VIETNAM VETERANS OF AMERICA
Madam Chair and Distinguished Members of the FDA's Advisory Committee, Vietnam Veterans of America (VVA) thanks you for the opportunity to present our statement for the record regarding the use of VIVITROL (Naltrexone for extended-release injectable suspension) for the treatment of opioid dependence.
Here are some of the resulting issues that face our soldiers and veterans related to addiction and abuse of pain medications:
• One in four soldiers admitted abusing prescribed drugs, mostly pain relievers, in the 12 months prior to a Pentagon survey in 2008, according to results released this year.
• Fifteen percent said they had abused drugs in the 30 days before the survey.
• Pentagon records also show the abuse of prescription drugs is higher in the military than among civilians. Five percent of civilians reported abusing prescription drugs in a 30-day period in 2007, compared to 11% of military personnel surveyed in 2008.
• Military officials and analysts say the increase in the use of narcotic pain medication reflects the continuing toll on ground troops fighting in Iraq and Afghanistan, often through more than one combat deployment. In addition to those who are wounded, larger numbers of soldiers and Marines develop aches and strains carrying heavy packs, body armor and weapons over rugged and mountainous terrain.
Furthermore, our veterans seek relief from the chronic pain that accompanies their war wounds -- opioid addiction, as in prescription drug addiction to pain killers such as OxyContin, Demerol, Dilaudid, Vicodin and Codeine, which are available to veterans at virtually no cost through the Veterans Health Administration (i.e., in contrast, many of the more expensive and non-addictive pain management drugs used in private sector health plans such as anti-inflammatory biologics, are not available to veterans because of their costs).
Opioid use and addiction is not new to our soldiers and veterans – because the American history of opioid use and addiction began with her veterans during and after the Civil War, when opioids were widely prescribed to alleviate soldiers' acute and chronic pain (2). Now, one hundred thirty years later, the issue of opioid use and
addiction is more acute than ever, with our soldiers returning from the current conflicts in Iraq and Afghanistan (3,4). Unlike other wars, however, current service personnel are being deployed for a longer duration and with greater frequency. This creates psychosocial stressors that may increase the likelihood of chronic pain syndrome, even in the absence of physical injury (5). Of the first two hundred thousand OEF and OIF veterans accessing the Veterans Health Administration, the number one reason for presentation was various types of somatic pain - primarily back and joint pain. Thus, the current generation of veterans joins the large population of Vietnam-era veterans who have struggled with the same problems for decades.
Now let's overlay the issue of pain with the prevalence of mental illness among our veterans. Among 100,000 OEF/OIF veterans first seen at the VHA facilities between 2001 and 2005, 25% received mental health diagnoses (4), and the research shows a significant interrelationship between mental health issues and substance use disorder, including opioids (6,7). In addition, it has been demonstrated in civilian populations that "telescoping" or rapid progression from appropriate use to abuse of opioids occurs more frequently in women versus men (8,9). This makes prescribing safe and effective pain medicines for the female veteran population more challenging (10).
Currently, women represent a larger proportion of U.S. military forces than ever before, comprising approximately 14% of forces deployed in support of OEF/OIF, and representing over 180,000 deployed female troops . The proportion of women in active military service is increasing and is expected to double in the next 5 years (11). These new female veterans are younger, more likely to identify as belonging to a racial minority, have a high prevalence of mental health disorders, have higher rates of exposure to combat trauma than previous cohorts of women veterans, and may have high rates of exposure to sexual trauma. All of these factors place them at risk for chronic pain syndromes (12,13,14).
Although prescription opioids remain indispensable for the management of acute pain, long-term solutions to opioid addiction are not as readily accessible. So this is to put everyone here on notice that we and the American public should have deep concerns about our veterans and their propensity for rapidly developing substance use disorder. And because our current health care systems are NOT able to effectively manage or handle this growing crisis, we could reasonably expect to see many of our veterans knocking at the doors of the criminal justice system.
Now, I'd like to turn to some remarks about long-acting Naltrexone – the medication being considered by this panel today. The potential for the application of long acting anti-addiction medications was recognized very early by the National Institute of Drug Abuse. As long ago as 1976 and 1981, research monographs on the subject of long acting formulations of Naltrexone were published (15,16). Naltrexone (Vivitrol® Alkermes) is a once monthly injection for opioid addiction is currently available in the market for alcohol abuse (17). More significantly, this drug has already been tested in opioid-dependent parolees and probationers in clinical trials. These trials specifically tested its impact on such endpoints as retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs compared to usual community treatment programs. Furthermore, these endpoints were reviewed at six, twelve and eighteen months into the study (18).
