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The Mark O. Hatfield Clinical Research Center at the National Institutes of Health in Bethesda, Maryland.

The Mark O. Hatfield Clinical Research Center at the National Institutes of Health in Bethesda, Maryland.

National Institutes of Health

NIH in uproar over report slamming Clinical Center, leadership shakeup

A decision to overhaul the leadership of the National Institutes of Health (NIH) Clinical Center after an outside review group found serious patient safety problems has sparked an uproar at the NIH campus in Bethesda, Maryland. In a recent letter, department chiefs at the center wrote that the review, triggered by problems with a drug production facility, unfairly concluded that patient safety has been compromised across the research hospital. They say the working group’s report has demoralized staff, worried patients, and “demonized” the center’s leadership.

Patient advocates and clinical research leaders across NIH have also written letters taking issue with the review. NIH Director Francis Collins yesterday responded to one of the letters, from Clinical Center department heads. In a statement, Collins said he is “taking the comments … very seriously. They are highly dedicated senior leaders, and I have great respect for all of them.” At the same time, he “stand[s] by” the outside working group’s process and expertise and agrees that the center needs “more central authority and accountability.” Collins was expected to meet with clinical leaders today to discuss their concerns.

The Clinical Center’s troubles began about a year ago, when fungal contamination was found in two vials of a drug from a sterile production unit in the center’s pharmaceutical development section. A review found other problems at the facility, such as insects in light fixtures. Although no patients were harmed, in December 2015 Collins asked a so-called Red Team—a working group of his Advisory Committee to the Director—to review the entire Clinical Center. The team’s April report found “substantial operations issues” with patient safety, regulatory compliance, and leadership. It described a culture in which patient safety “became subservient to research demands.”

In response, Collins announced several changes, including a new hospital board. And on 10 May, he said that Clinical Center Director John Gallin’s team would be replaced with a new leadership structure similar to that used by most hospitals: a chief executive officer, chief operating officer, and chief medical officer. Gallin’s team will stay on during the changes, Collins said.

But Clinical Center staff say the Red Team’s report went too far. In the strongly worded letter dated 16 May from seven Center department heads and senior scientist Harvey Alter, they wrote that the claim that patient safety took a back seat to research is “quite simply, incorrect.” They suggested the Red Team would have come to different conclusions if they had met with more clinical research leaders and patients, examined positive reviews by outside accrediting organizations, and reviewed standard metrics for quality of care— such as data on patient falls and infections.

Instead the Red Team “conflated deficiencies in certain clinical center operations” as “indicative of the quality” of individual patient care, stated the letter, first described by The Wall Street Journal. The resulting report and subsequent news coverage, they write, has “demonized [Clinical Center] leadership, demoralized high effective employees … and alarmed our patients.”

Members of the Clinical Center’s patient advisory group have weighed in, too, noting in an open letter yesterday that they are not aware of any patient safety breaches. They make a plea to retain Gallin and his leadership team, who they argue have become “scapegoats” for broader problems, such as the center’s unsettled funding.

A more measured 27 May letter, from a committee comprised of the clinical directors from NIH’s institutes, also expressed “concerns.” The authors pointed out that the center’s safety standards are actually higher than in most hospitals, because all patients are part of an approved research protocol and are closely monitored. At the same time, the committee agrees with some problems identified in the report, including the fact that funding for the Clinical Center’s operations comes from a tax on NIH institutes. The center needs its own budget stream and more dedicated money to make needed changes, the letter suggests.

Another widely accepted conclusion in the Red Team report is that it is a problem that many staff working in the Clinical Center report to leaders at their institutes, and not the center’s leadership. Collins has already responded to this issue by giving these staff an additional reporting line to the Clinical Center director, NIH says. 

The Red Team’s chair, former Lockheed Martin CEO Norm Augustine, did not respond to an email request for comment. But team member Harlan Krumholz, a cardiologist at Yale University, defended the report’s conclusions, saying it was based on interviews with NIH experts, site visits, and reading “extensive materials.”

“We saw clear opportunities to elevate systems so that they could more reliably ensure the safety” of patients, Krumholz told ScienceInsider. As for the report's lack of data showing broader patient safety problems, he adds, “the issue that led to the Red Team should be evidence enough of a problem.”

Today, NIH posted a “correction” to the Red Team report’s assertion that the Clinical Center has not collected common quality control measures. “In fact, the Clinical Center does collect metrics associated with patient safety,” but NIH is evaluating whether more are needed, the Red Team web page states

Although several signers of the 16 May letter did not respond to emails requesting comment, one NIH clinical research leader told ScienceInsider that “hundreds” of staff are upset by the Red Team’s report and Collins’s response, which they worry will “ruin” the Clinical Center. A group called the NIH Assembly of Scientists that represents intramural staff is also considering whether to write Collins, but was holding off until after the meeting with him today.