As the quote above indicates, economists generally are more comfortable with self interest as a motivating force for social benefit than with altruism. This is because in most instances in a market economy, self interest will lead agents to provide benefits for others. Ultimately this is because the butcher or baker will not get paid unless he does something that others are willing to pay for. This is the source of the famous “invisible hand,” also discussed by Adam Smith.

This might sound trivial, except that in discussing aspects of medicine we seem to lose sight of this mechanism and rely on other tools to provide benefits. These tools do not work as well as naked self interest would. Some might say that medicine and medical progress is too important to depend on the market.

There is an old saw in health policy that everyone wants health care that is good, fast, and cheap — but it’s impossible to have more than two of these at one time.

A similar bit of folk wisdom seems intuitively true for the development and testing of new pharmaceutical products. The public is in a bind. We want breakthrough drugs, and fast. But we also want these drugs to be affordable, thoroughly tested, safe, and effective. It seems we can’t have it all.

In this paper, we will not claim that one can have it all — but that we can do far better than we are at present. First, we review extensive data on contemporary problems in the design, conduct, and analysis of industry-sponsored clinical trials. Finding major issues that have been solidly documented over more than a decade, we provide many examples of the multifarious ways in which industry-funded trials have been manipulated to raise the likelihood of producing industry-friendly results.

There is no doubt that industry-sponsored biomedical research is under the microscope. Unfortunately, this new era of skepticism prematurely rushes in doubts of the ethos of science. Skepticism can lead to positive changes, but only when timely and supported by sound reasoning. Snapshot views and theories, especially those that result in costly new regulations and inefficient policies often do more harm than good. Many critics would have the reader doubt scientific integrity because they believe that the relationship between the pharmaceutical industry and biomedical research poses an unavoidable and dangerous conflict of interest. However, these conflicts are neither unavoidable nor dangerous per se.

Wide-spread criticism of the pharmaceutical industry’s extravagant marketing practices and some doctors’ undignified, even appalling eagerness to stuff themselves, their pockets and their offices with the industry’s “stuff,” prompted physician groups, the drug and device industry itself (albeit synergized by the federal government’s ominous shadow) to institute reforms designed better to limit industry influence on physicians.

But according to Troyen Brennan and his coauthors, the reforms, while reducing some of the most egregious instances of industry influence peddling and physicians’ self-debasement, were doomed fundamentally, for three reasons. First, they were based on common sense but incorrect assumptions about the mechanism of industry influence and on myths about the efficacy of disclosure as an ethical disinfectant. Second, they relied on voluntary adherence and so failed to pinpoint responsibility for monitoring compliance and enforcement.

Like all interventions in health care, direct-to-consumer (DTC) advertising should be evaluated by comparing its risks to its benefits, in the context of the available or potentially available alternatives. The objective, of course, is to realize any unique benefits while minimizing the risks. On balance, the adverse effects of DTC advertising outweigh the still-undemonstrated benefits of the advertising.

DTC advertising must be seen in the context of overall pharmaceutical company expenditures on advertising. In 2005, the industry spent $29.9 billion dollars on promotions (up from $11.4 billion in 1996), of which a relatively small fraction, $4.2 billion (14.2%), was spent on DTC advertising. The percentage spent on DTC advertising has been relatively constant this decade. Promotions to professionals (24.2%) and samples (61.8%) accounted for far larger percentages of total promotional spending in 2005.

As early as the 1960s and 1970s, astute commentators began to call into question the degree of influence that the pharmaceutical industry was exercising over all aspects of medical research, education, and practice in the U.S. More recently, a spate of books and articles demonstrates that the issue has only become more serious in the last decade or two.

My focus in this paper will be on the industry’s influence on medical education. The influence that the industry exerts on undergraduate and graduate medical education (that is, the training of medical students and residents) often occurs through the system of pharmaceutical sales representatives, who also “detail” drugs to practitioners; or through the influence that the industry exerts over medical research. I will therefore devote my attention here primarily to the system of continuing medical education (CME) by which practitioners receive information about medical advances. The pharmaceutical industry currently supports about one-half of the costs of CME in the U.S., so it seems appropriate to question the degree of industry influence over the content of CME.

