Scientific Research Misconduct: Athira Pharma Inc. Will Pay $4M to Settle False Claims Act Allegations
Athira Pharma Inc., a Bothwell, Washington-based, clinical stage bio-pharmaceutical company, will pay $4,068,698 to resolve allegations that it violated the False Claims Act. It failed to report claims of research misconduct to the National Institutes of Health (NIH) and Department of Health and Human Services (HHS) Office of Research Integrity when filling out grant applications and grant award progress reports.
From January 1, 2016, to June 20, 2021, it was alleged that Athira failed to report allegations regarding its former CEO, Leen Kawas, for falsification and manipulation of scientific images in her doctoral dissertation, and in published research papers that were referenced in grant applications submitted to NIH, including in a 2019 NIH-funded grant.
Athira violated its regulatory obligations to disclose allegations to NIH in Research Progress Performance Reports, grant applications, and to the HHS Office of Research Integrity in Small Business Organization Statements, Institutional Assurances, or Annual Reports on Possible Research Misconduct.
Federally funded research is crucial to all Americans who desire accurate and reliable medical research to make advancements in science that impact our families and friends. Here, grant research for Alzheimer’s and Parkinson’s disease was implicated. Special Agent in Charge Steven J. Ryan of the HHS Office of Inspector General (OIG) commented: “The failure of Athira to properly disclose allegations of falsified and manipulated scientific images by its former CEO to the NIH undermines public trust in taxpayer-funded research.”
This civil settlement resolves claims brought by courageous whistleblower Andrew P. Mallon Ph.D. under the qui tam provisions of the False Claims Act, in which a person can file an action on behalf of the United States and receive a sizeable portion of the recovery. With this settlement, Mallon will receive $203,434. To its credit, in this case, Athira did also notify NIH after the full board of directors learned of the research misconduct.
Whistleblowers are one of our first lines of defense to ensure the proper stewardship of grant funds, according to Brook Hargrave, an Auditor in the Division of Program Integrity at NIH.
If you think you might have information relating to potential fraud against the government, please contact Constantine Cannon. We will connect you with an experienced member of our whistleblower team for a free and confidential consult.
Tagged in: False Claims Act, qui tam,