- The Washington Times - Friday, June 20, 2008

NEWSMAKER INTERVIEW:

Veterans Affairs Secretary James B. Peake sought Thursday to quell a growing controversy over his agency’s failure to quickly notify veterans about psychotic and suicidal side effects from the anti-smoking drug Chantix, vowing that his department will improve its communication process to ensure patients are alerted more quickly when dangerous side effects emerge.

Mr. Peake also said the letter the Department of Veteran Affairs (VA) sent to veterans in February - three months after learning about new complications from Chantix - should have identified suicidal behavior as one of the risks.

“It could have been stronger,” Mr. Peake said in an interview with The Washington Times. “I would liked to have seen us a little tighter in our execution.”

To make the point, the former Army surgeon turned VA chief said he was personally sending a letter to more than 32,000 veterans taking Chantix to ensure they understand all of the issues, including the risks of suicidal behavior as a side effect.



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PDF: Download the letter here

Related story: ABC News: 32,000 veterans to be warned about suicide-linked drug

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Mr. Peake said he did not want the growing controversy to dishearten veterans from participating in the VA’s efforts to help them stop smoking or even from using Chantix under the right conditions.

“My concern is that there is a perception that we don’t care about our veterans, but that is just the opposite,” he told The Times in a 90-minute interview. “Our first responsibility is to our veterans. My whole life has been about taking care of them.”

As Mr. Peake spoke for the first time about the Chantix controversy, Congress created more pressure.

Since The Times and ABC News first reported Tuesday about the three-month delay in alerting veterans to new problems with Chantix, lawmakers in both parties have sharply criticized the VA and promised investigative hearings.

The chairman of the House Committee on Veterans’ Affairs also has called for the VA to end the anti-smoking experiment in which Chantix was given to 143 veterans suffering from post-traumatic stress disorder (PTSD). Those patients suffered 26 serious side effects, including three with suicidal thoughts, The Times reported.

Sen. Barbara Boxer, California Democrat, was the latest to join the fray, demanding to know why the VA’s belated letter to Chantix users in February failed to mention the most serious side effects involving suicide and suicidal thoughts. “Such an omission is unacceptable and outrageous,” Mrs. Boxer said.

In explaining why the warning notice sent to veterans by the VA failed to include a warning about the risk of suicidal thoughts, a VA doctor told The Times that “the more verbiage you use, the more difficult and lengthy it becomes” and that some veterans had eyesight problems and would have trouble reading the letter.

“I find it hard to believe that the explicit use of the word ‘suicide’ would have been more difficult to interpret than the phrase the VA elected to use ‘untoward changes in behavior,’” Mrs. Boxer said in her letter.

Pressed about his own agency’s doctor’s explanation, Mr. Peake said, “I don’t understand that myself.”

“I would not get heartburn putting ‘suicide’ in there myself,” Mr. Peake said.

A prominent veterans group also weighed in, urging Mr. Peake to hold accountable any VA officials involved in the delayed notification.

“Those in the VA who failed to properly serve America’s veterans must resign their positions,” said George J. Lisicki, a Vietnam veteran and national commander of the Veterans of Foreign Wars. “If not, then the VA secretary must take decisive action to terminate them.”

Mr. Lisicki said Mr. Peake, who took over the VA a few months ago, was “an honorable professional who has only been at VA a few months, but it is obvious that those he has entrusted to help him carry out VA’s mission are not doing their jobs.”

Mr. Peake said he has ordered his agency to investigate the handling of the study, including whether it should be shut down and whether the letters went through the proper approval process.

“If we were doing something wrong, I want to know about it and I want to correct it,” he said. “I don’t want to be drinking my own Kool-Aid.”

At the same time, Mr. Peake said, he doesn’t see a reason to end the Chantix study immediately. “I would not hesitate to stop the study, but these numbers would not lead us to that conclusion,” he said, referring to the 26 serious side effects reported by 25 patients who are taking Chantix as part of the anti-smoking study.

Mr. Peake also responded to criticism from James Elliott, a disabled Iraq war veteran, who suffered a psychotic breakdown while taking Chantix during the three-month period in which the VA had not issued its warning. Mr. Elliott praised the VA for its medical services but said the agency should not be conducting drug experiments on veterans like him who suffer from PTSD, adding that he felt like he was being used as a “lab rat.”

“It hurt me to think that anyone would think we treat our own vets like lab rats,” Mr. Peake said. “I understand from his perspective he may feel that way.”

The study at the center of the controversy involved 945 veterans with PTSD and aimed to find the best means to help them stop smoking. A variety of treatments were available, including bupropion, transdermal nicotine patch, nicotine gum and Chantix.

Among the 143 study participants who took Chantix, 25 patients reported 26 serious adverse events, VA officials said Thursday. The VA has stressed that these can’t be linked definitively to any aspect of the study, because the veterans also were being treated for PTSD.

Of the 26 serious adverse events among Chantix users, the officials said, 11 were psychiatric: three instances of suicidal thoughts, three case of depression, three reports of nightmares, one case of anxiety and one instance of an auditory hallucination.

Beginning in February, leaders of the smoking-cessation study decided to start collecting reports of adverse events among study participants using Chantix, in addition to any serious adverse events, the VA officials said.

A serious adverse event is a standard described in federal regulation, and reactions or events that do not rise to that standard are described by the treating physician simply as adverse events.

Since February, 14 adverse events have been reported: five nightmares, four bouts of depression, two incidents of suicidal thoughts, one incident of anxiety, one incident of decreased energy and one case of upset stomach.

William Moore, a 62-year-old veteran from Chattanooga, Tenn., who also suffers from depression, received Chantix outside of the study as part of his normal treatment. He was eager to take the drug last fall, when it was presented to him as one of many options in an anti-smoking program at his local VA clinic.

Three weeks after starting the drug, he began having nightmares. “I would dream all kinds of horror-things,” he told The Times. “I’d wake up scared.”

He continued taking the drug until his next Tuesday night anti-smoking meeting at the clinic. When he told program leaders about his nightmares, they were adamant that he stop taking the drug, and he did, he said.

Mr. Moore is still trying to quit smoking, but these days he opts for willpower rather than drugs. “I’m down to half a pack a day. I’m limiting myself,” he said.

Mr. Moore, who was diagnosed with Parkinson’s disease in 1997 and takes various drugs for depression, blood pressure and digestive problems, splits his medical coverage between Medicare and the VA.

He said he is pleased with the care he has received through the VA, including how VA officials ran the smoking-cessation program. He also praised the VA’s “very good system” for yearly physicals, which includes reminders to veterans around their birthday and meticulous records on their conditions.

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