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Commentary

Small Leaps or Giant Steps
Dr. Scott Gottlieb, AEI Online, 7-13-05

Gottlieb points out that calls for more "comparative studies" between new medicines and older drugs misses the clinical differences that are relevant to real world patients:

This mandate for "comparative effectiveness" studies, where new drugs are compared to old drugs, is a standard that is used in Europe. But the European data generated from these kinds of head-to-head trials are often ignored by clinicians here, who argued to me when I was at the Food and Drug Administration that head-to-head trials are often underpowered and therefore do not take full stock of subtle but clinically important benefits such as improved dosing schedules that lead to better compliance or better side-effect profiles, which, in turn, allow safer administration of medicines.

Underpowered head-to-head trials do not reveal the small but important benefits offered by incremental advances in medicine. They often end up proving the null hypothesis, that there is no difference between two drugs, even when clinically important differences exist. Nonetheless, the policy change Dr. Angell and others advocate would reduce the total number of drugs approved, as well as the availability of back-up drugs that provide alternatives to medicines and create competition that lowers prices.



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