By Arthur Caplan
A new piece by Bill of Health contributor Art Caplan in Forbes:
Nathan Nascimento thinks that right-to-try laws aimed at the terminally ill are sound public policy. He is wrong.
Mr. Nascimento’s commentary misrepresents the complexities of the drug development process and the issues surrounding granting access to experimental medicines before they have been fully tested.
The overarching issue, despite his rhetoric to the contrary, is that the safety and efficacy profile of a new medicine is not sufficiently understood until after the drug has completed at least a pivotal Phase 3 clinical trial.
The underlying principle of every clinical development program is to understand, via testing first for safety usually in a small number of patients afflicted with the target condition, and, subsequently, in increasing numbers of patients, the benefits as well as the risks of new medicines. Like it or not, this is a time-consuming, expensive, but appropriate and necessary process. […]
Read the full post here.
