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Witness Testimony of David A. Broecker, Alkermes, Inc., Cambridge, MA, President and Chief Executive Officer

Mr. Chairman, Ranking Member Buyer and Members of the Committee, thank you for inviting me to testify here today on behalf of Alkermes. 

Overview

Alkermes is pleased to have the opportunity to submit testimony on innovative technologies and treatments for veterans.  Given the personal sacrifice that our brave servicemen and women have made, we believe that it is important to give them access to the best medicines and treatments currently available to help them get the care they need to live happy, healthy and productive lives.  Using innovative drug delivery technology, Alkermes has developed a unique medicine for the treatment of alcohol dependence, called VIVITROLâ (naltrexone for extended-release injectable suspension).  VIVITROL is a breakthrough medicine that, when combined with counseling, has the potential to greatly reduce the human and financial toll associated with alcohol dependence.

Alkermes

Alkermes is a small biotechnology company located in Cambridge, Massachusetts.  As a company, we are committed to developing medicines that make a difference in patients’ lives. Our products, which use novel molecules and innovative drug delivery technologies, target the unmet medical needs of patients suffering from diseases like schizophrenia, bipolar disorder, addiction and diabetes.  We approach the drug development process with patients as our top priority, beginning with a thorough understanding of the challenges they face on a day-to-day basis.  Our products are designed with patient needs and behaviors in mind, with the goal of dramatically improving therapeutic outcomes.

Substance Use Disorders Among OEF/OIF Veterans

Alcohol dependence is a major problem among military veterans.  In 2003, a survey conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA) estimated the veteran population in the United States to be 25 million, or roughly 11.5 percent of the entire non-institutionalized civilian population.[1]  Approximately 7.5 percent, or nearly 1.9 million, of these veterans reported drinking heavily in the month prior to being surveyed (compared to 6.5 percent of comparable nonveterans).  SAMHSA estimated that approximately 650,000 veterans (2.6 percent) were alcohol dependent.  By 2006, the VA’s own data showed that only 175,268 veterans were actually receiving treatment for their alcohol abuse or alcohol dependence within the VA system.[2]  In addition to post-traumatic stress disorder (PTSD), alcohol abuse and alcohol dependence are consistently among the most prevalent psychological disorders in male veterans of the Vietnam era.[3]  In female veterans of Vietnam, alcohol abuse and dependence are second only to depression and generalized anxiety.

Since the start of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF), over 1.8 million American military personnel have been deployed, with nearly a third coming from the National Guard and Reserves.[4]

In 2006, the New Jersey Department of Military and Veterans Affairs, in conjunction with the University of Medicine and Dentistry of New Jersey and the Bloustein Center for Survey Research at Rutgers University, surveyed New Jersey National Guard members who had returned from Iraq within the past year.  The results of the study were striking – 37 percent of those surveyed reported problem drinking in the year following their deployment.  Even more troubling, 55.3 percent of the veterans with PTSD reported problem drinking.[5]

In a study published in the Journal of the American Medical Association, Hoge et al. of the Walter Reed Military Research Institute administered anonymous surveys and assessed 2,530 U.S. combat duty personnel before their deployment to Iraq and 3,671 troops three to four months after their return from combat duty in Iraq or Afghanistan.  Over 35 percent of Marines reported experiencing at least one symptom of alcohol dependence (drinking more than intended) after deployment, and over 29 percent reported that they felt they needed to cut down on their drinking.[6]   

To put the seriousness of these alcohol problems in perspective, Hoge et al. found substantially lower rates for depression (7.1 percent), anxiety (6.6 percent) and PTSD (12.2 percent).  Only PTSD showed a comparable rate of increase (pre-deployment to post-deployment) – an expected finding given that over 90 percent of the combat duty personnel had been directly involved in gun battle and/or handling the bodies of fellow servicemen and women, killed in the line of duty.[7] 

The incidence of alcohol dependence symptoms appears to be the most common problem facing returning combat duty personnel.  Alcohol dependence exacerbates other psychiatric and medical problems and undermines treatment.  Combat duty personnel may be particularly likely to use alcohol to self-medicate their psychiatric problems, resulting in worsened overall mental health and alcohol dependence.  The strong reluctance to seek professional help may be a particularly important factor contributing to the misuse and ultimate dependence on alcohol. 

