Tag Archives: NIH

Supreme Court Approves Reductions to NIH Grants Challenging Trump’s DEI Policy

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WASHINGTON – On Thursday, the Supreme Court extended the Trump administration’s substantial reductions to the National Health Grants, part of the federal government’s initiative on diversity, equity, and inclusion policies.

However, in this intricate ruling, the court upheld another aspect of a lower court’s decision that discarded the administration’s guidance documents related to the policy, raising doubts about its viability going forward.

An emergency request by an administrator aiming to pause the Massachusetts federal judge’s ruling was partially granted, resulting in a 5-4 vote.

While the court did not extensively elaborate on its reasoning, the majority suggested that groups contesting the funding cuts would need to initiate a new lawsuit in a different federal court, specifically the Federal Court of Claims.

The decisive vote came from conservative Judge Amy Coney Barrett. All four conservative justices supported the Trump administration’s application, indicating that the other four justices, including Chief Justice John Roberts and three liberal justices, would have completely denied it.

Barrett stated in a concurring opinion, “As today’s order indicates, district courts likely lack jurisdiction to address the funding challenges that pertain to the federal claims court.” She added, “The government is not entitled to a stay of judgment as long as it possesses valid guidance documents.”

The National Institutes of Health (NIH) is a collection of agencies within the Department of Health and Human Services, receiving billions of dollars from Congress for medical research funding at universities, hospitals, and various institutions.

When President Donald Trump assumed office in January, he asserted that what is termed diversity, equity, and inclusion (DEI) constituted discrimination mainly against white individuals, rather than fostering equality as intended. He also championed policies recognizing transgender rights, including access to gender transition care.

Subsequently, the NIH conducted a review of grants and concluded that over 1,700 were inconsistent with Trump’s directives, resulting in their termination, which included programs related to teenage HIV prevention and gender identity studies.

Massachusetts, along with 16 states represented by the American Public Health Association, has contested this action.

After the trial, District Judge William Young of Massachusetts ruled that the government had not adhered to the proper legal protocols while enacting the policy, violating the Administrative Procedure Act.

In haste to execute Trump’s agenda, the NIH “failed to comply with legal requirements,” Young noted.

He characterized DEI as an “undefined enemy,” stating that government attorneys could not adequately clarify its meaning.

Young found evidence of “prevailing racism” and “widespread discrimination” against gay, lesbian, and transgender individuals in how grants were awarded. Furthermore, he identified “a distinct pattern of discrimination against women’s health issues.”

He declined to stay his ruling, a decision mirrored by the Boston-based First Circuit Court of Appeals.

Attorney General John Sauer requested the Supreme Court to intervene on behalf of the Trump administration, likening the situation to another incident in Massachusetts where the Trump administration obstructed plans to eliminate teacher training grants based on anti-DEI grounds.

The Supreme Court had blocked this earlier ruling in April with a 5-4 vote.

Sauer asserted, “This application presents a particularly clear case where this court must intervene to prevent the district court from disregarding this court’s previous decision.”

The state’s attorney countered Sauer’s assertion, stating it “bears little resemblance to reality.”

The judge deliberated Thursday on whether the April ruling impacted the latest case’s outcome.

In a brief opinion, Roberts, who had contested the previous case, asserted that Young’s findings fell within the permissible scope of district court jurisdiction.

However, conservative Justice Neil Gorsuch criticized Young in a separate opinion for failing to comply with the April ruling.

“While lower court judges may oppose this court’s ruling, they are never free to disregard it,” he wrote.

The Trump administration frequently relied on the Supreme Court when facing judicial challenges to its enforcement actions, generally securing favorable outcomes. Trump and his supporters have also aggressively criticized judges who opposed him.

Source: www.nbcnews.com

Trump Administration Reduces NIH Grants by Over $1.8 Billion

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The Trump administration discontinued its $18.1 billion grant to the National Institutes of Health within just 40 days.

This information comes from an analysis published in JAMA on Thursday, which utilizes data from the Department of Health and Human Services to monitor accountability within the government grant system.

The analysis offers the most extensive overview to date regarding the reduction of NIH funding following the Trump administration’s significant efforts to eliminate perceived waste and inefficiency in federal spending.

Michael Liu, a student at Harvard Medical School, noted that while some grants are still uncertain due to new terminations and temporary revivals due to court orders, the HHS grant tracker remains the most reliable and current dataset available.

