Shutdown halts NIH drug trials as researchers hit brakes on preclinical research

The National Institutes of Health normally enrolls about 200 patients a week in ongoing trials of experimental therapies. Now, with about 73% of NIH staff sitting at home, the agency can't begin any new studies, forcing researchers to turn patients away.

Patients already enrolled in studies are still receiving treatment, The Washington Post reports, and skeleton crews are still checking up on preclinical work and research animals. But the shutdown has trampled ongoing research, leaving remaining staff to just make sure "the cells in the Petri dishes don't die," a furloughed NIH director told the newspaper.

The majority of the furloughs affect NIH's nonclinical operations, and the agency has retained about 2,500 workers to maintain patient care at its Clinical Center in Bethesda, MD, which will run at roughly 90% capacity in the first weeks of the shutdown, according to a Health and Human Services memo.

But while no patients are being roused from bed and sent out into the street, saying no to sick people isn't something NIH is used to. Furthermore, of those 200 patients NIH enrolls in a normal week, an average of 30 are children, the agency said, 10 of whom have cancer.

"Everyone feels absolutely awful," NIH spokesman John Burklow told the Post. "It's antithetical to our mission and why we're all here. … If you have a child who needs help, even if you're told, 'Well, we can't help you today,' it just creates anxiety and frustration, I'm sure."

Beyond its threat to NIH's in-house research, the shutdown has also halted action on grant applications and awards, suspending the millions of dollars the agency doles out to external researchers each year. Also on pause is the BRAIN Initiative, a White House-supported research program to which NIH pledged $40 million.

NIH estimates it runs 1,500 studies at any given time, roughly half of which are clinical trials. NIH's clinical work is often early-phase, including many first-in-human tests of safety and efficacy.

On Wednesday, House Republicans introduced a bill that would restore NIH's funding and allow it to get back to trial enrollment, but Democrats have long said they will entertain only resolutions that reopen the entire government, and the effort has gone nowhere. Meanwhile, about 800,000 federal employees have been sent home without pay since the shutdown began Tuesday.

- read the Post story
- get more from FierceBiotech Research
- here's the HHS memo (PDF)