…Steve Novella, who will be featured as the guest on a live chat with Trine Tsouderos discussing alternative treatments for Alzheimer’s, ALS and other neurological conditions at noon CST. Be there, aloha.

I was surprised to get this e-mail from a reader:

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

My co-bloggers and I have addressed these issues repeatedly. Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again; and maybe by writing this post I can make it easier for new readers to find the information.

Food, Medicine, or Something In Between?

The FDA regulates foods and has been instrumental in improving the safety of our food supply. It regulates prescription and over-the-counter medications, requiring evidence of effectiveness and safety before marketing. Surveys have shown that most people falsely assume these protections extend to everything on the shelves including diet supplements, but they don’t.

Under the 1994 Diet Supplement Health and Education Act (DSHEA), a variety of products such as vitamins, minerals, herbs and botanicals, amino acids, enzymes, organ tissues, and hormones can evade the usual controls if they are sold as diet supplements. Under the DSHEA, the manufacturer doesn’t have to prove to the FDA that a product is safe and effective; it is up to the FDA to prove that it isn’t safe, and until recently there was no systematic method of reporting adverse effects (required reporting is still limited to serious effects like death).

So far the FDA has only managed to ban one substance, ephedra, and it took the death of a prominent sports figure and considerable skirmishing with the courts to accomplish that. Independent lab tests of diet supplements have found a high rate of contamination (with things like heavy metals and prescription drugs) and dosages wildly varying from the label. A striking example was Gary Null’s recent poisoning with vitamin D from one of his own products which contained 1000 times the intended amount.

The FDA has issued rules on good manufacturing practices, but standardization is not required and it remains to be seen whether the new rules will effectively improve product quality.

Rational Supplementation

It makes sense to supplement the diet with essential nutrients if the food in the diet is deficient in those nutrients or if the patient is not able to absorb nutrients normally. There are specific situations where that applies, such as providing folic acid to women to prevent birth defects or providing vitamins and minerals to bariatric surgery patients whose digestive functions are compromised. There are FDA-approved sources of nutrients for indications like these.

It is commonly claimed that “food is medicine” but there are very few situations where the evidence shows that specific nutrients are useful as medicine. Niacin for treatment of hyperlipidemia comes to mind.

The following (taken from a supplement website) are not rational reasons for supplements and are not supported by evidence:

• We can’t get all the nutrients we need from food.
• Supplements boost the immune system.
• Supplements help get rid of toxins.
• Even if you feel well, your health will only be optimal if you take supplements.

The Big Lie

DSHEA is based on a fiction. It prohibits claims that diet supplements prevent or treat any disease and only allows structure/function claims alleging that they “support” health in various ways. DSHEA is a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines. It allows the sale of products that are not intended to prevent or treat disease so people can buy them with the intent of preventing or treating diseases. People don’t buy St. John’s wort to correct a deficiency of SJW in their diet or in their bloodstream; they don’t buy it to “support” brain function; they buy it to treat depression. People don’t buy glucosamine to “support joint health” but to treat their arthritis pain. People don’t buy saw palmetto to “support prostate health” or correct a saw palmetto deficiency, but to relieve symptoms of benign prostatic hyperplasia or to prevent prostate cancer. The FDA’s “Quack Miranda warnings” are routinely ignored even by those few who actually read the fine print.

DHEA (dehydroepiandrosterone) is a hormone that was once approved by the FDA as a prescription drug; then it was taken off the market because the FDA decided it was unsafe. Now it’s available as a diet supplement without a prescription. When the FDA later saw evidence that DHEA was effective for a rare adrenal condition, they re-approved it with orphan drug status. Now the people with that rare disease, and only those with that disease, can get a prescription for the drug, while their perfect healthy neighbor can buy it at any health food store. Does that make any sense at all?

Advocates of CAM complain about “Big Pharma.” What about “Big Supplement” (“Big Suppla”?)? The diet supplement industry is a very profitable multibillion dollar industry that was able to lobby effectively to get the DSHEA passed. BP generates huge profits but it also saves lives. BS (double entendre intentional) has generated huge profits for its investors but hasn’t produced any measurable health benefits to those who use its products.

Yes, Some of Them Work

Some of them do work, but do they work better than prescription alternatives or FDA-approved over-the-counter products with more trustworthy, regulated sources? Are they as safe? They are admittedly cheaper and more convenient than prescription drugs, but is there any other reason to prefer them? One argument is that they are safer, but it isn’t safe to assume that—not until proper large-scale studies are done. Just think of all the prescription drugs that appeared to be safe until careful post-marketing surveillance revealed unexpected problems.

What are the chances that a diet supplement picked at random will turn out to be safe and effective when proper studies are done? Not high. Promising drugs that pharmaceutical companies submit to clinical trials only have about a 5% chance of making it to the market. A few years ago, I went through all the entries in the Natural Medicines Comprehensive Database and tabulated their effectiveness ratings.  Only 5% were rated “effective” and almost all of those were vitamins, minerals, and medicines that are also available as prescription or over-the-counter products approved by the FDA.

There are many products on the diet supplement market that combine multiple ingredients in a kitchen-sink mixture that has no rationale and has not undergone any testing. Maybe the ingredients act synergistically; maybe they interfere with each other. How would we know? Taking such products is a crap-shoot and is like being a guinea pig in an uncontrolled experiment. Many supplement mixtures are sold by multilevel marketing programs and improve health only to the extent that they improve the health of the promoters’ wallets.

Supplements can also harm. Kava has been associated with fatal liver damage. An herbal weight-loss remedy caused kidney failure in dozens of women in Belgium. One fifth of Ayurvedic remedies have unacceptable levels of arsenic, lead and mercury. Most trials of antioxidant vitamin supplements have shown that patients taking them either do no better or do worse than those taking placebos. Vitamin A supplementation increases the risk of fractures in post-menopausal women.

Conclusions

• As my correspondent put it, “the public mania for nutritional supplements is baseless.”
• In general, all our nutritional needs can be supplied by an adequate diet.
• Supplements are beneficial for a few specific evidence-based indications; otherwise, they offer no benefits and may even be risky.
• Diet supplements are not medicines, but are being used as medicines.
• DSHEA should be repealed.

Naturopathy has been a recurrent topic on this blog. The reasons should be obvious. Although homeopathy is the one woo to rule them all in the U.K. and much of Europe, here in the U.S. homeopathy is not nearly as big a deal. Arguably, some flavor of naturopathy is the second most prevalent “alternative medical system” here, after chiropractic of course, and perhaps duking it out with traditional Chinese medicine, although naturopathy does embrace TCM as part of the armamentarium of dubious medical systems that it uses. In any case, some sixteen states and five Canadian provinces license naturopaths in some form, and in some states naturopaths are fighting for–and in some cases winning–the power to prescribe certain real pharmaceutical medications and order real medical tests. For instance, in California, naturopaths can order laboratory tests and X-rays, which reminds me of a conversation I had with a mammographer from California at TAM last summer. He told me a tale of the dilemma he had when naturopaths and other “alt-med” practitioners ordered tests at his facilities. Specifically, the dilemma came about because he doubted that the naturopath knew what to do with the results. Meanwhile, in Oregon, naturopaths can prescribe certain types of pharmaceutical drugs (as opposed to the usual supplements, herbs, or homeopathic remedies they normally prescribe). Meanwhile, moves are under way to expand the prescribing privileges of naturopaths in Canada, as Ontario (which is, remember, just across the Detroit River, less than two and a half miles as the crow flies from my cancer center—a truly frightening thought to me).

Unfortunately, naturopathy is a hodge-podge of mostly unscientific treatment modalities based on vitalism and other prescientific notions of disease. As a result, typical naturopaths are more than happy in essence to “pick one from column A and one from column B” when it comes to pseudoscience, mixing and matching treatments including traditional Chinese medicine, homeopathy, herbalism, Ayurvedic medicine, applied kinesiology, anthroposophical medicine, reflexology, craniosacral therapy, Bowen Technique, and pretty much any other form of unscientific or prescientific medicine that you can imagine. Despite their affinity for non-science-based medical systems, naturopaths crave the imprimatur of science. As a result, they desperately try to represent what they do as being science-based, and they’ve even set up research institutes, much like the departments, divisions, and institutes devoted to “complementary and alternative medicine” (CAM) that have cropped up on the campuses of legitimate medical schools and academic medical centers like so many weeds poking through the cracks in the edifice of science-based medicine. Naturopaths also really, really don’t like it when they encounter criticism that their “discipline” is not science-based. Indeed, the president of the American Association of Naturopathic Physicians, Carl Hangee-Bauer, ND, LAc (he’s an acupuncturist, too!), wrote a revealing post on the official AANP blog entitled Science and Naturopathic Medicine.

Science. You keep using that word. I do not think it means what you think it means.

The President of the AANP takes umbrage

Apparently criticisms of naturopathy as unscientific have started to penetrate even the reality distortion field of the AANP, because Carl Hangee-Bauer has noticed them, and he’s not happy. Oh, no, he’s not happy at all. First, he begins by enumerating his bona fides as a science-loving geek, in order to prove to readers just how dedicated he is to science. These bona fides include a love of marine biology and a mention of how much he originally wanted to become a marine biologist. (Hey, I loved The Undersea World of Jacques Cousteau when I was a kid, too, you know.) Hangee-Bauer then discusses how he “took every course in biology, chemistry, physics, etc.” that he could in school and in college majored in biology, with dual minors in physics and chemistry. Then, somehow, while he was in the U.S. Army, he developed an interest in medicine as a Medical Service Corps officer, and that led him to naturopathy. Personally, this story leads me to ask: What happened to Hangee-Bauer? How could someone who was so interested in science go so far off the rails? Whatever happened, Hangee-Bauer’s narrative leads up to this lament about nasty bloggers like us:

I tell you this to let you know that I am no stranger to science. I still find it fascinating and appreciate the many ways it helps us understand the workings of nature and the world, helping us separate what appears to be the truth of things from reality. Studying naturopathic medicine, and especially acupuncture, presented me with many challenges, and I learned along the way that our medicine, as well as all other systems of medicine, are really a combination of science and art. When we work with our patients, we draw from both in order to stimulate the vis and provide well-rounded care to our patients.

Thus it has become an increasing concern to me when I read articles and blogs on the Internet blasting naturopathic medicine for being “unscientific.” These frequently polemic articles, while professing to come from scientific logic, to my eye are biased misrepresentations of the truth. They often lambast our profession and philosophy as unscientific, yet I have yet to see any one of them provide a critical analysis of research done by naturopathic physicians and researchers. It is sad that science can be used in these political ways.

It’s very hard for me not to point out that in Hangee-Bauer’s case science has apparently not been particularly successful in helping him to separate “what appears to be the truth of things from reality.” He is, after all, an acupuncturist and naturopath. It’s also apparent from the website of Hangee-Bauer’s practice, which treats all manner of ailments, as listed here on this page. Out of curiosity, I started clicking around on the conditions for which Hangee-Bauer provided links. For example, naturopaths frequently claim to be able to treat allergies (whether you have them or not!); so I gravitated to the page on allergies first. After a description about how “allopathic” medicine treats allergies by blocking histamine, having the patient avoid the allergen, and desensitization, we then see this passage:

Let’s look briefly at an example of TCM treatment for allergies. John presented with acute allergy symptoms of one-month’s duration which included sneezing, runny nose with lots of watery phlegm, extreme fatigue and occasional loose stools. After taking his history and doing an examination, his acupuncturist assessed his condition according to TCM as Wei Qi Deficiency resulting from a weakness of the Lung and Spleen. In addition to general recommendations for his condition, John was given Minor Blue Dragon formula which has decongestant properties for those with copious clear phlegm, as well as Astra 8, an herbal formula designed to tonify the Lung and Spleen Qi. He was also told to minimize or avoid dairy products and excessively sweet or spicy foods. As John’s condition improved, he and his acupuncturist developed a plan to strengthen his immune system in preparation for next year’s allergy season. This plan included replacing coffee with green tea, which is rich in catechins which exert anti-allergy effects, as well as taking quercetin, a bioflavonoid which has been shown to stabilize mast cells thus slowing the release of histamine and other chemicals related to allergic symptoms.

One wonders what “science” supports the vitalistic prescientific notion that allergies are due to “Wei Qi Deficiency” or detonification of “Lung and Spleen Qi” requiring “tonifying” (whatever that is). In all fairness, however, I will give Hangee-Bauer credit for one thing: on the same page, he actually states that applied kinesiology “may be of no value in testing for an allergy.” Imagine my relief, except that he should have said “is of no value whatsoever” for diagnosing allergies. That relief is also tempered by Hangee-Bauer’s suggesting that “strengthening the immune system” in an allergy would be a good thing in preparation for next year’s allergy season. Given that allergies are due to an excessive histamine response to a particular kind of antigen, “strengthening the immune system” might well make it worse. Of course, “strengthening the immune system” is a meaningless phrase, as we’ve pointed out many times before, but apparently, for all his love of science, Hangee-Bauer hasn’t figured that out.

But let’s move on. Elsewhere on the web page, Hangee-Bauer’s practice recommends breast thermography as an adjunct to mammography. I was shocked. No, I wasn’t shocked that he recommended thermography, as thermography is very popular among the “alternative medicine” set. Rather I was shocked and relieved that Hangee-Bauer apparently still recommends mammography. Even so, his website parrots scientifically unsupported claims common among CAM practitioners that thermography can find cancer ten years before breast cancer is identified by other methods (claims of the sort that I wrote about recently), and that it should be done at least once a year to screen for breast cancer. Amusingly, there was then this claim:

Finally, licensed acupuncturists can use thermography to detect slight temperature variations which reflect disturbances in the flow of Qi and blood, which can result in pain and dysfunction. Concrete evidence that acupuncture therapy actually restores blood flow and normalizes disrupted temperature patterns has been proven by thermographic studies.

I would so love to see the scientific studies demonstrating that thermography can detect disturbances in the flow of qi and how acupuncture restores it and blood flow. Surely there must be such studies; Hangee-Bauer, after all, claims that he is all about science and just bristles with outrage at the commentary of bloggers who correctly castigate much of naturopathy for being unscientific. What he does is based on science, isn’t it? So show it! What is the science demonstrating that thermography can detect disturbances in the flow of qi?

These are but a couple of examples that stood out of unproven treatments modalities and scientifically–shall we say?–”debatable” statements that I found on Carl Hangee-Bauer’s web page. I encourage SBM readers to check out other examples, such as the pages on tips for lung health (complete with recommendations for regular acupuncture sessions to “increase your resistance to both viruses and allergens”), treating springtime allergies, naturopathic “detoxification” (it’s always about those evil “toxins,” isn’t it?), and, of course, treatment of heavy metal poisoning. You know, whenever I see the term “heavy metal poisoning,” I can’t help but think of Ozzy Osbourne being the way he is as a result of 40 years of heavy metal poisoning. Oh, wait. It was the alcohol and illicit drugs. And perhaps the heavy metal poisoning.

But I digress.

Perhaps the most bizarre bit of ostensibly “science-based” recommendations to be found on Hangee-Bauer’s website is something called biotherapeutic drainage. I must admit, I had never heard of biotherapeutic drainage before. It turns out that if you Google the term “biotherapeutic drainage,” you’ll find that naturopaths appear to love this particular treatment modality. But what is it? Erika Horowitz, one of Bangee-Bauer’s naturopath partners, describes it thusly:

Detoxification is a big part of naturopathic theory and practice.

I can’t help but interrupt right here and say: No kidding! Too bad these “toxins” are as fantastical as the “science” that naturopaths invoke to support “detoxification.” Horowitz then continues:

Helping the body eliminate toxins safely and effectively can play an important role in improving health and preventing disease. One of the most useful detoxification therapies I use in my practice is the use of UNDA numbers, which are unique combinations of liquid homeopathic formulas founded on the theories of Chinese medicine, homeopathy, and anthroposophy.

Wow. Apparently one woo isn’t enough; so Horowitz combines three. It’s hard for me not to imitate a commercial and say something like, “Biotherapeutic drainage. It’s three, three, three woos in one!” Oh, wait. I just did. In any case, I had never heard of UNDA numbers before, which means I’m definitely learning something while writing this post. Unfortunately what I’m learning is that, even though I’ve been at this several years now, I still haven’t learned all the forms of unscientific medicine and treatments that exist out there. I can still be surprised, and UNDA surprised me. Apparently, it’s this:

UNDA numbers consist of homeopathically prepared low-dose combinations of plants and minerals. The plants possess specific characteristics as to how they affect an organ or organ system; some may have a stimulating effect, whereas others will calm or sedate an organ’s functions. The minerals in the compounds affect how the cells carry out chemical reactions that are necessary to efficiently begin the detoxification process. So the plants guide the remedy to the appropriate organ system (be it digestive, cardiovascular, or respiratory) and the minerals help change the cells’ biochemical function. These remedies help the body detoxify by helping cells work more efficiently and eliminate waste effectively, and by improving how our organs of elimination work.

UNDA numbers treat both acute ailments and chronic disease, addressing symptoms but more importantly concentrating on the reason that the body is manifesting the symptoms in the first place. The remedies are nontoxic, won’t interfere with other allopathic or holistic medications, and have a gentle yet deep-acting effect.

If they’re homeopathic, then I can’t really argue with two out of the three claims made for UNDA numbers. They certainly must be nontoxic and I’m sure they don’t interfere with other medications. Speaking of homeopathy…

One huge reason (among many) that naturopathy can’t be scientific

After this detour to Hangee-Bauer’s website, where we can find ample evidence suggesting that, when the rubber hits the road (or the patients hit the exam rooms) his dedication to science-based medicine is not nearly as strong as he proclaims in his message to the AANP, let’s move on to the single most glaring reason why naturopathy can’t be scientific. It begins when Hangee-Bauer lionizes Joseph Pizzorno, a prominent naturopath on the faculty at Bastyr University, arguably the most influential school of naturopathic medicine in North America, as having spent the past 25 years trying to use science to increase the credibility of naturopathy. Now I’ll give Pizzorno credit. For example, he did recognize as quackery Hulda Clark’s “parasite”-zapping “syncrometer,” which is a lot better than a lot of proponents of “natural medicine” have ever done.

On the other hand…

Pizzorno is currently the President Emeritus of Bastyr University, having been its founding President. Presumably he is still involved in Bastyr University, but until 2000 he was the one running its day-to-day operations right from the very beginning. Hangee-Bauer lauds Pizzorno as being a visionary in terms of trying to make naturopathy science-based, but there’s one problem with that view. Pizzorno’s school embraces homeopathy uncritically. It is, after all, a school of naturopathy, and there is are few forms of woo that naturopathy doesn’t embrace uncritically. Indeed, Bastyr not only embraces homeopathy, but requires its students to study it. Don’t believe me? Let’s start by looking at Bastyr University itself. Here is what the Bastyr University website says about homeopathy. First, it describes homeopathy as “natural” and “nontoxic” (the latter of which is hard to argue with, given that homeopathy is nothing more than water). It goes beyond that, though. Bastyr also offers homeopathy services in its clinics. As you may know, one of my favorite litmus tests for any CAM advocate’s connection with science and reality is how he reacts to homeopathy. If he embraces it, then I know that any protestations of being “science-based” are utter piffle. Bastyr University embraces homeopathy, just as naturopathy in general does.

More pertinent to the question of whether naturopathy embraces homeopathy is this answer to a question in Bastyr’s FAQ about homeopathy:

Q. Do all naturopathic physicians use homeopathy?

A. All naturopathic physicians are trained in the use of homeopathy, but not every naturopathic physician will use it as part of their treatment.

Let’s repeat that: All naturopathic physicians are trained in the use of homeopathy.

All. Of. Them.

Consistent with the answer to this question on the Bastyr University FAQ, there’s a lot of homeopathy being taught and practiced at Bastyr. For example, if you look at its curriculum to become a doctor of naturopathic medicine, you’ll rapidly see that Bastyr requires a full year of homeopathy courses spread out over three classes for a total of 8 credit hours. The same is true for Bastyr’s five year track and its combined degree of Doctor of Naturopathic Medicine (ND)/Master of Science in Acupuncture (MSA) or Acupuncture and Oriental Medicine (MSAOM). In addition, Bastyr has a clinical homeopathy department and homeopathy teaching clinic. The department chair is a naturopath and homeopath named Richard Mann, ND.

But it’s not just Bastyr. Taking on Hangee-Bauer’s claims that the AANP is all about the science, let’s take a look at the AANP itself. If you take a look at the official AANP blog and search it for the word “homeopathy, you’ll rapidly see that the largest “professional” organization of naturopaths not only embraces homeopathy but defends it against attacks. Perhaps the best example of the attitude of the AANP towards homeopathy is found in this post from several months ago entitled Getting over it. In it, a naturopath named Christopher Johnson gets all indignant about recent “10²³” campaigns that skeptics and proponents of science-based medicine have been using with some success to demonstrate the utter ridiculousness of homeopathy. (Indeed, one such event occurred recently, on February 5.) In response, Johnson writes:

They named their campaign “10:23″, a reference to Avogadro’s number. This number is significant to chemists in that it supposedly sets the limit below which no material elements are likely to be present in a given dilution. Homeopathic remedies are made with solutions far more dilute than Avogadro’s number.

Do these “skeptics” really think the public cares about Avogadro’s number when homeopathy has just significantly improved their toddler’s autism or offered help with any of a vast range of diseases which respond so well to homeopathic (and often not to conventional) treatment?

This is just another tantrum by the clueless wing of the scientific/medical community that can’t understand why the people don’t praise them for their ideological purity and courage, even when the fruits of their scientific labors rot like a brown banana. Note to protestors: maybe they’re just not that into you.

Remember, this is the official blog of the AANP—the organization of which Hangee-Bauer is the current president!—and it’s not just attacking, but rabidly attacking, a valid criticism of homeopathy. This valid criticism is nothing more than pointing out that most homeopathic remedies are diluted far, far more than Avogadro’s number, meaning that it’s highly unlikely (damned near impossible, actually) that a single molecule of the original starting material of the homeopathic remedie remains for dilutions of 12C or greater. When a typical homeopathic dilution is 30C (thirty 100-fold dilutions, or a 10⁶⁰ dilution), that’s almost 10³⁷-fold greater than Avogadro’s number. The magnitude of this dilution is simply incredible, and the odds against a single molecule remaining are just as incredible.

Particularly amusingly, Johnson likens these 10²³ events to the persecution of Galileo in what is arguably one of the most hilariously over-the-top invocations of the “Galileo gambit” I’ve ever seen before. Behold:

These hooligans purport to stand up for scientific principles, while in fact their zealous dogmatism and denial of evidence would make Galileo’s persecutors proud. Score one for book burning and witch trials.

