Click here to read an original op-ed from the TED speaker who inspired this post and watch the TEDTalk below.
Medicine's evidence base -- our hard drive -- is corrupt, in all senses of that word.
She was 86 years old, frail, with limited income. Her aching and fever had started two days ago. Although she had gotten the flu shot like I had asked her to, this was still most likely the flu. Ads for Tamiflu came immediately to mind, but like Ben Goldacre, I knew that the published data on Tamiflu has been as cherry-picked as your weekend bounty from the farmers' market. My patient asked me: "Should I be on Tamiflu?" Should she, indeed. I don't know. Worse yet, I don't know because I don't trust the hallowed literature. I don't trust PubMed, or highly cited articles in prominent journals, or the glossy circulars in my mailbox. Sitting across from her, at that moment, I felt my desire to practice evidence-based medicine completely undercut by the systematic suppression of "unfavorable" studies. The corruption of the evidence by publication bias isn't theoretical. It's there every day in our clinics and bedsides, affecting every patient and every doctor, breeding cynicism and distrust.
It turned out that her insurance didn't cover Tamiflu, and she didn't have the money for it anyways.
Ben Goldacre calls out this research fraud and calls for a radical transparency: "publish all trials in humans, including older trials, for all drugs in current use." I cannot be against that, but I won't be holding my breath. There are too many entrenched interests that will fight hard, and have, to limit disclosure. I had a front row seat to the grueling negotiations that established a global policy for trial registration when I led the World Health Organization's International Clinical Trials Registry Platform project. Much as there were questionable interests from some quarters, the reality is that the current system is a creation of many players: authors, journals, pharmaceutical and device companies, regulators, the press that feeds on new positive studies, academic medicine promotion practices, clinicians who enjoy lucrative endorsement fees. Responsibility is diffuse. Change will be hard.
Yet we must rebuild the scientific foundation for modern medicine. When your hard drive has crashed and is corrupt, you will try to recover your data -- in this case, we want both the positive and the negative results of past trials. All well and good, but you wouldn't continue using that hard drive, would you? It's time to reformat our clinical research system.
First, let's consider if the studies that are being conducted are the ones we really need. About 80 percent of clinical trials are funded by the commercial sector, but the commercial sector disproportionately studies drugs, and understudies behavioral treatments or older treatments that can't be patented or profited from. When 75 percent of our medical costs are for chronic diseases that are largely due to poor lifestyle habits, where are the studies on prevention? On behavior? On effective patient-doctor or public health strategies? Where are the studies that examine the balance of benefits and harms, that guide patients and doctors on side effects and cost-effectiveness? These non-commercial studies are critical for evidence-based medicine and will need to be funded from public and non-profit sources. The relatively new Patient-Centered Outcomes Research Institute (PCORI) starts to address these evidence needs, but the National Institutes of Health, with a budget almost 100 times the size of PCORI's, also needs to step up to the plate and balance its research portfolio with more patient-centered research.
We need to stop doing bad studies. -- Ida Sim, M.D., Ph.D.
Second, there's a dirty secret about clinical trials. Many published studies are so poorly designed and poorly reported that their findings are suspect. Look at systematic reviews, which are scientific summaries of the research literature (e.g., from the Cochrane Collaboration), and see how many studies need to be sifted out to net a sometimes stunningly small number of high quality studies, even on major clinical questions. We need to stop doing bad studies.
Finally, when patients sign up for clinical trials, they take on risks and discomfort to help generate knowledge that benefits the rest of us. This is the ethical compact on human trials, as stated in the Declaration of Helsinki. Clinical trial results are a public good, and should be shared as "big data" in a new era of open science.
This is how I envision a reformatted clinical research system. New drugs, devices, or behavioral interventions are developed by commercial or non-commercial innovators. Public funding is used to test these interventions using appropriately rigorous study designs. Patients and clinicians are involved in making sure that the studies ask and answer relevant questions. Mobile technology is used to embed clinical research into our daily lived experience of health and disease, to generate large-scale, useful, and relevant evidence. And through open source approaches to data integration (e.g., Open mHealth), these relevant, publicly-funded, patient-centered, large-scale, fully reported study results can be pulled together so that I can face my patient and tell her, without cynicism or distrust, just exactly what treatment is best for her.
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