Decades old Alzheimer’s research may have used falsified data

by Jacob Fuller

Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News 

 

A shocking new report published this week by “Science” suggests that the last two decades of Alzheimer’s disease research may be based on falsified data.

If accurate, the report could turn back the clock on twenty years’ worth of research and nearly everything the medical and scientific communities thought they had come to understand about the progressive neurological disorder.

The discovery was made by Matthew Schrag, a neuroscientist and physician at Vanderbilt University, during an investigation of an experimental medication to treat the brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks.

Schrag was hired by attorneys to investigate Simulfilam, which the developer, Cassava Sciences, claims can treat Alzheimer’s disease symptoms by attacking amyloid proteins. However, according to a legal petition filed with the FDA, this claim may be based on research that was fabricated.

A request was submitted to the FDA to halt clinical trials of Simulfilam due to “grave concerns about the quality and integrity of the laboratory-based studies surrounding this drug candidate and supporting the claims for its efficacy.” The FDA, however, found no cause for this concern and said that the request did not include “relevant factual information.”

The FDA previously approved Aduhelm, which underperformed in two separate clinical trials and had little evidence to support that the drug worked the way the developer said it would. The drug remains controversial, with many physicians refusing to prescribe it due to a lack of evidence proving its safety and efficacy.

During the course of his evaluation of the data, Dr. Schrag found that the images used in the groundbreaking study, which was first published in “Nature” in 2006, were manipulated to falsely show the presence of amyloid proteins.

The results of this study, which was conducted by Sylvain Lesné from the University of Minnesota Twin Cities, have been the basis for the theory that Aβ clumps, also called plaques, in brain tissue are the leading cause of Alzheimer’s disease.

Lesné and his team performed experiments on older mice with memory impairments. The “memory deficits in middle-aged mice” were caused by the accumulation of clumps of a specific amyloid protein, Aβ*56, which seemed to confirm the leading hypothesis that toxic oligomers were the cause of the progressive, neurodegenerative disease and a contributing factor in cognitive decline.

Following the release of this study, its reported findings have driven much of the research and development for an Alzheimer’s cure.

While Schrag does not outright accuse Lesné and his colleagues of fraud or misconduct, he does believe that his findings cast doubt on the original study. However, without access to the original work and untouched images, he said, these are just “red flags.”

“The data should speak for itself,” Dr. Schrag said.

To verify the validity of Schrag’s findings, “Science” enlisted the help of several experts in a 6-month-long investigation, which resulted in the same final conclusion as Schrag’s research. Experts found an additional 70 studies authored by Lesné with “shockingly blatant” image manipulation, causing experts to wonder if Aβ*56 exists or is completely fabricated.

Elisabeth Bik, a molecular biologist and forensic image consultant, said that Lesné and his team “appeared to have composed figures by piecing together parts of photos from different experiments,” adding that “the obtained experimental results might not have been the desired results, and that data might have been changed to…better fit a hypothesis.”

There are currently more than 6 million Americans living with Alzheimer’s disease. The disease costs the United States an estimated minimum of $321 billion annually.

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