Because a little skeptical activism poking fun at the ridiculousness of the beliefs underlying the pseudoscience of homeopathy in such a way as to point out to nonscientists why it is pseudoscientific nonsense is exactly like putting Galileo under house arrest and burning books and witches. I am thankful for small favors in that Johnson restrained himself from comparing skeptics to Hitler or Nazis. Just barely. (Come on, Mr. Johnson, let it out. Play the Hitler/Nazi card! You know you really, really want to, and you’ll feel much better after you do.)

Science versus naturopathy

So far, all I’ve looked at is Bastyr University and the official blog of the AANP. In fact, though, every school of naturopathy whose curriculum I’ve ever examined includes homeopathy as a requirement, even as the AANP requires and defends homeopathy. It’s no wonder, too. There is actually a North American Board of Naturopathic Examiners, just like medicine’s National Board of Medical Examiners. The NABNE even has a certifying examination, just like real doctors! It’s all science-y and medicine-y, too, with all the trappings of science-based medicine but none of the rigor. This examination, the NPLEX (Naturopathic Physicians Licensing Examinations), which is required for naturopaths to be licensed in the sixteen states and five Canadian provinces that license naturopathic physicians tests naturopaths on homeopathy (emphasis mine):

The current examination, based on these original blueprints, forms the Core Clinical Science Examination now required by every state and province that regulates the practice of naturopathic medicine. The Core Clinical Science Examination is a case-based examination that covers the following topics: diagnosis physical, clinical, lab), diagnostic imaging, botanical medicine, nutrition, physical medicine, homeopathy, counseling, behavioral medicine, health psychology, emergency medicine, medical procedures, public health, pharmacology, and research. Two additional treatment examinations (Minor Surgery and Acupuncture) may also be required for eligibility to become licensed to practice as a naturopathic physician in some jurisdictions.

[...]

The NPLEX Part II – Core Clinical Science Examination is designed to test your knowledge of: diagnosis (physical, clinical, and lab), diagnostic imaging, botanical medicine, nutrition, physical medicine, homeopathy, counseling, behavioral medicine, health psychology, medical procedures, emergency medicine, public health, pharmacology, and research. The examination is comprised of a series of clinical summaries followed by several questions pertaining to each patient’s case. For example, you might be asked to provide a differential diagnosis, to select appropriate lab tests, to prescribe therapies which safely address the patient’s condition, and to respond to acute care emergencies.

I would love to see what questions the NPLEX includes regarding homeopathy. My guess is that the multiple choice questions would be a hoot; that is, if I didn’t know they were completely serious. Unfortunately, as Kimball Atwood points out, no one other than naturopaths really knows what’s on the examination. Indeed, Dr. Atwood observed that naturopaths seem to take great pains not to let scientifically-minded physicians see a copy of an actual NPLEX examination. Be that as it may, homeopathy is but one example of how strongly naturopathy embraces pseudoscience. Be it myofascial analysis, vega testing, traditional Chinese medicine, Ayurveda, germ theory denialism, or even distant healing, there is no nonsense that naturopathy excludes as being too unscientific for it. Yet none of this stops Hangee-Bauer from bragging about how next year at the AANP Convention, it’ll be all about the science:

On August 16, 2011, the Tuesday before the start of the 2011 AANP Convention, the AANP will be sponsoring a scientific summit. While only in the early stages of planning, it promises to be a gathering for the different players in the naturopathic profession to connect and define how the AANP mission, naturopathic research, and evidence-informed health policy can join and result in healthier patients, a more effective health-care system, and a flourishing naturopathic profession. Core discussion points will include articulating policy and practice issues driving our research agenda, where the profession is now and what future possibilities exist, and defining the core research questions relating to safety, effectiveness, and costs.

You might recall that I wrote about last year’s AANP Convention, as did Dr. Atwood, both in the context of lamenting the appearance of Dr. Josephine Briggs, director of the National Center for Complementary and Alternative Medicine (NCCAM) as a speaker. You might also recall that last year’s AANP Convention was chock full of pseudoscience, including (of course) homeopathy, “medical intuitive” scans, emunctorology, “detoxification,” functional medicine, water-only fasting, and many others. If you click around the Naturopathic Physicians Research Institute (NPRI) website a bit (which Hangee-Bauer referenced in his post), you’ll find “research” about chelation therapy for autism and cardiovascular diseases (which is an utterly useless and potentially dangerous intervention) and homeopathy in pediatric care. I do have to thank Hangee-Bauer, however. I’ll keep my eye out for when the AANP announces its speaker list and agenda for its scientific conference on August 16 and the AANP Convention to follow immediately. I’m sure it’ll provide at least one good blog post in a few months.

In the meantime, if I may be so bold, I will make one small suggestion. If Hangee-Bauer is truly serious about making naturopathy science-based, there’s one thing he could do right away to prove it. It would be a simple, powerful, and unequivocal indication of the strength and sincerity of his intent. It’s all Hangee-Bauer has to do as a first step, albeit tiny, to demonstrate that he is not simply mouthing the words in praise of science and proclaiming how much he loves science and wants naturopathy to be based on science. All he has to do is to state that homeopathy is quackery, that it should no longer be considered part of naturopathy, and that he is going to put the weight of the AANP behind removing homeopathy as a required component of training in naturopathy and the examinations used to certify naturopaths. Extra points would be given for correctly stating why homeopathy is nothing but water and how there is no evidence supporting the law of similars as a general principle. If Hangee-Bauer does that, I might start to take his pontificating about the wonders of science and the scientific rigor of naturopathy somewhat seriously. If he can’t do it, then I know it’s a load of hot air.

After Hangee-Bauer deals adopts a science-based approach to homeopathy, then we can talk about purging distance healing, anthroposophy, applied kinesiology, and many of the other bits of pure pseudoscience embraced by naturopaths. However, like infants naturopaths have to creep before they can crawl and crawl before they can walk. Eliminating homeopathy would be that first attempt at creeping. Anyone want to lay any odds on whether or not they’ll take that first creep forward?

The Australian anti-Vaccination Network (AVN) in Australia has not been having a good time of late.

First, they were smacked down by the Health Care Complaints Commission. Following a 12 month investigation into the information provided on the AVN’s website, the HCCC issued a public warning stating the AVN “pose(s) a risk to public health and safety”.

The AVN was then investigated by the charity watchdog in New South Wales, the OLGR (yes you are not alone in thinking “why the hell are they a charity?”) which found that the AVN had “…breached charitable fundraising laws and potentially misled the public”. This was largely as a result of their collecting funds for one purpose and then spending the money elsewhere -  something you’re not allowed to do as a charity.

For example, in 2008 the AVN collected $11,810 for a “Fighting Fund”, an appeal set-up to raise money to support a family allegedly on the run from a court order to immunize a child. But the OLGR reported none of the funds raised were spent on this cause.

In addition, in March 2009 the AVN was seeking funds to run a Generation Rescue autism ad in the Australian press and raised $11,910 for the cause. The ad was never run – perhaps because they were gazumped by the Australian Skeptics and were subsequently knocked back by a parents’ publication – and likewise the money was spent elsewhere.

For many years the AVN was asking for funds to place its literature into Bounty Bags – the information packs for new mums – and to have vaccines independently tested for toxins and heavy metals. The money was collected, but the makers of Bounty Bags claimed they never had an agreement with the AVN. And the vaccine testing? Well, that never went ahead either.

In an e-newsletter, Meryl Dorey described the OLGR’s initial findings as;

“…from the very minor such as the fact that our collection box was the wrong size and didn’t have a lock and our receipt books were not numbered or kept in an assets register….”

Umm, methinks you have to do much more than have the wrong size cash box to lose your charity license.

But even more incredible is that the AVN operated for approximately 2 years without a valid charity license. Of this breach, Dorey explained:

“For 1 year, we were unable to find an auditor …. We finally found a firm who performed our audit but … since we were paying them a discounted rate, we were not really in a position to rush them along.”

The end result was the AVN’s authority to fundraise was revoked on October 20, 2010 meaning it can no longer conduct public fundraising appeals. Rather it can only ask existing members (of which it claims to have 2500) for money. This outcome is a savage blow for the AVN financially.

Indeed, even before its ability to publicly fundraise was revoked, auditors examining the financial report for the year ending December 31, 2009 stated “there is an inherent uncertainty whether the association will be able to continue as a going concern, without the ability to continue to generate external funding from donations and sponsorships.”

This on the back of the financial statement for December 31, 2008 where the AVN posted a loss of A$58,696.65. In fact, the AVN have been haemorrhaging money in the last few years. Just 12 months earlier (year ending December 2007) they posted a profit of A$88,007.97, meaning in the space of 2 years, they lost A$146,704.62.

As is its right, the AVN has appealed the loss of their charity license, and a hearing was set for Feb 14th 2011, but this has been postponed so the AVN can “re-frame their case” (whatever that means). Although its media spokesperson and sometimes president Meryl Dorey claims the audit conducted by the OLGR “…found no evidence of fraud in the breaches they discovered in our operations – (just) breaches of a purely administrational nature” the case has been referred higher up the bureaucratic chain to the Department of Justice (DoJ) and the Attorney General’s Department and to the Crown Solicitor. This is because the AVN is now being investigated for breaches of the Charitable Fundraising Act and if found guilty, these incur fines totaling $25,000 and 12 months jail. The findings of these departments are expected to be handed down any day.

So it appears that the “wrong size cash box” or “breaches of a purely administrational nature” may amount to much more than just loss of its charity license. Referral to the DoJ and Crown Solicitor are serious matters indeed.

And it seems the stress is beginning to show on Meryl Dorey. Let’s go back to January, when a family court matter in NSW was successful in getting the child of divorced parents vaccinated – Mom didn’t want the child vaccinated, but Dad did.

According to an article in the Sun Herald newspaper, the father said that if the girl remained unvaccinated, she would be forced to withdraw from school during outbreaks of some diseases, and that she would also be unable to spend time with any new babies he had, given she was not immunized against whooping cough.

The mother produced opposing evidence that the vaccinations were unnecessary, but was criticized in the judgment for submitting evidence from an “immunization skeptic”, who made what the magistrate described as “outlandish statements unsupported by any empirical evidence”.

Meryl Dorey naturally wasn’t happy about this (it is unknown if she was the “immunization skeptic”) and made it clear in a most distasteful post on the AVN Facebook page, where she said this after a link to the story:

“Court orders rape of a child. Think this is an exaggeration? Think again. This is assault without consent and with full penetration too.”

Rape of a child is akin to vaccination? Wow. I don’t think anyone who has been subject to this type of sexual assault would agree with you Meryl. And as the post was discussed, it turned out that indeed, a few people did not agree with Meryl’s assessment of the situation.

Another administrator of the AVN page, “SB” said:

“I disagree with the rape analogy, but the forcible administration of a vaccine? Vaccines are not compulsory – yet.”

And then another:

“I disagree with the rape analogy too.”

Dorey responded further down the thread justifying her use of the term rape:

“Guys, I apologize if anyone was offended with the rape analogy. I take the issue of rape VERY seriously as two very close family members were raped…”

She then made a non-apology further on, where she redefined the meaning of the term rape:

“I know that the word does tend to mainly have sexual connotations nowadays, but historically, rape has meant so much more. And as I said, rape is not a crime of sex – it is a crime of violence, control and anger/hatred.

“It is an act of violence that demonstrates power over someone … who cannot defend themselves and to my mind – forcing a child to be vaccinated against the informed consent of his or her parent is exactly that – an act of violence by someone who is more powerful against someone who is less powerful.”

Not according to my dictionary.

From Dictionary dot com:

– noun?; 1. the unlawful compelling of a woman through physical force or duress to have sexual intercourse;? 2. any act of sexual intercourse that is forced upon a person; ?3. statutory rape: ?4. an act of plunder, violent seizure, or abuse; despoliation; violation: the rape of the countryside; 5. Archaic: the act of seizing and carrying off by force.

The Apple OSX dictionary defines it as:

Noun: the crime, committed by a man, of forcing another person to have sexual intercourse with him without their consent and against their will, esp. by the threat or use of violence against them; figurative – the wanton destruction or spoiling of a place or area : the rape of the Russian countryside.

Violence may be involved in sexual assault, but rape is not so without sexual assault. And if she meant an act of violence, “wanton destruction” or the archaic definition, then why did she include the phrase “with full penetration”?

So here comes Meryl’s non-apology:

“To anyone who was insulted or hurt by my comparing the forced vaccination of a child against the custodial parent’s wishes with rape, I do apologise wholeheartedly and without reservation. I looked up the definition of rape prior to posting … that comparison and in the dictionary sense of the word, it is accurate…”

See above.

Sorry Meryl, but redefining the meaning of the word rape and saying it’s okay because you know two people who were raped does not make it acceptable.

The discussion went on for 3 days and reached 57 comments before the topic dropped off the front page and people, including Meryl probably, thought it would all go away. But even one of her admins was astute enough to notice that everything on the internet stays forever and “someone somewhere will be keeping a scrapbook”.

Well, she was right. The rape comments fell into the hands of Tracey Spicer, the same journalist who hung up on Meryl Dorey on live radio just a few weeks earlier when she was discussing British Medical Journal’s fraud findings into Andrew Wakefield’s Lancet paper.

On air, Tracey discussed Dorey’s comments with Hettie Johnstone, an Australian child abuse campaigner who runs a child protection organisation called Bravehearts. Naturally, Hettie was appalled that someone would compare an injection for the purposes of protection against communicable disease with rape.

As expected, Dorey was livid and asked her followers to bombard the radio station with disapproving emails. She also asserted that she had apologized (well, kinda) and that it was a heat-of-the-moment comment. Me, well I’m skeptical this is the case. According to her defense above, she bothered to look up the definition of rape in the dictionary before she posted it:

“I looked up the definition of rape prior to posting …that comparison and in the dictionary sense of the word, it is accurate…”

In addition, she posted similar comments to her mailing list:

“This is immoral. It should be illegal. This is medical rape. Since it is illegal to force yourself on someone for the sake of having sex, why is it not illegal for society to force itself on an innocent child whose informed parent has chosen not to subject them to a potentially dangerous medical procedure?”

Posting her rape comments in two places and looking up a definition in the dictionary prior to doing so constitutes more than a ‘heat-of-the-moment’ outburst to me.

In directing her supporters to spam the radio station with emails, Dorey attempted to project the publicity away from herself and towards the “rights of pro-choice parents”. But this issue was not about parents who choose not to vaccinate. It was about the media spokesperson (sometimes president) for “Australia’s Vaccine Watchdog” comparing vaccination to rape, which is not only offensive and distasteful, but completely inappropriate.

Even one of the commenters on Facebook pointed this out:

“On another note had you not made such a crude comparison which upset so many people this attention may not have happened. You made us all look bad on this one.”

Eighteen months ago it was a different landscape in the Australian media for the AVN. Meryl Dorey was the go-to person for comment whenever there was a story on vaccination. She would sit alongside professors of immunology and epidemiology and Gish Gallop her way through debates. She was all over morning television – of which the target audience is stay-at-home mums – spouting nonsense about vaccine safety and efficacy. She was given a forum to spread her fear and misinformation far and wide.

Not any more. The worm has turned and the false balance is shifting. She is finally being treated in a manner which she deserves – relegated to the pages of natural health media and websites rife with conspiracy theories and quackery. But importantly, she is finally being held accountable for her nonsense, not just by skeptics but by the mainstream media and government departments too. And with opinions like “vaccination = rape” , it’s about time.

Rachael A. Dunlop BSc (Hons), PhD., is a skeptic and blogger, as well as the winner of Twitter Shorty Award for Health 2010

Rachael came to science after a career in graphic design and advertising because she was “bored and needed and challenge”. She got what she wanted. Her research focuses on ageing disorders including heart and Parkinson’s disease. She is particularly interested in how cells respond to damaged proteins especially those which undergo suicide – a process known as apoptosis. Her current project examines the role of blue green algae in motor neurone disease.

Rachael is a reporter on the Skeptic Zone Podcast and a Vice President of the NSW committee of Australian Skeptics. She is also part of the Mystery Investigators show for schools and co-organises the Sydney Skeptics meet-up group, and contributes to The Sceptics’ Book of Pooh-Pooh blog. Rachael has a passion for combining her knowledge of art and science through scientific communication.

Following my recent critique here of the book Disconnect by Devra Davis, about the purported dangers of cell phones to health, David Gorski asked me to comment on a recently published “review article” on the same subject. The article is entitled “Risk of Brain Tumors from Wireless Phone Use” by Dubey et al [1] published in the J. Comput Assist Tomography. At the outset, the same question occurred to both of us: what is a “review article” about cell phones and brain tumors doing in a highly technical journal dedicated to CT scans and CT imaging? While we are both still guessing about the answer to this question, we agreed that the article itself is a hodge-podge of irrational analysis.

As you might surmise, Dubey and his Indian co-authors come to the conclusion that “that the current standard of exposure to microwave during mobile phone use is not safe for long-term exposure and needs to be revised.” But within the conclusion there is also the following: “There is no credible evidence from the Environmental Health and Safety Office (I presume in India) about the cause of cancer or brain tumors with the use of cell phones. It is illogical to believe that evidence of unusual brain tumors is only because of hundred’s of millions of people using cell phones worldwide.” What?! These are opposite and contradictory statements. The main body of the article includes a lot more instances of such inconsistency.

Dubious Sources, References, & Studies

Another highly dubious feature of this review article is the nature of its sources. Many of its references are merely news reports, not scientific articles and some even come from pseudo-scientific web sites. For example, figure 1 purports to illustrate cell phone radiation penetrating a 5 year old, 10 year old, and adult head. It purports to show that cell phone radiation penetrates a child’s head much more deeply than an adult’s. The source given for this image is http://www.environmentalhealthtrust.org — the web site of none other than Devra Davis! The main feature on this web site is the promotion of her book Disconnect!

This particular image is one that is frequently used by alarmists. The original source is a 1996 paper by Gandhi et al [2]. This paper has long been discredited and the image is simply wrong. Gandhi himself published an update in another paper in 2002 [3] with quite different results. Numerous papers have been published examining the issue of cell phone penetration of the head. The consensus is that RF absorption in children’s heads is not greater than adults and is well within exposure limits [4].

One particularly dubious reference is to a book by the notorious industry gadfly George Carlo that even Devra Davis treats with caution. A number of the scientific papers that are listed are of dubious quality and/or have failed to be reproduced in follow up studies. For example one of the sections is entitled “Male fertility damaged by radiation.” Orac has written a critique on this hypothesis in which he takes apart one of the studies cited by Dubey et al. Male fertility is also one of the principle subjects in the book Disconnect, which I rebutted in my review on SBM. To summarize the three papers cited by Dubey et al. are of poor quality and/or have failed attempts at replication. The authors do not list or comment on the negative studies that contradict the one’s they listed.

Other statements and references that have been contradicted by follow up studies include claims that:

• “The RF emissions from cell phones have been shown to damage genetic material in blood cells”
• “Long-term cell phone use can increase the likelihood of being hospitalized for migraines and vertigo by 10% to 20%”
• “Cell phone radiation damages DNA, an undisputed cause of cancer”
• “Cell phone radiation has been shown to cause the blood-brain barrier to leak”

The fact that each one of these “findings” has failed replication attempts in rigorous follow up studies is not even mentioned.

In the conclusion, Dubey et al. makes the bold claim that: “Moreover it was repeatedly confirmed that the radiation from base stations is harmful to health. The existing ICNIRP and FCC exposure limits are based on a false premise that only thermal effects cause harm.” Here they are referring to cellular telephone base stations. But no references are provided to support either of these assertions.

Industry Funding

Figure 2 in the article is a chart that purports to show industry bias in brain tumor research. This establishes the principle theme of this article: the claim that most of the studies on brain cancer and cell phones with negative results have been funded by industry. This is not a scientific argument, it is a conspiracy theory. Other posts on SBM have observed that conspiracy theories are a favorite tactic of purveyors of pseudo-science. This “industry funding” theory is also the main thesis of the book Disconnect and alarmist cell phone web sites. The source given for this “industry funding bias” chart is the web site http://www.psrast.org/mobileng/mobilstarteng.htm. The organization behind this web site is a group called:  “Physicians and Scientists for Responsible Application of Science and Technology (PSRAST).” This web page is full of references to the usual unscientific alarmist material found throughout the Internet.

Dubey et al. do not mention the generally accepted alternative explanation for the dichotomy in positive vs. negative studies. First there is the issue of publication bias [5]. If a researcher makes an initial positive finding, he is more likely to rush his results to publication. An initial negative finding is less likely to ever be published. Rigorous studies with all necessary controls and a large number of trials are more expensive to conduct. It is important to note that virtually all such follow-up replication studies have been negative.

An extremely important fact that is not discussed by Dubey et al. is that expert reviews by virtually all of the industrialized world’s public health organizations have come to the same conclusion as the World Health Organization “that current evidence does not confirm the existence of any health consequences from exposure to low level electromagnetic fields.” One presumes that they have also been either co-opted or duped by this industry funded conspiracy.

Hardell vs. Interphone

By far the largest and most important case control study on the possible link between cell phones and brain cancer was the Interphone study [6]. The Interphone study was an international collaboration involving 13 countries which was coordinated by the International Agency for Research on Cancer (IRAC) which is part of the WHO. The conclusion of Interphone was “Overall, no increase in risk of glioma or meningioma was observed with use of mobile phones. There were suggestions of an increased risk of glioma at the highest exposure levels, but biases and error prevent a causal interpretation. The possible effects of long-term heavy use of mobile phones require further investigation.”

Dubey et al. characterize the important Interphone study as follows: “This nonblinded, interview-based, substantially wireless industry-funded case-control study….” They are clearly discounting Interphone with the “industry funding” conspiracy theory. They compare the Interphone studies with another set of case control studies conducted by the Swedish researcher Lennart Hardell.  “The 2 sets are the industry-funded Interphone studies and the independently funded Swedish studies reported by Hardell team.” Dubey et al. make a number of additional dubious criticisms of Interphone. To support these criticisms they list a number of letters to a journal including a couple by Hardell. Much of this criticism boils down to splitting hairs over who did a better job of controlling for “recall bias.”

Those of you who are regular readers of SBM may have seen a post by David Gorski commenting on another cell phone cancer review article in which the work of Hardell was given prominence. Gorski had this to say about Hardell: “Whenever one group of researchers keeps finding a result that no other group seems able to replicate or that otherwise disagrees with what everyone else is finding, that’s a huge red flag for me. Remove those studies, and even the wisp of a hint of a shadow of the association between cell phone use and cancer found in this study disappears. I’d have a lot more confidence in this seeming association in “high quality” studies if the association didn’t depend upon a single researcher and if this researcher was not also known for being an expert witness in lawsuits against mobile phone companies.” It would appear the Hardell himself has a conflict of interest.

