The Corruption of the Evidence Based Medicine System with Dr. John Abramson
Occasionally, you come across an interview or subject that blows you away with incredible claims that are both out in the open - and yet invisible. Today's guest is an author and expert witness for some of the biggest pharmaceutical cases of this century, Dr. John Abramson. He reveals the rot that centers not only in the pharmaceutical industry but also the institutions that are constructed to serve as its guardrails - the medical journals, federal agencies, and guideline committees.
What Would Physicians Say if They Knew Medical Journals Had No Access to Data for Peer Review?
The most stunning aspect of the whole conversation centered around how the most prestigious medical journals conducted peer review without all of the clinical data. This means if anything was misrepresented or omitted there is no check on the truth of the claims from the study. Essentially, the journal and its reviewers are relying on the good faith submission of all important details from the study designers who are usually paid employees or have research paid for by the pharmaceutical manufacturers.
The most famous landmark case was with Pfizer withholding adverse event data (or misclassifying them to avoid statistical significance) on cardiovascular events (heart attacks and strokes) with their medication, Vioxx. Only when Pfizer was sued in a huge class action lawsuit did the actual clinical data get revealed showing that they had seen a signal for adverse events but intentionally did not disclose it (or the raw data) to the medical journal reviewers. Worse yet, once the error was presented, the medical journals spent very little time discussing the error. According to Dr. Abramson, this is in large part because up to 40% or more of medical journal revenue comes from study reprints. This financial incentive to find positive results and publish makes for a twisted system that incentivizes the promotion of new medications and devices when they may not be safe or very useful.
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I appreciated the comments by Dr. Abramson and share his concerns about lack of good data for decision making. Vinay Prasad has similar concerns in his books, including in Malignant about cancer studies and on his podcast, https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjQ5MTEwODUzMi9zb3VuZHMucnNz/episode/dGFnOnNvdW5kY2xvdWQsMjAxMDp0cmFja3MvMTMyNjU3NTU3Mg?ep=14
I wonder if a more libertarian way of solving part of this problem is demanding journals supply this data via lack of purchases from us and then have the FDA evaluate for safety only and put the responsibility on us as physicians to use our new data access to counsel patients on best options.
Also, I was thinking about your recent episode about functional medicine. It seems like they use even less rigorous studies to justify treatment. If anyone corrupts evidence based medicine, functional medicine do as much as anyone. Sure, they potentially treat less patients overall so the impact may not be as much. However, with the amount of antibiotics and anti-fungals I see functional medicine prescribe without good data justifying their use, contributing to resistant organisms could have a huge impact on society.
Thanks for your comment. I think you’re right that Dr. Prasad offers some good perspectives too. I do feel that EBM might be oversold in some respects too but where it falls in the “truth” is hard to pin down. I’d refer you to the episode with Dr. Accad a few years ago to hear his skepticism of EBM as the be all and end all. (theparadocs.com/011)
As to functional medicine, there are certainly a lot of confounding factors involved there which makes it even harder to approach it from an EBM perspective. Ultimately, I think discovering how your body works uniquely is a lifelong challenge where you hopefully have thoughtful professionals helping you along the way.
Finally, I’m all for libertarian solutions to these problems and I always look for those people who are offering different ways of fixing them.