Dad always thought laughter was the best medicine, which I guess is why several of us died of tuberculosis. ~Jack Handey, “Deep Thoughts” We have a saying in medicine that you can’t kill an jerk.  Not that we try to kill anyone, but that particularly unpleasant individuals, rife with psychopathology, survive whatever illness comes their way.  The corollary is that particularly nice people are prone to having horrible diseases with unpleasant outcomes.  We all know intellectually that it is not true, but there is an ongoing feeling in health care providers that somehow patient personality determines the consequences of their diseases.  As an aside, I am often  left with the explanation for patients that the reason for their odd infection comes down to bad luck.  Everyone responds something to the effect that “Typical. I get all the bad luck.”  I have never had a patient say, “That’s odd, I am usually so lucky.” On the question of nurture vrs nature, raising two children has convinced me of the relative lack of importance of nurture in the personalities of my children.  While abusive/pathologic environments will certainly lead to pathologic personalities,  for the average child raised in middle class America I can’t help but think that, to quote Popeye, “I yam what I yam and that’s all what I yam.”  I expect to be schooled in the comments on that subject.  Yes, I read the Blank Slate and have some understanding of the literature.  And yet.  My kids, my friends kids.  I watch them grow in what is (and isn’t) a similar environment and end up with diverse personalities that often appear present before they can speak.  I am well aware of the multiple logical fallacies that lead to that conclusion.  Parenthood and medical practice (where people seem to do the same damn stupid things over and over) have lead me to the conclusion that free will is mostly a myth and we are mostly programmed to behave the way we do. Discuss.  It is not the main point of the post, but my bias. “Nothing shows a man’s character more than what he laughs at.” Johann Wolfgang von Goethe. One personality trait is a sense of humor.  No one admits to being a bad driver and I have never met someone who admits that they lack a sense of humor.   Humor is, of course, personal.  I find Seinfeld irritating, not funny.  The rest of my family does not share that assessment.  During Pulp Fiction, my wife and I realized that we were the only ones in the theater laughing during the scene when they are doing a cardiac injection to revive Uma Thurman after her drug overdose.  I once read that in choosing a mate, the best indication of long term compatibility was whether or not you both share a understanding of the essential hilarity of Bob and Ray.  I would agree and wonder if eHarmony uses that in their compatibility tests.  What would those examples say about whether or not I have a sense of humor and if so what kind? What effects, if any, does a sense of humor have on health?  Emotional states alter physiology, some for the better, some for the worse. The popular opinion is that laughter is of benefit; there is a reason Readers Digest didn’t call their column  ’Schadenfreude, the Best Medicine’.   Are funny people or people who laugh easily more prone to better health because they have a sense of humor or laugh?  Or it is an association without causation, that whatever personality that laughs easily also leads to improved health outcomes? Whoever said “laughter is the best medicine” never had gonorrhea.  ~Kat Likkel and John Hoberg. Perhaps the topic of laughing your way to health gained the most traction with the publication in 1979 of Norman Cousins book Anatomy of an illness as perceived by the patient: reflections on healing.  The book, which I read thirty years ago, details how, after being diagnosed with a ankylosing spondylitis, Cousins left the hospital for a nice hotel, where he treated himself with good food, high dose vitamin C, and laughter from watching Marx brothers movies. Did he have  ankylosing spondylitis?  The interwebs suggest he did not, and I can’t find the diagnostic criteria that were used to make the diagnosis and  ankylosing spondylitis is a disease that can spontaneously resolve.  So causality is particularly problematic in Cousin’s case, since the diagnosis is uncertain. Even though I am an avowed Marxist, I would be suspicious of the power of Duck Soup to alter the course of disease for the better, as is the popular misconception of Mr. Cousin’s book.  I would not doubt that a good laugh will help decrease the perception of the severity of pain, as Mr Cousin’s suggested. Is laugher medically beneficial?  Is a sense of humor medically beneficial?  Not the same question. Perhaps I know best why it is man alone who laughs; he alone suffers so deeply that he had to invent laughter.  ~Friedrich Nietzsche Laughter, of note, is not limited to humans Vocalizations referred to as “laughter” also occur in great apes engaged in tickling and social play. Vettin and Todt16 have shown key similarities in the respective acoustics of play- and tickling-induced vocalizations in juvenile chimpanzees (Pan troglodytes) and tickling-induced laughter in adult humans. They estimated that laughter has been present in the human lineage for 10 to 16 million years.  I would estimate that is also how long humans have been farting.  Still nothing funnier to my children. And some suggest that rats have a laughter equivalent with play and tickling.  Tickling rats.  I laugh at the mental image.  Is that laughter, if not the best medicine, a useful therapeutic intervention? Laughter decreases blood glucose 2 hours after eating in type 2 diabetics.  I prefer eating in restaurants.   Laughter leads to vascular relaxation and decrease in serum cortisol,  decreases renin in type two diabetics, and increases Natural killer cell function. Some studies seemed needlessly perverse Twenty-four male patients with atopic eczema viewed a humorous film (Modern Times, featuring Charlie Chaplin). Just before and immediately after viewing, semen was collected, and seminal B cells and sperms were purified. Seminal B cells were cultured with sperms and IgE production was measured, while expression of galectin-3 on sperms was assessed. RESULTS: After viewing the humorous film, IgE production by B cells cultured with sperms was significantly decreased. Moreover, expression of galectin-3 on sperms was reduced. I can’t access the complete reference to discover the rationale behind the study, except, perhaps, to induce giggling. I am thankful for laughter, except when milk comes out of my nose.  ~Woody Allen Are there clinical correlates to these  physiologic effects? Sort of. Laughter may help the depressed (why wouldn’t it?) and cheer up the schizophrenic (what a surprise).  Pello the clown, with his noted a humor intervention, decreased air trapping in COPD patients and laughing decreases the bronchial responsiveness in asthmatics. That is about it for the medical application of laughter.  A smattering of small studies, rarely repeated, with small numbers of patients published in the more obscure journals.  I would not doubt the laughter is of benefit, but the benefit is small. What is more interesting are the pathologic laugher syndromes: some (Angelmans) are genetic and some due to central nervous system strokes or tumors.  I suppose the silver lining for these unfortunates is the beneficial physiologic effects  of the continued laugher. Somehow the potential health benefits  does not seem worth it. These studies involved making people laugh, usually with movies.  Humor is not without its dangers in the medical field, given the idiosyncratic nature of what people find funny. When used sensitively, respecting the gravity of the situation, humor can build the connection among the caregiver, patient, and family. However, insensitive joking is offensive and distressing, and experience suggests a variable acceptance of humor by patients with life-threatening illnesses, making humor a high-risk strategy. So if laugher is the best medicine, it is best used sparingly and with the knowledge that as an intervention to cause lasting physiologic change, laughter has has little support. “A sense of humor always withers in the presence of the messianic delusion, like justice and truth in front of patriotic passion” ~ Henry Louis Mencken. Maybe it is not laughing that is important, but the more vague idea of having a sense of humor, that is important to health. Four studies have tested the association between sense of humour and longevity. One reported that comedians and serious entertainers on average die earlier than authors. Two publications from the Terman Life-Cycle Study reported a negative association. Cheerfulness (sense of humour and optimism) was the index variable in the first study. In the second study, optimism was taken out, but the negative association prevailed. The fourth study reported a 31% reduction of mortality risk among patients with end-stage renal failure provided that they scored above the median on a test of sense of humour. Dr Sven Svebak evaluated a sense on humor based on three questions and looked at survival in a large cohort of Norwegians who were being followed for long term health, much like the Framingham study.  The questions he used were Do you easily recognize a mark of humorous intent?” (Cognitive; N = 53,546; standardized item alpha = .91, item correlating .87 with sub-scale sum); “Persons who are out to be funny are really irresponsible types not to be relied upon” (Social; N = 52,198; standardized item alpha = .91, item correlating .88 with sub-scale sum); and “Do you consider yourself to be a mirthful person?” (Affective; N = 53,132; standardized item alpha = .74, item correlating .78 with sub-scale sum). The participants responded to four-step scales (labeled for the three items respectively: very sluggishly – very easily; yes indeed – not at all; not at all – yes indeed). Not an impressive criteria for determining a sense of humor and this is noted in the discussion of the article.  ”It may be regarded a hazardous task to assess psychological characteristics by use of three items.”  However, they felt that similar studies in depression validated the approach. These questions  measure  friendly humor. The test is not sensitive to humor that creates conflicts, is insulting or that is a variation of bullying.  So much for laughing at my posts as evidence of a sense of humor. What they found was those with a friendly sense of humor as judged by these three questions were more likely to survive compared to those that scored low on a sense of humor. The authors are quite thoughtful on the applicability of this study There is a semantic point in the affective item where “mirthful” was used in the present study instead of “cheerful.” In Norwegian as well as English language “cheerful” and “mirthful” (Norwegian equivalent “munter”) can refer to a subjective state of mirthfulness as well as to the overt expression of mirth through smiling and laughing. The present assessment was by subjective report that may have addressed both the subjective and the expressive tendencies of an individual for being mirthful. A subjective state of mirthfulness appears to be closely related to cognitive processes, whereas expressive display is often triggered by social context. Support to this view came from the relatively high coefficient of correlation between scores on the cognitive and the affective items (r = .40: Table 4). In prospective studies of positive wellbeing, subjective state appears to have been at focus and has proven to reduce mortality. This association has been a fairly consistent pattern of outcome in prospective studies of healthy populations as well as of diseased populations [26]. In light of these findings for positive wellbeing, as well as of the complex conceptual content of sense of humor, it is possible that sense of humor is best conceived of as one aspect of a broader psychological characteristic that facilitates a general state of wellbeing, rather than a specific emotional state of mirthfulness.  Emphasis mine I think this is interesting and have little argument with the study except in on interview, Dr. Svebak stated “He adds that a sense of humor can be learned and improved through practice.” There I have my doubts.  I cannot find evidence that people can learn to appreciate humor or learn to become humorous.  In my experience (do I dare use those words?) the capacity for understanding and producing humor appears fixed. That has therapeutic implications.  If a sense of humor can be developed, the humorless grouch can be taught to laugh and experience the benefits of humor.  More likely, your sense of humor, like your ability to run the mile or learn French, is mostly static in the adult. Being thoughtful, the authors conclude There is a risk of taking the present humor findings too far as a booster of longevity. The role of confounding variables is hard to precisely assess in multi- variate approaches, partly because of the often opportunistic availability of such variables in population research projects as well as all the potentially relevant variables that may have been included, but were left out for many reasons, such as lack of funding and time consuming data sampling procedures. The present study included quite a range of variables that are well established in the scientific community as influencing health hazard. A cautious approach is to directly compare hazard ratios across the range of variables, including traditional risk variables as well as an index of sense of humor. An interesting study with a nuanced discussion. However, a molehill of interesting information does not prevent some doctors for making a mountain of advice.  The You Docs are hard at work again. Analyzing humor is like dissecting a frog. Few people are interested and the frog dies of it. ~ E. B. White In this new Norwegian study, researchers who tracked the health of 70,000 people found that those who scored highest on sense-of-humor tests were twice as likely as dour sorts to still be alive — and laughing — seven years later. You didn’t have to be the type that laughs at the drop of a hat, either. All sorts of humor styles boosted survival. “A twinkle in your eye can be more than enough,” notes lead researcher Sven Svebak of the Norwegian University of Science and Technology. Oh, for that twinkle in the eye, the key to health.  The study, based on three questions, makes no conclusions based on humor styles. What’s behind humor’s life-prolonging powers? For one thing, laughter is a mini-workout. Ten to 15 minutes of mirth burns up to 40 calories and exercises your abdominal muscles. About the same as is burned during 15 minutes of sex.  For a real work out combine the two as has been what my partners do… I may be oversharing here.  Everything can be considered a “mini workout” and is a lame reason to suggest laughing.  Given how much I laugh, where is my 6-pack. The You Docs evidently reviewed the same marginal literature and discovered that A good belly laugh also boosts your immunity, motivating natural killer cells in your bloodstream to work harder. In one study, watching a funny movie relaxed the endothelium — the fragile inner lining of your arteries — enough to boost blood flow by 15 percent. Laughter eases stress and reduces levels of the high-anxiety hormone, cortisol. In people with diabetes, it can even help keep blood sugar lower and steadier. Then there’s resilience. Laughter helps you build and maintain friendships, eases fears and gives you a hand at coping with whatever life throws your way. It may also thwart the flu and protect against cancer. The last two I cannot find the reference for, but protecting against cancer? My goodness.  They make it sound so all encompassing, rather than the limited results I found.  And they never mentioned the sperms. “What soap is to the body, laughter is to the soul”  ~ Yiddish Proverb The You Docs end with suggesting by suggesting you get a daily dose of humor for its health benefits, and they give multiple ways to find a good laugh.  It is interesting how the authors of the study suggest that humor is part of an over arching personality, whilst the You Docs go for simplistic and overwrought advice: Get your daily quota of yucks. Check in with yourself at lunch time: Have you chuckled today, or maybe even gotten that tingly “this is hysterically funny” feeling? If not, do something about it. E-mail or call your funniest friend. Plan to watch your favorite sitcom or wise-cracking commentator tonight. The Web is loaded with joke sites, bookstores are brimming with humor books, video stores offer thousands of comedies and stand-up comic shows. Make it a point to learn at least one new joke a week, then tell it to your friends. See the humor in your life. You took the stray cat you rescued to be spayed and discovered that she’s a he? Trade funny stories: Make it a habit to ask friends and family about the most ridiculous thing that’s happened to them today, this week, this month. Discover what really tickles your funny bone. Your sense of humor is as unique as your fingerprints, so stop laughing at what you think you ought to find amusing (Who does that? Besides Ed McMahon?  If he had heeded that advice, he would have lived longer than 86 years) and do a little research into what really hits your sweet spot. Try watching, reading or listening to types of humor that are new for you. You may discover you prefer political humor or cowboy jokes, martini-dry wit or a really bad knock-knock (Or the You Docs). It is always curious how a few studies of limited scope get inflated.  Sad advice really. Research what makes you laugh.  That is one of many annoyances of the alt med life style recommendation: the medicalization of the joys of life.  Drink red wine because it is good for you, not because it is joy in a bottle. Eat chocolate because it is a natural medicine, not because it is delicious.  Laugh  because it improves your health, but not because it soothes your soul.  I prefer to laugh and eat and drink and work for the pleasure it provides, not for the health benefits. Live a good life and you will reap the rewards.  I see a lot of people at the end of their lives. When people look back, the regrets they express  are not for the time they wished they had spent laughing to manage their sugars, but the time they did not spend laughing with their loved ones. Fortunately I read the You Docs.  They provide me yucks, in both senses if the word.  As a result I expect I am never going to get ill, never get cancer and will live forever. So tell me.  Are you healthier after reading this blog?

On this site there have been several thoughtful posts (e.g. by Dr. Atwood and by Dr. Novella), and subsequently much heated commentary, on the distinction between Evidence-Based Medicine (EBM) and Science-Based Medicine (SBM). I agree wholeheartedly with the position that the two are not mutually exclusive, and that SBM is essentially EBM as it should be practiced, with a comprehensive consideration of all relevant evidence, including the subject of plausibility. As a practicing veterinarian, and an officer of the Evidence-Based Veterinary Medicine Association (EBVMA), I am keenly interested in bringing to my profession a greater reliance on high quality research evidence and sound scientific judgment, and reducing the reliance on individual practitioner intuition and experience in making clinical decisions. However, those of us in veterinary medicine face some special challenges which make the subtle but important distinction between EBM and SBM especially salient.  Where’s the Evidence? The first of these challenges is the paucity of high quality clinical research evidence. As an example, in his 2007 book Snake Oil Science, R. Barker Bausell examined the research evidence concerning the use of glucosamine as a treatment for osteoarthritis in humans. He was able to analyze the strengths and weaknesses of a Cochrane Review which included 20 studies with 2570 patients (the most recent revision of this review includes 25 studies with 4963 patients), a NEJM study with 1583 patients, and an Annals of Internal Medicine study with 222 patients treated for two years. His conclusion was that the intervention was not more effective than placebo. I recently did a targeted search of the PubMed literature database for a brief evidence-based medicine feature on the subject of glucosamine and chondroitin as treatment for osteoarthritis in dogs, currently in press at the Journal of the American Veterinary Medical Association. A search of the terms “glucosamine,” “arthritis,” and “dog” yielded eight references, of which three were relevant (a more comprehensive search strategy yielded sixteen references, but only the same three were relevant to the clinical question). The three useful references included two clinical trials involving a total of 113 dogs and each lasting about 2 months, and a systematic review of treatments for canine osteoarthritis which evaluated one of these two clinical studies. Predictably, the larger, better designed trial with objective measurement criteria showed no benefit of glucosamine, while the smaller, less well-controlled trial with only subjective criteria and a 23% dropout rate in the glucosamine group showed some benefit at some assessment points. Where’s the Money? Glucosamine is an extremely popular, and profitable, supplement routinely recommended by veterinarians and administered by owners to their geriatric dogs. Yet the clinical trial evidence concerning its effects is nearly non-existent. The depth of the evidence is no better for many, many routine clinical interventions in veterinary medicine. The primary reason for this is simple: money.  Obviously, the health of companion animals is not as high a societal priority as human health. Many countries have little or no formal companion animal medicine at all, of course, much less high quality, evidence-based pet medicine. And even in the developed world, the absolute size of the veterinary medical profession and associated industries is dwarfed by that of the human medical industry.  In the United States, surveys show that most dog and cat owners have come to consider their pets to be members of their family, and their willingness to pay for veterinary care has increased along with this shift in attitude. The same appears to be the case in Europe and other developed nations. This has allowed the quality and technological sophistication of veterinary care to increase.  Pharmaceutical companies have followed this trend, increasing their financial investment in their own internal research activities, as well as funding the lion’s share of companion animal health research generally (with all the ethical and practical problems that creates). Pfizer, the largest fish in the “Big Pharma” pond, claims to spend $300 million annually on veterinary research globally, for both companion and agricultural animals. However, the company is expected to spend $9-$9.6 billion this year on its human research and development. The same pattern is true of government research spending. Veterinary medicine will always be the poor stepchild of medicine, and we cannot expect to have anything close to the quantity or quality of research evidence available to MDs trying to practice evidence-based medicine.  A Pack of Lone Wolves? Another barrier to effective utilization of research evidence in veterinary medicine may be demographic and cultural. In the United States, the average veterinary practice has fewer than three veterinarians, and between one-third and one-half of veterinarians are self-employed practice owners. And most companion animal veterinarians are general practitioners, only about 10-15% of practicing vets being board-certified, with the extended academic training and, hopefully, greater awareness of and respect for research evidence that might be expected to come from this training. As a profession, we veterinarians tend to be entrepreneurial, self-reliant, and independent. This contributes to a reluctance to let anyone tell us what to do, which may be how veterinarians perceive the position of evidence-based medicine. There is no solid data on the subject (though I am involved in a survey study which will hopefully provide some soon), but in discussions with colleagues I have sensed a great deal of anxiety about the notion of “cookbook medicine” which disdains the hard-won wisdom and experience of the individual clinician. Veterinarians are reluctant to accept the idea that there may be broadly applicable standards of care they ought to adhere to, even if their personal judgment conflicts with the evidence for these. Undoubtedly, our colleagues in human medicine share a similar temperament and similar sorts of anxieties about “cookbook medicine”. However, these may be tempered to some extent by more widespread advanced training, more structured and supervised practice environments, and greater assessment and monitoring of outcomes, which may partially explain the greater acceptance of EBM in the human medical profession. And though the case of Dr. Rolando Arafiles, Jr. illustrates the weaknesses in the systems for monitoring physician behavior, I think it is clear that the influence of government regulation, and the threat of litigation, give the concept of adhering to a recognized medical standard of care far greater teeth in the field of human medicine than it has in veterinary medicine. SBM, EBM, or OBM? So how does this relate to the difference between SBM and EBM? Well, traditionally the scarcity of clinical trial evidence has led veterinarians to practice primarily opinion-based medicine. Personal experience and intuition and the opinions of individual experts or mentors are the predominant foundations for clinical decision-making. There is little or no outcome assessment, so veterinarians must rely on their own clinical experience to judge whether their practices are effective.  The negative consequences of these strategies are many. There is dramatic inconsistency in the diagnosis and treatment of even common diseases. I routinely have to explain to my clients that if they ask ten vets a question, they are likely to get seven or eight different answers. You can imagine how frustrating this is for them, and how little confidence it inspires in our expertise. OBM Leads Kids to the Hard Stuff, FBM! As most readers of this blog likely already know, there are many reasons why individual judgment is an unreliable guide to the true efficacy of a medical intervention, and why we should be reticent to entirely trust our own intuitions and experience. But opinion-based medicine is also a “gateway drug” to faith-based medicine, otherwise known as complementary or alternative medicine. If you are accustomed to judging the safety and efficacy of interventions on the basis of the cases you have seen personally or the opinions of “experts,” you are more likely to be persuaded by the individual experiences of clinicians promoting and alternative practice, and more likely to think that giving it a try yourself is the most reliable way to know if it really works or not.  The Internet abounds with holistic veterinarians who claim they started their careers as scientific, skeptical doctors but that their frustration with the limitations of mainstream medicine and the problems they could not solve led them to experiment with, and ultimately become promoters of, faith-based miracle therapies of every kind that share no theoretical or practical features in common other than being validated primarily by testimonial and not consistent with scientific knowledge or evidence.  Tooth Fairy Science exists in veterinary medicine, but it is less of a problem than the simple lack of research evidence and the consequent reliance on even less trustworthy forms of evidence. So veterinary medicine needs a science-based approach even more desperately than human medicine because we have so little clinical trial evidence to rely on, and so few resources to generate more and better evidence. The tragedy of money and talent wasted on studying therapies that have vitalist theoretical foundations inconsistent with established scientific knowledge is even more poignant in the relatively impoverished world of companion animal medical research. Plausibility must play an important role in deciding how we allocate the scarce resources we have in order to maximize the useful information we can generate, and the subsequent clinical benefits for our patients. Towards a One Health Approach Veterinarians must also take advantage of the evidence that our colleagues in human medicine have generated for us. There are serious dangers in extrapolating research evidence across species, of course, but we cannot afford to entirely ignore the wealth of human medical research that is relevant to our patients. Examined cautiously and judiciously, this data can help us target our own research efforts more efficiently. Just as animal models have an important role, despite their limitations, in human health research, so human clinical research can inform veterinary medicine. As clinicians, we can make more science-based decisions, even when relevant veterinary research is lacking, if we are aware of the research in humans that already exists on the conditions and interventions we are considering.  If glucosamine is shown to be no more than a placebo after years of research in thousands of people, how much money and effort should we invest in studying its effects in dogs? And how strongly should we promote it to our clients, the vast majority of whom must pay for their pet’s care out of pocket, without insurance coverage, and who commonly must eschew needed care or even euthanize their companions for want of money to pay medical costs? A Worthy Goal There has been a steady growth in the quality and sophistication of care available to companion animals in the last several decades, and I am hopeful that this will continue. But I believe the interests of our patients and clients will be best served if the care we provide is as soundly science-based as possible. And while I think evidence-based medicine can become the standard in the veterinary field, with beneficial effects on the quality of the care we provide, we need the additional features of the science-based medicine approach even more than our MD colleagues: a respect for the importance of plausibility in allocating research resources and an understanding of the need to integrate all relevant evidence when making clinical decisions about interventions in the face of a scarcity of high quality clinical trial research.  Despite all the histrionic accusations of some alternative medicine advocates about mainstream veterinarians being tools of the pharmaceutical industry or reluctant to accept unconventional approaches only out of closed-minded prejudice or a fear for our income, the reality is that we care deeply for our patients and want to provide them with the best care we can. I truly believe, and I hope the profession as a whole will come to accept, that science-based medicine is far more likely to help us do so than the opinion-based medicine we have traditionally relied on.

