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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.
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Posted in: Basic Science, Cancer, Surgical Procedures

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Bad scientific arguments in the service of animal rights activism

One of the greatest threats to the preclinical research necessary for science-based medicine today is animal rights activism. The magnitude of the problem came to the forefront again last week with the news that animal rights terrorists tried to enter the home of a researcher at the University of California Santa Cruz (UCSC) whose research uses mice to study breast cancer and neurologic disease while she and her husband were having a birthday party for one of their children and assaulted her husband, who had gone to the front of the house to confront them. Fortunately, the license plate number of the car fleeing the scene was reported to police, leading to a raid on a house by police and the confiscation of computers and other materials. This attack appeared to be the latest crescendo in an increasing campaign of harrassment and intimidation by animal rights “activists” that has also been observed in nearby Berkeley.

This sort of threat to researchers is not a problem just in Santa Cruz and the Bay area, but in particular has been a problem in southern California as well. Just earlier this week, the University of California Los Angeles announced that it was suing several animal rights groups and individuals suspected of attacks on researchers who use animals, including UCLA Primate Freedom Project, the Animal Liberation Front (ALF), and the Animal Liberation Brigade (ALB), as well as several individuals believed to affiliate with these groups. The inciting event for this action was the second attack on the home of Edythe London, Professor of Psychiatry and Bio-behavioral Sciences and of Molecular and Medical Pharmacology at the David Geffen School of Medicine at UCLA, in early February. Her research involves the use of primate models to study nicotine addiction. In this most recent attack, an attempt was made to set her house on fire. This came on the heels of a previous attack in October, in which animal rights activists flooded her house. Prior to that, animal rights terrorists had indeed succeeded in their aim of intimidating a scientist sufficiently that he gave up animal research after a fellow researcher was targeted with a Molotov cocktail meant for her home that was mistakenly placed on the porch of an elderly neighbor. Also, we in the U.S. often forget how much more radical animal rights extremists are in the U.K., where the campaign of intimidation takes the form of death threats, intimidation of personnel of companies that supply researchers, and even in one case digging up the grave of Gladys Hammond, whose family ran a farm that raised Guinea pigs for use in medical research, and stealing her remains.

Readers may make the argument that my introduction to this discussion is unfairly inflammatory, but I have my reasons for starting this way, and I think they are good ones. First, make no mistake, the aim of the most radical of these activists is nothing short of the cessation of the use of all animals in biomedical research. Second, sooner or later, someone will be hurt or killed. As a researcher who on occasion uses mouse models of cancer myself, I state up front that I could be on the firing line just as much as the UCSC researcher or others and am justifiably disturbed when I hear spokesperson for the ALF Dr. Jerry Vlasak, for example, repeatedly advocate violence against researchers who use animals. In this article, I am not going to discuss the moral issues involved in animal research. What I am going to discuss is the seemingly scientific arguments that some opponents of animal research and animal rights activists like to invoke, arguments increasingly used in addition to the moral arguments that extremists use to justify their actions. If the arguments of opponents of animal rights research were indeed good science, then their appropriation by extremists would not allow me to do much other than bemoan the misuse of valid science as a justification for extremism. Unfortunately, such is not the case, and the bad scientific arguments used by opponents of animal research are often piled onto the extreme moral arguments that fuel actions such as those earlier this week at UCSC. Consequently, given the events of the last month or so, I thought I would take this opportunity to look at some of the common scientific indictments of animal research by its opponents.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation, Science and Medicine

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Prior Probability: The Dirty Little Secret of “Evidence-Based Alternative Medicine”

This is actually the second entry in this series;† the first was Part V of the Homeopathy and Evidence-Based Medicine series, which began the discussion of why Evidence-Based Medicine (EBM) is not up to the task of evaluating highly implausible claims. That discussion made the point that EBM favors equivocal clinical trial data over basic science, even if the latter is both firmly established and refutes the clinical claim. It suggested that this failure in calculus is not an indictment of EBM’s originators, but rather was an understandable lapse on their part: it never occurred to them, even as recently as 1990, that EBM would soon be asked to judge contests pitting low powered, bias-prone clinical investigations and reviews against facts of nature elucidated by voluminous and rigorous experimentation. Thus although EBM correctly recognizes that basic science is an insufficient basis for determining the safety and effectiveness of a new medical treatment, it overlooks its necessary place in that exercise.

