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Legal and Ethical Issues in Heroin Diagnosis, Treatment, and Research

2007; Taylor & Francis; Volume: 28; Issue: 2 Linguagem: Inglês

10.1080/01947640701357730

1521-057X

Sana Loue, Beatrice Gabriela Ioan,

Opioid Use Disorder Treatment

Click to increase image sizeClick to decrease image size Dr. Loue holds secondary appointments in the Departments of Bioethics, Psychiatry, and Global Health. She was the 2003 Dr. Arthur Grayson Distinguished Visiting Professor of Law and Medicine at Southern Illinois University School of Law. Dr. Ioan holds a medical degree and license and a doctoral degree from Romania and an M.A. in Bioethics. Much of her empirical research focuses on substance use. Dr. Ioan has written extensively on substance use and ethical issues in the research and clinical contexts Notes 1. National Institute on Drug Abuse, Pub. No. 05-4165, Research Report Series: Heroin Abuse and Addiction 1-2 (2005). 2. United States Department of Health and Human Services, Summary of Findings from the 1999 National Household Survey on Drug Abuse 31 (2000). 3. Humberto Fernandez, Heroin 37 (1998). 4. Jeff Stryker, IV Drug Use and AIDS: Public Policy and Dirty Needles, 14 J. Health Pol. Pol'y & L. 719 (1989) (defining "mainlining" as an injection into the vein). 5. Fernandez, supra note 3, at 53. 6. Oakley S. Ray & Charles Ksir, Drugs, Society and Human Behavior (1990). 7. Id. This practice of subcutaneous injection is known as "skin popping." 8. H. Thomas Milhorn, Jr., Chemical Dependence: Diagnosis, Treatment, and Prevention 168-71 (1990). 9. Lester Grinspoon & James Bakalar, Cocaine: A Drug and Its Social Evolution 177 (1985). 10. American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) 197 (2000) [hereinafter DSM-IV]. In the past, the term "dependence" was used interchangeably with the term "addiction," defined as a "chronically relapsing [disorder] characterized by compulsive drug taking, an inability to limit the intake of drugs, and the emergence of a withdrawal syndrome during cessation of drug taking (dependence)." George F. Koob et al., Neuroscience of Addiction, 21 Neuron 467 (1998). For other definitions of drug abuse used within the scientific, regulatory, and enforcement spheres, see James Zacny et al., College on Problems of Drug Dependence Taskforce on Prescription Opioid Non-Medical Use and Abuse: Position Statement, 69 Drug & Alcohol Depend. 215, 217 (2003). This lack of consensus regarding the nature of dependence hinders both research and treatment. 11. Tolerance is characterized by a need for increased amounts of the substance to achieve either intoxication or desired effect or by a diminished effect of the substance with the use of the same amount. DSM-IV, supra note 10, at 197-98. 12. Withdrawal is manifested by a set of symptoms resulting from the cessation of, or a reduction in the use of, a particular substance or by the use of the same or a closely related substance to avoid these symptoms. Id at 201-09. 13. Id. at 197-98. 14. Id. at 198. 15. See Solomon H. Snyder, Drugs and the Brain 164-66 (1996). 16. Milhorn, supra note 8, at 172. 17. DSM-IV, supra note 10, at 199. 18. Id. 19. Id. at 456-63. 20. Id. at 460. For a discussion of the similarities in mechanism between compulsive behavior and substance dependence, see David E. Comings et al., A Study of Dopamine D 2 Receptor Gene in Pathological Gambling, 6 Pharmacogenetics 223 (1996); David E. Comings, The Molecular Genetics of Pathological Gambling, 3 CNS Spectrums 20 (1998). 21. Adrian Furnham & L. Thomson, Lay Theories of Heroin Addiction, 43 Soc. Sci. & Med. 29, 30 (1996). There are also integrated theories and models of drug abuse that attempt in various ways to address the multifactorial nature of substance use and abuse and incorporate elements of one or more of these more basic models. Examples include: the biopsychosocial model that integrates biological, psychological, and social processes; the triadic influence theory, which encompasses interpersonal, intrapersonal, and attitudinal/cultural domains; and the hedonic treadmill model, which posits that drug use represents a pursuit of pleasure that has gone awry. For additional discussion of these integrated theories and models, see generally Steve Sussman & Susan L. Ames, The Social Psychology of Drug Abuse 78-88 (2001). A study of lay perceptions of the causes of heroin addiction found that, in general, respondents attributed the addiction to psychological and social pressures rather than biological or genetic factors or moral shortcomings. Additionally, study responders indicated a preference for treatments that utilize counseling and social support rather than isolation in drug-free communities. Furnham & Thomson, supra note 21, at 38. 