmony among bodily functions and between body and nature. Internal disharmony is believed to cause blockage of the body’s vital energy, known as humors: black bile, yellow bile, phlegm, and blood which flows in the body. Blockage of humors is thought to be manifested as illness. Bleeding and purging is supposed to restore the proper flow of balance of humors.

If anyone sees a conceptual difference between the two paragraphs, let the editors of the NEJM know after they accept my review on therapeutic bleeding. Being published in the NEJM is the medical equivalent of being on the cover of the Rolling Stone, and I think I have my opportunity.

Efforts have been made to characterize the effects of acupuncture in terms of the established principles of medical physiology on which Western medicine is based.

Why? Isn’t an ancient physiological system enough upon which to base a therapeutic intervention?

These efforts remain inconclusive, for several reasons. First, the majority of studies have been conducted in animals, and it is difficult to relate findings from such studies to effects in humans. Second, acupuncture has been shown to activate peripheral-nerve fibers of all sizes, rendering a systematic study of responses complex. Third, the acupuncture experience is dominated by a strong psychosocial context, including expectations, beliefs, and the therapeutic milieu.

And fourth, having no basis in reality, acupuncture can’t work any more than homeopathy or reiki. It is tooth fairy science, published in the NEJM.

Then they delve into the physiology of acupuncture and the basic science studies. Fine. You stick people with needles, you will get a variety of physiologic responses, both locally and in the brain. The question is whether these effects are specific to acupuncture or nonspecific results of poking people with a sharp object. Like all acupuncture apologists, they lack a certain precision in what they consider acupuncture, and offer electroacupuncture as evidence.

In the rat, electroacupuncture has been shown to induce pituitary secretion of adrenocorticotropic hormone and cortisol, leading to systemic antiinflammatory effects.

Ah yes, electroacupuncture. I remember when they discovered those ancient Chinese Duracell’s and alligator clips that allowed the Chinese to shock their patients.

I quote from the electroacupuncture article, referenced above:

While the EA frequency was held constant, intensity was adjusted slowly over the period of approximately 2 min to the designated level of 3 mA, which is the maximum EA current intensity that a conscious animal can tolerate. Mild muscle twitching was observed… For sham treatment control, acupuncture needles were inserted bilaterally into GB30 without electrical stimulation or manual needle manipulation.

And when shocked, the rabbits released ACTH and cortisol, as any animal would if electrocuted. Release of ACTH and cortisol is part of the response to stress. I can just see the poor rat, “placed under an inverted clear plastic chamber” for observation saying,” don’t tase me bro, don’t tase me bro.” Wait. It’s not a taser. It’s a projectile electroacupuncture remote deliver system, and if I use it on you, you are going to release some cortisol and ACTH as well, bro.

Did the NEJM editors look at the references? They seriously need some new reviewers.

But I will grant them that sticking needles in people has physiologic effects and shocking a rat makes it squirt cortisol.

However, acupuncture is about putting needles in specific sites. In the animal models and human studies they attempt to needle specific sites that correlate with treating a disease. Most acupuncture studies use the traditional sites associated with whatever illness they are not really treating; acupuncture is about putting the needle just so.

The basic science concerns, as I read it, the effects of needling people. If you are going to recommend acupuncture, and they will, then you need to justify the use of needles in specific sites by people trained in acupuncture, and the literature doesn’t support that. It doesn’t matter where you put the needles, or even if you use needles at all, as we have mentioned, since twirling a toothpick has better effects on knee pain than needling. And I will ask again: whose style of acupuncture are you going to use? Ear, tongue, foot, Japanese or German or Chinese?

Then they move on to the clinical trials and my gaster is flabbered.

… real acupuncture treatments were no more effective than sham acupuncture treatments. There was nevertheless evidence that both real acupuncture and sham acupuncture were more effective than no treatment and that acupuncture can be a useful supplement to other forms of conventional therapy for low back pain.

Lets take a trip back in time.

There was procedure for the treatment of angina where they ligated the internal mammary artery. The theory was that by tying off the artery the back-pressure forced blood down the coronary arteries and relieved cardiac pain.

Angina improved and there are about 40 plus papers in the 50s and 60s on the benefit of the procedure as well as the underlying physiology of the procedure. Mammary artery ligation ‘worked’ and was popular in the early 60s. Until the procedure was compared to a sham operation. That’s right. They opened people up and did nothing.

The result?

The combined results of two RCTs comparing an earlier surgical procedure for angina — bilateral internal mammary artery ligation (BIMAL) — to a sham surgery clearly show that patients “experienced significant subjective improvement,” with both BIMAL (67% substantial improvement) and the sham procedure (82% substantial improvement). [see Moerman, Meaning, Medicine and the “Placebo Effect”, 2002]

So how would you interpret the study? If a procedure is equal sham, then I would say the procedure does not work. In the case of sham surgery, no underlying change occurred in the blood supply to the ischemic heart. This study is perhaps the classic clinical trial that demonstrates the difficulty in assessing the results of an intervention for pain. Patients had significant improvement in their angina. Much better than doing nothing (although these studies did not have a ‘usual care’ wing), 2/3 of angina patients do not get significant improvement on their own.

And guess what? Open heart surgery “has been shown to induce pituitary secretion of adrenocorticotropic hormone and cortisol, leading to systemic antiinflammatory effects.” Surgery releases endogenous opioids and I bet it actives both peripheral and central pain fibers.

Hmmmm. Looks like we have a justification for going back to treating angina with internal mammary artery ligation.

The authors of the review justify the recommendation on the two studies that demonstrate the equivalence of sham acupuncture and real acupuncture in treating low back pain, the same number of studies for mammary artery ligation.

Now being an article on back pain, they did not include the article that showed knee pain treated with sham acupuncture (in this case twirling tooth picks on the skin) is superior to real acupuncture. It matters not where the needles are placed or even if needles are used.

So far the authors provide no historical scientific plausibility, non-specific modern pathophysiology, a bit of gratuitous rabbit torture, and two clinical trials that demonstrate no efficacy of acupuncture over placebo. Their level of justification reaches that of mammary artery ligation. I start to wonder if the NEJM editors actually read the review before publishing it. The authors then move on to clinical use.

(Acupuncture) not been established to be superior to sham acupuncture for the relief of symptoms of low back pain [translation: it doesn’t work]. As a result, it is not often regarded as the first choice of therapy [translation: clinicians do not like to use ineffective therapy].

However, since extensive clinical trials [er, since when did two become extensive? Are the authors even reading the manuscript?] have suggested that acupuncture may be more effective than usual care, it is not unreasonable to consider acupuncture before [you mean as first line therapy? when it doesn’t work?] or together with conventional treatments, such as physical therapy, pain medication, and exercise [adding nothing to something does not increase the net effect].

That is some interesting sentence structure, worthy of Animal Farm: even though acupuncture doesn’t work, and isn’t first line therapy for pain, it should be used for first line therapy. Although the qualifiers ‘not been established,’ ’suggested’, ‘may be,’ and ‘not unreasonable’ muddy the water with their density.

Acupuncture is a regulated discipline, and patients should be referred only to practitioners who are licensed by the state in which they practice.

Why? It’s like Duck’s Breath Mystery Theatre’s Dr. Science. A license to practice ineffective nonsense still results in ineffective nonsense.

In the traditional practice of acupuncture, needle insertion itself may be accompanied by a variety of ancillary procedures, including palpation of the radial artery and other areas of the body, examination of the tongue, and recommendation of herbal medications. All of these steps are based on the application of principles of traditional Chinese medicine, as opposed to Western physiological and medical concepts. To what extent such procedures may contribute to the psychological milieu of acupuncture is unknown, and only a few studies have examined the context in which acupuncture treatment is delivered.

Note, it is not that radial artery palpation and tongue examination increase the diagnostic accuracy, it is to contribute to the psychological milieu. Like a psychic talking to your dead parent, it is important to make the environment conducive to fooling the patient into believing that an actual effect is occurring.

Take the pulse. In TCM they are not looking for tachycardia, but imaginary diseases based on imaginary diagnosis. An example:

Each pulse position can reflect different phenomena in different situations. For example, in a state of health, the left middle pulse (Liver) will be relatively soft and smooth, neither superficial nor deep. Therefore, we can say the liver and gall bladder energies are balanced or that the Yin and Yang within the Liver/Gall Bladder sphere are balanced. If a patient is experiencing migraine headaches and her pulse feels wiry (harder or tighter than normal) and more superficial and pounding, then we may diagnose this as Excessive Liver Fire (Yang) Rising (up the Gall Bladder channel to the head). The pulse reflects the rising energy.”

Or tongue examination, which is another example of prescientific nonsense where the body is represented on the tongue.

The editors of the NEJM seem to think this is reasonable, worthy of unqualified discussion. Of course, there is no reference to demonstrate that these additions increase diagnostic or therapeutic accuracy.

The practitioner may further stimulate the needle with electrical current (electroacupuncture), moxibustion (burning the herb artemisia vulgaris at the end of the acupuncture needle), or heat.

Why? No data given that this nonsense increases efficacy. I keep telling myself this is the NEJM, adding their imprimatur to the respectability of burning a plant on top a needle stuck in the skin to ease chronic pain. Then they note that patients need multiple treatments, a minimum of 12, with boosters, and they need to come in to prophylactically keep their spine aligned — no wait, the last is what chiropractors do. It seems, at 65 to 125 dollars a pop, that acupuncturists have recognized the financial wisdom of D.D. Palmer’s descendants. The NEJM is suggesting that people pay around 1200 bucks for what is, at best, a placebo.

The authors go on to the adverse effects. “8.6% reported at least one adverse event, and 2.2% reported one that required treatment.” Pretty impressive complication rate for an expensive, ineffective therapy! They do not mention that in the acupuncture/toothpick for knee pain study, toothpicks had the same effect as acupuncture and zero side effects, nor do they mention the well-reported cases of infection from sloppy aseptic technique.

I will ask you. If you have two procedures of equal efficacy and one has zero side effects, are you not ethically bound to suggest the procedure with no complications? If you are going to suggest acupuncture, ethically you have to offer sham acupuncture with twirled toothpicks, especially when what you offer is no better than a placebo effect.

Then, in the areas of uncertainty section of the review, they note that the effects of acupuncture are mostly explained by elaborate placebo effects. Benefit from acupuncture is

mostly attributable to contextual and psychosocial factors, such as patients’ beliefs and expectations, attention from the acupuncturist, and highly focused, spatially directed attention on the part of the patient. These studies also seem to indicate that needles do not need to stimulate the traditionally identified acupuncture points or actually penetrate the skin to produce the anticipated effect.

It does nothing, and you do not need to do acupuncture to get the effect. Acupuncture has complications and ethically can one recommend and charge for an elaborate placebo? I do not think so. Not the authors.

The patient in the vignette has chronic back pain that has not responded to a number of medical treatments.

So instead, we will go with the unethical, expensive, useless placebo.

He has specifically requested a referral for acupuncture, and we would suggest a course of 10 to 12 treatments over a period of 8 weeks from a licensed acupuncturist or a physician trained in medical acupuncture.

Can you believe this? From the NEJM! Such total tripe. I rely on the NEJM to provide reviews of relevant medical topics as, outside of ID and quackery, I do not have the time to read the primary literature. If this is the best NEJM can do on a topic upon which I have some background, then I suppose I cannot trust them in the future. As I tell my kids, you can judge a person by the company they keep.

The NEJM has lost some of its credibility. I doubt they will ever get it back.

One of the strengths of modern medical education is its emphasis on basic science.  Conversely, the basic weakness of so-called alternative medicine is its profound ignorance of science and its reliance on magical thinking.  Nowhere is this more apparent than in the attempts of altmed cults to conduct and publish research.  From “quantum water memory” to “almost as good as placebo”, the altmed literature is filled with basic failures in the proper formulation and testing of hypotheses.

One of the finest examples of these failures was just published in the journal Homeopathy.  Leaving aside for the moment the absurdity of a journal devoted to magic, let’s see what they did here.

Leptospirosis, a systemic disease caused by bacteria of the genus Leptospira, is probably the most common zoonotic (spread by non-human animals) disease on the planet.  It can cause anything from a mild flu-like illness to liver failure and death.  It is spread in water contaminated by urine from infected animals.  An outbreak occurred during my internship year among triathletes swimming in a lake in Illinois, but occupational exposures are more common.  There are no widely-available vaccines for disease prevention.

Given the common and sometimes serious nature of the disease, especially in developing countries, there is a need for effective prevention of leptospirosis.  One proposed solution, published this month in Homeopathy, is “Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control.”

Methods

The authors conducted what they called an “epidemiologic cohort study”.  For the study, the designated a large area of eastern Cuba the “test” population (”intervention region (IR)”), and the rest of Cuba the “control” population.  These were assumed to be distinct geographic regions.

In the intervention region, local outbreaks were treated with vaccination and antibiotic prophylaxis which, according to the study, reached about 3% of the population, but they do not indicate whether this is 3% if the total population or a targeted, at-risk population.  The entire population of the intervention region was also targeted to receive a homeopathic  (i.e., inert*) preparation especially designed and “potentised” (i.e., shaken up) to prevent leptospirosis, as per homeopathic beliefs.

The authors state that the study complied with ethics requirements of the authoritarian regime who runs the country and presumably profits from the manufacture of the product being tested.

Data

The authors report that the control region had fewer natural disasters (and presumably were at lower risk for lepto) than the intervention region.  During one such emergency in the IR, the potion was widely used.  A drop in reports of the disease were noted afterward.

The statistical analysis section of the paper is quite long, but fails to address fundamental problems.  There was, in effect, no control group.  There was an opportunity to apply this alleged therapy on one group and placebo (chuckle) on another and compare rates of disease in each group.  This wasn’t done.  The entire population in question was treated, and rates of disease recorded.  The authors note that leptospirosis is occurs in cycles, and there is no reason to think that the drop in disease seen after the application of homeoprophylaxis is due to the intervention rather than to the natural course of the endemic.  Given that the intervention is supposed to be prophylactic rather than therapeutic, the authors’ conclusions are even more suspect.  Finally, the did end up comparing rates in the intervention region and the rest of the country, but these regions were defined as being geographically distinct, with different geography and differing rates of natural disaster.

This study has nothing to do with natural disasters.  Blame for the disaster here rests completely with the authors.  They conducted a study of questionable ethics and questionable methodology, and came up with questionable conclusions.  Most important, however, was the lack of a plausible hypothesis from the start.  There is no reason to think that ultra-diluted potions containing nary a molecule of “medicine” should affect anything.  Given this lack of plausibility, statistically significant findings should be examined with suspicion, and other explanations for any such findings should be sought aggressively.  The authors do not discuss possible alternative explanations, exacerbating the travesty that is their work.

References

Bracho, G., Varela, E., Fernández, R., Ordaz, B., Marzoa, N., Menéndez, J., García, L., Gilling, E., Leyva, R., & Rufín, R. (2010). Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control Homeopathy, 99 (3), 156-166 DOI: 10.1016/j.homp.2010.05.009
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*From the paper:

From the mother tinctures, 1/100 serial dilutions wereprepared using homeopathic pharmaco-technical methods(Korvsakovian dilutions). Between each dilution step, thesolution was succussed 100 times using an automatic dynamizerup to 200C (200 1:100 dilutions) and 10 MC(104 1:100 dilutions).

There is an interesting controversy raging in the Multiple Sclerosis (MS) world that reflects many of the issues we discuss at science-based medicine. Dr. Paolo Zamboni, and Italian vascular surgeon, has now published a series of studies claiming that patients with clinically defined MS have various patterns of chronic cerebrospinal venous insufficiency (CCSVI). Further Dr. Zamboni believes CCSVI is a major cause of MS, not just a clinical side-consequence, and is exploring treatment with venous angioplasty or stenting.

The claims have captured the attention of MS patients, many of whom have a progressive course that is only partially treated by currently available medications. There are centers popping up, many abroad (such as India), providing the “liberation procedure” and anecdotes of miraculous cures and spreading over the internet. There is even a Facebook page dedicated to CCSVI, and you can read the anecdotes for yourself. Many profess dramatic improvement immediately following the procedure, which seems unlikely even if Zamboni’s hypothesis is correct.

Zamboni is also getting attention from neurologists and MS specialists, who remain skeptical because Zamboni’s claims run contrary to years of research and thousands of studies pointing to the current model of MS as an autoimmune disease.

There are at least two stories to follow here. The first is the scientific story – the questions being proposed are answerable with scientific research, and they will be answered. MS remains a serious illness that is inadequately treated (not to downplay the important advances we have made, but we certainly are far from an adequate cure for MS). The potential of a new treatment deserves serious research attention, and CCSVI is getting it. It will probably take another ten years for the research to play itself out adequately for there to be a confident consensus on CCSVI, but eventually we will have a scientific answer.

The other story is the the reaction of the public and the MS community. This has been mixed, but already there are conspiracy theories that the neurology community, the MS society, and Big Pharma (of course) are fighting against CCSVI as part of a misguided turf war. (See the comments to my previous posts on this topic at NeuroLogica for some examples.) Anecdotes are being used to argue against published scientific evidence, and negative studies are being dismissed. If CCSVI is eventually found to be a scientific dead end, I have to wonder if it will survive as just another fringe “alternative” treatment, like Laetrile, psychomotor patterning, and other discarded ideas in medicine.

The Scientific Story

So far there is not much of a scientific story to tell. A PubMed search on CCSVI yields a total of 19 publications (a pittance), indicating how new this concept is. I suspect this number will grow into the hundreds at least before this story plays itself out. If CCSVI is proven to be legitimate then this number will grow into the thousands over the next few decades. If it is disproved, publications will trickle off.

Most of the current research is published by Zamboni’s team. He is building an impressive list of studies, exploring various aspects of CCSVI and MS, but evidence that derives entirely from a single research team is always suspect. The role of bias in research is well documented, and further most new ideas in medicine turn out ultimately to be wrong. Therefore skepticism is the proper approach to bold new claims being supported by a lone research team. Replication will be necessary for the broader scientific community to take CCSVI seriously.

The core claim made by Zamboni is that most patients with MS display 2 or more out of 5 criteria on studies of venous anatomy (using ultrasound or venography) of venous insufficiency. While control patients (healthy subjects or those with other neurological disorders) display 1 or no criteria, and never 2 or more. All other claims (benefit from angioplasty, matching patterns of venous insufficiency with types of MS) derive from this core claim.

I found four independent replications in the literature, three very recently published. The first is by Al-Omari MH, Rousan LA, who found:

“According to the described criteria, 92% of the MS patients showed abnormal findings and 84% of them showed evidence of CCSVI, however; only 24% of controls showed abnormal findings, but none of them showed evidence of CCSVI (OR=7.25, 95% CI 2.92-18.01, P<0.0001).”

These are similar numbers to Zamboni, although the 84% is a little less. This study used only ultrasound, which is a non-invasive technique and therefore good for screening, but the results are very operator dependent. There is no indication in the study that the patients were assessed in a blinded fashion.

The next study by Florian Doepp et al used the following methods:

We performed an extended extra- and transcranial color-coded sonography study including analysis of extracranial venous blood volume flow (BVF), cross-sectional areas, IJV flow analysis during valsalva manoever (VM) as well as ‘CCSVI’ criteria. 56 MS patients and 20 controls were studied.

They found no subjects met the Zamboni critieria for CCSVI – a completely negative replication.

The second was performed by Krogias at al, who found:

The authors conclude that the „chronic cerebrospinal venous insufficiency (CCSVI)“ cannot represent the exclusive pathogenetic factor in the pathogenesis of MS. In our cohort, only 20% of the patients fulfilled the required neurosonological features of CCSVI. So far, the pathogenetic relevance of these findings remains speculative. Thus, based on the current scientific position we cannot justify invasive „therapeutic“ approaches, especially if they are performed outside of clinical trials.

The third study is a Swedish study by SundstrÃm et al (“Venous and cerebrospinal fluid flow in multiple sclerosis – a case-control study.” Peter SundstrÃm, Anders WÃ¥hlin, Khalid Ambarki, Richard Birgander, Anders Eklund and Jan Malm. Annals of Neurology) – not yet available online. This study used MRI scanning to assess blood flow in the internal jugular vein in 21 MS patients and 20 controls, and found no difference.

Conclusion

One of four replications found results similar to Zamboni. A second found only 20% of MS patients met Zamboni’s criteria, while two others found that no patients with MS did. Four studies is not a lot – and is not even close to ending this controversy from a scientific point of view. But these early results are not promising and will tend to deepen skepticism within the neurological community.

Clearly there is a need for more research so that both patients and professionals can feel comfortable that CCSVI has been given a thorough investigation and we can say with confidence what role, if any, it plays in MS. The results, also, do not have to be black and white. While it seems unlikely that Zamboni has discovered the sole and ultimate cause of MS in most or all patients, it is possible he has found a significant consequence of MS. Chronic inflammation may result in venous insufficiency in some patients. This venous insufficiency may further play a role in worsening the clinical course in a subset of those patients, who may benefit from treatment. So CCSVI may ultimately play a minor but important role in the management of MS.

Or it may all turn out to be a figment of Zamboni’s imagination, spawned by the sincere hope of finding a cure for MS. Time and research will tell.

My open plea to the MS community, especially those who are going down the rabbit hole of conspiracy theories, is to keep this discussion about the scientific evidence. This is not the place for cheap conspiracy theories. I fear my plea will fall on deaf ears, but it never hurts to ask.

Alchemy is alive and well! Yes, that medieval precursor of chemistry, that chimerical search for the philosopher’s stone and the transmutation of lead to gold. Modern alchemists have found the philosopher’s stone and are selling it and teaching people how to make it themselves out of dew and Celtic sea salt.

The philosopher’s stone apparently is an elixir of life that you have to take on a regular basis. According to Nicholas Collette, it “completely eliminates the pharmaceutical industries by curing EVERY disease, and opens the mind to it’s [sic] full potential.”   It extends the life span, reverses the aging process, and opens the door to psychic power.

Instructions for making it are detailed on this website. It takes time and is complicated, but the starting ingredient is simple: morning dew. 

It allegedly turns lead into gold: one milligram of the Stone can turn 20 pounds of lead to gold. But you are warned to be careful: 

 …the alchemists warned that you must be careful not to transmute too much gold at once, or it will become radioactive and the radiation will harm you and eventually kill you. And selling gold is considered a trite waste of the Stone in alchemy. You will feel like a **** if you make all your money selling a product of alchemy and disgracing and defiling the Holy Art.

 There are apparently 3 colors of stone. The White elixir can cure all mental disorders and diseases or psychosis, and depression. It also causes receptive psychic ability to develop in the user, like mind reading and spirit contact. The green stone is like the white stone but takes more time to produce.

The Red Stone is used primarily for its regenerative abilities: it is not taught. It is an end product or manifestation that gives you godly powers and allows you to live for hundreds of years.

 And then there is the Ormus monoatomic alchemical elixir:

It has been discovered in this regard that what is being called carbon is actually not always carbon; sometimes it is something else. What is being called calcium is actually not always calcium; sometimes it is something else. What is being called silicon is actually not always silicon; sometimes it is something else. What is being called iron sometimes is actually not always iron; sometimes it is something else. And that something else is actually ORMUS. ORMUS (sometimes also referred to as ORME, monoatomic elements, and/orm-state materials) is a class of physically distinct atomic mineral substances that are unique forms of matter that appear to be closer to the state of aether or vacuum or pure energy than normal matter such as the common mineral and atomic compounds found on Mendeleyev’s  Periodic Table of the Elements.

