Two prominent doctors associated with the University of California San Diego and the local VA used blood and stool samples taken from sick veterans to bolster a paper published this month in an academic research journal.
The specimens were not supposed to be used, according to the project’s lead researcher, because they were part of a study that unethically collected biological samples from living subjects without their consent, which investigators called “serious noncompliance.”
Why this matters
When people volunteer to be human research subjects, they accept potential health risks in order to contribute to a growing bank of scientific and medical knowledge.
Their medical history, blood, organs, DNA or participation in drug trials can help improve the diagnosis and treatment of diseases, or develop new technologies to help people live longer, healthier lives.
The researchers are expected to follow ethical guidelines meant to protect their patients.
Ethics experts told inewsource publishing academic papers based on unethical research is dangerous and encourages researchers to perform more problematic studies in the future.
The paper was published months after an inewsource investigation raised questions about the dangers of the study and an internal VA report found violations of research practices. Since then, a lawmaker called for a congressional hearing, the study was put on hold and the lead researcher told inewsource all samples collected in San Diego would not be used in publications.
Drs. Bernd Schnabl and Samuel Ho had staff at the San Diego VA perform liver biopsies on alcoholic veterans and gather samples of their blood and stool as part of an international project to study liver disease from 2014 to 2016. Allegations about problems with the study came to inewsource from VA whistleblowers, who have called the liver biopsies medically unnecessary and potentially dangerous for this type of patient.
One whistleblower, a VA physician and researcher, said a patient returned from the procedure “oozing with blood,” with “stool scattered” on his body and in need of an emergency transfusion.
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An internal San Diego VA investigation in October confirmed the veterans did not give doctors permission to remove pieces of their livers for research. Reports by federal agencies also found patient privacy violations, shoddy recordkeeping, improperly trained staff, conflicts of interest and the lack of any investigation by leadership after questions were first raised about the study six years ago.
Ho is a former professor of medicine at UCSD and former division chief at the San Diego VA. He resigned from both positions in July to take a job in Dubai at the Mohammed Bin Rashid University of Medicine and Health Sciences. He was responsible for “enrolling subjects for bio-specimen collection,” according to his contribution line in the paper published May 10.
Schnabl is a professor of medicine at UCSD and attending physician at the VA, where he conducts liver research and publishes extensively in top tier medical journals. As senior author on the recent paper, he was responsible for the study concept, design and supervision.
Along with an international team, Ho and Schnabl submitted their work in March to Digestive Diseases and Sciences, a journal that “publishes high-quality, peer-reviewed, original papers.” UCLA’s Dr. Jonathan Kaunitz is the journal’s editor-in-chief.
Kaunitz, Schnabl and Ho would not comment for this story.
A UCSD spokeswoman said, “The university is investigating the matter and will provide information once that investigation is complete.”
A San Diego VA spokeswoman said, “It would be a disservice to participants who allowed their specimens to be collected for research purposes to not publish valuable information based on that participation.”
A spokeswoman for the journal’s UK publisher, Springer Nature, said, “We take all concerns raised about papers we have published very seriously and we look into them carefully, following an established process.” She added she was unable to comment further.
“This is unfortunately a classic story of how much falls through the cracks in scientific literature,” said Ivan Oransky, former global editorial director of MedPage Today and co-founder of Retraction Watch, a website that covers scientific integrity and fraud.
Publishing unethical research in authoritative medical journals fuels mistrust in science, he said, and can potentially harm people in the future.
“There are people in clinical trials based on these data, getting treatments that are not as safe or proven as effective as people would like you to think they are,” Oransky said.
“This is real life. This is not some abstract experiment.”
An international effort amid a federal investigation
The academic paper is the latest of more than two dozen research articles published since 2016 based on the work of the InTeam consortium – an international group of doctors taking part in a nearly $6 million liver study funded by the National Institutes of Health.
But the new paper is the first inewsource has found that used samples taken from San Diego veterans after the October VA report discovered “serious noncompliance” with the research.
Schnabl was on the eight-person steering committee that helped manage the international project along with David Brenner, UCSD’s vice chancellor for health sciences. Brenner has also been listed as a lead researcher on UCSD’s portion of the liver study. He did not respond to inewsource’s interview request.
The InTeam is led by Dr. Ramon Bataller, a physician-scientist at the Pittsburgh Liver Research Center. Bataller told inewsource three times during a February interview that all samples collected from San Diego — including liver, blood and stool — were “banished” from use in any academic articles.
“I don’t want to retract any paper after years of work,” he said.
Bataller is not one of the 10 authors on the new paper, but he is listed on another recently published article with Ho and Schnabl even though he told inewsource he would never work with Ho again.
Dr. Ramon Bataller Interview Transcript
BATALLER: “When it was brought to the attention by the IRB people there, we concluded .. we agreed to close the study. We immediately wanted to because I told you I’m obsessive with these topics. All the samples from this center, all the samples of any kind, including biopsy, no biopsy, everything. I have not used for any of our studies now. And I talked to every investigator. Nobody can use anything.”
INEWSOURCE: “Okay, so are you saying that all the samples collected at the VA were not used?”
BATALLER: “No, there were no, they were not used and now I have given orders to all centers and they cannot be used. Even any clinical data that was initially obviously de-identified. All the data from San Diego has been banished from any study that (we can) publish.”
INEWSOURCE: “Even what was done at UCSD, the clinical research there?”
BATALLER: “Everything. Any clinical data. Any biospecimen of any kind before, after, during. All samples have been put aside in any clinical data. Okay. Because I don’t want to retract any paper after years of work.”
Bataller has not responded to multiple emails and phone calls since March.
The lead author on the Digestive article along with Schnabl is Dr. Peter Stärkel at the Cliniques Universitaires Saint-Luc in Brussels.
He said he was “not aware of any breach concerning protocols and consent,” and didn’t know “if and how many alcoholic hepatitis samples Dr. Ho has contributed to the study.” He said Schnabl should be able to provide that information.
Typically, lead authors – like Schnabl and Stärkel – are responsible for ensuring the accuracy and integrity of data submitted to journals, said Kayte Spector-Bagdady, chair of the University of Michigan’s research ethics committee.
“The fact that one of these researchers under investigation is a senior author of the article would lead me to believe that he should have been responsible for knowing the pedigree of all the data used,” Spector-Bagdady said.
Schnabl is also an associate editor for Digestive Diseases and Sciences, though it’s not uncommon for editorial board members to publish in the journals they edit.
Meanwhile, an investigation into the San Diego liver study by the VA Office of the Medical Inspector is in its third year. Its staff have already submitted two reports to the U.S. Office of Special Counsel, but the counsel called those reports “unreasonable” for failing to address the basic foundations of the whistleblower complaints that sparked the inquiry.
Congressman Scott Peters, D-San Diego, called for a hearing on Capitol Hill after learning about the allegations from inewsource in November. It has not yet been scheduled.