Congress To Hold Hearing On Allegations Of Dangerous Human Research At San Diego VA
Friday, February 1, 2019
Congress will hold a hearing as early as this spring into allegations by two whistleblowers of dangerous human research conducted at the San Diego VA medical center — a development that resulted from an inewsource investigation.
inewsource has also confirmed representatives from two of the VA's investigating offices visited the La Jolla facility in January to re-interview the whistleblowers and look further into their claims that a former doctor – along with other higher-ups at the institution – put veterans’ lives at risk so they could profit from the research.
The study under scrutiny was led by former San Diego VA division chief Dr. Samuel Ho from at least 2014 to 2016. It involved taking liver biopsies through a catheter in the neck from veterans suffering from alcoholism and liver disease. New documents reveal how one patient returned from the procedure “oozing with blood,” in need of an emergency transfusion and later became delirious.
San Diego Rep. Scott Peters asked for congressional hearings on the research in November, after learning from inewsource about federal investigations into the whistleblowers’ allegations. The Democratic congressman told inewsource on Thursday that it was “your reporting that got us to look into it, and that's the role of journalism.”
The VA San Diego HealthCare System serves the nearly quarter-million veterans in San Diego and Imperial counties and has one of the largest research programs in the national VA network.
Whistleblowers Martina Buck and Mario Chojkier first alleged to federal investigators in 2016 that Ho performed medically unnecessary liver biopsies to obtain samples for his research. Buck, a research scientist, and Chojkier, the VA liver clinic director, both witnessed the research and have reported their concerns to two other federal agencies since then.
Ho collected 28 biopsies and co-authored three published papers from his research. He resigned from the VA and his role as professor of medicine at the University of California San Diego this past July to take a job at a university in Dubai. He has not responded to multiple inewsource messages for an interview since November, including two requests to comment for this story.
The San Diego VA referred comment about the congressional hearing and second site visit to Veterans Administration spokesman Curt Cashour in Washington, D.C. Cashour would not explain what prompted the January visit from investigators and would not provide details or updates. He emailed a statement nearly identical to one he gave inewsource in November, and refused to answer questions.
Patient ‘oozing with blood’
Before Ho’s research project was approved in 2014, Chojkier alerted the chief of medicine at the San Diego VA to his concerns about the study. According to a 2017 report by the Office of the Medical Inspector, there was “no documentation that the Chief of Medicine, the fact-finding team, or the past or present” chief of staff “followed up on these allegations or reported them” to the VA research review board or the research and development committee.
Buck also alerted the VA’s review board before the study was approved.
Chojkier, who is married to Buck, is the director of the liver and transplantation clinics at the VA and professor of medicine at UC San Diego. He told inewsource 10 of his liver patients participated in Ho’s study. One had hepatitis C and liver failure due to sepsis, which under the research grant application with the National Institutes of Health should have disqualified the patient from the study.
Chojkier said during multiple consultations the patient had with other doctors, a biopsy wasn’t mentioned. Yet as soon as Ho became aware of the patient, he indicated the need for a liver biopsy, Chojkier told investigators in December.
Ho performed the procedure and the patient returned from the operation “oozing with blood,” with “stool scattered” on his body and in need of an emergency transfusion, according to Chojkier’s report.
“It’s tremendously depressing and really terribly offensive as a physician and as a citizen,” Chojkier told inewsource. “This is what we were trying to tell leadership in 2013, and to stop it. They were not doing anything. They neglected it. They didn’t investigate.”
Staff from two divisions of the VA headquarters — the Office of the Medical Inspector and the Office of Research Oversight — asked during the January visit for more details on how the liver samples were collected and whether the researchers obtained informed consent from the patients to do the biopsies, according to an email from San Diego VA staff about the visit.
Buck told investigators in January that the VA “should not be a human subject pool available for sample procurement at a lesser degree of scrutiny than anywhere else.”
Buck and Chojkier said they have been retaliated against for speaking up: Chojkier said he faces constant harassment at work, and according to internal VA emails, Buck was terminated from the VA and UCSD last year for “harassment” and creating a “hostile work environment” after speaking to investigators.
The upcoming congressional hearing is “a welcome change of direction,” Chojkier said, which he hopes will be “far more effective in getting to the truth.” Buck said she’s also hopeful, but since this “has been going on for such a long time” any change “needs to be dramatic.”
“Unless somebody starts making some changes from the top down, not from the bottom up, it’s not going to work,” she said.
