Promoting opioids, a story about how to influence medical science and opinions.

Key origins of the opioid crisis in the US lie in some pharmaceutical companies' substantial efforts to sell prescription painkillers. To legitimize opioids, the companies built up a body of medical science and opinions, and channels with which to communicate. Archival searches found 876 contracts that together provide information on how Mallinckrodt, an opioid manufacturer, attempted the ghost-management of medicine. These records-available because of litigation-involved contract research organizations, medical education and communication companies, publishers, professional societies, researchers, and other people who could be Mallinckrodt's agents. Together, they produced and circulated scientific messages to increase physicians' comfort with prescribing opioids. This article gives an overview of that activity, as seen in the contracts and related documents.

Industry Relationships With Medical Oncologists: Who Are the High-Payment Physicians?

PURPOSE: Many oncologists have relationships with industry. Previous work has shown that these payments are usually modest; however, there exist a subset of medical oncologists who receive more than $100,000 US dollars (USD) annually. Here, we describe the characteristics of these physicians. METHODS: This retrospective cohort study used the Open Payments data set to identify all US-based medical oncologists/hematologists who received $100,000+ USD in general payments linked to cancer medications in 2018. Open Payments and a web-based search were used to identify physician characteristics, demographics, research profile, and leadership positions. RESULTS: One hundred thirty-nine medical oncologists received > $100,000 USD in general payments. The median payment was $154,613 USD, and the total payment was $24.2 million USD. These high-payment physicians represent 1% of all US medical oncologists (N = 10,620) yet account for 37% of all industry payments in 2018. Sixty percent (84 of 139) and 21% (29 of 139) of these high-payment physicians hold hospital and specialty association leadership roles, respectively. One quarter (24%, 33 of 139) serve on journal editorial boards, and 10% (14 of 139) have authored clinical practice guidelines; 72% (100 of 139) hold faculty appointments. CONCLUSION: A small number of medical oncologists receive very high payments from the pharmaceutical industry. These physicians hold major leadership roles within oncology. Further work is needed to understand the extent to which these conflicts of interest may shape clinical practice and policy.

Tax credits for pharmaceutical research, development and marketing?

BACKGROUND: The pharmaceutical industry is believed to receive considerable support through research and development (R&D) tax credits. OBJECTIVE: The objectives of this paper are (a) to show that many of the pharmaceutical industry's apparent R&D activities are entangled with marketing efforts, and (b) to argue that supporting these activities through tax credits does not serve public interests in health. METHODS: The bulk of this paper summarizes the author's extended qualitative mixed-methods approach to following connections between pharmaceutical research and marketing. RESULTS: The pharmaceutical industry's R&D should be understood as broadly entangled with marketing, and so generally should be understood as integrated research, development and marketing (RD&M). CONCLUSIONS: R&D tax credits to the pharmaceutical industry largely do not serve public interests.

Epistemic Corruption, the Pharmaceutical Industry, and the Body of Medical Science.

When a knowledge system importantly loses integrity, ceasing to provide the kinds of trusted knowledge expected of it, we can label this epistemic corruption. Epistemic corruption often occurs because the system has been co-opted for interests at odds with some of the central goals thought to lie behind it. There is now abundant evidence that the involvement of pharmaceutical companies corrupts medical science. Within the medical community, this is generally assumed to be the result of conflicts of interest. However, some important ways that the industry corrupts are not captured well by standard analyses in terms of conflicts of interest. It is not just that there is a body of medical science perverted by industry largesse. Instead, much of the corruption of medical science via the pharmaceutical industry happens through grafting activities: Pharmaceutical companies do their own research and smoothly integrate it with medical science, taking advantage of the legitimacy of the latter.

Access to Medicines, Access to Markets.

This article explores some uses by the pharmaceutical industry of language from the "access to medicines" movement in global health, sometimes for goals almost completely opposite to those of the movement. Important in the context of extremely expensive treatments, the industry draws on the idealistic discourse around access to medicines to create a very specific continuity between the needs of the Global South and its own marketing needs. By focusing on "access," the industry can promote the opening up of markets in relatively wealthy countries with important public or highly regulated payers.

Academic lives and cultures.

The current themed issue came about by chance. A number of manuscripts examining academic lives and cultures came through Social Studies of Science's review process at roughly the same time, and have been grouped together here. This introduction briefly describes some of their themes, and connects them with some other articles recently published in this journal, to broaden virtually the themed issue so as to represent some of the current work on the topic.

Ontological turns, turnoffs and roundabouts.

