Relationships of Physicians with Pharmaceutical Sales Representatives and Pharmaceutical Companies:

Physicians were surveyed in Northwestern Pennsylvania to examine how they viewed their relationships with pharmaceutical sales representatives (PSR) and the pharmaceutical industry. Physicians viewed the PSR as an important source of information, but felt that they could get needed information from other sources without the PSR's assistance. Physicians also had friendly relationships with the PSRs and did not distrust them, but they did not view PSRs as a vital part of their practice. Samples and gifts provided by the pharmaceutical companies were not viewed as vital to gaining access to physicians. However, the financial support the companies provided for continuing medical education was seen as vital. The selling approaches used by PSRs was not considered manipulative, nor were PSRs thought to be perceived negatively by the medical community. A majority of the physicians said they would accept honoraria for delivering lectures to pharmaceutical companies. Twenty-five percent of the responding physicians also owned stock in pharmaceutical companies.     

Of mugs, meals and more: the intricate relations between physicians and the medical industry

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.     

Relationships of physicians with pharmaceutical sales representatives and pharmaceutical companies: an exploratory study

Physicians were surveyed in Northwestern Pennsylvania to examine how they viewed their relationships with pharmaceutical sales representatives (PSR) and the pharmaceutical industry. Physicians viewed the PSR as an important source of information, but felt that they could get needed information from other sources without the PSR's assistance. Physicians also had friendly relations with PSRs and did not distrust them, but they did not view PSRs as a vital part of their practice. Samples and gifts provided by the pharmaceutical companies were not viewed as vital to gaining access to physicians. However, the financial support the companies provided for continuing medical education was seen as vital. The selling approaches used by PSRs was not considered as manipulative, nor were PSRs thought to be perceived negatively by the medical community. A majority of the physicians said they would accept honoraria for delivering lectures to pharmaceutical companies. Twenty-five percent of the responding physicians also owned stock in pharmaceutical companies.     

The hidden costs of free lunches: fraud and abuse in physician-pharmaceutical arrangements

When it comes to physician-pharmaceutical manufacturer relationships, the old adage "there's no such thing as a free lunch" has been given much support lately by federal fraud and abuse enforcement authorities. In light of recent enforcement developments and initiatives, physicians must now, more than ever, develop an understanding of the legal boundaries of regulatory and ethical guidelines and carefully evaluate their relationships with pharmaceutical manufacturers for compliance. This article reviews existing regulatory and ethical guidance applicable to physician-pharmaceutical industry relationships, applies that guidance to common interactions between physicians and the industry, and offers tips for maintaining compliance.     

Social responsibility and research ethics in community-driven studies of industrialized hog production

Environmental health research can document exposures and health effects that result from inequitable relationships between communities of low income or people of color and the institutions that derive benefits (profits, federal and state funding or services, avoidance of wastes) from activities and policies that burden these communities. Researchers, most of whom work in relatively privileged institutions, are placed in situations of conflicting loyalties if they conduct research in collaboration with, or on behalf of, communities burdened by environmental injustices. These conflicts can threaten the self-interest of researchers and may raise social and ethical issues that do not typically arise in research projects that respond to the agendas of institutions. This article describes how we addressed issues of research ethics and social responsibility in environmental health research on industrialized hog production in North Carolina. Researchers and institutional review boards are not well prepared to address ethical issues when interests of entire communities, as well as individual research participants, are involved. Community-driven research partnerships can help address problems in research ethics and can enhance the social responsibility of researchers and their institutions.     

A review of improved ethical practices in environmental and public health research: case examples from native communities.

This article presents a review of 14 case studies and articles of research ethics issues in the conduct of environmental and public health research with Native American and other indigenous populations. The purpose of this review is to highlight new practices in the ethical conduct of research with native community populations. The findings from this review can promote more dialogue and policy development on the issue of community protections in research. Formal guidelines exist in ethical codes for individual rights as human subjects, but there is a lack of development on community rights in the ethics of research. This review illustrates how community-based participatory research practices can provide working guidelines that can overcome past research harms. More important, the compilations of guidelines offer tested field methods for improving the ethical conduct of research with native community populations.     