What to expect from the congressional hearing
Peters said a hearing will most likely occur in the spring before an oversight and investigations subcommittee of the House Veterans’ Affairs Committee.
Congressional staff will research the issue and write a brief for the subcommittee members, and then Congress will invite witnesses to testify, Peters said. Democrats, as the majority party in the House, will typically invite three witnesses, and the Republicans will invite one.
After hearing from the witnesses, the subcommittee members will decide what happens next.
“They may decide that this is a matter of a great concern,” Peters said, and refer it to the FBI or other law enforcement. They could also decide to call more witnesses or conclude their concerns have been addressed.
“But the main purpose of a hearing is to make the issues public, give everybody a chance to say their peace and get to the truth,” the congressman said.
Peters, a former member of the Veterans’ Affairs panel, said it is “probably the least partisan” congressional committee.
The VA has been under scrutiny since 2014, when it wasn’t meeting its goal to see patients within 14 days and was found to be falsifying wait time data. An internal audit found that more than 120,000 veterans were left waiting or never got care. In congressional hearings, the acting VA inspector general said his office was reviewing “possible criminal misconduct by VA senior hospital leadership.”
A 2018 report showed some veterans still wait months to see doctors.
‘Pattern of problems’ in VA investigations
When Chojkier and Buck contacted the federal Office of the Special Counsel in 2016 about Dr. Ho’s research, the independent agency charged the VA Office of the Medical Inspector to investigate the whistleblowers’ allegations. That led to four days of visits in April 2017 at the La Jolla medical center.
After interviewing more than 30 people, the Office of the Medical Inspector found policy violations but “no substantial danger to public health.”
However, the Special Counsel’s Office, which has a limited enforcement role in these cases, said in a letter to President Donald Trump and Congress that the VA’s investigation was “unreasonable” because it was inconsistent and didn’t properly address the whistleblowers claims.
The office urged a “truly critical look at the research being conducted and care provided to liver patients.”
A spokesman for the special counsel told inewsource on Wednesday the office was “happy to learn” the VA is revisiting the issue, and they’re looking forward to reviewing the “updated report to ensure patients were not subjected to unnecessary risks, and that all research protocols were followed.”
In the past two years, the Special Counsel’s Office has found eight of the VA’s internal investigations nationwide to be unreasonable.
Former Special Counsel Carolyn Lerner told inewsource her office found “a pattern of problems emanating from the Office of the Medical Inspector” in 2013. But new leadership the next year prompted “a real change in the quality of the investigations” that led to corrective actions, Lerner said.
Trump rejected the advice of Republicans and Democrats to keep Lerner as special counsel, and in May 2017 nominated Henry Kerner to replace her.
“I can't speak to what's been happening since I left,” Lerner said.
inewsource attempted to interview someone from the Office of the Medical Inspector, but the agency has no public email address or phone number, and the local VA would not provide a contact.
The liver samples collected at the San Diego VA were part of a nearly $6 million federally funded study that involved 11 collaborating institutions looking to improve the diagnosis of liver inflammation caused by alcoholism. The biopsies collected at the VA were sent to a repository at the University of North Carolina Chapel Hill to be used in other studies.
Ho’s original research proposal outlined collecting liver biopsies from patients as a part of their treatment and included pregnant patients as potential research subjects. The San Diego VA’s review board denied that proposal in part because the procedure would endanger fetuses.
The amended proposal excluded pregnant patients and said the study would collect “archival” liver samples, which means samples that already exist.
But Buck and Chojkier claim the samples didn’t exist. Instead, they were taken from patients who were told the biopsies were necessary for diagnosing their ailments, even though they provided no benefit and are potentially dangerous for people with liver problems because they are already at a high risk for bleeding.
“I’m a believer in doing human research, but it’s a privilege not a right,” Buck told inewsource. “You need to keep that in mind and you can never, never, never abuse the privilege.”
Buck and Chojkier have also sent a complaint to the Office for Human Research Protections, another federal agency that investigates alleged research violations. That office said it is reviewing the complaint.
A federal report describes one San Diego VA patient returning from a procedure “oozing with blood” and in need of an emergency transfusion.
Clarification, Feb. 1, 2019: The story has been updated to clarify that President Donald Trump rejected the advice of Republicans and Democrats to keep Carolyn Lerner as head of the Special Counsel's Office, an independent federal investigatory and prosecutorial agency.
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