I just thought I’d make a brief announcement that I’m currently in St. Louis attending the annual meeting of the Society of Surgical Oncology. If any of our St. Louis readers are attending the meeting, look me up. I’d be tickled to death to know whether any of my colleagues here are even aware of SBM, much less regular readers. (If no one is aware, though, I’ll be disappointed.) Heck, if you show me your mad skillz at writing and that you share our philosophy, maybe you can even join us as another blogger here!
Also, if anyone’s interested in attempting a meetup, let me know. I’ll be in St. Louis until Sunday morning. It may or may not be possible, given that the SSO meeting fills each day quite nicely and most evenings have something booked, including meeting up with a former postdoc of mine who happens to be at Washington University now, but you never know until you ask. Unfortunately, Saturday night probably out, unless it’s before 7 PM or after 10 PM. My mentor, Dr. Mitch Posner, is the incoming president of the SSO; so I want to go to the Presidential Banquet that evening.
Surgeon and journalist, Atul Gawande, is getting quite a bit of deserved press and blog attention for his new book, The Checklist Manifesto: How to Get Things Right. The premise of his book is simple – checklists are an effective way to reduce error. But behind that simple message are some powerful ideas with significant implications for the culture of medicine.
One of the biggest ideas is that medicine has culture – a way of doing things and thinking about problems that subconsciously pervades the practice of medicine. This idea is not new to Gawande, but he puts it to powerful practice.
The Humble Checklist
Gawande tells not only the story of the checklist but of his personal experience designing and implementing a surgery checklist as part of a WHO project to reduce morbidity and mortality from surgery. He borrowed the idea from other industries, like aviation, that use checklists to operate complex machinery without forgetting to perform each little, but vitally important, step.
Editor’s note: Given the controversial nature of the topic, I think it’s a good time to point out my disclaimer before this post. Not that it’ll prevent any heated arguments or anything…
The Science-Based Medicine blog was started slightly over two years ago, and this is a post I’ve wanted to do since the very beginning. However, since January 2008, each and every time I approached this topic I chickened out. After all, the topic of abortion is such a hot button issue that I seriously questioned whether the grief it would be likely to cause is worth it. (Take the heat generated any time circumcision is discussed here and ramp it up by a factor of 10.) On the other hand, there is so much misinformation out there claiming a link between abortion and the subsequent development of breast cancer when the data simply don’t support such a link, and the name of this blog is Science-Based Medicine. Why should I continue to shy away from a topic just because it’s so religiously charged? More importantly, in my discussion how can I focus attention on the science rather than letting the discussion degenerate into the typical flamefest that any discussion of abortion on the Internet (or anywhere else, for that matter) will almost inevitably degenerate into. Indeed, such discussions have a depressing near-inevitability of validating Godwin’s law not once but many times — usually within mere hours, if not minutes.
My strategy to try to keep the discussion focused on the science will be to stay silent about my own personal opinions regarding abortion and, other than using it to introduce my trepidation about discussing the topic, the religious and moral arguments that fuel the controversy. That’s because the question of whether abortion is the murder of a human being, merely the removal of a lump of tissue, or somewhere in between is a moral issue that, at least as far as I’m concerned, can’t ever be definitively answered by science. That is why it is not my purpose to sway readers towards any specific opinion regarding the morality of abortion. Indeed, I highly doubt that any of our readers care much about my opinions on the matter. On the other hand, I would hope that I’ve built up enough trust over the last two years that our readers will be interested in my analysis of the existing data regarding something another related issue. It is my purpose to try to dispel a myth that is not supported by science, specifically the claim that elective abortion is causes breast cancer or is a very strong risk factor for its subsequent development. That is a claim that can be answered by science and, for the most part, has been answered by science with a fairly high degree of certainty. Despite the science against it, the medical myth that abortion causes breast cancer or vastly increases the risk of it is, like the myth that vaccines cause autism, a manufactroversy that won’t die, mainly because it is largely fueled by religious beliefs that are every bit as immune to science as the ideological beliefs that drive the antivaccine movement.
With some degree of sadness I recently “outed” a former co-resident of mine who has turned to the dark side and begun putting money-making before truth and science. Without any clear evidence of benefit beyond placebo, platelet-rich plasma (PRP) is now being marketed aggressively as a cure-all for sports injuries. And at about $300 per injection (the NYT reports $2000/treatment), there’s plenty of money to be made.
Like the fake “stem cell” clinics in Russia (where, according to Sanjay Gupta’s recent book, Chasing Life, a person’s fat cells are harvested, washed, and re-injected into their blood stream), PRP also involves injection of autologous body fluids. Essentially, a small amount of blood is drawn from the patient, centrifuged, and the plasma supernatant is then injected directly into tendons and/or joints. After a series of 3 injections (one/month), most sports injuries are “cured.” Of course, most injuries would heal themselves in three months anyway. (more…)
I’ve often marveled at the marketing successes of “integrative” medicine – a practice which generally refers to the act of blending effective treatments with ineffective or untested/equivocal ones. Only the marketing elite know how integrative medicine became associated with enlightenment. Perhaps they’re the very same people who came up with the idea that women should be excessively concerned about cellulite? Thanks a lot, guys.
