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
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
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)