new treatments for addiction: behavioral, ethical, legal, and social questions
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New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions. Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction Henrick J. Harwood and Tracy G. Myers, editors. Committee Charge. - PowerPoint PPT PresentationTRANSCRIPT
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New Treatments for Addiction:Behavioral, Ethical, Legal, and Social Questions
Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction
Henrick J. Harwood and Tracy G. Myers, editors
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Committee Charge
• Advise NIDA about behavioral, ethical, legal, and social issues concerning potential uses of immunotherapies and sustained-release formulations.
• Asked for consensus about potential issues.
• Decide which issues are the most pressing.
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Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction
• HENRICK J. HARWOOD (Chair), The Lewin Group
• ALEXANDER M. CAPRON, Pacific Center for Health Policy and Ethics, Univ. of Southern California
• JONATHAN P. CAULKINS, Heinz School of Public Policy and Management, Carnegie Mellon Univ.
• JAMES W. CORNISH, Philadelphia Department of Veterans Affairs Medical Center and Univ. of Pennsylvania Department of Psychiatry
• LEWIS E. GALLANT, National Association of State Alcohol and Drug Abuse Directors, Inc.,
• SHIRLEY Y. HILL, Univ. of Pittsburgh School of Medicine
• MARTIN Y. IGUCHI, Drug Policy Research Center, RAND Corporation
• THOMAS R. KOSTEN, Yale Univ. Medical School
• JOSEPH O. MERRILL, Harborview Medical Center and Univ. of Washington
• S. MICHAEL OWENS, Univ. of Arkansas for Medical Sciences
• CHARLES R. SCHUSTER, Department of Psychiatry and Behavioral Neurosciences, Wayne State Univ.
• ZILI SLOBODA, Institute for Health and Social Policy, Univ. of Akron
• KATHRYN E. STEIN, Macrogenics, Inc., • ELLEN M. WEBER, Univ. of Maryland
School of Law• TRACY G. MYERS, Study Director• WENDY KEENAN, Senior Project
Assistant
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Commissioned Paper Authors and Topics
• Paul Pentel, Science Issues
• Thomas Kosten and Henry Kranzler, Clinical Trials
• George Woody, Lessons Learned
• Cindy Parks Thomas and Dennis McCarty, Integration with Current Treatment Systems
• M. Susan Ridgeley, Martin Iguchi, and James Chiesa, Legality of Mandated Treatment
• Thomas Murray, Ethics and Consent
• Mark Kleiman, Costs and Benefits
• Robert MacCoun, Behavioral Responses
• Frances Miller and Kaley Klanica, Treatment of Minors
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Major Themes and Issues
• Great need for medications and great promise
• Risk of over-promising, not a “magic bullet”
• Risk from unintended behavioral reactions
• Special problems consent/coercion
• Risks of off-label use
• Some health care systems not ready for these therapies
• Need for new standards of treatment success
• What NIDA can do . . . and the private sector is unlikely to do: 10 primary recommendations
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Medical Basis of Medications
• Active Immunization– No immediate response (first response delayed for 3-6 weeks)– Requires booster shots every 1-6 months– Timing and duration of effects requires coordination with
behavioral and other interventions– Not expensive
• Passive Immunization (monoclonal antibodies)– Pre-formed antibodies are administered– Dosing ever 3-6 weeks– Immediate and more predictable effects than active immunization– Currently expensive
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Medical Basis of Medications(continued)
• Depot Formulations
– Long-acting (up to 1 month) formulations of current medications to enhance adherence.
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Medical Basis Conclusions
• Potential Uses of Immunotherapies
– Overdose treatment (with monoclonal antibodies)
– Relapse prevention
– Protection against drug use or in vulnerable populations (e.g., fetus)
• Depot medications for relapse prevention
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Medical Basis Recommendation
• Recommendation 1
– Support basic immunology studies for increasing the stability and longevity of antibody blood levels for sustained effects.
– Develop combination therapies to simultaneously treat a variety of abused drugs.
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Clinical Trials Considerations
• FDA Clinical Trials Process
– Phase I-IV considerations
– FDA will likely specify the populations and indications. Examples: • Overdose is a different indication that relapse• No medications during pregnancy until proven safe
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Clinical Trials Recommendations
• Recommendation 2
– Since immunotherapy and sustained-release medications will likely be used in off-label situations NIDA should support • Preclinical studies addressing the potential safety and
efficacy of these medications in vulnerable populations (e.g., pregnant women, fetus, adolescents, etc.).