This entry develops the argument in a more formal way. In so doing it advocates a solution to the problem that has been offered by several others, but so far without real success: the adoption of Bayesian inference for evaluating clinical trial data.
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Posted in: Basic Science, Clinical Trials, Homeopathy, Science and Medicine

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Homeopathy and Evidence-Based Medicine: Back to the Future Part V

Homeopathy and Science: Discussion, Summary and Conclusions

I was not surprised by a couple of the dissenting comments after Part IV of this blog. One writer worried that I had neglected, presumably for nefarious reasons, to cite replications of Benveniste’s results; another cited several examples of “positive” homeopathy studies that I had failed to mention. I answered some of those points here. I am fully aware of such “positive” reports, including those seeming to support Benveniste. I didn’t cite them, but not in some futile hope of concealing their existence from the watchful eyes of the readership. I also didn’t cite several “negative” reports, including an independent, disconfirming report of one of the claims of David Reilly, whose words began this series,* and the most recent of several reviews (referenced here) to conclude that “the clinical effects of homoeopathy are placebo effects.” I didn’t cite those reports for the same reasons that I didn’t cite the “positive” studies: they are mere footnotes to the overwhelming evidence against homeopathy.

To explain why, it will be necessary to discuss some of the strengths and weaknesses of the project known as “Evidence-Based Medicine.”

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Posted in: Basic Science, Clinical Trials, Homeopathy, Medical Academia, Science and Medicine

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The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work

What’s an advocate of evidence- and science-based medicine to think about the National Center for Complementary and Alternative Medicine, better known by its abbrevation NCCAM? As I’ve pointed out before, I used to be somewhat of a supporter of NCCAM. I really did, back when I was more naïve and idealistic. Indeed, as I mentioned before, when I first read Wally Sampson’s article Why NCCAM should be defunded, I thought it a bit too strident and even rather close-minded. At the time, I thought that the best way to separate the wheat from the chaff was to apply the scientific method to the various “CAM” modalities and let the chips fall where they may.

Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine. However, NCCAM cannot do otherwise, given its mission:

  • Explore complementary and alternative healing practices in the context of rigorous science.
  • Train complementary and alternative medicine researchers.
  • Disseminate authoritative information to the public and professionals.

If, in fact, NCCAM actually did devote itself solely to “rigorous science” with regard to “alternative” healing practices, I would have much less problem with it than I do. However, it broadly interprets the second and third parts of its mission. For example, it views part of its mission as promotion, rather than study: “Supporting integration of proven CAM therapies. Our research helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.” This would be all well and good if NCCAM had as yet actually proven any CAM therapies to be at least effective, but it has not. Worse, it has not even managed to demonstrate any of them to be ineffective, either, thus leading to endless studies of modalities that either do not work or at the very least would have marginal efficacy.

Still, I thought; All questions of promotion of CAM modalities aside, least there’s the science. Surely, under the auspices of the NIH, NCCAM must be funding some high-quality studies into CAM modalities that couldn’t be done any other way. That thought died when NCCAM announced last week the studies that it had funded during FY 2007.
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Posted in: Basic Science, Clinical Trials, Medical Academia, Politics and Regulation, Science and Medicine

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Science by press release: A helmet to fight Alzheimer’s disease?

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Recently, I’ve had a number of people bring to my attention a news story that has apparently been sweeping the wire services and showing up in all sorts of venues. It is, on its surface, a story of hope, hope for the millions of elderly (and even the not-so-elderly) who are or will be afflicted by that scourge of the mind, memory, and personality, Alzheimer’s disease. This disease is one of the most feared of diseases. A progressive and fatal disease of the brain, it robs a person of his memory and personality, until he no longer recognizes loved ones and becomes too demented to care for himself. The pathophysiology involves the accumulation in the brain of a protein known as β-amyloid, which forms plaques outside of cells, while neurofibrillary tangles believed to be due to the hyperphosphorylation of a protein known as tau develop in dying cells. The exact mechanism by which neuron death occurs is not fully understood, but over time this process leads to a decrease in the amount of gray matter in the cortex. There is no known cure, and the current treatments that we have result in at best a modest delay of the inevitable dementia that accompanies progression of the disease.

