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PubMed2004

Reimagining the learned intermediary rule for the new pharmaceutical marketplace.

For the past decade, the learned intermediary rule--the rule of tort law that provides that drug manufacturers may satisfy their duty to warn of a drug's dangers by warning the prescribing physician rather than the end user of the drug--has been the subject of vigorous academic debate. That debate has been largely moot, however, as the courts have proven reluctant to make significant inroads on the protection offered by the Rule to drug manufacturers. This Article proposes a new approach to the Rule. Part I discusses the history and overwhelming adoption of the Rule pursuant to the Restatement (Second) of Torts. Part II argues that changes in the health care delivery system have resulted in a legal system that introduces market distortions by effectively immunizing the pharmaceutical industry from the legal and social consequences of its own actions. Part III then sets forth a reconceptualization of the Rule, which preserves the Rule's benefits with respect to the drug industry, the health care system, and the goals of tort law, while also strengthening the protection the tort system offers to individuals injured by prescription drugs.

Advertising↗
PubMed1987

[Clinical research studies from the ethical and legal point of view].

Relevant cases that had come to public knowledge and critical analysis of medical research on human beings prompted the USA to introduce the provision of approval by a committee and other forms of administrative control. In the 70's, ethics commissions were set up in Central Europe in compliance with the recommendations of the revised Helsinki-Tokyo Declaration. In Austria, the guiding principles are now legally safeguarded by the Pharmaceuticals Act, whereby general principles of research on human beings such as benefit-risk calculation and consent of the test person are laid down by statute. The risks involved in a novel method of treatment must nowadays be shared by the patient, which presupposes that the patient must be adequately informed. Notwithstanding the patient's consent, however, the risk must be socially acceptable, meaning that the experiment must be scientifically relevant and carried out in compliance with accepted methods and rules. The concept of cumulative justification is demanded today; it consists of the scientist's freedom of research, the test person's right to self-determination and the benefit-risk calculation. Ethics commissions composed of researchers themselves are invaluable consultant bodies for the scientist when soberly viewing his own particular project and who must himself undertake to observe the generally accepted principles regulating research on human beings. Only positive control by the medical profession itself will, in the long run, be able to effectively stave off an ever increasing encroachment of legislative and state control upon medical research.

Ethics, Medical↗
PubMed2004

A prospective before-and-after trial of an educational intervention about pharmaceutical marketing.

PURPOSE: There is increasing evidence that physicians may be compromised by their interactions with the pharmaceutical industry. The authors aimed to develop and determine the effect of an educational intervention to inform family medicine residents about pharmaceutical marketing. METHOD: Confidential, self-administered questionnaires were administered to family medicine residents at McMaster University, Hamilton, Canada, immediately before and after a two-part, 2.5-hour educational intervention. The curriculum consisted of (1) a faculty-led debate and discussion of a systematic review of physician-pharmaceutical industry interactions, and (2) an interactive workshop that included a presentation highlighting key empirical findings, a video illustrating techniques to optimize pharmaceutical sales representatives' visits, and small- and large-group problem-based discussions. Residents were asked about their attitudes toward five marketing strategies: drug samples, industry-sponsored continuing medical education, one-on-one interactions with sales representatives, free meals, and gifts worth less than CAN $10. RESULTS: A total of 37 residents responded to both questionnaires. After the intervention residents had more cautious attitudes, rating marketing strategies on a five-point Likert scale as less ethically appropriate (-0.41, p < .05) and less valuable to patients or useful to the resident (-0.39, p < .05), and reporting less intention to use them in the future (-0.44, p < .01). CONCLUSION: This intervention appears to have promoted more cautious attitudes toward pharmaceuticals marketing. Its long-term sustainability and effect on behavior remain unknown.

Adult↗
PubMed2006

The pervasiveness of pharmaceutical expenditure inertia in the OECD countries.

