In September 2006, a small start-up company in Cambridge, MA called Sermo, Inc., launched a social networking site with an unusual twist: only physicians practicing medicine in the United States would be allowed to participate. Sermo, which means “conversation” in Latin, marketed its website as an online community exclusively for doctors that would allow them to talk openly about a range of topics, from challenging and unusual medical cases to the relative merits of one treatment versus another. “Sermo enables the (...) private and instant exchange of knowledge among MDs,” the company announced in its first press release. Even better, participation was free and the site carried no advertising. (shrink)

The point, for the 946,326th time is that people get elected to office by currying the favor of powerful interest groups. They don’t get elected for their excellence as political philosophers.Congress has consistently failed to solve some serious problems with the cost, effectiveness, and safety of pharmaceuticals. In part, this failure results from the pharmaceutical industry convincing legislators to define policy problems in ways that protect industry profits. By targeting campaign contributions to influential legislators and by providing them with selective (...) information, the industry manages to displace the public’s voice in developing pharmaceutical policy. (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)

To sell a new drug, pharmaceutical companies must discover a compound, run clinical trials to test its efficacy and safety, get it approved by regulatory bodies, produce the drug, and market it. As this process brings the drug through so many hands, there are risks of many kinds of corruption. The pharmaceutical industry has recently gone from being one of the most admired industries to being described by the majority of Americans as “dishonest, unethical, and more concerned with profits than (...) with individual and public health.” Legal scholar Marc Rodwin suggested that the pharmaceutical industry can be viewed through the lens of institutional corruption as defined by legal scholar Lawrence Lessig, whereby widespread or systemic practices undermine the main purposes of drug therapy — healing illness, preventing medical problems, and alleviating suffering. Many drugs do serve these goals, yet a significant number of drugs churned out by pharmaceutical companies are ineffective or have dangerous side effects that could have been predicted had the companies conducted the appropriate research. (shrink)

It is easier to resist at the beginning than at the end.– Leonardo da VinciPhysicians often believe that a conscious commitment to ethical behavior and professionalism will protect them from industry influence. Despite increasing concern over the extent of physician-industry relationships, physicians usually fail to recognize the nature and impact of subconscious and unintentional biases on therapeutic decision-making. Pharmaceutical and medical device companies, however, routinely demonstrate their knowledge of social psychology processes on behavior and apply these principles to their marketing. (...) To illustrate how pharmaceutical marketing strategies use psychological techniques to promote targeted therapies, we draw on the relevant social psychology literature on conflicts of interest and on the six principles of influence articulated by the eminent social psychologist Robert Cialdini. Hospitals, professional organizations, medical educators, and other stakeholders must also draw on social psychology to respond effectively to commercial activities that compromise good medical practice. (shrink)

Why, when confronted with policy alternatives that could improve patient care, public health, and the economy, does Congress neglect those goals and tailor legislation to suit the interests of pharmaceutical corporations? In brief, for generations, the pharmaceutical industry has convinced legislators to define policy problems in ways that protect its profit margin. It reinforces this framework by selectively providing information and by targeting campaign contributions to influential legislators and allies. In this way, the industry displaces the public's voice in developing (...) pharmaceutical policy. Unless citizens mobilize to confront the political power of pharmaceutical firms, objectionable industry practices and public policy will not change. Yet we need to refine this analysis. I propose a research agenda to uncover pharmaceutical influence. It develops the theory of dependence corruption to explain how the pharmaceutical industry is able to deflect the broader interests of the general public. It includes empirical studies of lobbying and campaign finance to uncover the means drug firms use to: (1) shape the policy framework adopted and information used to analyze policy; (2) subsidize the work of political allies; and (3) influence congressional voting. (shrink)

Two insights of psychology on which we would like to draw are that people react to law in more complex ways than rational-choice models assume and that good people sometimes do bad things. With that starting point, this article provides a behavioral perspective on some of the factors that policymakers seeking to reduce the level of misconduct in the pharmaceutical industry should consider. Effective regulation and enforcement need to address the following questions: Who are the regulation's targeted actors — researchers (...) or executives? Are the regulations directed toward research or marketing activities? Is the misconduct a product of explicit rational choice or implicit processes of which the actor is unaware? Is it reasonable to address all types of misconduct using the same approach? Certain misconduct — particularly by researchers — is due to automatic, intuitive, and unconscious decisions and needs to be addressed through different means than those used to address misconduct due to controlled, deliberate decisions. This article therefore recommends using different sorts of regulation depending on the context. It suggests more tailored enforcement mechanisms that will be sensitive to the pharmaceutical researchers’ unique work motivations and to their awareness or lack of awareness of their own misconduct. (shrink)

A growing number of doctors in the United States are joining online professional networks that cater exclusively to licensed physicians. The most popular are Sermo, with more than 135,000 members, and Doximity, with more than 100,000. Both companies claim to offer a valuable service by enabling doctors to “connect” in a secure online environment. But their business models raise ethical concerns. The sites generate revenue by selling access to their large networks of physician-users to clients that include global pharmaceutical companies, (...) market research and consulting firms, and hedge funds and other investors. In exchange for a fee, these clients are offered a variety of tools to monitor, analyze, and solicit physicians’ opinions. In Sermo's case, clients are also offered opportunities to conduct “awareness campaigns” on the site that are aimed at influencing physician sentiment about specific drugs and medical devices. In effect, these online networks have created an even more efficient means for the pharmaceutical industry to track physician sentiment, disseminate messages, and cultivate key opinion leaders. This paper argues that the dual nature of these sites (a) undermines their integrity and transparency as forums for the exchange of medical opinion and (b) presents an ethical conflict for the doctors who use them. (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)

Pharmaceutical and medical device companies apply social psychology to influence physicians' prescribing behavior and decision making. Physicians fail to recognize their vulnerability to commercial influences due to self-serving bias, rationalization, and cognitive dissonance. Professionalism offers little protection; even the most conscious and genuine commitment to ethical behavior cannot eliminate unintentional, subconscious bias. Six principles of influence — reciprocation, commitment, social proof, liking, authority, and scarcity — are key to the industry's routine marketing strategies, which rely on the illusion that the (...) industry is a generous avuncular partner to physicians. In order to resist industry influence, physicians must accept that they are vulnerable to subconscious bias and have both the motivation and means to resist industry influence. A culture in which accepting industry gifts engenders shame rather than gratitude will reduce conflicts of interest. If greater academic prestige accrues to distant rather than close relationships with industry, then a new social norm may emerge that promotes patient care and scientific integrity. In addition to educating faculty and students about the social psychology underlying sophisticated but potentially manipulative marketing and about how to resist it, academic medical institutions should develop strong organizational policies to counteract the medical profession's improper dependence on industry. (shrink)

The rise of liberal market economies, propagated by neoliberal free market thought, has created a vacant responsibility for public interests in the market order of society. This development has been critiqued by Catholic social teaching (CST), forcefully arguing that governments and businesses should be directed to the common good. In this debate, no attention has yet been given to the Reformational tradition and its principle of sphere sovereignty, which provides guidelines on the responsibilities of governments and companies for the public (...) interest of society. This article analyzes the differences and similarities between CST and the Reformational philosophy in their critiques of the neoliberal free market perspective of Hayek. We apply the three perspectives to the case of orphan drugs in the pharmaceutical industry and show that CST and the Reformational philosophy offer valuable insights in correction to Hayek’s views on the responsibilities of governments and companies for public health interests. (shrink)