VVA Testimony Concerning The Smoking Cessation Drug Chantix

Chairman Filner, Ranking Member Buyer, and members of the House Veterans' Affairs Committee, Vietnam Veterans of America (WA) would like to submit the following for the record concerning the subject of today's hearing.

It is an indisputable fact that far too many veterans, particularly those who have
experienced combat and those who have seen the broken bodies of buddies torn by
bullets and shrapnel, are addicted to nicotine. Smoking is responsible for causing or
exacerbating an array of chronic and often fatal illnesses, including lung cancer, heart
disease, and emphysema. Simply put, this insidious addiction kills tens of thousands of veterans every year.

That the Department of Veterans Affairs has elected to conduct studies into potentially effective drug interventions to help veterans overcome their dependence on tobacco is important. It is laudable. What is not laudable, however, is the VA's violation of its own research protocols on the use of human subjects in medical research. This is not a new problem for the VA; it has become a bureaucratic nightmare over the past several years.
As credible media reports have made increasingly clear, alerts by VA researchers and officials to veterans involved in the smoking cessation studies of Chantix (varenicline) concerning severe psychotic side effects among some test subjects lagged, to put it
mildly. VA officials have acknowledged that they knew of these severe side effects up to a year before they bothered to issue any public warning.

Basic common sense as well as institutional protocols would dictate that when testing a drug like Chantix - or any drug that affects brain chemistry - on veterans with post-
traumatic stress disorder or other mental disorders, this should be, this must be, done
under close supervision. Basic common sense would dictate, too, that when the
manufacturer of a drug issues a warning that suicidal thoughts and hallucinogenic
behavior are potential side effects of a drug, a warning that is reiterated soon thereafter
by the Food and Drug Administration (FDA), that VA researchers notify their test
subjects immediately.

It is our hope that any misfeasance on the part of VA officials will not adversely affect the emphasis that must be placed on prevention to reduce the incidence of chronic illness among veterans. It is our hope that the potential benefits of Chantix do not get trashed because of the VA's failure to communicate. We say this because we know of some of the successes of this drug. We know of one veteran, a Marine who served honorably and bravely in Vietnam, who was wounded in action, who smoked almost incessantly for 47 years, yet who was able to quit smoking less than three weeks after beginning a
regimen of Chantix. We know of another veteran who has tried the patch, to no avail; Chantix, for him, represents potential salvation from the straitjacket of nicotine addiction.

It is our hope that the VA will renew its commitment to promulgating the safeguards
necessary for the safe conduct of experiments on human subjects - on veterans who are deserving of their faith and best efforts. It is our hope, too, that Congress will not, in a rush to judgment, damn a drug with great potential for good.

Thomas J. Berger, Ph.D.

Dr. Tom Berger is a Life Member of Vietnam Veterans of America (VVA) and founding member of VVA Chapter 317 in Kansas City, Missouri. He currently serves as National Chair of VVA's PTSD and Substance Abuse Committee, and has recently been named
Senior Analyst for Veterans Benefits & Mental Health Issues. He is a member and Chair of the Veterans Health Administration's (VHA) Consumer Liaison Council for the
Committee on Care of Veterans with Serious Mental Illness (SMI Committee), the
Executive Committee of the Mental Health Quality Enhancement Research Initiative
Depression Work Group (MHQUERI), and the South Central Mental Illness Research
and Education Clinical Center (SC MIRECC).

In addition, Dr. Berger holds the distinction of being the first representative of a national veterans' service organization to hold membership on the VHA's Executive Committee of the Substance Use Disorder Quality Enhancement Research Initiative (SUD QUERI). He also serves as a member of the National Leadership Forum for Behavioral Health and Criminal Justice Services with the CMHS National GAINS Center, the National Steering Committee of the CMHS National Center for Trauma-Informed Care and as a reviewer of research proposals for DoD's "Congressionally Directed Medical Research Programs".

He is a member of VVA's national Health Care, Government Affairs, Agent Orange and Toxic Substances and Women Veterans committees.

Dr. Berger served as a Navy Corpsman with the 3rd Marine Division in Vietnam, 1967-
68. Following his military service and upon the subsequent completion of his post-
doctoral studies, he has held faculty and administrative appointments at the University of Kansas in Lawrence, the State University System of Florida in Tallahassee, and the
University of Missouri-Columbia, as well as program administrator positions with the Illinois Easter Seal Society and United Cerebral Palsy of Northwest Missouri. His
professional publications include books and research articles in the biological sciences, wildlife regulatory law, adolescent risk behaviors, and post-traumatic stress disorder.

Dr. Berger now devotes his efforts full-time to veterans' advocacy at the local, state and national levels on behalf of Vietnam Veterans of America. He presently resides in
Columbia, Missouri, and his hobbies are cycling, music, cooking, and reading.

The national organization Vietnam Veterans of America (VVA) is a non-profit veterans' membership organization registered as a 501(c)(19) with the Internal Revenue Service. VVA is also appropriately registered with the Secretary of the Senate and the Clerk of the House of Representatives in compliance with the Lobbying Disclosure Act of 1995.
VVA is not currently in receipt of any federal grant or contract, other than the routine allocation of office space and associated resources in VA facilities for outreach and direct services through its Veterans Benefits Program (Service Officers). This is also true of the previous two fiscal years.

For further information, contact:
Director of Government Relations
Vietnam Veterans of America
(301) 585-4000 ext. 127