Archive for Surgical Procedures

Alternative medicine use and breast cancer

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.)

Posted in: Cancer, Herbs & Supplements, Science and Medicine, Surgical Procedures

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When fraud undermines science-based medicine

The overriding them, the raison d’être if you will, of this blog is science-based medicine. However, it goes beyond that in that we here at SBM believe that science- and evidence-based medicine is the best medicine. It’s more than the best medicine, though; it’s the best strategy for medicine to improve therapy for our patients. We frequently contrast science-based medicine with various forms of “complementary and alternative medicine,” specifically pointing out that SBM changes its practices as new science and new evidence mandates it while CAM tends to rely on ancient, vitalistic, pre-scientific or pre-modern scientific beliefs about how disease occurs as the basis for its therapies. Although it may be painfully slow and frustrating at times and even though there may be major stumbles along the way, the overall course of SBM over the last century has in general been to produce ever more effective therapies and to discard therapies that are either ineffective or whose risk-benefit ratios are insufficiently favorable. The one single most important thing behind the advancement of medicine is good science.

That’s why I really, really hate scientific fraud, and I’m really, really upset, perhaps even more so than Dr. Atwood, over the discovery last week of what is arguably one of the most massive scientific frauds in medical history. It doesn’t matter that Dr. Atwood is an anaesthesiologist and I am not, meaning that the specific scientific fraud unearthed, which was perpetrated by an anesthesiologist studying multimodal anesthesia, as reported in Anesthesiology News, the Wall Street Journal, and the New York Times. I am a surgeon, and the relief of surgical pain in my patients is an important part of my practice. If the scientific basis of what my colleagues in anesthesiology do before, during, and after my operations is called into doubt, I have to wonder if I am giving my patients the best surgical care. Aside from that, there is the intellectual outrage I feel as a result of seeing science and patients betrayed in such a systematic and blatant manner.

Posted in: Clinical Trials, Health Fraud, Pharmaceuticals, Science and Medicine, Surgical Procedures

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Another challenge to surgical dogma

Better late than never with this one.

The dogma that I’m referring to is the remaining practice of using NG tubes in anyone with upper gastrointestinal surgery (liver, stomach, pancreas, duodenum, proximal small intestine) and then placing a jejunostomy tube (a tube, also often called a J-tube, that goes into the jejunum, or the proximal part of the small intestine, through which feedings can be given). The rationale for this was that the peristalsis of the small bowel returns almost immediately; it’s the large bowel and stomach whose return of peristalsis is delayed. Consequently, liquid tube feedings, it was thought, could be given beyond the point of surgery into the small bowel because if there is one surgical dogma that the evidence generally supports and probably always will, it’s always better to use the gut for nutrition than to use total parenteral nutrition (TPN, or feeding by veins). Moreover, there was evidence that such feedings had a protective effect on the lining of the bowel, preventing a phenomenon known as bacterial translocation, in which bacteria could pass through the compromised lining of the bowel after surgical stress. The price, however, was the placement of a tube into the proximal intestine, a procedure that, while safe, was definitely not without complications, some of which (such as bowel perforation) could be serious and require reoperation.

Challenging this dogma is the largest multicenter randomized study yet looking at this question: Which is better, bowel rest (NPO) and J-tube feedings or just letting the patient eat the next day? The study comes out of Norway1 and involved 453 patients. Blinding, much less double blinding, was, as is the case in many surgical trials, not possible because of the very nature of the question being examined, but other than that the design of the study was about as strong as a surgeon could ask for. Basically, patients were randomized to a routine of NPO and J-tube feeding until flatus indicated return of bowel function versus normal food at will beginning on postoperative day one; the experimental design is summarized below:

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

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South Dakota’s Abortion Script: The Hijacking of Informed Consent

In a previous post, I suggested that informed consent could sometimes be misused. South Dakota has provided a clear example of such misuse and has set a frightening precedent reminiscent of Big Brother in George Orwell’s 1984.

