The history of the politics and abuse of methodology

About my post on RCT’s gold-standard reputation, below is text of an email from a reader who wishes to remain anonymous. I’m posting it not because of the compliments (I do like them, though) but because I am grateful for the final two paragraphs on the history of the politics and abuse of methodology, about which I know very little.

The comments are open for one week. Chime in if you know any relevant history. Bring the dirt! References welcome.

I think when thinking about the role RCTs have in medicine you’re dead-on when saying the conceptual simplicity is really, really important. The people who read economics journals almost all have major quant training. Doctors are supposed to understand medical journals and most of them have very little.

I’d bring up 2 related points.

The first is FDA. B/c medications must be approved with 2 pivotal trials, we’re all used to seeing RCTs regularly and seeing them as literally the government’s official imprimatur of success.

The second is marketing. In the ’90s pharma figured out how to use RCTs to their advantage. Design massive trials in highly-selected populations, don’t look hard for side effects, and don’t publish the negative trials. If p<0.05, market to everyone. Gold standard blockbuster! For example, there’s reason to worry if SSRIs help much of anyone.

The third, supporting your contention, is history. In the ’90’s there were really 3 schools fighting over how clinical data should be used in clinical practice. At Yale, Alvan Feinstein wanted a very detail-oriented, methods-based clinical epidemiology. David Eddy instead envisioned systems of care involving RCTs, decision analyses, and decision support. Finally at McMaster, Sackett, Guyatt, etc, developed a very simple view of the evidence hierarchy. McMaster won. Their success in marketing a simple approach toward clinicians with books, curricula, and doctor-focused series in JAMA was central to that.


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