Pharmaceutical promotion is a negative influencing force for prescribing. However, very few regulatory initiatives are taken to overcome this unwarranted influence. The present research was conducted in such context with an attempt to review the regulatory documents related to pharmaceutical promotion in Bangladesh including Code of Pharmaceutical Marketing Practices (CPMP), and to compare CPMP with different global guidelines. The studied guidelines demonstrate effort to regulate promotion, though that varies to a great extent, particularly in (...) enforcement aspects. Clearly defined ethical and legal prohibitions, provisions of punishment for violations and entrusted agency with defined authority are crucial. (shrink)

BackgroundThe pharmaceutical market in Bangladesh is highly concentrated. Due to high competition aggressive marketing strategies are adopted for greater market share, which sometimes cross limit. There is lack of data on this aspect in Bangladesh. This exploratory study aimed to fill this gap by investigating current promotional practices of the pharmaceutical companies including the role of their medical representatives.MethodsThis qualitative study was conducted as part of a larger study to explore the status of governance in (...) health sector in 2009. Data were collected from Dhaka, Chittagong and Bogra districts through in-depth interview, observation, and round table discussion.ResultsFindings reveal a highly structured system geared to generate prescriptions and ensure market share instituted by the pharmaceuticals. A comprehensive training curriculum for the MRs prepares the newly recruited science graduates for generating enough prescriptions by catering to the identified needs and demands of the physicians expressed or otherwise, and thus grab higher market-share for the companies they represent. Approaches such as inducements, persuasion, emotional blackmail, serving family members, etc. are used. The type, quantity and quality of inducements offered to the physicians depend upon his/her capacity to produce prescriptions. The popular physicians are cultivated meticulously by the MRs to establish brand loyalty and fulfill individual and company targets. The physicians, willingly or unwillingly, become part of the system with few exceptions. Neither the regulatory authority nor the professional or consumer rights bodies has any role to control or ractify the process.ConclusionsThe aggressive marketing of the pharmaceutical companies compel their MRs, programmed to maximize market share, to adopt unethical means if and when necessary. When medicines are prescribed and dispensed more for financial interests than for needs of the patients, it reflects system’s failed ability to hold individuals and entities accountable for adhering to basic professional ethics, code of conduct, and statutory laws. (shrink)

In 2008 pharmaceutical companies spent over $12 billion on product promotion and detailing aimed at U.S. health care practitioners. Drug and device manufacturers rely on a workforce of detailers and physician speakers to reach health care practitioners and nudge their prescribing habits. To prevent undue influence and protect the public fisc, a number of states began regulating these marketing practices, requiring companies to disclose all gifts to practitioners, prohibiting the commercialized sale of prescription data, and prohibiting certain (...) gifts altogether. The 2010 enactment of the Physician Payment Sunshine Act marks the first Congressional involvement in the regulation of disclosure related to pharmaceutical marketing. Overall, the Act improves transparency in pharmaceutical marketing to physicians and expands the regulation of disclosure of pharmaceutical marketing activities in important substantive ways. (shrink)

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice.

The federal government indirectly subsidizes the pharmaceutical industry by funding basic research, various tax credits and deductions, patent rules, grants of market exclusivity, and other means, in order to spur drug development, promote public health, and improve medical care. But today, the pharmaceutical industry often neglects these goals and sometimes even undermines them, due to what Lawrence Lessig refers to as institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or (...) integrity. A key source of institutional corruption is improper dependence by the institution or its key actors on the actions of third parties that have fundamentally different interests. It is the health care system’s improper dependency on pharmaceutical firms that allows them to displace some public policy goals and to compromise the attainment of others. (shrink)

Direct-to-consumer advertising of healthcare products refers to a variety of marketing practices based on a combination of information and promotion strategies directed at consumers through different media such as radio and television broadcasts, newspaper and magazine ads, and, more recently, through the Internet. The principal form of marketing used by the pharmaceutical industry is the distribution of free samples to physicians but DTCA is an increasing part of global promotional spending for prescription drugs. Latest estimates suggest that (...) DTCA now represents an annual $3.2 billion enterprise for the U.S. pharmaceutical industry. Findings from the literature show that these substantial efforts are geared toward the newer pharmaceuticals for chronic conditions with huge market potentials. The lion's share is going to the 20 most prescribed pharmaceuticals. (shrink)

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. (shrink)