This paper constructs and estimates an economic model for testing statistically the strength of possible 'expenditure inertia' as a plausible reason for rising drug expenditures of the Organization for Economic Cooperation and Development (OECD) countries. The ethical drugs sector in the OECD health care systems is increasingly targeted as the major culprit in the rising cost. Using multiple regression analysis, and the maximum likelihood estimation method, the data of each country (taken from OECD Health Data, 1997) were first tested for functional form optimality with the Box-Cox power family transformations model. Drug expenditure elasticities, at data means, were computed using each country's optimal regression model estimates. The results indicate that the traditionally fitted a priori limited functional form models (e.g., linear, log-log) are not globally consistent with data across countries. The effect of a one-period lagged real per-capita drug expenditure (capturing inertia or habit persistence) on current period real per-capita prescription expenditure is statistically significant in most countries. Pharmaceutical demands are inelastic, and tend to behave like a necessity, as expected. Since the significant effects of economic, demographic, and other drivers of high drug spending differ across countries, country-specific implications and policy suggestions for cost controls ought to differ.

Aged↗
PubMed2003

[Doctor-initiated clinical trials and the revised pharmaceutical affairs law].

In Japan, clinical trials aiming at application for approval of new drugs take a long time and a lot of money, and their quality thought to be poor. Japanese pharmaceutical companies tend to conduct more clinical studies in the United States and/or Europe than in Japan. The Ministry of Health, Labour and Welfare (MHLW) announced a three-year plan to facilitate clinical trials in Japan; the establishment of a large-scale clinical trial network, the improvement of the clinical research infrastructure, and the utilization of doctor-initiated clinical trials. The revised Pharmaceutical Affairs Law enables doctors and medical institutions to perform clinical trials using unapproved products spontaneously without any corporate sponsorship. Drugs needed by some patients but unapproved because they are unprofitable for companies are expected to be approved under this system. MHLW stipulated the ethical and scientific quality standard of doctor-initiated clinical trials, which is consistent with the principles of the Declaration of Helsinki, and Good Clinical Practice (GCP). To establish a system that allows expedited approval of safer and more effective products, the integration of the functions of the current review bodies, such as the Organization for Pharmaceutical Safety and Research (OPSR) and the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), into an independent administrative agency is scheduled.

Clinical Trials as Topic↗
PubMed2003

The high road to success: how investing in ethics enhances corporate objectives.

There is a growing gap between the tidal wave of information emerging from the Human Genome Project and other molecular biology initiatives, and the clinical research needed to transform these discoveries into new diagnostics and therapeutics. While genomics-based technologies are being rapidly integrated into pharmaceutical R&D, many steps in the experimental process are still reliant on traditional surrogate model systems whose predictive power about human disease is incomplete or inaccurate. There is a growing trend underway in the research community to introduce actual human disease understanding as early as possible into discovery, thereby improving accuracy of results throughout the R&D continuum. Such an approach (known as clinical genomics: the large scale study of genes in the context of actual human disease) requires the availability of large quantities of ethically and legally sourced, high-quality human tissues with associated clinical information.Heretofore, no source could meet all of these requirements. Ardais Corporation was the first to address this need by pioneering a systematized, standardized network for the collection, processing, dissemination and research application of human tissue and associated clinical information, all of which rest on the highest ethical standards. Based on a novel model of collaboration between industry and the academic/medical community, Ardais has created procedures, structures, technologies, and information tools that collectively compromise a new paradigm in the application of human disease to biomedical research. Ardais now serves as a clinical genomics resource to dozens of academic researchers and biopharmaceutical companies, providing products and services to accelerate and improve drug discovery and development.

Advisory Committees↗
PubMed1996

Biological diversity, indigenous knowledge, drug discovery and intellectual property rights: creating reciprocity and maintaining relationships.

When new plant-derived therapeutics based on indigenous knowledge are being explored, it is important that the pharmaceutical companies return benefits to the native populations and the local governments from which the research material was obtained. When a potentially marketable plant product is being developed, it is essential that equitable agreements have already been established between the pharmaceutical companies and the people and/or countries from which this indigenous knowledge was acquired. Equally important is the commitment to provide immediate reciprocity that will enhance the welfare, the biocultural diversity and the well-being of the forest peoples. These measures should commence when a research project begins and continue during its duration. The development of these measures must be based upon the expressed needs of the indigenous communities. The relationship between the stability of the rain forest biocultural diversity, the creation and development of agro-forest resources and the long term benefits to the forest people is highlighted. Examples of initiatives taken by Shaman Pharmaceuticals Inc. and the Healing Forest Conservancy are described and discussed in the context of exploring appropriate use of intellectual property law to address the ethical issues facing all business and research groups working in the tropics.

