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Posts Tagged science based medicine

Spreading the Word

Lest some of our readers imagine that the authors of this blog are mere armchair opinion-spouters and keyboard-tappers for one little blog, I’d like to point out some of the other things we do to spread the word about science and reason. Steven Novella’s new course about medical myths for “The Great Courses” of The Teaching Company is a prime example: more about that later.

First, some examples of the kinds of things we have been doing: (more…)

Posted in: Book & movie reviews

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Supreme Court Saves Nation’s Immunization Program

The Supreme Court of the United States made a ruling the other day that has profound implications for the health of millions of children. Since October 12, 2010, The Court has been quietly deliberating the case of Bruesewitz v. Wyeth, inc. The case centers on Russell and Robalee Bruesewitz’s allegation that their 18 year old daughter, Hannah, was irreversibly injured by a DTP vaccine she received when she was 6 months old. What is important about this case is not the allegation itself (I will discuss its merits, or lack thereof, in a moment), but the ramifications the ruling has for the future of childhood immunization in this country. The Supreme Court’s ruling against the Bruesewitz’s and in favor of the U.S. vaccination program was the right one, and safeguards our children from the irrationality of the anti-vaccine movement. Some important background is necessary here to understand why this is so.

Prior to the development of effective vaccines, diphtheria, tetanus, and pertussis were common diseases, terrifyingly familiar to all parents. Death records from Massachusetts during the latter half of the 1800’s indicate that diphtheria caused 3-10% of all deaths. In the first part of the 20th century, these dreaded organisms still caused illness in hundreds of thousands of people each year in the United States. These are devastating diseases which, if not resulting in death, often produced severe and permanent damage to those afflicted. In the 1920’s, vaccines against each of these scourges were finally developed, and in the mid 1940’s the combined DTP vaccine was introduced. The vaccines were so effective that cases of these deadly infections were practically eliminated. Today, few parents know the terror once routinely wrought by these pathogens.

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Posted in: Legal, Science and Medicine, Vaccines

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Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

Review

This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”

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Posted in: Chiropractic, Clinical Trials, Energy Medicine, Health Fraud, History, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

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Lies, damned lies, and…science-based medicine?

I realize that in the question-and-answer session after my talk at the Lorne Trottier Public Science Symposium a week ago I suggested in response to a man named Leon Maliniak, who monopolized the first part of what was already a too-brief Q&A session by expounding on the supposed genius of Royal Rife, that I would be doing a post about the Rife Machine soon. And so I probably will; such a post is long overdue at this blog, and I’m surprised that no one’s done one after nearly three years. However, as I arrived back home in the Detroit area Tuesday evening, I was greeted by an article that, I believe, requires a timely response. (No, it wasn’t this article, although responding to it might be amusing even though it’s a rant against me based on a post that is two and a half years old.) Rather, this time around, the article is in the most recent issue of The Atlantic and on the surface appears to be yet another indictment of science-based medicine, this time in the form of a hagiography of Greek researcher John Ioannidis. The article, trumpeted by Tara Parker-Pope, comes under the heading of “Brave Thinkers” and is entitled Lies, Damned Lies, and Medical Science. It is being promoted in news stories like this, where the story is spun as indicating that medical science is so flawed that even the cell-phone cancer data can’t be trusted:

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Let me mention two things before I delve into the meat of the article. First, these days I’m not nearly as enamored of The Atlantic as I used to be. I was a long-time subscriber (at least 20 years) until last fall, when The Atlantic published an article so egregiously bad on the H1N1 vaccine that our very own Mark Crislip decided to annotate it in his own inimitable fashion. That article was so awful that I decided not to renew my subscription; it is to my shame that I didn’t find the time to write a letter to The Atlantic explaining why. Fortunately, this article isn’t as bad (it’s a mixed bag, actually, making some good points and then undermining some of them by overreaching), although it does lay on the praise for Ioannidis and the attacks on SBM a bit thick. Be that as it may, clearly The Atlantic has developed a penchant for “brave maverick doctors” and using them to cast doubt on science-based medicine. Second, I actually happen to love John Ioannidis’ work, so much so that I’ve written about it at least twice over the last three years, including The life cycle of translational research and Does popularity lead to unreliability in scientific research?, where I introduced the topic using Ioannidis’ work. Indeed, I find nothing at all threatening to me as an advocate of science-based medicine in Ioannidis’ two most famous papers, Contradicted and Initially Stronger Effects in Highly Cited Clinical Research and Why Most Published Research Findings Are False. The conclusions of these papers to me are akin to concluding that water is wet and everybody dies. It is, however, quite good that Ioannidis is there to spell out these difficulties with SBM, because he tries to keep us honest.
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Posted in: Clinical Trials, Science and Medicine

