VA Medical Center Probed on Clinical Trial Deaths
February 06, 2003 02:45:16 PM PST, Reuters
The Inspector General for the Department of Veterans Affairs ( news - web sites) (VA) has begun a criminal inquiry into several deaths that occurred in a number of clinical trials at a VA medical center in Albany, New York, a VA spokesman confirmed Thursday.

It is unclear how many deaths or how many studies are being examined, or who might be the target, as John Wooditch, assistant inspector general for management and administration at the VA, would not comment on specifics.

"To comment on any aspect could potentially impact the outcome," Wooditch told Reuters Health.

According to the Bureau of National Affairs' Medical Research Law & Policy Report, two investigators in the Stratton Veterans Affairs Medical Center's oncology department are under scrutiny for alleged improper enrollment, falsification of medical charts and failure to report adverse events. The newsletter says that at least one death, and possibly four, may be related to the researchers' actions.

The Stratton facility would neither confirm nor deny the report, and referred inquiries to Wooditch.

San Antonio, Texas-based Ilex Oncology was the first to notice a problem. Stratton researchers were studying four patients as part of a large, nationwide trial of Ilex's bladder cancer drug eflornithine, said Ilex spokesman Barry Cohen. The paperwork concerned Ilex enough that it reported the irregularities to the National Cancer Institute ( news - web sites), Cohen told Reuters Health. NCI is co-sponsoring the eflornithine study.

Ilex is not a target of the VA investigation, but is cooperating, said Cohen, who added that Ilex has removed the four Stratton patients from the database it will use to seek Food and Drug Administration ( news - web sites) approval.

Reportedly, studies involving 100 patients at Stratton were under the two alleged suspects' oversight. Those investigators were "dismissed" by the VA facility in January, according to BNA.

The newsletter said that VA officials had abolished the VA's own Office of Research Compliance and Assurance in response to the Stratton situation. A VA spokeswoman says the office is "on hold."

The Stratton investigation is a top priority, says Wooditch. "We're hopeful we can bring this to completion soon," he said, noting that evidence will be turned over to the US Attorney for prosecution.