Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
Note: The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on Monday issued a report in response to a complaint filed by Public Citizen over interference by the National Institutes of Health in an ongoing investigation of a controversial clinical trial.
The inspector general’s failure to find any impropriety by high-ranking U.S. Department of Health and Human Services (HHS) officials is extremely disturbing and represents a complete whitewash. In failing to take stronger action, the OIG has become part of the problem of inadequate HHS oversight of research involving people.
The Office of Inspector General’s (OIG) report came in response to a complaint submitted by Public Citizen and nine prominent scholars and bioethicists. Documents Public Citizen had obtained under the Freedom of Information Act demonstrated that HHS officials in the immediate Office of the Secretary and Office of the Assistant Secretary for Health knowingly allowed the director of the National Institutes of Health (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 on premature infants. NIH officials and some SUPPORT study researchers were given opportunities to review and edit drafts of a letter documenting findings of what should have been an independent inquiry into serious ethical lapses in the study.
The OIG report confirms that NIH officials indeed were permitted to review and edit drafts of an OHRP compliance letter related to the SUPPORT study. However, astonishingly, the OIG characterized the NIH interactions as simply “consultations” and concluded that “none of the [applicable] statutes, regulations, or policy documents bars HHS components from expressing opinions on proposed OHRP compliance findings or prohibits OHRP from consulting with NIH or other components in HHS.”
The emails obtained by Public Citizen indicated that the interactions between NIH and OHRP were not benign consultations. Instead, the NIH – 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. These actions compromised the integrity and independence of OHRP’s ongoing investigation into the SUPPORT study. While they may not have been strictly illegal, such conduct was unethical and damaging to OHRP’s mission and should not have been permitted. By not taking the opportunity to criticize the improper conduct of senior HHS and NIH officials, the OIG has guaranteed such interference will recur.
It is now imperative that Congress take action by passing legislation making OHRP an independent agency that is free of the corrupting influences of NIH and other conflicted agencies regulated by OHRP.