Pharmacy Administration, Policy and Regulation Commons^™

Tripartite Conflicts Of Interest And High Stakes Patent Extensions In The Dsm-5, Lisa Cosgrove, Sheldon Krimsky, Emily E. Wheeler, Jenesse Kaitz, Scott B. Greenspan, Nicole L. Dipentima

Counseling and School Psychology Faculty Publication Series

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 …

Drug Firms, The Codification Of Diagnostic Categories, And Bias In Clinical Guidelines, Lisa Cosgrove, Emily E. Wheeler

Counseling and School Psychology Faculty Publication Series

The profession of medicine is predicated upon an ethical mandate: first do no harm. However, critics charge that the medical profession’s culture and its public health mission are being undermined by the pharmaceutical industry’s wide-ranging influence. In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests. Moving beyond a conflict-of-interest model, we use the conceptual and normative framework of institutional corruption to examine how organized psychiatry’s dependence on drug firms has distorted science. We suggest that academic-industry relationships have led to the corruption of …

Conflicts Of Interest And The Quality Of Recommendations In Clinical Guidelines, Lisa Cosgrove, Allen F. Shaughnessy, Deborah R. Erlich, Emily E. Wheeler, Harold J. Bursztajn

Counseling and School Psychology Faculty Publication Series

Background: There is increasing concern that conflicts of interest affect the development process of clinical practice guidelines. We evaluated The American Psychiatric Association's Practice Guideline for the Treatment of Patients with Major Depressive Disorder to determine the existence of financial and intellectual conflicts of interest and examine their possible effects. We selected this guideline because of its influence on clinical practice and because this guideline recommends pharmacotherapy for all levels of depression, despite controversies over the evidence base.

Methods and Findings: We determined the number and type of financial conflicts of interest for members of the guideline development group as …

Finding Solutions To Institutional Corruption: Lessons From Cognitive Dissonance Theory, Lisa Cosgrove, Robert Whitaker

Counseling and School Psychology Faculty Publication Series

The American Psychiatric Association and academic psychiatry in the United States have two conflicts of interest that may affect their assessment of psychiatric drugs and their development of diagnostic and clinical care guidelines: payments from pharmaceutical companies and guild interests. Until recently, the proposed solution to industry-academic relationships has been transparency. However, cognitive dissonance research reveals that disclosure is not a solution because cognitive biases are commonplace and difficult to eradicate. Indeed, bias is most often manifest in subtle ways unbeknownst to the researcher or clinician, and thus is usually implicit and unintentional. Also, recent studies suggest that disclosure of …

Warum Gesunde Menchen Immer Häufiger Fur Psychisch Krank Erklärt Werden, Lisa Cosgrove

Counseling and School Psychology Faculty Publication Series

zuerst einmal nicht schaden": Das ist der wohl wichtigste Grundsatz der Medizin. Aber diese Mission droht durch den Einfluss großer Pharmafirmen unterhöhlt zu werden. Der Vorwurf einer Verstrickung von Ärzten und Arzneimittelherstellern ist schon in fast allen medizinischen Fachrichtungen aufgekommen. Vor allem aber die Psychiatrie steckt in einer Glaubwürdigkeitskrise. Das zeigt sich in der aktuellen Debatte um die neue Auflage des "Diagnostischen und Statistischen Manual Psychischer Störungen" (DSM).

Dieses von der US-Psychiater-Vereinigung APA herausgegebene Handbuch definiert, was eine psychische Erkrankung ist. Die Bedeutung dieser Wertung geht weit über die USA hinaus - das Handbuch nimmt oft Definitionen der Weltgesundheitsorganisation vorweg. …

Industry’S Colonization Of Psychiatry: Ethical And Practical Implications Of Financial Conflicts Of Interest In The Dsm-5, Lisa Cosgrove, Emily E. Wheeler

Counseling and School Psychology Faculty Publication Series

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 …

Opinion: Bias Is Unavoidable, Lisa Cosgrove

Counseling and School Psychology Faculty Publication Series

It is part of the human condition to have implicit biases—and remain blissfully ignorant of them. Academic researchers, scientists, and clinicians are no exception; they are as marvelously flawed as everyone else. But it is not the cognitive bias that’s the problem. Rather, the denial that there is a problem is where the issues arise. Indeed, our capacity for self-deception was beautifully captured in the title of a recent book addressing researchers’ self-justificatory strategies, Mistakes Were Made (But Not by Me).

The American Psychiatric Association’S Guideline For Major Depressive Disorder: A Commentary, Lisa Cosgrove, Allen F. Shaughnessy, Emily E. Wheeler, Kirsten E. Austad, Irving Kirsch, Harold J. Bursztajn

Counseling and School Psychology Faculty Publication Series

The American Psychiatric Association (APA) published a new guideline for Major Depressive Disorder (MDD) which will undoubtedly be used by many practitioners to guide clinical decision-making. In fact, it is non-psychiatrist clinicians who prescribe the majority of antidepressants (AD). We review the APA’s most recent guideline on MDD and report on our observations.

