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May 20, 2014

Investigation Needed: Senior HHS Officials Facilitated NIH Interference With Investigation of the SUPPORT Study, Despite Direct Conflict of Interest

Deputy Secretary, Other High-Ranking HHS Officials Allowed NIH Director, Deputy Director to Review and Edit Office of Human Research Protections’ Compliance Oversight Letter, Emails Show

WASHINGTON, D.C. – Public Citizen, joined by nine prominent scholars, today called for an immediate investigation by the U.S. Department of Health and Human Services (HHS) Office of Inspector General into the conduct of senior HHS officials, who, according to an email trail, permitted top National Institutes of Health (NIH) officials to edit drafts of a letter documenting findings of what should have been an independent inquiry into serious ethical lapses in a major NIH trial.

According to documents Public Citizen recently obtained under the Freedom of Information Act (FOIA), HHS officials in the immediate Office of the Secretary and Office of the Assistant Secretary for Health (OASH) knowingly allowed the director of NIH and other senior NIH officials to interfere with the independence of the Office for Human Research Protections’ (OHRP’s) ongoing compliance oversight investigation of the controversial SUPPORT study, Public Citizen said in a letter to the HHS inspector general.

In a separate letter to the HHS inspector general, U.S. Rep. Rosa DeLauro (D-Conn.) today echoed the call for an investigation.

Though heavily redacted, the documents Public Citizen obtained reveal that named NIH officials were, inappropriately, given multiple opportunities to review and edit drafts of a pending OHRP compliance oversight determination letter regarding the SUPPORT study, as well as apparently allowing NIH to influence the timing of the release of the letter, which occurred on June 4, 2013. This letter put on hold all compliance enforcement actions taken by OHRP that had been outlined in an earlier letter issued on Feb. 8, 2013, to the University of Alabama at Birmingham. This hold is still in effect.

The SUPPORT study was funded by the NIH at a cost of more $20 million, and NIH scientists were co-investigators on the study. The experimental study exposed 1,316 premature infants to increased risk of blindness, brain injury and death without informing parents of the risks to their babies or the true nature and purpose of the research.

“It is deeply disturbing and unacceptable that the NIH, which was involved in the development, approval, conduct and oversight of the SUPPORT study, was allowed to review and edit OHRP’s compliance oversight letter,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The most troubling part is that numerous high-ranking officials facilitated this interference by senior NIH officials, despite the fact that NIH had obvious actual, direct conflicts of interest in the research under investigation.”

“The emails obtained by Public Citizen strongly suggest that the NIH – apparently desperate to undo OHRP’s earlier compliance oversight determinations – launched an aggressive campaign to undermine OHRP’s regulatory authority and regrettably found several willing partners for this campaign at the highest levels of HHS,” said renowned bioethicist Ruth Macklin, a professor at Albert Einstein College of Medicine and director of a training program in research ethics sponsored by the NIH Fogarty International Center.

Said DeLauro, “The very reason OHRP was administratively moved out of NIH was because of the long-recognized conflicts of interest that exist between NIH and OHRP. That move was intended to prevent exactly the type of NIH interference that has now apparently occurred. It appears that actions displayed by senior HHS leaders have compromised the integrity and independence of OHRP’s ongoing investigation into the SUPPORT study.”

The series of email communications between NIH, the HHS secretary’s office and OHRP paints a truly disturbing picture, Carome said. A sampling of some of the most revealing emails includes:

Email on May 3, 2013, 4:54 PM

From: Jerry Menikoff (Director, OHRP):
Addressed to: Kathy Hudson (Deputy Director for Science, Outreach, and Policy, NIH); Howard Koh (Assistant Secretary for Health, HHS); Wanda Jones (Principal Deputy Assistant Secretary for Health, HHS); and Kirby Bumpus (OASH, HHS)
Subject: RE: Support study -
Message:

Kathy,

For your weekend enjoyment, here is the revised version of the SUPPORT letter… [Emphasis added]

• Email on May 12, 2013, 02:10 PM

From: Kathy Hudson (Deputy Director for Science, Outreach, and Policy, NIH)
Addressed to: Howard Koh (Assistant Secretary for Health, HHS) and Jerry Menikoff (Director, OHRP)
Subject: Suggested correction to OHRP-UAB draft letter [Emphasis added]

An apparent attachment is completely redacted.

A June 2, 2013, email, from Francis Collins, director of NIH, sent to many senior leaders of HHS – including the deputy secretary and chief of staff – thanked them “for the opportunity to weigh in on OHRP’s letter to UAB [University of Alabama Birmingham] and the Federal Register Notice related to SUPPORT” and stated that the NIH is “grateful for the opportunity to work with such a dedicated team within HHS.”

“This interference has seriously compromised the integrity and independence of OHRP’s compliance oversight investigation into the SUPPORT study, fundamentally undermining OHRP’s regulatory authority and almost certainly doing long-lasting and possibly irreparable harm to the status of this critically important regulatory agency, whose primary mission is to protect human subjects,” said Carome.

Public Citizen and the nine prominent scholars in bioethics, law and history seek to ensure that all HHS officials who played a role in the corrupt conduct revealed by the HHS emails are held accountable and that appropriate corrective actions are taken to prevent such improper and unethical interference by NIH in the compliance oversight activities of OHRP from recurring.

In a separate letter to the HHS inspector general, DeLauro asked the inspector general “to assess whether OHRP needs to be relocated, and if so where, in order to prevent the type of NIH and other HHS interference that seem to have occurred in this episode.”

View Public Citizen’s letter.

View DeLauro’s letter.

Read further email correspondence between NIH, the HHS secretary’s office and OHRP (PDF).

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