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-ofinterest 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 the evidence base upon which accurate diagnosis and sound treatment depend. We describe the current dependency corruption and argue that transparency alone is not a solution — and sometimes even produces iatrogenic effects. Furthermore, we argue that the corruption of the evidence base for diagnostic and practice guidelines renders obsolete the traditional informed consent process, and we offer suggestions for reforming this process. (shrink)

The Food and Drug Administration authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as off-label prescribing. This occurs (...) when physicians prescribe a drug for a therapeutic purpose other than the one approved by the FDA; treat patients in a different age cohort or gender than the population on which it was tested; or prescribe a different dose, for a different duration of use, or a different mode of administration than indicated on the label. (shrink)

Post-industrial societies confront common problems in pharmaceutical industry-physician relations. In order to promote sales, drug firms create financial relationships that influence physicians' prescriptions and sometimes even reward physicians for prescribing drugs. Three main types exist: kickbacks, gifts, and financial support for professional activities. The prevalence of these practices has evolved over time in response to changes in professional codes, law, and markets. There are certainly differences among these types of ties, but all of them can compromise physicians' independent judgment and (...) rational prescribing.Drug firms have paid kickbacks for prescribing drugs, purchasing drugs, switching brands prescribed, adding a drug to a hospital formulary, enrolling patients in post-marketing clinical trials, and writing practice guidelines that encourage the use of certain drugs. (shrink)

The pharmaceutical industry, in its marketing efforts, often turns to “key opinion leaders” or “KOLs” to disseminate scientific information. Drawing on the author's fieldwork, this article documents and examines the use of KOLs in pharmaceutical companies’ marketing efforts. Partly due to the use of KOLs, a small number of companies with well-defined and narrow interests have inordinate influence over how medical knowledge is produced, circulated, and consumed. The issue here, as in many other cases of institutional corruption, is that a (...) few actors have accumulated the power to shape the information on which many others base their decisions. Efforts to address this corruption should focus on correcting large imbalances in the current political economy of medical knowledge. A sequestration of pharmaceutical research and development on one hand from pharmaceutical marketing on the other, though difficult to achieve, would address this and many other problems. (shrink)

This article compares the means that the United States, France, and Japan use to oversee pharmaceutical industry-physician financial relationships. These countries rely on professional and/or industry ethical codes, anti-kickback laws, and fair trade practice laws. They restrict kickbacks the most strictly, allow wide latitude on gifts, and generally permit drug firms to fund professional activities and associations. Consequently, to avoid legal liability, drug firms often replace kickbacks with gifts and grants. The paper concludes by proposing reforms that address problems that (...) persist when firms replace kickbacks with gifts and grants based on the experience of the three countries. (shrink)

The possibility that industry is exerting an undue influence on the culture of medicine has profound implications for the profession's 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 psychiatry's 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. (shrink)

Prescribing drugs for uses that the FDA has not approved — off-label drug use — can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the (...) cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers’ conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. (shrink)

Why do physicians have financial conflicts of interest? They arise because society expects physicians to act in their patients’ interest, while simultaneously, financial incentives encourage physicians to practice medicine in ways that promote their own interests or those of third parties. Because physicians’ clinical choices, referrals, and prescriptions affect the fortune of third parties (providers, medical facilities, insurers, drug firms and suppliers of ancillary services), these third parties may offer physicians financial incentives to make income-driven clinical choices. In the past, (...) physicians and scholars typically conceived of conflicts of interest as an ethical issue to be resolved according to individual judgment or professional and organizational norms. However, society can mitigate or eliminate conflicts of interest by changing financial and organizational arrangements in medicine. Conflicts of interest, therefore, are as much matters of public policy and management as individual choices or social norms. (shrink)