Taxpayers have invested billions in the theory, too. In fiscal year 2022, as allegations of fraud first broke, half of the NIA budget for Alzheimer’s research — $1.6 billion — focused on amyloid. In 2024, $1.5 billion in NIA projects mentioned “amyloid,” according to an NIH database.
The Trump administration’s cuts to National Institutes of Health (NIH) funding have been met with an outcry from Democrats, with some critics spotlighting cuts to Alzheimer’s research as particularly outrageous.
“When you’re talking about medical research, when you’re talking about people’s lives, when you’re talking about clinical trials for Alzheimer’s disease or cancer that may take 3 or 4 years, you can’t just go in and decide, ‘I’m going to shut those down and maybe I’ll try something else.’ Those are people’s lives at risk,” said former NIH Director Francis Collins in an interview with 60 Minutes Sunday.
Nearly 800 NIH grants have been terminated so far, including some focused on HIV and AIDS, trans health, and COVID-19, after researchers were told their work was no longer an agency priority. https://cbsn.ws/3YkDndI
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— 60 Minutes (@60minutes.bsky.social) April 27, 2025 at 7:54 PM
But the talking points gloss over the current reckoning in the discipline and in the scientific community at large after allegations of fraud. (RELATED: Trump Admin Freezes Additional $1 Billion In NIH Grants To Harvard University)
A 2006 paper in the prestigious journal Nature coauthored by University of Minnesota neurologists Sylvain Lesné and Karen Hsiao Ashe describing an amyloid-beta subtype called an oligomer was retracted in 2024 amid “overwhelming”evidence of image manipulation, following an investigation by Science reporter Charles Piller.
Further investigation implicated NIH employees too. Four months after a whistleblower first flagged concerns about Lesné’s work to the NIH, an NIH program officer who had coauthored the 2006 retracted paper approved a new $3 million grant for Lesné. Piller found that former Neuroscience Division Director of the National Institute on Aging (NIA) Eliezer Masliah coauthored 132 papers with evidence of image manipulation, which were in turn cited in 18,000 scientific papers. Masliah oversaw approximately $2.6 billion in annual research grants by his 2024 ouster.
The scrutiny on the field has provoked blowback from proponents of the conventional wisdom.
Hardy argued in his email to Perry that the Lesné retraction is irrelevant because nobody believed the paper. The paper has been cited 2,372 times.
“No-one believed Lesne anyway,” said Hardy in the email to Perry.
Hardy made a distinction in the email to Perry between the focus of Lesné and Ashe on amyloid oligomers – subtypes of amyloid beta proteins – and the broader amyloid cascade hypothesis that Hardy first postulated.
“Amyloid oligomers the emperor without clothes,” Hardy said.
A Dramatic Shift At HHS
The crossroads in Alzheimer’s research comes amid a dramatic shift at the Department of Health and Human Services (HHS).
HHS Secretary Robert F. Kennedy Jr. said during a January confirmation hearing that stymied Alzheimer’s research epitomizes wider problems at NIH, where hierarchies can perpetuate irreproducible research and box out novel ideas.(RELATED: RFK Jr. Meets With Food Company CEOs, Calls For Removal Of Food Dyes)
“We’ve lost 20 years in figuring out a cure for Alzheimer’s,” Kennedy said.
By contrast, Hardy argued in the email to Perry that clinical trials of drugs targeting amyloid provide strong evidence that the amyloid cascade hypothesis remains solid.
“Amyloid therapies are working and real world data from wash u and mayo and possibly elsewhere looks better than the trials (admittedly with very careful patient selection),” he wrote. “It looks like the next round of drugs … will be both better and safer.”
Other scientists echo that amyloid-targeting drugs represent a breakthrough.
“It is an extraordinarily exciting time in Alzheimer’s research,” said Indiana University neuroscientist Donna Wilcock, who has been critical of the field’s alleged fraud and advised Piller on his investigation. “We have the first FDA-approved medicines that are proven to slow down the progression of the clinical syndrome as well as remove the plaques from the brain,” she said in reference to two drugs called lecanemab and donanemab.
Lecanemab and donanemab are monoclonal antibody drugs that remove amyloid beta from the brain.
Wilcock said in an email to the DCNF that the Lesné paper “only briefly influenced the field.”
“Very quickly laboratories, including the one I was in at the time, tried to reproduce the findings and were not able to. Within 6 months, through conversations at conferences, it was understood that the beta-amyloid aggregate described by Lesné could not be identified in our studies and the field moved on,” Wilcock said.
It took another 17 years for the study to be retracted.
Others like Castellani said that the drugs have uncertain payoffs and risks of fatal side effects.
“[Hardy’s] ‘doing harm’ comment is a bit much for me, having seen a complication of amyloid therapies on our autopsy table,” Castellani said.
Castellani authored a 2023 paper on a patient receiving lecanemab who experienced a multifocal brain hemorrhage and died.
Like Perry, Castellani is critical of the dominance of the amyloid cascade theory.
“Everyone plays follow the leader and follow the orthodoxy,” he said.
An estimated 60% of people have amyloid plaques in their brains by the end of their lifespans, but only one-fifth of amyloid-positive individuals will develop dementia, according to Alberto J. Espay, a University of Cincinnati neurologist.
Drugmakers have not released detailed data that could answer outstanding questions about side effects like brain swelling and the degree to which anti-amyloid drugs slow cognitive decline, Espay said.
“Hardy is fearmongering Perry. True harm has been and continues to be done to patients in the name of an unfalsifiable and unsupported hypothesis,” he said.
(Featured Image Media Credit: Screenshot/YouTube/National Institutes of Health, NIH)
