Report: VA failed to safeguard veterans

Handling of drug trials an 'unacceptable' failure

By Audrey Hudson (Contact)

Originally published 07:13 p.m., September 19, 2008, updated 10:29 p.m., September 19, 2008

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The Veterans Affairs Department is responsible for numerous "unacceptable failures" in ensuring safeguards for soldiers with post-traumatic stress disorder who were enrolled in a medical experiment to help them stop smoking, an internal review found Friday.

Despite the stinging report, the agency has decided to proceed with the experiment, including allowing participants to take a drug that carries risks of suicide and other psychotic behavior, officials said.

The investigation, prompted by a series of stories earlier this summer in The Washington Times as part of a joint investigation with ABC News, said that the smoking cessation study "did not adequately fulfill VA's singular responsibility to maximize safeguards for veterans who volunteer to participate in research."

The review by the VA's Office of Research Oversight (ORO) also found "unacceptable failures to maximize safeguards for the veterans who had volunteered to participate" in the study, including the lack of a system in place to alert researchers and participants when drug safety warnings are issued.

Researchers responsible for the smoking cessation study first failed to notify internal review boards that oversaw the experiment at 10 locations when the Food and Drug Administration (FDA) first publicized concerns in November that the drug varenicline, commercially known as Chantix, may induce suicidal thoughts or actual suicides.

When a second warning was issued in February it took anywhere from 16 to 134 days to alert veterans, and the review expressed doubts as to whether all veterans in the study received the warnings.

Despite a multitude of discrepancies and failures identified by the review, the study made no recommendation either in favor of terminating or of continuing the study, which involves more than 900 veterans.

VA spokeswoman Alison Aikele told The Times on Friday that the experiment will continue, and that Chantix, prescribed to 240 veterans in the study by their own doctors, will continue to be made available to the participants.

"It is an FDA-approved medication, and guidelines have been distributed to providers and information to patients," Miss Aikele said.

The smoking cessation study came under fire in June after a Washington Times/ABC News joint investigation reported that the VA had taken at least three months before it began to alert the veterans taking Chantix about the possible new side effects.

The notice came nearly one month late for Iraqi war veteran James Elliott, who suffered a mental breakdown while taking the drug. In what he later described as an attempt at "suicide by cop," Mr. Elliott was shocked with a Tazer during a stand-off with police in Silver Spring.

The report urged VA officials to conduct an investigation to "hold appropriate individuals accountable for any research protection failures in [the study], specifically including responsibility for factors contributing to undue delays in notifying participants about the risks associated with varenicline."

Rep. Bob Filner, California Democrat and chairman of the House Veterans Affairs Committee, held a July 9 hearing in response to the Times/ABC News investigation where Dr. Tom Puglisi, chief officer of the ORO and author of the review, said he feared that similar notification problems exist throughout the agency's human-subject testing programs, particularly those that target veterans with PTSD.

Dr. Puglisi's testimony then said he was "very concerned" about the study, but he did not explicitly back either canceling or continuing it. Mr. Filner and other lawmakers have demanded that the VA end the study.

The review recommended that the VA establish a reliable system to notify the researchers and study participants about new or emerging medication safety information, and the VA says it has developed an action plan to implement this and all the recommendations contained in the report.

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