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When impressive science fails to impress patients

One of the greatest challenges in medicine can sometimes be to convince patients that the results of scientific and medical research apply to them, or, at the very least, to explain how such results apply. One of the reasons that medicine based not on science or evidence fluorishes is because it can be so hard to explain to patients why a particular intervention is viewed as effective. My co-blogger Steve Novella wrote about some of the fallibilities of human perception that lead to perceiving correlations and treatment effectiveness where there are none. R. Robert Bausell wrote about the same thing in his recent book Snake Oil Science. While it is undoubtedly true that people tend to pay more attention to anecdotes than to studies and statistics, there is also another reason why doctors often have problems convincing patients of the value of health interventions, and that’s the difference in perception and how we value different kinds of evidence.

A couple of years ago, I came across an article that explains this gulf between how those of us trying to practice science- and evidence-based medicine perceive the world and how most human beings not trained in medicine or science perceive it. The article, which was published in 2006 in the New York Times and written by Dr. Abigail Zuker, proposed one reason why this might be, beginning with a discussion with her mother in which she tries to convince her of the benefit of exercise, even in the elderly, a concept that her mother would have none of and dismissed contemptuously:

“Studies,” she says, dripping scorn. “Don’t give me studies. Look at Tee. Look at all the exercise she did. She never stopped exercising. Look what happened to her.”

End of discussion. Tee, her old friend and contemporary, took physical fitness seriously, and wound up bedbound in a nursing home, felled by osteoporosis and strokes, while my mother, who has not broken a sweat in the last 60 years, still totters around on ever-thinning pins. So much for exercise. So much for studies. So much for modern clinical medicine, based on the randomized allocation of treatment and placebo. All that beautiful science, stymied by the single, incontrovertible, inescapable image of Tee, the one who exercised but grew hunched and crippled anyway.

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Posted in: Clinical Trials, Public Health, Science and Medicine

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Where Are We Going?

Where is it all headed? Medicine on another threshold. Allow me to present several previously unconnected news articles that illuminate the serious problem we face in today’s increasingly scientifically rootless world.

Who are scientific medicine’s friends; on whom can we rely for support of reason and common sense, unbiased approaches to funding, unbiased efficacy evaluation, fair law enforcement, and a return to the logical world of decades ago? The private insurance industry is taking it in the gut, while Pharma receives the repeated jabs. Corrupt administrations run off with hundreds of millions, inadequately punished for the degree of misbehavior. Academicians, no longer squeaky clean, unwilling to keep house on big-money grant recipients while tolerating massive private consulting fees. Schools infiltrated by mindless relativism satisfy the lowest academic levels despite the revolutionary changes in biology and massive knowledge base new MDs have to apply.

Just in 2 weeks a number of seemingly unrelated developments in the news got one to thinkin’, …there aren’t any to trust anymore. The government agencies are just as bad. Start with the FDA. Steve Barrett’s Consumer Health Digest Quackwatch.com has been trying to reassess the status of one or more quackery proponents and practitioners. One of his routes is the examination of FDA records of enforcement and warning letters to violators. From CHD of 3/11/08:

FDA “hides” old warning letters. The FDA Web site has made several changes that greatly decrease the visibility of warning letters about products and safety violations. Letters issued before January 2007 have been moved into a new directory so that all incoming links to them from other sites have been broken. This directory is also coded so that search engines cannot index its contents. Searching for warning letters on the FDA site is difficult because (a) the newer and older letters have to be searched separately, (b) the search page for pre-2007 pages in not easy to find. (c) letters are moved to the archive folder at irregular intervals, and (d) many of the older letters are in PDF format, which means that they will be found only if the searcher uses specific keywords. The agency as become extremely slow in responding to Freedom of Information Act requests. In August 2005, Dr. Barrett asked for a document related to a warning letter. If one exists, finding it would take only a few minutes. Barrett’s Congressman has asked twice for the document, and FDA staff members have phoned Barrett four times during the past year to find out whether he still wants it. But it still has not come. Bloomberg News has reported that in May 2007, the agency had 20,365 unfilled requests, including 1,924 that were more than three years old and that the the number of workers filling requests has been cut even though the backlog had been steadily rising. [Blum J. (more…)

Posted in: Politics and Regulation, Science and Medicine, Vaccines

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The ultimate in “integrative medicine”: Integrating the unscientific into the medical school curriculum

For the second week in a row I find myself throwing out the original post that I had planned on doing in favor of a different topic. The reason this week is, quite simply, having read Dr. Atwood’s excellent two part post Misleading Language: The Common Currency of “CAM” Characterizations (Part I; Part II). I don’t at this time intend to expand on what Dr. Atwood said, although I may do so at one future time. What caught my attention in his lengthy deconstruction was his segment on the “woo-ification” of health care, which very much echoed my post a while back in which I lamented the creeping infiltration of non-science-based modalities into academic medical centers, as well as the credulous teaching of such modalities in medical schools. What I wanted to explore was just how far this might go and what the end result might be. It turns out that we are already witnessing an experiment in just such a thing.

