May 20, 2014
Officials at federal health agencies, including the Department of Health and Human Services and National Institute of Health, have been accused of ethical misconduct, according to The Huffington Post. The accusations by the consumer advocacy group Public Citizen say that officials at those agencies worked too closely with their oversight organization, the Office for Human Research Protections in lessening the severity of criticism concerning a study involving premature babies.
The specific study ran from 2005 to 2009 and researched the optimal oxygen levels for premature babies. Tests were performed on more than 1,300 infants, but the OHRP in a March 2013 letter reported that 23 sites had not adequately informed parents of the risks of the study. Those risks included blindness, brain damage, and death.
A second letter published two months later was less harsh in its criticism, adding that guidelines needed clarification, promising public meetings on the issue, and dropping a compliance enforcement effort against the University of Alabama Birmingham, the study’s main research institution.
Included in the many emails Public Citizen accessed under a FOIA request:
During the period between the two reports, officials at the NIH reached out to senior HHS officials to “chat about” the SUPPORT study. On May 1, 2013, the director of the NIH, Dr. Francis Collins, wrote to Bill Corr, the deputy secretary at HHS, explaining that his staff had been working with top HHS officials “to develop a consensus set of statements that OHRP could put forward to clarify the situation with the SUPPORT study.”
Subsequent emails show continued discussions between HHS, NIH and OHRP. In mid-May, Jerry Menikoff, the director of OHRP, exchanged correspondence with NIH officials in which they appeared to be going over potential edits to the second letter.
The issue has already attracted the attention of at least one congressional representative. Democrat Rosa DeLauro of Connecticut told HuffPo, "“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.” She has requested an inquiry into the affair from HHS Inspector General Daniel Levinson.
May 20, 2014