Carl Elliott

Ghost Marketing: Pharmaceutical Companies and Ghostwritten Journal Articles

The use of ghostwriters by industry is subject to increasing public attention and scrutiny. This article addresses the practice and ethics of scientific ghostwriting. We focus on the type of ghostwriting that involves a pharmaceutical company hiring a medical education and communications company to write a paper favorable of their product, who then hires a well-known academic to publish it under his or her name without disclosing the papers true origins. We argue that this practice is harmful both to the public and to the institutions of science and that it is not justified by an analogy to accepted scientific authorship practices. Finally, we consider ways to discourage the practice.

Moral Agency and the Family: The Case of Living Related Organ Transplantation

Living related organ transplantation is morally problematic for two reasons. First, it requires surgeons to perform nontherapeutic, even dangerous procedures on healthy donors—and in the case of children, without their consent. Second, the transplant donor and recipient are often intimately related to each other, as parent and child, or as siblings. These relationships challenge our conventional models of medical decisionmaking. Is there anything morally problematic about a parent allowing the interests of one child to be risked for the sake of another? What exactly are the interests of the prospective child donor whose sibling will die without an organ? Is the choice of a parent to take risks for the sake of her child truly free, or is the specter of coercion necessarily raised?

Guinea Pigs on the payroll: The ethics of paying research subjects

Regulatory bodies and scholars have traditionally conceptualized biomedical research on healthy subjects in the same way as research on patients. Guidelines and regulations have portrayed payment to a healthy subject as a potential constraint, or “undue influence,”; on the subjects free consent. In this essay we suggest an alternative way of conceptualizing research on healthy subjects, which sees the basic issue not as one of undue influence but as one of justice. Healthy subjects generally enroll in research protocols not for humanitarian reasons but for the money they will receive. Many of these protocols are conducted by profit‐driven corporations. Yet current guidelines and regulations prohibit subjects from negotiating for fair payment for the risks, discomforts and inconveniences they undergo, and IRBs are not staffed adequately to monitor the subjects safety. We propose to remedy the situation by regulating payment to healthy subjects as a labor relation.

Pursued by Happiness and Beaten Senseless: Prozac and the American Dream

Since the publication of Listening to Prozac there have been many debates about how and why Prozac and other similar drugs are prescribed. The articles that follow take up debates about what conditions such drugs can and should address, questions about authenticity in using drugs for psychic well-being, and concerns about what means we morally endorse in projects of self-creation. The contributions from Carl Elliott, Peter Kramer, James Edwards, and David Healy derive from a project supported by the Social Sciences and Humanities Research Council of Canada, “Enhancement Technologies and Human Identity.” Psychiatry, like the Prozac it prescribes, aims to enhance the patients internal psychic well-being. Yet what ails many may be not an internal state like depression or anxiety, but alienation. And the experts of the self to whom we turn cannot “cure” our collective form of life in which alienation takes root.

Exploiting a Research Underclass in Phase 1 Clinical Trials

Paying study subjects is not a new practice, but neither is it uncontroversial. Dr. Carl Elliott and Roberto Abadie ask, is it ethically problematic to pay poor people to test the safety of new drugs?

Doing harm: living organ donors, clinical research and The Tenth Man.

This paper examines the ethical difficulties of organ donation from living donors and the problem of causing harm to patients or research subjects at their request. Graham Greene explored morally similar questions in his novella, The Tenth Man.

Justice for the Professional Guinea Pig

(2001). Justice for the Professional Guinea Pig. The American Journal of Bioethics: Vol. 1, No. 2, pp. 51-53.

Improving Detection of Suicidal Ideation Among Depressed Patients in Primary Care

PURPOSE Primary care clinicians have difficulty detecting suicidal patients. This report evaluates the effect of 2 primary care interventions on the detection and subsequent referral or treatment of patients with depression and recent suicidal ideation. METHODS Adult patients in 12 mixed-payer primary care practices and 9 not-for-profit staff model health maintenance organization (HMO) practices were screened for depression. Matched practices were randomized within plan type to intervention or usual care. The intervention for mixed-payer practices entailed brief training of physicians and office nurses to provide care management. The intervention for HMO practices consisted of guided development of quality improvement teams for depression care. A total of 880 enrolled patients met study criteria for depression, 232 of whom met criteria for recent suicidal ideation. Intervention effects on suicide detection and referral to mental health specialty care were evaluated with mixed-effects multilevel models in intent-to-treat analyses. RESULTS Depressed patients with recent suicidal ideation were detected on 40.7% of index visits in intervention practices, compared with 20.5% in usual care practices (odds ratio = 2.64, 95% confidence interval, 1.45–5.07), with HMO plan type and male sex associated with detection. The interventions had no effect on referral of patients, starting an antidepressant, or suicidal ideation reported at a 6-month follow-up, although power was limited for all 3 analyses. CONCLUSIONS Primary care interventions to improve depression care can improve detection of recent suicidal ideation. Further work is needed to improve physician response to detection, including referral to specialty care and more aggressive treatment, and to observe the effect on outcomes.

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

Pulling the plug on futility

If the fashionableness of a new idea can be measured by the number of publications it generates these are piping times for the idea of “medical futility.” As it has been developed in the medical literature futility provides a basis for doctors to refuse demands for treatment from patients and families. According to the results of a Medline search, articles on futility have undergone a small scale population explosion: two articles in 1987, five in 1990, and 23 in 1993. As with any new intellectual tack, after the initial intoxication has begun to wear off we must ask soberly: “Are we any further ahead?” The idea of futility is admittedly seductive. Over the past few years the familiar “right to die” issue has been turned on its head. Rather than refusing life sustaining treatment in the face of intransigent doctors, patients (and their surrogates) have begun to demand treatment that doctors are reluctant to provide, either because its efficacy is questionable or, more problematically, because it serves goals that the doctors are reluctant to endorse. The most contentious of these cases have been those in which families have asked for aggressive life sustaining treatment for anencephalic children1 or patients in …