Doctors on a Veterans Affairs research project harvested liver tissue from sick veterans without their consent, breaking the department’s own rules and placing the patients themselves “at serious risk,” the government’s top whistleblower watchdog agency said in a report to President Biden this week.
The Office of Special Counsel has been probing the matter for several years and had previously disclosed the operations, sparking a back-and-forth with the VA over whether the liver biopsies were standard care. The VA contended the operations were valid, even though it acknowledged consent wasn’t always obtained.
In the new report, dated Tuesday, the special counsel says the whistleblowers who came forward have made a convincing case that the VA is wrong about the standard of care, and veterans are being hurt, and possibly even killed, by the unnecessary operations.
“The overall picture of alleged malfeasance painted by the whistleblowers is compelling,” Special Counsel Henry J. Kerner said in his memo to Mr. Biden. “The whistleblowers also provided extensive information to support their assertion that patients were, in fact, harmed by their participation in this study.”
The VA admitted in a 2019 letter that doctors took samples for research “without effectively verifying whether this was approved by the Institutional Review Board.”
Still, the VA said after a review of the procedures done without approval, a re-review found them to be justified.
On Wednesday the department acknowledged the new findings but said it believed its own previous medical review addressed the issue adequately.
The operation in question is known as a transjugular biopsy.
Whistleblowers fingered one doctor at the VA San Diego Healthcare System who they said was performing them on “seriously ill” vets as part of a research project.
The goal was to create a database of specimens from patients with alcoholic hepatitis. San Diego was one of seven sites in the U.S. helping with the study.
The research began in 2013, and the OSC began investigating in 2017, after whistleblowers raised concerns over San Diego’s practices.
Mr. Kerner, in his final report, said he appreciated the VA’s willingness to go back and investigate, but said the VA’s conclusions can’t be squared with what the whistleblowers have said.
He said one example was “several egregious flaws” in the research protocols themselves, which he said call into question the “integrity” of the VA’s review.
And even though the VA defended the biopsies as valid care in these cases regardless of the research study, it couldn’t explain why no such biopsies had been done before the study was taking place.
“The agency’s determination that the standard of care was met, in light of the whistleblowers’ evidence, remains unconvincing, as do the agency’s continued assertions regarding the meaning of ‘archival tissue,’” Mr. Kerner wrote.
He urged the VA to go back for another review of the researchers and to rethink its own standards of care for vets at the San Diego system.