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Infiltration of Quackademic Medicine into Mainstream: A pernicious influence

Editor’s note: Kausik Datta, Ph.D. is postdoctoral research fellow at the Johns Hopkins School of Medicine. He works in immunology, specifically as related to two major mycoses (Aspergillosis and Cryptococcosis). Rationality and skepticism have been his long-standing interests, which led him into science- and evidence-based medicine. This is his first contribution to this blog.

Quackademic ‘Medicine’* is a collective of pseudoscientific, data-free, evidence-less, nonsensical therapeutic modalities (the so-called “alternative” therapies) – otherwise known as “complementary and alternative” medicine (CAM) or integrative or holistic medicine. These include, among other things, chelation therapy (for autism and cardiovascular diseases); chiropractic; use of random nutritional supplements; abuse of various prescription drugs; coffee enemas; naturopathy; homeopathy; reiki; energy healing that invokes manipulation of ‘life force’ or qi; acupuncture; ‘healing touch’, and intercessory prayer – the list goes on, since there is essentially no limit to human stupidity and no depth that the human mind cannot plumb.

Qualified professionals – those who are in the business of doing the hard work of science to gather critical evidence regarding the action of a therapy, as well as those who implement those modalities routinely and save lives – may perhaps find it easy to dismiss the proponents of quackademic medicine as an ill-informed, misguided, or downright lunatic, fringe. However, much like a bad case of household mold infestation, this community with its myrmidons continues to thrive and grow, impervious to reason, immune to evidence, unable to comprehend the danger they pose (and the harm they cause) to themselves, their children and millions of others on the planet. As discussed in the science blog Respectful Insolence, a large part of that harm derives from their promotion of unfounded (and repeatedly proven to be untrue) fears of vaccines causing autism, discouraging a lot of parents from vaccinating their children and prompting many of them to seek quack treatments (some of which are potentially dangerous) to try to ‘cure’ autistic
children. But still another part – a far more pernicious and pervasive one – has to do with the growing presence (and, it seems, acceptance) of quackademic pseudoscience in establishments of mainstream academic medicine.

Most holistic medicine systems (of which CAM, in its current avatar, forms a part) were developed in pre-scientific cultures at a time when important tenets of modern medicine were not around, such as the germ theory of infectious disease (the basis for myriads of successful public health measures), in-depth knowledge of anatomy, physiology and biochemistry, and most importantly, the scientific method, including basic research, evidence-based medicine and clinical trials. Modern medicine emerged in the late 19th century, after much struggle with the existing alternative therapeutic practices. In modern times, much of the holistic medical systems have directly borrowed from outmoded, outdated, often incorrect, and mostly ideology- or religious faith-based concepts from the pre-modern medicine days; but a signficant part of the CAM movement has taken a different approach, euphemistically called ‘biomedical treatment’. This term has caught the fancy of the alternative medicine crowd, particularly those of the ‘vaccine-causes-autism’ flavor. In this approach, they take various substances of biological or biochemical origin at random – such as various amino acids (or chemical modifications thereof), vitamins, chelators of divalent cations (such as EDTA), enzymes and other nutritional supplements, probiotics, and so forth – and put them into the body of the so-called patients (including autistic children) through various routes. Of course, not only there isn’t a shred of evidence that any of this, alone or in combination, actually works to ‘cure’ anything (including autism), this approach unerringly reveals a profound ignorance of physiology and biochemistry of any healthy or diseased systems, as well as an egregious lack – on part of the CAM practitioners – of caring and empathy with the recipients, who are nothing less than victims of negligence and abuse, for unregulated alternative medical practices can turn quite deadly. And for the conspiracy theorists amongst the CAM crowd who insist that all medical research is sponsored the evil pharmaceutical companies whose only goal is taking people’s money, CAM therapies of various flavors can easily run upto thousands of dollars every month.

If CAM is all holistic medicine, why this insistence on using biochemical substances of doubtful provenance? Ah, therein lies the nub of the affair. All form of CAM practitioners, all purveyors of pseudoscientific nonsensical modalities, crave, above all, the veneer of legitimacy and respectability. They have been steadily pushing for that for quite some time now. The CAMsters desire to camouflage their ignorance and weird beliefs with science-y sounding ideas and concepts, so that their quackery is considered science without them having to go through the hard, often ill-remunerated, work that is the scientific method. As David Gorski has indicated in his post, the CAM crowd starts by co-opting and corrupting the language of science, resulting in scientifically untenable concepts (such as chelation therapy, and ‘detoxication’, an extremely popular term with the CAM followers), unethical practices (such as injection of untested stem cells into cerebrospinal fluid), oversimplified theories (such as gluten-free/casein-free diet fixing a “leaky gut”, when, in reality, the “leaky gut” is an extreme and potentially lethal stage in the progression of Celiac disease, a genetic condition), and so on. Next step in pushing CAM is to produce and publish in journals that appear to contain science, but not quite, as if an article in print were an automatic ascension to credence and respectability. And now to complete the circle, the CAMsters are holding meetings that have all the trappings of a scientific meet; this includes a recent meeting of a vaccine-denying, autism -pseudoscience-promoting group, that is to be held at the University of Toronto, an institution with a rich history of quality medical education and research (see below). This begs the questions: (a) Is the University of Toronto a willing accomplice to this woo-mongering, or has it been duped? (b) Is there a growing acceptance of pseudoscience at premier medical centers in North America? To answer, first a small history lesson:

Though modern medicine began its steady journey in the late 19th century, institutionalization of medical education and teaching in the United States did not commence until after 1910. Prior to that, medical education and practice in the US left a lot to be desired, with poor standards of training, understaffed and inadequate medical schools, wide disparity in their curricula, methods of assessment, and requirements for admission and graduation. In 1908, the Council on Medical Education of the American Medical Association commissioned the Carnegie Foundation for the Advancement of Teaching to survey the state of American medical education and suggest reform measures wherever necessary. The job was entrusted to Abraham Flexner, a professional educator with the Carnegie Foundation, with experience of the education system in continental Europe. He visited all of 155 medical schools in existence in North America at that time, and compiled a report in 1910, which made several bold recommendations (discussed here) that forever changed the structure and practices of American medical education and medicine in general. In his report, Flexner came down hard on various forms of ‘alternative’ medicine whose scientific validity was questionable, even recommending closure or loss of accreditation and underwriting support for such medical schools as offered training in those. On the other hand, several schools received praise for excellent performance, including the Harvard Medical School, Case Western Reserve University, McGill University, University of Toronto, and especially the Johns Hopkins University School of Medicine – the latter being described as ‘model for medical education’.

