A key contractor at the National Institutes of Health is urging employees to forgo compliance with federal guidelines, citing consent agreements signed by patients that acknowledge the risk of participating in clinical research at the agency, Roll Call has learned.
The agency denies the contractor’s actions and that it would ever relax compliance.
While the situation has prompted knowledgeable individuals to speak out, others welcome the contractor’s alleged approach and see it as the paradigm shift needed to revitalize a stagnant research portfolio and improve widespread morale issues.
Just over two years after revelations of serious safety issues shook the NIH, internal disagreements over the federal standards that should govern how research is conducted at the agency threaten to unravel any progress made in the wake of that scandal.
At the heart of the debate is what exactly the mission of the agency is.
NIH Director Francis Collins — in the aftermath of the discovery in 2015 of two contaminated vials of medicine in the agency’s Clinical Center scheduled to be used on patients — pledged that all research conducted on the agency’s premises would adhere to federal manufacturing standards, a benchmark met by giant pharmaceutical companies with billions more in available funds each year.
That received substantial internal criticism from researchers who say such an approach would cripple ongoing work on breakthrough medical treatments, some of which have had miraculous results for patients that are largely faced with no other options.
“It was a politically expedient and potentially protective move to avoid criticism of contamination, which definitely needed to be addressed. But it then overreached to affect everybody doing anything experimental,” said one source, who spoke on the condition of anonymity to discuss internal agency issues. “Everything we do is a prototype. It’s like making the first Macintosh or the car you are trying to put on the road. There were problems, there is definitely room for improvement.”
There remains an ongoing House investigation into the issues at the NIH Clinical Center, a 200-bed hospital located on the Bethesda, Maryland, campus.
To comply or not to comply
Among the most startling developments for some are the calls by one key contractor to avoid adherence with certain federal compliance standards.
The contractor, Dondi Pulse-Earle, joined the NIH in January 2017 as associate director in the Office of Research and Support Compliance. Because she is a contract adviser, Pulse-Earle does not retain the ability to make final decisions.
Still, recent comments have struck alarm bells among some.
At a meeting to discuss construction of a new lab for renowned National Cancer Institute scientist Steven Rosenberg, Pulse-Earle said certain Food and Drug Administration standards did not need to be met.
As a result, “certain aspects were removed to remove cost since these standards were not necessary for this facility,” according to meeting notes obtained by Roll Call, corroborated through an anonymous whistleblower tip. Those notes and Pulse-Earle’s comment were both verified through the source with knowledge of internal agency discussions.
Rosenberg’s lab was closed in 2016 after compliance issues as a result of an independent audit launched after the issues in 2015 at the Clinical Center.
The anonymous whistleblower, who provided information to Roll Call sent via the U.S. Postal Service, wrote the new facility would be built “without the high-level air filtration and materials used by everyone else for that type of facility.”
The NIH, after a thorough review, denied these allegations.
“All projects being designed and constructed at the NIH Clinical Center or other NIH locations are fully compliant with all requisite standards, including the most rigorous FDA standards,” the agency said in an emailed statement.
The source with internal knowledge described Pulse-Earle as a “moderate Republican, easy to attack from both wings but trying to do the right thing.”
“She is trying to find a reasonable, middle-of-the road thing that answers, that balances risk and benefit, that addresses concerns about safety and improving the conditions, at the same time not stopping the work, and I think she’s been the first reasonable voice in this entire discussion,” the source said.
The issues stem around the materials produced within Rosenberg’s lab and what FDA guidance should be applied. The products developed are infused into patients and are required to be manufactured under what are called aseptic conditions.
The FDA in 2004 released a guidance document outlining the standards that must be met for products developed in under those conditions that have been in use since.
But some argue that because the research done at NIH is considered experimental, it would therefore fall under a separate FDA guidance document regarding early-stage developmental products.
“The FDA, which has issued guidance already for … how a lab, a developmental lab, what standards they should have to meet, and they are very different than industrial, big pharma … standards,” the source said. “This is developing brand new therapies … for people who are dying within months with no options.”