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Dr. Amy Tuteur has decided to leave Science-Based Medicine

The editors and crew at SBM have an announcement that needs to be made. This morning, Dr. Amy Tuteur tendered her resignation and will therefore no longer be a blogger at SBM. Some of you might already be aware of this development because Dr. Tuteur has already announced her decision on her own blog. That is why we considered it important to post an announcement here on SBM as soon as possible.

While we are sorry to see Dr. Tuteur go and wish her well in whatever future endeavors she decides to pursue, over the last several weeks it had become clear to both the editors of SBM and Dr. Tuteur herself that, although Dr. Tuteur had routinely been able to stimulate an unprecedented level of discussion regarding the issues we at SBM consider important, SBM has not been a good fit for her and she has not been a good fit for SBM. Over the last few days mutual efforts between the editors and Dr. Tuteur to resolve our differences came to an impasse. Unfortunately for all parties, that impasse appeared to be unresolvable and resulted in Dr. Tuteur’s decision to leave SBM.

As a result of Dr. Tuteur’s departure, we will be adjusting the posting schedule in order to cover her normal Thursday slot. Final decisions have not been made yet, but we expect that every weekday will continue to be covered, with at least one post per weekday. 

Posted in: Announcements

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Be careful what you wish for, Dr. Dossey, you just might get it

If there’s one thing about the so-called “complementary and alternative medicine” (CAM) movement that I’ve emphasized time and time again, it’s that its adherents have a definite love-hate relationship with science. They hate it because it is the single greatest threat to their beliefs system and the pseudoscience that underlies it. At the same time, they crave the legitimacy that science confers. They crave it not because they have any great love for science. Quite the contrary. It is simply that they recognize that science actually delivers the goods. Of course, they believe that they deliver the goods too, but they come to this belief not through science but rather through all the cognitive shortcomings and biases to which humans are prone, such as confusing correlation with causation, confirmation bias, not recognizing regression to the mean, and being fooled by the placebo effect. Whether it’s through a misunderstanding of science or less innocent reasons, they go to great lengths to torture it into superficially appearing to support their claims through a combination of cherry-picking of studies that seem to support them and misrepresenting ones that don’t, discussions of which abound right here in this very blog.

The other thing I’ve emphasized about the CAM movement is that, even more than scientific credibility, they crave legitimacy. To them, however, science is but one pathway to legitimacy, because, unlike practitioners of science-based medicine, they are more than willing to bypass science to obtain the legitimacy–or at least the appearance of the legitimacy–they so crave. If it means doing an end run around science by trying to hijack the Obama health insurance reform bill that is currently being negotiated to resolve the differences between the Senate and House versions, so be it. Indeed, earlier this year, I described how Senator Tom Harkin has tried to promote CAM through the National Center for Complementary and Alternative Medicine (NCCAM) and trying to insert provisions into the bill that would mandate that government-subsidized insurance exchanges pay for CAM. Meanwhile, prominent CAM advocates have been carpet-bombing the media with dubious arguments in support of CAM, as in when Deepak Chopra, Rustum Roy, Dean Ornish, and Andrew Weil teamed up in different combinations to promote the idea that CAM is all about “prevention” and that science-based medicine, in all its reductionistic evil, is nothing more than pushing pills.

They’re at it again.
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Posted in: Energy Medicine, Herbs & Supplements, Homeopathy, Medical Academia, Neuroscience/Mental Health, Politics and Regulation

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Conflicts of interest in science-based medicine

