- The Washington Times - Thursday, July 10, 2008

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.

Mr. Peake said anecdotal and statistical results were forwarded to the FDA and the VA asked it to examine the drug’s interaction in patients with mental health issues.

“The notion we weren’t doing anything is not correct,” Mr. Peake said.

Safety problems are regularly identified after a drug goes on the market, said Paul Seligman, associate director of safety policy and communication in the Center for Drug Evaluation and Research at the FDA.

“No amount of pre-market study can find out all we need to know” about how the drugs may affect different groups of people, he said.

James Elliott, a veteran with PTSD who experienced a psychotic episode while on Chantix, testified that the drug cut in half his two-pack-a-day smoking habit.

But he said he “strongly” feels that Chantix provoked his confrontation with police and that he wasn’t adequately informed of potential side effects.

He said that he was drinking alcohol while taking Chantix but doubted that it was enough to influence his actions.

Mr. Filner said the Chantix investigation is troubling, especially in addition to reports earlier this year showing that the VA downplayed veteran suicide rates.

“They have caused all of us in this committee to question the VA’s accountability measures handling human research subjects,” Mr. Filner said.

The hearing’s title, “Why Does the VA Continue to Give a Suicide-Inducing Drugs to Veterans with PTSD?” sparked arguments even before the panelists spoke.

Republicans on the committee said the title was irresponsible.

“To characterize an FDA approved drug as suicide inducing … is irresponsible and inflammatory,” said Rep. Steve Buyer of Indiana, the committee’s ranking Republican.

Rep. Cliff Stearns, Florida Republican, said the hearing’s title was as inflammatory as a political campaign.

To read the entire testimony of Sect. Peake, click here.



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