Effective executive management in the pharmaceutical industry

Along with the boom in information technology and vast development in genomic and proteomic discoveries, the pharmaceutical and biotech industries have been provided the means and tools to create a new page in medicinal history. They are now able to alter the classic ways to cure complex diseases thanks to the completion of the human genome project. To be able to compete in this industry, pharmaceutical management has to be effective not only internally but also externally in socially acceptable conduct. The first department that requires focus is marketing and sales. As the main driving force to increase revenues and profits, marketing and sales employees should be highly motivated by compensation. Also, customer relationships should be maintained for long-term gain. As important as marketing, research and development requires the financial support as well as the critical decision making to further expand the product pipeline. Similarly, finance and technologies should be adequately monitored and invested to provide support as well as prepare for future expansion. On top of that, manufacturing processes and operations are operated per quality systems and FDA guidelines to ensure high quality. Human Resources, on the other hand, should carry the managing and motivation from upper management through systematic recruitment, adequate training, and fair compensation. Moreover, effective management in a pharmaceutical would also require the social welfare and charity to help patients who cannot afford the treatment as well as improving the organization's image. Last but not least, the management should also prepare for the globalization of the industry. Inevitably, large pharmaceutical companies are merging with each other or acquiring smaller companies to enhance the competitive advantages as well as expand their product mix. For effectiveness in a pharmaceutical industry, management should focus more than just the daily routine tasks and short-term goals. Rather, they need vision as well as commitment regarding the unique requirements of the industry.     

The pharmaceutical corporation and the 'good work' of managing women's bodies

Pharmaceutical companies are intricately intertwined with every aspect of contemporary medical reality, and they increasingly drive the social process of medicalization in order to establish and dominate markets for their drugs and devices. In addition to funding the majority of clinical research, organizing it to generate an evidence base that favors their innovations, and influencing the regulation of pharmaceutical drugs and devices, companies still spend substantial resources on direct attempts to shape the attitudes, dispositions, and prescribing behavior of physicians. This article sheds new light on our picture of the relationship between the pharmaceutical industry and physicians by examining a novel form of physician-directed communication produced by one prominent corporation. An interpretive, thematic analysis of ORGYN - the unique, full-length magazine published by the Organon Corporation between 1990 and 2003 - reveals two overarching messages it communicated to physicians during that period. First, it offered a compelling picture of the "good work" obstetricians and gynecologists do, which involves enabling women of reproductive age to control their fertility through contraception and infertility treatment, and providing symptom relief and preventive benefits to older women by increasing compliance with hormone therapy regimes. Second, it included pharmaceutical technology in every aspect of the doctor's work, portraying pharmaceutical corporations as the physician's "natural partner", and women patients as passive, disempowered objects of medical practice. Through these consistent messages, the print magazine ORGYN represented one important set of mechanisms by which a pharmaceutical corporation helped drive and sustain medicalization. The article ends with a consideration of the implications of ORGYN's messages for companies, doctors, women patients, and the study of medicalization.     

Ethical issues in occupational medicine practice: knowledge and attitudes of occupational physicians

Views on ethical conduct in occupational medicine practice canvary from country to country and even between occupational healthpractitioners. However, there are many areas of common agreement,and this is apparent on comparing guidance documents on ethicsproduced by several different organizations. The usefulnessof these documents will depend in part on how aware practitionersare of their existence. A standardized questionnaire administeredto 70 occupational physicians in the Netherlands, UK, and Singaporeshowed that there was a lack of awareness of guidance documentson ethics, even for publications from their own countries. Onlyfive of the 70 respondents consulted an ethics document in thepast year. In addition to publications, other avenues were usedfor advice on ethical issues. There was a difference in opinionbetween the physicians from Singapore and those from the twoEuropean countries on whether specific occupational health activitieswere ethical. These findings reinforce the need for internationalguidance on ethics to take into account differences in attitudesand practice between countries. On many issues there was nounanimity of opinion, even between occupational physicians fromthe same country. This may be an indication of the complexityof ethical matters, and provides a rationale for publishingguidance on ethics in occupational medicine.     