This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as law and medicine, (...) truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver educational talks to groups of physicians in the community to help market the company's brand-name drugs. These speakers receive substantial compensation to lecture at events sponsored by pharmaceutical companies, a practice that has garnered attention, controversy, and scrutiny in recent years from legislators, professional associations, researchers, and ethicists on the issue of whether it is appropriate for academic physicians to serve in a promotional role. These (...) relationships have become so contentious that three years ago the pharmaceutical industry trade association, the Pharmaceutical Research and Manufacturers of America, adopted voluntary guidelines stating that drug companies should stop giving doctors free pens, calendars, sports bags, or tickets to entertainment events. Further, numerous medical associations, such as the Association of American Medical Colleges, the American Board of Internal Medicine and the Institute on Medicine as a Profession, and government bodies such as the Institute of Medicine have recommended that medical schools and teaching hospitals prohibit or strongly discourage faculty from participating in so-called industry Speakers Bureaus — promotional events designed solely to market pharmaceutical products. (shrink)

This paper explains how the current architecture of the pharmaceutical markets has created a misalignment of financial incentives and public health that is a central cause of harmful practices. It explores three possible solutions to address that misalignment: taxes, increased financial penalties, and drug pricing based on value. Each proposal could help to partly realign financial incentives and public health. However, because of the limits of each proposal, there is no easy solution to fixing the problem of financial (...) incentives. (shrink)

This article argues that the misalignment of private profit-maximizing objectives with public health needs causes institutional corruption in the pharmaceutical sector and systematically leads firms to act contrary to public heath. The article analyzes how financial incentives generate a business model promoting harmful practices and explores several means of realigning financial incentives in order to foster therapeutic innovation and promote the rational use of medicines.

Bangladesh, a Muslim-majority country, has a national organ donation law that was passed in 1999 and revised in 2018. The law allows living-related and brain-dead donor organ transplantation. There are no legal barriers to these two types of organ donations, but there is no legislation providing necessary costs and incentive measures associated with successful organ transplants. However, many governments across the globe provide different types of incentives for motivating living donors and families of deceased donors. This study assesses the (...) merits and demerits of incentive measures already in use around the world and proposes ethical measures that can promote organ donation in Bangladesh. The primary focus of this paper is to present an ethical analysis of the comparison of incentive measures on organ donation between Bangladesh and the Islamic Republic of Iran as two Muslim countries that operate organ donation for transplantation practices according to Islamic principles. In this paper, I mainly argue that providing a fixed bare minimum financial incentive measure to distantly related living donors and families of deceased donors will encourage Bangladeshis to donate organs in a manner that is ethically justifiable, morally permissible, and socio-economically appropriate. The government of Bangladesh should revise the existing biomedical law to include a provision related to incentive measures and set a strict policy to properly regulate these measures as key stewardship that can ethically promote organ donation for transplantation. (shrink)

BackgroundIn Pakistan, drug promotion practices, ethical or unethical, have rarely been in the spotlight. We aimed to assess the perception and barriers of medical representatives (MRs) and doctors (MDs) regarding ethical promotion of pharmaceuticals in Pakistan.MethodsA cross sectional survey was conducted in seven major cities of Pakistan for 6-months period. Self-administered questionnaire was used for data collection. Logistic regression and five-point Likert scale scoring was used to estimate the perceptions and barriers.ResultsCompared to national companies (NCs), the medical (...) representatives (MRs) of multinational companies (MNCs) strongly believed that their companies follow World Health Organization (WHO) (OR; 5.31, p = 0.0005), International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) (OR; 6.45, p = 0.0005) and national codes of ethics (OR; 5.84, p = 0.0005). MNCs trained their MRs (OR; 6.68, p = 0.0005), provide accurate and valid scientific data (OR; 4.01, p = 0.007) with adequate system of accountability and controls on product samples (OR; 1.96, p = 0.047), while, NCs sponsor social or entertainment activities, seminars and conferences, and all sort of facilitation in form of gifts of their choice and clinic renovation for medical doctors (MDs). MDs perceptions were similar to MRs mentioned above, yet strongly agreed that companies offer cash payments or equivalents to MDs. The MRs of NCs/mncs and MDs agreed/strongly agreed that no external accountability, profiteering, pressure on sale targets, job insecurity, condoning unethical promotion by high-ups’ and business promotion by junior MDs were the predominant barriers.ConclusionIn conclusion, MRs of MNCs and MDs believed that MNCs follow certain codes of ethics in the promotion of pharmaceuticals, while NCs tend to be more profit oriented and even condone unethical promotion. All stakeholders, MRs, MDs and companies, might pose certain barriers, intentionally or unintentionally, in ethical promotion. (shrink)