It is important to re-emphasize at this point that we are talking about premier medical education and research institutions, institutions that should necessarily distance themselves from pseudoscientific approaches on doubtful provenance and non-existent efficacies, or at least provide truthful information (as the Mayo Clinic has done). These are the institutions that should additionally recognize that ideology- or faith-based approaches to medicine, lacking evidence or any kind of rational justification, often engender false hope, leading the patients, their friends and family members through a deplorable waste of time, effort, energy, as well as of money. Therefore, we can perhaps reasonably expect them to be at the forefront of the scientific community’s battle against the proliferation of ignorance, delusions and pseudoscientific mumbo-jumbo, can’t we?

Erm… No, it appears!

In a thoughtfully presented report in 2008, the US News and World Report mentioned that:

All 18 hospitals on U.S. News’s 2008 “America’s Best Hospitals” superselective Honor Roll provide CAM of some type. Fifteen of the 18 also belong to the three-year-old Consortium of Academic Health Centers for Integrative Medicine, 36 U.S. teaching hospitals pushing to blend CAM with traditional care… Each center has its own notion of CAM and how best to fit it into the medical mix, which can be challenging. “There is rarely a consensus among CAM experts on the optimal product, dose, or intended users,” states a report from the National Center for Complementary and Alternative Medicine, an arm of the National Institutes of Health charged with doling out research funds and tidying the thicket of therapies deemed to fall within CAM’s broad reach.

The report also observed that:

At one extreme are found techniques such as yoga and massage, acknowledged by the most hard-line skeptics to have some benefit, if only to lower stress and anxiety. At the other are therapies that even many who applaud CAM’s new-found academic popularity call “woo-woo medicine” because of the sheer implausibility of their rationale. Homeopathy, which involves remedies often lacking a single molecule of active substance, is the poster child; some would add energy therapies such as healing touch. The broad middle takes in acupuncture, herbal medicine, and other CAM approaches that seem to benefit some people with certain conditions.

Until the mid-1990s, most academic centers treated CAM like a pack of scruffy mutts, noisy and unworthy of notice. A large pot of federal and foundation research funds—now close to $250 million per year just from NCCAM and the National Cancer Institute, plus tens of millions more from private donors such as the Bravewell Collaborative—helped turn that sniffy attitude into solicitous attention, says longtime CAM commentator Donald Marcus. “The funding gave them respect from the medical school community,” says Marcus, a professor of medicine and immunology at Baylor College of Medicine in Houston, where he has long taught a CAM course.

As mentioned above, many of the premier universities of the US now sport Centers for studying “integrative medicine” or CAM. Most of these centers are engaged in legitimate research work dealing with some psychological studies among HIV positive patients and yoga-breathing techniques for alleviation of chronic fatigue in cancer patients (The Osher Center for Integrative Medicine of the University of California at San Francisco); chronic pain management (as in cancer patients), including animal modeling and mechanistic studies related to genesis, metastasis and treatment of cancer (Johns Hopkins Center for Complementary and Alternative Medicine), and so forth. But not all. At the Cleveland Clinic, for example, NIH money has been poured into a clinical trial to investigate the effect of reiki, an “energy therapy”, in reduction of stress and anxiety in prostate cancer patients. The integrative medicine program at Children’s Memorial Hospital in Chicago, the principal pediatric teaching hospital for Northwestern University’s Feinberg School of Medicine, is involved in various types of unconventional therapy, and David Steinhorn, MD, a pediatric intensivist and medical director of the hospital’s CAM program, indicates that several privately funded trials are underway or in the works. According to the US News report, Steinhorn is a passionate champion of investigating CAM therapies, no matter how unlikely, if he believes they may help patients and are safe. “I’m a very serious, hard-core ICU doctor, but I have seen these therapies benefit my patients, even if I don’t know how,” he says. Other elite centers like the Mayo Clinic, Duke University Medical Center, the University of California San Francisco, University of Maryland School of Medicine, the Johns Hopkins University School of Medicine, and others now offer acupuncture, massage, and other CAM services.

It is often claimed in CAM literature that a few CAM treatments have demonstrated at least modest results. Massage shows promise for relieving postoperative pain. Studies were done demonstrate that acupuncture is somewhat effective at relieving nausea from chemotherapy or surgery and discomfort from dental procedures. It is used at Memorial Sloan-Kettering Cancer Center in New York, among others, for relief of chemotherapy-related nausea, and at many centers for chronic pain – from arthritis, for example. Clinical trials are still going on to determine the efficacy of acupuncture in a variety of different situations involving post-operative nausea and vomiting. However, analyses of reported studies on acupuncture/acupressure, as well as subsequent studies, have demonstrated (a) no effects on the natural history of any disease, (b) disappointing results in acute and chronic pain management, and (c) no evidence for a specific peri-operative antinausea or antiemetic effect (extensively reviewed here, here and here).

