For the second time, a federal watchdog agency found that the Department of Veterans Affairs’ investigation into unethical liver research performed on San Diego veterans was “not reasonable.”
The U.S. Office of Special Counsel published new reports on Tuesday revealing more details about the mistakes and violations that occurred during the research and its dissatisfaction with the VA’s investigation into what happened. inewsource broke the story about the unethical study in 2018 as the first article in its Risky Research series.
Why this matters
The VA San Diego Healthcare System serves nearly a quarter million veterans and has one of the largest research programs in the national VA network. Its roughly $40 million annual research budget funds hundreds of studies on veterans.
When people volunteer to be human subjects in that research, they accept potential health risks in order to contribute to a growing bank of scientific and medical knowledge.
The researchers are expected to follow ethical guidelines meant to protect their patients.
The study at the San Diego VA was part of a $6 million international project to find new therapies for people with alcoholic hepatitis. Researchers around the world were supposed to collect these patients’ leftover liver tissue after they received biopsies and look for patterns.
But that’s not what happened in San Diego.
In 2016, two whistleblowers filed complaints with the special counsel’s office, claiming researchers at the La Jolla hospital had persuaded veterans to undergo medically unnecessary biopsies and then used the samples for research purposes without telling the patients. The whistleblowers, who were both San Diego VA employees at the time, said it put seriously ill subjects at an unnecessary risk for bleeding and other complications.
VA investigators from Washington, D.C., flew to San Diego in 2017 to look into the concerns, and found violations of policies and procedures. But the special counsel’s office declared the VA’s work “unreasonable” for failing to address most of the whistleblowers’ claims.
New documents reveal what the VA team found when it revisited the La Jolla hospital in 2019 and re-interviewed employees involved in the research. This time, much more serious wrongdoing was uncovered.
Reconstructing the research
The second investigation focused on the role of Dr. Samuel Ho, the San Diego VA’s former chief of gastroenterology who led the research when it began in 2013.
Investigators found that Ho instructed technicians to remove extra pieces of tissue from sick veterans during their liver biopsies for his research — without getting the patients’ consent — which increased the chance of complications. Investigators called this “noncompliance with federal regulation and VA policy.”
The technicians performing the biopsies never received a copy of the research plan, so they had no way of verifying that Ho was following protocol, according to the reports. They followed Ho’s direction because they were “susceptible to the influence from a senior member” of the San Diego VA staff.
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The reports showcase a long list of other problems that occurred during the study, too.
Researchers used the wrong assessment forms to determine if someone was too cognitively impaired to agree to participate. And one patient had a liver sample taken the day before he gave consent to be in the study.
Plus, the study staff kept such poor records that inspectors were forced to reconstruct a timeline and a list of participants through interviews and partial documents. They found at least 22 subjects with alcoholic hepatitis had enrolled. At least 13 of them received biopsies and at least eight had their tissue samples sent to a repository on the East Coast to be used by other researchers.
The San Diego VA decided that the patients who received biopsies — and were severely ill during the research — should be tracked down and told about the ethics violations. By the time the letters were mailed two months later, only four of them were still alive.
There were at least 37 other subjects who did not have hepatitis and whose samples were supposed to serve as a comparison, but the details of what occurred in many of these cases were missing from research records.
When the special counsel’s office asked the VA why it didn’t discover these issues during its initial investigation, they were told that Ho had “intentionally provided false information and was untruthful” about his work.
“They could have easily discovered this in the first investigation if they had wanted to — if they had wanted to really question the validity of a lot of these people as they questioned the whistleblowers’ validity,” Martina Buck, one of the whistleblowers, told inewsource this week.
Buck used to be on the research review board at the San Diego VA and first raised concerns about the study before it was approved in 2013. She said she was fired after she later alleged that misconduct occurred.
In response to questions from inewsource, VA spokesperson Randy Noller said Thursday the department requires employees to honestly answer questions from investigators and failing to do so could lead to disciplinary action.
An ‘unreasonable’ finding
Even though the VA’s new investigation corroborated more of the whistleblowers’ claims than it had before, it left major gaps, questions and inconsistencies.
For one, the reports show the San Diego VA never terminated the study after finding major ethics and policy violations. It ended when the funding ran out in November 2018.
Also, the investigation didn’t address claims about patient harm. Medical records from the whistleblowers show at least one patient left the procedure “oozing with blood,” with “stool scattered” on their body and in need of an emergency transfusion. Another had their medication delayed so they could fit the enrollment criteria, according to the special counsel’s report.
What is the Office of Special Counsel?
This federal office “is an independent investigative and prosecutorial federal agency that protects the merit system for over 2.1 million federal employees.” It reports directly to the president about wrongdoing in federal agencies.
Its responsibilities include:
- Providing federal workers a safe channel to disclose violations of law, rule, or regulation; gross mismanagement; a gross waste of funds; an abuse of authority; or a substantial and specific danger to public health or safety. The office does not have investigative authority in disclosure cases but plays a critical oversight role in agency investigations of alleged misconduct.
- Investigating allegations of whistleblower retaliation to determine whether an employee has been fired, demoted, suspended or subjected to another personnel action for blowing the whistle. If the office can demonstrate that a personnel action was retaliatory, it works with the agency to provide relief to the employee.
After reviewing the VA’s reports, the special counsel’s office this week wrote letters to President Joe Biden and Congress, stating that the department’s investigation didn’t meet its standards.
