In 1995, Dennis Thompson, the founding director of Harvard’s program in Ethics and the Professions, authored a book entitled Ethics in Congress. That subject, in and of itself, seemingly was not new. And it undoubtedly inspired a few irreverent snickers. Consider that a Goggle search of “Ethics in Congress oxymoron” recently produced 5.79 million results in just over a tenth of a second.

But it was the subtitle of the book — From Individual to Institutional Corruption — that revealed how Thompson’s tome signaled an abrupt departure from the standard paradigms for measuring political corruption.

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.

This article argues that the misalignment of private profit-maximizing objectives with public health needs causes institutional corruption in the pharmaceutical sector and systematically leads firms to act contrary to public heath. The article analyzes how financial incentives generate a business model promoting harmful practices and explores several means of realigning financial incentives in order to foster therapeutic innovation and promote the rational use of medicines.

The federal government indirectly subsidizes the pharmaceutical industry by funding basic research, various tax credits and deductions, patent rules, grants of market exclusivity, and other means, in order to spur drug development, promote public health, and improve medical care. But today, the pharmaceutical industry often neglects these goals and sometimes even undermines them, due to what Lawrence Lessig refers to as institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. A key source of institutional corruption is improper dependence by the institution or its key actors on the actions of third parties that have fundamentally different interests. It is the health care system’s improper dependency on pharmaceutical firms that allows them to displace some public policy goals and to compromise the attainment of others.

Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution’s societal mission. An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians. We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic of harms and the paucity of benefits.

Could an accreditation, certification, or rating mechanism help the pharmaceutical industry improve both its bioethical performance and its public reputation? Other industries have used such systems to assess, improve, distinguish, and demonstrate the quality of their services, processes, and products. These systems have also helped increase transparency, accountability, stakeholder confidence, and awareness of industry best practices. This article explains how market forces can be harnessed to recognize and promote better bioethical performance by pharmaceutical companies when there are good systems to accredit, certify, or rate. It concludes with a review of relevant failures of credit-rating agencies — such as conflicts of interests and revolving-door practices — to illuminate some of the pitfalls of developing a bioethics accreditation, certification, or rating system for pharmaceutical companies.

Good decision-making requires reliable information. In medicine, relevant information comes from clinical trials and other forms of scientific research. In business, one source is in corporate annual financial statements. As for-profit, publicly traded companies whose business is discovering, manufacturing, and marketing drugs, pharmaceutical companies sit at the nexus of these two fields. Determining the safety and efficacy of a pharmaceutical product and determining the profitability of a complex enterprise are similarly difficult tasks: each is fraught with deeply ambiguous information that requires sophisticated judgment to interpret reasonably.

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.

What does unethical behavior look like in everyday professional practice, and how might it become the accepted norm? Examinations of unethical behavior often focus on failures of individual morality or on psychological blind spots, yet unethical behaviors are generated and performed through social interactions across professional practices rather than by individual actors alone. This shifts the focus of behavioral ethics research beyond the laboratory exploring motivation and cognition and into the organizations and professions where unethical behavior is motivated, justified, enabled and supported in specific social contexts. For instance, when pharmaceutical firms fund academic research, how do the funding arrangements intersect with individual behaviors that are typical in academic research? In turn, how do academic-industry interactions affect scientific norms, particularly those involving compliance with rules, regulations, and ethical codes of conduct? A social organization approach to ethics allows us not only to examine ethics in practice, but also to tease apart unethical behaviors that might operate on an unreflective level and become accepted as “just the way it is.”

In 2010, in connection with the Patient Protection and Affordable Care Act (Obamacare), the United States Congress passed the Physician Payment Sunshine Act. This legislation requires pharmaceutical companies, medical device companies, and other manufacturers of medical supplies to collect information on their payments to physicians, beginning on August 1, 2013, and to annually report this information to the Centers for Medicare and Medicaid Services (CMS), beginning on March 31, 2014. All payments of over $10 are to be reported and aggregate payments of more than $100 to a single physician in a single year must also be reported.

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.

The Food and Drug Administration (FDA) 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.

Physicians 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.

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 (and anonymously) 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.

Patient advocacy organizations (PAOs) provide patient- and caregiver-oriented education, advocacy, and support services. PAOs are formally organized nonprofit groups that (a) concern themselves with medical conditions or potential medical conditions and (b) have a mission and take actions that seek to help people affected by those medical conditions or to help their families. Examples of PAOs include the American Cancer Society, the National Alliance on Mental Illness, and the American Heart Association. These organizations advocate for, and provide services to, millions of people with physical and mental conditions — such as cancer, mental illness, diabetes, and cardiovascular disease — via their outreach, meetings, counseling, websites, and published materials. A PAO usually seeks to raise public awareness of a disease’s symptoms, risk factors, and treatment options and promotes research to cure or to prevent that disease.

Antibiotic use triggers evolutionary and ecological responses from bacteria, leading to antibiotic resistance and harmful patient outcomes. Two complementary strategies support long-term antibiotic effectiveness: conservation of existing therapies and production of novel antibiotics. Conservation encompasses infection control, antibiotic stewardship, and other public health interventions to prevent infection, which reduce antibiotic demand. Production of new antibiotics allows physicians to replace existing drugs rendered less effective by resistance.

In recent years, physicians and policymakers have raised concerns about the pipeline for new antibiotics, pointing to a decline in the number of antibiotics approved since the 1980s. This trend has been attributed to high research and development costs, low reimbursement for antibiotics, and regulatory standards for review and approval. Professional societies and researchers around the world have called for renewed emphasis on antimicrobial stewardship, while also supporting antibiotic research and development through grants, changes to intellectual property laws to extend market exclusivity periods, and modification of premarket testing regulations to reduce antibiotic development time and expenses.

Since their revelation to the public, the sexually transmitted disease (STD) experiments in Guatemala from 1946 to 1948 have earned a place of infamy in the history of medical ethics. During these experiments, Public Health Service (PHS) researchers intentionally exposed over 1,300 non-consenting Guatemalan soldiers, prisoners, psychiatric patients, and commercial sex workers to gonorrhea, syphilis, and/or chancroid under conditions that have shocked the medical community and public alike. Expert analysis has found little scientific value to the experiments as measured by current or contemporaneous research standards.

Such an obvious case of research malfeasance, which violated research norms in place both in the past and now, has been uniformly repudiated. The Guatemala STD experiments were labeled “clearly unethical” by President Barack Obama and “reprehensible” by the Secretaries of State and Health and Human Services.

Cancer rates in men and women of reproductive age have continued to increase in recent years; however, therapy has dramatically decreased the mortality rates. Since 1990, the prevalence of cancer survivors in young adults increased from 1 in 1,000 to 1 in 250 patients due to more aggressive therapies. Current therapies may have profound toxic effects on gamete function with infertility as an expected consequence of cancer therapy. Depending on the site and stage of cancer, age of the patient, and the type of treatment, approximately 90% of men and women diagnosed with cancer may be at risk of permanent infertility.

Fertility preservation has emerged as a discipline dedicated to improving the future reproductive potential of cancer survivors. Significant progress in the advancement of fertility preservation therapies and a heightened awareness of the availability of therapies has occurred in the past 10 years. The American Society of Clinical Oncology (ASCO) and the American Society of Reproductive Medicine (ASRM) have advanced these efforts by formally recognizing the importance of fertility awareness.