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).
Posts Tagged CAM
This essay is the latest in the series indexed at the bottom.* It follows several (nos. 10-14) that responded to a critique by statistician Stephen Simon, who had taken issue with our asserting an important distinction between Science-Based Medicine (SBM) and Evidence-Based Medicine (EBM). (Dr. Gorski also posted a response to Dr. Simon’s critique). A quick-if-incomplete Review can be found here.
One of Dr. Simon’s points was this:
I am as harshly critical of the hierarchy of evidence as anyone. I see this as something that will self-correct over time, and I see people within EBM working both formally and informally to replace the rigid hierarchy with something that places each research study in context. I’m staying with EBM because I believe that people who practice EBM thoughtfully do consider mechanisms carefully. That includes the Cochrane Collaboration.
To which I responded:
We don’t see much evidence that people at the highest levels of EBM, eg, Sackett’s Center for EBM or Cochrane, are “working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”
Well, perhaps I shouldn’t have been so quick to quip—or perhaps that was exactly what the doctor ordered, as will become clear—because on March 5th, nearly four months after writing those words, I received this email from Karianne Hammerstrøm, the Trials Search Coordinator and Managing Editor for The Campbell Collaboration, which lists Cochrane as one of its partners and which, together with the Norwegian Knowledge Centre for the Health Services, is a source of systematic reviews:
OK, I admit that I pulled a fast one. I never finished the last post as promised, so here it is.
This systematic review has clearly identified the need for randomised or controlled clinical trials assessing the effectiveness of Laetrile or amygdalin for cancer treatment.
I’d previously asserted that this conclusion “stand[s] the rationale for RCTs on its head,” because a rigorous, disconfirming case series had long ago put the matter to rest. Later I reported that Edzard Ernst, one of the Cochrane authors, had changed his mind, writing, “Would I argue for more Laetrile studies? NO.” That in itself is a reason for optimism, but Dr. Ernst is such an exception among “CAM” researchers that it almost seemed not to count.
Until recently, however, I’d only seen the abstract of the Cochrane Laetrile review. Now I’ve read the entire review, and there’s a very pleasant surprise in it (Professor Simon, take notice). In a section labeled “Feedback” is this letter from another Cochrane reviewer, which was apparently added in August of 2006, well before I voiced my own objections:
Working in pharmacies where supplements are sold alongside traditional (over-the-counter) medications, I’m regularly astonished at the different perceptions consumers can have about the relative efficacy and safety of different types of products. Once, speaking with a customer about a medical condition she wanted to treat, I indicated that there were no effective non-prescription therapies — she needed to see a physician for access to an effective treatment by prescription — and I gestured behind the counter. “Back there?!” she pointed. “That’s where you keep the stuff that kills people! I want something natural!” Suggesting that my patients with heart disease or HIV had a somewhat different perspective, I tried (unsuccessfully) to talk her out of a questionable-looking supplement (Hint: avoid anything from a company with a P.O. box as a mailing address.) This appeal to nature, combined with a perception that natural products are safe, and conventional drugs are unsafe, is pervasive. (more…)
This one crept up on me by surprise. You see, I recorded an interview with D.J. Grothe, President of the James Randi Educational Foundation and host of the podcast For Good Reason back in November. I wasn’t sure when it would appear. Well, it turns out that it popped up on my iTunes podcast feeds sometime over the last few days. (It’s been really busy at work, and I haven’t really been paying attention to podcasts–at least, not until yesterday.)
So, here it is. I haven’t listened to it all yet, but hopefully I explained myself well enough and did credit to my fellow SBM bloggers. DJ is a good interviewer, which means he presses his subjects a bit and sometimes gets them out of their comfort zone.
Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2
NB: If you haven’t yet read Part 1 of this blog, please do so now; Part 2 will not summarize it.
At the end of Part 1, I wrote:
We do not need formal statistics or a new, randomized trial with a larger sample size to justify dismissing the Gonzalez regimen.
In his editorial for the JCO, Mark Levine made a different argument:
Can it be concluded that [the] study proves that enzyme therapy is markedly inferior? On the basis of the study design, my answer is no. It is not possible to make a silk purse out of a sow’s ear.
That conclusion may be correct in the EBM sense, but it misses the crucial point of why the trial was (ostensibly) done: to determine, once and for all, whether there was anything to the near-miraculous claims that proponents had made for a highly implausible “detoxification” regimen for cancer of the pancreas. Gonzalez himself had admitted at the trial’s inception that nothing short of an outcome matching the hype would do:
DR. GONZALEZ: It’s set up as a survival study. We’re looking at survival.
SPEAKER: Do you have an idea of what you’re looking for?
DR. GONZALEZ: Well, Jeff [Jeffrey White, the director of the Office of Cancer Complementary and Alternative Medicine at the NCI—KA] and I were just talking a couple weeks ago. You know, to get any kind of data that would be beyond criticism is—-always be criticism, but at least three times.
You would want in the successful group to be three times — the median to be three times out from the lesser successful groups.
So, for example, if the average survival with chemo, which we suspect will be 5 months, you would want my therapy to be at least — the median survival to be at least 15, 16, 17 months, as it was in the pilot study.
We’re looking for a median survival three times out from the chemo group to be significant.
Recall that the median survival in the Gonzalez arm eventually turned out to be 4.3 months.