A new study published in The American Journal of Clinical Nutrition is reporting an association with eating meat and weight gain. This is a fairly robust epidemiological study, but at the same time is a good example of how such information is poorly reported in the media, leading to public confusion. The data is taken from the European Prospective Investigation into Cancer and Nutrition–Physical Activity, Nutrition, Alcohol, Cessation of Smoking, Eating Out of Home and Obesity (EPIC-PANACEA) project. This is a long term epidemiological study involving hundreds of thousands of individuals, and is therefore a great source of data. We are likely to see many publications from from it. This one looked at the association of meat eating – poultry, red meat, and processed meat – with total weight.  From the methods: A total of 103,455 men and 270,348 women aged 25–70 y were recruited between 1992 and 2000 in 10 European countries. Diet was assessed at baseline with the use of country-specific validated questionnaires. A dietary calibration study was conducted in a representative subsample of the cohort. Weight and height were measured at baseline and self-reported at follow-up in most centers. Associations between energy from meat (kcal/d) and annual weight change (g/y) were assessed with the use of linear mixed models, controlled for age, sex, total energy intake, physical activity, dietary patterns, and other potential confounders. They found that an increase in 240 grams per day of meat in the diet was associated with a 2kg increased weight after 5 years (that’s about 5 pounds, or 1 pound per year). The BBC reported this study as finding: A European study of almost 400,000 adults found that eating meat was linked with weight gain, even in people taking in the same number of calories. and Although it is not clear why meat would lead to weight gain in people eating the same number of calories, one theory is that energy-dense foods like meat alter how the body regulates appetite control. I find that conclusion problematic in several ways. Let’s look at the study design. One primary weakness is that weight (after the initial weighing) was self reported in most centers. This is a odd study design, and I can only assume this was a matter of practicality. Regardless of reason, self-reported weight is a major weakness. However it pales in comparison to the fact that total caloric intake was estimated, not rigorously controlled. To put this into perspective, 1 pound per year is 3500 Calories, or 67 Calories per week on average. There is no way someone can estimate their caloric intake within 67 Calories per week – that’s less than 10 calories per day. The notion that appetite control was responsible for the findings also contradicts the assertion that total caloric intake was the same – appetite can only affect weight by increasing caloric intake. The correlation itself is in question because of the self-reported weight. But if we take the correlation as a given, the easiest explanation is that people who consume more meat also tend to consume slightly more calories, which add up over the years. Another possibility is that increased consumption of meat might also correlate with slightly less physical activity. Assigning a cause and effect is difficult because slight changes that are difficult to measure accurately can result in modest weight differences over years. Also, the authors concluded: Our results suggest that a decrease in meat consumption may improve weight management. “Suggest” and “may” are appropriate in that statement, but were largely lost in the secondary reporting. Again – even if we take the correlation as a given, this kind of data cannot be used to assign cause and effect. It cannot be concluded, in other words, that reducing meat will help reduce weight. Perhaps people who are more hungry for other reasons consume more meat, and if they cut down on their meat consumption they will just replace those calories with other sources. Other studies show that it is the consumption of calorie dense foods that correlate with weight gain, which can either be high fat and protein or high sugar. Calorie density seems to be the common element – which makes sense as increased calorie density can easily lead to overeating total calories, and it only takes a small amount to result in the kind of weight differences typically reported by these studies. What we don’t have is evidence that decreasing meat intake as an intervention aids in weight control. Conclusion This study is interesting, but ultimately does not add much to our knowledge of diet and weight. It is not evidence that diets with the same calories but of different types lead to different weight outcomes, as has been reported. It does add to the literature that suggests that calorie dense foods correlate with weight gain, and this is likely due to increased overall caloric intake. There may be other factors as well, such as total activity, effects on hunger, and even calorie efficiency – how efficiently our bodies extract calories from certain foods. But I am also struck in such studies, even intervention studies, by how small the difference are among the various diet types. This leads me to the conclusion that varying the ratios of macronutients (protein, carbohydrates, and fats) is of little ultimate utility in weight control. These studies get much attention in the media, but it is often much ado about nothing. Meanwhile, the more significant factors are basic things like portion control and regular exercise. For health reasons other than weight control eating more vegetables is also a good idea, and this is also a good way to reduce total caloric intake.

Glucosamine is widely used for osteoarthritis pain. It is not as impossible as homeopathy, but its rationale is improbable. As I explained in a previous post, Wallace Sampson, one of the other authors of this blog, has pointed out that the amount of glucosamine in the typical supplement dose is on the order of 1/1000th to 1/10,000th of the available glucosamine in the body, most of which is produced by the body itself. He says, “Glucosamine is not an essential nutrient like a vitamin or an essential amino acid, for which small amounts make a large difference. How much difference could that small additional amount make? If glucosamine or chondroitin worked, this would be a medical first and worthy of a Nobel. It probably cannot work.” Nevertheless, glucosamine (alone or with chondroitin) is widely used, and there are some supporting studies. But they are trumped by a number of well-designed studies that show it works no better than placebo, as well as a study showing that patients who had allegedly responded to glucosamine couldn’t tell the difference when their pills were replaced with placebos. The GAIT trial was a large, well-designed, multicenter study published in The New England Journal of Medicine that showed no effect in knee osteoarthritis. A subsequent study of hip osteoarthritis also showed it worked no better than placebo. A new study shows that glucosamine works no better than placebo for osteoarthritis pain in the low back. It was published in the JAMA: Effect of Glucosamine on Pain-Related Disability in Patients with Chronic Low Back Pain and Degenerative Lumbar Osteoarthritis: A Randomized Controlled Trial, by Wilkens et al. It is well-designed, randomized and double blind, with 250 subjects, a low drop-out rate, a 6 month duration with a one year follow-up, appropriate clinical criteria for improvement (disability, pain, quality of life, use of rescue medications), intention-to-treat analysis, and even an “exit poll” to insure that blinding had been effective, that patients couldn’t guess which group they were in. It used the doses of glucosamine sulfate that had been called for by critics of previous studies. It was done in Norway, where glucosamine is a prescription drug (in the US it is marketed as a diet supplement under DSHEA regulations so there is a greater possibility of dosage variations and impurities); it was independently funded, with no involvement of industry. Although no one study can be definitive, this one is pretty convincing when viewed in the context of all the other published data. The authors rightly conclude that glucosamine doesn’t work any better than placebo, but they go on to say some rather strange things. They say it should not be recommended for “all” patients with osteoarthritic low back pain, implying that it might still be recommended for “some” patients. But if so, which patients and according to what criteria? They seem strangely defensive. They stress that glucosamine caused no side effects and could be used safely. They suggest that glucosamine might work for a subset of patients or for joints other than the spine. For instance, the knee. But another new study has confirmed that it is ineffective for the knee. I don’t understand this. If they had found that a new antibiotic worked no better than a placebo for pneumococcal pneumonia, would they say it should not be recommended for “all” patients with pneumococcal pneumonia or would they simply say it should not be used for pneumococcal pneumonia? Would they speculate that it might work for a small subset of pneumonia patients or for infections in other parts of the body? Probably not. They thought glucosamine worked; they tested it; it didn’t. Why not just say so? Are they letting a prior belief in glucosamine influence their thinking? Unbiased science-based researchers are not usually so hesitant to give up on a treatment that repeatedly fails to pass tests. I must be psychic, because I had predicted this in a post I wrote two and a half years ago (about the study showing that glucosamine didn’t work for hip pain). I said: They can always complain that maybe it works for knees but not for hips, or that a different dosage might have worked better, or that it works for some small sub-set of patients. There will always be “one more study” to do. This new study confirms my opinion that we shouldn’t spend any more research dollars doing “one more study” on glucosamine.

On Friday, one of my partners in crime here at Science-Based Medicine, Dr. Kimball Atwood, wrote an excellent Open Letter to Dr. Josephine Briggs. Dr. Briggs, as most regular readers of SBM know, is the Director of the National Center for Complementary and Alternative Medicine (NCCAM). As most regular readers of SBM also know, we at SBM have been quite critical of NCCAM for its funding of studies of dubious scientific value, including one that I mentioned quite early on in the history of this blog, in which an R21 grant was awarded to investigators at the University of Arizona for a project entitled Dilution and succussion in homeopathic remedy dose-response patterns. The purpose of this project was to compare the effectiveness of a homeopathic remedy at different dilutions. It even compared remedies that are succussed (vigorously shaken) at each dilution step against remedies that were merely stirred. Although this is merely the most egregious example I could find at the time, two years ago I did catalog many more examples, as well as the “educational” grants disbursed through NCCAM in order to teach (and, by doing so, promote) CAM. Given NCCAM’s long history of promoting pseudoscience, we were all quite surprised when early this year we received an e-mail from Dr. Briggs herself inviting us to NCCAM to meet with her. Unfortunately, due to our work obligations, Steve Novella, Kimball Atwood, and I were not able to coordinate our schedules to travel to Bethesda and enter the heart of darkness itself until early April. Our conversation with Dr. Briggs and her staff was cordial and mutually respectful, as Steve Novella described, and we assured her that we understood that studies such as the one I mentioned above were funded before her tenure. At the same time we were a bit disappointed that Dr. Briggs appeared far too eager to dismiss such problems as being before her time. Still, we understood and approved of Dr. Briggs’ stated goal of making NCCAM more scientifically rigorous, even though we did point out that there is nothing done at NCCAM that couldn’t be done as well in the NIH’s structure before NCCAM existed. Unfortunately, not too long before or after Dr. Briggs met with us, she also met with a group of homeopaths, leading us to worry that perhaps in her quest to appear “open-minded,” Dr. Briggs was being so open-minded that her brain was in acute danger of falling out, particularly after we saw her infamous “science must be neutral” director’s newsletter a month later, which Dr. Kimball skewered as part of his open letter and I recently used as an example of misinterpreting what scientific “neutrality” means during my talk at the SBM Workshop at TAM8 a couple of weeks ago. In fact, I now wonder if I missed a little gray matter oozing out of Dr. Briggs’ ears during the meeting even though I sat right next to her. Unfortunately, Dr. Atwood’s open letter gives me even more reason to despair, because in it he pointed out that Dr. Briggs will be speaking at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP) from August 11-15 in Portland, OR. (One wonders if Mark Crislip would be willing to make an appearance there for a Very Special Episode of his Quackcast and thereby continue to expand his Internet empire. I realize that doing so would really be “taking one for the team,” but think of the blogging and podcast material!) Kimball’s explanation why this is disturbing is excellent and detailed, as usual, but one thing he didn’t do as much of as I would have is to go into a bit more detail of what sorts of dubious medical modalities and even outright quackery Dr. Briggs will be associating herself with by speaking at this particular convention. He probably didn’t feel the need, given that he referenced his two comprehensive deconstructions of the quackery that is naturopathy, but I’m not as well-versed in naturopathy as he is, and, I suspect, neither are you. Dr. Atwood didn’t need to delve into the woo that will be presented at the AANP. I do. That’s why I thought a bit of a survey of what will be presented at the conference was in order. A selection of AANP speakers Before I discuss the speakers with whom Dr. Briggs will be sharing the podium in Portland, let’s take a look at the title of Dr. Briggs’ talk, which will be “Complementary and Alternative Medicine: Promising Ideas from Outside the Mainstream.” As Dr. Atwood speculates, this is probably a variation or expansion of a slide Dr. Briggs used in her talk at the 2nd Yale Research Symposium on Complementary and Integrative Medicine entitled “Quirky ideas from outside the mainstream” that listed ideas that once weren’t considered mainstream medicine but ultimately became accepted, the implication being, of course, that there are such ideas in CAM that are now considered “quirky” but will become accepted. Of course, ideas such as those embodied in reiki, therapeutic touch, homeopathy, and many other CAM modalities go far beyond merely “quirky,” and the “quirky” ideas that Dr. Briggs mentioned in her Yale talk weren’t really ever considered that “quirky,” but the probable implication of her talk at the AANP convention will be that some of the ideas about health to which naturopaths cling may well be accepted one day. So, based on the panel of speakers, which, according to the AANP blog, will make this year’s woo-fest “one of the best gatherings to date,” what ideas might Dr. Briggs consider to be quirky but likely to be accepted as mainstream in the future? Given that the speakers are listed in alphabetical order, I couldn’t help but notice immediately as I perused the list this “quirky idea” from Mikhael Adams, BSc, ND, who will be giving a talk entitled Viruses & Pandemics in the 21 st Century: Truth or Dare and the Case for Nature Cure. His talk is described thusly: This presentation will explore the researched and documented facts relating to viruses and pandemics in the modern age and the vaccinations offered to prevent them, as well the immense toxic burden the average human presents with and its effects on the immune system. Historically, Nature Cure has provided us with a template for repairing and maintaining the “self-healing” and “auto-regulating” mechanisms of our body. This presentation will focus on updated, detailed, effective, and successful “Nature Cure” for today’s chronic conditions. Connoisseurs of CAM language will recognize immediately a number of code words and phrases in this paragraph, chief among them being the “immense toxic burden” and how it allegedly destroys our immune systems. It’s highly unlikely, of course, that Adams will present anything resembling actual scientific evidence to support his claims of an “immense toxic burden,” but previous experience tells me that it’s extremely likely that he will be laying down a swath of anti-vaccine propaganda, given his reference to “facts” relating to viruses, pandemics, and vaccinations, particularly given how deeply imbedded anti-vaccine beliefs are in naturopathy (only 20% of whom even recommend vaccination), coupled with the belief that uncharacterized (and often unnamed) “toxins” are responsible for most disease. Anyone want to lay down money that Adams’ talk will blame vaccines for some of this “immense toxic burden” from which we all supposedly suffer? I don’t blame you for saying no. It’d be a sucker’s bet. It’s disappointing that Dr. Briggs would associate herself with a speaker who is very likely to be spewing anti-vaccine pseudoscience, given that one area of agreement we found with her in our discussion was that NCCAM must not support the anti-vaccine beliefs that are associated with so many “alternative medical” modalities. The description of Adams’ “qualifications” reads: Dr. Mikhael Adams, B.Sc., N.D., received his Doctor of Naturopathy from the National College of Naturopathic Medicine in 1981. He practiced for ten years in Seattle, and is now in private practice in Milton, Ontario. He uses drainage, nutrition, homeopathy, acupuncture and auricular medicine as his primary therapeutic tools. He has studied homeopathy since 1977. Dr. Adams is the president of the International Association of Auricular and Bioenergetic Medicine, past president of the North American Association of Auricular Medicine, and has studied intensively with Dr. Paul Nogier in France. Dr. Adams taught Clinical Pathology at the Northwest Institute of Acupuncture & Oriental Medicine from 1987 to 1993 and has been giving workshops in auricular medicine since 1984. Dr. Adams has been lecturing in North America on homeopathy and drainage since 1988. So he’s a homeopath, and, as SBM readers know, homeopathy is The One Quackery To Rule Them All. It’s disappointing that Dr. Briggs would associate herself uncritically with homeopathy, as well, although I suppose we shouldn’t be surprised, given her earlier meeting with homeopaths. Next, “drainage” refers to lymphatic drainage a treatment modality favored by many naturopaths that claims to aid in “detoxification” by improving lymphatic drainage using various nostrums, the claim being that all sorts of symptoms are in reality due to a failure of lymphatic drainage to “detoxify” the body properly. Methods as varied as massage (which is used in science-based medicine, by the way, to improve lymphatic drainage in patients with documented lymphedema) and castor oil, although the “alternative” medical practitioners advocating this latter approach often appear not to understand the significance of pitting edema. (Hint: Lymphedema is usually not pitting, and pitting edema is usually due to cardiac, liver, or kidney abnormalities, although venous insufficiency can also cause it.) While there is a science-based rationale for using various physical techniques to improve lymphatic drainage in people who suffer from lymphedema, be it post surgical or due to other causes, science-based uses of lymphatic drainage are not what we’re talking about here. If you really want to get a feel for what kind of practitioner Mr. Adams is, you should check out the webpage of his group naturopathy practice, The Renascent Integral Health Center in Milton, Ontario, which describes its approach to patient care thusly: The emphasis of treatment is placed on removing the blockages that keep the individual from being a self-healing, auto-regulating organism. Therapies are implemented that support the individual’s body, as it specifically responds to external stress, toxic challenges and energetic impressions held by the body, that have manifested into the current state of disease. Whether entering treatment at the centre, or having a Medical Intuitive Scan done by distance, the goal becomes to target disease by identifying and addressing the body’s underlying imbalances that have created its symptoms. To resolve the symptoms, Mikhael and Alison’s approaches go beyond the given diagnosis, to reinitiate the body’s ability to recognize the challenges it faces, and support its ability to resolve its state of disease. It gets better. I didn’t really know for sure what Auricular Medicine or a “Medical Intuitive” scan is. Fortunately, Adams is happy to tell us, given that he has a “medical intuitive” on his staff, namely his wife Alison Feather Adams. A medical intuitive scan is: A Medical Intuitive Scan can be done by distance, a written report is sent, and a follow-up phone consultation is arranged to discuss the scan. The Scan records the information held in the body, at a subconscious level, therefore during the phone consult the information presented will be discussed in relation to what the individual is currently experiencing on a conscious level. Medical Intuition can give insight into the emotional and energetic components of the disease state that are not detected using standard diagnostic equipment. Meanwhile, as best as I can figure it out, Auricular Medicine is reflexology, only with the “mappings” of various body parts and organs to the ears, rather than to the feet and hands. Here’s Adams’ description: Auricular Medicine is an energetic reflex technique in which the pulse and filters are used to detect points on the ear. The points that show up on the ear can indicate the location of specific imbalances within the body. Through the use of filters we are able to identify specific dysfunctions within the body. Auricular Medicine is a specialized field of Energetic Medicine…The Doctors in this clinic use Auricular Medicine as their key diagnostic tool and work with their clients to stimulate self-healing (vis medicatrix naturae) through assessment of the disease state, prevention of disease, evaluation of a client’s state of health, and treatment and care of client’s using means and substances that are in harmony with the client’s own self healing processes. Auricular Medicine in conjunction with conventional medical tests can find and treat the cause of disease. Many conditions, acute and chronic, can be treated by Auricular Medicine. I’m sure many diseases and conditions “can” be treated by Auricular Medicine. Whether they can be treated successfully with Auricular Medicine is another question entirely. I wonder if Adams uses Col. Niemtzow’s auricular acupuncture as well. He does, however, use something that he calls Inner Alchemy, which promises to help you: …reconnect with your inner potential by taking you past your discomfort into the wisdom of subtle energy where your intuition can guide you to see things the way they really are, in truth. Truth is the foundation for healing and reinitiating your physical body as well as the mental, emotional and spiritual bodies to work together to bring you back to the state of ease and health again. You come to experience the essence of who you are, and release the outdated programming that the body is compensating for, and outgrown impressions about yourself that has been influencing you unknowingly. I think we’ve found a new candidate for Dr. Atwood’s Weekly Waluation of the Weasel Words of Woo. I spent more verbiage than I had expected on just one speaker, but I suppose I was just fortunate that the very first speaker on the list happened to provide me with such a rich source of evidence to demonstrate how unscientific naturopathic modalities are. In fact, the title of one of the talks listed piqued my interest for just this reason, specifically a panel discussion by Thomas Kruzel, M.T., ND; Dickson Thom, ND; Stephen Myers, ND, Bmed, PhD; Kate Broderick, ND entitled Emunctorology: An Old Clinical Science Brought to a New Generation of Naturopathic Physicians. Kimball mentioned this briefly in his post, but I had never heard of emunctorology, either. It’s not a simple matter to figure out what it is, other than that it has something to do with the “organs of elimination,” namely the kidneys, colon, skin, etc., and that the group of naturopaths writing the naturopathy text Foundations of Naturopathic Medicine are trying to codify it as some sort of formal naturopathic study. Also, a naturopath named Sabine Thomas, who Tweets under the ‘nym @emunctorology, rejoiced that apparently there are FINALLY emunctorology courses at that bastion of naturopathy, Bastyr University. Given how obsessed naturopaths are with “detoxification,” one can only imagine what sort of “detox” woo is encompassed by this new/old naturopathic “discipline.” No doubt it will include colon cleanses and sweat lodges to “flush the toxins out.” Speaking of “toxins,” Charles Masur, ND will be giving a talk on that favorite “toxin” in many branches of “alt-med,” namely the dreaded heavy metals, with a talk entitled Toxic Metals in the Environment and their Role in Oxidative Stress. One wonders if he’ll advocate provoked urine testing for heavy metals of the kind championed by Doctor’s Data, which is currently suing Stephen Barrett for having had the temerity to point out that there is no scientific basis for such a test. The optimist in me hopes not. The pessimist in me realizes that pretty much any naturopath I’ve ever seen blaming all sorts of chronic disease on some sort of fantastical, never adequately documented, heavy metal toxicity also advocates chelation therapy, which is rank quackery, except in unusual case real cases of heavy metal toxicity. Maybe Masur will be the exception. Even if he is, he can count on Jessica Tran, ND, to take up the slack with a talk entitled Overview of heavy metal detoxification strategies using natural and pharmaceutical medicines, which explicitly promises to discuss chelation therapy. Finally, here are a couple more “quirky” ideas being presented at the AANP meeting. One comes from an actual medical doctor named Dr. E. Denis Wilson, whose talk is entitled The use of T3 and herbal medicine to reset the body temperature and recalibrate many bodily functions. Dr. Wilson promises: Body temperature is one of the most fundamental physiologic parameters but is often overlooked. Dr. Wilson will discuss the synergy between the use of T3 and herbal medicine to recalibrate body temperature patterns to aid in the restoration of good health. Thyroid endocrinology and physiology will also be discussed. Quackwatch retorts: “Wilson’s Syndrome” entered the health marketplace in 1990, when E. Denis Wilson, M.D., of Longwood, Florida, coined its name. Its supposed manifestations include fatigue, headaches, PMS, hair loss, irritability, fluid retention, depression, decreased memory, low sex drive, unhealthy nails, easy weight gain, and about sixty other symptoms. However, Wilson claims that his “syndrome” can cause “virtually every symptom known to man.” He also claims that it is “the most common of all chronic” ailments and probably takes a greater toll on society than any other medical condition.” Wilson claims to have discovered a type of abnormally low thyroid function in which routine blood tests of thyroid are often normal. He states that the condition is “especially brought on by stress” and can persist after the stress has passed. He claims that the main diagnostic sign is a body temperature that averages below 98.6° F (oral), and that the diagnosis is confirmed if the patient responds to treatment with a “special thyroid hormone treatment.” Dr. Wilson’s also apparently killed at least one patient by prescribing too much thyroid hormone. As a result, according to Quackwatch, he lost a malpractice suit and hasn’t practiced medicine since 1992, which is when the Florida Board of Medicine suspended his license and ordered him to undergo psychological testing. At least he isn’t speaking the same day that Dr. Briggs is, although a talk by Jim Paoletti, RPh, FAARFM entitled A Holistic Natural Approach to Treating Hypothyroidism will occur in the session right after Dr. Briggs speaks. Perhaps my favorite talk, at least judging by its title, will be the talk by Sharum Sharif, ND entitled Visual Homeopathy – Identifying a Person’s Constitutional Homeopathic Remedy in Minutes, which promises: Patient and Hollywood videos will be used to demonstrate how to quickly identify a patient’s constitutional remedy by looking for simple behavioral cues and asking 2-5 questions. The presentation will be focused on the most common remedies accounting for the majority of the population of a general naturopathic clinic. Who knew it was that easy? As a couple of questions, and pick out some water to treat your patient. Overall, there appear to be at least seven homeopaths speaking. There’s also Matthew Baral, ND, who is a certified Defeat Autism Now! practitioner, and if there’s a richer source of autism and anti-vaccine quackery besides the roster of DAN! practitioners, I am unaware of it. There’s so much more than even this lengthy post can encompass. What Dr. Briggs should say I realize that Dr. Briggs is in a delicate situation. Her heart appears to be in the right place as far as wanting to make NCCAM more science-based, but her head doesn’t seem able to acknowledge just how deep into pseudoscience she’s buried herself. Given that NCCAM is not going away unless somehow the public can be rallied against it to the point where even its patron, Senator Tom Harkin (D-IA), can no longer protect it against demands for its dissolution, something exceedingly unlikely to happen any time soon, I realize that NCCAM could do a lot worse for a director than Dr. Briggs and probably will some day if its “stakeholders” get their way. However, as some readers chastised me in the comments of Dr. Atwood’s post, Dr. Briggs chose to accept the directorship of NCCAM when offered, and, as was pointed out, a scientist doesn’t get to be the director of a major center in the NIH if she isn’t a capable politician as well as scientist. In fact, although I don’t believe this to be the case for Dr. Briggs, sometimes being a politician counts for more than being a scientist, as the appointment of Dr. Bernadine Healy to head the NIH in 1991 demonstrates. I also understand that, when one holds a position like director of NCCAM, it is necessary to do things like speak to the AANP, given that, in the U.S., at least, naturopaths probably represent the most politically connected group of CAM practitioners, perhaps as much as homeopaths in the U.K. So turning down an invitation to speak would probably have caused Dr. Briggs trouble. But wouldn’t it be really cool if Dr. Briggs were to walk into the lions’ den and speak science to woo? I realize it’s as unlikely to happen as it is for me to find a single molecule of original remedy in a 30C homeopathic remedy, but I’d love to see Dr. Briggs use the opportunity to speak to a large gathering of naturopaths to set a few things straight. For example, not too long ago, as I pointed out in my post about “naturopathic oncology” being practiced at the Cancer Treatment Centers of America, Timothy Birdsall, ND, FABNO, wrote a rather telling post for the AANP blog entitled The problem with research after having attended the National Advisory Council for Complementary and Alternative Medicine, the advisory body to NCCAM. Presumably Dr. Briggs knows, or at least has met, Dr. Birdsall, given that she must deal with NCCAM’s advisory council as part of her job. In his post, Dr. Birdsall challenged the next generation of naturopaths to be more science-based and to produce “great scientists,” while at the same time attacking “reductionism,” “allopathy,” and the “biochemical model,” characterizing research as an “impediment” to homeopaths and writing: In the end, we must create and validate the tools to dethrone the randomized controlled trial as the gold standard, and construct new ways to validate clinical approaches to health issues. Much as the homeopaths of 2+ centuries ago created the proving as a way to better understand and utilize their remedies, we must refuse to be limited by the way conventional medicine views health and disease. In particular, Birdsall writes: But ultimately, I find myself becoming offended because I believe that these therapies work… Whoa! Believe? OK, but where is the role for evidence? Where, indeed? Remember, this is the 2009 AANP Physician of the Year. Wouldn’t it be cool if Dr. Briggs were to quote Dr. Birdsall’s article, point out to the naturopaths that medicine is not a matter of “belief,” and educate them that, while randomized trials have shortcomings, they are currently the best tool we have for answering many medical questions, including many of those of naturopathy? Wouldn’t it be even cooler if Dr. Briggs correctly pointed out that what Dr. Birdsall really appears to be advocating is not improving how science is applied to medicine, but changing our medical paradigm so that naturopathy can gain scientific acceptance using a different, much weaker standard of evidence? If she would state boldly that, if naturopathy can’t be scientifically validated, then it should be abandoned, I’d give her extra points. Then there are other things I fantasize seeing Dr. Briggs do with her talk to the AANP: Say outright that homeopathy is water, that water doesn’t have memory (at least not the way homeopaths claim), and that, for homeopathy to be true, many of the laws of physics would have to be not just wrong, but spectacularly and completely wrong. Then point out that there’s no evidence that our understanding of physics and chemistry is that spectacularly wrong and challenge the AANP to give up homeopathy. Outline the real history of H. pylori, reminding the assembled naturopaths that the idea that H. pylori causes duodenal and gastric ulcers was accepted less than a decade after it was first proposed by Warren and Marshall in 1984, with treatment for H. pylori being the standard of care for duodenal ulcers by the mid-1990s. Challenge the naturopaths to gain acceptance for their “quirky” ideas the same way Warren and Marshall did for their quirky idea, through real science and real clinical trials. Point out that using provoked urine levels of heavy metals for any diagnosis or monitoring of treatment is not scientifically supported and is thus best viewed as quackery. Reiterate that vaccines are the single greatest medical advance there has ever been, arguably saving more lives than any other and tell the naturopaths that it is disgraceful that only 20% of naturopaths support vaccination. Tell them that there is no convincing scientific evidence that vaccines cause autism or any of the other conditions and diseases attributed to them by many naturopaths. Then point out that naturopaths who “don’t believe in vaccination” or won’t vaccinate should not be practicing medicine. Argue that there is no good scientific evidence that there is a human “life energy” field or that people, needles, or touch can manipulate such a field, meaning that “energy medicine” produces nothing but placebo effects. Challenge the naturopaths to change their practices based on what science shows, just as “conventional” physicians practicing science-based medicine do, rather than clinging to prescientific notions of “life energy,” sympathetic magic (homeopathy), and ritual purification (”detoxification”) as the basis of their treatments. I know. It’ll never happen. But a guy can dream, can’t he? Unfortunately, whether Dr. Briggs realizes it or not, by speaking to the AANP convention without criticism, she is giving it her imprimatur of approval. I once mentioned George Annas, who is a bit of a contrarian and agreed to speak at the National Vaccine Information Center quackfest last fall. Even after he was informed of the nature of the conference, he did not withdraw. According to reports I’ve gotten, he did, however, tell it like it is and refuse to kowtow to the anti-vaccine audience. I didn’t agree with his decision to go through with the talk, but I could respect it. Apparently Annas is the sort of person who actually does like to speak to hostile audiences and rile them up by telling them what they don’t want to hear. Similarly, I could understand and even respect Dr. Briggs if she were to do the same and refuse to kowtow to the pseudoscience that will be surrounding her as she gives her talk to the AANP, if she were to point out that the ideas of the AANP go beyond “quirky” and straight into the woo. She won’t, though, at least not if she wants to keep her job.