Based on the results seen to date, I would make these key observations:
I think it is fair to expect that the impact on reducing opioid use could have significant economic outcomes for everyone involved in terms of the costs of recidivism.
While I am not advocating that medication is the sole answer to substance use disorder, I am suggesting that we can look at a treatment such as this one to create the possibility for cost-effective, directly observed therapy. This is one of the strategies known to create a practical means of patient compliance. In directly observed therapy, the patient receives their administered dose in front of the health care practitioner, thus serving two vital roles:
Ensuring patient compliance with the treatment program, and
Enabling an augmentation of the medication treatment regimen with an appropriate psychosocial intervention.
Addiction science is stepping up to support our efforts to make it easier to increase our compassion and necessity to change the way we approach treatment of Americans – including our Veterans – who struggle with addiction to drugs, like opiates. In 2004, the Institute of Medicine published findings from the Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction at the National Academies. Among the many recommendations presented, it was determined that the National Institute on Drug Abuse should indeed support these clinical effectiveness studies and financing models that integrate the new pharmacotherapies with psychosocial services in specialty addiction and primary medical care settings (19). So clearly there is a consensus in the research community that an integrated model – sensitive to the cost benefit ratio of these new treatment options – will advance our efforts in changing the paradigm for dealing with substance use disorders, like opioid addiction.
I would like to make it clear that Veterans with substance abuse disorders face significant barriers to treatment. At present, our Veterans are unable to gain access to today's most effective treatments for opioid dependence, currently methadone and buprenorphine. This is in spite of countless government reports – from the Centers for Disease Control and Prevention (20), the Institute of Medicine (21) of the NationaI Institutes of Health (22), the Substance Abuse and Mental Health Services Administration (SAMHSA) of the U.S. Department of Health and Human Services(23), the National Institute on Drug Abuse (NIDA) (24), the World Health Organization (25) and over four decades of government-funded, peer-reviewed medical research (26) – which have unequivocally and repeatedly proven that substitution therapies are the most effective treatments for opioid dependence (27,28).
I'm here today to say that our Veterans with substance abuse disorders need more treatment options. I hope that the FDA will seriously consider this request for the supplemental new drug application for VIVITROL for the treatment of opioid dependence in order to expand medication-assisted therapies to treat addiction that in turn, can decrease incarceration and accidental overdose.
Again, thank you for the opportunity to address this important health issue.
1. Veterans Health Administration drug formulary
2. U.S. Department of Health & Human Services, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment. SAMHSA/CSAT Treatment Improvement Protocols (TIP) 43: Medication-assisted treatment for opioid addiction in opioid treatment programs. [March 14, 2010]; Available from: http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=hssamhsatip&part=A82724
3. Cohen SP, Griffith S, Larkin TM, Villena F, Larkin R. Presentation, diagnoses, mechanisms of injury, and treatment of soldiers injured in Operation Iraqi Freedom: an epidemiological study conducted at two military pain management centers. Anesth Analg 2005 Oct;101(4):1098-103.
4. Veterans Health Administration. Office of Public Health and Environmental Hazards. Analysis of VA health care utilization among US global war on terrorism (GWOT) veterans: operation enduring freedom, operation Iraqi freedom. Washington DC. Veterans Health Administration. 2009.
5. Invisible wounds of war: Psychological and cognitive injuries, their consequences, and services to assist recovery. Santa Monica, CA Rand; 2008. [March 14, 2010]; Available from: http://www.rand.org/pubs/monographs/MG720
6. Seal KH, Metzler TJ, Gima KS, Bertenthal D, Maguen S, Marmar CR. Trends and risk factors for mental health diagnoses among Iraq and Afghanistan veterans using Department of Veterans Affairs health care, 2002-2008. Am J Public Health 2009 Sep;99(9):1651-8.
7. Edlund MJ, Steffick D, Hudson T, Harris KM, Sullivan M. Risk factors for clinically recognized opioid abuse and dependence among veterans using opioids for chronic non-cancer pain. Pain2007 Jun 129(3):355-62.
8. Ballantyne JC, LaForge KS. Opioid dependence and addiction during opioid treatment of chronic pain. Pain 2007 Jun;129(3):235-55.
