WASHINGTON May 20 An advocacy group on Tuesday demanded an investigation into what it called interference by U.S. health officials in the oversight of a federally funded study involving breathing problems in premature infants.
Public Citizen said Department of Health and Human Services officials interfered with a government probe into whether parents had been fully informed of possible risks to the babies in the ongoing study, which was funded by the National Institutes of Health, the government's medical research agency.
Nine bioethicists and Representative Rosa DeLauro of Connecticut, the ranking Democrat on the U.S. House of Representatives panel overseeing health funding, joined Public Citizen in calling for an investigation by the HHS Office of Inspector General.
At issue is the conduct and oversight of the study, called SUPPORT, investigating experimental ventilation treatments to improve breathing in premature infants who were enrolled between 2005 and 2009 at about two dozen facilities.
The Office of Human Research Protections, an independent office at HHS tasked with protecting patients in clinical trials, in February 2013 cited the University of Alabama, which was a lead investigator in the study, for using consent forms that did not adequately address possible risks such as brain damage and blindness, and called for reforms.
Then, in June 2013, the office sent another letter saying no further corrective action was needed, advocates said.
Emails obtained by Public Citizen and released on Tuesday showed that top officials at HHS and NIH were involved in reviewing and revising the letter, the advocacy group told HHS Inspector General Daniel Levinson, calling for a probe.
Such interference is a direct conflict of interest given that NIH funded the study, which cost more than $20 million, set up the research protocol and included many of its staff as investigators, the advocates said.
The emails show that officials who appear to be involved include NIH Director Francis Collins and HHS Deputy Secretary Bill Corr, among others, the group added.
"They should have had no involvement at all in the investigation," Michael Carome, director of Public Citizen's Health Research Group, told Reuters. "That type of interference is unprecedented."
HHS, in a statement, said that after the research office sent the initial letter, it "became aware of different understandings of what is meant by 'standard of care' and risks that must be disclosed to potential subjects in the research context" and is currently drafting new related guidelines.
Carome called the HHS response "not believable" and urged HHS to make public all records related to the matter.
Don White, a spokesman for the HHS Office of the Inspector General, said the office would carefully evaluate the group's request for an investigation. (Reporting by Susan Heavey; Additional reporting by Will Dunham; Editing by Mohammad Zargham)