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

The Main Event: Novella vs. Katz

The remainder of the Symposium comprised two panels. The first was what I had come to see: a Moderated Discussion on Evidence and Plausibility in the Context of CAM Research and Clinical Practice, featuring our Founder, Steve Novella, who is also Assistant Professor of Neurology at Yale; and David Katz, the speaker who had borne the brunt of the criticism after the 2008 conference (as I wrote in Part I). According to the Symposium syllabus, he is:

David L. Katz, MD, MPH, FACPM, FACP, an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. Katz is the Director and founder (1998) of Yale University’s Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, CT; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. He currently serves as Chair of the Connecticut Chapter of the Partnership to Fight Chronic Disease and represents Yale University on the Steering Committee of the Consortium of Academic Health Centers for Integrative Medicine.

The syllabus had excerpted that statement from a much larger, remarkable document, which I urge you to review.

I will attempt to report the Moderated Discussion as neutrally as possible, as though I were a disinterested journalist (don’t worry: later I’ll rail).

The session began with 10-minute remarks by each of the two panelists. Each was then asked to respond to a few scripted questions posed by the moderator, Dr. Barry Boyd (whose earlier talk I discussed in Part I). The panelists were aware of the questions beforehand.

Dr. Novella went first. He began by suggesting that everyone in the room shares a common ground: wanting to do what’s best for patients, and in particular wanting to offer them things that work. He proceeded to summarize what he means by “science-based medicine.” My notes are scant and illegible, but I’ll try to re-create the points. Steve can fill in any glaring omissions later.

Science-based medicine, said Dr. Novella, is not a list of treatments, procedures, specialties, drugs, diseases, or whatever; rather, it is a methodology. It seeks the best diagnostic and therapeutic options wherever it may find them; it is, like science in general, always open to new directions and willing to scrap existing ones, if the evidence so leads. It is based in the natural sciences, especially biology, but it also applies scientific methods to practical aspects of clinical medicine, such as testing diagnostic and therapeutic hypotheses. It assumes “consilience”: like science itself, it is not “Eastern” or “Western,” but universal.

Science-based medicine doesn’t “cherry-pick”: it starts with a problem and follows the evidence toward or away from potential solutions; it does not first pick a solution and then assemble whatever evidence there may be to support it. It acknowledges numerous sources of bias and error, from our flawed brains to small studies and studies sponsored by advocates (Steve cited drug companies). It recognizes the necessity to consider the “meta-evidence” (I think that was Steve’s term), meaning evidence gleaned from the entire range of potential sources: basic science to clinical trials to clinical realities.

Dr. Katz followed. He began by observing that it isn’t very often that he begins a debate by agreeing with the other debater. This yielded a smattering of appreciative chuckles. He continued with a series of “bullets,” and once again I’m afraid I don’t have them all in my notes, but here’s my attempt, followed by most of the points that Dr. Katz made in his opening remarks:

“Plausibility and Pandora”
“Tail wags Dog”
(illegible), Serendipity
Absolute Relationship
Scylla and Charybdis

Dr. Katz mentioned that according to astrophysicists (or perhaps one in particular that he had read or heard speak), there is more empty space between the elementary particles in each of our bodies than exists in the entire universe. He doesn’t understand it himself, but assuming it is true he wonders, for example, how others can so easily dismiss Therapeutic Touch merely because it isn’t really touch, since what we think of as touch isn’t really touch, either.

He listed a few innovations in the recent history of medicine that were “heresy” when first proposed, suggesting that if plausibility had ruled the day they would never have emerged:

H. pylori shown to be the cause of peptic ulcers;
Beta-blockers beneficial even for patients prone to congestive heart failure;
Rocky Mountain spotted fever established as caused by a bacterium.
(Later he mentioned the right heart catheter as an example of something that everyone thought was safe and effective, until a study showed that it wasn’t; but even then it took a long time for MDs to finally stop using it)

He mentioned that the monoamine oxidase inhibitor (MAOI) class of antidepressants had been discovered serendipitously when TB patients taking isoniazid (INH), a related drug, didn’t seem so depressed.

He said, “relative absence of evidence is not absolute evidence of absence.”

Evoking Scylla and Charybdis, he invited the audience to consider this choice: that something “works whether or not it’s plausible”; or that something is “implausible whether or not it works.”