There has been much talk of an 'ontological turn' in Science and Technology Studies. This commentary explores some recent work on multiple and historical ontologies, especially articles published in this journal, against a background of constructivism. It can be tempting to read an ontological turn as based and promoting a version of perspectivism, but that is inadequate to the scholarly work and opens multiple ontologies to serious criticisms. Instead, we should read our ontological turn or turns as being about multiplicities of practices and the ways in which these practices shape the material world. Ontologies arise out of practices through which people engage with things; the practices are fundamental and the ontologies derivative. The purchase in this move comes from the elucidating power of the verbs that scholars use to analyze relations of practices and objects--which turn out to be specific cases of constructivist verbs. The difference between this ontological turn and constructivist work in Science and Technology Studies appears to be a matter of emphases found useful for different purposes.

Key opinion leaders and the corruption of medical knowledge: what the Sunshine Act will and won't cast light on.

The pharmaceutical industry, in its marketing efforts, often turns to "key opinion leaders" or "KOLs" to disseminate scientific information. Drawing on the author's fieldwork, this article documents and examines the use of KOLs in pharmaceutical companies' marketing efforts. Partly due to the use of KOLs, a small number of companies with well-defined and narrow interests have inordinate influence over how medical knowledge is produced, circulated, and consumed. The issue here, as in many other cases of institutional corruption, is that a few actors have accumulated the power to shape the information on which many others base their decisions. Efforts to address this corruption should focus on correcting large imbalances in the current political economy of medical knowledge. A sequestration of pharmaceutical research and development on one hand from pharmaceutical marketing on the other, though difficult to achieve, would address this and many other problems.

Industry sponsorship and research outcome.

BACKGROUND: Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical industry sponsored studies are more often favorable to the sponsor's product compared with studies with other sources of sponsorship. This review is an update using more stringent methodology and also investigating sponsorship of device studies. OBJECTIVES: To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. SEARCH METHODS: We searched MEDLINE (1948 to September 2010), EMBASE (1980 to September 2010), the Cochrane Methodology Register (Issue 4, 2010) and Web of Science (August 2011). In addition, we searched reference lists of included papers, previous systematic reviews and author files. SELECTION CRITERIA: Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions. DATA COLLECTION AND ANALYSIS: Two assessors identified potentially relevant papers, and a decision about final inclusion was made by all authors. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals). MAIN RESULTS: Forty-eight papers were included. Industry sponsored studies more often had favorable efficacy results, risk ratio (RR): 1.24 (95% confidence interval (CI): 1.14 to 1.35), harms results RR: 1.87 (95% CI: 1.54 to 2.27) and conclusions RR: 1.31 (95% CI: 1.20 to 1.44) compared with non-industry sponsored studies. Ten papers reported on sponsorship and effect size, but could not be pooled due to differences in their reporting of data. The results were heterogeneous; five papers found larger effect sizes in industry sponsored studies compared with non-industry sponsored studies and five papers did not find a difference in effect size. Only two papers (including 120 device studies) reported separate data for devices and we did not find a difference between drug and device studies on the association between sponsorship and conclusions (test for interaction, P = 0.23). Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment and follow-up. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.32 (95% CI: 1.05 to 1.65), compared with non-industry sponsored studies. In industry sponsored studies, there was less agreement between the results and the conclusions than in non-industry sponsored studies, RR: 0.84 (95% CI: 0.70 to 1.01). AUTHORS' CONCLUSIONS: Sponsorship of drug and device studies by the manufacturing company leads to more favorable results and conclusions than sponsorship by other sources. Our analyses suggest the existence of an industry bias that cannot be explained by standard 'Risk of bias' assessments.

Publication ethics and the ghost management of medical publication.

It is by now no secret that some scientific articles are ghost authored - that is, written by someone other than the person whose name appears at the top of the article. Ghost authorship, however, is only one sort of ghosting. In this article, we present evidence that pharmaceutical companies engage in the ghost management of the scientific literature, by controlling or shaping several crucial steps in the research, writing, and publication of scientific articles. Ghost management allows the pharmaceutical industry to shape the literature in ways that serve its interests. This article aims to reinforce and expand publication ethics as an important area of concern for bioethics. Since ghost-managed research is primarily undertaken in the interests of marketing, large quantities of medical research violate not just publication norms but also research ethics. Much of this research involves human subjects, and yet is performed not primarily to increase knowledge for broad human benefit, but to disseminate results in the service of profits. Those who sponsor, manage, conduct, and publish such research therefore behave unethically, since they put patients at risk without justification. This leads us to a strong conclusion: if medical journals want to ensure that the research they publish is ethically sound, they should not publish articles that are commercially sponsored.