Josephine P. Briggs, M.D. Director, National Center for Complementary and Alternative Medicine Dear Dr. Briggs, As you know, we’ve met twice. The first time was at the Yale “Integrative Medicine” Symposium in March. The second was in April, when Drs. Novella, Gorski and I met with you for an hour at the NCCAM in Bethesda. At the time I concluded that you favor science-based medicine, although you are in the awkward position of having to appear ‘open-minded’ about nonsense. More about that below, but first let me address the principal reason for this letter: it is disturbing that you will shortly appear at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP). It is disturbing for two reasons: first, it suggests that you know little about the tenets and methods of the group that you’ll be addressing; second, your presence will be interpreted as an endorsement of those methods and of that group—whether or not that is your intention. If you read nothing more of this letter or its links, please read the following articles (they’re “part of your education,” as my 91 y.o. mother used to say to me): Naturopathy: A Critical Appraisal Naturopathy, Pseudoscience, and Medicine: Myths and Fallacies vs Truth The first article is an introduction to the group to which you will be speaking; the second is my response to complaints, from that group and a few of its apologists, about the first article. It was a surprise to me that the editor, George Lundberg, preferred that I make my response a comprehensive one. Thus the second article inevitably became the crash course—call it CAM for Smarties—that your predecessors never offered you, replete with examples of useless and dangerous pseudoscientific methods, real science being brought to bear in evaluating such methods, proponents’ inaccurate or cherry-picked citations of biomedical literature, bits of pertinent but little-known history, the standard logical fallacies, embarrassing socio-political machinations, wasteful and dangerous ‘research’ (funded—unwittingly, I’m sure—by the NCCAM), bait-and-switch labeling of rational methods as “CAM,” vacuous assertions about ‘toxins’ and ”curing the underlying cause, not just suppressing the symptoms,” anti-vaccination hysteria, misleading language, the obligatory recycling of psychokinesis claims, and more. Please excuse me if this sounds preachy; I admit that it does, but understand that I’m writing in good faith. My own views of “CAM” did not dawn on me overnight, but were the result of years of research. My ‘internship,’ as it were, consisted of sitting on a state commission from the fall of 2000 until the spring of 2002, listening to AANP members (including at least one with whom you will share the podium), reading about ‘naturopathic medicine,’ and attempting (unsuccessfully) to engage its advocates in rational discussion. I began that task open to forming opinions based on whatever information became available; by its end it had become abundantly clear that the group is best characterized as a pseudoscientific cult, and nothing since has altered that opinion. Regarding your presence at the convention being tantamount to an endorsement of ‘naturopathic medicine,’ this is so obviously true that it ought not be necessary to mention it. Previous experience, however, has taught me to expect an air of—please don’t take this personally—utter cluelessness whenever I’ve raised such an issue. If you’ve read the second naturopathy article linked above, you already know that according to proponents, The validity of naturopathic medicine is demonstrated by its support in government (including accreditation of its schools and NIH-funded research), on medical school Web sites, and in other parts of the public domain. An appearance at their annual convention by the most important “CAM” administrator at the NIH surely has the political arm of the AANP licking its chops. NDs, as they call themselves, are currently licensed in 14 or 15 states and a couple of provinces, and aggressively seek licensure throughout the U.S. and Canada. They appear to wield political clout well out of proportion to their numbers, no doubt thanks in part to the legislative language that created the NCCAM’s National Advisory Council for Complementary and Alternative Medicine (NACCAM): Of the 18 appointed members…Nine…shall be practitioners licensed in one or more of the major systems with which the Center is involved. Six of the members shall be appointed by the Secretary from the general public and shall include leaders in the fields of public policy, law, health policy, economics, and management. Three of the six shall represent the interests of individual consumers of complementary and alternative medicine. Thus there have been 1-3 NDs on the NACCAM since its inception in 1999, although their numbers in general are, by any measure, miniscule: I reckoned there were about 2500 in the U.S. in 2003; the AANP now places that number at 6000. By comparison, there are about 800,000 MDs and 50,000 DOs in the U.S. NDs claim to be well trained to practice what most people think of as family medicine or primary care medicine, although their version of training is chock full of pseudoscientific nonsense and lacks a true residency program. They began by purporting to use only “natural medicines,” but in regions where they’ve become politically connected they’ve sought, and been granted, the license to prescribe numerous drugs. Predictably, they’ve recently begun to bump people off with such exotic choices as intravenous colchicine and disodium ethylenediaminetetraacetic acid (that pesky TACT drug), in addition to more folksy nostrums such as acupuncture, vitamin B12, and an “herbal tincture” for a teenage girl who would shortly die of asthma. I see that your talk is titled “Complementary and Alternative Medicine: Promising Ideas from Outside the Mainstream.” I imagine that it will cover some of the material that you covered at the Yale Symposium, where you used the similar phrase, “Quirky Ideas from Outside the Mainstream.” Without reading more into that word substitution than is warranted, let me assure you that there are no promising ideas emanating from naturopathy, even if there are plenty of quirky ones, e.g., inflating balloons in the nasopharynx to effect a “controlled release of the connective tissue tension to unwind the body and return it toward to its original design.” Regarding the implicit requirement of your office that you appear open-minded even to medical absurdities, you made that clear in your own account of our NCCAM meeting and of another that you’d had a few weeks earlier, involving a group of homeopaths and associated crackpots who called themselves “the leading scientists in the field”: Recently, I hosted two meetings with groups that represent disparate views of CAM research. These meetings have given me a renewed appreciation for the value of listening to differing voices and perspectives about the work we do. My NCCAM colleagues and I know there are differing views of the value of doing CAM research. On one side, we have stakeholders who are staunch CAM advocates, and on the other side, we have CAM skeptics. Each group has its own beliefs and opinions on the direction, importance, and value of the work that NCCAM funds. The advocates would like to see more research dollars supporting various CAM approaches while the skeptics see our research investment as giving undue credibility to unfeasible CAM modalities and want less research funding. As I’ve stated before, our position is that science must remain neutral, and we should be strictly objective. There are compelling reasons to explore many CAM modalities, and the science should speak for itself. (emphasis yours) Certainly science must remain neutral in the face of not-yet-seen data from rigorous studies, but that is different from what you, in your dual roles as “CAM” Explicator-in-Chief and Steward of Public Funds, must remain. You typically face questions that are, for all purposes relevant to the NIH, to modern medicine, and to the American citizenry, already settled—whether by basic science, clinical studies, rational thinking, or all three. I’ve offered several examples in the two naturopathy articles linked above. Consider homeopathy, a core claim of “naturopathic medicine” and the subject of your meeting with the “staunch CAM advocates.” It makes no more sense for you to remain neutral on that topic than it would for the NIMH Director to remain neutral on exorcisms, or for the NCI Director to remain neutral on Krebiozen. Edzard Ernst, a one-time homeopath whose own portfolio of “CAM” investigations dwarfs the entire output of the NCCAM, puts it this way: Should we keep an open mind about astrology, perpetual motion, alchemy, alien abduction, and sightings of Elvis Presley? No, and we are happy to confess that our minds have closed down on homeopathy in the same way. Science and skepticism, moreover, are not distinct. Good science involves, first and foremost, skepticism. This is true for the design of any experiment, in which the primary goal is to attempt to falsify the hypothesis, and also for scientific thinking in general. Bruce Alberts, the editor of Science, discussed this in a 2008 editorial titled “Considering Science Education”: …society may less appreciate the advantage of having everyone acquire, as part of their formal education, the ways of thinking and behaving that are central to the practice of successful science: scientific habits of mind. These habits include a skeptical attitude toward dogmatic claims and a strong desire for logic and evidence. As famed astronomer Carl Sagan put it, science is our best “bunk” detector. Individuals and societies clearly need a means to logically test the onslaught of constant clever attempts to manipulate our purchasing and political decisions. (emphasis added) I believe that you know all this at some level, but that your current job demands that you bend over backward to frame skeptics as extreme—distinguishing them from “neutral” scientists. Thus you, like many reporters, have placed skeptics of homeopathy or naturopathy at one end of a contrived belief spectrum, and “staunch CAM advocates” at the other. Please indulge me while I compare this version of ‘neutrality’ with others that exist in the popular domain: Some people feel strongly that the moon landings were a collective hoax. Others feel just as strongly that they really happened. Some people believe that the Holocaust didn’t happen. Others believe that it did. Some people believe that the variety of species on earth is a product of Intelligent Design (ID). Others believe in the theory of evolution by variation and natural selection. This could go on and on, but you probably get the point. The last bullet is more pertinent to your tacit endorsement of the AANP than you might imagine. What follows is a representative view of herbalism offered by Thomas Kruzel, with whom you will also share the podium at the convention (he will discuss “Emunctorology”; don’t ask). Kruzel is Past President of the AANP and the former Vice President of Clinical Affairs and Chief Medical Officer at the Southwest College of Naturopathic Medicine. He was selected Physician of the Year by the AANP in 2000, and Physician of the Year by the Arizona Naturopathic Medical Association in 2003: Herbal Medicine: Naturopathic physicians have been trained in the art and science of prescribing medications derived from plant sources. The majority of prescription drugs are derived as well from plants but are often altered and used as single constituents. What makes herbal medicine unique is that plants have evolved along with human beings and have been used as non-toxic medications for centuries. If there is any problem with herbal medicines it is that unless one knows how to prescribe them, they may not be effective. Herbal medications should be prescribed based on the symptoms that the person presents rather than for the name of the disease. Herbal medications are much more effective at relieving the patients symptoms when prescribed in this manner. When prescribed the medicines act with the body’s own innate healing mechanism to restore balance and ultimately allows healing to occur. What’s nice about plant or herbal medicines is that because they are derived from the whole plant they are considerably less toxic to the body. The plant medicine has evolved to work in harmony with the normal body processes rather than taking over its function as many drug therapies do. Because of this herbal medicines may be taken for longer periods of time without the side effects so often experienced with drugs. You are particularly impressed, I hope, by the magical, ID-like claim that “plant medicine has evolved to work in harmony with the normal body processes.” Other curious assertions include the conflation of herbal medicine with the core claims of either homeopathy or the non-existent ‘allopathy’ (we can’t tell which)—”…should be prescribed based on the symptoms…”—demonstrating that the author doesn’t know much about even the fanciful methods for which he claims expertise; and the dangerously false statement that medicines “derived from the whole plant are considerably less toxic” (than are well-researched and precisely dosed “prescription drugs”). Dr. Briggs, please consider the possibility that you no longer must hide your considerable scientific prowess in order to be a good NCCAM Director. Your ’stakeholders’ include not only very small numbers of naturopaths, homeopaths, and other fringe practitioners, but also far larger numbers of citizens who wonder about the validity of what those practitioners are peddling. It is to those citizens that you should be directing your efforts, which ought to begin with sober, objective, skeptical, scientific considerations of the various claims, the vast majority of which can, like balloons in the nasopharynx, be deflated in milliseconds by anyone with even a modest understanding of nature. They don’t require clinical trials. Things are changing elsewhere. My colleague Steve Novella has just written about substantial efforts to deny insurance coverage for homeopathy in the land of its birth, Germany. In the UK, homeopathy has been far more popular than it is here, even to the point of its being funded by the National Health Service. One of the “staunch CAM advocates” who reportedly attended your meeting by teleconference was Peter Fisher, Homeopath to the Queen. Yet both the British Medical Association and the House of Commons Science and Technology Committee have seen through the ruse of pseudoscience that is homeopathy, the former declaring it “witchcraft” and latter making this statement: The Committee concurred with the Government that the evidence base shows that homeopathy is not efficacious (that is, it does not work beyond the placebo effect) and that explanations for why homeopathy would work are scientifically implausible. American citizens want and deserve, for their tax money, exactly that sort of definitive evaluation of such claims. Your first responsibility, Dr. Briggs, is to them—it is not to the AANP, other “CAM stakeholders,” Tom Harkin, Orrin Hatch, or Dan Burton, and certainly not to the members of the NACCAM. Yes, we “skeptics see [the NCCAM] research investment as giving undue credibility to unfeasible CAM modalities,” because the evidence is overwhelming that this is the case. We also see your appearing at conventions of pseudomedical pseudoprofessional organizations as giving undue credibility to unfeasible and dangerous claims. Sincerely yours, Kimball C. Atwood, M.D. Skeptic … The Naturopathy Series: “CAL”: a Medico-Legal Parable Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 1 Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 2 Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 3 Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 4 Colorado is Nearer to Promoting Naturopathic Pseudomedicine—Aided by the Colorado Medical Society Naturopathy and Liberal Politics: Strange Bedfellows Open Letter to Dr. Josephine Briggs