A pair of review articles on cell phone brain cancer studies in the journal Epidemiology [7, 8] had this to say about Hardell: “One notable feature of the literature to date is that authorship by Lennart Hardell is associated with finding an adverse effect of mobile telephone use for several different endpoints. The discrepancy between the findings of Hardell and those of other scientists was striking enough that Ahlbom et al presented some of their summary findings in 2 forms, including and excluding the studies by Hardell and colleagues.”

Case control studies such as those conducted by Hardell and Interphone involve recruiting subjects who have been diagnosed with brain cancer. The subjects respond to a questionnaire in which they are asked to recall – purely from memory – how much they had used their cell phones over the years. The cancer patients are matched with a healthy control group who respond to the same questionnaire. If the study shows that people who have brain cancer used cell phones more that the controls, the conclusion is that cell phone use increases the risk of brain cancer.

But case control studies such as this suffer from a number of limitations, the most serious being “recall bias.” Brain cancer patients are certainly aware of the theory that cell phone use may lead to brain cancer. This theory has been in the news for years. Such patients are likely to over report past cell phone use when completing a questionnaire. Memory is notoriously unreliable, and it becomes more so over time. I don’t know about you, but I could only make a wild guess about how much I used my cell phone 10 years ago. This simple fact alone makes it hard to interpret conflicting studies.

Dubey et al. seem to acknowledge the issue of recall bias, but their treatment of the issue is inconsistent and contradictory. The authors even discount one of Hardell’s studies with the following: “this finding is probably explained by recall bias, with patients with glioma systematically overreporting use on the same side as their tumor and consequently underreporting use on the opposite side.” Yet despite this admission, Dubey et al. accept all of the Hardell studies and include them in their meta-analysis. They give greater credence to Hardell than Interphone and conclude: “The meta-analysis shows that long-term cell phone use can approximately double the risk of developing a glioma or an AN (acoustic neuroma) in the more exposed brain hemisphere.” This opposite to the conclusion of mainstream scientists as reflected in papers such as Ahlbom et al. [8].

What about incidence rates?

Perhaps the simplest and most compelling argument against any possible cell phone brain cancer association is the fact that brain cancer incidence rates have remained unchanged since the introduction of cell phones. Dubey et al. dismiss this evidence with a one sentence section entitled: “Outdated Central Brain Tumor Registry of the United States Tumor Data” and the statement that “the most recent data are already at least 4 years outdated.” The authors reference only a couple of older studies, and ignore the most recent ones from Europe, the US, and the UK that show no increase in brain cancer incidence up to 2003, 2006, and 2007 respectively [9, 10 11]. Furthermore, the data in the US & UK studies are more recent than any of Hardell’s studies!

Conclusion

The Dubey et al. review article is sprinkled with statements such as:

• “Most studies have not found any association between cell phone use and the development of head tumors”
• “There is generally a lack of convincing and consistent evidence of any effect of exposure to RF field on risk of cancer”
• “Although some positive findings have been reported, so far the totality of epidemiological evidence (meningioma) does not demonstrate an increase in risk of meningiomas related to mobile phone use”
• “There was no association between the use of cellular or cordless phones and salivary gland tumors found, although few studies reported for long-term heavy use”

As I wrote at the beginning of this review: these statements are opposite and contradictory to the overall conclusion of Dubrey et al. One supposes that the authors are trying to give the appearance of “balance.” However they reconcile these contradictory findings not with a scientific weight of evidence approach, but with their “industry funding” conspiracy theory. This brings me to add an additional question on top of our original query about what an article about cell phones is doing in a specialized journal on CT imaging. How did an article that promotes Internet conspiracy theories with a hodge-podge of irrational analysis even get published at all?

About the Author

Lorne Trottier is a co-founder of Matrox Ltd. and holds B. Eng., M. Eng., and Doctorate (honoris causa) degrees from McGill University. He has had a lifelong passion for science and technology and believes in the importance of combating pseudoscience. He is President of the Board of the Montreal Science Center Foundation, and is also a board member of a number of science outreach organizations including the NCSE, CFI Canada, and The Planetary Society. Trottier sponsors the annual Trottier Symposium at McGill University that deals with a variety of science topics of interest to the public, such as Confronting Pseudoscience. Trottier also maintains a web site on the subject of EMF and Health.

References

1. Risk of Brain Tumors from Wireless Phone Use J Comput Assist Tomogr Vol 4 No 6,Nov/Dec 10. doi: 10.1097/RCT.0b013e3181ed9b54
2. Gandhi O P, Lazzi G and Furse CM. Electromagnetic absorption in the human head and neck for mobile telephones at 835 and 1900 MHz IEEE Trans. Microw. Theory Tech. 44:1884–97, 1996. doi: 10.1109/22.539947
3. Gandhi O and Kang G. Some present problems and a proposed experimental phantom for SAR compliance testing for cellular telephones at 835 and 1900 MHz Phys. Med. Biol. 47:1501–18, 2002. doi: 10.1088/0031-9155/47/9/306
4. Beard et al. Comparisons of Computed Mobile Phone Induced SAR in the SAM Phantom to That in Anatomically Correct Models of the Human Head, IEEE Trans. Electro Comp, Vol. 48, No. 2, May 2006. doi: 10.1109/TEMC.2006.873870
5. Vijayalaxmi et al. Genetic Damage in Mammalian Somatic Cells Exposed to Radiofrequency Radiation: A Meta-analysis of Data from 63 Publications Radiation Research 169, 561–574, 2008 doi: 10.1667/RR0987.1
6. Cardis et al. Brain tumour risk in relation to mobile telephone use: results of the INTERPHONE international case-control study Int’l Journal of Epidemiology 2010; 1–20. doi: 10.1093/ije/dyq079
7. Rothman. Health Effects of Mobile Phones Epidemiology Vol 20 No 5, Sept 2009. doi: 10.1097/EDE.0b013e3181aff1f7
8. Ahlbom et al. Epidemiologic Evidence on Mobile Phones and Tumor Risk Epidemiology Vol 20 No 5, Sept 2009. doi: 10.1097/EDE.0b013e3181b0927d
9. Inskip et al. Brain cancer incidence trends in relation to cellular telephone use in the United States, Neuro Oncol 12(11): 1147-1151 , 2010. doi: 10.1093/neuonc/noq077
10. Deltour et al. Time Trends in Brain Tumor Incidence Rates in Denmark, Finland, Norway, and Sweden, 1974–2003, J Natl Cancer Inst,101(24):1721–4, . 2009 Dec 16. doi: 10.1093/jnci/djp415
11. Vocht et al. Time Trends (1998–2007) in Brain Cancer Incidence Rates in Relation to Mobile Phone Use in England Article first published in Bioelectromagnetics online 28 Jan 2011. doi: 10.1002/bem.20648

As a pharmacist, when I dispense medication, it’s my responsibility to ensure that the medication is safe and appropriate for the patient. There are numerous checks we go through including verifying the dose, ensuring there are no interactions with other drugs, and verifying the patient has no history of allergy to the product prescribed. Asking about allergies is a mandatory question for every new patient.

Penicillin is one of the oldest antibiotics still in use despite widespread bacterial resistance. Multiple analogs of penicillin have been developed to change its effectiveness, or improve its tolerability. And other classes of antibiotics (e.g., cephalosporins) share some structural features with penicillin. These products are widely used for both routine and serious bacterial infections. Unfortunately, allergies to penicillin are widely reported. Statistically, one in ten of you reading this post will respond that you’re allergic to penicillin. Yet the incidence of anaphylaxis to penicillin is estimated to be only 1 to 5 per 10,000. So why do so many people believe they’re allergic to penicillin? Much of it comes down to how we define “allergy.”

Adverse Events, Reactions, and Allergies

There are a number of confounders when it comes to evaluating allergies. A big one is terminology. While different groups vary in their definitions, the term “adverse drug event” typically means that an undesirable event has occurred, but isn’t causally linked to the consumption of a drug. In contrast, “adverse drug reaction” is usually reserved to where a causal link to the drug has been established, or is fairly certain. Adverse drug reactions can occur under completely normal use of a drug. And they’re not uncommon, as I’ve pointed out before. An allergic reaction to a drug is an adverse drug reaction that is mediated by an immune response. If there is no immune response, it’s not an allergic reaction. So if you take codeine and it makes you drowsy and constipated, that’s not an allergic reaction—that’s an effect of the drug. Erythromycin commonly causes stomach upset, so if you vomit, that’s not an allergy either. So, to sum:

Penicillin Allergies

Within that box of adverse reactions we’re calling “drug allergies” there’s a number of methods of classifying the different immune responses. The most common way is to split events into immunoglobulin E (IgE)–mediated (immediate) reactions, or non–IgE-mediated (delayed) hypersensitivity reactions. The IgE-mediated reactions are the ones we might immediately think of when we hear “penicillin allergy”: flushing, itchy skin, wheezing, vomiting, throat swelling, and even anaphylaxis. These reactions can occur immediately to a few hours after a dose. The non-IgE-mediated reactions are delayed, and can be mild or severe, ranging from serum sickness to the horrific (but fortunately rare) Stevens-Johnson syndrome.

Skin rash (morbilliform eruptions) are non-IgE reactions commonly reported with penicillin therapy, though their relationship to the penicillin itself isn’t clear. Rashes that appears several days after starting therapy (or even after finishing a course of antibiotics) may be due to a poorly-understood relationship between the antibiotic and any concurrent viral infection. These rashes are not itchy. With subsequent exposure to penicillin (or a related drug) the rash can reappear. These types of reactions do not mean that one cannot receive penicillin again, however.

It’s the structure of the penicillin molecule itself that triggers allergic reactions. Both the “parent” drug and any iterations created through metabolism can induce allergic responses. Analogs of penicillin, with different molecular side chains, can trigger selective sensitivity in some. So one could have an allergic reaction to amoxicillin or ampicillin, but be able to tolerate penicillin.

Testing for allergies

Determining if you’re actually allergic to penicillin is important to sort out, as not all reactions mean penicillin cannot be administered again. Skin testing is the standard for testing for IgE-mediated allergies, and needs to be performed under medical supervision, usually by allergy specialists, in settings where access to resuscitation medication is available. Given the unreliability of memory, skin testing is the standard when there’s any doubt all about the type of prior reaction. In cases of the severe non-Ig-E type reactions, there’s no rechallenge attempted, and those patients should never receive penicillins again.

So if you think you’re allergic to penicillin, but are not certain of the type of allergy you have, testing is something worth thinking about. Without it, you’re setting yourself up for a lifetime of risk and consequences of the avoidance of penicillin. Data show that patients considered penicillin-allergic will typically receive more broad-spectrum antibiotics, which may have more side effects, be more expensive, and in some situations, less effective. And given IgE-mediated allergy can wane over time, even significant childhood reactions may not manifest as adult allergies—but only testing can determine this for certain.

Formal evaluations of penicillin allergies support this approach. A recent paper in the Journal of Allergy and Clinical Immunology describes a prospective evaluation of children that presented to an emergency room with a delayed-onset rash from penicillin. Eighty-eight children were enrolled over two years. At the time of enrollment, they were screened for viruses. Each child returned to the hospital two months after their initial visit, where they underwent skin (patch and intradermal) as well as blood evaluations for allergy. They all had an oral challenge with the original antibiotic, too. After evaluation, none had a positive skin test, 11 children (12.5%) had a intradermal reaction, and only six (6.8%) had the rash recur after an oral challenge. Within the group that had a positive oral challenge, two had intradermal-negative, and one was intradermal-positive. Most of the children had tested positive for viral infections, too.

The authors concluded that penicillin allergies are overdiagnosed, and viral infections may be a factor leading to rashes and over-diagnosis. The authors recommended oral challenges, rather than skin, intradermal, or blood tests for all children that develop delayed-onset rashes during treatment with penicillins.

Conclusion

While penicillin allergies can be real, and can be serious, only a small percentage of people that consider themselves allergic actually cannot receive penicillin. Avoiding penicillin can mean using antibiotic alternatives that are less effective, more expensive, and have greater side effects. For this reason, confirming a penicillin allergy with a physician is warranted—before an antibiotic is needed. After all, unless it’s necessary, you don’t want to end up with someone like Mark Crislip standing over your hospital bed, being asked what his second choice of antibiotic is going to be.

Reference

Caubet JC, Kaiser L, Lemaître B, Fellay B, Gervaix A, & Eigenmann PA (2011). The role of penicillin in benign skin rashes in childhood: a prospective study based on drug rechallenge. The Journal of allergy and clinical immunology, 127 (1), 218-22 PMID: 21035175

For the last week I have had a cold. I usually get one each winter. I have two kids in school and they bring home a lot of viruses. I also work in a hospital, which tends (for some reason) to have lots of sick people. Although this year I think I caught my cold while traveling.  I’m almost over it now, but it’s certainly a miserable interlude to my normal routine.

One thing we can say for certain about the common cold – it’s common. It is therefore no surprise that there are lots of cold remedies, folk remedies, pharmaceuticals, and “alternative” treatments. Finding a “cure for the common cold” has also become a journalistic cliche – reporters will jump on any chance to claim that some new research may one day lead to a cure for the common cold. Just about any research into viruses, no matter how basic or preliminary, seems to get tagged with this headline.  (It’s right up there with every fossil being a “missing link.”)

But despite the commonality of the cold, the overall success of modern medicine, and the many attempts to treat or prevent the cold – there are very few treatments that are actually of any benefit. The only certain treatment is tincture of time. Most colds will get better on their own in about a week. This also creates the impression that any treatment works – no matter what you do, your symptoms are likely to improve. It is also very common to get a mild cold that lasts just a day or so. Many people my feel a cold “coming on” but then it never manifests. This is likely because there was already some partial immunity, so the infection was wiped out quickly by the immune system. But this can also create the impression that whatever treatment was taken at the onset of symptoms worked really well, and even prevented the cold altogether.

What Works

There is a short list of treatments that do seem to have some benefit. NSAIDs (non-steroidal anti-inflammatory drugs), like aspirin, ibuprofen, and naproxen, can reduce many of the symptoms of a cold – sore throat, inflamed mucosa, aches, and fever. Acetaminophen may help with the pain and fever, but it is not anti-inflammatory and so will not work as well. NSAIDs basically take the edge off, and may make it easier to sleep.

Decongestants may also be of mild benefit. Antihistamines have a mild benefit in adults, but not documented in children. There are also concerns about safety and side effect in children. Overall, other than some TLC and NSAIDS (although not aspirin) parents should probably not give their children anything for a cough or cold. The benefit of antihistamines in adults is very mild and of questionable value. There is better evidence for antihistamines in combination with a decongestant, but the benefits are still mild. Nasal sprays are probably better than oral medication, and overall use a much lower dose. These treatments do not seem to have any effect on the course of the cold, but may relieve symptoms. Perhaps the best use of nasal spray decongestants is just prior to going to sleep, to reduce a post nasal-drip cough that can be very disruptive to sleep.

There is weak evidence for the use of hot liquids. There does not seem to be any advantage to chicken soup over other hot liquids, like tea. They may provide a symptomatic benefit in clearing the sinuses and loosening phlegm so that it can be cleared easier. Since this is a low risk intervention (just make sure the liquids are not too hot for small children), if it makes you feel better, go for it. There also may not be any advantage over just humidified air to help keep the membranes moist. Honey may be soothing, but there is no evidence of real benefit.

A neti pot looks like a small teapot with a thin spout that is meant to pour hot liquids up your nose to irrigate your sinuses. The evidence for the use of neti pots is mixed. Briefly – there is no evidence for their routine or preventive use, and in fact they may be counterproductive. However, they may be useful for acute symptoms of sinus congestion. The concept is actually simple and well established – irrigating an infected space to help wash out the germs and prevent impaction. There is probably no benefit to using a neti pot for a regular cold – unless you have significant sinusitis and feel that your sinuses are clogged. And again, this is probably no better than just moist air or hot liquids.

What Does Not Work

In short – everything else.

Over the counter (OTC) cough suppressants simply do not work and are not safe in children. If you have a serious cough, the kind that can cause injury, you need prescription medication (basically narcotics, like codeine). Also, in most cases using a cough suppressant makes no sense, especially in combination with an expectorant. You want to cough up the mucus and phlegm. If your cough is caused by a sore throat, take an NSAID. If it’s post nasal drip, treat the congestion as above. And if it’s severe, see your doctor. But don’t bother with OTC cough suppressants.

I have covered echinacea previously in detail – it does not work for the prevention or treatment of the cold or flu.

Vitamin C has been a favorite since Linus Pauling promoted in decades ago. But decades of research has not been kind to this claim. The research has failed to find a consistent and convincing effect for vitamin C in treating or preventing the common cold. For routine prevention, the evidence is dead negative. For treating an acute infection, there is mixed evidence for a possible very mild benefit, but this is likely just noise in the research.

What about homeopathic treatments? Since homeopathy is one big pseudoscientific scam, its products are nothing but water, and they don’t work for anything – I don’t need to go into more detail here.

Finally, there is some evidence that zinc or zinc oxide may reduce symptoms of a cold, but this evidence is mixed and unconvincing at present. At best the benefit is very mild (again, likely within the noise of such studies). Further, zinc comes with a nasty taste (something that also complicates blinding of studies) and many people may find this worse than symptoms it treats. Zinc oxide nasal sprays have been linked to anosmia (loss of smell, which can be permanent) and is certainly not worth the risk to treat a self-limited condition like the cold – even if they did work, which is unclear.

Conclusion

The common cold remains a difficult syndrome to treat effectively. In most cases it is best to just let the cold run its course. Limited use of NSAIDs and decongestants may be helpful. Otherwise, if there is an intervention that is risk free and makes you feel better, do it. We all need to feel comforted when we’re sick. But don’t waste your time or money on other medications, supplements, herbs, or other concoctions. There are also endless snake-oil products out there, too many to deal with here. A good default position is simply not to believe any product that claims to prevent or treat the common cold. And don’t be compelled by the anecdotal evidence of your neighbor’s cousin’s boss. Everyone thinks they have the secret to treating the cold, but no one does. It’s all placebo effect and confirmation bias.

Is unmedicated natural childbirth a good idea? The American College of Obstetrics and Gynecology (ACOG) points out that

There is no other circumstance in which it is considered acceptable for a person to experience untreated severe pain, amenable to safe intervention, while under a physician’s care.

It is curious when an effective science-based treatment is rejected. Vaccine rejecters have been extensively discussed on this blog, but I am intrigued by another category of rejecters: those who reject pain relief in childbirth. They seem to fall into 3 general categories:

1. Religious beliefs
2. Heroism
3. Objections based on safety

1. “In pain you will bring forth children” may be a mistranslation, and it certainly is not a justification for rejecting pain relief. Nothing in the Bible or any other religious text says “Thou shalt not accept medical interventions to relieve pain.” Even the Christian Science church takes no official stand on childbirth and its members are free to accept medical intervention if they choose.

2. The natural childbirth movement seems to view childbirth as an extreme sport or a rite of passage that is empowering and somehow enhances women’s worth. Women who “fail” and require pain relief or C-section are often looked down upon and made to feel guilty or at least somehow less worthy.

3. I’m not impressed by religious or heroic arguments, although I support the right of women to reject pain relief on the autonomy principle. What inquiring science-based minds want to know is what the evidence shows. Does avoiding medical treatment for pain produce better outcomes for mother and/or baby? It seems increasingly clear that it doesn’t. A new book, Epidural Without Guilt: Childbirth Without Pain, by Gilbert J. Grant, MD, helps clarify these issues.

Some of his points:

• Not providing adequate pain relief is inhumane.
• A large percentage of women who attempt childbirth without medication find the pain intolerable and end up asking for relief.
• Pain should be treated early, ideally before it even develops. The dentist doesn’t wait to inject Novocain until you feel the pain and complain.
• Excellent pain relief can be provided by epidurals with a high degree of safety. No other method is as good.
• There is no justification for outdated practices of delaying epidurals until cervical dilation is advanced or for stopping the epidural during the last stages of labor.
• Non-epidural analgesia is arguably less safe than epidurals.
• Many safety objections to epidurals are based on outdated information about older techniques. New epidural/spinal techniques use a combination of low-dose anesthetics and narcotics to abolish pain without interfering with muscle function. They do not prolong labor or increase the need for instrument-assisted deliveries, and they allow patients to control the dose and to get up out of bed and walk around.
• Epidural catheters can be left in place to better treat post-partum pain.
• If an emergency C-section becomes necessary, having an epidural in place can speed the preparations for surgery.
• Current data indicate that epidurals may actually speed up labor and have other health advantages.

He doesn’t deny that epidurals can cause adverse effects (from low blood pressure to spinal headaches). He discusses all reported complications of epidurals, explains them, and puts them into context with the adverse effects of other methods and with the adverse effects of unrelieved pain. Unrelieved pain during labor and post-partum has been shown to

• Cause stress responses that can reduce the baby’s oxygen supply
• Increase the risk of post-partum depression and post-traumatic stress disorder (PTSD)
• Interfere with breast-feeding
• Increase the risk of development of chronic pain conditions

A 2005 Cochrane review of studies comparing epidurals to other or no analgesia found a small increased risk of instrument-assisted delivery but no increase in the rate of C-sections, no effect on neonatal outcomes, and greater maternal satisfaction. The increased risk of instrument-assisted deliveries is not seen when newer epidural techniques are used.

In evaluating the literature, we must remember that epidurals have improved, and earlier studies looked at higher doses and less safe epidural practices.  Another confounder is that patients with problematic labors are more likely to ask for pain relief, so some of the complications previously attributed to epidurals might well have been due to other factors. I was particularly intrigued by one study he cited about a natural experiment. In 1993 the Department of Defense mandated that epidurals should be available on demand. At the Army hospital studied, the epidural rate went from 2% to 92%, but the rate of forceps deliveries and cesareans did not change.

Childbirth is a subject that seems to bring out the worst in strongly opinionated people. When I last checked Amazon.com, there were 4 reader reviews of this book. One was a gushing 5-star testimonial by a patient and friend of the author and the other three were 1-star emotional attacks on him for allegedly presenting inaccurate information and having a self-serving agenda for financial benefit. In reality, his information is accurate, is supported by the literature, and his conclusions are echoed by the ACOG and by a Clinical Therapeutics review article in the New England Journal of Medicine.

