Letter to the Honorable James Peake, Secretary of Veterans Affairs

Letter

Letter to the Honorable James Peake, Secretary of Veterans Affairs

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:

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. Almost 1,000 veterans suffering from post-traumatic stress disorder (PTSD) were paid $30 a month to participate in a study examining ways to end smoking. A total of 143 of the study participants took the anti-smoking drug Chantix.

Last November, the Food and Drug Administration (FDA) issued an alert regarding reports that Chantix led to hallucinations, suicide attempts, and psychotic behavior. Even though almost 40 suicides and more than 400 examples of suicidal behavior were eventually attributed to Chantix nationwide, the VA waited three months after the FDA advisory to alert its study participants about the mental health risks of the drug. And when the VA did finally notify study participants, it failed to mention the most serious side effects of suicide and suicidal thoughts. According to the Washington Times/ABC News investigation, 21 veterans have reported adverse effects from Chantix. In addition to Chantix, the VA is testing other drugs on veterans with PTSD that carry warnings of suicidal side effects.

I understand that clinical research is a vital mission of the VA. Clinical research is not only a source of new treatments for veterans but also a way to recruit and retain the nation's best doctors. However, as I am sure you would agree, the VA has a special responsibility to maintain the most rigorous standards when conducting research on such a vulnerable population. These trials should only be conducted when VA fully informs patients of the risks of the drugs they are taking, and adequately monitors the patients for side effects. These requirements are especially important when dealing with vulnerable patients such as veterans suffering from PTSD.

Unfortunately, the lack of protections for participants in clinical trials is a longstanding problem at VA. Following the suspension of all research at the Veterans Affairs of Greater Los Angeles Health Care System in 1999, the Government Accountability Office (GAO) identified numerous problems in the way that human research subjects were treated at VA facilities, including "failures to provide adequate information to subjects before they participated in research."

In a follow-up investigation in June 2003, GAO found that "VA has not taken sufficient action to strengthen protections for human subjects since we made our recommendations nearly 3 years ago" and that "VA has not established a mechanism for handling adverse event reports to ensure that [Institutional Review Boards] have the information they need to safeguard the rights and welfare of human research participants."

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.

I ask that you notify my office by Friday, June 20, 2008, as to whether you will order such an investigation. Thank you.

Sincerely,

Barack Obama
United States Senator

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