LR vet research: 'rampant violations' UPDATE | Arkansas Blog

Tuesday, August 5, 2008

LR vet research: 'rampant violations' UPDATE

Posted By on Tue, Aug 5, 2008 at 12:22 PM

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The Washington Times reports something that sounds like a bombshell in the local medical community:

An investigation of research conducted at an Arkansas veterans hospital has uncovered rampant violations in its human experiments program, including missing consent forms, secret HIV testing and failure to report more than 100 deaths of subjects participating in studies.

The Office of the Inspector General of the Department of Veterans Affairs (VA) on Tuesday will release its findings in a report on human subject protection violations at the Central Arkansas Veterans Healthcare System in Little Rock. The studies involved thousands of veterans who had volunteered for behavioral and drug experiments.

The investigation, which began last August, reviewed more than a half-dozen human experiments - including studies of colon, breast and prostate cancer - that had been conducted since 2006.

It found that entire consent forms were missing, signatures were missing from consent forms, HIV testing was conducted without documented consent, and research officials failed to obtain witness signatures in a study involving patients with dementia.

Additionally, the investigation found that researchers had failed to report "serious adverse events" during the experiments, including the deaths of 105 veterans. The researchers were required to report such events, regardless of whether they were accidental or linked to the experiments, to the Internal Review Board.

The board, which conducted oversight of the experiments, had been implemented and operated by the University of Arkansas for Medical Sciences but was transferred to the VA after the investigation began. The VA created a review board and halted all new experiments involving human subjects.

UPDATE: I've talked with Dr. I. Dodd Wilson, chancellor at UAMS. He defended the hospital work and said the newspaper report has erred in some places and taken some incidents out of context.  None of the investigations involved medical treatment or experimental drug protocol and those investigations most at issue for procedural shortcomings were of a particularly limited nature, he said. More on the jump.

 

Dr. Wilson said UAMS had been informed of the inspector general's tentative findings about two weeks ago and had responded with a number of corrections and additional information which he expects to be incorporated in the final OIG report. He speculated that the Washington Times was leaked a preliminary finding. In any case, Wilson said he'd release the hospital's full account when the full VA report is released. It is not to be available until Wednesday.

Key point concerning the study in which a number of subjects died: This was a simple one-day investigation in which existing cancer patients were given No Doze pills to test the metabolization of caffeine, Wilson said. A blood sample was also drawn. A number of these patients died, but they were "natural deaths," not a result of treatment, Wilson said. He said the investigation didn't require followup.

He took issue, too, with the report's finding of a lack of authorization in some investigations. Papers were scattered because of the numerous audits performed by various agencies, but he said UAMS had located the authorizations in most cases.

The unavailability of one batch of reports arose because they'd been sequestered at the request of the Food and Drug Administration after an internal disagreement between UAMS researchers, one of whom accused another of plagiarism and suggested that reports might be destroyed.

As for the "secret HIV testing," Wilson said a researcher engaged in drawing blood samples to study the effect of exercise had, in two cases, done an HIV test in addition to other blood work. UAMS auditors caught that, told the researcher it wasn't a part of the protocol for the test or necessary for the project, and testing was stopped after those two tests.

Wilson said researchers had attempted some simple verbal tests to see if they could get patients with dementia to be more responsive and so it is correct that they were done without consent. "They were asked to walk by investigators," he said. "There is no harm in that."

Wilson said he was proud of his Internal Review Board, a volunteer group of unpaid people "who take a lot of pride in what they do and are trying to do the right thing."

"The bottom line is, they're making a lot out of this. They're overreacting."

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