Ethics in medicine

In recent years the gap between what is medically and technically feasible on the one hand, and what is ethically acceptable on the other has widened more and more rapidly. What is required now are concrete solutions which do not leave physicians alone with the decisions they must take. One such possibility consists in clinical ethics, support services as clinics consultation or ethics committees acting upon request by discussing ethical reasons for or against alternative therapies or questions related to patient care and information in individual cases. Even cost-related problems are debated by these circles. Conflicts which affect many persons who are in charge of the patients either as physicians or as nurses, feelings of insecurity, disagreement, or difficulty with uncooperative patients may all be subjects of the committees' deliberations. Interdisciplinary and public debates, which may also include lay persons, can serve to develop and discuss basic principles. They help to take medical ethics closer to the patients and reduce the focus on experts. It should also be mentioned that such a highly differentiated field urgently needs an appropriate debating culture. It is also vital to introduce students and physicians to the thinking which underlies medical ethics and to accompany them through their entire professional lives by offering them the right courses. That these may not consist in the typical "learning" experience which normally dominates teaching is self-evident. It is absolutely necessary for the professionals in charge not only to take decisions in accordance with ethical principles but also to be able to justify and discuss them in an appropriate fashion. Finally, clinical ethical research provides the possibility of achieving relevant results in this area as well. In this context the establishment of a research cooperation by the German Research Council can be regarded as an encouraging sign and a step in the right direction.     

Family consent and the pursuit of better medicines through genetic research.

Rapid changes in the science and technology related to genetic research are challenging scientists, health care providers, ethicists, regulators, patient groups, and the pharmaceutical industry to keep pace with ethically grounded, workable guidelines for both the research and clinical applications of human genetics. We describe the genetic research being conducted by one pharmaceutical company (GlaxoSmithKline) and how the company is addressing the ethical, legal, and social issues surrounding this research; discuss an industry working group's attempt to advance pharmacogenetic research by openly addressing and disseminating information on related ethical, legal, and regulatory issues; identify scientific and ethical differences among various types of genetic research; discuss potential implications of family consent on subject privacy and autonomy, data collection, and study conduct; and suggest points to consider when study sponsors, investigators, and ethics committees evaluate research proposals. Public and expert opinion regarding informed consent in genetic research is evolving as a result of increased education, discussion, and understanding of the relevant issues. Five years ago, there was strong support for anonymity in genetic research as a privacy safeguard. Now, an increasingly popular school of thought advocates against anonymity to preserve an individual's ability to withdraw and, if desired, access research results. It is important to recognize this evolution and address consent issues in a reasoned, practical, and consistent way, including input from patients and their families, health care providers, ethicists, scientists, regulatory bodies, research sponsors, and the lay community. Responsibility for assessing issues related to family consent for research should remain with local investigators, ethics boards, and study sponsors. A "one-size-fits-all" perspective in the form of new regulations, for example, would likely be a disservice to all.     

Institutional mistrust in the organization of pharmaceutical clinical trials

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products.

Perceptions of the effectiveness of ethical guidelines: an international study of physicians

The intent of ethics is to establish a set of standards that will provide a framework to modify, regulate, and possibly enhance moral behaviour. Eleven focus groups were conducted with physicians from six culturally distinct countries to explore their perception of formalized, written ethical guidelines (i.e., codes of ethics, credos, value and mission statements) that attempt to direct their ethical practice. Six themes emerged from the data: lack of awareness, no impact, marginal impact, other codes or value statements supersede, personal codes or values dictate, and ethical guidelines are useful. Overall, codes were valued only when they were congruent with existing personal morality. The findings suggest the need to re-evaluate the purpose, content, and delivery of codes for them to improve their function in promoting ethical conduct.     