I’m certain by now many of our readers have come across news of the current pertussis, aka whooping cough, epidemic in California.  Beginning this February and accelerating dramatically through May and June, California has so far seen a ~500% increase in pertussis cases compared to last year, and only two days ago announced the death of a sixth baby from infection.  Public health officials in California are currently working to control its spread and determine the factors that allowed this outbreak to occur, unfortunately, at this time the available data is very rough. The number of confirmed cases as of 6/30/2010 is growing rapidly (1,377), with an additional ~700 cases pending investigation.  General geographic location, ages, and ethnicity have been identified, and general vaccination rates and exemption rates are known, but other important demographic and epidemiologic data, including vaccination status of infected children and adults, has yet to be fully described.  Lack of data notwithstanding, I have read equally hasty stories and comments blaming the outbreak on vaccine refusal, a large immigrant population, an inadequate adult vaccination program, and normal cyclical variation in pertussis incidence, among other factors.  Finding where the system has broken down enough to allow this resurgence is exceedingly important, but in this situation pointing fingers is not as important as taking action. Pertussis A bit of background first.  Pertussis is a highly contagious infection of the respiratory tract by a bacteria Bordetella pertussis.  After an incubation period of 7-10 but up to 42 days, the disease progresses through three stages.  The catarrhal stage is often indistinguishable from the symptoms of the common cold, with runny nose, mild cough, and lasts 1-2 weeks.  During the second or “paroxysmal” stage infected people will have fits or “paroxysms” of uncontrollable rapid-fire coughing.  Examples can be seen here (caution, may be disturbing to watch). At the end of these paroxysms people take a large, rapid intake of breath through raw and often partially closed vocal cords, producing a high-pitched “whoop.”  The paroxysmal stage can last anywhere from 1-6 weeks.  The final stage is one of prolonged convalescence with a persistent dry cough lasting weeks to months (this is where pertussis got its other name, the “hundred day cough”). A persistent cough isn’t the worst of pertussis.  60% of children under 6 months of age infected with pertussis need to be hospitalized, 5-10% get pneumonia, 1 in 125 have seizures, and 1 in 1000 suffer from an encephalopathy (inflammation of the brain) that frequently causes permanent brain damage.  And of course pertussis can kill.  Children under 3 months of age are at the greatest risk, and make up 84% of all pertussis related deaths. Treatment is possible, but limited in utility.  Even though pertussis is bacterial and we have multiple antibiotics that reliably kill it, treatment after the first stage (when it becomes clear someone has more than a cold) only limits the ability of a person to spread it to others, it does not reduce the severity or length of the disease.  Once symptoms start, we are forced to ride out the illness.  Prevention is far better than treatment.  And speaking of prevention… The Vaccine The first vaccine to prevent pertussis was licensed in the US in the 1940s.  At that time we had an average yearly of 157 per 100,000 people, though this is likely to be a low-ball figure, given the state of medicine at the time and under-reporting.  From its release through the 1970s we saw a steady drop in cases from the pre-vaccination rate of 157 down to <1 infection per 100,000 people per year.  Though effective, the original vaccine had multiple side effects, including inducing a febrile seizure in 1 in 10,000 children.  These serious complications were enough to begin to undermine the public trust in the vaccine in the US, and to prompt several countries to stop pertussis immunization entirely. In the 1980s and 90s several countries ceased or severely curtailed their use of DTP, including Japan, Sweden, and the UK.  Each of them saw a sharp and immediate rise in pertussis incidence to levels 10-100 times that of countries that continued to have high rates of vaccination with DTP.  This is a pattern we see repeated time and again when vaccines are withdrawn; it represents one of the best and most tragic demonstrations of vaccine efficacy you could ask for. Effectiveness aside, the original DTP vaccine had legitimate problems, so a new vaccine was developed, tested, and eventually licensed for use.  By 1997 DTaP had fully replaced the original DTP vaccine.  Subsequent testing confirmed that it was just as effective as its predecessor, and induced significantly fewer side effects.  DTaP replaced DTP in the US before significant outbreaks could occur, and when instituted in countries that had stopped vaccination with DTP, quickly brought pertussis back under control. DTaP, like all vaccines, continues to be studied, and is holding up very well to scrutiny.  Just this month, a self-controlled case series study in Pediatrics including 433,654 children and 7191 seizure events failed to find any significant association between DTaP and febrile seizures. That the current pertussis vaccine is effective is beyond any serious contention, and its safety profile is excellent, but it’s not perfect.  The immune response the vaccine generates is relatively weak, necessitating multiple doses at 2, 4, 6, 15-18 months and 4-6 years to generate an adequate response (this isn’t unique to the vaccine; natural pertussis infection isn’t capable of providing long-lasting immunity either), and protection wanes after 5-10 years. These characteristics predispose the vaccine, when used exclusively in childhood, to leave a couple of populations susceptible to infection.  First, the children most at risk of death from pertussis, those under the age of 3 months, have little to no direct protection from the vaccine or from maternal antibodies; this population relies heavily on herd immunity for protection.  The second vulnerability is that since neither the childhood vaccine nor natural infection provides lasting immunity, adults can become repeatedly infected, and serve as the primary reservoir of disease.  This is grimly illustrated by the fact that infants are most frequently infected not by other children, but by their parents. Of course, this has been known for some time, and the vaccination schedule isn’t focused exclusively on early childhood.  A late childhood booster dose of TDaP (a reformulation of DTaP) at 11-18 years has been recommended since 2005, and adults are supposed to receive TDaP once between the ages of 19-64 to address this very problem.  Unfortunately, these doses are infrequently given for a variety of reasons, creating vulnerable populations to act as reservoirs for pertussis. Though I may wish to have a vaccine that is somewhat less burdensome to use, it’s hard to complain about the current pertussis vaccine’s safety record, and properly administered, it’s capable of controlling and preventing epidemics (some even optimistically speculate the possibility of eradication).  To be fully effective though, it requires the dedicated support of both public health officials and the community. The California Epidemic Without a doubt, the relatively high-maintenance vaccination schedule contributes to our inability to fully control pertussis, but even if we had a vaccine capable of inducing lifelong immunity from birth onward, we would still have sections of the population that remain vulnerable to infection.  An embarrassingly large fraction of our fellow citizens lack access to health care.  Some immigrant populations may not have had the benefit of a modern medical system and immunization before arriving in the US, and some again lack access to health care after arrival.  A relatively small number of people are unable to be vaccinated or are immunocompromised due to medical conditions.  Finally, there are people who utilize California’s notoriously lax Personal Belief Exemption (PBE) policy to opt out of vaccination. To what degree each of these factors is to blame for the current epidemic is not yet clear.  While it is true that some of the counties with the highest attack rates also happen to be counties where PBEs are common and vaccination rates low, other counties with reasonable vaccination rates are also being heavily affected.  (The attack rates of individual California counties can be found here.)  We simply do not yet have the entire epidemiologic picture, and it appears likely that several, if not all of these factors are in play.  That doesn’t mean, however, that we don’t know what action needs to be taken. The California Department of Public Health is approaching this problem in the right way by addressing all of these elements at once, educating the public and expanding their TDaP program (TDaP program FAQ here, CDPH’s current activities and news releases here, and local California public health services here), though I think they may need to be even more aggressive.  In particular, I’d like to see a heavy revision of California’s PBE policy to make PBEs more difficult to obtain. At the beginning of this post I said that in this pertussis epidemic, pointing fingers isn’t as important as taking action; to some this may have sounded hasty, but I hope you now understand my rationale.  An increase in size of any of any vulnerable group pushes the population as a whole closer to that nebulous cliff where herd immunity can no longer prevent an outbreak from becoming an epidemic.  No matter what the underlying cause(s) turns out to be, the single best intervention to control the spread of the current epidemic is the same: Vaccination. There may be multiple reasons for an outbreak of pertussis… but in our society there really is no excuse for it.

Homeopathy is having a bad year. From a scientific point of view, it has had a couple of bad centuries. The progress of our scientific understanding of biology, chemistry, and physics has failed to confirm any of the core beliefs of homeopathy. Like does not cure like (this is a form of superstition known as sympathetic magic, with no basis in science). Diluting substances does not make them stronger – a notion that violates the chemical law of mass action and the laws of thermodynamics. And countless clinical studies have shown that homeopathic preparations are nothing more than placebos. That homeopathy cannot work and does not work is settled science, as much as it is possible for science to be settled. Despite the science, homeopathy has persevered through a combination of cultural inertia and political support. But in the last year there are signs that this trend may be reversing. In the UK The House of Commons Science and Technology Committee (STC) released a report, Evidence Check 2: Homeopathy, in which they conclude that homeopathy is failed science and should be completely abandoned – no further support in the NHS and no further research. Following that the British Medical Association has openly called for an NHS ban on homeopathy, calling the practice “witchcraft.” Now German politicians are starting to echo the same sentiments. Karl Lauterbach, the centre-left Social Democrats’ chair on the Bundestag health committee, told German news magazine Der Spiegel that insurers should be “prohibited from paying for homeopathy.” and According to Spiegel, Rainer Hess of the Federal Joint Committee for doctors and insurers also characterized the current situation as “extremely unsatisfactory.” The common thread in the UK and Germany is rising health care costs, which is creating the political will to oppose worthless interventions like homeopathy. Up until now systems like homeopathy which are not science-based have received political support from individual believers and promoted largely through the notion of “health care freedom.” But the political climate is changing, and suddenly paying for interventions that do not work seems unnecessarily wasteful. This creates an opportunity to focus attention on interventions like homeopathy. In Germany, as in the US, homeopathy has received support from individual politicians. According to the cited news article: “There have already been many attempts to drop protective provisions on such remedies, but influential politicians have consistently prevented this from happening,” Hess said, adding that despite hundreds of medical studies failing to clearly prove the benefits of homeopathics, insurers are still made to pay for them. It sounds like Germany has had their own Tom Harkin and Orin Hatch to contend with. Political support for homeopathy in the US actually goes back much further. In 1938 Senator Royal Copeland from New York, a homeopath, managed to insert into the new FDA regulations automatic approval for homeopathic products. This situation continues to today – homeopathic products do not require any testing for safety and efficacy. It is good to hear that politicians in Germany are now openly discussing not only removing the protections that force insurance companies to pay for homeopathy, but actually banning insurance companies from paying for it. This would be similar to the BMA proposed ban on NHS support for homeopathy. In both cases no one is proposing that homeopathy itself be banned. If an individual wants to pay for water in the mistaken belief that it is an effective remedy, they are free to do so. However, the seller should not be free to make misleading or fraudulent claims – but that is a different type of regulation. What is now being discussed in Germany and the UK is simply preventing public money from being spent on treatments which have already been proven not to work. I would like to see these efforts spread to the US. We are facing our own health care crisis here, with a new focus on cost-effective medicine. Amazingly, Harkin was able to hijack efforts to deal with the situation (through “Obamacare”) to increase public support for unscientific medicine. This trend needs to reverse – and homeopathy seems like the low-hanging fruit to me. With homeopathy the science could not be more clear, and recent exhaustive reviews, like Evidence Check 2: Homeopathy, have shown that it simply does not work. It should therefore be an easy political position to take, that our limited health care dollars should not be spent on ineffective medicine.

Over a year ago I wrote about The China Study, a book by T. Colin Campbell and his son based on a huge epidemiologic study of diet and health done in China. The book’s major thesis is that we could prevent or cure most disease (heart disease, cancer, diabetes, autoimmune diseases, bone, kidney, eye and other diseases) by eating a whole foods plant-based diet, drastically reducing our protein intake, and avoiding meat and dairy products entirely. I noticed a number of things in the book that bothered me. I found evidence of sloppy citations, cherry-picked references, omission of data that contradicted the thesis, and recommendations that went beyond the data. I concluded: He marshals a lot of evidence, but is it sufficient to support his recommendation that everyone give up animal protein entirely, including dairy products? I don’t think so. The China Study involved 367 variables and 8000 correlations. I said I would leave it to others to comment on the study design and the statistical analysis, and now someone has done just that.  Denise Minger devoted a month and a half to examining the raw data to see how closely Campbell’s claims aligned with the data he drew from; she found many weaknesses and errors. Campbell says Plasma cholesterol… is positively associated with most cancer mortality rates. Plasma cholesterol is positively associated with animal protein intake and inversely associated with plant protein intake. The data do show that cholesterol is positively associated with various cancers, that cholesterol is positively associated with animal protein, and that cholesterol is negatively associated with plant protein. So by indirect deduction they assume that animal protein is associated with cancers and that reducing intake is protective. But if you compare animal protein intake directly with cancer, there are as many negative correlations as positive, and not one of those correlations reaches a level of statistical significance. Comparing dietary plant protein to various types of cancer, there are many more positive correlations and one of them does show strong statistical significance. The variable “death from all cancers” is four times as strongly associated with plant protein as with animal protein. And Campbell fails to mention an important confounder: cholesterol is higher in geographic areas with a higher incidence of schistosomiasis and hepatitis B infection, both risk factors for cancer. Campbell says breast cancer is associated with dietary fat (which is associated with animal protein intake). The data show a non-significant association with dietary fat, but stronger (still non-significant) associations with several other factors and a significant association with wine, alcohol, and blood glucose level. The (non-significant) association of breast cancer with legume intake is virtually identical to the (non-significant) association with dietary fat. Animal protein itself shows a weaker correlation with breast cancer than light-colored vegetables, legume intake, fruit, and a number of other purportedly healthy plant foods.) He indicts animal protein as being correlated with cardiovascular disease, but fails to mention that plant protein is more strongly correlated and wheat protein is far, far more strongly correlated. The China Study data show the opposite of what Campbell claims: animal protein doesn’t correspond with more disease, even in the highest animal food-eating counties. These are just a couple of examples. Minger found many more, which she describes in her long article, complete with impressive graphs. Her exposé is well worth reading in its entirety, if only as a demonstration of how to think about epidemiologic data. Minger goes on to reveal gaping logical holes in Campbell’s own research on casein, a milk protein that he believes causes cancer. He showed that casein was associated with cancer when given in isolation to lab animals, but he projects those results onto humans and onto all sources of animal protein. Other animal proteins have been shown to have anti-cancer effects, and the results of a normal diet containing multiple protein sources are likely to be very different from his casein-only studies. Minger concludes  I believe Campbell was influenced by his own expectations about animal protein and disease, leading him to seek out specific correlations in the China Study data (and elsewhere) to confirm his predictions. She is being polite. This is a cautionary tale. It shows how complex issues can be over-simplified into meaninglessness, how epidemiologic data can be misinterpreted and mislead us, and how a researcher can approach a problem with preconceptions that allow him to see only what he wants to see. The China Study was embraced by vegetarians because it seemed to support their beliefs with strong evidence. Minger has shown that that evidence is largely illusory. The issues raised are important and deserve further study by unbiased scientists. At any rate, one thing is clear: the China Study is not sufficient reason to recommend drastic reductions in protein intake, let alone total avoidance of meat and dairy foods.