The secrets of alchemy are no longer secret. All civilizations had understandings and mysteries of people who took the stone and were potential gods, with powers of healing and creation. These modern alchemists have reclaimed the lost knowledge.

Science can’t explain it. For instance, if you measure the powder, heat it to 1000 degrees and cool it, it weighs 25% less. Science says this is impossible, but it happens. Hundreds of investigations have proven that it doesn’t behave like normal matter.

You can buy it, but it’s better to make your own so it carries your own vibes. And making your own is cheaper. You will need to take 1 ½ gm a day. The price has been reduced from 105 to 75 euros for 3 grams. By my rough calculation, this would add up to an expense of nearly $24,000 a year.

A medical doctor turned alchemist explains that it isn’t as simple as “this cures cancer.” Patients become shinier, and their aura glows. There is a stronger presence of life energy. Illness is expressed in darkness and the stone produces light.  

Testimonials abound. One user said

With regards to noticeable effects, I can say that I was aware of more energy circulating, specifically vibrating in my palms and laogong. I practice high level internal alchemy (for immortality) and I could ‘see’ that the combination of my practices with the consumption of the Stone you produce would potentially yield exponential results.

Collette has written books explaining how to make the stone and raving about Rosicrucians, the Holy Grail, the Tarot, 3-mile-wide UFOs, a civilization of alien beings living right here on our planet that only show up in the ultraviolet range, astral projection, astrology, and other things that don’t seem to cohere with each other into any rational framework. I tried to make sense out of what he is actually claiming, but couldn’t. I don’t think it’s me; I think there’s no sense there to be found.

I don’t think the pharmaceutical industries are in any danger of being eliminated. I can’t imagine that many sick people will fall for this nonsense and try to “cure every disease” with it, but then I couldn’t imagine that anyone would still be practicing alchemy in the 21^st century. The human capacity for self-deception is truly inexhaustible.

This may be too silly to dignify with a post on a science-based website, but it shows the depth of human gullibility that science must strive to overcome.

The longer I’m in this whole science-based medicine thing, not to mention the whole skepticism thing, the more I realize that no form of science is immune to woo. To move away from medicine just for a moment, even though I lament just how many people do not accept evolution, for example, I can somewhat understand it. Although the basics of the science and evidence support the theory of evolution as the central organizing principle of all biology, much of the evidence is not readily apparent to those who don’t make it a calling to study biology, evolution, and speciation. It’s not like, for example, gravity, which everyone experiences and of which everyone has a “gut level” understanding. So, not unexpectedly, when the theory of evolution conflicts with a person’s religious beliefs, for most people it’s very easy to discount the massive quantities of evidence that undergird the theory of evolution. It’s not so easy to discount the evidence for gravity.

In many ways, medicine is similar to evolution, but the situation is possibly even worse. The reason is that much of the evidence in medicine is conflicting and not readily apparent to the average person. There’s more than that, though, in that there are a number of confounding factors that make it very easy to come to the wrong conclusion in medicine, particularly when looking at single cases. Placebo effects and regression to the mean, for example, can make it appear to individual patients that, for example, water (i.e., what the quackery that is homeopathy is) or placebo interventions (i.e., acupuncture) cures or improves various medical conditions. Add to that confirmation bias, the normal human cognitive quirk whereby all of us — and I do mean all of us — tend to remember information that reinforces our preexisting beliefs and to forget information that would tend to refute those beliefs — and, at the level of a single person or even practitioner, it’s very, very easy to be misled in medicine into thinking that quackery works. On the other hand, at the single patient/practitioner level, one can also see evidence of the efficacy of modern medicine; for example, when a person catches pneumonia, is treated with antibiotics, and recovers quickly. Regardless of whether they’re being used to demonstrate quackery or scientific medicine, because personal experience and the evidence that people observe at the level of the people they know can be very deceptive in medicine, science-based medicine, with its basic science underpinnings and clinical trial evidence, is necessary to try to tease out what actually works and what doesn’t.

Medicine does, however, have its version of a theory of evolution, at least in terms of how well-supported and integrated into the very fabric of medicine it is. That theory is the germ theory of disease, which, just as evolution is the organizing principle of biology, functions as the organizing principle of infectious disease in medicine. When I first became interested in skepticism and medical pseudoscience and quackery, I couldn’t envision how anyone could deny the germ theory of disease. It just didn’t compute to me, given how copious the evidence in favor of this particular theory is. It turns out that I was wrong about that, too.

On Friday there was a video released that provides a very clear, succinct explanation of germ theory denialism:

Germ theory denialism: History

The only thing I would disagree with is the conclusion at the end that germ theory denialists are not much of a threat. (I’d also quibble with the inclusion of doctors of osteopathy with chiropractors and naturopaths. These days, most DOs are indistinguishable from MDs in how they practice.) In fact, germ theory denialism is a major strain of “thought” driving many forms of pseudoscience, such as chiropractic and naturopathy, as is shown in the video itself.

Given the content of the video, however, I thought it might be worth considering the question: How on earth could people seriously deny the germ theory of disease, given how much success the application of this theory has demonstrated in decreasing mortality? Think about it! Antibiotics, modern hygiene and public health measures, and vaccines have been responsible for preventing more deaths and arguably for saving more lives than virtually any other intervention, preventative or treatment, that science-based medicine has ever devised.

The first thing we should clarify is just what we mean by the “germ theory of disease.” In most texts and sources that I’ve read, the germ theory of disease is stated something like, “Many diseases are caused by microorganisms.” We could argue whether viruses count as microorganisms, but for purposes of the germ theory they do. (Most biologists do not consider viruses to be true living organisms, because they consist of nothing other than genetic material wrapped in a protein coat and lack the ability to reproduce without infecting the cell of an organism.)

The funny thing about germ theory denialism is that, long before Pasteur, there were concepts about disease that resembled the germ theory. For example, it was written in the Atharvaveda, a sacred text of Hinduism, that there are living causative agents of disease, called the yatudh?nya, the kim?di, the k?imi and the dur?ama (see XIX.34.9). One of the earliest Western references to this latter theory appears in a treatise called On Agriculture by Marcus Terentius Varro in 36 BC. In it, there is a warning about locating a homestead too close to swamps:

…and because there are bred certain minute creatures which cannot be seen by the eyes, which float in the air and enter the body through the mouth and nose and there cause serious diseases.

That certain infectious diseases are contagious and somehow spread from person to person or from other sources is so obvious that various explanations of how this could happen held sway over many centuries. One common idea was the miasma theory of disease, which stated that diseases such as cholera, chlamydia or the Black Death were caused by a miasma, which translates into “pollution” or “bad air.” Certainly some diseases can be spread through the air. However, it’s long been recognized that other diseases could be spread through the water and in other ways. In any case, various ideas about how disease develops battled it out in various places over various times throughout the era of prescientific medicine. Many of these ideas involved, as we have seen, various concepts of mystical “life energy” such as qi, whose ebbs and flows could be manipulated for therapeutic effect (as in acupuncture, for example). Other ideas involved various concepts of “contamination,” in which miasmas or various other “poisons” somehow got into the body from the environment. Given the knowledge and religion of the time, these ideas were not unreasonable because science did not yet exist in a form that could falsify them as hypotheses, nor did the technology yet exist to identify the causative agents of disease. Given that background, attributing infectious disease to “bad air” doesn’t seem so unreasonable.

The beauty of Pasteur’s work is that it provided an explanation for many diseases that encompassed the concepts of miasma and various other ideas that preceded it. It should not be forgotten, however, that Pasteur was not the first to propose germ theory. Scientists such as Girolamo Fracastoro (who came up with the idea that fomites could harbor the seeds of contagion), Agostino Bassi (who discovered that the muscardine disease of silkworms was caused by a tiny parasitic organism, a fungus that was named Beauveria bassiana), Friedrich Henle (who developed the concepts of contagium vivum and contagium animatum), and others had proposed ideas similar to the germ theory of disease earlier. Pasteur was, however, more than anyone else, the scientist who provided the evidence to show that the germ theory of disease was valid and useful and to popularize the theory throughout Europe. Moreover, it should be noted, as it is in the video, that there were competing ideas; for example, those of Antoine Béchamp, who did indeed postulate nearly the exact opposite of what Pasteur did: that microorganisms were not the cause of disease but rather the consequence of disease, that injured or diseased tissues produced them and that it was the health of the organism that mattered, not the microorganisms.

Basically, Béchamp’s idea, known as the pleomorphic theory of disease, stated that bacteria change form (i.e., demonstrate pleomorphism) in response to disease. In other words, they arise from tissues during disease states. Béchamp further postulated that bacteria arose from structures that he called microzymas, which to him referred to a class of enzymes. Béchamp postulated that microzymas are normally present in tissues and that their effects depended upon the cellular terrain. Ultimately, Pasteur’s theory won out over that of Béchamp, based on evidence, but Béchamp was influential at the time, and, given the science and technology of the time, his hypothesis was not entirely unreasonable. It was, however, superseded by Pasteur’s germ theory of disease and Koch’s later work that resulted in Koch’s postulates. Besides not fitting with the scientific evidence, Béchamp’s idea had nowhere near the explanatory and predictive power that Pasteur’s theory did. On the other hand, there is a grain of truth in Béchamp’s ideas. Specifically, it is true that the condition of the “terrain” (the body) does matter when it comes to infectious disease. Debilitated people do not resist the invasion of microorganisms as well as strong, healthy people. Of course, another thing to remember is that the “terrain” can facilitate the harmful effect of microorganisms in unexpected ways. For example, certain strains of the flu (as in 1918 and H1N1) are more virulent in the young because the young mount a more vigorous immune response.

Béchamp is unusual, though, in that he is frequently invoked by peddlers of quackery as having been “right” while Pasteur and Koch were “wrong.” Just Google “Béchamp” AND “alternative medicine,” “Béchamp germ theory,” or “Béchamp vaccination,” and you’ll see what I mean. Right on the first page are multiple links to that one-stop shopping site for all things quackery Whale.to, as well as links to that king of “acid-base” woo, the man who thinks all diseases are due to “excess acid,” Robert O. Young. One example of how Béchamp has come to be used to justify quackery appears on this discussion of vaccination at the Arizona Center for Advanced Medicine:

He [Pasteur] is remembered for promoting vaccinations.

Béchamp had a different idea. He believed in the pleomorphic theory, that bacteria change form and are the result of disease. He said bacteria change into organisms that are increasingly detrimental to the body. The waste products of their metabolism are harmful to local body fluids, causing pain and inflammation. It is not the germs, viruses, and bacteria that make you sick, it is the waste products of the metabolism of those organisms that make you sick.

Here’s the kicker:

Germs seek their natural habitat – diseased tissue. During the Civil War, maggots were brought into hospitals to feed on the diseased tissue of the wounded because the bugs were better at cleaning it up than potions or anticeptics. Think of mosquitoes. They seek stagnant water, but do not cause the pool to become stagnant. So when the terrain is weakened and sickly, all manner of bugs want to set up house. But they come after the disease has begun; they come because the terrain is inviting.

Not surprisingly, included in this article is the myth that Pasteur “recanted” on his deathbed and said that Béchamp is correct. The article also uses poor Béchamp to justify all manner of quackery, including live blood analysis, anti-vaccine beliefs, and claims that, because of Pasteur, the pharmaceutical companies have come to rule health, all standard tropes of the alt-med movement.

Germ theory denialism now: A “softer” form of Béchamp

In 2010, as hard as it is to believe, germ theory denialism still exists. In fact, contrary to the video above, I would argue that such denialism is actually a significant threat, as it is frequently used as a justification for anti-vaccine views, as demonstrated by the article above from Arizona Advanced Medicine. Moreover, it goes beyond anti-vaccine beliefs, to the point where I’m half tempted to label it as the alt-med/pseudoscience equivalent of the theory of evolution in its importance to woo. What I mean is that, just as the evolution is the central organizing principle of biology, germ theory denialism borders on being the central organizing idea behind the alt-med approach to disease.

Right now, the predominant form of germ theory denialism appears to be a “softer” form of denialism, just as the predominant form of evolution denialism is not young earth creationism, but rather “intelligent design” (ID) creationism. True, there are still young earth creationists around, who state that the world is only 6,000 years old and that the creatures that exist now were put there by God in their current state, but most denialists of evolutionary theory now accept that the earth is several billion years old and that organisms do evolve. They simply deny that natural selection and other mechanisms encompassed in current evolutionary theory are sufficient to account for the complexity of life and instead postulate that there must be a “designer” guiding evolution. Similarly, there are still some die-hard germ theory denialists out there who cite Béchamp in much the same way young earth creationists cite the Bible and deny that germs have anything to do with disease whatsoever, claiming instead that microbes appear “because of the terrain” and are an indicator, rather than a cause, of disease (or, as they frequently call it, “dis-ease”). However, most cases of germ theory denialism are of a piece with ID creationism. Like ID promoters who admit that evolution “does” happen, this variety of germ theory denialist accepts that microbes “can” cause disease, but they argue that microbes can only cause disease if the host is already diseased or debilitated. Using such claims, they argue that the “terrain” is by far the most important determinant of whether or not I get sick. As a result, they claim that eating the right diet, doing the right exercises, and taking the right supplements will protect you against disease as well as any vaccine — better, in fact, because supposedly you’re not injecting all those “toxins” from vaccines into your body.

We see this all the time among proponents of “alt-med.” For example, as I’ve written before many times, comedian Bill Maher expresses just such views. My favorite example was when he was having a discussion with Bob Costas about the flu and the flu vaccine and stated that, because he lives right and eats a healthy diet he “never gets the flu” and wouldn’t get the flu on an airplane even if several people with the flu were on that plane, to which Bob Costas made a hilariously spot-on reply, “Oh, come on, Superman!” That’s not too far from the truth, because the modern form of germ theory denialism does seem to claim that diet, exercise, and living the “right way” will make us all super men and super women, able to resist the nastiest of infectious disease.

Germ theory denialism: An example from naturopathy

After I saw C0nc0rdance’s video on germ theory denialism, I couldn’t resist looking at some of the videos that popped up on the sidebar of the YouTube link to see what was there. Prominent among the related videos that Google served up was a video by Dr. Shawn Sieracki of the Whole Body Healing Center of Lewisville. One might expect a whole lot of dubious therapies from Dr. Shawn based on what’s on his practice’s website, which touts woo such as the “detox challenge,” which boasts “Detoxify or die!” and offers services such as the infamous woo known as the “detox foot bath”:

Dr. Shawn has produced a video that demonstrates the germ theory denialism at the heart of much of what is espoused by naturopathy. His video is entitled Naturopathic Minute: Germ Theory, and he begins by baldly stating that “germ theory is not correct”:

Dr. Shawn bases much of his argument on a straw man version of germ theory. First, he claims that germ theory is what “traditional medicine” bases “all of its studies and research” on and that the “medical model” is based on germ theory. These statements are sort of true in that science-based medicine does primarily base its studies and therapies of infectious disease on germ theory (germ theory does, after all, work), but Dr. Shawn seems to be implying that all disease is caused by “germs” according to scientific medicine. He then goes on to misstate germ theory by stating first that it says that disease is caused by bacteria, viruses, and parasites (true) but that scientific medicine also says that infectious disease is caused by “toxins” (false; that’s not what scientific medicine says–unless Dr. Shawn means something like the cholera toxin, and somehow I doubt that he does). He then boldly proclaims that germ theory is “not correct” because:

It’s not the germs that cause the disease. It’s the condition of the environment that causes the disease…I’m going to give you a layman’s terms example so that you can understand. Cockroaches are the germs. Now why do you have cockroaches in your kitchen sink and all over the kitchen counter? Is the cockroaches the problem, or is it the dirty dishes, the stinky syrup on the kitchen counter, the food crumbs all over the place? That, more than likely, is why the cockroaches are there. So, doctors treat the cockroaches as the problem. They spray the insecticides; they spray the pesticides, but they keep the dirty dishes in the kitchen sink. OK, does that make sense? A natural health practitioner is going to help you clean up that dirty kitchen sink…If you clean up the dirty kitchen sink, the cockroaches go away. They can’t feed on that environment.

Personally, having worked in a restaurant that had a cockroach infestation cockroaches before, I’d like to see Dr. Shawn get rid of cockroaches in a house by doing nothing more than cleaning up the kitchen. Once you have cockroaches, they won’t go away with such a minimal intervention. Just ask anyone who’s had them in his home. Restaurant management was already strict about proper food practice and keeping things clean. It became even more so after cockroaches were discovered. After all, cockroaches were bad for business. If a customer saw one, it’d be disastrous, and if the health inspector saw them on the next visit, it would be even more disastrous in that there would be fines and the restaurant might even be shut down. In addition to excellent food hygiene practices, it also took visits from the exterminator to get rid of the cockroaches, and we were under no illusion that the cockroaches wouldn’t be back promptly if our guard lapsed.

Dr. Shawn goes even further:

Another analogy would be a stagnant swamp, a stagnant swamp versus a river. A river is full of life. A river is healthy. It’s flowing just like the blood should be flowing in your body. Okay? You’ve got eagles floating, you’ve got cold water fish floating in a river. Now in a stagnant swamp, you’ve got mosquitos, gnats, flies. You’ve got deadly snakes swimming in that moldy, filthy water. It’s the condition of the pond that attracts that, okay, it’s the condition of the pond that attracts the mosquitos, that attracts the gnats, etc.

Of course, again, there is more than a grain of truth in the idea that the “terrain” matters. If you’re unhealthy or debilitated, your resistance to bacteria is decreased. For example, it’s well known that diabetics have difficulty fighting off infections; a whole specialty (vascular surgery) deals with the complications of that problem in the feet. This is not anything new, nor is studying the effect of nutrition and overall health on resistance to infectious disease. Scientists and physicians have been studying these questions for decades. Where naturopaths go off the deep end is in claiming that good health is enough to ward off infectious disease. You can be a perfectly healthy 20 year old and die of the flu. It happened to millions in the 1918 pandemic, which in the U.S. got its start in Army barracks, where very healthy 18-22 year old males congregated. You can be perfectly healthy, but if you are exposed to a pathogenic virus or bacteria, you can still come down with a disease that will kill you. It is also not correct to argue, as Dr. Shawn argues, that ill health “attracts” these bacteria. They’re out there. They live on your body; they’re in the environment; just by living you’re exposed to them.

It’s also not true that the flu shot “gives you the flu,” as Dr. Shawn claims in one of his more ignorant statements.

Dr. Shawn also parrots another germ theory denialist argument, frequently found on numerous websites. Specifically, he gives the example of ten people on an elevator with a person with the flu (sometimes it’s a pathogenic bacteria when repeated elsewhere), who’s coughing all over the place. He points out that, although everyone in the elevator was exposed to the flu virus, not everyone gets the flu, as if that were evidence that the germ theory is incorrect! Germ theory denialists seem to think that anything less than a 100% infection rate in people exposed to a pathogenic organism means that that organism doesn’t cause the disease. This is a particularly prominent trait among HIV/AIDS denialists because HIV only causes disease in only a relatively small percentage of people exposed to it once. It’s an example of all-or-nothing thinking that’s so prevalent in promoters of pseudoscience. For example, it’s very much akin to when anti-vaccine zealots in essence argue that if a vaccine doesn’t prevent disease 100% of the time it’s useless, as they so frequently do with, for example, the flu vaccine or the measles vaccine, the latter of which is approximately 90% effective. Sometimes, it leads to arguments like this, where it is argued that pathogenic bacteria are not only not the cause of disease, but they are there to rid the body of disease:

Germs take part in all disease phenomena because these are processes requiring the breaking down or disintegration of accumulated refuse and toxic matter within the body, which the system is endeavouring to throw off. But to assume, as our medical scientists do, that merely because germs are present and active in all disease phenomena, they are therefore the cause of the same diseases, is just as wrong as it would be to assume that because germs are present and active in the decomposition processes connected with all dead organic matter, they are the cause of the death of the organic matter in question. The analogy is absolutely just and fair! And equally ridiculous!

But no one would say that because the decaying body of a dead dog is full of bacteria, the bacteria are the cause of the dog’s death. We know they are there as a part of the natural disintegration process taking place as a result of the death of the dog. And so it is with germs and disease. Germs are a part of the results of disease, not its cause.

Germs are present in disease not as causes, but as superficial helpers brought there by Nature to rid the body of disease. They are the “scavengers” employed by Mother Nature to break up and “bring to a head” the accumulated internal filth of years of unhygienic and unwholesome living, which are clogging the tissues of the body and preventing proper functioning.

While it’s true that there are many bacteria that live as commensal organisms in the colon of each and every human, not to mention the trillions upon trillions of bacteria that live on the skin, the statement is denialist in that it refuses to acknowledge that there are both helpful and very harmful bacteria. To the author, bacteria not only don’t cause disease, but they are what’s trying to eliminate disease. While it is true that there are cases in which the native bacterial flora living on our body “crowd out” pathogenic bacteria and the elimination of that bacterial flora with antibiotics can leave a person susceptible to pathogenic bacteria that are there all along (C. difficile colitis comes to mind), to make such a blanket statement is the sheerest folly.

Still, it doesn’t take very much searching through the “alt-med” parts of the Internet to find all sorts of mind-bogglingly ignorant attacks against Pasteur, for example:

• Louis Pasteur’s germ Theory- Wrong (not surprisingly, this one is on a Homeopathy World Community)
• The Post-Antibiotic Age: Germ Theory by Tim O’Shea
• Why Louis Pasteur’s Germ Theory Is A Curse by Nancy Appleton
• A Faulty Medical Model: The Germ Theory by Judie C. Snelson
• Why the Anthrax Bacteria is No More Dangerous to You Than Any Other Germ by Judie C. Snelson
• Chapter One: That Fallacious Germ Theory, in: Handbook of Nature Cure Volume One: Nature Cure vs. Medical Science, by John L. Fielder.

One can’t help but notice that in the last example, a chapter attacking germ theory is the very first chapter in a book on “natural cures.”

Why is germ theory denialism so attractive?

There is little doubt that germ theory denialism is a strain of “thought” (again, if you can call it that) that undergirds a lot of quackery. The question is: Why? After all, despite its flaws and despite the manner in which microorganisms have become resistant to antibiotics, thanks to our overuse, the germ theory of disease arguably marked the beginning of the scientific revolution in medicine and the birth of science-based medicine. After Pasteur’s popularization of the germ theory of disease, medicine entered a period of remarkable advances that continue to this day. Before Pasteur, there was no unifying theory for infectious disease. After Pasteur, there was, and the success of Pasteur’s theory revolutionized not just medicine but food preparation, particularly the process of Pasteurization of milk and other products, which greatly decreased the chance of illness borne by dairy products and other products that could be treated. Proper surgical antisepsis led to declines in surgical mortality.

I suspect that a large part of the reason that germ theory denialism persists in a range of forms from hardcore belief that Béchamp was right and Pasteur wrong to softer forms that claim that better nutrition and health would be as effective, or more so, than vaccines or antibiotics in preventing and treating disease derives from the very worship of the “natural” that so much of “alt-med” is built upon. If nature is so benevolent, then how could it be that there are microorganisms that will harm or even kill us if they gain a foothold in our bodies? Also, there is a great deal of “Secret“-like mystical thinking in alt-med, making it unsurprising that, if Béchamp were right, that would imply that disease or lack of disease is within us. That further implies that the means of ridding ourselves of disease is also within us through diet, exercise, and whatever activities that promote health we can undertake. This is far more reassuring than the idea that there are microorganisms out there that care nothing for our hopes or activities and are just waiting for an opportunity to attack. It’s far more reassuring to believe that we can have complete control over our health than it is to think that a random twist of fate could inoculate us with microbes that care nothing for any of that.

