NIH

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22 states sue to block new NIH funding policy—court puts it on hold

Grant funding, grants, HHS, indirect costs, lawsuit, NIH, Policy, Science / /

Regardless of what else they might be doing, the indirect costs pay for various critical campus services, including at research hospitals. Suddenly having that amount slashed would create a major budgetary shortfall that will be hard to cover without shutting programs down.

The resulting damage to research campuses in their states was one of the harms cited by the states that joined the suit as part of their effort to establish standing. The other was the harm caused by the general slowdown in biomedical research that the policy will trigger, which the states argue will delay the availability of treatments for their citizens.

The states taking part include most of those that were won by Kamala Harris in 2024, as well as states that voted for Trump but currently have Democratic governors and attorneys general: Arizona, Michigan, Nevada, North Carolina, and Wisconsin. Notably, the suit only seeks relief from the altered NIH policy for institutions located in those states; they’re essentially leaving states controlled by Republicans to suffer the damages caused by the new policy.

Allegations and backup allegations

The states allege that the new NIH policy, by applying to all grants in progress, is equivalent to rewriting a contract. It cites an earlier legal decision that determined that “Once the [Notice of Award] is signed or money is drawn, the [Notice of Award] and the grant terms are binding on the grantee and the government.” Beyond that, the states argue the policy violates two separate pieces of legislation.

The first is the Administrative Procedures Act, which describes the processes that agencies need to follow when they formulate formal rules to translate legislation into implementations. Among other things, this prevents agencies from formulating rules that are “arbitrary and capricious.” It argues that, by including audits and negotiations in the process of setting them, the current individualized indirect rates are anything but.

By contrast, the states argue, there’s no significant foundation for the 15 percent indirect rate. “The Rate Change Notice is arbitrary and capricious in, among other ways, its failure to articulate the bases for the categorical rate cap of 15 percent,” the suit alleges, “its failure to consider the grant recipients’ reliance on their negotiated rates, and its disregard for the factual findings that formed the bases for the currently operative negotiated indirect cost rates.”

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National Institutes of Health radically cuts support to universities

grants, NIH, research funding, Science / /

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

Alzheimer's, Cassava, CUNY, fraud, health, Hoau-Yan Wang, NIH, NIH grant, research, research funding, research misconduct, Science, Simufilam, Western blots / /

Funding Scheme —

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

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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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