One of the recurring themes of this blog, not surprisingly given its name, is the proper role of science in medicine. As Dr. Novella has made clear from the very beginning, we advocate science-based medicine (SBM), which is what evidence-based medicine (EBM) should be. SBM tries to overcome the shortcomings of EBM by taking into account all the evidence, both scientific and clinical, in deciding what therapies work, what therapies don’t work, and why. To recap, a major part of our thesis is that EBM, although a step forward over prior dogma-based medical models, ultimately falls short of making medicine as effective as it can be. As currently practiced, EBM appears to worship clinical trial evidence above all else and nearly completely ignores basic science considerations, relegating them to the lowest form of evidence, lower than even small case series. This blind spot has directly contributed to the infiltration of quackery into academic medicine and so-called EBM because in the cases of ridiculously improbable modalities like homeopathy and reiki, deficiencies in how clinical trials are conducted and analyzed can make it appear that these modalities might actually have efficacy.
Given this thesis, if there’s one aspect of medical education that I consider to be paramount, at least when it comes to understanding how to analyze and apply all the evidence, both basic science and clinical, it’s a firm grounding in the scientific method. Unfortunately, in medical school there is very little, if any, concentration on the scientific method. In fact, one thing that shocked me when I first entered what is one of the best medical schools in the U.S., the University of Michigan, was just how “practical” the science taught to us as students was. It was very much a “just the facts, ma’am,” sort of presentation, with little, if any, emphasis on how those scientific facts were discovered. Indeed, before I entered medical school, I had taken graduate level biochemistry courses for a whole year. This was some truly hard core stuff. Unfortunately, I couldn’t get out of taking medical school biochemistry my first year, but taking the course was illuminating. The contrast was marked in that in medical school there was very little in the way of mechanistic detail, but there was a whole lot of memorization. The same was true in nearly all the other classes we took in the first two years. True, for anatomy it’s pretty hard not to have to engage in a lot of rote memorization, but the same shouldn’t necessarily be true of physiology and pharmacology, for example. It was, though.
Over time, I came to realize that there was no easy answer to correcting this problem, because medical school is far more akin to a trade school than a science training school, and the question of how much science and in what form it should be taught are difficult questions that go to the heart of medical education and what it means to be a good physician. Clearly, I believe that, among other things, a good physician must use science-based practice, but how does medical education achieve that? That’s one reason why I’m both appalled and intrigued by a program at the Mt. Sinai School of Medicine for humanities majors to enter medical school without all the hard sciences. It’s a program that was written up in the New York Times last Wednesday in an article entitled Getting Into Med School Without Hard Sciences, and whose results were published in Medical Academia under the title Challenging Traditional Premedical Requirements as Predictors of Success in Medical School: The Mount Sinai School of Medicine Humanities and Medicine Program.
Let’s first take a look at how the NYT described the program:
NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable of writing a shorter post than is Dr. Gorski.
On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which “exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a ‘quality chasm’.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its “100,000 Lives Campaign” and, more recently, its “5 Million Lives Campaign.”
Berwick’s CMS gig is a “recess appointment”: it was made during the Senate’s July 4th recess period, without a formal confirmation hearing—although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama had made the recess appointment in order to avoid a reprise of “last year’s divisive health care debate.” The president had originally nominated Berwick for the position in April, and Republicans have opposed “Berwick’s views on rationing of care,” claiming that he “would deny needed care based on cost.”
A “Patient-Centered Extremist”
If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described “Patient-Centered Extremist.” He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the “professionally dominant view of quality of health care”:
In a previous post I described a lecture given by a faculty member to first-year medical students on my campus introducing us to integrative medicine (IM). Here I describe his lecture to the second-year class on legal and ethical aspects of complementary and alternative medicine (CAM).
Dr. P began his lecture by describing CAM using the now-familiar NCCAM classification. He gave the NCCAM definition of CAM as “a group of diverse medical and healthcare systems, practices, and products that are not presently considered to be part of conventional medicine.” To illustrate how this definition can lead to surprises, he asked us if the therapeutic use of maggots is CAM or conventional. Although it sounds rather CAM-ish, maggot therapy is used at some surgical centers for wound debridement, he told us, and therefore is part of “conventional medicine.”
One advantage of having a blog is that I can sometimes tap into the knowledge of my readers to help me out. As many readers know, a few of the SBM bloggers (myself included) will be appearing at the Northeast Conference on Science and Skepticism (NECSS) on Saturday, April 17. Since the topic of our panel discussion is going to be the infiltration of quackademic medicine into medical academia, I thought that now would be a very good time for me to update my list of medical schools and academic medical centers in the U.S. and Canada that have embraced (or at least decided to tolerate) quackademic medicine in their midst. After all, the list is over two years old and hasn’t been updated.
My list is long past due for an update, and I want to post that update right here, either right before or right after NECSS. But I need your help. Please peruse the previous roll of shame. Then either post here in the comments or e-mail to me any examples of quackademic medical programs in the U.S. and Canada (I’ll leave Europe to others better qualified to deal with it) that I may have missed. Equally important, if there are programs I listed before that no longer peddle woo, let me know that too, so that I can investigate and decide if I should remove the program from my list.
I’m particularly interested in the most egregious examples (although your submitting all examples is greatly appreciated). Yoga and meditation don’t bother me that much, for example. Neither do dietary studies, because diet and exercise are science-based medicine that have all too often been coopted by purveyors of woo. Homeopathy and reiki, on the other hand, do bother me. A lot. I’m also particularly interested in educational programs in CAM that are funded by the National Center for Complementary and Alternative Medicine (NCCAM).
Please help me construct the definitive list of academic programs in the U.S. and Canada that have adopted quackademic medicine.