Clinical Shutdown: Critically Ill Patients Caught In Bureaucratic Nightmare

Oct 3, 2013
Originally published on October 3, 2013 3:15 pm

For some critically ill patients, the government shutdown feels like a matter of life or death. And it has nothing to do with funding or defunding the Affordable Care Act.

The patients in question have pinned their hopes for survival on clinical trials funded by the the National Institutes of Health, and without that money, the studies are being halted — some of them before even they start.

For one man suffering from end-stage bile duct cancer in Boston, the shutdown means his upcoming clinical trial can’t be registered on a federal website forced to stop processing applications. That trial has been indefinitely postponed.

He says traditional chemotherapy is no longer shrinking his tumors. The National Institutes of Health estimates that for each week the shutdown continues, its hospital in Bethesda, Maryland, will have to turn away 200 patients — 30 of them children — seeking to enroll in studies.

Reporter Deborah Katz and researcher Dr. Thomas Michel join Here & Now to discuss the short and long-term impacts.


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Well, we have been hearing how the shutdown has affected the National Institutes of Health. In a moment we're going to look at lab research but first trials involving patients. We've heard that the National Institutes of Health estimates that its own hospital in Bethesda, Maryland, will have to turn away 200 patients, 30 of them children, for every week that the shutdown continues.

Deborah Kotz is a health reporter for The Boston Globe in Washington, and Deborah, this has been a matter of life or death for some. You have an example.

DEBORAH KOTZ: Yes, actually, there's a man named Leo Finn(ph) living in Cape Cod who has been traveling to Dana-Farber Cancer Institute in Boston for treatments for his metastatic bile duct cancer, was told on Wednesday not to come in to Dana-Farber to get a bone scan and fill out some paperwork for a trial that he was about to enter for an experimental drug, and that was because of the government shutdown.

YOUNG: Well, and what do doctors at Dana-Farber tell you? Isn't it possible that there's some other way to treat him, or is the problem, that these are experimental programs, the funding and the trials only come through the National Institutes of Health?

KOTZ: Well, what happens is actually in order to start any new trial, whether it's funded by NIH or the government or just funded by industry, researchers have to register it on the government's website, and that website is down. And it's not - you can put an application in, register a trial on it, but no one's going to process it while the government is shut down.

So until that trial can be processed in the system, the researchers are not really allowed to start a new clinical. If a clinical trial is already underway, they can continue it, but because this patient at Dana-Farber is the first one to get this drug for his kind of cancer, they consider it to be a new trial, and that's where the glitch is coming in.

YOUNG: Tell us other ways that research - well not just research because we're going to talk about that in a second but these clinical trials and whatever comes from the NIH are being impacted.

KOTZ: Well, I mean, I think that it's - you know, we don't want to scare people too much, but I think what's happening is that there are people who are, you know, trying to get into new trials who are not able to. There are people who may have been traveling to NIH for experimental treatments that are told that they can't.

And even on a broader base, there are government-run hospitals, things that are run for the military who are on active duty, as well as the VA hospitals, that certainly have not shut down because the government has shut down, but they do have some people who are on furlough, and a result of that, people who may be calling to make appointments just for routine care may be told to wait a few weeks or maybe put on hold for a lot longer, so they may be getting some frustrations there, as well.

YOUNG: That's Deborah Kotz, who covers health for The Boston Globe on the impact of the shutdown on the National Institutes of Health. Deborah, thank you.

KOTZ: My pleasure.

YOUNG: And let's turn to research with Dr. Thomas Michel. He's a senior physician in cardiovascular medicine and researcher at Brigham and Women's Hospital in Boston. Dr. Michel, how is the shutdown affecting not just you but your colleagues?

THOMAS MICHEL: Well, I think that the challenges in biomedical research started well before the shutdown. It actually started well before sequestration, with a declining federal budget for biomedical research. Sequestration certainly impacted that in a very substantive way, and the shutdown seems like it's another nail in the coffin.

YOUNG: Well, you had colleagues who were supposed to be at grant review panels, in other words going to the NIH in Washington to propose their work in order to receive funding. That was supposed to happen this week, and it was canceled?

MICHEL: Yes, October is actually a very busy month for the review of new grants at the National Institutes of Health, and those grants and review sessions are - some have been canceled. Others are going to be delayed. And these involve the engagement of scientists from across the country to try and access what should move forward from the standpoint of new research programs, and that's obviously going to be delayed.

And there's that short-term impact, but I think there's a longer-term impact that also has me deeply concerned, which is that it takes a long time to train a biomedical scientist, and these are people now that are looking at an environment for biomedical research in the country that is at best challenged.

YOUNG: Well, in other words you're worried about young people coming into the field, looking at what's happening today.

MICHEL: I think that's a major concern. I think that the long-term impact of the increasingly grim environment for support of science in general in the country and biomedical research in particular is one that has many of us involved in training quite concerned.

YOUNG: Well, we know other hospital researchers are worried about another grant application deadline, which is Monday. Do you have one, as well?

MICHEL: I have one that's actually going to be reviewed later in October. Who knows whether we will be back on track by the middle of the month, but it's entirely possible that we are not, and if that's the case, then that grant won't be renewed until some point in the future.

YOUNG: Well, Dr. Michel, we mentioned you worked in cardiovascular medicine. You work in biochemistry. You're trying to understand cells in the blood to prevent things like heart disease. I'm presuming you feel that this is important work that needs to continue.

MICHEL: Well, I think that there is a tremendous amount that remains to be learned. We have a huge burden of diabetes in this country. we have an aging population. Understanding both at the population level, people that study biomedicine at the level of populations, people that study at the level of cells, people that study at the level of molecules all have important contributions to make to advance knowledge and to enhance our ability to diagnose, treat and prevent cardiovascular disease.

YOUNG: Dr. Thomas Michel, senior physician at Brigham and Women's Hospital here in Boston, thank you.

MICHEL: Well, thank you very much as well, and I appreciate your interest in this very important problem.

YOUNG: So are you part of trials or research affected by the shutdown? Let us know at Meanwhile, up next a small business owner who says she thinks that health care reform should be defunded, which is of course at the heart of the shutdown. That's in a minute, HERE AND NOW. Transcript provided by NPR, Copyright NPR.