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May 20, 2014

HHS Response to Public Citizen’s Finding of Agency Misconduct Doesn’t Add Up

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

The U.S. Department of Health and Human Services (HHS) response to our letter today to the HHS Inspector General can only be viewed as a pitiful and continuing attempt to cover up the unprecedented and unethical HHS/National Institutes of Health (NIH) interference in Office for Human Research Protections’ (OHRP’s) responsibility to ensure that human research is ethical.

In an initial reaction to Public Citizen’s letter to the HHS Inspector General calling for a formal investigation of the NIH’s interference with the OHRP’s investigation of the SUPPORT study, HHS spokesperson Tait Sye, according to media reports, argued that the NIH merely worked to correct “incomplete information” in the first report issued by OHRP and that such communication was not “uncommon.” Sye was quoted as saying, “OHRP regularly works with entities such as NIH … and others to ensure the protection of human subjects in research.”

If such communications are so routine and involve only providing OHRP with more complete information, why was such information redacted from the email provided to Public Citizen in response to our Freedom of Information Act request? We call on HHS to immediately make public all of the records related to this troubling episode, without the redactions.

The HHS response not only lacks credibility, it attempts to cover up the NIH’s disturbing interference — facilitated by high-ranking officials in the HHS Office of the Secretary — which compromised the integrity and independence of OHRP’s investigation of the SUPPORT study and threatens to undermine the protection of human subjects participating in HHS-funded research more broadly. In particular:

  • It is not believable that senior HHS officials, such as the deputy secretary and HHS chief of staff, regularly involve themselves in discussions with senior NIH officials and others about draft OHRP compliance investigation letters.
  • It is not believable that NIH officials, including the NIH director and deputy director, routinely are given opportunities to review and edit draft OHRP compliance investigation letters.
  • It is not believable that NIH scientists, who are co-investigators on NIH-funded multicenter studies, are given opportunities to review draft OHRP compliance investigation letters related to their own studies.

The involvement of NIH and senior HHS officials in OHRP’s ongoing compliance investigation of the SUPPORT study was unprecedented.

The redactions from the emails released to Public Citizen no doubt were intended to prevent embarrassment to HHS and keep secret communications that documented the true nature and scope of NIH’s interference in OHRP’s investigation and the facilitation of this interference by senior HHS officials in the Office of the Secretary.

When the full text of these emails becomes known, the redacted material will clarify and expose the unacceptable and unprecedented role played by top HHS and NIH officials in fending off OHRP’s investigation of unethical research and appropriate enforcement action.

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