“I continue to be concerned about the quality of care provided to veterans at (the San Diego VA), especially those who participated in the research protocol,” Special Counsel Henry J. Kerner wrote.
“I encourage the VA to consider additional critical review of the actions of the (researchers) during the lifecycle of the study,” Kerner added.
The special counsel’s office has a long history of concerns about the VA. An inewsource analysis in 2019 found the watchdog agency has declared about 16% of investigations by the VA medical inspector’s office “unreasonable.”
In the case of the liver research, the special counsel’s major concern was the reason patients were asked to undergo biopsies at all.
The whistleblowers contend that patients were persuaded to get biopsies as a part of their medical care even when they didn’t need them so their samples could be collected for research.
To support their claim, the whistleblowers pointed out that the kind of biopsies performed in the study — which involve inserting a catheter in the neck — had never been conducted at the San Diego VA on patients with alcoholic liver disease before this study began.
They also documented seven cases where the lead researcher ordered these biopsies over the objections of his colleagues.
But after conducting an external review of all seven cases, the VA concluded the procedures were appropriate given the patients’ medical conditions.
In a statement Thursday, the VA stood by its conclusion that the biopsies were appropriate.
Noller, the VA spokesperson, said the department’s external reviews were thorough and performed by physicians outside the VA with expertise in liver disease. He provided six written comments the experts submitted during the review and said the American College of Gastroenterology Guidelines don’t support the whistleblowers’ opinions.
However, the special counsel’s report to the president said the VA’s reasoning “remains unconvincing.”
“The whistleblowers continue to provide consistent, clear support for their contention that transjugular biopsies were unnecessary for many of the patients in this study,” Kerner said in a statement announcing the newest findings.
‘No science here’
Despite the myriad of problems that occurred, there are no records indicating anyone has been disciplined for their role in the liver research, no publications using the tissue samples have been retracted and the VA has not acknowledged to the whistleblowers that many of their allegations were ultimately proven true.
Ho left the VA and took a job at a university in Dubai in mid-2018, while the investigations were ongoing. The VA said it couldn’t take any action against him since he’s no longer a federal employee, and it couldn’t determine that any other VA employees were responsible for what occurred.
Ho didn’t respond to questions inewsource emailed him for this story.
In 2019, Ho told investigators he didn’t follow the study protocol because the bureaucratic steps involved would have interfered with the research, which “goes against the purpose of what the patient had signed up for and what the (researchers) and ultimately what I believe society is interested in.”
Ho was replaced by Dr. Bernd Schnabl, a staff physician and attending at the San Diego VA and the UCSD Medical Center. Schnabl was previously working alongside Ho as one of the study’s researchers.
Schnabl, along with UCSD Vice Chancellor for Health Sciences Dr. David Brenner, also served on the steering committee for the international liver project. Their research proposal sent to the NIH stated they would use stool samples collected from the hepatitis patients to examine gut bacteria.
The whistleblowers filed complaints with UCSD about the roles that Brenner and Schnabl played in the research. A UCSD spokesperson wouldn’t comment on the complaints, saying the university doesn’t discuss personnel matters or ongoing investigations.
In 2019, Schnabl was the lead author on an article in Digestive Diseases and Sciences that used samples collected from the San Diego VA during the liver research. Ho was also listed as an author on the paper and his contribution line says he was responsible for enrolling participants.
Ethics experts have told inewsource that publishing academic papers based on unethical research is dangerous and encourages researchers to perform more problematic studies in the future.
Buck, the whistleblower, said the number of problems that occurred during the study should render the samples invalid.
“There was no science here,” Buck said. “There was no research achieved that you can glean anything from. No one should be basing any research studies using this as a foundation.”
inewsource contacted the journal’s publisher, Springer Nature, in 2019 and was told its staff would look into the issue.
On Thursday, Springer Nature spokesperson Alice Henchley said the study relied on serum and stool samples that the hepatitis patients provided, not their liver samples. She added that the publisher takes ethics complaints seriously and would reopen its investigation in light of the special counsel’s latest reports.
“We will be looking at the new reports you have provided to us in detail, so are unable to comment further at this time,” Henchley said. “We are grateful to you for bringing them to our attention.”
The whistleblowers have exhausted almost all avenues for reporting concerns about the liver research. Buck’s fellow whistleblower, Dr. Mario Chojkier, is a gastroenterologist at UCSD and the VA. They are married.
The two of them have filed complaints with at least three federal agencies, were interviewed twice by VA investigators and sent their allegations to other research institutions involved in the study.
They watched a congressional committee hearing in 2019 where Rep. Scott Peters, a San Diego Democrat, asked VA leaders to address how they handled the whistleblowers’ claims. But the committee didn’t take any official actions.
As for the special counsel’s newest reports, spokespeople for the House Committee on Veterans Affairs didn’t comment this week on whether they were reviewing the latest findings.
Rep. Mike Levin, a Democrat whose district stretches from Del Mar to Dana Point, was announced as the vice chair of the veterans committee Thursday. A spokesperson said Levin is reviewing the special counsel’s work.
Buck said the special counsel didn’t do enough to address the harms that occurred or prevent similar incidents from happening in the future.
“Something needs to be done,” she said.
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Type of Content
News: Based on facts, either observed and verified directly by the reporter, or reported and verified from knowledgeable sources.