Latest news with #NIH
6 hours ago
- Business
Confusion at NIH as administration halts, then releases, billions of dollars for scientific research
Billions of dollars of National Institutes of Health research were stuck in limbo for hours, causing confusion after a memo from the Office of Management and Budget appeared to direct a halt to its funding. The funding halt at NIH came after an OMB memo's footnote was interpreted to mean the release of money for research grants was prohibited, according to an email sent to NIH staff Tuesday afternoon by its associate director for budget, Neil Shapiro. "We are working to make this limitation short-term and temporary," Shapiro wrote in the email. This back-and-forth comes after a string of large-scale cuts at the Health and Human Services Department, led by Secretary Robert F. Kennedy Jr., that has cast agencies such as NIH, the Food and Drug Administration and the Centers for Disease Control and Prevention into confusion as they execute directives from the top. Following reporting by several outlets, OMB reversed the decision publicly, with a spokesperson saying on Tuesday evening the money was "undergoing a programmatic review" but "is being released." Confusion remained at NIH, however. At almost the same time OMB publicly said the funding halt wasn't happening, NIH leadership emailed staff that it was still "only authorized to obligate funds" for limited purposes such as salaries and clinical expenses, but that "NIH leadership is diligently working to resolve this issue and hopes to provide further updates soon." And on Wednesday morning, regular processes were gummed up briefly by the confusion, including credit card purchase approvals. An email sent to a group of agency employees who approve credit card purchases indicated the halt was still in effect, saying "a pause on the obligation of funds pertaining to the conduct of research and development," with a promise to keep the group updated with any changes to the new requirements. Two hours later, those same employees were informed the halt had been lifted. The funding freeze would've impacted approximately $15 billion in funding that would be given to research institutions around the country between now and Sept. 30, according to an estimate from Democratic Sen. Patty Murray of Washington, a high-ranking official on the Senate Appropriations Committee. "What is stunning to me is that OMB is saying that these funds are being released, while HHS is saying exactly the opposite—the chaos and dysfunction of the Trump administration is staggering. These people should not be managing a lemonade stand, much less all federal cancer research," Murray said in a statement. Since taking office in February, Kennedy has overseen massive overhauls of the health system. Beginning in April, nearly 10,000 people were estimated to be laid off, including entire offices at the Food and Drug Administration, Centers for Disease Control and Prevention and NIH. Hundreds of employees were later hired back after public outcry or internal agency discussions over the impact, leaving the full scope of the layoffs unclear. Research cuts have also been a consistent tenet of Kennedy's HHS. Despite the secretary's repeated claims that scientific research was not hit by the cuts, the NIH had released $1.6 billion less in funding by April of this year compared to last year -- a reduction of one-fifth -- according to a New York Times analysis. Other grants have been cut completely because the administration has deemed them ideologically at odds with the president's agenda.
Time Magazine
6 hours ago
- Health
- Time Magazine
How Bureaucracy and Budgets Shape American Medical Research
President Donald Trump's proposed budget for the 2026 fiscal year has made drastic cuts to the National Institute of Health's (NIH) budget, sparking alarm among many. While the level of proposed cuts is unprecedented, calls for efficiency are nothing new. In fact, they echo decades-old efforts to make publicly funded science more accountable. What has gone largely unnoticed, however, is how these reforms reshaped how NIH research is managed—as well as the very definition of what counts as rigorous, worthwhile health research in the first place. Even as the NIH's budget soared over the past half-century, much of that growth came at a price: a narrowing of NIH's scientific imagination. Driven by bureaucratic reforms and the need to demonstrate fiscal responsibility, the agency gradually shifted away from large, community-based, longitudinal studies aimed at understanding what keeps people healthy. Instead, it prioritized smaller, faster studies with statistical significance and quantifiable data, but far less explanatory power about how to stay healthy. In the late 1950s, the NIH was beginning to expand its mission to address chronic ailments like heart disease and cancer. These growing health threats required a fundamentally different kind of science—slower, more complex, and deeply embedded in communities. Early NIH leaders, such as James Shannon, embraced this challenge with a bold vision: government-led, multi-site observational studies tracking large populations over decades. The Framingham Heart Study, launched in 1948, embodied this approach. It aimed to enroll over 5,000 healthy residents of Framingham, Mass., and follow them for at least 20 years to understand