Bioethics and Medical Ethics 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, School Psychology & Sport 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, School Psychology & Sport 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 …

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

Counseling, School Psychology & Sport 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, School Psychology & Sport 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, School Psychology & Sport 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).

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, School Psychology & Sport 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 …

Diagnosing Conflict-Of-Interest Disorder, Lisa Cosgrove

Counseling, School Psychology & Sport 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 …

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

Counseling, School Psychology & Sport 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, School Psychology & Sport 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, School Psychology & Sport 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 …

Genetic Testing: A Cautionary Tale Of Foster And Pre-Adoptive Children, Janet Farrell Smith

New England Journal of Public Policy

Genetic testing of children in the foster care and pre-adoptive stage may be thought to facilitate child placement and satisfy prospective parents’ need to know. But, the policy analysis in this paper recommends great caution, especially given eugenic attitudes in the history of adoption and the risk of creating a second tier of un-adoptable children. Testing should be done only when two conditions are satisfied: test information is medically useful for childhood onset diseases; test information supports and does not diminish the child’s access to present and future healthcare (or the child’s future insurability). Public policy needs to make a …

Editor's Note, Padraig O'Malley

New England Journal of Public Policy

This issue of the journal can be summed up in one word: provocative. At least two articles break new ground. Anthony Robbins and Phyllis Freeman explore the ways in which environmentally oriented public health is uniquely suited to help organized medical care in providing health and in restraining expenditures. Janet Farrell Smith challenges policymakers to look at what will soon become a hot issue — the medical use of genetic information. The genetic testing of children, now becoming prevalent in the foster care and pre-adoptive stage in order to facilitate placement and satisfy prospective parents’ “need to know,” is already …

Environmental Public Health Awaits Rediscovery, Anthony Robbins, Phyllis Freeman

New England Journal of Public Policy

Preventing environmental exposures that threaten human health remains among the best but least attended to opportunities to improve everyone’s health. For more than a decade, medical care concerns, exacerbated by voracious competition among medical empires and the implacably growing number of uninsured, have often been misconstrued as constituting a complete agenda for health system reform. The authors explain the predicament from an historical perspective — how defining events moved U.S. health policy away from protecting the public against dangerous exposures toward unrealistic expectations that doctors will fix whatever goes wrong, at least for individuals with ample medical insurance. They explain …

Ethnic Minorities And Mental Health: Ethical Concerns In Counseling Immigrants And Culturally-Diverse Groups, Gemima M. Remy

Trotter Review

Between 1980 and 1990 nearly 9 million foreign-born individuals migrated to the United States. In 1993, the Immigration and Naturalization Service recorded the entry of over 900,000 immigrants and refugees. This figure is believed to be higher given the estimated 1.5 to 2.5 million people who enter this country illegally each year. Currently, ethnic minority groups make up one-fourth of the United States population. It is estimated that by the year 2000, one-third of the U.S. population will be comprised of ethnic minorities. As the population of the United States becomes increasingly diverse, considerable attention is being directed to a …

The Aids Epidemic: A Prism Distorting Social And Legal Principles, Alec Gray

New England Journal of Public Policy

The AIDS epidemic is affecting American society in far-reaching and unexpected ways. It touches our institutions, our value systems, and our private lives. Social issues seem to change and become distorted by the epidemic 's prismlike effect. This article examines some of the major public health issues raised by the epidemic, ranging from testing to contact tracing and quarantine. It argues that while the civil rights of individuals may have to be sacrificed to stem the spread of the disease, those rights should not be abandoned unless a clear benefit to the public health would result.

Issues of discrimination in …

Ethical Issues In Aids Research, Michael A. Grodin, Paula V. Kaminow, Raphael Sassower

New England Journal of Public Policy

There is a need for carefully controlled and scientifically rigorous research studies of the acquired immunodeficiency syndrome (AIDS). The morbidity and mortality associated with AIDS patients and the public health concerns for control of this epidemic have distorted the usual process of research. The Institutional Review Board at Boston City Hospital is suggested as an appropriate mechanism for clarifying the distinctions between research and innovative therapies and for assuring the protection of this vulnerable population of research subjects. This article addresses ethical concerns relating to the time frame of research, drug and antibody testing, vaccine trials, and questions of justice …

Hiv Antibody Screening: An Ethical Framework For Evaluating Proposed Programs, Ronald Bayer, Carol Levine, Susan M. Wolf

New England Journal of Public Policy

The acquired immunodeficiency syndrome (AIDS) poses a compelling ethical challenge to medicine, science, public health, the legal system, and our political democracy. This report focuses on one aspect of that challenge: the use of blood tests to identify individuals who have been infected with the retrovirus human immunodeficiency virus (HIV). In this article, we follow the terminology recently proposed by the International Committee on the Taxonomy of Viruses; that is, we use the term human immunodeficiency virus. This replaces the more cumbersome dual terminology of human T-cell lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV).

The issue is urgent: the tests are …