VVA Testimony VVA Testimony
VVA Testimony


 Presented By
 Thomas J. Berger, Ph.D.
Executive Director, Veterans Health Council
Vietnam Veterans of America

"On-Label and Off-Label Use of Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer"
November 19, 2010
Centers for Medicare & Medicaid Services
Baltimore, Maryland


Ladies and gentlemen, the Veterans Health Council of Vietnam Veterans of America (VVA) thanks you for the opportunity to present our statement regarding "On-Label and Off-Label Use of Autologous Cellular Immunotherapy Treatment of Mestastatic Prostate Cancer."

A host of herbicides were sprayed by the U.S. military in Vietnam and other Southeast Asian countries to protect American and allied troops by defoliating the dense jungle vegetation hiding enemy positions. The herbicides were named for the color-coded bands on the 55-gallon drums in which they were shipped; examples included Agent Blue, Agent White, and the most extensively used herbicide, Agent Orange. It is estimated that between 1962 and 1971 almost 20 million gallons of Agent Orange were sprayed in Vietnam, primarily through an aerial spray program code-named "Operation Ranch Hand." Some three million veterans served in Southeast Asia, and no one knows for sure how many of these veterans were exposed to Agent Orange.

In early 1996 the Institute of Medicine (IOM) of the National Academy of Sciences concluded in its report "Veterans and Agent Orange: Update 1996" that there was "limited evidence of a positive association between prostate cancer and exposure to herbicides used in Vietnam including Agent Orange." As a result, in November 1996 Secretary Jesse Brown of the Department of Veterans' Affairs (VA) issued the final rule recognizing prostate cancer as a service-connected presumptive disease associated with exposure to Agent Orange and other phenoxy herbicides during military service. Therefore, such exposed veterans became eligible for VA disability compensation and health care. In addition, surviving spouses, children and dependent parents of veterans who were exposed to Agent Orange and died as the result of diseases associated with Agent Orange may be eligible for survivors' benefits.

In 2008, University of California - Davis Cancer Center physicians released results of research showing that Vietnam veterans exposed to Agent Orange have greatly increased risks of prostate cancer and even greater risks of getting the most aggressive form of the disease as compared to those who were not exposed. Based on medical evaluations conducted between 1998 and 2006, the study revealed that:

  • twice as many Agent Orange-exposed men were identified with prostate cancer than non-exposed;
  • Agent Orange-exposed men were diagnosed two-and-a-half years younger than non-exposed; and
  • Agent Orange-exposed men were nearly four times more likely to present with metastatic disease than non-exposed.

Thus, veterans exposed to Agent Orange are at least twice as likely to develop prostate cancer, their recurrence rates are higher, and recurring cancers are more aggressive.

I am not advocating that on-label and off-label use of autologous cellular immunotherapy is the sole answer to treating metastatic prostate cancer; but I am here today to say that our Agent Orange-exposed veterans with metastatic prostate cancer deserve appropriate access to this new and innovative therapy because it provides yet another evidence-based treatment option for them. The decision for treatment options should be made by physicians in consultation with patients, based on current clinical evidence and NOT by the government. Vietnam veterans in particular have painfully learned that government cannot always be trusted to make the best decisions as it relates to their health, and our country's veterans deserve the best possible health care.
Again, thank you for the opportunity to address this important health issue among America's Vietnam veterans.

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. Dr. Berger served as a Navy Corpsman with the 3rd Marine Corps Division in Vietnam, 1966-68. Following his military service and upon the subsequent completion of his postdoctoral studies, he held faculty, research 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.

After serving as chair of VVA's national PTSD and Substance Abuse Committee for almost a decade, he joined the staff of the VVA national office as "Senior Policy Analyst for Veterans' Benefits & Mental Health Issues" in 2008. Then in June 2009, he was appointed as "Executive Director of the VVA Veterans Health Council", a 501c3, whose primary mission is to improve the healthcare of America's veterans through education and information.

Dr. Berger has been involved in veterans' advocacy for over thirty years, and he is a member of VVA's national Health Care, Government Affairs, Agent Orange and Toxic Substances, and Women Veterans committees. As such, he is a member and the former Chair of the Veterans Administration's (VA) Consumer Liaison Council for the Committee on Care of Veterans with Serious Mental Illness (SMI Committee) in Washington, D.C.; he is also a member of the VA's Mental Health Quality Enhancement Research Initiative Depression Executive Committee (MHQUERI) based in Little Rock, Arkansas and the South Central Mental Illness Research and Education Clinical Center (SC MIRECC) based in Houston, Texas. Dr. Berger holds the distinction of being the first representative of a national veterans' service organization to hold membership on the VA's Executive Committee of the Substance Use Disorder Quality Enhancement Research Initiative (SUD QUERI) based in Palo Alto, California and serves as a national committee member on the National Association of Alcohol and Drug Abuse Counselors (NAADAC) veterans' working group and a member of the National Leadership Forum on Behavioral Health-Criminal Justice Services with the CMHS-funded national GAINS Center. He has also served as a reviewer of research proposals for the Department of Defense (DoD) "Congressionally Directed Medical Research Programs" and is a current member of the Education Advisory Committee for the National Center on PTSD.

Dr. Berger has addressed veterans' health care issues on local Washington and national media outlets including CNN, before FDA committees and Justice Department commissions, and on many occasions, has presented on-the-record testimony before both the U.S. House of Representatives and Senate Veterans' Affairs Committees, Subcommittees and Roundtables regarding mental health, substance abuse and related health issues affecting America's veterans.

Dr. Berger's varied academic interests have included published research, books and articles in the biological sciences, wildlife regulatory law, adolescent risk behaviors, domestic violence, substance abuse, suicide, and post-traumatic stress disorder. He currently resides in Silver Spring, Maryland.

Funding Statement
November 19, 2010

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 Regional Offices for outreach and direct services through its Veterans Benefits Program (Service Representatives).  This is also true of the previous two fiscal years.

For Further Information, Contact:

Executive Director of Policy and Government Affairs
Vietnam Veterans of America.
(301) 585-4000, extension 127



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