- 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.

“Once the FDA issued the warning that it had received reports linking Chantix to suicidal thoughts and aggressive and erratic behavior, the VA should have immediately suspended this study and notified participants of the possible dangers. Instead, the VA took more than three months to notify patients and they did so in bureaucratese that did not clearly state the side effects of the drug.”

Mr. Filner also announced that he will hold hearings in early July “to figure out why it took so long to notify patients of the side effects of the drug that was used in this study.”

The VA warning was issued too late for James Elliott, a decorated Army marksman who suffered a psychotic episode that ended in a nearly fatal confrontation with police. Mr. Elliott said the VA treated him as a “disposable hero.”

According to the FDA, nearly 40 suicides and more than 400 incidents of suicidal behavior have been linked to Chantix. Yet the VA has continued the study and administered Chantix to veterans with PTSD.

Arthur Caplan, one of the nation’s premier medical ethicists, said the VA’s behavior in the anti-smoking study violated basic protections for humans in medical experiments, The Times reported.

On Tuesday, presumptive Democratic presidential candidate Sen. Barack Obama and congressional leaders on both sides of the aisle called for investigations into the VA’s failure to inform in a timely manner veterans participating in the medical tests.

Rep. Steve Buyer of Indiana, the ranking Republican on the House Veterans’ Affairs Committee, sent a letter to the VA inspector general and the VA’s chief research and development officer requesting an investigation. A spokesman for House Speaker Nancy Pelosi, California Democrat, also said Congress also will look into the matter.

The White House on Tuesday said that the VA is doing everything it can to be mindful of the safety of these veterans in all its programs and try to help them.

“These are people who care for our veterans. They care for the troops that have been out there every day, fighting for this country. And they’re interested in their safety,” White House spokesman Tony Fratto said.

On Wednesday afternoon, Mr. Filner told The Times’ “Inside the Story” radio program that Mr. Elliott’s story “speaks volume.”

“This is the bureaucratic dynamic in all its glory,” Mr. Filner said.

Mr. Elliott praised the medical treatment he has received from his doctors at the VA but said human testing belongs in the private sector.

“I don’t lambaste the VA as a whole,” he said. “They have treated me well, the prosthetics department, my primary care doctor, a lot of people work very, very hard and they themselves are veterans and they do care.”

“It’s just sad the psychiatric department has bought into human research. The VA should never conduct human research. They should be there to treat veterans’ existing problems. Advancing health care should not be at the cost of men and women in the military,” Mr. Elliott said.

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