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• LETTER: Pill to stop smoking not endorsed by FCAP 

Recent Safety News About Smoking Cessation Therapies Leaving Smokers Confused, More Reluctant to Quit 

A new survey found that this news has raised safety concerns and caused confusion among a significant percentage of smokers who are aware of the issues and has left them reluctant to quit. Moreover, the survey shows many smokers are avoiding medication to aid in their cessation efforts.(A)

The public health stakes are high as tobacco use kills five million people a year.(B) The majority of people who try quitting do so without assistance.(c) Less than five percent of people who try to quit on their own (cold-turkey) are successful long-term.(D) This underscores the need to get people help with medication when quitting smoking in order to address this important public health issue. Quitting with assistance can more than double one's chances of success.(E)

According to the survey, 31 percent of smokers aware of the safety issues said the recent news concerning a prescription stop-smoking medication has affected their decision to quit smoking or delayed their attempt. . . .

TN products, such as Nicorette, NicoDerm and Commit lozenge have been proven to double the chances of quitting and remaining smoke-free long-term and are far safer than continued smoking.

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Anti-smoking drug Champix may spur depression, agitation 

Health Canada has issued another warning about adverse neuropsychiatric effects linked to Champix, a drug intended to help smokers butt out for good.

A number of patients taking Champix (varenicline tartrate) have experienced unusual feelings of agitation, depressed mood, hostility, changes in behaviour or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others, Health Canada said Friday in an advisory.

The medication acts on sites in the brain affected by nicotine. The drug helps ease withdrawal symptoms and blocks the effects of nicotine if users resume smoking.

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32,000 Vets To Be Warned About Suicide-Linked Drug 

Responding to an ABC News/Washington Times investigation, the Veterans Administration plans to inform 32,000 veterans that they are using a drug linked to suicide or violent behavior.

The investigation revealed that the VA waited three months to notify veterans in a VA experiment of the possible side effects from the anti-smoking drug Chantix.

All of the veterans enrolled in the Chantix study suffered from Post Traumatic Stress Disorder (PTSD) and had been recruited, with monthly $30 payments, for a behavioral study with the drug.

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VA reports more Chantix effects 

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.

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• VA to warn veterans about anti-smoking drug 

The Veterans Affairs Department is sending letters to about 33,000 veterans who are taking the anti-smoking drug Chantix, warning them about possible side effects, including thoughts of suicide.

VA Secretary James Peake told reporters in a conference call Thursday that agency doctors will continue to prescribe the drug because they are seeing no serious problems or trends with its use.

He defended the VA's use of the drug to treat some of the veterans with stress disorders who were participating in a study to stop smoking.

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Obama Demands VA Immediately Investigate Drug Testing on Veterans 

U.S. Senator Barack Obama today sent the following letter to Veterans Affairs Secretary James Peake, calling on him to immediately investigate reports that the VA failed to notify veterans about severe side effects from drug testing after the FDA issued a serious warning last November. According to a Washington Times/ABC News investigation, more than 1,000 veterans suffering from post-traumatic stress disorder (PTSD) participated in a study to examine ways to end smoking. 143 of the study participants took the anti-smoking drug Chantix, which the FDA found lead to side effects, including hallucinations, suicide attempts, and psychotic behavior. Study participants were not notified about the FDA warning until three months later, and were not warned about the drug's most severe side effect - suicide.

In the letter Obama calls on Peake to conduct a full and thorough investigation of the process by which VA conducts clinical trials and to take immediate corrective action to address the problems that were first identified by GAO eight years ago.

The text of the letter is below:

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Cornyn Asks VA to Investigate Troubling New Claims by Media  

U.S. Sen. John Cornyn, a member of the Senate Armed Services Committee, today requested that the Department of Veterans Affairs report to Congress without delay on the validity of news reports indicating drugs with negative mental health side effects are being tested on U.S. combat veterans. After an initial inquiry to the VA this morning, Sen. Cornyn followed up with a letter to VA Secretary James B. Peake. The full text of the letter is here.

"I've requested that VA Secretary Peake look into the allegations and, if needed, take the immediate steps necessary to identify the responsible parties, provide appropriate care to any veterans who have undergone this testing, and ensure that any unethical practices are immediately brought to a halt," Sen. Cornyn said. "Our wounded troops and veterans deserve the very best in care, but unfortunately, recent studies and incidents illustrate that some VA services have failed to live up to the standard of excellence that is expected. As a member of the Senate Armed Services Committee, I will continue to work with my colleagues to ensure any negligence in the care of our troops and veterans is identified and properly addressed."

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Cornyn Calls For Probe Of Reports Of Harmful Military Drug Trials  

U.S. Sen. John Cornyn, R-Texas, called on the Veterans Administration Tuesday to investigate reports the VA is subjecting combat veterans to potentially harmful drug trials.

Cornyn made the request Tuesday in a letter to VA Secretary James Peake.

"Our wounded troops and veterans deserve the very best in care, but unfortunately, recent studies and incidents illustrate that some VA services have failed to live up to the standard of excellence that is expected,” Cornyn said in the letter.

