AHRP- Doctors Treating Premature Infants in Oxygen Experiment Were Intentionally Deceived

 ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 

Advancing Honest and Ethical Medical Research
www.ahrp.org

FYI

A legitimate research question: what is the appropriate amount of oxygen an essential therapy for fragile premature infants? Too much oxygen therapy could cause blindness and to little death?

An illegitimate research protocol: the extremely low weight premature infants—whose mortality rate is 20% if treated with the best current practice--were randomized to be maintained at either high oxygen saturation SOP2 (91-95%) or low (85-89%) oxygen saturation, whereas normally the full range of oxygen saturations was used. 
The level usually selected to be maintained based on trying to give the minimal oxygen necessary to prevent blindness while maintaining adequate oxygen delivery so the neonate will survive.

The researchers reported in The New England Journal of Medicine:

"our data suggest that there is one additional death for approximately every two cases of severe retinopathy that are prevented.”

http://www.nejm.org/doi/pdf/10.1056/NEJMoa0911781

 

Update: The most disturbing fact that has emerged about the neonatal SUPPORT trial design--described in the PROTOCOL-is that the pulse oximeter readings of oxygen levels that treating neonatologists rely on to determine an infants’ need for supplementary oxygen, was deliberately altered to give either false high or false low oxygen saturation levels.

I’m not making this up! See the SUPPORT protocol: http://www.nih.gov/icd/od/foia/library/Protocol.pdf 

A lawsuit has been filed on behalf of 5 infants against the University of Alabama, the lead medical center among the 23 at which the experiment was conducted.

Experiments such as SUPPORT—and similarly designed experiments conducted on critically ill patients in intensive care units—represent an extreme breakdown in medical research ethics.

This case sheds light on the profound chasm between the patient-centered objectives of practicing critical care specialists, and the objective of research whose protocols are not guided by ethical principles and patient / subject’s best interest.

Read the details:   http://www.ahrp.org/cms/content/view/918/9/