Are Alzheimer’s and Parkinson’s Disease Patients Taking Drugs Based on Fraudulent Research?
Finding of scientific misconduct against NIH’s National Institute on Aging: They might as well just start painting the lab mice
Science magazine this week revealed an extensive investigation into alleged fraud by “veteran brain researcher” Dr. Eliezer Masliah, the Director of the Division of Neuroscience at the National Institute of Aging (NIA). He was appointed to that position in 2016, when Congress appropriated vast new monies for Alzheimer’s disease research; the neuroscience division received $2.6 billion in fiscal year 2023, according to Science, more than all other divisions of NIA combined. (1)
“As a leading federal ambassador to the research community and a chief adviser to NIA Director Richard Hodes, Masliah would gain tremendous influence over the study and treatment of neurological conditions in the United States and beyond,” Sciencesaid of his appointment.
Masliah not only had the power to decide which grants to fund, thereby creating the direction of most clinical research, but he also had the power to control the paradigms of neurological diseases and freeze out—i.e., not fund—any research that didn’t fit, or that questioned, his paradigm of (for example) Alzheimer’s disease.
This week, however, Science magazine revealed an investigation identifying 132 of Masliah’s 800 published research papers that contain apparently fraudulently altered images. (1)
The two-year investigation by Science found “scores” of Masliah’s studies at University of California San Diego (his previous employer) and NIA that are “riddled with apparently falsified Western blots—images used to show the presence of proteins—and micrographs of brain tissue,” Charles Pillar reported. “Numerous images seem to have been inappropriately reused within and across papers, sometimes published years apart in different journals, describing divergent experimental conditions.”
To conduct the independent investigation, Science assembled an unpaid group of neuroscientists and forensic analysts to review Masliah’s published work. This group produced “a 300-page dossier revealing a steady stream of suspect images between 1997 and 2023 in 132 of his published research papers.” (1)
“In our opinion, this pattern of anomalous data raises a credible concern for research misconduct and calls into question a remarkably large body of scientific work,” the Science magazine investigation concluded. (1)
In other words: Regardless of the stated goal or research design of any lab studies or research grants, the subsequently published papers contained Western blot images that were used, reused, and altered, sometimes over several years. Instead of generating new data and publishing images that supported their reputed new results, Masliah’s papers simply reused various old images, or fraudulently altered them to meet the study’s objectives.
Although Science gave NIH, as well as Masliah’s other collaborators including drug companies, two weeks to respond to the 300-page dossier, Pillar reported that there had so far been no responses. “And today [September 26], the National Institutes of Health (NIH) released a statement saying that following an investigation, it had “made findings of research misconduct” against Masliah for ‘falsification and/or fabrication involving re-use and relabel of figure panels’ in two publications. According to the statement, Masliah no longer serves as NIA’s neuroscience division director, but NIH declined to further clarify his employment status.” (1)
Masliah was the “sole common author” on all the papers in Science’s dossier. Nonetheless, NIH has announced no plans to conduct a more wide-reaching misconduct probe and even featured Masliah, along with NIA Director Richard Hodes, at the kickoff of a national “Alzheimer’s summit” at NIH.
The Science dossier “challenges far more studies than the two cited in NIH’s statement, including many that underpin the development and testing of experimental drugs,” Pillar pointed out.
Which takes us to the heart of the matter: Issues of personal integrity aside, much of the research Masliah directed concerned proteins thought to play pivotal roles in Alzheimer’s and Parkinson’s diseases, and that research has been relied upon to develop potential therapeutics that are even now being tested on uninformed patients.
Let’s review that: Aging patients with incapacitating neurological illnesses are being given experimental drugs based on fraudulent research.
One such drug approved for clinical trials by the Food and Drug Administration (FDA) is prasinezumab, a medication for Parkinson’s disease. It’s manufactured by a company named Prothena, which Science noted is “backed by big money.” The drug attacks a protein (alpha-synuclein) that’s thought to induce the symptoms of Parkinson’s disease when it accumulates in the brain.
However, when Parkinson’s patients were given the drug, it “showed no benefit compared with a placebo,” according to Science. “And volunteers given infusions of the antibody [drug] suffered from far more side effects such as nausea and headaches than those in a placebo group who received sham infusions.” This Phase I clinical trial, published in The New England Journal of Medicine in 2022, included 316 patients, Pillar reported. (1)
Did someone involved in this study step up and say: Maybe we should give this a second look? Is this drug doing more harm than good? Maybe it’s not targeting the real problem in Parkinson’s patients’ brains? Why are patients receiving the drug having more adverse effects than the patients receiving the placebo?
Of course not. Instead, Prothena is now conducting a Phase II clinical trial with almost twice as many—586—Parkinson’s disease patients.
And lest anyone think that only professional pride and reputations are at stake, Science makes it clear that Prothena is being paid hundreds of millions of dollars by a much larger pharmaceutical company, Hoffmann-La Roche, to bring this questionable drug to market. (1)
Eleven neuroscientists not involved with any of the 132 problematic studies, or with the Science investigation, agreed to review the dossier’s disputed images.
