1 Boring Old Man

POGO Letter to NIH on Ghostwriting Academics
Project on Government Oversight

by Danielle Brian, Executive Director and Paul Thacker, Investigator
November 29, 2010

Drs. Dwight Evans and Dennis Charney
NIH funding since FY 2006: $30.6 million
NIH funding FY 2010: $10,929,790

According to the documents, Sally Laden of STI wrote an editorial for Biological Psychiatry in 2003 for Drs. Dwight Evans, Chairman of the Department of Psychiatry at the University of Pennsylvania School of Medicine, and Dennis Charney, then an employee at the NIH and now Dean of Research at the Mt. Sinai School of Medicine at New York University.

In an email to a GSK employee, Ms. Laden wrote, “Is there a problem with my invoice for writing Dwight Evans’ editorial for the [Depression and Bipolar Support Alliance]’s comorbidity issue to Biological Psychiatry?” [Attachment B] Yet, when published, the “authors” Evans and Charney only stated, “We acknowledge Sally K. Laden for editorial support.” [Attachment C]

According to the NIH Reporter database of grants, Dr. Evans is the primary investigator on two NIH grants. The funding for these grants in 2010 is $940,450. Dr. Charney is the primary investigator on one NIH grant, whose funding in 2010 is $9,989,340. Over the last five years, the NIH has given both researchers $30.6 million in grants.

The article could easily be summarized, "When people are very sick, they are depressed and unhappy." That wouldn’t have made a very good editorial. Instead, the way this is written – depression or unhappiness is not something that’s part of the human experience of medical illness, it’s an entity ["mood disorder"] that is "comorbid" with the illness. It’s a way of talking that takes an experience of living, objectifies it, and discusses it as a public health problem that must be detected and treated. The "bidrectional" piece has to do with depression making the physical illness worse, like treating it might make your cancer better and not treating it might make it worse. And what does treating it mean? It’s in the first line, "Despite efficacious and widely available antidepressants and psychotherapeutic interventions…" I suspect that "psychotherapeutic interventions" means Cognitive Behavior Therapy. We all know that "widely available antidepressants" means drugs, like SSRIs, like Paxil. This editorial [and whole issue] is about encouraging medical physicians to put physically ill people on antidepressants. It’s a drug ad, plain and simple. "The relationship between depression and medical illnesses is complex. A chronically ill patient who also is clinically depressed may experience enhanced morbidity, a poorer prognosis, and even increased mortality from the medical diagnosis." Most people think that kind of thing anyway, so it passes muster here without documentation.

EDITORIAL
Mood Disorders and Medical Illness: A Major Public Health Problem

^{Despite efficacious and widely available antidepressants and psychotherapeutic interventions, the psychosocial and medical burden of depression is increasing. In fact, the World Health Organization projects that depression will continue to be prevalent, and by the year 2020, will remain a leading cause of disability, second only to cardiovascular disease [Michaud et al 2001]. Although we do not know with certainty why rates and disability associated with depression are increasing, it is likely that this mood disorder continues to be remarkably under-recognized and under-treated. Depression frequently occurs in the context of chronic medical illness, and it is only relatively recently that the research community has turned its attention to the relationship between depression and chronic medical conditions. However, there is much work yet to be done. The recently released Institute of Medicine report [2003] acknowledged depression as one of a number of chronic conditions that requires priority action, but did not address the importance of comorbid depression and medical illness. The relationship between depression and medical illnesses is complex. A chronically ill patient who also is clinically depressed may experience enhanced morbidity, a poorer prognosis, and even increased mortality from the medical diagnosis. Simply put, depression makes everything worse. But the association with depression goes beyond the effects of comorbidity on the course and outcome of a medical illness. A burgeoning body of evidence has now demonstrated that the relationship between depression and certain medical illnesses may indeed be bidirectional in nature. Depression may be both a cause and a consequence of some medical illnesses, such as cardiovascular disease, stroke, HIV/AIDS, cancer, and epilepsy.}

^{In recognition of the need to increase awareness about this topic and improve the quality of life for persons with depression, the Depression and Bipolar Support Alliance, the world’s largest patient advocacy organization, convened a two-day, multidisciplinary consensus conference on November 12, 2002 in Washington, DC. Nearly 50 experts in the fields of psychiatry, cardiology, immunology, oncology, neurology, endocrinology, internal medicine, family medicine, federal health care agency policy and research, and patient advocacy participated in this process. Formal presentations centered around the perspectives and goals of the National Institutes of Health and the Food and Drug Administration, the personal and societal burden of depression and medical illness, and the epidemiology, mechanisms, diagnosis, treatment, and prognosis of depression in the context of cardiovascular disease, cancer, HIV/AIDS, stroke, neurologic diseases, diabetes, osteoporosis, obesity, and chronic pain. Workgroups met to discuss specific issues related to these topics and on the second day, workgroup leaders presented their findings and facilitated open discussions from the group.}