While the incidence of mental health and alcohol problems within a few months of returning from combat is high, alcohol problems in particular often take years to manifest.  For this reason it is important to consider research from past military conflicts.  Specifically, the National Vietnam Veterans Adjustment Survey found 40 percent of male veterans reported lifetime alcohol problems post-deployment.  In 2000, the Department of Defense's Alcohol Abuse and Tobacco Use Reduction Committee reported that, even prior to the start of the conflict, 21 percent of service members admitted to drinking heavily, costing the Department of Defense more than $600 million each year in terms of medical care and lost productivity. [8]

A February 2007 report by the American Psychological Association on the mental health needs of returning veterans found a variety of barriers are preventing military personnel from accessing much needed mental health and alcohol treatment.  The report cited stigma and a lack of availability of services as the primary reasons why personnel and their families are not accessing care.[9]  Shortages of trained uniformed personnel, high burn out rates among providers and difficulties in referring military personnel to civilian providers often mean long waits for care.  Moreover, in other reports and testimony before this Committee, providers have reported significant recent decreases in the availability of inpatient beds for alcohol dependence treatment.  During these high service utilization periods,  medication assisted treatment for alcohol dependence may improve VA care delivery by integrating primary care and behavioral health care and providing immediate help upon substance use disorder diagnosis during high volume periods.

Vivitrol

As researchers have gained a deeper understanding of the complex brain mechanisms that trigger alcohol dependence, medications are increasingly considered to be important treatment options for this disease.  In 2005, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) issued guidelines, recommending the combination of medications and psychosocial support as part of an integrated treatment program.[10]

One of the products currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcoholism is VIVITROL, an extended-release naltrexone product developed and manufactured by Alkermes.  Naltrexone is a non-addictive, non-aversive agent that binds to opioid receptors in the brain.  In people with alcohol dependence, it is believed that this blockade diminishes craving for alcohol and leads to a greater ability to resist urges to drink excessively.[11]  Eliminating the urge to drink allows patients the stability they need to focus on the psychosocial therapy component of their recovery. [12]

Approved by the FDA in April 2006, VIVITROL is the first and only once-monthly injectable medication for the treatment for alcohol dependence.  It is intended for patients who are able to abstain from drinking in an outpatient setting in the week prior to initiation of treatment with VIVITROL; patients using VIVITROL in combination with psychosocial support have demonstrated significantly increased abstinence and decreased both drinking and heavy drinking days beyond what was achieved with counseling and placebo alone.[13]

In a 2005 study in the Journal of the American Medical Association, authors reported on the results of a six-month phase III clinical trial on extended-release naltrexone.  When extended-release naltrexone was added to counseling alone, the average patient experienced a 48 percent reduction in heavy drinking days compared to counseling plus placebo alone.[14]  For those who had abstained from alcohol in the week prior to receiving their first dose of medication, there was a 90 percent or better reduction in heavy drinking, a two to three times greater likelihood of maintaining continuous abstinence and a 90 percent reduction in drinking days compared to the counseling plus placebo group over the six-month period.  VIVITROL is the only pharmacologic treatment for alcohol dependence that extends a medication’s release over 30 days, which assures that measurable blood plasma concentrations are present in the patient’s bloodstream every day during the expected treatment period.

In fact, studies show that VIVITROL, when combined with psychosocial therapy, triples the duration of initial abstinence and nearly triples the proportion of patients who maintain total abstinence over six months.[15]  Even at times when alcoholics are most at risk for drinking – for example, the ten deadliest U.S. national holidays due to drunk driving – this once-monthly medication has been found to reduce the median level of drinking to virtually zero.[16], [17] 

While there are other pharmacologic treatments for alcohol dependence, a SAMHSA study found that the vast majority of patients with this disease have difficulty adhering to an alcohol pharmacotherapy that requires them to take a pill every day.[18], [19]  Anticipating this challenge, the National Institute on Drug Abuse (NIDA) issued two reports in 1976 and 1981 calling for the development of sustained-release preparations. [20], [21]  The VIVITROL clinical development program was funded in part with a Small Business Innovation Research Program grant from NIAAA. The proprietary Medisorbâdrug delivery technology in VIVITROL allows the medication to be gradually released into the body at a controlled rate, delivering the naltrexone throughout the bloodstream and to the brain for 30 days after each injection.  It provides patients the convenience of monthly dosing, which alleviates the difficulty of adhering to a daily medication regimen.

