Two decades of Alzheimer’s research was based on deliberate fraud by 2 scientists that has cost billions of dollars and millions of lives
Two decades of Alzheimer’s researchwas based on deliberate fraud by 2 scientists that has cost billions of dollars and millions of lives
Last year, the Food and Drug Administration (FDA) narrowly approved the use of Aduhelm, a new drug fromBiogenthat the company has priced so highly that it’s expected todrive up the price of Medicare for everyone in America, even those who never need this drug. Aduhelm was the first drug to be approved that fights the accumulation of those “amyloid plaques” in the brain. What makes the approval of the$56,000-a-dose drugso controversial is that while it does decrease plaques, it doesn’t actually slow Alzheimer’s. In fact, clinical trials were suspended in 2019 after the treatment showed“no clinical benefits.”(Which did not keep Biogen from seeking the drug’s approval or pricing it astronomically.)
Over the last two decades,Alzheimer’s drugs have been notable mostly for having a 99% failure ratein human trials. It’s not unusual for drugs that are effective in vitro and in animal models to turn out to be less than successful when used in humans, but Alzheimer’s has a record that makes the batting average in other areas look like Hall of Fame material.
And now we have a good idea of why. Because it looks likethe original paper that established the amyloid plaque model as the foundation of Alzheimer’s research over the last 16 years might not just be wrong, but a deliberate fraud.
The suspicion that something was more than a little wrong with the model that is getting almost all Alzheimer’s research funding ($1.6 billion in the last year alone) began with a fight over the drug Simufilam. The drug was being pushed into trials by its manufacturer, Cassava Sciences, but a group of scientists who reviewed the drug maker’s claims about Simufilam believed that it was exaggerating the potential. So they did what any reasonable person would do: They purchased short sell positions in Cassava Sciences stock, filed a letter with the FDA calling for a review before allowing the drug to go to trial, and hired an investigator to provide some support for this position.
As Science reports, it was that investigator, Vanderbilt University neuroscientist and junior professor Matthew Schrag, who tipped over the whole applecart to discover that it wasn’t just that Cassava’s drug was ineffective. There’s good evidence thatfor the last 16 years, almost everyone has had the wrong idea about the cause of Alzheimer’s. Because of a fraud.
That 2006 paper was primarilyauthored by neuroscience professor Sylvain Lesnéand given more weight by the name ofwell-respected neuroscientist Karen Ashe, both from the robust neuroscience research team at the University of Minnesota.
The results of the study seemed to demonstrate the amyloids-to-Alzheimer’s pipeline with a clarity that even the most casual reader could understand, and it became one of—if not the most—influential papers in all of Alzheimer’s…Both Ashe and Lesné became neuroscience rock stars, the leaders of a wave based on their 2006 paper.
What intrigued Schrag when he came back to this seminal work were the images.Imagesin the paper that were supposed to show the relationship between memory issues and the presence of Aβ*56appeared to have been altered. Some of them appeared to have beenpieced together from multiple images. Schrag shied away from actually accusing this foundational paper of being a “fraud,” but he definitely raised “red flags.”
They (Science) concurred with his overall conclusions, which cast doubt on hundreds of images, including more than 70 in Lesné’s papers. Some look like“shockingly blatant” examples of image tampering, says Donna Wilcock, an Alzheimer’s expert at the University of Kentucky.
Should this fraud turn out to be as extensive as it appears at first glance, the implications go well beyond justmisdirecting tens of billions in funding and millions of hours of researchover the last two decades. Since that 2006 publication, the presence or absence of this specific amyloid has often been treated as diagnostic of Alzheimer’s. Meaning that patients who did die from Alzheimer’smay have been misdiagnosed as having something else.
And it seemshighly likely that for the last 16 years, most research on Alzheimer’s and most new drugs entering trials have been based on a paper that, at best, modified the results of its findings to make them appear more conclusive, and at worst is an outright fraud.
https://wallstreetpro.com/2022/07/23/two-decades-of-alzheimers-research-was-based-on-deliberate-fraud-by-2-scientists-that-has-cost-billions-of-dollars-and-millions-of-lives/