Qualitative research with small connected communities: generating new knowledge while upholding research ethics

Qualitative researchers have a dual mission: to generate knowledge through rigorous research and to uphold ethical standards and principles. Qualitative researchers often conduct studies with small connected communities in which relationships exist among community members. When engaging such communities, researchers might face ethical issues in upholding confidentiality standards while they work to achieve their dual mandate. Qualitative scholars have paid little attention to the ethical challenges that might arise in this context. Drawing on our experiences conducting studies with such communities, we expand the dialogue concerning qualitative research ethics by making explicit conceptual and practical tensions that emerge at various stages of the research process; articulating our respective reflective processes; and exploring issues associated with strategies for upholding confidentiality. We conclude with lessons learned to guide researchers who might face similar challenges.     

Physicians’ Access to Ethics Support Services in Four European Countries

Clinical ethics support services are developing in Europe. They will be most useful if they are designed to match the ethical concerns of clinicians. We conducted a cross-sectional mailed survey on random samples of general physicians in Norway, Switzerland, Italy, and the UK, to assess their access to different types of ethics support services, and to describe what makes them more likely to have used available ethics support. Respondents reported access to formal ethics support services such as clinical ethics committees (23%), consultation in individual cases (17.6%), and individual ethicists (8.8%), but also to other kinds of less formal ethics support (23.6%). Access to formal ethics support services was associated with work in urban hospitals. Informal ethics resources were more evenly distributed. Although most respondents (81%) reported that they would find help useful in facing ethical difficulties, they reported having used the available services infrequently (14%). Physicians with greater confidence in their knowledge of ethics (P = 0.001), or who had had ethics courses in medical school (P = 0.006), were more likely to have used available services. Access to help in facing ethical difficulties among general physicians in the surveyed countries is provided by a mix of official ethics support services and other resources. Developing ethics support services may benefit from integration of informal services. Development of ethics education in medical school curricula could lead to improved physicians sensititity to ethical difficulties and greater use of ethics support services. Such support services may also need to be more proactive in making their help available.     

Drug marketing in french-speaking African countries

Pharmaceutical companies are often criticized for the quality of their drug advertisements in developing countries. The quantitative data we have collected on advertisements in Francophone African countries confirm these criticisms. In 1990, only 41 out of 141 advertisements published in 6 medical and paramedical journals aimed at Francophone health personnel in Africa conformed to French standards for accuracy and objectivity.Indications were absent from 5 (3.5%) advertisements and exaggerated in 42 (29.8%); side-effects were not mentioned at all in 37 (26.2%) advertisements and were incomplete in a further 20 (14.2%). Similarly, contraindications were absent from 30 (21.3%) advertisements and incomplete in 19 (13.5%). It is clear that pharmaceutical companies do not always follow a code of ethical conduct and that they frequently exploit the lack of effective controls in developing countries. This attitude creates a hazard to public health and tarnishes the image of the companies concerned.     

Characteristics of Physicians Targeted by the Pharmaceutical Industry to Participate in E-detailing

Electronic detailing (e-detailing) has been introduced in the last few years by the pharmaceutical industry as a new communication channel through which to promote pharmaceutical products to physicians. E-detailing involves using digital technology, such as Internet, video conferencing, and interactive voice response, by which drug companies target their marketing efforts toward specific physicians with pinpoint accuracy. A mail survey of 671 Iowa physicians was used to gather information about the physician characteristics and practice setting characteristics of those who are usually targeted by pharmaceutical companies to participate in e-detailing. A model is developed and tested to explain firms' targeting strategy for targeting physicians for e-detailing.