AHRP Opposes Drug Implants for Psychiatric Patients
Those promoting the implants focus on its delivery of continuous sustained drug action to ensure that patients take the drugs they’re prescribed, presumably to prevent relapse. But critics who are familiar with widespread psychotropic drug prescribing abuses recognize the serious potential for harm and abuse.
First, the targeted population is mentally disabled people who are dependent on public assistance. They are, therefore, doubly vulnerable to coercion.
Second, the drugs prescribed for schizophrenia are not benign, their adverse effects are often more severe than the condition for which they are prescribed. [See, Mad in America by Robert Whitaker] How is that information dealt with by IRBs determination of risk/ benefit ratio?
Third, many patients cannot tolerate the side effects of neuroleptic drugs such as Haldol, the drug used in the experiment. For patients who cannot tolerate the drugs’ debilitating side effects, an implant is inhumane as it would cause them considerable suffering.
Antipsychotic drugs produce akathisia (excruciating mental and physical restlessness) that has been known to drive patients to suicide. Neuroleptic malignant syndrome (NMS) is a fatal risk linked to all neuroleptic/antipsychotic drugs and if the drug is not withdrawn immediately at onset of NMS, patients will die. How do these risk factors comport with the Nuremberg Code or, for that matter, with the Code of Federal Regulations (45 CFR 46)?
Fourth, practically all patients prescribed psychiatric drugs will need dose adjustments since psychiatric drug doses are individualized, mostly by trial and error. Another confounding problem is that such patients’ clinical symptomotology changes over time, requiring dose adjustments. Since a drug implant does not allow for dose adjustments, how can their use be justified in patients?
Fifth, there is concern about misuse of the implant against these people’s will stripping those implanted of human dignity. Others are concerned that “psychiatric implants” will be used for thought control purposes, and are likely to signal a trend in human rights infringement. Should medical research facilitate a covert policing function?
Finally, there is concern that those who promote the development and use of such devices are motivated by commercial interests and expanded state ordered behavior control, rather than improving patient care. Indeed, the experiment is sponsored by the National Alliance for the Mentally Ill (NAMI) and the National Alliance for Research on Schizophrenia and Depression (NARSAD)–two organizations that receive millions of dollars from pharmaceutical companies that manufacture the drugs to be dispensed by the implant, and the Stanley Foundation, a private foundation that established the leading lobbying organization that promotes legislation to empower states to force psychiatric patients to be drugged against their will– whether the drugs help or harm them.
The University of Pennsylvania held a discussion with about the ethics of psychiatric implants that included representatives of patient advocacy groups and the principle investigtor who plans to conduct the experiment on patients and a senior bioethicist at U Penn’s Center for Bioethics, who is also the Director of Psychiatry and Ethics at the medical school.
A debate between AHRP President, Vera Sharav, and Bioethicist, Paul Root Volpe, Ph.D., University of Pennsylvania, was prompted by an AHRP Infomail critical of a drug implant experiment at the University of Pennsylvania. In Dr. Volpe’s final email of this debate, accusations were made about Dr. David Healy. In fairness we invited Dr. Healy to respond.