From February 28th to April 8th, the administration processed close to 700 grants at 24 NIH labs and centers, concentrating on areas such as aging, cancer, child health, diabetes, mental disorders, and neuropathy.

“These cuts haven’t been evenly distributed,” Liu remarked. “The National Institute on Health and Health Disparities in Minority has faced the steepest reductions, with approximately 30% of its funding cut—ten times the average.”

President Trump’s upcoming budget proposal aims to eliminate all funding for the National Institute focused on health disparities among minorities, labeling the Institute as “full of DEI spending.” His January executive order called for the cessation of a program centered on diversity, equity, and inclusion.

The proposal also suggests an overall reduction in NIH funding, slashing its budget for the next fiscal year to $27 billion, a decrease of around $18 billion, which would eliminate gender-focused research and studies on climate change. The administration plans to emphasize research on chronic diseases and other epidemics.

So far, most NIH grants that have been finalized have been directed toward research projects, with about 20% allocated to early career grants, training, or development. The analysis indicates that larger grants are more prone to termination, though it’s unclear if they were intentionally targeted based on the data.

“These sizable grants typically support large clinical trials and extensive research centers,” Liu explained. “Halting these initiatives is incredibly damaging, as it prevents patients from receiving necessary medications or interventions.”

Liu also pointed out that the analysis suggests that the rescinded grants are severely disrupted by both public and private institutions.

Among the grant recipients, Columbia University faced the highest number of terminations, totaling 157. The Trump administration targeted Columbia for funding cuts, citing “ongoing omissions at schools amid the persistent harassment of Jewish students” following significant Palestinian protests on campus. Columbia recently laid off 180 staff members associated with federal grants affected by these cuts.

“Columbia’s leadership continues to engage with the federal government to seek a resolution for resuming these research activities,” an official wrote in a letter to the Columbia community. “We are actively planning to address all potential contingencies, but tensions with federal authorities impact our financial situation and our research mission.

Source: www.nbcnews.com

NIH Prohibits New Funding for US Scientists Collaborating with Overseas Partners

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The National Institutes of Health has implemented a policy that prevents American scientists from allocating their funds to international research collaborators, raising concerns about the implications for studies on critical issues like malaria and pediatric cancer.

On Thursday, the new NIH director, Dr. Jay Bhattacharya, made this announcement. Coincidentally, Deputy Director Dr. Matthew J. Memoli criticized these so-called sub-awards in an email shared with the New York Times.

Dr. Memoli stated, “If you can’t clearly justify why you’re doing something overseas, you can’t do it anywhere else and can’t benefit Americans.”

The impending restrictions will also extend to domestic sub-awards in the future, coinciding with executive orders aimed at reshaping the nation’s scientific priorities amidst declining NIH funding and stalled federal grants at numerous premier universities.

On Monday, President Trump enacted an executive order to restrict experiments that could enhance the risks posed by pathogens and limit support for so-called gain-of-function research in nations like China.

Researchers receiving NIH grants have frequently employed sub-awards to foster international collaboration, a crucial component for studying diseases such as childhood cancer, malaria, and tuberculosis, which is less prevalent in the U.S.

Sub-awards are legal and financial arrangements between grant recipients and their international counterparts. This practice is widespread across the federal government and not exclusive to the NIH.

However, there has been increased scrutiny in recent years due to lax reporting and tracking of funds. Following a critical report from the Government Accountability Office (GAO) in 2023, the NIH introduced more stringent oversight requirements.

Proponents of scientific and medical research argue that as science grows more complex, collaborative efforts that engage participants and researchers globally are becoming increasingly vital.

“Competitiveness in science necessitates a collaborative approach,” stated Dr. E. Anderskolb, CEO of the Leukemia and Lymphoma Association. “No single lab, agency, or investigator possesses all the necessary tools to address the complex questions we’re facing.”

Many of these studies require a significant number of subjects. For instance, scientists can more precisely classify the types of pediatric cancers, leading Dr. Kolb to comment, “we’re entering a niche of diseases that are becoming progressively smaller.”

“Thus, if you’re aiming to conduct clinical trials for new treatments that could aid these children, attempting to only enroll U.S. children might prolong the trial duration by decades,” he added. “Collaborating with international partners allows us to expedite these trials and deliver treatments to our children much sooner.”