22. Institute of Medicine, Dispelling the Myths About Addiction: Strategies to Increase Understanding and Strengthen Research 37 (2001). 23. Id. 24. Jack R. Cooper et al., Cellular Foundation of Neuropharmacology, in The Biochemical Basis of Neuropharmacology 9 (Jack R. Cooper et al. eds., 8th ed. 2002). 25. Id. 26. Gaetano Di Chiara & Assunto Imperato, Drugs Abused by Humans Preferentially Increase Synaptic Dopamine Concentrations in the Mesolimbic System of Freely Moving Rats, 85 Proc. Nat'l Acad. Sci. U.S.A. 5274 (1988). 27. Charles P. O'Brien, Drug Addiction and Drug Abuse, in Goodman and Gilman's The Pharmacological Basis of Therapeutics 557 (Joel G. Hardman & Lee Limbird eds., 1996); see also Robert Mathias, Rate and Duration of Drug Activity Play Major Roles in Drug Abuse, Addiction, and Treatment, 12 Nat'l Inst. Drug Abuse Res. Findings 23 (1997), available at http://www.streetdrugs.org/pdf/NNHeroin.pdf. 28. O'Brien, supra note 27, at 557. 29. Institute of Medicine, supra note 22, at 46. 30. O'Brien, supra note 27, at 557. 31. Paul Gendreau & L.P. Gendreau, The "Addiction-Prone" Personality: A Study of Canadian Heroin Addicts, 2 Can. J. Behav. Sci. 18 (1970). 32. Rebecca Schilit, Drugs and Behavior: A Sourcebook for the Human Services (1991). 33. Patrick Zickler, Nicotine Craving and Heavy Smoking May Contribute to Increased Use of Cocaine and Heroin, 15 Nat'l Inst. Drug Abuse Res. Findings 1 (2000). 34. Lee N. Robins & Sergey Slobodyan, Post-Vietnam Heroin Use and Injection by Returning U.S. Veterans: Clues to Preventing Injection Today, 98 Addiction 1027 (2003). 35. Joan Moore, The Chola Life Course: Chicana Heroin Users and the Barrio Gang, 29 Int'l J. Addict. 1115 (1994); Kathleen R. Marikangas et al., Familial Factors in Vulnerability to Substance Abuse, in Vulnerability to Drug Abuse 75 (Meyer D. Glantz & Roy W. Pickens eds., 1996). 36. J. David Hawkins et al., Risk and Protective Factors for Alcohol and Other Drug Problems in Adolescence and Early Adulthood: Implications for Substance Abuse Prevention, 112 Psychol. Bull. 64 (1992); Charles E. Dodgen & W. Michael Shea, Substance Use Disorders: Assessment and Treatment 85 (2000). 37. See Howard B. Kaplan & Robert J. Johnson, Relationships Between Initial Illicit Drug Use and Escalation of Drug Use: Moderating Effects of Gender and Early Adolescent Experiences, in Vulnerability to Drug Abuse, supra note 35, at 299. 38. Lisa Kaplan, Working with Multiproblem Families (1986). 39. Patricia Cohen et al., Common and Uncommon Pathways to Adolescent Psychopathology and Problem Behavior, in Straight and Devious Pathways from Childhood to Adulthood (Lee N. Robins & Michael Rutter eds., 1990). 40. Terry E. Dielman et al., Health Locus of Control and Self-Esteem as Related to Adolescent Health Behavior and Intentions, 19 Adolescence 935 (1984); Richard Jessor & S.L. Jessor, Problem Behavior and Psychosocial Development: A Longitudinal Study of Youth (1997). 41. Robert E. Booth & Yiming Zhang, Conduct Disorder and HIV Risk Behaviors Among Runaway and Homeless Adolescents, 48 Drug Alcohol Depend. 69 (1997). 42. Fernandez, supra note 3, at 53. 43. William S. Cartwright, Cost of Drug Abuse to Society, 2 J. Mental Health Pol'y & Econ. 133, 134 (1999), available at http://www.icmpe.org/test1/journal/issues/v2pdf/2-133__text.pdf; Larry Gostin, The Interconnected Epidemics of Drug Dependency and AIDS, 26 Harv. C.R.