research funding

harvard-sues-to-block-government-funding-cuts

Harvard sues to block government funding cuts

The suit also claims that the funding hold, made in retaliation for Harvard’s letter announcing its refusal to accept these conditions, punishes Harvard for exercising free speech.

Separately, the lawsuit focuses on Title VI, part of the Civil Rights Act, which prohibits the government from funding organizations that engage in racial discrimination. It’s Harvard’s alleged tolerance for antisemitism that would enable the government to put a hold on these funds. But the suit spells out the requirements for cutting funding—hearings, a 30-day waiting period, notification of Congress—that the law requires before funding can be cut. And, quite obviously, the government has done none of them.

Harvard also alleges that the government’s decision to hold research funds is arbitrary and capricious: “The Government has not—and cannot—identify any rational connection between antisemitism concerns and the medical, scientific, technological, and other research it has frozen.”

Finally, the court is asked to consider an issue that’s central to a lot of the questions regarding Trump Administration actions: Can the executive branch stop the flow of money that was allocated by Congress? “Defendants do not have any inherent authority to terminate or freeze appropriated federal funding,” the suit claims.

Remedies

The suit seeks various remedies. It wants the government’s actions declared illegal, the freeze order vacated, and prohibitions put in place that will prevent the government from accomplishing the freeze through some other means. Harvard would also like any further reactions to allegations of antisemitism to follow the procedures mandated by Title VI and to have the government cover its attorney’s fees.

It also wants the ruling expedited, given the potential for damage to university-hosted research. The suit was filed in the District of Massachusetts, which is the same venue that has been used for other suits seeking to restrain the Trump administration’s attack on federally funded research. So far, those have resulted in rapid responses and injunctions that have put damaging funding cuts on hold. So, there’s a good chance we’ll see something similar here.

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after-harvard-says-no-to-feds,-$2.2-billion-of-research-funding-put-on-hold

After Harvard says no to feds, $2.2 billion of research funding put on hold

The Trump administration has been using federal research funding as a cudgel. The government has blocked billions of dollars in research funds and threatened to put a hold on even more in order to compel universities to adopt what it presents as essential reforms. In the case of Columbia University, that includes changes in the leadership of individual academic departments.

On Friday, the government sent a list of demands that it presented as necessary to “maintain Harvard’s financial relationship with the federal government.” On Monday, Harvard responded that accepting these demands would “allow itself to be taken over by the federal government.” The university also changed its home page into an extensive tribute to the research that would be eliminated if the funds were withheld.

In response, the Trump administration later put $2.2 billion of Harvard’s research funding on hold.

Diversity, but only the right kind

Harvard posted the letter it received from federal officials, listing their demands. Some of it is what you expect, given the Trump administration’s interests. The admissions and hiring departments would be required to drop all diversity efforts, with data on faculty and students to be handed over to the federal government for auditing. As at other institutions, there are also some demands presented as efforts against antisemitism, such as the defunding of pro-Palestinian groups. More generally, it demands that university officials “prevent admitting students hostile to the American values and institutions.”

There are also a bunch of basic culture war items, such as a demand for a mask ban, and a ban on “de-platforming” speakers on campus. In addition, the government wants the university to screen all faculty hires for plagiarism issues, which is what caused Harvard’s former president to resign after she gave testimony to Congress. Any violation of these updated conduct codes by a non-citizen would require an immediate report to the Department of Homeland Security and State Department, presumably so they can prepare to deport them.

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Trump administration’s attack on university research accelerates

Shortly after its inauguration, the Trump administration has made no secret that it isn’t especially interested in funding research. Before January’s end, major science agencies had instituted pauses on research funding, and grant funding has not been restored to previous levels since. Many individual grants have been targeted on ideological grounds, and agencies like the National Science Foundation are expected to see significant cuts. Since then, individual universities have been targeted, starting with an ongoing fight with Columbia University over $400 million in research funding.

This week, however, it appears that the targeting of university research has entered overdrive, with multiple announcements of funding freezes targeting several universities. Should these last for any considerable amount of time, they will likely cripple research at the targeted universities.

On Wednesday, Science learned that the National Institutes of Health has frozen all of its research funding to Columbia, despite the university agreeing to steps previously demanded by the administration and the resignation of its acting president. In 2024, Columbia had received nearly $700 million in grants from the NIH, with the money largely going to the university’s prestigious medical and public health schools.

But the attack goes well beyond a single university. On Tuesday, the Trump administration announced a hold on all research funding to Northwestern University (nearly $800 million) and Cornell University ($1 billion). These involved money granted by multiple government agencies, including a significant amount from the Department of Defense in Cornell’s case. Ostensibly, all of these actions were taken because of the university administrators’ approach to protests about the conflict in Gaza, which the administration has characterized as allowing antisemitism.

