Yers truly will speak at Tommy Doyle’s, Harvard Square, Cambridge. 7:00 PM on March 29.
Implausible Health Claims and Human Studies Ethics: A Collision Course
A broad international consensus regarding protections for subjects in human trials emerged during the 2nd half of the 20th century. It can be summarized in several tenets, most of which pertain explicitly or implicitly to scientific considerations. Recent projects involving human trials of implausible health claims (“CAM”) have been at odds with some of those tenets. I’ll discuss one trial in detail and mention a few others. I will argue that all such trials are likely to be unethical.
Pearl of wisdom for the day: If given the option, don’t let your heart stop. Very Bad Things soon follow if your heart stops.
In spite of what the entertainment industry would have you believe, it is extremely difficult to save the life of someone in cardiac arrest. A few random breaths, slow rocking chest compressions, even the ever-so-dramatic overhand blow to the chest accompanied by the scream “Don’t you die on me, dammit!” are unlikely to successfully resuscitate someone following an arrest, and even if it does, they won’t be in any shape to go chase Locke across the island with Jack and Kate five minutes later.
Even with properly performed CPR, started within seconds of an arrest, in a hospital with all the required expertise and support equipment, only roughly half survive their initial arrest event. Even fewer (25-33%) survive to discharge from the hospital, and ~75% have a good neurologic outcome. For arrests out of the hospital, where there can be huge delays in treatment, mere survival is significantly lower, often measured in the single digits.
The Limitations Of CPR
Why doesn’t CPR save more people? Well, it really isn’t meant to; at least, not on its own. Cardio-respiratory arrest is the common pathway of death, but it isn’t in itself a diagnosis. The essential question to be answered is why someone stopped breathing, or why their heart stopped in the first place. Unless you can answer that question and address the problem, even if CPR manages to restore a heartbeat it’s likely to stop again in short order. (more…)
A couple of years ago, a number of us raised concerns about an “investigative reporter” at a Detroit television station. At the time I noted that investigative reporters serve an important role in a democracy, but that they can also do great harm, as when Channel 7′s Steve Wilson parroted the talking points of the anti-vaccine movement. Wilson has since been canned but apparently, not much has changed. While performing my evening ablutions, I stumbled upon the latest abomination.
The story is about a surgeon turned faith healer. I can think of about a half-dozen different ways to make an interesting story out of this. But Channel 7, rather than doing the harder but more interesting story about the chicanery of faith healers, presented an infomercial. (more…)
When Dr. Novella recently wrote about plausibility in science-based medicine, one of our most assiduous commenters, Daedalus2u, added a very important point. The data are always right, but the explanations may be wrong. The idea of treating ulcers with antibiotics was not incompatible with any of the data about ulcers; it was only incompatible with the idea that ulcers were caused by too much acid. Even scientists tend to think on the level of the explanations rather than on the level of the data that led to those explanations.
A valuable new book elaborates on this concept: Diagnosis, Therapy and Evidence: Conundrums in Modern American Medicine, by medical historian Gerald N. Grob and sociologist Allan V. Horwitz. They point out that
many claims about the causes of disease, therapeutic practices, and even diagnoses are shaped by beliefs that are unscientific, unproven, or completely wrong. (more…)
The core information supporting science-based medicine resides in the scientific literature. There, scientists and physicians publish the results of experiments and clinical trials that seek to understand the biological mechanisms by which the human body functions and through which disease forms and to apply this understanding to test new treatments for diease. Consequently, the quality and integrity of the biomedical literature are topics of utmost importance to supporters of science-based medicine. We’ve discussed problems with the scientific literature before here, ranging from how pseudoscientific “complementary and alternative medicine” journals have insinuated themselves into the medical literature and how drug companies have managed exercise undue influence over clinical trials and journals.
One question that perhaps we have not dealt with so much is the question of the very nature of a good scientific journal, particularly what is suitable material for such a journal. For purposes of this discussion, I will focus mainly on the biomedical literature, which spans a range from basic science journals dealing with biomedical science to clinical journals, which mainly report the results of clinical trials and clinical research. Of these journals, there are in general two types, journals that primarily report original research and those that present reviews of existing research. Most journals do a mix of the two, the majority tending towards a form where most of the articles are reports of orginal research mixed in with a much smaller number of review articles.