Awards and Prizes↗
PubMed2005

Empirical uncertainty and moral contest: a qualitative analysis of the relationship between medical specialists and the pharmaceutical industry in Australia.

Alliances between the medical profession and the pharmaceutical industry have become increasingly widespread in recent years. While there are clearly benefits for doctors and their patients derived from the medical profession working with industry, concern has arisen that the commercial imperative of industry may conflict with physicians' independence and professional integrity. This paper reports the findings of an in-depth interview study with 50 Australian medical specialists undertaken to explore how and why they interact with the pharmaceutical industry and to gain insight into specialists' moral evaluation of the relationship and its consequences. Analysis of the qualitative data led to the categorizing medical specialists into three types--Confident Engagers, Ambivalent Engagers and Avoiders--based on their descriptions and evaluations of their relationship. The majority of interviewees believed that some relationship with the pharmaceutical industry was inevitable, that there were both risks and benefits associated with the relationship and that as individuals they were competent in minimizing the risks and maximizing the benefits. However, their views diverged on the extent and magnitude of the risks and benefits. The data suggested that there is considerable variance in specialists' judgments of what constituted appropriate industry largesse. Specialists' relationship with the pharmaceutical industry has inherent tensions that are managed by different doctors in different ways. Moral evaluation of the relationship and its consequences varies and the ethical concerns surrounding the relationship appeared as an area of contest. The findings suggest that in developing normative guidelines for academic and professional practice, policy makers should recognise and account for the complexity of the relationship and for the variation in medical specialists' views and feelings.

Australia↗
PubMed2004

Watson and Crick 50 years on. From double helix to pharmacogenomics.

The second half of the 20th century has seen quantum leaps in our understanding of molecular biology. The technological advances, which facilitated the recent successful completion of the Human Genome Project, have provided the tools for deciphering the complexity of the human condition. At present, the function of only 50% of genes is known. However, as understanding of the human genome improves, a plethora of gene targets for treating disease will be uncovered - leading to therapies which will be considered revolutionary. Genome related science has begun to impact almost every facet of medicine including anaesthesia and intensive care. Better understanding of interindividual differences will enable better prediction of illness susceptibility as well as response to treatment. These insights will permit therapies to be tailored to individuals or racial groups. At present, there is only rudimentary knowledge of factors controlling gene regulation, but in the future, better understanding of gene-environment interactions and gene expression will enable pharmaceutical companies to develop new therapies and permit clinicians to optimise their effects, without recourse to current laborious testing regimens. As genomic science progresses, new ethical, legal, social and philosophical dilemmas will also continue to emerge.

DNA↗
PubMed1996

Conscientious objection to assisted death: can pharmacy address this in a systematic fashion?

OBJECTIVE: To describe a legal structure for the accommodation of pharmacists' rights of conscience in the dispensing of drugs for pharmaceutically assisted death. BACKGROUND: Pharmacists have indicated that there is disagreement in the profession regarding the appropriateness of a practice known as "pharmaceutically assisted death," in which lethal medications are prescribed for terminally ill patients who want to end their lives. Pharmacists who object to pharmaceutically assisted death may be asserting a conscientious objection that threatens to create a conflict with their employers. In addition, pharmacists who support pharmaceutically assisted death, but whose employers forbid the dispensing of medications for this purpose, may face a similar conflict. Current laws and principles of professional ethics fail to adequately address the resolution of either of these conflicts. DISCUSSION: We propose a system within which the pharmacy profession could accommodate the right to conscientious objection without sacrificing the quality of patient care. At the heart of our proposal is the understanding that employers must respect an employee's right to beliefs that differ from those of the employer and, correspondingly, the understanding that employees must respect the employer's duty to provide products and services to those who seek them from the employer. CONCLUSIONS: Pharmacy associations can adopt policies for conscientious objection and have those policies become law through action of the state legislature or the state board of pharmacy. This approach could lead to the development of a clear policy and procedure for resolving the issue of conscientious objection within the pharmacy community, making it far less likely that institutions outside pharmacy would be required to develop a solution for pharmacy.

Ethics, Pharmacy↗
PubMed2004

Informed consent and the use of placebo in Poland: ethical and legal aspects.

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials.

Controlled Clinical Trials as Topic↗