About a year and a half ago, I first became aware of just how far this infiltration of unscientific “medicine” has infiltrated academia when I saw this brochure published by the Georgetown University School of Medicine. If you’re scientifically inclined, as I am, it ought to make you shudder. Reading this brochure, I truly have to worry whether woo really is the future of American medicine, as has been suggested in some quarters. Certainly, if other medical schools start following Georgetown’s lead, it will be. Not content to offer so-called complementary and alternative medicine (“CAM”) modalities as part of electives that interested students can take if they are so inclined, Georgetown is taking the next logical step that I feared: It’s dedicating significant educational resources and time to teaching “CAM” in its mandatory general medical curriculum, where every student has to learn it:
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Posted in: Medical Academia, Science and Medicine

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Misleading Language: the Common Currency of “CAM” Characterizations Part II

Background

I promised readers the “Advanced Course” for this week, which undoubtedly has you shaking in your boots. Fear not: you’ve already had a taste of advanced, subtle, misleading “CAM” language, and most of you probably “got” it. That was R. Barker Bausell’s analysis of how homeopathy is “hypothesized to work.” In the interest of civility, let me reiterate that I don’t think of Bausell as a horrible person or an ignorant boor for having written that statement. Rather, I think of him as having been so steeped in the de rigueur “CAM” language distortions of the 1990s that he is largely unaware of their insidious power. I suspect too that he, like most of us who grew up when schools no longer stressed the rigors of English composition, has an underdeveloped sense of the relation between the craft of writing and the integrity of its content. That doesn’t excuse him from writing honest prose, of course.

Last week’s post cited blatant language distortions of “CAM”—euphemisms, slogans, and outright falsehoods—and some that were more subtle: question-begging, misrepresentation, and derogation. It would require a semester’s worth of seminars to delve into the overlapping categories of misleading “CAM” language, but here we can consider a few. Then, perhaps, we’ll engage in an amusing diversion—more about that at the end of this post. (more…)

Posted in: Medical Academia, Medical Ethics, Science and Medicine

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Persistence of Memory

I have steadily endeavored to keep my mind free so as to give up any hypothesis, however much beloved (and I cannot resist forming one on every subject), as soon as the facts are shown to be opposed to it.
— Charles R. Darwin

I’m getting old: 50, almost 51, and that’s over 350 in dog years. As a result of my advancing age there are things I do not get: tattoo’s, hip hop, visible undergarments, and those rectangular, square plastic glasses that seem so popular and look hideous on everyone. It gets harder to change.

I have been able to stick MD after my name for almost a quarter century now (175 dog years for those keeping track), and it does give a sense of perspective to the ebb and flow of medical therapies. Medicine for the last hundred years has been all about change. Dogma from last century is nonsense this century, all due to that damn science. It gets so tiresome having to learn something new.

Last month’s New England Journal of Medicine was another in a seemingly endless series of plus ça change, plus c’est la même chose moments.4 They published the results of the CORTICUS study, a trial that looked at Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration, was conducted by Irving Kirsch and colleagues, who reviewed clinical trials of six antidepressants (fluoxetine, venlafaxine, nefazodone, paroxetine, sertraline, and citalopram). They looked at all studies submitted to the FDA prior to approval, whether published or unpublished. They found:

Drug–placebo differences in antidepressant efficacy increase as a function of baseline severity, but are relatively small even for severely depressed patients. The relationship between initial severity and antidepressant efficacy is attributable to decreased responsiveness to placebo among very severely depressed patients, rather than to increased responsiveness to medication.

The press has largely reported this study as showing that “antidepressants don’t work” but the full story is more complex. This analysis certainly has important implications for how we should view the body of evidence for these antidepressants. It also illuminates the possible role of publication bias in the body of scientific literature – something that has far ranging implications for science-based medicine.

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Posted in: Clinical Trials, Neuroscience/Mental Health, Pharmaceuticals, Science and Medicine

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The Hannah Poling case and the rebranding of autism by antivaccinationists as a mitochondrial disorder

