The National Institutes of Health's response to infection control issues at a specialized pharmacy in its hospital in Bethesda, Md., has put clinical trials in jeopardy and patients on the backburner, according to an in-depth report from The Wall Street Journal.
In 2015, fungus was found in two drug vials made at the pharmacy. In response, Director Francis Collins, MD, PhD, convened an outside panel, known as a "red team," which investigated the NIH and released its findings in April.
Based on the red team's findings, the NIH suspended production at two facilities that make materials for research participants in April and decided to not enroll new patients in affected trials until it resolved the problems. Dr. Collins also restructured leadership at its research hospital.
Inside the NIH, a group of senior physicians have been critical of Dr. Collins' response to the expert panel's findings.
"The destruction of this fine-tuned medical machinery and its service to patients and scientists is a tragedy," said Markus Heilig, MD, PhD a former clinical director at NIH who is now director of Centre for Social and Affective Neuroscience in Linköping, Sweden, according to the Wall Street Journal.
Indicative of the slowdown at the center, enrollment at the NIH hospital in 2016 dropped 37 percent from April 30 through Dec. 31. An immunotherapy lab at NIH's Cancer Institute shuttered for three months in 2016, and the center now operates at reduced capacity and is able to offer breakthrough treatments to fewer cancer patients.
Recently, the NIH has made overwhelming progress in the treatment of metastatic colon cancer. Since news of this progress was published in The New England Journal of Medicine in December, 50 patients a week have pursued admission in the NIH trials, according the Wall Street Journal.
"We're turning away many people, the overwhelming majority of whom have metastatic cancer not responding to other treatment," Steven A. Rosenberg, MD, PhD, NCI's chief of surgery, told the Wall Street Journal. Dr. Rosenberg said he treats approximately six patients a month due to restrictions and could probably double the number treated otherwise. "We have treated over 1,000 patients in a row without giving a contaminated treatment to a patient."
The criticism leveled at Dr. Collins comes at an inopportune time as the current director hopes to keep his post once Donald Trump assumes the presidency.
To read the Wall Street Journal's full in-depth report, click here.
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