Arguing that ecological thinking can animate an epistemology capable of addressing feminist, multicultural, and other post-colonial concerns, this book critiques the instrumental rationality, hyperbolized autonomy, abstract individualism, and exploitation of people and places that western epistemologies of mastery have legitimated. It proposes a politics of epistemic location, sensitive to the interplay of particularity and diversity, and focused on responsible epistemic practices. Starting from an epistemological approach implicit in Rachel Carson’s scientific projects, the book draws, constructively and critically, on ecological theory (...) and practice, on (post-Quinean) naturalized epistemology, and on feminist and post-colonial theory. Analyzing extended examples from developmental psychology, from medicine and law, and from circumstances where vulnerability, credibility, and public trust are at issue, the argument addresses the constitutive part played by an instituted social imaginary in shaping and regulating human lives. The practices and examples discussed invoke the responsibility requirements central to this text’s larger purpose of imagining, crafting, articulating a creative, innovative, instituting social imaginary, committed to interrogating entrenched hierarchical social structures, en route to enacting principles of ideal cohabitation. (shrink)

Conflicts of interest are rampant in the American medical community. Today it is not uncommon for doctors to refer patients to clinics or labs in which they have a financial interest (40% of physicians in Florida invest in medical centers); for hospitals to offer incentives to physicians who refer patients (a practice that can lead to unnecessary hospitalization); or for drug companies to provide lucrative give-aways to entice doctors to use their "brand name" drugs (which are much more expensive (...) than generic drugs). In Medicine, Money and Morals, Marc A. Rodwin draws on his own experience as a health lawyer--and his research in health ethics, law, and policy--to reveal how financial conflicts of interest can and do negatively affect the quality of patient care. He shows that the problem has become worse over the last century and provides many actual examples of how doctors' decisions are influenced by financial considerations. We learn how two California physicians, for example, resumed referrals to Pasadena General Hospital only after the hospital started paying $70 per patient (their referrals grew from 14 in one month to 82 in the next). As Rodwin writes, incentives such as this can inhibit a doctor from taking action when a hospital fails to provide proper service, and may also lead to the unnecessary hospitalization of patients. We also learn of a Wyeth-Ayerst Labs promotion in which physicians who started patients on INDERAL (a drug for high blood pressure, angina, and migraines) received 1000 mileage points on American Airlines for each patient (studies show that promotions such as this have a direct effect on a doctor's choice of drug). Rodwin reveals why the medical community has failed to regulate conflicts of interest: peer review has little authority, state licensing boards are usually ignorant of abuses, and the AMA code of ethics has historically been recommended rather than required. He examines what can be learned from the way society has coped with the conflicts of interest of other professionals --lawyers, government officials, and businessmen--all of which are held to higher standards of accountability than doctors. And he recommends that efforts be made to prohibit and regulate certain kinds of activity (such as kickbacks and self-referrals), to monitor and regulate conduct, and to provide penalties for improper conduct. Our failure to face physicians' conflicts of interest has distorted the way medicine is practiced, compromised the loyalty of doctors to patients, and harmed society, the integrity of the medical profession, and patients. For those concerned with the quality of health care or medical ethics, Medicine, Money and Morals is a provocative look into the current health care crisis and a powerful prescription for change. (shrink)

With the passage of the Physician Payment Sunshine Act as part of the federal health care reform law, pharmaceutical manufacturers are now required to disclose a wide range of payments made by manufacturers to physicians. We review current state regulation of pharmaceutical marketing and consider how the federal sunshine provision will affect existing marketing regulation. We analyze the legal and practical implications of the Physician Payment Sunshine Act.

Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver “educational” talks to groups of physicians in the community to help market the company's brand-name drugs.Although presented as educational, and even though they provide educational content, these events are intended to influence decisions about drug selection in ways that are not based on the suitability and effectiveness of the product, but on the prestige and persuasiveness of the speaker. A number of state legislatures and most (...) academic medical centers have attempted to restrict physician participation in pharmaceutical marketing activities, though most restrictions are not absolute and have proven difficult to enforce. This article reviews the literature on why Speakers' Bureaus have become a lightning rod for academic/industry conflicts of interest and examines the arguments of those who defend physician participation. It considers whether the restrictions on Speakers' Bureaus are consistent with principles of academic freedom and concludes with the legal and institutional efforts to manage industry speaking. (shrink)

