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Published Online: 7 December 2007

Pharma, Outpatient Commitment High on APA Ethics Agenda

Ethical issues related to outpatient commitment and drug industry relationships were among the many thorny psychiatric issues with which experts wrestled at APA's ethics workshop for district branch executives and chairs of ethics committees.
The biennial workshop was held last month in Washington, D.C., prior to the fall meeting of the Assembly and was sponsored by APA's Ethics Committee. The goal was to educate district branch ethics chairs and executive staff about APA's “Procedures of Handling Complaints of Unethical Conduct” and key ethical issues so they can more effectively deal with ethics issues at the local level.
As psychiatrists continue to struggle with many complex ethical questions, recent events and news coverage have given some questions increased urgency.
One of those questions concerns the ethically appropriate uses of outpatient commitment. Such use has been urged in the wake of the April killing of 32 students and professors at Virginia Tech by a student with mental illness. The 23-year-old student, who ended his rampage by killing himself, had been involuntarily committed to a psychiatric hospital in 2005 after two women students complained about his behavior to campus police, and he sent friends an instant message implying he was suicidal. He was released after a doctor at the hospital said he was mentally ill but not an imminent threat.
In the wake of the killings, legislators and others in Virginia and other states have pushed for stricter outpatient civil commitment laws under which a larger number of people with mental illness could be committed. The also have urged review of laws and university regulations governing privacy to ensure they have not been misinterpreted.
Paul Appelbaum, M.D., chair of APA's Council on Psychiatry and Law, says that civil commitment laws are failing in many states because of inadequate funding for mental health services and follow-up.
©Sylvia Johnson Photography 2007
Paul Appelbaum, M.D., the Dollard Professor of Psychiatry, Medicine, and Law at Columbia University, said the gunman had been deemed suitable for outpatient commitment, but there was never any follow-up. The reason the Virginia law failed and many other states' civil commitment laws would have been similarly ineffective, he said, is because state governments don't provide funding for the appropriate number of mental health personnel needed to track such individuals, and they don't fund the psychiatric beds to enforce mandatory treatment of those who do not comply with outpatient care.
Some states have begun to allocate greater resources for better enforcement of their civil commitment statutes, however, which raises the ethical question of whether limited resources should be concentrated on a small number of patients or spread more broadly to benefit a greater number through other treatment approaches.
“Does outpatient commitment shift resources from those who want it to those who don't want it and are treatment resistant?” asked Appelbaum, who is chair of APA's Council on Psychiatry and Law.
But how often should states require coercive treatment? Increasingly, states have generally addressed the thorny ethical question of how much individual liberty to constrict to protect the public through outpatient commitment laws, while lacking funding for inpatient care or outpatient follow-up.
The result has been many outpatient commitment laws that lack any real enforcement mechanism. Without a comprehensive approach, civil commitment statutes “cannot protect the public from rare acts of violence by people with mental illness,” Appelbaum said.

Pharma Conflicts Addressed

Another area of ethics that has grabbed the public's attention in recent years has been the issue of physicians' relationship with the pharmaceutical industry. APA has attempted to address the public's concerns about this relationship as it begins work on DSM-V by instituting an in-depth industry-relations disclosure, divestiture, and confirmation process for psychiatrists being considered for appointment to work on DSM-V, according to Donna Norris, M.D., secretary-treasurer of APA. The inherent intrusiveness of the process has drawn complaints from some, and several psychiatrists have refused to contribute to the DSM-V process because of it; however, many others have successfully completed the requirements of the disclosure process.
APA President Carolyn Robinowitz, M.D., discusses the complicated ethics of the relationship between physicians and drug makers.
©Sylvia Johnson Photography 2007
The issue of industry affiliations also applies to individual psychiatrists, said Carolyn Robinowitz, M.D., APA president.
“We are living in an age where we do have to question whether pharma is our friend or our foe,” Robinowitz said.
The greater importance and effectiveness of pharmacotherapy in recent decades, coupled with the role of industry as the primary funding source of psychiatric medication research, have created strong bonds between industry and medicine. Third-party payers also have encouraged the greater use of medications stemming from a single visit, instead of talk therapy over many visits.
“And patients often prefer less time spent in a doctor's office and more of the magic that newspaper advertisements and movies tell us about medications,” she said.
Differentiations between education and marketing became entangled because drug companies traditionally undertake new drug development and disseminate much of the information about new medications and newer uses for older medications.
“They want people to use their product properly, but they also want people to use their products, and sometimes those are a bit in conflict,” Robinowitz said.
In response to a question from Robinowitz about who received what free drug samples from manufacturers, only one audience member said they had received generic as well as name-brand samples.
David Baron, M.D., chair of the Ethics Committee of the Illinois Psychiatric Society, was among the many district branch officials who posed complex questions to presenters at APA's 2007 ethics workshop.
©Sylvia Johnson Photography 2007
The questions surrounding industry promotion should not be allowed to overwhelm the advocacy role of psychiatrists, which entails informing the public that treatment works and is available and affordable. It is important to remember, she said, that the research shows that the best patient outcomes often stem from a combination of medication and talk therapies.
Increasing questions among policymakers and the media about the influence of the drug industry on clinicians' pharmaceutical prescribing patterns mean that psychiatrists need to be as circumspect and as open as possible. If the public is convinced that conflicts exist, then policymakers will enact overly simple “solutions,” or patients will lose trust in their clinician's treatment plan.
“We need to be clear about what we do so that the science doesn't get tainted. That's the bottom line,” Robinowitz said.

Specific Steps Described

She called for specific steps to clarify the role of industry. One step would have psychiatry residents meet with an industry representative and a senior faculty member “who understands the literature and who can help them evaluate and assess what they are being told,” which will help them develop critical thinking and assess what they are told by drug makers.
Robinowitz urged individual psychiatrists to disclose industry relationships as fully as possible, while avoiding the use of company-provided items that feature drug names or manufacturer names. Any industry-funded presentation meals are marketing, she said. And presenters should always disclose any industry funding they have received.
Researchers also can avoid ethical conflict allegations by making sure they register, review, and report industry relationships. The Association of American Medical Colleges responded to growing concerns about researcher conflicts in recent months by issuing specific principals to maintain the integrity of clinical research.
“We need to educate people about these relationships and about critical evaluation and prohibit inappropriate participation,” Robinowitz said. ▪

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Published online: 7 December 2007
Published in print: December 7, 2007

Notes

Individual psychiatrists and teaching institutions can take steps to clarify the role of the drug industry. Some of these actions might follow APA's efforts to address the public's concerns about conflicted financial relationships.

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