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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.

Varenicline, sold under the trade name Chantix, is a non-nicotine drug made by Pfizer that blocks nicotine receptors in the brain, according to the drug company. There are several known side effects. The most common is nausea, experienced by about 30 percent of patients. Constipation, vomiting, changes in dreams, and gas are other common side effects.

There also have been reports of psychotic behavior, including hallucinations and suicide attempts, that led the FDA to issue a warning to physicians. VA officials said they passed the warnings on to doctors, and sent a letter to people in the test, but did not mention suicide because they thought that was better discussed face to face.

Paying a stipend to people taking part in a research project is standard practice in the medical community, VA officials said.

“The implication that a modest payment for volunteers in medical research programs is somehow wrong is a distortion,” the VA statement said. “Such payments are a widely used practice, both in VA and in the private sector, to help volunteers pay for expenses. The characterization of the purpose of these payments was entirely incorrect.”

The fee paid to veterans taking part in the study is $30 a month, according to the Washington Times article.

Two Republicans, Rep. Steve Buyer of Indiana and Sen. John Cornyn of Texas, want VA to investigate.

Buyer, the former chairman and now ranking Republican member of the House Veterans Affairs Committee, asked VA’s inspector general and chief research and development officer to review the research program.

Buyer said VA research “has been invaluable in providing breakthrough medical advances for veterans and the American public,” but he is “troubled by allegations that these safeguards may have not been in place for this study.”

Cornyn, a member of the Senate Armed Services Committee, said the news reports appear to show VA may have “failed to live up to the standard of excellence that is expected.”

He has asked VA Secretary James Peake to “look into the allegations” and take corrective action, if needed.

VA officials said treating PTSD and getting veterans to stop smoking are both important health issues, and the research is trying to determine if smokers would have a greater chance of stopping if their attempt was combined with other counseling.

Safeguards are being used, VA officials said. “This research program, like all VA research, is approved by independent institutional review boards to ensure the safety of all participants.”