I can’t speak for anyone else who blogs here at Science-Based Medicine, but there’s one thing I like to emphasize to people who complain that we exist only to “bash ‘alternative’ medicine.” We don’t. We exist to champion medicine based on science against all manner of dubious practices. Part of that mandate involves understanding and accepting that science-based medicine is not perfect. It is not some sort of panacea. Rather, it has many shortcomings and all too often does not live up to its promise. Our argument is merely that, similar to Winston Churchill’s invocation of the famous saying that “democracy is the worst form of government except all the others that have been tried,” science-based medicine is the worst form of medicine except for all the others that have been tried before. (Look for someone to quote mine that sentence soon.) It’s not even close, either. SBM has produced far and away better results than any form of medicine that has come before it, which is why it’s always puzzled me that so much of “alternative” medicine seems to be a throwback to ancient, pre-scientific, sometimes religion-based medical systems that existed in the days before germ theory and a rudimentary understanding of human physiology. After all, it wasn’t until William Harvey in 1626 that doctors even knew for sure that there was a direct connection between the arterial and venous system, for example, and the sphygmomanometer wasn’t invented until 1881. Monitoring blood pressure didn’t become routine until the early 20th century, and monitoring the diastolic blood pressure wasn’t routine until the 1920s. If there’s one area that SBM needs to do better in, it’s regulating our own. To me, the license to practice medicine is a privilege, not a right. That I should even have to emphasize such a statement is bothersome to me, but all too often medical licenses, once obtained, seem to be treated as a right that can’t easily be taken away. That’s not to say that actually getting to the point of being licensed and board-certified isn’t difficult. It is. There’s the need to maintain excellent grades in college, after which there’s medical school and residency, both of which can be quite brutal. But once a physician is fully trained, board certified, and licensed, it seems that medical boards bend over backwards not to take away his license, seemingly even if he’s providing treatments so far outside the standard of care that they might as well be magic. The case that provoked this complaint from me is one I’ve written about before, namely that of the Winkler County, TX family practitioner, Dr. Rolando Arafiles, Jr.. At the time, Dr. Arafiles was selling dubious supplements, hawking colloidal silver, promoting Morgellon’s disease quackery, and had anti-vaccine propaganda on his website. It turns out that — finally! — Dr. Arafiles is facing the Texas Medical Board for his substandard practice, as documented in a story on Medscape entitled Physician in Whistle-Blower Case Charged by Texas Medical Board: The Texas Medical Board (TMB) has charged a family physician at the center of a nationally publicized whistle-blower case involving 2 nurses with poor medical judgment, nontherapeutic prescribing, failure to maintain adequate records, overbilling, witness intimidation, and other violations. The charges follow a report that the 2 nurses — Anne Mitchell, RN, and Vickilyn Galle, RN — made anonymously to the TMB last year about patient care rendered by Rolando Arafiles, Jr, MD, at Winkler County Memorial Hospital in Kermit, Texas, where the 2 nurses and Dr. Arafiles worked. After the TMB contacted him about the report, Dr. Arafiles asked the sheriff of Winkler County to investigate its source. The sheriff, the physician’s acknowledged friend and patient, traced the report back to Mitchell and Gale, who were then charged in a state court with misuse of official information, which is a third-degree felony. The American Nurses Association at the time called the criminal prosecution “outrageous,” arguing that nurses were obligated to stand up for patient safety. A local news report on the case can be found here: A brief recap of the Winkler County nurses case Readers might recall that Dr. Arafiles achieved notoriety when these two brave nurses reported their concerns about Dr. Arafiles’ substandard care to the Texas Medical Board. However, it should be noted that the failure to discipline Dr. Arafiles is not simply a problem of the TMB. Remember, prior to going to the TMB, Galle and Mitchell had taken their complaint through formal channels at the 25-bed rural hospital where they worked, Winkler County Memorial Hospital. Their complaints were in essence ignored. Moreover, it’s not as though these problems were subtle. They weren’t, and they became apparent immediately after Dr. Arafiles joined the medical staff of Winkler County Memorial Hospital, as I documented. More appallingly and all too often not mentioned or barely mentioned is that Winkler County Sheriff Robert Roberts, Jr. was not only just Dr. Arafiles friend and patient, but he had been in business with Dr. Arafiles selling supplements. In fact, during crossexamination, Dr. Arafiles even described how Sheriff Roberts had sold his nutritional supplement called “Zrii,” going so far as to hold meetings at the local Pizza Hut to recruit other sellers. No wonder when it came to chasing down these nurses, Sheriff Roberts transformed himself from Barney Fife to, as I put it, Jack Bauer on crack. At least he didn’t torture anyone — physically, that is. He certainly tortured Mitchell and Galle mentally and emotionally, destroying their careers in the process with his misuse of his power. To bring this post back to the topic of SBM and how state medical boards too often fail to restrain or discipline physicians who not only don’t practice SBM but practice medicine far enough outside the realm of SBM to be dangerous, let’s take a look in light of what we know about Dr. Arafiles the charges pending against him before the TMB: In a complaint filed last month with a state administrative court, the TMB charged Dr. Arafiles with 9 instances of substandard care. In 1 case, the TMB stated, he sutured part of the rubber from suture-kit scissors to a patient’s torn and broken thumb (in his trial testimony, Dr. Arafiles said he was attempting to stabilize the fracture). And when another patient was admitted to the hospital for an abscess caused by methicillin-resistant Staphylococcus aureus, Dr. Arafiles rubbed an olive oil solution — not on the hospital’s formulary and not approved by the US Food and Drug Administration for this purpose — on the abscess, according to the TMB. The nurses had reported to the TMB that Dr. Arafiles promoted the use of herbal medicines. I’m going to be honest right here. This doesn’t sound very bad at all compared to Arafiles’ promotion of Morgellons disease and anti-vaccine quackery, as well as his hawking of colloidal silver to treat H1N1. As a surgeon, I may frown on suturing part of the rubber from a suture kit scissors to a patient’s thumb as a not particularly effective way to stabilize anything but, given that disposable suture sets are sterile, it probably didn’t do any harm. I doubt I’d recommend yanking Arafiles’ license over this alone, although I’d probably recommend that Arafiles have a bit of education over the proper way to suture. As for rubbing olive oil on an MRSA abscess, it’s true that this is inadequate treatment in and of itself for an abscess. Although some abscesses can be treated with antibiotics alone, the vast majority of abscesses require drainage of the pus in order to heal. For skin abcesses, that usually ends up meaning “lancing” the boil, cleaning out the pus, and packing the wound daily. If the only thing Dr. Arafiles was doing were rubbing olive oil on the abscess, then there’s no doubt that would be substandard care. If, on the other hand, he were also treating it with vancomycin and/or “lancing” the boil, then, although the olive oil didn’t add anything, it’s probably didn’t do any harm or interfere with the treatment of the abscess, either. I e-mailed a representative of the Texas Nurses Association a request for the full complaint, but did not receive it in time for this post; perhaps I’ll post an addendum when I have the full text of the complaint. A strange set of charges Upon perusing the list of charges brought by the TMB against Dr. Arafiles, I find it odd that the TMB focuses on these things, rather than Dr. Arafiles’ egegrious offenses against SBM that are easily found on the Internet. More serious are the charges in this list: The TMB also alleged that Dr. Arafiles: diagnosed hypothyroidism in 1 patient without any testing and diagnosed the same disorder in a second patient despite normal thyroid function tests; prescribed hormone replacement therapy (HRT) for a woman whose lab work showed testosterone, estradiol, and progesterone levels within the normal range — HRT was contraindicated for the woman because of a history of deep vein thrombosis, which reoccurred after HRT was initiated; performed and billed for unnecessary genitourinary exams; failed to adequately document the care he provided; and engaged in witness intimidation regarding the 2 whistle-blowing nurses. The first two complaints are common in the “alt-med” world. Suzanne Somers, for example, appears to believe that virtually every woman needs supplementation with “bioidentical” estrogens, while diagnosing thyroid disorders based on dubious tests or not tests at all also appears to be a cottage industry. There’s a lot of quackery in both areas, that’s for sure. More disturbing is Dr. Arafiles’ performing unnecessary genitourinary examinations. Usually, when a state medical board examines such a complaints, it’s almost always a male physician doing unnecessary pelvic examinations. Failure to adequately document care is a bit of a catch-all; I daresay that virtually every physician could be accused of that for one or more patients if someone looked at his or her patient charts. All of these are bad. Indeed the charge of witness intimidation should go far beyond mere action against his license by the TMB. This is a felony. Given that the Winkler County prosecutor, Sheriff, and Dr. Arafiles himself are clearly part of a good ol’ boy network that closed ranks against these “uppity” nurses, the Texas state attorney general should investigate and press charges against not just Dr. Arafiles, but against Sheriff Roberts as well. What I can’t help but note is the selectivity of the choice of the TMB, given that many of Dr. Arafiles’s other offenses against the standard of care and medical ethics were right there on his website, Health2Fit, which Dr. Arafiles has eliminated since February and is not archived anywhere that I can find. I knew I should have downloaded the entire website when I was writing about this last in February. Fortunately, I kept several pages because I knew Arafiles’ website would disappear down the memory hole soon, including its links to other Morgellons sites and the section where it sells “Alka Vita Silver” to cure various ailments, including H1N1. Here are some screen shots from my archive of Dr. Arafiles’ Health2Fit website. (Note that Dr. Arafiles claims ownership of Health2Fit on his LinkedIn page.) Here’s where Health2Fit sells a “water alkalinizer” for $1,495 (click on images to embiggen): And here are some of the claims Dr. Arafiles made for his alkalinizer: Here’s Dr. Arafiles’ quack Miranda warning, which is quite extensive: Finally, here’s the page where Dr. Arafiles sells colloidal silver and claims that it is efficacious against H1N1: There are other examples, such as Dr. Arafiles taking a homeopathy course taught by Sherri Nakken and belonging to a group of physicians who prescribe intravenous hydrogen peroxide and bioluminescence therapy (whatever that is), but I think I’ve made my point, which is that Dr. Arafiles appears to have committed far more serious offenses against the standard of care and SBM than what the TMB is charging him with. In fact, other than the charge of witness intimidation, the charges that the TMB is bringing against Dr. Arafiles remind me more than anything else of the government’s prosecuting Al Capone for tax evasion. Of course, Al Capone went to jail and spent some time in Alcatraz, but it was rather unsatisfying that it was for a much lesser offense. Worse, there’s no guarantee that Dr. Arafiles will even have his medical license revoked. As I pointed out before, state medical boards are often very loathe to strip a doctor of his medical license. More than a case about a single doctor As I’ve pointed out before, the Arafiles case is about far more than just Dr. Arafiles. It’s easy for physicians like myself, who have never practiced in rural areas with few physicians but rather always in large cities or heavily populated suburban areas, to come to think that this is the way that medicine is practiced everywhere. I know I’d never be able to get away with what Dr. Arafiles got away with for as long as he got away with it. I can be easily replaced. Physicians like Dr. Arafiles cannot, and don’t think that they don’t know it. Add to that the problem that most state medical boards are understaffed, underfunded, and enforce regulations that are insufficient to deal with all the issues with which they are charged, and it’s not surprising that it takes truly egregious offenses to get their attention. Does anyone think that Dr. Arafiles would be likely to be facing the TMB this way now if he hadn’t been the focus of an internationally reported case and been caught using his crony the Sheriff to find out who had reported him and make sure they were punished. True, Galle never went to trial and Mitchell was acquitted by the jury in less than an hour, but neither of them have found work since then. Awards for integrity and bravery, as deserved as they are, don’t change that, nor does a $15,850 fine against the hospital. Unfortunately, because most states devote too few resources to their state medical boards and the enforcement of laws and regulations governing physician conduct, most state medical boards are very reluctant to go after physicians practicing “alternative” medicine as being below the standard of care because doing so involves a value judgement regarding medical science and evidence. Also, most state medical boards are made up of physicians, and if there’s one thing about physicians it’s that we all realize that all of us, even the best among us, are one mistake away from a potentially bankrupting malpractice suit. Consequently, physicians tend to be loathe to be too critical of other physicians, much less sit in judgment of their decisions or the science (or lack thereof) by which they justify their decisions. It’s far easier to go after physicians who are impaired due to drugs or alcohol, who commit obvious crimes, or who sexually abuse patients. These are offenses that virtually everyone understands and condemns in a physician (or anyone else, for that matter). No need to adjudicate on scientific evidence or clinical trials. As Kimball Atwood put it: When a physician is accused of DUI, “substance abuse,” being too loose with narcotic prescriptions, throwing scalpels in the OR, or diddling patients, the response of a state medical board tends to be swift and definitive. Shoot first, ask questions later. After all, the first responsibility of the board is to the public’s safety, not to preserving the physician’s livelihood. One might therefore expect that a physician accused of using dangerous, substandard treatments would face a similar predicament. As you’ve undoubtedly guessed, such is not the case. Indeed, it is not, and Kimball proceeded to provide four examples. Then there’s the issue of licensure itself. As we have pointed out numerous times right here on SBM, there is a concerted effort by proponents of unscientific medical modalities, such as naturopathy, to obtain licensure, or at least to make the law more friendly to them. Perhaps the most spectacular example of the latter tactic is that of Dr. Rashid Buttar. Regular readers will recall that Dr. Buttar has been under investigation by the North Carolina Board of Medical Examiners for quite some time for his tendency to diagnose cancer patients and children with autism as having “heavy metal toxicity” and then to treat them all with some variant of his chelation therapy, plus lots of supplements and other woo, of course. He even referred to the board as a “rabid dog” at one point, something that most people accused of breaking the law would probably be well-advised not to do before their case reaches trial. Dr. Buttar, however, apparently had reason to be confident. During the last two or three years, during which time the NCBME was investigating him, Dr. Buttar led a charge by the North Carolina Integrative Medical Society to get legislators to change state law to make it friendlier to practitioners of alternative medicine. He succeeded. As a result, the board didn’t think it could succeed in stripping Dr. Buttar of his medical license or even banning him from treating cancer patients and children: Dr. Rashid Buttar, whose alternative medical practice in Huntersville has been under scrutiny by the N.C. Medical Board for a decade, has accepted a reprimand from the licensing agency. But Buttar, who was facing potential restrictions to his license, instead can continue offering unconventional treatments as long as he asks patients to sign a form acknowledging his practice is outside the mainstream. The reason was clear: Mansfield, the board’s attorney, said a change in state law, which took effect in October, was partly the reason. The law, one of those that Buttar had pushed for, prevents the medical board from disciplining a physician for using non-traditional or experimental treatments unless it can prove they are ineffective or more harmful than prevailing treatments. It’s an astounding double standard. All Dr. Buttar has to do is to have patients sign in essence a waiver, an acknowledgment that what he is doing does not meet the standard of care and is not validated by science, and he can do whatever he wants, even treat autistic children with urine therapy to “boost their immune systems.” He doesn’t have to prove a thing; if the board wants to go after him it has to prove that “non-traditional” treatments are ineffective or more harmful because North Carolina law now deceptively conflates experimental treatments (which don’t get to the point of being experimental without a lot of preclinical evidence) with “non-traditional” treatments (which often have little or no good scientific evidence for their efficacy). In other words, Dr. Buttar and his ilk don’t have to demonstrate that their woo works; authorities have to demonstrate that it doesn’t. It’s a perfect reversal of what the standard of evidence should be in medicine, and means that North Carolina is now as quackery-friendly a state as there is. Meanwhile, doctors with ethics who treat patients according to science-based guidelines have to justify their treatment decisions. Nor is this a problem that is confined to the United States. Just consider how long it took the U.K. to finally strip Andrew Wakefield of his license to practice medicine. If we as physicians are ever going to counter this problem, we’re going to have to accept that the problem exists and then do two things. First, we have to restrain our longstanding impulse to circle the wagons and protect a member of the tribe at all costs, even when we know that member has stepped far afield from the land of science-based medicine. Second, we have to lose some of our reluctance, particularly at the state medical board level, to pass judgment on non-scientific treatments like homeopathy, naturopathy, or others. Being a shruggie is no longer acceptable. Our system of regulating physicians and protecting the public from quackery is clearly broken. Will we rise to the challenge to fix it, or will we allow promoters of unscientific medicine to infiltrate and destroy it? In the meantime, here’s hoping that Mitchell and Galle prevail in their civil suit against Dr. Arafiles, Sheriff Roberts, Winkler County, and Winkler County Memorial Hospital, among others. A message needs to be sent that complaints against physicians practicing below the standard of care should not endanger the livelihood of the whistleblower. ADDENDUM: A copy of the formal complaint against Dr. Arafiles can be found here.

One of my goals in writing for this blog is to educate the general public about how to evaluate a scientific study, specifically medical studies. New studies are being reported in the press all the time, and the analysis provided by your average journalist leaves much to be desired. Generally, they fail to put the study into context, often get the bottom line incorrect, and then some headline writer puts a sensationalistic bow on top. In addition to mediocre science journalism we also face dedicated ideological groups who go out of their way to spin, distort, and mutilate the scientific literature all in one direction. The anti-vaccine community is a shining example of this – they can dismiss any study whose conclusions they do not like, while promoting any horrible worthless study as long as it casts suspicion on vaccines. Yesterday on Age of Autism (the propaganda blog for Generation Rescue) Mark Blaxill gave us another example of this, presenting a terrible pilot study as if we could draw any conclusions from it. The study is yet another publication apparently squeezed out of the same data set that Laura Hewitson has been milking for several years now - a study involving macaque infants and vaccinations. In this study Hewitson claims a significant difference in brain maturation between vaccinated and unvaccinated macaque infants, by MRI and PET analysis. Blaxill presents the study without noting any of its crippling limitations, and the commenters predictably gush. The first (and really only) thing you need to know about this study is that it involves 9 vaccinated monkeys and 2 controls. That’s right – just 2 controls. The fact that Hewitson bothers to do statistical analysis on such a small set of subjects is laughable. Let’s keep in mind that most pilot studies turn out to be wrong – they are called pilot studies because they are intended to point the way to further research, not as a basis for any conclusions. Serious researches recognize that pilot studies are shots in the dark – and that counts even for good pilot studies, which this is not. If the outcome were something hard and dramatic – like survival vs death, then 2 subjects would be a reasonable pilot study. But in this case Hewitson is doing a somewhat tricky measurement of brain volume changes over time and binding of opioid ligands in the amygdala. It is also worth noting that there were originally 4 controls, but one was eliminated due to improper protocol. We never learn what happened to the third monkey, we are just told there is data on two controls. This kind of missing data, especially when the overall numbers are so pathetically low, is very concerning. She is also making multiple analyses (another red flag by itself), which means she can compare multiple variables looking for any difference. Then she invokes the sharpshooter fallacy and declares any change she does find to be clinically meaningful. So while there is no difference in brain volume or amygdala volume between exposed and unexposed monkeys, she finds differences in the change over time. We don’t know if still other variables were looked at and not reported – this is another weakness of pilot studies and why follow up studies replicating the specific effects reported are necessary before any conclusions can be drawn. As further evidence of looking for any difference then declaring that the outcome of interest, we can look back to Hewitson’s 2008 reporting of her monkey data, in which she wrote: “Compared with unexposed animals, exposed animals showed attenuation of amygdala growth and differences in the amygdala binding of [11C]diprenorphine.” But in the current study she finds increased amygdala growth in exposed monkeys: Not surprisingly, given the different maturational trajectories in exposed vs. unexposed animals, (unexposed decreasing and exposed increasing) there was a statistically significant interaction between exposure and time on total amygdala volume (Wald ?2=10.93; P=0.001). However, there were no significant main effects on total amygdala volume of either exposure (Wald ?2=0.75; P=0.39) or time (Wald ?2=1.14; P=0.29). So which is it? Reading the results of the current study, especially in light of previous publications, gives the overall impression of a random scatter of data with incredible cherry picking in order to make the argument that there are any meaningful results at all. Taken by itself, this is a worthless study. The numbers of subjects is too small to do any meaningful analysis. The results are all over the place, and not even consistent with prior publications by the same authors. The analysis is also far-fetched. Hewitson argues that both thimerosal-containing vaccine and MMR (which does not contain thimerosal) contribute to the alleged brain changes she is reporting. While the word “autism” does not appear in her report, Blaxill is concluding in his reporting that these brain changes are the same as those found in autism (an absurd conclusion given how non-specific these changes are, even if real, which cannot be concluded from this study). The anti-vaccine agenda is now clear – they get to have their cake and eat it too. They can now argue that an interaction between thimerosal and MMR cause or contribute to autism, through completely independent mechanisms, apparently. To put this study further into context, this research is being conducted by the Thoughtful House Center for Children – Andrew Wakefield’s home after he was essentially kicked out of the UK and subsequently struck off. Wakefield’s name, however, does not appear anywhere on the current study, although he was listed as final author on previous publications from the same research. Apparently his name has become too toxic for the Thoughtful House. The current study also appears in a obscure journal, Acta Neurobiologiae Experimentalis – which dedicated an entire issue to publishing dubious research on autism. The same issue includes two articles by the father and son Geier team – other vaccine and autism researchers who are off in their own world and whose research cannot be replicated. Conclusion This current study, as well as the entire macaque research program by Hewitson, is a good example of terrible research. The subject numbers are far too small for any meaningful statistics, and the outcomes being followed are numerous and tricky with a random scatter of results not even consistent between different publications of the same research. What we have is far worse than ideological reporting and spinning of the scientific research – apparently we have the ideological conduction of research in the first place. This is similar to the research program of Benveniste on homeopathy. In general it is a good rule to be suspicious of research that seems to be unique to one researcher or research team and is out of step with the broader research community. Unfortunately, such research contaminates the literature and is easily exploited to confuse the media and the public who often do not distinguish crank research from legitimate science. ___________________ Crossposted on NeuroLogicaBlog Others reporting on this study: Respectful Insolence – Orac also points out that Hewitson failed to disclose her COI – that she has a child with autism who is part of the Autism Omnibus suit. Ibrb – Author, Sullivan, also points out that amygdala size should increase in macaques, so it is especially odd that the non-exposed monkeys’ amygdalas shrank. That makes no sense, and is likely due to the quirkiness of having only two controls. So the authors conclusions are entirely based upon a weird result in their tiny control group – i.e. this is completely bunk science.

