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D.J. Nutt, "Addiction: Brain Mechanisms and their Treatment Implications," Lancet, 347 (1996): 31-36, at 32 ("Because addiction is an imprecise and potentially pejorative term, the WHO [World Health Organization] recommended in 1969 that it should be replaced by the term drug dependence."). Since the term "addiction" is the more familiar term, I will use "addiction" interchangeably with "substance dependence," as defined by the DSM-IV criteria, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (Washington, D.C.: American Psychiatric Association, 1994).
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Nutt, D.J.1
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0030045709
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Washington, D.C.: American Psychiatric Association
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D.J. Nutt, "Addiction: Brain Mechanisms and their Treatment Implications," Lancet, 347 (1996): 31-36, at 32 ("Because addiction is an imprecise and potentially pejorative term, the WHO [World Health Organization] recommended in 1969 that it should be replaced by the term drug dependence."). Since the term "addiction" is the more familiar term, I will use "addiction" interchangeably with "substance dependence," as defined by the DSM-IV criteria, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (Washington, D.C.: American Psychiatric Association, 1994).
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3
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Actual Causes of Death in the United States
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J. Areen et al., eds., Westbury, New York: Foundation Press
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In 1990, deaths attributed to drug use were estimated as follows: 400,000 from tobacco; 100,000 from alcohol; and 20,000 from "illegal" drugs. It was estimated that 3 million people in the United States had serious problems related to illegal drugs. J.M. McGinnis and W.H. Foege, "Actual Causes of Death in the United States," in J. Areen et al., eds., Law, Science and Medicine, 2nd ed. (Westbury, New York: Foundation Press, 1996): 502-10. Overall lifetime prevalence of drug use disorders is 6.2 percent; overall lifetime prevalence of alcohol disorders is 13.5 percent. R.M. Crum, "The Epidemiology of Addictive Disorders," in A.W. Graham and T.K. Schultz, eds., Principles of Addiction Medicine, 2nd ed. (Chevy Chase, Maryland: American Society of Addiction Medicine, 1998): 3-15. In 1995, illegal drug use was estimated to have cost approximately $110 billion and to have resulted in approximately 9,300 deaths. Drug-related emergency room visits were over half a million annually. The social costs of drug and alcohol abuse in 1995 were estimated at $277 billion. National Drug Control Strategy (Washington, D.C.: Office of National Drug Control Policy, 1999): at 14-15. From 1990 to 1992, the National Comorbidity Survey of more than 8,000 Americans ages 15-54 demonstrated that 7.5 percent had developed dependence on illicit drugs. Injection drug use is the leading factor for new HIV infections in the United States. Institute of Medicine, Pathways of Addiction: Opportunities in Drug Abuse Research (Washington, D.C.: National Academy Press, 1996): at 102, 161.
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Law, Science and Medicine, 2nd Ed.
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McGinnis, J.M.1
Foege, W.H.2
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4
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The Epidemiology of Addictive Disorders
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A.W. Graham and T.K. Schultz, eds., Chevy Chase, Maryland: American Society of Addiction Medicine
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In 1990, deaths attributed to drug use were estimated as follows: 400,000 from tobacco; 100,000 from alcohol; and 20,000 from "illegal" drugs. It was estimated that 3 million people in the United States had serious problems related to illegal drugs. J.M. McGinnis and W.H. Foege, "Actual Causes of Death in the United States," in J. Areen et al., eds., Law, Science and Medicine, 2nd ed. (Westbury, New York: Foundation Press, 1996): 502-10. Overall lifetime prevalence of drug use disorders is 6.2 percent; overall lifetime prevalence of alcohol disorders is 13.5 percent. R.M. Crum, "The Epidemiology of Addictive Disorders," in A.W. Graham and T.K. Schultz, eds., Principles of Addiction Medicine, 2nd ed. (Chevy Chase, Maryland: American Society of Addiction Medicine, 1998): 3-15. In 1995, illegal drug use was estimated to have cost approximately $110 billion and to have resulted in approximately 9,300 deaths. Drug-related emergency room visits were over half a million annually. The social costs of drug and alcohol abuse in 1995 were estimated at $277 billion. National Drug Control Strategy (Washington, D.C.: Office of National Drug Control Policy, 1999): at 14-15. From 1990 to 1992, the National Comorbidity Survey of more than 8,000 Americans ages 15-54 demonstrated that 7.5 percent had developed dependence on illicit drugs. Injection drug use is the leading factor for new HIV infections in the United States. Institute of Medicine, Pathways of Addiction: Opportunities in Drug Abuse Research (Washington, D.C.: National Academy Press, 1996): at 102, 161.