how lifestyle factors and social context shaped long-term health outcomes. Read More: RFK Jr. Says Ultra-Processed Foods Are 'Poison'—But That He Won't Ban Them Over the next decade, the NIH became the de facto institution for carrying out this sort of bold population-based investigation into health and disease. But as the 1960s progressed, this vision for the NIH ran afoul of a growing government-wide push for budgetary control. Reforms like Planning, Programming, Budgeting, and Execution and Zero-Base Budgeting demanded that all federal agencies and initiatives define outcomes in advance and justify expenses with quantifiable projections. Large-scale observational studies—by their very nature, exploratory, slow, and expensive—were easy targets for government watchdogs obsessed with efficiency. For example, the Wooldridge Committee, a task force appointed by President Lyndon B. Johnson's Office of Science and Technology to review the federal research enterprise, sharply criticized the NIH in 1965 for failing to provide adequate oversight of its biggest studies The committee warned that scientific freedom could no longer excuse a lack of fiscal discipline. The NIH responded, not by defending the long arc of discovery required for understanding the causes of chronic disease, but by adapting. Researchers were asked to project statistical returns on investment. Studies were re-evaluated not just for scientific merit, but for how likely they were to generate measurable results within a budget cycle. Framingham, once a flagship of public health research, was deemed too open-ended. By 1970, it had lost its privileged status and instead had to compete for grants like any university-based project. This shift marked an institutional pivot away from NIH-led, community-grounded studies and towards a more manageable model of research. During this time, the NIH also shelved several other large, prospective population-based studies of health and disease, including the Diet-Heart Study—an ambitious effort to definitively test the role of high-fat diets in causing heart disease. In their place, a new framework for investigating chronic diseases emerged, one built around smaller, investigator-initiated grants awarded to outside researchers. These grants, and the peer-review process that governed their approval, increasingly relied on the tools of biostatistics to demonstrate methodological rigor and fiscal discipline. From an administrative perspective, these outside projects were easier to justify: they were shorter in duration, cleaner in design, and more narrowly focused. Politically, they were appealing too—distributed across universities in different congressional districts, they helped spread NIH funding across the country. By encouraging investigators to design studies with tightly defined objectives, measurable outcomes, and clear statistical models, the NIH was able to present its growing budget as aligned with the broader federal push for transparency and accountability. In effect, the agency avoided deeper scrutiny by embedding oversight expectations into the very structure of scientific inquiry. By doing so, it created the conditions for its outside grant program to flourish. Yet, this shift also produced a subtle, but profound, change in the kinds of questions NIH research was designed to answer. Rather than pursuing the fundamental causes of health and disease, the types of population-based investigations that received NIH grants looked at discrete, isolated lifestyle factors and their relative impact on specific conditions — what have come to be known as risk factor epidemiology. In the case of heart disease, this involved studies on the impact of certain foods on conditions commonly associated with heart disease, especially high cholesterol, high blood pressure, and elevated body mass index. And while these types of investigations yielded a flood of peer-reviewed publications and some effective interventions at the individual level, they also left crucial questions unanswered. After decades of risk factor research, for example, we still do not fully understand the causes of heart disease—or how best to prevent it. Read More: NIH Budget Cuts Are the 'Apocalypse of American Science,' Experts Say In the decades since, many investigators and commentators have criticized the dominance of 'risk factor epidemiology.' Critics include Gary Taubes, a science journalist known for his writing on nutrition science and the history of dietary guidelines, and John Ioannidis, a Stanford researcher who has long argued that most epidemiological studies of nutrition are limited in scope and contradictory. They and others contend that risk factor–driven research has led to public health guidance built on fragile associations and patterns in data that do not reflect causality. These critics often point to the decades-long emphasis on reducing dietary fat to lower cholesterol and prevent heart disease as problematic. This advice led many Americans to adopt low-fat, high-carbohydrate diets—a diet that is now linked to obesity, diabetes, and ironically, heart disease. Today, many health experts and institutions have reversed course, encouraging the consumption of healthy fats and warning against excess sugar and refined carbohydrates. The result has been public confusion, eroded trust in nutrition science, and a generation of