According to a report in Science, critical elements of one of the most cited pieces of Alzheimer’s disease research in the past two decades may have been manipulated on purpose.
Alzheimer’s is the most common cause of dementia worldwide, according to the World Health Organization. The highly influential paper, which was published in Nature in 2006, has helped guide billions of dollars in US federal government research into Alzheimer’s, according to Science.
The study, which looked at cognitive decline in mice, proposed that a specific amyloid protein could be responsible for cognitive decline. Since then, the hypothesis has dominated the field, and researchers have worked for years to understand the mechanism by which these proteins can lead to the decline.
But a Tennessee neuroscientist, Vanderbilt University professor Matthew Schrag, said in a Science article that he and other reviewers have identified as many as 10 papers about the protein that deserve deeper scrutiny. The report also cited other prominent researchers who have had difficulty replicating the results of studies on specific proteins.
“I focus on what we can see in the published images and describe them as red flags, not final conclusions,” he told Science, when revealing his role as a whistleblower. “The data should speak for itself.”
At the heart of the matter is whether the images in various articles were manipulated to better support a hypothesis, with the work of researcher Sylvain Lesné under particular scrutiny. Lesné, an associate professor at the University of Minnesota, is now under investigation by the university.
His co-author on several articles is Dr. Karen Ashe, also a researcher at the University of Minnesota and one of the most prominent Alzheimer’s researchers in the country. He described the possible manipulation of images as “devastating” to the Minneapolis Star Tribune, but criticized the idea that his research on amyloid proteins singularly guides federal and drug company spending.
Finding a treatment for Alzheimer’s has eluded scientists for decades. Although there are drugs to treat the symptoms of early and mid-stage Alzheimer’s, only one drug has been approved by the US Food and Drug Administration (FDA) to treat the protein plaques associated with Alzheimer’s: aducanumab .
This drug, sold under the brand name Aduhelm and developed by Biogen, was the subject of its own controversy last year. As it was being considered for approval in 2021, several FDA officials said there was not enough evidence of its benefit to support approval.
Nevertheless, the agency approved the drug, which Biogen priced at $56,000. This led to the resignation of three FDA officials, one of whom said there was “no good evidence that the drug works.”
More than 6 million Americans are believed to have Alzheimer’s, according to the National Institute on Aging. More than 850,000 people in the UK suffer from dementia, according to the Alzheimer’s Society.