In this study of advertisements appearing in medical periodicals and by direct mail advertising to general practitioners, Dr. Stimson, a sociologist, concludes that from what is intended to provide therapeutic information hardly any therapeutic information is provided. He reminds the reader of the safeguards which surround all drug advertising by law and by the code of practice of the Association of the British Pharmaceutical Industry but these safeguards do not appear to control real or potential sins of (...) omission. Frequently in these advertisements the literature relating to the drug is quoted but Dr. Stimson found that it was difficult to trace all the papers quoted in different types of medical library. (Some references quoted were to unpublished papers but surely the blame should be shared in this situation?) Dr. Stimson also gives a vivid and fascinating glimpse of what he calls the 'images and stereotypes' of the patients who, it is claimed, would benefit from the drug being advertised. Certainly most general practitioners must be aware that when they prescribe that image is displaced by an individual but the portrait gallery is indeed depressing. However, to balance these advertisements drug companies issue data sheets which must be more informative than advertisements and conform to regulations in their format. Unfortunately data sheets are only issued every 15 months whereas the 'average general practitioner is potentially exposed to 1,300 advertisements every month'. In other words, the data sheet and not the advertisement should be the guideline but it arrives too infrequently to offset the lack of therapeutic information contained in advertisements. (shrink)

While pharmaceutical industry involvement in producing, interpreting, and regulating medical knowledge and practice is widely accepted and believed to promote medical innovation, industry-favouring biases may result in prioritizing corporate profit above public health. Using diabetes as our example, we review successive changes over forty years in screening, diagnosis, and treatment guidelines for type 2 diabetes and prediabetes, which have dramatically expanded the population prescribed diabetes drugs, generating a billion-dollar market. We argue that these guideline recommendations have emerged under pervasive (...) industry influence and persisted, despite weak evidence for their health benefits and indications of serious adverse effects associated with many of the drugs they recommend. We consider pharmaceutical industry conflicts of interest in some of the research and publications supporting these revisions, and in related standard-setting committees and oversight panels. We raise concern over the long-term impact of these multifaceted involvements. Rather than accept industry conflicts of interest as normal, needing only to be monitored and managed, we suggest challenging that normalcy, and ask: what are the real costs of tolerating such industry participation? We urge the development of a broader focus to fully understand and curtail the systemic nature of industry’s influence over medical knowledge and practice. (shrink)

This paper examines ethical issues involved in the mass marketing of securities to individuals. The marketing of products deemed “socially questionable” or “sinful” (like tobacco and alcohol) has long been recognized as posing special ethical challenges (Kotler, P. and S. Levy: 1971, Harvard Business Review 49, 74–80; Davidson, D. K: 1996, Selling Sin: The Marketing of Socially Unacceptable Products (Quorum Press, Westport). We contend that marketers should consider securities (i.e. common stock, options) in a similar (...) vein, as a potentially dangerous product. Given the inherent volatility of equity prices, responsible marketers need to exercise caution and restraint in promoting securities. We evaluate whether the NYSE’s current guidelines adequately encourage ethical marketing practices and deter unethical ones. Using recent examples of controversial brokerage advertisements, we expose weaknesses in the Exchange’s vague injunction that members not “mislead” reasonable people by making “exaggerated claims” in their communications. From a moral perspective, we find it troublesome that intentionality need not be present for a promotion to be considered misleading. Also problematic is the continued invocation of the reasonable person standard to judge the propriety of advertisements. We close with some thoughts on improving the quality of securities marketing. We suggest that the NYSE, in the interests of fostering higher ethical behavior among member marketers, may need to revive a marketing code of conduct prevalent on Wall Street in an earlier era. (shrink)

Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into (...) the FDA's prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication; independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few, if any, new clinical benefits; and the creation of a National Drug Safety Board. (shrink)

Even though Corporate Social Responsibility (CSR) has become a widely accepted concept promoted by different stakeholders, business corporations' internal strategies, known as corporate self-regulation in most of the weak economies, respond poorly to this responsibility. Major laws relating to corporate regulation and responsibilities of these economies do not possess adequate ongoing influence to insist on corporate self-regulation to create a socially responsible corporate culture. This book describes how the laws relating to CSR could contribute to the inclusion (...) of CSR principles at the core of the corporate self-regulation of these economies in general, without being intrusive in normal business practice. It formulates a meta-regulation approach to law, particularly by converging patterns of private ordering and state control in contemporary corporate law from the perspective of a weak economy. It proposes that this approach is suitable for alleviating regulators' limited access to information and expertise, inherent limitations of prescriptive rules, ensuring corporate commitment, and enhance the self-regulatory capacity of companies. This book describes various meta-regulation strategies for laws to link social values to economic incentives and disincentives, and to indirectly influence companies to incorporate CSR principles at the core of their self-regulation strategies. It investigates this phenomenon using Bangladesh as a case study. (shrink)

