Review

The recent albuterol vs. placebo trial reported in the New England Journal of Medicine (NEJM) found that experimental subjects with asthma  experienced substantial, measured improvements in lung function after inhaling albuterol, but not after inhaling placebo, undergoing sham acupuncture, or “no treatment.” It also found that the same subjects reported having felt substantially improved after either albuterol or each of the two sham treatments, but not after “no treatment.” Anthropologist Daniel Moerman, in an accompanying editorial, wrote, “the authors conclude that the patient reports were ‘unreliable,’ since they reported improvement when there was none”—precisely as any rational clinician or biomedical scientist would have concluded.

In Part 1 of this blog we saw that Moerman took issue with that conclusion. He argued, with just a bit of hedging, that the subjects’ perceptions of improvement were more important than objective measures of their lung function. I wondered how the NEJM editors had chosen  someone whose bibliography predicted such an anti-medical opinion. I doubted that Editor-in-Chief Jeffrey Drazen, an expert in the pathophysiology of asthma, had ever heard of Moerman. I suggested, in a way that probably appeared facetious, that Ted Kaptchuk, the senior author of the asthma report, might have recommended him.

Editorial Cronyism?

I wasn’t being facetious, even if I was a bit snide. In a 2009 article Kaptchuk touted Moerman’s notion of “the meaning response,” also discussed in Part 1. In a 1998 article, one of Kaptchuk’s early forays into the placebo topic, he had thanked Moerman and others “for advice, discussion, and feedback.” In the Acknowledgments for his 2002 book Meaning, Medicine, and the “Placebo Effect,” Moerman returned the complement to Kaptchuk. In a very recent essay on “placebo studies and ritual theory,” Kaptchuk showed some serious cultural anthropology chops with a serviceable impression of Moerman:

…healing rituals are never simply enactments of plots, stories or assertions of truth. Instead, they are compelling multi-sensory dramas involving evocation, enactment, embodiment and evaluation. Rituals and their sensory, affective, moral and aesthetic components transmute the mythos into an experiential reality for participants. Metaphors and symbols, the healer’s prestige, social interactions with relatives and community members in the course of preparation and performance of the ritual, and gesture, recitation, costume, iconography, touch, ingestion and the physical ordeal—all provide vehicles for and multi-dimensional guideposts to a process that is meant to transform a patient from brokenness to intactness.

Authorship by Committee and Mixed Messages

The asthma trial authors themselves seemed ambivalent about the meaning of their results. Here is the larger passage from which Moerman culled the “unreliable” comment:

…although improvement in objective measures of lung function would be expected to correlate with subjective measures, our study suggests that in clinical trials, reliance solely on subjective outcomes may be inherently unreliable, since they may be significantly influenced by placebo effects. However, even though objective physiological measures (e.g., FEV₁) are important, other outcomes such as emergency room visits and quality-of-life metrics may be more clinically relevant to patients and physicians.

David Gorski has previously mentioned that his “jaw dropped” when he read those words; so did mine, and so, everywhere, should jaws of asthmatic patients and competent physicians drop. The two sentences are contradictory: if the first is true, the second—essentially similar to the theme in Moerman’s editorial, weasel words and all—is perverse. How could the same authors have written both? Perusing the list of authors provides some hints:

Michael E. Wechsler, M.D., John M. Kelley, Ph.D., Ingrid O.E. Boyd, M.P.H., Stefanie Dutile, B.S., Gautham Marigowda, M.B., Irving Kirsch, Ph.D., Elliot Israel, M.D., and Ted J. Kaptchuk

Thus there were eight authors, suggesting that there may not have been a unanimity of opinion. Of the eight, five—M.E.W., I.O.E.B., S.D., G.M., and E.I.—are identified as “from the Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital and Harvard Medical School” (the same Division, as I mentioned in Part 1, that spawned NEJM Editor Jeffrey Drazen). It’s a safe bet that those five subscribed to the first sentence quoted above, but not to the second.

I don’t know about the other two authors, but Ted Kaptchuk would appear to agree with the second sentence. Here he’s quoted in the Brigham and Women’s Hospital press release:

“We chose to study patients with asthma because earlier evidence had suggested that placebos would change the underlying medical problem,” explains senior author Ted Kaptchuk, Director of the Program in Placebo Studies at BIDMC and Associate Professor of Medicine at HMS. “While I was initially surprised that there was no placebo effect in this experiment [after looking at the objective air flow measures] once I saw patients’ subjective descriptions of how they felt following both the active treatment and the placebo treatments, it was apparent that the placebos were as effective as the active drug in helping people feel better.”

…adds Kaptchuk, the study results imply that placebo treatment is just as effective as active medication in improving patient-centered outcomes.”It’s clear that for the patient, the ritual of treatment can be very powerful,” notes Kaptchuk. “This study suggests that in addition to active therapies for fixing diseases, the idea of receiving care is a critical component of what patients value in health care. In a climate of patient dissatisfaction, this may be an important lesson.”

