A great editorial in the PNEJM today from Jeffrey Drazen, he deconstructs the OHRP ruling about the SUPPORT trial consent form. He ends with this phrase ‘We are dismayed by the response of the OHRP and consider the SUPPORT trial a model of how to make medical progress’.
Also yesterday the PNEJM published a letter from the investigators of the SUPPORT trial. Wally Carlo and colleagues note ‘The infants in both treatment groups had lower rates of death before discharge (16.2% in the higher-oxygen-saturation group and 19.9% in the lower-oxygen-saturation group) than did those who were not enrolled (24.1%) and historical controls (23.1%), and rates of blindness did not differ between the treatment groups.’ So one of the major criticisms of the OHRP which is : ‘It would have been appropriate for the consent form to explain (i) that the study involves substantial risks’ is shown to be baseless, participation in the trial was less risky than not participating.
Even the higher mortality group, the lower saturation group, had lower mortality than the non-enrolled infants, and lower than the historical controls.