Evidence-based Backlash: The Xigris eXample
Rich Savel, has a wonderful editorial in this month's issue of the American Journal of Critical Care (AJCC) discussing the importance and dangers of evidence-based medicine as currently practiced. He and co-author Cindy Munro use the rise and fall of Drotrecogin Alfa (Xigris, activated protein C) as an example for what can go wrong and why.
Their key conclusions:
1) "Though the results of a single, large RCT are important, they clearly are not sufficient for future agents to be rapidly integrated into national guidelines or consensus statements."
2) "Another important lesson is that pharmaceutical companies should stay as far removed as possible from development of guidelines promulgated by national medical societies. One of the most important things such a society has is its reputation, which it must be careful not to tarnish. Although this can often be a great challenge, it has become quite clear from the controversies surrounding APC that the relationship between pharmaceutical corporations on the one hand and academia and national medical societies on the other should be kept distinct and transparent."
3) and finally - “... the single most important lesson from the rise and fall of APC is that we should maintain skepticism: maintain it until the trial can be reproduced; maintain it in the face of trusted medical societies integrating recommendations for agents before sufficient evidence is presented; and maintain it until all potential conflicts of interest have been shared. EBM is not merely one way to practice; it is the only way. In addition to understanding all of the dynamic complexities and nuances of EBM, we must develop a healthy skepticism toward new research results and apply that approach liberally as the scientific method does its important job of confirming the validity of those results."
Full Disclosure: Rich and I were residents at NYH-Cornell back in the 1990s and we were also co-Assistant Chief Residents at Memorial Sloan Kettering under Kent Sepkowitz. Rich has gone on to great things as co-editor of the AJCC and medical directorship of the surgical intensive care unit at Montefiore Medical Center, Albert Einstein College of Medicine in NYC. Rich is also the editor and founder of the SCCM iCritical Care Podcast - which rocks.
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| Rich Savel in the center |
1) "Though the results of a single, large RCT are important, they clearly are not sufficient for future agents to be rapidly integrated into national guidelines or consensus statements."
2) "Another important lesson is that pharmaceutical companies should stay as far removed as possible from development of guidelines promulgated by national medical societies. One of the most important things such a society has is its reputation, which it must be careful not to tarnish. Although this can often be a great challenge, it has become quite clear from the controversies surrounding APC that the relationship between pharmaceutical corporations on the one hand and academia and national medical societies on the other should be kept distinct and transparent."
3) and finally - “... the single most important lesson from the rise and fall of APC is that we should maintain skepticism: maintain it until the trial can be reproduced; maintain it in the face of trusted medical societies integrating recommendations for agents before sufficient evidence is presented; and maintain it until all potential conflicts of interest have been shared. EBM is not merely one way to practice; it is the only way. In addition to understanding all of the dynamic complexities and nuances of EBM, we must develop a healthy skepticism toward new research results and apply that approach liberally as the scientific method does its important job of confirming the validity of those results."
Full Disclosure: Rich and I were residents at NYH-Cornell back in the 1990s and we were also co-Assistant Chief Residents at Memorial Sloan Kettering under Kent Sepkowitz. Rich has gone on to great things as co-editor of the AJCC and medical directorship of the surgical intensive care unit at Montefiore Medical Center, Albert Einstein College of Medicine in NYC. Rich is also the editor and founder of the SCCM iCritical Care Podcast - which rocks.
Thank you for posting this. It is an honor to be on your blog.
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