In the comments, Bruce Charlton writes:
The failure to fund trials is combined with a suffocating dominance of the perspective of self-styled ’evidence-based medicine’ (EBM) – including the groundless notion that only mega-trails should be taken seriously. . . Since the vast majority of randomized trials are industry funded, EBM has meant that industry has a de facto monopoly on ’reputable’ therapeutic knowledge.
Delivering us into the hands of Big Pharma was not – of course – intended by the socialistic founders of EBM, but it has happened nonetheless.
This reminds me of something one of my students said. We were discussing male/female differences — in particular, the observation that women are more religious than men. One student said that in her experience, guys were either not religious at all or very religious.
I agree with her. I think this is why EBM has the form it does. Its male founders — not understanding the tendency that my student pointed out — went from one extreme (medical orthodoxy, unrelated to evidence) to another (evidence-based medicine). Reliance on evidence is a good idea, yes, but the founders of EBM couldn’t help making it resemble a religion. You might think that relying on evidence is the opposite of religion but they made the whole thing as religious as possible. EBM became just another way — just another excuse, really — to sneer at people.
Seth, why don’t you just do a clinical trial of shangri-la and get over with it?
Because they’re extremely difficult.
So you just need to find a big corporation that stands to profit from the results of the experiment…oh, wait, never mind.
A problem with Evidence-Based Medicine is that the evidence is often corrupted by being based on bad science or bad regulation — making EBM potentially worse than the alternatives. It has the credibility of “evidence” but that evidence can actually be wrong, misguiding the public and policy makers.
Apparently the FDA approval process only requires drug companies to submit a certain number and type of studies, and in the case of SSRIs this has meant that if they do a study showing a lack of efficacy of their tested product they don’t have to submit that result for consideration. They can ignore ten negative results, as long as the submitted studies suggest efficact.
Similarly, if they are in the midst of a study whose outcome is likely to suggest the product doesn’t work, they can abort the study.
So what quality of “evidence” are we really getting?
It isn’t that EBM is a bad principle, it is that the standards for evidence are so distorted by systemic institutional inefficiencies and moral hazards.
It really depends how you define evidence. With EBM if the patient feels better that doesn’t count unless you can measure it, but there are no valid objective measures of “better”. If your evidence is from a mega trial that shows statistically significant improvement, as it will with a big enough cohort, but is not clinically significant what good is it? But from EBM viewpoint it’s a goer.
The emperor really has no clothes!