But I do find a lot of integrative medicine vexing because it often starts with a grain of truth, and then usually proceeds to make wildly exaggerated claims about its efficacy.
If there’s one thing we emphasize here on the Science-Based Medicine blog, it’s that the best medical care is based on science. In other words, we are far more for science-based medicine, than we are against against so-called “complementary and alternative medicine” (CAM). My perspective on the issue is that treatments not based on science need to be either subjected to scientific scrutiny if they have sufficient prior plausibility or strong clinical data suggesting efficacy or abandoned if they do not.
Unfortunately, even though the proportion of medical therapies not based on science is far lower than CAM advocates would like you to believe, there are still more treatments in “conventional” medicine that are insufficiently based on science or that have never been validated by proper randomized clinical trials than we as practitioners of science-based medicine would like. This is true for some because there are simply too few patients with a given disease; i.e., the disease is rare. Indeed, for some diseases, there will never be a definitive trial because they are just too uncommon. For others, it’s because of what I like to call medical fads, whereby a treatment appears effective anecdotally or in small uncontrolled trials and, due to the bandwagon effect, becomes widely adopted. Sometimes there is a financial incentive for such treatments to persist; sometimes it’s habit. Indeed, there’s an old saying that, for a treatment truly to disappear, the older generation of physicians has to retire or die off.
That is why I consider it worthwhile to write about a treatment that appears to be on the way to disappearing. At least, I hope that’s what’s going on. It’s also a cautionary tale about how the very same sorts of factors, such as placebo effects, reliance on anecdotal evidence, and regression to the mean, can bedevil those of us dedicated to SBM just as much as it does the investigation of CAM. It should serve as a warning to those of us who might feel a bit too smug about just how dedicated to SBM modern medicine is. Given that the technique in question is an invasive (although not a surgical technique), I also feel that it is my duty as the resident surgeon on SBM to tackle this topic. On the other hand, this case also demonstrates how SBM is, like the science upon which it is based, self-correcting. The question is: What will physicians do with the most recent information from very recently reported clinical trials that clearly show a very favored and lucrative treatment does not work better than a placebo?
Here’s the story that illustrates these issues, fresh from the New York Times this week:
James Reston’s Appendectomy
For many Americans, the current wave of public fascination with “complementary and alternative medicine (CAM)” can be traced to a single event: New York Times columnist James Reston’s appendectomy in China during the summer of 1971, which Reston reported in an interesting and amusing article on July 26 of that year. Many of those who noticed the publicity following this event erroneously concluded that Mr. Reston had undergone “acupuncture anesthesia.” A few years ago, a Google search for “acupuncture and Reston” revealed that approximately 50% of the numerous “hits” reported this, as though it were an uncontroversial fact. Other sources have suggested the same, but in veiled language. Here are examples of each:
In the 1970s, interest in the procedure was sparked when New York Times editor James Reston wrote an article about his experience with acupuncture. Reston was covering Richard Nixon’s visit to China when Reston needed an emergency appendectomy, and acupuncture was used as an anesthetic.—UPenn News 1995
In 1972 President Nixon opened the doors to China. A New York Times journalist James Reston was in China at the time and had an emergency appendectomy with acupuncture used as the anesthetic.—American Acupuncture
[Acupuncture] made its official appearance in the U.S. in 1971 when an article by J. Reston was published in the New York Times describing his personal experience with acupuncture. While in Beijing reporting on a Ping-Pong tournament, he underwent an emergency appendectomy. Acupuncture was used as surgical anesthesia and to relieve post-operative pain. —Center for the Healing Arts, P.C.
The first US national media coverage concerning Acupuncture was in 1971 during President Nixon’s visit to China. There, visiting columnist James Reston told of his emergency appendectomy performed under Acupuncture anesthesia.— AZ Multicare
When New York Times columnist James Reston underwent an appendectomy while accompanying the Nixon entourage to Beijing in 1971, he wrote about a medical discovery called “acupuncture anesthesia.” Eisenberg, David, with Thomas Lee Wright: Encounters with Qi (p. 28)
About a month after his appendectomy, Reston did write about acupuncture anesthesia—but not referring to his own operation.
Those who don’t report that Reston had acupuncture anesthesia are likely to write, also erroneously, that his “intense post-operative pain was relieved by acupuncture”:
Arguably the most difficult aspect of science-based medicine is where the rubber hits the road, so to speak. That’s where scientists and physicians take the results of preclinical studies performed in vitro in biochemical assays and cell culture models and in vivo in animal models to humans. There are numerous reasons for this, not the least of which that preclinical models, contrary to what animal rights activists would like you to believe, do not predict human responses to new therapeutic agents as much as we would like. However, the single biggest reason that we cannot answer questions in human studies as easily as we can in cell culture and animal studies is ethics. Of course, answering questions using cell culture and animal studies is not “easy,” either, but performing studies using human beings as subjects is an order of magnitude (at least) more difficult because the potential to cause harm exists, and if harm is caused by the experimental treatment under study, that harm will be done to human beings, rather than cells in a dish or mice bred for research.
