Publication of pharmaceutical company-sponsored research in medical journals, and its presentation at conferences and meetings, is mostly governed by ‘publication plans’ that extract the maximum amount of scientific and commercial value out of data and analyses through carefully constructed and placed papers. Clinical research is typically performed by contract research organizations, analyzed by company statisticians, written up by independent medical writers, approved and edited by academic researchers who then serve as authors, and the whole process organized and shepherded through to (...) journal publication by publication planners. This paper reports on a conference of an international association of publication planners. It describes and analyzes their work in an ecological framework that relates it to marketing departments of pharmaceutical companies, medical journals and publishers, academic authors, and potential audiences. The medical research described here forms a new kind of corporate science, designed to look like traditional academic work, but performed largely to market products. (shrink)

The best studies on the relationship between pharmaceutical corporations and medicine have recognized that it is an ambiguous one. Yet most scholarship has pursued a simpler, more saleable narrative in which pharma is a scheming villain and medicine its maidenly victim. In this article, I argue that such crude moral framing blunts understanding of the murky realities of medicine's relationship with pharma and, in consequence, holds back reform. My goal is to put matters right in respect to one critical area (...) of scholarly interest, the medical journal publication.Pharma relies on peer advocacy to sell its wares to prescribing doctors. This is an arrangement in which clinicians’ qualified colleagues, including “key opinion leaders,” are recruited by pharmaceutical corporations and marketing agencies to deliver commercially expedient content to their professional fellows. Precisely how this practice works in the setting of publications is not well understood because ethicists studying the problem have made too much of the narrative of corporate villainy and medical victimhood. Accordingly, criticism of industry publications has been preoccupied with the crudely dishonest practices of ghostwriting, ghost authorship, and “ghost management,” vices condemned as “dirty little secrets” perpetrated from “behind the scenes” with the connivance of academic “shills” or “guest authors,” in contempt of standards set by the International Committee of Medical Journal Editors. This account is appealing, and yet it is wrong or, at the very least, seriously incomplete, with only limited relevance to the actualities of contemporary industry practices. In truth, many commercial publications are not developed in secret but fashioned within a culture of open collaboration, where academic authors make substantial, independent contributions; pharmaceutical companies are showcased rather than hidden; and medicine's editorial standards assist rather than impede the workings of commerce. (shrink)

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. (shrink)

Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in (...) industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of seeding trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it’s not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials. (shrink)

Academic-industry collaborations and the conflicts of interest (COI) arising out of them are not new. However, as industry funding for research in the life and health sciences has increased and scandals involving financial COI are brought to the public’s attention, demands for disclosure have grown. In a March 2008 American Council on Science and Health report by Ronald Bailey, he argues that the focus on COI—especially financial COI—is obsessive and likely to be more detrimental to scientific progress and public health (...) than COI themselves. In response, we argue that downplaying the potential negative impact of COI arising out of academic-industry relationships is no less harmful than overreacting to it. (shrink)

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. (shrink)

Nihilism, as most commonly understood, is the existential thesis that life is without objective meaning, purpose, or intrinsic value. Medical nihilism is the radical skepticism, indeed cynicism, about the objectivity, purpose or value of medical interventions. According to Stegenga, it is the view that we should have little confidence in the effectiveness of medical treatments. Stegenga provides a rigorous epistemological investigation into the evidence for medical interventions, one that is informed by the methods of analytical philosophy and a Bayesian formalism.

We live in a world in which scientific expertise and its epistemic authority become more important. On the other hand, the financial interests in research, which could potentially corrupt science, are increasing. Due to these two tendencies, a concern for the integrity of scientific research becomes increasingly vital. This concern is, however, hollow if we do not have a clear account of research integrity. Therefore, it is important that we explicate this concept. Following Rudolf Carnap’s characterization of the task of (...) explication, this means that we should develop a concept that is (1) similar to our common sense notion of research integrity, (2) exact, (3) fruitful, and (4) as simple as possible. Since existing concepts do not meet these four requirements, we develop a new concept in this article. We describe a concept of epistemic integrity that is based on the property of deceptiveness, and argue that this concept does meet Carnap’s four requirements of explication. To illustrate and support our claims we use several examples from scientific practice, mainly from biomedical research. (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)