There are two topics about which I am a crank. The first, as you might have guessed, is alternative medicine. The other is pharmaceutical reps. Drug companies are somewhat schizophrenic. They have amazing scientists who invent drugs that treat an astounding array of diseases. Then, they take these drugs and turn them over to marketing, to be sold with all the enthusiasm and truthiness of a late night infomercial. In the spirit of openness, I will say that I have not talked to a drug rep in 20 years. As far as industry supported gifts and food, I have not taken a pen or eaten pizza from industry in almost 30 years, since I was a fourth year medical student. I have accepted one gift over the years. Years ago, when the Pfizer rep left, he sent me Fleets enema with a Unasyn sticker on it. I still have it in my office, unused. But you never know when it might come in handy. Being an absolutist about industry gifts does have downsides. It is distracting to sit in an auditorium filled with the smell of pizza and not eat any; somehow the PB&J I bring with me doesn’t smell as sweet. Administration has received one letter complaining about me that was ostensibly from an employee, but curiously was printed from a windows folder that had the same name as the levofloxacin rep. Just a coincidence, I am sure. As an Infectious Diseases fellow I was the on call physician for the hospitals antibiotic stewardship program where expensive or problematic drugs had to be approved before they could be released from pharmacy. It was curious how there would be spikes in approval requests, often for drugs that the surgical resident couldn’t pronounce correctly. Ain’t no drug called ciprofloxacillin, although there should be. Investigation revealed that these spikes often occurred shortly after a service was treated to a good dinner by the drug rep. Hmm. Funny thing, that. Probably just another coincidence. I remember once as an intern late at night trying to decide what antibiotic to give a patient and I decided to prescribe what was embossed on my pen. Turned out Bic was not on the formulary. Over the years it has been rare to find a physician as extremist as I am. It is curious, since the literature supports the concept that interaction with pharmaceutical reps is detrimental to patient care: docs who interact with reps are more likely to prescribe expensive and/or inappropriate drugs after being detailed. When pointed out, every doctor tells me the same thing: That may be true of others, but I am not swayed by information provided by drug reps. It is the one area of science-based medicine to which most physicians are immune, and understandably so: who wants to jeopardize free pizza? Most of the literature on the topic is collected at nofreelunch.org, which appears to be under construction. It all may be publication bias, but I know of no reference that demonstrates improved patient care as a result of physicians interacting with drug companies. So imagine my surprise when someone came out in favor of physicians learning from drug companies. Over at Slate.com is “Appetite for Instruction. Why Big Pharma should buy your doctor lunch sometimes,” by Jessica Wapner. It starts out sedately enough “The war against industry-sponsored medical education is in full tilt.” War? It is an interesting choice of words. I might have started by writing “physicians are finally reclaiming their integrity after whoring for 50 years,” but I have a dog in the fight. But with the mounting concern about ties between doctors and the pharmaceutical industry, commercially supported medical education is being axed from hospitals and university medical centers around the country. Not only is this change unfortunate for anyone with a doctor, but it also doesn’t make any sense. It does make sense if you bother to read the extensive literature. The preponderance of data strongly suggests that medical practice and research is altered, and not for the better, by interaction with pharma. She quotes only one reference in her article in support of drug company sponsored education. There is no substitute for a small group of people listening to a doctor talk about how to treat a disease. And there is no substitute for the commercial support required to run such programs. In a recent study, academic researchers were paid a modest honorarium to travel around the country teaching more than 14,000 doctors about new treatment guidelines for high blood pressure. Each researcher met with small groups of doctors to educate them about the latest advances. In counties where the most sessions took place, adherence to the guidelines rose by more than 8 percent. In counties with the fewest such sessions, adherence decreased by 2 percent. The approach that the pharmaceutical industry has been taking for years is actually an effective way to educate doctors. The “recent study” refers to “Impact of the ALLHAT/JNC7 Dissemination Project on thiazide-type diuretic use.” I pulled the article, and it does not say what the author thinks it says. What a surprise. The academic researchers were educating physicians about generic medications, it was “was supported by contract N01-HC-35130 from the National Heart, Lung, and Blood Institute (NHLBI), as well as an NHLBI mentoring award (RSS, K24HL086703),” not pharmaceutical money, and if they were paid an honorarium it is not mentioned in the reference. Academic detailing, or counter-detailing, is what is done to try and give evidenced based, minimally unbiased information about treatments in an attempt to give practitioners information free from pharmaceutical company spin and bias. Academic detailing incorporates many of the approaches used in pharmaceutical marketing. By using persuasive, individualized small group or one-on-one communication of key points, detailing can summarize findings, suggest concrete changes in practice patterns, and explore potential barriers to change. In addition, by targeting specific physicians recognized as opinion leaders, resources can be concentrated on locally influential prescribers. Several systematic reviews have examined the effectiveness of academic detailing in changing clinical practice and found this type of intervention to be effective. The effectiveness of academic detailing is described as ranging from small to strong with results that are consistently favorable. The effectiveness of academic detailing in affecting prescribing practices is particularly prominent. In this situation, even small changes in prescribing may be important when the population affected is large or where large cost differences exist between alternative medications. Academic detailing is the Spock without the goatee. The effects of the intervention was modest: The ALLHAT/JNC7 Dissemination Project was associated with a small effect on thiazide-type diuretic use consistent with its small dose and the potential of external factors to diminish its impact. What external factors may have impacted the results? …There was substantial questioning of the ALLHAT findings by recognized hypertension authorities, as well as by the pharmaceutical industry, that likely reduced the potential impact of the results on clinical practice. So the authors suggest that using inexpensive, effective generic drugs for hypertension are being undermined by drug companies. The take home message is that academic detailing, using the methods of drug reps but not their funding, is an effective alternative to pharma-financed education. It so irritates me when I read the original reference and discover it was almost completely misrepresented or misunderstood. I suppose she will be writing for Medical Voices next. When Consumer Reports discusses cars, it is education. When Chrysler discusses cars, it’s an advertisement, even if they are having Dale Earnhardt Jr. as the discussant. She also says the lack of pharmaceutical-sponsored education has lead to an increase in the misuse of drugs. No reference. So I went looking. Pubmed? Nothing. Google? The only reference is her article. Stephen Hanauer, one of the clinical investigators who developed Remicade and who has been paid to speak to doctors about it, explains that as Remicade teaching sessions have been nixed, misuse of the drug has risen and Hanauer thinks that the two phenomena are connected. The basis of the increased misuse is the experience of Dr. Hanauer. Well. Good enough for me. Lets get him back on the paid speaker trail, ASAP. Patient care depends on it. Even if the literature suggests that it is interaction with drug companies that more commonly leads to more medication mis-prescribing. Who are you going to believe, the published literature or the anecdotes of Dr. Hanauer? He has been paid to speak. I wonder how much, because the money can be substantial. However, the largest median payments were for research ($6593; range, $109-$922,239), speakers ($1430; range, $118-$154,188), consulting ($1000; range, $121-$334,180), and unspecified purposes ($1000; range, $100-$331,947). I have always thought as part of mentioning conflicts of interest at the start of a talk, speakers should be required to give a dollar amount of direct and indirect (food, hotels, airfare etc) payments they have received. Does anyone think $154,188 isn’t going to buy something? I know if I were making that kind of cash as a speaker in this economy, I would want to keep the cash cow alive. But I really shouldn’t suggest others are subject to base motivations for their actions — I sound too much like Mike Adams. Of course, if the drug company doesn’t provide food, no one will come to the talks. But surely there must be other options. Can’t doctors meet with the experts in the absence of fancy cheese? Not necessarily. Teaching sessions often take place during the lunch hour. As Hanauer, who practices at the University of Chicago School of Medicine, describes, the elimination of paid lunches sent hungry doctors to the cafeteria instead of the lecture hall. “But the lines were so long that they missed the conference,” he says. “So attendance at our grand rounds conferences went to miniscule.” Now the doctor has a sandwich but isn’t up to date on how to treat a serious disease. That may sound silly, but it’s often the mundane reality. “There are sometimes times when residents have to choose between lunch and a conference,” Richard Goldberg, an oncologist at the University of North Carolina, wrote in an e-mail. I just had to laugh. At my hospital system, administration takes education seriously and there is lunch provided at Grand Rounds. We get a sandwich and a lecture. University of Chicago is evidently not all that serious about the ’school’ part of their title. Or, I don’t know, try planning ahead: it is Wednesday and we’ve had Grand Rounds every Wednesday at noon for the last 100 years, maybe I will pack a sandwich. Pu-lease. If my doc doesn’t have enough on the ball to plan for eating at conference, I don’t want them prescribing my Remacaid. Of course, I don’t know how I manage to keep up in my field with no pharmaceutical support. I can’t read journals, can’t use websites like Medscape (I am a paid blogger for Medscape, so of course I suggest them), can’t go to conferences, can’t listen to podcasts, can’t attend meetings, can’t do the MKSAP. There is such a wealth of educational opportunities in medicine to keep up you have to be either lazy or stupid not to find them. It does takes discipline and time to keep up. I spend a minimum of 24 hours a month on CME. If you want job that requires no continuing medical education, perhaps you should be a naturopath or homeopath. Part of being an MD is the endless education it takes to stay current. The problem is that drugs have more and different uses than the FDA approved indications and the only way that information can be disseminated is pharma sponsored education. Only way? Sure worked for Neurontin. …ParkeDavis executive reportedly told Franklin, I want you out there every day selling Neurontin. . . . We all know Neurontin’s not growing for adjunctive therapy, besides that’s not where the money is. Pain management, now that’s money. Monotherapy [for epilepsy], that’s money. . . . We can’t wait for [physicians] to ask, we need [to] get out there and tell them up front. Dinner programs, CME programs, consultantships all work great but don’t forget the one-on-one. That’s where we need to be, holding their hand and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything. I don’t want to see a single patient coming off Neurontin before they’ve been up to at least 4800 mg/day. I don’t want to hear that safety crap either, have you tried Neurontin, every one of you should take one just to see there is nothing, it’s a great drug… The Neurontin marketing plan consisted of both general strategies such as the promotion of Neurontin use among high-prescribing physicians and cultivation of thought leaders and tactical programs. Local physicians were recruited, trained, and paid to serve as speakers in “peer-to-peer selling” programs, which the company saw as “one of the most effective ways to communicate our message.” Academic leaders were solicited with educational grants, research grants, and speaking opportunities; some received up to $158,250 over a 4-year period. Advisory boards and “consultants” were convened so that the firm could cultivate relationships with them and deliver “a hard-hitting message about Neurontin. Marketing “tactics” included education, publications, and research whose promotional intent was disguised, in addition to more transparent activities, such as advertising and sales visits. “Educational programs” reflected the belief that “medical education drives this market!” Teleconferences involving practicing physicians were moderated by physicians who were paid as much as $176,100 over 4 years. ParkeDavis formed speakers bureaus and sought “strong Neurontin advocates and users to speak locally for Neurontin.” “Unrestricted educational grants” were made to for-profit medical-education companies that produced programs to discuss unapproved uses of Neurontin and to grant credit approved by the Accreditation Council for Continuing Medical Education. Yep. That’s what I want for continuing medical information, programs that resulted in payments “of more than $430 million to resolve criminal charges and civil liabilities.” Of course, industry has learned their lesson. I can trust industry, and my patients life and health, with information about off-label indications provided by an industry that stands to profit from giving me the information. “There’s an old saying in Tennessee — I know it’s in Texas, probably in Tennessee — that says, fool me once, shame on, shame on you. Fool me, you can’t get fooled again.” She concludes: But the entanglement caused by for-profit drug development can’t be undone by eliminating the free lunch. As one physician suggested, perhaps pharmaceutical companies should be required to pay for medical education. After all, if companies are going to unleash new drugs into the world, shouldn’t they be responsible for teaching people how to use it? Ousting commercial support is creating a huge chasm in medical education, leaving doctors not only hungry but also starved for knowledge. No, but it is a start. Physicians can take responsibility for their own education. And lunch isn’t free. In the end, our patients pay for it. The price of drugs, in part, takes into account the cost of advertisement. Maybe you feel it is fine for the underinsured to pay $1500 out of pocket for a 10-day course of linezolid, but I can’t justify my patients indirectly subsidizing my pizza and education. While we are at it, let’s have MacDonalds be responsible for teaching nutrition, Nintendo teach us about fitness, lobbyists determine congressional voting, tobacco companies provide research cancer and oil companies tell us the cause of global warming. “The only way that information can be disseminated is ‘fill in the industry’ sponsored education” indeed. Perhaps as professionals, doctors should be responsible for their own education, especially when the lives and health of their patients may depend on it. The conclusion of the only other journal article referenced sums it up: … attending sponsored CME events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor’s medication. Attending presentations given by pharmaceutical representative speakers was also associated with non rational prescribing. That’s the chasm being created by banning pharma-sponsored education: more rational prescribing, more physician integrity and patient trust, better education and information. I can live with that, and so can my patients.

NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable of writing a shorter post than is Dr. Gorski. … On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which “exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a ‘quality chasm’.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its “100,000 Lives Campaign” and, more recently, its “5 Million Lives Campaign.” Berwick’s CMS gig is a “recess appointment”: it was made during the Senate’s July 4th recess period, without a formal confirmation hearing—although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama had made the recess appointment in order to avoid a reprise of “last year’s divisive health care debate.” The president had originally nominated Berwick for the position in April, and Republicans have opposed “Berwick’s views on rationing of care,” claiming that he “would deny needed care based on cost.” A “Patient-Centered Extremist” If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described “Patient-Centered Extremist.” He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the “professionally dominant view of quality of health care”: I think it wrong for the profession of medicine—or any other health care profession, for that matter—to “reserve to itself the authority to judge the quality of its work.” I eschew compromise words like “partnership.” For better or worse, I have come to believe that we—patients, families, clinicians, and the health care system as a whole—would all be far better off if we professionals recalibrated our work such that we behaved with patients and families not as hosts in the care system, but as guests in their lives. I suggest that we should without equivocation make patient-centeredness a primary quality dimension all its own, even when it does not contribute to the technical safety and effectiveness of care. A new definition. My proposed definition of “patient-centered care” is this: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care. Does this mean that Dr. Berwick would also eschew professional, i.e., expert, judgment in favor of patients’ wishes? In a word, yes: Evidence-based medicine sometimes must take a back seat. First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.” Dr. Berwick is not so naive as this opinion might suggest. He envisions a “mature dialogue” in such a case, and argues that “if, over time, a pattern emerges of scientifically unwise or unsubstantiated choices…then we should seek to improve our messages…” He also admits that there might be an occasional patient whose demands are so unreasonable that “it is time to say, ‘No’.” That exception, he argues, should not dictate the rule. There are situations in which most civilized people would agree with Dr. Berwick’s view of ‘patient-centeredness’. In both the Health Affairs article and in his recent address to the 2010 graduating class of the Yale School of Medicine, he offered real examples of petty, arbitrary hospital rules causing unnecessary sorrow for patients and their loved ones. It is in such contexts that he makes a convincing case that health professionals ought to behave “as guests in their lives.” In an interview for the New York Times, he argued: We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated. Nothing to disagree with there. To create that standard, moreover, would not undermine settled medical practice ethics—it would celebrate them, even as it rightly embarrasses the profession for having taken so long to do so. Enter the Woo Eschewing the scientific basis for modern medical practice, however, is another matter. In February of 2009, Dr. Berwick gave a ‘keynote’ address at the IOM and Bravewell Collaborative-sponsored Summit on Integrative Medicine and the Health of the Public. He shared the podium with Mehmet Oz, Dean Ornish, Senator Tom Harkin, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term “integrative medicine“: literature emanating from the Summit characterized it as “preventive” and “patient-centered,” whereas the only characteristic that distinguishes it from modern medicine is its inclusion of various forms of pseudomedicine. I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions. I didn’t bother to listen to his speech until the CMS appointment was announced a few days ago. It is troubling, to say the least. Dr. Berwick did not argue, as he had in the NYT piece, that “If we doctors feel a person is going to make unwise choices, we have to take on the responsibility of being teachers, educators and informers.” Rather, he praised his fellow speakers, most of whom were spouting nonsense, for their “reach” and “eloquence.” He praised the IOM for its “glorious record…in pursuit of better designs in health care…traditional, allopathic curative care and now migrating into this distinguished and important new arena.” He mentioned homeopathy and acupuncture, not to wonder why they should be promoted as effective, but merely to warn that they will fail—presumably in some economic sense—if they try to compete with each other for reimbursement. Such language, and Dr. Berwick’s very presence at the Summit, were a far cry from advocating “patient-centeredness.” What they amounted to was a generous endorsement of pseudoscientific practices and of the socio-political movement that promotes them. Even granting some naivete on his part (he called himself “an amateur at this topic”), he must have known this. Such an endorsement, unlike tearing down the “technocratic castle,” has ethical implications at least as profound as those that Dr. Berwick tacitly or explicitly relies upon to support his arguments for patient-centeredness. “Physicians have no Immunity to Moral or Ethical Constraints” The relevant medical ethics treatises (reviewed here) are in substantial agreement that it is unethical for physicians to prescribe scientifically implausible methods or to refer patients to other practitioners for the same purpose. They are also in agreement that it is unethical to prescribe a placebo to a patient while claiming that the treatment has specific biologic activity—a point that has been vigorously argued in the UK this year, with regard to homeopathy. These ethical tenets are not mere odes to nerdy, sciency thinking; they are matters of honesty and integrity—fundamental bases for ethical interactions between physicians and patients. In 1983, philosophers Clark Glymour and Douglas Stalker published an article in the New England Journal of Medicine titled “Engineers, cranks, physicians, magicians.” They framed modern medicine as follows, comparing it to what was then called “holistic medicine” (the article is quoted extensively here): Medicine in industrialized nations is scientific medicine. The claim tacitly made by American or European physicians, and tacitly relied on by their patients, is that their palliatives and procedures have been shown by science to be effective. Although the physician’s medical practice is not itself science, it is based on science and on training that is supposed to teach physicians to apply scientific knowledge to people in a rational way. The practice of medicine in the United States and in other industrialized nations is a form of consultant engineering… That statement is just as accurate now—even more so, in this era of Evidence-Based Medicine—as it was nearly 30 years ago, even if some might find the likening of medicine to engineering displeasing. Nor is it at odds with almost any definition of “patient-centeredness,” other than one that presumes that the patient’s desires trump the physician’s ethics: A physician engineer can act as consoler; nothing in either logic or social psychology forbids it. But certain combinations are impossible or extraordinarily unlikely. A physician engineer cannot honestly claim powers of magic or occult knowledge. The principles governing scientific reasoning and belief are negative as well as positive, and they imply that occult doctrines are not worthy of belief. Moreover, physician engineers have no immunity to moral or ethical constraints. On the contrary, they are by training and by culture enmeshed in a tradition of rational thought about the obligations and responsibilities of their profession. Dr. Berwick—if he really believes what his presence and words at the “Integrative Medicine” Summit imply—is playing with ethical fire. (If, as I hope, he doesn’t really believe those things, he’s playing with ethics of another kind). Will we begin to see pseudomedicine “integrated” into Medicare and Medicaid? That is certainly the expectation of those who observed Dr. Berwick’s performance at the Summit, and who appear intent to hold him to his word.

I was a bit torn when trying to figure out how to approach this piece.  A reader emailed me about an article in the Huffington Post, and there is so much wrong with it that I felt overwhelmed.  My solution is to focus on a few of the problems that can help illuminate broader points. There is a small but vocal movement of people who refuse to believe that skin cancer caused by sunlight is a significant health risk.  These people tend to also believe that the risk is being purposely hyped by others, and that our current approach to skin cancer prevention is causing an epidemic of vitamin D deficiency. Leaving aside the seemingly insane denialism regarding sunlight and cancer, there are two broad problems with this article.  The first is pretty bad. With the summer months upon us I wanted to find out firsthand what exactly the mantra is that dermatologists are telling patients. So I went undercover to several San Francisco dermatologists in order to see if there is legitimate concern about the sun-scare media hype. Are these doctors being sensible or going overboard when it comes to advice on sunscreen use and skin cancer prevention? Is the sky falling with dangerous UV rays or are we being induced into a media panic? He goes on to give links to recorded conversations, and prints out partial transcripts.  He does not specify whether or not he received permission to record these conversations, as required by California law.  Whether or not the law requires it, the writer should have disclosed to his readers whether or not he had received permission.  This information is important in interpreting the conversations he reports to us. The next problem is broader, and deals with physicians’ willingness to lie on behalf of patients.  The author’s presumably-clandestine recordings of his deceptive visits to dermatologists (catching my breath—this is striking and requires a digression.  The act of deceiving these doctors is not only unethical, but can influence the outcome of the visit.  Doctors make the assumption that most patients are interacting with them out of good faith, and are not intentionally deceiving them.) In the first conversation the author has with a doctor, the interviewer makes it clear that he wants a mole removed, and the doctor essentially leads him to say “the right thing” so that insurance will cover the procedure.  One thing the author seems to miss is that the dermatologist is going to be paid whether or not insurance covers the procedure.  If the insurance company says “no”, the patient will be billed.  The doctor is lying for the patient, not for herself. Data have shown that physicians are willing to lie on behalf of patients. There are a number of reasons that this poses ethical problems.  It could be argued that the doctor is lying to help get the patient something that they need, and that lying is a peccadillo compared to the benefit.  This can backfire in a number of ways, not least of which is that both the doctor and the patient can probably be prosecuted for fraud, something that is unlikely to be of benefit to either one. But there is a fine line between a lie and a truth, one that anyone familiar with the intimacies of the exam room will often experience.  As a doctor, your overall impression may be that the patient is at high risk for coronary artery disease, but perhaps the patient doesn’t quite meet the insurance company’s criteria.  You can then lay out the cost of the test and the risks and benefits for the patient, but I wouldn’t be surprised if some doctors took the short cut of asking, “are you sure you’ve never had any chest pain or difficulty breathing?” He begins his second dermatology visit by telling the doctor that he has a family history of melanoma, and finds fault in the doctor’s description of the statistics of the disease.  The problem of properly rendering statistics is a common one, and he links to an excellent piece by Ivan Oransky explaining the difference between relative risk and absolute risk.  Unfortunately, he uses this to spin a tale of some sort of dermatology conspiracy to inflate cancer numbers.  Skin cancers (including melanomas and non-melanoma skin cancers) are very, very common, and though many are not fatal, their diagnosis and treatment can be expensive and disfiguring. His visit continues and the doctor tells him that insurance won’t cover his mole removal because it’s not necessary, and refuses to lie in the medical record. The doc then gives some sound medical advice about how to prevent skin cancers. I then ask what measures I should take to prevent skin cancer. I’m told to apply sunscreen 24/7, wear a hat and sunglasses, as well as avoid the sun as much as possible. (The only thing she doesn’t mention is to live underground with the mole people.) “Mole people”?  He asked the doc how to prevent skin cancer, the doc gave the correct answer.  It’s up to the patient to decide if the application of sunscreen is too onerous for the potential benefit. This article shows a misunderstanding of journalistic ethics, medical ethics, and medical science.  It’s a disaster.  And it’s no surprise that it’s in the Huffington Post.

Last week at TAM8 some SBM colleagues (David Gorski, Kimball Atwood, Harriet Hall, Rachel Dunlop) and I gave two workshops on how to find reliable health information on the web. As part of my research for this talk I came across a recent and interesting study that I would like to expand upon further – Quality and Content of Internet-Based Information for Ten Common Orthopaedic Sports Medicine Diagnoses. The fact that the article focuses on orthopedic diagnoses is probably not relevant to the point of the article itself, which was to assess the accuracy of health information on the web. They looked at 10 orthopedic diagnoses and searched on them using Google and Yahoo, and then chose the top results. They ultimately evaluated 154 different sites with multiple reviewers for quality of content and also for their HON rating. For background, the HON rating comes from an independent organization, the Heath on the Net Foundation, that rates health care sites on a number of criteria. These include assessment of how authoritative the sources are, the level of transparency, and if opinions expressed are justified with evidence and references. While generally reasonable, the HON assessment does not necessarily involve a thorough assessment of the quality of the science on a given website, and many sites with what I would consider dubious information have earned the HON seal of approval. Among other things, this new study evaluated how scientifically accurate health information on the websites they reviewed was, and also compared them to their HON ratings. They divided the websites evaluated into various types – non-profit, academic, commercial, and individually run. What they found was that the quality of information was significantly better on non-profit and academic sites than on commercial and individually run sites. This is not surprising – commercial sites are likely to be compromised by a desire to advertise or sell product. But “commercial” also refers to sites that monetize content – not necessarily selling products, but simply providing content as their product in order to sell advertising. This includes sites such as WebMD. It is also not surprising that individual sites also scored relatively low on average. An individually run site is only as good as the individual running it, so there is bound to be a great deal of variability. Also, individuals are more likely to make mistakes or have missing information than groups. Non-profit and academic sites are more likely to have editorial policies that emphasize quality and integrity of content. But also they are more likely to have some vetting process for information. At SBM (a non-profit site) for example, we carefully guard our editorial integrity and also provide some layer of editorial oversight. But the study also provides reason to be cautious, even about the best sites. They rated quality of information on a 100 point scale and found a range of 45-61%. So even the best sites had a mediocre score. This is likely due to the fact that health information is complex and rapidly changing. Nothing short of a thorough editorial and peer-review process is likely to generate both reliable and thorough up-to-date information. This study is therefore reason for all providers of health information on the net to raise their game. There is definitely room for improvement. The study also found that having the HON seal of approval did significantly correlate with higher quality and integrity scores. So the code does mean something, even if it is still not a guarantee of science-based content. Conclusion Further study of health information on the net is warranted as the results of this one study argue for caution. For providers it suggests we need to improve our filters and editorial process to improve the quality of our content. For consumers the results suggest that non-profit and academic health information sites are most reliable, while commercial and individual sites should be viewed with caution. But further I would suggest to consumers of health information on the net that no single site or article should ever be relied upon for information. The best way to get a thorough and accurate treatment of a health topic is to look at multiple sites. Try to determine what the consensus of opinion and information is, and be very wary of outliers. This is generally good advice for any research, not just health information.

