Complaints from a top scientist at the National Institutes of Health preceded at least a partial rollback of restrictions on the number of patients that could receive treatment in his lab, according to emails obtained by CQ Roll Call under the Freedom of Information Act.
The facility in question was previously closed after an independent audit revealed black mold in the lab, among other major compliance issues.
The correspondences are further evidence of the seriousness of the issues uncovered at the NIH in the fallout of revelations in 2015 of safety problems at the Clinical Center, a hospital located at the agency’s Bethesda, Maryland, campus, and the significant and swift measures taken by leadership in its wake.
It also shows the internal pushback officials received in their attempts to navigate a situation that spawned two separate congressional investigations, one of which remains active.
In an email to top NIH officials, Steven Rosenberg, a renowned scientist and chief of surgery at the agency’s National Cancer Institute, said a new policy proposal that would have limited the number of patients that could undergo therapy in his lab to one to two individuals a month would “continue to decimate our program.”
“Our translational research has largely ground to a halt, we have no patients in the hospital, our staff is increasingly demoralized (and some talking about looking for other jobs), our patient referral patterns built over many years is being disrupted and most importantly, we are daily turning away cancer patients who have no other alternatives that I believe we can help if not cure,” he wrote.
Rosenberg did not respond to request for comment. He recently vented to The Wall Street Journal about the difficulty in conducting clinical research in the aftermath of revelations in 2015, when fungus was found in two vials of medicine intended to be used on patients.
Individuals copied on the email exchange included William Dahut, the Center for Cancer Research’s clinical director and Kathryn Zoon, interim director of the NIH Office of Research Support and Compliance.
The lab run by Rosenberg, who treated President Ronald Reagan’s colon cancer, was closed in 2016 after an independent auditor uncovered significant compliance issues. It underwent renovations and was reopened, but with a limit imposed on the number of individuals that undergo therapy there each month. A new facility is currently under construction.
One of the key complaints from Rosenberg was the impact the new patient policy would have on his immunotherapy program, a type of cancer therapy that relies on an individual’s own immune systems.
“Our program of immunotherapy research depends on our ability to treat a minimum of up to 2 patients per week and that was my understanding of where we were headed in the short term until additional facilities could be made available,” he wrote. “I do not think that anyone in the NIH leadership intended our program to be so impacted. Can we meet on Monday to agree on a plan forward for the renovated facility? I need your help.”
The NIH said operations in the facility were suspended on April 6, 2016, and reopened on Sept. 21, 2016, after improvements were made. Rosenberg, the agency said, was then allowed to treat four patients a month, an increase from the “one to two patient” policy the NIH initially tried to impose.
Currently, six patients per month can undergo therapy in the lab.
In a memo attached to the correspondence, Rosenberg presented what is referred to as an “analysis” of a route to treating additional patients beyond one to two per month. That document was not made available in the FOIA response and the NIH did not respond to requests to provide it.
In one exchange, Rosenberg said he would “try to contribute some funds” if necessary from a program at the NIH that allows industry and academia to use government facilities in partnership with the agency.
“This has been the most difficult period for me in all of my years at the NIH. I believe that we have developed and are developing innovative new immunotherapies for patients with advanced cancer and I am anxious to resume our work,” he wrote.