He offered the metaphor of a solid floor and a moving ceiling to represent proven and unproven treatments, and noted that if we insist on using only proven treatments, we will soon get squeezed (he didn’t say it exactly that way, but I think you get the point).

The two participants then sat down and the moderator asked the questions. I can remember only one, but I remember most of the discussion. A large part of it involved how to deal with patients who are suffering, but for whom scientific medicine has no clear solution. Dr. Novella argued that he would never abandon such a patient, and that there are ways to be compassionate and caring without offering implausible treatments. He has also discussed similar points here on SBM. When asked what he would do if a patient asked his opinion about a particular method, he replied that he would be honest. He said that according to surveys, only a small fraction of those who seek “CAM” do so because of having exhausted all “conventional” options. Most do it for other reasons, having more to do with their beliefs.

I must admit that I can’t remember exactly how Dr. Katz responded to that point and to Dr. Novella’s opinions, but it presumably had to do with his floor/ceiling metaphor; his views on the same general topic are available elsewhere.

The scripted question that I distinctly remember went something like this: “what would you do if your hospital decided, in response to a perceived demand in its community, to establish a Therapeutic Touch program?”

Dr. Novella replied that he would oppose it on the grounds that hospitals have made an implicit commitment to offer science-based treatments, and Therapeutic Touch does not meet that standard.

Dr. Katz disagreed, suggesting that we don’t really know that TT doesn’t work; there have been intriguing studies, he said, showing effects on cells in tissue culture that couldn’t possibly be explained by a placebo effect. He suggested that extreme skeptics believe that TT doesn’t work and can’t work, while extreme advocates are certain that it does, and thus the reasonable, moderate position—represented by himself, presumably—would seem to be somewhere in the middle. He made similar comments about homeopathy.

Dr. Katz said that if he were advising the hospital in question and certain physicians were adamantly opposed, he would suggest that the hospital offer Therapeutic Touch to patients but provide them with a disclaimer stating that those (named) physicians were opposed to it.

Dr. Novella, referring to Dr. Katz’s earlier point about the space between elementary particles justifying a tentative plausibility for TT, asserted that counter-intuitive concepts in quantum mechanics and cosmology do not apply to the macroscopic, everyday world of clinical medicine.

There was a brief exchange about plausibility and mechanism. After Dr. Katz asserted that we needn’t know the mechanism to conclude that something works, Dr. Novella replied that “knowing the mechanism” and plausibility are not equivalent.

Dr. Novella asked if “CAM” advocates would ever be willing to say that something doesn’t work; he noted that even among Cochrane Reviews one doesn’t find such conclusions for “CAM” methods. Dr. Katz said that he had concluded that one particular substance (I don’t remember what it was) doesn’t work, but he was not willing to say the same for many others, including homeopathy, TT, and Myers’ Cocktail, although his own studies of homeopathy and Myers’ cocktail had not shown benefit. He argued that his studies had been hampered by stipulations from the IRB that made them not applicable to typical use.

………

I’ve witnessed these sorts of debates before. The usual scenario is that the audience is heavily biased in favor of the pro-“CAM” stance, and the skeptic finds himself backpeddling from the outset. The pro-“CAM” participant need merely raise his eyebrows or utter a word such as “reductionistic” to get supportive laughter or applause, whereas the skeptic can barely open his mouth without being hissed and booed. That this did not happen at the Yale Symposium is a tribute to Steve Novella, who is better at being sympathetic to others’ heartfelt beliefs while maintaining his intellectual integrity than anyone I’ve seen in such a spot. It also reflects the civil tone of the meeting as a whole and of the tone presented by the moderator, Barry Boyd. I congratulate them all, even Dr. Katz—although I must admit to a secret suspicion that he was frustrated by not having succeeded in making Steve Novella look like a curmudgeon. I could be wrong.

………

The final panel of the day consisted of Drs. Novella, Katz, and a few other Symposium faculty fielding questions from the audience. Most of the questions were directed to the two debaters, who reiterated several of the previous points. Other panelists spoke to an extent; Auguste Fortin, Associate Professor of Medicine and Director of Communication Skills Training for the Yale Primary Care Internal Medicine Residency Program, repeatedly referred to himself and his colleagues as “allopaths.”