Regardless of the motivations behind germ theory denialism, I can’t help but find it odd that a mere three days from now the director of the National Center for Complementary and Alternative Medicine (NCCAM), Dr. Josephine Briggs, will be speaking to the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP). I wonder if Dr. Briggs knows the depths of germ theory denialism and anti-science that form the basis of so much “alternative medicine” in general and of naturopathy in particular. Perhaps Dr. Shawn will even be in the audience when she speaks. I wonder if he’ll approve of Dr. Briggs’ talk.

Bordetella pertussis is the bacterium that causes whooping cough – the main clinical feature of which is a severe lingering cough that can last for weeks or even months. Right now we are in the midst of an epidemic of pertussis cropping up in pockets throughout the US, most notable California. According to the CDC:

During January 1– June 30, 2010, a total of 1,337 cases were reported, a 418% increase from the 258 cases reported during the same period in 2009. All cases either met the Council of State and Territorial Epidemiologists definitions for confirmed or probable pertussis or had an acute cough illness and Bordetella pertussis–specific nucleic acid detected by polymerase chain reaction from nasopharyngeal specimens.

In addition, if the trends continue through the end of this year, which they are likely to do, this will be the highest incidence of pertussis in almost 50 years. These numbers are not in question, but there is some discussion about what, exactly, is causing it.

The tempting conclusion is that pertussis is making its way back into the population due largely to vaccine refusal and anti-vaccine propaganda. However, there is yet no data to support that conclusion. It may or may not be the case – we will know once a more thorough analysis is done of the individual cases of pertussis. And in any case, there are many factors at work.

First, pertussis has a natural tendency to cycle every 5 years or so, and this year is the peak of the cycle. This is certainly a significant part of the increase this year, regardless of other contributors.

In addition, the lack of vaccine-induced immunity is also playing a role, but not necessarily from vaccine refusal. Pertussis is a very contagious illness, partly because people are often contagious with it for days or weeks prior to knowing they have it, or that their cough is not just a common cold. Prior to vaccination pertussis was a significant cause of childhood death, causing about 8,000 deaths a year in the US alone. After the wide availability of vaccination against pertussis there has been on average about 10 deaths per year.

The current vaccine is an acellular pertussis vaccine (part of the DTaP injection, which included diphtheria and tetanus). The aP vaccine is a toxoid vaccine – it contains inactivated toxin proteins which are themselves harmless. It is therefore  a very safe vaccine with few side effects. Prior to 1996 the whole-cell pertussis vaccine was used – this was similar but still contained entire bacteria (although inactivated) and had a higher incidence of side effects. The DTaP vaccine is actually less effective than the older DTP vaccine, but a little bit of efficacy was traded for increased safety.

The childhood vaccine schedule requires 5 injections between 2 months and 6 years of age. Young infants are therefore most susceptible to pertussis because they have not yet had time to get vaccinated and develop immunity. Immunity does last for years, but wanes in teenagers and older adults. Therefore periodic boosters (with a vaccine called Tdap) are recommended to maintain lifelong immunity. Incidentally, immunity from the vaccine is not much different than immunity from the illness itself:

A review of the published data on duration of immunity reveals estimates that infection-acquired immunity against pertussis disease wanes after 4-20 years and protective immunity after vaccination wanes after 4-12 years.

The factors, therefore, that are contributing to the fact that the current epidemic is likely to be the biggest in 50 years are – the natural cycle of pertussis, a lower degree of immunity from the current DTaP vaccine vs the older DTP vaccine, and waning immunity in older children and adults with low rates of booster shots to maintain immunity.

Two other factors are currently under investigation. One is the rate of undocumented aliens in California that may not have been vaccinated. The CDC reports:

Incidence among Hispanic infants (49.8 cases per 100,000) was higher than among other racial/ethnic populations. Five deaths were reported, all in previously healthy Hispanic infants aged <2 months at disease onset; none had received any pertussis-containing vaccines.

So early indications are that the Hispanic population is disproportionately getting pertussis. But the burning question is – are there pockets of low vaccination rates among vaccine-refusers, lacking herd immunity, that are also contributing to the epidemic? A recent New York Times article by Tara Parker-Pope argues that vaccine refusal is likely not a contributor because there is no association between county-wide vaccine rates and pertussis incidence. However, this argument is not valid. Counties are a mostly arbitrary political boundary, not a meaningful population or social boundary. There are small pockets of low immunization rates in communities that have been centers of vaccine-preventable diseases in the past, and it is still possible (even probable) that pertussis is having an easier time spreading through these populations as well.

Further – we are on the cusp of a new school year. Once children go back to school, the pertussis epidemic may get into full swing. There are schools that, because of their culture and policies, have very low vaccination rates. We will have to see what happens with pertussis in these schools once the classroom doors open.

Conclusion

What we can say at this point for certain is that 2010 is an epidemic year for pertussis, and this cycle will be the worst in half a century. We know that vaccination with DTaP is safe and effective, but requires booster shots as adults, and that not enough people are getting this booster shot. This epidemic is still nothing compared to the pre-vaccine era of pertussis, but it highlights the ongoing need for vaccination and herd immunity against contagious and deadly diseases like pertussis.

Whether vaccine refusal is playing a significant role has neither been confirmed or rejected by current information, but eventually this data will be available. And unlike the anti-vaccine crowd, we will base our conclusions on the evidence, not rhetorical expediency.

On the heels of Scott Gavura’s superb post yesterday on dietary supplement regulation in the US and Canada, I bring you one of the most egregious and obscene product cases I have seen in 15 years of teaching on botanical and non-botanical products: Miracle Mineral Solution. Please accept my apologies in advance for not having a scholarly post for you today – this is just too unbelievable not to share with Science-Based Medicine readers.

On July 30, the FDA released this warning:

FDA NEWS RELEASE

For Immediate Release: July 30, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)
Product contains industrial strength bleach

The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.”  The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away.

MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.

The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.

The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible and to discard the product. Consumers and health care professionals should report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at http://www.fda.gov/medwatch/report.htm.

Even with this forceful warning, the product website is still live and it is full of the most unreal claims I’ve seen in any online marketing scheme:

This Breakthrough can save your life, or the life of a loved one.
Please read.

The answer to AIDS, hepatitis A,B and C, malaria, herpes, TB, most cancer and many more of mankind’s worse diseases has been found. Many diseases are now easily controlled. More that 75,000 disease victims have been included in the field tests in Africa. Scientific clinical trials have been conducted in a prison in the country of Malawi, East Africa.

Separate tests conducted by the Malawi government produced identical 99% cure results. Over 60% of the AIDS victims that were treated in Uganda were well in 3 days, with 98% well within one month. More than 90% of the malaria victims were well in 4 to 8 hours. Dozens of other diseases were successfully treated and can be controlled with this new mineral supplement. It also works with colds, flu, pneumonia, sore throats, warts, mouth sores, and even abscessed teeth (it’s the only thing that controls and cures abscessed teeth).

The inventor believes that this information is too important to the world that any one person or any group should have control. The free e-book download on this site gives complete details of this discovery. Please help make sure that it gets to the world free. There are many medical facts that have been suppressed and this invention must not be added to that list. The name of the e-book is The Miracle Mineral Supplement of the 21st Century. This book tells the story of the discovery, and how to make and use it. This book can save your life. Give it a try.

No. No. Don’t give it a try.

Instead, please follow this advice from FDA if you are a consumer who has stumbled upon this post in a search term query:

The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible and to discard the product. Consumers and health care professionals should report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at http://www.fda.gov/medwatch/report.htm.

Blogging colleague, Liz Ditz, brought me this information from the “inventor’s” Q&A blog:

Is taking MMS IV much more efficient than drinking it? Should I stop taking my medication for HIV?

Posted by: admin in AIDS, HIV, Intravenously (IV), MMS General, tags: AIDS, HIV virus, Intravenous treatment, iv, medications, vomit

Please treat me as your son and tell me what best should I do to get rid of this HIV virus. Would you tell me to stop my three drugs medication and when? Is it ok to overlap MMS with current medication? Should I take MMS IV if it’s much more efficient than drinking it? Stopping medication is a big decision for me to make as I always felt to rely on them in order to live. Please help me with your experience and testimonials.

=====

MMS IV is much more effective than taking by mouth. Stop the drugs immediately. HIV is not dangerous. It does not cause AIDS. What causes AIDS is the drugs that you are taking, each one is extremely poisonous. That causes AIDS. The vomiting was a good sign. It means you body is getting rid of bad stuff. It takes a certain amount of courage to stop the drugs, but you really know that they are bad, and that they will not help you live longer. Just depend on the MMS as it is a thousand times better. Read the MMS data a few times. See the logic. Ask yourself that is not more logical that taking poisons. Visit http://www.miraclemineral.org for the MMS book and DVD and http://www.jimhumble.com for more info.

Keywords: Intravenous treatment, HIV virus, AIDS, medications, vomit, iv

In cases such as these, the US Federal Trade Commission has more power to intervene than even the FDA. False advertising to the point of directing the consumer to harm themselves is much more their purview. In fact, some readers will recall that in 2001 the FTC ran “Operation Cure All,” a multi-agency initiative to target internet health fraud in cooperation with Health Canada.

But I’m wondering where the FTC is in the case of Miracle Mineral Solution. A site search conducted at the time of this post revealed no FTC action against the marketers or manufacturers of this bleach product. I am simply stunned that this product website and associated promotional materials remain online.

This is not a case of a supplement adulterated with a prescription drug or containing trace amounts of heavy metals. This is an active scheme directed not only to driving the consumer to use a harmful product (and even inject it IV), but also encourages the discontinuation of beneficial prescription drugs.

I will be filing a complaint today with the FTC – I encourage those of you so inclined to do so here.

Here is the conclusion quoted from a recent New England Journal of Medicine (NEJM) review article on acupuncture for back pain:

As noted above, the most recent wellpowered clinical trials of acupuncture for chronic low back pain showed that sham acupuncture was as effective as real acupuncture. The simplest explanation of such findings is that the specific therapeutic effects of acupuncture, if present, are small, whereas its clinically relevant benefits are mostly attributable to contextual and psychosocial factors, such as patients’ beliefs and expectations, attention from the acupuncturist, and highly focused, spatially directed attention on the part of the patient.

Translation – acupuncture does not work. Why, then, are the same authors in the same paper recommending that acupuncture be used for chronic low back pain? This is the insanity of the bizarro world of CAM (complementary and alternative medicine). Yesterday David covered the same article, which I had also covered on NeuroLogica, but we both thought this issue important enough to document our thoughts and objections on SBM.

Let’s break down their conclusions a bit. They have reviewed the clinical evidence, as I and others have done before, and found that when real acupuncture is compared to various forms of sham acupuncture (the acupuncture version of a placebo) there is no difference. As I have written many times before – it doesn’t matter where you stick the needles, or even if you stick the needles. Reviews have also concluded that there is no evidence for the mere existence of acupuncture points. Since acupuncture consists of sticking needles in acupuncture points, the only reasonable conclusion from this evidence is that there is no specific effect from acupuncture – acupuncture does not work.

The phrase, “contextual and psychosocial factors, such as patients’ beliefs and expectations, attention from the acupuncturist, and highly focused, spatially directed attention on the part of the patient.” is a fancy way of saying “placebo effects.” In other words, there are some non-specific subjective benefits to getting attention from a practitioner. There is this assumption, however, that these benefits are real and worthwhile. However, they are likely to be illusory – an artifact of observation and reporting, not a real improvement in the patient’s condition. In real science-based medicine, that is the underlying assumption – placebo effects are largely illusory – a variable to be controlled for.

But there has been recent controversy over the role of the placebo effect in ethical and evidence-based practice. This is, in my opinion, largely a back door attempt to justify CAM treatments that do not work. The claim is that placebo effects are real and useful. But a systematic review of the placebo effect in clinical trials concluded:

We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed.

In other words – for any objective outcome, there is no important placebo effect. For outcomes that are subjectively reported by patients, there is a highly variable placebo effect. It is plausible that the expectation of benefit could result in the release of dopamine and endorphins and produce a physiological decrease in pain, for example, in a subset of people, and there is some evidence for this. But this is, at best, a transient symptomatic effect – not therapeutic.

Such effects are also non-specific – meaning they do not derive from the intervention itself, but from the therapeutic ritual surrounding the intervention. Even treatments that do not work may therefore provide these non-specific benefits. My opinion is that the non-specific benefits of the ritual of treatment should be combined with an actually effective treatment, not magic pretending to be medicine. There are many reasons for this. One is the ethics of patient autonomy and informed consent – giving a fake treatment to a patient violates the patient’s rights, in my opinion.

Further, there is potential downstream harm from convincing patients that fake magical treatments are effective, because of placebo effects. Then using obscure language to hide the fact that the treatment actually does not work. This distorts the public’s view of medicine, and of what works, and sets them up to be victims of fake treatments when their ailment is not subjective or self-limiting. In other words – refer them to an acupuncturists when they have back pain and they may rely upon acupuncture, or some other non-scientific intervention, when they have a more serious illness.

There is further harm caused by diverting research time, money, and other resources from more fruitful lines of investigation in order to pursue a theory that has no basis in biology. There are thousands of published studies on acupuncture – given the negative results of this research most of this has been a waste of time and resources.

The authors of this article recommend:

He has specifically requested a referral for acupuncture, and we would suggest a course of 10 to 12 treatments over a period of 8 weeks from a licensed acupuncturist or a physician trained in medical acupuncture.

This contradicts their own conclusions. Why is training in acupuncture necessary? That training largely consists of identifying acupuncture points, knowing which points to use on an individual patient, and knowing the technique of needle insertion – but none of these things matter. The sham ritual is all that matters – you can literally fake it and get the same response. I bet a 10 minute video is all that is necessary. In fact I bet even that is not necessary – you could probably fake it well enough to get a maximum placebo effect without any prior demonstration.

What the authors of this article have done is something that is increasingly common in CAM (when it is trying to infiltrate academia and peer-reviewed journals like the NEJM) – reviewing the evidence, admitting that the CAM treatment does not work, then making an elaborate and misleading appeal to placebo effects, and ending with a recommendation to use the treatment that does not work. Specifically, they not only recommend using the treatment, but in its fullest magical form, complete with all the disproven claims (that is what “medical acupuncture” is). It’s a bait and switch con game, nothing more. Come for the placebo effect, then be treated with magical nonsense.

A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls and changes to DSHEA, an international comparison may help focus the discussion around what a more science-based framework could look like.

Briefly, the DSHEA is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:

Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

Quackwatch has excellent resources on the DSHEA, and SBM bloggers have brought up specific criticisms of the Act at posts like this, this and this. The main concerns with the Act can be summarized as:

• DSHEA draws a crude distinction between food and drugs, even defining therapeutic and pharmacologically-active products (e.g., herbs, botanicals, some hormones) to be categorized as foods, and therefore eligible for DSHEA exemptions from the FDA’s drug regulations.
• Manufacturers can put virtually any claim on a supplement, without any requirement to provide persuasive clinical evidence, as long as it’s accompanied by the Quack Miranda Warning: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” Disease treatment claims are not permitted, but are typically restated as permissible “structure/function” claims, implying an ability to improve the structure or function of the body only. (Colloidal silver is one example)
• There is a lack of regulatory oversight of manufacturing practices.
• In multi-chemical products such as herbals, there is no standardization of active ingredient(s), nor are there mandatory purity guarantees.
• There are essentially no pre-marketing requirements before selling products. Once available for sale, there is little ability for the FDA to issue cease-sale orders and recalls. Regulators can block the sale of products only after significant problems have been identified (i.e., ephedra)
• The regulation of marketing claims is effectively left to the Federal Trade Commission (FTC), which can prosecute manufacturers for fraud.

The Canadian Regulatory Framework

Until several years ago, Canadian natural health products fell into a regulatory grey zone. Products were treated either as drugs, or as foods. Consultation began in the late 1990’s on a new framework to provide regulation and oversight to these products. In 2004, the Natural Health Product (NHP) Regulations, under Canada’s Food and Drugs Act, became a reality. The NHP Regulations cover nutritional supplements, probiotics, traditional Chinese medicine, vitamins, herbal products, and homeopathy – many of the same products that would be considered “dietary supplements” under DSHEA. Rather than fully regulating these products as drugs, or leaving them virtually unregulated, the NHP regulations were a regulatory compromise: implementing manufacturing quality and safety standards, while significantly relaxing the standards for product efficacy claims. The Natural Health Products Directorate is the unit of Health Canada (Canada’s version of the FDA) that administers the NHP Regulations. Health Canada assures Canadians of the following:

Through the Natural Health Products Directorate, Health Canada ensures that all Canadians have ready access to natural health products that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity.

Let’s look at the DSHEA through the Canadian regulatory framework lens. Does it set a science-based example?

Lowering the Efficacy Bar

One of the biggest problems with DSHEA is that it facilitates unsubstantiated efficacy claims. While DSHEA doesn’t apply to homeopathy, the NHP regulations do. Health Canada says that regulated products are “effective,” so what’s the evidence standard being applied?

Health Canada’s Evidence for Homeopathic Medicines: Guidance Document states that applications for licenses for homeopathic products must include evidence to support the “safety, efficacy, and quality” of a homeopathic medication. All “homeopathic medicine” must be from substances referred to in homeopathic pharmacopias, such as the Homeopathic Pharmacopeia of the United States (HPUS), or other references.

Under the NHP Regulations, if randomized, double-blind, placebo-controlled trials are not conducted, manufacturers can make efficacy claims based on “traditional uses”, i.e., anecdotal evidence of use and efficacy. The two most common types of traditional use claims are provings, and references to homeopathic materia medica, which are essentially compilations of provings. There is no objective evaluation of efficacy in provings or in materia medica. Health Canada offers a list of 59 references it will accept at “evidence”, with publication dates as old as 1834 — dating back before the germ theory of disease was proposed.

Consider the popular remedy Oscilliococcinum, sold as an influenza treatment. It’s prepared by decapitating a duck, taking 35 grams of its liver and 15 grams of its heart and fermenting it for 40 days. The solution then undergoes serial dilutions (1 part in 100) 200 times in a row, (in homeopathy lexicon, “200C”) and is dried on lactose/sucrose tablets. (Wikipedia notes that that in order to obtain even a single molecule of the original fermented duck, a volume of tablets greater that the mass of the entire universe would need to be consumed.) Consulting Health Canada’s NHP database (Search NPN 80014156 here) Health Canada has registered the product, with the labelled medicinal ingredient as “Extract of the liver and heart of Annas barbariae: 200C” and approved the following recommended use (translated from French):

Homeopathic medicine to relieve flu symptoms: fever, chills, body aches, headaches.

This is one consequence of Canadian regulation: the efficacy standard has been lowered so far, it’s meaningless. The Canadian regulatory process assigns distinct registration numbers, dosages, and specific “recommended uses” to hundreds of physically indistinguishable brands of sugar pills.

Shifting categories, let’s consider an herbal product. Ginkgo biloba was discussed back in December in the SBM post Ginkgo Biloba-No Effect. Yet the product Dr. Andrew Weil, M.D. Ginkgo Biloba is approved by Health Canada (Search NPN 80003088 here) with the following recommended use:

helps to improve memory. helps to improve attention. consult a health care practitioner for use beyond 6 weeks. [sic]

Again, the evidence bar is far lower than a critical appraisal of the evidence would suggest is accurate. The result? Arguably worse than under the DSHEA. Statements based on questionable evidence gain a regulatory stamp of approval.

Manufacturing Oversight

The NHP Directorate establishes manufacturing standards and issues site licenses. Good Manufacturing Practices (GMP) must be followed. Setting aside the labelling accuracy of homeopathic remedies, the licensure should provide consumers and health professionals with more assurance that what is on the label is actually in the product. Health Canada’s FAQs include a question on DSHEA and it states:

In the United States, dietary supplements are considered as food products under the Dietary Supplements Health Education Act (DSHEA) and, as such, claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease. These products are not subject to mandatory review, approval or quality requirements, including appropriate testing for identity, purity or potency of active ingredients.

However, GMP standards also exist for supplements sold under DSHEA, so it’s not clear if the NHP regulations impose more strict requirements for Canadian products.

Standardization

The NHP Directorate has created a series of monographs about dozens of single-ingredient products which are intended to provide more standardization of product labeling, dosing and constituents. All of this is worthwhile. Unfortunately a quick scan reveals some significant discrepancies between the current state of the evidence and what’s in the monographs. Harriet Hall’s recent SBM post on glucosamine points out there’s little persuasive data to suggest it has any meaningful effects. In contrast, the current Health Canada-approved monograph for glucosamine selectively cites the positive trials, and labels it effective for osteoarthritis pain. So while the Regulations may be supporting improvements in the consistency of the the finished products,  the evidence standards may be compromising their real-world utility.

Marketing and Post-Marketing Surveillance

One of most important elements of the NHP regulations is the implementation of pre-marketing registration requirements. That is, only products reviewed and deemed to meet minimal standards of product quality, safety, and the (relaxed) standard for efficacy claims are permitted to be sold. Unfortunately, even after after six years, thousands of products remain unregistered due to a backlog at Health Canada. Until then, these products continue to be sold. Despite the published standards for consumer advertising of natural health products, there seems to be little enforcement of these requirements. As noted by Tom Blackwell in the National Post,

Recent ads, for instance, tout unapproved natural remedies as being able to prevent diabetes, heart and eye disease, treat menopause and Parkinson’s and help melt away excess weight. By contrast, makers of prescription drugs are essentially barred from promoting their products directly to consumers at all.

Federal law says even natural products — considered generally safer — must be approved under the natural health regulatory system before they can publish or air any kind of ad, and even then must stick closely to the claims allowed in the licence. Many companies that are waiting for word on their applications have chosen to ignore that rule, however, while others have not even attempted to get approval, observers say.

This regulatory backlog seems to have complicated the enforcement of marketing claims, and advertising standards for both approved and unapproved products don’t seem to be facing any serious scrutiny. In Canada, the Competition Bureau is the agency most comparable to the FTC, but it doesn’t seem to have the same focus on actively and publicly prosecuting fraudulent claims. While it has on occasion required companies to change their messaging, it’s rare, and only when the company has gone beyond the already over-generous efficacy claims allowed through the regulations. Perhaps this situation will change when the registration backlog is eliminated.

With respect to product withdrawals, the Minister of Health has the authority under the NHP regulations to direct the stop sale of a product or to cancel licenses of products to prevent injury. Licenses can also be suspended for regulation contravention, or if a product does not appear to meet safety criteria. It’s difficult to directly compare the FDA to Health Canada in this regard, as most Canadian warnings echo FDA advisories for products that may or may not be sold in Canada.

A Science-Based Regulatory Framework for Supplements

Given the regulatory approaches of Canada and the USA, what might a science-based framework look like? I see at least four different perspectives towards supplements/NHPs. I’m sure more will emerge in the comments.

