Emily E. Wheeler

Drug Firms, the Codification of Diagnostic Categories, and Bias in Clinical Guidelines

The possibility that industry is exerting an undue influence on the culture of medicine has profound implications for the professions public health mission. Policy analysts, investigative journalists, researchers, and clinicians have questioned whether academic-industry relationships have had a corrupting effect on evidence-based medicine. Psychiatry has been at the heart of this epistemic and ethical crisis in medicine. This article examines how commercial entities, such as pharmaceutical companies, influence psychiatric taxonomy and treatment guidelines. Using the conceptual framework of institutional corruption, we show that organized psychiatrys dependence on drug firms has led to a distortion of science. We describe the current dependency corruption and argue that transparency alone is not a solution. We conclude by taking the position that the corruption of the evidence base in diagnostic and practice guidelines has compromised the informed consent process, and we suggest strategies to address this problem.

Industry’s colonization of psychiatry: Ethical and practical implications of financial conflicts of interest in the DSM-5

The revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM), scheduled for publication in May 2013 by the American Psychiatric Association (APA), has created a firestorm of controversy because of questions about undue industry influence. Specifically, concerns have been raised about financial conflicts of interest between DSM-5 panel members and the pharmaceutical industry. The authors argue that current approaches to the management of these relationships, particularly transparency of them, are insufficient solutions to the problem of industry’s capture of organized psychiatry. The conceptual framework of institutional corruption is used to understand psychiatry’s dependence on the pharmaceutical industry and to identify the epistemic assumptions that ground the DSM’s biopsychiatric discourse. APA’s rationale for including premenstrual dysphoric disorder in the DSM-5 as a Mood Disorder is reviewed and discussed.

Tripartite Conflicts of Interest and High Stakes Patent Extensions in the DSM-5

Background: The revision process for and recent publication of the DSM-5 initiated debates about the widening of diagnostic boundaries. The pharmaceutical industry had a major financial stake in the outcome of these debates. This study examines the three-part relationship among DSM panel members, principal investigators (PIs) of clinical trials for new DSM-5 diagnoses, and drug companies. Methods: Financial conflicts of interest (FCOI) of DSM panel members responsible for some new diagnoses in the DSM-5 and PIs of clinical trials for related drug treatments were identified. Trials were found by searching ClinicalTrials.gov. Patent and revenue information about these drugs was found using the US Food and Drug Administrations Orange Book and manufacturer Annual Reports. Results: Thirteen trials met inclusion criteria (testing drugs for some new DSM disorders). Sixty-one percent of the DSM Task Force members and 27% of Work Group members reported FCOI to the trial drug manufacturers. In 5 of the 13 trials (38%), PIs reported ties other than research funding to the drug manufacturer. In 3 of the trials (23%), a PI had financial ties to the drug manufacturer and was also a DSM panel member who had decision-making authority over the revision process. Conclusions: These findings suggest that increased transparency (e.g., registration on ClinicalTrials.gov) and mandatory disclosure policies (e.g., the American Psychiatric Associations disclosure policy for DSM-5 panel members) alone may not be robust enough strategies to prevent the appearance of bias in both the DSM revision process as well as clinical decisions about appropriate interventions for DSM disorders.

From caveat emptor to caveat venditor: time to stop the influence of money on practice guideline development

Associate Professor, Doctoral Student, University of Massachusetts Boston, Boston, MA, USA Network Fellow, Edmond J. Safra Center for Ethics, Harvard University, Cambridge, MA, USA Professor, Department of Family Medicine, Tufts University School of Medicine, Boston, MA, USA Professor, Department of Urban and Environmental Policy and Planning, Tufts University, Malden, MA, USA Visiting Professor, Department of Philosophy and Honors Academy, Brooklyn College, Brooklyn, NY, USA Professor, School of Health Policy and Management, York University, Toronto, Ontario, Canada doi:10.1111/jep.12244

Conflict of Interest Policies and Industry Relationships of Guideline Development Group Members: A Cross-Sectional Study of Clinical Practice Guidelines for Depression.

ABSTRACT Because of increased attention to the issue of trustworthiness of clinical practice guidelines, it may be that both transparency and management of industry associations of guideline development groups (GDGs) have improved. The purpose of the present study was to assess a) the disclosure requirements of GDGs in a cross-section of guidelines for major depression; and, b) the extent and type of conflicts of panel members. Treatment guidelines for major depression were identified and searched for conflict of interest policies and disclosure statements. Multi-modal screens for undeclared conflicts were also conducted. Fourteen guidelines with a total of 172 panel members were included in the analysis. Eleven of the 14 guidelines (78%) had a stated conflict of interest policy or disclosure statement, although the policies varied widely. Most (57%) of the guidelines were developed by panels that had members with industry financial ties to drug companies that manufacture antidepressant medication. However, only a minority of total panel members (18%) had such conflicts of interest. Drug company speakers bureau participation was the most common type of conflict. Although some progress has been made, organizations that develop guidelines should continue to work toward greater transparency and minimization of financial conflicts of interest.

Sexual Minority Families of Choice and Family Networks: We Are Family

In the lesbian, gay, bisexual, transgender, and queer (LGBTQ) community, the concept of ‘family’ has different meanings. Historically the right to form a traditional family (e.g., two parents and children) with associated legal rights and protections has not been an option for LGBTQ couples. In the absence of formal family arrangements, LGBTQ individuals have created their own family and community structures. Yet, over time, steps have been taken to create and legitimize family rights for LGBTQ people, and as social and political attitudes and norms have changed and laws and policies followed suit, so has the ability of LGBTQ individuals to form legally recognized family structures.