Comment

A quick aside to Dr. Fortin: please, for the sake of your residents and of accurate communication skills in medicine, learn the basis for the term “allopath” and cease using it to refer to physicians. (Hint: look here). Modern medicine is “modern medicine.” We are “medical doctors.”

Regarding Dr. Katz’s assertions, particularly amusing to me was the one about H. pylori and plausibility. I usually find wanton self-promotion distasteful, but He Who Debunked the Marshall-and-Warren-as-Galileo Myth was sitting right there in the audience! The short story, for the benefit of John Millet and medical students in general, is that even if clinicians scoffed at the hypothesis when they first heard it, there was no discernible effect on its progress from bench to practice.

Practicing physicians and even academics tend to be conservative (with a small ‘c’) and risk-averse; this is a different issue from that of how scientific medicine as a whole deals with novel hypotheses. (Josephine Briggs also failed to appreciate the distinction when she offered her list of “quirky ideas from outside the mainstream,” reported in Part I). The notion that bacteria might cause an inflammatory lesion was entirely plausible, of course, and even if some physicians were surprised to hear that bacteria can adapt to an acidic environment, bacteriologists were not.

The H. pylori hypothesis became intriguing at the moment that Marshall and Warren reported having successfully cultured the organism. It was rapidly investigated all over the world, and within a few years the old etiologic “paradigm”—ironically, a rather implausible mind-body hypothesis involving stress—was no more. The story of H. pylori is a great triumph of science-based medicine, not a reason to dismiss plausibility arguments.

After the conference I approached Dr. Katz and suggested that the time it took for H. pylori to be accepted as the cause of peptic ulcer disease was entirely reasonable. He replied, “reasonable for whom? What about patients?” I’d meant, of course, “reasonable according to how long it takes to do the work,” which I told him, adding, “so what do you mean about patients? That we should have started treating them with antibiotics before…?” I didn’t finish the obvious question, but what would we have been treating? Marshall and Warren had no idea what the organism was when they first saw it.

In talking with Katz I quickly realized that he is surprisingly naïve for someone who holds himself out as an expert in “integrative medicine.” It hadn’t occurred to him that Therapeutic Touch (like all versions of “energy medicine”) is a form of psychokinesis (PK), nor did he know that PK has been studied for well over 100 years without having yielded any reproducible evidence for its existence. (The notion that it is a recent hypothesis deserving the attention of medical academia is a ruse). In an attempt to offer another example of strange powers that are beyond our understanding, he stumbled when he reported that during his recent vacation, a “mentalist” in a restaurant had come right up to him and effortlessly bent the tines of his fork with merely two fingers of one hand, a task that Katz himself could barely accomplish with both hands. He exclaimed, “I don’t know how he did it, but I know he did it!” I replied, “but you know that it was a trick, don’t you?”

There is no shame in being fooled by a good conjurer—most people are—unless the very field in which you claim expertise requires that you know about such things. Spoon bending (or, in this case, fork bending), is claimed by some of its more illustrious practitioners to be a form of PK. There is a pattern here: Dr. Katz’s counterpart at Harvard, Dr. David Eisenberg, is also innocent of such matters. He is also the co-author of language quoted in Part I of this report, praising chiropractors for “never failing to find a problem.”

Dr. Katz betrayed a naïveté about clinical trials, in spite of his professed expertise in that realm. When Dr. Novella and I asked what he thought the aggregate results of several trials of an ineffective but passionately advocated method are likely to be, he replied that they would certainly hover around the null. We would all like this to be true, but it isn’t. Clinical trials are not physics experiments. Even RCTs are fraught with opportunities for error and bias.

Experience shows that the typical history of clinical research for a “CAM” method is this: early trials, usually small, poorly designed, and performed by advocates, tend to be “positive”; later ones that are larger and better trend toward the null, but it can take years and many trials before it becomes clear that this is their fate—if it happens at all. There will inevitably be sporadic “positive” studies that are trumpeted by advocates, even if they can’t be replicated. The study that Dr. Katz mentioned at the Symposium, purporting to demonstrate Therapeutic Touch exerting an effect on cells in culture, is a perfect example.

