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

Background: the distinction between EBM and SBM

An important theme on the Science-Based Medicine blog, and the very reason for its name, has been its emphasis on examining all the evidence—not merely the results of clinical trials—for various claims, particularly for those that are implausible. We’ve discussed the distinction between Science-Based Medicine (SBM) and the more limited Evidence-Based Medicine (EBM) several times, for example here (I began my own discussion here and added a bit of formality here, here, and here). Let me summarize by quoting John Ioannidis:

…the probability that a research finding is indeed true depends on the prior probability of it being true (before doing the study), the statistical power of the study, and the level of statistical significance.

EBM, in a nutshell, ignores prior probability† (unless there is no other available evidence) and falls for the “p-value fallacy”; SBM does not. Please don’t bicker about this if you haven’t read the links above and some of their own references, particularly the EBM Levels of Evidence scheme and two articles by Steven Goodman (here and here). Also, note that it is not necessary to agree with Ioannidis that “most published research findings are false” to agree with his assertion, quoted above, about what determines the probability that a research finding is true.

The distinction between SBM and EBM has important implications for medical practice ethics, research ethics, human subject protections, allocation of scarce resources, epistemology in health care, public perceptions of medical knowledge and of the health professions, and more. EBM, as practiced in the 20 years of its formal existence, is poorly equipped to evaluate implausible claims because it fails to acknowledge that even if scientific plausibility is not sufficient to establish the validity of a new treatment, it is necessary for doing so.

Thus, in their recent foray into applying the tools of EBM to implausible health claims, government and academic investigators have made at least two, serious mistakes: first, they have subjected unwary subjects to dangerous but unnecessary trials in a quest for “evidence,” failing to realize that definitive evidence already exists; second, they have been largely incapable of pronouncing ineffective methods ineffective. At best, even after conducting predictably disconfirming trials of vanishingly unlikely claims, they have declared such methods merely “unproven,” almost always urging “further research.” That may be the proper EBM response, but it is a far cry from the reality. As I opined a couple of years ago, the founders of the EBM movement apparently “never saw ‘CAM’ coming.”

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Posted in: Cancer, Clinical Trials, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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Tai chi and fibromyalgia in the New England Journal of Medicine: An “alternative” frame succeeds

It never seems to fail. I go away for a few days, in this case to combine fun with pleasure and pleasure with fun by giving a talk to the Chicago Skeptics and at the same time meeting my brand new (well, by this time three weeks old) nephew for the first time, and something always happens. Before I get to what happened, I just want to point out that the talk actually went pretty darned well. I was utterly shocked that it was pretty much standing room only, with perhaps 50 people there to hear me. Honestly, don’t you people have anything better to do on a beautiful Saturday afternoon in August? But, seriously, the whole thing was a blast, and the assembled skeptics there didn’t even let me off the hook, as at least a couple of them asked some fairly challenging questions, one of which, I must admit, I wasn’t prepared for. In any case, my thanks go out to Dr. Jennifer Newport, skeptical Chicago pediatrician extraordinaire and organizer of my talk and the party at her apartment afterward. Between the two events she raised hundreds of dollars for the vaccination drive going on at DragonCon this weekend, Chicago Skeptics, the Women Thinking Free Foundation, and CFI-Chicago for inviting me and being such fantastic hosts.

Back to business. Science-based medicine (SBM) business, that is.

What happened while I was away could almost be characterized by the New England Journal of Medicine (NEJM) singing “Oops, I did it again.” Three weeks ago, the hallowed pages of the NEJM hosted a truly execrably credulous review article about acupuncture. So bad was the article that it “merited” the incredibly rare triple beat-down from this very blog, with posts by Steve Novella, the ever-irascible Mark Crislip, and myself in rapid succession applying the clue-by-four. As I was preparing to leave for Chicago on Thursday, I happened to look at the very latest issue of the NEJM hot off the presses, and what to my wondering (and watering–it is ragweed season) eyes should appear but an article reporting a study on the use of tai chi in treating fibromyalgia. Entitled A Randomized Trial of Tai Chi for Fibromyalgia, the study comes out of the Tufts University School of Medicine and the Newton-Wellesley Hospital in Boston and was carried out by a team led by Chenchen Wang, MD, MPH. Not surprisingly, the study has gotten a lot of play in the media, for example, in this story in the L.A. Times, which is at least reasonably restrained, probably because it an AP wire story by Marilynn Marchione, who has written some excellent articles about “alternative” medicine before. Even the usually reliable GoozNews seems smitten with this study beyond what it rates, characterizing it as “rare victory for the National Institute of Health’s National Center for Complementary and Alternative Medicine and Sen. Tom Harkin (D-IA), who routinely comes under fire for pushing funding for these types of studies.”

I’m less impressed. You’ll see what I mean in a few minutes, I hope. First, however, let’s look at the study itself.
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Posted in: Clinical Trials, Medical Academia, Science and the Media

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Peer Review and the Internet

Peer-review has been the cornerstone of quality control in academia, including science and medicine, for the past century. The process is slow and laborious, but a necessary filter in order to maintain a certain standard within the literature. Yet more and more scholars are recognizing the speed, immediacy, and openness of the internet as a tool for exchanging ideas and information, and this is causing some to question the methods of peer review. A recent New York Times article discusses this issue.

