VA leaders questioned at congressional hearing about ‘egregious’ San Diego human research
The San Diego VA Medical Center in La Jolla is shown on Sept., 26, 2019. (Zoë Meyers/inewsource)

VA leaders questioned at congressional hearing about ‘egregious’ San Diego human research

Leadership from the U.S. Department of Veterans Affairs answered questions at a congressional hearing Wednesday about inewsource’s investigation into dangerous liver research conducted at the San Diego VA and poor oversight of the VA healthcare system.

The Veterans Health Administration is the largest integrated healthcare system in the country, serving more than 9 million patients.

Growing scrutiny over the VA medical facilities could lead to changes or improvements in the system that provides medical care to the nation’s veterans.

The congressional inquiry was the first public opportunity to hear from VA leaders about San Diego whistleblowers’ allegations, which were first made in 2013. inewsource has reported on their claims over the past year, but the VA had only provided brief statements saying the department was looking into the matter.

The House Committee on Veterans’ Affairs conducted the hearing to confront VA leaders about patient harm in the VA healthcare system, referencing examples of misconduct at veterans medical facilities around the country.

Rep. Scott Peters, D-San Diego, acknowledged during the meeting that “there’s a lot of fine work going on at the VA,” but it’s the nature of the committee to examine things that aren’t going well. He then recounted accusations from San Diego whistleblowers that unethical liver biopsies were performed on ill veterans without their consent at the La Jolla VA hospital, and he asked VA leaders to address how they handled the whistleblowers’ claims.

“This story presents a case that could have consequences in other settings, especially for VA medical centers that conduct research on-site,” Peters said during the hearing.

The VA investigated the claims in 2017 and found “no substantial danger to public health” had occurred. But when the case was reviewed by an independent agency called the Office of Special Counsel, it concluded the investigation was “unreasonable” and urged the VA to take a “truly critical look” at what happened in San Diego.

Dr. Gerard R. Cox, the VA’s deputy under secretary for health for organizational excellence, said the VA had completed a second investigation into the San Diego whistleblowers’ claims, which “substantiated that there was egregious research misconduct.” He said the VA submitted a second report to the independent special counsel’s office, which is reviewing it. The report has not been made public yet.

“Finally to have them substantiate it and to say that there were egregious violations was a good thing after so long,” said Martina Buck, one of the two whistleblowers from the San Diego facility, after watching the hearing. Buck has spent seven years raising concerns about the liver research. “Finally finally, finally (they found) that the two of us were correct.”

Buck was terminated from her position as a VA researcher in 2018, allegedly as retaliation for bringing her concerns to management. She told inewsource Wednesday that “like the patients that were harmed, the consequences to the whistleblowers need to be remedied.”

“Who’s taking care of that?” she asked.

Cox said the reason the VA’s initial investigation didn’t uncover the misconduct was because “at least one key witness was not truthful, was not forthcoming with information.” He did not say who that witness was.

The research, 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 to better understand their condition.

An internal report from the San Diego VA obtained by inewsource in February confirmed extra liver samples had been taken from the veterans during biopsies that were not necessary for their clinical care — they were only taken for research purposes. The patients were not informed that this increased the risk of severe complications, including internal bleeding.

“There is no question that it is malpractice in my view,” said San Diego VA liver clinic director Mario Chojkier, the other San Diego whistleblower. He is also married to Buck.

“Obtaining additional pieces of liver without authorization by the regulatory group … and from each patient is a gross violation of the essential ethical rules of human research and clinical practice” Chojkier said. “It’s medical assault, unequivocally in certain counts with premeditation, and malice, for profit and prestige.”

The investigation into the liver research was led in part by the VA Office of the Medical Inspector, which oversees the VA healthcare system, a network providing services to 9 million veterans at 1,255 facilities around the country.

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In the hearing, Peters brought up inewsource’s recent article, which reported that poor investigations into the VA healthcare system extend beyond San Diego. inewsource’s original data analysis found 16% of all VA medical inspector investigations reviewed by the special counsel’s office are deemed “unreasonable,” meaning they were not thorough enough to meet the special counsel’s standards. That includes investigations conducted at VA medical facilities around the country.

Peters asked VA leadership to explain whether they believed the medical inspector’s office had enough resources to “thoroughly handle whistleblower complaints.”

Yes, said Cox, who is also the former interim director of the medical inspector’s office. He added that the VA “conducted our own analysis of the rate at which the Special Counsel of the United States finds our reports are not reasonable. We came up with a very different number.”

Cox said only 5% of the VA’s investigations are labeled “unreasonable,” compared to inewsource’s much higher estimate.

Before publishing the article, inewsource sent its findings to the VA for review. In response, spokeswoman Christina Mandreucci said the analysis was “misleading and ignores key information,” saying the VA’s estimate was 5%. But after she was sent a detailed methodology behind inewsource’s numbers on Sept. 18, she did not respond to questions or explain her statement.

inewsource’s data analysis was fact-checked three times before publication.

When asked again to explain the VA’s own data analysis after Wednesday’s hearing, Mandreucci responded over email. She said the reason for the discrepancy was: “You counted each individual whistleblower as though he or she represented a separate case.”

But Mandreucci is incorrect. inewsource’s detailed methodology, which she has been given, stated that whistleblowers were grouped together if they reported the same allegations.

Mandreucci told inewsource late Wednesday the VA stands by its methodology.

Updated Oct. 16, 2019, 7:58 p.m.: This story has been updated with a response  from the VA about the methodology.

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About Jill Castellano:

Jill Castellano
Jill Castellano is an investigative data reporter for inewsource. To contact her with tips, suggestions or corrections, please email jillcastellano [at] inewsource [dot] org.

About Brad Racino:

Brad Racino
Brad Racino is a senior investigative reporter and assistant director at inewsource. To contact him with tips, suggestions or corrections, please email bradracino [at] inewsource [dot] org. You can contact him securely on Signal (845-553-4170).