- The Washington Times - Wednesday, June 18, 2008

Democratic presidential candidate Sen. Barack Obama and congressional leaders on both sides of the aisle Tuesday called for investigations into the Department of Veterans Affairs (VA) failure to inform in a timely manner veterans participating in medical tests that a drug they were taking has side effects that can lead to psychosis and suicide.

Responding to an investigative report published in The Washington Times Tuesday, Mr. Obama, a member of the Senate Committee on Veterans’ Affairs, said the VA’s actions in sponsoring the drug tests were “outrageous” and “unacceptable.”

“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,” said Mr. Obama, Illinois Democrat.

Rep. Steve Buyer of Indiana, the ranking Republican on the House Committee on Veterans’ Affairs, sent a letter to the VA inspector general and the VA’s chief research and development officer requesting an investigation.

“I am troubled by allegations that these safeguards may have not been in place for this study and I am requesting an immediate investigation into this matter and I asked that VA report back to me as soon as possible,” he said.

A spokesman for House Speaker Nancy Pelosi, California Democrat, said Congress also will look into the matter.


“This report raises many disturbing questions about the treatment of our veterans and the House Veterans’ Affairs Committee will get to the bottom of this,” said Pelosi spokesman Nadeam Elshami. “We expect full and immediate cooperation from the VA.”

The VA took three months to notify its patients about severe mental side effects of the anti-smoking drug Chantix, after the Food and Drug Administration issued an alert about side effects that could lead to psychosis and suicide.

The VA said notification letters were tied up in bureaucracy, but thought the three-month time frame was not unrealistic. The VA also said warnings about suicide were omitted from the letter notification because many veterans are elderly or have eyesight problems.

“This is the most pathetic excuse that can be dredged up; it’s insulting,” retired Marine Lt. Col. Roger Charles, editor of DefenseWatch, the Internet newsmagazine of Soldiers for the Truth, said Tuesday.

“And then to brag you got it done in three months because of a cumbersome bureaucracy? What if people’s lives were at risk? Oh wait, they are,” Col. Charles said.

The VA continues to test Chantix on veterans suffering from post-traumatic stress disorder (PTSD), even as the Federal Aviation Administration has banned airline pilots and air traffic control personnel from taking the drug, citing the adverse side effects.

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.

The White House on Tuesday defended the VA, saying the program is designed to help soldiers with PTSD.

“The VA 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 [VA], under wonderful leadership by [Secretary James B. Peake], who is interested in the health and safety of these veterans that are under his care, and every other member of that VA system is the same,” White House spokesman Tony Fratto said.

“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,” he said. “Remember, this is a program dealing with former soldiers with PTSD. And it’s a smoking-cessation program. And they’re interested in helping these veterans. So that’s my reaction to it.”

Nearly 1,000 veterans with PTSD were enrolled in the VA study to test methods of ending smoking, with 143 using Chantix. Twenty-one veterans reported adverse effects from the drug, including one who suffered suicidal thoughts, a three-month investigation by The Times and ABC News found.

“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,” Mr. Obama said in a letter Tuesday to Mr. Peake.

Mr. Obama cited a Government Accountability Office investigation of VA health care in Los Angeles that resulted in the suspension of all human testing because of numerous problems, including “failures to provide adequate information to subjects before they participated in research.”

“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,” he said in the letter.

Sen. John Cornyn, Texas Republican and a member of the Senate Armed Services Committee, also requested that Mr. Peake review the studies and identify everyone involved, as well as provide care “to any veterans who have undergone this testing and ensure that any unethical practices are immediately brought to a halt.”

“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,” Mr. Cornyn said.

In addition, Senate Veterans’ Affairs Committee Chairman Daniel K. Akaka said his panel will question the ethics of the clinical trial involving the drug Chantix.

“The suggestion that VA researchers are not properly informing veterans about possible risks is troubling and deserves further investigation,” the Hawaii Democrat said.

Sen. Richard M. Burr of North Carolina, ranking Republican on the Veterans’ Affairs Committee, also is questioning the VA clinical trial - in particular the timing of notification to study participants.

“VA should make every effort to quickly inform participants of any new drug information,” Burr spokesman Mark Williams said.

Added Kevin Bishop, spokesman for Sen. Lindsay Graham, South Carolina Republican: “Advances in medicine should not come at the expense of our troops.”

Stephen Dinan and Jon Ward contributed to this report.

• To read the full investigation, click here.

REACTION: Obama’s office sent a letter Tuesday to James Peake, secretary of the Department of Veterans Affairs, on the issue. You can read the full text of the letter here.

REACTION II: Sen. John Cornyn, Texas Republican, issued his own letter to Peake as well. You can read it here.