Regular readers of this blog may have noticed that I seem to have taken on the role of the primary vaccine blogger of this little group of bloggers trying desperately to hold the forces of pseudoscience and magical thinking at bay in the face of powerful forces trying to “integrate” prescientific belief systems with science- and evidence-based medicine, a process that would be unthinkable in just about any other field of applied science, such as aeronautics or the physics used in engineering, just as creationists try to “integrate” religion with biology. Although I do have a strong interest in the antivaccination movement in general and the claim that vaccines, or the mercury in the thimerosal preservatives that was in many childhood vaccines in the U.S. until late 2001 or early 2002 (when they were taken out) are a major cause or contributor to autism, such had not been my intention. When I started here on SBM, I had intended to be a lot more diverse. Indeed, I had even had another topic entirely in mind for this week’s post, but, as happens far too often, news events have overtaken me in the form of a story that was widely reported at the end of last week. It was all over the media on Thursday evening and Friday, showing up on CNN, Larry King Live, the New York Times, and NPR. It happens to be the story of a girl from Georgia named Hannah Poling whose case before the Vaccine Injury Compensation Program (VICP), which had originally part of a much larger proceeding known as the Autism Omnibus in which nearly 5,000 parents are petitioning the VICP for compensation based on the claim that their children’s autism were caused by vaccines, was settled by the government. This settlement was based on the observation that Poling had a rare genetic mitochondrial disease that may have been exacerbated by a series of vaccines that she had, after which, among many other problems, Hannah regressed and developed some autism-like symptoms and then months later a seizure disorder. Instantly, it was being trumpeted all over the Internet, blogosphere, and media that the government had “admitted” that vaccines cause autism. One particularly excitable antivaccinationist named Kent Heckenlively (whom we’ve met before), even went so far as to foreshadow the propaganda blitz that was to come as he wrote on the antivaccine blog Age of Autism a full week before this news blitz began:

It’s official.  The sky has fallen.  The fat lady has sung.  Pigs are flying.

[...]

In a settlement, the settling party tries to admit as little as possible.  It’s like what I imagine the settlement claim against Bill Clinton in the Paula Jones case must look like.  Nowhere in the document does he admit to dropping his pants in a hotel room and asking her to kiss it.  It likely says something along the lines of he concedes they were in a hotel room together, they were alone, and something happened which formed the basis of her law suit.

But we all know what happened there.  And we know what this settlement means.

The government just dropped its pants.

One thing this shows us is just how the blogosphere can be bubbling with information that lets one predict a public relations blitz like this. The mainstream press seemed to have been totally blindsided by this story, but if reporters had only been checking the right blogs, they would have known about it a full week before, if not longer. In any case, since Thursday, there has been a very well orchestrated public relations campaign to frame this settlement as the government “admitting” that vaccines cause autism. It’s not, as I will try to explain, but framing it that ways has thus far been a very effective PR strategy for antivaccinationists. In my nearly three years of following this topic, I thought that I had never seen anything like it before.

But I had.

This case is nothing more than a demonstration that everything old is new again and that, no matter what the science says, it’s always all about the vaccines, the claims of antivaccinationists otherwise notwithstanding, as I will now show. What we are seeing now, as we did a few years ago, is the rebranding of autism as a condition in order to serve the purposes of the antivaccination movement.
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Posted in: Public Health, Science and Medicine, Science and the Media, Vaccines

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RCT Plausibility Scale

RCT Plausibility Scale

After a few intro paragraphs, I want to present a scale of probability to estimate a value of a “prior” to plug into the formula for obtaining a Bayes Factor. The scale can help to estimate a value, but will still rely on an estimate, the non-quantitative element in Bayesian simulations. However, the checklist may at least provide some objective bases on which to hang a value, and that value would actually make a semi-quantitative statement of its own. Although that value would retain some subjective quality, it would at least be backed by known quantities and laws of nature.

Begging your patience again, I became aware of this problem in 1999 when asked to moderate an online (BioMednet.com) debate on “CAM” among 4 physicians. My role soon morphed into participant-debater when I could not get all to agree on what I thought was obvious common ground to proceed with the discussion – that 1) concepts that violate scientific laws do not have to be subjected to clinical trial (RCT) and that trial results had to be interpreted in light of previous knowledge; and 2) clinical trials could not constitute adequate evidence in the absence of plausibility because their results were too varied and inconsistent. The matter was p-recipitated by systematic reviews (SRs) showing efficacy of acupuncture in back pain. I was truly surprised when one of the participants (Dr. Edzard Ernst) assured me that indeed, RCTs were now the gold standard for efficacy. The debate went downhill from there.

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Posted in: Clinical Trials, Science and Medicine

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Science-Based Nutrition

One of the most successful propaganda campaigns within health care in the last few decades has been the re-branding of nutrition as “alternative” or out of the mainstream of scientific medicine. I have marveled at how successful this campaign has been, despite all the historical evidence to the contrary. I suppose this is partly a manifestation of the public’s short-term memory, but it also seems to reflect basic psychology.

Some History

There is evidence that most ancient cultures recognized the importance of diet in health. The Greeks recognized both the benefits of a varied diet and the negative health consequences of obesity, for example. But knowledge of nutrition was limited to these broad observations and was mixed with superstition and cultural beliefs.

The science of nutrition probably dates back to 1614 when scurvy (the disease that results from vitamin C deficiency) was first recognized as a dietary deficiency, one that could be cured by eating fresh fruits and vegetables. In 1747 Lind conducted what might be the first clinical trial – systematically comparing various diets for the treatment of scurvy and finding that citrus fruits were the key to treatment.

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Posted in: Herbs & Supplements, Nutrition, Public Health, Science and Medicine

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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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