The “gold standard” type of study that we do to test the efficacy of a new drug is known as the randomized, placebo-controlled, double-blinded study, often abbreviated RCT. Indeed, this remains the gold standard and is accorded the highest level of “power” in the framework of evidence-based medicine. Of course, as we have argued time and time again, using the RCT to test therapies that are incredibly implausible on a strictly scientific basis (homeopathy or reiki, for instance) inevitably leads to numerous “false positives” in which the therapy appears to produce results statistically significantly better than the control. John Ioannidis has done numerous clever analyses that demonstrate how easily clinical research is led astray if it is not grounded in scientific plausibility. Indeed, the probability of false positive studies increases, the more improbable the modality. It is for these very reasons that we have proposed the concept of science-based medicine, which takes into account estimates of prior probability based on preclinical studies and basic scientific principles, rather than evidence-based medicine, which does not. Indeed, Wally Sampson has even proposed a “plausibility scale” for rating RCTs, and Steve Novella has pointed out how difficult it can be to interpret the medical literature.
We criticize alternative medicine for not being evidence-based, and they criticize conventional medicine in turn, saying that much of what conventional medicine does is not based on evidence either. Sometimes that criticism is justified. I have run across a conventional practice that I suspect began because it sounded like a good idea, but that never was adequately tested and is not carefully thought out for individual patients.
I recently had a bone marrow aspiration. The written instructions said not to eat or drink for 6 hours before the procedure, to bring someone to drive me home, and to expect an IV. I suspected from these instructions that they were planning to use IV sedation, and I was right.
I questioned the need for sedation. I am prejudiced about bone marrow aspirations. I observed several and did one myself during my internship. When I had finished, the patient asked me when I was going to start. We did the procedure at the patient’s bedside in a multi-bed ward with no sedation, only local anesthesia. So my prejudice was that the procedure was no big deal and was not terribly painful.
I can imagine that some patients may be terrified by the idea of a needle going into their bone and may want to be sedated and not remember the experience. But I was not anxious about it, and I saw no need for the fentanyl and Versed they wanted to give me. I figured it would only prolong my time in the hospital, produce amnesia, expose me to a small risk of adverse effects, and leave me groggy; so I asked to opt out. They readily agreed – although they did keep asking me if I was really sure I didn’t want it. They would not have offered the option of no sedation if I had not known to ask. (more…)
Of all the posts I and my cobloggers have written for SBM over the last 15 months, most provoke relatively few comments. However, a few stand out for having provoked hundreds of comments. The very first post that provoked hundreds of comments was Harriet’s excellent discussion of the International Network of Cholesterol Skeptics. In fact, Harriet seems to be quite good at writing posts that provoke a lot of comment, as another of her posts, specifically the one in which she discussed circumcision, also garnered hundreds of comments. However, to my great surprise, the one post that stands out as having received the most comments thus far in the history of SBM is one that I wrote. Specifically, it was a post I called Death by “alternative” medicine: Who’s to blame?, which has collected an astonishing 611 comments thus far. The topic of the post was a case report that I had heard while visiting the tumor board of an affiliate of my former cancer center describing a young woman who had rejected conventional therapy for an eminently treatable breast cancer and then returned two or three years later with a large, nasty tumor that was much more difficult to treat and possibly metastatic to the bone, which would make it no longer even potentially curable. My discussion centered on what the obligation of a physician is to such patients who utterly refuse the science- and evidence-based medicine that we know to be able to cure them of a potentially fatal disease, and I was not only surprised but somewhat taken aback by the vehemence of the discussion.
Since that post, I’ve always been meaning to take a look at what, exactly, the effect of choosing “alternative” medicine over “conventional” medicine is on the odds of survival for breast cancer patients. Even though intuitively one would hypothesize that refusing scientific medicine and relying on placebo medicine instead would have a detrimental effect on survival, it turns out that this question is not as easy to answer as you might think. For example, if you do a search on PubMed using terms like “alternative medicine,” “breast cancer,” and “survival,” the vast majority of the hits will be studies of complementary and alternative medicine (CAM) and breast cancer with little reference to what possible effect these therapies might have on survival. I can envision several reasons for this, the first being that–thankfully–relatively few women actually use alternative medicine exclusively to treat their breast cancer. Also, those that do probably drop off the radar screen of their science-based practitioners, and it is difficult, if not impossible, to capture data regarding their outcomes, given that they all too often stick with their alternative healers until the end. True, they may pop up again in their surgeon’s or primary care doctor’s office with huge, fungating tumors, only to be told that they have to undergo chemotherapy to shrink the tumor before any surgery is possible, after which they will often disappear again. Another important reason is that the natural history of breast cancer is extremely variable, from nasty, aggressive tumors that kill within months to indolent, slow-growing tumors that, even when metastatic, women can survive with for several years. (It is, of course, these women who usually show up in “alternative medicine” testimonials, because they can survive a long time with little or no treatment before their tumors progress.)