Questions on NIH Funding Leave ENT Researchers Pondering Next Steps and Leaving Everything Up in the Air

Early in his career, Lawrence Lustig, MD—now the chair of otolaryngology–head and neck surgery at Columbia University in New York— was studying basic cell physiology with a colleague at the University of California, San Francisco, and found a mouse model for congenital deafness that responded to gene therapy.

Using crucial funding from the National Institutes of Health (NIH), they were able to move on to other types, including diseases associated with the rare gene otoferlin. Since then, a therapy targeting otoferlin has been developed for people using a similar technique that was developed in Dr. Lustig’s lab and is having life-changing effects today.

Dr. Lustig said he had just administered the treatment in a child in the previous week.

“That kid’s likely going to go from needing a cochlear implant now to having natural hearing,” he said. “That whole process was enabled by the research funding coming from the NIH. If that never happened, we wouldn’t be here today.”

With the Trump administration interrupting research at academic medical centers, court fights over the proposal of a 15% cap on the indirect rate, diversity research de-funded, and a proposal that would cut the NIH budget by 40%, traditionally robust federal support for medical research in the U.S. has eroded, and the research community shows little confidence that this will change in the short term.

This fog of uncertainty has led ENT researchers and research centers—along with academic research overall—to rethink how their research gets funded, what they research and how, and even whether the country still believes that science is worthwhile.

“I’m passionate about hearing, I’m passionate about solving why people get hearing loss and developing treatments for hearing loss—this is like an attack on that very premise,” Dr Lustig said.

No one is sure how much funding will ultimately be reduced. The proposal to cut the indirect rate to 15% down from 50% or more at many centers would mean much less money for the general research infrastructure that is not associated with any specific study or trial, but that is crucial to many of them. But that proposal is being litigated, and the result is unknown.

The budget proposal for the coming fiscal year called for a 40% cut in NIH funding, which would be a cut of about $20 billion. But Congress has pushed back, and it is unknown whether that amount will ultimately be passed legislatively or, if it is, how the reduction would materialize—for instance, how much would affect research projects, which projects would be funded and which would not, and how much this would affect the infrastructure of research, such as labs. The federal government has also proposed that the National Institute on Deafness and Other Communication Disorders (NIDCD) be absorbed into other agencies, another change that could affect how research is evaluated and funded.

Dr. Lustig said the university, which had its federal research funding totally halted on the grounds that Columbia had not done enough to address anti-Semitism on campus, had successfully argued, on humanitarian grounds, for the continuation of trials involving life-saving drugs. And, in late summer, Columbia reached a settlement with the government to restore that funding. But the dread of what might be on the horizon remains, researchers and administrators say.

“I think everything’s up in the air—we just don’t know,” Dr. Lustig said.

It’s very hard to tell somebody, “We have to let you go because you happen not to be funded.” And we’re not there yet by any means, but that’s the risk. As this becomes more real, we’re going to really hyperfocus on our people who have the most funding. And we will inherently lose the diversity of our researchers. —José Zevallos, MD, MPH

José Zevallos, MD, MPH, chair of otolaryngology–head and neck surgery at the University of Pittsburgh and interim chair of the Hillman Cancer Center there, said the announcement of a plan for a 15% cap in the indirect rate at first felt like “an existential crisis.” Then things continued as they were for a while, until two R01 grants were lost because the Trump administration began pulling funding for research associated with diversity, equity, and inclusion (DEI).

The grants have nothing to do with DEI, but they were awarded from a pool of funding designed to promote workforce diversity, so they were flagged, Dr. Zevallos said. One of the studies is looking at gene therapy for congenital hearing loss, and the other is looking at the brain’s perception of cochlear implants in pursuit of ways to restore hearing more effectively.

He said the department and the university have been exploring other sources of funding, including philanthropy, industry, and even entrepreneurship, as a way to raise money for research aims. They have also been assessing how to share resources better, such as consolidating labs. Plans for a translational hearing institute—a center in which clinics and research labs would be together in one space—have been put on hold, even though the prospect of the institute was a factor in the recent recruiting of new researchers to his center, Dr. Zevallos said. And there has been “a lot of discussion of trying to limit the number of people who have unfunded research,” he said.

