In shutdown's aftermath, medical research could see delays

Oct 18, 2013

Researchers operating on federal grants have welcomed the end of the partial government shutdown. As federal employees return to work, IPR’s Durrie Bouscaren considers some of the lasting implications for medical research in Iowa. 

At the University of Iowa Hospitals and Clinics, Doctor Sue O’Dorisio is working on a drug for children with brain cancer. She pulls up an MRI image from a young woman who participated in one of her clinical trials—a tumor sits at the base of her brain.

"This is the only area that would receive the radiation," O'Dorisio says, pointing to the orange-sized lump. "This would not be damaging to their bone marrow, so they wouldn't have the low counts and wouldn't be as immune suppressed, wouldn’t be as likely to get infections."

O’Dorisio’s new drug works kind of like a seek and destroy missile. The first dose is an imaging agent, that marks the tumor so doctors know the drug will work. In phase two, the drug enters the bloodstream through an IV and goes straight to the tumor.

O’Dorisio’s cancer drug is one of thousands of projects around the country that are funded by the federal government through the National Institutes of Health. Her team is waiting on FDA approval for a clinical trial of the drug for about 40 children with cancer, who have not responded to other treatments. FDA approval takes time, but O’Dorisio worries it will take longer following the government shutdown.

"We were hoping to start in January. We almost certainly won’t make that deadline now. We may not even hear from the FDA until January," O'Dorisio said. 

In an email, the FDA did not comment on whether researchers should expect delays in the shutdown’s aftermath—but said they have continued to monitor submissions over the past three weeks.

In the past few years O’Dorisio says federal budget cuts and the sequester have cut her project’s funds over and over. It got to the point where she realized she couldn’t afford to keep a medicinal chemist on their research team. Recently, a private foundation called Alex's Lemonade Stand selected her for a $100,000 grant.

"That grant will allow me to keep my lab going and keep our research going while the government gets up and running, where nobody knows how long that’s going to take," O'Dorisio said. 

In early October, Senator Tom Harkin spoke on the Senate floor to protest the National Institutes of Health in Bethesda, MD being forced to stop enrolling new patients in 497 clinical research trials.

"Mr. President. These are ongoing, clinical trials, right now. Stopped. Fifty of them involving children with cancer. What do you say to those kids, what do you say to those families?" Harkin said. 

For those 16 days, NIH couldn’t review new research grants, either.

Jennifer Lassner works in the University of Iowa’s Division of Sponsored Programs.

"October is actually busy for grant deadlines," Lassner said. Many of those deadlines will now be rescheduled, and Lassner's office held at least 60 applications for various federal grants in-house during the shutdown.

UI receives the most medical research grants from the NIH of any entity in the state—362 awards totaled about $144 million in 2013.

Lassner says that although UI researchers received no stop work orders, new grant applications couldn’t be submitted, and some federal agencies outside the NIH weren’t able to reimburse the university for research costs as they usually do. Lassner said the school was able to receive those funds after the shutdown ended, but they're expecting delays in receiving grant awards in the spring. 

On Friday morning, the National Institutes of Health released a statement on the shutdown's effects on their research: 

"NIH staff is reporting to work on their regular schedules and NIH is ramping up to full operation as quickly as possible to recover from the impact of the shutdown. The NIH operates a world class hospital called the NIH Clinical Center where every patient is on a research protocol.  During the shutdown only a small number of new patients with life-threatening illnesses were admitted and only one new clinical trial involving such patients was started.  The NIH Clinical Center is now fully operational and again initiating new clinical protocols and resuming its normal patient admission process.  This was critically important since the hospital sees many seriously ill patients.

NIH has about 6,000 scientists who conduct research in the agency’s own research laboratories. While some basic and translational research projects involving large or unique investments of resources continued at a greatly reduced pace to protect these investments, the majority of research projects were placed on hold. This has resulted in a profound loss of momentum. Hundreds of experiments will require starting over, which may take many months. 

More than eighty percent of the NIH budget is awarded competitively to over 2,500 universities and research institutions throughout the U.S. to conduct life-saving research.  While researchers with existing grants were able to draw down funds during the shutdown, NIH was not able to process new grant applications or make any new or continuing grant awards.  All submission deadlines for grant applications that were scheduled in October are being rescheduled for November so that applicants can have access to NIH staff to assist with the application process.  Hundreds of peer review meetings that had been scheduled in October must now be rescheduled, and there will be some delays in grant awards. Specific dates will be shared with the research community through the NIH Guide for Grants and Contracts."