Given this grim backdrop and the general aging of the population in developed nations, it is expected that there will be a large increase in the number of people developing Alzheimer’s disease over the next few decades. Naturally, this provides a great deal of incentive to develop more effective treatments. Not surprisingly, sometimes the treatments proposed may sound somewhat outlandish and may even be somewhat outlandish. The treatment about which people were e-mailing me falls into this category, and I haven’t decided yet whether it’s science or pseudoscience. It could be legitimate. What I do know, however, is that I don’t like the way its inventors are promoting it by press conference before any evidence of its clinical efficacy in humans has been accepted by a peer-reviewed publication, leading to a flurry of stories about a new possible “miracle cure” for Alzheimer’s disease grounded in not a lot of science. I’m referring, of course, to the “Alzheimer’s helmet” developed by Dr. Gordon Dougal and his colleagues Dr. Paul Chazot and Abdel Ennaceur at Durham University. Dr. Dougal is a director of Virulite, a medical company based in County Durham in the U.K. Here’s a widely cited article from the Daily Mail that describes the device:
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Posted in: Basic Science, Medical devices, Medical Ethics, Neuroscience/Mental Health, Science and Medicine, Science and the Media

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The infiltration of complementary and alternative medicine (CAM) and “integrative medicine” into academia

A few years back, my co-blogger Wally Sampson wrote a now infamous editorial entitled Why the National Center for Complementary and Alternative Medicine (NCCAM) Should Be Defunded. When I first read it, I must admit, I found it to be a bit harsh and–dare I say?–even close-minded. After all, plausibility aside, I believed at the time that the only way to demonstrate once and for all in a way that everyone would have to accept that many of these “alternative” therapies were no more effective than a placebo would be to do high-quality randomized clinical trials to test whether they worked, and NCCAM seemed to be the perfect funding agency to see that this occurred. Yes, this attitude in retrospect was quite naïve, as I have since learned the hard lesson over several years that no amount of studies will convince advocates of complimentary and alternative medicine (CAM) that their favored therapy doesn’t work, be it chelation therapy for autism or cardiovascular disease, homeopathy, reiki, or various other “energy” therapies that invoke manipulation of qi as a means of “healing,” such as acupuncture, but that is what I believed at the time.
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Posted in: Basic Science, Clinical Trials, Energy Medicine, Medical Academia, Public Health, Science and Medicine, Science and the Media

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Dr. Judah Folkman (1933-2008): The epitome of what a science-based physician should be

The name of this blog is Science-Based Medicine. The reason it is so called is because we, the bloggers who will be contributing, believe that “the best method for determining which interventions and health products are safe and effective is, without question, good science.” Sadly, one of the people who best represented this very sort of philosophy, Dr. Judah Folkman (1933-2008), has died. Dr. Folkman was the epitome of everything that a science-based surgeon or physician should be, and he was first among my scientific and surgical heroes.
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Posted in: Basic Science, Medical Academia, Pharmaceuticals, Surgical Procedures

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Homeopathy and Evidence-Based Medicine: Back to the Future – Part II

Part I of this blog† summarized the origin of homeopathy, invented in 1790 by Samuel Christian Hahnemann. It discussed Hahnemann’s first two “homœopathic laws of nature,” similia similibus curantur (like cures like) and the “law of infinitesimals,” and showed that his rationales for each have long been refuted. Hahnemann proclaimed a third doctrine, the “law of psora” [“itch”], said by him to be “the mother of all true chronic diseases except the syphilitic and sycotic.”[1] Oddly, it seems to have been forgotten.

Part II gives Hahnemann the opportunity to explain his assertions more thoroughly, as is his due. It considers those assertions from the vantage point of modernity, as is ours.

“Leave None of them Uncured”

According to Hahnemann, homeopathy is a panacea:

“Now, however, in all careful trials, pure experience, the sole and infallible oracle of the healing art, teaches us that actually that medicine which, in its action on the healthy human body, has demonstrated its power of producing the greatest number of symptoms similar to those observable in the case of disease under treatment, does also, in doses of suitable potency and attenuation, rapidly, radically and permanently remove the totality of the symptoms of this morbid state, that is to say, the whole disease present, and change it into health; and that all medicines cure, without exception, those diseases whose symptoms most nearly resemble their own, and leave none of them uncured.”[2]

How might this happen?

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Posted in: Basic Science, Homeopathy, Politics and Regulation, Science and Medicine

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