John D. Lantos, 05/16/2013 

Public Citizen, the so-called “citizen’s advocacy group,” continues to criticize the NIH-sponsored clinical trials of oxygen therapy for premature babies.  They followed up their April 10^th letter with another, on May 8^th.  The April letter was wrong on a number of counts, as I documented in Bioethics Forum on April 18^th .  The latest document is worse. The authors of the previous letter, Sidney Wolfe and Michael Carome, are joined by bioethicist Ruth Macklin. Together, they manage to mangle the facts, misrepresent clinical research, and misinform the citizens for whom they claim to advocate.

Their central claim is that the “consent form failed to mention the serious, reasonably foreseeable risks related to the part of the study comparing two experimental strategies for managing oxygen in extremely premature infants. Those risks, correctly identified by OHRP, included increased risks of brain injury; an eye disease called retinopathy of prematurity, which can lead to blindness in severe cases; and death, depending on the randomized group assignment of each baby.”

The problem here is that those risks were not “correctly identified.” Neither Public Citizen nor OHRP understand the differences between, on the one hand, the risks of enrolling in the research project and, on the other, the risks associated with being an extremely premature baby. All of the risks that they talk about are risks associated with neonatal intensive care for premature babies. Not one of these risks was increased by being in the study.

The state of knowledge regarding oxygen therapy at the time this study was designed and initiated can found in many papers that were written at the time.  Ten years ago, Cole and colleagues summarized what was known about oxygen therapy for premature babies.  They wrote, “We do not understand optimal oxygenation management in extremely low gestational age neonates (<28 weeks’ gestation).  No randomized control trial has clarified the relation between retinopathy of prematurity (ROP) and blood oxygen (PaO₂), transcutaneous oxygen (tcO₂), or oxygen saturation (SpO₂) levels.”[i]

Given that, here is a partial list of the information that the new letter insists should have been included in the consent form, but which is in fact incorrect

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