-C.L. L. Rev. 113, 115 (1991). The probability of infection as the result of each injection with a shared, contaminated needle has been estimated at .0067, based on data from the New Haven, Connecticut legal needle/syringe exchange program. Edward H. Kaplan & Robert Heimer, A Model-Based Estimate of HIV Infectivity Via Needle Sharing, 5 J. Acquired Immune Deficiency Syndromes 1116 (1992); Edward H. Kaplan & Robert Heimer, HIV Prevalence Among Intravenous Drug Users: Model-Based Estimates from New Haven's Legal Needle Exchange, 5 J. Acquired Immune Deficiency Syndromes 163 (1992). 44. Harvey W. Feldman & Patrick Biernacki, The Ethnography of Sharing Needles Among Intravenous Drug Users and Implications for Public Policies and Intervention Strategies, in Needle Sharing Among Intravenous Drug Users: National and International Perspectives 28 (Nat'l Inst. on Drug Abuse Research Monograph Series, 1988). 45. National Institute on Drug Abuse, Series 1, No. 11-B, 1992, Annual Medical Examiner Data 1991: Data from the Drug Abuse Warning Network (DAWN) (1991). In some jurisdictions, the number of deceased persons who have tested positive for heroin use has increased markedly in recent years. See Nancy E. Walker et al., Drug Policies in the State of Michigan: Economic Effects 15 (Apr. 2003). 46. Michael T. French & Robert F. Martin, The Cost of Drug Abuse Consequences: A Summary of Research Findings, 13 J. Substance Abuse Treatment 453, 459 (1996). 47. Id. at 455-58. 48. Benedikt Fischer et al., Illicit Opiates and Crime: Results of an Untreated User Cohort Study in Toronto, 43 Can. J. Criminology & Criminal Justice 197, 201 (2001); United States Department of Health and Human Services, Drug Abuse and Drug Abuse Research: Third Triennial Report to Congress (1991). 49. Fernandez, supra note 3, at 16. 50. Id. at 20 (citing Ben Attias, History of Opium 2, available at The number of individuals addicted to opiates increased even more with the inadvertent addition of Civil War soldiers who became addicted to the morphine used to soothe the pain from their war wounds.Footnote 52 http://www.csun.edu/∼hfspc002/xxx.html). 51. Id. at 17. 52. Fernandez, supra note 3, at 20. 53. Attias, supra note 51, at 1. 54. Julian Durlacher, Heroin: Its History and Lore 8 (2000). 55. Id. at 9; Fernandez, supra note 3, at 19, 25. 56. David F. Musto, The American Disease: Origins of Narcotic Control 3 (3d ed. 1999). Prior to this time, it was not uncommon for private physicians to treat their opiate-addicted patients by prescribing narcotics. Nat'l Inst. of Health, Consensus Development Statement: Effective Medical Treatment of Heroin Addiction (1997), available at http://consensus.nih.gov/1997/1998TreatOpiateAddiction108html.htm. 57. 38 Stat. 785, ch. 1, Comp. Stat. 1916, 6287h. 58. An editorial in American Medicine harshly condemned this new law: Narcotic drug addiction is one of the gravest and most important questions confronting the medical profession today. Instead of improving conditions, the laws recently passed have made the problem more complex. Honest medical men have found such handicaps and dangers to themselves and their reputations in these laws … that they have simply decided to have as little to do as possible with drug addicts or their needs. … The druggists are in the same position and for similar reasons many of them have discontinued entirely the sale of narcotic drugs. [The addict] is denied the medical care he urgently needs. … See Durlacher, supra note 54, at 16. 59. Alfred W. McCoy, The Politics of Heroin: CIA Complicity in the Global Drug Trade 18 (1991). 60. Fernandez, supra note 3, at 37. 61. Durlacher, supra note 54, at 30-35 & 42-44. 62. McCoy, supra note 59, at 18. 63. Fernandez, supra note 3, at 37. The purity of heroin has increased during the last decade, facilitating use by smoking and snorting it. Drug Enforcement Administration & The National Guard, Drugs of Abuse 13 (1997). It has been estimated that the prevalence of heroin ingestion by smoking or snorting increased from 55% in 1994 to 71% in 1997. Office of Nat'l Drug Control Policy, Pulse Check: National Trends in Drug Abuse 30 (Summer 1998). 64. Vernon E. Johnson, I'll Quit Tomorrow: A Practical Guide to Alcoholism Treatment (rev. ed. 1990). 65. Id. 66. Terence T. Gorski & Merlene Miller, The Phases and Warning Signs of Relapse (1993). 67. Id. 68. James O. Prochaska & C.C. DiClemente, Stages and Processes of Self-Change of Smoking: Toward an Integrative Model of Change, 51 J. Consult. Clin. Psychol. 