Perhaps it is a matter of great irony that schools named in the Flexner report of 1910 as paragons of virtues in medical education have all now embraced pseudoscientific, evidence-free therapeutic systems with great alacrity. I wrote above how University of Toronto seems to have bought into the autism-pseudoscience business. Harvard employs amongst its faculty Dr. Martha Herbert, who is known for her grandiose claims (completely unsupported by any evidence) that neuroinflammation is a major cause of autism, and that molds and other environmental influences trigger it; she is also very popular amongst the anti-vaccination crowd. McGill University of Canada, by far the sanest of all these, recently launched a searchable database of outcome measures intended for CAM researchers – the IN-CAM Outcomes Database – as a collaboration between its Health Centre Research Institute and the University of Calgary. Interestingly, Eric Fombonne, MD, the Head of the Division of Child Psychiatry at McGill and Director of the Department of Psychiatry at the Montreal Children’s Hospital, and a leading authority on Autism Spectrum Disorders, is the author of studies that showed (a) no difference in mercury levels between autistic children and the general population, thereby invalidating the entire chelation therapy business, and (b) no link between MMR-vaccine and autism, but one doesn’t – of course – find a mention of these studies in autism-pseudoscience literature.

I was particularly outraged by the description of a severe woo-woo infestation at the Johns Hopkins School of Nursing. Their Spring 2007 magazine was quite illuminating (the PDF of the issue here):

In an effort to broaden their methods for healing, Johns Hopkins nursing faculty and students are increasingly looking outside the scope of conventional training to explore Complementary and Alternative Therapies… techniques like massage therapy, acupuncture, meditation, yoga, herbs, Reiki, aromatherapy, and others that fall under a broad category of healing systems and methods called Complementary and Alternative Medicine (CAM)… At the Johns Hopkins University School of Nursing, the Introduction to Complementary and Alternative Healthcare has become a popular choice among students since it was first introduced in 1998…

As an evidence of the extent to which CAM has been institutionalized, faculty and students of the JH School of Nursing may also attend lectures and workshops (’at reduced rates’) at the Tai Sophia Institute, in Laurel, Maryland, which offers courses and master’s degree programs in acupuncture, herbal medicine, and applied healing arts.

Says Lori Edwards, MPH, RN, APRN, BC, who teaches the Introduction to CAM course, “Nursing students should be learning about CAM because the patients nurses are working with are using these modalities.” However, rather than discouraging these unproven, unscientific practices, the nurses are encouraged to “…teach patients how to blend alternative practices with conventional medical care…”  In her course, Edwards discusses the four categories of CAM, as designated by the NCCAM: mind-body methods (such as meditation, yoga, and prayer); biologically-based methods (such as the use of herbs or homeopathy); manual healing methods (massage, acupuncture, and chiropractic care); and energy therapies (Reiki).  Nursing School Faculty member Carol Libonati, MS, APRN, BC, CS-P, is a practitioner of Reiki, and uses a series of hand positions done either just above or directly on the body to restore “the normal energy flow”. According to her, “a subtle energy flows from the practitioner into the client, and the energy creates a healing effect.” Let me emphasize that: Prayer as medicine, Homeopathy, reiki – all under official sanction. The fact that there is an absolute lack of evidence that any of this works, ever, seems to have been conveniently dismissed.

It also turns out that according to a US Government report (from the NCCAM, no less), Complementary and alternative medicine such as acupuncture, herbal supplements and meditation are big business in the United States, totaling nearly $34 billion in out-of-pocket spending annually (giving the complete lie to the ‘pharma shill’ gambit that CAM proponents like to use to denigrate scientists working in mainstream medical research). And that is hardly surprising, considering how the Senate working groups on prevention and public health (Sen. Tom Harkin, D-IA) – yes, that Tom Harkin – and health care quality (Sen. Barbara Mikulski, D-MD) are tirelessly working to institute a system that rewards health promotion, wellness and quality in health care delivery in order to restore the vitality of American lives and also save money, which is why they invited two acupuncturists from the Tai Sophia Institute in Laurel, MD, to testify before the Senate Committee on Heath, Education, Labor and Pensions (HELP) and “share their recommendations for policy changes to help put the American health care system on the path to wellness“.

Oh, the insanity of it all!

A recent article in the New York Times reported on how the Mercy Medical Center in Merced, CA, has been employing Hmong Shamans for the benefit of their large Hmong (from Northern Laos) patient populations. Because many Hmong rely on their spiritual beliefs to get them through illnesses, the hospital’s new Hmong shaman policy, the country’s first, formally recognizes the “cultural role of traditional healers, inviting them to perform nine approved ceremonies in the hospital, including “soul calling” and chanting in a soft voice.” Traditionally, the Hmong fear Western medicine; in their belief system, surgery, anesthesia, blood transfusions and other common procedures are taboo. Therefore, the new Shaman-liaison program has been devised to defuse that fear and to provide a culturally sensitive context. The shamans are allowed to perform healing rituals, going into trances for hours, negotiating with and warding off evil spirits, and protecting the patient’s soul from being kidnapped by some dead near-relative.

I admit I felt uneasy about this. Granted, not many would see a huge problem with this. The Hmong are being given the same access as their clergy as with other religions. To many it would seem a rather reasonable compromise to get patients in sooner for proper care through scientific medicine, and that is being equitable to the people of this culture. I am just not sure that the best interest of the Hmong is  served this way in the long run; perhaps it would serve the Hmong better to train their Shamans to dispel the fear and distrust about modern medicine and procedures amongst the Hmong community. My concern, upon reading that NY Times article, was more generalized, more to do with the fact that unreason and irrationality, in various forms, have crept in (and are continuing to do so) our hospitals and medical institutions, and general institutional policy seems to be restricted to encouraging that – not taking proactive steps so as to ensure that people (not just the patients, but ‘prospective’ patients as well) are not held in thrall to the said unreason and irrationality. Consider the instances of the reiki and Prayer Healing performed by nurses in some hospitals, including the Johns Hopkins. The patients obviously want those, and the nurses justify those pseudoscientific
procedures as ‘connecting’ to those patients through their cultural beliefs. And therein lies the slippery slope. I guess the question is: if and when a so-called cultural belief is mired in superstition, misinformation and ignorance, how far should an institutional policy go to pander to such a belief just because it is considered culturally appropriate? Where to draw the line?