Wouldn’t it be great if we could find a way to prolong our lives and to keep us healthy right up to the end? Ponce de León never found that Fountain of Youth, but science is still looking. What are the chances science will succeed? How’s it doing so far? In his new book The Youth Pill: Scientists at the Brink of an Anti-Aging Revolution, David Stipp tries to answer those questions. From the title of the book, I expected hype about resveratrol or some other miracle pill; but instead it is a nuanced, levelheaded, entertaining, informative account of the history and current state of longevity research. It makes that research come alive by telling stories about the people involved, the failures and setbacks, and the agonizingly slow process of teasing out the truth with a series of experiments that often seem to contradict each other. Anti-aging can mean several things. Extending the average lifespan is not the same as extending the maximum life span. Extending lifespan is not the same as preventing the degenerative changes characteristic of aging. We don’t even have a handle on why we die, why we deteriorate over time, or how it could benefit “selfish genes” for women to live past menopause. Several contradictory evolutionary explanations have been proposed. Comparisons with other species have not been helpful: every hypothesis has run up against counter-examples. Generally, the lifespan of animals correlates with body size; humans live longer for their size than expected. Some animals appear not to age. Naked mole rats are a fascinating anomaly: these animals that live in colonies underground and look like saber-toothed sausages live a long life for their size and appear not to show the usual changes of aging even though they have high levels of free radical damage and low levels of antioxidants (70 times less glutathione activity than mice). Scientists hoped to find an aging gene that they could turn off. It’s not that simple. A large number of genes are involved in aging processes, and there are unpredictable interactions between them. Studying centenarians has provided inconsistent clues. Antioxidants neutralize the free radicals that cause cell damage. They sounded promising, but their effect is modified by many factors, they can harm as well as help, and raising their levels with supplements may even turn off some of the body’s natural defenses. Telomerase (the enzyme that keeps the ends of chromosomes from fraying as they age) was another false lead. Drugs that slow aging by boosting telomerase may cause cancer, and it turns out that telomere shortening isn’t the chief driver of body-wide aging. The most promising idea is severe calorie restriction (CR). It prolongs life in several species, but this effect has not yet been verified in humans. And it is inconsistent and may have different effects at different ages and in different individuals. CR lowers body temperature and fertility and has other side effects. It is not an option most people would willingly choose. Scientists have studied the chemical changes in CR humans and are looking for a pill that will cause those same changes while allowing people to eat unrestricted calories. Two main candidates have surfaced. Resveratrol (a substance found in red wine) seems to work: it allows overfed mice to live longer and stay healthier. It appears to have a number of benefits in lab animals, but human studies have not been done and it appears that very large doses will be required (comparable to the amount you would get by drinking 200 bottles of wine a day). Rapamycin extends the life of mice and prevents various diseases, but it also inhibits protein synthesis in the brain, suppresses immune function, and raises cholesterol. Researchers are trying to find related compounds that offer the benefits without the harms. There are all too many variables that can interfere with the results of a study. In one experiment, the female mice lived longer with treatment but the males didn’t. They finally figured out that was because the males’ cagemates were killing them! Stipp does an excellent job of presenting the theoretical underpinnings, the experiments, and the difficulties of anti-aging research. The subject is overwhelmingly complicated, but he simplifies it enough to at least help the reader understand how very complicated it is. There are longevity clinics and anti-aging products on the market offering all kinds of promises that go way beyond the knowledge. Futurist Ray Kurzweil takes handfuls of supplement pills and spends one day a week getting IVs and other treatments at a longevity clinic and he is convinced this regimen will keep him alive until science finds a way to keep him alive forever. The author of The Youth Pill is more conservative. He is enthusiastic about the promising research on pills like resveratrol and rapamycin, but he’s reluctant to start taking them “until enough clinical data are available to let me make a reasonably well-informed decision about optimal dosing.” Me too.

There’s been a bit of buzz in the health blogs over President Obama’s decision last week to use the mechanism of a recess appointment to be the director of the Centers for Medicare and Medicaid Services (CMS). Recess appointments, for those who may not be aware, allow a President to put a nominee in place when Congress is in recess in order to have him in place without the messy process of having him approved by the Senate. True, the Senate still has to approve a recess appointment by the end of its term, or the seat goes vacant again, but it’s an excellent way to avoid having nasty confirmation fights during election years. Of course, both parties do it, and the reaction of pundits, bloggers, and politicians tend to fall strictly along partisan lines. If you support the President, then a recess appointment is a way to get around the obstructionism of the other party. If you don’t support the President, it’s a horrific abuse of Presidential power. And so it goes. Either way, I don’t really care much about the politics of how such officials are appointed so much as who is being appointed. The man who was appointed last week to head CMS is Donald Berwick, M.D., CEO of the Institute for Healthcare Improvement. His being placed in charge of CMS will likely have profound consequences not just for how the recent health care/insurance reform law is implemented but for how the government applies science-based medicine to the administration of the this massive bill. Most of the criticism of his views that I’ve seen thus far comes from conservatives, who do not like Berwick’s apparent penchant for health care systems like the British NHS. Ironically, it’s views held by Berwick that will likely come into direct conflict with his mandate to hold down costs that are the problem with Dr. Berwick, at least to me. It is in these views where there is much that is admirable. Unfortunately, I also fear that there is much about Berwick’s views that are very friendly to the possibility of allowing the infiltration of woo into the U.S. health care system as well, and these fears begin with what Berwick is most known for, a term he calls “patient empowerment.” What a grand word! After all, who doesn’t want to be “empowered”? Certainly not me. Perhaps that’s the reason why it’s become the new buzzword in a movement known as “patient-centered” care. Old fart that I am, when I first encountered the term I was a bit puzzled by exactly what “patient empowerment” means. After all, I’ve always thought I have been practicing patient-centered care, ever since my first days in medical school. Apparently these days it means something different, at least if this article from about a year ago in the New York Times is any indication. It’s an interview with Dr. Donald Berwick, who advocates what he himself calls a “radical” patient-centered care, having at the time recently published an article in Health Affairs entitled What ‘Patient-Centered’ Should Mean: Confessions Of An Extremist. It was unclear to me then and it’s unclear to me now whether Berwick was being sarcastic or flippant in his characterization of himself as an “extremist.” What is “patient-centered care”? Patient-centered care seems, at least from the wording of the term, like an unequivocal good, like mom and apple pie, but is it? Let’s start with the good. In his Health Affairs article from a year ago, Dr. Berwick attacked some aspects of the health care system that richly deserve attacking, specifically the inflexibility of so much of it: Three years ago, a close friend began having chest pains. She headed for a cardiac catheterization, and, frightened, she asked me to go with her. As I stood next to her gurney in the pre-procedure room, she said, “I would feel so much better if you were with me in the cath lab.” I agreed immediately to go with her. The nurse didn’t agree. “Do you want to be there as a friend or as a doctor?” she asked. “I guess both,” I replied. “I am both.” “It’s not possible. We have a policy against that,” she said. The young procedural cardiologist appeared shortly afterward. “I understand you want to have your friend in the procedure room,” she said. “Why?” “Because I’d feel so much more comfortable, and, later on, he can explain things to me if I have questions,” said my friend. “I’m sorry,” said the cardiologist, “I am just not comfortable with that. We don’t do that here. It doesn’t work.” “Have you ever tried it?” I asked. “No,” she said. “Then how do you know it doesn’t work?” I asked. “It’s just not possible,” she answered. “I am sorry if that upsets you.” Moments later, my friend was wheeled away, shaking in fear and sobbing. What’s wrong with that picture? Most doctors and nurses, I fear, would answer that what is wrong with that picture is the unreasonableness of my friend’s demand and mine, our expecting special treatment, our failure to understand standard procedures and wise restrictions, and our unwillingness to defer to the judgment of skilled professionals. I disagree. I find a lot wrong with that picture, but none of it is related to unreasonable expectations, special pleading, or disrespect of professionals. What is wrong is that the system exerted its power over reason, respect, and even logic in order to serve its own needs, not the patient’s. What is wrong was the exercise of a form of violence and tolerance for untruth, and–worse for a profession dedicated to healing–needless harm. To the extent that hospital policies are rigid, inflexible, and not necessarily in the patient’s best interest, Dr. Berwick remains on firm ground. In counterpoint, I will admit that I’ve had the occasional request by a family member to be in the operating room when I’m working and personally I don’t in general think it’s a good idea to allow friends and family in the operating room. I do, however, think it would be acceptable for everyone, as is done with pediatrics, to allow a family member or friend into the O.R. until the patient has gone to sleep. Be that as it may, I don’t disagree at all that many hospitals have policies and procedures that are not patient-friendly, much less patient-centered. Indeed, I’ve at times referred to such policies as “patient-hostile” and encountered them when visiting family members in the hospital. Coming from that perspective, I can say unequivocaly that Dr. Berwick was perfectly correct to castigate such policies. He even described three maxims of patient-centered care that are indeed quite admirable: “The needs of the patient come first.” “Nothing about me without me.” “Every patient is the only patient.” The first maxim is self-explanatory. The second refers to the need to collaborate with the patient, not to make decisions without informing the patient and discussing them with him. The third is more or less a restatement of the first, at least in my book. Dr. Berwick, however, takes it farther: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care. While this sounds on the surface quite reasonable, as in many things the devil is in the details, more specifically in the interpretation of what these things mean. There is no doubt that the age of the paternalistic, “doctor knows best” model of health care is gone. For the most part, this is a good thing, although at times I’ve discovered that there are actually quite a few patients who actually want their doctors to tell them what to do. They become uncomfortable, sometimes even angry, when I present options to them, discuss the pros and cons of each option, and in essence leave the choice to them with my advice as to which option I consider the best. Indeed, early in my career, I actually got feedback from my division chief that I was perceived as being too wishy-washy and indecisive by some patients, as though presenting options suggested indecision. Maybe back then I just wasn’t that good at doing it yet, and I got better with time. At least, I hope so. In any case, it’s a fine balance, and, I suspect, patients expect more decisiveness from surgeons, who are going to cut into their bodies, than from internists, who are not. Be that as it may, I fully accept that every doctor-patient relationship should represent a collaborative effort in which patient needs and wants need to be taken into account and, wherever it doesn’t conflict with science- and evidence-based medicine, patients’s wishes should be paramount. That’s where Dr. Berwick and I part company. He doesn’t think that clear science- and evidence-based guidelines should trump patient desires: First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. [Emphasis mine.] One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.” I contemplate in this a mature dialogue, in which an informed professional engages in a full conversation about why he or she–the professional–disagrees with a patient’s choice. If, over time, a pattern emerges of scientifically unwise or unsubstantiated choices–like lots and lots of patients’ choosing scientifically needless MRIs–then we should seek to improve our messages, instructions, educational processes, and dialogue to understand and seek to remedy the mismatch. I’ll give Dr. Berwick credit. He’s an idealist. I’ll test his idealism in a minute. What “patient-centered” medicine means: Patients as consumers In order to find out more about what “patient-centered” care means, let’s move on to an interview in the NYT with Dr. Berwick from June 2009: When you are in a position of having to deny and exclude patients, it is draining on the spirit. I actually think the mode I am counseling would be more satisfying or joyous for caregivers. Not all of the time or always, but it would be a better place to be. You would be putting yourself at more of a level with the patient, as more of a peer. And you wouldn’t have to carry on as if you were mythical. Medicine is imperfect and doctors know that. I wasn’t sure I liked where Dr. Berwick’s train of thought was going then, and now, a year later, I’m sure I have some serious misgivings about it. First off, these days it’s a bit of a straw man. Physicians, by and large, have come down off their pedestals, at least in part. Even so, I would posit that professional expertise still matters. Dr. Berwick seems to think that it should take a back seat to patient wants, which is reasonable occasionally but most definitely not in many situations. In fact, Dr. Berwick seems to view patients as consumers more than anything else and physicians as service providers whose primary purpose is to satisfy these consumers, just like any other service provider or merchant. Worse, my impression at the time I read his interviews was that Dr. Berwick seems to think that medicine is easy: Medicine is not nuclear physics. Most adults and kids can basically understand. There can be uncertainty in medicine, but if there’s mystery, something is wrong. Medicine’s so easy, even kids get it? Is that like “So easy, even a caveman can do it?” I wonder what Dr. Berwick would make of the case of Daniel Hauser, the 13-year-old who, with the indulgence of his parents, refused life saving chemotherapy and radiation for his Hodgkin’s lymphoma. Perhaps I’m not Dr. Berwick’s intellectual equal (being nothing more than just a dumb surgeon and all), but personally I don’t find medicine that easy at all, at least not keeping up with the science and evidence and applying it to individual patients. Heck, and I’m a subspecialist. The breadth of knowledge that I have to keep up with isn’t nearly what it is for an internist like Dr. Lipson, although, granted, I’m supposed to substitute depth for breadth. Maybe my communication skills are simply inferior to those of Dr. Berwick, but I don’t think it’s easy (as Dr. Berwick seems to be implying that it is) to explain complex medical issues in language a patient with no background in medical science can grasp. Indeed, I always wonder if and how I can do better. In essence, Dr. Berwick is advocating that we move away from a professional model of medicine to a more consumerist model. In this view, he is the perfect enabler for pseudoscience in medicine. After all, if evidence-based medicine should “sometimes” take a back seat to patient desires, then there’s no reason to deny patients quackery if they request it, is there? Certainly Dr. Berwick doesn’t provide any guidance on this score that I’ve been able to find. How far outside of evidence-based medicine does a patient desire have to be before a physician can properly refuse to acquiesce to it? It would seem there are no limits. Then there’s the word “sometimes.” I wonder what Dr. Berwick means by that word. He seems to argue that, if patients make choices that conflict with science-based medicine, then over time we physicians should be able to persuade them why such choices are not in their best interest. If not, he is saying, then it is our fault for not getting the message through well enough. While there’s some merit to the contention that it is our responsibility as physicians to present science-based medicine in a way that patients can understand and explain to them why certain choices are not justified by the evidence and that we all too often fail in that task, what should we do when patients have heard the message, tell us that they understand, but reject the message? For example, take the example of the patient asking for an MRI that isn’t indicated. What would Dr. Berwick do if he had explained to the patient that the MRI wasn’t indicated, laid out the evidence for that position, and the patient said he completely understood but wanted the MRI anyway? There’s nothing in Dr. Berwick’s writings or statements that indicate to me any guidelines whatsoever that allow a physician practicing his brand of “patient-centered” care to decide when it is acceptable to refuse a patient’s request for non-science-based medical interventions. The best he can come up with is this: I can imagine just as easily as my critics can a crazy patient request–one so clearly unreasonable that it is time to say, “No.” A purely foolish, crazy, or venal patient “want” should be declined. But my wife, a lawyer, told me long ago the aphorism in her field: “Hard cases make bad law.” So it is in medicine: “Exceptional cases make bad rules.” You do not successfully rebut my plea for extreme patient-centeredness by telling me that, on rare occasions, we ought to say, “No.” I say, “Your ‘rare occasions’ make for very bad rules for the usual occasions.” See what I mean? Dr. Berwick dismisses exceedingly unreasonable requests as “rare.” They’re not. I’ll give him an example of one such unreasonable, non-science-based request that is not at all rare and wonder how he would respond to it. Regular readers of this blog can probably guess where I’m going with this. Of course, before I get there, I could always ask what Dr. Berwick would do if a patient wanted him to zap his liver flukes “zapped” à la Hulda Clark to cure his cancer, but I hope that he would consider such a request to be a request “so clearly unreasonable that it is time to say, ‘No.’” One hopes that Dr. Berwick’s vision of patient empowerment would have at least that as a limit. I’m not so sure, though, because Dr. Berwick has given no examples for a patient-centered physician to use as guidance for when it would be acceptable to say “no,” presumably because he considers such examples to be so rare. Unfortunately, there is another request that thousands of pediatricians all over the nation face each and every day that is not evidence-based and, even worse, endangers public health. That’s right. I’m talking about the antivaccine movement, which has placed so much misinformation in the public sphere that thousands upon thousands of parents have been sufficiently frightened that vaccines will make their children autistic, thanks to propaganda efforts by useful idiots like Jenny McCarthy, that they refuse vaccines for their children. Let’s say that a Berwick-like physician has used every tool in his patient-centered armamentarium of “education” and “information exchange” to try to persuade these parents that vaccination is safe and effective. Let’s say they still refuse. What would Dr. Berwick do then? He is, after all, a pediatrician, and this is a common problem that pediatricians face. Come to think of it, the fact that Berwick seems blissfully unaware of this particular threat to public health does not leave me with the impression that he’s actually hooked into what’s going on “in the trenches,” so to speak. The problem to which Berwick seems oblivious is that this is an example of a non-science-based patient request that is not at all rare and that is incredibly resistant to the “information exchange” that he touts above all. It is also a request that doesn’t just affect that patient; it endangers public health. What would Dr. Berwick do about that? It doesn’t even have to be the anti-vaccine movement. Patients ask for or even demand non-science-based care all the time. Antibiotics for viral infections is an excellent example, and thanks to physicians’ overuse of antibiotics, among other factors, bacteria are becoming more and more resistant to once powerful antibiotics. These are issues that don’t just affect individual patients who demand care not based on science; declining vaccination rates and bacterial resistance to antibiotics potentially endanger everyone. I believe in the collaboration between me and my patients in order to solve their problems if we can. However, contrary to Dr. Berwick’s belief, most patients are not my “peers,” at least not in the professional sense. They may be my peers in the human sense, but working together to try to treat their medical problem is not the same thing as their being my professional peers. I view the collaborative nature of the doctor-patient as a consultation. The patient is coming to me for my expert opinion, and I try to deliver, at the same time trying to educate the patient about her disease process and why science-based medicine recommends what it does. I try as much as possible to take into account what the patient wants and provide science-based options acceptable to the patient. For example, a while back I very strongly advised against a bilateral mastectomy on a patient who had been diagnosed with a very tiny pre-invasive breast cancer (ductal carcinoma in situ), had no family history of breast cancer, no risk factors, and a bilateral MRI that showed no suspicious lesions in the opposite breast. I spent an hour explaining my recommendation for a lumpectomy and radiation therapy and why bilateral mastectomies were not indicated. Even though I likened it to killing a mouse with a Howitzer, because it is within the range of evidence-based practice I expressed a willingness to do a simple mastectomy of the side with the DCIS with immediate reconstruction by a plastic surgeon if that was what the patient really wanted, while again explaining why removing the other breast without evidence that it has cancer would not prolong her life or even lessen her chance of dying of breast cancer. In the end, she seemed to understand, but she clearly did not accept. She never came back. Of course, regardless of where I’ve practiced, there have always been other surgeons in the area who are more than happy to do bilateral mastectomies on almost woman with cancer or DCIS who wants the procedure, regardless of how tenuous or nonexistent the evidence supporting such an option is in a specific patient’s case. It is easier just to say yes, as Dr. Berwick suggests. In fact, it’s more profitable, too; a surgeon can bill a lot more for a bilateral mastectomy than for a lumpectomy. In academia, I’m fortunate in that my salary doesn’t depend on the number of operations I perform; the same is not true in private practice. Indeed, Dr. Berwick’s “patient is always right” sort of misreading of patient-centered medicine could easily lead to the vast overutilization of resources beyond what we see now. How Berwick will be able to implement such a view and at the same time keep costs down, as is a major stated purpose of the new health care reform law, I have no idea. Worse, patient=centered care, at least as I interpret it from Dr. Berwick, can cause a major conflict of interest in that physicians and hospitals often make more money by delivering more care. There’s already a huge incentive in the medical system to give the patient what he wants, if what he wants is more tests, more procedures, more medicine. Dr. Berwick’s vision, if realized as he envisions it, would vastly exacerbate that conflict of interest. I also can’t help but wonder about liability concerns. If a doctor orders an unnecessary test or provides an unnecessary treatment that causes harm, he’s still on the hook for malpractice. Indeed, he should be even more on the hook for malpractice for the very reason that the test or medical intervention was not medically indicated and not evidence-based! Lawyers would have a field day: “Why did you order that test that caused my client harm? Because my client asked for it? Do you believe the test was indicated based on scientific evidence and the standard of care? No? Then why did you order it anyway? Who has the MD? You or my client? My client depended on you for your best evidence-based medical advice, and you failed him.” And the lawyer starts counting his share of the judgment. In the end, I cannot agree with Dr. Berwick that science-based medicine should “take a back seat” to patient “empowerment.” Indeed, upon reading Dr. Berwick’s ideas, I wondered if he actually practices medicine. It turns out that he has not, as Dr. Douglas Farrago found out at the time: He ends his interview by stating that “we have to fix the health care system so that it gives doctors the time to do the job they want to do”. Funny, nothing he recommends saves time or saves money or makes the job any easier. This begs the question: does Dr. Berwick actually see patients anymore and how many? I called his office and it turns out that he does not. If fact, the person answering the phone states he hasn’t “in years”. Maybe it is time for him to get his hands dirty again? Or not. Berwick strikes me as a very well-meaning person with some good ideas about how to make our health care system less rigid and more responsive to patients’ needs, both medical and nonmedical. Unfortunately, he also appears to be naive to the point of my wondering whether he has any clue what it’s like to practice medicine in the real world or even in the idealized world of academics. Berwickian “patient-centered care”: An enabler of woo? Berwick’s “patient-centered care,” as we have seen, is an idea that has the potential to improve our health care system if implemented properly. Unfortunately, Berwick’s vision of it would in essence give the patient what he or she wants all the time. Not only would it be very expensive, but it provides no rationale for leaving out woo. In fact, in February 2009, Dr. Berwick participated in the Institute of Medicine’s Summit on Integrative Medicine, where Dr. Berwick was featured with luminaries of the movement trying to infiltrate unscientific medicine into the then embryonic health reform bill such as Dr. Dean Ornish, Dr. David “a more fluid concept of evidence” Katz, Dr. Mehmet Oz, and Senator Tom Harkin, creator of NCCAM. All they lacked was Rustum Roy and Deepak Chopra. Some of the slides in Dr. Berwick’s presentation are not reassuring. For instance: Integrative Medicine is health care that offers you the best shot at getting what you really, really want. Dr. R.W., the physician who coined the term “quackademic medicine” described Berwick’s contribution to the conference thusly: Even without regard to what he had to say it’s significant enough that Donald Berwick, M.D., CEO of the prestigious and (up to now!) very mainstream Institute for Healthcare Improvement, lent his good name to this woo fest. But what he had to say was rich. After introductory remarks about how happy and honored he was to be there he mentioned homeopathy and acupuncture, not to criticize them as health claims, but only to warn that they shouldn’t compete with each other, or with other modalities, for limited health care resources. In other words, let’s stop fighting and work together. (Groan). He praised the IOM for its contributions to the design of health care, starting (now get this) with “traditional, allopathic and curative care and now migrating into this distinguished and important new arena.” But here’s the bomb. Berwick, who seems to believe that healthcare should be like any consumer industry, said that quality is defined by patients’ perceptions. This is his idea of patient centered care which he defines as the patient having all the control. The IHI’s metric for quality, he said, is (watch this, now, emphasis mine) “…give me exactly the help I need and want exactly when I need and want it.” Think about that for a moment. The woosters and quackademicians of the world point to surveys like these which show that patients, in large numbers, really seem to want woo. They support their unscientific promotions by saying that because so many patients seek it out it must be valid. Adherents of science based medicine often point out the silliness of such thinking. Now, though, this argumentum ad populum is given new life and legitimacy because the Institute of Medicine and the Institute for Health Care Improvement endorse it! Unfortunately Dr. Berwick’s philosophy is custom-made to be an enabler of the very woo that we so frequently rail against on this blog. After all, if patient empowerment and “patient-centeredness” trump science- and evidence-based medicine (except in “rare” circumstances that Dr. Berwick declines to define), then there really is no reason not to give the people what they want when they want it, how they want it, all the time, so to speak. In fact, Berwick even has a slide that says: They give me exactly the help I need and want exactly when and how I need and want it. Berwick’s philosophy could so easily be turned to say: Patients want woo? Give it to them! They don’t want to vaccinate? No problem. Just keep trying to “educate” them. And if you want to try to use education and “information exchange” to persuade a patient who is unpersuadable, good luck with that. Unfortunately (and I do mean that; it is truly unfortunate), insurance companies don’t exactly bend over backwards to pay for lots of time spent educating patients. I wish they did, but they don’t. Truly, Dr. Berwick is, as I said, an idealist, and it is true that the current medical system is, all too often, not patient centered in any meaningful sense of the term. Sadly, his idealism is not grounded in the real world and, worse, it does not place science- and evidence-based medicine on even close to the same level as it does to turning patients into “consumers” and physicians into people who cater to those consumers no matter what. No matter John Weeks at The Integrator Blog is so happy.

