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PubMed2005

Intellectual property and pharmaceutical drugs: an ethical analysis.

The pharmaceutical industry has in recent years come under attack from an ethical point of view concerning its patents and the non-accessibility of life-saving drugs for many of the poor in both less developed countries and in the United States. The industry has replied with economic and legal justifications for its actions. The result has been a communication gap between the industry on the one hand and poor nations and American critics on the other. This paper attempts to present and evaluate the arguments on all sides and suggests a possible way out of the current impasse. It attempts to determine the ethical responsibility of the drug industry in making drugs available to the needy, while at the same time developing the parallel responsibilities of individuals, governments, and NGOs. It concludes with the suggestion that the industry develop an international code for its self-regulation.

Developed Countries↗
PubMed1993

Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations.

The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring is a continuous process in industry trials due to the regulatory requirements and the need to more thoroughly evaluate safety of new compounds. As part of this process, interim analyses are employed to make decisions about treatment effects. In some cases, such analyses may require the use of an external data monitoring committee to assist in the data review, analysis and decision making. A number of examples of interim analyses, with and without data monitoring committees, are discussed. Issues surrounding the need for external data monitoring committees and recommendations are presented. In particular the issues of sponsor participation in the data monitoring committee and controls of the decision making process are considered.

Clinical Trials Data Monitoring Committees↗
PubMed1993

Ethics in pharmaceutical advertising.

Pharmaceutical manufacturing is one of the most financially lucrative industries in America due, in part, to massive marketing and advertising. The content of many symposia and medical journals as well as physician prescribing decisions seems to be influenced by the promotional efforts of pharmaceutical companies. In an effort to increase sales, the industry now advertises directly to the public. The role of the Food and Drug Administration and ethical standards established by medical organizations are discussed.

Advertising↗
PubMed2004

The ethics of pharmaceutical industry relationships with medical students.

Little research has been done on the extent of the relationship between the pharmaceutical industry and medical students, and the effect on students of receiving gifts. Potential harms to patients are documented elsewhere; we focus on potential harms to students. Students who receive gifts may believe that they are receiving something for nothing, contributing to a sense of entitlement that is not in the best interests of their moral development as doctors. Alternatively, students may be subject to recognised or unrecognised reciprocal obligations that potentially influence their decision making. Medical educators have a duty of care to protect students from influence by pharmaceutical companies.

Conflict of Interest↗
PubMed1995

The ethics of the pharmaceutical industry and the need for a dual market system.

In an era of increasing medical costs and cries for health care reform in the United States, the pharmaceutical industry has come under intense scrutiny. Ethical issues are inherent in the pharmaceutical marketplace, and there is a need to address the moral rights and responsibilities of drug manufacturers, consumers, health care professionals, and governmental agents in the production, distribution, regulation, and use of these products. A dual market system protecting individual rights to access and autonomy without placing an undue strain on societal resources would provide an adequate and equitable framework for an ethical pharmaceutical industry.

Advertising↗
PubMed2006

Gifts to physicians from the pharmaceutical industry: an ethical analysis.

Gifts to physicians by the pharmaceutical industry pose numerous ethical questions. Although individual patients and physicians may benefit financially and educationally from certain gifts, the risk of bias resulting from such gifts makes them ethically challenging. After a brief description of the nature and scope of the practice of gift giving, this article examines major arguments for and against this practice. We then review the development of guidelines by professional societies, trade organizations, and government agencies. We conclude with a list of summary recommendations designed to help individual physicians, educators, and administrators engage in careful reflection and analysis and make sound ethical decisions about acceptance of gifts.

Conflict of Interest↗
PubMed2006

Guiding Principles for Pharmaceutical Physicians from the Ethical Issues Committee of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK.

Medical practitioners practising in the field of pharmaceutical medicine, whether in industry, regulatory bodies or an academic environment, are bound by the same ethical standards which apply to all doctors. Their work, however, leads to some very specific ethical considerations which may not be fully explored in ethical codes based in clinical medicine. This document aims to establish some guiding principles which should underpin a working ethical framework for pharmaceutical physicians. It clearly places the protection of patients (and research subjects) and the doctor's duties to wider society ahead of responsibilities to an individual employer while emphasising the importance of adherence to high standards of research, including dissemination of findings. These principles form the basis of a fuller report which offers more specific practical advice on possible ethical conflicts or dilemmas.