Make no mistake about it: irrationality is like a cancer. Unless diagnosed early and treated aggressively, it will eventually overwhelm the system. The science-based medicine community must take cognizance of the potentially harmful effect of pseudoscience on humanity, and fight it at every step with reason, and evidence, and a heaping helping of scorn that it rightfully deserves.

* – The first time I came across this fantastic and apt term was in RW Donnell’s blog. If he has indeed coined it, a tip of my hat to him for a job well done!!

Posted in: Medical Academia

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30 thoughts on “Infiltration of Quackademic Medicine into Mainstream: A pernicious influence

  1. Lets look at those category labels because medicine already has them:

    “mind-body methods” = Psychology based stress management (Psychology)
    “biologically-based methods ” = Chemical Interventions (Pharmacology & Nutrition)
    “manual healing methods” = Physical Interventions (Physical Therapy)
    “energy therapies” = Witchcraft and outright bull$hit. (Real Medicine is missing this one)

    Homeopathy (along with most other CAM) clearly belongs in the last category and not “biologically-based methods “/Chemical Intervention as it is only water and requires some non-scientific infusion of energy/witchcraft.

    Something is either shown to be scientifically safe and effective or it isn’t. If it is, we already have categories in real medicine for it, otherwise it doesn’t belong in the practice of medicine.

    I am always confused by any individual or institution that embraces more than one “CAM” modality as nearly all of them have different and mutually exclusive understandings of health and disease; they can’t all be right.

  2. daijiyobu says:

    Regarding the “pseudoscientific, data-free, evidence-less, nonsensical [...including] naturopathy”, and U.S. News & World Report overall,

    I see them as enablers of naturopathy sCAMster education robbing, per:

    http://colleges.usnews.rankingsandreviews.com/best-colleges/kenmore-wa/bastyr-university-22425

    “best colleges 2010 [...including] Bastyr University [...whose] international faculty teaches the natural health sciences with an emphasis on integrating mind, body, spirit [supernaturalism] and nature [their vitalistic context].”

    Wherein nonscience is a subset of science. Truly insanity.

    -r.c.

  3. Kausik Datta says:

    Good point. This is an example of the co-opting of legitimate medical terminology and concepts by the CAM proponents. The following is yet another example of this skulduggery:

    A collaborative study between University of Florida and the Chungham National University, Korea with adults diagnosed with type 2 diabetes found that those who participated in a supervised Tai Chi exercise program for six months significantly lowered their fasting blood glucose levels (and Hb1Ac, i.e. better management of diabetes), and enhanced their overall quality of life.

    This study, as you can understand, would be touted as a revelation as to the beneficial effect of alternative medicine, and indeed, it was published in the June issue of the Journal of Alternative and Complementary Medicine from Mary Ann Liebert, Inc.

    I ask them this: what is “alternative” and “complementary” about Tai Chi, in the sense propounded by CAM? Tai chi is an ancient Chinese martial art that combines deep diaphragmatic breathing and relaxation with slow, gentle circular movements. It is a low impact exercise program – with both endurance and resistance routines – that uses shifts in body position and steps with coordinated arm movements, and is gentle on bones, joints and muscles – which makes it an ideal aerobic activity for older people, with better compliance than for more strenuous exercises. Why would it not be beneficial for a type 2 diabetic, and indeed, for anyone else?

    If one discounts the woo-spin part of Tai Chi (involving qi and energy flow), it is just like any other mild-to-moderate aerobic exercise regimen; in fact, its effects were found to be just the same as those of aerobic routines. “Tai chi really has similar effects as other aerobic exercises on diabetic control,” said Beverly Roberts, PhD, RN, a professor at the U Florida College of Nursing, and a co-author of the study.

    In the study, the adherent group (i.e. the group that practiced Tai Chi) had significantly improved quality of life based on psychometric assessments, social functioning, mental health, and vitality as compared to the non-adherent control group. Again, that does not surprise me. Mean age of the subjects was 64 years old, with most being female (80%), married (84%), and not currently employed (85%). The majority of the subjects had less than high school education (<12 years). If one engages such elderly people in a group activity and a regular exercise regimen, is there any surprise that their social functioning and vitality would increase?

    Interestingly, when controlling the data for diabetic self-care activities (i.e. diabetic diet, medication, glucose management, exercise, and hospital visit), the difference in the effects on mental health between the adherent and non-adherent groups became non-significant.

    Tai Chi is a perfectly valid exercise program with expected benefit. It is only woo-meisters of the CAM world that try to make it out to be more than it is. Sometimes I think it has to do with the American fascination with everything oriental; commenter MedsVsTherapy over at Mark Crislip’s post used the term “faux-riental”. Broadening the definition a little bit, I think that encompasses this perfectly.

  4. CarolynS says:

    I think it is a mistake to consider that there is a “bright line” between CAM and valid medical therapies. In fact, there’s a rather fuzzy area that sounds good but isn’t supported by much if any evidence at all. Much of this is in the area of nutrition. How many servings of fruits and vegetables should a person have each day, and will achieving the requisite number ward off disease? New York City health officials seem to think that if people drink fewer sodas, the prevalence of obesity will decrease. The probability that this will happen approaches zero. Michael Pollan’s words of wisdom, also supported by zero evidence, are starting to be taken as gospel truths in perfectly respectable contexts. Yesh, this kind of stuff is not as frankly implausible as reiki, but the evidence base is similarly non-existent. The idea that “lifestyle” management will somehow improve health and save lots of money on medical care costs has definitely edged into the mainstream, again with no evidence to speak of. The real “bright line” might be between approaches that are supported by evidence versus those that are more wishful thinking, but the line might not fall quite where the opponents of CAM think it does.

  5. Kausik Datta says:

    Carolyn,
    I am intrigued by this statement of yours:

    New York City health officials seem to think that if people drink fewer sodas, the prevalence of obesity will decrease. The probability that this will happen approaches zero.

    Would you care to explain?