In my opinion, it is unconscionable to let patients suffering from severe pain go untreated unless there is compelling evidence that not treating pain results in improved health outcomes. It is even more unconscionable for ideologically motivated people to influence a patient to feel guilty about accepting pain relief. A typical natural childbirth website tells women that if they try but can’t stand the pain, they shouldn’t feel bad about asking for medication. The very fact that they felt compelled to say that is an admission that some women do feel bad. Alarmist midwifery websites ask “Why are so many women taking dangerous drugs during labor?” They  exaggerate the dangers of epidurals, referring to doctors as “drug pushers.” They tell women they should “embrace the full pain of childbirth.”

Novocain is a potentially dangerous drug, but can you imagine a dentist telling a male patient to “man up” and have a root canal procedure without any anesthetic?  Because it will be safer? Because embracing the pain will be empowering?

A double standard? Misogyny? Ideology? The “natural fallacy”? Gullible acceptance of anti-establishment myths and misconceptions? Whatever is going on, Dr. Grant offers a science-based corrective. He provides complete and accurate information in an accessible format so that pregnant women can understand and give informed consent. Some will cry “bias” and “cui bono” since he is an obstetric anesthesiologist, but I think his presentation is fair and supported by the published evidence. Is he motivated by money and self-justification, or is he a good doctor who is sincerely concerned for the best interests and comfort of his patients? What’s wrong with aspiring to give all your patients a pain-free birth experience using the safest possible science-based state-of-the-art methods?

Disclaimer:  I have no dog in this fight. As a family physician I delivered around 200 babies. I never gave an epidural (because I was not taught how), but I received one for my first baby.  For my second baby, epidurals were not available and I was given a paracervical/pudendal block. Both methods worked.

Non-overlapping magesteria. I always loathed that concept, as if one aspect of culture could be separate from, and not answerable to, reality. However, there might be something to the concept, as there certainly appears to be two approaches to medicine, and they are non-overlapping. I am not certain the two approaches are even in the same universe.

One approach to medicine is reality-based, where understanding of the world is seen though the lens of science, and as the science  evolves, so does the understanding of reality. What characterizes this approach is, in part,  an understanding of cognitive errors and logical fallacies and the insight of understanding that these cognitive errors and fallacies apply to themselves as much as they apply to others. Skeptics and science-based medicine (SBM) practitioners attempt to live in this magisteria.

The other approach is opinion-based, where reality is fixed and objective data ignored or warped to fit preconceived notions as to how the world should be.  Cognitive errors and logical fallacies are the foundation of this world view, and its practitioners behave as if these concepts do not apply to them. This is the not so magisteria of much of alt-med.

It is two world views that do not, and cannot, talk to each other since neither one understands the language of the other. I, for example, cannot understand  arguments based on information that has been repeatedly disproved yet still promulgated as fact.  The creationist viewpoint is an example of arguments using information years after the information has been discredited. I cannot wrap my head around deliberately misusing information that runs contrary to my current understanding of how the world works. I have a respect for, and a fidelity to, the truth.

A far better description of this dichotomy is to be found in The Panic Virus by Seth Mnookin.  As I write this I am about a quarter of the way through the book and I cannot recommend it enough.

The  International Medical Council on Vaccination, with the probably not intentionally ironic motto “Critical Thinking for a Critical Dilemma,” released a position paper entitled Vaccines: Get the Full Story Doctors, Nurses and Scientists on Protecting Your Child and Yourself (direct download link here) with 83 signatories with various initials after their names (conveniently listed here). 83 seems like a lot at first, but the numbers are not that impressive.

After all, there are 800,000 physicians in the US; so that represents 0.006% of physicians,  about .0004% of PhD’s (out of about 2.5 million) and .00017% of nurses (out of 2.9 million).  Not a ringing majority of the medical industrial complex; a fringe on the medical surrey.

They note at the beginning “MD, DO, MB, MBBCh all indicate a doctor of medicine. ND indicates a medically trained and licensed doctor in some areas. FNP indicates a family nurse practitioner,” leaving out an explanation of DC. I suppose even the International Medical Council on Vaccination feels that DC’s are not really doctors, and do not want to call attention to the fact.  I always think of comic books when I think of DC.  I was never a Marvel guy as a kid.

Of course these are all courageous mavericks, including a brain surgeon with a Galileo-like understanding of The Truth (big T) and are fighting against a corrupt and blind authority who are protecting their turf at the expense of you and your children. As an aside, I often find it odd when Galileo is used as an example. I just realized his first name is Galileo.  In that respect he was like Cher or the Donald.  Galileo was a man of science oppressed by the irrational and superstitious.  Today,  he (Galileo, not the Donald)  is used by the irrational and the superstitious who say the are being oppressed by science.  So 1984.

I prefer to quote  Arthur Schopenhauer:

All antivaccination “truth” passes through three stages. First, it is based upon feelings instead of reality. Second, it is opposed by the rationally inclined. Third, the more complete the information that falsifies it, the more vehemently it is embraced as self-evident.

Or something like that; I am using Bing for my search engine.

Then, without referencing any primary literature, the Vaccine Council of Vaccination proceeds with their Critical Thinking for a Critical Dilemma and where are sarcasm html tags when you need them:

These are some of the diseases that have documented associations with vaccines.

A laundry list follows.  Are any of the diseases on list been shown to be CAUSED by vaccines.  Nope.  Association is not causation, although the decline in pirates is not only associated with global heating, it is the cause of global heating. Or is it the contrariwise, for if it was so, it might be; and if it were so, it would be; but as it isn’t, it ain’t. That’s logic. Praise be to the Flying Spaghetti monster!

The list is interesting. I quasi-randomly picked sudden infant death syndrome (SIDS) to Pubmed, since that is the scariest one on the list. In my reality based understanding there is an association:

AIMS: To conduct a meta-analysis examining the relationship between immunization and SIDS.

METHODS: Nine case-controls studies were identified examining this association, of which four adjusted for potential confounders.

RESULTS: The summary odds ratio (OR) in the univariate analysis suggested that immunisations were protective, but the presence of heterogeneity makes it difficult to combine these studies. The summary OR for the studies reporting multivariate ORs was 0.54 (95% CI=0.39-0.76) with no evidence of heterogeneity.

CONCLUSIONS: Immunisations are associated with a halving of the risk of SIDS. There are biological reasons why this association may be causal, but other factors, such as the healthy vaccinee effect, may be important. Immunisations should be part of the SIDS prevention campaigns.

Cancer is also on the list. Again, there is an association. The HPV vaccine is used to  decrease risk of  cervical cancer and the hepatits B vaccine to decrease the risk for hepatocellular carcinoma. Of course, I am assuming that the Vaccine Council of Vaccination means a beneficial  association, but that is not stated explicitly. I was surprised to find the Vaccine Council of Vaccination trumpeting the benefits of vaccination and oh wait, I misunderstand. They imply vaccines cause SIDS and cancer. That’s different. The data to support the assertion? None that I can find. Maybe the Vaccine Council of Vaccination motto should really be, “I reject your reality and substitute my own” Or maybe, “There is no reality but what we make for ourselves.” Sara Connor almost had it right.

Autoimmune and allergic diseases?  Data?  Nope.

If you generate a list of diseases, unreferenced and unsupported by the literature, that you attribute to vaccines, what could be more worrisome and frightening than

And many, many more.

Not just one many, but two. Two many’s!!! If you Google “many” and “vaccine,” there are over 16 million hits!!! If you Google “many, many more”  and “vaccine” you get a quarter of a million hits. That is an incredible association between vaccines and many, many more. That is the kind of compelling arguments that I find convincing. No more vaccinations for me and mine!

They follow with another list, this time of vaccine side effects. After the first list I am not so confident of the rigor used to generate the document.  I will never say that vaccines are 100% safe. Nothing is. Life, as I understand it, is about relative risks. Seat belts and air bags kill people every year. I still want my car equipped with both.  Nothing is perfect, and it is an issue of the relative risk. An accident without seat belts is far more likely to cause morbidity and mortality.

Life without vaccines is likely to have more potential morbidity and mortality  with 250,000 kids injured each year in car accidents, approximately 2,000 die from their injuries. Your best bet, if you really want to prevent vaccine associated injury, is to not let people drive their kids to the doctors.

Few aspects of medicine offer as much benefit for as little risk as vaccination.  But people do not remember the plagues of the past and pay little attention to the outbreaks of the present unless it directly affects them and theirs.  I understand that.  Who cares if children are dying of pertussis in California, of measles in Africa, and paralyzed by polio in Nigeria?

Every anti-vax is an island entire of itself;
…no childs’s death diminishes me,
because I am uninvolved in mankind.
And therefore never send to know for whom
the bell tolls; it is none my concern.

or something like that.  Again, my searches are not working quite right.

Fainting a side effect?  Sure.

Kidney failure requiring dialysis.  They say that these side effects are “documented in medical literature and/or in package inserts.”  but I can’t find the reference that a vaccine side effect is renal failure.  Maybe it is this underwhelming reference, but given the lack of documentation, it is hard to know. It is probably there somewhere, since the Vaccine Council of Vaccination would not make up data.

More worrisome is “Many common diagnoses given for hospital admissions,” which, when combined with ‘vaccine’, results in 3,350,000 Google hits, although which package insert and which reference in the medical literature  is hard to precisely narrow down.

I am shocked they did not mention that vaccines are associated with hip fractures.  Really. 3% of children get a fracture each year and most are vaccinated.  The Amish, who do not get vaccinated, have less fractures. Coincidence?  I think not.  Maybe I should write for the Vaccine Council of Vaccination.

Then the Vaccine Council of Vaccination says “Autism is associated with vaccines” and point to Fourteenstudies.org, which Dr. Gorski, Dr. Novella, I have discussed before. The approach of 14 studies can be summarized in one ‘critique’: “We gave this study our highest score because it appears to actually show that MMR contributes to higher autism rates.”

If a study agrees with their position, that defines  a good study.  The bass ackwards approach to the medical literature, but telling nonetheless.  It is the world were belief determines the facts. But I am not swayed by such incisive analysis as “What is it with Eric Fombonne and Pediatrics?” and “Fombonne again,”  linking him to a paper he is not an author of.  Still.  I pointed out the mistake years ago.  Seriously, if you are going use guilt by association, at least get your association correct.

The Vaccine Council of Vaccination continues with “Drug companies, insurance companies and the medical system get rich when you get sick.”

The first and third do make money when you are ill, but the second?  Then why do they spend so much time denying coverage?  It is an opinion that seems removed from reality.

The issue is not that vaccines have almost eradicated numerous childhood diseases for which I could make a healthy living if they existed.  The issue is “Vaccine side effects can make you sick for the rest of your life. Conveniently, there are many drugs to treat the side effects caused by vaccines.”  The odd idea that most medical problems are due to “the zeal to eliminate a short list of relatively benign microbes, we have traded temporary illnesses for pervasive, life?long diseases, disorders, dysfunctions and disabilities.”

All the  “many many more” and the “many common diagnoses given for hospital admissions” that result from vaccines.

Nothing specific, ominous appearing, unsupported by data, and feeding into the peculiar paranoid conspiracy  train of thought so common in parts of the world.  I have to confess, I have little appreciation of the conspiratorial mind-set.  As best I can tell,  life is dominated by inadvertent stupidity and randomness mixed with a dollop of greed; one does not need to invoke the Trilateral commission or Big Pharma machinations, although they have machinated enough over the years to earn our distrust.

And, as the data would suggest, most physicians who give childhood vaccines break even.

For hoots and giggles, I Googled  random names of the list  and 6 of 7 are selling products online of an “alternative” nature: books, tapes, DVDs, etc.  I do not know if the names of the signatories are the same people I found who are shilling on the net. Still, later in the paper they bemoan the conflicts of interest of  Dr’s Offit and Gerberding and pediatricians:

…the average U.S. 10?doctor pediatric group has over $100,000 of vaccine inventory in their office to sell. These doctors make money from office visits and from giving your children vaccines, and also from follow up office visits for assessing reactions.

For 250 workdays a year, that is  40 dollars a day, or 5 dollars an hour, before taxes and expenses,  of inventory they have to sell off on their patients.  Less than the minimum wage. Yeah. That’s the way to get rich, selling vaccines, not peddling material on the internet.

Oddly, neither the paper nor the website have a Conflict of Interest (COI) Statement that I can find.  I wonder if the Vaccine Council of Vaccination are in the palms of big Alt.  Who knows how much money  the Vaccine Council of Vaccination are paid by homeopathic preparation  and supplement manufacturers?  Who knows how many thousands of dollars of herbs, supplements, homeopathic products, books and videos the members of Vaccine Council of Vaccination has stocked away to sell for a profit over the internet. It is probably nothing, since I am sure the signatories are not in for the money, but for the benefit of their patients, but with no COI, no transparency,  it is impossible to say.   In the pursuit of openness, I have two ebooks for sale on my website, but really, I am using this as an opportunity to shill for myself in the guise of openness. Or am I?

The Vaccine Council of Vaccination  then notes “Many doctors and healthcare practitioners do not get vaccinated and do not vaccinate their children” and declare that HCW’s do not get vaccinated because they know all the dangers of vaccination. More often it is laziness and inconvenience that prevents HCW’s from vaccination although there is a subset who sign manifestos whose reasons appears to be a profound and pervasive misunderstanding about vaccinations efficacy and safety.

There are the mavericks  who question the status quo, who notice plate tectonics, or that the gravity of the visible  mass  of the universe is insufficient to hold everything together or that  ulcers are caused by bacteria.  Mankind owes a debt of gratitude to those who have extended our knowledge and understanding against the dogma of the day.

Then there are those who publicize cold fusion*, perpetual motion, and water powered cars. The same world view that also writes

“Vaccines are the backbone of the medical system. Without vaccines, healthcare costs would go down because we would have a healthier overall society. We have exchanged chicken pox for autism, flu for asthma, ear infections for diabetes. The list goes on and on. In the zeal to eliminate a short list of relatively benign microbes, we have traded temporary illnesses for pervasive, lifelong diseases, disorders, dysfunctions and disabilities.”

The words are there.  I understand each word individually.  When strung together they are, when compared against the last 100 years of advances in infectious diseases and medicine, gibberish. That paragraph is as divorced from medicine as I understand it  as anything I have ever encountered.  I feel like I am reading

a tale/Told by an idiot, full of sound and fury, Signifying nothing.

Unfortunately, the preceding paragraph was not written by “a poor player/That struts and frets his hour upon the stage/And then is heard no more”

Anti-vax is probably forever.

The Vaccine Council of Vaccination continues with “If U.S. children receive all doses of all vaccines, they are injected with up to 35 shots that contain 113 different kinds of disease particles, 59 different chemicals, four types of animal cells/DNA, human DNA from aborted fetal tissue and human albumin.”
Well, vaccines are evidently a step up from Taco Bell beef.

As discussed, vaccines are nothing compared to the volume of particles the child receives from the real diseases.  Biochemistry is not the strong point of those who are against vaccines.  As usual they point to the presence of formaldehyde, ignoring that the concentration in the vaccine is less than the body makes as part of normal biochemistry in the course of a day.  The net effect of the concentration gradient should be to remove formaldehyde from the blood and into the vaccine.  But in the upside down world of homeopathy, promulgated by some of the signatories, the less the chemical, the stronger it becomes.

And gelatin.  Vaccines have gelatin. The horror, the horror.  I always knew Jello was bad. Not as dangerous as dihydrogen monoxide, a major ingredient in all vaccines that kills 4000 Americans a year, 20% of them children.   And it is in our vaccines.  Think about the children.  Come on. Gelatin? Really? Really?

The Vaccine Council of Vaccinations  wind down by emphasizing you do have the right to refuse vaccination, and that doing so is a shameful, embarrassing, repellant act, which is why, I suppose, they say “Vaccination decisions are between you and your spouse/partner. No one else needs to know. It is not the business of your family members, your neighbors, or your in-laws.”  Or am I reading it wrong?

They conclude with a combination of advice on how to avoid vaccinations and how wonderful  infections are compared to vaccines:

Babies are born with powerful, natural defenses. If this were not so, all would die shortly after birth. Enormous cascades of complex immune processes start with the first cry. This needs to occur naturally, without the interruption caused by the injections of toxic substances.

Learn about the “vaccine preventable”  diseases. Your children will never come in contact with most of them and if they do, nearly all healthy and unvaccinated children recover uneventfully, with long term immunity. Health cannot come through a needle.

Tell that to UNICEF :

Almost 40 per cent of all under-five deaths occur during the neonatal period, the first month of life, from a variety of complications. Of these  neonatal deaths, around 26 per cent, accounting for 10 per cent of all under-five deaths, are caused by severe infections. A significant proportion of these infections is caused by pneumonia and sepsis (a serious blood-borne bacterial infection that is also treated with antibiotics).

Around 2 million children under five die from pneumonia each year‚ around 1 in 5 deaths globally. In addition, up to 1 million more infants die from severe infections including pneumonia, during the neonatal period. Despite progress since the 1980s, diarrhoeal diseases account for 17 per cent of under-five deaths. Malaria, measles and AIDS, taken together, are responsible for 15 per cent of child deaths.”

The industrialized West, having routed, at least locally, three of the four hoursemen of the apocolapse (War, Famine, Pollution (Pestilence having retired in 1936 following the discovery of penicillin)),  has developed  many interventions, including vaccines, that have resulted in a decrease in childhood infectious diseases, not a one discovered or implemented by the practitioners touted in this manifesto “a naturopathic doctor, a pediatric chiropractor, a doctor of oriental medicine, or a homeopathic doctor.”

I do not want to return to the bad old days when

For example, in 1900, 21,064 smallpox cases were reported, and 894 patients died. In 1920, 469,924 measles cases were reported, and 7575 patients died; 147,991 diphtheria cases were reported, and 13,170 patients died. In 1922, 107,473 pertussis cases were reported, and 5099 patients died.

Those who cannot remember the past are condemned to be against vaccination.

The Vaccine Council of Vaccination bids you remember

Learn about the vaccine preventable  diseases. Your children will never come in contact with most of them” and “Understand that your child can be vaccinated and still contract the illness you are wishing to prevent.

Which is it? They will be exposed or they won’t.   I know.  A foolish consistency is the hobgoblin of little minds.

They finish, with a not so subtle reminder that they take Visa, Mastercard and cash, but not Blue Cross:

“Know that healthcare is something you pay for; sick care is covered by insurance. Your insurance will pay for drugs and vaccines.

Budget accordingly to stay healthy. Your life depends on it.”

The Vaccine Council of Vaccination concludes not with  primary references,  but links to more web sites.

The Vaccine Council of Vaccination is the group who wanted to debate vaccines. Besides the fact that I am a lousy debater, having lost every substantive discussion with my wife, how can  one debate the Vaccine Council of Vaccination?  My assumption is that those who hold opinions that are contrary to mine are not bad people. I presume good intentions and, since the Road to Hell is paved with frozen door-to-door salesmen,  I need not fret about ultimate consequences of their intent, although the Vaccine Council of Vaccination strains my credulity.   I always feel like I am constrained by the truth as best I understand it, and a fidelity to reality is a handicap in any argument.   It would be like debating the nature of the moon with Wallace. Bad example.  He had objective data to support his position, unlike the Vaccine Council of Vaccination.

Non-overlapping indeed.

===

* Dude.  You know who you are.  Don’t fill the thread with cold fusion commentary again.  It is not the point of the entry. Thanks in advance for understanding.

I emerge from the haze of board exams and residency interviews to blog about a recent development on campus that disappointed me, involving a university celebration of Black History Month.

To provide context, I must tell you that my medical school campus has the university hospital for a poor city full of immigrants and racial minorities. White citizens make up about a quarter of the city population. I am extremely proud of our faculty and students who strive to serve our surrounding community. Some of these efforts are based, predictably, in medical care. This care is provided not just by working in the hospital and clinic, but also by promoting health and prevention through community health fairs and mobile outreach programs. Other efforts are aimed at helping local kids get to college and into health-related careers. Establishing a physician workforce that represents a diversity of racial, ethnic, and cultural backgrounds is considered an important step in reducing racial disparities in health care access and outcomes (e.g., 1, 2), and that mission is embraced wholeheartedly at my institution. (An anecdotal example of the diversity in our school and hospital: it is neither rare nor surprising for me to look around a random gathering and realize that I am the only pale, American-born man in attendance.) Therefore, one might expect my university’s celebration of Black History Month to be kind of a big deal.

Here is the announcement for our university-sponsored celebration of Black History Month. The title of the speech that kicks off the celebration is “Holistic Medicine – Ancient Africans to African-Americans.” The next event is a screening of a video called “Hidden Dangers in Kids’ Meals: Genetically Engineered Foods.” Clearly the celebration is being used to address health concerns in the black community, which seems entirely appropriate for a medical university. However, as regular blog readers have already predicted, I found myself getting increasingly upset about the particular topics chosen to meet this worthy goal.

I am upset not simply because my skeptical hackles raise at the term “holistic medicine,” but because I feel that here is an example of CAM ideology marring an opportunity for meaningful service. The most charitable word I can use for the topics listed is “controversial.” Airing of controversial views can certainly be appropriate in a university setting, but not if and when the goal is supporting the health of a historically disenfranchised part of our community.

Guest speaker on “holistic medicine”

Local physician Kevin Holder, MD gave a talk titled, “Holistic Medicine – Ancient Africans to African-Americans.” I am sad that my clinical duties prevented me from attending the talk. I will refrain from speculating on its content, but one might infer what Dr. Holder means by “holistic medicine” from the website of his Center for Preventive Medicine, particularly the “Our Philosophy” and “Our Team” pages.

From the standpoint of understanding the history and current prevalence of unconventional health beliefs in African and African-American communities, I can appreciate this topic as germaine to Black History Month even if I would disagree with Dr. Holder as to the medical value of those beliefs. It is a shame I missed the event, because it might have been a great opportunity to have a discussion about the appropriateness of incorporating pre-(non-)scientific philosophies into a modern medical practice. It is a fascinating question: where should we draw the line between hard-nosed adherence to science-based medicine and pragmatic appeals to a community with strongly held traditions? Perhaps the celebration organizers had in mind to foster such a debate.

The cranky skeptic in me cannot help speculating, however, that it was explicit sympathy for CAM in the planning committee that resulted in the scheduling of both Dr. Holder and the subsequent, much less defensible event.

