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One Year Into A New Administration, Funding for Biomedical Research is Mixed Bag
Some Gains for Neurology, But Stability of Funds is A Concern

ARTICLE IN BRIEF

Investigators discuss how recent trends in biomedical funding are affecting neurology research.

Federal support for biomedical research has been a mixed bag for neurology more than one year into the Obama administration. Investigators have benefited from the boon of stimulus funding, but are bracing themselves for the possible drop-off when the funds dry up. And while President Obama's plan to combat the federal deficit with a freeze on non-discretionary spending sent a chill through the scientific community, his 2011 budget request to Congress increases the budget of the NIH by $1 billion, to $32.1 billion.

“The NIH received an increase of 3.2 percent in the President's budget,” said Story Landis, PhD, director of the NINDS. “NINDS received an increase of 2.8 percent, which would result in an annual budget of $1,681,333,000. This increase is particularly noteworthy since the Department of Health and Human Services actually had a small cut of 0.1 percent in its overall budget.”

The President also has stressed the importance of translational research that may lead to useful therapies more quickly than basic research. In releasing the budget request, the Office of Management and Budget called on the NIH to “initiate 30 new drug trials in 2011, and double the number of novel compounds in phase 1–3 clinical trials by 2016.”

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DR. ALAN FADEN: “Most increases in research funding over the past five years have come not from the federal government but from the pharmaceutical industry. But the pharmaceutical industry has begun to slow the rate of funding growth.”

If passed, the budget increase would help alleviate the effects of a 2 percent decline in overall biomedical research funding from government, private and industry sources in 2008 calculated by the authors of a Jan. 13 analysis in the Journal of the American Medical Association (JAMA). “Since 2005, the rate of increase of research spending has slowed, with a compounded annualized growth rate of 3.4 percent (2003–2007) vs. 7.8 percent (1994–2003),” the authors stated.

STIMULUS FUNDING

In the past year, however, several investigators in neurology have benefitted from additional funds from President Obama's economic stimulus package. Fay Bahling Horak, PhD, professor of neurology and biomechanical engineering at Oregon Health and Science University in Portland, received stimulus funds to develop a system for measuring mobility in Parkinson disease (PD). The grant enabled her and her colleagues to team up with a local start-up company to develop, produce, and test the Timed Up and Go Test to measure balance and gait in people with PD.

Stimulus funding has helped other investigators preserve jobs to help support research projects. For example, Anthony DiMarco, MD, professor of physiology and biophysics at Case Western Reserve University in Cleveland, is developing a method of stimulating cough in people with spinal cord injury so they won't be so susceptible to pneumonia. He said “the grant meant that some [research] jobs would be preserved.” That was also the case for Frances E. Jensen, MD, professor of neurology at Children's Hospital Boston, who received stimulus funds for her research into controlling neonatal seizures, in part because the money provided jobs for researchers. She noted that stimulus funding allowed her to add a new project to her existing funded work. But she and other investigators were only cautiously optimistic about the trend for future research funding.

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DR. STORY LANDIS: “NINDS received an increase of 2.8 percent, which would result in an annual budget of $1,681,333,000. This increase is particularly noteworthy since the Department of Health and Human Services actually had a small cut of 0.1 percent in its overall budget.”

“The stimulus money may have saved the careers of people who were running low on funds,” Dr. Horak said, “but in 2011, when that money is done, we could find ourselves approaching a cliff. There will be a flood of good grants going in based on the work funded by the stimulus money. People will develop these excellent proposals for their next project based on the great pilot data they are getting.”

Funding such proposals will remain a challenge, Dr. Horak continued, even if Congress approves the spending boost for the NIH. “Neuroscience in particular is exploding,” she said, “and the funding has not kept up with number of excellent young people going into research. I mentor several young neurologists who are very good, but even if they're exceptional scientists and good writers, they still don't get funded sometimes. It's disheartening when only five of 100 get funded.”

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DR. ANTHONY DiMARCO, who is developing a method of stimulating cough in people with spinal cord injury so they wont be so susceptible to pneumonia, said stimulus funding “meant that some [research] jobs would be preserved.”

PHARMA FUNDING

The JAMA report noted that support from pharmaceutical, biotechnology, and medical device companies increased to $58.6 billion in 2007, an increase of 25 percent when adjusted for inflation from the $40.0 billion provided in 2003, according to the authors, but biomedical device firms increased more than biotechnology companies, and both increased more than conventional pharmaceutical firms.

Although research and development by biopharmaceutical companies has increased steadily in recent years, reaching $65.2 billion in 2008, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical industry is hurting, and neurology is likely to be disproportionately affected, said Alan Faden, MD, professor of anesthesiology, anatomy and neurobiology, neurosurgery and neurology at the University of Maryland School of Medicine, and past president of the American Society for Experimental Neurotherapeutics.

“Most increases in research funding over the past five years have come not from the federal government but from the pharmaceutical industry,” he said. “But the pharmaceutical industry has begun to slow the rate of funding growth.”

The JAMA study supports that perception. Despite the 25 percent increase in biomedical research funding from 2003 to 2007, the annual growth rate of such funding declined from 8.1 percent from 1994–2003 to 5.8 percent for 2003–2007. Also, from 2003–2008 “the number of new and novel and device approvals did not increase,” the authors found.

Drug failures affect neurological research disproportionately, Dr. Faden said, because drugs for neurological conditions tend to fail in the later stages of clinical trials, and therefore result in greater financial losses.

“In many areas of clinical neuroscience research, the success rates are typically lower than for cardiovascular, oncology, or infectious disease research,” he said. “Moreover, many trials in clinical neuroscience fail at phase 3, whereas failures in other fields are often observed earlier.”

For example, there have been 30 phase 3 trial failures of treatments that confer neuroprotection in traumatic brain injury, according to Dr. Faden, and more than 100 failures of stroke treatments.

“The only success in either area has been the use of tPA [tissue plasminogen activator] for thrombotic stroke, but even there the therapeutic window is very narrow, which has limited its implementation,” he said. “This has led to an increasing sense of nihilism in the drug industry with regard to such studies, which is unfortunate since considerable advances have been made at the pre-clinical science and methodological levels – advances that may increase the likelihood of future successful trials in those important areas where effective treatments are lacking.”

The future of research funding for neurology will require re-educating Congress about the realities of biomedical research, investigators told Neurology Today. “I think Congress needs to be made more aware that research is a labor-intensive process,” Dr. Jensen said. “They're not going to see new drugs immediately. It's going to take a while. Science is a big-ticket item, and I hope we can win Congress and the President over for more than a 3 percent increase. It should be vastly higher if we're going to avoid going over a cliff in 2011.”

References

Dorsey ER, de Roulet J; Moses H III, et al. Funding of US biomedical research, 2003–2008. JAMA 2010;303(2):137–143.
Office of Management & Budget Fact Sheet on NIH Budget:www.whitehouse.gov/omb/factsheet_department_health/