Ann E. Mills

Role of organization ethics in critical care medicine

The authors view the activities involved in critical care medicine as composing a complex adaptive system that is itself operating within a complex adaptive system, the healthcare organization. The authors explain why it is necessary that these systems be viewed this way, and they explain what is necessary to allow them to produce creative or emergent outcomes. They provide a justification for the role of an organization ethics program within this context. They provide a definition of organization ethics and outline the characteristics that an effective organization ethics program would possess.

Tools for tomorrow's health care system: a systems-informed mental model, moral imagination, and physicians' professionalism.

Physician educators have been charged with incorporating systems-based approaches into medical education and residency training to help future physicians understand how their ability to provide high-quality health care depends on other individual and organizational stakeholders with whom and, in some cases, for whom they work. In part, this also requires that physicians accept that they have responsibilities to various system stakeholders. These changes are controversial because some fear they might distract physicians from their primary ethical obligation to their patients. However, systems theories and their applications in organizational management and business ethics support the notions that individuals can maintain primary professional ethical obligations while working within complex systems and that organizational systems can be constructed to support individual professional practice. If physicians are to commit to working within and, ultimately, improving systems of care as part of their ethical practice of medicine, then they will need a new mental model. Leading thinkers have used various models of systems and have highlighted different aspects of systems theories in describing organizations, groups of organizations, and organizational processes. This essay draws from these models some basic concepts and elements and introduces a simple but comprehensive mental model of systems for physicians. If it is used with professionalism and moral imagination, physicians might have a tool that they can use to understand, work with, and, ultimately, improve the systems of care that they rely on in their practice of medicine and that critically affect the welfare of their patients.

Total quality management and the silent patient.

This essay examines the impact of the imposition of businesses techniques, in particular, those associated with Total Quality Management, on the relationships of important components of the health care delivery system, including payers, managed care organizations, institutional and individual providers, enrollees, and patients. It examines structural anomalies within the delivery system and concludes that the use of Total Quality Management techniques within the health care system cannot prevent the shift of attention of other components away from the enrollee and the patient, and may even contribute to it. It speculates that the organization ethics process may serve as a quality control mechanism to prevent this shift and so help eliminate some of the ethically problematic processes and outcomes within the health care delivery system.

Changing patent strategies: what will they mean for the industry?

Could the decline in DNA-based patent applications actually increase the potential for an anticommons effect?

Empirical analysis of major stem cell patent cases: the role of universities

325 inquiry. On appeal, the US Court of Appeals for the Federal Circuit reversed the decision and remanded the case. Duke’s petition to the Supreme Court seeking review of the Federal Circuit’s decision was denied11. The Federal Circuit held that the experimental-use exemption for patent infringement does not apply to research that furthers universities’ “business objectives,” including research and educating and enlightening students and faculty. The court held that “so long as the act is in furtherance of the alleged infringer’s legitimate business and is not solely for amusement, to satisfy idle curiosity or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental-use defense”9. Moreover, the profit or nonprofit status of the user is not relevant. Thus, the court found that the experimental-use exception should not insulate commercial research from claims of patent infringement. This applied to Duke University, which, as Judge Gajarsa noted, was “not shy in pursuing an aggressive patent licensing program from which it derives a not insubstantial revenue stream”9. The FTC and NRC reports question whether the absence of an observed anticommons is associated with researchers’ lack of knowledge about the Madey decision6–8. As more researchers and their institutions become more knowledgeable about the potential for patent violations following Madey, they, as well as private industry, may become more litigious in protecting their intellectual property rights, allowing an anticommons to emerge. We studied stem cell patents to determine the rate of litigation of such patents, to describe that litigation and to determine if it has, in fact, been increasing since Madey. We chose to study stem cell patent litigation industry is unable to innovate and successfully commercialize new products. Moreover, the risk of being sued for patent violation has now become a major concern to universities since Madey v. Duke University9. John Madey was a laboratory director at Duke University who received two patents related to free electron laser technology. After internal disagreements, Duke removed him as a director but continued to use his patents. Madey sued, claiming patent infringement. The district court dismissed his claim based on the common law experimental-use doctrine10 or the idea that infringement is acceptable when done to satisfy “philosophical” or scientific inquiry. The experimental-use exemption was articulated in 1813 by Judge Story10, who used the term “philosophical” instead of “scientific” to describe the experimentaluse exemption from patent infringement. The essential component of the court’s reasoning was that those skilled in such “useful arts” are free to use the knowledge imparted by a patent disclosure for amusement, to satisfy idle curiosity or for strictly philosophical It has been theorized1,2 that litigation is an important contributor to the concept of the anti-commons, which occurs when multiple owners hold the right to exclude each other from a scarce resource, so that no one holds an effective right of entry and underuse of the resource results3. This may occur with royalty stacking, where an inventor must obtain multiple licenses to commercialize a product. If this activity is leading to an anti-commons, then, is the multitude of patents that has been granted actually inhibiting, rather than facilitating, the transfer of technology3? Patent litigation and the strategies firms follow to protect themselves from the risk of litigation (e.g., defensive patenting by enlarging a firm’s portfolio of patents to influence settlement terms or foregoing otherwise valuable research because of the risk of litigation)4 generate costs that may divert resources away from innovative activities, or make subsequent commercialization no longer feasible or more costly. Thus, litigation and strategies to avoid litigation can be seen as contributing to an anti-commons. The perception that a large amount of litigation is occurring is one point advocates use to justify patent reform. For example, the 110th Senate Judiciary Committee’s Report on the Patent Reform Act of 2007 warns that excessive litigation creates costs for industry participants5. This notion derives from reports by the Federal Trade Commission (FTC) and the National Research Council (NRC)6–8 that warn of dire consequences if Empirical analysis of major stem cell patent cases: the role of universities