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Principles of Addiction Medicine, 2nd Ed.
, pp. 3-15
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Crum, R.M.1
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5
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0003790090
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Washington, D.C.: Office of National Drug Control Policy
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In 1990, deaths attributed to drug use were estimated as follows: 400,000 from tobacco; 100,000 from alcohol; and 20,000 from "illegal" drugs. It was estimated that 3 million people in the United States had serious problems related to illegal drugs. J.M. McGinnis and W.H. Foege, "Actual Causes of Death in the United States," in J. Areen et al., eds., Law, Science and Medicine, 2nd ed. (Westbury, New York: Foundation Press, 1996): 502-10. Overall lifetime prevalence of drug use disorders is 6.2 percent; overall lifetime prevalence of alcohol disorders is 13.5 percent. R.M. Crum, "The Epidemiology of Addictive Disorders," in A.W. Graham and T.K. Schultz, eds., Principles of Addiction Medicine, 2nd ed. (Chevy Chase, Maryland: American Society of Addiction Medicine, 1998): 3-15. In 1995, illegal drug use was estimated to have cost approximately $110 billion and to have resulted in approximately 9,300 deaths. Drug-related emergency room visits were over half a million annually. The social costs of drug and alcohol abuse in 1995 were estimated at $277 billion. National Drug Control Strategy (Washington, D.C.: Office of National Drug Control Policy, 1999): at 14-15. From 1990 to 1992, the National Comorbidity Survey of more than 8,000 Americans ages 15-54 demonstrated that 7.5 percent had developed dependence on illicit drugs. Injection drug use is the leading factor for new HIV infections in the United States. Institute of Medicine, Pathways of Addiction: Opportunities in Drug Abuse Research (Washington, D.C.: National Academy Press, 1996): at 102, 161.
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National Drug Control Strategy
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6
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0003691096
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Washington, D.C.: National Academy Press
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In 1990, deaths attributed to drug use were estimated as follows: 400,000 from tobacco; 100,000 from alcohol; and 20,000 from "illegal" drugs. It was estimated that 3 million people in the United States had serious problems related to illegal drugs. J.M. McGinnis and W.H. Foege, "Actual Causes of Death in the United States," in J. Areen et al., eds., Law, Science and Medicine, 2nd ed. (Westbury, New York: Foundation Press, 1996): 502-10. Overall lifetime prevalence of drug use disorders is 6.2 percent; overall lifetime prevalence of alcohol disorders is 13.5 percent. R.M. Crum, "The Epidemiology of Addictive Disorders," in A.W. Graham and T.K. Schultz, eds., Principles of Addiction Medicine, 2nd ed. (Chevy Chase, Maryland: American Society of Addiction Medicine, 1998): 3-15. In 1995, illegal drug use was estimated to have cost approximately $110 billion and to have resulted in approximately 9,300 deaths. Drug-related emergency room visits were over half a million annually. The social costs of drug and alcohol abuse in 1995 were estimated at $277 billion. National Drug Control Strategy (Washington, D.C.: Office of National Drug Control Policy, 1999): at 14-15. From 1990 to 1992, the National Comorbidity Survey of more than 8,000 Americans ages 15-54 demonstrated that 7.5 percent had developed dependence on illicit drugs. Injection drug use is the leading factor for new HIV infections in the United States. Institute of Medicine, Pathways of Addiction: Opportunities in Drug Abuse Research (Washington, D.C.: National Academy Press, 1996): at 102, 161.