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National Institutes of Health radically cuts support to universities

Grants paid by the federal government have two components. One covers the direct costs of performing the research, paying for salaries, equipment, and consumables like chemicals or enzymes. But the government also pays what are called indirect costs. These go to the universities and research institutes, covering the costs of providing and maintaining the lab space, heat and electricity, administrative and HR functions, and more.

These indirect costs are negotiated with each research institution and average close to 30 percent of the amount awarded for the research. Some institutions see indirect rates as high as half the value of the grant.

On Friday, the National Institutes of Health (NIH) announced that negotiated rates were ending. Every existing grant, and all those funded in the future, will see the indirect cost rate set to just 15 percent. With no warning and no time to adjust to the change in policy, this will prove catastrophic for the budget of nearly every biomedical research institution.

Cut in half or more

The new policy is described in a supplemental guidance document that modifies the 2024 grant policy statement. The document cites federal regulations that allow the NIH to use a different indirect cost rate from that negotiated with research institutions for “either a class of Federal awards or a single Federal award,” but it has to justify the decision. So, much of the document describes the indirect costs paid by charitable foundations, which tend to be much lower than the rate paid by the NIH.

The new rate of indirect cost reimbursement will be applied to any newly funded grants and retroactively to all existing grants starting with the issuance of this notice. The retroactive nature of this decision may end up being challenged due to the wording of the regulations cited earlier, which also state that “The Federal agency must include, in the notice of funding opportunity, the policies relating to indirect cost rate.” However, even going forward, this will likely severely curtail biomedical research in the US.

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Alzheimer’s scientist indicted for allegedly falsifying data in $16M scheme

Funding Scheme —

The work underpinned an Alzheimer’s drug by Cassava, now in a Phase III trial.

Alzheimer’s scientist indicted for allegedly falsifying data in $16M scheme

A federal grand jury has indicted an embattled Alzheimer’s researcher for allegedly falsifying data to fraudulently obtain $16 million in federal research funding from the National Institutes of Health for the development of a controversial Alzheimer’s drug and diagnostic test.

Hoau-Yan Wang, 67, a medical professor at the City University of New York, was a paid collaborator with the Austin, Texas-based pharmaceutical company Cassava Sciences. Wang’s research and publications provided scientific underpinnings for Cassava’s Alzheimer’s treatment, Simufilam, which is now in Phase III trials.

Simufilam is a small-molecule drug that Cassava claims can restore the structure and function of a scaffolding protein in the brain of people with Alzheimer’s, leading to slowed cognitive decline. But outside researchers have long expressed doubts and concerns about the research.

In 2023, Science magazine obtained a 50-page report from an internal investigation at CUNY that looked into 31 misconduct allegations made against Wang in 2021. According to the report, the investigating committee “found evidence highly suggestive of deliberate scientific misconduct by Wang for 14 of the 31 allegations,” the report states. The allegations largely centered around doctored and fabricated images from Western blotting, an analytical technique used to separate and detect proteins. However, the committee couldn’t conclusively prove the images were falsified “due to the failure of Dr. Wang to provide underlying, original data or research records and the low quality of the published images that had to be examined in their place.”

In all, the investigation “revealed long-standing and egregious misconduct in data management and record keeping by Dr. Wang,” and concluded that “the integrity of Dr. Wang’s work remains highly questionable.” The committee also concluded that Cassava’s lead scientist on its Alzheimer’s disease program, Lindsay Burns, who was a frequent co-author with Wang, also likely bears some responsibility for the misconduct.

In March 2022, five of Wang’s articles published in the journal PLOS One were retracted over integrity concerns with images in the papers. Other papers by Wang have also been retracted or had statements of concern attached to them. Further, in September 2022, the Food and Drug Administration conducted an inspection of the analytical work and techniques used by Wang to analyze blood and cerebrospinal fluid from patients in a simufilam trial. The investigation found a slew of egregious problems, which were laid out in a “damning” report obtained by Science.

In the indictment last week, federal authorities were explicit about the allegations, claiming that Wang falsified the results of his scientific research to NIH “by, among other things, manipulating data and images of Western blots to artificially add bands [which represent proteins], subtract bands, and change their relative thickness and/or darkness, and then drawing conclusions” based on those false results.

Wang is charged with one count of major fraud against the United States, two counts of wire fraud, and one count of false statements. If convicted, he faces a maximum penalty of 10 years in prison for the major fraud charge, 20 years in prison for each count of wire fraud, and five years in prison for the count of false statements, the Department of Justice said in an announcement.

In a statement posted to its website, Cassava acknowledged Wang’s indictment, calling him a “former” scientific adviser. The company also said that the grants central to the indictment were “related to the early development phases of the Company’s drug candidate and diagnostic test and how these were intended to work.” However, Cassava said that Wang “had no involvement in the Company’s Phase 3 clinical trials of simufilam.”

Those ongoing trials, which some have called to be halted, are estimated to include over 1,800 patients across several countries.

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