390 (1983) (discussing the transtheoretical model). Other models of motivation include the direction-energy model and the self-regulation model. See generally Sussman & Ames, supra note 21, at 111-12. 69. G. Alan Marlatt, Harm Reduction: Come As You Are, 21 Addict. Behav. 779, 785 (1996). 70. Id. For a more in-depth review of the moral model and the basis for this perspective in Christian theology, see Bill Bush & Max Neutze, In Search of What Is Right: The Moral Dimensions of the Drug Debate (2000), available at http://www.ffdlr.org.au/ethics/InSearchOfRight.htm. 71. Sussman and Ames have asserted that the disease model of addiction is open to dispute because neither the drug use nor its resulting behaviors indicate the processes that underlie the use and behaviors, drug use falls along a continuum rather than simply being present or absent as is the case with many diseases, the wide variation in behavioral symptoms of drug abuse may reflect different underlying processes, and specific etiologic factors for substance abuse have not been identified. Sussman & Ames, supra note 21, at 22. Twelve-step programs, such as Narcotics Anonymous, also view addiction as a disease, but one that is spiritual in nature, as well as physical, mental, and emotional. Alcoholics Anonymous, Alcoholics Anonymous (1976). These programs are premised on the belief that individuals must turn to a higher power to assist in their recovery. The mutual support of members is deemed essential to recovery and the avoidance of relapse. These interventions are not addressed in this article because they are outside the scope of patient care. Also, because of their emphasis on anonymity, they are often outside of the reach of formal research undertaken to evaluate efficacy and effectiveness. Although reliance on such programs consequently may not raise legal and ethical issues in the context of treatment from a health care provider or the conduct of research, the lack of data relating to their efficacy and effectiveness should raise ethical issues for judges, who often order participation in such programs. 72. Marlatt, supra note 69. 73. Institute of Medicine, supra note 22, at 83. Other modalities include therapeutic communities and outpatient drug-free communities. Id. Buprenorphine has been touted as a desirable alternative to methadone because it has weaker opiate effects. However, as of March 2004, only 3,951 physicians in the United States were eligible to prescribe buprenorphine to more than the 900,000 existing chronic heroin users. National Institute on Drug Abuse, supra note 1, at 6. Other pharmacological interventions include clonidine, lofexidine, naloxone, and naltrexone. Id. A broader range of pharmacological interventions may be available in other locales, such as the United Kingdom. Harold John Melville & P.C. McLean, Acceptability and Availability of Pharmacological Interventions for Substance Misuse by British NHS Treatment Services, 97 Addiction 59 (2002); see Nicky Metrebian et al., Survey of Doctors Prescribing Diamorphine (Heroin) to Opiate-Dependent Drug Users in the United Kingdom, 97 Addiction 1155 (2002) (finding a large proportion of physicians licensed to dispense heroin refrain from doing so). 74. Grinspoon & Bakalar, supra note 9, at 243. 75. Alan I. Leshner, Addiction Is a Brain Disease, and It Matters, 287 Science 45 (1997). 76. Grinspoon & Bakalar, supra note 9, at 244. 77. Marlatt, supra note 69, at 785. 78. Id. 79. G. Alan Marlatt, Basic Principles and Strategies of Harm Reduction, in Harm Reduction: Pragmatic Strategies for Managing High-Risk Behaviors 49, 51 (G. Alan Marlatt ed., 1998). 