Veterans Access to Vivitrol

While Alkermes is pleased that many top tier addiction treatment centers have now adopted Vivitrol on their formularies as a first-line treatment for patients with alcohol dependence, the Committee should be aware that our nation’s veterans do not have the same access to the latest alcohol pharmacotherapies.[22]

The VA conducted a clinical review of VIVITROL from January 2007 through February 2008 and declined to grant the product formulary status.  Although VA providers may prescribe non-formulary products for their patients, significant barriers may prevent VA patients from receiving treatment with VIVITROL.  A longstanding VA directive limits the interaction that companies can have with VA physicians to discuss non-formulary products.  This type of restriction may limit provider education and hamper patient access to novel therapies.  Although some providers within the VA have fought for access to VIVITROL and have prescribed it for their patients with great success, the usage rate for VIVITROL within the VA is effectively zero.

To the credit of the VA, the agency published policy guidance, Uniform Mental Health Services in VA Medical Centers and Clinics, in June 2008.  This document promotes the use of medication assisted treatment for alcohol dependent individuals; however, to date, few veterans have been able to obtain access to VIVITROL.  While there are approximately 650,000 veterans who meet the criteria for alcohol dependence, only about one quarter of those individuals actually receive SUD treatment within the VA system.[23]  In 2008, our estimates suggest that fewer than 125 patients in the entire VA system (less than 0.07 percent) have received VIVITROL.

In March 2008, the VA testified before this Committee that the VA/DoD Clinical Practice Guidelines for Substance Use Disorders would be published within six months.[24]  These guidelines are a necessary element of educating providers about SUD treatment, which is key to broadening patient access and eliminating the stigma associated with this devastating disease.  The guidelines were last updated in 2001 and, since their initial release, new medications for the treatment of alcohol dependence have been approved by the FDA.  Nevertheless, in the absence of updated guidelines, our veterans appear to have enormous difficulty accessing these newer agents.[25], [26]

The VA has outlined a performance measure to assess its success in continuity of care for veterans in treatment for SUD; however, by the VA’s own admission, “Many VA SUD programs have found it difficult to meet the Office of Quality and Performance’s Continuity of Care performance measure. The measure requires that patients entering a new episode of specialty SUD treatment receive at least two VA substance abuse clinic visits for each of three successive 30-day periods after qualifying as a new patient.”[27]  VIVITROL is a powerful tool that could improve continuity of care for veterans being treated for SUD and bring VA closer to meeting this performance measure.

Many people outside of the VA have had access to VIVITROL for some time.  Beneficial results have been reported in state public treatment systems, in many other community-based treatment programs throughout the U.S., in primary care settings, in DUI and drug courts and in private commercial insurance patients.[28],[29], [30], [31], [32]  In these privately insured patients, this medicine was associated with the greatest reduction in hospitalization and emergency room visits while simultaneously increasing patients’ utilization of counseling – leading Aetna Behavioral Health to introduce disease management with the medicine before patients even leave alcohol rehabilitation programs.  Similar cost benefits were reported by a major state-wide Blue Cross Blue Shield health plan – a 49 percent reduction in hospital and pharmacy costs after VIVITROL treatment.[33]  Improved outcomes and reduced costs are significant and attainable, but the VA must make SUD treatment a priority – both in policy and in funding.

Real Patients, Real Success

I would like to share with you a story, told to me by a physician, about the success one patient realized with VIVITROL.  The patient’s name is Chris, and he is currently 26 years old.  Chris started drinking when he was in high school, on Friday nights after football games with his friends and fellow band members.  After graduating from high school, Chris enrolled as a college freshman and soon found himself drinking more and more.  Pretty soon, he started skipping classes and instead spent all his time drinking with his new friends.  Unfortunately, Chris dropped out of school before the end of his freshman year and moved back to his father’s home in Nashville, Tennessee.

Chris enrolled in a local community college, but his drinking continued to get out of control.  Every day, he would take a cooler of beer with him to school in the back of his car, drinking between classes and later showing up to work drunk.   During the summers, he would visit his mother and stepfather in Dallas, Texas, where his drinking led to arguments and a concern that he might assault his mother.  His anger and drinking led to a total of six arrests for driving under the influence (DUI) – three in Texas and three in Tennessee – and one arrest for aggravated assault.  Chris would get sober during his times in jail, and he attempted to get longer-term treatment through the Salvation Army and numerous half-way houses.  Each time he would “dust himself off” and try to stay sober, but, unfortunately, he relapsed every time.  Finally, someone he knew convinced him to try VIVITROL.