^{Burden of Mood Disorders and Medical Illness
The functional impairment associated with depression contributes significantly to the economic burden of chronic medical illness. Depression also is becoming recognized as a cause of increased morbidity and mortality in chronic medical illness. As reviewed by Katon [2003], medical costs for patients with major depression are approximately 50% higher than the costs of chronic medical illness alone. In addition, Katon [2003] underscores the equally important, but often less appreciated, effects of depression on adverse health behaviors, such as smoking, unhealthy diet, sedentary lifestyle, and poor adherence to medical regimens [e.g., cardiac rehabilitation]. The findings from a number of studies have established that major depression is associated with significant functional impairment, lost work productivity, occupational disability, and increased health care resource utilization, and that effective treatment restores functioning.}

^{Simon [2003] reviews these data in the context of evidence from recent cross-sectional, longitudinal, and treatment studies of depressed patients with and without arthritis, chronic obstructive pulmonary disease, diabetes, or heart disease. This emerging body of evidence demonstrates that depression significantly increases the burden of functional impairment in medical illness, and that treatment reduces disability and health service costs. The effect of other mood disorders, such as dysthymia or bipolar disorder, on the burden of chronic medical illness is remarkably understudied.}

^{Cardiovascular Disease…}

^Cancer…

^HIV/AIDS…

^{Neurologic Disease…}

^{Call for Action}

^{The contributions made by this conference and the papers published in this special issue of Biological Psychiatry should not simply be measured by the quality and quantity of the data, which are impressive. Rather, the strength of this publication also lies in the fact that the views of experts from widely divergent fields of clinical and scientific endeavor resonate along 4 basic themes:}

^{[1] Depression is very common in chronic medical illness;}

^{[2] Comorbidity with depression inevitably hinders recovery and worsens prognosis;}

^{[3] Medical illness is a risk factor for depression because of psychosocial stressors, functional impairment, and other biological mechanisms (e.g., Parkinson’s disease);}

^{[4] Depression may figure prominently as an etiologic factor in the onset and course of medical illness, particularly cardiovascular disease, stroke, HIV/AIDS, cancer, and epilepsy.}

^{The latter observation is truly remarkable. Much more research is needed to better understand this bidirectional relationship and identify possible common pathogenic, mechanistic pathways that link depression and serious medical illness. These are powerful messages that must not be ignored. The weight of evidence is so persuasive that there should never again be a valid reason for not aggressively seeking out and treating depression in medically ill patients. Increasing awareness, reducing stigma, and maintaining a high level of vigilance for depression in medically ill patients must become a priority for clinicians. In addition, the efforts of the research communities must continue to better elucidate the prevalence, risk profile, diagnostic criteria, treatment, and biological underpinnings of the comorbid relationship between depression and medical illness. Only by furthering research efforts and aggressively diagnosing and treating depression, will we be able to achieve substantive gains in health care and in our patients’ quality of life.}

^{Dwight L. Evans
Department of Psychiatry
University of Pennsylvania School of Medicine…}

^{Dennis S. Charney
Mood and Anxiety Disorders Research Program
National Institute of Mental Health
Bethesda, Maryland}

I’ve come to hate hearing people talk like this. It’s not that I disagree that people in the throes of serious or terminal illness often need help with their psyche. They’re in a frightening, frustrating place in their lives, often a place they’ve never been before and don’t know how to be there. They’re surrounded with family and friends who want to help and don’t know how. And there’s a medical loneliness known to anyone who has been seriously ill. Occasionally, psychiatric medications are helpful, but "antidepressants" aren’t the first choice. They aren’t very helpful, at least in my experience. They are for another kind of suffering. Many sick people need to learn to talk a new way, accessing emotions often not acknowledged, transcending social niceties and speaking more directly, talking about their feelings without fearing that they will drive others away or cause them pain, talking about death or the difficulty of a limited life. It’s very rewarding work, helping the medically ill. But it’s not a Public Health problem, it’s an individual human problem – an existential problem.