The second Trump administration has been defined by widespread cuts to federal spending, including at the National Institutes of Health (NIH). A new analysis reveals that the termination of NIH grants has disrupted at least 383 clinical trials, which collectively include more than 74,000 patients.
The study, published on Nov. 17 in JAMA Internal Medicine, is a stark example of the real-world repercussions of Trump’s health cuts.
“It is distressing,” Vishal Patel, M.D., a surgical resident at Brigham and Women's Hospital and clinical fellow at Harvard Medical School who led the study, told Fierce Biotech. “It affects the future of patient care.”
Patel and his colleagues drew from a database called NIH ExPORTER to identify 11,008 trials that received NIH funding between Feb. 28 and Aug. 15. Of those, about 3.5% have lost funding, though more trials could have been impacted since—on the cutoff date for the analysis, NIH Director Jay Bhattacharya, M.D., Ph.D., issued a memo ordering a review of all current and planned research activities, with those not aligning with new agency priorities liable to be cut.
"Generally, NIH grant funding supports research, not patient care," Andrew Nixon, communications director for the Department of Health and Human Services, which oversees the NIH, told Fierce. "The institutions that receive NIH grants are responsible for the clinical care of their patients. Therefore, any changes to NIH research funding do not affect an institution’s ability to provide standard-of-care therapies to patients."
But experts told Fierce the lost funding is harmful to patients, both those actively enrolled in trials and others who could benefit from new clinical practice down the line.
“Since grant disruptions and terminations started, questions about the scope of clinical trials affected has been a concern of paramount importance,” Jeremy Berg, Ph.D., former director of the NIH's National Institute of General Medicine, told Fierce. “These actions are tremendously damaging in many ways, from the impact on specific trials to a degradation of trust in the entire process.”
Patel and colleagues found that not all trials were affected equally. The disrupted trials were more likely to be conducted outside of the U.S., testing preventive or behavioral interventions, and with a primary condition in infectious diseases. That said, 118 of the terminated trials were in cancer, and 140 were testing new treatments.
“Those findings suggest that there's a bias towards termination of grants that have nothing to do with the quality of research being conducted,” Patel said. Historically, grant funding has only been revoked in extreme circumstances, like in cases of research misconduct.
“That is so rare that we weren't really able to find more than one or two instances ever,” Patel said, underscoring how rarely clinical trials had previously been disrupted by revoked funding
Some of the terminated trials were in diseases like HIV and COVID-19, Patel said—both areas that Bhattacharya has identified as being of special importance to the NIH. HIV research is included among the agency’s priorities, updated on Aug. 15, while Bhattacharya has discussed the importance of funding research on Long COVID in interviews.
“This paper validates what we knew and felt was happening all around us,” Allison Agwu, M.D., an infectious disease specialist at Johns Hopkins University and former chair of the HIV Medicine Association, told Fierce. “We were disproportionately being attacked, essentially, and there are real implications.”
Health interrupted
One need not look far for evidence of the harm that comes with canceling clinical trial funding. A February report from The New York Times documented how cuts to the U.S. Agency for International Development—led by Elon Musk’s Department of Government Efficiency—left trial participants around the world in the lurch, with experimental compounds and medical devices still in their bodies as they lost access to the researchers monitoring them.
Agwu has felt the effects of the NIH’s cuts personally. She is a site leader for the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), a research network that was terminated in March. Ongoing studies were halted and employees were laid off as a result, but one of the biggest hits was to patient and community trust.
“A lot of what we're doing, as we're developing studies and developing questions and planning, is engaging communities,” Agwu said, adding that many have little trust for the scientific and medical establishment due to past harms. “Then you say, just kidding, we have to go out, not because we want to do that, but because, literally, the rug was pulled out from underneath us.”
The ATN has since had funding restored, Agwu said, and is working to rebuild, but has had to overhaul its focus to match the federal government’s priorities. For example, the network can no longer study transgender youth, a population at higher risk of HIV.
Those studies “now have to be all youth,” Agwu said. “Some of the demographic disparities that we see for HIV and adolescents are no longer able to be looked at because they no longer align with the administration's priorities.”
Disrupting trials also means patients given investigational drugs were exposed to potential side effects without the chance of benefitting, Patel said, and an interrupted trial often can’t pick up where it left off even if funding returns.
While Patel doesn’t work in clinical trials himself, he has colleagues at Harvard who do, and they see the impacts every day, he said.
Berg, the former NIH institute director, has been involved in analyzing clinical trial data, he said, and has “witnessed firsthand the challenges of recruiting trial participants.” If a trial loses funding while in progress, all that effort can go to waste.
And while more than 74,000 patients are enrolled in trials that have lost funding, according to Patel’s analysis, the impacts can extend far beyond even that. The loss of knowledge from a disrupted trial can reverberate for years as a missed opportunity to improve patient care.
“Clinical trials are the gold standard by which clinical practice is defined,” Patel said. “These are probably the pinnacle of all studies for clinicians, because this is what we look at when we are prescribing medicines or deciding on treatments for patients.”
The NIH, with its $48 billion budget, is uniquely positioned to spark medical advances as the largest funder of biomedical research in the world. But the agency has been rocked by unprecedented defunding and policy changes since Trump’s second inauguration.
In May, Patel and colleagues found that 694 NIH grants had been terminated, totaling $1.81 billion in value. By September, a different team found that 760 grants had been axed, including more than $1.3 billion of funding in Massachusetts alone. Despite numerous legal challenges, the Supreme Court did allow some of these terminations to go ahead in August.
The NIH has also hampered international collaboration, prohibiting foreign researchers from receiving subawards from grants and cutting off database access for scientists in certain countries.
Numerous NIH leaders have departed or been fired, mirroring similar upheaval at the top of other health agencies like the FDA’s Center for Drug Evaluation and Research and the Centers for Disease Control and Prevention.
Over the summer, hundreds of NIH staffers signed an open letter, called the Bethesda Declaration, urging Bhattacharya to reverse the drastic changes made to the agency, including mass layoffs that only worsened during the recently-ended government shutdown.
Patel hopes to further quantify how these extreme changes are impacting the scientific enterprise, he said, including by analyzing how many new trials are being registered and by the number of scientific papers being published. He sees his studies of health policy as a way to help a large number of people at once, in parallel with his day-to-day work seeing individual patients as a surgical resident.
“I can only affect one person at a time when I'm doing an operation,” he said. “Being able to do both of those in my career, affecting patients on an individual level but also being able to affect a lot of other people, is very satisfying.”
The kind of data collection being done by Patel is vital, Agwu told Fierce, as a way of chronicling what has been a “not-so-natural experiment” of what happens to health when federal support is undermined.
“We can point to decreasing rates of vaccination and increased rates of measles. We can point to decreased uptake of influenza vaccine and worse hospitalizations,” she said. “Facts are facts. Feelings are feelings, but feelings are not facts. And we've got to move forward in that way.”