In unveiling the new directive, Dr. Bhattacharya referenced a GAO report criticizing the funding awarded to international universities, research institutes, and firms.

Dr. Bhattacharya added that the issues raised by the GAO “could undermine trust and safety for U.S. biomedical research entities.”

Tracking NIH expenditures for these international organizations is challenging. A notable obstacle pointed out by the GAO, as reported by journal Nature, estimated total funding to be about $500 million annually.

Dr. Monica Gandhi, a professor of medicine at the University of California, San Francisco, is utilizing NIH funding for HIV prevention and treatment research in Kenya and South Africa.

Researchers like her are required to furnish detailed information when applying for international sub-awards, she explained.

Currently, international partners must access lab notebooks, data, and other documents at least once annually, as noted by Dr. Gandhi. All expenses must comply with Foreign Awards and Component Tracking Systems.

“It’s extremely stringent, similar to using taxpayer funds,” Dr. Gandhi remarked.

“Each year, when submitting your progress report, you must account for every dollar spent on international locations. You’ll detail where it was allocated, how much laboratory testing costs, and who the principal investigators are—every facet.”

It remains unclear how the new policy will be implemented. The NIH has not responded to requests for further information.

The NIH stated it will not retroactively reverse foreign sub-awards that are already in effect “at this time,” and will continue to grant funding to international organizations.

However, the new policy prohibits the reissuance of new, competitive awards if they include proposals for sub-awards to foreign institutions.

“If the project is unfeasible without foreign sub-awards, the NIH will collaborate with the recipient to negotiate the bilateral termination of the project,” stated the agency.

The new policy seems to be slightly less comprehensive than what Dr. Memoli outlined in his internal email.

“Sub-awards to foreign sites cannot proceed,” he wrote. “This has been mismanaged horrendously in recent years and is utterly irresponsible. We must act immediately. If there is a foreign site involved in our research, we need to either start closing it or devise another method to track it properly.”

GAO reports indicate that several federal departments are seeking improved surveillance following criticism regarding lax reporting. However, the office did not advocate for the complete termination of such funding.

The 2023 GAO Report reviewed $2 million in direct and sub-awards, the majority coming from the NIH, awarded to three Chinese research institutions, including the Wuhan Virology Institute, between 2014 and 2021.

The Virology Institute received a sub-award from the University of California, Irvine and the non-profit EcoHealth Alliance. Collaborating with the Alliance and Chinese scientists led former President Joseph R. Biden Jr. to suspend funding last year. Recently, the Trump administration updated its government portal for COVID-19 information to suggest that a novel virus emerged from a lab in Wuhan.

According to a GAO report, NIH oversight has not consistently ensured that foreign agencies comply with requirements, including biosafety regulations.

Another GAO report indicated that one reason for the difficulty in tracking spending is a federal policy requiring the reporting of sub-awards of $30,000 or more.

The report examined approximately $48 million in NIH and State Department funding provided to Chinese companies and research institutions between 2017 and 2021.

“The full extent of these sub-awards remains unknown,” and the data retrieved were found to be incomplete and inaccurate, with numerous expenditures exempt from reporting.

Apoorva Mandavilli Reports of contributions.

Source: www.nytimes.com

Halting Submissions: The Impact of NIH Budget Cuts on Scientific Journals

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The Environmental Health Perspective is widely regarded as the premier magazine in the field, announcing its suspension of new research submissions due to uncertainties surrounding federal funding cuts.

For over 50 years, this journal has been supported by the National Institutes of Health to evaluate research on the impacts of environmental toxins, including persistent chemicals and air pollution, publishing findings at no cost.

Joel Kaufman, the journal’s editor-in-chief, opted to halt new submissions because of the “lack of confidence” regarding the funding of critical expenses such as copyediting and updating editing software.

He refrained from providing comments on the publication’s future outlook.

“If the journal were to disappear, it would be a tremendous loss,” stated Jonathan Levy, Chair of the Department of Environmental Health at Boston University. “It diminishes access to crucial information needed for insightful decision-making.”

The NEJM editor referred to the letter as “blushy threats.” Recently, the journal Obstetrics and Gynecology, published by the American College of Obstetricians and Gynecologists, reported receiving similar letters.

Scientific journals have been under scrutiny from leading health officials during the Trump administration.

