McNerney Reaction to VA Secretary Peake Testimony on Drug Side Effects

July 9, 2008

Washington, D.C. – Today, Department of Veterans Affairs Secretary James Peake appeared in front of the House Committee on Veterans Affairs to answer questions regarding the VA’s failure to disclose the serious side effects of a drug to veterans under VA care who were involved in a study of that drug.

The hearing came as a result of reports that veterans involved in a VA study of the smoking cessation drug Chantix were not informed in reasonable timeframe of the side effects of the medication, including the possibility of psychotic or suicidal episodes.

The Food and Drug Administration issued its first warning about Chantix on November 20, 2007.  The VA did not inform veterans involved in the Chantix study until over three months later, on February 29, 2008, of the drug’s reported serious side effects.  And even then, the VA did not inform study participants of the most severe possible side effects.  And it took until just a few weeks ago, June 19, to inform all 30,000-plus veterans under some sort of VA care and taking Chantix of the possible suicidal side effects.

In response, Congressman Jerry McNerney (CA-11) issued the following statement.

“I appreciate that Secretary Peake came before the Committee today to answer questions about the Chantix drug study.  However, he was frustratingly unable to provide a reasonable explanation as to why the VA failed for more than three months to inform veterans of the serious side effects of Chantix.  Even more frustrating is the Secretary’s inability to provide an explanation given that last year VA doctors identified suicidal or psychotic thoughts as side effects of the drug.

“It’s disturbing that the VA waited three months after an FDA warning to inform patients of serious, and possibly even fatal, consequences.  Principles of patient treatment have been ignored or pushed aside.

“Any patient given a drug is entitled to know what the side effects are, especially if they are life-threatening, and even more so if the patients are particularly susceptible to the side effects.  Some of the veterans taking Chantix suffered from post-traumatic stress disorder.

“It is clear that though the VA has policies to safeguard our men and women who have returned home from serving their country overseas, those policies are not being carried out.  This episode is only the latest in a troubling pattern of behavior from the VA.  In recent months we have also heard of an attempt to cover up the number of veteran suicides as well as the suggestion from a VA psychologist to other medical professionals to avoid diagnoses of post-traumatic stress disorder for a lesser ‘adjustment disorder’.

“The apparent inability of the VA to abide by its own policies is unacceptable.”

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