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The continuum of surgical research in science-based medicine

Editor’s note: Three members of the SBM blogging crew had a…very interesting meeting on Friday, one none of us expected, the details of which will be reported later this week–meaning you’d better keep reading this week if you want to find out. (Hint, hint.) However, what that means is that I was away Thursday and Friday; between the trip and the various family gatherings I didn’t have time for one of my usual 4,000 word screeds of fresh material. However, there is something I’ve been meaning to discuss on SBM, and it’s perfect for SBM. Fortunately, I did write something about it elsewhere three years ago. This seems like the perfect time to spiff it up, update it, and republish it. In doing so, I found myself writing far more than I had expected, making it a lot more different from the old post than I had expected, but I guess that’s just me.

In the meantime, the hunt for new bloggers goes on, with some promising results. If we haven’t gotten back to you yet (namely most of you), please be patient. This meeting and the holiday–not to mention my real life job–have interfered with that, too.

The continuum of surgical research in science-based medicine

One of the things about science-based medicine that makes it so fascinating is that it encompasses such a wide variety of modalities that it takes a similarly wide variety of science and scientific techniques to investigate various diseases. Some medical disciplines consist of mainly of problems that are relatively straightforward to study. Don’t get me wrong, though. By “straightforward,” I don’t mean that they’re easy, simply that the experimental design of a clinical trial to test a treatment is fairly easily encompassed by the paradigm of randomized clinical trials. Medical oncology is just one example, where new drugs can be tested in randomized, double-blinded trials against or in addition to the standard of care without having to account for many difficulties that arise from difficulties blinding. We’ve discussed such difficulties before, for instance, in the context of constructing adequate placebos for acupuncture trials. Indeed, this topic is critical to the application of science-based medicine to various “complementary and alternative medicine” modalities, which do not as easily lend themselves to randomized double-blind placebo-controlled trials, although I would hasten to point out that, just because it can be very difficult to do such trials is not an excuse for not doing them. The development of various “sham acupuncture” controls, one of which consisted even of just twirling a toothpick gently poked onto the skin, shows that.

One area of medicine where it is difficult to construct randomized controlled trials is surgery. The reasons are multiple. For one thing, it’s virtually impossible to blind the person doing the surgery to what he or she is doing. One way around that would be to have the surgeons who do the operations not be involved with the postoperative care of the patients at all, while the postoperative team doesn’t know which operation the patient actually got. However, most surgeons would consider this not only undesirable, but downright unethical. At least, I would. Another problem comes when the surgeries are sufficiently different that it is impossible to hide from the patient which operation he got. Moreover, surgery itself has a powerful placebo effect, as has been shown time and time again. Even so, surgical trials are very important and produce important results. For instance, I wrote about two trials for vertebral kyphoplasty for ostoporotic fractures, both of which produced negative results showing kyphoplasty to be no better than placebo. Some surgical trials have been critical to defining a science-based approach to how we treat patients, such as trials showing that survival rates are the same in breast cancer treated with lumpectomy and radiation therapy as they are when the treatment is mastectomy. Still, surgery is a set of disciplines where applying science-based medicine is arguably not as straightforward as it is in many specialties. At times, applying science-based medicine to it can be nearly as difficult as it is to do for various CAM modalities, mainly because of the difficulties in blinding. That’s why I’m always fascinated by strategies by which we as surgeons try to make our discipline more science-based.
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Posted in: Clinical Trials, Science and Medicine, Surgical Procedures

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Halsted: The Father of Science-Based Surgery

One (dark and stormy?) night in 1882, a critically ill 70 year old woman was at the verge of death at her daughter’s home, suffering from fever, crippling pain, nausea, and an inflamed abdominal mass. At 2 AM, a courageous surgeon put her on the kitchen table and performed the first known operation to remove gallstones. The patient recovered uneventfully. The patient was the surgeon’s own mother.

This compelling story is the beginning of an excellent new biography of William Halsted, the father of modern surgery, Genius on the Edge: The Bizarre Double Life of Dr. William Stewart Halsted, by Gerald Imber, MD.

When Halsted went to medical school, surgeons still operated in street clothes, with bare hands, and major surgical procedures carried a mortality rate of nearly 50 percent. Suppuration of wounds was called laudable pus. Lister had recently introduced carbolic acid dips and sprays (that were irritating and toxic), but hand washing was discouraged because it was thought to force germs into skin crevices. (more…)

Posted in: Book & movie reviews, History, Surgical Procedures

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Meet me in St. Louis?

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.

Posted in: Announcements, Surgical Procedures

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Checklists and Culture in Medicine

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.

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Posted in: Science and Medicine, Surgical Procedures

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Abortion and breast cancer: The manufactroversy that won’t die

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.
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Posted in: Cancer, Obstetrics & gynecology, Religion, Surgical Procedures

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A Case Study In Aggressive Quackery Marketing

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…)

Posted in: Clinical Trials, Dentistry, Health Fraud, Surgical Procedures

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Platelet-Rich Plasma

As I mentioned in a not-so-recent blog post, 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.

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Posted in: Surgical Procedures

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Vertebroplasty for compression fractures due to osteoporosis: Placebo medicine

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:
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Posted in: Clinical Trials, Science and Medicine, Surgical Procedures

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“Acupuncture Anesthesia”: A Proclamation from Chairman Mao (Part I)

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”:

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Posted in: Acupuncture, Medical Academia, Science and the Media, Surgical Procedures

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Human subjects protections and research ethics: Where the rubber hits the road for science-based medicine

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.
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Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Surgical Procedures, Vaccines

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