Screening of an anti-GM food movie

The next event is a screening of “Hidden Dangers in Kids’ Meals: Genetically Engineered Foods” by anti-GM (genetically modified) food activist Jeffrey Smith. Here can be found the 24-minute video for the brave, and below is an outline for everyone else:

• Ominous music opens the video, and scattered throughout are gripping quotes like “I don’t want to sell my children’s future for a handful of magic beans.”
• Descriptions of how the industry controls research programs and regulatory bodies (I do not know to what extent this is true) are plentiful, along with stories of individuals being pressured or even expelled if they ask the wrong questions or voice the wrong opinions. An analogy is made to tobacco companies spinning science about cigarettes.
• Frequently cited experiments document the horrible effects of a particular GM food on a group of laboratory animals. Interestingly, there seems to be no consistent pattern in the particular adverse effects cited; it sounds like GM foods can cause just about any pathology.
• Anecdotes are also offered about adverse effects in farm animals, ranging from the mysterious death of twelve cows in Germany to “The cows didn’t care for it” in Iowa.
• Broad claims are made for the effect of food on behavior. An unidentified study apparently showed that “25% of tantrums in 3-year-olds [were] due to additives or colorings in their food.” A Wisconsin school that instituted sweeping changes in its lunch offerings and cafeteria environment reported a resulting improvement in student behavior and attention. Neither of these dramatic examples, of course, specifically involved GM foods. But the audience gets the message that healthy food is better than processed junk, and presumably they can make the connection from there.
• Another example of this implicit yet bold assumption—that GM food is associated with all manner of ills—is the closing statement that begins, “With the rise in obesity and diabetes…” and ends with concerns about GM food.
• At one point the video creator Jeffrey Smith, to his credit, speaks carefully about not being over-confident about conclusions based on a single, small experiment in animals. He says it “would be irresponsible,” however, not to proceed cautiously until better studies are done. The audience is left to take his word that better studies than these have indeed not been done.

The most detailed, science-y part of the video involves the implications of an article published in Nature Biotechnology titled “Assessing the survival of transgenic plant DNA in the human gastrointestinal tract.” Jeffrey Smith describes how transgenes were shown to jump from GM soy to bacterial flora in the human gut. He expresses concerns about transfer of antibiotic resistance genes, pesticide production genes, promoters that might insert themselves anywhere in the new genome… It all sounds pretty scary until you read the abstract of the Nature paper, which ends with “we conclude that gene transfer did not occur during the feeding experiment.” Reading the full article in order to judge the researchers’ conclusion versus Jeffrey’s opposite interpretation is left as an exercise for the blog reader.

Finally, for those who like a good “Quack Miranda Warning,” the one at the end of the video (at 8:40 here) is amusing.

A scathing critique of Jeffrey Smith’s claims and use of evidence can be found here, at a site that appears to have been founded by a couple of food science professors fed up by this guy. I do not have the time and patience to wade through it, but suffice to say that the creator of the video “Hidden Dangers in Kids’ Meals” looks an awful lot like a crank to me. The link to Dr. Gorski’s favorite Health Ranger, Mike Adams, on Jeffrey Smith’s home page increases my suspicion. I welcome any comments by blog readers better versed in this field or with this individual.

The purpose of screening the Jeffrey Smith video for Black History Month eludes me. Only a handful of the activists, experts, parents, and innocent children depicted had much melanin in their skin. But more importantly, I do not think we support a marginalized community by promoting fear of greedy corporations and complicit government. Raise your hand if you think a conspiracy theory about food is what black Americans really need right now.

Honoring Black History Month by serving black Americans

For my university, a public celebration of Black History Month is not simply an exercise in honoring diversity. Our school and hospital are prominent institutions in a city of many black children who could benefit greatly from inspiration and guidance. I applaud the goal of using the celebration to spotlight the health of Black Americans, which by many metrics lags deplorably behind the health of other racial groups in this country. A particularly salient problem is the high rate of obesity in this population, making all the more potentially valuable a program to promote healthy lifestyle and diet.

I wish, however, that this intention had found a different execution than holistic medicine and anti-GM hysteria. Here is an alternative: how about featuring First Lady Michelle Obama’s “Let’s Move!” initiative? She is focused on urban children’s health, though her concerns are more about access to fresh produce and safe playgrounds rather than exposure to GM foods. Our mayor Cory Booker recently kicked off the Let’s Move! campaign in this city and is using Facebook to lose weight himself. The messages from this campaign could have been tailored to black youth (include yoga for exercise if you want some CAM) and used as part of the Black History Month celebration instead of the dubious health messages we are sending now. Even better than the non-magical, non-paranoid character of the Let’s Move! campaign: its national and local leaders are terrific black American role models. (Of course, I appreciate that it would be very difficult to secure either of these high-profile individuals for a guest appearance. But I bet there are other folks in our city working on this problem…)

Americans, whether African- or any other kind, deserve from their medical universities the truth as best as we know it. We can do better than this misguided, misleading, fear-mongering video.

Last year it was reported that there was a possible increase in narcolepsy, a sleep disorder characterized by excessive sleepiness, in children who had received the Pandemrix brand of H1N1 flu vaccine in Sweden, Finland, and Iceland. However a review of the data did not find a convincing connection, although concluded there was insufficient data at present and recommended further surveillance. A narcolepsy task force was formed in Finland, and now we have their preliminary report.

They conclude that the evidence suggests there is a connection:

Based on the preliminary analyses, the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was 9-fold in comparison to those unvaccinated in the same age group. This increase was most pronounced among those 5–15 years of age. No cases were observed among those under 4 years of age. Also, no increase in cases of narcolepsy or signs of vaccination impacting risk of falling ill with narcolepsy was observed among those above 19 years of age.

The World Health Organization (WHO) has reviewed these results and concluded:

WHO’s Global Advisory Committee on Vaccine Safety (GACVS) reviewed this data by telephone conference on 4 February 2011. GACVS agrees that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines. An increased risk of narcolepsy has not been observed in association with the use of any vaccines whether against influenza or other diseases in the past. Even at this stage, it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon and this complicates interpretation of the findings in Finland.

I agree with the WHO, who is basically saying that these results are intriguing, but are problematic and should be considered preliminary. They then follow with – more research is needed. Epidemiology is a complex endeavor, and there are lots of wrinkles to this data. The increased risk of narcolepsy was only seen within a certain age range. In Iceland (but not Sweden or Finland) the increase in narcolepsy was also seen in those who were not vaccinated. And further, other countries (47 in total) that also used the Pandemrix vaccine have seen no increase in narcolepsy, including Norway, the UK, Germany, and Canada.

Overall we have a very inconsistent pattern. The vaccine does not appear to be a consistent or unique risk factor for narcolepsy in these populations. The task force concludes from this that there must be another factor or factors that is combining with the vaccine to increase the risk. This is logically possible, but until this factor X is identified it remains speculation.

Narcolepsy is a neurological disorder characterized by excessive daytime sleepiness (narcoleptics sleep all night and all day), cataplexy (a tendency to lose muscle tone and collapse in response to stress), hypnagogia (hallucinations associated with a fusion of the dream state and the waking state, so-called waking dreams), and sleep paralysis (being paralyzed upon awaking from sleep). There is a strong genetic predisposition for narcolepsy. In fact it is only seen with a certain genetic type known as the (HLA) DQB1*0602 genotype.

All of the individuals who developed narcolepsy following the Pandemrix vaccine have the narcolepsy HLA type. Therefore there is the possibility that the vaccine only increases risk within this genetic populations, perhaps combined with other gene variants. Perhaps something else is also triggering the increase in Iceland, but not Finland and Sweden, to explain the rise in narcolepsy there in the unvaccinated.

Another possibility is that there is one or more confounding factors leading to the increase in narcolepsy, and the vaccines are a correlating but not causative factor.

Such is the nature of epidemiology, or observational studies. Variables are not controlled for and confounding factors are always a possibility. That does not mean that observational data is not useful or cannot be definitive – but it requires careful, thoughtful, and thorough collection and analysis of data from multiple different angles. The data we have so far from Finland is very preliminary, and generates more questions than answers. There is certainly sufficient cause for caution and further analysis. But at this point I would not be surprised by any particular outcome, since the data can be interpreted in many ways.

Conclusion

While there is an intriguing correlation between the Pandemrix vaccine and narcolepsy, this correlation is inconsistent – it is isolated to a few countries and to one age group and there is a rise in narcolepsy in Iceland not correlated to the vaccine. Further the cases identified so far are restricted to those with a known genetic predisposition to narcolepsy. This could mean that this population is susceptible to some factor in the vaccine, but it could also mean that they are susceptible to some other trigger, or perhaps were destined to get narcolepsy and the apparent increase in entirely an artifact of observation and reporting.

I agree with the WHO that this data should be considered preliminary – which means it is worthy of further monitoring and research, but we are not able to make any firm conclusions at this time.  I would not be surprised if it turns out to be a real effect of the Pandemrix vaccine. Vaccines are not without risk, although over the decades the risks have proven to be very small and vastly outweighed by the benefits. Obviously it would be hugely useful to identify which ingredient was the culprit and exactly how it triggered narcolepsy in this population. But I would also not be surprised if this turns out to be entirely a red herring. Such is the nature of observational data.

Ear infections used to be a devastating problem. In 1932, acute otitis media (AOM) and its suppurative complications accounted for 27% of all pediatric admissions to Bellevue Hospital. Since the introduction of antibiotics, it has become a much less serious problem. For decades it was taken for granted that all children with AOM should be given antibiotics, not only to treat the disease itself but to prevent complications like mastoiditis and meningitis.

In the 1980s, that consensus began to change. We realized that as many as 80% of uncomplicated ear infections resolve without treatment in 3 days. Many infections are caused by viruses that don’t respond to antibiotics. Overuse of antibiotics leads to the emergence of resistant strains of bacteria. Antibiotics cause side effects. A new strategy of watchful waiting was developed.

Current Medical Guidelines

In 2004, the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) collaborated to issue evidence-based guidelines based on a review of the published evidence

Something was lost in the transmission: the guidelines have been over-simplified and misrepresented, so it’s useful to look at what they actually said. There were six parts:

1. Criteria were specified for accurate diagnosis.

• History of acute onset of signs and symptoms
• Presence of middle ear effusion (ear drum bulging, lack of mobility, air-fluid level)
• Signs and symptoms of middle ear inflammation: Either red ear drum or ear pain interfering with normal activity or sleep

They stressed that AOM must be distinguished from otitis media with effusion (OME). OME is more common, occurs with the common cold, can be a precursor or a consequence of AOM, and is not an indication for antibiotic treatment.

2. Pain should be treated regardless of whether antibiotics are used.

3A. Observation without antibiotics is an option for a child with uncomplicated AOM.

• Limited to otherwise healthy children and stratified by age
  • 6 mo to 2 years with non-severe illness and uncertain diagnosis
  • 2 and older without severe symptoms or with uncertain diagnosis.
  • All children under 6 mo should be treated.
• Parents must have ready means of communicating with clinician.
• A system must be in place to re-evaluate the child. Strategies include a parent-initiated visit and/or phone contact for worsening condition or no improvement at 48 to 72 hours, a scheduled follow-up appointment in 48 to 72 hours, routine follow-up phone contact, or use of a safety-net antibiotic prescription to be filled if illness does not improve in 48 to 72 hours.

3B. Amoxicillin is the treatment of choice

4. Reassess in 48-72 hours.

• If AOM is confirmed in a patient being observed, start antibiotics.
• If patient is already on an antibiotic and symptoms persist, change it.

5. Encourage prevention

• Modify the modifiable risk factors: limit attendance at child care centers, breastfeed for 6 months, avoid supine bottle feeding and bottle propping, and avoid exposure to passive tobacco smoke.
• Influenza vaccine is 30% effective in reducing the incidence of AOM.
• Pneumococcal vaccine provides a 6% reduction.

6. No recommendations for CAM. They reviewed alternative medicine treatments and found no evidence to support them.

Alternative Medicine

Alternative medicine often misrepresents the facts: for instance, one homeopathic website says

Recent medical studies have shown that giving antibiotics does not effect [sic] the course of ear infections at all.

CAM offers a smorgasbord of options for treating ear infections, but none of them are supported by any credible scientific evidence. Here are a few examples:

• Jay Gordon, MD recommends herbal and homeopathic remedies.
• Joseph Mercola, DO warns that antibiotics are harmful, ineffective, and unnecessary. He recommends garlic ear drops, putting breast milk in the ear canal, and onion poultices.
• Natural News recommends chiropractic; essential oils; herbal remedies including Echinacea, goldenseal, olive leaf and St. John’s wort; and eliminating dairy.
• Andrew Weil, MD recommends cranial osteopathy and eliminating dairy products.
• Many chiropractors claim to treat ear infections with upper cervical adjustments to promote drainage of the ear and support immune function. Ear-related claims are particularly common in that profession because D.D. Palmer, founder of chiropractic, claimed to have been originally inspired by a case of curing deafness with a neck “adjustment.”
• An acupuncture website recommends needling TH 5, GB 41, GB 20, TH 17 and GB 2.
• A homeopathic website offers to treat the whole child instead of just treating ear infections. They consider the child’s personality, likes and dislikes, and other factors; then choose the right homeopathic remedy to strengthen the health of the child. They claim that their treatment will make everything in the patient’s life get better.

Difficulty of diagnosis

Parents suspect their child has an ear infection when they notice irritability, pulling at the ear, and fever. These symptoms may be due to other causes, some of them serious, so a diagnosis by a doctor is essential. Anyone who has attempted to examine the ears of a struggling 2-year-old realizes that diagnosis is not a straightforward, black-and-white procedure. Many clinicians are not skilled in pneumatic otoscopy and tympanometry and they may have to rely on the appearance of the tympanic membrane (TM) through a simple otoscope. The ear canal is narrow and the view often obstructed by wax. The TM can be red because the child is crying. It can be a difficult judgment call to say whether the TM is bulging or dull, especially when you can only see part of it. When a doctor sees a sick child with an unexplained fever, it is tempting to call it AOM and have an answer and an excuse to “do something” (give antibiotics) when the diagnosis is not really so clear.

New Studies

Critics have suggested that the studies the recommendations were based on had limitations such as biases in patient selection, varying diagnostic criteria, and suboptimal antibiotic regimens. Two new studies have re-assessed antibiotic treatment using strict diagnostic criteria and optimum antibiotic regimens.

On January 13, 2011 The New England Journal of Medicine published two very similar high-quality studies done in Pittsburgh and Finland. Neither was funded by Big Pharma or any other commercial entities. Both addressed acute otitis media in very young children (6-23 months and 6-35 months respectively). Both were randomized double-blind studies. Both used stringent diagnostic criteria, with examiners who were skilled otoscopists. Both used amoxicillin/clavulanate rather than amoxicillin alone, since the evidence now indicates it is the most effective treatment.

Both studies found that antibiotics were clearly superior to placebo. The Finnish study calculated an NNT of 3.8 (the number of children that must be treated for one to benefit). It found that the benefit was the same regardless of the severity of the illness. Diarrhea and diaper rash were more common in those getting antibiotics. One patient in the placebo group developed mastoiditis. No increase in colonization by antibiotic-resistant bacteria was found.

An accompanying editorial stresses that the key to the optimal management of acute otitis media remains the accuracy of the diagnosis.

Conclusion

It is now clear that young children with a certain diagnosis of AOM recover more quickly with antibiotic treatment. The benefits of antibiotic treatment must be balanced against the development of resistant strains and the recognized side effects of antibiotics. Watchful waiting is only appropriate for patients over 6 months old when the diagnosis is uncertain. The new studies suggest that severity of illness should not be a criterion for deciding which children to treat, but that the emphasis should be on accurate diagnosis. I’m guessing that these two new studies will lead to revised guidelines.

As hard as it is to believe, it’s been nearly a year since Steve Novella, Kimball Atwood, and I were invited to meet with the director of the National Center for Complementary and Alternative Medicine (NCCAM), Dr. Josephine Briggs. Depending upon the day, sometimes it seems like just yesterday; sometimes it seems like ancient history. For more details, read Steve’s account of our visit, but the CliffsNotes version is that we had a pleasant conversation in which we discussed our objections to how NCCAM funds dubious science and advocacy of complementary and alternative medicine (CAM). When we left the NIH campus, our impression was that Dr. Briggs is well-meaning and dedicated to increasing the scientific rigor of NCCAM studies but doesn’t understand the depths of pseudoscience that constitute much of what passes for CAM. We were also somewhat optimistic that we had at least managed to communicate some of our most pressing practical concerns, chief among which is the anti-vaccine bent of so much of CAM and how we hoped that NCCAM would at least combat some of that on its website.

Looking at the NCCAM website, I see no evidence that there has been any move to combat the anti-vaccine tendencies of CAM by posting pro-vaccination pieces or articles refuting common anti-vaccine misinformation. Of all the topics we discussed, it was clearest that everyone, including Dr. Briggs, agreed that the NCCAM can’t be perceived as supporting anti-vaccine viewpoints, and although it doesn’t explicitly do so, neither does it do much to combat the anti-vaccine viewpoints so ingrained in CAM. As far as I’m concerned, I’m with Kimball in asserting that NCCAM’s silence on the matter is in effect tacit approval of anti-vaccine viewpoints. Be that as it may, not long afterward, Dr. Briggs revealed that she had met with homeopaths around the same time she had met with us, suggesting that we were simply brought in so that she could say she had met with “both sides.” Later, she gave a talk to the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP), which is truly a bastion of pseudoscience.

In other words, I couldn’t help but get the sinking feeling that we had been played. Not that we weren’t mildly suspicious when we traveled to Bethesda, but from our perspective we really didn’t have a choice: if we were serious about our mission to promote science-based medicine, Dr. Briggs’ was truly an offer we could not refuse. We had to go. Period. I can’t speak for Steve or Kimball, but I was excited to go as well. Never in my wildest dreams had it occurred to me that the director of NCCAM would even notice what we were writing, much less take it seriously enough to invite us out for a visit. I bring all this up because last week NCCAM did something that might provide an indication of whether it’s changed, whether Dr. Briggs has truly embraced the idea that rigorous science should infuse NCCAM and all that it does, let the chips fall where they may. Last week, NCCAM released its five year strategic plan for 2011 to 2015.

Truly, it’s a case of The Good, The Bad, and The Ugly.

The Good (more accurately: The Least Bad)

Let’s start by listing the goals of the NCCAM Strategic Plan 2011-2015:

• GOAL 1: Advance the science and practice of symptom management.
• GOAL 2: Develop effective, practical, personalized strategies for promoting health and well-being.
• GOAL 3: Enable better evidence-based decision making regarding CAM use and its integration into health care and health promotion.

To accomplish these goals, NCCAM proposes five Strategic Objectives:

• Strategic Objective 1: Advance Research on Mind and Body Interventions, Practices, and Disciplines
• Strategic Objective 2: Advance Research on CAM Natural Products
• Strategic Objective 3: Increase Understanding of “Real-World” Patterns and Outcomes of CAM Use and Its Integration Into Health Care and Health Promotion
• Strategic Objective 4: Improve the Capacity of the Field To Carry Out Rigorous Research
• Strategic Objective 5: Develop and Disseminate Objective, Evidence-Based Information on CAM Interventions

As much as I detest NCCAM as a political tool foisted upon the NIH by quackery-friendly legislators, in particular Senator Tom Harkin (D-IA), even I have to admit that there is some good in NCCAM’s strategic plan, specifically Objective 4: Improve the Capacity of the Field To Carry Out Rigorous Research. If you’re a scientist, arguing against improving the capacity to do rigorous science is akin to arguing against mom and apple pie; no serious scientist would do it. Of course, implicit in this NCCAM objective is an admission that the CAM research NCCAM has tended to fund in the past has not been very good, and, worse, it is very telling that NCCAM should even find it necessary to make improving the quality of its funded research a strategic objective. After all, improving the the capacity of a field to carry out rigorous research should be part of the mission of every NIH institute and center, so much so that it should almost go without saying. Unfortunately, how NCCAM proposes to go about improving the scientific rigor of its work isn’t exactly the way it should go about improving the scientific rigor of its work. For example, one key method proposed by NCCAM is to “support a variety of high-quality research training and career development opportunities to increase the number, quality, and diversity of CAM researchers”:

A successful and robust CAM research enterprise must draw from two sources of well-trained, skilled, and experienced talent: CAM practitioners expert in their respective disciplines and biomedical/behavioral scientists expert in cutting-edge scientific methods. CAM practitioners are the key holders of knowledge related to the potential application of CAM interventions and disciplines. NCCAM has always recognized the need for research training and career development efforts targeted specifically toward this diverse community. Over the years the Center has developed a number of programs aimed at enhancing CAM practitioners’ abilities to critically evaluate biomedical literature, participate in clinical research, and, in some cases, seek advanced training and career development opportunities for careers in the field of CAM and integrative medicine research.

All of this sounds very nice, but where the rubber meets the road, what this means is listening to reiki practitioners, acupuncturists, therapeutic touch practitioners, and homeopaths (in other words, believers in unsupported modalities based on magical thinking) when setting priorities, in addition to listening to less unreality-based CAM practitioners, such as herbalists or even chiropractors who stick with musculoskeletal disorders and don’t claim that chiropractic can cure asthma or other unrelated diseases. Using such practitioners to set research priorities and to collaborate with real scientists is what Harriet Hall would call Tooth Fairy science. It’s putting the cart before the horse. Implicit in this strategy is the assumption that there is an actual phenomenon to be studied in modalities like reiki, which, let’s face it, is nothing more than faith healing stripped of its Christian religious background and replaced with Eastern mysticism. If I knew that NCCAM was in actuality trying to determine whether these phenomena exist, rather than “how” they work, perhaps I’d be less critical. Another part of me can’t help but note that trying to suck real scientists into the study of pseudoscience, NCCAM is blatantly trying to cloak various modalities in the mantle of scientific respectability before they deserve to wear it.

Whether I’m being cynical or realistic I leave to the reader to judge. Certainly, given that Objective 3 (Increase Understanding of “Real-World” Patterns and Outcomes of CAM Use and Its Integration Into Health Care and Health Promotion) seems custom-designed to develop a case for “integrating” CAM into science-based medicine, rather that determining which modalities actually have some utility supported by science and therefore should cease being “alternative” and become just “medicine.”

Less irritating is Strategic Objective 2: Advance Research on CAM Natural Products. Actually, it’s not so much “good” as least objectionable and even somewhat scientifically defensible. Here are the strategies proposed by NCCAM:

Strategy 2.1: Harness state-of-the-art “omics” and other high-throughput technologies and systems biology approaches of the sciences of pharmacology and pharmacognosy to:

• Elucidate biological effects, mechanisms of action, and safety profiles of CAM natural products
• Study interactions of components with each other and with host biology
• Build a solid biological foundation for translational research needed to carry out clinical studies.

