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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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Posted in: Homeopathy

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Barriers To Adoption of Science-Based Medicine

I have a confession to make – it’s not easy keeping up with the other “Joneses” on this blog. My colleagues do a terrific job with thoroughly referenced analyses of key issues in medicine – and I sometimes struggle to think of topics that they haven’t already covered in more depth than I can. So today I asked my friends on Twitter if they had any suggestions for this week’s post.

One Twitter respondent asked me for my “perspective on the biggest barriers to better funding and adoption of science- based medicine.” As I contemplated that question, an experience leapt immediately to mind…

I attended a recent press conference held at a major Washington, DC think tank. An all-star cast was assembled, including Senator Baucus and Peter Orszag, to discuss the subject of comparative effectiveness research (CER). The most memorable part of the conference, however, was when one of the CER policy “experts” took the podium and actually said this (I’m going to paraphrase slightly):

The problem with science is that it’s too narrow. We’d have a lot more information to go on if we got rid of the narrow inclusion criteria in clinical trials. The exclusivity is not an irreversible flaw in the method – we just need to open up trials to larger groups of people of all kinds of different backgrounds so we can get better information.

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Posted in: Politics and Regulation

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Being Right Versus Being Influential

On May 9th I had the pleasure of lecturing to an audience of critical thinkers at the NYC Skeptics meeting. The topic of discussion was pseudoscience on the Internet – and I spent about 50 minutes talking about all the misleading health information and websites available to (and frequented by) patients. The common denominator for most of these well-intentioned but misguided efforts is a fundamental lack of understanding of the scientific method, and the myriad ways that humans can fool ourselves into perceiving a cause and effect relationship between unrelated phenomena.

But most importantly, we had the chance to touch upon a theme that has been troubling me greatly over the past couple of years: the rise in influence of those untrained in science on matters of medicine. I have been astonished by the ability of “thought leaders” like Jenny McCarthy to gain a broad platform of influence (i.e. Oprah Winfrey’s TV network) despite her obviously flawed beliefs about the pathophysiology of autism. Why is it so hard to find a medical voice of reason in mainstream media?

The answer is probably related to two issues: first, good science makes bad television, and second, physicians are going about PR and communications in the wrong way. We are taught to put emotions aside as we carefully weigh evidence to get to the bottom of things. But we are not taught to reinfuse the subject with emotion once we’ve come to an impartial consensus. Instead, we tend to bicker about statistical analyses, and alienate John Q. Public with what appears to him as academic minutiae and hair-splitting.

I’m not sure what we can or should offer in place of our “business as usual” behavior – but I’ve noticed that being right isn’t the same as being influential. I wonder how we can better advance the cause of science (for the sake of public health at a minimum) to an audience drawn more to passion than to substance?

I would really enjoy your input, dear readers of Science Based Medicine, because I’m at a loss as to what we should do next to reach people in our current culture, and with new communications platforms. What would you recommend?

Posted in: Public Health, Science and Medicine, Science and the Media

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Placebo Therapies: Are They Ethical?

Is it ethical to overstate the efficacy of a treatment option, if it might lead to a patient’s enhanced experience of that treatment? Your response to this question may reveal the degree to which you favor Complementary and Alternative Medicine (CAM). Let me explain.

As far as I can tell, no CAM treatment has been proven effective beyond placebo. (If you’re not convinced of this, I suggest you take a look at Barker Bausell’s book on the subject.) That means that treatments like acupuncture, homeopathy, Reiki, energy healing, Traditional Chinese Medicine (such as cupping), and others (like “liver flushes”) perform about as well as placebos (inert alternatives) in head-to-head studies. Therefore, the effects of these treatments cannot be explained by inherent mechanisms of action, but rather the mind’s perception of their value. In essence, the majority of CAM treatments are likely to be placebo therapies, with different levels of associated ritual.

For the sake of argument, let’s assume that CAM therapies are in fact placebos – the question then becomes, is it ethical to prescribe placebos to patients?  It seems that many U.S. physicians believe that it is not appropriate to overstate potential therapeutic benefits to patients. In fact, the AMA strictly prohibits such a practice:

“Physicians may use [a] placebo for diagnosis or treatment only if the patient is informed of and agrees to its use.”

Moreover, a recent article in the New England Journal of Medicine concludes:

“Outside the setting of clinical trials, there is no justification for the use of placebos.”

However, there is some wavering on the absolute contraindication of placebos. A recent survey conducted by researchers at the Mayo Clinic asked physicians if it was permissible to give a dextrose tablet to a non-diabetic patient with fibromyalgia if that tablet was shown to be superior to no treatment in a clinical trial. In this case 62% of respondents said that it would be acceptable to give the pill.

The authors note:

“Before 1960, administration of inert substances to promote placebo effects or to satisfy patients’ expectations of receiving a prescribed treatment was commonplace in medical practice. With the development of effective pharmaceutical interventions and the increased emphasis on informed consent, the use of placebo treatments in clinical care has been widely criticized. Prescribing a placebo, it is claimed, involves deception and therefore violates patients’ autonomy and informed consent. Advocates of placebo treatments argue that promoting the placebo effect might be one of the most effective treatments available for many chronic conditions and can be accomplished without deception.”

How do you feel about placebos? Are they a legitimate option in some cases, or a violation of patient autonomy and informed consent?
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Posted in: Medical Ethics, Science and Medicine

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

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How To Get Physicians To Use The Same Science-Based Playbook

Pretty much everyone agrees that we need to improve the quality of healthcare delivered to patients in the US. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.

However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.

There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.

I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.

Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.
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Posted in: Politics and Regulation, Public Health, Science and Medicine

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Research, Minus Science, Equals Gossip

“A person is smart. People are stupid.”

– Agent K (Tommy Lee Jones), Men In Black

Regular readers of my blog know how passionate I am about protecting the public from misleading health information. I have witnessed first-hand many well-meaning attempts to “empower consumers” with Web 2.0 tools. Unfortunately, they were designed without a clear understanding of the scientific method, basic statistics, or in some cases, common sense.

Let me first say that I desperately want my patients to be knowledgeable about their disease or condition. The quality of their self-care depends on that, and I regularly point each of them to trusted sources of health information so that they can be fully informed about all aspects of their health. Informed decisions are founded upon good information. But when the foundation is corrupt – consumer empowerment collapses like a house of cards.

There is growing support in the consumer-driven healthcare movement for a phenomenon known as “the wisdom of crowds.” The idea is that the collective input of a large number of consumers can be a driving force for change – and is a powerful avenue for the advancement of science. It was further suggested (in a recent lecture on Health 2.0), that websites that enable patients to “conduct their own clinical trials” are the bold new frontier of research. This assertion betrays a lack of understanding of basic scientific principles. In healthcare we often say, “the plural of anecdote is not data” and I would translate that to “research minus science equals gossip.” Let me give you some examples of Health 2.0 gone wild:

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Posted in: Public Health, Science and Medicine, Science and the Media

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