It may be formally true that one can’t “prove a negative,” but this is no reason to take seriously every crackpot notion that comes along. To position oneself as “middle of the road” or “balanced” regarding a claim such as homeopathy or Therapeutic Touch is misleading and unscientific. It is the equivalent of asserting the same for long-settled questions such as whether the earth is planar or spheroid, whether or not perpetual motion machines can work, and so on. It is akin to a call to “teach the controversy” of evolution vs. “creation science.”

In the meantime, implausible “CAM” methods continue to be held out as “promising” or at the least not disproven, and more trials are invariably called for—no matter that in many cases existing knowledge is sufficient to refute the hypothesis. This has been the trajectory of research in homeopathy, acupuncture, ‘distant healing,’ the ‘supplements’ discussed by Dr. Briggs at the Symposium, and other “CAM” proposals. (Natural products are not highly implausible, of course, but for a number of reasons are usually moderately implausible). In acupuncture and homeopathy research, such futility has continued for decades. The same is true for the entire field of parapsychology (the investigation of paranormal claims such as PK, ESP, etc.), in spite of highly sophisticated experimental designs over the past 30-40 years—more sophisticated than would be possible for most “CAM” trials.

As several have argued, parapsychology research is an example of pathological science. I suspect that this is the inevitable result of performing trials of any highly implausible claim that has passionate adherents, and that much of “CAM” research is doomed to repeat this history. Just as paranormal claims are an important subset of “CAM,” parapsychology research is an important historical precursor of “CAM” research—even if most medical academics, including those who identify with “integrative medicine,” are unaware of it.

I’ve sparred with Dr. Katz in the past, in print, addressing some of the other points that he made at this Symposium:

Dr. Katz here; my reply (to his and a ton of other indignant letters) here (included are responses to his right heart catheter argument, a discussion of “mechanism” as it applies to plausibility, a rebuttal to post-modern language devices, and more).
Dr. Katz’s response to his critics following the 1^st Yale Symposium here; my take on his response: here and here (including comments on the false dichotomy of proven methods vs. “CAM”; his hyping of homeopathy, TT, craniosacral therapy, Myers’ Cocktail, and other bogus treatments; his and others’ casual flouting of well-established medical ethics)

Conclusion

Most of the content of the 2^nd Yale Research Symposium on Complementary and Integrative Medicine, Dr. Katz’s comments being a notable exception, was not “complementary” or “integrative,” but simply medicine. What proponents mean by the term “integrative medicine” seems to vary according to political expediency. To onlookers it is not substantially different from the “holistic medicine” of 30 years ago, described by philosophers Clark Glymour and Douglas Stalker:

Is there another, holistic, conception of medicine distinct from [modern medicine]? Certainly, many people seem to think so…Popular bookstores are filled with works on “holistic medicine,” many edited by medical doctors…[or]…authored by professors at distinguished medal schools… The therapies described and recommended in a typical book of the genre include biofeedback, hypnosis, psychic healing, chiropractic, tai chi, iridology, homeopathy, acupuncture, clairvoyant diagnosis, human auras, and Rolfing…

What ties together [these] diverse practices…? In part, a banal rhetoric about the physician as consoler… In part, familiar and rather useless admonitions about not overlooking the abundance of circumstances that may contribute to one condition or another. Such banalities are often true and no doubt sometimes ignored, with disastrous consequences, but they scarcely amount to a distinctive conception of medicine. Holist therapies can be divided into those that are adaptations of traditional medical practices in other societies—Chinese, Navajo, and so forth—and those that were invented, so to speak, the week before last by some relatively successful crank…

The recent success of the “Integrative Medicine” (IM) movement at medical schools is a curious turn of history. Enthusiasts portray it as “patient-centered,” “healing-oriented,” “preventive health” and more, but what can honestly be held out as distinct from modern medicine is no more than a collection of practices that don’t withstand either scientific or ethical scrutiny. To claim otherwise distorts the history of medicine and of what the practice of modern medicine involves. It misrepresents the relation between science and medicine and the extent to which the tools of Evidence-Based Medicine can be brought to bear on highly questionable claims. It distracts from the usefulness of physicians learning a wide range of critical thinking skills. Such skills might be applicable, for example, to evaluating strange powers such as PK and fork-bending, or to the ethics of studying “Lyme-Literate” practitioners. Perhaps most importantly, it constitutes a radical departure from firmly established medical ethics.

