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Pediatrics & “CAM” I: the wrong solution

Oh no!  Not again! The venerable medical journal Pediatrics devotes an entire supplement this month to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical, and Clinical Issues in Decision-Making.

We sense from the very first sentence that we are in familiar territory:

Rapid increases the use of complementary and alternative medicine (CAM) raise important legal, ethical, clinical, and policy issues. (S150)

“Rapid increases”? And evidence of these “rapid increases?” None cited.

We do, however, see the same shopworn reference to popularity deconstructed elsewhere on SBM. What we learned by actually examining “the large 2007 US survey” which purportedly “revealed that ~4 in 10 adults and 1 in 9 children and youth used CAM products or therapies within the previous year”(S150) is that

…most hard-core CAM modalities are used by a very small percentage of the population. Most are less than five percent. Only massage and manipulation are greater than 10 percent. These numbers are also not significantly different from 10 or 20 years ago — belying the claim that CAM use is increasing.

We also find this definition of “CAM”:

a broad domain of healing resources …other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. (S150)

I’m not sure what it takes to become “intrinsic” to the “politically dominant” healthcare system. If it includes being legal, licensed or covered by public and/or private insurance, that would appear to disqualify dietary supplements, chiropractic, acupuncture, homeopathy, homeopathic products and naturopathy as “CAM” in some, or in some cases all, of the American states.

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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine, Vaccines

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Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.3: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD (concluded)

Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.3: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD (concluded)

A Loose End

In the last post I wondered if Ted Kaptchuk, when he wrote the article titled “Effect of interpretive bias on clinical research,” had understood this implication of Bayes’s Theorem: that interpretations of most scientific investigations are exercises in inverse probability, and thus cannot logically be done without consideration of knowledge external to the investigation in question. I argued that if Kaptchuk had

…understood the point when he wrote his treatise, he was dishonest in not explaining it and in not citing at least one pertinent article, such as Steven Goodman’s (which I’m willing to bet he had read). If he didn’t understand the point he should have withheld his paper.

In researching more of Kaptchuk’s opinions I’ve discovered that he had certainly read Goodman’s article, but that he either didn’t understand it or preferred to obscure its implications in deference to his ongoing project in belittling scientific knowledge. In a letter to the editor of the Annals of Internal Medicine in 2001, Kaptchuk opined that even if “more trials of distant healing with increased methodologic rigor” were positive, it still would not “be persuasive for the medical community”:

The situation resembles the predicament with homeopathy trials, another seemingly implausible intervention, where the evidence of multiple positive randomized, controlled trials will not convince the medical community of its validity. Additional positive trials of distant healing are only likely to further expose the fact that the underpinning of modern medicine is an unstable balance between British empiricism (in the tradition of Hume) and continental rationalism (in the tradition of Kant).

…It seems that the decision concerning acceptance of evidence (either in medicine or religion) ultimately reflects the beliefs of the person that exist before all arguments and observation. [Kaptchuk cites the second of the two Goodman articles that I referred to above, discussed here]

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Steve Jobs’ cancer and pushing the limits of science-based medicine

Editor’s note: There is an update to this post.

An Apple fanboy contemplates computers and mortality

I’m a bit of an Apple fanboy and admit it freely. My history with Apple products goes way back to the early 1980s, when one of my housemates at college had an Apple IIe, which I would sometimes use for writing, gaming, and various other applications. Indeed, I remember one of the first “bloody” battle games for the IIe. It was called The Bilestoad and involved either taking on the computer or another opponent with battle axes in combat that basically involved hacking each other’s limbs off, complete with chunky, low-resolution blood and gore. (You youngsters out there will be highly amused at the gameplay here.) Of course, it’s amazing that nothing’s changed when it comes to computer games except the quality of graphics. Be that as it may, this same roommate was one of the first students to get a hold of the new Macintosh when it was released in early 1984. I really liked it right from the start but only got to play with it occasionally for a few months. After using a Macintosh SE to do a research project during my last year of medical school, I have used the Macintosh platform more or less exclusively, and the first computer I purchased with my own money was a Mac LC back in 1990 or 1991. Today, I have multiple Apple products, including my MacBook Air, my iPhone, and my old school iPod Classic, among others. Oddly enough, I do not have an iPad, but that’s probably only a matter of time, awaiting software that lets me do actual work on it.

