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The U.S. Office of Special Counsel (OSC) has alerted the President and Congress that physicians at the U.S. Department of Veterans Affairs San Diego Healthcare System (VASDHS) collected liver tissue from seriously ill veterans without their prior informed consent. Whistleblowers disclosed to OSC that the former VASDHS Chief of Gastroenterology directed sick patients enrolled in a hepatitis research study to undergo transjugular liver biopsies, which the whistleblowers alleged placed the veterans in danger of serious harm. A subsequent internal investigation by the VA determined that VA physicians who collected these biopsies violated the research protocol and put patients at increased risk of bleeding and pain.
Despite these findings, the VA confirmed its previous determination that transjugular biopsies are the “standard of care" for such patients and failed to adequately reconcile this finding with the fact that, prior to the research protocol, no transjugular biopsies were performed at VASDHS. In comments, the whistleblowers disagreed with the VA's finding that biopsies were appropriate and alleged “deceitful" statements. They described in detail the complications experienced by patients who underwent unnecessary biopsies, including bleeding from the neck and liver that necessitated blood transfusions, and clinical deterioration that led to a life-threatening medical emergency.
“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," said Special Counsel Henry J. Kerner. “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."