80. School of Public Heath, University of California Berkeley & Institute for Health Policy Studies, University of California-San Francisco, The Public Health Impact of Needle Exchange Programs in the United States and Abroad: Summary, Conclusions and Recommendations (Oct. 1993). The federal government continues to oppose the establishment of needle exchange programs and the use of federal funding to support such programs, despite scientific evidence documenting the benefits of such programs to the addicts, their families, and the larger community and, in most cases, the absence of any discernible negative impact. One research team commented on this position: The Secretary of Health & Human Services announced two things: (1) needle exchange works; (2) the government will not fund it or support it in any concrete way. Let us be clear here—such cases do not mean that governments are "in denial." They often understand the issue perfectly well—that is, they know that harm reduction saves the lives of drug users. They willfully and wittingly choose to let users die, and to repress them even more strongly, as a not-necessarily-fully-thought-out aspect of a much more general policy of divide-and-rule and of austerity and obedience in behalf of competitive efficiency. Samuel R. Friedman et al., Harm Reduction—A Historical View from the Left, 12 Int'l J. Drug Pol'y 3, 8 (2001). 81. Benedikt Fischer et al., Heroin-Assisted Treatment as a Response to the Public Health Problem of Opiate Dependence, 12 Eur. J. Pub. Health 228 (2002); Ingo Ilja Michels, Heroin-Based Treatment, J. Drug Issues 523 (Spring 2002). The irony here is worth noting. In the United States, methadone is portrayed as an opioid agonist, meaning it will mimic the action of a natural neurotransmitter to produce a biological response and, as a result, its use is incompatible with the use of heroin. In the Swiss trial of prescription heroin, however, it was found that many heroin-dependent persons preferred to combine the prescription heroin with methadone. Ambros Uchtentagen, in Essais de Prescripton Medicale de Stupefiants [Essays on the Medical Prescription of Narcotics] 162 (1997). 82. Eric C. Strain & Kenneth B. Stoller, Introduction and Historical Overview, in Methadone Treatment for Opioid Dependence 1 (Eric C. Strain & Maxine L. Stitzer eds., 1999). 83. Id. at 10. One must question the extent to which urine testing and contingency contracting represent forms of therapy, rather than enforcement. This has been described as the medical model of methadone treatment, which some allege is "particularly necessary in the USA politically, where the concept of a substitute drug would fit uneasily with the strong emphasis on enforcement." Nicholas Seivewright, Community Treatment of Drug Misuse: More than Methadone 23 (2000). The medical model of methadone is premised on the theory that methadone acts to correct a metabolic imbalance resulting from opiate dependence, it reduces the craving for the drug and blocks the effects of opiates, a high dose is required for an indefinite period of time, and improvements in health and well-being are directly and primarily attributable to the effects of the methadone. Id. at 22. In contrast, the substitution model of methadone treatment, which is favored in the United Kingdom, conceives of methadone as providing a "reasonably satisfying drug effect" that lessens the need to take other drugs. A minimum comfortable dose is prescribed, with the expectation that the individual will be able to withdraw from it over time. Improvements in health and well-being are attributed to cessation of street use and life on the street and only secondarily to the effects of methadone. Id. Methadone maintenance treatment progresses in three stages: dose induction, or the initiation of methadone treatment; dose stabilization or maintenance, during which the individual receives a stable dosage of methadone; and dose withdrawal, also known as detoxification, during which the dosage is gradually reduced and administration of the drug is ultimately discontinued. Eric C. Strain, Beginning and Ending Methadone Dosing: Induction and Withdrawal, in Methadone Treatment for Opioid Dependence, supra note 82, at 53. 84. Philippe Bourgois, Disciplining Addictions: The Bio-Politics of Methadone and Heroin in the United States, 24 Cult., Med. Psychiatry 165, 183 (2000). 85. Id.; T. D'Aunno & T. Vaughn, Variations in Methadone Treatment Practices: Results from a National Study, 267 J.A.M.A. 253 (1992). 86. Sharon L. Walsh & Eric C. Strain, The Pharmacology of Methadone, in Methadone Treatment for Opioid Dependence, supra note 82, at 38. 87. Maxine L. Stitzer & Mary Ann Chutuape, Other Substance Use Disorders in Methadone Treatment: Prevalence, Consequences, Detection, and Management, in Methadone Treatment for Opioid Dependence, supra note 82, at 86. 