Online research in philosophy

As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation. Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change. *Provides a balanced picture of the current role of the pharmaceutical industry in society *Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases *This is the only book addressing the legal implications of big pharma activities and ethical standards.

The paper focuses on the rapidly evolving concept of “harmful products” and its connection with marketing practices. It examines (a) products generally recognized as harmful, and (b) innocuous products that are sometimes (unintentionally) transformed into harmful ones by marketing activities. We indicate how the effects of these activities depend on individual perceptions as well as the norms of social and business ethics. We advocate the creation of marketing codes of ethics for particular product categories, as well as the dissemination of product information that can link the ethical codes with individual values. We illustrate these concepts with a case study of the fragrance industry and olfactory marketing.

Despite the importance of the interorganizational nature of the marketing research process, very little research has addressed how research organizations differ and how they affect each other in the conduct of ethical marketing research. The purpose of this study is to examine differences among three typical participants in the research process: corporate research departments, marketing research firms, and data subcontractors. These organizations were examined with respect to having and enforcing internal codes of conduct and the awareness and enforcement of external codes of conduct. By exploring these differences, this study should help marketing researchers better understand the relationships among participants in the research process. Understanding these differences is the first step toward controlling the potential for ethical conflict among research participants.

While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products. The industry and its associated medical communication firms state that publications in the medical literature primarily serve marketing interests. Suppression and spinning of negative data and ghostwriting have emerged as tools to help manage medical journal publications to best suit product sales, while disease mongering and market segmentation of physicians are also used to efficiently maximize profits. We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality.

Empirical research has proven the influence exerted by the medical industry on physicians’ decision-making. Physicians are the gatekeepers who determine how money is spent within the healthcare system. Hence, they are the target group of powerful lobbies in the field, i.e. the manufacturers of medical devices and the pharmaceutical industry. As clinical research lies in the hands of physicians, they play an exclusive and central role in launching new medical products. There are many ethical problems involved here: physicians may develop a mindset of entitlement; biased decisions may put patients at risk; academic interests and research activities will no longer be free if they are influenced considerably by financial incentives; fair resource allocation may be restricted. An aspect that has been neglected so far is the administrators’ involvement as they not rarely expect physicians to acquire external financial resources from industry as benefits often lie with the institutions. To “protect” physicians from undue sway may be in the best interest of patients in order to guarantee a fair allocation of resources and to prevent the application of technologies (and medications) that would not have been used according to current standards of care. The latter may and obviously does put patients at risk. On the other hand, medico-industrial relations are of great importance. A considerable part of medical progress is driven by private industry. Yet, any co-operation between those who care for patients and industry ultimately has to serve the patient. Hence, strong policies to guide conduct are sorely needed. The following points are held to be pivotal in order to secure ethical conduct: (1) professional codes of ethics; (2) a stronger academic attitude amongst medical staff, (3) rules of transparency for medico-industrial relations including online disclosure and limiting scale of payments, (4) establishing rules (and laws) that ban unethical conduct and mandate vigorous surveillance of adherence to guidelines.

Self-regulation exists at the firm-level, the industry-level, and the business-level of economic organization. Industry self-regulation has faced economic (free rider) and legal (antitrust) impediments to widespread implementation, although there exist examples of effective industry self-regulation, e.g., securities industry and the SEC, advertising and the FTC. By instituting industry codes of conduct, national trade associations have shown to be natural vehicles for self-regulation. While there has been long-standing general encouragement for establishing industry codes, adopting and enforcing conduct codes has been seriously circumscribed by restrictive Supreme Court decisions and FTC advisory opinions. One approach to clearing legal confusion is to petition the FTC to issue an industry guide on promulgating and enforcing trade association codes of conduct. Another strategy is to utilize a stakeholder approach to association ethics committee appointments that subsequently influence code creation and enforcement. Finally, a new concept of an industry code of conduct will consist of three subcodes: an economic code; an environmental code; and a socio-political code. Combined, these strategic approaches will offer new opportunities for effective nonmarket regulation.

In a perfect world, physicians and drug producers would have only one goal: to advance the health of their patients. Unfortunately, ours is not a perfect world. While every physician’s prime responsibility—by oath and by law—is to the patient, every pharmaceutical producer’s first and foremost obligation, by design, is to shareholders and employees. Their ultimate objectives are diagonally diverse. This situation calls for a code of ethics to govern the marketing and prescription of pharmaceuticals. This paper attempts to identifythe business practices prevailing in the Indian pharmaceutical industry, in order to provide a basis for constructing an appropriate code of ethics. The research is based on surveys or in-depth interviews of physicians, patients, retail pharmacists, and drug manufacturers.

Physician-pharmaceutical industry interactions continue to generate heated debate in academic and public domains, both in the United States and abroad. Despite this, recent research suggests that physicians and physicians-in-training remain ignorant of the core issues and are ill-prepared to understand pharmaceutical industry promotion. There is a vast medical literature on this topic, but no single, concise resource. This book aims to fill that gap by providing a resource that explains the essential elements of this subject. The text makes the reader more aware of the key ethical issues and allows the reader to be a more savvy interpreter of industry promotion, have a heightened awareness of the public and medical legal consequences of some physician-pharmaceutical industry interactions, and be better equipped to handle real-life encounters with industry.