According to an internal investigation from the San Diego VA, at least nine ill veterans had pieces of their liver stolen during biopsy procedures for an undisclosed research study.
The study was conducted at the La Jolla facility on veterans suffering from alcoholism and liver disease and the veterans were never informed the extra samples would be taken or of the risks involved, KPBS News reported last week.
— San Diego Informer (@sandiegoinforme) February 27, 2019
The unethical study took place from 2014 to 2016 and was led by Dr. Samuel Ho and Bernd Schnabl.
The initial purpose of the study was to combat liver inflammation stemming from alcohol use since the number of deaths from liver disease has been increasing in recent years.
Researchers were only supposed to use leftover liver samples from biopsies conducted as a part of the patient’s regular medical treatment. Instead, they helped themselves to extra samples without patients’ consent.
The $6 million study was approved by the San Diego VA’s Institutional Review Board, whose duty is to enforce strict guidelines to protect patients that are undergoing these studies.
A report was released in October and while it did not mention the findings from the investigation, disciplinary actions, or whistleblower concerns, it did find “serious noncompliance occurred.”
The review board didn’t cite any complications caused during the biopsies. However, Mario Chojkier, a whistleblower and director of the VA liver clinic, said that he saw a patient return from the procedure “oozing with blood with stool scattered on his body and in need of an emergency transfusion,” KPBS News said.
Kyle Galbraith, a bioethicist at Piedmont Athens Regional Medical Center in Georgia, said, “We ask these individuals to serve with their time and their bodies and putting their lives on the line for our own safety and defense. I think they deserve to be treated with the utmost respect when they return home, with great medical care and certainly not with being lied to in research studies. That’s a slap in their face.”
Ho took a new job in Dubai last July, and Schnabl was left in charge of the study provided he could adhere to the guidelines.
Schnabl definitely qualifies to lead the project as a “widely published liver researcher, member of three distinguished medical societies and a reviewer for all the top tier medical journals,” KPBS News stated.
Neither Ho or Schnabl agreed to comment.
C.K. Gunsalus, director of the National Center for Professional and Research Ethics, said, “The VA healthcare system should operate at the highest levels of standard of care. If this has gone so badly wrong, it’s legitimate to ask what else is going wrong – and that’s a little scary.”
Congress is scheduled to hold a spring hearing on the findings.