• Consumers want products that are safe, and labeled accurately. They may consult health professionals, or make their own decisions about whether products are effective.
• Science-based health advocates, like the contributors at this blog, argue that that product safety and quality are paramount, and efficacy statements must be based on good science. They argue against a different approval standard for products just because they’re deemed a “supplement.”
• Free market advocates, and those that call for health “freedom” question the value of most regulation that inhibits choice, emphasizing personal responsibility over government-legislated consumer protection measures.
• Supplement manufacturers generally seek a market where they face as few regulatory restrictions as possible, whether it be safety, efficacy, or quality.

Certainly, there is some common ground here. Many will likely be agreeable to a regulatory framework that give consumer and health professionals assurance that they’re being protected from health fraud and dangerous products. Even free market advocates generally accept that markets operate less effectively when consumers cannot evaluate benefits and consequences (risks). With respect to health “freedom” claims, I question if anyone anyone wants the “freedom” to be sold products that don’t contain what is claimed, or have not been evaluated to be safe. Turning to manufacturers, some may welcome more rigorous regulatory verification of their own quality processes, especially if it helps with market acceptance.

One approach to to a new framework could be to unbundle the various types of supplements and treat each according to the science. Herbal products and botanicals stands out as the most likely to benefit from some elements of the Canadian regulations. Without quality manufacturing and standardization of active ingredients, it is impossible to infer anything about a particular herb. However, with respect to homeopathy, it’s questionable if anyone benefits from the regulation of sugar pills.

The biggest differences in opinion will clearly be the standards for efficacy and safety claims. Supplements/NHPs will rarely be be supported by the rigorous data we require for prescription and over-the-counter drugs. Through the NHP regulation process, Canada effectively eliminated any meaningful efficacy requirements, to accommodate products like homeopathy. Yet if all treatment and efficacy statements are forbidden, the information will emerge elsewhere. It’s an issue that other regulators are grappling with, too. Ben Goldacre, writing in The Guardian, points out the European Union’s process, evaluating health claims for similar products, has rejected 80% of claims submitted for formal approval. Ben’s solution is unorthodox, but one that I’m starting to warm up to:

You’ll never stop companies making these claims. You’ll never stop people enjoying their claims. This game is at least 200 years old. The best solution I can foresee is an EU-mandated bullshit box, where people can say whatever they want about their product, where consumers can join in, but the game at last is clearly labelled.

Conclusion

Canada has implemented a supplement registration and regulation framework with the goal of assuring Canadians that natural health products are safe, effective, and of high quality. While its approach to manufacturing quality is laudable, there are significant shortcomings with respect to product efficacy standards, and the regulation of marketing. The DSHEA at least informs consumers that the labelled statements on supplements haven’t been evaluated by the FDA. In Canada, with approved products, such as homeopathy, recommended use statements have been both evaluated and approved.

Yet if we want to incorporate dietary supplements into science-based practices, consumers and health professionals need quality products, but also objective and transparent evaluations of efficacy. As a health professional that advises consumers on natural health products, I welcome any regulation assures me, and my patients, that what’s on label is actually in the bottle. Without this information, I can’t make evidence-based recommendations. Yet if a regulatory system doesn’t also properly inform consumers about product effectiveness and safety, how can they be expected to make rational decisions about their own health? Canada’s approach offers some lessons, but also some cautions, for those calling for supplement regulation.

One of the things that disturbs me the most about where medicine is going is the infiltration of quackery into academic medicine. So prevalent is this unfortunate phenomenon that Doctor RW even coined a truly apt term for it: Quackademic medicine. In essence, pseudoscientific and even prescientific ideas are rapidly being “integrated” with science-based medicine, or, as I tend to view it, quackery is being “integrated” with scientific medicine, to the gradual erosion of scientific standards in medicine. No quackery is too quacky, it seems. Even homeopathy and naturopathy can seemingly find their way into academic medical centers.

Probably the most common form of pseudoscience to wend its way into what should be bastions of scientific medicine is acupuncture. Harvard, Stanford, Yale, M. D. Anderson, and many others, they’ve all fallen under the sway of the idea that somehow sticking thin little needles into points that bear no relationship to any known anatomic structure and that supposedly “unblock” the flow of some sort of “life energy” that can’t be detected by any means that science has. Most recently, as I described, studies that seek to “prove that acupuncture works” have found their way into high quality, high impact journals whose editors should know better but apparently can’t recognize that the evidence in the study doesn’t actually show what the authors claim it shows. Even so, there are some journals that I didn’t expect to see this sort of infiltration of quackademic medicine. Granted, I never expected it to show itself in one of the Nature journals, as it did in the study I just mentioned. I also never expected it to show up in that flagship of clinical journals, a journal that is one of the highest impact and most read medical journals that exists. I’m talking the New England Journal of Medicine, and, unfortunately, I’m also talking an unfortunately credulous article from Dr. Brian M. Berman, who is the founder of the Center for Integrative Medicine, University of Maryland School of Medicine and the holder of multiple NCCAM center grants, and other institutions, entitled Acupuncture for Chronic Low Back Pain.

The article appeared under the section of the NEJM known as Clinical Therapeutics. Articles published in this section begin:

…with a case vignette that includes a therapeutic recommendation. A discussion of the clinical problem and the mechanism of benefit of this form of therapy follows. Major clinical studies, the clinical use of this therapy, and potential adverse effects are reviewed. Relevant formal guidelines, if they exist, are presented. The article ends with the authors’ clinical recommendations.

And this is the clinical vignette:

A 45-year-old construction worker with a 7-year history of intermittent low back pain is seen by his family physician. The pain has gradually increased over the past 4 months, despite pain medications, physical therapy, and two epidural corticosteroid injections. The pain is described as a dull ache in the lumbosacral area with episodic aching in the posterior aspect of both thighs; it worsens with prolonged standing and sitting. He is concerned about losing his job, while at the same time worried that continuing to work could cause further pain. The results of a neurologic examination and a straight-leg–raising test are normal. Magnetic resonance imaging (MRI) shows evidence of moderate degenerative disk disease at the L4–L5 and L5–S1 levels and a small midline disk herniation at L5–S1 without frank nerve impingement. The patient wonders whether acupuncture would be beneficial and asks for a referral to a licensed acupuncturist.

Berman et al begins with a simple discussion of low back pain, which, as he correctly notes, is an incredibly common clinical problem. He also points out that most of the really bad causes of low back pain (tumors, infection, or inflammatory disorders) are seen relatively infrequently in common practice. The most common cause of low back pain is the dreaded “I” or “N” word: idiopathic or nonspecific, both of which basically mean that we don’t know what causes it. So far, fair enough. Berman et al even produce a fairly good discussion of the pathophysiology of low back pain, including the role of the central nervous system, behavioral elements, and musculoskeletal contributions, among others. Then, unfortunately, the authors go off the deep end:

Traditional Chinese medicine espouses an ancient physiological system (not based on Western scientific empiricism) in which health is seen as the result of harmony among bodily functions and between body and nature. Internal disharmony is believed to cause blockage of the body’s vital energy, known as qi, which flows along 12 primary and 8 secondary meridians (Figure 1). Blockage of qi is thought to be manifested as tenderness on palpation. The insertion of acupuncture needles at specific points along the meridians is supposed to restore the proper flow of qi.

They even include a figure of acupuncture points

It was at this point that I wondered whether I was reading the NEJM or a quackademic medical journal such as the Journal of Alternative and Complementary Medicine. Here was an actual discussion of qi as though it might actually exist and as though meridians and qi were anything other than the result of prescientific concepts about how the body works and disease develops. One wonders if, for its next trick, the NEJM will publish Clinical Therapeutics articles touting the wonders of the humoral theory of disease and how the four humors must be balanced. Or maybe the miasma theory. That was a good one, and quite in accord with the modern day obsession with contamination and “detoxification.”

My expectation to see greater woo appearing in the NEJM notwithstanding, as most CAM advocates do, Berman et al next try to justify acupuncture, starting with the belief that it works and then working backwards to cherry pick studies that they believe to support the hypothesis that acupuncture works for low back pain as anything other than a placebo effect. They begin with several inconclusive and conflicting animal studies, concluding by mentioning the study that I blogged so extensively about two months ago without noting that it didn’t show what the authors thought it showed, nor did it demonstrate that adenosine mediates the effects of acupuncture. As I pointed out, what really irritated me about the adenosine study was that it was relatively interesting science but it was yoked into the service of trying to justify acupuncture with an animal model that had very little to do with acupuncture.

Next, Berman et al decide to delve into the clinical evidence for acupuncture:

A number of clinical trials have evaluated the efficacy of acupuncture for chronic low back pain. A meta-analysis in 2008, which involved a total of 6359 patients,⁴⁴ showed that real acupuncture treatments were no more effective than sham acupuncture treatments. There was nevertheless evidence that both real acupuncture and sham acupuncture were more effective than no treatment and that acupuncture can be a useful supplement to other forms of conventional therapy for low back pain.

At least Berman’s honest about this one in admitting that the meta-analysis showed that real acupuncture is no more effective than sham acupuncture, something that regular readers of this blog know. Then Berman tries to do what acupuncture apologists do every time they encounter studies that show that “true” acupuncture performs no better than the acupuncture control. Rather than simply admitting that acupuncture doesn’t work and that acupuncture effects are placebo effects, they try to spin the results by pointing out that both sham and “real” acupuncture “work” and therefore are useful! In other words, they argue for placebo medicine without calling it placebo medicine. They then do it again for a German trial. Unfortunately for them, it’s a study in which, as is the case with many acupuncture studies, the results didn’t mean what the authors claimed they mean. Once again, Berman tries to represent the finding that sham acupuncture was just as effective as “real” acupuncture. In any randomized clinical trial of a conventional therapy, such a result would lead to the conclusion that the therapy doesn’t work, but not in acupuncture. If both the placebo control and the treatment are indistinguishable from each other, then that means acupuncture must work.

The third study that Berman chooses is a so-called “pragmatic” trial. Basically, it’s a mixed randomized trial with a non-randomized cohort. Let me quote one small passage from the trial that demonstrates why it is an utterly useless study:

In this study, neither providers nor patients were blinded to treatment. Therefore, a bias due to unblinding cannot be ruled out.

That’s putting it mildly. Basically, the study is utterly worthless because it can’t account for the rather large placebo effect that is common in intervention studies for back pain. In fact, it’s fairly amazing that the peer reviewers at the NEJM let that pass. Be that as it may, Berman et al next write an amazing series of statements, beginning with:

Acupuncture is considered to be a form of alternative or complementary medicine, and as noted above, it has not been established to be superior to sham acupuncture for the relief of symptoms of low back pain.

In other words, acupuncture does not work. Even so:

However, since extensive clinical trials have suggested that acupuncture may be more effective than usual care, it is not unreasonable to consider acupuncture before or together with conventional treatments, such as physical therapy, pain medication, and exercise. Many pain specialists incorporate acupuncture into a multidisciplinary approach to the management of chronic low back pain.

In other words, even though acupuncture does not work, we should use it anyway because there are enough practitioners who believe it works and use it even though extensive clinical trials have shown that acupuncture is no better than sham acupuncture, and neither are better than placebo effects.

Even though:

As noted above, the most recent well-powered clinical trials of acupuncture for chronic low back pain showed that sham acupuncture was as effective as real acupuncture. The simplest explanation of such findings is that the specific therapeutic effects of acupuncture, if present, are small, whereas its clinically relevant benefits are mostly attributable to contextual and psychosocial factors, such as patients’ beliefs and expectations, attention from the acupuncturist, and highly focused, spatially directed attention on the part of the patient.^34,65 These studies also seem to indicate that needles do not need to stimulate the traditionally identified acupuncture points or actually penetrate the skin to produce the anticipated effect.

In other words, acupuncture does not work.

Let’s put it this way. Berman concedes that “true acupuncture” doesn’t work any better than sham acupuncture for low back pain. He concedes that it doesn’t matter where you stick the needles. It makes no difference; the effect is the same. He concedes that any perceived benefit from acupuncture in low back pain is due to nonspecific factors, in particular psychosocial factors, patient’s expectations, and the attention paid to the patient by the acupuncturist. What, I ask, do we call such a treatment, a treatment that is no better than placebo control and whose efficacy depends on beliefs and expectations, attention from the provider, and contextual factors.

We call it a placebo, and placebo is just what Berman is recommending to this patient in the clinical vignette that started out this post. In fact, his recommendation that the patient go to a licensed acupuncturist with “adequate training” doesn’t even jibe with his findings in his review article. After all, if it doesn’t mater where you place the needles, then it doesn’t matter if the acupuncturist is trained.

As Steve Novella points out, what Berman is doing in this article in the NEJM is the same thing that CAM advocates in general and acupuncture apologists in particular have a maddening tendency to do. They either cherry pick studies that appear to indicate that their favored woo works. When, as Berman et al were, they are forced to admit that well-designed studies with lots of patients show that their woo is no better than a valid placebo control, they then shift to embracing the placebo, to owning it, so to speak, all without actually calling it placebo.

What I find so disturbing about this NEJM article is not so much that Berman et al pulled these usual CAM tricks. I expect that. I see it all the time in CAM journals and sometimes in unsuspecting legitimate medical or scientific journals. What I find so disturbing about this NEJM article is that the peer reviewers did not spot the obvious CAM abuses of language designed to obscure the fact that acupuncture is no better than placebo. The editors of the NEJM should be ashamed of themselves. The peer reviewers who reviewed this article should be ashamed of themselves. Those of us who rely on the NEJM for evidence-based findings and assessments of various treatments should be afraid.

After all, if quackademic medicine can infiltrate the NEJM, there’s nowhere it can’t go.

More and more American women (1 in 200) are opting for home birth, and midwife-assisted home birth is common in other developed countries. How safe is it compared to birth in a hospital? A new study sheds some light on the subject. It was recently published in the American Journal of Obstetrics and Gynecology: Maternal and newborn outcomes in planned home birth vs planned hospital births: a metaanalysis, by Wax et al.

All the existing studies have flaws. It would be ideal to do a study where women were randomly assigned to home or hospital birth; that isn’t possible, so we have to fall back on studies that are possible. Just comparing home births to hospital births isn’t good enough, because high-risk births occur primarily in hospitals, and between 9% and 37% of planned home births end up with transfer to the hospital during labor and are converted into hospital births. Cohort studies comparing planned home with planned hospital births provide the best sources of data by intended delivery location. There have been several such studies, but the numbers were small and the results were inconclusive. This new study is a meta-analysis that combines the data into one large set for better understanding.

Wax et al. combed the published literature and found studies covering 342,056 planned home and 207,551 planned hospital deliveries. Studies were included in their analysis if they were performed in developed Western countries, published in English-language peer-reviewed literature, if maternal and newborn outcomes were analyzed by planned delivery location, and if data were presentable in a 2X2 table. They looked at several measures of maternal intervention (epidurals, C-sections, etc.), maternal outcomes (mortality, hemorrhage, infection, etc.), and neonatal outcomes (Apgar scores, perinatal deaths, etc.). Here’s what they found:

RESULTS: Planned home births were associated with fewer maternal interventions including epidural analgesia, electronic fetal heart rate monitoring, episiotomy, and operative delivery. These women were less likely to experience lacerations, hemorrhage, and infections. Neonatal outcomes of planned home births revealed less frequent prematurity, low birthweight, and assisted newborn ventilation. Although planned home and hospital births exhibited similar perinatal mortality rates, planned home births were associated with significantly elevated neonatal mortality rates.
CONCLUSION: Less medical intervention during planned home birth is associated with a tripling of the neonatal mortality rate.

It’s important to understand the difference between perinatal and neonatal mortality. The write-up of the study is confusing because a typo erroneously defines perinatal mortality as deaths up to 28 days after birth. Perinatal mortality includes stillbirths and deaths in the first 7 days of life; neonatal mortality includes all deaths in the first 28 days of life.

Neonatal death was twice as likely overall with home birth (Odds Ratio 1.98, 95% confidence interval 1.19–3.28) and three times as likely for non-anomalous births (OR 2.87, CI 1.32–6.25). Non-anomalous means without congenital defects. These findings are robust, consistent across all studies, and even more impressive in that women planning home deliveries had equal or lower obstetric risk. The relative risk is striking, but the absolute risk is small due to the small number of home births. They estimate the population-based attributable risk of overall neonatal death to be 0.3%.

One of the stated goals of women planning home births is to avoid unnecessary interventions. They did indeed have fewer interventions. But planned home births were characterized by a greater proportion of deaths attributed to respiratory distress and failed resuscitation. Intrapartum asphyxia is a major cause of death in hospital births, and it is decreased by interventions. This raises the question of whether the decreased obstetric intervention in the home birth group may have caused more neonatal deaths due to asphyxia.

Women intending home deliveries had better outcomes: fewer infections, 3rd-degree lacerations, perineal and vaginal lacerations, hemorrhages, and retained placentas; and there was no significant difference in the rate of umbilical cord prolapse. There were too few maternal deaths to analyze.

Babies of mothers planning home births were less likely to be born preterm or be of low birthweight, but were more likely to have an extended gestation of 42 weeks. Perinatal mortality was similar, but neonatal mortality was significantly greater. This is puzzling and it would have been helpful to know more about the cause of death and the course of illness. How could intrapartum events cause equal mortality up to one week and greater mortality only between 7 and 28 days? The incidence of infection in the babies was not reported. Fear of hospital-acquired infections is one stated reason for choosing home delivery: is it a valid reason? One could argue that the best solution is to reduce the rate of hospital-acquired infection, not to avoid the hospital. Mothers had fewer infections, but is it possible that more babies got infections during home births, infections that contributed to death between 7 and 28 days? What other factors might account for delayed deaths? And why should the death rate of normal babies exceed that of babies with congenital defects?

The authors commented that

the lower obstetric risk characterizing women self-selecting planned home birth likely underestimates the risk and overestimates the benefit of this delivery choice.

They reported that a study published after their analysis found similar perinatal mortality rates in planned home and hospital deliveries, but after adjustment for the later gestational ages at delivery and greater birthweights among home births, the perinatal mortality was actually greater for planned home deliveries, especially for women who required transfer to the hospital. Up to 37% of women planning a home birth with their first pregnancy end up being transferred to the hospital because of emergencies that arise during the labor process.

They commented that the studies analyzed were of low-risk women considering home birth with highly trained, regulated midwives who are fully integrated into existing health care systems. As such, they might not be generalizable to all women opting for home birth in the United States.

Midwives’ groups are already attacking this new study as flawed and politically motivated, but of course they themselves are politically motivated to show the safety of home birth, and their own studies are flawed. Passions run high on both sides of the debate. This study is far from perfect, and it’s certainly not the final answer, but it’s the best we’ve got to go on at the moment.

I think the real message from this study is that we need to develop a better understanding of which interventions are really necessary to save babies’ lives and how to improve the outcome of all deliveries, whether at home or in a hospital.

A non-trivial percentage of planned home births end up with transport to a hospital. Home birth advocates recognize that these emergencies occur. It seems intuitively obvious that increasing the time delay for emergency interventions ought to increase adverse outcomes, that distance from a hospital is a crucial factor, and that the optimum scenario is immediate availability of emergency response, i.e. labor in a hospital rather than at home.

I submit that delayed treatment of unexpected emergencies constitutes a small but undeniable risk for planned home births. It has not been established that the benefits of home birth (lower maternal infection rate, etc.) can outweigh that risk. And it has not been established that those benefits couldn’t be obtained just as well by improving hospital practices. What do women really want? If they just want to be at home, they may be willing to accept a small increase in risk. If they want fewer interventions, that doesn’t require that they give birth at home.

I admit to prejudice. I support the right of informed patients to choose home birth with a qualified midwife and reasonable precautions, but I personally want no part of it. Having delivered a lot of babies myself and having seen normal low-risk deliveries turn to disaster in a heartbeat, I would never have considered having my own babies at home, and I would personally be very frightened to attend a home birth, especially if there was a 37% chance of it ending with a nerve-wracking rush to the hospital. I would rather see babies born within easy reach of a C-section and other lifesaving interventions. I think this could be accomplished by integrating the “kinder, gentler,” less interventionist midwife approach into a home-like hospital birthing facility in close coordination and communication with obstetricians and pediatricians. This approach would increase patient satisfaction without sacrificing safety, and it is already being tried in many hospitals.

This study leaves a lot of questions unanswered, but it does give us better information to help patients make an informed decision.

One of the recurring themes of this blog, not surprisingly given its name, is the proper role of science in medicine. As Dr. Novella has made clear from the very beginning, we advocate science-based medicine (SBM), which is what evidence-based medicine (EBM) should be. SBM tries to overcome the shortcomings of EBM by taking into account all the evidence, both scientific and clinical, in deciding what therapies work, what therapies don’t work, and why. To recap, a major part of our thesis is that EBM, although a step forward over prior dogma-based medical models, ultimately falls short of making medicine as effective as it can be. It worships clinical trial evidence above all else and completely ignores basic science considerations, relegating them to the lowest form of evidence, lower than even small case series. This blind spot has directly contributed to the infiltration of quackery into academic medicine and so-called EBM because in the cases of ridiculously improbable modalities like homeopathy and reiki, deficiencies in how clinical trials are conducted and analyzed can make it appear that these modalities might actually have efficacy.

Given this thesis, if there’s one aspect of medical education that I consider to be paramount, at least when it comes to understanding how to analyze and apply all the evidence, both basic science and clinical, it’s a firm grounding in the scientific method. Unfortunately, in medical school there is very little, if any, concentration on the scientific method. In fact, one thing that shocked me when I first entered what is one of the best medical schools in the U.S., the University of Michigan, was just how “practical” the science taught to us as students was. It was very much a “just the facts, ma’am,” sort of presentation, with little, if any, emphasis on how those scientific facts were discovered. Indeed, before I entered medical school, I had taken graduate level biochemistry courses for a whole year. This was some truly hard core stuff. Unfortunately, I couldn’t get out of taking medical school biochemistry my first year, but taking the course was illuminating. The contrast was marked in that in medical school there was very little in the way of mechanistic detail, but there was a whole lot of memorization. The same was true in nearly all the other classes we took in the first two years. True, for anatomy it’s pretty hard not to have to engage in a lot of rote memorization, but the same shouldn’t necessarily be true of physiology and pharmacology, for example. It was, though.

Over time, I came to realize that there was no easy answer to correcting this problem, because medical school is far more akin to a trade school than a science training school, and the question of how much science and in what form it should be taught are difficult questions that go to the heart of medical education and what it means to be a good physician. Clearly, I believe that, among other things, a good physician must use science-based practice, but how does medical education achieve that? That’s one reason why I’m both appalled and intrigued by a program at the Mt. Sinai School of Medicine for humanities majors to enter medical school without all the hard sciences. It’s a program that was written up in the New York Times last Wednesday in an article entitled Getting Into Med School Without Hard Sciences, and whose results were published in Medical Academia under the title Challenging Traditional Premedical Requirements as Predictors of Success in Medical School: The Mount Sinai School of Medicine Humanities and Medicine Program.

Let’s first take a look at how the NYT described the program:

For generations of pre-med students, three things have been as certain as death and taxes: organic chemistry, physics and the Medical College Admission Test, known by its dread-inducing acronym, the MCAT.

So it came as a total shock to Elizabeth Adler when she discovered, through a singer in her favorite a cappella group at Brown University, that one of the nation’s top medical schools admits a small number of students every year who have skipped all three requirements.