88. Bourgois, supra note 84, at 184. 89. See Beny J. Primm, Banquet Keynote Address, in Alcohol & Drug Addiction Services Board of Cuyahoga County, Heroin and Other Opioid Treatment: Best Practices and Futuristic Models for the New Millennium: Conference Proceedings 27, 29 (Oct. 1999). As an example, there are only eight methadone treatment centers in the entire state of Ohio and these are concentrated in six cities. Id. As of December 1993, there were only 759 methadone maintenance programs in the entire country, which together could handle approximately 115,000 patients. Institute of Medicine, Federal Regulation of Methadone Treatment 77 (1995). 90. Bourgois, supra note 84, at 174. 91. Kenneth B. Stoller & George E. Bigelow, Regulatory, Cost, and Policy Issues, in Methadone Treatment for Opioid Dependence, supra note 82, at 15. The average annual cost of continuous methadone maintenance treatment per client, adjusted to 1994 dollars, is approximately $4,722; the average cost per treatment episode per client for methadone maintenance treatment is approximately $6,742. French & Martin, supra note 46, at 458. 92. Alex Wodak, Methadone and Heroin Prescription: Babies and Bath Water, 37 Substance Use Misuse 523, 524 (2002). 93. See Peter R. Jones, The Risk of Recidivism: Evaluating the Public Safety Implications of a Community Corrections Program, 19 J. Crime & Justice 49 (1991); Nancy Marion, Community Corrections in Ohio: Cost Savings and Program Effectiveness (Justice Pol'y Inst. 2002); C. Pete Rydell & Susan S. Everingham, Controlling Cocaine: Supply Versus Demand Programs (1994); Joan Petersilia et al., Granting Felons Probation: Public Risks and Alternatives (1985). 94. One substance use professional flatly stated: "Methadone is an opiate antagonist. Naltrexone and Buprenorphine are opiate agonists and antagonists. I want to repeat loud and clear: All treatment modalities are effective and they can be used alone or mixed in combination at different times and stages." Primm, supra note 89, at 29. Unfortunately, it appears that non-pharmacological strategies and prescription heroin were not encompassed in this remark, despite the evidence suggesting effectiveness in reducing harm. 95. Bourgois, supra note 84, at 174. 96. Needle Exchange Programs, supra note 80, at 11-12. 97. Rebecca Ferrini, American College of Preventive Medicine Public Policy on Needle-Exchange Programs to Reduce Drug-Associated Morbidity and Mortality, 18 Am. J. Preventive Med. 173 (2000). 98. Scott Burris et al., The Legal Strategies Used in Operating Syringe Exchange Programs in the United States, 86 Am. J. Pub. Health 1161 (1996). 99. Ferrini, supra note 97, at 173. 100. Meg C. Doherty et al., The Effect of a Needle-Exchange Program on Numbers of Discarded Needles: A 2-Year Follow-Up, 90 Am. J. Pub. Health 936 (2000); Joseph Guydish et al., Evaluating Needle Exchange: Do Distributed Needles Come Back?, 81 Am. J. Pub. Health 617 (1991). 101. Joseph Guydish et al., Evaluating Needle Exchange: Are There Negative Effects?, 7 AIDS 871 (1993). 102. Richard H. Schwartz, Syringe and Needle Exchange Programs: Part I, 86 Southern Med. J. 318 (1993). 103. Holly Hagan et al., Reduced Risk of Hepatitis B and Hepatitis C Among Injection Drug Users in the Tacoma Syringe Exchange Program, 85 Am. J. Pub. Health 1531 (1995); Don C. Des Jarlais et al., Continuity and Change Within an HIV Epidemic: Injecting Drug Users in New York City, 1984 Through 1992, 271 J.A.M.A. 121 (1994). 104. Miranda W. Langendam et al., The Impact of Harm-Reduction-Based Methadone Treatment on Mortality Among Heroin Users, 91 Am. J. Pub. Health 774 (2001). 105. Cornelia Brehmer & Peter X. Iten, Medical Prescription of Heroin to Heroin Addicts in Switzerland—A Review, 121 Forensic Sci. Int'l 23 (2001); World Health Organization, Models of Medication Supported Treatment for Opioid Addicts: Report (2002). 106. Richard Hartnoll, Heroin Maintenance and AIDS Prevention: Going the Whole Way?, 4 Int'l J. Drug Pol'y 36 (1993). 107. Swiss Federal Office of Public Health, Treatment with Prescription Heroin: Arguments Concerning the Popular Vote on the Urgent Federal Ordinance on the Medical Prescription of Heroin (Treatment with Medically Prescribed Heroin) (1999). 