The U.S. Department of Veterans Affairs San Diego Healthcare System collected liver tissue from “seriously ill” veterans without their prior informed consent, according to a federal investigation.
The U.S. Office of Special Counsel alerted President Biden and Congress on Tuesday of a report based on allegations from whistleblowers that the VA’s collection of liver sample biopsies violated protocol and “put patients at increased risk of bleeding and pain.”
In April 2018, the whistleblowers alleged to the VA facility leadership that biopsy samples intended only for clinical diagnostics were taken for research purposes from nine participants.
The allegations prompted the San Diego Healthcare System to initiate an institutional review board that “did not substantiate these allegations,” though the board said the additional biopsy samples were taken for specific research purposes in “serious violation of the research protocol.”
In 2019, the Office of Special Counsel’s continued concerns led to an internal review, which confirmed an unnamed doctor and other research staff collected “nonarchival liver tissue from” seven study participants, adding that medical staff went “above and beyond what was needed for diagnoses.”
Despite the VA’s findings, the healthcare system confirmed the transjugular biopsies in patients with alcoholic hepatitis are the “standard of care.”
The whistleblowers said they disagreed with the VA’s findings that the biopsies were appropriate, alleging they produced “deceitful” statements.
Whistleblowers described detailed complications some patients experienced, including “bleeding from the neck and liver that necessitated blood transfusions, and clinical deterioration that led to a life-threatening medical emergency.”
In a statement to Congress and the president, OSC special counsel Henry Kerner said the whistleblowers’ accounts maintain sufficient evidence that the San Diego Healthcare System conducted unnecessary transjugular biopsies.
“While I appreciate the VA’s work to provide additional insight into wrongdoing in this case, I remain troubled that liver tissue was collected from sick patients without informed consent,” Kerner said.
He added, “The whistleblowers continue to provide consistent, clear support for their contention that transjugular biopsies were unnecessary for many of the patients in this study. The agency’s determination, in light of the whistleblowers’ evidence, remains unconvincing.”
The Washington Examiner reached out to the White House and the House Committee on Veterans’ Affairs but did not immediately receive a response.