Until then, despite being the daughter of a physician, she said, “I was kind of thinking medical school was not the right track for me.”

Ms. Adler became one of the lucky few in one of the best kept secrets in the cutthroat world of medical school admissions, the Humanities and Medicine Program at the Mount Sinai medical school on the Upper East Side of Manhattan.

The program promises slots to about 35 undergraduates a year if they study humanities or social sciences instead of the traditional pre-medical school curriculum and maintain a 3.5 grade-point average.

I first became aware of this program four years ago, when the NYT ran a story about how art appreciation was being taught as part of the curriculum at Mt. Sinai. At the time, I was puzzled why such courses were being offered in medical school when there is so little time and so much to teach. Don’t get me wrong. I wish I had taken more humanities and arts classes during my undergraduate years. My not having done so is one of the great regrets of my life, truly a missed opportunity. However, in medical school, unless one is going into medical illustration, my thought at the time was that such a program was all very well and good, but medical school is not a liberal arts school; it is, as I have pointed out, more or less a specialized school, an advanced program of education designed to inculcate into students the basic knowledge and skills that all physicians should have.

But who knows? I might be wrong.

Humanities versus basic science in a cage match for pre-med

Let’s look at the study itself. Basically, it’s pretty thin gruel whose only findings the authors, Dr. David Muller and Dr. Nathan Kase (the latter of whom is the founder of Mount Sinai’s Humanities in Medicine Program), extrapolate far beyond what is justified. It amazes me, in fact, that Academic Medicine would allow so much data-free speculation and pontification in the discussion section of this study. Let’s put it this way. There are really only three findings in this study regarding the Humanities in Medicine (HuMed) students. Basically, Muller and Kase looked at the outcomes of HuMed students from 2004 to 2009 and compared them to the outcomes of medical students on the “traditional” track and found that:

• There was a trend among HuMed students toward residencies in primary care and psychiatry and away from surgical subspecialties and anesthesiology.
• There were no statistically significant differences between the groups in clerkship honors other than psychiatry (HuMed students outperformed their peers, P < .0001) or in commencement distinctions or honors. Although HuMed students were significantly more likely to secure a scholarly-year mentored project (P = .001), there was no difference in graduating with distinction in research (P = .281).
• HuMed students were more likely to have lower United States Medical Licensing Examination Step 1 scores (221 ± 20 versus 227 ± 19, P = .0039) and to take a nonscholarly leave of absence (P = .0001).

The wag in me can’t resist wondering whether the way HuMed students apparently excelled in psychology says anything about the scientific basis of psychiatry, but that’s just the nasty, reductionistic cancer researcher in me. The most important point of this study is that, for the most part, the HuMed students don’t appear to do significantly differently than students in the traditional medical education track other than a tendency towards more “touchy-feely” specialties. This result doesn’t actually surprise me much, given that it is the mission of medical schools to teach the common knowledge and skills that all doctors require. One would expect that, if the medical school curriculum is constructed to provide adequate “catch up” instruction to students whose background in the basic sciences is somewhat…lacking, then most students, particularly students who are highly motivated, as medical students tend to be, should be able to keep up. And HuMed students do get a bit of a catch up course in the form of a “summer boot camp,” described thusly by the NYT:

The students apply in their sophomore or junior years in college and agree to major in humanities or social science, rather than the hard sciences. If they are admitted, they are required to take only basic biology and chemistry, at a level many students accomplish through Advanced Placement courses in high school.

They forgo organic chemistry, physics and calculus — though they get abbreviated organic chemistry and physics courses during a summer boot camp run by Mount Sinai. They are exempt from the MCAT. Instead, they are admitted into the program based on their high school SAT scores, two personal essays, their high school and early college grades and interviews.

I must admit that I’m a bit disturbed by some of this, and here’s why. The reason we know that, for example, homeopathy is incredibly–nay, monumentally–implausible is based primarily on basic science, specifically very basic physics and chemistry. It is chemistry and Avagadro’s number that tell us that a 30C homeopathic dilution almost certainly has not a single molecule of original remedy left. It is basic physics and chemistry that tell us that water doesn’t have “memory,” at least not the way that homeopaths tell us. It is basic chemistry that tells us that, even if water did have “memory,” there’s no known mechanism by which such “memory” could be transmitted to cells for therapeutic effect. In other words, I worry that science-based medicine is in danger if future generations of physicians eschew the hard sciences and elect to “get by” on the bare minimum that they can get by with. Worse, the attitude that seems to be underlying the entire HuMed program is that science is an obstacle to becoming a physician.

Science: An “obstacle” rather than a prerequisite?

From my perspective, science and medicine should go hand in hand. Science informs what is good medicine, and physicians should have a sufficient grounding in the scientific method to be able to recognize what is and is not good scientific and clinical evidence for a therapy. EBM only goes part of the way to reaching that goal. SBM, properly applied, is what EBM could and should be were it not for its devaluation of basic science. Now that devaluation appears to be evident in medical education. Witness some of the quotes from the NYT story and Muller and Kase’s article. For example, from the NYT:

“You have to have the proper amount of moral courage to say ‘O.K., we’re going to skip over a lot of the huge barriers to a lot of our students,’ ” said Dr. David Battinelli, senior associate dean for education at Hofstra University School of Medicine.

And, from Muller and Kase’s study:

The HuMed program at Mount Sinai was designed to determine the extent to which the MCAT and traditional premed courses in organic chemistry, physics, and calculus are necessary for successful completion of a medical school curriculum. It was also designed to encourage students interested in the humanistic elements of medicine to seriously consider pursuing a medical career. Many of these students are initially reluctant to pursue medicine because they are uncertain about their interest in science, they are concerned about their ability to meet the high scholastic expectations of admissions committees,15 or they are unwilling to divert the time and effort required to meet standard medical school admission requirements.

And, from Dr. Kase himself, as quoted in the NYT:

“There’s no question,” Dr. Kase said. “The default pathway is: Well, how did they do on the MCAT? How did they do on organic chemistry? What was their grade-point average?”

“That excludes a lot of kids,” said Dr. Kase, who founded the Mount Sinai program in 1987 when he was dean of the medical school, and who is now dean emeritus and a professor of obstetrics and gynecology. “But it also diminishes; it makes science into an obstacle rather than something that is an insight into the biology of human disease.”

Is anyone else disturbed at how apparently Dr. Battinelli characterizes the basic sciences as “barriers” to medical students, rather than reasonable prerequisites that try to ensure a knowledge base necessary to succeed in medical school? Or how Muller and Kase seem to dismiss science as relatively unimportant in medicine to the point that they seriously argue that, just because some students are discouraged from a medical career because they fear the science? Or how Kase seems to think of basic science as more of an “obstacle” than anything else? Or how Muller and Kase seem want to bend over backwards to admit students who can’t be bothered to “divert the time and effort required to meet standard medical school admissions requirements”?

I would counter that pretty much every prerequisite and requirement to be admitted to medical school and then complete its curriculum are “barriers” and “obstacles”–yes, even any new set of prerequisites that Muller and Kase might come up with to replace the currently existing paradigm. They’re supposed to be barriers! That’s what maintaining standards is all about: Excluding those who can’t make the cut and making sure that the educational curriculum gives those who do make the cut the knowledge and skill base to be at least competent physicians, preferably excellent physicians. What is being argued is what is the proper nature and difficulty of these barriers? Should there be more basic science? Are we demanding too much basic science? Is it enough to have a humanities degree and “fill in” later the science? Certainly this study doesn’t answer any of these questions. Even Dr. Batinelli points out that the more important question is how graduates of Mt. Sinai’s HuMed program do 5 and 10 years down the road, after they’ve completed their residency training and entered practice. What I do not like to see are students who voice attitudes like this student in the NYT article:

Among the current crop is Ms. Adler, 21, a senior at Brown studying global political economy and majoring in development studies.

Ms. Adler said she was inspired by her freshman study abroad in Africa. “I didn’t want to waste a class on physics, or waste a class on orgo,” she said. “The social determinants of health are so much more pervasive than the immediate biology of it.”

My suggestion to Ms. Adler is that if she doesn’t want to “waste” time on physics or especially organic chemistry, then perhaps she shouldn’t become a physician. Social determinants of health are indeed very important, but in actually treating a patient you still need to understand the biology of disease and the treatment used to combat the disease. I suppose I’ll be labeled “arrogant” for being so blunt in saying that, but I don’t care.

What is the proper role of science in medical education?

Proving once again that everything old is new again, this study and entire discussion remind me that this sort of debate has been going on over 100 years, since before Abraham Flexner published the Flexner Report in 1910. Even now, on the 100th year since ithe release of that report, it is not a debate that is likely to go away. For one thing, as Muller and Kase point out, there has been opposition to the ideas embodied in the Flexner Report that medical schools require at least two years of college- or university-level basic science education grounded in basic sciences like physics, chemistry, and biology, characterizing as such opposition as falling into three categories, as they describe in their study:

According to Gross and colleagues,⁹ critics of premed requirements fall into three categories: those who would eliminate all requirements,¹⁰ those who advocate for continuously updating the premed science curriculum,^5–7 and those who believe that the premed curriculum must broadened to reflect a richer liberal arts education.^5,6,8

Personally, my view would probably fall between the last two categories: I believe that the premed science curriculum should be continuously updated based on the latest science but see room for a richer liberal arts educations. The two are not necessarily incompatible. However, such a fusion is not what I see happening in Mt. Sinai’s HuMed program. Rather, what I see is a fusion of numbers one and three, meeting halfway, so to speak, between eliminating all requirements and requiring a richer liberal arts education.

In fact, I would go further than that. What bothers me about Muller and Kase’s thesis is, as I have said before, the way that it seems to view science as an obstacle to getting into medical school and becoming a doctor, as opposed to being a necessary prerequisite to being able to put the flood of information taught in medical school into context. The humanistic part of medicine is very important to being an effective, but if those humanistic elements are not also wedded to a firm understanding of the science of clinical practice, we risk producing a generation of physicians who are very good at holding their patients’ hands and offering encouragement to them but not so good at actually treating their medical problems.

In other words, I fear a generation of physicians perfectly suited to “integrate” so-called “complementary and alternative medicine” (CAM) into their practices.

I understand that much of the basic science that we learn in prerequisites for medical school (i.e., the “premed” curriculum) is not strictly necessary to be a good physician. However, I would argue that learning the scientific method and, even better, internalizing it as part of one’s being, is critical to being a good physician. Consider, for example, EBM. In EBM, science matters almost not at all. Basic science considerations are in fact relegated to the lowest form of evidence for or against a treatment, even below small case series (i.e., anecdotes). Under normal circumstances, such a ranking of basic science considerations may not seem particularly unreasonable. After all, many are the treatment modalities that seem as though they should work on the basis of science alone but turn out not to work when tested in clinical trials, thus showing us either that our understanding of the science of disease is not as strong as we think or that there are other considerations that we have not taken into account. Either way, it’s not unreasonable in general not to rely on basic science alone–with one exception. That exception, as regular readers of this blog no doubt can guess, is when a treatment proposes a mechanism that is not just implausible based on basic science but so implausible that for all intents and purposes it can be considered impossible because for it to work large swaths of well-established science would have to be not just in error but spectacularly and outrageously wrong.

Think homeopathy. Think reiki. Think “therapeutic touch.”

Even leaving aside the question of distinguishing quackery from science, science is important in medicine, as Dr. RW pointed out four years ago:

It’s probably a waste for most of us to memorize the chemical structure of amino acids, but it may be important to know enough about their structure and properties to understand that some are hydrophobic and comprise membrane lipid bilayers while others are hydrophilic and form hydrogen bonds, the basis for the secondary structure of proteins. Memorizing all the steps in the glycolytic sequence and the Krebs cycle won’t make you a better doctor but it could be important to understand how those reactions yield energy, why a molecule of glucose yields only a couple of ATPs in the glycolytic sequence, but an additional 30 some odd in the Krebs cycle, a fact that explains the difference between aerobic and anaerobic metabolism and why folks have to breathe. It’s all about the how and why of health and disease.

Or, as I would put it, physicians need to have a firm grounding in basic science for two reasons. First, as my professors used to reiterate almost ad nauseam, a significant fraction of what we learn in medical school and residency will be obsolete in a decade, and one of the main purposes of medical school is to give us sufficient background knowledge and understanding to be able to keep up with new developments, understand them, and incorporate them into our practices. A strong basic science background makes it easier for physicians to adapt to changes in knowledge leading to changes in recommended therapy and provides the conceptual framework against which to evaluate new scientific and medical findings. As Mark Crislip put it in his usual inimitable sarcastic fashion, if you want job that requires no constant reevaluation of what we do for patients based on new science, perhaps you should be a naturopath or homeopath. Physicians we must be constantly learning, from training all the way to retirement, and that learning is much easier if we have a firm background the physiological, biochemical, and anatomical principles involved, even if we quickly forget details like the structures of various amino acids or where Rotter’s nodes are (although as a breast surgeon, I’ll never forget this; that’s why I chose Rotter’s nodes as an example). Second, as I have argued before, a firm grounding in science helps us to recognize pseudoscience when we see it. A poor scientific understanding of one area that leads to credulity towards a pseudoscience is all too often a marker for or harbinger of a tendency to accept other pseudoscience uncritically.

I would agree with Dr. RW that no one knows for sure what the optimal amount of basic science education should be a prerequisite to be admitted to medical school. Similarly, no one knows what the optimal mix between basic science and clinical instruction is to produce the best possible physicians. Certainly I don’t. These are questions for legitimate debate. What worries me is that the role of science in medicine has, ever since I finished medical school, appeared to be continually under siege. The science that is taught in medical school appears to be purely practical in nature. Memorize this. Memorize that. Apply that equation. Don’t think too deeply about it; a superficial knowledge is fine. A survey course in organic chemistry over the summer is just fine. Never mind that one of the key aspects of organic chemistry that most challenged me and made me understand is that you can’t just memorize things. You have to understand reaction mechanisms and how to apply them. You have to be able to use that understanding to design plans to synthesize chemicals. It’s really cool and fun stuff. And I say this even though the lowest grade I ever got in an undergraduate science class was in my second term honors organic chemistry class.

The ideas being pushed by academics like Muller and Kase also strike me as a false dichotomy. Either we require a ridiculous amount of science as prerequisites or we in essence require almost no basic science, supplemented with survey courses that can’t convey the richness of science or emphasize the scientific method at the heart of the sciences that underlie medical knowledge. As Dr. RW also pointed out, it’s perfectly possible to major in the humanities and take sufficient prerequisite science courses to be accepted into medical school. Students have been doing it for generations.

Perhaps what concerns me the most is not so much the deemphasis of science in medicine but rather the deemphasis of the scientific method and the critical thinking that underlies the scientific method. Teaching science to premed and medical students isn’t necessarily going to innoculate them against pseudoscientific ideas, such as many of the aspects of CAM that have infiltrated medicine over the last 20 years. A broader approach is needed. Teaching critical thinking skills, a subset of which is the scientific method, would represent a powerful strategy to keep medicine science- and evidence-based. If we could wed a strong understanding of the scientific method with a broader understanding of critical thinking, the latter of which could certainly be taught as part of a humanities curriculum, it would be a powerful weapon against quackademic medicine. Unfortunately, I fear we’re going in exactly the wrong direction, wedding a watered down science curriculum with postmodernist nonsense.

On this site there have been several thoughtful posts (e.g. by Dr. Atwood and by Dr. Novella), and subsequently much heated commentary, on the distinction between Evidence-Based Medicine (EBM) and Science-Based Medicine (SBM). I agree wholeheartedly with the position that the two are not mutually exclusive, and that SBM is essentially EBM as it should be practiced, with a comprehensive consideration of all relevant evidence, including the subject of plausibility. As a practicing veterinarian, and an officer of the Evidence-Based Veterinary Medicine Association (EBVMA), I am keenly interested in bringing to my profession a greater reliance on high quality research evidence and sound scientific judgment, and reducing the reliance on individual practitioner intuition and experience in making clinical decisions. However, those of us in veterinary medicine face some special challenges which make the subtle but important distinction between EBM and SBM especially salient. 

Where’s the Evidence?

The first of these challenges is the paucity of high quality clinical research evidence. As an example, in his 2007 book Snake Oil Science, R. Barker Bausell examined the research evidence concerning the use of glucosamine as a treatment for osteoarthritis in humans. He was able to analyze the strengths and weaknesses of a Cochrane Review which included 20 studies with 2570 patients (the most recent revision of this review includes 25 studies with 4963 patients), a NEJM study with 1583 patients, and an Annals of Internal Medicine study with 222 patients treated for two years. His conclusion was that the intervention was not more effective than placebo.

I recently did a targeted search of the PubMed literature database for a brief evidence-based medicine feature on the subject of glucosamine and chondroitin as treatment for osteoarthritis in dogs, currently in press at the Journal of the American Veterinary Medical Association. A search of the terms “glucosamine,” “arthritis,” and “dog” yielded eight references, of which three were relevant (a more comprehensive search strategy yielded sixteen references, but only the same three were relevant to the clinical question). The three useful references included two clinical trials involving a total of 113 dogs and each lasting about 2 months, and a systematic review of treatments for canine osteoarthritis which evaluated one of these two clinical studies. Predictably, the larger, better designed trial with objective measurement criteria showed no benefit of glucosamine, while the smaller, less well-controlled trial with only subjective criteria and a 23% dropout rate in the glucosamine group showed some benefit at some assessment points.

Where’s the Money?

Glucosamine is an extremely popular, and profitable, supplement routinely recommended by veterinarians and administered by owners to their geriatric dogs. Yet the clinical trial evidence concerning its effects is nearly non-existent. The depth of the evidence is no better for many, many routine clinical interventions in veterinary medicine. The primary reason for this is simple: money. 

Obviously, the health of companion animals is not as high a societal priority as human health. Many countries have little or no formal companion animal medicine at all, of course, much less high quality, evidence-based pet medicine. And even in the developed world, the absolute size of the veterinary medical profession and associated industries is dwarfed by that of the human medical industry. 

In the United States, surveys show that most dog and cat owners have come to consider their pets to be members of their family, and their willingness to pay for veterinary care has increased along with this shift in attitude. The same appears to be the case in Europe and other developed nations. This has allowed the quality and technological sophistication of veterinary care to increase. 

Pharmaceutical companies have followed this trend, increasing their financial investment in their own internal research activities, as well as funding the lion’s share of companion animal health research generally (with all the ethical and practical problems that creates). Pfizer, the largest fish in the “Big Pharma” pond, claims to spend $300 million annually on veterinary research globally, for both companion and agricultural animals. However, the company is expected to spend $9-$9.6 billion this year on its human research and development. The same pattern is true of government research spending. Veterinary medicine will always be the poor stepchild of medicine, and we cannot expect to have anything close to the quantity or quality of research evidence available to MDs trying to practice evidence-based medicine. 

A Pack of Lone Wolves?

Another barrier to effective utilization of research evidence in veterinary medicine may be demographic and cultural. In the United States, the average veterinary practice has fewer than three veterinarians, and between one-third and one-half of veterinarians are self-employed practice owners. And most companion animal veterinarians are general practitioners, only about 10-15% of practicing vets being board-certified, with the extended academic training and, hopefully, greater awareness of and respect for research evidence that might be expected to come from this training.

As a profession, we veterinarians tend to be entrepreneurial, self-reliant, and independent. This contributes to a reluctance to let anyone tell us what to do, which may be how veterinarians perceive the position of evidence-based medicine. There is no solid data on the subject (though I am involved in a survey study which will hopefully provide some soon), but in discussions with colleagues I have sensed a great deal of anxiety about the notion of “cookbook medicine” which disdains the hard-won wisdom and experience of the individual clinician. Veterinarians are reluctant to accept the idea that there may be broadly applicable standards of care they ought to adhere to, even if their personal judgment conflicts with the evidence for these.

Undoubtedly, our colleagues in human medicine share a similar temperament and similar sorts of anxieties about “cookbook medicine”. However, these may be tempered to some extent by more widespread advanced training, more structured and supervised practice environments, and greater assessment and monitoring of outcomes, which may partially explain the greater acceptance of EBM in the human medical profession. And though the case of Dr. Rolando Arafiles, Jr. illustrates the weaknesses in the systems for monitoring physician behavior, I think it is clear that the influence of government regulation, and the threat of litigation, give the concept of adhering to a recognized medical standard of care far greater teeth in the field of human medicine than it has in veterinary medicine.

SBM, EBM, or OBM?

So how does this relate to the difference between SBM and EBM? Well, traditionally the scarcity of clinical trial evidence has led veterinarians to practice primarily opinion-based medicine. Personal experience and intuition and the opinions of individual experts or mentors are the predominant foundations for clinical decision-making. There is little or no outcome assessment, so veterinarians must rely on their own clinical experience to judge whether their practices are effective. 

The negative consequences of these strategies are many. There is dramatic inconsistency in the diagnosis and treatment of even common diseases. I routinely have to explain to my clients that if they ask ten vets a question, they are likely to get seven or eight different answers. You can imagine how frustrating this is for them, and how little confidence it inspires in our expertise.

OBM Leads Kids to the Hard Stuff, FBM!

As most readers of this blog likely already know, there are many reasons why individual judgment is an unreliable guide to the true efficacy of a medical intervention, and why we should be reticent to entirely trust our own intuitions and experience. But opinion-based medicine is also a “gateway drug” to faith-based medicine, otherwise known as complementary or alternative medicine. If you are accustomed to judging the safety and efficacy of interventions on the basis of the cases you have seen personally or the opinions of “experts,” you are more likely to be persuaded by the individual experiences of clinicians promoting and alternative practice, and more likely to think that giving it a try yourself is the most reliable way to know if it really works or not. 

The Internet abounds with holistic veterinarians who claim they started their careers as scientific, skeptical doctors but that their frustration with the limitations of mainstream medicine and the problems they could not solve led them to experiment with, and ultimately become promoters of, faith-based miracle therapies of every kind that share no theoretical or practical features in common other than being validated primarily by testimonial and not consistent with scientific knowledge or evidence. 

Tooth Fairy Science exists in veterinary medicine, but it is less of a problem than the simple lack of research evidence and the consequent reliance on even less trustworthy forms of evidence. So veterinary medicine needs a science-based approach even more desperately than human medicine because we have so little clinical trial evidence to rely on, and so few resources to generate more and better evidence. The tragedy of money and talent wasted on studying therapies that have vitalist theoretical foundations inconsistent with established scientific knowledge is even more poignant in the relatively impoverished world of companion animal medical research. Plausibility must play an important role in deciding how we allocate the scarce resources we have in order to maximize the useful information we can generate, and the subsequent clinical benefits for our patients.

Towards a One Health Approach

Veterinarians must also take advantage of the evidence that our colleagues in human medicine have generated for us. There are serious dangers in extrapolating research evidence across species, of course, but we cannot afford to entirely ignore the wealth of human medical research that is relevant to our patients. Examined cautiously and judiciously, this data can help us target our own research efforts more efficiently. Just as animal models have an important role, despite their limitations, in human health research, so human clinical research can inform veterinary medicine. As clinicians, we can make more science-based decisions, even when relevant veterinary research is lacking, if we are aware of the research in humans that already exists on the conditions and interventions we are considering. 