    We do appear to have quite compelling evidence linking soda consumption to obesity and related disorders (one can access those by simply putting ‘soda and obesity’ as search terms in PubMed). Such studies in recent times have been published in journals dealing with chronic disease, obesity, nutrition, epidemiology, as well as general clinical medicine. A group at Harvard, as well as others from Yale, UNC Chapel Hill, U Chicago at Illinois, and several public health officials, have made quite a case for it. One recent study, published in Diabetes Care, found that even diet soda taken daily was associated with significantly greater risks of select incident metabolic syndrome components and type 2 diabetes, although the observational study was not designed to establish causality.

    OTOH, there are studies (for example, here, here and here) that show just the opposite, a lack of clear association between soda and obesity.

    Since I haven’t been able to read through these studies in their entirety (and since I am not a Nutrition expert), I cannot make a judgment call either way, and would have to think about it as
    inconclusive. But I am willing to listen and understand if someone provides evidence and explains.

  6. Necandum says:

    –”The idea that “lifestyle” management will somehow improve health and save lots of money on medical care costs has definitely edged into the mainstream, again with no evidence to speak of.”–

    Actually, it has never been out of the mainstream. The value of nutrition and exercise has been a part of standard medical education for quite awhile. It has been proven to prevent a good number of conditions and the associated costs with treating those conditions. Simply think of all the health-conditions associated with obesity and smoking. Are you claiming that “lifestyle” management cannot have an impact on obesity and smoking?

    –”How many servings of fruits and vegetables should a person have each day, and will achieving the requisite number ward off disease?”–

    No, but a healthier person will become sick less often than one who is less so. Something to with undernourishment and malnutrition interrupting normal body function….

  7. CarolynS says:

    Kausik – I am not aware that anyone has ever demonstrated that a program to reduce soda consumption, even if it succeeds in reducing soda consumption, has any significant effect on the body weight of the participants. All the evidence is completely indirect, along the lines of “well, it seems like it should work.” Remember randomized clinical trials are all done for treatments that someone thinks are likely enough to work that they are worth doing a clinical trial on, and in a large proportion of cases, the trial shows that the new treatment has no beneficial effect over the standard treatment.

    There are a few interventions in school children (see the article by Brownell et al in the New England Journal in early 2009). Those interventions don’t show significant effects on body weight, and they don’t appear to show any actual declines in the prevalence of overweight as the outcome. Mostly it looks like lots of handwaving. And hese are actual interventions, more directed and focused on getting these particular children to drink fewer sodas.

  8. Kausik Datta says:

    Wait, Carolyn. Do you mean this study – N Engl J Med. 2009 Sep 16; The Public Health and Economic Benefits of Taxing Sugar-Sweetened Beverages – when you say:

    There are a few interventions in school children (see the article by Brownell et al in the New England Journal in early 2009). Those interventions don’t show significant effects on body weight, and they don’t appear to show any actual declines in the prevalence of overweight as the outcome.

    If ‘yes’, this is the study I quoted above as the case for reducing soda consumption made by several people from Yale (Brownell), Harvard (Ludwig), along with others.

    I quote a paragraph from the paper [emphasis mine]:

    The relationship between the consumption of sugar-sweetened beverages and body weight has been examined in many cross-sectional and longitudinal studies and has been summarized in systematic reviews [1,2] A meta-analysis showed positive associations between the intake of sugar-sweetened beverages and body weight — associations that were stronger in longitudinal studies than in cross-sectional studies and in studies that were not funded by the beverage industry than in those that were [2] A meta-analysis of studies involving children [10] — a meta-analysis that was supported by the beverage industry — was interpreted as showing that there was no evidence of an association between consumption of sugar-sweetened beverages and body weight, but it erroneously gave large weight to several small negative studies; when a more realistic weighting was used, the meta-analysis summary supported a positive association [11] A prospective study involving middle-school students over the course of 2 academic years showed that the risk of becoming obese increased by 60% for every additional serving of sugar-sweetened beverages per day [12] In an 8-year prospective study involving women, those who increased their consumption of sugar-sweetened beverages at year 4 and maintained this increase gained 8 kg, whereas those who decreased their intake of sugar-sweetened beverages at year 4 and maintained this decrease gained only 2.8 kg [13]Where is the handwaving of which you speak? Or are you asking me to selectively ignore the evidence that links soda consumption to various health issues?

    Are you fond of your soda, if I may ask? :D

  9. Kausik Datta says:

    Sorry, blockquote fail in the last line. I meant to write this:
    Where is the handwaving of which you speak? Or are you asking me to selectively ignore the evidence that links soda consumption to various health issues? (I have provided hyperlinks to the study references)

    Are you fond of your soda, if I may ask? :D

  10. CarolynS says:

    Hi Kausik. No, I never drink soda, as it happens, nor do I make any money off sodas in any way whatsoever. Go ahead and read on in the Brownell article about the effects of interventions. I think you are confusing two different issues. One is: do fatter people drink more sodas. But the intervention issue is not whether fatter people drink more sodas, but rather if people drink fewer sodas will they lose weight? In the Brownell article, they describe several focused interventions. In none of them, did reducing sodas result in a significant change in body weight. They describe some subgroup analyses which I regard as a form of handwaving in this case because they don’t seem to be taking a very balanced view, but rather more like a prosecutorial argument.

  11. CarolynS says:

    –”How many servings of fruits and vegetables should a person have each day, and will achieving the requisite number ward off disease?”–

    “No, but a healthier person will become sick less often than one who is less so. Something to with undernourishment and malnutrition interrupting normal body function….”

    I think we can all agree that healthier people are healthier than sick people :-)). And it’s pretty clear that adequate nutrition is important. But it’s not that clear that less than five (or nine) servings of fruits and vegetables will lead to “undernourishment” and malnutrition! Most people in the US don’t get those five servings, and it’s hard to say they are undernourished. Nor is it clear that if you eat more servings you will become a healthier person.

    I know it’s hard to be objective. And I also believe that eating fruits and vegetables is a good idea and good for you. But when you immediately slide into talking about “undernourishment” and “malnutrition” … well it starts to sound kind of like the way CAM practitioners tend to talk.