With this post, I’m happy to return to Science-Based Medicine on a regular basis, at least monthly and perhaps more depending upon how often commentary is required on natural products, whether they be herbal medicines or single-agent pharmaceuticals derived from natural sources. Next week, I’ll be attending the 2010 Annual Meeting of the American Society of Pharmacognosy being held jointly with the Phytochemical Society of North America in St. Petersburg, Florida. I hope to bring back the latest on novel natural products in preclinical development. But today, I bring recent news that revisits a timeworn folly of the young (and some older folks): recreational use of toxic plants for the purpose of hallucination. Toxicity reports are re-emerging in southern California this week after a dozen hospitalizations of kids using teas made from a fragrant flowering plant called Angel’s Trumpet. The tea is used to produce hallucinations, but they can progress to extremely unpleasant experiences. Moreover, Angel’s Trumpet can be deadly, accelerating the heart rate and causing fatal cardiac rhythmic disturbances and bronchoconstriction that can trigger asthma attacks in sensitive individuals. Angel’s Trumpet is one of a series of plants in the Brugmansia genus that make a variety of muscarinic cholinergic antagonists such as atropine (dl-hyoscyamine, pictured to the right) and scopolamine (l-hyoscine). These compounds are also known chemically as tropane alkaloids or belladonna alkaloids, the latter derived from their classical isolation from Atropa belladonna. The belladonna name derives from the use of eye drops made from the plants that prevent constriction of the pupils (mydriasis), back when the size of a woman’s pupils was a sign of beauty and arousal. The tropane alkaloids are ubiquitous in plants and fungi and act as classic hallucinogens when used in high doses. Their legend goes back to witches brews and beyond. A wonderfully colorful history of tropane alkaloids by Robert S. Holzman of Children’s Hospital and Harvard Medical School was offered in this free 1998 paper in the journal, Anesthesiology (1998; 89:241-249). However, the aftermath of Angel’s Trumpet use is far from colorful. In cases like these, I like to turn to the Erowid site, a respected, user-supported site that offers non-judgmental information on plant-derived and synthetic psychoactive agents. The Erowid Experience Vault has several descriptions of the use of Angel’s Trumpet but this one is the most detailed and representative of the downsides of this plant. (Note that the colloquial term for Angel’s Trumpet in Australia is sometimes “Tree Datura,” although Brugmansia is a closely-related but distinct genus from Datura within the Solanaceae family.) I also came across a poorly-documented 2003 news article cited a German teenager cutting off his penis and tongue with garden shears after using Angel’s Trumpet. While I’m NOT a physician, emergency personnel stumbling upon this post would do well to note that physostigmine or pilocarpine are typical antidotes for anticholinergic poisonings with Angel’s Trumpet, Atropa, Datura, and other similar plants that cause dilated pupils with loss of accommodation, xerostomia (dry mouth), and tachycardia. Click on this paragraph to access the Medscape poisoning article with more details on when and where specific treatments should be employed. From the eMedicine article linked to in the above paragraph: Remember common signs and symptoms with the mnemonic, “red as a beet, dry as a bone, blind as a bat, mad as a hatter, and hot as a hare.” The mnemonic refers to the symptoms of flushing, dry skin and mucous membranes, mydriasis with loss of accommodation, altered mental status (AMS), and fever, respectively. I encourage all clinicians to be vigilant about anticholinergic poisonings in the weeks to come. In some cases in the past, I have found that reports such as these from southern California will often give rise to attempts to use the hallucinatory plant elsewhere despite the risks detailed.

I’ve previously described the consequences of acute and chronic sun exposure, and the rationale for topical sunscreen products. But wouldn’t it be easier to just take a pill that can boost our skin’s resistance to to the harmful effects of the sun? Is it possible to get all the benefits of sunscreen without the bother of creams, or even clothing? Protecting your skin from ultraviolet (UV) damage is the central claim with products like Heliocare, Fernblock, and Sunpill. All contain extracts of Polypodium leucotomos (cabbage palm fern), a plant native to Central America. Like many plants, there are some interesting biological compounds inside. The active ingredients seem to be in the rhizome (rootstalk), and they include calagualine, ecdysone, ecdysterone, and several phenolic compounds that may provide antioxidant effects. There is some preliminary evidence to suggest that these chemicals may reduce oxidative damage caused by UV light. In animal models that have looked at simulated UV radiation, inflammation and irritation have been reduced.[1] During a decade of clinical trials, FernBlock® has shown remarkable effectiveness in shielding skin against dangerous ultraviolet exposure [source] So let’s look at this evidence, and start with a focused clinical question: In typical sunscreen users, does consuming Polypodium leucotomos supplements provide UVA and UVB skin protection that is comparable to, or a substitute for, topical sunscreen products? A search of the literature identified four semi-relevant trials. There are no published studies that directly compare oral supplements to topical sunscreens. Villa studied the effect of Polypodium leucotomos on a marker for chronic UVA-initiated skin damage.[2] Ten volunteers were recruited, and all underwent pre-study skin biopsies and UVA exposure to identify baseline values. One week later, five participants took two doses of a Polypodium leucotomos supplement (8 hours and 2 hours before UVA exposure), and the others received no treatment. Then all received another dose of UVA radiation, at 2-3x the minimum dose determined to produce a sunburn. More biopsies were taken to evaluate UVA damage. The authors reported that the control group experienced large increases in the marker for UVA damage, while the Polypodium leucotomos group experienced decreases, compared to control. However, these results were not statistically significant. Further, the authors noted that Polypodium leucotomos did not prevent inflammatory infiltrates associated with UVA damage. The limitations to this study are numerous: The sample size of 10 is modest, and no information is provided to demonstrate the groups are well matched, or how they were allocated. No rationale for the dose used is provided. Two patients were dropped from the control group. The study was not blinded for participants. There is no information about the product used, other than it was a 240mg dose. Without standardization, it’s impossible to extrapolate the observed effects to any commercially available product. Finally, given it appears to be a letter to the editor, it may not have been subject to peer review. The results should properly be called hypothesis-generating — at best. They look promising, but should be followed by more study – not routine use. Middelkamp-Hup studied Polypodium leucotomos in the prevention of sunburn.[3] In this small open-label study, nine volunteers were given different doses of UV radiation, and then the radiation was repeated after two days of taking Fernblock. A small skin biopsy was taken  before and after treatment, and the samples were compared. Researchers found less evidence of skin damage, and concluded that Fernblock protected the skin from inflammation and the effects of sunburn. This was an interesting preliminary study, but not one that helps us understand its effectiveness compared to sunscreen. The study was not blinded, the effects were modest, and long-term effects were not studied. Another study by the same author examined the effect of Polypodium leucotomos in ten volunteers that were given sensitizers that accelerate UV damage.[4] There was no blinding. Volunteers received simulated sun exposure before and after 7.5mg/kg of Polypodium leucotomos. The author concluded that Polypodium leucotomos was an effective skin protector against the simulated sun exposure. As this study examined the products effectiveness in patients given UVA sensitizers, it’s difficult to draw conclusions about its usefulness in typical consumers seeking protection from regular or intermittent sun exposure. González studied both topical and oral forms of Polypodium leucotomos in 21 people.[5] Some patients were given sensitizers to accelerate UVA damage, some were untreated. Skin was evaluated to measure the protective impact of the product. The author observed that the time to initial reddening increased significantly, and reduced other initial signs of skin damage. He concluded that both versions offered some degree of skin protection. This was a small study, with no blinding. No comparison was made to sunscreen. That’s the extent of the published research that’s relevant to our question. There are some other trials, that are suggestive, but not conclusive, that Polypodium leucotomos supplements may provide some benefit to people who have atypical skin reactions to sunshine. Without double-blind trials, we are left with considering this lesser-quality evidence. That doesn’t mean we ignore the published data, but we should remain skeptical, and look for confirming evidence. Unfortunately, the manufacturer’s websites have little in the way of objective clinical information. The Sunpill manufacturer links to this clinical study summary [PDF], but there’s not enough information to evaluate the results. There is also a laboratory report [PDF] of a Sunpill evaluation designed to follow the FDA’s standard for sunscreen testing. An eight week evaluation, it measures the efficacy of the supplement in conjunction with daily sunscreen use. While the results look promising, it’s difficult to draw conclusions from the data when presented in this format. Dosing and Use If you read the marketing, these products sound pretty impressive: Fernblock: For the first time you can achieve essential protection from dangerous sun exposure in a pill. Heliocare works to turn back the sun. Sunpill protects the skin from the harmful rays of the sun, but still allows your body to receive the benefits that sunshine gives you. Clearly there’s a gap between the marketing copy and what the evidence says. In light of the limited clinical data, let’s look closer at the dosing recommendations. Are manufacturers telling consumers to put away their topical sunscreen? Not quite: Fernblock’s dose is 240-480mg in the morning, 30 minutes before sun exposure, and “for extended sun exposure take one additional capsule at noon.” The manufacturer also recommends use with SPF 30 sunscreen, and cautions, “Use topical sunscreens whenever exposed to sunlight. This product is not a sunscreen.” Heliocare has a similar dose: two 240mg capsules daily before exposure to sun, with a third capsule for prolonged exposure to the sun. There is a caution: “Do not exceed the stated recommended daily consumption of three Heliocare capsules per day.” The manufacturer also notes, “Heliocare is definitely NOT a substitute for good sunscreens and protective clothing.” Sunpill is packaged as a 639 mg dose of Polypodium leucotomos and several other ingredients including green tea, aloe, pomegranate, and beet root, all without persuasive evidence of effectiveness for UVA/UVB sun protection. It’s not clear how much Polypodium leucotomos is in the product. The manufacturer states, “New research from the University of Miami School of Medicine shows that the fern extract in these pills significantly reduced UVA-related DNA damage that leads to wrinkling and brown spots. For best results, pop one each day starting a week before you plan on fun in the sun.” It also adds, “It is alway (sic) advisable to use a topical sunscreen when you are going to be out in the sun for an extended period of time.” Safety The most common side effect reported in the limited research is stomach upset. Advertisers repeatedly use the statement, “has been safely used for over 20 years in Europe,” but I can find no published evidence of this. Based on the the evidence above, these products seems to be safe when taken for a week – the longest trial that’s been published. There is no published information showing these Polypodium leucotomos products are safe if taken for a longer period. [1] Another formulation of the same ingredient appears to be safe when taken for up to five months, however. [1] In light of the small studies that have been conducted, the full safety profile may not yet be well understood. There’s no information about the supplement’s safety in children, or in pregnant or breastfeeding women. Bottom line The consequences of unprotected exposure to UV light can be severe.  Physical barriers and sunscreen in the forms of creams and other topical products have been demonstrated to reduce acute and chronic consequences of UV exposure. The idea of a well-tolerated, safe, oral supplement that protects against UVA and UVB without the need for topical products is an attractive one – but it’s not clear we have the evidence yet.  Oral sunscreens, taking the most optimistic view of the data, may slightly reduce some of the severity of a sunburn, and may provide some UVA protection. González, one of the researchers cited above, has suggested Polypodium leucotomos offers an SPF of about 3 – insufficient for most people that need sunscreen. Most importantly, these products are still recommended for use in combination with topical sunscreen. Given most sunscreens offer an SPF of 15 or more (when properly applied), it’s not clear if the incremental benefits would be meaningful. So do the potential benefits outweigh the unanswered questions and additional cost? Until better effectiveness and longer-term safety data emerges, a risk-benefit evaluation suggests we’re better off seeking shade behind, instead of eating, Polypodium leucotomos. References [1] Natural Medicines Comprehensive Database [database on the Internet]. Stockton (CA): Therapeutic Research Faculty; 1995-2010 [cited 4 July 2010] Available from: http://www.naturaldatabase.com. Subscription required to view – Sorry. [2] Villa, A., Viera, M., Amini, S., Huo, R., Perez, O., Ruiz, P., Amador, A., Elgart, G., & Berman, B. (2010). Decrease of ultraviolet A light–induced “common deletion” in healthy volunteers after oral Polypodium leucotomos extract supplement in a randomized clinical trial Journal of the American Academy of Dermatology, 62 (3), 511-513 DOI: 10.1016/j.jaad.2009.05.045 [3] Middelkamp-Hup MA, Pathak MA, Parrado C, Goukassian D, Rius-Díaz F, Mihm MC, Fitzpatrick TB, & González S (2004). Oral Polypodium leucotomos extract decreases ultraviolet-induced damage of human skin. Journal of the American Academy of Dermatology, 51 (6), 910-8 PMID: 15583582 [4] Middelkamp-Hup MA, Pathak MA, Parrado C, Garcia-Caballero T, Rius-Díaz F, Fitzpatrick TB, & González S (2004). Orally administered Polypodium leucotomos extract decreases psoralen-UVA-induced phototoxicity, pigmentation, and damage of human skin. Journal of the American Academy of Dermatology, 50 (1), 41-9 PMID: 14699363 [5] González S, Pathak MA, Cuevas J, Villarrubia VG, & Fitzpatrick TB (1997). Topical or oral administration with an extract of Polypodium leucotomos prevents acute sunburn and psoralen-induced phototoxic reactions as well as depletion of Langerhans cells in human skin. Photodermatology, Photoimmunology & Photomedicine, 13 (1-2), 50-60 PMID: 9361129

Last year Ben Kavoussi published an interesting article on SBM called Astrology with Needles in which he purported a historical connection between acupuncture and bloodletting. I had previously thought that bloodletting was a uniquely Western cultural invention – part of Galenic medicine involving the balancing of the four humors, one of which being blood. (In the West bloodletting faded away with the advent of science-based medicine in the 19th century.) I was intrigued by this connection and have since been doing my own reading on the topic. It turns out that bloodletting was common throughout ancient cultures and not unique to the west. In fact acupuncture was originally a form of bloodletting – the “needles” were really lances and the acupuncture points locations over veins to be opened. Chi, or the Chinese concept of the life force, was believed to be partly in the blood, and blood letting could be used to free the flow of chi. This was closely related to the Galenic concept of using bloodletting to free the flow of static blood in the tissue. For example, in the ancient medical text of Suwen, we find: When heaven is warm and when the sun is bright,
then the blood in man is rich in liquid
and the protective qi is at the surface
Hence the blood can be drained easily, and the qi can be made to move on easily… We also see in the text the connection of the functions of the body to celestial events. The concepts of blood, life force, and astrology all came together in acupuncture, but also in the ancient medical traditions of the West, just with different names and specific variations. The main concepts were balance and flow – lancing or needling were used to restore balance and flow to the natural rhythms dictated by the heavens. You may be surprised to learn that these concepts have a continuous cultural connection to the present. In general the concept of bloodletting has fallen out of popularity because it seems barbaric and because the real physiological function of blood is now understood, and so are the dangers of bloodletting. But the techniques that were originally developed for bloodletting have been “rebranded” to be more acceptable to modern sensibilities (at least to a degree). And so acupuncture is now purely about chi and no longer about blood, and even more scientific explanations for how it might work are being sought. In my opinion, this is all a fool’s errand – chasing the bloodletter’s craft. Cupping was also developed as a method of drawing out the blood. But now it is used to draw out imaginary toxins. I had thought this “rebranding” was complete and all traces of bloodletting removed from the modern variants of these practices. But the cultural roots go deep, and even modern practitioners, relying on ancient texts, still adhere to some of the bloodletting concepts. They talk about treating blood “stasis”, which is a very Galenic concept. The Japanese version of acupuncture, Shiraku, which survives today also closely ties together bloodletting and acupuncture (Shiraku means bloodletting). They combine cupping with lancing within an “acupuncture framework.” The Institute for Tradition Medicine online has this gem, which extols the therapeutic benefits of “bleeding points.” Peripheral blood-letting today is mainly carried out at the fingers and toes. At the tips of the toes, for example, are the qiduan points, located 0.1 cun behind the nails. These are said to be useful for emergency treatment for stroke or for numbness of the toes, also for redness, swelling, and pain of the instep of the foot. I will have to remember that the next time a patient comes in with a stroke. It seems that the amount of blood drawn has been significantly reduced, which is good, but the ancient bloodletting concepts are all there unchanged. Further, Acupuncture Today contains an article describing the use of bloodletting in modern acupuncture. The author, Skya Abbate, DOM, writes: However, bleeding is a specialized technique for specific conditions that can produce effective and dramatic results when the patient’s condition is diagnosed properly and the bleeding method expertly executed. As an example of the use of bloodletting, Abbate writes: It can invigorate the smooth flow of qi and blood, thereby picking up and facilitating its flow when the qi and blood need invigoration. An example of this scenario occurs when a patient presents with a wiry pulse and mild feelings of stagnation that indicate qi stagnation. The concepts of the flow of qi and blood are alive and well. I could have told you that was a quote from a medieval text and you probably would not have questioned it. Conclusion: When the actual history of acupuncture, bloodletting, cupping, and similar techniques are investigated we find that there are many modern myths about these practices. One myth is that there were completely different traditions in the various cultures, especially East and West. In reality, these were only cultural variations on the same themes – restoring balance and flow to blood and life energy in accordance to some astrological principles. There is also evidence of direct cultural contact – not just reinventing the same concepts. For example, the iceman is the frozen remains of a 5200 year old man found in the Alps. He was covered with tattoos of points and lines over traditional acupuncture points. This was probably an example of therapeutic tattooing – the tattoos themselves were meant to be therapeutic. There are also needle punctures as some of these points. Think about the implications of a person living near the Alps (what is now Europe) 5200 years ago being tattooed over what later were known as acupuncture points. It is further a myth that what we know today as acupuncture or cupping were developed in line with their modern incarnations. In reality, these techniques were just variations of bloodletting and were very deliberately and fairly recently distanced from their bloodletting roots to make them more acceptable. And finally it is a myth that bloodletting itself has been eliminated from traditional practice. It survives in muted form in various traditions.