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Lawmakers: VA meds for smokers may be risky 

Although the Department of Veterans Affairs says it has done nothing wrong, key lawmakers are demanding an investigation of a research program that involves giving a potentially dangerous prescription medication to veterans with post-traumatic stress disorder who are trying to quit smoking.

The Washington Times and ABC News say the VA is using a drug in its research that has dangerous side effects -- such as mental health problems and the risk of suicide -- and is paying a stipend to encourage use of the drug as part of a research program.

In a statement, VA officials said the news reports were "inaccurate and misleading."

A key point, they said, is that nobody was tricked into anything. Everyone taking part in research on stopping smoking is a volunteer who is closely monitored, VA officials said. And VA said the drug they were using, Varenicline, is approved by the Food and Drug Administration as a medication for smoking cessation.

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White House Derides Investigation That Exposed Drug Testing On Vets As ‘Irresponsible Reporting,’ ‘Awful’ 

FRATTO: I don't know if the president's seen it. I saw the reporting in your paper and on I think it was ABC this morning. I thought actually some of it was some of the most -- certainly at least what I saw on television this morning was some of the more irresponsible reporting that I've ever seen, in terms of taking what this one -- the experience of this one veteran and trying to leave the impression that this was a situation for all veterans.

We're in a difficult position of being able to comment on this case because of the privacy concerns of the veteran in question and the other veterans in this program, but I could tell the V.A. is doing everything they can to be mindful of the safety of these veterans in all their programs and try to help them.

This is the Veterans Administration, under wonderful leadership by General Peake, Secretary Peake, who's interested in the health and safety of these veterans that are under his care. And every other member of that V.A. system is the same.

And to try to imply that -- and, in fact, not even imply. I see the words scrolled on a television screen this morning that the V.A. is using our veterans as guinea pigs, I thought was one of the most awful things I've ever had to watch on television.

These are people who care for our veterans.

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Congress: Stop Drug Testing on Vets Now and Investigate  

At least three more members of Congress are calling for an immediate suspension of government tests on veterans involving an anti-smoking drug that has been linked to suicide.

"Nearly 40 suicides and more than 400 incidents of suicidal behavior have been linked to Chantix, yet the VA has chosen to continue the study and administer Chantix to veterans with PTSD," said Congressman Bob Filner (D-CA).

"The VA must immediately suspend this study until a comprehensive review of the safety of the protocol is conducted," said Rep. Filner.

Rep. Filner along with Rep. Ed Markey (D-MA) and Rep. Paul Hodes (D-NH) sent a letter to the Secretary of Veterans' Affairs today expressing their concern over the ABC News report and asking, among other things, for copies of consent and notification forms related to the study.

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CORNYN LETTER TO VA on Chantix (PDF) 

I request your prompt attention to a troubling report released this morning by ABC News and the Washington Times. According to press accounts, Department of Veterans Affairs medical personnel have been subjecting some of our returning warriors to potentially dangerous clinical trials involving the anti-smoking drug Chantix. Specifically, this report alleges that VA doctors learned of possible serious side effects of this drug, including suicide and erratic behavior, but waited more than three months before warning veterans who had been a part of these studies.

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OBAMA LETTER TO VA on Chantix (PDF) 

The Honorable James B. Peake, M.D. Secretary Department of Veterans Affairs 810 Vermont Ave., NW Washington, DC 20420

Dear Secretary Peake:

I was very concerned to read this morning's Washington Times and learn that the Department of Veterans Affairs (VA) has yet again failed to take appropriate steps to safeguard the health and well-being of veterans participating in drug trials.

According to a Washington Times/ABC News investigation, the VA took three months to notify patients about severe side effects from the anti-smoking drug Chantix. . . .

It is outrageous and unacceptable that our government would irresponsibly endanger veterans who have already sacrificed so much for our country. Our veterans particularly those suffering from mental health injuries - should have the very best health care and support in the world. They should never be needlessly exposed to drugs without proper notification of the dangers involved or effective monitoring of the side effects.

It is distressing that our government could once again let down our veterans and their families who have given so much to their country. It is time to demand accountability and to ensure that this kind of breach of trust never takes place again. Accordingly, I call on you to conduct a full and thorough investigation of the process by which VA conducts clinical trials and to take immediate corrective action to address the problems that were first identified by GAO eight years ago.

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Test nearly lethal, veteran says 

James Elliott thought his recurring nightmares of exploding bombs, dogs eating corpses, a child's head blown off its body and other war horrors from his Iraq tour had ended in 2004 when he returned to his home in Silver Spring. . . .

He even signed up for a Veterans Affairs experiment to kick his habit of nearly three packs of cigarettes a day using the drug Chantix, and was succeeding.

But after two weeks on the drug, his night terrors returned with a vengeance, and his fiancee built a wall of stuffed animals across their bed to serve as a security buffer.

"I just thought she really liked stuffed animals," said Mr. Elliott, 38.

Within a few weeks of his taking Chantix, VA officials learned the drug was causing serious side effects across the nation, including psychotic behavior, suicides and suicidal tendencies. But the agency took three months to get that warning through its system and to the veterans in the study.

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