All of this is my typical long-winded way of explaining why I was immensely saddened when I learned of Steve Jobs’ death last week. Ever since speculation started to swirl about his health back 2004 and then again in 2008, capped off by the revelation that he had undergone a liver transplant for a rare form of pancreatic cancer in 2009, I feared the worst. Last week, the end finally came. However, there is much to learn relevant to the themes of this blog in examining the strange and unusual case of Steve Jobs. Now, after his death five days ago, which coincidentally came a mere day after the launch of iCloud and the iPhone 4S, it occurs to me that it would be worthwhile to try to synthesize what we know about Jobs’ battle with cancer and then to discuss the use (and misuse) of his story. Of course, this is a difficult thing to do because Jobs was notoriously secretive and I can only rely on what has been published in the media, some of which is conflicting and all of which lacks sufficient detail to come to any definite conclusions, but I will try, hoping that the upcoming release of his biography by Walter Isaacson in couple of weeks might answer some of the questions I still have remaining, given that Isaacson followed Jobs through his battle with cancer and was given unprecedented access to Jobs and those close to him.

In the meantime, I speculate. I hope my speculations are sufficiently educated as not to be shown to be completely wrong, but they are speculations nonetheless.
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Posted in: Cancer, Medical Ethics, Nutrition, Science and the Media, Surgical Procedures

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Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.0: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD

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. (more…)

Posted in: Acupuncture, Chiropractic, Clinical Trials, Health Fraud, Herbs & Supplements, History, Medical Academia, Medical Ethics, Naturopathy, Pharmaceuticals, Science and Medicine, Science and the Media

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Dummy Medicines, Dummy Doctors, and a Dummy Degree, Part 1: a Curious Editorial Choice for the New England Journal of Medicine

Background

This post concerns the recent article in the New England Journal of Medicine (NEJM) titled “Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma.” It was ably reviewed by Dr. Gorski on Monday, so I will merely summarize its findings: of the three interventions used—inhaled albuterol (a bronchodilator), a placebo inhaler designed to mimic albuterol, or ‘sham acupuncture’—only albuterol resulted in a clinically important improvement of bronchial airflow; for that outcome the two sham treatments were equivalent to “no intervention.” For all three interventions, however, self-reported improvements were substantial and were much greater than self-reported improvements after “no intervention.” In other words, dummy treatments made the subjects (report that they) feel better, whereas real medicine not only made them feel better but actually made them better.

Before proceeding, let me offer a couple of caveats. First, the word ”doctors” in the flippant title of this post refers mainly to two individuals: Daniel Moerman, PhD, the anthropologist who wrote the accompanying editorial, and Ted Kaptchuk, the Senior Author of the trial report. It does not refer to any of the other authors of the report. Second, I have no quarrel with the trial itself, which was quite good, or with the NEJM having published it, or even with most of the language in the article, save for the “spin” that Dr. Gorski has already discussed.

My quarrels are the same as those expressed by Drs. Gorski and Novella, and by all of us on the Placebo Panel at TAM. This post and the next will develop some of those points by considering the roles and opinions of Moerman and Kaptchuk, respectively.

A True Story

Late one night during the 1960s a friend and I, already in a cannabis-induced fog, wandered into a house that had been rented by one of his friends. There were about 8-10 ‘freaks’ there (the term was laudatory at the time); I didn’t know any of them. The air was thick with smoke of at least two varieties. After an uncertain interval I became aware of a guy who was having trouble breathing. He was sitting bolt upright in a chair, his hands on his knees, his mouth open, making wheezing sounds. He took short noisy breaths in, followed by what seemed to be very long breaths out, as though he was breathing through a straw. You could hear the wheezing in both directions. Others had also noticed that he was in distress; they tried to be helpful (“hey, man, ya want some water or somethin’?”), but he just shook his head. He couldn’t talk. My friend, who had asthma himself, announced that this guy was having an asthma attack and asked if he or anyone else had any asthma medicine. No one did.

