By design, clinical trials ask their participants to take on risk. To develop new vaccines, drugs, or therapies, scientists first have to ask volunteers to try out those interventions, with no guarantee that they’ll work or be free of side effects. To minimize harm, researchers promise to care for and monitor participants through a trial’s end, long enough to collect the data necessary to determine if a therapy is effective and at what cost. End a trial too early, and researchers might not be able to figure out if it worked—or participants may be left worse off than when they started.
But that is exactly what the Trump administration has been asking scientists across the country to do. Since the end of last month, the administration has forced the National Institutes of Health, the world’s largest public funder of biomedical research, to terminate hundreds of research awards made to scientists across the country. Among those NIH-funded projects are more than 100 clinical trials that now may be forced to halt abruptly, agency officials told me. And those officials expect further orders to cancel hundreds more. (The NIH officials I spoke with for this story requested anonymity for fear of job loss or other retaliation from the federal government.)
The Trump administration has been laying siege to science for months—just this week, the Department of Health and Human Services, which oversees the NIH, announced that it will fire 10,000 people. But the federal government’s disregard for clinical trials is one of the most direct illustrations yet that the nation’s new leaders have abandoned people’s health.
Grinding these trials to a screeching halt is “completely reckless,” Katie M. Edwards, a social-work professor at the University of Michigan, told me. Participants might still need to be tapered off a drug regimen to avoid the symptoms of withdrawal, or monitored for reactions to a device implanted in their body; they might depend on the intervention they’re receiving for their mental or physical health. Edwards herself has had three clinical trials terminated this month, including one testing whether an online mentoring program could reduce rates of depression, anxiety, and self-harm among trans teens; halting it, she told me, “could lead to a number of negative outcomes, including increasing suicidality.” The canceled trials also include studies on safety and effectiveness of COVID-19 vaccines during pregnancy; increasing use of PReP, the HIV preventative, among people with substance-abuse disorders; probiotics and prebiotics for infants born to mothers living with HIV; and improving adherence to breast-cancer and heart-disease drugs.
In boilerplate letters, the federal government has told scientists that their science is no longer consistent with agency priorities or a good use of taxpayer funds, and that the agency will no longer fund their work. That’s tantamount to being told to “stop work immediately,” Matthew Spinelli, an infectious-disease physician at UC San Francisco, told me: He received a termination for a study trialing an antibiotic that can prevent sexually transmitted bacterial infections but that also can cause rare but substantial side effects.
After The Atlantic reached out to NIH for comment, a spokesperson wrote over email that HHS is altering its funding practices to align with new department priorities, and that “it’s important to prioritize research that directly affects the health of Americans while taking the protection of human participants in our supported clinical research very seriously.”
In the past, if an NIH-funded clinical trial needed to halt—in an instance of, say, misconduct or clear harm to patients—the agency could be counted on to provide money and support to ensure that the study’s participants wouldn’t take on further risk and that even prematurely ending work remained ethically intact. Now, though, the government is the one causing risks to patients, well beyond what they signed up for.
Clinical trials are usually designed with a predetermined end date so that researchers can collect the data they need and make sure participants’ efforts don’t go to waste. Generally speaking, trials are halted midway only if it’s in the participants’ best interest—if, say, the treatment being tested is clearly doing more harm than good. Even then, winding down a clinical trial safely can take months as researchers perform final check-ins with participants, collect additional data on safety, and in some cases help make arrangements for additional clinical care—work that requires time, personnel, and funds. “To stop all of a sudden, with no warning and no grace period? I’ve never seen that,” Domenico Accili, the director of the Columbia University Diabetes and Endocrinology Research Center, told me.
The Trump administration has said that the projects it’s ending are unscientific or not in service of improving the health of Americans. But as I’ve previously reported, its decisions about which grants to cut have been made seemingly without regard to scientific legitimacy, according to even the NIH officials being forced to sign the cancellation letters. The cuts have variously targeted studies on LGBTQ populations, DEI, health equity, and vaccine uptake; projects in foreign countries; grants that happen to have been housed at universities the Trump administration is sanctioning for other reasons; projects that make mention of COVID-19. This blitz has also hit grants less focused on those topics: Projects on antibodies, genetics, and dementia have been cut simply because—as far as scientists and NIH officials can tell—their titles or descriptions mention words such as diversity.
All of these research grants were awarded on the basis of scientific merit, and to halt them for political reasons is “totally unethical,” Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania, told me: “Once you have asked people to undertake the burden and risk of research participation, you don’t get to then just decide, Oh, we don’t want to do it anymore.”
But that’s the position researchers have been forced into. Without financial resources, they can’t deliver the care and monitoring they promised participants when they enrolled them in their trials—even though they’ve already collected data and personal information. “People are being left in every stage of the research pipeline,” Delivette Castor, an epidemiologist at Columbia, who received a termination for a cervical-cancer-prevention clinical trial, told me. “It is a violation of trust, and all the resources we have put in.”
