Biogen, Fresh off Coveted FDA nod for Aduhelm, Must now Navigate Ethics Minefield for Phase 4 Trial
“When you’re running a trial in places outside the U.S. for a drug that is primarily going to be developed and marketed in the U.S., you have to be very concerned about protecting vulnerable populations,” said Charles Binkley, M.D., director of Bioethics at the Markkula Center for Applied Ethics at Santa Clara University.
“If people in the U.S. refuse to participate because they believe the risk-benefit ratio is too great, [and you find] a group of people who, for other reasons, may not feel that way, you have to be even more careful to protect them and that you’re not exploiting their vulnerability,” Binkley said.
“[Aducaumab has] been approved under the accelerated process but it’s not clear to me that we actually moved these patients from being trial subjects to being actual patients, which has interesting repercussions for ethics in terms of research informed consent,” Binkley said. “Is there going to be a higher standard that physicians are going to need to comply with when prescribing this drug?”
Charles E. Binkley, MD, director of bioethics at the Markkula Center for Applied Ethics, quoted on Fierce Biotech.