Strategy 2.2: Support translational research to build a solid biological foundation for research on CAM natural products to:

• Develop and validate sensitive and reliable translational tools to detect and measure mechanistically relevant signatures of biological effect and to measure efficacy and other outcomes
• Conduct preliminary/early phase studies of safety, toxicity, dosing, adherence, control validation, effect/sample sizes, ADME (absorption, distribution, metabolism, and excretion), and pharmacokinetics
• Build upon established and proven product integrity policies and processes.

Strategy 2.3: Support targeted large-scale clinical evaluation and intervention studies of carefully selected CAM natural products.

Of course, the reason that I label this as being part of “the good” is because, of all the aspects of CAM, natural products represent the area with the most scientific plausibility. On the other hand, it’s hard not to point out that there is nothing here that natural products pharmacologists haven’t been doing for decades. Nothing. What NCCAM is in essence describing is nothing more than pharmacogonosy, the study of natural products pharmacology. It’s the sort of thing that our very own David Kroll does. It’s the sort of thing that thousands of pharmacologists do every day. Heck, it’s even the sort of thing that a lot of pharmaceutical companies do when they try to isolate drugs from natural products. There are many examples of drugs that have come from natural products, including taxol (Pacific Yew tree); vinca alkaloids (periwinkle plant); related drugs like campothecin, irinotecan, and topotecan (Camptotheca acuminata, a.k.a. Happy tree); and, of course, aspirin. The list is extensive, arguably longer than the list of synthetic drugs.

In fact, what NCCAM is doing here, whether Dr. Briggs realizes it or not, is the classic “bait and switch” that I discussed when kvetching about Dr. Oz’s promotion of various Ayruvedic medicines and “detox” diets. In essence, NCCAM has claimed for itself all of natural products pharmacology as being “CAM.” The difference is that there is a layer of belief slathered on it, specifically the CAM belief that somehow the natural plant is superior to purified components or molecules found to have medicinal value. The assumption is that the mixture of unpurified compounds somehow allows the components in the plant or natural product to be “synergistic.” While this sort of synergy is possible, it is actually pretty implausible, with precious few examples known. Worse, it’s very hard to demonstrate true synergy between only two or three components, much less the hundreds — or even thousands — of components in many plants used in CAM. In reality, for all practical purposes and even when a plant does have an active compound (or active compounds) in it that function as a drug, using whole plant extracts, as most CAM practitioners do, substitutes adulterated active ingredients whose purity and potency can vary wildly for well-characterized, predictable, purified active drug.

Actually, I don’t mind this sort of research so much, as long as it’s testing hypotheses that are supported by sound basic science and preclinical data. Certainly, that’s what NCCAM appears to be trying to do, and if NCCAM can’t be dismantled (as I would prefer), its components absorbed into the appropriate institutes and centers of the NIH, then I suppose this is the sort of research that is least likely to cause harm and might actually produce useful results, far more so than much of the rest of the research that NCCAM funds. However, I continue to question why such research should now be considered “CAM” when natural products research has long been a major area of “conventional research.” After all, the study of natural products and herbs with useful pharmacological activity has been an active area of research in pharmacology since time immemorial. There’s no scientific rationale why such studies should be segregated away as “alternative”; they could and should be evaluated just like any other scientific study. Worse, trying to segregate natural product pharmacology at NCCAM devalues pharmacognosy, and by association with the other woo (see below) also being funded under the rubric of “CAM” makes it look like woo too.

In fact, the entire set of goals set forth by Dr. Briggs in the introduction are a “bait and switch.” Notice how two out of the three of these have nothing to do with CAM. Seriously. Why is it that symptom management is CAM? Take the example of oncology. Considerable research and effort go into trying to develop strategies to minimize the effects of therapy. A whole branch of anesthesiology is devoted to the management of chronic pain. If that’s not “symptom management,” I don’t know what is. So what does CAM bring to the science and practice of symptom management? Very little, I would argue, that can’t be studied outside the context of CAM. Unfortunately, what CAM really does bring to symptom management is pseudoscience and prescientific ideas of how the body works. It brings qi. It brings human energy fields. It brings vitalism. Do we really need to “integrate” nonsense with science in symptom management? Perhaps NCCAM can help us understand placebo effects better, for example, but that is research that can and should be the bailiwick of other NIH institutes and centers.

And don’t get me started on Goal 2, which, similarly, is a province of science-based medicine. One might argue that medicine hasn’t done as good a job of developing personalized strategies to promote health and well-being, but the solution to that problem is to emphasize such strategies more in science-based medicine, not to bring in pseudoscience.

The Bad and The Ugly

Let’s take a look at all the strategic objectives. I only discussed Strategic Objective 2 above, but that’s just because I wanted to discuss the least objectionable objective. Actually, in and of itself, Strategic Objective 2 is not objectionable. After all, natural products pharmacology is something I consider fascinating. So here are the five Strategic Objectives in the NCCAM Strategic Plan 2011-2015. Neither would Objective 4 be objectionable if the science were truly rigorous and subject to analyses of Bayesian prior probability before highly improbable modalities like homeopathy or reiki are tested in human beings.

So let’s look at Strategic Objective 5 (Develop and Disseminate Objective, Evidence-Based Information on CAM Interventions). These sound rather benign, don’t they? I mean, who could argue with disseminating “objective, evidence-based information on CAM interventions,” for example? Certainly not me. And I actually do hope that NCCAM does do that, that it really is serious about it. If so, it would tell people that homeopathy is nothing but water, that there is no evidence that reiki practitioners can manipulate a “universal energy field” to heal, and that there’s no scientifically convincing evidence that practitioners of therapeutic touch practitioners can detect or manipulate human energy fields. Let’s look at the key points NCCAM emphasizes about reiki:

• People use Reiki to promote overall health and well-being. Reiki is also used by people who are seeking relief from disease-related symptoms and the side effects of conventional medical treatments.
• Reiki has historically been practiced as a form of self-care. Increasingly, it is also provided by health care professionals in a variety of clinical settings.
• People do not need a special background to learn how to perform Reiki. Currently, training and certification for Reiki practitioners are not formally regulated.
• Scientific research is under way to learn more about how Reiki may work, its possible effects on health, and diseases and conditions for which it may be helpful.
• Tell your health care providers about any complementary and alternative practices you use. Give them a full picture of what you do to manage your health. This will help ensure coordinated and safe care.

Pointing out:

Reiki is based on the idea that there is a universal (or source) energy that supports the body’s innate healing abilities. Practitioners seek to access this energy, allowing it to flow to the body and facilitate healing.

Although generally practiced as a form of self-care, Reiki can be received from someone else and may be offered in a variety of health care settings, including medical offices, hospitals, and clinics. It can be practiced on its own or along with other CAM therapies or conventional medical treatments.

I could provide other examples, such as the entry on NCCAM for Ayruvedic medicine. However, perhaps the most instructive example is the entry for homeopathy. A truly science-based assessment of homeopathy would point out that the principles of homeopathy violate multiple well-established laws of physics and chemistry and that, for homeopathy to work, these well-established laws would have to be found not to be just wrong, but spectacularly wrong. It would also point out that, for that to happen, the amount of evidence in support of homeopathy would have to start to approach the level of evidence that tells us that homeopathy can’t work. While NCCAM does concede that homeopathy is “controversial” and that its tenets violate known laws of physics, it does so in a weaselly, wishy-washy way:

Homeopathy is a controversial area of CAM because a number of its key concepts are not consistent with established laws of science (particularly chemistry and physics). Critics think it is implausible that a remedy containing a miniscule amount of an active ingredient (sometimes not a single molecule of the original compound) can have any biological effect—beneficial or otherwise. For these reasons, critics argue that continuing the scientific study of homeopathy is not worthwhile. Others point to observational and anecdotal evidence that homeopathy does work and argue that it should not be rejected just because science has not been able to explain it.

Three of its “key points” about homeopathy are:

• The principle of similars (or “like cures like”) is a central homeopathic principle. The principle states that a disease can be cured by a substance that produces similar symptoms in healthy people.
• Most analyses have concluded that there is little evidence to support homeopathy as an effective treatment for any specific condition; although, some studies have reported positive findings.
• There are challenges in studying homeopathy and controversies regarding the field. This is largely because a number of its key concepts are not consistent with the current understanding of science, particularly chemistry and physics.

Yes, NCCAM presents a classic “tell both sides” false equivalence argument. On the one hand, established laws of science tell us homeopathy can’t work. On the other hand, anecdotal evidence tells us it does work and therefore we should study it. Never mind that the two principles upon which homeopathy is based (“like cures like” and the law of infinitesimals) have no real basis in science, particularly the law of infinitesimals, which states that diluting and succussing a remedy to the point where not a single molecule is likely to remain somehow makes it stronger.

This brings us to the meanest, ugliest, nastiest one, the meanest Strategic Objective of them all, Strategic Objective 1 (Advance Research on Mind and Body Interventions, Practices, and Disciplines). Personally, I find it telling that this is Objective 1 on the list, and NCCAM even lists examples of CAM mind-body interventions:

• Acupuncture
• Breath practices
• Meditation
• Guided imagery
• Progressive relaxation
• Tai chi
• Yoga
• Spinal manipulation
• Massage therapy
• Feldenkreis method
• Alexander technique
• Pilates
• Hypnosis
• Trager psychophysical integration
• Reiki
• Healing touch
• Qi gong
• Craniosacral therapy
• Reflexology

Here’s the “bait and switch” again. If NCCAM had restricted itself to modalities that, right or wrong, fall under “mind-body” interventions, such as meditation, guided imagery, breathing practices, hypnosis, and the like, I would have had little problem with proposing to study them as a major strategic initiative of NCCAM. Unfortunately, that’s not what NCCAM did. Notice how NCCAM also throws in there all manner of pure quackery, such as reiki, healing touch, craniosacral therapy, and even reflexology. Seriously, reflexology! You know, the idea that every organ and part of the body “maps” to parts of the foot or hand, an idea that is not supported — and, in fact, is contradicted — by what we know about human anatomy and physiology. Placing these forms of quackery next to forms of interventions such as guided imagery that could well turn out to be science-based and useful implies, either wittingly or unwittingly, that “mind-body” interventions already known to be quackery are somehow worthy of study. Also note how NCCAM includes modalities like Tai Chi, yoga, and Pilates in the mix as well. These are, in essence, forms of relatively gentle exercise, at least for most people. (Yes, I realize that some yoga workouts can become quite intense.) What makes them more “mind-body” than other forms of low impact exercise? Finally, I’m really puzzled about the inclusion of massage therapy on this list. No doubt about it, massages feel good, and they are probably even useful for some musculoskeletal disorders, but what makes massage therapy a “mind-body” interaction? It’s a body-body interaction!

In fact, this very list looks to me like a blurring of the line between things that might be true mind-body interventions (meditation, progressive relaxation, guided imagery, etc.) and so-called “energy medicine” (reiki, healing touch or therapeutic touch, acupuncture, and qi gong). In fact, this is intentional, as there is a notice after the list that states, “As used in this plan, mind and body encompasses interventions from the three domains of mind/body medicine, manipulative and body-based practices, and energy medicine.” The problem here is that certain forms of what is called “mind-body” medicine might actually have value, whereas “energy healing” is pure religion or pseudoscience. Yet they are lumped together.

Truly, Strategic Objective 1 is The Bad and The Ugly.

It’s also evidence that neither Dr. Briggs nor the NCCAM leadership understand the problem that is at the heart of CAM. For example, look at this statement from Dr. Briggs in her introduction:

My experience as a physician who has cared for patients struggling with chronic, painful, and debilitating symptoms greatly informs my perspective on our work. When I began medical school, one of my teachers taught that “the secret of care of the patient is in caring for the patient.”* I took these words to heart. Symptoms matter, and few would dispute the fact that modern medicine does not always succeed in alleviating them. Few would also dispute the need for better approaches for encouraging healthy lifestyle choices. These are places in which I believe CAM-inclusive approaches offer promise, and I look forward to exploring the possibilities in the years ahead.

No one, of course, is arguing that symptoms don’t matter, although I note with some amusement that some CAMsters might not be too happy with Dr. Briggs’ emphasis on symptoms given how they like to claim that “Western medicine” treats only the symptoms and CAM treats the “root cause” of disease. Be that as it may, upon reading this, I can’t help but ask: How can “CAM-inclusive” practices offer promise above and beyond science-based medicine in encouraging healthy lifestyle choices, particularly when so much of CAM bases its recommendations on a prescientific understanding of how the body works? You have to know what the body needs before you can encourage healthy choices, and to a large degree we already do know what most American bodies need: More exercise, more fruits and vegetables in their diets, and less fat and calories. To add to that knowledge, we don’t need CAM. We need science-based medicine. More importantly, I would wonder on what evidence, specifically, Dr. Briggs bases her assessment.

Inquiring minds want to know!

Lest I be left out of the fun, I can’t help but point out that yesterday the Amazing One himself, James Randi, issued a challenge to manufacturers of homeopathic remedies and retail pharmacies that sell such remedies, in particular large national chains like Walgreens and CVS and large national chains that include pharmacies in their stores, such as Walmart and Target. This was done in conjunction with the 10:23 Challenge, which is designed to demonstrate that homeopathy is nonsense. All over the world, skeptics and supporters of science-based medicine gathered to engage in overdoses of homeopathic medicines in order to demonstrate that there is nothing in them.

As much as I like Randi, unfortunately, I doubt that the prospect of winning $1 million will make much difference to huge companies like Boiron (a French company that manufactures popular homeopathic remedies), Walmart, or Walgreens, but I do like the spirit of the protest, in particular how it drives home a very simply message about homeopathy: There’s nothing in it.

NB: This is a partial posting; I was up all night ‘on-call’ and too tired to continue. I’ll post the rest of the essay over the weekend, when this note will disappear.

Review

This is the fourth and final part of a series-within-a-series* inspired by statistician Steve Simon. Professor Simon had challenged the view, held by several bloggers here at SBM, that Evidence-Based Medicine (EBM) has been mostly inadequate to the task of reaching definitive conclusions about highly implausible medical claims. In Part I, I reiterated a fundamental problem with EBM, reflected in its Levels of Evidence scheme, that although it correctly recognizes basic science and other pre-clinical evidence as insufficient bases for introducing novel treatments into practice, it fails to acknowledge that they are necessary bases. I explained the difference between “plausibility” and “knowing the mechanism.”

I showed, with several examples, that in the EBM lexicon the word “evidence” refers almost exclusively to the results of clinical trials: thus, when faced with equivocal or no clinical trials of some highly implausible claim, EBM practitioners typically declare that there is “not enough evidence” to either accept or reject the claim and call for more trials—although in many cases there is abundant evidence, other than clinical trials, that conclusively refutes the claim. I rejected Prof. Simon’s assertion that we at SBM want to “give (EBM) a new label,” making the point that we only want it to live up to its current label by considering all the evidence. I doubted Prof. Simon’s contention that “people within EBM (are) working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”

In Part II I responded to the widely held assertion, also held by Prof. Simon, that there is “societal value in testing (highly implausible) therapies that are in wide use.” I made it clear that I don’t oppose simple tests of basic claims, such as the Emily Rosa experiment, but I noted that EBM reviewers, including those employed by the Cochrane Collaboration, typically ignore such tests. I wrote that I oppose large efficacy trials and public funding of such trials. I argued that the popularity gambit has resulted in human subjects being exposed to dangerous and unethical trials, and I quoted language from ethics treatises specifically contradicting the assertion that popularity justifies such trials. Finally, I showed that the alleged popularity of most “CAM” methods—as irrelevant as it may be to the question of human studies ethics—has been greatly exaggerated.

In Part III I continued to argue against trials of implausible methods. I didn’t share Prof. Simon’s optimism, expressed in another post on his blog, that “research can help limit the fraction of CAM expenditures that are inappropriate.” I argued that whatever evidence there is suggests otherwise. I argued that if existing science is sufficient to reject a method, as is the case for much of “CAM,” then the research has already been done, and the task of EBM is to explain this kind of evidence—not to pretend that the jury is still out. I argued, furthermore, that efficacy trials of highly implausible, ineffective methods inevitably yield equivocal, rather than merely disconfirming results, and that this leads to an endless cycle of further (equivocal) trials. I offered parapsychology as a longstanding example of such an “an immortal field of fruitless inquiry: a pathological science.”

I promised that in this final part of the series I would mention a few more points about Cochrane Reviews of highly implausible methods, and even report some reasons for slight optimism. Finally, I promised to respond briefly to this comment by Prof. Simon:

…how can we invoke scientific plausibility in a world where intelligent people differ strongly on what is plausible and what is not? Finally, is there a legitimate Bayesian way to incorporate information about scientific plausibility into a Cochrane Collaboration systematic overview(?)

Cochrane Reviews 

The ongoing theme is that Cochrane Reviews ignore key ‘external’ evidence, by which I mean all evidence other than what might be found in randomized, controlled trials (RCTs). I’ve previously alluded to the 2002 Cochrane Review of “Chelation Therapy for Atherosclerotic Cardiovascular Disease,” which concluded,

At present, there is insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes of people with atherosclerotic cardiovascular disease.

Elsewhere we have shown that the evidence against such effectiveness is substantial, far exceeding the evidence against Laetrile for cancer or against bilateral ligation of the internal mammary arteries for coronary disease, two long-since discredited methods that no biomedical researcher in his right mind would consider resurrecting for further trials. Oops, make that almost no biomedical researcher.

Quips aside, my reason for bringing up the chelation review again is as follows. The review acknowledges that there have been RCTs, involving about 250 subjects, which

…showed no significant difference in the following outcomes: direct or indirect measurement of disease severity and subjective measures of improvement.

That those findings weren’t sufficient reasons for the Cochrane reviewers to judge chelation ineffective was apparently due first to their having ignored the abundant non-RCT evidence, and second to their having been intrigued by a single, tiny RCT that reported a positive outcome:

One of the studies, which included only 10 participants, was interrupted prematurely, because of an apparent treatment effect. However, relevant data were not available in the report and have been requested from the authors.

I had to chuckle when I read that passage, because I know a lot about that study and its authors. If you look here and scroll down to “Olszewer (1988),” you will know, too. I wonder if the Cochrane Reviewers ever got a straight story from the authors. There hasn’t been an update of that review, so whether they did or not is anyone’s guess.

I’m sorry to say that I haven’t been able to get a copy of that review in its entirety, so my comments apply only to the abstract. I have recently obtained a few other complete reviews, of which two are worth mentioning. A 2008 review of “Touch therapies for pain relief in adults” looked at Healing Touch, Therapeutic Touch, and Reiki. It doesn’t mention the Emily Rosa experiment. Its conclusion is what we’ve come to expect:

Touch therapies may have a modest effect in pain relief. More studies on HT and Reiki in relieving pain are needed. More studies including children are also required to evaluate the effect of touch on children.

In this review we are told why it is that not touching is called “touch”:

Touch Therapies are so-called as it is believed that the practitioners have touched the clients’ energy ?eld.

For readers who are unfamiliar with such practices, which consist of waving one’s hands over a “client” (you really have to see it to believe it), the review continues:

It is believed this effect occurs by exerting energy to restore, energize, and balance the energy ?eld disturbances using hands-on or hands-off techniques (Eden 1993). The underlying concept is that sickness and disease arise from imbalances in the vital energy ?eld. However, the existence of the energy ?eld of the human body has not been proven scienti?cally and thus the effect of such therapies, which are believed to exert an effect on one’s energy ?eld, is controversial and lies in doubt.

Indeed. The following passages are not to be read in detail, other than by the masochistic. Their purpose is to demonstrate the elaborate wheel spinning that EBM treatments of such fanciful methods inevitably involve. The perseveration of statistics, as if they can support the house of cards that is the basis for the technique, will, I hope, ruffle Prof. Simon’s own energy field: 

Types of touch therapies

The effects of different kinds of Touch Therapies were examined (Comparison 3). It appears that all three types of Touch Therapy, HT, TT and Reiki, may decrease pain to a certain extent. Substantial heterogeneity exists among the HT group and TT group. The HT group (163 participants) had an I2 of 76% and a P value= 0.04 (Chi-square) and the TT group (686 participants) had an I2 of 70% and a P value < 0.00001 (Chi-square). The results for both the TT and the HT group indicate that there is signi?cant heterogeneity and that the effects were positive. There were two studies in HT included in the analyses (Cook 2004; Post-White 2003). The pooled results showed that participants exposed to HT had, on average, 0.71 units less pain, however, this was not statistically signi?cant (95% CI: -2.27 to 0.86). The pooled estimates of TT suggested a statistically signi?cant result of 0.81 units (95% CI: -1.19 to -0.43) less pain in the exposed group. Nonsigni?cant heterogeneity was detected in the Reiki group (116 participants) which consisted of three studies (Dressen 1998; Olson 2003; Tsang 2007) with an I2 of 7% and a P value = 0.34 (Chi-square). The pooled estimates of the results for Reiki reported a statistically signi?cant effect. Participants exposed to Reiki had an average of 1.24 (95% CI: -2.06 to -0.42) less pain.

Experience of practitioner

The experience of the practitioner on the effects of touch therapies was also analyzed. This helped to explore whether a less experienced touch practitioner would result in less effect and an experienced touch practitioner would result in an increased effect. Subgroup analyses were thus performed. There are usually four levels of training in HT, TT and Reiki, level I, II, III and a master level or teacher level. Studies were divided into subgroups according to the level of training. Due to a small number of studies having reported the experience of touch practitioners, studies were divided into two groups, level I and II , and level III or above, rather than four groups. Four studies were included in the subgroup of less experienced practitioners (212 participants) (Blank?eld 2001; Cook 2004; Frank 2003; Redner 1991). An I2 of 2% and a P value = 0.38 (Chi-square) was found. In the subgroup of more experienced practitioners (116 participants), three studies were included (Dressen 1998; Olson 2003; Tsang 2007) and an I2 of 7% and a P value = 0.34 (Chi-square) was found. No signi?cant heterogeneity was detected in the two subgroups. Participants in the subgroup of less experienced practitioners had, on average, 0.47 units (95% CI: -0.73 to -0.22) less pain. More experienced practitioners yielded higher contribution, having on average of 1.24 units reduction in pain intensity (95% CI: -2.63 to -0.23) (Comparison 4). Minor non-signi?cant heterogeneity existed in both the experienced and less-experienced group. This might suggest that any heterogeneity calculated in other subgroups was owing to the difference in the experience of the practitioners. However, only a small number of identi?ed studies were included in this subgroup and the apparent small heterogeneity may be owing to the low power of the chi-square test or due to having a small numbers of studies (Higgins 2005), it would not be appropriate to make conclusions about the existence of heterogeneity at this stage with the current results. 