  12. Kausik Datta says:

    Carolyn,

    do fatter people drink more sodas. But the intervention issue is not whether fatter people drink more sodas, but rather if people drink fewer sodas will they lose weight?

    You do understand the concept of risk-reduction, don’t you?

    I also could not find (or probably could not understand) the ‘focused interventions’ that you mentioned in the Brownell paper. Would you mind pointing them out to me?

    As for your other argument:

    How many servings of fruits and vegetables should a person have each day, and will achieving the requisite number ward off disease?

    You are injudiciously oversimplifying a point, perhaps? Fruits and vegetables aren’t like pills with a specific quantity of medicine (i.e., say, like an antibiotic that you take BID for 5 days). The beneficial effects of fruits and vegetables are linked to the fiber and nutrients that they provide. Different fruits and vegetables may provide different benefits, and some, indeed, may be proscribed for someone with specific conditions (such as diabetes, or hyperuricemia). Therefore, it is difficult to quantify down to the serving size and frequency the effects of fruits and vegetables. That they should comprise a part of a healthy and balanced diet is not a point of contention, I hope! :D

  13. CarolynS says:

    The interventions don’t seem that hard to find, but here they are from the second page of the Brownell article

    A school-based intervention to reduce the consumption
    of carbonated beverages was assessed
    among 644 students, 7 to 11 years of age, in the
    United Kingdom with the use of a cluster design.
    16 After 1 year, the intervention group, as
    compared with the control group, had a nonsignificantly
    lower mean body-mass index (the weight
    in kilograms divided by the square of the height in
    meters) and a significant 7.7% lower incidence
    of obesity. In a study involving 1140 Brazilian
    schoolchildren, 9 to 12 years of age, that was designed
    to discourage the consumption of sugarsweetened
    beverages, no overall effect on bodymass
    index was observed during the 9-month
    academic year.17 Among students who were overweight
    at baseline, the body-mass index was
    nonsignificantly decreased in the intervention
    group as compared with the control group; the
    difference was significant among overweight
    girls. In another clinical trial, 103 high-school
    students in Boston were assigned to a control
    group or to an intervention group that received
    home delivery of noncaloric beverages for 25
    weeks. The body-mass index was nonsignificantly
    reduced in the overall intervention group, but
    among students in the upper third of body-mass
    index at baseline, there was a significant decrease
    in the body-mass index in the intervention
    group, as compared with the control group
    (a decrease of 0.63 vs. an increase of 0.12).18 The
    effects of replacing sugar-sweetened beverages
    with milk products were examined among 98
    overweight Chilean children.19 After 16 weeks,
    there was a nonsignificantly lower increase in
    the percentage of body fat in the intervention
    group than in the control group (0.36% and
    0.78% increase, respectively), whereas there was
    a significantly greater increase in lean mass in
    the intervention group (0.92 vs. 0.62 kg).

  14. Kausik Datta says:

    I see. Thank you, Carolyn, for taking the trouble. So where in this is the hand-waving you indicated?

    All the studies described in the intervention groups were designed to address one, and only one, risk factor, the sweetened beverage consumption. Because they did not correct for (as least, from this commentary, it does not appear that they did) other concomitant risk factors, there were some statistically non-significant results. But for those with particular risks (lower lean mass, higher BMI, overweight) at baseline did benefit significantly from the interventions, as you would expect from a risk-reduction measure. Why exactly would you not accept the validity of these results?

  15. CarolynS says:

    Why do you say I am not accepting the validity of these results? They are limited but they are what they are, and none of these studies showed any significant decrease in weight or body mass index. You don’t seem to think those results are valid and you adduce “rescue” hypotheses about correcting for other concomitant risk factors. These appear to be some kind of randomized trials so actually there should be some control for other factors built into the designs. There were some subgroup analyses, which like all subgroup analyses need to be interpreted cautiously, that suggest in some subgroups there was a change, although it was quite small and in some cases it was “less of an increase” rather than a decrease.

    Let’s get back to your original question. You wanted to know why I thought it was very unlikely that the actual prevalence of obesity would be reduced by a program to limit soda consumption. I answered you by saying that the reason is that no one has demonstrated this through an intervention study and the (few) existing intervention studies show no significant impact, at least according to the Brownell paper.

    What would you estimate the probability is that obesity prevalence will be reduced by a program to limit soda consumption? I am just asking. Do you think it’s highly likely, somewhat likely, somewhat unlikely or what? And do you have an estimate by how much you think obesity prevalence might change? 1 percentage point? 5 percentage points? What would you base that on?

  16. Kausik Datta says:

    Carolyn, you said in the post above:

    no one has demonstrated this through an intervention study and the (few) existing intervention studies show no significant impact, at least according to the Brownell paper.

    This is where I would beg to differ. My reading of the Brownell paper seems to be substantially different than yours.

    IMO, the Brownell paper has -
    ** Made a case for Risk Reduction measures, such as restriction of the consumption of sweetened beverages like soda, providing enough evidence of how soda consumption impacts health of the consumers.

    ** Quoted a few intervention studies where subjects at higher risk at baseline (overweight, lower lean mass, and higher BMI) benefited in a statistically significant manner from restricting their soda consumption.

    Would you agree with me on this, at least?

    You indicated:

    They are limited but they are what they are, and none of these studies showed any significant decrease in weight or body mass index.

    But, as I mentioned just now, these studies did show the beneficial effects of the risk-reduction intervention on those at higher risk. I urge you to read that section of the Brownell paper once more.

    You don’t seem to think those results are valid and you adduce “rescue” hypotheses about correcting for other concomitant risk factors.

    Ah, you misunderstand me! I am sorry if my comment came out that way, but that is not it at all.

