March 4, 2010

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

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

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

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

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

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

Yale Research Symposium on Complementary and Integrative Medicine

Welcome and Opening Remarks

John Millet YSM 2012 and Richard Belitsky MD

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

D. Barry Boyd MD, MS (Not CAM)

Keynote Lecture:  Progress in Research in Complementary and Alternative Medicine

Josephine P. Briggs MD (Mostly Not CAM )

Concurrent Sessions:

Traditional Chinese Medicine, Nutrition, and Research Methods Track

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

Shu-Ming Wang MD, Lac (CAM)

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

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

N-Acetylcysteine for Pediatric Trichotillomania

Michael H. Bloch MD (Not CAM)

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

John Millet YSM 2012 (Not CAM)

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

Ather Ali ND, MPH and Lawrence A. Vitulano PhD

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

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

Karl L. Insogna MD (Not CAM)

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

Rachel Lampert MD (Not CAM)

Piloting a Mindfulness Based Stress Reduction Curriculum for Internal Medicine Residents

Auguste H. Fortin VI MD, MPH

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

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

Mindfulness Training as Treatment and Mechanistic Probe for Addictions

Judson Brewer MD, PhD

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

Rajita Sinha PhD

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

Haleh Saadat MD

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

Moderator: D. Barry Boyd MD, MS

Panel:  David Katz MD, MPH

and Steven Novella MD

Open Forum Discussion with Expert Panel

Moderator:  Lawrence A. Vitulano PhD

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

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

The Morning: Drs. Boyd and Briggs

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Afternoon

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

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

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

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

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

On finally obtaining a diagnosis:

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

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

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

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

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

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

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

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

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

End of Part I