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NIH Clinical Center Report Criticized

Clinicians and researchers at the National Institutes of Health's Clinical Center are disputing the findings of a report that examined safety and quality standards there, the Wall Street Journal reports.

NIH commissioned an outside taskforce to review procedures at the center following a series of contamination and oversight issues there. In April, the taskforce released its report, which recommended the center establish a research support and compliance office, systems to monitor and enforce safety and quality standards, and reinforce leadership and authority.

Based on that, NIH Director Francis Collins decided to change up the leadership by creating three new posts, including a CEO to oversee the Clinical Center. Those changes would then mean the ouster of Clinical Center Director John Gallin.

According to the Journal, eight senior physicians and researchers at the hospital wrote a letter to Collins last month decrying the report's conclusions. While the letter authors noted there were "important safety-related issues" at the center's pharmacy, they were "dismay[ed] with the process and decisions" and said the report "demonized" the hospital's leadership and "demoralized highly effective employees."

As the Journal notes, the issues that sparked the review revolved around the center's pharmacy rather than the hospital at large. However, the taskforce concluded that the issues at the pharmacy reflected wider problems in the structure and culture of the Clinical Center. The "lapses in safety and compliance in the sterile manufacturing components of the pharmacy were likely symptomatic of more systemic issues in the structure and culture" of the hospital, the report said. It also said that patient safety had become "subservient to research."

The physicians and researchers disagree in their letter. "The implication that these [issues] indicate a culture that overlooks patient safety and/or reflects a general attitude of putting research considerations ahead of patient care and safety is, quite simply, incorrect," they wrote. 

Collins tells the Journal that he is taking these comments seriously.

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