Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not (...) be exploited and that eligible candidates who may benefit from participation not be excluded without good cause. Studies must be designed in a way that ensures the validity of findings and must address questions of sufficient importance to justify the risks of participation. In any clinical trial there must be genuine uncertainty as to which treatment arm offers the most benefit, and placebo controls should not be used if effective standard therapies exist. Researchers have a responsibility to inform themselves about the ethical, legal and policy standards that govern their activities. When difficulties arise, they should consult the existing literature and seek the advice of experts in research ethics. (shrink)

This book brings together, in systematic and generalized form, the main outlines of a conceptual scheme for the analysis of the structure and processes of social systems. It carries out Pareto's intention by using the "structural-functional" level of analysis.

Genetic testing is currently subject to little oversight, despite the significant ethical issues involved. Repeated recommendations for increased regulation of the genetic testing market have led to little progress in the policy arena. A 2005 Internet search identified 13 websites offering health-related genetic testing for direct purchase by the consumer. Further examination of these sites showed that overall, biotech companies are not providing enough information for consumers to make well-informed decisions; they are not consistently offering genetic counseling services; and some (...) sites even offer tests with little evidence of clinical value. This article aims to raise company and consumer awareness about the ethical concerns surrounding the direct-to-consumer marketing of health-related genetic tests. It also suggests ways that biotech companies can bring their services to the public in an ethically responsible manner, without increased regulatory oversight. (shrink)

This article introduces the concept of economic medicalization where non-medical problems are transformed into medical problems in order to achieve the objective of corporate shareholder wealth maximization. Following an overview of the differences in ethical norms applicable to medical ethics and business ethics, the economic medicalization of medical research practice and publication is examined in some detail. This motivates a general discussion of the problems involved in the ethical approval process for medical research that balances the interests of both business (...) and government in the market for medical products and services. (shrink)

In 2003, the pharmaceutical company Biovail received a spate of negative publicity around a program for its heart medication Cardizem LA. For a three-month period Biovail paid US doctors US$1000 (and their office managers US$150) for patient data when at least 11 of their patients renewed a prescription to Cardizem. Doctors who signed up for the trial but who did not keep 11 patients on the drug received US$250 for participation. According to Biovail, this was a research trial, meeting US (...) federal regulations for research trials – the consulting firm that had designed the trial had guaranteed that it would meet US criteria. The trial was expected to provide data that would help ‘in designing future clinical trial programs’, according to Biovail’s vice-president of finance. In addition, the results would eventually be published. However, the program was originally presented as a marketing campaign, and was being handled by Biovail’s sales department and sales force. According to ethicists who commented on the case, a US$1000 payment to doctors was unusually high for a post-marketing research trial, and a US$150 payment to office managers was thought to raise novel ethical conflicts. Cardizem is a drug intended for long-term use, so paying doctors to get patients started on a course of treatment could lead to substantial profits from these prescriptions. In line with this, immediate comments from professional ethicists and representatives of medical associations focused on questions about whether the Biovail campaign amounted to paying doctors to prescribe specific drugs. And that is a concern for the obvious reason that it has the potential to compromise doctors’ decisions about best care. Payments for prescriptions place doctors in ethically difficult situations: Peter Singer, a medical ethicist, says ‘There is clearly the potential for [physicians’] conflict of interest’ (Toronto Globe and Mail, 2003). Physicians’ decision-making is the most common locus of discussion in medical ethics.. (shrink)

No discussion of academic freedom, research integrity, and patient safety could begin with a more disquieting pair of case studies than those of Nancy Olivieri and David Healy. The cumulative impact of the Olivieri and Healy affairs has caused serious self examination within the biomedical research community. The first part of the essay analyses these recent academic scandals. The two case studies are then placed in their historical context—that context being the transformation of the norms of science through increasingly close (...) ties between research universities and the corporate world. After a literature survey of the ways in which corporate sponsorship has biased the results of clinical drug trials, two different strategies to mitigate this problem are identified and assessed: a regulatory approach, which focuses on managing risks associated with industry funding of university research, and a more radical approach, the sequestration thesis, which counsels the outright elimination of corporate sponsorship. The reformist approach is criticised and the radical approach defended. (shrink)

Businesses that produce bioscience products—gene tests and therapies, pharmaceuticals, vaccines, and medical devices—are regularly confronted with ethical issues concerning these technologies. Conflicts exist between those who support advancements in bioscience and those who fear the consequences of unfettered scientific license. As the debate surrounding bioscience grows, it will be increasingly important for business managers to consider the larger consequences of their work. This groundbreaking book follows industry research, development, and marketing of medical and bioscience products across a variety of fields, (...) including biotechnology, pharmaceuticals, and bio-agriculture. Compelling and current case studies highlight the ethical decisions business managers frequently face. With the increasing visibility and public expectation placed on businesses in this sector, managers need to understand the ethical and social issues. This book addresses that need and provides a framework for incorporating ethical analysis in business decision making. (shrink)

The primary objective of this article is to develop a framework for analyzing the ethical foundations and implications of shareholder wealth maximization (SWM). Distinctions between SWM and the more widely examined construct of profit maximization are identified, the most significant being the central role played in SWM by the market mechanism for pricing the corporation''s securities. It is argued that empirical tests concerned with evaluating the ethical implications of SWM will almost surely involve a joint hypothesis. A number of recent (...) empirical studies aimed at testing hypotheses with explicit ethical content are reviewed. (shrink)

As the rapidly advancing possibilities of biotechnology have outstripped the adaptive capacity of current legal and ethical institutions, a vigorous debate has arisen that considers the boundaries of appropriate use of this technology, particularly when applied to humans. This article examines ethical concerns surrounding the development of markets in a particular form of human genetic engineering in which heterozygotes are fitter than both homozygotes, a condition known as heterozygous advantage. To begin, we present a generalized model of the condition, illuminated (...) by the application to sickle-cell anemia. Next, we propose a typology of related markets, some of which are currently functioning with available products and services, and others that are widely viewed as imminent. We suggest the manner in which perverse incentives may arise for firms that market genetic intervention in circumstances where heterozygous advantage is possible. Finally, we propose that this misalignment of incentives with social welfare has arisen from both ill-conceived market intervention where markets are capable of achieving efficient outcomes and the lack of market intervention where markets have failed. We offer specific legal and regulatory approaches for reform. (shrink)

The best things in my Ufe have come to me by accident and this book results from one such accident: my having the opportunity, out of the blue, to go to work as H. Tristram Engelhardt, Jr. 's, research assistant at the Institute for the Medical Humanities in the University of Texas Medi cal Branch at Galveston, Texas, in 1974, on the recommendation of our teacher at the University of Texas at Austin, Irwin C. Lieb. During that summer Tris "lent" (...) me to Chester Bums, who has done important schol arly work over the years on the history of medical ethics. I was just finding out what bioethics was and Chester sent me to the rare book room of the Medical Branch Library to do some work on something called "medical deontology. " I discovered that this new field of bioethics had a history. This string of accidents continued, in 1975, when Warren Reich (who in 1979 made the excellent decisions to hire me to the faculty in bioethics at the Georgetown University School of Medicine and to persuade Andre Hellegers to appoint me to the Kennedy Institute of Ethics) took Tris Engelhardt's word for it that I could write on the history of modem medical ethics for Warren's major new project, the Encyclopedia of Bioethics. Warren then asked me to write on eighteenth-century British medical ethics. (shrink)