    I do think that those results, as mentioned by Brownell et al., are valid. But because I could not read the original papers referenced therein, I was going by only Brownell’s commentaries on them. And the said commentary (in the Brownell paper) does not mention if and how those intervention studies considered additional risk factors for the parameters they were studying, i.e. lean body mass, BMI, gross weight and so forth. But EVEN THEN, in all the studies quoted, the benefit was quite apparent in the higher risk group.

    Have I been able to clarify my position on this now? I commend your caution in interpreting subgroup analyses, but in a risk-reduction study, it forms an important part.

  17. Kausik Datta says:

    Oh, and about your question, I cannot guesstimate – I have only superficial knowledge of obesity related epidemiological issues.

  18. CarolynS says:

    Well, this doesn’t seem to be a productive discussion so I will bow out. I do think this actually confirms my original point though. Suppose we were talking about, say, yoga instead of soda reduction. CAM opponents would rightly cast scorn on an argument that just goes something like

    - well studies show that obese people are less likely to practice yoga (reiki, whatever), plus we have four intervention studies none of which should any significant effect of yoga on body weight BUT if you look at a few subgroups of those studies, then we see something, therefore my case is proved and we have good valid evidence that yoga reduces obesity so we are going to incorporate this into our clinics.

    Your point about risk reduction is fine, but these are not the predefined study endpoints and so they are more like chance observations. In one study it’s overweight girls, in another it’s lean mass etc. If in one study only overweight girls seemed to have benfited would you then conclude by the same token that overweight boys won’t benefit? None of these studies appear to have been intended to test the hypothesis that among overweight children but not among lean children soda reduction will lead to loss of body weight. As to subgroup analyses, I recommend an article by Wang in 2007 also in NEJM – Statistics in Medicine — Reporting of Subgroup Analyses in Clinical Trials.

    More generally, advocates, whether they be CAM advocates or in the case of soda a bunch of Harvard and Yale professors, are good at cherry picking results and making round-about arguments about the plausibility of what they are advocating despite the lack of clear evidence. You might feel that the Harvard and Yale professors are more credible and that what they are advocating is more plausible, and that’s fine. But you should try to examine for yourself whether you are actually applying the same evidentiary standards in the two cases or whether you are falling into the same thought pattern that a CAM advocate would follow.

  19. Dacks says:

    I am so happy – I learned a new word today: myrmidons! Thank you.

    CarolynS,
    It’s hard to tell from your comments whether you think the evidence for the reduction of soda intake leading to weight reduction is not strong enough, or that the hypothesis is not plausible. Plausibility is the crux of the matter for many of the blog posts here – the attempt to quantify plausibility as a separate issue from the studies that are carried out.

    In the sugar soda case, it seems logical in a common sense kind of way, that there is SOME plausibility to the idea that reducing soda intake could reduce weight. Aside from the calories eliminated, there are also questions about how we feel satiety when taking in liquid calories, how we metabolically process the calories in soda, etc. This is not to say anything definitive about the hypothesis, simply that it merits study.

    On the other hand, the hypothesis that yoga reduces obesity may also have some plausibility, in that it is a form of exercise, and exercise is known to have a beneficial impact on weight. But to throw reiki in with yoga brings in an entirely different level of plausibility. In order to defend studying reiki for weight loss, one would have to support the hypothesis that waving your hands over energy lines influences obesity. Because we have so far not been able to find any evidence of the existence of these energy lines this case seems to me much harder to make.

  20. CarolynS says:

    Just to restate my point, things that seem plausible may not actually work. Randomized clinical trials are conducted becaue the treatments studied seem plausible and RCTs often show that actually those treatments don’t work.

    If the critique of CAM just depends on ‘plausibility” well, plausibility might be in the eye of the beholder and then why bother discussing evidence? Just argue about plausibility until the cows come home.

    In terms of the sodas, my original statement, which Kausik questioned, was that is was highly unlikely this intervention would reduce the prevalence of obesity. Really I suppose that should be based on two reasons: first, there are no interventions showing that this would work, and second, it’s very difficult to reduce the prevalence of obesity and it usually takes super-intensive individual interventions to reduce obesity prevalence in a sample.

    I honestly don’t think it’s very plausible that if someone stops drinking soda, with no other special intentional change, that person will weigh less at the end of the year. Certainly there does not appear to be any evidence that this happens. One of the studies mentioned by Brownell showed that women who decreased soda intake gained less weight than the other women, but they did gain and not lose weight. I guess if someone were a true skeptic, they would see this as evidence against the idea that stopping soda drinking would reduce weight. However, the idea that stopping soda drinking is benefically is very culturally acceptable so the evidence is not that important. Sort of like the Hmong shamans, really.

  21. Charon says:

    If the critique of CAM just depends on ‘plausibility” well, plausibility might be in the eye of the beholder and then why bother discussing evidence? Just argue about plausibility until the cows come home.

    Postmodernist relativist bullshit.

    Plausibility is based on mature, well-tested ideas in physics, chemistry, biology, etc. It is evidence. It’s not an RCT, and plausibility is not the end of the conversation, but it clearly has a place in the conversation.

    I won’t address the soda/obesity thing because not only am I not an obesity epidemiologist, I’m not in medicine at all. But I am a physicist, I teach philosophy of science, and you do not understand plausibility.

  22. Charon says:

    (Sorry if this is posted twice. Did not show up the first time.)

    If the critique of CAM just depends on ‘plausibility” well, plausibility might be in the eye of the beholder and then why bother discussing evidence? Just argue about plausibility until the cows come home.

    Postmodernist relativist nonsense.

    Plausibility is based on mature, well-tested ideas in physics, chemistry, biology, etc. It is evidence. It’s not an RCT, and plausibility is not the end of the conversation, but it clearly has a place in the conversation.

    I won’t address the soda/obesity thing because not only am I not an obesity epidemiologist, I’m not in medicine at all. But I am a physicist, I teach philosophy of science, and you do not understand plausibility.

  23. Dacks says:

    “Just to restate my point, things that seem plausible may not actually work. Randomized clinical trials are conducted becauae the treatments studied seem plausible and RCTs often show that actually those treatments don’t work.

