Tags: health | preemies | NIH | HHS | misconduct

Federal Health Agencies Accused of Misconduct in Preemie Study

Tuesday, 20 May 2014 09:14 AM

Two leading federal health agencies have been accused of unethical conduct by exerting undue influence on their own oversight group.

A report by Public Citizen claims that the Department of Health and Human Services and the National Institutes of Health applied inappropriate pressure on their watchdog, the Office for Human Research Protections, according to the Huffington Post.

Public Citizen, a consumer advocacy group, says the result was that the two agencies weakened the conclusions of an NIH-funded study into the correct levels of oxygen levels for premature infants.

The first version of the oversight agency’s report slammed researchers for not properly letting the babies' parents know about the study’s risks, which included blindness, brain damage, even death. But the report was later softened following a series of communication involving the NIH and HHS.

The Public Citizen report, released Tuesday, was based on documents obtained through a Freedom of Information Act request.

Democratic Rep. Rosa DeLauro has demanded an official investigation "to prevent such improper interference" from happening again.

"What appears to have happened here is that NIH, despite substantial conflicts of interest, was allowed to interfere and, in my view, improperly influence the investigation," DeLauro of Connecticut told the Post.

Tait Sye, an HHS spokesman, denied the accusations, saying that the NIH was simply adding more information to the original report from an HHS agency, Office for Human Research Protections (OHRP), which NIH did on a regularly basis.

"OHRP regularly works with entities such as NIH, [Institutional Review Boards] and others to ensure the protection of human subjects in research," Sye said.

The research into the correct amount of oxygen for premature babies, called SUPPORT, began in 2004 with a $20 million grant, and ended in 2009. The findings showed that that babies who received supplemental oxygen suffered "no more blindness, but greater survival" than babies who were given a little less oxygen, according to reports.

Public Citizen says that communications in 2013 between OHRP and the NIH, as well as officials in the HHS Office of the Secretary, showed "an unprecedented amount of coordination" to tone down the more harsh segments of the first report about the dangers of the study.

Michael Carome, director of Public Citizen’s Health Research Group, criticized the HHS and NIH for crossing the line between watchdog and the agency it was reviewing.

"This type of interference is simply unprecedented and simply disturbing," said Carome. "This is like the Department of Justice preparing an indictment against some criminal and allowing the criminal to view the indictment and edit it before it moves forward.

"It is like the FDA investigating a drug trial and the FDA commissioner allowing a draft warning letter to be shared with the drug company before it was issued and letting them review and suggest edits to the letter."

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Two leading federal health agencies have been accused of unethical conduct by exerting undue influence on their own oversight group.
health, preemies, NIH, HHS, misconduct
Tuesday, 20 May 2014 09:14 AM
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