WASHINGTON -- High-level government officials at the top federal health agencies placed inappropriate pressure on their own watchdog agency, a new report alleges.
The report by the consumer advocacy group Public Citizen, released Tuesday, accuses the Department of Health and Human Services and the National Institutes of Health of breaching ethical boundaries by working too closely with their oversight group, the Office for Human Research Protections. In doing so, Public Citizen alleges, officials at the two agencies helped soften the watchdog's critical assessment of the conduct of NIH-funded researchers studying the optimal oxygen levels for prematurely born infants. The first version of the watchdog's report criticized researchers for failing to adequately inform the babies' parents of study risks.
Public Citizen's findings, based on internal government emails obtained through a Freedom of Information Act request, were serious enough that at least one member of Congress -- a major NIH supporter -- is calling for a formal investigation "to prevent such improper and unethical interference" from reoccurring.
"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," said Rep. Rosa DeLauro (D-Conn.) in an interview.
At the heart of the allegations are the often gray lines of research ethics, specifically to what extent and in what fashion an agency can plead its case to its own watchdog committee. In a statement hours before the Public Citizen report was officially released, Tait Sye, an HHS spokesperson, argued that the NIH merely worked to correct incomplete information in the first report issued by Office for Human Research Protections, or OHRP, and that such communication was not uncommon.
"OHRP regularly works with entities such as NIH, [Institutional Review Boards] and others to ensure the protection of human subjects in research," said Sye.
The case dates to 2004, when NIH started funding a $20 million-plus study to look into how much oxygen a prematurely born baby should be given during the early stages of life.
The study, called SUPPORT, involved tests on more than 1,300 infants. The research ended in 2009, with findings showing "that babies who got supplementary oxygen in the higher end of the acceptable range had no more blindness, but greater survival, than babies that got slightly less oxygen," according to The Washington Post.
The SUPPORT study, however, was clouded by criticism over the conduct of those doing the investigation. In March 2013, OHRP -- part of HHS -- said 23 research sites had not given parents of infants in the trial a proper warning about the risks of the study, which included blindness, brain damage, even death. In addition, OHRP, told the University of Alabama at Birmingham -– the main institution conducting the research -- that it would begin screening university consent forms for compliance with HHS regulations. A class-action lawsuit has since been filed against University of Alabama at Birmingham providers over the Support study.
The study's authors and members of the scientific research community, meanwhile spoke out against the OHRP ruling. There was no basis to predict that infants in one group or the other would be more at risk of death from participating in the trial, they argued, adding that all levels of oxygen given to the infants fell within the standard range, just at different ends of the spectrum. They also warned the compliance actions demanded of future research could have a chilling effect.
Two months later, OHRP produced a second letter on the SUPPORT study, maintaining that more warnings about experimental risk should have been offered. But it also acknowledged the general guidelines for researchers in the field needed more clarification and pledged to hold a public meeting to discuss the issue further. In a reversal, OHRP also said it was dropping its compliance enforcement against University of Alabama at Birmingham for the time being, and that it wouldn't enforce disciplinary action against other studies until clearer guidance was finalized.
"The OHRP has said, 'You're guilty, but we're not going to do anything about it," Alice Dreger, a professor of clinical medical humanities and bioethics at Northwestern University, said at the time.
Seeking an explanation for the reversal, Public Citizen filed a Freedom of Information Act request for communications between OHRP and the NIH, as well as officials in the HHS Office of the Secretary, from March 2013 to early June. The records that were produced, Public Citizen argues, show an unprecedented amount of coordination between the agencies to sand down the rough parts of the first report.
According to the 439 pages of emails, 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 day after that second letter was issued, a group of bioethicists published a piece in the New England Journal of Medicine defending the SUPPORT study. That same say, Collins co-authored a piece in the same publication titled "In Support of SUPPORT –- A View from the NIH." In it, he wrote that OHRP had put its compliance actions on hold.
Dr. Michael Carome, director of Public Citizen’s Health Research Group, said he found the timing more than suspicious, though emails in the FOIA tranche show the Collins' piece had been in the works well before the OHRP letter was released.
Concerns over OHRP's independence date back many years. In 2000, agency was moved from NIH to HHS after outcries about conflicts of interest and inappropriate pressure being placed on its oversight officials. With respect to SUPPORT, the documents uncovered by Public Citizens do not show instances of overt pressure being applied by NIH officials to get OHRP to amend initial conclusions. Rather, the emails suggest a collaborative process in which the two groups managed to find a middle ground.
"In the wake of extensive scientific and public discussions since OHRP’s March 2013 determination letter related to the SUPPORT study, OHRP 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," said Sye.
Because some of the emails are heavily redacted, the view of what was actually said between NIH and OHRP is incomplete. And even then, the question being raised by DeLauro and Public Citizen is why that wall of demarcation between watchdog and agency was breached in the first place.
"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 lettering them review and suggest edits to the letter."
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