San Diego VA allegedly removed extra tissue from patients for research without consent

Eric Oliver - Print  |

The U.S. Office of Special Counsel revealed more details of an incident when the Department of Veterans Affairs San Diego Healthcare System allegedly collected liver tissue from patients without their consent.

The Office of Special Counsel started investigating the alleged wrongdoings in 2016. The story was first reported on in 2018, and the government office released its subsequent report Feb. 10.

Two whistleblowers told the office that the hospital's former chief of gastroenterology, Samuel Ho, MD, had patients undergo transjugular liver biopsies to harvest liver tissue for a hepatitis-focused research study, according to a report by local CBS affiliate CBS8.

The hospital conducted an internal investigation and determined the GI physician was in violation of research protocol and put patients at increased risk for bleeding and pain, according to the Office of Special Counsel. However, the VA subsequently determined the procedures were the "standard of care."

Before the hepatitis research-related collection began, the system did not perform any transjugular liver biopsies, the government report said.

Henry Kerner, special counsel, said in the government's report: "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 Office of Special Counsel wrote letters to President Joe Biden and Congress this week, stating the VA's investigation into the study didn't meet its standards. Mr. Kerner said, "I encourage the VA to consider additional critical review of the actions of the [researchers] during the lifecycle of the study."

The VA released a statement Feb. 12, standing by its conclusion the biopsies were the standard of care, CBS8 reported.

The VA was participating in a $6 million international research project to find treatment for patients with alcoholic hepatitis, CBS8 reported. Researchers were supposed to collect leftover liver tissue after patients received biopsies to study.

Twenty-two patients with alcoholic hepatitis enrolled in the study, and at least 37 other patients without hepatitis were supposed to serve as a comparison, but those cases often had incomplete medical records.

The San Diego VA never terminated the study after discovering major ethics and policy violations. The study concluded when funding ran out in November 2018. No one was punished for their role in the research. Dr. Ho left the VA and took a job in Dubai, United Arab Emirates, in mid-2018.

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