A law went into effect in July, 2008, requiring that any woman seeking an abortion in South Dakota must be told that she is terminating the life of “a whole, separate, unique, living human being” with whom she has an “existing relationship” and that abortion terminates “her existing constitutional rights with regards to that relationship.”

It requires that doctors give patients information about medical risks, but it doesn’t leave anything to chance: it specifies what the risks are, including depression, suicide, danger to subsequent pregnancies, and death. The current state of development of the fetus must be described, and the woman must be asked if she wants to see a sonogram of the fetus. All of this must be done in writing, and the woman must sign each page of documentation. Physicians who fail to comply can lose their license or be charged with a misdemeanor. (more…)

Posted in: Politics and Regulation, Surgical Procedures

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Fecal Transplants: Getting To The Bottom Of The Matter

Many Americans will be introducing more food than usual to their GI tracts on this Thanksgiving Day, and so I thought I’d provide you with a special gastroenterology-related post to complement the mood. If you have already eaten, I might suggest that you come back to this post on an empty stomach. I will be discussing the alternative medicine practice known as “fecal transplantation” and it is rather unsavory.

The idea of transferring stool from one person to another (for the treatment of various GI disorders) was first described in the 1950s. This month the TV show, Grey’s Anatomy, featured the practice in one of their plot lines – which rekindled interest in the therapy, and resulted in an explosion of search engine activity. I figured it was probably my duty, as a member of Science Based Medicine, to offer a rational analysis of the treatment in the hope that the Google gods will serve up my post to a few of the information-seekers out there. I hope to reach them before the snake oil salesmen, wrapped in their mantle of “gentle, natural cures,” convince them that they desperately need a good colon or liver cleanse, if not a fecal transplant.

Like most alternative therapies, fecal transplantation is based on a drop of truth and a gallon of pseudoscience. It is true that the gastrointestinal tract is teeming with hundreds of thousands of bacterial species and pseudo-species, and that without them we would die. It is also true that certain nasty bugs (like clostridium difficile) cause problems when they take up residence within the gut. Antibiotics do upset intestinal flora, much to the consternation of infectious disease specialists. Now, all that being said – the practice of repopulating the gut with another person’s stool requires some fairly grand assumptions about efficacy and safety that are not founded upon any clinical trial data whatsoever.

Posted in: Surgical Procedures

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Circumcision: What Does Science Say?

Some people think circumcision is mutilation; others want one even if they don’t know what it is. When I was working in an Air Force hospital emergency room one night, a young airman came in requesting a circumcision. I asked him why he wanted one. He said a couple of his friends had had it done, and he’d heard it was a good idea, and he was going to be getting out of the Air Force pretty soon and wanted to have it done while Uncle Sam would still foot the bill. I examined him: he had a neatly circumcised penis without so much as a hint of any foreskin remnant. I’ve always wondered what he thought we were going to cut off.

The subject of circumcision evokes strong emotions. Some people think of neonatal circumcision as a religious duty or a valuable preventive health measure; others think it is the epitome of child abuse. I have no strong feelings either way. I’m not sure what I would have decided if I’d had sons; fortunately my children were both daughters so I didn’t have to decide. I’m going to try to stand back and look at the scientific evidence objectively. What are the medical benefits and risks of circumcision? (more…)

Posted in: Medical Ethics, Surgical Procedures

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The Orange Man

The first thing that struck me about him was that he was orange.

It was not a shade of orange I had ever ever encountered before in a patient. It was a yellowish orange, an almost artificial-looking color. At first I wondered if he was suffering from liver failure with jaundice, but this orange was just not the right shade of yellow for jaundice, and his sclerae were not yellow. I also considered whether he was suffering from renal failure, but the orange color of his skin didn’t quite match the rather coppery color that some patients suffering from longstanding renal failure necessitating dialysis sometimes acquire. I was puzzled. His chart said that he was being admitted for surgery for rectal cancer. So I sent the intern in to get the story, do the history and physical, and get him all plugged in for his bowel prep. Believe it or not, there was actually a time when it was not all that uncommon for patients to come into the hospital the night before major abdominal surgery in order to undergo a preoperative bowel prep, rather than being forced by their insurance companies to undergo the torture of drinking four liters of the purgative known as Go-Lytely–a misnomer, if ever there was one!–at home and spending the next several hours having to rush periodically to the toilet, waiting in vain for the liquid exploding out of their hind end to run clear.

