Why Does the VA Continue to Give a Suicide-Inducing Drug to Veterans with PTSD?”

MEDIA ADVISORY
FOR IMMEDIATE RELEASE

http://veterans.house.gov
Schedule for Week of July 7, 2008
*Wednesday, July 9 – 10 a.m. – 334 Cannon House Office Building
Full Committee Hearing
“Why Does the VA Continue to Give a Suicide-Inducing Drug to Veterans with PTSD?”
This hearing is part of the House Committee on Veterans’ Affairs ongoing oversight of mental health care activities at the Department of Veterans Affairs (VA). The hearing will focus on a smoking cessation study and the risks to the veterans that were enrolled and participating in the study. One of the drugs used in the study was Chantix.
· May 11, 2006: Chantix receives approval from the Food and Drug Administration
· November 20, 2007: FDA issues an early communication about an ongoing safety review of Chantix and reports “suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix”
· February 1, 2008: FDA issues Public Health Advisory stating that symptoms of Chantix may include “anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempted suicide”
· February 29, 2008: VA sends letter and new consent form to study participants to notify them of the dangers associated with Chantix.
The hearing will review the process VA has in place for handling human research subjects, VA’s responsibility to respond to the FDA’s advisories, and the relationship between pharmaceutical companies and researchers. The hearing will also investigate the methods of accountability at the VA in response to a series of recent events, including an e-mail suggesting that VA providers downgrade the diagnosis of PTSD to “adjustment disorders” and leaders at the VA attempting to manipulate suicide data to portray a lesser problem.
WITNESS LIST
Panel 1
· James Elliott, Iraq War Veteran
Accompanied by:
o Tammy Hilburn
· Lt. Col. Roger Charles (Ret.), Editor of DefenseWatch, Soldiers for the Truth
Panel 2
· The Honorable James B. Peake, M.D., Secretary, U.S. Department of Veterans Affairs
Accompanied by:
o Joel Kupersmith, MD, Chief of Research and Development
o Miles McFall, Ph.D., Researcher
o J. Thomas Puglisi, Ph.D, Chief Research Oversight Officer, Office of Research Oversight
· Paul Seligman, M.D., M.P.H., Associate Director of Safety Policy and Communication, Center for Drug Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services
Accompanied by:
o Robert Temple, M.D., Director, Office of Medical Policy, Center for Drug Evaluation and Research
Panel 3
· Ponni Subbiah, M.D., M.P.H., Pfizer, Inc.
· Gerald P. Koocher, Ph.D., ABPP, Dean and Professor, School of Health Sciences, Simmons College
Panel 4
· John D. Daigh, Jr., M.D., CPA, Assistant Inspector General for Healthcare Inspections, Office of the Inspector General, U.S. Department of Veterans Affairs
Accompanied by:
o Andrea Buck, M.D., JD, Senior Physician, Medical Consultation and Review Division, Office of Healthcare Inspections
o Mr. Randall Snow, Associate Director, Washington, DC Regional Office, Office of Healthcare Inspections
Thursday, July 10 – 10 a.m. – 334 Cannon House Office Building
Subcommittee on Health Markup
*Thursday, July 10 – 1 p.m. – 334 Cannon House Office Building
Subcommittee on Economic Opportunity Hearing
“Independent Living”
*Watch the hearing live: Go to the Committee homepage http://veterans.house.gov/ and click on ‘Live Webcast’.
Keep updated on the committee schedule here: HVAC Website

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