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Posted in: Acupuncture, Cancer, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Pharmaceuticals, Public Health, Science and Medicine, Science and the Media

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Spin City: Using placebos to evaluate objective and subjective responses in asthma

As I type this, I’m on an airplane flying home from The Amazing Meeting 9 in Las Vegas. Sadly, I couldn’t stay for Sunday; my day job calls as I’ll be hosting a visiting professor. However, I can say—and with considerable justification, I believe—that out little portion of TAM mirrored the bigger picture in that it was a big success. Attendance at both our workshop on Thursday and our panel discussion on placebos on Saturday was fantastic, beyond our most optimistic expectations. There was also a bit of truly amazing serendipity that helped make our panel discussion on placebo medicine an even bigger success.

If there’s one thing about going away to a meeting, be it TAM or a professional meeting, it’s that it suddenly becomes very difficult for me to keep track of all the medical and blog stuff that I normally keep track of and nearly impossible to keep up with the medical literature. This is the likely explanation for why I had been unaware of a study published in the New England Journal of Medicine (NEJM) on Thursday that was so relevant to our discussion and illustrated out points so perfectly that it was hard to believe that some divine force didn’t give it to us in order to make our panel a total success.

Just kidding. It was TAM, after all. It was, however, embarrassing that I didn’t see the study until the morning of our panel, when Kimball Atwood showed it to me.

Before I get to the meat of this study and why it fit into our nefarious plans for world domination, (or at least the domination of medicine by science-based treatments), a brief recap of the panel discussion would seem to be in order. First, for the most part, we all more or less agreed that the term “placebo effect” is a misnomer and somewhat deceptive because it implies that there is a true physiologic effect caused by an inert intervention. “Placebo response” or “placebo responses” seemed to us a better term because what we are observing with a placebo is in reality a patient’s subjective response to thinking that he is having something active done having something done. In general, we do not see placebo responses resulting improvement in objective outcomes; i.e., prolonged survival in cancer. The relative contributions of components of this response, be they expectancy effects (if you expect to feel better you likely will feel better), conditioning, or one that is frequently dismissed or downplayed, namely artifacts of the design of randomized clinical trials and even subtle (or even not-so-subtle) biases in trial design. This issue of placebo responses being observed only in subjective patient-reported clinical outcomes (pain, anxiety, and the like) and not in objectively measured outcomes is an important one, and it is one that goes to the heart of the NEJM study that so serendipitously manifested itself to us. As Mark Crislip so humorously pointed out, the placebo response is the beer goggles of medicine (this is not a spoiler or stealing Mark’s line; several TAM attendees have already tweeted Mark’s line), and much of what is being observed are changes in the patient’s perception of his symptoms rather than true changes in the underlying pathophysiology. This study drove the point home better than we could.

Another point discussed by the panel is also quite relevant. As more and more studies demonstrate very convincingly that “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) therapies do not produce improvements in symptoms greater than placebo. Moreover, multiple studies, including a famous NEJM meta-analysis and a recently updated Cochrane review, demonstrate, placebo responses probably do not constitute meaningful responses. In light of these findings, CAM apologists, driven by ideology rather than science and masters of spin, have begun to admit grudgingly that, yes, in essence their treatments are elaborate placebos. Not to be deterred, instead of simply concluding that their CAM interventions do not work, they’ve moved the goal posts and started to try to argue that it doesn’t matter that CAM effects are placebo effects because placebos are “powerful” and good and—oh, yes, by the way—there are a lot of treatments in science-based medicine that do little better than placebos. In other words, CAM advocates elevate the subjective above the objective and sell the subjective, and that’s exactly what they are doing with this study.
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Posted in: Acupuncture, Clinical Trials, Medical Ethics

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“CAM” Education in Medical Schools—A Critical Opportunity Missed

Mea culpa to the max. I completely forgot that today is my day to post on SBM, so I’m going to have to cheat a little. Here is a link to a recent article by yours truly that appeared on Virtual Mentor, an online ethics journal published by the AMA with major input from medical students. Note that I didn’t write the initial scenario; that was provided to me for my comments. The contents for the entire issue, titled “Complementary and Alternative Therapies—Medicine’s Response,” are here. Check out some of the other contributors (I was unaware of who they would be when I agreed to write my piece).