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7
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note
-
The neurochemical mechanisms responsible for addiction to "legal" and "illegal" drugs are similar. The same ethical considerations apply to alcohol and nicotine dependence as illegal drug dependence because it is the impact of compulsive use and denial on an addict's competency to consent that are in question. That alcohol and cigarettes are "legal drugs" is not germane to the discussion.
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8
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0028860188
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College on Problems of Drug Dependence, "Special Report: Human Subject Issues in Drug Abuse Research,"
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See, for example, M.W. Adler, College on Problems of Drug Dependence, "Special Report: Human Subject Issues in Drug Abuse Research," Drug and Alcohol Dependence, 37 (1995): 167-75; A.I. Leshner, "What We Know: Drug Addiction Is a Brain Disease," in A.W. Graham and T.K. Schultz, eds., Principles of Addiction Medicine, 2nd ed. (Chevy Chase, Maryland: American Society of Addiction Medicine, 1998): xxix-xxxvi; Nutt, supra note 1.
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A.W. Graham and T.K. Schultz, eds., Chevy Chase, Maryland: American Society of Addiction Medicine, Nutt, supra note 1
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See, for example, M.W. Adler, College on Problems of Drug Dependence, "Special Report: Human Subject Issues in Drug Abuse Research," Drug and Alcohol Dependence, 37 (1995): 167-75; A.I. Leshner, "What We Know: Drug Addiction Is a Brain Disease," in A.W. Graham and T.K. Schultz, eds., Principles of Addiction Medicine, 2nd ed. (Chevy Chase, Maryland: American Society of Addiction Medicine, 1998): xxix-xxxvi; Nutt, supra note 1.
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E.L. Gardner and J.H. Lowinson, "Drug Craving and Positive/Negative Hedonic Brain Substrates Activated by Addicting Drugs," The Neurosciences, 5 (1993): 359-68.
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See, for example, D.A. Gorelick, R.W. Pickens, and F.O. Bonkovsky, "Clinical Research in Substance Abuse: Human Subjects Issues," in H.A. Pincus, J.A. Liberman, and S. Ferris, eds., Ethics in Psychiatric Research (Washington, D.C.: American Psychiatric Association, 1998): 177-218; Adler, supra note 4.
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M. Ernst and E.D. London, "Brain Imaging Studies of Drug Abuse: Therapeutic Implications," Seminars in Neuroscience, 9 (1997): 120-30; S. Grant et al., "Activation of Memory Circuits During Cue-Elicited Cocaine Craving," Proceedings of the National Academy of Science, 93 (1996): 12040-45; E.D. London et al., "Morphine-Induced Metabolic Changes in Human Brain. Studies with Positron Emission Tomography and [Fluorine 18]-Fluorodeoxy-glucose," Archives of General Psychiatry, 47 (1990): 73-81; E.D. London et al., "Cocaine-Induced Reduction of Glucose Utilization in Human Brain. Studies with Positron Emission Tomography and [Fluorine 18]-Fluorodeoxyglucose," Archives of General Psychiatry, 47 (1990): 567-74; N.D. Volkow et al., "Long-Term Frontal Brain Metabolic Changes in Cocaine Abusers," Synapse, 11 (1992) 184-90; N.D. Volkow et al., "Cocaine Addiction: Hypotheses Derived from Imaging Studies with PET," Journal of Addictive Diseases, 15 (1996): 55-71; N.D. Volkow et al., "Brain Glucose Metabolism in Chronic Marijuana Users at Baseline and During Marijuana Intoxication," Psychiatry Research and Neuroimaging, 67 (1996): 29-38.