In a book published last year, Dr. Martin A. McCurry, the newly appointed FDA commissioner, indicated that the Editorial Committee of “Gatekeeping” will only disseminate information that aligns with “groupthink narratives.”

In an interview from last year’s “Dr. Hyman Show” podcast, current HHS Secretary Robert F. Kennedy Jr. expressed intentions to take legal action against medical journals under the Federal Anti-Corruption Act.

“If you don’t establish a plan to publish credible science now, I will find a way to sue you,” he warned.

Still, the uncertainty surrounding EHP has left researchers perplexed. They noted that funding cuts seem to conflict with the Trump administration’s declared priorities.

For instance, Kennedy has consistently highlighted the significance of investigating environmental factors in chronic diseases. The new administration has also shown interest in transparency and public access to scientific journals, a principle EHP pioneered.

EHP was among the first “open access” journals, accessible to anyone without a subscription, and unlike many other open access journals that impose substantial fees, EHP’s federal backing allowed researchers at smaller institutions to publish without financial concerns.

“There are several layers of irony in this situation,” Dr. Levy remarked.

EHP isn’t the only journal affected by funding cuts at the Department of Health and Human Services.

A draft budget obtained by The New York Times suggests that two journals published by the CDC—Emerging Infectious Diseases and Chronic Diseases—may face cuts. Both are available at no cost to authors and readers and are among the leading journals in their fields.

HHS spokesman Andrew Nixon stated that there was “no final decision” on the forthcoming budget.

Published monthly, Emerging Infectious Diseases provides state-of-the-art insights on global infectious disease threats.

Jason Kindrachuk, a virologist at the University of Manitoba, who has published studies on Marburg and MPOX in the journal, noted its importance in shaping response strategies during outbreaks.

The news is “very disheartening,” he remarked.

Source: www.nytimes.com

ACLU challenges NIH for allegedly removing researchers based on ideology

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The U.S. Civil Liberties Union has filed a lawsuit alleging that the National Institutes of Health violated federal law by engaging in an unconstitutional “continuous ideological purging.”

The lawsuit, filed in Massachusetts District Court on behalf of members, four researchers, and three unions that rely on NIH funding, claims that federal scientific agencies have abruptly cancelled hundreds of research projects without providing scientifically sound explanations.

According to the lawsuit, the cancellations were justified by the NIH based on “ideological purity instructions” regarding research areas such as diversity, equity, inclusion (DEI), vaccine reluctance, and gender identity.

The lawsuit argues that this new arbitrary regime lacks any legal or policy basis, and accuses the NIH of failing to establish clear guidelines, definitions, or explanations for the restrictions on research related to DEI, gender, and other areas that do not align with the agency’s standards.

The defendants named in the lawsuit include the NIH, its director Jay Battacharya, the American Department of Human Health Services, and Director Robert F. Kennedy Jr. Both federal agencies have declined to comment on the pending lawsuit.

The ACLU is working with the Science Center for the Public Interest and Conservation Democracy Project on this litigation.

This lawsuit is just one of several legal challenges facing the NIH as the Trump administration seeks to reduce research funding, change allocation methods, and diminish the emphasis on diversity in academia.

After facing legal challenges, a Massachusetts judge halted the NIH’s efforts to restrict overhead funding in February. Other lawsuits are challenging the freeze on federal-wide funding and the administration’s ban on DEI programs.

Olga Axelrod, senior attorney for the ACLU Racial Justice Program, emphasized the importance of maintaining a fair grant review process and ending NIH’s alleged lawless grants that have disrupted numerous research projects and affected the careers of many scientists.

According to the lawsuit, at least 678 research projects, including studies on breast cancer, Alzheimer’s disease, and HIV prevention, have been terminated by the NIH, amounting to over $2.4 billion in cancelled grants.

The lawsuit highlights the significant impact of these cancellations not only in terms of financial loss but also in the disruption of years of dedicated research aimed at addressing critical biomedical issues.

Plaintiffs in the lawsuit include researchers like Brittany Charlton, a Harvard Medical School professor who focuses on LGBTQ health inequality, and Katie Edwards, a professor at the University of Michigan School of Social Work who studies sexual violence prevention in minority communities.

These researchers, along with others, have had their grants abruptly cancelled by the NIH, prompting the lawsuit to seek justice and protection for the affected research projects and scientists.

Source: www.nbcnews.com