This issue is very relevant to Science-Based Medicine as this is in part an experiment – an attempt to produce a high quality, editorially filtered, but not peer-reviewed, online journal. Our process here is simple. Outside submissions are reviewed by two or more editors and typically are either accepted with minor revisions or rejected. In addition we have a staff of regular contributors – those who have a proven track record of producing high quality articles. There is no pre-publication review for their submissions, and they are able to post directly to SBM.

Because many of the issues we cover are timely, we emphasize speed of publication. Therefore copy-editing is done post-publication – the notion being that our readers can tolerate a few typos in order to gain access to material more quickly.

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Posted in: Medical Academia

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Does peer review need fixing?

One of the most important aspects of science is the publication of scientific results in peer-reviewed journals. This publication serves several purposes, the most important of which is to communicated experimental results to other scientists, allowing other scientists to replicate, build on, and in many cases find errors in the results. In the ideal situation, this communication results in the steady progress of science, as dubious results are discovered and sound results replicated and built upon. Of course, scientists being human and all, the actual process is far messier than that. In fact, it’s incredibly messy. Contrary to popular misconceptions about science, it doesn’t progress steadily and inevitably. Rather, it progresses in fits and starts, and most new scientific discoveries go through a varying period of uncertainty, with competing labs reporting conflicting results. To achieve consensus about a new theory can take relatively little time (for example, the less than a decade that it took for Marshall and Warren’s hypothesis that peptic ulcer disease is largely caused by H. pylori or the relatively rapid acceptance of Einstein’s Theory of Relativity) to much longer periods of time.

One of the pillars of science has traditionally been the peer review system. In this system, scientists submit their results to journals for publication in the form of manuscripts. Editors send these manuscripts out to other scientists to review them and decide if the science is sound, if the methods appropriate, and if the conclusions are justified by the data presented. This step of the process is very important, because if editors don’t choose reviewers with the appropriate expertise, then serious errors in review may occur. Also, if editors choose reviewers with biases so strong that they can’t be fair, then science that challenges such reviewers’ biases may never see print in their journals. The same thing can occur to grant applications. In the NIH, for instance, the scientists running study sections must be even more careful in choosing scientists to be on their study sections and review grant applications, not to mention picking which scientists review which grants. Biases in reviewing papers are one thing; biases in reviewing grant applications can result in the denial of funding to worthy projects in favor of projects less worthy that happen to correspond to the biases of the reviewers.

I’ve discussed peer review from time to time, although perhaps not as often as I should. My view tends to be that, to paraphrase Winston Churchill’s invocation of a famous quote about democracy, peer review is the worst way to weed out bad science and promote good science, except for all the others that have been tried. One thing’s for sure, if there’s a sine qua non of an anti-science crank, it’s that he will attack peer review relentlessly, as HIV/AIDS denialist Dean Esmay did. Indeed, in the case of Medical Hypotheses, the lack of peer review let the cranks run free to the point where even Elsevier couldn’t ignore it any more. One thing’s for sure. Peer review may have a lot of defects and blindnesses, but lack of peer review is even worse. It’s no wonder why cranks of all stripes loved Medical Hypotheses.
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Posted in: Medical Academia, Science and Medicine

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Dr. Gorski to be speaking at the Chicago Skeptics on Saturday

The week is finally here! Believe it or not, I’m heading back to my old stomping grounds in the 1990s to appear as a guest of the Chicago Skeptics.

This Saturday, August 21, I’ll be giving a talk co-sponsored by Chicago Skeptics, Women Thinking Free Foundation, and the Center For Inquiry-Chicago at the Black Rock Pub & Kitchen. My talk will be on a topic near and dear to my heart (or a topic that fills me with alarm–the two are not mutually exclusive), mainly the infiltration of pseudoscience into medicine. I’ll be sure to touch on a number of issues, and you can be sure I’ll have something to say about the recent acupuncture review that appeared in the New England Journal of Medicine and perhaps a bit about the sort of pseudoscience that’s being practiced at some of our largest and most respected cancer centers. Afterwards, you–yes, you!–can ask me about anything you want if you show up. Anything, including vaccines, skepticism, and even Bill Maher!

If you live in Chicago and want to harass me (not the way Age of Autism harasses me), head on over to the Chicago Skeptics event page and click on the link to RSVP!

ADDENDUM: Holy crap! Someone just informed me that Chicago Comic Con will be in Chicago the same weekend as me. Even worse, William Shatner will be there on Saturday, which is when I’m giving my talk. How on earth can I possibly compete with the Shat?

Posted in: Announcements, Medical Academia

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Credulity about acupuncture infiltrates the New England Journal of Medicine

One of the things that disturbs me the most about where medicine is going is the infiltration of quackery into academic medicine. So prevalent is this unfortunate phenomenon that Doctor RW even coined a truly apt term for it: Quackademic medicine. In essence, pseudoscientific and even prescientific ideas are rapidly being “integrated” with science-based medicine, or, as I tend to view it, quackery is being “integrated” with scientific medicine, to the gradual erosion of scientific standards in medicine. No quackery is too quacky, it seems. Even homeopathy and naturopathy can seemingly find their way into academic medical centers.