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M. Ernst and E.D. London, "Brain Imaging Studies of Drug Abuse: Therapeutic Implications," Seminars in Neuroscience, 9 (1997): 120-30; S. Grant et al., "Activation of Memory Circuits During Cue-Elicited Cocaine Craving," Proceedings of the National Academy of Science, 93 (1996): 12040-45; E.D. London et al., "Morphine-Induced Metabolic Changes in Human Brain. Studies with Positron Emission Tomography and [Fluorine 18]-Fluorodeoxy-glucose," Archives of General Psychiatry, 47 (1990): 73-81; E.D. London et al., "Cocaine-Induced Reduction of Glucose Utilization in Human Brain. Studies with Positron Emission Tomography and [Fluorine 18]-Fluorodeoxyglucose," Archives of General Psychiatry, 47 (1990): 567-74; N.D. Volkow et al., "Long-Term Frontal Brain Metabolic Changes in Cocaine Abusers," Synapse, 11 (1992) 184-90; N.D. Volkow et al., "Cocaine Addiction: Hypotheses Derived from Imaging Studies with PET," Journal of Addictive Diseases, 15 (1996): 55-71; N.D. Volkow et al., "Brain Glucose Metabolism in Chronic Marijuana Users at Baseline and During Marijuana Intoxication," Psychiatry Research and Neuroimaging, 67 (1996): 29-38.
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M. Ernst and E.D. London, "Brain Imaging Studies of Drug Abuse: Therapeutic Implications," Seminars in Neuroscience, 9 (1997): 120-30; S. Grant et al., "Activation of Memory Circuits During Cue-Elicited Cocaine Craving," Proceedings of the National Academy of Science, 93 (1996): 12040-45; E.D. London et al., "Morphine-Induced Metabolic Changes in Human Brain. Studies with Positron Emission Tomography and [Fluorine 18]-Fluorodeoxy-glucose," Archives of General Psychiatry, 47 (1990): 73-81; E.D. London et al., "Cocaine-Induced Reduction of Glucose Utilization in Human Brain. Studies with Positron Emission Tomography and [Fluorine 18]-Fluorodeoxyglucose," Archives of General Psychiatry, 47 (1990): 567-74; N.D. Volkow et al., "Long-Term Frontal Brain Metabolic Changes in Cocaine Abusers," Synapse, 11 (1992) 184-90; N.D. Volkow et al., "Cocaine Addiction: Hypotheses Derived from Imaging Studies with PET," Journal of Addictive Diseases, 15 (1996): 55-71; N.D. Volkow et al., "Brain Glucose Metabolism in Chronic Marijuana Users at Baseline and During Marijuana Intoxication," Psychiatry Research and Neuroimaging, 67 (1996): 29-38.
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M. Ernst and E.D. London, "Brain Imaging Studies of Drug Abuse: Therapeutic Implications," Seminars in Neuroscience, 9 (1997): 120-30; S. Grant et al., "Activation of Memory Circuits During Cue-Elicited Cocaine Craving," Proceedings of the National Academy of Science, 93 (1996): 12040-45; E.D. London et al., "Morphine-Induced Metabolic Changes in Human Brain. Studies with Positron Emission Tomography and [Fluorine 18]-Fluorodeoxy-glucose," Archives of General Psychiatry, 47 (1990): 73-81; E.D. London et al., "Cocaine-Induced Reduction of Glucose Utilization in Human Brain. Studies with Positron Emission Tomography and [Fluorine 18]-Fluorodeoxyglucose," Archives of General Psychiatry, 47 (1990): 567-74; N.D. Volkow et al., "Long-Term Frontal Brain Metabolic Changes in Cocaine Abusers," Synapse, 11 (1992) 184-90; N.D. Volkow et al., "Cocaine Addiction: Hypotheses Derived from Imaging Studies with PET," Journal of Addictive Diseases, 15 (1996): 55-71; N.D. Volkow et al., "Brain Glucose Metabolism in Chronic Marijuana Users at Baseline and During Marijuana Intoxication," Psychiatry Research and Neuroimaging, 67 (1996): 29-38.