Fundamental to the movement is euphemism: accurate terms are replaced by those that seek to reassure and soothe. This obscures, rather than elucidates the phenomenon. It facilitates bait-and-switch ruses both for individual practices and for “CAM” or IM as a whole. One of our fellow bloggers, a Stanford oncologist who has been a student of such matters since the peak years of the Laetrile fraud, wrote a depressingly accurate satire explaining how medical schools have been duped by what amounts to a clever PR campaign. Language distortions have literally changed the standards of care in medicine, and not for the better. The term “integrative medicine” is now central to that change.

Medical students have not been told these things by “integrative medicine” mentors, who themselves are largely innocent of them—just as they tend to be naïve about many of the practices that they find so intriguing, as documented in the two parts of this report.

I hope that this report provides some small impetus for John Millet and other IM enthusiasts at Yale and elsewhere to re-evaluate their thoughts. They are, almost without exception I’m sure, smart, committed, enthusiastic, caring young people who are trying to become the best that they can be in medicine. I certainly developed that opinion of John in the short time that I spoke with him and observed him. He reminded me, in fact, of our very own Tim Kreider. I hope that this report will suggest to John and others that there is more to an honest, comprehensive, and ethical evaluation of IM than its proponents acknowledge.

In addition to this report and the links from it, here is a short template for how medical schools might begin to teach “CAM” in an honest, rigorous way (scroll down to “ ‘CAM’ for Medical Students”). I’m slightly embarrassed to say that we at SBM have been talking for a couple of years about creating a more comprehensive set of materials just for that purpose, perhaps to occupy its own website, but we’ve not yet done it.

For John and other Yalies, of course, there is a much better resource: Dr. Steve Novella himself, who is without a doubt the most knowledgeable skeptic under the age of 80 that I’ve ever met. I’m not kidding, Yale medical students: this guy is the real deal, and you don’t want to miss your brief opportunity to learn from him.

Finally, I’m imagining that some who read this report will wonder whether it really matters: if medical students are learning real medicine anyway, so what? Who cares if a little woo sneaks through the doors of the White Coat Academy? Isn’t it better that IM is calling attention to some things (walnuts, nutrition, exercise, relaxation methods) that tend to be short-changed by medicine even if they shouldn’t be?

Uh, nupe. Those who are interested in walnuts and exercise and relaxation are to be encouraged, but should also be encouraged to repudiate “CAM” or IM precisely because of its pseudoscientific, unethical content. There are all sorts of hazards awaiting those who fail to understand this—we saw a small example in Part I, regarding “Lyme-Literate” practitioners prescribing colloidal silver. (If the Yale IRB is still watching, please scroll down Part I to the comment from ‘rosemary’). There are, of course, larger, almost unbelievable hazards emanating from the very pinnacles of “CAM” research: for starters, look here and here.

Afterword

The philosophers Glymour and Stalker were uncanny in their predictions, made more than 25 years ago:

If holistic-health advocates were content with encouraging sensible preventive medicine or with criticizing the economic organization of American medicine, we might be enthusiastic, but they are not. If the movement were without influence on American life, we would be indifferent, but it is not. Holistic medicine is a pablum of common sense and nonsense offered by cranks and quacks and failed pedants who share an attachment to magic and an animosity toward reason. Too many people seem willing to swallow the rhetoric—even too many medical doctors—and the results will not be benign. At times, physicians may find themselves in sympathy with the holistic movement, because some fragment of the rhetoric rings true, because of certain practices and attitudes they encounter in their daily work with colleagues and patients, or because of dissatisfaction with the economic and social organization of medicine. One hopes they will speak bluntly, but it does no good to join forces with cranks and quacks, magicians and madmen.

A not-benign result that even Glymour and Stalker may not have predicted is the epidemic of commercialism and self-promotion that would have been unthinkable only a few years ago. It is abundantly evident on Dr. Katz’s website and on “integrative medicine” websites elsewhere. If the mood of society has changed so much that this does not strike today’s medical students as profoundly unprofessional (as it would have struck us in the 1970s), I hope that they will at least consider the conflicting interests of practitioners whose patients expect untainted advice. It is self-evident that we should strive to immunize ourselves, our patients, and our institutions against sales pressures from Big Pharm, no? Why should this, which by virtue of its infatuation with magical thinking is even more likely to lead us astray, be any different?

Link to Part I

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

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

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

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

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

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

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

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

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

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