health advice that, in retrospect, may have done more harm than good. These studies have flourished since the 1970s not because they promised definitive answers on how to stay healthy, but because they appeared to offer a clear return on investment. Their study designs were statistically rigorous and focused on narrowly defined variables and outcome measures, which enabled these projects to routinely yield statistically significant results for the questions they were designed to answer. That gave policymakers and funders the impression that public dollars were driving scientific progress, even as it provided few answers to the biggest scientific questions. Ironically, it was the promotion of this particular style of research—narrow in scope, statistically precise, and managerially friendly—that helped the NIH expand its budget and reach. But the accumulation of these rigorous, but smaller-in-scope, findings rarely translated into an applicable understanding of the complex, long-term, and interconnected forces that truly shape health. Today, as the NIH again faces oversight and budget pressures, the American scientific establishment has a chance to course-correct. The current administration has emphasized health promotion and the importance of diet. But if those goals are to be more than talking points, President Trump, Congress, and the NIH must be willing to invest in the kind of science that can actually reveal what keeps us well. That means returning to community-based, long-term observational studies—even if they are expensive, even if they take decades, and even if they do not fit neatly into the bureaucratic logic of annual performance metrics. Sejal Patel-Tolksdorf is a health policy analyst and former chief research historian at the National Institutes of Health. Her work focuses on the politics and policy of American health research. Made by History takes readers beyond the headlines with articles written and edited by professional historians. Learn more about Made by History at TIME here. Opinions expressed do not necessarily reflect the views of TIME editors.
Yahoo
7 hours ago
- Health
- Yahoo
FDA's Makary wants to increase drug access, reduce 'addictive' foods
FDA Commissioner Marty Makary has an ambitious plan to overhaul how quickly patients can access drugs in the US, but also wants to reduce reliance on pharmaceuticals by shifting the focus of research to finding the root causes of common diseases. At the top of his list is reducing Americans' consumption of ultra-processed foods and making subsidized federal food programs healthier. "No one has been talking about the fact that food has been designed to be addictive. So when we have a crisis in our nation's children, that is, 40% have a chronic disease and 31% have prediabetes or insulin resistance, it's not their fault," Makary told Yahoo Finance in an interview Wednesday. "We don't think that our childhood obesity epidemic is a willpower problem. We think this is something adults are doing to kids," Makary added. He spoke with Yahoo Finance while on a nationwide tour to connect with drug industry leaders at companies big and small. But while Makary is focused on streamlining access to medicines and allowing access to some that may not be fully tested in traditional clinical trials, he is also focused on reducing the use of drugs in daily life. "We've got to talk about school lunch programs, not just putting every 6-year-old on Ozempic," Makary said, referencing the blockbuster diabetes drug from Novo Nordisk (NVO). "We've got to talk about sleep medicine and the quality of sleep, not just antihypertensive after antihypertensive [drugs that treat high blood pressure]. And we've gotta talk about environmental exposures that cause cancer, not just the chemo to treat it. We've got to talk about food as medicine and the microbiome," Makary said. He has also been vocal about revamping the food pyramid, which hasn't been updated in more than a decade, and sees it as one path to regaining trust in the agency — which has declined in the years since the pandemic. "We are going to rewrite those dietary guidelines. I think that'll go a long way too in rebuilding trust," Makary said. Research and rebuilding trust In addition to the FDA's work in addressing chronic diseases, the National Institutes of Health (NIH) are also directing funds to do the same. When asked about cuts to health equity-focused research, including women's health, Makary defended the Trump administration's moves to cut some federally funded research, to the tune of $18 billion, or a 40% reduction. "The NIH, when we came into office, was a mess. Fourteen percent of grants went to descriptive studies on health equity, not reducing health equities." Meanwhile, Makary has been focused on ensuring quicker access to drugs, questioning why it takes 10 years for a drug to reach market, and more transparency about drugs that are approved. He did not specify when the public would get greater access to decision letters, but continued to promise more access. "We're releasing the FDA decision letters so the public can see them, drug developers can see them. We can give more predictability. We're modernizing the agency. We're trying to cut some of the idle time," Makary said, noting this was key to rebuilding trust as well. Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, provider services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee as AnjKhem on social media platforms X, LinkedIn, and Bluesky @AnjKhem. Click here for in-depth analysis of the latest health industry news and events impacting stock prices Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Guardian