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T. Beauchamp and J.F. Childress, Principles of Biomedical Ethics, 4th ed. (New York: Oxford University Press, 1994); National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research, DHEW Pub. No. (OS) 78-0012 (Washington, D.C.: U.S. Gov't Printing Office, 1978).
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See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18 (1996): 1-5; J. Bor, "Mental Patients at Risk in Research," Baltimore Sun, June 7, 1998, at A1; P.J. Hilts, "Agency Faults a U.C.L.A. Study for Suffering of Mental Patients," New York Times, March 10, 1994, at A1; P.J. Hilts, "House Panel Told of More Tests Done Without Consent," New York Times, May 24, 1994, at A13; P.J. Hilts, "Psychiatric Researchers Under Fire," New York Times, May 19, 1998, at F1; E. Marshall, "NIMH to Screen Studies for Science and Human Risk," Science, 283 (1999): 464-65; R. Pear, "Study Finds Risks to Patients in Drug Trials," New York Times, May 30, 1998, at A9; R. Weiss, "Research Volunteers Unwittingly at Risk," Washington Post, August 1, 1998, at A1.
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29
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June 7
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See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18 (1996): 1-5; J. Bor, "Mental Patients at Risk in Research," Baltimore Sun, June 7, 1998, at A1; P.J. Hilts, "Agency Faults a U.C.L.A. Study for Suffering of Mental Patients," New York Times, March 10, 1994, at A1; P.J. Hilts, "House Panel Told of More Tests Done Without Consent," New York Times, May 24, 1994, at A13; P.J. Hilts, "Psychiatric Researchers Under Fire," New York Times, May 19, 1998, at F1; E. Marshall, "NIMH to Screen Studies for Science and Human Risk," Science, 283 (1999): 464-65; R. Pear, "Study Finds Risks to Patients in Drug Trials," New York Times, May 30, 1998, at A9; R. Weiss, "Research Volunteers Unwittingly at Risk," Washington Post, August 1, 1998, at A1.
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Baltimore Sun
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Bor, J.1
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30
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0028770045
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Agency Faults a U.C.L.A. Study for Suffering of Mental Patients
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March 10
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See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18 (1996): 1-5; J. Bor, "Mental Patients at Risk in Research," Baltimore Sun, June 7, 1998, at A1; P.J. Hilts, "Agency Faults a U.C.L.A. Study for Suffering of Mental Patients," New York Times, March 10, 1994, at A1; P.J. Hilts, "House Panel Told of More Tests Done Without Consent," New York Times, May 24, 1994, at A13; P.J. Hilts, "Psychiatric Researchers Under Fire," New York Times, May 19, 1998, at F1; E. Marshall, "NIMH to Screen Studies for Science and Human Risk," Science, 283 (1999): 464-65; R. Pear, "Study Finds Risks to Patients in Drug Trials," New York Times, May 30, 1998, at A9; R. Weiss, "Research Volunteers Unwittingly at Risk," Washington Post, August 1, 1998, at A1.
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New York Times
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31
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May 24
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See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18 (1996): 1-5; J. Bor, "Mental Patients at Risk in Research," Baltimore Sun, June 7, 1998, at A1; P.J. Hilts, "Agency Faults a U.C.L.A. Study for Suffering of Mental Patients," New York Times, March 10, 1994, at A1; P.J. Hilts, "House Panel Told of More Tests Done Without Consent," New York Times, May 24, 1994, at A13; P.J. Hilts, "Psychiatric Researchers Under Fire," New York Times, May 19, 1998, at F1; E. Marshall, "NIMH to Screen Studies for Science and Human Risk," Science, 283 (1999): 464-65; R. Pear, "Study Finds Risks to Patients in Drug Trials," New York Times, May 30, 1998, at A9; R. Weiss, "Research Volunteers Unwittingly at Risk," Washington Post, August 1, 1998, at A1.