Dose-response analyses

Dose-response analyses were also conducted to investigate if there was any difference in effect due to differences in duration of treatment. The study with the shortest session had the session lasting for ?ve minutes while studies with the longest session lasted for ninety minutes. The number of treatment sessions ranged from a single session to ten sessions. Data regarding the duration and number of treatment sessions were pooled. Data were analyzed in terms of total duration of treatment (duration of a single session multiplied by the number of treatment sessions). Three hundred and ninety six participants exposed to touch for less than an hour had an average of 1.16 units (95% CI: -1.85 to -0.47) less pain; 239 participants exposed to touch for more than one hour but less than two hours had an average of 0.75 units (95% CI: -1.81 to 0.31) less pain, but this was insigni?cant; 255 participants exposed to touch for between two to three hours had an average of 0.47 units (95% CI: -1.09, 0.14) less pain; 116 participants exposed for over three hours to touch therapies had an average of 1.57 units less pain (95% CI: -2.38 to -0.76). No dose-response relationship can be gained as yet from this information (Comparison 7).

Phew! (‘Dose-response analyses’ ?). At the end of the monograph are the first author’s acknowledgements:

I would like to thank Dr Yan-Kit Cheung, who is my Reiki teacher and an expert in complementary and alternative medicine, in giving me valuable advice in conducting this review…Last but not least, I would like to express my gratitude to Miss Wan-Choi Patsy Lee who brought me to Reiki. Without her, I would know nothing about Reiki and would not be enlightened by this precious gift.

I don’t know who should be more embarrassed: Cochrane, for having asked a devout believer to pass judgment on the sacred object of her belief, or me, for having stumbled upon her supplication.

…

*The Prior Probability, Bayesian vs. Frequentist Inference, and EBM Series:

1. Homeopathy and Evidence-Based Medicine: Back to the Future Part V

2. Prior Probability: The Dirty Little Secret of “Evidence-Based Alternative Medicine”

3. Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued

4. Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued Again

5. Yes, Jacqueline: EBM ought to be Synonymous with SBM

6. The 2nd Yale Research Symposium on Complementary and Integrative Medicine. Part II

7. H. Pylori, Plausibility, and Greek Tragedy: the Quirky Case of Dr. John Lykoudis

8. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1

9. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

10. Of SBM and EBM Redux. Part I: Does EBM Undervalue Basic Science and Overvalue RCTs?

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

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

13. Of SBM and EBM Redux. Part IV: More Cochrane and a little Bayes

A number of news outlets (e.g. Bloomberg Business Week, MSN.Com, US News, etc) have recently reported that use of complementary and alternative therapies (CAT) is widespread in hospice care facilities. This is based on a report from the Centers for Disease Control, Complementary and Alternative Therapies in Hospice: The National Home and Hospice Care Survey, Untied States, 2007. According to most news reports, about 42% of hospice care providers offer some kind of CAT.

I was initially inclined to find this a little worrisome. In my own field of veterinary medicine, advocates of alternative therapies are prominent among the organizers of the nascent hospice care movement. And while I am strongly supportive of better and more available veterinary hospice care, the involvement of CAM advocates raises the concern that animals at the end of their life might receive ineffective palliative care, or be denied the benefits of conventional treatments by some CAM providers, who often characterize “allopathic” treatments as “unnatural” and harmful.

In practice, I have seen this happen to patients with terminal diseases. I will never forget a Rottweiler dog I diagnosed with osteosarcoma, a very painful bone cancer, whose owner was convinced that homeopathy was adequate to control his pain and refused to use NSAIDs because of her conviction they were “toxic.” I have also seen my patients denied euthanasia even in the face of great suffering because so-called “animal communicators” claimed the pet was “not ready to leave” and had expressed a desire to remain with their owner as long as possible.

Perhaps these experiences have made me overly sensitive on this subject, but I saw these recent news reports and pictured people at the end of their lives being similarly denied effective palliative care or subjected to pointless therapies like homeopathy and “energy medicine,” or even more worrisome treatments like chiropractic or herbal remedies with real risks. However, a little digging into the details suggests that the headlines are a bit misleading, and these fears are probably unfounded.

As always, when trying to assess how popular alternative medical therapies are, the tricky issue arises of defining “alternative.” In this study, the authors referenced the MedlinePlus definition:

Complementary and alternative medicine (CAM) is the term for medical products and practices that are not part of standard care. Standard care is what medical doctors, doctors of osteopathy and allied health professionals, such as registered nurses and physical therapists, practice. Alternative medicine means treatments that you use instead of standard ones. Complementary medicine means nonstandard treatments that you use along with standard ones. Examples of CAM therapies are acupuncture, chiropractic and herbal medicines.

Personally, I prefer Dr. Novella’s definition:

CAM is a political/ideological entity, not a scientific one. It is an artificial category created for the purpose of promoting a diverse set of dubious, untested, or fraudulent health practices. It is an excellent example of the (successful) use of language as a propaganda tool.

In any case, in order to measure the popularity of something, one has to define it in some way, and in the past assessments of how popular or widespread CAM use is have created misleading impressions due to dodgy definitions. For example, the 2007 National Health Interview Survey (discussed in detail here) reported 30% of Americans to be regular CAM users. A closer look at the details of the survey, however, showed that very little of this self-reported usage involved the application of the usual dubious CAM approaches (e.g. acupuncture, chiropractic, homeopathy, various herbal traditions, etc) to treat specific medical problems. Much of this supposed CAM usage involved the non-medical application of massage, yoga, tai chi, prayer, and so on to provide psychological comfort or facilitate relaxation.

Of course, if one argues that massage, yoga, or even prayer are effective in reducing the objective signs or disease, or even bringing about a cure, then one could argue these are forms of alternative medicine. But such methods are mostly employed to provide comfort and help patients cope with their illness, and as such they can be valuable and legitimate interventions. This does not make them medical therapies, however, alternative or otherwise.

The hospice care survey suffers from the same kind of problematic definition for “complementary and alternative.” According to the report’s technical notes, providers of hospice care were asked first to choose all the services they offered from a list, and “Complementary and Alternative Medicine (CAM)” was one of the choices. Those that indicated they offered CAM were then asked to indicate “Which of these complementary and alternative medicine therapies does this agency use?”

Here is the list:

1. Acupuncture
2. Aromatherapy
3. Art therapy
4. Guided imagery or relaxation
5. Massage
6. Music therapy
7. Pet therapy
8. Supportive group therapy
9. Therapeutic touch (a westernized version of reiki)
10. TENS (Transcutaneous Electrical Nerve Stimulation)
11. Other

Personally, I see little on this list that I would classify as CAM. Acupuncture, certainly, along with therapeutic touch (like reiki) and aromatherapy. But most of the rest, unless specifically marketed as treatments for disease, seem more like benign, pleasurable activities designed to provide comfort, relaxation, and enjoyable stimulation. As a veterinarian, I work with a lot of pet therapy dogs, and I have yet to run across a handler of one who thought they were practicing alternative medicine! (Though I suppose there might be some such folks out there). And TENS is a perfectly conventional intervention, often somewhat disingenuously confused with acupuncture.

The most popular of the “true” CAM therapies offered was therapeutic touch, available at 48.3% of facilities. Aromatherapy was offered by 39.7% of hospice providers. I cannot even find a number for acupuncture in the report. And by far the most popular “alternative” therapies offered were massage (71.7%), group therapy (69%), music therapy (62.2%), and pet therapy (58.6%).

The report also indicates that only 8.6% of patients discharged from a hospice facility that offered CATs actually received one of these therapies. So even under such a loose definition of alternative, there is no evidence that large numbers of hospice patients are receiving alternative medical treatments.

It wouldn’t surprise me if we begin to see advocates of alternative medicine proclaiming that this report shows CAM is widely available, popular, and even indispensible in hospice care. The 2007 National Health Interview Survey results were frequently used this way to create the impression that CAM is becoming mainstream and that resistance to it is the province of extremists and ultimately futile. The details of both surveys, however, indicate that even with aggressive expansion of the definition of CAM to include conventional therapies such as TENS and non-medical interventions like pet therapy, CAM is not truly as popular ubiquitous as its proponents claim.

There is little objectionable from a science-based medicine perspective in most of the therapies hospice care providers are offering, according to this study. I enjoy a good massage, relaxing music, and the company of a friendly dog as much as anyone. And those elements that are truly nonsense, such as therapeutic touch and aromatherapy, are unlikely to do harm or replace appropriate conventional therapies, and they seem in any case not to be especially popular with patients even when they are available. So regardless of what PR use is made of this study, it does not suggest that human hospice care is becoming predominantly the domain of CAM providers, as I might have feared. I only hope the same will be true of veterinary hospice care as that becomes, hopefully, more commonplace.

A couple of weeks ago, both Steve Novella and I criticized Dr. Mehmet Oz (a.k.a. “America’s doctor”) for not only hosting a man I consider to be a major supporter of quackery, but going far beyond that to defend and promote him. After that, I considered Dr. Oz to be a lost cause, with nothing to excuse him for his having embraced a man whose website is a wretched hive of scum and quackery almost as wretched as NaturalNews.com (in my opinion, of course). Unfortunately, apparently Dr. Oz’s defense of Dr. Mercola was only the beginning of the end of whatever minimal credibility Dr. Oz had left as a practitioner of evidence-based medicine.

This week, Dr. Oz put the final nails in the coffin of his credibility as a practitioner of science-based medicine. I realize that some would argue that he did that long ago. Fair enough. However, I always held out some hope that he might stop mixing pseudoscience like reiki with science. Then he embraced Dr. Joseph Mercola. Strike one! Unfortunately, strikes two and three followed over the last week or so.

Dr. Oz embraces the “bait and switch” of alternative medicine.

One message that we’ve been trying to get SBM readers to understand is that much of what falls under the rubric of “alternative” medicine, “complementary and alternative medicine” (CAM), and “integrative medicine” (IM) is in reality a fairly obvious “bait and switch,” as Steve Novella put it so well. The bait consists of various modalities that naturally fall into the bailiwick of science-based medicine (SBM)–or at least should. These modalities include diet, exercise, relaxation. Indeed, it irritates me to no end when various apologists and advocates for CAM claim that science-based physicians don’t recognize the importance of diet and exercise or how they can have a profound effect on health, in particular on diseases like type II diabetes. I ranted about this not long ago when i wrote about the woo of raw “living food” diets, in which “living food” advocates claim that it requires extreme raw vegan diets to “cure” diabetes. Diet and exercise are every bit a part of science-based medicine; yet CAMsters appropriate them as being somehow “alternative,” the better to bring in the real woo along with them. The pitch is, in essence, that diet and exercise clearly work and are “alternative.” Therefore there must be something to other forms of “alternative” medicine. That’s the “switch” in the bait and switch. Nowhere is this switch better demonstrated than in a segment from The Dr. Oz Show last week called Dr. Oz’s Holistic Health Overhaul.

At the beginning of part 1 of this segment, Dr. Oz appears on stage and announces his “holistic health overhaul.” What strikes me is that what Dr. Oz is supposedly “overhauling” is based on people who feel run down, who lack energy, who feel older than they are, symptoms virtually all of us feel at one time or another to one degree or another. (How is one supposed to know if one feels his or her age, anyway?) Right from the start, Dr. Oz promises that he can make you feel younger and better, all within 28 days. To do this, he immediately introduces a yoga instructor named Yogi Cameron Alborzian, who pontificates about spirituality, yoga, and how he became a yogi. As is typical for such practitioners, there are many softly lit and fuzzy shots of Yogi Cameron doing yoga poses in beautiful, natural surroundings (of course!) interspersed with shots of him talking about “mind-body” connections and how he asks his clients what they’re feeling.

In part 2, Patricia from New Jersey is introduced. Patricia is a stay-at-home mother of four boys, who describes herself as feeling “toxic, tired, and stressed-out.” Patricia’s biggest problem, according to her, is that she’s a self-admitted “junk food junkie” who doesn’t exercise. She also complains of sluggishness, feeling “hung over,” and wiped out. In response to her complaints, Yogi Cameron and Dr. Oz show Patricia her health risks, pointing out that her body mass index qualifies her as obese and that her waist size suggests that most of her fat is in her abdomen, which is known to be a risk factor for type II diabetes and a variety of other health problems. Basically, the problem is laid out. It’s (mostly) science-based. Unfortunately, the solution is a mixture of woo and science-based diet and lifestyle changes. That’s the bait. Enter Dr. Oz and Yogi Cameron and his “holistic health overhaul” in part 3 and part 4. Here’s where the switch comes in.

First, let me show why the woo that flows is not a surprise at all by referring you to Yogi Cameron’s own website and a promotional video for a book he’s written:

We learn that Yogi Cameron was a fashion model for several years and even was cast in what looks like the video for Madonna’s song Express Yourself. (He’s the buff, sweaty, half-naked worker seduced by Madonna near the end of the video.) Also on his website, Yogi Cameron opines about Ayruvedic medicine, referring to it as the “science of life”:

Before Western medicine, before homeopathic medicine, and before even traditional Chinese medicine, there was Ayurveda. This is an ancient system of healing created by sages in India over five thousand years ago. While yoga was developed as a science for the practitioner to bring balance and control to the mind, Ayurveda is a sister science developed for the practitioner to bring balance to the body.

Western medicine tends to treat a patient’s symptoms with different pills and medications without any attention to healing the cause of a disease that is feeding the symptom. It is like weeding a garden without taking out the roots; the weeds just grow back. Ayurveda works to define the cause of the patient’s symptoms and to treat the body with various methods for the sake of restoring balance to the system as a whole. These methods include eating in a way appropriate to one’s constitution, taking herbal supplements and remedies, and receiving treatments such as oil massage. Effective use of Ayurveda can help to alleviate digestive problems, allergies, insomnia, asthma, obesity, migraines, and many other bodily complaints.

The ancient sages who developed Ayurveda many centuries ago observed that our bodies are formed by three fundamental energy types or doshas. The first (Pitta) is responsible for metabolizing for the sake of processing oxygen and perpetuating life. The second (Kapha) forms our bodies, which serves as a container so that life can exist as matter. The third (Vata) shifts matter’s position in space through the act of motion.

And this is how Yogi Cameron treats his clients’ problems:

Through other Ayurvedic treatments such as Pancha Karma we also clean the inside of the body. Cleaning the inside of our system is fundamental to our wellbeing and without such cleanings we can never experience complete health and vitality, youth and vigor. When the inside of the body is clean we experience young skin and vibrate energy on the outside.

For those of you who don’t know what Pancha Karma is, it the name for five actions that make up an Ayruvedic method to purify the body. There are three stages of treatment. First, there is the pretreatment, which consists of oil therapy, massage, and something called formentation therapy. This part actually doesn’t sound too bad. Whether it cures anything or not, who knows? However, having your body oiled up and massage can’t be all bad. The formentation therapy is basically heat, either steam from herbs, sitting under the sun, or using warm blankets. Of course, this latter treatment, depending on what it is used for, is a perfectly fine science-based treatment. Be that as it may it’s the next part of the Pancha Karma that is supposed to do the purification. This consists of Nasya (nasal therapy), Vamana (emesis or vomiting), Virechana (purging) and two kinds of Vasti (therapeutic enema), Nirooha Vasti and Sneha Vasti.

Enemas? What is it with enemas? Truly, enemas seem to be the woo that knows no national or ethnic boundaries, the quackery that is truly world-wide. Fortunately, there does appear to be an alteration to this ancient art of purging in America:

Originally, this phase consisted of five practices: nasal cleansing, enemas, laxatives, emesis (vomiting), and blood-letting. Although the five practices are followed in India, the practice of emesis and blood-letting is omitted in North America.

I suppose we should be grateful for small favors in that the bloodletting is left out by our very North American woo-meisters. Dr. Oz then reveals the “switch,” describing week 1 of this plan as “detox.” For his part, Yogi Cameron helpfully chimes in that his methods “burn off toxins.” Dr. Oz then immediately asks Yogi Cameron about tongue examination. Now, there’s one thing you need to know about tongue examination. When an Ayruvedic practitioner or a practitioner of traditional Chinese medicine talks about tongue examination, he is not referring to the sorts of things I learned in medical school about tongue examinations, where we look for turgor, moistness, plaques, and a variety of other physical findings that can be indicative of disease. No, the Ayruvedic art of tongue diagnosis is very much like reflexology in that various organs are claimed to map to various parts of the tongue:

To be fair, some of the tongue diagnoses actually do agree with science-based medicine, for example, a yellow tongue being indicative of jaundice. However, someone with jaundice will also usually have yellow visibile in their sclerae, which are probably more sensitive. In reality, the Ayruvedic tongue diagnoses that match science-based medicine diagnoses are actually a classic case of being right for all the wrong reasons, and most of them are wrong, wrong, wrong, particularly the mapping of various organs to different parts of the tongue. Not that that stops Yogi Cameron from proclaiming that the “head is represented by the tip of the tongue.”

I will admit that there is one mildly amusing part of this entire segment. Yogi Cameron has a rather strong disagreement about the amount of sex people should have. Yogi thinks that people shouldn’t have sex too much; Dr. Oz is apparently a randy little bugger and thinks people should have sex all the time, the thought of which is an image I don’t want in my head. Be that as it may, one thing that strikes me about this argument is that it appears to be vitalistic in nature. Yogi Cameron claims you shouldn’t have too much sex because it’s about “conserving energy,” in essence implying that sex somehow saps your life energy. This is not unlike various pre-scientific beliefs that semen is the equivalent of life energy, which is why men shouldn’t have sex before battle, athletic contests, or anything that’s likely to require a large energy expenditure.

At this point, the “bait and switch” is complete. Dr. Oz had presented the story of a typical middle class mother who works hard, doesn’t eat right, is a bit obese, and as a consequence of her lack of exercise, her work, and her poor diet feels run down all the time. A perfectly fine science-based solution to her problems would involve a change in diet to something healthier, cutting out the junk food, and adding regular exercise (all things that I myself have a lot of problem managing to do, truth be told). Instead, what Dr. Oz and his guest Yogi Cameron present is an improved diet, plus yoga, plus woo that includes tongue diagnosis, “detox,” and “Nasya lite” (given that all Yogi Cameron had Patricia do was to place some Ghee in her nose, rather than shooting water in and out of it). At least he spared her the purging and enemas, but I bet if Patricia had come to Yogi Cameron’s center those would have been part of the mix. But there’s enough there, even the classic favorite of apologists for Ayruveda and traditional Chinese medicine, the appeal to ancient wisdom, the claim that, if people have been doing this for thousands of years, there must be something to it, they must know something we don’t.

Strike two!

To mix baseball and Star Wars metaphors (hmmm, light sabers instead of bats?), Dr. Oz has two strikes against him now, but is his journey to the Dark Side complete? He’s certainly controlled his message, but has he fully released his woo? Unfortunately, Tuesday’s episode this weeks demonstrates that Dr. Oz has truly become the master of woo.

Dr. Oz: Falling for faith healing

To abuse my Star Wars metaphors yet again, if Dr. Oz’s featuring of Yogi Cameron on an episode of his show last week was the equivalent of Anakin Skywalker slaughtering a tribe of Tusken raiders for having tortured and killed his mother Shmi, Tuesday’s episode was Anakin cum Darth Vader hitting the Jedi temple with a bunch of storm troopers and slaughtering all the younglings. Either that, or it was Anakin cutting off Mace Windu’s hand, allowing Emperor Palpatine the opening he needed to kill Windu. Take your pick. In other words, Dr. Oz’s credulous treatment of faith healing definitively marks the point of no return, the point at which Dr. Oz’s journey to the Dark Side is now complete. All he needs is a Darth Vader mask. Or maybe a mask of Samuel Hahnemann. Or something.

The reason Tuesday’s episode definitively marks a point of no return for Dr. Oz when it comes to his support for quackery is because he has apparently decided to follow his TV mentor Oprah Winfrey’s example in realizing that faith healing sells. Of course, Dr. Oz, as popular as he is, is not as well established as Oprah. Whereas Oprah got John of God, complete with his “psychic surgery,” Dr. Oz gets a second tier faith healer. He gets Dr. Issam Nemeh. Of course, Dr. Oz is a surgeon; so maybe he is less easily taken in by parlor tricks in which tiny superficial incisions are made. Or maybe not. Just being a physician does not guarantee not being taken in by faith healing nonsense, as we’ve seen many times. In any case, Dr. Nemeh must be very grateful to Dr. Oz, because when you look at his website, you’ll be greeted with a message:

Welcome Dr. Oz Viewers!

Dr. Nemeh has received an overwhelming response from the viewers of the Dr. Oz show. Medical office appointments with Dr. Nemeh are already filled for the next four months.

To add your name to the cancelation list, send an email with your name, phone number, and reason for treatment to appointments@drnemeh.com.

But how did Dr. Nemeh get so popular suddenly? Behold the power of Dr. Oz and his segment on Tuesday’s show entitled, Is this man a faith healer?

If you recall my discussion of Oprah Winfrey’s utterly credulous treatment of John of God, you might wonder if Dr. Oz did any better than Oprah’s staff and Oprah herself. Going in, I actually expected that Dr. Oz’s segment about Dr. Nemeh would be harder for me to deconstruct. Indeed, I expected it to be much harder to deconstruct. Dr. Oz is, after all, a cardiothoracic surgeon. Also, in the preview for the episode featuring Dr. Nemeh, there was a clip showing Dr. Oz with small pile of charts saying that he had asked to be allowed to examine the medical records of some of Dr. Nemeh’s patients. Given that and given that Dr. Nemeh is a physician himself, I figured that, between the two of them, Drs. Oz and Nemeh would be able to cherry pick cases that would appear truly convincing and thus be very difficult to refute. When that happened, I feared I’d be reduced to saying that single anecdotes are not convincing, which, while true, is a relatively hard sell to lay readers without medical training. Even some physicians remain unsatisfied by such an explanation, and it’s not hard to figure out why. Fortunately for me (and unfortunately for Drs. Nemeh and Oz), I needn’t have worried. You’ll see what I mean in a minute.

