For many years, we have been very fortunate to be supported by the NHLBI, as well as NIA and National Institute of Neurological Disorders and Stroke (NINDS), he continued, but “we understand that their payline is very low and that they aim to fund more investigator-initiated research grants accordingly by cutting back the amount of money they're giving to contracts, particularly prospective epidemiologic studies.”
We don't know what next year holds, said Dr. Wolf. “It's unfortunate because it really does impinge on our ability to do science,” he said. “We're pursuing a number of strategies to replace this loss of funding and hope to carry on as we did after a similar funding cut-off in 1968.”
REDUCING RESEARCH COSTS, BUT AT WHAT PRICE?
“Our purchasing power [at the National Institutes of Health] is down to where it was in 2000; it's not good,” said Walter Koroshetz, MD, deputy director of the National Institutes of Neurological Diseases and Stroke (NINDS). “As a result, NINDS is struggling to get needed resources to our investigators. NINDS is committed to preserving as stable a funding environment as possible for the majority of our investigator-initiated research. However the large multicenter projects, which are most expensive are really under the microscope. That includes some of the big epidemiologic studies, centers grants, program project grants, and clinical trials. ... To advance the science, we all realize that you need a portfolio of different projects, including the big epidemiologic projects, clinical trials to test new therapies, research infrastructure, etc., which may carry a lot of upfront costs.”
Dr. Elkind acknowledged that many epidemiologic studies “involve recruiting large numbers of people and following them over time, which means lots of research assistants, making telephone calls and interviewing people, and a lot of tests like ultrasounds, MRI scans, neuropsychological evaluations — all fairly labor-intensive, technology-intensive tests, which can be costly. So the Institutes have to decide: Are they going to fund a few of these large studies or are they going to fund a lot of smaller studies? I think they haven't yet figured out the optimal way to go about this.”
Regarding his own project, Dr. Elkind, an associate professor of neurology and epidemiology and the fellowships director in the neurology department at Columbia University School of Medicine, said that the Northern Manhattan Study was fortunate to only receive a 4-5 percent funding cut due to sequestration. However, Dr. Elkind and colleagues are already planning strategies for keeping their research afloat in spite of continued budget cuts.
“We would like to think that we'll be successful by leveraging our experience doing large epidemiologic studies into conducting more interventional research that has a more direct outcome in terms of patient care,” he said. “We think we're in a good position to do these kinds of studies, but we also know that if we do intervene in our cohort, we lose the ability to conduct the observational study in a natural setting that has been the strength of our research in the past.”
Ultimately, Dr. Elkind said, “we recognize that there are fiscal constraints federally and there may be a political climate that is less conducive to research, so we have to focus in on those questions that we think are the most important, make a strong case for why the funding is needed, and probably emphasize things that we think have the highest likelihood of being successful interventions.
“The plus-side is that it will cost less money, but the downside is that we may not make as many discoveries as perhaps we did in the past, and we may miss things that could be important,” said Dr. Elkind.
DR. WALTER KOROSHETZ: ‘ON SURVIVING SEQUESTRATION’
In his oral testimony on May 15 to the Senate Appropriation Committee for fiscal year 2014, National Institutes of Health Director Francis S. Collins, MD, PhD, said, “Many of my role models, top scientists with amazing ideas and the potential to change the world, are unable to get funding. I can't erase the fear that this is my future.... Sequestration is compromising the future of medical research and slowing improvement in the health of all Americans.”
In order to survive sequestration, Walter Koroshetz, MD, deputy director of the National Institute of Neurological Disorders and Stroke, told Neurology Today, researchers should try to address this question: “How can we get the answers that we want for less cost?”
“We've been trying hard to encourage more cost-effective research, by eliminating inefficiencies in the system, for example, by creating effective clinical trial networks. In the old system, a clinical trial would get funded, the government would spend a lot of money starting it up, do its work, and would spend more money as it closed down. And then you'd repeat the process for another study and there would be a lot of redundant costs.” By creating a clinical trial network, such as the NINDS Stroke Trials Network and NeuroNEXT, the start-up and the close-down costs are taken away, he explained.
“Another question neurology researchers have to ask, he added, is whether we can employ new technology to cut costs. Do we really need study participants to come in for all the follow-up visits? Or can we do follow-ups using Skype? Would that be more efficient? Easier for the patient? Cost less?” Other technologies, such as electronic medical records, said Dr. Koroshetz, are also touted as presenting an opportunity for gathering more cost-efficient answers since the data are already being collected in the practice setting.
“It wasn't so expensive to do research when I first started my career in the 1970s and 80s, but it wasn't as complicated; in those days, the practitioners were researchers. In these days, there are researchers and then there are practitioners, but it's harder to have research in practice. Would it be more cost-effective to start getting data out of practice, and would that have lots of other benefits by involving more patients and doctors in research?” he asked.
While the focus in medical research is shifting to cost-effective care, the government is also shining some light on the importance of patient-reported outcomes. In many studies, Dr. Koroshetz explained, the outcome measures are neurologic scales or extensions of the neurologic exam that the neurologist performs, “but what we really care about is how the patient is doing.” With the use of the Internet, he said, there are groups like 23andMe that are using patient-reported responses as a statistically valid research tool, for example, in the study of lithium use in people with amyotrophic lateral sclerosis. “We did a study that cost us a couple of million dollars, and this Internet-based study got the same answer, but it cost hardly anything,” Dr. Koroshetz told Neurology Today. “The Patient-Centered Outcomes Research Institute funds these very patient-oriented research questions.”
The cost-reduction strategies are a bit more tenuous when it comes to imaging tools in neurology research, Dr. Koroshetz acknowledged; “we're so dependent on imaging because it is our window into what is going on in the brain or spinal cord; it's a great tool but it's a big problem in terms of cost.” NIH is working with GE right now to build a head-only MR scanner that would be much less expensive, he said.
Nevertheless, we must remember that the US investment in neuroscience research is still large, Dr. Koroshetz said, and “although financial concerns certainly impact the budget, working with the neurology community we're going to advance the science in spite of more difficult financial times. Neurology is not going to stop improving the health of our patients. We still need young people to come in with their fresh ideas, and there are lots of opportunities in neurology for young people to make great discoveries.
“We've been used to budgets increasing all the time and that's not going to happen... we can't give up. We just have to get more clever.”
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•. See the AAN President's Column in the October issue of AANnews
for more on the impact of NIH budget cuts on neurology: “How Seriously Are Sequestration Cuts Affecting US Biomedical Research?”
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