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

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The media versus the frontiers of medicine and surgery

A couple of months ago, one of my esteemed co-bloggers, Wally Sampson, wrote an excellent article about borderlines in research in conventional medicine. Such borderlines are particularly common in my area of expertise (cancer, which is also Dr. Sampson’s area of expertise) because there are so many cancers for which we do not as yet have reliably curative therapies. Patients faced with unresectable pancreatic cancer (as, for example, Patrick Swayze and the President of the American Medical Association have been diagnosed with) or metastatic solid cancers against which medicine generally has mostly palliative treatments, it is very tempting to take a “what have we got to lose?” attitude and pursue increasingly aggressive therapies that may actually shorten what little life a patient has left, all too often making that little bit of life more miserable than it had to be. As Dr. Sampson described in great detail, this sort of push to the borderlines and beyond led to the widespread acceptance during the 1990s of bone marrow transplantation as a treatment for advanced or inflammatory breast cancer based on uncontrolled studies that suggested a benefit. Later studies demonstrated no survival benefit (and possibly even a detriment), and that, or so it would seem, was that.

Except it wasn’t. Indeed, the other point that Dr. Sampson made was how the press covers these sorts of issues. He discussed a story that appeared in the San Francisco Chronicle about a young woman with advanced breast cancer who underwent stem cell transplantation for stage IV breast cancer at M.D. Anderson Cancer Center and was embroiled in a fight with Kaiser Permanente, her insurer, which refused to cover the treatment because it was deemed experimental and was at the time covering the cost of radiation therapy but refusing to cover the costs of extra followup scans required by the M.D. Anderson protocol. The article, not surprisingly, covered the story from the angle of the brave young cancer victim being further victimized by a greedy insurance company. And Evanthia Pappas is no doubt brave, and no one could read about her plight without rooting for her to beat the odds. The problem is that no consideration was given to just how unlikely this incredibly expensive treatment was to benefit her and whether it was even ethical to be doing such a study in which the patient bore over $200,000 of the cost for a treatment that was indeed experimental and being studied in an uncontrolled clinical trial. There are some very thorny medical, ethical, and financial issues there indeed.

Perhaps the reason Dr. Sampson’s post resonated with me was because it reminded me of a story that was extensively discussed last year, so much so that I saved the link to it. The story (Cancer Patients, Lost in a Maze of Uneven Care) appeared on the front page of the New York Times last summer. The article in question starts out by telling a truly sad story about a 35 year-old woman who, after giving birth, was diagnosed with Stage IV colon cancer as the human interest “hook” with which to represent what is described as a systemic problem with cancer care in this country:

Posted in: Cancer, Medical Ethics, Science and Medicine, Science and the Media, Surgical Procedures

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Early detection of cancer, part 2: Breast cancer and MRI

Note: If you haven’t already, you should read PART 1 of this two-part series. It defines several terms that I will be using in this post, and I don’t plan on explaining them again, given that they were explained in detail in Part 1. Of course, if you’re a medical professional and already know what lead time bias, length bias, and stage migration are, then it goes without saying that you should still read Part 1 for its scintillating prose.

ResearchBlogging.orgWhen last I left this topic three weeks ago, I had discussed why detecting cancer at ever-earlier stages and ever-smaller sizes is not necessarily an unalloyed good. At that time, I discussed in detail a landmark commentary in the New England Journal of Medicine entitled, Advances in Diagnostic Imaging and Overestimations of Disease Prevalence and the Benefits of Therapy. The article, although nearly 15 years old, rings just as true today in its cautioning doctors about whether ever-increasing diagnostic sensitivity that imaging technology and new blood tests were (and are) providing was actually helping patients as much as we thought it was. Before we dive into this problem as applied to breast cancer, let’s review what Drs. Black and Welch had to say about screening tests for breast cancer 15 years ago, as way of background and linking my last post and this one:

Before the widespread use of mammography, most breast cancers were discovered on physical examination, as palpable lumps. In one of the few studies to assess directly the accuracy of physical examination in screening for breast cancer, only 27 percent of tumors more than 1.0 cm in diameter and 10 percent of those less than 1.0 cm in diameter were detected by physical examination. However, the mean size of breast cancers detected by state-of-the-art screening mammography is about 1.0 cm, and many of the cancers detected as microcalcifications are only a few millimeters in size.