The Pre-conditions for “Building Capacity” in an Ethics Program

Most organizations and/or their sub-units like ethics programs want to acquire the knowledge, skills and other resources needed to achieve their goals efficiently and effectively. Thus, they want to acquire or develop needed “capacity.” But there are pre-conditions to building capacity that are often overlooked or forgotten, but which nevertheless, must be in place before capacity can be developed. This essay identifies these pre-conditions and discusses why they are necessary before attempts are made to enhance the capacity of any ethics program. The essay closes by offering a series of questions that ethics program leaders/and or members can asked themselves to assess whether or not these pre-conditions exist.

Evidence-based medecine: Why clinical ethicists should be concerned

Evidence-based medicine purports to be the integration of three prongs; best research evidence, clinical expertise, and patient values and preferences. Controversy still surrounds the application of evidence-based medicine and undoubtedly controversy will persist in the treatment of specific diseases, thus allowing for some flexibility in decision-making. Yet, the idea that variation is expensive has gained wide acceptance and variation can best be controlled through rigid systems. So given the financial constraints facing healthcare organizations, as well as pressure from such august organizations like the Institute of Medicine to implement evidence-based medicine, flexibility in decision-making may ultimately become the exception rather than the rule. Certainly, in the short-term, the advantages of a rigid system, notably its cost advantage, overwhelm the advantages of a more naturally adaptive system--and so where possible evidence-based medicine will probably be implemented within a rigid context. Rigidity in system design will affect the activities of clinical ethics. To be effective in such a system, clinical ethicists will need an understanding of the system within which they practice including its values, goals, operations, and tools. This is a knowledge area which few in this field currently have and which they may not wish to acquire. But, if clinical ethicists expect to have credibility in responding to these changes, they must understand the values, goals, processes and outcomes of the system in place and be able to advocate for greater flexibility and greater attention to patient values and preferences even within a rigid mechanical system.

DNA-based patents: an empirical analysis

The perception of rising litigation rates is driving the push for patent reform.

The rashomon effect: Organization ethics in health care

The Academy-Award winning 1950 Japanese movie Rashomon depicts an incident involving an outlaw, a rape or seduction of a woman, and a murder or suicide of her husband. A passer-by, who is also the narrator, explains how the story is told to officials from four different perspectives: that of the outlaw, the woman, the husband and himself. The four narratives agree that the outlaw, wandering through the forest, came upon the woman on a horse being led by her husband; the outlaw tied up the husband, sex took place between the woman and the outlaw in front of the bound husband, and the husband was found dead. The narratives do not agree on how these events occurred or who killed the husband. The outlaw contends that consensual sex occurred between him and the wife, and he claims to have killed the husband. The wife depicts the sex as rape and claims that because of her disgrace she killed her husband. The husband, through a medium, says that the sexual act began as rape and ended in consent, and that in shame, after being untied by the outlaw he killed himself. The passer-bys story agrees with the husbands account of the sex and the bandits account of the murder. Because the passer-by is also the narrator of the film, we tend to believe his version. But what actually took place is never resolved.

COI Policies: Tax Dollars Should Not Be Used to Fund U.S. Institutions Not Making the Grade

Over two billion dollars was awarded by the U.S. Department of Health and Human Services (HHS) in research funding from 2010 to March 2012 to institutions receiving a grade of “C,” “D,” or “F” on their conflict of interest policies, as determined by the American Medical Student Associations scorecard on conflict of interest policies. More institutional oversight is needed with regard to assuring conflict of interest policies at U.S. research institutions are adequate. As stewards of public funds, HHS should require a minimum standard which institutional conflict of interest policies should meet, beyond current regulatory requirements, before granting funding.