Back in 2012, Nature took note of the stagnation of pharmaceutical innovation: "The number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms."
The authors called this phenomenon "Eroom's Law," as an ironic gallows humor tribute to Moore's Law that applies to rapid, logarythmic tech evolution.
They rightly put much of the onus on the Kefauver Amendment of 1962, which mandated that the Food and Drug Administration study "efficacy," as well as "safety" in its examination of new drugs. Safety is easy enough to test for, efficacy is not. Efficacy is an endless swamp of unknown unknowns.
If personalized medicine means anything, it means that a drug that might work for Smith might not work for Jones, and vice versa. And yet these questions are beyond the ken of the FDA. As the above chart shows, there's been no improvement since 2012.
The chart shows that from 1953 to 2023, the real GDP of he U.S. rose 707 percent.. And yet during that same seven-decade span, the number of new drug approvals by the FDA fell 87 percent.
Reversing the FDA's dead hand through legislation is a supremely worthy goal. However, the FDA has proven itself to be remarkably resilient, impervious, even, to reform.
So perhaps the better path is to take the matter to the states, as far aways as physically and legally possible from FDA HQ. To seek a Brandeisian answer, the states as "laboratories of democracy," as I have argued here.
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