VA mishaps shake Congress’ confidence

A key congressional leader says he has no confidence in the Department of Veterans Affairs and would have pulled his own children out of the VA’s human subject study that used a drug with dangerous side effects that is being prescribed to veterans with mental disorders.

“I don’t have confidence in the leadership that allowed this to happen,” said Rep. Bob Filner, California Democrat and chairman of the House Veterans’ Affairs Committee, which oversees the VA.

A review released Friday of a smoking-cessation study on veterans suffering post-traumatic stress disorder (PTSD) found that the VA was responsible for numerous “unacceptable failures” in ensuring safeguards for soldiers in the experiment.

The smoking-cessation study at one time included more than 200 veterans who took the drug Chantix, which was later found to have psychosis and suicidal behavior among its possible side effects.

The internal review was prompted by an investigation by The Washington Times and ABC News published in June, which found that the veterans were not notified in a timely manner about new warnings from the Food and Drug Administration (FDA) about the drug’s side effects.

Dr. Tom Puglisi, chief officer of the VA’s Office of Research Oversight (ORO) and author of the report, confirmed that the study “did not adequately fulfill VA’s singular responsibility to maximize safeguards for veterans who volunteer to participate in research.”

“I’m just disappointed,” Mr. Filner said. “If my children were involved here, I would be scared to death. They don’t have any right putting my kids, or any veterans, in serious jeopardy.”

The review of the study points out that Chantix was “newly approved by the FDA for smoking cessation when it became available for use by [the study’s] participants, and it had not been formally evaluated in a comparable study population.”

“ORO was unable to locate any documentation that the [study] considered the possibility that the use of varenicline [Chantix] by participants might warrant a re-evaluation of the study’s safety monitoring plan.”

The review also found that no system was in place to warn veterans when the FDA issues new warnings that drugs they are taking might cause serious side effects.

The Times report prompted concern from Democratic and Republican lawmakers on Capitol Hill, many of whom asked the VA to cease the experiment.

VA officials later briefed congressional staff that every veteran taking Chantix in the study had been notified by telephone and e-mail about the possible side effects.

“In other words, this has forced the VA to be more forthcoming and take real steps to address the problems The Washington Times previously identified,” said Brian Walsh, spokesman for Sen. John Cornyn, Texas Republican and a critic of the study.

“Clearly, the consent procedures the VA had in place for the study were neither adequate nor timely,” Mr. Walsh said.

VA officials promised Mr. Filner that they would provide concerned lawmakers with a review of the study in early August. But delaying the report until late September - just days before Congress is set to recess - provides no way to dismantle or defund the study, he said.

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