Probably the most common form of pseudoscience to wend its way into what should be bastions of scientific medicine is acupuncture. Harvard, Stanford, Yale, M. D. Anderson, and many others, they’ve all fallen under the sway of the idea that somehow sticking thin little needles into points that bear no relationship to any known anatomic structure and that supposedly “unblock” the flow of some sort of “life energy” that can’t be detected by any means that science has. Most recently, as I described, studies that seek to “prove that acupuncture works” have found their way into high quality, high impact journals whose editors should know better but apparently can’t recognize that the evidence in the study doesn’t actually show what the authors claim it shows. Even so, there are some journals that I didn’t expect to see this sort of infiltration of quackademic medicine. Granted, I never expected it to show itself in one of the Nature journals, as it did in the study I just mentioned. I also never expected it to show up in that flagship of clinical journals, a journal that is one of the highest impact and most read medical journals that exists. I’m talking the New England Journal of Medicine, and, unfortunately, I’m also talking an unfortunately credulous article from Dr. Brian M. Berman, who is the founder of the Center for Integrative Medicine, University of Maryland School of Medicine and the holder of multiple NCCAM center grants, and other institutions, entitled Acupuncture for Chronic Low Back Pain.
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Posted in: Acupuncture, Medical Academia

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“Hard science” and medical school

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:
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Posted in: Medical Academia, Science and Medicine

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Bought and Sold: Who Should Pay for CME

There are two topics about which I am a crank. The first, as you might have guessed, is alternative medicine. The other is pharmaceutical reps. Drug companies are somewhat schizophrenic. They have amazing scientists who invent drugs that treat an astounding array of diseases. Then, they take these drugs and turn them over to marketing, to be sold with all the enthusiasm and truthiness of a late night infomercial.

In the spirit of openness, I will say that I have not talked to a drug rep in 20 years. As far as industry supported gifts and food, I have not taken a pen or eaten pizza from industry in almost 30 years, since I was a fourth year medical student. I have accepted one gift over the years. Years ago, when the Pfizer rep left, he sent me Fleets enema with a Unasyn sticker on it. I still have it in my office, unused. But you never know when it might come in handy.

Being an absolutist about industry gifts does have downsides. It is distracting to sit in an auditorium filled with the smell of pizza and not eat any; somehow the PB&J I bring with me doesn’t smell as sweet. Administration has received one letter complaining about me that was ostensibly from an employee, but curiously was printed from a windows folder that had the same name as the levofloxacin rep. Just a coincidence, I am sure.
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Posted in: Medical Academia, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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Acupuncture CME

Some Universities have more cachet than others. On the West coast it is Stanford that has the reputation as the best. There is Oxford, Yale, MIT, and maybe Whatsamatta U. I would wager that in most people’s mind the crème de la crème is Harvard. Harvard is where you find the best of the best. If Harvard is involved, a project gains an extra gobbet of credibility. Brigham and Women’s Hospital also has a similar reputation in the US as one of the hospitals associated with only Harvard and the New England Journal of Medicine. Premier university, premier hospital, premier journal.

So if Brigham and Women’s Hospital and Harvard Medical School are offering continuing medical information (CME) for acupuncture, there must be something to it, right? A course called “Structural Acupuncture for Physicians” must have some validity.

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Posted in: Medical Academia, Science and Medicine

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The price of opposing medical pseudoscience

EDITOR’S NOTE: This post is a followup to a post from two weeks ago entitled In which Dr. Gorski once again finds himself a target of the “pharma shill” gambit. If you haven’t read that post before, you might want to go back and read it now before proceeding with this post. Please also note the disclaimer.

I want to beg your indulgence this week, hoping that my history as a blogger here on SBM and then as managing editor allows me that. Today’s post will be a little different because last week was really, really, hectic. First and foremost, I was busy writing a preapplication for a Susan J. Komen Foundation grant for a deadline of last Friday. The Komen Foundation, it turns out, has changed its procedures this year so that the preapplication is now evaluated much more rigorously. It’s no longer looked at just to make sure that the proposed project matches the subject matter and criteria for the request for applications (RFA). This year, the preapplication actually matters! Moreover, it’s so long that writing it is practically like writing the entire grant, other than the budget. But I got it done, and it looks pretty good, if I do say so myself. None of that is any guarantee that Komen will invite us to submit a full application, but I’m hopeful because if it does we should have a good shot at the grant.

Then, this weekend I had to pivot on a dime and return to writing the R01 I had been working on with my collaborator. To make the July resubmission deadline, it has to be done, in the can, and submitted by this Friday. In any case, these are the reasons why this post is likely to be uncharacteristically personal in nature.

Oh, those reasons plus a little bit of character assassination launched at me on Monday by Jake Crosby over at the Age of Autism, entitled David Gorski’s Financial Pharma Ties: What He Didn’t Tell You.
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Posted in: Medical Academia, Neuroscience/Mental Health, Vaccines

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