Eh, fuggadaboudit — the FDA’s got friends in need
/
Images used to prove a protein is behind Alzheimer's may have been tampered
Forensic imaging experts say they appear doctored to 'better fit a hypothesis'
Seminal paper was used as starting point for billions of pounds of research
The data behind the most influential theory of what causes Alzheimer'sdisease may have been 'manipulated', a damning scientific probe has claimed.
Experts fear the allegedly falsified results have misled research over the last 16 years, potentially wasting billions of pounds of funding.
A six-month investigation by Science, considered one of the world's most respected research journals, uncovered 'shockingly blatant' tampering of results in the seminal 2006 University of Minnesota study.
The paper pointed to a particular protein — known as amyloid beta — as the driving force behind Alzheimer's. It was the first substance in brain tissue ever identified that seemed to be behind the condition's memory-robbing effects.
Published in rival journal Nature, the study became one of the most cited articles on Alzheimer's ever published.
Around £1.3billion ($1.6billion) of funding for studies mentioning amyloids was spent by the US Government over the last year alone. It made up half of the country's total Alzheimer's research funding.
But images from the study, which involved injecting mice with the protein, appear to be doctored to 'better fit a hypothesis', according to Dr Elisabeth Bik, a forensic image consultant who was asked to review the data.
German psychiatrist Aloiz Alzheimer first identified plaques in the brain in dementia patients in 1906.
A study in the 1980s then suggested amyloid beta was behind the build-up.
But hundreds of trials over the next 20 years, designed to finally find a therapy that targets the toxic accumulation of proteins in the brain, were unsuccessful.
The theory had lost momentum until the landmark University of Minnesota paper in 2006, which became the basis of hundreds of studies since.
Reviewing the pictures used to prove amyloid beta's effect on mice in the study, Dr Dennis Selkoe, a Harvard University neurologist, claimed 'there are certainly at least 12 or 15 images where I would agree there is no other explanation' than manipulation.
RELATED NEWS
08 June 2021
Landmark Alzheimer’s drug approval confounds research community
Many scientists say there is not enough evidence that Biogen’s aducanumab is an effective therapy for the disease.
The US Food and Drug Administration (FDA) approval yesterday of the first new drug for Alzheimer’s disease in 18 years was welcomed by some people looking for hope against an intractable condition. But, for many researchers, it came as a surprise — and a disappointment.
Aducanumab — developed by biotechnology company Biogen in Cambridge, Massachusetts — is the first approved drug that attempts to treat a possible cause of the neurodegenerative disease, rather than just the symptoms. But the approval has sparked a contentious debate over whether the drug is effective. Many experts, including an independent panel of neurologists and biostatisticians, advised the FDA that clinical-trial data did not conclusively demonstrate that aducanumab could slow cognitive decline.
“This is going to set the research community back 10–20 years,” says George Perry, a neurobiologist at the University of Texas at San Antonio and a sceptic of the amyloid hypothesis.
‘Problematic data set’
Aducanumab, an intravenously infused antibody, is the latest in a long line of therapeutic candidates that aims to tackle amyloid plaques. Although every drug of this type has so far failed to improve cognition, questions have persisted about whether amyloid-β is the right drug target, as well as whether researchers are testing the optimal therapeutic candidates, the correct doses and the appropriate patients.
“The problem with most of the amyloid trials is that they didn’t disprove anything,” says Bart De Strooper, director of the UK Dementia Research Institute in London. “They just proved that a drug, in the way it was applied, didn’t work.”
The bottom line, and I do mean the bottom line:
Biogen is now in line for a major windfall with aducanumab; its share price jumped by 40% on the approval.
Some experts had expected the FDA to approve the antibody only for people with early-stage disease, but the regulator has not limited its use — anyone with Alzheimer’s can take it. Biogen will charge around US$56,000 per year per person for the drug. If 5% of 6 million people with Alzheimer’s in the United States receive the treatment, the drug’s revenue would reach nearly $17 billion per year. This would make it the second top-selling drug, by current revenues.
It is surely pure coincidence that most Alzheimer sufferers are over 65 and eligible for Medicare.
UPDATE:
Big Pharma May Have Made Billions Based On A Falsehood About Depression, New Research Shows