Therefore, "while monitoring drug levels to optimize benefit-risk balance has intuitive appeal, given the complex exposure-response relationship and confounding effects of demographic variables, this should remain an area of active investigation. It is not ready for prime time to inform or guide clinical practice," Dr. Kaul said.
Dr. Kaul disclosed that he is a consultant for Boehringer Ingelheim and has equity interest in Johnson and Johnson.
At press time, the FDA had not responded to a request for a comment on the BMJ investigation.
