Brad Racino & Jill Castellano | inewsource
An internal report from the San Diego VA obtained by inewsource reveals liver samples were taken from sick veterans without their permission for a study that provided no benefit to the patients.
It’s the latest development in an ongoing inewsource investigation into a flawed human research study at the La Jolla facility.
The October report found “serious noncompliance occurred” when extra pieces of liver were removed from at least nine veterans. The patients weren’t told those samples would be taken or that it could increase the risk of bleeding.
The report did not address many of the findings from a recent federal investigation or concerns raised by whistleblowers. It did not recommend discipline against the doctors involved or VA leadership.
“The VA healthcare system should operate at the highest levels of standard of care,” said C.K. Gunsalus, director of the National Center for Professional & Research Ethics.
“If this has gone so badly wrong, it’s legitimate to ask what else is going wrong – and that’s a little scary,” Gunsalus said.
The study, led in part by Dr. Samuel Ho from at least 2014 to 2016, involved collecting liver tissue, blood, stool and urine samples from patients suffering from alcoholism and liver disease. An inewsource investigation in November found whistleblowers alleged for years that the project was dangerous and unethical. Congress plans to hold a hearing on the findings this spring.
inewsource spoke with four medical ethics experts for this story, and all were troubled by the study. Among their statements were that the research violations were “pretty egregious,” the gaps in the report were “disturbing” and the veterans “were not accorded respectful treatment.”
“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,” said Kyle Galbraith, a bioethicist at Piedmont Athens Regional Medical Center in Georgia.
“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,” Galbraith said. “That’s a slap in their face.”
Investigators from the Veterans Health Administration were in San Diego last month, working on a different report that will be forwarded to President Donald Trump and Congress. It will be the agency’s third attempt in less than two years to figure out what went wrong with the human research project.
Cindy Butler, a San Diego VA spokeswoman, told inewsource the “VA is unable to comment further until the completion” of that report.
Increasing the risk for veterans
The liver is one of the largest organs in the body. It’s a factory, located under the right rib cage, that performs more than 2,000 functions, said Dr. Catherine Frenette, medical director for the liver transplantation program at Scripps Health.
“It processes every single thing that goes through our intestines,” Frenette explained.
That includes alcohol, which irritates the liver and can lead to inflammation and cirrhosis, meaning the buildup of scar tissue. Deaths from cirrhosis have increased 65 percent in nearly two decades in the United States, hitting those 25 to 34 years old the hardest.
In 2013, doctors at the San Diego VA wanted to participate in a large, international collaborative project that aimed to study liver inflammation resulting from alcohol use and design therapies to fight it. The VA San Diego HealthCare System was a good fit because it serves nearly a quarter million veterans and has one of the largest research programs in the national VA network.
Drs. Samuel Ho and Bernd Schnabl, who were both physicians at the San Diego VA with professorships at the University of California San Diego, submitted a proposal that said future findings “may serve to increase types of treatments available to patients that are suffering” from the disease.
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But “there is no benefit from this research for the subject,” the proposal said.
The San Diego VA’s Institutional Review Board oversees its research programs and is comprised of doctors, scientists, researchers and other staff. The board’s job is to ensure projects like this one meet strict rules designed to protect patients.
That board approved Ho and Schnabl’s part in a nearly $6 million study funded by the federal government. San Diego would be one of 10 sites around the world to collect blood, stool and urine from patients and send samples to a biorepository at the University of North Carolina Chapel Hill.
They’d also take liver tissue through a transjugular liver biopsy, a procedure that involves inserting a catheter through the neck, snaking it down to the liver and removing pieces.
“We do them all the time,” said Scripps’ Frenette, talking about the transjugular procedure. “It sounds really invasive, but it’s actually the safest way to do the liver biopsy.”
San Diego’s study was supposed to be observational: Researchers told the board they wouldn’t do anything to patients that wasn’t part of their normal treatment. If a veteran with alcoholic hepatitis had a biopsy, the researchers requested access to any leftover tissue. They repeated that six times in their five-page proposal.
But that’s not what happened.
Instead, researchers had extra liver tissue removed from at least nine veterans during their biopsies and provided the surgeon with a pre-labeled specimen tube for that purpose.
With each sample taken, the risk of complications increases, including internal bleeding.
None of the patients were told this was happening, the report said.
Galbraith, who has coordinated investigations into research misconduct and overseen a human subject protection office, told inewsource, “A lot of other researchers have spent tons of time trying to build up public goodwill and public trust so that they can move their research forward and help society at large, and something like this makes you take a few steps back.
“And it’s hard to regain that trust.”
What’s not in the report
The report from the San Diego VA didn’t mention many of the study’s other flaws that were documented in a 2017 investigation led by the Veterans Health Administration in Washington, D.C. Those included patient privacy violations, shoddy recordkeeping, improperly trained staff, conflicts of interest and the lack of any investigation by leadership after first hearing the allegations in 2013.
“This report raises more questions than it answers,” Gunsalus, from the national ethics center, told inewsource. She added that it appears the San Diego review board is not “owning its mission of protecting human subjects of research.”
The report found no records of “procedural complications” during the biopsies. But whistleblower Mario Chojkier, the VA liver clinic director, alleged to federal investigators that one of his patients returned from the biopsy “oozing with blood,” with “stool scattered” on his body and in need of an emergency transfusion.
The San Diego VA report did not mention this patient, nor did it address most of the concerns from whistleblowers. It did not say whether patients who underwent biopsies were notified of the violations or if those samples could be used in future research. It did not discipline Ho or Schnabl.
Ho left for a job in Dubai in July. Schnabl took over the study and was told to acknowledge “the serious protocol violation” and assure the board he’d follow the rules going forward. Schnabl is a widely published liver researcher, member of three distinguished medical societies and a reviewer for all the top tier medical journals, according to his bio with UC San Diego.
Ho did not respond to a request for comment. Schnabl said VA policy mandates media requests go to the public affairs office. The VA spokeswoman declined to comment.
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