If glucosamine is shown to be no more than a placebo after years of research in thousands of people, how much money and effort should we invest in studying its effects in dogs? And how strongly should we promote it to our clients, the vast majority of whom must pay for their pet’s care out of pocket, without insurance coverage, and who commonly must eschew needed care or even euthanize their companions for want of money to pay medical costs?

A Worthy Goal

There has been a steady growth in the quality and sophistication of care available to companion animals in the last several decades, and I am hopeful that this will continue. But I believe the interests of our patients and clients will be best served if the care we provide is as soundly science-based as possible. And while I think evidence-based medicine can become the standard in the veterinary field, with beneficial effects on the quality of the care we provide, we need the additional features of the science-based medicine approach even more than our MD colleagues: a respect for the importance of plausibility in allocating research resources and an understanding of the need to integrate all relevant evidence when making clinical decisions about interventions in the face of a scarcity of high quality clinical trial research. 

Despite all the histrionic accusations of some alternative medicine advocates about mainstream veterinarians being tools of the pharmaceutical industry or reluctant to accept unconventional approaches only out of closed-minded prejudice or a fear for our income, the reality is that we care deeply for our patients and want to provide them with the best care we can. I truly believe, and I hope the profession as a whole will come to accept, that science-based medicine is far more likely to help us do so than the opinion-based medicine we have traditionally relied on.

Dad always thought laughter was the best medicine, which I guess is why several of us died of tuberculosis.

We have a saying in medicine that you can’t kill an jerk.  Not that we try to kill anyone, but that particularly unpleasant individuals, rife with psychopathology, survive whatever illness comes their way.  The corollary is that particularly nice people are prone to having horrible diseases with unpleasant outcomes.  We all know intellectually that it is not true, but there is an ongoing feeling in health care providers that somehow patient personality determines the consequences of their diseases.  As an aside, I am often  left with the explanation for patients that the reason for their odd infection comes down to bad luck.  Everyone responds something to the effect that “Typical. I get all the bad luck.”  I have never had a patient say, “That’s odd, I am usually so lucky.”

On the question of nurture vrs nature, raising two children has convinced me of the relative lack of importance of nurture in the personalities of my children.  While abusive/pathologic environments will certainly lead to pathologic personalities,  for the average child raised in middle class America I can’t help but think that, to quote Popeye, “I yam what I yam and that’s all what I yam.”  I expect to be schooled in the comments on that subject.  Yes, I read the Blank Slate and have some understanding of the literature.  And yet.  My kids, my friends kids.  I watch them grow in what is (and isn’t) a similar environment and end up with diverse personalities that often appear present before they can speak.  I am well aware of the multiple logical fallacies that lead to that conclusion.  Parenthood and medical practice (where people seem to do the same damn stupid things over and over) have lead me to the conclusion that free will is mostly a myth and we are mostly programmed to behave the way we do. Discuss.  It is not the main point of the post, but my bias.

“Nothing shows a man’s character more than what he laughs at.” Johann Wolfgang von Goethe.

One personality trait is a sense of humor.  No one admits to being a bad driver and I have never met someone who admits that they lack a sense of humor.   Humor is, of course, personal.  I find Seinfeld irritating, not funny.  The rest of my family does not share that assessment.  During Pulp Fiction, my wife and I realized that we were the only ones in the theater laughing during the scene when they are doing a cardiac injection to revive Uma Thurman after her drug overdose.  I once read that in choosing a mate, the best indication of long term compatibility was whether or not you both share a understanding of the essential hilarity of Bob and Ray.  I would agree and wonder if eHarmony uses that in their compatibility tests.  What would those examples say about whether or not I have a sense of humor and if so what kind?

What effects, if any, does a sense of humor have on health?  Emotional states alter physiology, some for the better, some for the worse. The popular opinion is that laughter is of benefit; there is a reason Readers Digest didn’t call their column  ’Schadenfreude, the Best Medicine’.   Are funny people or people who laugh easily more prone to better health because they have a sense of humor or laugh?  Or it is an association without causation, that whatever personality that laughs easily also leads to improved health outcomes?

Whoever said “laughter is the best medicine” never had gonorrhea.  ~Kat Likkel and John Hoberg.

Perhaps the topic of laughing your way to health gained the most traction with the publication in 1979 of Norman Cousins book Anatomy of an illness as perceived by the patient: reflections on healing.  The book, which I read thirty years ago, details how, after being diagnosed with a ankylosing spondylitis, Cousins left the hospital for a nice hotel, where he treated himself with good food, high dose vitamin C, and laughter from watching Marx brothers movies.

Did he have  ankylosing spondylitis?  The interwebs suggest he did not, and I can’t find the diagnostic criteria that were used to make the diagnosis and  ankylosing spondylitis is a disease that can spontaneously resolve.  So causality is particularly problematic in Cousin’s case, since the diagnosis is uncertain. Even though I am an avowed Marxist, I would be suspicious of the power of Duck Soup to alter the course of disease for the better, as is the popular misconception of Mr. Cousin’s book.  I would not doubt that a good laugh will help decrease the perception of the severity of pain, as Mr Cousin’s suggested.

Is laugher medically beneficial?  Is a sense of humor medically beneficial?  Not the same question.

Perhaps I know best why it is man alone who laughs; he alone suffers so deeply that he had to invent laughter.  ~Friedrich Nietzsche

Laughter, of note, is not limited to humans

Vocalizations referred to as “laughter” also occur in great apes engaged in tickling and social play. Vettin and Todt16 have shown key similarities in the respective acoustics of play- and tickling-induced vocalizations in juvenile chimpanzees (Pan troglodytes) and tickling-induced laughter in adult humans.

They estimated that laughter has been present in the human lineage for 10 to 16 million years.  I would estimate that is also how long humans have been farting.  Still nothing funnier to my children.

And some suggest that rats have a laughter equivalent with play and tickling.  Tickling rats.  I laugh at the mental image.  Is that laughter, if not the best medicine, a useful therapeutic intervention?

Laughter decreases blood glucose 2 hours after eating in type 2 diabetics.  I prefer eating in restaurants.   Laughter leads to vascular relaxation and decrease in serum cortisol,  decreases renin in type two diabetics, and increases Natural killer cell function.

Some studies seemed needlessly perverse

Twenty-four male patients with atopic eczema viewed a humorous film (Modern Times, featuring Charlie Chaplin). Just before and immediately after viewing, semen was collected, and seminal B cells and sperms were purified. Seminal B cells were cultured with sperms and IgE production was measured, while expression of galectin-3 on sperms was assessed.

RESULTS: After viewing the humorous film, IgE production by B cells cultured with sperms was significantly decreased. Moreover, expression of galectin-3 on sperms was reduced.

I can’t access the complete reference to discover the rationale behind the study, except, perhaps, to induce giggling.

I am thankful for laughter, except when milk comes out of my nose.  ~Woody Allen

Are there clinical correlates to these  physiologic effects? Sort of.

Laughter may help the depressed (why wouldn’t it?) and cheer up the schizophrenic (what a surprise).  Pello the clown, with his noted a humor intervention, decreased air trapping in COPD patients and laughing decreases the bronchial responsiveness in asthmatics.

That is about it for the medical application of laughter.  A smattering of small studies, rarely repeated, with small numbers of patients published in the more obscure journals.  I would not doubt the laughter is of benefit, but the benefit is small.

What is more interesting are the pathologic laugher syndromes: some (Angelmans) are genetic and some due to central nervous system strokes or tumors.  I suppose the silver lining for these unfortunates is the beneficial physiologic effects  of the continued laugher. Somehow the potential health benefits  does not seem worth it.

These studies involved making people laugh, usually with movies.  Humor is not without its dangers in the medical field, given the idiosyncratic nature of what people find funny.

When used sensitively, respecting the gravity of the situation, humor can build the connection among the caregiver, patient, and family. However, insensitive joking is offensive and distressing, and experience suggests a variable acceptance of humor by patients with life-threatening illnesses, making humor a high-risk strategy.

So if laugher is the best medicine, it is best used sparingly and with the knowledge that as an intervention to cause lasting physiologic change, laughter has has little support.

“A sense of humor always withers in the presence of the messianic delusion, like justice and truth in front of patriotic passion” ~ Henry Louis Mencken.

Maybe it is not laughing that is important, but the more vague idea of having a sense of humor, that is important to health.

Four studies have tested the association between sense of humour and longevity. One reported that comedians and serious entertainers on average die earlier than authors. Two publications from the Terman Life-Cycle Study reported a negative association. Cheerfulness (sense of humour and optimism) was the index variable in the first study. In the second study, optimism was taken out, but the negative association prevailed. The fourth study reported a 31% reduction of mortality risk among patients with end-stage renal failure provided that they scored above the median on a test of sense of humour.

Dr Sven Svebak evaluated a sense on humor based on three questions and looked at survival in a large cohort of Norwegians who were being followed for long term health, much like the Framingham study.  The questions he used were

Do you easily recognize a mark of humorous intent?” (Cognitive; N = 53,546; standardized item alpha = .91, item correlating .87 with sub-scale sum);

“Persons who are out to be funny are really irresponsible types not to be relied upon” (Social; N = 52,198; standardized item alpha = .91, item correlating .88 with sub-scale sum); and

“Do you consider yourself to be a mirthful person?” (Affective; N = 53,132; standardized item alpha = .74, item correlating .78 with sub-scale sum).

The participants responded to four-step scales (labeled for the three items respectively: very sluggishly – very easily; yes indeed – not at all; not at all – yes indeed).

Not an impressive criteria for determining a sense of humor and this is noted in the discussion of the article.  ”It may be regarded a hazardous task to assess psychological characteristics by use of three items.”  However, they felt that similar studies in depression validated the approach.

These questions  measure  friendly humor. The test is not sensitive to humor that creates conflicts, is insulting or that is a variation of bullying.  So much for laughing at my posts as evidence of a sense of humor.

What they found was those with a friendly sense of humor as judged by these three questions were more likely to survive compared to those that scored low on a sense of humor.

The authors are quite thoughtful on the applicability of this study

There is a semantic point in the affective item where “mirthful” was used in the present study instead of “cheerful.” In Norwegian as well as English language “cheerful” and “mirthful” (Norwegian equivalent “munter”) can refer to a subjective state of mirthfulness as well as to the overt expression of mirth through smiling and laughing. The present assessment was by subjective report that may have addressed both the subjective and the expressive tendencies of an individual for being mirthful. A subjective state of mirthfulness appears to be closely related to cognitive processes, whereas expressive display is often triggered by social context. Support to this view came from the relatively high coefficient of correlation between scores on the cognitive and the affective items (r = .40: Table 4). In prospective studies of positive wellbeing, subjective state appears to have been at focus and has proven to reduce mortality. This association has been a fairly consistent pattern of outcome in prospective studies of healthy populations as well as of diseased populations [26]. In light of these findings for positive wellbeing, as well as of the complex conceptual content of sense of humor, it is possible that sense of humor is best conceived of as one aspect of a broader psychological characteristic that facilitates a general state of wellbeing, rather than a specific emotional state of mirthfulness.  Emphasis mine

I think this is interesting and have little argument with the study except in on interview, Dr. Svebak stated “He adds that a sense of humor can be learned and improved through practice.”

There I have my doubts.  I cannot find evidence that people can learn to appreciate humor or learn to become humorous.  In my experience (do I dare use those words?) the capacity for understanding and producing humor appears fixed.

That has therapeutic implications.  If a sense of humor can be developed, the humorless grouch can be taught to laugh and experience the benefits of humor.  More likely, your sense of humor, like your ability to run the mile or learn French, is mostly static in the adult.

Being thoughtful, the authors conclude

There is a risk of taking the present humor findings too far as a booster of longevity. The role of confounding variables is hard to precisely assess in multi- variate approaches, partly because of the often opportunistic availability of such variables in population research projects as well as all the potentially relevant variables that may have been included, but were left out for many reasons, such as lack of funding and time consuming data sampling procedures. The present study included quite a range of variables that are well established in the scientific community as influencing health hazard. A cautious approach is to directly compare hazard ratios across the range of variables, including traditional risk variables as well as an index of sense of humor.

An interesting study with a nuanced discussion. However, a molehill of interesting information does not prevent some doctors for making a mountain of advice.  The You Docs are hard at work again.

Analyzing humor is like dissecting a frog. Few people are interested and the frog dies of it. ~ E. B. White

In this new Norwegian study, researchers who tracked the health of 70,000 people found that those who scored highest on sense-of-humor tests were twice as likely as dour sorts to still be alive — and laughing — seven years later. You didn’t have to be the type that laughs at the drop of a hat, either. All sorts of humor styles boosted survival. “A twinkle in your eye can be more than enough,” notes lead researcher Sven Svebak of the Norwegian University of Science and Technology.

Oh, for that twinkle in the eye, the key to health.  The study, based on three questions, makes no conclusions based on humor styles.

What’s behind humor’s life-prolonging powers? For one thing, laughter is a mini-workout. Ten to 15 minutes of mirth burns up to 40 calories and exercises your abdominal muscles.

About the same as is burned during 15 minutes of sex.  For a real work out combine the two as has been what my partners do… I may be oversharing here.  Everything can be considered a “mini workout” and is a lame reason to suggest laughing.  Given how much I laugh, where is my 6-pack.

The You Docs evidently reviewed the same marginal literature and discovered that

A good belly laugh also boosts your immunity, motivating natural killer cells in your bloodstream to work harder.

In one study, watching a funny movie relaxed the endothelium — the fragile inner lining of your arteries — enough to boost blood flow by 15 percent. Laughter eases stress and reduces levels of the high-anxiety hormone, cortisol. In people with diabetes, it can even help keep blood sugar lower and steadier.

Then there’s resilience. Laughter helps you build and maintain friendships, eases fears and gives you a hand at coping with whatever life throws your way. It may also thwart the flu and protect against cancer.

The last two I cannot find the reference for, but protecting against cancer? My goodness.  They make it sound so all encompassing, rather than the limited results I found.  And they never mentioned the sperms.

“What soap is to the body, laughter is to the soul”  ~ Yiddish Proverb

The You Docs end with suggesting by suggesting you get a daily dose of humor for its health benefits, and they give multiple ways to find a good laugh.  It is interesting how the authors of the study suggest that humor is part of an over arching personality, whilst the You Docs go for simplistic and overwrought advice:

Get your daily quota of yucks. Check in with yourself at lunch time: Have you chuckled today, or maybe even gotten that tingly “this is hysterically funny” feeling? If not, do something about it. E-mail or call your funniest friend. Plan to watch your favorite sitcom or wise-cracking commentator tonight. The Web is loaded with joke sites, bookstores are brimming with humor books, video stores offer thousands of comedies and stand-up comic shows. Make it a point to learn at least one new joke a week, then tell it to your friends.

See the humor in your life. You took the stray cat you rescued to be spayed and discovered that she’s a he? Trade funny stories: Make it a habit to ask friends and family about the most ridiculous thing that’s happened to them today, this week, this month.

Discover what really tickles your funny bone. Your sense of humor is as unique as your fingerprints, so stop laughing at what you think you ought to find amusing (Who does that? Besides Ed McMahon?  If he had heeded that advice, he would have lived longer than 86 years) and do a little research into what really hits your sweet spot. Try watching, reading or listening to types of humor that are new for you. You may discover you prefer political humor or cowboy jokes, martini-dry wit or a really bad knock-knock (Or the You Docs).

It is always curious how a few studies of limited scope get inflated.  Sad advice really. Research what makes you laugh.  That is one of many annoyances of the alt med life style recommendation: the medicalization of the joys of life.  Drink red wine because it is good for you, not because it is joy in a bottle. Eat chocolate because it is a natural medicine, not because it is delicious.  Laugh  because it improves your health, but not because it soothes your soul.  I prefer to laugh and eat and drink and work for the pleasure it provides, not for the health benefits. Live a good life and you will reap the rewards.  I see a lot of people at the end of their lives. When people look back, the regrets they express  are not for the time they wished they had spent laughing to manage their sugars, but the time they did not spend laughing with their loved ones.

Fortunately I read the You Docs.  They provide me yucks, in both senses if the word.  As a result I expect I am never going to get ill, never get cancer and will live forever.

So tell me.  Are you healthier after reading this blog?

A new study published in The American Journal of Clinical Nutrition is reporting an association with eating meat and weight gain. This is a fairly robust epidemiological study, but at the same time is a good example of how such information is poorly reported in the media, leading to public confusion.

The data is taken from the European Prospective Investigation into Cancer and Nutrition–Physical Activity, Nutrition, Alcohol, Cessation of Smoking, Eating Out of Home and Obesity (EPIC-PANACEA) project. This is a long term epidemiological study involving hundreds of thousands of individuals, and is therefore a great source of data. We are likely to see many publications from from it. This one looked at the association of meat eating – poultry, red meat, and processed meat – with total weight.  From the methods:

A total of 103,455 men and 270,348 women aged 25–70 y were recruited between 1992 and 2000 in 10 European countries. Diet was assessed at baseline with the use of country-specific validated questionnaires. A dietary calibration study was conducted in a representative subsample of the cohort. Weight and height were measured at baseline and self-reported at follow-up in most centers. Associations between energy from meat (kcal/d) and annual weight change (g/y) were assessed with the use of linear mixed models, controlled for age, sex, total energy intake, physical activity, dietary patterns, and other potential confounders.

They found that an increase in 240 grams per day of meat in the diet was associated with a 2kg increased weight after 5 years (that’s about 5 pounds, or 1 pound per year). The BBC reported this study as finding:

A European study of almost 400,000 adults found that eating meat was linked with weight gain, even in people taking in the same number of calories.

and

Although it is not clear why meat would lead to weight gain in people eating the same number of calories, one theory is that energy-dense foods like meat alter how the body regulates appetite control.

I find that conclusion problematic in several ways. Let’s look at the study design. One primary weakness is that weight (after the initial weighing) was self reported in most centers. This is a odd study design, and I can only assume this was a matter of practicality. Regardless of reason, self-reported weight is a major weakness. However it pales in comparison to the fact that total caloric intake was estimated, not rigorously controlled. To put this into perspective, 1 pound per year is 3500 Calories, or 67 Calories per week on average. There is no way someone can estimate their caloric intake within 67 Calories per week – that’s less than 10 calories per day.

The notion that appetite control was responsible for the findings also contradicts the assertion that total caloric intake was the same – appetite can only affect weight by increasing caloric intake. The correlation itself is in question because of the self-reported weight. But if we take the correlation as a given, the easiest explanation is that people who consume more meat also tend to consume slightly more calories, which add up over the years. Another possibility is that increased consumption of meat might also correlate with slightly less physical activity.

Assigning a cause and effect is difficult because slight changes that are difficult to measure accurately can result in modest weight differences over years.

Also, the authors concluded:

Our results suggest that a decrease in meat consumption may improve weight management.

“Suggest” and “may” are appropriate in that statement, but were largely lost in the secondary reporting. Again – even if we take the correlation as a given, this kind of data cannot be used to assign cause and effect. It cannot be concluded, in other words, that reducing meat will help reduce weight. Perhaps people who are more hungry for other reasons consume more meat, and if they cut down on their meat consumption they will just replace those calories with other sources. Other studies show that it is the consumption of calorie dense foods that correlate with weight gain, which can either be high fat and protein or high sugar. Calorie density seems to be the common element – which makes sense as increased calorie density can easily lead to overeating total calories, and it only takes a small amount to result in the kind of weight differences typically reported by these studies.

What we don’t have is evidence that decreasing meat intake as an intervention aids in weight control.

Conclusion

This study is interesting, but ultimately does not add much to our knowledge of diet and weight. It is not evidence that diets with the same calories but of different types lead to different weight outcomes, as has been reported. It does add to the literature that suggests that calorie dense foods correlate with weight gain, and this is likely due to increased overall caloric intake. There may be other factors as well, such as total activity, effects on hunger, and even calorie efficiency – how efficiently our bodies extract calories from certain foods.

But I am also struck in such studies, even intervention studies, by how small the difference are among the various diet types. This leads me to the conclusion that varying the ratios of macronutients (protein, carbohydrates, and fats) is of little ultimate utility in weight control. These studies get much attention in the media, but it is often much ado about nothing.

Meanwhile, the more significant factors are basic things like portion control and regular exercise. For health reasons other than weight control eating more vegetables is also a good idea, and this is also a good way to reduce total caloric intake.

Glucosamine is widely used for osteoarthritis pain. It is not as impossible as homeopathy, but its rationale is improbable. As I explained in a previous post,

Wallace Sampson, one of the other authors of this blog, has pointed out that the amount of glucosamine in the typical supplement dose is on the order of 1/1000th to 1/10,000th of the available glucosamine in the body, most of which is produced by the body itself. He says, “Glucosamine is not an essential nutrient like a vitamin or an essential amino acid, for which small amounts make a large difference. How much difference could that small additional amount make? If glucosamine or chondroitin worked, this would be a medical first and worthy of a Nobel. It probably cannot work.”

Nevertheless, glucosamine (alone or with chondroitin) is widely used, and there are some supporting studies. But they are trumped by a number of well-designed studies that show it works no better than placebo, as well as a study showing that patients who had allegedly responded to glucosamine couldn’t tell the difference when their pills were replaced with placebos. The GAIT trial was a large, well-designed, multicenter study published in The New England Journal of Medicine that showed no effect in knee osteoarthritis. A subsequent study of hip osteoarthritis also showed it worked no better than placebo.

A new study shows that glucosamine works no better than placebo for osteoarthritis pain in the low back. It was published in the JAMA: Effect of Glucosamine on Pain-Related Disability in Patients with Chronic Low Back Pain and Degenerative Lumbar Osteoarthritis: A Randomized Controlled Trial, by Wilkens et al.

It is well-designed, randomized and double blind, with 250 subjects, a low drop-out rate, a 6 month duration with a one year follow-up, appropriate clinical criteria for improvement (disability, pain, quality of life, use of rescue medications), intention-to-treat analysis, and even an “exit poll” to insure that blinding had been effective, that patients couldn’t guess which group they were in. It used the doses of glucosamine sulfate that had been called for by critics of previous studies. It was done in Norway, where glucosamine is a prescription drug (in the US it is marketed as a diet supplement under DSHEA regulations so there is a greater possibility of dosage variations and impurities); it was independently funded, with no involvement of industry.

Although no one study can be definitive, this one is pretty convincing when viewed in the context of all the other published data. The authors rightly conclude that glucosamine doesn’t work any better than placebo, but they go on to say some rather strange things. They say it should not be recommended for “all” patients with osteoarthritic low back pain, implying that it might still be recommended for “some” patients. But if so, which patients and according to what criteria? They seem strangely defensive. They stress that glucosamine caused no side effects and could be used safely. They suggest that glucosamine might work for a subset of patients or for joints other than the spine. For instance, the knee. But another new study has confirmed that it is ineffective for the knee.

I don’t understand this. If they had found that a new antibiotic worked no better than a placebo for pneumococcal pneumonia, would they say it should not be recommended for “all” patients with pneumococcal pneumonia or would they simply say it should not be used for pneumococcal pneumonia? Would they speculate that it might work for a small subset of pneumonia patients or for infections in other parts of the body? Probably not. They thought glucosamine worked; they tested it; it didn’t. Why not just say so? Are they letting a prior belief in glucosamine influence their thinking? Unbiased science-based researchers are not usually so hesitant to give up on a treatment that repeatedly fails to pass tests.