“ ‘I’m floored,’ says Samuel Gandy, a prominent neurologist at the Mount Sinai Alzheimer’s Disease Research Center who was visibly shaken during a video interview. ‘Hundreds of images. There had to have been ongoing manipulation for years.’ ” (1)
Pillar continued: “Gandy was disturbed, for example, that Masliah and colleagues seem to have used the same image of a mitochondrion, a cellular energy-producing structure, in two articles on different topics published 2 years apart in different journals. ‘The bus driver could see that they are identical,’ Gandy says.” (1)
Before publication, Science was unable to obtain comments about the alleged fraud from Masliah or his boss, NIA Director Richard Hodes, or his boss, NIH Director Monica Bertagnolli.
This is not the first time I’ve reported apparent research fraud in Alzheimer’s disease and other forms of dementia that ranges from altered images in papers by prominent researchers to the administration of drugs that actually shrink dementia patients’ brains. (2-7)
Sadly, there’s nothing new about scientific fraud, even at its most blatant. In May 1974, an immunologist at Memorial Sloan Kettering Cancer Center “deliberately falsified and misrepresented research results,” Jane E. Brody reported in the New York Times. The researcher, Dr. William T. Summerlin—only 35 years old—was given “up to a one-year medical leave of absence with pay while he undergoes psychiatric care for an emotional illness,” according to the Times. Memorial Sloan Kettering made it clear that Dr. Summerlin would not be invited to return to the cancer center following his leave. (8)
What went wrong here?
“...Dr. Summerlin admitted to the committee that he had darkened the skin of two white mice with a pen to make it appear that the mice had accepted skin grafts from genetically different animals, and that on four occasions he had misrepresented the results of experimental transplants of human corneas into rabbit eyes,” Brody reported. (8)
According to the New York Times, Summerlin’s aim was to prove that transplants between species were possible without using dangerous immunosuppressive drugs. (8)
In the mid-1980s, I worked at a biotech company in Cambridge, Massachusetts, alongside a scientist who’d been a graduate student in Summerlin’s lab. He was a reticent and talented researcher, but once his stint in Summerlin’s lab became common knowledge, there were questions: Didn’t he realize something was wrong when no one else in the lab—or in the world, as it turned out—could replicate Summerlin’s results? Didn’t anyone look closely enough at the mice to see that they were painted with a marker?
He shrugged, looked sheepish, and said, “We all just assumed he was smarter and better than we were.”
Science is clearly unable to police itself and even today often operates as a rigid hierarchy. It’s past time that everyone involved in scientific research, from graduate students to Chairs of departments and Directors of NIH, holds each other responsible for identifying—and reporting—the painted mice and other instances of potential scientific fraud. The ultimate recipients of their findings deserve no less.
BIBLIOGRAPHY
1. Charles Piller. “Picture Imperfect: Scores of Papers by Eliezer Masliah, Prominent Neuroscientist and Top NIH Official, Fall Under Suspicion.” Science, September 26, 2024. https://www.science.org/content/article/research-misconduct-finding-neuroscientist-eliezer-masliah-papers-under-suspicion
2. Neenyah Ostrom. “Breaking News: Controversial Alzheimer’s Disease Drug Dumped.” February 1, 2024. The Real AIDS Epidemic SubStack.
3. Neenyah Ostrom. “Fraud in Stroke and Alzheimer’s Disease Drug Trials—Again? Whistleblowers detect data and images in published papers that appear to have been manipulated, according to Science magazine.” November 16, 2023. Chronic Illness & HHV-6 Report SubStack.
4. Neenyah Ostrom. “What’s Gone Wrong in Alzheimer’s Disease Research?Published research once again found to contain fudged images—can any neuroscience research be trusted?” July 20, 2023. Chronic Illness & HHV-6 Report SubStack.
5. Neenyah Ostrom. “Alzheimer’s Disease Drugs Make Patients’ Brains Shrink.”April 3, 2023. Chronic Illness & HHV-6 Report SubStack.
6. Neenyah Ostrom. “Are Alzheimer’s Disease Drugs Failing Because They’re not Targeting the Viruses Now Found in AD Patients’ Brains?” March 30, 2023. Chronic Illness & HHV-6 Report SubStack.
7. Neenyah Ostrom. “Alzheimer’s + Long Covid & ME/CFS ‘Brain Fog’: What do They Have in Common? The diagnostic protein ‘blobs’ of Alzheimer’s disease may not be its cause after all—and some sleuthing suggests it may all be fraud.” January 27, 2023. Chronic Illness & HHV-6 Report SubStack.
8. Jane E. Brody. “Inquiry at Cancer Center Finds Fraud in Research.” New York Times, May 25, 1974. https://www.nytimes.com/1974/05/25/archives/article-5-no-title-fraud-is-charged-at-cancer-center-premature.html