Claims of Fraud In Alzheimer’s Research

It’s one of the most cited scientific articles on Alzheimer’s ever published – a breakthrough 2006 study that identified amyloid beta star 56 as the cause of memory loss in mice.

This single study led to billions of dollars in funding and a major research effort to find a treatment that would sweep the damaging protein from the brain.

There’s just one problem. A six-month investigation by the journal Science accuses the scientists of tampering with the results. They’re saying that this particular amyloid beta may not even exist. Here’s the disturbing story…

Seven years ago, Richard Horton, Editor-in-Chief of one of the world’s most respected medical journals, The Lancet, wrote about the state of modern medical research: “…much of the scientific literature, perhaps half, may simply be untrue.

“Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness.”

The latest controversy unfolding in the Alzheimer’s research world is just one example of this.

Accusations Of Doctored Images

The 2006 paper in question was written by scientists at the University of Minnesota and published in the journal Nature. The protein they identified was the first ever found in brain tissue to cause memory loss.

They employed a well-known and commonly used technique called western blots to detect proteins in blood or tissue. The findings are presented as photographic images. The investigation claims there’s “shockingly blatant” evidence the images used were manipulated.

In fact, Dr. Elisabeth Bik, a research fraud expert who reviewed the images, explained, saying, “Manipulating images like these is simple to do with Photoshop. You can edit out parts you don’t want. Both of these things appear to have been done in this case.”

Dennis Selkoe, professor of neurologic diseases at Harvard University, said there was “precious little evidence” the amyloid the researchers claimed to have found even existed.

Meanwhile, Richard Smith, former editor-in-chief of the British Medical Journal said he wasn’t surprised. He’s been concerned about research fraud in the medical field for 40 years.

He wrote last year: “We have now reached a point where those doing systematic reviews must start by assuming that a study is fraudulent until they can have some evidence to the contrary.”

The University of Minnesota paper isn’t the only example to rock the field of dementia research.

Shoddy Procedures

The dementia drug simufilam, produced by Cassava Sciences, looked promising. Trial data showed it could slow and might even reverse cognitive decline in Alzheimer’s patients.

But the scientists involved have encountered allegations of data manipulation and misrepresentation, the use of questionable methods of analysis, numerous methodological errors, and trial results that were “overblown, inappropriate, and uninterpretable.”

Not surprisingly, one of the study authors has had five other papers retracted because of “serious concerns about the integrity and reliability of the results.” What’s more, Cassava Sciences is now being investigated by the U.S. Department of Justice to see whether investors and government agencies have been defrauded.

FDA Members Resigned Over This Drug

Another dementia drug, aducanumab, hit the headlines last year when it became the first new Alzheimer’s drug to be approved by the FDA in 20 years. But its usefulness has been disputed by scientists, including three members of the FDA’s own advisory committee who resigned in protest of its approval.

Robert Howard, Professor of Old Age Psychiatry at University College London, was dismayed by the FDA’s decision.

“I consider the approval of aducanumab represents a grave error that will have only negative impact on patients and their families and that could derail the ongoing search for meaningful dementia treatments for a decade.

“Amazingly, the FDA have sidestepped available clinical trial outcomes data that indicate the drug probably doesn’t work.”

What Can Be Done?

Richard Smith believes scientific journals should be held accountable and be fined if they publish fraudulent research and don’t put it right swiftly. He also supports criminal prosecutions against scientists who carry out such research.

Dr. Bik agrees that publishers need to take responsibility and suffer penalties and the threat of punishment, otherwise nothing will change.

Professor Chris Chambers, a neuroscientist from Cardiff University, Wales, said, “The main reason researchers fake results is because beautiful results are more likely to be published than boring results. We can solve this problem if journals evaluate study plans and then accept papers based on the quality of the plan rather than the sexiness of the results.

“Some journals do this, but others fear that publishing science based on quality rather than flashiness will reduce their journal’s newsworthiness. The price for their arrogance is the kind of fraud we see. Until we hold them accountable, it will be the public that suffers the consequences of fraud.”

My Takeaway

There’s another problem: Regulatory capture, whereby regulators act in the interests of the industry they are supposed to be regulating. The FDA gets 45 percent of its budget from the pharmaceutical industry and lucrative “revolving door” jobs await employees once they exit their government posts. Addressing this issue is a far tougher prospect in my opinion.