Bothell biopharmaceutical company pays $4 million to resolve allegations it relied on falsified academic papers to obtain federal grant
Monday, January 6, 2025
Athira Pharma is located in the North Creek Parkway Center in Bothell Photo from Google maps |
CEO resigned after her doctoral work was found to have falsified and manipulated images
The research studies in question were into age-related cognitive decline such as Alzheimer’s. However, when the company applied for a federal grant, it failed to notify NIH of allegations that its former Chief Executive Officer (CEO) committed research misconduct when she falsified images from her doctoral dissertation.
The allegations were called to the government’s attention through a qui tam lawsuit. The relator will receive a portion of the payment for uncovering the fraud.
“The partnership between the scientific community and the federal government is built on trust and shared values of ethical scientific conduct,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Today’s settlement demonstrates that the Department of Justice will pursue grantees that undermine the integrity of federal funding decisions.”
The settlement resolves allegations that between January 1, 2016, and June 20, 2021, Athira failed to report allegations that its former CEO, Leen Kawas, falsified and manipulated scientific images in her doctoral dissertation and in published research papers that were referenced in several grant applications submitted to NIH, including in a grant that NIH funded in 2019.
“The research into neurological disorders such as Alzheimer’s and Parkinson’s Disease is critical to growing numbers of patients in our community. That research must not be tainted by the misconduct highlighted in this case,” said U.S. Attorney Tessa M. Gorman.
“To its credit, Athira immediately notified NIH of the research misconduct after the full board of directors learned of it. 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 partnership between the scientific community and the federal government is built on trust and shared values of ethical scientific conduct,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Today’s settlement demonstrates that the Department of Justice will pursue grantees that undermine the integrity of federal funding decisions.”
The settlement resolves allegations that between January 1, 2016, and June 20, 2021, Athira failed to report allegations that its former CEO, Leen Kawas, falsified and manipulated scientific images in her doctoral dissertation and in published research papers that were referenced in several grant applications submitted to NIH, including in a grant that NIH funded in 2019.
Specifically, Athira violated its regulatory obligations to disclose the allegations to NIH in grant applications and Research Progress Performance Reports, and to disclose them to the HHS Office of Research Integrity in Small Business Organization Statements, Institutional Assurances, or Annual Reports on Possible Research Misconduct.
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Andrew P. Mallon, Ph.D. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Mallon will receive $203,434 under today’s settlement. The qui tam case is captioned U.S. ex rel. Andrew Mallon v. Athira Pharma, Inc., No. 2:21-853-RSL (W.D. Wash.).
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the Western District of Washington, with assistance from the Department of Health and Human Services Office of Inspector General.
The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act.
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Andrew P. Mallon, Ph.D. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. Mallon will receive $203,434 under today’s settlement. The qui tam case is captioned U.S. ex rel. Andrew Mallon v. Athira Pharma, Inc., No. 2:21-853-RSL (W.D. Wash.).
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the Western District of Washington, with assistance from the Department of Health and Human Services Office of Inspector General.
The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act.
Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
The matter was handled by Assistant U.S. Attorney Nickolas Bohl for the Western District of Washington and Trial Attorney Erin Colleran.
The claims resolved by the settlement are allegations only and there has been no determination of liability.
The matter was handled by Assistant U.S. Attorney Nickolas Bohl for the Western District of Washington and Trial Attorney Erin Colleran.
The claims resolved by the settlement are allegations only and there has been no determination of liability.
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