I must be psychic, because I had predicted this in a post I wrote two and a half years ago (about the study showing that glucosamine didn’t work for hip pain). I said:

They can always complain that maybe it works for knees but not for hips, or that a different dosage might have worked better, or that it works for some small sub-set of patients. There will always be “one more study” to do.

This new study confirms my opinion that we shouldn’t spend any more research dollars doing “one more study” on glucosamine.

On Friday, one of my partners in crime here at Science-Based Medicine, Dr. Kimball Atwood, wrote an excellent Open Letter to Dr. Josephine Briggs. Dr. Briggs, as most regular readers of SBM know, is the Director of the National Center for Complementary and Alternative Medicine (NCCAM). As most regular readers of SBM also know, we at SBM have been quite critical of NCCAM for its funding of studies of dubious scientific value, including one that I mentioned quite early on in the history of this blog, in which an R21 grant was awarded to investigators at the University of Arizona for a project entitled Dilution and succussion in homeopathic remedy dose-response patterns. The purpose of this project was to compare the effectiveness of a homeopathic remedy at different dilutions. It even compared remedies that are succussed (vigorously shaken) at each dilution step against remedies that were merely stirred. Although this is merely the most egregious example I could find at the time, two years ago I did catalog many more examples, as well as the “educational” grants disbursed through NCCAM in order to teach (and, by doing so, promote) CAM.

Given NCCAM’s long history of promoting pseudoscience, we were all quite surprised when early this year we received an e-mail from Dr. Briggs herself inviting us to NCCAM to meet with her. Unfortunately, due to our work obligations, Steve Novella, Kimball Atwood, and I were not able to coordinate our schedules to travel to Bethesda and enter the heart of darkness itself until early April. Our conversation with Dr. Briggs and her staff was cordial and mutually respectful, as Steve Novella described, and we assured her that we understood that studies such as the one I mentioned above were funded before her tenure. At the same time we were a bit disappointed that Dr. Briggs appeared far too eager to dismiss such problems as being before her time. Still, we understood and approved of Dr. Briggs’ stated goal of making NCCAM more scientifically rigorous, even though we did point out that there is nothing done at NCCAM that couldn’t be done as well in the NIH’s structure before NCCAM existed.

Unfortunately, not too long before or after Dr. Briggs met with us, she also met with a group of homeopaths, leading us to worry that perhaps in her quest to appear “open-minded,” Dr. Briggs was being so open-minded that her brain was in acute danger of falling out, particularly after we saw her infamous “science must be neutral” director’s newsletter a month later, which Dr. Kimball skewered as part of his open letter and I recently used as an example of misinterpreting what scientific “neutrality” means during my talk at the SBM Workshop at TAM8 a couple of weeks ago. In fact, I now wonder if I missed a little gray matter oozing out of Dr. Briggs’ ears during the meeting even though I sat right next to her.

Unfortunately, Dr. Atwood’s open letter gives me even more reason to despair, because in it he pointed out that Dr. Briggs will be speaking at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP) from August 11-15 in Portland, OR. (One wonders if Mark Crislip would be willing to make an appearance there for a Very Special Episode of his Quackcast and thereby continue to expand his Internet empire. I realize that doing so would really be “taking one for the team,” but think of the blogging and podcast material!) Kimball’s explanation why this is disturbing is excellent and detailed, as usual, but one thing he didn’t do as much of as I would have is to go into a bit more detail of what sorts of dubious medical modalities and even outright quackery Dr. Briggs will be associating herself with by speaking at this particular convention. He probably didn’t feel the need, given that he referenced his two comprehensive deconstructions of the quackery that is naturopathy, but I’m not as well-versed in naturopathy as he is, and, I suspect, neither are you. Dr. Atwood didn’t need to delve into the woo that will be presented at the AANP. I do. That’s why I thought a bit of a survey of what will be presented at the conference was in order.

A selection of AANP speakers

Before I discuss the speakers with whom Dr. Briggs will be sharing the podium in Portland, let’s take a look at the title of Dr. Briggs’ talk, which will be “Complementary and Alternative Medicine: Promising Ideas from Outside the Mainstream.” As Dr. Atwood speculates, this is probably a variation or expansion of a slide Dr. Briggs used in her talk at the 2nd Yale Research Symposium on Complementary and Integrative Medicine entitled “Quirky ideas from outside the mainstream” that listed ideas that once weren’t considered mainstream medicine but ultimately became accepted, the implication being, of course, that there are such ideas in CAM that are now considered “quirky” but will become accepted. Of course, ideas such as those embodied in reiki, therapeutic touch, homeopathy, and many other CAM modalities go far beyond merely “quirky,” and the “quirky” ideas that Dr. Briggs mentioned in her Yale talk weren’t really ever considered that “quirky,” but the probable implication of her talk at the AANP convention will be that some of the ideas about health to which naturopaths cling may well be accepted one day.

So, based on the panel of speakers, which, according to the AANP blog, will make this year’s woo-fest “one of the best gatherings to date,” what ideas might Dr. Briggs consider to be quirky but likely to be accepted as mainstream in the future? Given that the speakers are listed in alphabetical order, I couldn’t help but notice immediately as I perused the list this “quirky idea” from Mikhael Adams, BSc, ND, who will be giving a talk entitled Viruses & Pandemics in the 21 st Century: Truth or Dare and the Case for Nature Cure. His talk is described thusly:

This presentation will explore the researched and documented facts relating to viruses and pandemics in the modern age and the vaccinations offered to prevent them, as well the immense toxic burden the average human presents with and its effects on the immune system. Historically, Nature Cure has provided us with a template for repairing and maintaining the “self-healing” and “auto-regulating” mechanisms of our body. This presentation will focus on updated, detailed, effective, and successful “Nature Cure” for today’s chronic conditions.

Connoisseurs of CAM language will recognize immediately a number of code words and phrases in this paragraph, chief among them being the “immense toxic burden” and how it allegedly destroys our immune systems. It’s highly unlikely, of course, that Adams will present anything resembling actual scientific evidence to support his claims of an “immense toxic burden,” but previous experience tells me that it’s extremely likely that he will be laying down a swath of anti-vaccine propaganda, given his reference to “facts” relating to viruses, pandemics, and vaccinations, particularly given how deeply imbedded anti-vaccine beliefs are in naturopathy (only 20% of whom even recommend vaccination), coupled with the belief that uncharacterized (and often unnamed) “toxins” are responsible for most disease. Anyone want to lay down money that Adams’ talk will blame vaccines for some of this “immense toxic burden” from which we all supposedly suffer? I don’t blame you for saying no. It’d be a sucker’s bet. It’s disappointing that Dr. Briggs would associate herself with a speaker who is very likely to be spewing anti-vaccine pseudoscience, given that one area of agreement we found with her in our discussion was that NCCAM must not support the anti-vaccine beliefs that are associated with so many “alternative medical” modalities.

The description of Adams’ “qualifications” reads:

Dr. Mikhael Adams, B.Sc., N.D., received his Doctor of Naturopathy from the National College of Naturopathic Medicine in 1981. He practiced for ten years in Seattle, and is now in private practice in Milton, Ontario. He uses drainage, nutrition, homeopathy, acupuncture and auricular medicine as his primary therapeutic tools. He has studied homeopathy since 1977. Dr. Adams is the president of the International Association of Auricular and Bioenergetic Medicine, past president of the North American Association of Auricular Medicine, and has studied intensively with Dr. Paul Nogier in France. Dr. Adams taught Clinical Pathology at the Northwest Institute of Acupuncture & Oriental Medicine from 1987 to 1993 and has been giving workshops in auricular medicine since 1984. Dr. Adams has been lecturing in North America on homeopathy and drainage since 1988.

So he’s a homeopath, and, as SBM readers know, homeopathy is The One Quackery To Rule Them All. It’s disappointing that Dr. Briggs would associate herself uncritically with homeopathy, as well, although I suppose we shouldn’t be surprised, given her earlier meeting with homeopaths.

Next, “drainage” refers to lymphatic drainage a treatment modality favored by many naturopaths that claims to aid in “detoxification” by improving lymphatic drainage using various nostrums, the claim being that all sorts of symptoms are in reality due to a failure of lymphatic drainage to “detoxify” the body properly. Methods as varied as massage (which is used in science-based medicine, by the way, to improve lymphatic drainage in patients with documented lymphedema) and castor oil, although the “alternative” medical practitioners advocating this latter approach often appear not to understand the significance of pitting edema. (Hint: Lymphedema is usually not pitting, and pitting edema is usually due to cardiac, liver, or kidney abnormalities, although venous insufficiency can also cause it.) While there is a science-based rationale for using various physical techniques to improve lymphatic drainage in people who suffer from lymphedema, be it post surgical or due to other causes, science-based uses of lymphatic drainage are not what we’re talking about here.

If you really want to get a feel for what kind of practitioner Mr. Adams is, you should check out the webpage of his group naturopathy practice, The Renascent Integral Health Center in Milton, Ontario, which describes its approach to patient care thusly:

The emphasis of treatment is placed on removing the blockages that keep the individual from being a self-healing, auto-regulating organism. Therapies are implemented that support the individual’s body, as it specifically responds to external stress, toxic challenges and energetic impressions held by the body, that have manifested into the current state of disease. Whether entering treatment at the centre, or having a Medical Intuitive Scan done by distance, the goal becomes to target disease by identifying and addressing the body’s underlying imbalances that have created its symptoms. To resolve the symptoms, Mikhael and Alison’s approaches go beyond the given diagnosis, to reinitiate the body’s ability to recognize the challenges it faces, and support its ability to resolve its state of disease.

It gets better. I didn’t really know for sure what Auricular Medicine or a “Medical Intuitive” scan is. Fortunately, Adams is happy to tell us, given that he has a “medical intuitive” on his staff, namely his wife Alison Feather Adams. A medical intuitive scan is:

A Medical Intuitive Scan can be done by distance, a written report is sent, and a follow-up phone consultation is arranged to discuss the scan. The Scan records the information held in the body, at a subconscious level, therefore during the phone consult the information presented will be discussed in relation to what the individual is currently experiencing on a conscious level. Medical Intuition can give insight into the emotional and energetic components of the disease state that are not detected using standard diagnostic equipment.

Meanwhile, as best as I can figure it out, Auricular Medicine is reflexology, only with the “mappings” of various body parts and organs to the ears, rather than to the feet and hands. Here’s Adams’ description:

Auricular Medicine is an energetic reflex technique in which the pulse and filters are used to detect points on the ear. The points that show up on the ear can indicate the location of specific imbalances within the body. Through the use of filters we are able to identify specific dysfunctions within the body.

Auricular Medicine is a specialized field of Energetic Medicine…The Doctors in this clinic use Auricular Medicine as their key diagnostic tool and work with their clients to stimulate self-healing (vis medicatrix naturae) through assessment of the disease state, prevention of disease, evaluation of a client’s state of health, and treatment and care of client’s using means and substances that are in harmony with the client’s own self healing processes.

Auricular Medicine in conjunction with conventional medical tests can find and treat the cause of disease. Many conditions, acute and chronic, can be treated by Auricular Medicine.

I’m sure many diseases and conditions “can” be treated by Auricular Medicine. Whether they can be treated successfully with Auricular Medicine is another question entirely. I wonder if Adams uses Col. Niemtzow’s auricular acupuncture as well. He does, however, use something that he calls Inner Alchemy, which promises to help you:

…reconnect with your inner potential by taking you past your discomfort into the wisdom of subtle energy where your intuition can guide you to see things the way they really are, in truth. Truth is the foundation for healing and reinitiating your physical body as well as the mental, emotional and spiritual bodies to work together to bring you back to the state of ease and health again. You come to experience the essence of who you are, and release the outdated programming that the body is compensating for, and outgrown impressions about yourself that has been influencing you unknowingly.

I think we’ve found a new candidate for Dr. Atwood’s Weekly Waluation of the Weasel Words of Woo.

I spent more verbiage than I had expected on just one speaker, but I suppose I was just fortunate that the very first speaker on the list happened to provide me with such a rich source of evidence to demonstrate how unscientific naturopathic modalities are. In fact, the title of one of the talks listed piqued my interest for just this reason, specifically a panel discussion by Thomas Kruzel, M.T., ND; Dickson Thom, ND; Stephen Myers, ND, Bmed, PhD; Kate Broderick, ND entitled Emunctorology: An Old Clinical Science Brought to a New Generation of Naturopathic Physicians. Kimball mentioned this briefly in his post, but I had never heard of emunctorology, either. It’s not a simple matter to figure out what it is, other than that it has something to do with the “organs of elimination,” namely the kidneys, colon, skin, etc., and that the group of naturopaths writing the naturopathy text Foundations of Naturopathic Medicine are trying to codify it as some sort of formal naturopathic study. Also, a naturopath named Sabine Thomas, who Tweets under the ‘nym @emunctorology, rejoiced that apparently there are FINALLY emunctorology courses at that bastion of naturopathy, Bastyr University. Given how obsessed naturopaths are with “detoxification,” one can only imagine what sort of “detox” woo is encompassed by this new/old naturopathic “discipline.” No doubt it will include colon cleanses and sweat lodges to “flush the toxins out.”

Speaking of “toxins,” Charles Masur, ND will be giving a talk on that favorite “toxin” in many branches of “alt-med,” namely the dreaded heavy metals, with a talk entitled Toxic Metals in the Environment and their Role in Oxidative Stress. One wonders if he’ll advocate provoked urine testing for heavy metals of the kind championed by Doctor’s Data, which is currently suing Stephen Barrett for having had the temerity to point out that there is no scientific basis for such a test. The optimist in me hopes not. The pessimist in me realizes that pretty much any naturopath I’ve ever seen blaming all sorts of chronic disease on some sort of fantastical, never adequately documented, heavy metal toxicity also advocates chelation therapy, which is rank quackery, except in unusual case real cases of heavy metal toxicity. Maybe Masur will be the exception. Even if he is, he can count on Jessica Tran, ND, to take up the slack with a talk entitled Overview of heavy metal detoxification strategies using natural and pharmaceutical medicines, which explicitly promises to discuss chelation therapy.

Finally, here are a couple more “quirky” ideas being presented at the AANP meeting. One comes from an actual medical doctor named Dr. E. Denis Wilson, whose talk is entitled The use of T3 and herbal medicine to reset the body temperature and recalibrate many bodily functions. Dr. Wilson promises:

Body temperature is one of the most fundamental physiologic parameters but is often overlooked. Dr. Wilson will discuss the synergy between the use of T3 and herbal medicine to recalibrate body temperature patterns to aid in the restoration of good health. Thyroid endocrinology and physiology will also be discussed.

Quackwatch retorts:

“Wilson’s Syndrome” entered the health marketplace in 1990, when E. Denis Wilson, M.D., of Longwood, Florida, coined its name. Its supposed manifestations include fatigue, headaches, PMS, hair loss, irritability, fluid retention, depression, decreased memory, low sex drive, unhealthy nails, easy weight gain, and about sixty other symptoms. However, Wilson claims that his “syndrome” can cause “virtually every symptom known to man.” He also claims that it is “the most common of all chronic” ailments and probably takes a greater toll on society than any other medical condition.” Wilson claims to have discovered a type of abnormally low thyroid function in which routine blood tests of thyroid are often normal. He states that the condition is “especially brought on by stress” and can persist after the stress has passed. He claims that the main diagnostic sign is a body temperature that averages below 98.6° F (oral), and that the diagnosis is confirmed if the patient responds to treatment with a “special thyroid hormone treatment.”

Dr. Wilson’s also apparently killed at least one patient by prescribing too much thyroid hormone. As a result, according to Quackwatch, he lost a malpractice suit and hasn’t practiced medicine since 1992, which is when the Florida Board of Medicine suspended his license and ordered him to undergo psychological testing. At least he isn’t speaking the same day that Dr. Briggs is, although a talk by Jim Paoletti, RPh, FAARFM entitled A Holistic Natural Approach to Treating Hypothyroidism will occur in the session right after Dr. Briggs speaks.

Perhaps my favorite talk, at least judging by its title, will be the talk by Sharum Sharif, ND entitled Visual Homeopathy – Identifying a Person’s Constitutional Homeopathic Remedy in Minutes, which promises:

Patient and Hollywood videos will be used to demonstrate how to quickly identify a patient’s constitutional remedy by looking for simple behavioral cues and asking 2-5 questions. The presentation will be focused on the most common remedies accounting for the majority of the population of a general naturopathic clinic.

Who knew it was that easy? As a couple of questions, and pick out some water to treat your patient.

Overall, there appear to be at least seven homeopaths speaking. There’s also Matthew Baral, ND, who is a certified Defeat Autism Now! practitioner, and if there’s a richer source of autism and anti-vaccine quackery besides the roster of DAN! practitioners, I am unaware of it. There’s so much more than even this lengthy post can encompass.

What Dr. Briggs should say

I realize that Dr. Briggs is in a delicate situation. Her heart appears to be in the right place as far as wanting to make NCCAM more science-based, but her head doesn’t seem able to acknowledge just how deep into pseudoscience she’s buried herself. Given that NCCAM is not going away unless somehow the public can be rallied against it to the point where even its patron, Senator Tom Harkin (D-IA), can no longer protect it against demands for its dissolution, something exceedingly unlikely to happen any time soon, I realize that NCCAM could do a lot worse for a director than Dr. Briggs and probably will some day if its “stakeholders” get their way. However, as some readers chastised me in the comments of Dr. Atwood’s post, Dr. Briggs chose to accept the directorship of NCCAM when offered, and, as was pointed out, a scientist doesn’t get to be the director of a major center in the NIH if she isn’t a capable politician as well as scientist. In fact, although I don’t believe this to be the case for Dr. Briggs, sometimes being a politician counts for more than being a scientist, as the appointment of Dr. Bernadine Healy to head the NIH in 1991 demonstrates. I also understand that, when one holds a position like director of NCCAM, it is necessary to do things like speak to the AANP, given that, in the U.S., at least, naturopaths probably represent the most politically connected group of CAM practitioners, perhaps as much as homeopaths in the U.K. So turning down an invitation to speak would probably have caused Dr. Briggs trouble.

But wouldn’t it be really cool if Dr. Briggs were to walk into the lions’ den and speak science to woo? I realize it’s as unlikely to happen as it is for me to find a single molecule of original remedy in a 30C homeopathic remedy, but I’d love to see Dr. Briggs use the opportunity to speak to a large gathering of naturopaths to set a few things straight. For example, not too long ago, as I pointed out in my post about “naturopathic oncology” being practiced at the Cancer Treatment Centers of America, Timothy Birdsall, ND, FABNO, wrote a rather telling post for the AANP blog entitled The problem with research after having attended the National Advisory Council for Complementary and Alternative Medicine, the advisory body to NCCAM. Presumably Dr. Briggs knows, or at least has met, Dr. Birdsall, given that she must deal with NCCAM’s advisory council as part of her job. In his post, Dr. Birdsall challenged the next generation of naturopaths to be more science-based and to produce “great scientists,” while at the same time attacking “reductionism,” “allopathy,” and the “biochemical model,” characterizing research as an “impediment” to homeopaths and writing:

In the end, we must create and validate the tools to dethrone the randomized controlled trial as the gold standard, and construct new ways to validate clinical approaches to health issues. Much as the homeopaths of 2+ centuries ago created the proving as a way to better understand and utilize their remedies, we must refuse to be limited by the way conventional medicine views health and disease.

In particular, Birdsall writes:

But ultimately, I find myself becoming offended because I believe that these therapies work… Whoa! Believe? OK, but where is the role for evidence?

Where, indeed? Remember, this is the 2009 AANP Physician of the Year.

Wouldn’t it be cool if Dr. Briggs were to quote Dr. Birdsall’s article, point out to the naturopaths that medicine is not a matter of “belief,” and educate them that, while randomized trials have shortcomings, they are currently the best tool we have for answering many medical questions, including many of those of naturopathy? Wouldn’t it be even cooler if Dr. Briggs correctly pointed out that what Dr. Birdsall really appears to be advocating is not improving how science is applied to medicine, but changing our medical paradigm so that naturopathy can gain scientific acceptance using a different, much weaker standard of evidence? If she would state boldly that, if naturopathy can’t be scientifically validated, then it should be abandoned, I’d give her extra points.

Then there are other things I fantasize seeing Dr. Briggs do with her talk to the AANP:

• Say outright that homeopathy is water, that water doesn’t have memory (at least not the way homeopaths claim), and that, for homeopathy to be true, many of the laws of physics would have to be not just wrong, but spectacularly and completely wrong. Then point out that there’s no evidence that our understanding of physics and chemistry is that spectacularly wrong and challenge the AANP to give up homeopathy.
• Outline the real history of H. pylori, reminding the assembled naturopaths that the idea that H. pylori causes duodenal and gastric ulcers was accepted less than a decade after it was first proposed by Warren and Marshall in 1984, with treatment for H. pylori being the standard of care for duodenal ulcers by the mid-1990s. Challenge the naturopaths to gain acceptance for their “quirky” ideas the same way Warren and Marshall did for their quirky idea, through real science and real clinical trials.
• Point out that using provoked urine levels of heavy metals for any diagnosis or monitoring of treatment is not scientifically supported and is thus best viewed as quackery.
• Reiterate that vaccines are the single greatest medical advance there has ever been, arguably saving more lives than any other and tell the naturopaths that it is disgraceful that only 20% of naturopaths support vaccination. Tell them that there is no convincing scientific evidence that vaccines cause autism or any of the other conditions and diseases attributed to them by many naturopaths. Then point out that naturopaths who “don’t believe in vaccination” or won’t vaccinate should not be practicing medicine.
• Argue that there is no good scientific evidence that there is a human “life energy” field or that people, needles, or touch can manipulate such a field, meaning that “energy medicine” produces nothing but placebo effects.
• Challenge the naturopaths to change their practices based on what science shows, just as “conventional” physicians practicing science-based medicine do, rather than clinging to prescientific notions of “life energy,” sympathetic magic (homeopathy), and ritual purification (”detoxification”) as the basis of their treatments.

I know. It’ll never happen. But a guy can dream, can’t he?

Unfortunately, whether Dr. Briggs realizes it or not, by speaking to the AANP convention without criticism, she is giving it her imprimatur of approval. I once mentioned George Annas, who is a bit of a contrarian and agreed to speak at the National Vaccine Information Center quackfest last fall. Even after he was informed of the nature of the conference, he did not withdraw. According to reports I’ve gotten, he did, however, tell it like it is and refuse to kowtow to the anti-vaccine audience. I didn’t agree with his decision to go through with the talk, but I could respect it. Apparently Annas is the sort of person who actually does like to speak to hostile audiences and rile them up by telling them what they don’t want to hear. Similarly, I could understand and even respect Dr. Briggs if she were to do the same and refuse to kowtow to the pseudoscience that will be surrounding her as she gives her talk to the AANP, if she were to point out that the ideas of the AANP go beyond “quirky” and straight into the woo.

She won’t, though, at least not if she wants to keep her job.

Homeopathy is having a bad year. From a scientific point of view, it has had a couple of bad centuries. The progress of our scientific understanding of biology, chemistry, and physics has failed to confirm any of the core beliefs of homeopathy. Like does not cure like (this is a form of superstition known as sympathetic magic, with no basis in science). Diluting substances does not make them stronger – a notion that violates the chemical law of mass action and the laws of thermodynamics. And countless clinical studies have shown that homeopathic preparations are nothing more than placebos. That homeopathy cannot work and does not work is settled science, as much as it is possible for science to be settled.

