David B. Resnik

The undertreatment of pain: Scientific, clinical, cultural, and philosophical factors

This essay provides an explanation and interpretation of the undertreatment of pain by discussing some of the scientific, clinical, cultural, and philosophical aspects of this problem. One reason why pain continues to be a problem for medicine is that pain does not conform to the scientific approach to health and disease, a philosophy adopted by most health care professionals. Pain does not fit this philosophical perspective because (1) pain is subjective, not objective; (2) the causal basis of pain is often poorly understood; (3) pain is often regarded as a “mere” symptom, not as a disease; (4) there often are no “magic bullets” for pain; (5) pain does not fit the expert knowledge model. In order for health care professionals to do a better job of treating pain, some changes need to occur in medical philosophy, education, and practice.

The ethics of HIV research in developing nations.

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.

Developing drugs for the developing world: an economic legal moral and political dilemma.

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on (1) the prospects for a reasonable profit and (2) the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industrys efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying.

The Conflict Between Ethics and Business in Community Pharmacy: What About Patient Counseling?

Patient counseling is a cornerstone of ethical pharmacy practice and high quality pharmaceutical care. Counseling promotes patient compliance with prescription regimens and prevents dangerous drug interactions and medication errors. Counseling also promotes informed consent and protects pharmacists against legal risks. However, economic, social, and technological changes in pharmacy practice often force community pharmacists to choose between their professional obligations to counsel patients and business objectives. State and federal legislatures have enacted laws that require pharmacists to counsel patients, but these laws have had mixed results. This essay argues that community pharmacys patient counseling conundrum can be solved through additional moral education and moral persuasion, not through additional legal mandates.

Trans Fat Bans and Human Freedom

A growing body of evidence has linked consumption of trans fatty acids to cardiovascular disease. To promote public health, numerous state and local governments in the United States have banned the use of artificial trans fats in restaurant foods, and additional bans may follow. Although these policies may have a positive impact on human health, they open the door to excessive government control over food, which could restrict dietary choices, interfere with cultural, ethnic, and religious traditions, and exacerbate socioeconomic inequalities. These slippery slope concerns cannot be dismissed as far-fetched, because the social and political pressures are place to induce additional food regulations. To protect human freedom and other values, policies that significantly restrict food choices, such as bans on types of food, should be adopted only when they are supported by substantial scientific evidence, and when policies that impose fewer restrictions on freedom, such as educational campaigns and product labeling, are likely to be ineffective.

Eliminating the daily life risks standard from the definition of minimal risk

The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research are not greater than those encountered during the performance of routine physical or psychological examinations or tests”.

DNA Patents and Human Dignity

hose objecting to human DNA patenting frequently do so on the grounds that the practice violates or T threatens human dignity.’ For example, from 1993 to 1994, more than thirty organizations representing indigenous peoples approved formal declarations objecting to the National Institutes of Health’s (NIH) bid to patent viral DNA taken from subjects in Papua New Guinea and the Solomon Islands. Although these were not patents on human DNA, the organizations argued that the patents could harm and exploit indigenous peoples and violate their cultural values. NIH eventually dropped one of its patent applications? On May 18,1995,180 religious leaders, led by biotechnology critic Jeremy Rifkin, held a press conference objecting to DNA patenting in Washington, D.C. In their “Joint Appeal against Human and Animal Patenting,” these leaders decried any attempt to patent nature. Some of the more outspoken members of the Joint Appeal likened DNA patenting to slavery, while others objected to treating human beings as marketable comrnoditie~.~ In his recent book, The Biotech Century, Rifkin rehashed the objections to DNA patenting voiced by members of the Joint Appeals4 The European Commission also voiced its opinion on the practice of DNA patenting when it ruled that the European Patent Convention may refuse to patent any invention that infringes on the rights of a person or violates human dignitys Unlike patent laws in the United States, the European Commission’s patent laws stipulate that patents should not be granted for inventions that are contrary to public morality? Although DNA patents are currently legal in countries that accept the Convention, there has been much discussion about whether human DNA patents are contrary to public morality.’

The Commercialization of Human Stem Cells: Ethical and Policy Issues

The first stage of the human embryonic stem(ES) cell research debate revolved aroundfundamental questions, such as whether theresearch should be done at all, what types ofresearch may be done, who should do theresearch, and how the research should befunded. Now that some of these questions arebeing answered, we are beginning to see thenext stage of the debate: the battle forproperty rights relating to human ES cells. The reason why property rights will be a keyissue in this debate is simple and easy tounderstand: it costs a great deal of money todo this research, to develop new products, andto implement therapies; and private companies,researchers, and health professionals requirereturns on investments and reimbursements forgoods and services. This paper considersarguments for and against property rightsrelating to ES cells defends the followingpoints: (1) It should be legal to buy and sellES cells and products. (2) It should be legalto patent ES cells, products, and relatedtechnologies. (3) It should not be legal tobuy, sell, or patent human embryos. (4) Patentson ES cells, products, and related technologiesshould not be excessively broad. (5) Patents onES cells, products, and related technologiesshould be granted only when applicants statedefinite, plausible uses for their inventions. (6) There should be a research exemption in EScell patenting to allow academic scientists toconduct research in regenerative medicine. (7)It may be appropriate to take steps to preventcompanies from using patents in ES cells,products, and related technologies only toblock competitors. (8) As the field ofregenerative medicine continues to develop,societies should revisit issues relating toproperty rights on a continuing basis in orderto develop policies and develop regulations tomaximize the social, medical, economic, andscientific benefits of ES cell research andproduct development.

The Human Genome Diversity Project: ethical problems and solutions.

The goal of the Human Genome Diversity Project (HGDP) is to provide a comprehensive study of genetic diversity across different human populations. Scientists working on the HGDP plan to collect samples from all 400 to 500 geographically isolated or culturally unique human populations that desire to participate in the project. Few people have questioned the scientific merits of the HGDP and its potential contribution to our understanding of human genetics, but the project has created a storm of moral, cultural, and political controversy during its brief existence. Opponents have argued that the HGDP smacks of racism, commercialism, exploitation, and cultural imperialism. Critics have also found fault with the informed consent process proposed by organizers of the HGDP. Opposition to the HGDP has succeeded in impeding (but not derailing) this project. The essay explores some of the key moral, political, and cultural issues raised by the HGDP and argues that the project should be implemented and should be funded, provided that researchers and organizers take steps to address the issues it raises.

Stem-cell tourism and scientific responsibility. Stem-cell researchers are in a unique position to curb the problem of stem-cell tourism.

Stem-cell tourism exploits the hope of patients desperate for therapies and cures. Scientists have both a special responsibility and a unique role to play in addressing this problem.