“This gets into really difficult conversations because suddenly you’re saying, ‘Hey, listen, you’re a valued member of this department because you bring this educational component, this teaching component, but right now you’re low on your funding,’” Dr. Zevallos said. “It’s very hard to tell somebody, “We have to let you go because you happen not to be funded.” And we’re not there yet by any means, but that’s the risk. As this becomes more real, we’re going to really hyperfocus on our people who have the most funding. And we will inherently lose the diversity of our researchers.”

The effects years down the line could be dramatic, he said.

“We also have a real chance of losing a generation of academic investigators,” he said. “Because the jobs that are going to be attractive to people who are doing science are going to be industry jobs.”

Reports that the NIH might fund research projects with lump-sum payments up front, rather than year by year, were jarring, said David O. Francis, MD, MS, professor of otolaryngology–head and neck surgery and vice chair of academic affairs and professional development at the University of Wisconsin–Madison. That’s because this way of funding could diminish the chances that a grant proposal would succeed; for instance, an estimate is that at the National Cancer Institute (NCI), one in 25 applicants will be funded, down from one in 10 (Science. https://tinyurl.com/4dymezt9).

“Established investigators may be able to pull off a score that’s high enough to get funded,” Dr. Francis said. “But someone who’s just coming up, like a junior investigator who may not have as much experience, may not be able to achieve a score that high, and then it kind of shuts down their ambitions about potentially becoming a researcher in the future.”

One of his own projects would be “on the cusp” in that scenario, he said. It is an NCI-funded study on developing models to predict the real-world effects on outcomes of thyroid cancer policy so that policy can be crafted in a more meaningful way.

Given the unknowns, no concrete changes have been made in his department, he said, although there is planning in the background, including ideas on bridge funding for affected studies.

“I think the implications are pretty big and are going to impact biomedical research in the long run,” he said. “Everyone’s kind of on edge about what’s going to happen.”

Bradley Goldstein, MD, PhD, professor of head and neck surgery and communication sciences at Duke University in Durham, N.C., and research coordinator for the Triological Society, said the society’s grant programs could help some researchers.

The Triological Society continues to use resources to provide research funding support to help augment otolaryngology research programs where we can. I want to emphasize that our grant programs remain available, and we look to partner with otolaryngologists, especially at early career stages, as much as we can to help provide research support and mentorship. —Bradley Goldstein, MD, PhD

“The Triological Society continues to use resources to provide research funding support to help augment otolaryngology research programs where we can,” he said. “I want to emphasize that our grant programs remain available, and we look to partner with otolaryngologists, especially at early career stages, as much as we can to help provide research support and mentorship.”

He said that at Duke, in light of the uncertain environment, the university has examined its spending and looked at how to expand its portfolio of funding.

“The approach that leadership at our medical center took was just one of caution, mainly asking people to proactively essentially slow spending where we can and to prepare for the worst, hope for the best kind of thing,” Dr. Goldstein said.

He said the prospect of major cuts is a reason to make changes that would be prudent in any budgetary environment.

“I think those of us in academia tend to view federal funding, NIH funding, as kind of the gold standard when we talk about medical research, but the reality is that we should have a diversified funding portfolio at a department and institution level,” he said. “Pragmatically, I think there are major challenges in making up for the amount of funding that can be provided by federal programs like NIH. It’s very unlikely that any foundation support is going to completely make up for a canceled grant program.”

Emily Boss, MD, MPH, director of pediatric otolaryngology at Johns Hopkins University in Baltimore, said the cuts could put at risk lines of research that might not be as high profile as trials on therapeutics, but are nonetheless clinically important, such as research on decision making for surgery. She wrote a piece for the university’s HUB publication, recounting how communication used in the conversation between her and the family of a six-year-old girl helped them through decisions involving tracheostomy placement (HUB. https://tinyurl.com/5n77shem).

