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October 23, 2024

NIH and Scientific Integrity

I’m not sure what it is about the Alzheimer’s field, but we just learned of yet another long series of apparent fraud by one of the field’s putative leaders. As reported by Charles Piller a few days ago:

In 2016, when the U.S. Congress unleashed a flood of new funding for Alzheimer’s disease research, the National Institute on Aging (NIA) tapped veteran brain researcher Eliezer Masliah as a key leader for the effort. He took the helm at the agency’s Division of Neuroscience, whose budget—$2.6 billion in the last fiscal year—dwarfs the rest of NIA combined. . . .

Masliah appeared an ideal selection. The physician and neuropathologist conducted research at the University of California San Diego (UCSD) for decades, and his drive, curiosity, and productivity propelled him into the top ranks of scholars on Alzheimer’s and Parkinson’s disease. His roughly 800 research papers, many on how those conditions damage synapses, the junctions between neurons, have made him one of the most cited scientists in his field. His work on topics including alpha-synuclein—a protein linked to both diseases—continues to influence basic and clinical science.

But over the past 2 years questions have arisen about some of Masliah’s research. A Science investigation has now found that scores of his lab studies at UCSD and NIA are riddled with apparently falsified Western blots—images used to show the presence of proteins—and micrographs of brain tissue. Numerous images seem to have been inappropriately reused within and across papers, sometimes published years apart in different journals, describing divergent experimental conditions.

After Science brought initial concerns about Masliah’s work to their attention, a neuroscientist and forensic analysts specializing in scientific work who had previously worked with Science produced a 300-page dossier revealing a steady stream of suspect images between 1997 and 2023 in 132 of his published research papers. (Science did not pay them for their work.) “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,” they concluded.

Neither Masliah nor the various drug companies, universities, or federal ­agencies that were provided the dossier have so far rejected or challenged any of its examples of possible misconduct despite being given the material more than 2 weeks ago. And today, 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.

132 problematic and possibly fraudulent papers? By an NIH leader responsible for $2.6 billion in yearly funding? Words fail.

* * *

As luck would have it, the NIH just today released a “Final Scientific Integrity Policy,” which is available here. About a year ago, the Good Science Project submitted comments on the draft policy, and we made one key point:

The Draft Policy notes that there are already several NIH offices that adjudicate integrity issues “when an allegation or complaint is received,” and that the new Scientific Integrity Official will help coordinate how NIH responds to “allegations to ensure effective oversight.”

We believe that NIH should take one further step as to ensuring accountability: Give the Scientific Integrity Official enough of a budget and staff to proactively look for research integrity issues, rather than merely reacting to allegations and complaints.

The reason for this recommendation is straightforward: Problems with research integrity are much more prevalent than the rate of official allegations and complaints would suggest. In many cases, we will not find research integrity problems unless we look for them more proactively.

We proposed that instead of sitting around waiting for integrity complaints to be filed:

The NIH should look to the Center for Medicare and Medicaid Services, which devotes substantial resources to a Center for Program Integrity that proactively looks for signs of fraud, improper payments, etc. That is, the NIH Scientific Integrity Official should be given a staff and budget to proactively audit NIH-funded studies for signs of fraud, data manipulation, and other violations of research integrity. One-twentieth of one percent of NIH’s overall budget would be a good starting point.

Notably, the NIH’s release of the Final policy has a section discussing our comment:

Public Comments: While commenters were generally supportive of the establishment and proposed roles and responsibilities of the CS and SIO, a few suggested clarifying both roles and adding additional roles and responsibilities for other NIH leadership. Suggestions also included clearly defining the adjudication processes for losses of scientific integrity and ensuring adequate resources are allotted to the SIO and staff to implement the Policy and proactively seek out potential allegations of losses of scientific integrity.

Final Policy: The Final NIH Scientific Integrity Policy affirms the roles and responsibilities of the CS and SIO required by the 2021 Presidential Memorandum and includes some additional roles and responsibilities suggested by public comments. Detailed processes for adjudicating findings of loss of scientific integrity will be outlined in a NIH Manual Chapter and/or additional guidance. Additionally, NIH will ensure the SIO and other relevant agency offices and staff receive adequate support and resources to fulfill the functions outlined in the Policy.

That paragraph is a bit vague as to whether the NIH will actually empower and fund its Scientific Integrity Officer so as to proactively search for cases of academic fraud. But in light of the recent scandal involving NIH’s own Masliah — involving a string of 132 papers stretching back to 1997!! — proactive fraud detection is all the more important.

Moreover, Congress has already required NIH to start looking for fraud proactively!

Funding Replication Experiments and/or Fraud Detection.–The Committee recognizes that many biomedical research studies have turned out to be irreproducible or even outright fraudulent. The recent Reproducibility Project in Cancer Biology showed that cancer biology studies in top journals often failed to be replicable, and a prominent line of Alzheimer’s studies was recently found to be based on an allegedly fraudulent study funded by NIH in the early 2000s. Given the importance of detecting both reproducibility and fraud, the Committee provides $10,000,000 to establish a program to fund replication experiments on significant lines of research, as well as attempts to proactively look for signs of academic fraud. The Committee directs NIH to brief the Committee within 180 days of enactment on the establishment, staffing and plans for this effort in fiscal years 2024 and 2025.

It’s inexcusable for a scientist to get away with what is apparently academic fraud for over 25 years, let alone to be installed in a position of such influence at NIH. It was embarrassing enough that the SEC didn’t react quickly enough to complaints about Bernie Madoff’s conduct, but imagine that the SEC had made Madoff the Deputy Director for its Division of Enforcement.

The best political move NIH could make in this context is to announce a multi-million-dollar program to look for academic fraud by the most highly-funded NIH researchers and by NIH leaders themselves. Otherwise, it will be difficult to restore trust with congressional leaders.