The use of nonhuman animals as models in research and drug testing is a key route through which contemporary scientific knowledge is certified. Given ethical concerns, regulation of animal research promotes the use of less “sentient” animals. This paper draws on a documentary analysis of legal documents and qualitative interviews with Named Veterinary Surgeons and others at a commercial laboratory in the UK. Its key claim is that the concept of animal sentience is entangled with a particular (...) imaginary of how the general public or wider society views animals. We call this imaginary societal sentience. Against a backdrop of increasing ethnographic work on care encounters in the laboratory, this concept helps to stress the wider context within which such encounters take place. We conclude that societal sentience has potential purchase beyond the animal research field, in helping to highlight the affective dimension of public imaginaries and their ethical consequences. Researching and critiquing societal sentience, we argue, may ultimately have more impact on the fate of humans and nonhumans in the laboratory than focusing wholly on ethics as situated practice. (shrink)

The Food and Drug Administration and the European Medicines Agency have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human (...) Use as a mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation. (shrink)

What does unethical behavior look like in everyday professional practice, and how might it become the accepted norm? Examinations of unethical behavior often focus on failures of individual morality or on psychological blind spots, yet unethical behaviors are generated and performed through social interactions across professional practices rather than by individual actors alone. This shifts the focus of behavioral ethics research beyond the laboratory exploring motivation and cognition and into the organizations and professions where unethical behavior is motivated, justified, enabled (...) and supported in specific social contexts. For instance, when pharmaceutical firms fund academic research, how do the funding arrangements intersect with individual behaviors that are typical in academic research? In turn, how do academic-industry interactions affect scientific norms, particularly those involving compliance with rules, regulations, and ethical codes of conduct? A social organization approach to ethics allows us not only to examine ethics in practice, but also to tease apart unethical behaviors that might operate on an unreflective level and become accepted as “just the way it is.”. (shrink)

Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials (...) to test whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies. (shrink)

This article explores whether the bioethical performance and trustworthiness of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating. Other industries have used such systems to define best practices, set standards, and assess and signal the quality of services, processes, and products. These systems have also informed decisions in other industries about where to invest, what to buy, where to work, and when to regulate. Similarly, accreditation, certification, and rating programs can (...) help drug companies address stakeholder concerns in four areas: clinical trial design and management, dissemination of clinical trial results, marketing practices, and the accessibility of medicines. To illuminate processes — such as conflicts of interests and revolving-door policies — that can jeopardize the integrity of accreditation, certification, and ratings systems, the article concludes with a consideration of recent failures of credit-rating agencies and a review of the regulatory capture literature. (shrink)

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 the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s 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 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. (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration and, second, the scheduling decisions made by the Drug Enforcement Administration. If a (...) “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin and began marketing it as an analgesic. (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration and, second, the scheduling decisions made by the Drug Enforcement Administration. If a (...) “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin and began marketing it as an analgesic. (shrink)

In 2001 the Italian Government defined Essential Assistance Levels (LEA), which can be considered as an important step forward in the health care system. The Italian health care system would provide payment of essential and uniform aid services in order to safeguard many values such as human dignity, personal health, equal assistance and good health practices. The Ministry of Health has worked to rationalize the National Formulary and to define evaluation methods for drugs in order to choose what to reimburse (...) without penalizing the rights of the individual and society.This paper describes how this job of rationalization was done and tries to illustrate the choices made in Italy by the use of two meaningful examples (statins and rivastigmine). (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration (FDA) and, second, the scheduling decisions made by the Drug Enforcement Administration (DEA). (...) If a “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin (acetylsalicylic acid) and began marketing it as an analgesic. (shrink)

