A biotech company whose CEO faced allegations of manipulating data in papers used in NIH grant applications will pay a settlement of $4 million to resolve those allegations, the Department of Justice announced January 6.
The settlement is the latest installment in a series of allegations surrounding research by Leen Kawas, the former CEO of the company, Bothell, Wash.-based Athira Pharma. In October 2021, four months after placing cofounder and then-CEO Kawas on leave, an internal investigation found she falsified images in her doctoral dissertation and at least four research papers.
But concerns had been raised about the images as early as 2016, and Athira failed to report them, the DOJ statement noted. Those papers “were referenced in several grant applications submitted to NIH, including in a grant that NIH funded in 2019,” the statement continued.
In September 2021, four papers in the Journal of Pharmacology and Experimental Therapeutics earned expressions of concern after they were flagged for possible image manipulation. (To date, none of these papers have been retracted, and have a combined 106 citations, according to Clarivate’s Web of Science.)
In October of that year, Athira released the results of its internal investigation, finding “that Dr. Kawas altered images in her 2011 doctoral dissertation and in at least four research papers that she co-authored while a graduate student at WSU, published from 2011 to 2014.”
At the time, Athira said Kawas’s research wasn’t the subject of its leading drug candidate or a patent application for it. However, STAT reported in October 2021:
Two of the papers were cited in a 2013 patent granted to the company, while three altered papers co-authored by Kawas were referenced in an Athira application for $15 million funding from the National Institutes of Health, which STAT obtained through a Freedom of Information request.
“To its credit, Athira immediately notified NIH of the research misconduct after the full board of directors learned of it,” U.S. attorney Tessa M. Gorman said in the Jan. 6 statement. “The company’s transparency significantly helped Athira mitigate its damages and demonstrated its resolve towards coming into compliance with the relevant law and regulations.”
The settlement resolves claims made by Andrew P. Mallon, who filed a whistleblower suit under the False Claims Act. Mallon is to receive $203,434 as part of the settlement, according to the DOJ statement.
At publication time, Kawas, Athira and Mallon had not responded to requests for comment.
The settlement comes on the heels of news that Athira faces Nasdaq delisting because its stock price does not meet the minimum bid price requirement. In September, the company announced it was cutting 49 positions, or 70 percent of its workforce.
Kawas is now cofounder and managing general partner of Propel Bio Partners, a venture capital firm, according to the Propel Bio Partners website. She has also published a regular column at Medium, including a recent entry on turning “setbacks into strengths.”
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Kawas’ Medium site looks like generic stuff published by a reputation management company.
I suspect “Bothwell” in the second paragraph should be “Bothell.”
Ah, yes it is! Thank you – it has been updated.