Politics

NIH Probe by House Panel Expands

Energy and Commerce asks for documents related to 2015 scandal

Francis S. Collins, director of the National Institutes of Health, is under fire from House Republicans, upset over a scandal at the agency, as well as Collins’ views on research issues. (Tom Williams/CQ Roll Call File Photo)

The National Institutes of Health is in hot water again with the House Energy and Commerce Committee over a scandal that occurred nearly two years ago at one of the agency’s main research institutions.

On Thursday, the panel broadened its probe into safety and compliance issues at the NIH Clinical Center, a research hospital located on the agency’s campus in Bethesda, Maryland. In a letter sent to Director Francis Collins and obtained by Roll Call, the committee requested a larger swath of documents not yet provided by the agency.

The inquiry — which stems in part from new information uncovered by the committee — resurfaces a scandal the NIH has tried vigorously to move past. But despite assuring congressional leaders that immediate corrective action was taken, the agency has yet to implement several of the key recommendations included in a report issued over a year ago.

In an emailed statement to Roll Call, Energy and Commerce Chairman Greg Walden of Oregon and Rep. Tim Murphy of Pennsylvania, chairman of the panel’s Oversight Subcommittee, said they have received “substantial information” from the agency so far. 

“After about a year since the NIH announced reforms to the NIH Clinical Center, it’s imperative the committee have an understanding of additional action taken to address our concerns, and ensure that NIH’s efforts to ensure safety and compliance of their work are effective,” the lawmakers wrote. 

An NIH spokeswoman confirmed the agency received the letter and will respond to it. 

The new inquiry comes at a particularly troubling time for the NIH. A group of more than 40 House Republicans earlier this week sent a letter to President Donald Trump urging him to fire Collins because of his views on stem cell research and human cloning.

The agency took another hit on Tuesday when Trump proposed cutting funding to the NIH by more than $7 billion in his proposed fiscal 2018 budget. 

The Food and Drug Administration in 2015 discovered two vials of a contaminated drug sample at the Clinical Center’s Pharmaceutical Development Section scheduled to be used on human subjects. The agency suspended activity at the lab shortly after.

The NIH has said no patients were harmed as a result of the tainted sample, but the discovery sparked national headlines and launched two separate congressional investigations.

In the midst of those probes, Collins established a working group staffed with both NIH leaders and nongovernment executives to analyze the broader issues within the center. The group released a scathing audit in April 2016 that, among other things, slammed management for creating a culture where research demands where placed above patient safety.

It also included a set of recommendations intended to help correct the issues outlined in the report. Collins endorsed that audit, but more than a year has passed since its release and the NIH has failed to implement several key suggestions.

The report suggested the creation of a Research Support and Compliance Office at the NIH, and that it be merged with the Office of Human Subjects Research Protections. When asked for an update on the merger, the NIH said it was “still considering how best to integrate” the two offices. The delay is noteworthy, as the combination was deemed a critical aspect of the working group’s recommendation, according to individuals with knowledge of the deliberations.

The audit also suggested that the Clinical Center begin to conduct internal, unannounced reviews of its various offices. The agency said it has not yet conducted a single audit.

“NIH learned of significant problems with timely reporting of adverse events, which required more immediate action and attention,” the agency told Roll Call. “Only after all NIH researchers have a consistent understanding of the expectations for reporting will the forthcoming internal audits turn out meaningful results.”

The NIH, however, has taken some corrective steps in the aftermath of the scandal. The agency created a hospital board tasked with overseeing safety and compliance at the Clinical Center. It also took several steps to improve the lines of communication for reporting patient safety issues.

The Energy and Commerce Committee, in its letter to Collins, requested additional documentation on the “further insights and information [the] NIH has obtained” from the corrective actions taken thus far. The panel included in that any “audits, reports, internal review, or analysis” generated by the NIH or an outside contractor.

The committee also said it uncovered “additional information and issues” about management at the Clinical Center. The expanded probe comes after the agency provided the committee “much more detailed information” that, in some cases, would have been outside the scope of the NIH’s own internal and external reviews so far, an aide told Roll Call. 

A separate investigation last month by CQ Roll Call unveiled that an outside reviewer failed to report significant safety issues at a separate lab within the National Instituteof Mental Health. The reviewer — who was hired by Eli Lilly and Co. to audit the facilities the pharmaceutical giant was using at the NIH — did not report the presence of black mold on the ceiling of the lab just weeks before it was closed by the agency. 

Thursday’s letter is the latest in a series sent by the Energy and Commerce Committee to the NIH on this issue. Among them was one sent in November 2015, marked “confidential” and obtained through the Freedom of Information Act. The letter asked the agency for information and documentation on personnel action related to the problems unearthed by the FDA in 2015.

“We would respectfully request that the NIH accommodate the committee’s investigation at this point. The committee has reason to believe that the NIH leadership has now reached a decision on personnel actions,” Michigan Republican Fred Upton, the panel’s then-chairman, wrote.

The NIH declined to comment on personnel issues.

A source with knowledge of the situation said agency leadership, in the aftermath of the scandal, transferred two individuals charged with overseeing the offices within the Clinical Center where contaminated samples were found to another office within the NIH. That transfer, the source said, came after leadership faced legal issues over the attempted firing of those employees.

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