Myocarditis with Immune Checkpoint Blockade

Paton raises the thorny issue of attribution of primacy.We were aware of multiple observational studies indicating favorable outcomes with the use of antihypertensive agents in patients with malignant hypertension. 1 In reexamining the literature, we did indeed find an important trial involving patients with severe hypertension (diastolic blood pressure, >130 mm Hg) who were randomly assigned to antihypertensive therapy (with reserpine, chlorothiazide, or hydrochlorothiazide-guanethidine) or matching placebos. 2We will resist calling this the first trial and instead use the term "early."Shamy and Fedyk appropriately remind us that there are special situations in responsible clinical research in which informed consent may be waived.Their point was recently illustrated in the Informed Fresh versus Old Red Cell Management (INFORM) trial. 3In this trial, each site's ethics committee waived the need for patient consent "because all the patients received treatment that was consistent with the current standard of care." 3 We agree with their additional points indicating that obtaining consent is only one of the many responsibilities of investigators in conducting quality clinical investigation.