- The Washington Times - Thursday, June 19, 2008

War veterans with post-traumatic stress disorder suffered a total of 26 serious adverse events while participating in a Veterans Affairs study of the anti-smoking drug Chantix, a VA official said Wednesday night.

“Based on current data 26 Serious Adverse Events (SAE) occurred in patients while on Chantix,” VA spokesman Matt Smith said in a statement e-mailed to The Washington Times, adding that 10 of the adverse events “were of a psychiatric nature.”

His e-mail also said, under a listing of “Adverse Events,” that there were two cases of suicidal thoughts.

The agency previously said that 21 adverse events, only one of them serious (a case of suicidal thoughts), were recorded in the study that uses a drug now linked to psychotic and suicidal behavior, the details of which were reported in an exclusive Washington Times/ABC News investigation this week.

Mr. Smith said officials could not determine whether the drug study is linked to the side effects.

“Causality can only be determined at the conclusion of a study when there are sufficient data available for analysis,” he said.

House Veterans’ Affairs Committee Chairman Bob Filner, with other Democrats on his panel, sent a letter Wednesday to VA Secretary James B. Peake requesting immediate response to dozens of questions about his agency’s treatment of service members in its medical studies. The letter was issued before the agency released the new numbers.

Mr. Smith said the new numbers are based on “additional data” that has accumulated since the agency spoke to The Times on May 21.

“A single patient can have more than one event - a breakdown patient by patient is not available,” Mr. Smith said.

Citing the investigative report, the congressmen inquired about how the VA informs participants involved in drug studies about possible side effects and whether the agency terminates studies that use drugs after the Food and Drug Administration (FDA) has issued alerts about them.

“This report raises serious questions about how the VA and FDA coordinate their studies, and how the VA responds to FDA post-approval alerts, particularly when vulnerable segments of the veteran population are involved in the studies,” Mr. Filner, California Democrat, and fellow Democratic Reps. Edward J. Markey of Massachusetts and Paul W. Hodes of New Hampshire, said in their letter.

The Times and ABC News first reported on Tuesday that a VA-sponsored smoking-cessation experiment on nearly 1,000 veterans suffering from post-traumatic stress disorder (PTSD) provided the drug Chantix to 143 participants.

The drug testing began in January 2007, and the FDA issued its first alert about dangerous side effects to Chantix in November. The VA did not warn its participants taking Chantix until three months later.

Earlier Wednesday, Mr. Filner demanded that the VA immediately terminate experiments in which a drug now linked to psychotic and suicidal behavior is being administered to soldiers suffering from PTSD.

“The VA must immediately suspend this study until a comprehensive review of the safety of the protocol is conducted,” he said.

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