Posted in: Acupuncture, Basic Science, Chiropractic, Energy Medicine, Herbs & Supplements, History, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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Blatant pro-alternative medicine propaganda in The Atlantic

Some of my fellow Science-Based Medicine (SBM) bloggers and I have been wondering lately what’s up with The Atlantic. It used to be one of my favorite magazines, so much so that I subscribed to it for roughly 25 years (and before that I used to read my mother’s copy). In general I enjoyed its mix of politics, culture, science, and other topics. Unfortunately, my opinion changed back in the fall of 2009, when, on the rising crest of the H1N1 pandemic, The Atlantic published what can only be described as an terrible bit of journalism lionizing the “brave maverick doctor” Tom Jefferson of the Cochrane Collaboration. The article, written by Shannon Brownlee and Jeanne Lenzer, argued, in essence, that vaccinating against H1N1 at the time was a horrendous waste of time and effort because the vaccine didn’t work. So bad was the cherry picking of data and framing of the issue as a narrative that consisted primarily of the classic lazy journalistic device of a “lone maverick” against the entire medical establishment that it earned the lovely sarcasm of our very own Mark Crislip, who wrote a complete annotated rebuttal, while I referred to the methodology presented in the article as “methodolatry.” Even public health epidemiologist Revere (who is, alas, no longer blogging but in his day provided a very balanced, science-based perspective on vaccination for influenza, complete with its shortcomings) was most definitely not pleased.

I let my subscription to The Atlantic lapse and have not to this day renewed it.

Be that as it may, last year The Atlantic published an article that wasn’t nearly as bad as the H1N1 piece but was nonetheless pretty darned annoying to us at SBM. Entitled Lies, Damned Lies, and Medical Science, by David Freedman, it was an article lionizing John Ioannidis (whom I, too, greatly admire) while largely missing the point of his work, turning it into an argument for why we shouldn’t believe most medical science. Now, Freedman’s back again, this time with a much, much, much worse story in The Atlantic in the July/August 2011 issue under the heading “Ideas” and entitled The Triumph of New Age Medicine, complete with a picture of a doctor in a lab coat in the lotus position. It appears to be the logical follow up to Freedman’s article about Ioannidis in that Freedman apparently seems to think that, if we can’t trust medical science, then there’s no reason why we shouldn’t embrace medical pseudoscience.

Basically, the whole idea behind the article appears to be that, even if most of alternative medicine is quackery (which it is, by the way, as we’ve documented ad nauseam on this very blog), it’s making patients better because of placebo effects and because its practitioners take the time to talk to patients and doctors do not. In other words, Freedman’s thesis appears to be a massive “What’s the harm?” argument coupled with a false dichotomy; that is, if real doctors don’t have the time to listen to patients and provide the human touch, then let’s let the quacks do it. Tacked on to that bad idea is a massive argumentum ad populum portraying alternative medicine as the wave of the future, in contrast to what Freedman calls the “failure” of conventional medicine.

Let’s dig in, shall we? I’ll start with the article itself, after which I’ll examine a few of the responses. I’ll also note that our very own Steve Novella, who was interviewed for Freedman’s article, has written a response to Freedman’s article that is very much worth reading as well.