• Long-term studies with laboratory animals of different ages, as well as their offspring, before undertaking trials with vulnerable human populations.
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Clinical Trial Recommendations (Continued)
• Recommendation 3
– NIDA should support studies of the likely extent and nature of off-label medication use
• Including factors and incentives that would promote or retard such use.
• Point out policy options for policy makers to intervene if the patterns of off-label use depart from what is in the best interest of the society.
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Treatment and Financing Issues
• Opportunity to substantially expand treatment.
• Potential to change social views of addiction.
• Challenges for current system.
– Organization– Philosophy– Costs– Privacy– Discrimination
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Lessons Learned from Previous Pharmacotherapies
• There are lessons to be learned from patient populations being treated for
– Opioids: stigma, NIMBY, patient acceptance, cost
– Alcohol: ideology, system capability, cost, effectiveness . . .
– Nicotine: good patient/clinician acceptance, more effective w psychosocial services, marketing
• These lessons are both positive and negative.
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Treatment and Financing Recommendations
• Recommendation 4
– NIDA should support studies of potential for patient discrimination due to
– Long-lasting markers in the blood or urine.– If these markers deters people with drug dependence from
accepting immunotherapies. – False-positive and/or false-negative drug testing.
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Cost Issues
• Cost: how much do different formulations and modes of delivery cost?
• Sensitivity to effectiveness: partial effectiveness may result in different client responses (decreases or even increases in use)
• Cost-effectiveness: need to compare these therapies to general health using CEA or CBA
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Treatment and Financing Recommendations (continued)
• Recommendation 5
–NIDA should support clinical effectiveness studies and financing models that integrate the new pharmacotherapies with psychosocial services in specialty and primary medical care settings.
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Behavioral Responses
Possible unintended consequences– Users attempt to overwhelm a partially effective treatment
(like low dose methadone)
– Drug substitution: e.g., cocaine to METH
– Risk calculations: risk reduction may increase the behavior
– Drug seller behavior: if use of drugs declines sellers might “compete” for market share by price or force
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Behavioral Response Recommendations
• Recommendation 6
– NIDA should support studies of behavioral consequences such as• Potential for accidental overdose.• Changes in drug use patterns include switching drugs,
increasing drug dosage or overall consumption. • Changing the route of administration (e.g. nasal to
intravenous for greater bioavailability)
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Behavioral Response Recommendations (continued)
• Recommendation 7
– NIDA should support studies that• Examine the extent to which the availability of
immunotherapy medications might reduce the perceived risk of drug use.
• The effects of such perceptions on drug use behavior in various populations.
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Behavioral Response Recommendations (Continued)
• Recommendation 8
– NIDA should support studies of the potential effect of immunotherapy medications on illicit drug markets and market-related behaviors.
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Consent and Coerced Treatment
• Vulnerable populations at risk
– Frequently excluded from clinical trials
– Responses to medications unknown
– Can be pressured to take medications based on inherently coercive setting or circumstances
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Consent and Coerced Treatment, Continued
• Right to determine care
– Legal issues
– Ethical considerations
• Parents may ask to give medication to minor children
• Legal mandates for treatment for competent adults
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Consent Recommendations
• Recommendation 9
– NIDA should support studies to clarify procedures and standards to be applied when immunotherapy medications are considered for use in the criminal justice and child welfare systems.
– This includes due process protections when there is a government-imposed treatment requirement.
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Consent Recommendations (Continued)
• Recommendation 10
– NIDA should support studies to carefully articulate the behavioral, ethical, and social risks associated with treatment of pregnant women and their fetuses and protective therapy in minors.
– Develop clinical practice guidelines for such use or discouragement of such use.
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Major Themes and Issues
• Great need for medications and great promise
• Risk of over-promising, not a “magic bullet”
• Risk from unintended behavioral reactions
• Special problems consent/coercion
• Risks of off-label use
• Some health care systems not ready for these therapies
• Need for new standards of treatment success
• What NIDA can do . . . 10 primary recommendations