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See, for example, P.S. Appelbaum, "Drug-Free Research in Schizophrenia: An Overview of the Controversy," IRB: A Review of Human Subjects Research, 18 (1996): 1-5; J. Bor, "Mental Patients at Risk in Research," Baltimore Sun, June 7, 1998, at A1; P.J. Hilts, "Agency Faults a U.C.L.A. Study for Suffering of Mental Patients," New York Times, March 10, 1994, at A1; P.J. Hilts, "House Panel Told of More Tests Done Without Consent," New York Times, May 24, 1994, at A13; P.J. Hilts, "Psychiatric Researchers Under Fire," New York Times, May 19, 1998, at F1; E. Marshall, "NIMH to Screen Studies for Science and Human Risk," Science, 283 (1999): 464-65; R. Pear, "Study Finds Risks to Patients in Drug Trials," New York Times, May 30, 1998, at A9; R. Weiss, "Research Volunteers Unwittingly at Risk," Washington Post, August 1, 1998, at A1.
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This charge is succinctly presented in the NBAC Report, supra note 17, at i: In this report, the National Bioethics Advisory Commission (NBAC) considers how ethically acceptable research can be conducted with human subjects who suffer from mental disorders that may affect their decisionmaking capacity; whether, in this context, additional protections are needed; and, if so, what they should be and how they should be implemented.... Although existing federal regulations for research involving human subjects provide special protection for certain populations that are regarded as particularly vulnerable, persons with mental disorders (who may have impaired capacity to make decisions about research participation) have not received any such special protections.
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Mental status is likely to fluctuate as a result of either internal stimuli (e.g., altered level of craving or occurrence of drug-associated memories) or external stimuli (e.g., verbal, visual, or auditory). The conduct of a proposed study may also affect mental status, e.g., does it involve the subject's drug of choice or is it "neutral" with respect to substance dependence?
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I emphasize that this potential decision-making impairment applies only to non-therapeutic protocols that involve individuals who have met the DSM-IV criteria (supra note 1) for substance dependence and where the study involves administering the addict's drug of choice. As already stressed, addicts (as long as they are not acutely intoxicated or in withdrawal) should not be presumed to lack competence to participate in other types of studies, including those in which substance abuse treatment is evaluated. This concept is consistent with the principle that an individual's capacity to consent to participate in research must be balanced against his or her right to participate in research. This concept was reiterated in the DHHS Working Group Report (supra note 17, at 4-5): Given the widespread incidence of mental disorders in the population, many protocols in different fields will involve subjects with conditions that may affect decisionmaking, even those where the protocol has nothing to do with the study of those conditions and the investigators intend to recruit only adults with decisional capacity. Thus, for example, a protocol studying cholesterol levels or eyewitness testimony - and including only incidentally a few subjects who experience mild depression or who are recovering alcoholics - does not warrant the same degree of scrutiny as would a protocol to study a potential treatment for advanced Alzheimer's disease.
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Denial is present even when craving is minimal or absent. Therefore, a fundamental biological and ethical issue - denial - must be confronted whether or not craving exists. The foundation of my thesis is that prospective subjects' failure to understand the nature of their disease or admit that they have the disease is prima facie evidence that they lack the information and decision-making competence necessary for making an informed consent to receive their drug of choice in non-therapeutic research. The presence of craving only exacerbates this situation.
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I do not use the concept of coercion to imply that clinical investigators, those treating substance abuse, or any other individuals are compelling the addict (with money or any other type of inducement) to participate in clinical research. Rather, I am suggesting that coercion is internal, resulting from the state of addiction itself, such that the associated craving and denial are likely to interfere with the ability to make a rational decision.
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