Federal budget woes continue to imperil cancer research
Patients also are affected by the loss of money available for trials
The impact of the federal budget sequester, across-the-board cuts that went into effect in March 2013 and required the National Institutes of Health (NIH) to cut $1.55 million (or 5%) from all of its 27 institutes and centers, continues to be felt in various capacities across the country.
Barry Stoddard, PhD, who is with the Fred Hutchinson Cancer Research Center in Seattle, Washington, is a 20- year veteran researcher who is developing tools that could revolutionize the treatment of cystic fibrosis, sickle-cell anemia, and Parkinson disease, and worries that one of his major projects is in jeopardy due to NIH cuts. As a result, if he is unable to find alternative funding sources, he may need to abandon his academic research career, according to sources at the center.
Dr. Stoddard is one of many scientists experiencing severe hits to their research. Margaret Offerman, MD, PhD, president of the Federation of American Societies for Experimental Biology (FASEB), says, “Labs are definitely closing down, and I know of a number of very famous and successful scientists who have lost their grants and had to lay off the majority of people in their labs.”
Sharon Dent, PhD, chair of the department of molecular carcinogenesis at The University of Texas MD Anderson Cancer Center in Houston, says she was forced to cut one of her grants by $12,000, which is “almost 50% of a graduate student's salary,” and she is waiting to hear whether another of her grants will be renewed.
“Our department lost $87,000 as a result of sequestration, and that's about to 6 to 7 projects,” Dr. Dent says. “It's a terrible waste, not just in terms of the immediate loss but also in terms of all the effort we've made in bringing researchers up to this level. A lot of young scientists are at risk of not being able to continue in the field.”
The combination of the sequester and the fact that its budget has not been able to keep pace with inflation for 10 years has led the NIH to fund 640 fewer research grants that had scored in the top 17% of submitted proposals, Francis Collins, MD, PhD, the director of the NIH, is quoted as saying in a New York Times column by Thomas Friedman published in September.
“I'm reminded of the Charles Dickens quote, ‘It was the best of times, it was the worst of times,'” says Dr. Offerman. “We have the technology to really improve health and other problems like the environment from our investment in science. At the same time, we have a very motivated, highly driven workforce, but with tight budgets and sequestration, we've lost a lot of ground.”
To illustrate the budget decline, Dr. Offerman notes that in 2003, NIH appropriations were approximately $27 billion, and had increased to slightly above $31 billion prior to sequestration. Although the proposed house budget for discretionary spending has not been detailed, it is estimated that it would be about $24 billion for the NIH, which, when adjusted for inflation, amounts to approximately $17 billion, she adds.
Impact on Cancer Care
Although leaders such as Dr. Offerman have been busy pleading the case for science on Capitol Hill, many in the cancer community are discouraged by what they call the “extreme government dysfunction” in Congress. “I came to Washington, DC, in 1974, and this could not have happened then,” says Chris Hansen, president of the American Cancer Society Cancer Action Network, an advocacy affiliate of the American Cancer Society. “They would have worked together to find a compromise, but now we have a group of people who think that compromise of any sort is inherently bad.”
The end result, adds Hansen, is that “more people are going to die of cancer.” In addition to NIH funding cuts, the Centers for Disease Control and Prevention has felt the sting of sequestration by having to reduce the number of breast and cervical cancer screenings for low-income recipients—offering 32,000 fewer screenings in 2013 than the previous year, Hansen says. “The great irony is the federal government will spend more money through Medicaid to treat these people than if their cancers had been detected early through screening,” he adds.
Patients also are being affected by the loss of money available for clinical trials, including some that will never be launched as a result of cuts. In September, the American Society of Clinical Oncology (ASCO) announced the results of its survey of 345 academic research members to determine the effects of sequestration and found that 27% of respondents had to postpone starting a trial, whereas 23% had to limit the number of patients they enrolled in a clinical trial. “It substantially delays the process of developing new therapies and even jeopardizes the trial altogether because it takes much longer to enroll patients than anticipated,” says Richard Schilsky, MD, chief medical officer of ASCO.