7 hours ago
- Health
- The Guardian
White House freezes $108m in funding to Duke University over allegations of racial discrimination
The Trump administration has frozen $108m in federal research funding to Duke University after the federal government announced this week that it was investigating allegations that the school engaged in racial discrimination in the form of affirmative action, according to a person familiar with the matter and media reports. The National Institutes of Health reportedly halted the funding to the private university in North Carolina, said the person who spoke to the Associated Press on Wednesday on the condition of anonymity to discuss internal deliberations. CNN and ABC News also reported the funding freeze. The development came as, earlier this week, the Department of Health and Human Services and the Department of Education issued a joint letter to Duke, stating that it had been made aware of allegations of what it called racial preferences in Duke's 'hiring, student admissions, governance, patient care, and other operations'. Duke is the latest institution to have its federal funding held up as the government investigates allegations of antisemitism and policies that support greater diversity, equity and inclusion that the Trump administration alleges are unlawful. It follows other investigations by the administration into top-flight private universities, including the Ivy League's Harvard, Columbia and Cornell. Duke did not immediately comment on the reported funding freeze. In Monday's letter to Duke, the Trump administration states that it has been made aware of allegations that Duke University and Duke Health are engaged in practices that, 'if true, would violate Titles VI of the Civil Rights Act and Section 1557 of the Affordable Care Act, and render Duke Health unfit for any further financial relationship with the federal government'. 'These practices allegedly include illegal and wrongful racial preferences and discriminatory activity in recruitment, student admissions, scholarships and financial aid, mentoring and enrichment programs, hiring, promotion, and more,' the letter from the government states. The letter does not provide any specific examples. 'Racism is a scourge when practiced by individuals, but it is especially corrosive when enshrined in the nation's most eminent and respected institutions,' the letter, signed by the US health secretary, Robert F Kennedy Jr, and the education secretary, Linda McMahon, adds. The letter ordered Duke to end any practices at its health system that give 'benefits or advantages' based on race. Saying Duke is unlikely to be capable of an 'honest and trustworthy review', the letter takes the unusual step of requesting a new merit and civil rights committee that would be approved by the government and authorized by the school's board of trustees. The panel would be tasked with identifying and ending any racial preferences. If problems remained after six months, the administration would pursue legal enforcement, the letter said. The education department separately opened an investigation into the Duke Law Journal on Monday over allegations that it gave advantages to prospective editors from underrepresented groups. The Trump administration has used federal research funding as leverage in its unprecedented effort to reshape universities that Trump has described as hotbeds of liberalism. Sign up to This Week in Trumpland A deep dive into the policies, controversies and oddities surrounding the Trump administration after newsletter promotion It has presented a crisis for universities that rely on federal grants as a major source of revenue, spurring some to take on debt and find other ways to self-fund research. Duke University spent $1.5bn on research last year, with nearly 60% coming from federal sources, according to the university's website. Even before the latest funding freeze, Duke faced financial turmoil. Last week, university leaders said almost 600 employees had accepted voluntary buyouts but that layoffs would still be needed. Officials said they needed to reduce costs amid uncertainty around federal research funding and a hike to the university's federal endowment tax. The Trump administration has been ratcheting up pressure on universities in hopes of striking deals such as one that Columbia University signed last week. The Ivy League school agreed to pay a $200m settlement over three years to the federal government and make changes to admissions, hiring, student discipline and more in exchange for regaining access to federal funding, among other things. In exchange for Columbia's concessions, the White House will reinstate $400m in federal funding it had stripped from the university earlier this year over allegations that it allowed antisemitism to fester on campus. The Columbia deal was met with mixed reactions from students, faculty and alumni. The administration has described it as a template for other universities including Harvard, which has been in talks with the administration even as it battles the White House in court.