    If the critique of CAM just depends on ‘plausibility” well, plausibility might be in the eye of the beholder and then why bother discussing evidence? Just argue about plausibility until the cows come home.”

    You are correct, things that seem plausible may not actually work. The goal of science is to differentiate between these.

    This is where we part ways – plausibility is NOT in the eye of the beholder. It is based on all the information coming before – medicine, physics, chemistry, etc. I believe that it is very important to scrutinize plausibility so that the idea that drinking less soda may influence weight loss is NOT seen as equivalent to the idea that Hmong shamans may influence weight loss.

  24. CarolynS says:

    I don’t think the idea that drinking soda influences weight loss is equivalent to the idea that Hmong shamans play a role in healing (I said nothing about Hmong shamans and weight loss but of course that’s also implausible).

    Getting back, if at all possible, to my original point – there is no “bright line” between CAM and conventional medical approaches. Rather there is a gray area, where evidence is weak to non-existent, but ideas are culturally compelling, and the standards applied are not very rigid. The idea that sodas are probably bad for you is a very culturally compelling idea at the moment. Thus even though the actual research to date happens to show no weight loss and even suggests weight gain from soda reduction, nonetheless people are quite ready to give the idea more credence than the evidence would suggest. Then they turn around and criticize the CAM adherents for ignoring the evidence.

    I did not say that plausibility is in the eye of the beholder. And I think I do understand plausbility pretty well, thanks. For a scientist, you jumpt to conclusions awfully fast on awfully limited evidence! Perhaps you had some trouble with the word “if” or the word “just.”

    My point is that plausibility can’t become the end or the “crux” of the discussion, because if it is then it becomes a kind of “he said, she said” type of back and forth. I think it’s preferable to try to get more evidence than just relying on plausibility arguments. We probably all know that there are episodes in science where an implausible idea has turned out to be true. For instance the H pylori-ulcer connection which earned Barry Marshall a Nobel prize, but which was considered completely implausible when it was first suggested. You could have argued over the plausibility of this idea until the cows came home, but it wouldn’t have gotten very far.

    Frankly I woud have thought that CAM opponents would agree with this idea, but I am starting to wonder.

    The soda stuff has some plausibility, though not much in terms of the effects of interventions. The evidence on the soda, at least as reported by Brownell, seems to point to the idea that reducing soda consumption either has no effect on weight or else it leads to increases in weight that are less than they would otherwise have been. But culturally the idea that reducing soda consumption will reduce weight seems to be about as compelling as the belief by a hospitalized Hmong that a shaman will aid in healing, regardless of the evidence.

  25. Tim Kreider says:

    Kausik, thanks for a great post.

    Carolyn, without weighing in on your example for lack of any expertise, I think you make extremely important points. Of course there are aspects of nutrition that we’d all agree are clearcut; I recently enjoyed a lecture on the discovery that niacin deficiency causes pellagra. But often, I think, the fervor with which we believe in particular nutrition nostrums is comparable to our loyalty to political or religious ideas. Sure, we give reasons for our beliefs, but it’s easy for us humans to rationalize a belief that is appealing to us for non-evidence reasons. I suspect that much of pop culture wisdom about food is of this sort. How high quality of evidence would you demand before taking a drug every day for years? I think it’s reasonable to apply similar standards to nutrition claims before changing your diet for the sake of disease prevention.

    Even if it is highly plausible that an individual person can lose weight by eliminating soda, surely we can all agree that such plausibilty isn’t proof that the population intervention will work. The basic science of immunology, the area of my graduate study, is a great analogy. Just because a particular cell or molecule is effective in an in vitro assay doesn’t guarantee that it is important at all in vivo, because the intact immune system is a mind-numbingly complex web of interactions full of pleotropy and redundancy. Sometimes blocking a molecule in a live animal has precisely the opposite effect of what we expected! Science is truly a humbling endeavor.

  26. Dacks says:

    CarolynS

    Agreed, “crux” was probably the wrong word to use. Plausibility should be a factor in evaluating whether studies should go forward, and how to interpret results, but certainly not the deciding factor. I am not a scientist, which is probably why I am having trouble expressing myself clearly.

  27. Carl Bartecchi says:

    Great post Kausik. You mentioned the Tai Sophia Institute. They tried to set up a co-operative program with the U. of Pennsylvania Medical School. Some woo-meisters at Penn were involved with this. All it took was to contact rational physicians at Penn and tell them about Tai Sophia and direct them to it’s web page with it’s board of directors. That information was enough for Penn to sever ties with Tai Sophia. These things occur and progress, usually under the radar. Once fully exposed to faculty and alumni, they become an embarrassment and are sometimes aborted.
    I believe that academic medicine’s flirtation with alternative medicine is all about the money. Otherwise good academic physicians in leadership positions in medical centers, not wanting to go against powerful money oriented administrators, influential directors, wealthy donors and celebrities, overlook their obligations to their patients and their profession and the harm that they do by their support of quackery.

  28. aaiou1 says:

    Great post! Can you tell me if this is quakery?
    https://tharrington.teamasea.com/product/science.html

    Thank you

  29. Scott says:

    aaiou1,

    Yes, most definitely. You’ll note that there’s no description of any real trials showing that it has any effect. The one thing they do that comes close is claiming that it had good effects on some athletes. But there are too many problems to count with that “study”, rendering it utterly meaningless. To list just a few that leaped out at me most strongly:

    – No placebo control. Drinking 8 oz right before the test would quite credibly have an effect.
    – Minimal actual data presented.
    – No examination of statistical significance (with 11 subjects, there wouldn’t be any unless the effect were gargantuan).
    – Two data points discarded for unspecified “experimental error”, which sounds an awful lot like “we didn’t like the results so there must have been something wrong”.

    So it amounts to “here’s some sciencey terminology that makes it sound good, and all these fancy tests we did, but we’ll wave our hands really fast and hope you don’t notice that none of the tests looked at whether or not it actually does anything.” Pure quackery.

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