Ethics of U Penn surgical "drug implant" experiment

Ethics of U Penn surgical “drug implant” experiment

Tuesday, October 07

Notwithstanding a legion of prominent bioethicists at major universities such as the University of Pennsylvania and Johns Hopkins University, researchers at these institutions are not deterred from engaging in high risk human experimentation whose ethics are questionable.

One has only to recall the preventable harm, undisclosed risks and high financial stakes in the fatal gene transfer experiment that killed Jesse Gelsinger. Or a hexamethonium inhalation experiment that killed Ellen Roche, or a lead abatement experiment in which children were exposed to the brain damaging effects of lead poison. All had been approved by ethics review boards.

The Philadelphia Inquirer reports that U Penn is preparing the ground for launching an experiment to test a drug releasing implant in human subjects– psychiatric patients. The surgically inserted implant, a drug tablet the size of a quarter will automatically deliver powerful psychotropic drugs.

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–often for exerting control and profits– recognize the serious potential for harm and abuse. Plans call for testing the implant on disabled patients diagnosed with schizophrenia. Such patients are dependent on public assistance, and cannot exercise free choice. They are a captive population that is vulnerable to coercion.

The drugs prescribed for schizophrenia are not benign, their adverse effects are often more severe than the condition for which they are prescribed. Patients are likely to need dose adjustments since psychiatric drug doses are determined individually, mostly by trial and error, and doses need to be changed over time. A drug implant is not adjustable, it is a device designed for the convenience of providers. For patients who cannot tolerate these drugs’ debilitating side effects, an implant is inhumane as it would cause them considerable suffering.

The 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malignant syndrome NMS) is a fatal risk linked to all neuroleptic /antipsychotic drugs and if the drug is not withdrawn immediately at onset of NMS, patients will die.

There is concern about the misuse of the implant against people’s will –much as tranquilizers are used in animals. Such coercive dispensing of drugs would strip those implanted of human dignity. Still others are concerned that “psychiatric implants” will be used for thought control purposes, and are likely to signal a trend in human rights infringement.

The Inquirer reports that U Penn “took the unusual step of” holding discussions about the ethics of “psychiatric implants. Joining the principle investigator, psychiatrist Steven Siegel, was and one of Penn’s senior fellows at the Center for Bioethics, Paul Root Wolpe, PhD, who is Director of Psychiatry and Ethics at the School of Medicine. Given that bioethicists are not free of financial conflicts of interest, having close ties to the biotech / drug industry, the unacknowledged purpose of such discussions is, no doubt, to pave the way for legitimizing “drug implant” technology “by consensus”–a favorite method for pushing through dubious public policies.

In his recent book, Science in the Private Interest (Rowman & Littlefield) Professor Sheldon Krimsky describes how the ethos of commercialism and the lure of profits has corrupted biomedical research and changed the social role of the university. Although he does not single out bioethicists, who have an unacknowledged function on industry and government advisory boards, which is to give their seal of approval for new biomedical technological products and procedures.

The difference between bioethicists who claim to serve the public interest, and biotech company employees is that the employees’ allegiance is known to all. Unlike university-affiliated bioethicists who serve on corporate advisory boards, company employees don’t pretend to serve other than company interests.

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http://www.philly.com/mld/philly/6876271.htm?template=contentModules/printstory.jsp

Sun, Sep. 28, 2003

A promising new treatment, and a need to set the rules
Stacey Burling
covers mental health for The Inquirer’s science and health desk.

Do a Google search on the words implant and mind control and you’ll get about 100,000 hits, a virtual primer on conspiracy theories and science-fiction nightmares.

So it’s no surprise that when the University of Pennsylvania announced that one of its scientists was perfecting an implant that could provide a year’s worth of medication for people with severe mental illness, it was met in some quarters with distrust.

David Oaks, executive director of Support Coalition International, which questions the dominant view that mental illnesses are biological at base, for example, calls the device “inherently coercive.”

Aware of the concerns, the university took the unusual step last week of inviting representatives of consumer-advocacy groups to a symposium on the ethical implications of the implants well before they are ready for marketing.

Paul Root Wolpe, a Penn ethicist who took part in the meeting, said he saw it as an opportunity for disparate groups to help set the ground rules for how a promising new treatment would be used.

“If we agree that this technology has a potential for misuse, and I really think it does, we can build coalitions to prevent that,” he said.

Researcher Steven Siegel, a psychiatrist and neurobiologist, conceived of the biodegradable implants as a way to solve a problem that has persistently plagued treatment of people with schizophrenia, the most serious of the mental illnesses. A high percentage stop taking their medications and almost inevitably descend into disorganized thinking, hallucinations and delusions that can leave them jobless, friendless and homeless.

The implants, he said, have the potential to give people with serious mental illnesses the stability they need to develop long-term friendships and careers. The technology could be used with many drugs, including those for treating other chronic illnesses. Studies show that half the people with all sorts of diseases fail to take their medicines consistently.

Siegel’s team at Penn so far has tested the implants – quarter-size devices containing polymers made of lactic acid and glycolic acid fused with haloperidol (Haldol) – in mice, rats, rabbits and monkeys. Siegel thinks the Food and Drug Administration will require at least one more round of animal-testing, possibly in dogs, before considering approval, so the implants are probably a year or two away from human-testing. The implants are placed under the skin during a 15-minute surgical procedure and can be removed.

Aside from the obvious advantage that patients could not forget to take their medication while using the implant, Siegel said that delivering the drug under the skin makes lower doses possible and may reduce side effects.

The biggest concern about the implants is that they would be forced upon patients and that it would be difficult for patients to change their minds. Volpe and patients worried that the criminal-justice system, in particular, would coerce patients to take the drugs. How much choice would people really have, they asked, if they were told that they could either have an implant or go to jail, or that they wouldn’t be allowed to leave the hospital until they accepted an implant?

Patients and others also worried that managed-care companies might find the implants more attractive than current approaches that require more monitoring. The result could be that patients would see their psychiatrists less, harming the doctor-patient relationship.

With minimal precedent and multiple arenas of concern – pharmacological, adjudicatory, sociological – broadly accepted protocols will not happen quickly.

Siegel says the implant would only be an option for stable, rational patients who chose to take their medicine this way. “This is a medicine like any other medicine,” he said. “We don’t give people medicine when they say no.”

While he made an effort to invite potential critics to last week’s meeting, most of his calls and e-mails about the implants have been supportive, he said. “Overwhelmingly, it’s, ‘When can I have this? When can my son have this?'”

© 2003 Philadelphia Inquirer and wire service sources.

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