Clinical Trials as Topic↗
PubMed1989

Guidelines for the use of dietary fluoride supplements in Australia.

A survey in 1988 of brands of fluoride supplements available in a non-fluoridated town in Western Australia, and tablets described in pharmaceutical product registers, revealed that six brands of tablets and one brand of solution (drops) were on the market. Tablets contained 2.2 mg or 1.1 mg NaF; the solution contained 2.2 mg NaF per mL. All products provided age-dose schedules which would give fluoride supplementation at levels greater than the National Health and Medical Research Council guidelines. In one case, infants following the schedule would receive four times the recommended dose for the first two years of life. Compliance with several of the age-dose schedules would be certain to cause significant dental fluorosis. Whether the others caused fluorosis would depend on the quantity of fluoride in the diet, and consumption of fluoride toothpaste. The survey showed a generalized disregard on the part of the ethical pharmaceutical industry for the risk of dental fluorosis, and reveals a need for a voluntary, or legally enforced, code of conduct for manufacturers of fluoride supplements. The value of guidelines which are not monitored is doubtful.

Australia↗
PubMed1995

In vitro evaluation of fentanyl and meperidine for immunomodulatory activity.

Exposure to drugs, either ethical pharmaceuticals or illicit street drugs, often results in medical complications, including alterations in the immune system. Among the drugs associated with immunomodulatory potential are the analgesics fentanyl and meperidine. The purpose of this study was to determine the potential of these drugs to alter immunological parameters subsequent to in vitro exposure at a range of concentrations. This potential immunotoxicity was assessed using a series of in vitro assays measuring B-lymphocyte proliferation, cytokine production by T-helper lymphocytes, T-lymphocyte cytolytic function, natural killer (NK) cell function, and macrophage function. Exposure to these analgesics was associated with a differential suppression of interleukin-4 production by T-cells, as well as a more generalized suppression of cytokine production by macrophages. In addition, T-cell cytolytic activity was suppressed at high drug concentrations. B-cell proliferation and NK cell activity were also inhibited, but to a lesser degree than noted with T-cell function. Addition of naltrexone to the cultures did not reverse these alterations in immune function, suggesting that these changes are not mediated via opioid receptors.

Adjuvants, Immunologic↗
PubMed1994

Mitogenic and chemotactic responses of human periodontal ligament cells to the different isoforms of platelet-derived growth factor.

A major focus of studies that center on regeneration of the periodontium is to determine the efficacy of the use of polypeptide growth factors. Platelet-derived growth factor has been reported to be a possible agent for clinical use. PDGF has various isoforms. Therefore, we decided to study the mitogenic and chemotactic responses of human periodontal ligament (PDL) cells to recombinant human PDGF-AB, AA, and BB. Addition of each isoform of PDGF to in vitro mitogenesis assays induced PDL cell proliferation in a dose-dependent manner. The maximum mitogenic effect was evident at the concentration of 100 ng/mL. In these assays, PDGF-BB was found to be the most potent mitogen. PDGF-AB elicited an intermediate response, and PDGF-AA was the least effective. The results of chemotaxis assays closely parallel those of the mitogenesis assays. PDGF-BB exhibited the most potent chemotactic effect. The maximal effect was observed at 10 ng/mL. The findings of these experiments indicate that PDGF-BB is more effective than the other isoforms in promoting mitogenesis and chemotaxis of PDL cells in vitro, and may therefore be a suitable ethical pharmaceutical for use in periodontal regeneration procedures.

Becaplermin↗
PubMed1992

The success of histamine-2 receptor antagonists.

The lives of both patients and doctors have been revolutionized since the development of histamine-2 receptor antagonists. Their development has introduced, for the first time, a rapid, reliable, and save means of healing both duodenal and gastric ulceration. The continuous administration of these agents has additionally been shown to reduce ulcer relapse and subsequent complications. In addition, they offer some protection from the development of nonsteroidal anti-inflammatory drug-induced damage. The symptomatic relief of reflux together with healing of oesophagitis has been of further benefit. The drugs in this group have become one of the most widely used ethical pharmaceuticals in the world, with ranitidine (Zantac) as the biggest-selling drug in the world for the last few years. Their success can be attributed to their simplicity of use, safety, and above all, their efficacy. Their current role in gastroenterologic practice, in the face of new developments such as Helicobacter eradication and the development of proton pump inhibitors, will be discussed.

Esophagitis, Peptic↗