Chris was hesitant at first, but he quickly saw the benefits of the medicine.  He liked being able to see a doctor once a month to receive his injection, without having to worry about taking his medicine every day.  He was able to get into and stay in counseling.  Currently, he is back in school.  He was recently invited to his family reunion for the first time in four years, and he has re-established good relationships with both his parents.  He has a new girlfriend, is holding down a job and has remained sober for more than a year.  Chris says that VIVITROL really helped him get back on the right track, and now he can’t wait to get up and enjoy each day.  The reason this physician’s story means so much to me is because Chris is his son.

Conclusion

Alkermes and its investors took a risk in pursuing a difficult manufacturing process to produce medicines with innovative delivery systems in order to treat the unmet needs of patients with devastating diseases.  If the company’s work were assuredly profitable, companies much larger than ours would pursue the same approach.  Patients, not profits, are the driving force behind what we do.  Since 1987, Alkermes has continually focused on one goal – improving the lives of patients by developing therapies that improve outcomes.  What started as a small research company is now a company that develops and manufactures treatments for diseases that others in the industry have largely ignored.  The federal government, through NIH and NIDA, partnered with Alkermes in development of VIVITROL many years ago, but the government must remain an active partner, following through on its commitment to assist patients with accessible, affordable SUD pharmacotherapy.  Our company is focused on the devastating problem of alcohol dependence among our veterans, and we believe that the VA must be equally committed.  Meaningful clinical guidelines must be published and regularly updated to reflect emerging therapies; performance measures must be developed, communicated and enforced in order to promote accountability; and the VA must make treatment of addiction among our nation’s veterans a real priority before we lose even one more veteran to the disease.  In closing, thank you again for the opportunity to testify here today about the Alkermes story.  We believe we offer a product that can dramatically improve the lives of our nation’s veterans; they deserve no less than the very best innovative technologies and treatments available.


[1] U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, National Survey on Drug Use and Health, November 10, 2005.

[2]U.S. Department of Veterans’ Affairs, Health Services for VA Substance Use Disorder Patients - Comparison of Utilization in Fiscal Years 2005, 2004, 2003, and 2002, June 2006.

[3] U.S. Department of Veterans’ Affairs, National Center for Posttraumatic Stress Disorder, Findings from the National Vietnam Veterans’ Readjustment Study, available at http://www.ncptsd.va.gov/ncmain/ncdocs/fact_shts/fs_nvvrs.html?opm=1&rr=rr45&srt=d&echorr=true.

[4] Legal residence/home address for service members currently deployed as of December 31, 2008. (2009) Defense manpower data center.  Retrieved April 8, 2009 from: dva.state.wi.us/WebForms/Data_Factsheets/ResDistribution_Dec08.pdf

[5] Kline, A. & Falca-Dodson, M. (2007) Presentation on substance abuse and mental health problem in returning Iraqi veterans.

[6]Hoge, C., Auchterlonie, J. & Milliken, C. (2006). Military mental health problems: Use of mental health services, and attrition from military services after returning from deployment to Iraq or Afghanistan. Journal of the American Medical Association, 295(9), 1023-1032.

[7] Hoge, C.W., Castro, C.A., Messer, S.C., McGurk, D., Cotting, D.I. & Koffman, R.L. (2004). Combat duty in Iraq and Afghanistan, Mental Health Problems, and Barriers to care. New England Journal of Medicine, 351(1), 13-22.

[8] Rhem, K. (2000, June 6) Alcohol abuse costs DoD Dearly.  American Forces Press Service.  Retrieved May 7, 2009 from: http://www.defenselink.mil/news/newsarticle.aspx?id=45284

[9] Johnson, S. et al (2007) The psychological needs of U.S. military service members and their families: a preliminary report.  Retrieved May 7, 2009 from: http://www.apa.org/releases/MilitaryDeploymentTaskForceReport.pdf

[10] U.S. Department of Health and Human Services, National Institutes of Health, Helping Patients Who Drink too Much: A Clinician’s Guide, 2005.

[11] Oswald LK, Wand GS. Opioids and Alcoholism. Physiology & Behavior 2004; 81: 339-358.

[12] Vivitrol [prescribing information]. Cambridge, MA: Alkermes, Inc; 2007.

