The Alzheimer’s scandal
Potential harm to thousands of people on clinical trials, the misdirection of £34Bn of research funding and over two decades possibly chasing down a blind alley in search of a cure for Alzheimer’s. The scandal involving allegedly faked research into Alzheimer’s disease could be the biggest medical fraud of our time.
Everyone knows someone who has endured Alzheimer’s disease in the twilight of their lives. The disease affects millions of people every year, usually the elderly, although sometimes younger people too. There is no cure. Decades of research has failed to deliver a breakthrough in treatment.
As life expectancy rises steadily across the world and an ageing population combine, particularly in the Western world, Alzheimer’s is one of the biggest public health problems faced by society.
The field has famously failed to yield promising treatments, despite significant investment from drug companies trying to find a cure. Pfizer, one of the world’s largest drug companies, famously gave up trying in 2018.
It has even been estimated that $42 Bn (£34Bn) has been spent on over 1,000 clinical trials, between 1995 and 2021. Despite the efforts, only a handful of drugs have been licensed to treat the disease, providing marginal benefits.
Most research in the field has focussed on beta-amyloid deposits in the brain – sometimes called amyloid plaques – which are protein deposits thought to disrupt neurons in the brain.
The theory has been questioned for many years, because all brains with Alzheimer’s show the deposits, but not everyone with them experiences cognitive symptoms.
Now, in one of the largest medical research scandals of our lifetimes, the “amyloid hypothesis” appears to be unravelling completely.
Accusations of data in the original paper being manipulated have given way to more and more views that the scientific data on which two decades of research has been built was faked from the start.
The roots of the scandal
Nature Magazine published a study called “A specific amyloid-β protein assembly in the brain impairs memory” in 2006. The work was submitted by a team from the University of Minnesota, led by a neuroscientist called Sylvain Lesné.
The paper showed a decline in cognitive ability in rats when they were injected with a precursor protein (a type of amyloid). It sent shockwaves throughout the scientific research community.
The paper became the basis of the “amyloid hypothesis”. Billions of dollars of public and private money poured into the field.
The paper set the path of medical research that has run for over two decades, absorbed billions of dollars and involved countless trials of medicines on volunteers, sometimes with sadly adverse consequences for the volunteer.
Reports estimate that the American National Institutes of Health devoted $1.6bn of research funding to amyloid research projects in 2022 – which was nearly half of all federal funds devoted to Alzheimer’s that year.
Accusations of fraud
In 2022, Matthew Schrag, a neurologist at Vanderbilt University, blew the whistle and went public with concerns that the original 2006 paper had been built upon manipulated data. He reported that images of brain tissue used in the paper had been manipulated or fabricated.
The story has run quietly, outside most mainstream press, for the last two years. Claims and counter-claims have flourished.
The original research paper was retracted from publication in June 2024, although the exact situation has not been clear. It is becoming more so now.
When the paper was retracted, every author signed the retraction statement, except Sylvain Lesné. Colleagues reported that Lesné was responsible for the final images.
The author resigns
Just days ago, the scientist at the heart of the scandal, resigned from the University of Minnesota.
Elisabeth Bik, a microbiologist who helped uncover some of the image alterations in Lesné’s work, who has been quoted in the press in the USA, called the manipulation “a severe breach of scientific integrity.”
The findings “led many other studies in the wrong direction,” which in turn caused “false hope among patients and their families” she said.
The University of Minnesota cleared Lesné of misconduct during its internal investigation into Nature paper. However, investigations into other papers authored by Lesné were ongoing in 2023. The University has stated that the resignation comes into effect on March 1st.
“Rewards for fraud in science are high, while the chances of getting caught or repercussions are low,” Bik said.
The consequences of the alleged fraud are profound. Experimental treatments often represent the last line of hope for loved ones. Resources may have been diverted from other promising treatments.
The set-back in finding a treatment for Alzheimer’s could have cost years of wasted research time and effort, impacted millions of lives, leaving society with the blight of a truly horrific disease for longer than anyone would wish.
The alleged fraud, if it was ever proven in a court of law, could easily rank as one of the most awful, egregious and serious scientific frauds of modern times. It raises profound questions about the traditional ‘self-policing’ approach to validating scientific research. The consequences of the alleged fraud could reverberate for years to come.
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