Again, prevalence depends on the degree of scrutiny. According to the Connecticut Tumor Registry, clinically apparent breast cancer afflicts about 1 percent of all women between the ages of 40 and 50 years. In a recent medicolegal autopsy study, however, small foci of breast cancer were found in 39 percent of women in this age group. Most cancers were in the form of ductal carcinoma in situ. Furthermore, over 45 percent of the women with cancer had two or more lesions, and over 40 percent had bilateral lesions. Although it has been argued that such small in situ lesions are not detected by and are therefore irrelevant to screening mammography, about half the lesions in that study were detected, usually as microcalcifications, on postmortem plain-film radiography of the resected breasts. Because of continual technical improvements and increasingly broad criteria for the interpretation of mammograms, the detection threshold for breast cancer has fallen considerably since the time of the Breast Cancer Screening Project of the Health Insurance Plan of Greater New York (1963 to 1975). This can explain the increased prevalence of cancer on mammographic screening, from 2.717 to 7.614 per 1000 examinations (with the incidence increasing from 1.517 to 3.214 per 1000 examinations). The lower detection threshold can also explain the increase in the percentage of carcinomas in situ (stage 0) among all mammographically detected cancers — from 12.7 percent to over 30 percent. The principal indication for biopsy has changed from suspicious mass to suspicious microcalcifications. This can explain why the reported incidence of breast cancer has increased and why most of the increase is in smaller lesions, particularly ductal carcinoma in situ.

About a year ago, three major articles hit the medical press that made me start thinking about this more than I had in the past. It’s my job, after all, because breast cancer surgery is a large part of my practice, and I do breast cancer lab-based research. What also tweaked me not to put off doing part 2 of this series is that, just two days ago, there was an abstract presented at the American Society of Clinical Oncology Meeting (where I still am today) that also serves to highlight just how difficult this question of integrating a test as sensitive as MRI into a screening regimen for and preoperative evaluation of breast cancer is and how MRI should fit into in this regimen can be.

Posted in: Clinical Trials, Public Health, Science and Medicine, Science and the Media, Surgical Procedures

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Barriers to practicing science-based surgery

ResearchBlogging.orgMuch to the relief of regular readers, I will now change topics from those of the last two weeks. Although fun and amusing (except to those who fall for them), continuing with such material for too long risks sending this blog too far in a direction that no one would want. So, instead, this week it’s time to get serious again.

A few weeks ago, I wrote about factors that lead to the premature adoption of surgical technologies and procedures or the “bandwagon” or “fad” effect among surgeons. By “premature,” I am referring to widespread adoption “in the trenches,” so to speak, of a procedure before good quality evidence from science and clinical trials show it to be superior in some way to previously used procedures, either in terms of efficacy, cost, time to recover, or other measurable parameters. As I pointed out before, laparoscopic cholecystectomy definitely fell into that category. The popularity of the procedure spread like wildfire in the early 1990s before there was any good quality data supporting its superiority to the “old-fashioned” gold standard procedure of open cholecystectomy. Another example, although not nearly as dramatic because the number of patients for whom the procedure would be appropriate is much smaller, is transanal endoscopic microsurgery. However, the difficulties in practicing science- and evidence-based medicine don’t just include fads and bandwagon effects. The example of laparoscopic cholecystectomy notwithstanding (which was largely driven by marketing and patient demand), surgical culture is deeply conservative in that it can be very reluctant to change practice even there is very strong evidence saying that they should.

Posted in: Basic Science, Cancer, Surgical Procedures

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