Consumer group protests controversial studies involving premature infants

{mosads}The event, which was interrupted by police, coincided with a public meeting at HHS about how to best protect human subjects in certain medical research contexts.

Public Citizen called the meeting a response to pressure from critics of two controversial studies on premature infants, one of which is still in progress.

The project that has received the most attention — the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) — took place from 2005-2009 and sought to improve oxygen therapy given to babies born too early.

Subjects were randomly divided into two groups and given oxygen concentrations on the high and low ends of the spectrum once endorsed by the American Academy of Pediatrics.

Federal auditors concluded this year that researchers failed to inform families about the study’s health risks, which included blindness for the group administered more oxygen and brain injury or death for the lower-oxygen group.

“The [oxygen] study looked good on paper,” stated Carrie Pratt, the mother of a baby involved in the trial that later required surgery for eye disease.

“We were shocked to learn that the care [our daughter] received was based not on what she needed but on what some protocol dictated.”

Pratt’s statement was distributed by Public Citizen, which is calling on HHS to contact parents of trial subjects and stop similar studies in order to review research and consent standards.

The department responded in a statement, saying that Wednesday’s meeting was convened to “hear from the public and gather feedback on the important issue of protection of human subjects in research.”

“This is an important issue that deserves thoughtful deliberation,” a spokeswoman said.

The agency also stated that HHS security policy prevents press conferences from taking place on federal property without prior permission.

—This post was updated to specify that HHS’s security policy applies to federal property.