Dangerous human research alleged at San Diego VA; Rep. Peters vows action
The outside of the San Diego VA Medical Center is shown on Nov. 2, 2018. (Megan Wood/inewsource)

Dangerous human research alleged at San Diego VA; Rep. Peters vows action

Rep. Scott Peters, D-San Diego, is shown at the Hotel Republic in downtown San Diego on election night, Nov. 6, 2018. (Megan Wood/inewsource)

Rep. Scott Peters, D-San Diego, is shown at the Hotel Republic in downtown San Diego on election night, Nov. 6, 2018. (Megan Wood/inewsource)

The allegations involve Dr. Samuel Ho, a former division chief at the San Diego VA and professor of medicine at the University of California San Diego. Ho resigned from both positions in July to take a job in Dubai at the Mohammed Bin Rashid University of Medicine and Health Sciences.


Ho told inewsource in a Nov. 11 email that he would respond to our questions soon, but he hasn’t. Nor did he respond to a follow-up email.

Ho used the San Diego VA’s facilities, staff and physicians from at least 2014 to 2016 to conduct research on alcoholic veterans suffering from liver disease as part of a federally funded study. His original research proposal included pregnant women, but it was denied on the grounds that it would endanger fetuses. It was allowed to continue with modifications.

The whistleblowers – Martina Buck and Mario Chojkieralleged to government investigators that Ho coerced patients to undergo a liver biopsy through a catheter in the neck so he could obtain grant money and publish scientific articles. They said the biopsies were medically unnecessary and potentially dangerous for this type of patient – one already seriously ill, at risk of excessive bleeding due to liver problems and unable to benefit from the long-term study.

“The optimal way to practice medicine is to do everything that is needed, but nothing that is not needed,” said Chojkier, director of the liver and transplantation clinics at the VA and professor of medicine at UCSD.

“What is the risk benefit?” he said.

Dr. Mario Chojkier, shown on Nov. 16, 2018, is one of two whistleblowers who has made allegations against Dr. Samuel Ho, a former San Diego VA division chief and professor of medicine at UCSD.

Dr. Mario Chojkier, shown on Nov. 16, 2018, is one of two whistleblowers who has made allegations against Dr. Samuel Ho, a former San Diego VA division chief and professor of medicine at UCSD. (Megan Wood/inewsource)

Whistleblower Martina Buck, shown on Nov. 15, 2018, is a former chair of a San Diego VA research safety board.

Whistleblower Martina Buck, shown on Nov. 15, 2018, is a former chair of a San Diego VA research safety board. (Megan Wood/inewsource)

A sign at the San Diego VA Medical Center is shown on Nov. 2, 2018.

A sign at the San Diego VA Medical Center is shown on Nov. 2, 2018. (Megan Wood/inewsource)

The Special Counsel’s Office called the VA’s reports “unreasonable” because they failed to comprehensively address the “basic foundations of the whistleblowers' allegations,” along with several other inconsistencies.

It was the eighth time in the past two years that the Special Counsel’s Office has found the Department of Veterans Affairs’ internal investigations were “unreasonable.”

“It's up to Congress if they want to move it forward in any fashion,” said Catherine McMullen, manager of the office’s whistleblower disclosure program.

Former Special Counsel Carolyn Lerner twice criticized the VA for too often using a “harmless error” defense, which is the department acknowledging problems but claiming patients weren’t hurt.

“This approach has prevented the VA from acknowledging the severity of systemic problems and from taking the necessary steps to provide quality care to veterans,” Lerner wrote to President Barack Obama following the national VA wait-time scandal in 2014.

“As a result, veterans’ health and safety has been unnecessarily put at risk,” Lerner said.

inewsource is unaware of any documented physical harm in the San Diego human research cases.

But Henry Kerner, the special counsel in this latest case, said in the conclusion of his report to Congress and the president that he remained “deeply concerned about the quality of care” provided to veterans at the San Diego VA, “especially those participating in the research protocol.”

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The Standard of Care

The whistleblowers allege Ho justified these biopsies as best practice – or “standard of care” – in diagnosing the veterans, even though the San Diego VA had never performed this surgery before on this group, according to the special counsel’s report.

“The procurement of these biopsies in this way, to these specific kind of alcoholic patients, even the nonpregnant ones, is not standard of care,” Buck said. “And so then it leads to the question of, ‘Well, are these samples being obtained for research purposes and not being acknowledged that way?’ So then that's another ethical dilemma. That's huge, and the foundation of the protocol begins to crumble at that point.”

The VA report substantiated the standard of care claim by citing the opinion of a UC San Diego physician who had trained under Ho and co-authored research papers with him on the biopsies under question.

The special counsel took issue with that opinion and with other findings in the VA’s investigation.

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.” The Office of Special Counsel also receives “whistleblower disclosures and protects whistleblowers from retaliation.”

In addition, the office:

  • Investigates 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.
  • Provides 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.

“Arguably, this individual has a conflict of interest,” the special counsel wrote, “which should have necessitated an additional independent opinion to answer questions of standard of care.”

Robert Cranston is the Illinois medical director for the American Academy of Medical Ethics and a clinical associate professor at the Carle Illinois College of Medicine. He read the special counsel’s report and told inewsource that if the allegations are true, Ho has “gone beyond” what the VA initially approved for research.

“But the second part that’s worrisome,” Cranston said, “is that if the whistleblowers' accusations are true, and the VA's responses are as stated, it looks like someone at the VA could be attempting to cover up exactly what went on."

Dr. Robert Cranston is the Illinois medical director for the American Academy of Medical Ethics.

Dr. Robert Cranston is the Illinois medical director for the American Academy of Medical Ethics. (Source: American Academy of Medical Ethics)

“I think this deserves closer scrutiny,” he said.

The whistleblowers shared documentation with the Office of Special Counsel stating Ho, on at least seven occasions, overruled colleagues who didn’t recommend this procedure.

The whistleblowers also questioned whether all of the research subjects were capable of consenting to the biopsy. Patient histories they provided to the special counsel’s office say at least eight veterans signed a consent form without undergoing a “cognitive assessment by an experienced and unbiased expert.”

The VA report did not address these concerns, but it did find violations of privacy laws in Ho’s research, along with participation by unqualified staff, miscommunication and poorly maintained or missing research records. It issued recommendations and follow-ups for the San Diego VA but did not address discipline.

In concluding the Office of Special Counsel report, Kerner wrote that he would “strongly urge the VA to revisit its findings in this matter and take a truly critical look at the research being conducted and care provided to liver patients” at the San Diego VA.

Chojkier said his colleagues at UCSD and the VA are “extraordinary, talented individuals with exceptional dedication to patient care.” What’s happening in this case, he said, is “an extraordinary exception to the rule.”

Congressman Peters told inewsource one of the concerns he has about the VA in general is a cultural problem.

“It's about preserving the bureaucracy rather than protecting the vet. And this is all cover your bottom kind of stuff. Like ‘Let's just not admit we have a problem, let's not admit we did anything wrong.’

“But to really change the culture at the VA, to make sure that it's first class, that's the first thing you have to do – you have to say, ‘Listen, this is what we're not getting right.’”

Peters said the House committee will have many questions for the VA about Ho’s research, and he expects the hearings would take place in the first half of 2019.

inewsource intern Lauren J. Mapp helped create the version of this story that shows it backed up by primary documents.

shadow-ornament

We'll let you know when big things happen.

About Brad Racino:

Brad Racino
Brad Racino is a senior reporter and assistant director at inewsource. To contact him with tips, suggestions or corrections, please email bradracino [at] inewsource [dot] org.