There is overwhelming evidence that the opioid crisis—which has cost hundreds of thousands of lives and trillions of dollars (and counting)—has been created or exacerbated by webs of influence woven by several pharmaceutical companies. These webs involve health professionals, patient advocacy groups, medical professional societies, research universities, teaching hospitals, public health agencies, policymakers, and legislators. Opioid companies built these webs as part of corporate strategies of influence that were designed to expand the opioid market from cancer patients to larger groups (...) of patients with acute or chronic pain, to increase dosage as well as opioid use, to downplay the risks of addiction and abuse, and to characterize physicians’ concerns about the addiction and abuse risks as “opiophobia.” In the face of these pervasive strategies, conflict of interest policies have proven insufficient for addressing corporate influence in medical practice, medical research, and public health policy. Governments, the academy, and civil society need to develop counterstrategies to insulate themselves from corporate influence and to preserve their integrity and public trust. These strategies require a paradigm shift—from partnerships with the private sector, which are ordinarily vehicles for corporate influence, to a norm of separation. (shrink)

Over the past two decades, the promotion of collaborative partnerships involving researchers from low and middle income countries with those from high income countries has been a major development in global health research. Ideally, these partnerships would lead to more equitable collaboration including the sharing of research responsibilities and rewards. While collaborative partnership initiatives have shown promise and attracted growing interest, there has been little scholarly debate regarding the fair distribution of authorship credit within these partnerships.

We live in a world in which scientific expertise and its epistemic authority become more important. On the other hand, the financial interests in research, which could potentially corrupt science, are increasing. Due to these two tendencies, a concern for the integrity of scientific research becomes increasingly vital. This concern is, however, hollow if we do not have a clear account of research integrity. Therefore, it is important that we explicate this concept. Following Rudolf Carnap’s characterization of the task of (...) explication, this means that we should develop a concept that is similar to our common sense notion of research integrity, exact, fruitful, and as simple as possible. Since existing concepts do not meet these four requirements, we develop a new concept in this article. We describe a concept of epistemic integrity that is based on the property of deceptiveness, and argue that this concept does meet Carnap’s four requirements of explication. To illustrate and support our claims we use several examples from scientific practice, mainly from biomedical research. (shrink)

Publication planning is the sub-industry to the pharmaceutical industry that does the organizational and practical work of shaping pharmaceutical companies' data and turning it into medical journal articles. Its main purpose is to create and communicate scientific information to support the marketing of products. This report is based mostly on information presented at the 2007 annual meeting of the International Society of Medical Planning Professionals, including a workshop entitled "Publication Planning 101/201", attended by one of us. We provide some analysis (...) of the role of publication planning in medical publishing, and its implications for the structuring of medical knowledge. (shrink)

Background: Breaches of publication ethics such as plagiarism, data fabrication and redundant publication are recognised as forms of research misconduct that can undermine the scientific literature. We surveyed journal editors to determine their views about a range of publication ethics issues. Methods: Questionnaire sent to 524 editors-in-chief of Wiley-Blackwell science journals asking about the severity and frequency of 16 ethical issues at their journals, their confidence in handling such issues, and their awareness and use of guidelines. Results: Responses were obtained (...) from 231 editors (44%), of whom 48% edited healthcare journals. The general level of concern about the 16 issues was low, with mean severity scores of <1 (on a scale of 0–3) for all but one. The issue of greatest concern (mean score 1.19) was redundant publication. Most editors felt confident in handling the issues, with <15% feeling “not at all confident” for all but one of the issues (gift authorship, 22% not confident). Most editors believed such problems occurred less than once a year and >20% of the editors stated that 12 of the 16 items never occurred at their journal. However, 13%–47% did not know the frequency of the problems. Awareness and use of guidelines was generally low. Most editors were unaware of all except other journals’ instructions. Conclusions: Most editors of science journals seem not very concerned about publication ethics and believe that misconduct occurs only rarely in their journals. Many editors are unfamiliar with available guidelines but would welcome more guidance or training. (shrink)

Roughly 40% of the sizeable medical research and literature on recently approved drugs is “ghost managed” by the pharmaceutical industry and its agents. Research is performed and articles are written by companies and their agents, though apparently independent academics serve as authors on the publications. Similarly, the industry hires academic scientists, termed key opinion leaders, to serve as its speakers and to deliver its continuing medical education courses. In the ghost management of knowledge, and its dissemination through key opinion leaders, (...) we see the pharmaceutical industry attempting to hide or disguise the interests behind its research and education. (shrink)

BackgroundThe International Committee of Medical Journal Editors Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels – scholarly discourse, article content, and article attribution.DiscussionWith respect to overall discourse, the most important measures in the ICMJE Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article content, the ICMJE (...) promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate “advocacy”-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves.ConclusionsThe ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science’s values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding – not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry. (shrink)