Let’s see: “patient-centered outcomes” are now defined as feeling better but not being better? (I wonder if Don Berwick, the nation’s most influential exponent of patient-centered care, would agree). According to whom? Other press reports were even worse:

Treatment, not medicine, helps asthma patients feel better

NEW YORK, July 15 (Reuters Life!) – Inhaling albuterol helps asthmatic lungs work better, but patients who get it don’t feel much better than those treated with a placebo inhaler or phony acupuncture, according to a U.S. study.

The results, which appeared in the New England Journal of Medicine, demonstrate the importance of, literally, caring for patients and not just providing drugs, said co-author Ted Kaptchuk of Harvard Medical School.

The findings also demonstrate the impact of the so-called “placebo effect,” or the phenomenon seen in clinical trials when people given inactive, fake “treatments,” such as a sugar pill or saline, show improvements.

“My honest opinion is that a lot of medicine is the doctor-patient relationship,” Kaptchuk told Reuters Health.

“A lot of doctors don’t know that, they think it’s their drugs. Our study demonstrates that the interaction between the two is actually a very strong component of healthcare.”

…

Treatment of Asthma now Possible with Placebo Treatments

A New study says, “Placebo treatments are equally effective in the treatment of asthma like [sic] any asthma medications.”

According to the researchers, the main reason behind proposition of this study is that several asthma patients have reported that they felt improvement in their asthma symptoms after they received placebo treatments. These treatments also include inhaler treatments and fake acupuncture. The improvement is similar to what they feel after taking asthma medication such as albuterol.

But the researchers also mentioned that unlike asthma medications, the placebo treatments are not capable of affecting the functioning of the lung.

The researcher of the study, Mr. Ted Kaptchuk said, “The practice of treatment can be highly effective for the patients”. “The study also recommends that patients should value not only the treatments for improving diseases but also the intensive care they receive from their healthcare providers” he added.

Mr. Ted Kaptchuk also said, “In the initial stage of the experiment, placebo treatments fail to make any impact. But later, when I observed that patient’s subjective descriptions about what they felt after receiving the two treatments then I concluded that placebo treatments work as well as other asthma treatments”.

At least one blog, citing the Reuters report quoted above, reported that “placebos were just as effective as real therapy” without even mentioning the trial’s having found a discrepancy between objective findings and subjective reports.

I am aware that authors of journal articles can’t be expected to control how every reporter characterizes those articles, but it’s fair to say that the emphasis of the various quotations attributed to Kaptchuk—which, as far as can be gleaned from the web, are accurate—was essentially the opposite of the study’s most important finding.

From Campus Radical to AltMed Superstar

You might have noticed that Kaptchuk’s is the only name on the list of authors that is not accompanied by the mark of an advanced degree, as I will eventually discuss. Like Moerman, Kaptchuk lacks formal training in either modern medicine or biomedical science, although he has learned a lot about the history and methods of clinical trials. How did he get to be Senior Author of an article published in the New England Journal of Medicine, and how did he become Associate Professor at the Harvard Medical School?

Here is the short version:

I was interested in science for a long time. In college, I studied religion and philosophy. Then I studied Chinese medicine in China and I came back and was a practitioner of Chinese medicine. When people became interested in alternative medicines, they asked me to help out at Harvard Medical School. I realized that in order to survive there, one had to become a scientist. So I became a scientist.

Here is the beginning of the longer version. Kaptchuk graduated from Columbia University in 1968, having majored in Asian philosophy. While there he was Chairman of the radical group Students for a Democratic Society (SDS), just prior to the emergence of its more famous chairman, Mark Rudd. I mention this not to commie-bash, but because it helps to elucidate some of Kaptchuk’s later opinions (hint: he has no trouble agreeing with both sentences in the jaw-dropping paragraph quoted above) and to demonstrate some of the ironies of his later choices.

After graduation, in Kaptchuk’s own words, ”I worked in the welfare and social services trying to help people.” During this time “I decided that I wanted to learn a healing art but was disillusioned with some of the aspects of Western allopathy and decided to learn acupuncture.” Kaptchuk pursued training with Asian practitioners in California and “studied every book in English on the subject,” but by 1972 had decided that this would not be sufficient:

Because of the relative unknowness [sic] among non-Chinese Americans of acupuncture and Dr. Hong’s limited practice, I cannot get enough experience to adequately master this healing art. In addition, there is a greater reluctance among other Chinese doctors who have more patients to have a student observe because of legal restrictions concerning their practice in the United States.

Kaptchuk reports having next spent a year in Taiwan, followed by 2.5 years in Macau (click on the image to enlarge):

Within a few years of his return to the United States, Ted Kaptchuk published the book that made him an alt-med superstar:

It is this book that I will discuss in the next part of this series.

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