Lauren Obsorne, an ob-gyn at Cornell, told me that she and her colleagues had just started a trial that paired doulas with women on Medicaid, or from racial-minority backgrounds, to test whether an education-focused intervention could reduce postpartum depression and heart problems. After the NIH terminated the study’s grant, the doulas had to call mothers who had given birth days or weeks before to say they could no longer offer help, Osborne told me. Kathleen Sikkema, a clinical psychologist at Columbia, told me she was close to completing her clinical trial, which aimed to improve engagement with HIV care among women in South Africa with a history of sexual trauma, when her termination letter arrived. But halting her work now would mean skipping a final assessment for at least 20 people, to check their viral load and determine their next course of treatment. “That’s terribly needed,” she told me.
Many researchers hit by the NIH’s funding cuts are still trying to figure out ways to safely offboard people from their studies. Some have sought funds from their department or university; some are turning to private donors or pharmaceutical companies, or dipping into money they’ve made as practicing physicians. But those resources are small and spotty. Several researchers told me that, even in a best-case scenario, they likely have just weeks or months of money left. Even now, “I’m hoping at some point I can charge NIH,” Sikkema, who’s working with her university to pool funds for the remainder of her study, told me. But “there isn’t an open federal fund that we can charge,” she added. “It’s not completely clear who’s going to pay for it in the end.”
During the NIH’s initial funding freeze, two officials told me, agency officials were told to alert leadership if the halt on payments to certain studies might compromise patient safety, so that exceptions might be considered. And early last month, a subset of clinical trials were among the first studies that NIH leadership said could have their grant funds unfrozen (though many payment halts continued in the weeks after). But on the whole, the NIH’s recent guidance on preserving patient safety has been murky at best, one of the officials said, and added that they were not aware of any exceptions that had ever been made. Another official described the policy on exceptions as “piecemeal permissiveness,” saying that it offered only the guise of safeguarding people in studies. And for grant terminations, scientific staff at NIH have not been allowed to petition for exceptions at all, even if participant safety is clearly on the line, officials told me. “If they are on the list, they are terminated,” one of them said.
A few researchers told me that they had received documents from the NIH saying that they “may request funds to support patient safety and orderly closeout of the project.” None of them, though, was told how exactly they might go about requesting those funds, what the budget might be, what sorts of actions would qualify, or even what counts as “patient safety” or “orderly closeout” under the agency’s new leadership. After the grant terminations began, at least one of the agency’s institutes, the National Institute of Child Health and Human Development, prepared more specific instructions for researchers on how to navigate closeout procedures, specifying, for instance, that all study participants should be informed of the study’s halt and that “there must be a plan” for any ongoing safety monitoring. But those documents did not accompany the first several rounds of NIH terminations, which began late last month. And although a few researchers told me they were now working with their university to try to seek additional funds from the NIH, they also said they weren’t hopeful that the government would grant their requests—or even honor any payments they did offer.
Even if researchers are able to cobble together the funds to help their participants exit trials safely, halting studies early could still nullify the contributions of the people who enrolled. Studies need a bare-minimum number of data points, and if the target number of participants fails to complete a trial, researchers might not be able to calculate anything about the interventions’ usefulness or safety. Nor can trials easily restart, if the flow of money picks back up. Many studies rely on collecting information at precise, regular intervals; miss just one data point, and an entire analysis can be thrown off. For other studies, skipping a scheduled dose of a drug, or a scheduled check-in with a patient with a progressing condition, can compromise how well an intervention works.
Many of the studies targeted by the Trump administration also focus on populations at higher risk of worse health outcomes, who have been historically neglected by science and medicine; recruiting participants to some of these trials, researchers told me, took years of establishing and maintaining trust, as well as careful partnerships with local leaders. Any betrayals to the commitments researchers made to those people could compromise the ability of scientists to work with them in the future. “Why are people going to be willing to contribute to science and enroll in these studies if they feel like the rug can be pulled out from under them at any time?” Fernandez Lynch told me.
Thiago Arzua, a neuroscientist at Columbia, told me that his research has been affected by the NIH’s recent grant cancellations. But Arzua was also enrolled as a participant in an NIH-terminated study that tracked HIV prevention and transmission among sexual and gender minorities. “It’s pretty sad,” he said, to see years of investment from underserved communities go to waste. The message coming from the government has never been clearer, he and others told me. From the start, the Trump administration has flaunted its lack of interest in advancing science or supporting the people who do it. Now its actions are declaring that it also doesn’t care about the people science is trying to help.
About the Author
Katherine J. WuFollowKatherine J. Wu is a staff writer at The Atlantic.Explore More TopicsNational Institutes of Health