Despite the science, homeopathy has persevered through a combination of cultural inertia and political support. But in the last year there are signs that this trend may be reversing. In the UK The House of Commons Science and Technology Committee (STC) released a report, Evidence Check 2: Homeopathy, in which they conclude that homeopathy is failed science and should be completely abandoned – no further support in the NHS and no further research.

Following that the British Medical Association has openly called for an NHS ban on homeopathy, calling the practice “witchcraft.”

Now German politicians are starting to echo the same sentiments.

Karl Lauterbach, the centre-left Social Democrats’ chair on the Bundestag health committee, told German news magazine Der Spiegel that insurers should be “prohibited from paying for homeopathy.”

and

According to Spiegel, Rainer Hess of the Federal Joint Committee for doctors and insurers also characterized the current situation as “extremely unsatisfactory.”

The common thread in the UK and Germany is rising health care costs, which is creating the political will to oppose worthless interventions like homeopathy. Up until now systems like homeopathy which are not science-based have received political support from individual believers and promoted largely through the notion of “health care freedom.” But the political climate is changing, and suddenly paying for interventions that do not work seems unnecessarily wasteful. This creates an opportunity to focus attention on interventions like homeopathy.

In Germany, as in the US, homeopathy has received support from individual politicians. According to the cited news article:

“There have already been many attempts to drop protective provisions on such remedies, but influential politicians have consistently prevented this from happening,” Hess said, adding that despite hundreds of medical studies failing to clearly prove the benefits of homeopathics, insurers are still made to pay for them.

It sounds like Germany has had their own Tom Harkin and Orin Hatch to contend with. Political support for homeopathy in the US actually goes back much further. In 1938 Senator Royal Copeland from New York, a homeopath, managed to insert into the new FDA regulations automatic approval for homeopathic products. This situation continues to today – homeopathic products do not require any testing for safety and efficacy.

It is good to hear that politicians in Germany are now openly discussing not only removing the protections that force insurance companies to pay for homeopathy, but actually banning insurance companies from paying for it. This would be similar to the BMA proposed ban on NHS support for homeopathy.

In both cases no one is proposing that homeopathy itself be banned. If an individual wants to pay for water in the mistaken belief that it is an effective remedy, they are free to do so. However, the seller should not be free to make misleading or fraudulent claims – but that is a different type of regulation. What is now being discussed in Germany and the UK is simply preventing public money from being spent on treatments which have already been proven not to work.

I would like to see these efforts spread to the US. We are facing our own health care crisis here, with a new focus on cost-effective medicine. Amazingly, Harkin was able to hijack efforts to deal with the situation (through “Obamacare”) to increase public support for unscientific medicine. This trend needs to reverse – and homeopathy seems like the low-hanging fruit to me.

With homeopathy the science could not be more clear, and recent exhaustive reviews, like Evidence Check 2: Homeopathy, have shown that it simply does not work. It should therefore be an easy political position to take, that our limited health care dollars should not be spent on ineffective medicine.

Over a year ago I wrote about The China Study, a book by T. Colin Campbell and his son based on a huge epidemiologic study of diet and health done in China. The book’s major thesis is that we could prevent or cure most disease (heart disease, cancer, diabetes, autoimmune diseases, bone, kidney, eye and other diseases) by eating a whole foods plant-based diet, drastically reducing our protein intake, and avoiding meat and dairy products entirely.

I noticed a number of things in the book that bothered me. I found evidence of sloppy citations, cherry-picked references, omission of data that contradicted the thesis, and recommendations that went beyond the data. I concluded:

He marshals a lot of evidence, but is it sufficient to support his recommendation that everyone give up animal protein entirely, including dairy products? I don’t think so.

The China Study involved 367 variables and 8000 correlations. I said I would leave it to others to comment on the study design and the statistical analysis, and now someone has done just that.  Denise Minger devoted a month and a half to examining the raw data to see how closely Campbell’s claims aligned with the data he drew from; she found many weaknesses and errors.

Campbell says

Plasma cholesterol… is positively associated with most cancer mortality rates. Plasma cholesterol is positively associated with animal protein intake and inversely associated with plant protein intake.

The data do show that cholesterol is positively associated with various cancers, that cholesterol is positively associated with animal protein, and that cholesterol is negatively associated with plant protein. So by indirect deduction they assume that animal protein is associated with cancers and that reducing intake is protective. But if you compare animal protein intake directly with cancer, there are as many negative correlations as positive, and not one of those correlations reaches a level of statistical significance. Comparing dietary plant protein to various types of cancer, there are many more positive correlations and one of them does show strong statistical significance. The variable “death from all cancers” is four times as strongly associated with plant protein as with animal protein. And Campbell fails to mention an important confounder: cholesterol is higher in geographic areas with a higher incidence of schistosomiasis and hepatitis B infection, both risk factors for cancer.

Campbell says breast cancer is associated with dietary fat (which is associated with animal protein intake). The data show a non-significant association with dietary fat, but stronger (still non-significant) associations with several other factors and a significant association with wine, alcohol, and blood glucose level. The (non-significant) association of breast cancer with legume intake is virtually identical to the (non-significant) association with dietary fat. Animal protein itself shows a weaker correlation with breast cancer than light-colored vegetables, legume intake, fruit, and a number of other purportedly healthy plant foods.)

He indicts animal protein as being correlated with cardiovascular disease, but fails to mention that plant protein is more strongly correlated and wheat protein is far, far more strongly correlated. The China Study data show the opposite of what Campbell claims: animal protein doesn’t correspond with more disease, even in the highest animal food-eating counties.

These are just a couple of examples. Minger found many more, which she describes in her long article, complete with impressive graphs. Her exposé is well worth reading in its entirety, if only as a demonstration of how to think about epidemiologic data.

Minger goes on to reveal gaping logical holes in Campbell’s own research on casein, a milk protein that he believes causes cancer. He showed that casein was associated with cancer when given in isolation to lab animals, but he projects those results onto humans and onto all sources of animal protein. Other animal proteins have been shown to have anti-cancer effects, and the results of a normal diet containing multiple protein sources are likely to be very different from his casein-only studies.

Minger concludes

 I believe Campbell was influenced by his own expectations about animal protein and disease, leading him to seek out specific correlations in the China Study data (and elsewhere) to confirm his predictions.

She is being polite.

This is a cautionary tale. It shows how complex issues can be over-simplified into meaninglessness, how epidemiologic data can be misinterpreted and mislead us, and how a researcher can approach a problem with preconceptions that allow him to see only what he wants to see. The China Study was embraced by vegetarians because it seemed to support their beliefs with strong evidence. Minger has shown that that evidence is largely illusory. The issues raised are important and deserve further study by unbiased scientists. At any rate, one thing is clear: the China Study is not sufficient reason to recommend drastic reductions in protein intake, let alone total avoidance of meat and dairy foods.

I can’t speak for anyone else who blogs here at Science-Based Medicine, but there’s one thing I like to emphasize to people who complain that we exist only to “bash ‘alternative’ medicine.” We don’t. We exist to champion medicine based on science against all manner of dubious practices. Part of that mandate involves understanding and accepting that science-based medicine is not perfect. It is not some sort of panacea. Rather, it has many shortcomings and all too often does not live up to its promise. Our argument is merely that, similar to Winston Churchill’s invocation of the famous saying that “democracy is the worst form of government except all the others that have been tried,” science-based medicine is the worst form of medicine except for all the others that have been tried before. (Look for someone to quote mine that sentence soon.) It’s not even close, either. SBM has produced far and away better results than any form of medicine that has come before it, which is why it’s always puzzled me that so much of “alternative” medicine seems to be a throwback to ancient, pre-scientific, sometimes religion-based medical systems that existed in the days before germ theory and a rudimentary understanding of human physiology. After all, it wasn’t until William Harvey in 1626 that doctors even knew for sure that there was a direct connection between the arterial and venous system, for example, and the sphygmomanometer wasn’t invented until 1881. Monitoring blood pressure didn’t become routine until the early 20th century, and monitoring the diastolic blood pressure wasn’t routine until the 1920s.

If there’s one area that SBM needs to do better in, it’s regulating our own. To me, the license to practice medicine is a privilege, not a right. That I should even have to emphasize such a statement is bothersome to me, but all too often medical licenses, once obtained, seem to be treated as a right that can’t easily be taken away. That’s not to say that actually getting to the point of being licensed and board-certified isn’t difficult. It is. There’s the need to maintain excellent grades in college, after which there’s medical school and residency, both of which can be quite brutal. But once a physician is fully trained, board certified, and licensed, it seems that medical boards bend over backwards not to take away his license, seemingly even if he’s providing treatments so far outside the standard of care that they might as well be magic.

The case that provoked this complaint from me is one I’ve written about before, namely that of the Winkler County, TX family practitioner, Dr. Rolando Arafiles, Jr.. At the time, Dr. Arafiles was selling dubious supplements, hawking colloidal silver, promoting Morgellon’s disease quackery, and had anti-vaccine propaganda on his website. It turns out that — finally! — Dr. Arafiles is facing the Texas Medical Board for his substandard practice, as documented in a story on Medscape entitled Physician in Whistle-Blower Case Charged by Texas Medical Board:

The Texas Medical Board (TMB) has charged a family physician at the center of a nationally publicized whistle-blower case involving 2 nurses with poor medical judgment, nontherapeutic prescribing, failure to maintain adequate records, overbilling, witness intimidation, and other violations.

The charges follow a report that the 2 nurses — Anne Mitchell, RN, and Vickilyn Galle, RN — made anonymously to the TMB last year about patient care rendered by Rolando Arafiles, Jr, MD, at Winkler County Memorial Hospital in Kermit, Texas, where the 2 nurses and Dr. Arafiles worked.

After the TMB contacted him about the report, Dr. Arafiles asked the sheriff of Winkler County to investigate its source. The sheriff, the physician’s acknowledged friend and patient, traced the report back to Mitchell and Gale, who were then charged in a state court with misuse of official information, which is a third-degree felony.

The American Nurses Association at the time called the criminal prosecution “outrageous,” arguing that nurses were obligated to stand up for patient safety.

A local news report on the case can be found here:

A brief recap of the Winkler County nurses case

Readers might recall that Dr. Arafiles achieved notoriety when these two brave nurses reported their concerns about Dr. Arafiles’ substandard care to the Texas Medical Board. However, it should be noted that the failure to discipline Dr. Arafiles is not simply a problem of the TMB. Remember, prior to going to the TMB, Galle and Mitchell had taken their complaint through formal channels at the 25-bed rural hospital where they worked, Winkler County Memorial Hospital. Their complaints were in essence ignored. Moreover, it’s not as though these problems were subtle. They weren’t, and they became apparent immediately after Dr. Arafiles joined the medical staff of Winkler County Memorial Hospital, as I documented. More appallingly and all too often not mentioned or barely mentioned is that Winkler County Sheriff Robert Roberts, Jr. was not only just Dr. Arafiles friend and patient, but he had been in business with Dr. Arafiles selling supplements. In fact, during crossexamination, Dr. Arafiles even described how Sheriff Roberts had sold his nutritional supplement called “Zrii,” going so far as to hold meetings at the local Pizza Hut to recruit other sellers. No wonder when it came to chasing down these nurses, Sheriff Roberts transformed himself from Barney Fife to, as I put it, Jack Bauer on crack. At least he didn’t torture anyone — physically, that is. He certainly tortured Mitchell and Galle mentally and emotionally, destroying their careers in the process with his misuse of his power.

To bring this post back to the topic of SBM and how state medical boards too often fail to restrain or discipline physicians who not only don’t practice SBM but practice medicine far enough outside the realm of SBM to be dangerous, let’s take a look in light of what we know about Dr. Arafiles the charges pending against him before the TMB:

In a complaint filed last month with a state administrative court, the TMB charged Dr. Arafiles with 9 instances of substandard care. In 1 case, the TMB stated, he sutured part of the rubber from suture-kit scissors to a patient’s torn and broken thumb (in his trial testimony, Dr. Arafiles said he was attempting to stabilize the fracture). And when another patient was admitted to the hospital for an abscess caused by methicillin-resistant Staphylococcus aureus, Dr. Arafiles rubbed an olive oil solution — not on the hospital’s formulary and not approved by the US Food and Drug Administration for this purpose — on the abscess, according to the TMB. The nurses had reported to the TMB that Dr. Arafiles promoted the use of herbal medicines.

I’m going to be honest right here. This doesn’t sound very bad at all compared to Arafiles’ promotion of Morgellons disease and anti-vaccine quackery, as well as his hawking of colloidal silver to treat H1N1. As a surgeon, I may frown on suturing part of the rubber from a suture kit scissors to a patient’s thumb as a not particularly effective way to stabilize anything but, given that disposable suture sets are sterile, it probably didn’t do any harm. I doubt I’d recommend yanking Arafiles’ license over this alone, although I’d probably recommend that Arafiles have a bit of education over the proper way to suture. As for rubbing olive oil on an MRSA abscess, it’s true that this is inadequate treatment in and of itself for an abscess. Although some abscesses can be treated with antibiotics alone, the vast majority of abscesses require drainage of the pus in order to heal. For skin abcesses, that usually ends up meaning “lancing” the boil, cleaning out the pus, and packing the wound daily. If the only thing Dr. Arafiles was doing were rubbing olive oil on the abscess, then there’s no doubt that would be substandard care. If, on the other hand, he were also treating it with vancomycin and/or “lancing” the boil, then, although the olive oil didn’t add anything, it’s probably didn’t do any harm or interfere with the treatment of the abscess, either. I e-mailed a representative of the Texas Nurses Association a request for the full complaint, but did not receive it in time for this post; perhaps I’ll post an addendum when I have the full text of the complaint.

A strange set of charges

Upon perusing the list of charges brought by the TMB against Dr. Arafiles, I find it odd that the TMB focuses on these things, rather than Dr. Arafiles’ egegrious offenses against SBM that are easily found on the Internet. More serious are the charges in this list:

The TMB also alleged that Dr. Arafiles:

• diagnosed hypothyroidism in 1 patient without any testing and diagnosed the same disorder in a second patient despite normal thyroid function tests;
• prescribed hormone replacement therapy (HRT) for a woman whose lab work showed testosterone, estradiol, and progesterone levels within the normal range — HRT was contraindicated for the woman because of a history of deep vein thrombosis, which reoccurred after HRT was initiated;
• performed and billed for unnecessary genitourinary exams;
• failed to adequately document the care he provided; and
• engaged in witness intimidation regarding the 2 whistle-blowing nurses.

The first two complaints are common in the “alt-med” world. Suzanne Somers, for example, appears to believe that virtually every woman needs supplementation with “bioidentical” estrogens, while diagnosing thyroid disorders based on dubious tests or not tests at all also appears to be a cottage industry. There’s a lot of quackery in both areas, that’s for sure. More disturbing is Dr. Arafiles’ performing unnecessary genitourinary examinations. Usually, when a state medical board examines such a complaints, it’s almost always a male physician doing unnecessary pelvic examinations. Failure to adequately document care is a bit of a catch-all; I daresay that virtually every physician could be accused of that for one or more patients if someone looked at his or her patient charts.

All of these are bad. Indeed the charge of witness intimidation should go far beyond mere action against his license by the TMB. This is a felony. Given that the Winkler County prosecutor, Sheriff, and Dr. Arafiles himself are clearly part of a good ol’ boy network that closed ranks against these “uppity” nurses, the Texas state attorney general should investigate and press charges against not just Dr. Arafiles, but against Sheriff Roberts as well. What I can’t help but note is the selectivity of the choice of the TMB, given that many of Dr. Arafiles’s other offenses against the standard of care and medical ethics were right there on his website, Health2Fit, which Dr. Arafiles has eliminated since February and is not archived anywhere that I can find. I knew I should have downloaded the entire website when I was writing about this last in February. Fortunately, I kept several pages because I knew Arafiles’ website would disappear down the memory hole soon, including its links to other Morgellons sites and the section where it sells “Alka Vita Silver” to cure various ailments, including H1N1. Here are some screen shots from my archive of Dr. Arafiles’ Health2Fit website. (Note that Dr. Arafiles claims ownership of Health2Fit on his LinkedIn page.)

Here’s where Health2Fit sells a “water alkalinizer” for $1,495 (click on images to embiggen):

And here are some of the claims Dr. Arafiles made for his alkalinizer:

Here’s Dr. Arafiles’ quack Miranda warning, which is quite extensive:

Finally, here’s the page where Dr. Arafiles sells colloidal silver and claims that it is efficacious against H1N1:

There are other examples, such as Dr. Arafiles taking a homeopathy course taught by Sherri Nakken and belonging to a group of physicians who prescribe intravenous hydrogen peroxide and bioluminescence therapy (whatever that is), but I think I’ve made my point, which is that Dr. Arafiles appears to have committed far more serious offenses against the standard of care and SBM than what the TMB is charging him with. In fact, other than the charge of witness intimidation, the charges that the TMB is bringing against Dr. Arafiles remind me more than anything else of the government’s prosecuting Al Capone for tax evasion. Of course, Al Capone went to jail and spent some time in Alcatraz, but it was rather unsatisfying that it was for a much lesser offense. Worse, there’s no guarantee that Dr. Arafiles will even have his medical license revoked. As I pointed out before, state medical boards are often very loathe to strip a doctor of his medical license.

More than a case about a single doctor

As I’ve pointed out before, the Arafiles case is about far more than just Dr. Arafiles. It’s easy for physicians like myself, who have never practiced in rural areas with few physicians but rather always in large cities or heavily populated suburban areas, to come to think that this is the way that medicine is practiced everywhere. I know I’d never be able to get away with what Dr. Arafiles got away with for as long as he got away with it. I can be easily replaced. Physicians like Dr. Arafiles cannot, and don’t think that they don’t know it. Add to that the problem that most state medical boards are understaffed, underfunded, and enforce regulations that are insufficient to deal with all the issues with which they are charged, and it’s not surprising that it takes truly egregious offenses to get their attention. Does anyone think that Dr. Arafiles would be likely to be facing the TMB this way now if he hadn’t been the focus of an internationally reported case and been caught using his crony the Sheriff to find out who had reported him and make sure they were punished. True, Galle never went to trial and Mitchell was acquitted by the jury in less than an hour, but neither of them have found work since then. Awards for integrity and bravery, as deserved as they are, don’t change that, nor does a $15,850 fine against the hospital.

Unfortunately, because most states devote too few resources to their state medical boards and the enforcement of laws and regulations governing physician conduct, most state medical boards are very reluctant to go after physicians practicing “alternative” medicine as being below the standard of care because doing so involves a value judgement regarding medical science and evidence. Also, most state medical boards are made up of physicians, and if there’s one thing about physicians it’s that we all realize that all of us, even the best among us, are one mistake away from a potentially bankrupting malpractice suit. Consequently, physicians tend to be loathe to be too critical of other physicians, much less sit in judgment of their decisions or the science (or lack thereof) by which they justify their decisions. It’s far easier to go after physicians who are impaired due to drugs or alcohol, who commit obvious crimes, or who sexually abuse patients. These are offenses that virtually everyone understands and condemns in a physician (or anyone else, for that matter). No need to adjudicate on scientific evidence or clinical trials. As Kimball Atwood put it:

When a physician is accused of DUI, “substance abuse,” being too loose with narcotic prescriptions, throwing scalpels in the OR, or diddling patients, the response of a state medical board tends to be swift and definitive. Shoot first, ask questions later. After all, the first responsibility of the board is to the public’s safety, not to preserving the physician’s livelihood. One might therefore expect that a physician accused of using dangerous, substandard treatments would face a similar predicament. As you’ve undoubtedly guessed, such is not the case.

Indeed, it is not, and Kimball proceeded to provide four examples.

Then there’s the issue of licensure itself. As we have pointed out numerous times right here on SBM, there is a concerted effort by proponents of unscientific medical modalities, such as naturopathy, to obtain licensure, or at least to make the law more friendly to them. Perhaps the most spectacular example of the latter tactic is that of Dr. Rashid Buttar. Regular readers will recall that Dr. Buttar has been under investigation by the North Carolina Board of Medical Examiners for quite some time for his tendency to diagnose cancer patients and children with autism as having “heavy metal toxicity” and then to treat them all with some variant of his chelation therapy, plus lots of supplements and other woo, of course. He even referred to the board as a “rabid dog” at one point, something that most people accused of breaking the law would probably be well-advised not to do before their case reaches trial.

Dr. Buttar, however, apparently had reason to be confident. During the last two or three years, during which time the NCBME was investigating him, Dr. Buttar led a charge by the North Carolina Integrative Medical Society to get legislators to change state law to make it friendlier to practitioners of alternative medicine. He succeeded. As a result, the board didn’t think it could succeed in stripping Dr. Buttar of his medical license or even banning him from treating cancer patients and children:

Dr. Rashid Buttar, whose alternative medical practice in Huntersville has been under scrutiny by the N.C. Medical Board for a decade, has accepted a reprimand from the licensing agency.

But Buttar, who was facing potential restrictions to his license, instead can continue offering unconventional treatments as long as he asks patients to sign a form acknowledging his practice is outside the mainstream.

The reason was clear:

Mansfield, the board’s attorney, said a change in state law, which took effect in October, was partly the reason. The law, one of those that Buttar had pushed for, prevents the medical board from disciplining a physician for using non-traditional or experimental treatments unless it can prove they are ineffective or more harmful than prevailing treatments.

It’s an astounding double standard. All Dr. Buttar has to do is to have patients sign in essence a waiver, an acknowledgment that what he is doing does not meet the standard of care and is not validated by science, and he can do whatever he wants, even treat autistic children with urine therapy to “boost their immune systems.” He doesn’t have to prove a thing; if the board wants to go after him it has to prove that “non-traditional” treatments are ineffective or more harmful because North Carolina law now deceptively conflates experimental treatments (which don’t get to the point of being experimental without a lot of preclinical evidence) with “non-traditional” treatments (which often have little or no good scientific evidence for their efficacy). In other words, Dr. Buttar and his ilk don’t have to demonstrate that their woo works; authorities have to demonstrate that it doesn’t. It’s a perfect reversal of what the standard of evidence should be in medicine, and means that North Carolina is now as quackery-friendly a state as there is. Meanwhile, doctors with ethics who treat patients according to science-based guidelines have to justify their treatment decisions. Nor is this a problem that is confined to the United States. Just consider how long it took the U.K. to finally strip Andrew Wakefield of his license to practice medicine.

If we as physicians are ever going to counter this problem, we’re going to have to accept that the problem exists and then do two things. First, we have to restrain our longstanding impulse to circle the wagons and protect a member of the tribe at all costs, even when we know that member has stepped far afield from the land of science-based medicine. Second, we have to lose some of our reluctance, particularly at the state medical board level, to pass judgment on non-scientific treatments like homeopathy, naturopathy, or others. Being a shruggie is no longer acceptable. Our system of regulating physicians and protecting the public from quackery is clearly broken. Will we rise to the challenge to fix it, or will we allow promoters of unscientific medicine to infiltrate and destroy it?

In the meantime, here’s hoping that Mitchell and Galle prevail in their civil suit against Dr. Arafiles, Sheriff Roberts, Winkler County, and Winkler County Memorial Hospital, among others. A message needs to be sent that complaints against physicians practicing below the standard of care should not endanger the livelihood of the whistleblower.

ADDENDUM: A copy of the formal complaint against Dr. Arafiles can be found here.