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Time for a Drug Test Registry
Marcia Angell, Washington Post, 8-13-04

It's hard to decide exactly where to disagree with Marcia Angell. On the one hand, she has a point: a national drug registry would help to disseminate useful clinical information and serve as a valuable research tool for physicians in their quest to give their patients the best medications possible.

On the other hand, she completely glosses over the fact that the clinical trial model she pillories relentlessly is not the brainchild of the pharmaceutical industry – it's been mandated by the FDA for decades. Her criticisms of large placebo-controlled clinical studies echo many of the same complaints from industry.

Everyone recognizes that these trials are a poor standard for vetting new medicines. Patients in these trials are too homogenous, the trials themselves are ridiculously expensive, and they don't mirror what physicians do in actual clinical practice. Overall, they don’t really tell us much about how drugs interact with patient health in the real world.

Pharmaceutical companies and the FDA are laboring intensely to come up with a better model for drug development: one that is faster, cheaper, and more accurate. But until we get there, blaming for the industry for clinical trial design is a bit like shooting the messenger because you don’t like what he told you.

Until we reach the point where we can perfectly predict in advance how a drug compound will interact with every individual's genotype – that is to say, never – drug development is going to be two parts science and one part luck. If Angell thinks that she has discovered an infallible, low-cost process for creating safe innovative drugs she ought to let us know – or better yet, patent it first, because then we can all benefit from her discovery.

Project FDA.
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