Post-industrial societies confront common problems in pharmaceutical industry-physician relations. In order to promote sales, drug firms create financial relationships that influence physicians' prescriptions and sometimes even reward physicians for prescribing drugs. Three main types exist: kickbacks, gifts, and financial support for professional activities. The prevalence of these practices has evolved over time in response to changes in professional codes, law, and markets. There are certainly differences among these types of ties, but all of them can compromise physicians' independent (...) judgment and rational prescribing.Drug firms have paid kickbacks for prescribing drugs, purchasing drugs, switching brands prescribed, adding a drug to a hospital formulary, enrolling patients in post-marketing clinical trials, and writing practice guidelines that encourage the use of certain drugs. (shrink)

In purity and holiness I will guard my life and my art.Every physician-patient encounter is a conflict of interest. Every physician-payer encounter is also a conflict of interest.Wide-spread criticism of the pharmaceutical industry’s extravagant marketing practices and some doctors’ undignified, even appalling eagerness to stuff themselves, their pockets and their offices with the industry’s “stuff,” prompted physician groups, the drug and device industry itself to institute reforms designed better to limit industry influence on physicians.But according to Troyen (...) Brennan and his coauthors, the reforms, while reducing some of the most egregious instances of industry influence peddling and physicians’ self-debasement, were doomed fundamentally, for three reasons. First, they were based on common sense but incorrect assumptions about the mechanism of industry influence and on myths about the efficacy of disclosure as an ethical disinfectant. Second, they relied on voluntary adherence and so failed to pinpoint responsibility for monitoring compliance and enforcement. (shrink)

Relation between physicians and pharmaceutical industry is required for the benefit of the patient. But it may turn into business and overthrow the patients’ benefit. The relation might be in question at present and in future. Several questions are flowing in Bangladesh. To solve these queries we have explored the situation in developed and developing countries. The physicians and associations of pharmaceutical industries developed several ethical guidelines in those countries. They have addressed the long lasting (...) issues on gift provided to physician, cash back, sample, industry sponsored scientific meetings, research and hospitality. There are huge restrictions to ensure the right of the patient’s e.g. limitation of inexpensive gift by the pharmaceuticals, avoiding expensive medicine instead of equally effective low priced medicine. We are lacking behind to protect the patient right properly: regulation, adherence to existing guide line, lack of guidance from statutory bodies. The current scenario is far behind the right of patient. In Bangladesh it is not yet addressed either by professionals or by pharmaceutical associations. It is the immediate need to construct a guide line for physicians and pharmaceutical industry of Bangladesh.Bangladesh Journal of Bioethics 2015 Vol.6 (1):1-5. (shrink)

We thank our commentators for their thoughtful responses to our paper1 covering among other issues the relationships of ethics law and professional codes, the tensions between ethical universalism and cultural relativism and the phenomenon of moral judgement required when ethical norms conflict, including the norms of patient care versus obligations to others both now and in the future. Although the comments deserve more extensive discussion, in what follows we respond briefly to specific aspects of each commentary and remind (...) readers that professional codes of ethics are necessarily brief and that the International Code of Medical Ethics (ICoME) explicitly refers to the World Medical Association’s (WMA) mutually concordant and far more extensive ‘body of policies’.2 Sarela raises a fundamental and, as stated in the commentary, unresolved debate: ‘should ethics shape law or is it the converse’?3 We understand the ‘global medical ethos’ represented in the WMA’s revised ICoME to be firmly embedded in the assumption that ethics should shape law and that only where laws are so shaped do people governed by them have an ethical obligation to obey them. For the medical profession, laws permitting participation in torture or other cruel, inhuman or degrading practices and punishments are categorically unethical, and therefore, doctors must not facilitate or participate in them—difficult as it may be for some doctors in some regions or environments to act accordingly. Schantz and Mansoori claim that ‘if a code of ethics is an act of professional self-regulation and professional self-regulation is community-dependent, then a code of ethics cannot be …. (shrink)

Evidence suggests that the incidence of research misconduct is not in decline despite efforts to improve awareness, education and governance mechanisms. Two responses to this problem are favoured: first, the promotion of an agent-centred ethics approach to enhance researchers’ personal responsibility and accountability, and second, a change in research culture to relieve perceived pressures to engage in misconduct. This article discusses the challenges for both responses and explains how normative coherence through values alignment might assist. We argue that research integrity (...) and research ethics convey mixed messages, which are likely to contribute to a form of normative confusion. For the successful adoption of an agent-centred approach, normative coherence is needed between the two. To facilitate normative coherence, we propose that research ethics and research integrity be underpinned by a shared set of moral values that can be enacted via codes and guidelines and imbue research environments. Furthermore, to facilitate culture change, the same normative coherence is necessary at all levels of an institution. Only via values alignment between institutional aims, management, institutional practices and researchers can an ethical culture become truly embedded in research institutions. (shrink)

