Novel Molecular Targets for Mood Disorders and Psychosis Proceedings of a Workshop (2021) / Chapter Skim
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7 Ethical and Legal Principles Related to the Clinical Use of Psychoactive Drugs
7 Ethical and Legal Principles Related to the Clinical Use of Psychoactive Drugs
Pages 47-54
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From page 47... ...
. • Patients with a history of suicidality or drug abuse should be included in clinical trials of antidepressants because these patients are most likely to seek clinical care for depression (Appelbaum)
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From page 48... ...
, but has also received breakthrough therapy status for depression by FDA, raising complicated legal challenges (Marks)
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From page 49... ...
While these exclusion criteria are used in trials of nearly all new medications, Appelbaum suggested that they are particularly salient for psychoactive drugs because issues like intractable suicidality are exactly why patients seek clinical care and are what motivates clinicians to look beyond standard treatments to something such as ketamine. Moreover, he said, the differential impact of a drug on people with substance abuse histories may be more important for drugs with abuse potential.
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From page 50... ...
Ashley Clayton, whose personal experiences with ketamine treatment for treatment-resistant depression were described in Chapter 2, suggested leveraging the patient experience to improve the process of informed consent for experiences that may be difficult to articulate. When considering ECT, for example, she noted that reading the scientific literature and talking to her physician failed to give her the insight she obtained from reading patient narratives.
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From page 51... ...
Fair access can only be achieved on a societal level, he said, by instituting policies such as those that regulate predatory pricing or encourage companies to create patient assistance programs. Global access to these medications represents an additional ethical dilemma, added Ilina Singh, professor of neuroscience in society at the University of Oxford.
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From page 52... ...
These swings could disrupt the patient's sense of authenticity, and more discussion is needed to understand and address this phenomenon, she said. The second issue Singh raised relates to building an ethical framework around the regulation of these potentially lifesaving drugs that balances the need for good drug stewardship and the need to maximize access.
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From page 53... ...
Prescription monitoring databases raise significant concerns about privacy, can stigmatize people, and can perpetuate systemic racism and bias, particularly if they are using artificial intelligence to formulate risk prediction scores, he said. Appelbaum countered that easing access can contribute to more widespread abuse, as has been demonstrated with the opioid epidemic, where increasing the legitimate prescription of opioids failed to alleviate the oxycontin black market.
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From page 54... ...
Oregon passed a measure in November 2020 to set up a statewide industry for psilocybin therapy and will begin issuing licenses for manufacturers and facilitators in 2023. Other states have proposed similar bills or have taken more conservative approaches such as limiting its use to end-of-life care, creating task forces to explore the issue further, or developing bills to decriminalize psilocybin, he remarked.
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