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Posted in: Acupuncture, Medical Academia, Medical Ethics, Nutrition, Science and the Media

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Placebos as Medicine: The Ethics of Homeopathy

Is it ever ethical to provide a placebo treatment? What about when that placebo is homeopathy? Last month I blogged about the frequency of placebo prescribing by physicians.  I admitted my personal discomfort, stating I’d refuse to dispense any prescription that would require me to deceive the patient. The discussion continued in the comments, where opinions seemed to range from (I’m paraphrasing)  “autonomy, shmatonomy, placebos works” to the more critical who likened placebo use to “treating adults like children.”  Harriet Hall noted,  “We should have rules but we should be willing to break them when it would be kinder to the patient, and would do no harm.” And on reflection, Harriet’s perspective was one that I could see myself accepting should I be in a situation like the one  she described. It’s far easier to be dogmatic when you don’t have a patient standing in front of you. But the comments led me to consider possible situations where a placebo might actually be the most desirable treatment option. If I find some, should I be as dogmatic about homeopathy as I am about other placebos?

Nicely, Kevin Smith, writing in the journal Bioethics, examines the ethics of placebos, based on an analysis of homeopathy. Homeopathy is the ultimate placebo in routine use — most remedies contain only sugar and water, lacking a single molecule of any potentially medicinal ingredient. Smith’s paper, Against Homeopathy — A Utilitarian Perspective, is sadly behind a paywall.  So I’ll try to summarize his analysis, and add my perspective as a health care worker who regularly encounters homeopathy.
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Posted in: Homeopathy, Medical Ethics

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Anti-vaccine warriors vs. research ethics

Three weeks ago, the anti-vaccine movement took a swing for the fences and, as usual, made a mighty whiff that produced a breeze easily felt in the bleachers. In brief, a crew of anti-vaccine lawyers headed by Mary Holland, co-author of Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children, published a highly touted (by Generation Rescue and other anti-vaccine groups, that is) “study” claiming to “prove” that the Vaccine Injury Compensation Program (VICP) had actually compensated children for autism. As is typical with such “studies” generated by the anti-vaccine movement, it was bad science, bad law, and just plain bad all around. The authors intentionally conflated “autism-like” symptoms with autism, trying to claim that children with neurological injury with “autism-like” symptoms actually have autism. Never mind that there are specific diagnostic criteria for autism and that, if the children actually had autism, many of them would have been given a diagnosis of autism. Never mind that what they were doing was akin to claiming that all patients with “Parkinson’s-like symptoms” have Parkinson’s disease. (Hint: They don’t.) Never mind that all they did was to demonstrate a prevalence of autism spectrum disorders among the VICP-compensated children that was clearly within the range of what would be anticipated if there were no relationship between vaccines and autism. Never mind all that. This was Holland’s big chance, but it went over like the proverbial lead balloon. No one bit, other than FOX News.

The study rapidly faded into the obscurity it so richly deserves, in spite of mighty efforts by Generation Rescue, SafeMinds, and the likes of Ginger Taylor to keep it alive and use it as a rallying point to persuade legislators to pass anti-vaccine-friendly legislation. You could feel the frustration in its backers as Holland’s study, into which groups like Generation Rescue had apparently poured their hopes of being vindicated, crashed and burned.

However, there’s one aspect of this study that I didn’t discuss. In fact, I thought of it as I read it, but I wasn’t sure. What I (and others) have noticed is that there was no statement in the article that approval had been obtained from the relevant institutional review boards (IRBs) to do human subjects research. For those not familiar with what an IRB is, an IRB is a committee that oversees all human subject research for an institution. It is the IRB’s responsibility to make sure that all studies are ethical in design and that they conform to all federal regulations. Basically, IRBs are charged with weighing the risks and benefits of proposed human subject research and making sure that

  1. risks are minimized and that the risk:benefit ratio, at least as well as it can be estimated, is very favorable;
  2. to minimize any pain, suffering or distress that might come about because of the experimental therapy; and
  3. to make sure that researchers obtain truly informed consent.

During the course of a study, regular reports must be made to the IRB, which can shut down any study in its institution if it has concerns about patient welfare.
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Posted in: Medical Ethics, Neuroscience/Mental Health, Public Health, Vaccines

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