[13] Garbutt JC, Kranzler H, O’Malley S, Gastfriend D, Pettinati H, Silverman BL, et. al. Efficacy and Tolerability of Long-Acting Injectable Naltrexone for Alcohol Dependence: A Randomized Controlled Trial. Journal of the American Medical Association; 2005; 293:1617-1625

[14] Garbutt, J. et al (2005). Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial.  Journal of the American Medical Association; 293: 1617 – 1625.

[15] O'Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol 2007 Oct;27(5):507-12.

[16] Lapham S, Forman R, Alexander M, Illeperuma A, Bohn MJ. The effects of extended-release naltrexone on holiday drinking in alcohol-dependent patients. J Subst Abuse Treat 2009 Jan;36(1):1-6.

[17] Rosenbloom DL. Holidays, triggers, and willpower--is there a role for medications? A commentary on "The effects of extended-release naltrexone on holiday drinking in alcohol-dependent patients". J Subst Abuse Treat 2009 Jan;36(1):7.

[18] Other pharmacologic interventions to treat alcohol dependence include: oral naltrexone, acamprosate, and disulfuram.

[19] Harris KM, DeVries A, Dimidjian K (2004). Trends in naltrexone use among members of a large private health plan. Psychiatric Services. http://ps.psychiatryonline.org. 55(3):221

[20] Willette R, Barnett G, editors (1976). Narcotic Antagonists: The Search for Long-Acting Preparations. NIDA Res Monogr DHEW Publication No. (ADM) 76-296. http://www.drugabuse.gov/pdf/monographs/04.pdf

[21] Willette R, Barnett G, editors (1981). Narcotic antagonists: naltrexone pharmacochemistry and sustained-release preparations. NIDA Res Monogr 28:1-273. http://www.drugabuse.gov/pdf/monographs/28.pdf

[22] Alcoholism and Drug Abuse Weekly; 2007; 19(23).

[23] U.S. Department of Veterans’ Affairs, supra note 2.

[24] John Paul Allen, Ph.D., Associate Chief Consultant for Addictive Disorders, Veterans Health Administration, U.S. Department of Veterans Affairs, in testimony before the House Committee on Veterans’ Affairs Subcommittee on Health, March 11, 2008, available at http://veterans.house.gov/hearings/transcript.aspx?newsid=187.

[25] CAMPRAL® (acamprosate calcium) Delayed-Release Tablets were approved by the FDA on July 29, 2004.

[26] VIVITROL® (naltrexone for extended-release injectable suspension) was approved by the FDA on April 13, 2006.

[27]  Schaefer J et al. (2007).Program and Patient Factors that Influence Continuity of Care Performance Measure Outcomes in VA Substance Use Disorder Treatment Programs, available at http://www.chce.research.va.gov/docs/pdfs/CoC_Providers_Survey.pdf.  

[28] Colston S. Florida Advancing Recovery Project Implementing Medication Assisted Treatment using Vivitrol: November 2006 – October 2008 Preliminary Results. Available from: Florida Substance Abuse Program Office, Stephenie_Colston@dcf.state.fl.us.

[29] Abraham AJ, Roman PM. Early Adoption and Implementation of Vivitrol. Addiction Health Services Research Annual Conference, Boston MA, Oct 21, 2008

[30] Un H. Medication Assisted Treatment for Alcohol Use Disorder. SAMHSA/CSAT Invitational Conference on Economic Access to Treatment, Washington DC, Nov 3 2008

[31] Lee JD, Grossman E, DiRocco D, Truncalil A, Rotrosen J, Hanley K, Stevens D, Gourevitch MN. Extended-release Naltrexone Injectable Suspension for Treatment of Alcohol Dependence in Urban Primary Care - A Feasibility Study: Preliminary Analysis. Addiction Health Services Research Annual Conference, Boston MA, Oct 21, 2008

[32] Hon J Kandrevas, Hon D Gruenburg. Testimony on Use of Medication in Selected Michigan DUI Courts to State of Michigan House Subcommittee on Corrections, March 6, 2008.

[33] Borawala AS, Gill P, Jan S. Utilization Patters of Vivitrolâ (naltrexone for extended-release injectable suspension) for Alcohol Dependence.  Horizon Blue Cross Blue Shield of New Jersey, Newark NJ and Rutgers U.  Poster presented at Academy of Managed Care Pharmacy 21st Annual Meeting, April 17, 2009, Orlando FL.