The topic of conflicts of interest among medical researchers has recently bubbled up to the public consciousness more than usual. The catalyst for this most recent round of criticism by the press and navel-gazing by researchers is the investigation of Senator Charles Grassley (R-IA) of nine psychiatric researchers, one of which held $6 million in stock in a company formed to bring a drug for depression to market, but had allegedly concealed this, even though he was an investigator on an NIH grant to study the drug he was developing. From my perspective, there is more than a little politics going on in this story, given that for the last decade federal law, specifically the Bayh-Dole Act, and policy have actually encouraged investigators and universities to co-develop drugs and treatments with industry, but it does bring into focus the issue of conflicts of interest, in particular undisclosed conflicts of interest. There are two articles of note that recently appeared in the scientific literature discussing this issue, one in Science in July (about the Grassley investigation) and an editorial in the Journal of Psychiatry and Neuroscience by Simon N. Young, PhD, the Co-Editor-in-Chief of the journal and faculty at McGill University. I was more interested in the latter article because it takes a much braoder view of the issue. Science-based medicine (SBM) depends upon the integrity of the science being done to justify treatments; so it’s useful to discuss how conflicts of interest intersect medical research.

In most public discussions of conflicts of interest (COIs), Young notes, the primary focus is on payments by pharmaceutical companies to investigators. Make no mistake, this is a big issue, but COIs are not just payments from drug companies. Indeed, I’ve written about just such COIs that have arguably impacted patient care negatively right her on this very blog, for example seeding trials (in which clinical trials are designed by the marketing division of pharmaceutical companies), a case of fraud that appeared to have been motivated by COIs. What needs to be understood is that every single scientific and medical investigators have COIs of one sort or another, and many are not financial. That’s why I like Young’s introduction to what COIs are:
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Posted in: Clinical Trials, Medical Academia, Politics and Regulation, Vaccines

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An open letter to Dr. J. Douglas Bremner

Peter Lipson wrote a post last week entitled Before You Trust That Blog…, which was a criticism of Dr. J. Douglas Bremner’s blog Before You Take That Pill. Dr. Bremner was not pleased, and posted a rebuttal entitled Response to Peter Lipson MD of “Science” Based Blogs, My Blog Does Not Suck, Yours Does. Given the kerfuffle and my role as managing editor of SBM, I felt the need to put my two cents in, which is why I’m posting this open letter to Dr. Bremner. This letter started as a much briefer response that I was going to e-mail to Dr. Bremner, but as I wrote it grew and grew to the point where I decided that, given the public nature of the disagreement between Dr. Lipson and Dr. Bremner, I might as well make my commentary public too. Consider it a bonus post from me. I still plan a post for my usual slot on Monday. In the meantime, here’s my open letter:
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Posted in: Medical Academia, Pharmaceuticals, Public Health, Science and the Media, Vaccines

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SBM in primary practice: one student’s experience

EDITOR’S NOTE: Dr. Jones is off this week; fortunately, we have this guest post by Tim Kreider, our science-based medical student. Enjoy!

My first clerkship of my third year of medical school was Family Medicine, and I had a great experience. After the first two years spent mostly with books and then a three-year interlude in a basic science lab, these past five weeks were my first extended foray into the world of patient care. I had a few lectures and seminars on campus, but most days were spent in a primary care office learning on the job. I was assigned to an office attached to a community hospital with a Family Medicine residency program, so I was able to work with both attending physicians and residents in training. I learned a lot and gained some much needed confidence regarding my clinical exam skills, which were rather rusty after grad school.

I have heard as a criticism of the SBM mission that practicing medicine “in the real world” is different from what evidence-obsessed, ivory tower dwellers think it should be. Therefore I approached my Family Medicine clerkship as my first chance to see the challenges and realities of practice outside the university setting. How would the practice of community-based physicians compare to the perhaps lofty ideals espoused by academics? (more…)

Posted in: Medical Academia, Science and Medicine

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Science-Based Medicine 101: Plausibility

In part 2 of the Science-Based Medicine 101 series we take a look at the second pillar of good science: plausibility. This blog post was written for a lay audience so more advanced readers will need to indulge me here…

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I really enjoy sci-fi action movies. I love the convincing special effects and the fact that heroes can accomplish the physically impossible without skipping a beat. Implausible events unfurl with convincing reality, and you never know what might happen with the plot.

I also enjoy the TV show, America’s Funniest Home Videos, for different reasons. The mundane nature of actual reality, and the often predictable, but hilarious mistakes made by those I relate to result in some pretty hearty laughs.

But there is a big difference between these two forms of entertainment: science-fiction requires the suspension of belief in plausibility, while home videos are based on plausible outcomes. When it comes to medical research, though, plausibility can mean the difference between science fiction and reality.

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