There is one journal, however, that is different. It is a journal known as Medical Hypotheses. It is a journal that (or so it claims) exists to present radical scientific ideas, the more radical the better. Here is how the journal is described on its website:
Get your facts first, and then you can distort them as much as you please.
There is an educational approach to becoming a doctor. It involves learning massive amounts of basic science, followed by massive amounts of pathophysiology, which barely prepares you for the clinical years of the last half of medical school and subsequent residency, with the massive knowledge dump you will have to absorb. Much of the information is given by experts in the field, usually MDs or PhDs (or both), who lecture formally and informally. Being considered an expert in infectious disease (ID) at a teaching hospital, I now spend hours a day yammering on about infections to anyone who will listen, students in all the medical fields who rotate through our hospitals. I value the facts I have learned in my field and respect those who have worked to provide me with the information. I greatly value facts and the people who provide them.
Most of the information I get in medicine is from those in the field. It is rare for people to write about aspects of medicine that I will take seriously. Yes, there are a lot of people who write on the web about medicine, but given what it takes to achieve even a solid knowledge in medicine, much less develop expertise, I usually can’t take them too seriously. Call me arrogant, but if you want to be a legitimate source of information there are dues that have to be paid.
My previous posts have described guest lecturers at my medical school campus, invited by a student interest group in CAM. Those events continue; currently ongoing is an 8-weekend certification course in Ayurveda for the subsidized cost of $1500 (includes “tuition, syllabus, and personal guru”). I could pick on this student group, but what’s the point? There will always be medical students who organize to promote ideas that you or I disagree with, whether it be political, religious, or personal. The fact that Tim Kreider disagrees with a particular student group is not terribly interesting.
The more important issue is how CAM is treated by faculty in the curriculum. Particularly during the preclinical years, medical students are in the habit of transcribing and commiting to memory everything uttered by the professors who grade them. A lack of rigorous skepticism is frankly necessary given how much information we are required to master. Where would CAM fit in among the lectures on anatomy, physiology, and pathology?
A question that arises often when discussing the optimal role of science in medicine is the precise role of plausibility, or prior probability. This is, in fact, the central concept that separates (for practical if not philosophical reasons) science-based medicine (SBM) from evidence-based medicine (EBM).
The concept featured prominently in the debate between myself and Dr. Katz at the recent Yale symposium that Kimball Atwood recently discussed. Dr. Katz’s treatment of the topic was fairly typical of CAM proponents, and consisted of a number of straw man derived from a false dichotomy, which I will describe in detail below.
I also recently received (I think by coincidence) the following question from an interested SBM reader:
What would Science Based Medicine do if H. pylori was not known, but a study showed that antibiotics given to patients with stomach ulcers eliminated symptoms? I assume that SBM wouldn’t dismiss it outright saying that it couldn’t possibly be helping because antibiotics don’t reduce stomach acid. I assume a SBM approach would do further studies trying to discover why antibiotics work. But, in the meantime, would a SBM practitioner refuse to give antibiotics to patients because he doesn’t have a scientific explanation as to why it works?
This is the exact type of scenario raised by David Katz during our discussion. He claimed that strict adherence to the principles of SBM would deprive patients of effective treatments, simply because we did not understand how they work. This is a pernicious straw man that significantly misconstrues the nature of plausibility and its relationship to the practice of medicine.
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).
I get all sorts of mail. I get mail from whining Scientologists, suffering patients, angry quacks—and I get lots of promotional material. I get letters from publishers wanting me to review books, letters from pseudo-bloggers wanting me to plug their advertiblog—really, just about anything you can imagine.
Most of the time I just hit “delete”; it’s obvious that they’ve never read my blog and they’re just casting a wide net for some link love. But a recent email from a PR firm piqued my interest: (it’s a long letter, and I won’t be offended if you simply reference it rather than read the whole thing now):