The empirical literature exploring lawyers and their moral decision making is limited despite the “crisis” of unethical and unprofessional behavior in the bar that has been well documented for over a decade. In particular we are unaware of any empirical studies that investigate the moral landscape of the health lawyer’s practice. In an effort to address this gap in the literature, an interdisciplinary team of researchers at Vanderbilt University designed an empirical study to gather preliminary evidence regarding the moral reasoning of health care attorneys. The primary research question was how health lawyers respond when they encounter ethical or moral dilemmas in their practice for which the law fails to offer a bright-line solution. In exploring this question, we sought to understand better what motivations or influences guide action when health lawyers confront ethical quandaries, and whether there are specific differences, e.g., gender, experience, or religiosity, that are associated with specific responses to situations testing ethical or moral boundaries.

Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration (FDA). An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. When scientific and medical evidence justify off-label uses, physicians promote patients’ interests by prescribing products off label.

Off-label prescribing can also harm patients, however. The potential for harm is greatest when an offlabel use lacks a solid evidentiary basis. A 2006 study examining prescribing practices for 169 commonly prescribed drugs found high rates of off-label use with little or no scientific support. Researchers examining off-label use in U.S. children’s hospitals concluded, “[W]e still have incomplete knowledge about the safety and efficacy of many medications commonly used to treat children across a range of drug classes and clinical diagnoses.”

Futility has had a rough time in recent medical ethics literature. From about 1987 to 1996, various writers and groups tried to define futility within the context of medical treatment, but without success. Baruch Brody and Amir Halevy give an excellent summary of the morass in their 1995 article “Is Futility a Futile Concept?” where they argue that none of the then-proposed definitions succeed. While a smattering of other attempted definitions have appeared since then, for the most part writers about futility have found it more profitable to stop trying to define futility and instead move in a different direction, that of figuring out how to resolve disputes where patient families want more treatment which clinicians think is futile. This is, for example, the approach taken by the Texas Advance Directives Act (1999), which was the first futility legislation in North America and is often seen as an appropriate template. The idea embodied in this influential legislation is that our energies should be focused on creating a process which we can use to resolve difficult cases, and which everyone finds legitimate, rather than in trying to find a definition which everyone finds legitimate.

Data Safety and Monitoring Boards (DSMBs) were introduced in the 1960s to monitor data in clinical trials to ensure subject safety. It was thought important that DSMB members be experts in the field(s) of interest, but not otherwise involved in the study (e.g., sponsors and investigators) in order to maximize objectivity. Since then, the use of DSMBs has increased dramatically, and their scope has expanded to include scientific issues — in particular, to avoid bias that can result when trials are stopped early because of evidence that one treatment has greater efficacy or causes greater harm than another; or that no treatment is likely to do better than any other.

In order for the Food and Drug Administration (FDA) to receive the trust and deference it needs to accomplish its mission, it must be seen as relatively impervious to political manipulation. For most of the FDA’s history, it has been seen as an institution driven by scientific expertise, not by political maneuvering. However, the FDA was increasingly criticized during the Bush administration for politicizing decisions such as rejecting an application to grant the “morning after pill,” known as Plan B, over-the-counter (OTC) status for women of all ages. After an atypical approval process, the FDA approved OTC Plan B use only for women over the age of 18. Because some groups perceive the morning after pill as a form of abortion, the politically appointed leadership of the FDA was suspected of dramatically departing from normal FDA procedures in order to ensure that the application would not be approved.

In March 2009, the Supreme Court held in Wyeth v. Levine that federal drug labeling laws do not pre-empt state tort claims against drug manufacturers. The decision surprised many Court watchers, coming on the heels of a 2008 decision, Riegel v. Medtronic, in which the Court found that the Food, Drug, and Cosmetic Act (FDCA) does pre-empt state-law claims for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. Wyeth dealt an immediate and surprising blow to the pharmaceutical industry’s principal strategy for avoiding tort lawsuits, but failed to clarify the Court’s overall pre-emption jurisprudence.