The Australian Football League (AFL) is the premier sporting competition in Australia in terms of capital outlay, breadth of industry associations, public consumption, and arguably cultural significance. The AFL competition is now a domain of specialisations and interests, which provides vast opportunity for both sporting and non-sporting institutions seeking to utilise the game to capitalise on a society of consumption, entertainment and risk. AFL officials expect high standards of their players both on and off the field. These standards are expressed (...) in various forms of Codes and Policies. Off field player misconduct is an ongoing concern not escaping media attention, which is a resounding indication more needs to be done by the AFL to improve responsible player character development. Whether the current education programmes are sufficient to meet the AFL’s own expectations is the central issue addressed in this chapter. As it stands AFL governance is deficient on several counts. In this chapter I will focus on three governance deficiencies: firstly, the AFL Illicit Drug Policy (IDP) contains unnecessary inconsistencies relative to its primary purpose; secondly, the present measures undertaken to ensure players have appropriate education to achieve the expected character development are far from efficacious and so arguably can be vastly improved; and thirdly, the promotion of live-odds gambling during televised games is culturally problematic and inconsistent with its own demands. The ethical grounds central to this investigation are ‘fairness’ and ‘cultural influence’. In order to resolve some of its governance concerns I will explain why the AFL should be characterised as a practice-community and as such should adopt a comprehensive virtue and value-based compliance ethical education programme consistent with its own vision and conduct expectation of its players and officials. I will argue that the AFL as a practice community is much more than simply a game, given its cultural influence, commercial associations and community programmes. (shrink)

Relationships between physicians and pharmaceutical sales representatives (PSRs) often create conflicts of interest, not least because of the various benefits received by physicians. Many countries attempt to control pharmaceutical industry marketing strategies through legal regulation, and this is true in Poland where efforts are underway to eliminate any practices that might be considered corrupt in medicine. The present research considered Polish medical students’ opinions about domestic laws restricting doctors’ acceptance of expensive gifts from the industry, the (...) idea of compulsory transparency, and the possibility of introducing a Polish Sunshine Law. A qualitative, focus group-based, interview method was used. Data were gathered from nine focus groups involving 92 medical students from three universities located in major Polish cities. The article presents a classification of opposing student views with regard to the consequences of introducing different legal solutions; this should be useful for policy makers deliberating on how to optimally regulate pharmaceutical marketing. The study’s results are discussed in the context of the public bioethical debate in Poland. (shrink)

Existing regulation of end-of-life care is flawed. Problems include poorly-designed laws, policies, ethical codes, training, and funding programs, which often are neither effective nor helpful in guiding decision-making. This leads to adverse outcomes for patients, families, health professionals, and the health system as a whole. A key factor contributing to the harms of current regulation is a siloed approach to regulating end-of-life care. Existing approaches to regulation, and research into how that regulation could be improved, (...) have tended to focus on a single regulatory instrument (e.g., just law or just ethical codes). As a result, there has been a failure to capture holistically the various forces that guide end-of-life care. This article proposes a response to address this, identifying “regulatory space” theory as a candidate to provide the much-needed holistic insight into improving regulation of end-of-life care. The article concludes with practical implications of this approach for regulators and researchers. (shrink)

Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of (...) election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. (shrink)

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. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have (...) reached the deliberation processes. Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

Background: Expenditure on industry products (mostly drugs and devices) has spiraled over the last 15 years and accounts for substantial part of healthcare expenditure. The enormous financial interests involved in the development and marketing of drugs and devices may have given excessive power to these industries to influence medical research, policy, and practice.Material and methods: Review of the literature and analysis of the multiple pathways through which the industry has directly or indirectly infiltrated the broader healthcare systems. We present (...) the analysis of the industry influences at the following levels: (i) evidence base production, (ii) evidence synthesis, (iii) understanding of safety and harms issues, (iv) cost-effectiveness evaluation, (v) clinical practice guidelines formation, (vi) healthcare professional education, (vii) healthcare practice, (viii) healthcare consumer’s decisions.Results: We located abundance of consistent evidence demonstrating that the industry has created means to intervene in all steps of the processes that determine healthcare research, strategy, expenditure, practice and education. As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed, and clinical guidelines, medical practice, and healthcare expenditure decisions are biased. Conclusion: To serve its interests, the industry masterfully influences evidence base production, evidence synthesis, understanding of harms issues, cost-effectiveness evaluations, clinical practice guidelines and Healthcare professional education and also exerts direct influences on professional decisions and health consumers. There is an urgent need for regulation and other action towards redefining the mission of medicine towards a more objective and patient-, population- and society-benefit direction that is free from conflict of interests. (shrink)