108. Jurgen Rehm et al., Feasibility, Safety, and Efficacy of Injectable Heroin Prescription for Refractory Opioid Addicts: A Follow-Up Study, 358 Lancet 1417 (2001); Wim van den Brink, Results of the Dutch Trial (Amsterdam, The Netherlands), in Models of Medication Supported Treatment, supra note 105, at 11-12. 109. Rehm, supra note 108; Chris McCusker & Mark Davies, Prescribing Drug of Choice to Illicit Heroin Users: The Experience of a U.K. Community Drug Team, 13 J. Substance Abuse Treatment 521 (1996). 110. Rehm, supra note 108; Thomas Steffen et al., HIV and Hepatitis Virus Infections Among Injecting Drug Users in a Medically Controlled Heroin Prescription Programme, 11 Eur. J. Pub. Health 425 (2001). 111. Steffen, supra note 110. 112. Martin Killias et al., Effects of Heroin Prescription on Police Contacts Among Drug Addicts, 6 Eur. J. Crim. Pol'y & Research 433 (1998). 113. Dieter Ladewig et al., New Aspects in the Treatment of Heroin Dependence with Special Reference to Neurobiological Aspects, 17 Eur. Psychiatry 163 (2002). 114. This ethical requirement derives from several documents, including the Nuremberg Code, the Helsinki Declarations, and various documents promulgated by the Council for International Organizations of Medical Sciences. Affirmation of the Principles of International Law Recognized by the Charter of the Nürnberg Tribunal U.N. Doc. A/236, G.A. Res. 95(I), U.N. GAOR, 1st Sess., pt. 2, at 1144 (1946); World Medical Association, Nuremberg Code, 19 L. Med. & Health Care 266 (1991); World Medical Association, Declaration of Helsinki, 19 L. Med. & Health Care 264 (1991); Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002), available at http://www.fhi.org/training/fr/RETC/pdf files/cioms.pdf; see generally Michael A. Grodin, Historical Origins of the Nuremberg Code, in The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation 121 (George J. Annas & Michael A. Grodin eds., 1992); Thomas L. Beauchamp & James F. Childress, Principles of Biomedical Ethics 142 (1994). 115. Federal regulations provide that "no investigator may involve a human being as a subject in research … unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative." 45 C.F.R. § 46.116 (2006). 116. Ruth Faden et al., A History and Theory of Informed Consent (1986); Alan Meisel et al., Toward a Model of the Legal Doctrine of Informed Consent, 134 Am. J. Psychiatry 285, 286 (1977). Informed consent is a process that continues from the time of recruitment and enrollment throughout the course of the study, contrary to perceptions that it involves only the execution of a form. 117. Nuremberg Code, supra note 114. 118. In some circumstances, the confidentiality afforded to the data collected may be heightened if the investigator is able to obtain a Certificate of Confidentiality from the National Institutes of Health. The application process is described at http://grants2.nih.gov/grants/policy/coc/. Although one trial court found that this mechanism protected research data from discovery, People v. Newman, 298 N.E.2d 651 (N.Y 1973), it is unclear to what extent appellate courts would uphold the protection of research data from local law enforcement efforts on the basis of this federal mechanism. Lois A. Haggerty & Joellen Hawkins, Informed Consent and the Limits of Confidentiality, 22 West J. Nursing Res. 508 (2000). 119. For a discussion of "minimal risk" and varying levels of risk associated with research participation, see notes 148-49 infra and accompanying text. 120. 45 C.F.R. § 46.116(a)(7), (8) (2006). 121. Ron Schellings, The Zelen Design May Be the Best Choice for a Heroin-Provision Experiment, 52 J. Clin. Epidemiol. 503 (1999). This is known alternatively as the Zelen design, the randomized consent design, and prerandomization. Marvin Zelen, Randomized Consent Designs for Clinical Trials: An Update, 9 Stat. Med. 645 (1990); Susan S. Ellenberg, Randomization Designs in Comparative Clinical Trials, 310 New Eng. J. Med. 1404 (1984). 122. John Matts & Rebecca McHugh, Randomization and Efficiency in Zelen's Single-Consent Design, 43 Biometrics 885 (1987). 123. See Thomas L. Beauchamp et al., Ethical Guidelines for Epidemiologists, 4