The first segment begins, as usual, with Dr. Oz introducing the topic. In this case, Dr. Oz breathlessly proclaims this to be a show “unlike any other we have done before” and describes how he has been “fascinated” by “this doctor in Cleveland.” We’re then shown several people in the audience who claim to have been healed by Dr. Nemeh, who is described as a doctor who doesn’t use drugs or procedures but “heals with his hands.” Dr. Nemeh, we’re told, uses a “high tech form of acupuncture” in his office and the laying on of hands and the use of spirit in churches and meeting halls, all to “heal.” During this voiceover, we’re treated to images of Dr. Nemeh in action, including a paralyzed patient who claims that he’s noticed some movement in his feet since Dr. Nemeh started treating him, a woman who implied that she had her vision restored, and a woman who claims that her multiple sclerosis is gone. Dr. Oz’s chief medical correspondent, Dr. Michael Roizen, tells us that he definitely believes “there’s something here,” and Dr. Nemeh himself proclaims that his goal is to “bridge the gap between science and spirituality.” Certainly, there is a receptive audience among Dr. Oz’s studio audience, as Dr. Oz cites a poll of his audience, which reveals that 86% of them believe in the power of faith to heal.

It’s in this segment when Dr. Oz shows Dr. Nemeh’s stack of medical records. Quite frankly, to me it looks like a pretty darned small stack. Be that as it may, Dr. Oz tells the audience that he’s had his medical staff investigate the cases and that he personally has discussed them with Dr. Roizen. That’s when the interview with Dr. Nemeh begins. Dr. Nemeh, it turns out, is a trained anesthesiologist who in addition to his faith healing activities sees patients at his office in Rocky River (a suburb of Cleveland). As the interview progressed, it became clear that Dr. Nemeh used a lot of different “alternative medicine” modalities in addition to his “electroacupuncture” (which is, of course, not really acupuncture at all, but transcutaneous electrical nerve stimulation, or TENS) and prayer services. Dr. Nemeh, of course, is also represented not just as the Brave Maverick Doctor but as the reviled Brave Maverick Doctor, with even his family disapproving of what he is doing. I can sympathize–with Dr. Nemeh’s family. If one of my siblings were a faith healer, I’d be pretty disapproving and embarrassed too.

In the next part of the segment, Dr. Oz tells the audience to judge for themselves whether Dr. Nemeh is a faith healer on the basis of the patients of Dr. Nemeh’s whose story he will tell. Of course, as an academic surgeon (which Dr. Oz was for a long time before turning to woo and, given that he is still a professor of surgery at Columbia University, technically still is even though he long ago abandoned science in favor of nonsense), Dr. Oz should know that single anecdotes say at best little or nothing and at worst mislead. The plural of “anecdote,” as we say, is not “data.” Yet anecdotes are what he provides–and then only two of them. No science. No statistics. No real detailed case reports. Not even a mention of scientific studies to be presented along with the human interest anecdotes, other than late in the segment, when he mentions the infamous intercessory prayer study that failed to find that prayer works in helping cardiac patients heal after their surgery. All we see are testimonials and utterly unconvincing cherry picked clinical test results.

First up is a woman named Cathy. Cathy is presented as having a mass in her left lung and states that she was “so sick” that she was coughing up blood. A CT scan is presented, which does show a worrisome mass in the lower lobe of the left lung. We are not informed whether Cathy is a smoker, which would have made me even more worried if I were Cathy’s physician. In any case, Cathy describes a two hour visit with Dr. Nemeh, who, she reports, used acupuncture, “infra-ray light” (whatever that is; probably she meant “infrared” light), and prayer to treat her, after which her breathing got much better. Later, a PET scan was ordered, and–miracle of miracles!–the mass was gone. The problem with this anecdote, as regular readers of this blog can probably spot right away, is that there was no tissue diagnosis. In the story, it is implied that the mass was some sort of horrible lung tumor. Yet her doctor violated the cardinal rule of oncology: He never got a tissue diagnosis; it’s unclear if he even tried.

Whatever Cathy’s pulmonologist did or didn’t do, that mass could have had any number of nonmalignant explanations, including tuberculosis, sarcoidosis, focal pneumonia, or fungal infection, to name a few. Whatever it was, if the Cathy’s physician thought it was cancer, he should have gotten a core needle biopsy. Indeed, reading between the lines, I wonder if Cathy’s doctor really thought the mass was cancer. The fact that he ordered a PET scan implied that he thought it might be (although infection can light up on PET as well), but his failure to obtain a biopsy expeditiously implies that he either wasn’t very sure or that he doubted that the mass was cancer.

All in all, it’s a somewhat confusing case, but there is no evidence whatsoever other than the post hoc ergo propter hoc fallacy that, just because Cathy got better after seeing Dr. Nemeh, it must have been Dr. Nemeh’s woo that cured her. To be fair, Dr. Oz points out the possibility that the mass might have been infectious in nature, but in reality to me he didn’t sound as though he really believed that. In fact, he came across more as playing Devil’s advocate than anything else. Unfortunately, Cathy’s doctor (Dr. Kelly) was not particularly skeptical and served up a custom-made quote that Dr. Oz read on the air, completing the picture of faith healing having cured Cathy.

Next up is a woman named Dr. Patricia Kane, who is introduced as having been diagnosed with idiopathic pulmonary fibrosis (IPF) in 1995, when she was told that she probably had less than five years to live. IPF is a disease in which the lungs develop scar tissue for reasons we don’t understand (hence the label of “idiopathic”), gradually decreasing air exchange. In Dr. Kane’s case, we are informed that she underwent a biopsy that confirmed the diagnosis. We are not really informed whether Dr. Kane has gotten better, but, as you might expect, idiopathic pulmonary fibrosis is a disease with a highly variable rate of progression that can range from a very rapid scarring of the lung with concomitant loss of lung function to slow progression that takes many years or even to long periods of time (years) with no detectable progression. Overall, the five year survival is reported to be between 30% and 50%, with this caveat:

Keep in mind that researchers have noted a considerable variation in these life expectancies based on the factors that were mentioned previously.

We are not told whether Dr. Kane had any of the factors associated with a less malignant course for IPF. I’m left to conclude that she is almost certainly a woman who is fortunate enough to be an “outlier” on the survival curve. Like all such patients who are lucky enough to be outliers and who chose “alternative” medicine, Dr. Kane underwent conventional therapy and Dr. Nemeh’s quackery, after which she did better than predicted and–of course!–attributed her much better than expected outcome to the faith healing. Again, Dr. Oz plays the “skeptic” a little bit (but only a very little bit) by challenging Dr. Kane gently with the possibility that the diagnosis was mistaken, which, while most definitely a possibility, was not the only possibility. More likely is the possibility that, as I mentioned before, Dr. Kane is fortunate enough to be an outlier.

Dr. Oz finishes this segment by interviewing Dr. Jeffrey Redinger. Remember him? He’s the same physician who was taken in by John of God, and he lays down the same sort of barrage of credulous nonsense that he did when he commented on John of God for Oprah Winfrey:

What I think at this point is that we are just not physical beings, we are also spiritual beings, physical beings need oxygen and spiritual beings need love. One research questioned I believe is whether there is a connection between love and healing? That is something that modern science is begining to tiptoe into.

Finally, in the next segment (which, unfortunately, does not appear to be on Dr. Oz’s website), we’re treated to what has to be one of the most pathetic faith healings I’ve ever seen. A woman named Mary Beth is brought up on stage. After she states that she has lower back problems that she attributes to arthritis, Dr. Nemeh does his thing. The best Mary Beth could come up with was that she felt “a little” better afterward. I don’t know about those of you who saw this episode, but I was so not impressed by this “healing” at all. Indeed, I was left scratching my head and thinking, “This is the best Dr. Nemeh could come up with?” You know that if Dr. Nemeh could come up with better cases, he would have brought them with him to Dr. Oz’s studio. For instance, where’s the paralyzed patient who said he was getting some motion back? Why wasn’t his case featured? What about the woman who claims her MS is gone? Why wasn’t she featured? It makes me wonder if the evidence for these patients’ claims is even weaker than the evidence for the “healing” of Dr. Kane or Cathy. Not that any of this stops Dr. Nemeh from proclaiming:

You don’t have to be religious, you don’t have to have faith, you can be an Atheist, what matters is we were talking before about one very important principle, the love that we have. Because the heart of God himself is Love. No you don’t have to have any faith to be healed.

Imagine how relieved I am to hear this. Strike three! Or dip Dr. Oz in a lake of lava and slap a black metal respirator suit on him, whichever metaphor you prefer. Dr. Oz is done.

I often wonder how a man as obviously intelligent and well-trained as a surgeon as Dr. Oz can fall for such utter tripe. In his case, I suspect that it’s become more about the fame, the money, and the image that has developed as “America’s doctor.” Whatever the reason, Dr. Oz’s journey to the Dark Side is complete. When Dr. Oz left Oprah, he was but the learner. Now he is the master. The master of woo. Yes, yes, I know the analogy is flawed in that it inappropriately likens Oprah to being one of the good guys (i.e., Obi-Wan Kenobi), but I just love that line.

Unfortunately, it’s not just Dr. Oz, though, who suffers from a profound lack of skepticism and critical thinking when it comes to medicine. It’s all too many physicians. After all, Cathy’s doctor apparently believed that she had been the beneficiary of some sort of miraculous healing solely on the basis of the thinnest of thin evidence. And he is a pulmonologist! This should serve as a reminder to us physicians that, unless we apply skepticism, science, and critical thinking to our practices, we are just as prone as anyone else to confusing correlation with causation, the post hoc ergo propter hoc fallacy, and, above all, an over-reliance on our own personal experience and anecdotes. Indeed, from my perspective, it is the over-reliance on personal experience and anecdotes that is most prone to leading physicians astray, and physicians have to learn how not to confuse “my clinical experience” with science. Instead of educating about this pitfall, Dr. Oz, sadly, has apparently tried to capitalize on it to promote faith healing and other forms of quackery. In my opinion of course.

Also in my opinion, I’ll try to find different metaphors next time.

During my recent stint covering the Neuro ICU I noticed for the first time a checklist posted above each patient bed. The checklist covered the steps to undergo whenever performing an invasive procedure on the patient. I was glad to see that the checklist phenomenon had penetrated my hospital, although the implementation of safety checklists is far from complete.

A recent study published in the BMJ offers support for the efficacy of using checklists to reduce complications and improve patient outcomes. This is a retrospective study looking at mortality and length of stay in Michigan area ICUs, comparing those that had implemented the Michigan Keystone ICU project (including a safety checklist for the placement of central lines) with local ICUs that had not implemented the project. They found a 10% decrease in overall mortality, but the results were not significant for length of stay. Because this was a retrospective study it was not designed to prove cause and effect, but it is highly suggestive of the efficacy of implementing such checklists.

The checklist trend represents a culture change within medicine – and a good one. This change received its greatest boost with the publication of The Checklist Manifesto by Dr. Atul Gawande. He presents a compelling case for the need and efficacy of using checklists in order to minimize error.

He argues that historically medicine has had a culture of quality control through individual excellence and training. This culture still pervades medicine. Each year, for example, I have to go through a long list of safety and other training – the standard response of the powers that be is to institute a new training and certification program for each new regulation or identified safety issue. Training is good, but increasingly there is recognition that it is not adequate.

The problem, Dr. Gawande points out, is that there are areas of our complex civilization that are too complex for mere humans to adequately master. Or you can look at it from the perspective of minimizing error. Training to deal with a complex system can only minimize error to a certain degree. There are inherent human limitations of memory, attention, and consistency that mean that error will be inevitable. In situations where minor mental errors can have catastrophic consequences (like flying planes or performing major surgery) relying on training alone is folly. In such situations the implementation of a simple checklist can significantly reduce error far below what training alone can. It is a lot easier to remember to follow the checklist than to remember each item on the checklist.

There is no question that medicine is a high stakes and complex game. While I am a strong advocate of science-based medicine, we have to recognize its limitations. The opportunities for catastrophic error in medicine are enormous – from prescribing the wrong medication or dose, to forgetting important steps in a complex procedure, to removing the wrong limb. Even minor errors or oversights can have extreme consequences.

In medicine the overarching consideration of any intervention is risk vs benefit. We only use interventions that have potential benefit that is greater than the potential risk (while also understanding that our information is probability-based and imperfect). Often our knowledge is based upon clinical trials which are highly controlled, and therefore do not have the same risk of error that is likely to exist when implemented in the “real” world outside of a clinical trial. In any case minimizing error is key to minimizing risk and optimizing the risk-benefit ratio of medical interventions.

It seems that we have pushed the limits of training. Medicine has become highly technical, specialized, and complex. While extensive training is necessary, it is no longer sufficient to minimize risk. We are now entering the age of the checklist. This is a simple procedure that can significantly improve human performance. The latest study is further evidence in support of this. A 10% reduction in mortality is highly significant.

A related phenomenon, in my opinion, is the movement toward a team approach to patient care, especially in highly complex cases. There is increasing recognition that group intelligence can vastly outperform individual intelligence, and that a group can be smarter than even its smartest member. Complex or high risk cases can benefit from a team of experts, especially with a variety of specialties, collaborating on care. This is nothing new in medicine – tumor boards and multi-disciplinary clinics have been around for decades. But there is movement toward greater reliance on teams than on individual experts.

This is related to the checklist phenomenon in that both trends represent a movement away from over-reliance on the individual and training to minimize error and maximize performance. Both recognize the crushing complexity of modern medicine, and the need to be humble before this complexity.

To broaden the context further, I think these phenomena represent increasing recognition that we need to pay attention in medicine to how our knowledge is implemented, not just to the acquisition of greater knowledge. Pushing the limits of medical knowledge is, of course, incredibly important. But we also have to pay attention to how that knowledge is disseminated, how it is received by the public, how it affects regulation, and how it is implemented by systems and by individuals. We also need better understanding of these processes – we need increased  medical meta-knowledge. We need to learn how to deal with this vast body of scientific information we are rapidly accumulating.

Dr. H. Gilbert Welch has written a new book Over-diagnosed: Making People Sick in the Pursuit of Health, with co-authors Lisa Schwartz and Steven Woloshin.  It identifies a serious problem, debunks medical misconceptions and contains words of wisdom.

We are healthier, but we are increasingly being told we are sick. We are labeled with diagnoses that may not mean anything to our health. People used to go to the doctor when they were sick, and diagnoses were based on symptoms. Today diagnoses are increasingly made on the basis of detected abnormalities in people who have no symptoms and might never have developed them. Overdiagnosis constitutes one of the biggest problems in modern medicine. Welch explains why and calls for a new paradigm to correct the problem.

Where to draw the line? FDR had a BP of 200/100 at the time of his re-election in 1944 and subsequently died of a stroke with a BP of 300/190. At that time, elevated BP was not commonly recognized as a problem requiring treatment. Then studies showed that the higher the BP, the greater the risk, and now everyone diagnosed with HBP is treated. That has undoubtedly saved many lives; but for someone with only a mild elevation, the risk of heart attacks and strokes is smaller and the risk of complications from treatment becomes less acceptable. So where do you draw the line and start treatment?  When the limit of 160 systolic was dropped to 140, the new definition instantly turned 13 million people with “normal” BP into patients with hypertension. Not all of those new patients were better off with treatment. Welch gives the example of an 82 year old man who was treated for mild HBP at a level where the number needed to treat for one person to benefit (NNT) was 20; he passed out from medication side effects and declined further treatment.

Changing the Rules: We’ve changed the diagnostic thresholds for many diseases, so that people who were previously classified as normal are now diagnosed with diabetes, high cholesterol and osteoporosis. Dropping the threshold of fasting blood sugar from 140 to 126 instantly created 1.6 million new diabetics, diabetics who were less likely to develop symptoms and complications and were less likely to benefit from treatment. He tells about one of his patients who was put on blood sugar-lowering medication because of the new rules and passed out while driving and broke his neck because the medication brought his blood sugar too low.

Osteoporosis: here are the numbers for treatment of decreased bone density:

• Winners (treatment saved them from a fracture): 5%
• Treated for naught (had a fracture anyway, despite treatment): 44%
• Losers (treated but never would have had a fracture without treatment): 51%

Seeing too much: New technology allows us to detect abnormalities that would never have caused harm. In people without back pain, over 50% have bulging discs on MRI; 10% of asymptomatic people have gallstones on ultrasound. In patients without symptoms, what’s the value of knowing about these findings? In people with symptoms, such findings may lead to a false diagnosis.

10% of the general population and 7% of people under the age of 50 have findings of stroke on MRI. Whole body CT scanning finds abnormalities in 86% of asymptomatic people. The higher the resolution of your testing method, the more anomalies you will detect; but how many of them are important to know about? How will finding them affect health outcomes?

Prostate cancer: the harder you look, the more you find, and the smaller the cancers you detect, most of which would never have hurt the patient. Welch estimates that for every prostate cancer death avoided by screening, between 30 and 100 patients are harmed by unnecessary treatment.

In breast cancer, for every death prevented by mammography, 2 to 10 women are overdiagnosed and treated unnecessarily, 5 to 15 are diagnosed earlier without any effect on final outcome, 250-500 will have a false alarm and half of these will be biopsied. 999 out of 1000 women do not benefit from mammography. A study in Norway showed that screening resulted in 22% more diagnoses of invasive cancer; apparently some invasive breast cancers in the unscreened group had spontaneously regressed.

Other cancers: In an autopsy study, researchers determined that almost everyone has small thyroid cancers; so many that they could be considered “normal” findings. The US Preventive Services Task Force (USPSTF) recommended against screening for thyroid cancer, since it increases the diagnosis rate without affecting the death rate, and increases morbidity from unnecessary surgery and other treatments.

There is overdiagnosis of melanoma and lung cancer. For colon cancer and cervical cancer there is overdiagnosis of precancerous abnormalities.

The good news: We are learning that many, perhaps most, small cancers either regress or never progress. Spontaneous remissions may be far more common that we ever imagined. In one study, 14% of kidney cancers got smaller without any treatment. So we don’t really need to know if any cancer is present: we need to know if a cancer is present that is likely to progress and harm the patient. And so far we have no way of distinguishing which these are.

Incidentalomas are nodules or other unexpected findings noticed on imaging studies, often in body parts adjacent to the area being studied. About half of virtual colonosopies detect abnormalities outside the colon. More than 99% of the time, these are not cancers and not important to know about; but they lead to anxiety, further studies, surgeries, and complications. Protocols are being developed to follow incidentalomas suggestive of kidney and lung cancers over time rather than immediately pursuing diagnosis.

Routine electronic fetal monitoring has minuscule benefits and results in many more C-sections.

Vascular screenings: The Lifeline company and other commercial ventures offer tests direct to the public, tests that the USPSTF doesn’t recommend and that have not been shown to benefit those screened.

Genetic screening. These tests are not done for symptoms, and do not even detect signs of early disease, but just estimate future risks using inadequate data. Welch reminds us that genetics is not destiny and abnormal genes do not equal disease. The predictive value of these tests is small, and we seldom know what to do about the risk after we identify it. Low risk for a condition doesn’t mean you can’t get it, and everyone is at high risk of something.

A paradigm shift is needed, but it will be difficult to achieve for many reasons:

• It is hard to ignore information.
• Most people believe the more information, the better.
• Accepted wisdom and common sense are hard to overturn.
• Most people are convinced that it is always in people’s interest to detect health problems early, even though the data say otherwise.
• There is a common belief that early detection is cost-effective, even though the data show it actually ends up costing more.
• We find it hard to tolerate uncertainty.
• Commercial interests benefit from screening and overdiagnosis.
• Doctors fear being sued if they omit tests.
• Anecdotes about lives saved are emotionally persuasive.

We are easily impressed by anecdotes from people who believe their lives were saved by early detection; but we don’t hear anecdotes from people who were harmed by a diagnosis of a condition that would never have hurt them, mainly because we have no way of knowing which ones they were. I am a case in point: I had a suspicious mammogram and an excisional biopsy that removed a lobular carcinoma in situ. That is not really a cancer, but more like a risk factor for cancer. Did my surgery remove a part of my breast that would have eventually developed invasive cancer and killed me, or did it uselessly remove a harmless chunk of tissue? Did it save my life or just mutilate me? I will never know.

What’s the solution? Maintaining a healthy skepticism about early diagnosis. Informed consent for screening tests, based on accurate information. Resisting over-simplified hype about the benefits of screening. Putting our efforts into prevention (exercise, smoking cessation, healthy diet, etc.) rather than pursuing early detection. Pursuing health without paying too much attention to it and without developing anxieties about it. Welch argues for not even mentioning incidentalomas on imaging reports, but I think radiologists and lawyers would object to that strategy. He says

Severe abnormalities warrant action because net benefit is likely. But the best strategy for mild ones may be to leave well enough alone, otherwise net harm is likely. In fact, it may be better not to look for them in the first place…An overdiagnosed patient cannot benefit from treatment… [but] can only be harmed.

He doesn’t offer prescriptions. He recognizes that different individuals will assess the risk/benefit ratio differently; based on the same data, some will choose to be screened and some won’t. But they deserve accurate information to base their decisions on, and this book offers a lot of good data and thought-provoking analysis.

I couldn’t help but like this book, since it says many of the same things I have been saying about screening tests , colonoscopy, osteoporosis treatment, PSA tests , not always treating , ultrasound testing , overuse of CT angiograms, genetic testing in general and in specific situations, and the pitfalls of diagnostic tests. It explains complicated concepts like lead-time bias in simple terms and spices the story with patient anecdotes. I found it a bit repetitive but that is probably an asset for driving the message home to a general audience. Both patients and doctors would benefit from reading this book and thinking about the issues it raises.

For a touch of the lighter side, here’s Dr. Paul Offit appearing on The Colbert Report to discuss his new book:

Looks like a win to me. I particularly like how Dr. Offit says that the question of whether vaccines cause autism has been “asked and, fortunately, answered.” Heh. That’s a shot across the bow to J.B. Handley, who, as Steve Novella has pointed out (as have I) is utterly clueless about science and how to interpret the medical literature, as he has demonstrated time and time again with his “14 Studies” nonsense. Of course, anyone who calls Handley out on his ignorance is subject to personal attack. Reporters have felt it. Steve Novella has felt his wrath. So have I. Meanwhile Handley gloats over the decline in confidence in vaccines that his organization Generation Rescue has helped foster.

Fortunately, Colbert appears to get it. I like how Colbert does a faux rejection of one of Dr. Offit’s points by pointing out that he is “ruled by fear.” I particularly like how he mentions Andrew Wakefield, but not by name (rather like Lord Voldemort), and how he asks Dr. Offit a bunch of questions based on talking points the anti-vaccine movement likes to use to frighten parents. No wonder the anti-vaccine collective at Age of Autism is going crazy, having posted (and reposted) numerous attacks old and new on Paul Offit ever since it was announced that he was going to be on The Colbert Report last night, all topped off with one by J.B. Handley himself in which he calls Dr. Offit a “blowhard liar.”

Stay classy, J.B. Stay classy.