Reflecting on the tension of which he was aware between the imperial West and the still-mysterious East, Victorian writer Rudyard Kipling penned the above phrase to express the incommensurable situation wherein the Westerner never understands the Asian, as the latter’s culture differs too greatly from his own. However, aware that East and West nevertheless cannot remain separated forever, the author ends the poem with an eventual encounter between the two.Over 100 years have passed since this poem was written, yet (...) the ambivalent encounter between East and West that it depicts still exists and is currently playing out within the field of pharmaceuticals. On one side of the divide are the many people in the industry who want to standardize global acceptance of drugs; on the other are the local authorities who want to maintain the overruling legal need not to compromise on health care at a national level. In this sense, the divergence and unity that Kipling captures is what this paper aims to discuss as it addresses how race is debated at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (shrink)

The essays in Rhetorical Spaces grow out of Lorraine Code's ongoing commitment to engaging philosophical issues as they figure in people's everyday lives. The arguements in this book are informed at once by the moral-political implications of how knowledge is produced and circulated and by issues of gendered subjectivity. In their critical dimension, these lucid essays engage with the incapacity of the philosophical mainstream's dominant epistemologies to offer regulative principles that guide people in the epistemic projects that figure centrally (...) in their lives. In its constructive dimension, Rhetorical Spaces focuses on developing productive, case-by-case analyses of knowing other people in situations where social-political inequalities create asymmetrical patterns of epistemic power and privilege. Framing all of the essays is the conception of rhetorical spaces which shows that prevailing intellectual-political climates can work to enhance or to thwart possibilities of establishing cognitive authority for the members of a society who belong to groups other than the dominant ones. Finally, bridging the gap between theory and practice, Lorraine Code shows how the issue of reconfiguring structures of authority and expertise are not just matters of individual responsibility, but require a radical restructuring of the communities and social orders in which people know and act. (shrink)

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices by extending brand (...) exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017. (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical (...) concerns as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (shrink)

The marketing of unproven direct-to-consumer stem cell interventions is becoming widespread in Canada. There is little evidence supporting their use and they have been associated with a range of harms. Canada has been slower to act against clinics offering these interventions than other jurisdictions, including the United States. Here, we outline the regulatory and policy tools available in Canada to address this growing problem. Health Canada’s regulations governing cell therapies are complex, but recent statements make it clear that Health (...) Canada believes it has jurisdiction over many of the currently marketed stem cell interventions. Still, further regulatory clarity is needed from Health Canada, as are increased directed enforcement efforts on interventions that fall within their scope. The Competition Bureau, via the Competition Act, prohibits advertisers from making materially false or misleading promotional representations. The Competition Bureau could collaborate with the scientific community to analyze the claims of existing clinics in Canada, and impose sanctions upon those who breach the established standard. Professional regulators, including provincial colleges of physicians and surgeons, have considerable power over what products and services their members can offer. Every college of physicians in Canada requires, via policy and codes of ethics, that doctors maintain evidence-based practices. This requirement is incompatible with offering many unproven stem cell interventions. Litigation may be another tool, including the use of fraud, misrepresentation and/or negligence claims for failing to meet the required standard of care. Finally, political pressure on federal and provincial lawmakers could encourage changes to marketing, cell therapy and professional regulations that would allow a more comprehensive response. In sum, there are many existing tools that can be used to protect the public from unproven stem cell interventions. Increased bureaucratic will and grassroots efforts are needed in order to effect a positive policy response. (shrink)

These essays assess market liberal or libertarian political theory. They provide insights into the limits of government, develop market-oriented solutions to pressing social problems, and explore some defects in traditional libertarian theory and practice. Some of the essays deal with crucial theoretical issues, asking whether the promotion of citizens' welfare can serve as the justification for the establishment of government, or inquiring into the constraints on individual behavior that exist in a liberal social order. Some essays explore market liberal or (...) libertarian positions on specific public policy issues, such as affirmative action, ownership of the airwaves, the provision of healthcare, or the regulation of food and drugs. Other essays look at property rights, the morality of profit-making, or the provision of public goods. Still others address libertarianism as a political movement, suggesting ways in which libertarians can reach out to those who do not share their views. (shrink)