Congress probes VA's drug-warning delay

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By Amy Fagan and Jennifer Haberkorn

The secretary of the Department of Veterans Affairs plans to review drug protocols for treating patients with post-traumatic stress disorder (PTSD) after an investigation found it took his agency three months to alert its patients about the potentially dangerous side effects of a smoking-cessation drug.

VA Secretary James B. Peake said the agency's Institutional Review Board will analyze how drugs are distributed to soldiers with PTSD "to ensure that there is appropriate sensitivity to the study population in the context of FDA alerts and warnings," he told a House Veterans' Affairs Committee hearing on Wednesday.

"Where we find inadequacies, I will demand institutional and personal accountability," Mr. Peake said.

The hearing stemmed from an investigation by The Washington Times and ABC News that found that the VA took three months to alert its patients with PTSD about severe mental side effects of the smoking-cessation drug Chantix. The side effects include possible psychosis and suicidal thoughts.

The Food and Drug Administration (FDA) first issued its warning about Chantix in late 2007, saying it was linked to cases of hallucinations, suicide attempts and psychotic behavior.

One veteran using the drug in a VA smoking-cessation study became psychotic earlier this year and confronted police in a potentially fatal encounter.

"The loss of any veterans to suicide would be a tragedy," said Rep. Bob Filner, California Democrat and committee chairman. "That's why I fail to understand why the VA didn't act."

The VA's review board will determine "where we might have fallen down in terms of notification," Mr. Peake said.

He said one of the reasons for the delay in getting warning letters about Chantix's possible side effects to patients was that different branches sent out the letter at different times.

The committee also questioned whether the VA acted quickly or seriously enough about concerns that patients on Chantix were experiencing the psychotic episodes.