The Washington PostDemocracy Dies in Darkness

Patients and doctors urge reconsideration of NIH shake-up

June 2, 2016 at 7:11 p.m. EDT
Some patients and doctors are defending top leaders of the NIH Clinical Center, who would be replaced by Director Francis Collins as part of a management overhaul. (Michael Reynolds/EPA)

Some patients and high-ranking officials at the National Institutes of Health are urging Director Francis S. Collins to reconsider his planned demotion of top leaders at the agency’s flagship hospital, contending that blame for safety problems identified by an outside panel has been misplaced.

In a letter to Collins on Thursday, an advisory group of hospital patients asked him to rethink his plan to replace the Clinical Center’s current leaders with three new executives and a structure similar to the one at most hospitals.

Referring to the renowned hospital’s chief, John Gallin, and his top aides, members of the NIH Clinical Center Patient Advisory Group said that “while it is not unusual to call for someone’s head when a challenging report comes out, in this case the very people who can help fix the problem are instead becoming scapegoats.”

Last month, eight senior leaders from NIH institutes wrote a letter to Collins protesting his overhaul plan and rejecting the idea that the hospital “lacked a culture of safety.” News of the May 16 letter was first reported by the Wall Street Journal on Thursday.

In a statement Thursday, Collins said he agreed with many of the points made by the doctors, which, he noted, are consistent with the independent review panel’s recommendations.

But he added that “while change is never easy, our shared goal is to make the Clinical Center meet or exceed standards and expectations in every single area of its function.”

Patient safety issues prompt shake-up at NIH hospital

The growing conflict follows an April report from the task force appointed by Collins that said research needs and interests at the Clinical Center had taken priority over ensuring patient safety.

The blunt review revealed that the hospital had no adequate system for individuals to anonymously report errors in care or treatment that might have caused serious injury. It also noted that supervisors failed to appropriately address situations that were identified.

The review was launched last year after the NIH suspended the operation of a unit that manufactures drugs for clinical research when an inspection discovered contamination and other problems.

In April, the NIH suspended production at two other laboratory manufacturing facilities after an internal inquiry determined they were not in compliance with safety standards and posed potential risks to patients.

No one was harmed in those incidents, but five years ago, the hospital faced a superbug outbreak that left seven patients dead and was not detailed until researchers reported it in a scientific paper a year later.

The 63-year-old hospital is the largest of its kind.It sees thousands of patients with rare and difficult diseases, many of whom enroll in NIH clinical trials as their last hope. The free, cutting-edge care has led to numerous medical breakthroughs.

NIH hospital needs sweeping reform to protect patient safety, panel says

But most physicians and researchers conducting studies on those patients report to the NIH’s 27 institutes and centers, not the hospital’s managers. That diffusion of authority “makes central decision-making and accountability nearly impossible,” the review found.

Gallin, who started the patient group in 1998, has drawn widespread admiration for his responsiveness to patient needs, said Jerry Sachs, one of 14 patients who signed the letter to Collins. Sachs said he and two others began writing the letter after Collins announced the shake-up and have not had contact with Gallin or the protesting physicians.

“We know this guy’s dedication,” he said of Gallin. “We know these people and . . . their expertise and their extraordinary work.”

The physicians’ letter, released by the NIH late Thursday, contends that the review panel and media coverage “demonized [hospital] leadership, demoralized highly effective employees . . . and alarmed our patients.” It was signed by seven department heads and distinguished senior scientist Harvey Alter.