The improper acceptance by US National Institutes of Health scientists of payments from pharmaceutical and biotechnology companies represents “the largest scandal in all of the NIH's existence,” according to Representative Edward Whitfield, chairman of the House Energy and Commerce's subcommittee on oversight and investigations.
While the NIH has taken necessary steps to improve its ethics programme, more action is needed, the Republican legislator told a hearing on Wednesday, held to air continuing congressional concerns that the NIH is failing to discipline employees who violate its ethics rules.
A year ago, after the US Office of Government Ethics published a report that was highly critical of the “permissive culture” at the NIH, the agency banned its employees from carrying out any paid consulting work with industry. “We took this action because even the suggestion of ethical lapses, apparent or real, in NIH programmes would undermine public confidence in federally-supported medical research. We could not allow this to happen,” Raynard Kington, principal deputy director of the NIH, told the committee.
In addition, he said, the agency had disciplined 34 of its scientists who had violated its previous ethics rules by failing to seek approval for, or even report, consulting relationships with industry, failing to take annual leave while consulting, or consulting in areas that overlapped with their official duties. Sanctions implemented by the NIH against wrongdoers had ranged from “oral admonishments” to letters of reprimand, to suspensions, while those who failed to take leave to conduct outside activities were directed to pay back that leave to the government. “In many cases, the scientists returned honoraria that were inappropriately received,” said Dr Kington.
Wednesday's hearing focused particularly on the cases of two prominent NIH scientists, Alzheimer's disease researcher Dr Trey Sunderland and cancer specialist Dr Thomas Walsh. The NIH investigation had found both men guilty of misconduct so serious that, had they been civilians, they would have been dismissed. However, because they are officers of the US Public Health Service Commissioned Corps, their cases have to be held under Corps, not NIH, rules.
John Agwunobi, Assistant Secretary for Health at the Department of Health and Human Services, told the hearing that Dr Sunderland's Corps hearing had been delayed indefinitely because the Justice Department is considering criminal charges against him, while Dr Walsh's hearing had not commenced because it was awaiting the outcome of Dr Sunderland's. However, last week, plans began for a hearing for Dr Walsh, he said.
It is also reported that Dr Walsh's appearances with drug companies at US Food and Drug Administration meetings are the subject of a separate internal review recently begun at the NIH.
Admiral Agwunobi said he fully understood the gravity of the issues being explored by the subcommittee, and added that the Corps' policies are now undergoing scrutiny “to ensure they are robust and rigorous.” However, the legislators were not satisfied, with Republican Joe Barton, chairman of the House Energy/Commerce Committee, warning the Assistant Secretary that, if he waited for the Justice Department to finish its investigation of Dr Sunderland, “you may retire without it happening.” By Lynne Taylor