“What does the layperson or politician view as critical research? They’re going to view, appropriately, research focused on curing cancer, life-saving disease interventions, as key priorities, as they should be,” she said. “But if practice-related health services research is defunded, what we will miss is a lot of research that really reflects real-world practice and healthcare delivery, and outcomes like how patients experience care. Ironically, this type of research has the potential to more immediately and broadly impact how surgical care is delivered and received in the U.S.”

The communication behind decision making is especially crucial in otolaryngology, because often the choice of whether to proceed with surgery is not clear, she said.

“Otolaryngology is composed of more than 70% of elective surgical care,” she said. “These cases are the bread and butter of our specialty.”

She and a colleague also recently wrote a commentary expressing concern about how the Make America Healthy Again commission report characterized research on adenotonsillectomy and tympanostomy tube placement (STAT. https://tinyurl.com/mwu8j754). The report, they wrote, mistakenly concluded these procedures cause harm without benefit, while ignoring findings of improved sleep, behavior, hearing, and speech.

Dr. Boss added that examining NIH indirect costs is wise in principle, but the effects need to be understood.

“Just to be clear, I think some indirect rates are too expensive, and there’s probably a lot of opportunity to make costs more project-specific, which makes rates truly reflect the resources that are indirectly required to complete the research,” she said. “But no matter what, any cut in research funding, particularly to this degree, restricts the overall resources that we have to continue conducting rigorous science.”

In the spring, Jonathan Overdevest, MD, PhD, assistant professor of rhinology and skull base surgery at Columbia University, had funding stopped for his study to understand how olfactory dysfunction in COVID-19 patients is associated with neurocognitive and neuropsychiatric symptoms and development. The grant cessation was tied to both Columbia’s broad loss of funding and to the withdrawal of money for COVID-19 research, although post-COVID-19 olfactory dysfunction was simply a model for smell loss.

“Given the uncertainty, the decision was made to wind down the time frame for which we were following individuals,” so that part of the study has come to a close, he said. Rather than following patients for five years, the follow-up will be three years. When they were told they would no longer be followed, some patients clearly showed that they were invested in the research, asking who they could contact to restore funding or whether they should begin their own fundraising efforts.

In the study, patients were followed clinically, with biospecimens taken to examine how virally mediated olfactory dysfunction relates to other long-standing neurodegenerative populations, with the idea that this dysfunction could be a helpful, supplementary biomarker that can be assessed non-invasively.

“That funding was going to be paramount to facilitate that connectivity, whereas without it, we’re left scrambling for other sources of funding to complete the experiments,” he said. The research team is now trying to do assessments in a “piecemeal” way and pull it all together later, rather than in the more seamless fashion in the original plan, he said.

Facing the unknown has been difficult, he said.

“I think the imposition of uncertainty is the biggest challenge for these academic centers,” Dr. Overdevest said. “It affects the ability to sustain and maintain our core research infrastructure, all the research coordinators, post-doctoral students, and graduate students. These are all groups that need some level of certainty when determining what they’re going to be doing for the next months, years of their life.”

The uncertainty has prompted discussions among him and his colleagues about their futures in academic medicine.

“The conversations are absolutely happening. You run into colleagues, and it’s like, ‘What are you going to do about this?’ And nobody really knows.”

The research infrastructure that is required to do these sorts of complex studies requires a huge team. And if you lost funding from your lab, that team’s got to go. And once that thing shuts down, it’ll be years to recreate what currently exists. —Lawrence Lustig, MD

Dr. Lustig said the loss of researchers and the research framework would be hard to recover, even if lost funding is eventually restored, because of the logistics of having to re-hire people and recreate what is gone.

“The research infrastructure that is required to do these sorts of complex studies requires a huge team,” he said. “And if you lost funding from your lab, that team’s got to go. And once that thing shuts down, it’ll be years to recreate what currently exists.”    

Thomas R. Collins is a freelance medical writer based in Florida.