New Treatments for Addiction Behavioral, Ethical, Legal, and Social Questions (2004) / Chapter Skim
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Appendix F: Ethical Issues in Immunotherapies and Depot Mechanisms for Substance Abuse
Appendix F: Ethical Issues in Immunotherapies and Depot Mechanisms for Substance Abuse
Pages 188-212
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From page 188... ...
with a kind of passive immunotherapy, a monoclonal antibody (mAB) specifically engineered to neutralize the effects of PCP.
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From page 189... ...
Nor for that matter is she likely to be under the active surveillance of the criminal justice system, as might be the case with someone on probation after being convicted of illegal drug use. There is no reason to suppose that she is addicted to the date-rape drug whose effect she wishes to avoid, so we do not have to consider whether addiction impairs her ability to give free, voluntary, and informed consent.
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From page 190... ...
Then the discussion turns to the ethics of use, focusing on one of the most ethically complex possibilities for use -- when parents want to administer these technologies to their children in order to discourage or prevent them from engaging in substance abuse. FEATURES OF THE POSSIBLE INTERVENTIONS WITH SPECIAL ETHICAL RELEVANCE Immunotherapies or depot medications might be used for three purposes.
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From page 191... ...
For this any of the three available modalities might be useful: passive immunotherapy, active immunotherapy, and depot medications. In addition to concerns about the expense of relapse prevention protocols, which would require parallel intensive psychosocial interventions, there will be concerns about the meaningfulness of the person's informed consent to research or treatment.
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From page 192... ...
What are the ethical implications involved in study design, methodology, and outcome measures? How can informed consent be made to serve in practice the noble ethical purposes it is presumed to serve in theory (see Faden, Beauchamp, and King, 1986)
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From page 193... ...
People with mental disorders interfering with their capacity to understand and appreciate the implications of a decision to enroll in a research protocol may not be able to give a morally meaningful and valid informed consent to research (National Bioethics Advisory Commission, 1998; Appelbaum, 2002)
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From page 194... ...
In all such cases, voluntariness may be in question. Factors involving the person requesting consent may also pose challenges to obtaining fully voluntary and informed consent for research on immunotherapies and depot medications for substances of abuse.
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From page 195... ...
How did the potential research subject come into contact with the requester? There is no one scenario likely to account for all cases, but it may be instructive to consider plausible cases for the three categories of intervention mentioned earlier: overdose treatments, relapse prevention protocols, and protection protocols.
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From page 196... ...
Whenever the physician or someone perceived as that physician's agent makes the request, the prospective research subject may feel compelled to agree -- because of the requester's power over the person. Research on protection protocols is likely to come only after the interventions have been vetted in overdose and relapse prevention studies.
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From page 197... ...
Of the principal settings in which most clinical research subjects are recruited-the physician's practice and the specialty clinic or hospital -- the former is likely to be less commonly employed for the studies under consideration here, and the latter, in these cases the substance abuse clinic, has properties that place it outside the usual clinic environment, especially the social control aspects of treatment for substance abuse and the fact that much of the conduct creating the need for treatment may be illegal. Other settings include the emergency room (especially for overdose treatment protocols)
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From page 198... ...
Using depot medications and immunotherapies for substance abuse will be no exception to the rule of complexity and ambiguity. We may worry more intensely and systematically about informed consent in the context of research, but informed consent is important in treatment as well.
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From page 199... ...
If they are conscious and competent, they can consent to the intervention. If they are unconscious or incompetent, the treating physician has a professional ethical obligation to provide appropriate treatment; if passive immunotherapy is proven to be superior to other interventions, the physician is simply fulfilling his or her professional duty by applying it.
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From page 200... ...
But with reasonable attention to informed consent and treatment under emergency circumstances, to patient confidentiality, and to the training of health care professionals to gain perspective on the perils of moralizing, this category of interventions is not especially ethically problematic. Relapse prevention protocols present a wider spectrum of possible interventions as well as contexts of treatment.
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From page 201... ...
It should be no surprise if and when immunotherapies and depot medications against substances of abuse are approved for marketing that some parents will seek such interventions for their children. Policy makers and clinicians will be called on to anticipate and respond to such requests.
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From page 202... ...
A remote and unlikely alternative would be a state or federal policy requiring, for example, that all children be immunized against one or more substances of abuse, the way childhood immunizations are required for common infectious diseases. Or perhaps there could be voluntary programs promoting periodic administration of depot medications or active immunotherapies (that require regular reimmunization)
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From page 203... ...
With hGH, parents may be motivated by a desire to help their child overcome a disease (a lack of physiologically active hGH) , a disability (severe idiopathic short stature)
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From page 204... ...
When parents have their children put on immunotherapies or depot medications to protect them against substance abuse, the parents here, like the parents of children with severe idiopathic short stature, are attempting to protect their children against what the parents regard as the risk of serious harm. In both cases, parents may perceive their children as being vulnerable.
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From page 205... ...
However, even if a consensus is formed among physicians to strictly limit access to immunotherapies and depot medications for substance abuse, some physicians might, out of fear of drug dependency or because of sentiments strongly in favor of parental discretion, accede to parental requests for such access. Control by "policy" refers to formal governmental actions whether by legislation or regulation.
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From page 206... ...
This particular vaccine works very well and seems to provide longlasting protection, but to be safe the current recommendation is to have periodic booster shots. CHALLENGES TO PARENTS, HEALTH CARE PROFESSIONS, AND PUBLIC POLICY What would a good and responsible parent do with respect to depot medications or immunotherapies for substances of abuse?
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From page 207... ...
Other ways of framing the ethical issues for parents may appear simpler at first glance, but in practice are at least as complex. Take the case of Vicky and her parents.
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From page 208... ...
. seek third party mediation.
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From page 209... ...
Individual physicians will need to be informed about all of these issues. If and when effective and apparently safe depot medications and immunotherapies are approved for marketing, some people will approach physicians to prescribe them for off-label use, even in the complete absence of data on their safety and effectiveness for such use, especially by children and adolescents.
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From page 210... ...
Responding to the challenges posed by immunotherapies and depot medications for substance abuse will require attention to the medical and scientific aspects of these interventions, as well as their social, economic, legal, and ethical implications. We must accept the great need to educate the public, health care professionals, and policy makers about the realities of substance abuse and its causes, prevention, and treatment.
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From page 211... ...
. Growth hormone in the treatment of children with short stature.
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From page 212... ...
. Ethical issues in informed consent with substance abusers.
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