9. Hernandez-Avila CA, Rounsaville BJ, Kranzler HR. Opioid-, cannabis- and alcohol-dependent women show more rapid progression to substance abuse treatment. Drug Alcohol Depend 2004 Jun 11;74(3):265-72.
10. Nelson-Zlupko L, Dore MM, Kauffman E, Kaltenbach K. Women in recovery:
11. Street AE, Vogt D, Dutra L. A new generation of women veterans: stressors faced by women deployed to Iraq and Afghanistan. Clin Psychol Rev 2009 Dec. 29(8):685-94.
12. Haskell SG, Brandt CA, Krebs EE, Skanderson M, Kerns RD, Goulet JL. Pain among Veterans of Operations Enduring Freedom and Iraqi Freedom: do women and men differ? Pain Med 2009 Oct.10(7):1167-73.
13. Haskell SG, Papas RK, Heapy A, Reid MC, Kerns RD. The association of sexual trauma with persistent pain in a sample of women veterans receiving primary care. Pain Med 2008. Sept 9(6):710-7.
14. Dobie DJ, Kivlahan DR, Maynard C, Bush KR, Davis TM, Bradley KA. Posttraumatic stress disorder in female veterans: association with self-reported health problems and functional impairment. Arch Intern Med 2004. Feb 23.164(4):394-400.
15. Capozza RC, Schmitt EE, Sendelbeck LR. Development of chronomers for narcotic antagonists. NIDA Research monograph No.4: Narcotic Antagonists: The Search for long-acting preparations 1976:39-42.
16. Olsen JL, Kincl FA. A review of parenteral sustained release naltrexone systems. PP187-193. Narcotic Antagonists 1981"Naltrexone Pharmacotherapy and sustained release preparations.".NIDA research monograph No. 28 1981.
17. Alkermes November 16, 2009 press release. [March 14, 2010]; Available from: http://phx.corporate-ir.net/phoenix.zhtml?c=92211&p=irol-newsArticle&ID=1355632&highlight
18. Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coordinated/Data Management Site (ClinicalTrials.gov identifier: NCT00781898) Sponsor: NIDA. [March 14, 2010]: Available from: http://clinicaltrials.gov/ct2/show/NCT00781898
19. Harwood HJ, Myers TG, National Academies (U.S.). Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction. New treatments for addiction : behavioral, ethical, legal, and social questions. Washington, D.C.: National Academies Press; 2004.
21. Institute of Medicine, National Institutes of Health, Federal Regulation of Methadone Treatment (1995), http://www.nap.edu/catalog.php?record_id=4899>
22. National Institutes of Health, Effective Medical Treatment of Opiate Addiction, NIH Consensus Statement 1(1997):4.http://consensus.nih.gov/1997/1998 Treat Opiate Addiction108html.htm
23. Center for Substance Abuse Treatment, Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs, Treatment Improvement Protocol (TIP) Series 43, DHHS Publication No. (SMA) 05-4048. Rockville, MD: Substance Abuse and Mental Health Services Administration, 200 http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat5.chapter.82676.
24. National Institute on Drug Abuse (NIDA). Research Report: Heroin Abuse and Addiction. (Revised 2005). http://www.drugabuse.gov/ResearchReports/heroin/heroin.html ; NIDA International Program. Methadone Research Web Guide (Bethesda, National Institute on Drug Abuse: 2007).
25. World Health Organization (WHO). Substitution maintenance therapy in the management of opioid dependence and HIV/AIDS prevention: position paper (2004). World Health Organization, United Nations Office on Drugs and Crime, UNAIDS available at http://www.unodc.org/docs/treatment/Brochure_E.pdf.
26. Fiellin, D.A., P.G. O'Connor, M. Chawarski M, et al. "Methadone maintenance in primary care: a randomized controlled trial." Journal of the American Medical Association
27. National Institutes of Health; Centers for Disease Control and Prevention, Methadone Maintenance Treatment, (February 2002) http://www.cdc.gov/idu/facts/Methadone.htm.
28. National Institutes of Health (1997) 4; Center for Substance Abuse Treatment (2005); World Health Organization; Fiellin 1764-1765; Hser 503-508; Ward 221-226; Novick 233-239.
Thomas J. Berger, Ph.D.
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.
VIETNAM VETERANS OF AMERICA
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