Further findings from the survey included:
- 75% of respondents said their research budgets were cut.
- 44% have had to look for non-federal sources of funding to replace the sequestered funds.
- 38% have reduced their time spent on research.
- 37% had to restrict the research questions or clinical trial endpoints to reduce study costs.
- 35% have had to lay off staff.
- 28% have decided to participate in fewer federally funded clinical trials.
Scientists agree that the funding woes are discouraging a generation of young scientists from either entering or remaining in the biomedical research field. Many researchers who are still early in their careers have not had time to cultivate outside sources of funding the way more established investigators have, Dr. Dent says. “Even before the sequester, the mean age for a scientist to receive his or her first independent grant from the NIH was 42 or 43,” Dr. Offerman adds. “These people are willing to work long hours and train for many years, and when many of them lose their grants, they lose their jobs.”
Adds Paul Bunn Jr, MD, professor of medicine and former director of the University of Colorado Cancer Center, “All this uncertainty makes a career in science less attractive and puts the US at a competitive disadvantage compared to other countries. It's also not clear that in the future US universities will continue be the preferred place for people from other countries to come and train for careers in science.”
At the same time that it has impacted research, the sequester also has cut the Medicare reimbursement rate for chemotherapy drugs, which impacts smaller oncology practices in particular, according to Dr. Schilsky. Because most of these practices have many older patients who are receiving Medicare, they are struggling financially. These practices must make large financial outlays to purchase expensive chemotherapy drugs and are unable to buy in bulk the way larger facilities can. The lower reimbursement rate therefore lowers their profit margin.
In an ASCO spring survey of the community oncology practice community, 50% of respondents said they would not be able to continue care for Medicare patients if they did not have some type of supplemental insurance. In addition, 22% of physicians said they would be closing their satellite clinics, many in rural areas.
The investment in biomedical research has a huge impact on [our] long-term health and global competitiveness, and if we don't continue to make these investments, we are going to suffer widely in the decades ahead.
Still another impact of sequestration is the cut in funds that the US Food and Drug Administration (FDA) had received from manufacturer user-fee applications for new prescription drugs. Although the money came from the private sector, the funds were still cut, which may slow down the Federal Drug FDA's speed in approving new drugs, Dr. Schilsky says.
With regard to cancer research, he is not highly optimistic about federal funding for the NIH in the near future. “As one staffer put it to me, ‘stagnant budgets would be considered a victory.' But the problem with stagnant is it represents another cut. That's becoming the new normal.”
Dr. Schilsky and others caution that this lack of support for research is short-sighted. Many leading cancer and scientific organizations have launched efforts to communicate this message to Congress, ranging from sending E-mail “action alerts” encouraging members to contact their representatives to sponsoring lobbying trips to Capitol Hill. Nevertheless, Dr. Offerman points out that many scientists are so busy trying to do more with less, they often do not have time to contact Congressional representatives to plead their case. “The investment in biomedical research has a huge impact on the long-term health and global competitiveness of the country, and if we don't continue to make these investments, we are going to suffer widely in the decades ahead,” Dr. Schilsky says.
Dr. Bunn agrees, noting that overall investment by the US pharmaceutical industry and venture capitalists, always very robust in this country, will begin to slow under reduced funding. As a result, fewer US jobs will be created as Asian countries such as Korea and China begin to catch up in terms of drug development.
Meanwhile, Dr. Offerman remains hopeful that the situation might turn around. “Congress can come up with alternatives to sequestration by returning to standard appropriations—looking at the value of each program as well as their long- and short-term benefits,” Dr. Offerman says. “I think there's always hope. There are some pretty smart people on Capitol Hill, and hopefully they'll soon realize there's a better way to approach the deficit.”