Politico
8 hours ago
- Business
- Politico
Coming soon: Fewer cancer research grants
FOLLOW THE MONEY The National Cancer Institute has informed researchers that it's limiting the number of awards it gives out for the remainder of the fiscal year. The agency updated its funding policy, citing the White House's budget cut proposal for next year and a new National Institutes of Health policy, which requires the agency to provide at least half of the remaining funding for research project grants up front. That change 'reduces the number of competing awards NCI can fund in this fiscal year,' NCI said, adding, 'With these considerations, we expect to fund through the 4th percentile.' Before the announcement, the NCI had been funding around the top 7th percentile of new grants, which is already a conservative funding rate. Key context: Typically, NIH research grants are awarded for multiple years and funded incrementally. The change to forward-funding grants, also included in the White House budget proposal, would give grant recipients that money up front. For example, instead of spreading a $1 million award over four annual payments of $250,000, the full amount would now be paid in the first year. Sen. Tammy Baldwin (D-Wis.) has emerged as the most prominent critic of forward funding in Congress, which she says would result in even deeper cuts to the NIH than the 40 percent cut proposed by the White House. 'It means billions will effectively be put in escrow and won't actually be spent on research for a number of years to come,' Baldwin said during an NIH budget hearing last month. NIH Director Jay Bhattacharya defended the White House proposal. 'In the long run, what it does is allow you to spend more money and have more flexibility for new research projects,' he said. What's next: Unless Congress acts, the same policy is expected to continue when the new fiscal year starts on Oct. 1. 'What we're seeing now at NCI is a preview of what could happen next year if NIH continues this policy in FY26, but on an even larger scale,' Erik Fatemi, a principal at lobbying firm Cornerstone Government Affairs and former Democratic staffer on the Senate Appropriations subcommittee with authority over health care spending, told Erin. 'Even if overall funding remains flat, NIH would fund significantly fewer new grants than this year. That means fewer shots on goal, and fewer chances to uncover the next breakthrough for patients.' WELCOME TO FUTURE PULSE This is where we explore the ideas and innovators shaping health care. Authorities are investigating the cases of two women who became critically ill after receiving peptide injections, an alternative therapy promoted by HHS Secretary Robert F. Kennedy Jr., at an anti-aging festival, ProPublica reports. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@ Ruth Reader at rreader@ or Erin Schumaker at eschumaker@ Want to share a tip securely? Message us on Signal: Dannyn516.70, CarmenP.82, RuthReader.02 or ErinSchumaker.01. THE NEXT CURES The psychedelic drug ibogaine could be a promising treatment for veterans who develop mental health problems following a traumatic brain injury, the findings of a new, small study suggest. The Drug Enforcement Administration classifies ibogaine, a psychedelic drug derived from an African shrub, as a Schedule I drug with no currently acceptable medical use and a high risk of abuse. It can pose heart risks and has been linked to about two dozen deaths in recent decades. Inside the study: Stanford Medicine researchers analyzed brain scans of 30 male veterans who experienced traumatic brain injuries after exposure to blasts or combat, and who had post-traumatic stress disorder, depression, anxiety disorder or alcohol-use disorder. — Study participants received a combination of ibogaine and magnesium, which has heart-protective properties. — Participants had brain scans before treatment, three and a half days afterward and again one month after treatment. — Unlike some trials of psychedelic therapies being studied as mental health treatments, such as MDMA, participants didn't engage in talk therapy during treatment. Results: Participants who saw improvements in executive functioning also tended to show an increase in a brain wave pattern known as theta rhythms on their brain scans. Those with improved PTSD symptoms after treatment tended to have reduced complexity of activity in the brain's cortex. The improvements lasted a month after treatment, which is when the study ended. Researchers suggest that stronger brain waves in the theta region might encourage cognitive flexibility and neuroplasticity, or the brain's ability to make new connections. Less complex brain activity might lower the heightened stress response associated with PTSD. If they better understand those patterns, researchers think they might be able identify patients best suited for ibogaine treatment. Even so: The study, published last week in Nature Mental Health, had limitations. In addition to being small, it was observational, meaning it can't determine cause and effect, and open-label without a control group, so participants knew they were getting the treatment. More research, such as a randomized control trial, is needed to confirm the study's results. Big picture: Last month, Texas' Republican governor, Greg Abbott, signed a law to put $50 million into clinical trials of ibogaine as a mental health treatment. Other states are looking to Texas as an example, including Arizona, Indiana, Michigan, Mississippi, Missouri and West Virginia, according to W. Bryan Hubbard, who spearheaded the Texas bill and is executive director of the American Ibogaine Initiative.