A Comparison Of Dsm-Iv And Dsm-5 Panel Members’ Financial Associations With Industry: A Pernicious Problem Persists, Lisa Cosgrove, Sheldon Krimsky

Counseling and School Psychology Faculty Publication Series

All medical subspecialties have been subject to increased scrutiny about the ways by which their financial associations with industry, such as pharmaceutical companies, may influence, or give the appearance of influencing, recommendations in review articles and clinical practice guidelines. Psychiatry has been at the epicenter of these concerns, in part because of high-profile cases involving ghostwriting and failure to report industry-related income, and studies highlighting conflicts of interest in promoting psychotropic drugs. The revised 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 …

Dynamic Informed Consent Processes Vital For Treatment With Antidepressants, Abilash A. Gopal, Lisa Cosgrove, Itay Shuv-Ami, Emily E. Wheeler, Melissa J. Yerganian, Harold J. Bursztajn

Counseling and School Psychology Faculty Publication Series

Advances in technology and transparency have greatly accelerated the ability of clinicians to remain current with regards to being informed and informing patients about the risk/benefit ratio when considering antidepressant medication. In spite of this, the current climate of pharmaceutical industry influence on medical practice does much to hinder informed consent processes. Recent findings of previously unknown and potentially dangerous adverse effects of the second- and third-generation classes of antidepressants underscore the importance of enhancing the practice of informed consent. After considering the concept of informed consent as it has evolved over time, the authors summarize some of the newer …

The Role Of Situated Learning In Experiential Education: An Ethnographic Study Of The Knowledge-Construction Process Of Pharmacy Students During Their Clinical Rotations, Paul Difrancesco

Graduate Doctoral Dissertations

The purpose of this study was to explore learning through the social construction of new knowledge by pharmacy students engaged in experiential learning. Academic leaders and practitioners are responding to calls for the redesign of experiential education that will better prepare future pharmacists for practice. This has broad implications for educational programs and health care delivery.

Situated learning theory served as the theoretical framework for this study. The previous research of Lave and Wenger (1991); Bailey, Hughes, and Moore (2004); and others guided this research. Situated learning theory informed the research questions, which focused on understanding how students constructed knowledge …

Conflicts Of Interest In Clinical Practice Guidelines, Lisa Cosgrove, Allen F. Shaughnessy

Counseling and School Psychology Faculty Publication Series

Clinical practice guidelines are used increasingly across medical specialties and settings, making evaluation of their utility and validity a critical public health issue. In this paper, we describe some of the challenges that specialty organizations face as they try to ensure that their guidelines are trustworthy and useful. We examine the practice guidelines for Major Depressive Disorder recently published by the American Psychiatric Association (APA), identify five sources of potential bias that may affect the guideline development process and offer suggestions based on our review. For example, even for mild depression, this guideline privileges pharmacotherapy over other interventions, despite questions …

Diagnosing Conflict-Of-Interest Disorder, Lisa Cosgrove

Counseling and School Psychology Faculty Publication Series

In June 2010, the Association of American Medical Colleges issued the third and final portion of its conflict-of-interest policy initiatives. The task force on “Conflicts of Interest in Clinical Care” did not mince words when it described the impetus for these initiatives: “It is imperative that the possibility or perception of [financial conflict of interest] be advertently examined and appropriately evaluated to ensure that academic medicine in all of its missions is fundamentally dedicated to the welfare of patients and the improvement of public health.”

This report is especially timely because of recent questions raised by investigative journalists and policy …

Psychiatric Taxonomy, Psychopharmacology And Big Pharma, Lisa Cosgrove

Counseling and School Psychology Faculty Publication Series

Clinicians practicing today need to be aware of the ways in which the current industry-dominated climate may undermine the integrity of the scientific process and, thus, may compromise patient care. In the mental health field, corporate sponsorship bias can affect psychiatric taxonomy and clinical Practice Guidelines (CPG). Financial conflicts of interest (FCOI) can occur when there are financial associations between researchers, authors, or panel members developing psychiatric diagnostic and treatment guidelines, and the pharmaceutical industry, or when randomized clinical trials (RCTs) are industry funded. Therefore, clinicians need to be especially vigilant about the informed consent process when patients are prescribed …

Undue Pharmaceutical Influence On Psychiatric Practice, Lisa Cosgrove, Harold J. Bursztajn

Counseling and School Psychology Faculty Publication Series

Within the past few years, increasing concerns have arisen about the ways in which corporate sponsorship of clinical trials and continuing medical education activities may bias the information that is published and disseminated about the benefits and risks of medications. Questions have also been raised about the extent of industry influence on the American Psychiatric Association’s diagnostic and treatment guidelines—namely, its DSM and Clinical Practice Guidelines.

Pharmaceutical Philanthropic Shell Games, Lisa Cosgrove, Harold J. Bursztajn

Counseling and School Psychology Faculty Publication Series

In response to increasing public distrust and congressional concerns regarding pharmaceutical company influence on medical research and education, professional organizations have taken steps to phase out or regulate industry-sponsored educational support. A related problem is industry funding of philanthropic organizations, such as patient advocacy groups. Thus, when the office of Sen Charles Grassley (R-Iowa) recently reported that the National Alliance for the Mentally Ill received substantial pharmaceutical funding, there was concern among the membership’s psychiatric patients and their families.

Toward Credible Conflict Of Interest Policies In Clinical Psychiatry, Lisa Cosgrove, Harold J. Bursztajn

Counseling and School Psychology Faculty Publication Series

A recent letter to the American Psychiatric Association (APA) from Sen Chuck Grassley about the APA’s financial relationship with pharmaceutical companies raises concerns about undue industry influence. By instituting a disclosure policy for DSM-V, the APA took a halting first step in restoring public trust in the most influential text on psychiatric taxonomy in the world. Unfortunately, the APA’s efforts at creating a conflict of interest (COI) policy have failed to ensure that the process for revising diagnostic and therapeutic guidelines is one that the public can trust. The need for more safeguards was evidenced when the APA reported that …