Medical Ghostwriting and Informed Consent

Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author‐institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.     

PROFITS AND PLAGIARISM: THE CASE OF MEDICAL GHOSTWRITING

This paper focuses on medical ghostwriting in the United States. I argue that medical ghostwriting often involves plagiarism and, in those cases, can be treated as an act of research misconduct by both the federal government and research institutions. I also propose several anti‐ghostwriting measures, including: 1) journals should implement guarantor policies so that researchers may be better held accountable for their work; 2) research institutions and the federal government should explicitly prohibit medical ghostwriting and outline appropriate penalties; and 3) a publicly available database should be created to record researchers' ethics violations.     

Knowledge of undisclosed corporate authorship ("ghostwriting") reduces the perceived credibility of antidepressant research: a randomized vignette study with experienced nurses

ABSTRACT: BACKGROUND: There is much concern regarding undisclosed corporate authorship ("ghostwriting") in the peer-reviewed medical literature. However, there are no studies of how disclosure of ghostwriting alone impacts the perceived credibility of research results. FINDINGS: We conducted a randomized vignette study with experienced nurses (n = 67), using a fictional study of antidepressant medication. The vignette described a randomized controlled trial and gave efficacy and adverse effect rates. Participants were randomly assigned to one of two authorship conditions, either (a) traditional authorship (n = 35) or (b) ghostwritten paper (n = 32), and then completed a perceived credibility scale. Our primary hypothesis was that the median perceived credibility score total would be lower in the group assigned to the ghostwritten paper. Our secondary hypotheses were that participants randomized to the ghostwritten condition would be less likely to (a) recommend the medication, and (b) want the psychiatrist in the vignette as their own clinician. We also asked respondents to estimate efficacy and adverse effect rates for the medication. There was a statistically significant difference in perceived credibility among those assigned to the ghostwriting condition. This amounted to a difference of 9.0 points on the 35-point perceived credibility scale as tested through the Mann--Whitney U test. There was no statistically significant difference between groups in terms of recommending the medication, wanting the featured clinician as their own, or in estimates of efficacy or adverse effects (p > .05 for all such comparisons). CONCLUSION: In this study, disclosure of ghostwriting resulted in lower perceived credibility ratings.     

Conflicting interests in Toronto: anatomy of a controversy at the interface of academia and industry

In December 2000, the University of Toronto breached a contract it held with me, initiating a sequence of events that has led to a public letter to the University from a large number of senior figures in the psychopharmacology community, protesting against the infringement of academic freedom involved, and a first-ever legal action seeking redress for violation of academic freedom. This case has been intertwined from the start with a longer running debate about the possibility that the SSRI group of antidepressants may have the potential to trigger suicidality or other serious effects in a subgroup of takers. And this specific issue connects to concerns about conflict of interest in the domain of therapeutics, as well as in science in general, the ghostwriting of scientific articles, and a series of other hot-spots on the interface between academia and industry.     

The roles of integration in molecular systems biology

A common way to think about scientific practice involves classifying it as hypothesis- or data-driven. We argue that although such distinctions might illuminate scientific practice very generally, they are not sufficient to understand the day-to-day dynamics of scientific activity and the development of programmes of research. One aspect of everyday scientific practice that is beginning to gain more attention is integration. This paper outlines what is meant by this term and how it has been discussed from scientific and philosophical points of view. We focus on methodological, data and explanatory integration, and show how they are connected. Then, using some examples from molecular systems biology, we will show how integration works in a range of inquiries to generate surprising insights and even new fields of research. From these examples we try to gain a broader perspective on integration in relation to the contexts of inquiry in which it is implemented. In today's environment of data-intensive large-scale science, integration has become both a practical and normative requirement with corresponding implications for meta-methodological accounts of scientific practice. We conclude with a discussion of why an understanding of integration and its dynamics is useful for philosophy of science and scientific practice in general.     

From Evidence-based Medicine to Marketing-based Medicine: Evidence from Internal Industry Documents

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.     

Inventing a new diagnostic test for vaginal infection.

Bacterial vaginosis, which is underdiagnosed in clinical practice, has a characteristic fishy smell because of production of diamines. This smell is the basis of a visual rapid diagnostic test that is technically simple to perform. The test has been patented in Europe and America, and a licence agreement has been negotiated. This paper describes the process from idea to invention to patenting and licensing. The combined costs of research and patenting were met by a multinational company in return for rights to exploit the patent invention. The process has taken nine years and has needed clinical, scientific, legal, and commercial input to get the test to the marketplace.     

An Experiment on Prediction Markets in Science

Prediction markets are powerful forecasting tools. They have the potential to aggregate private information, to generate and disseminate a consensus among the market participants, and to provide incentives for information acquisition. These market functionalities can be very valuable for scientific research. Here, we report an experiment that examines the compatibility of prediction markets with the current practice of scientific publication. We investigated three settings. In the first setting, different pieces of information were disclosed to the public during the experiment. In the second setting, participants received private information. In the third setting, each piece of information was private at first, but was subsequently disclosed to the public. An automated, subsidizing market maker provided additional incentives for trading and mitigated liquidity problems. We find that the third setting combines the advantages of the first and second settings. Market performance was as good as in the setting with public information, and better than in the setting with private information. In contrast to the first setting, participants could benefit from information advantages. Thus the publication of information does not detract from the functionality of prediction markets. We conclude that for integrating prediction markets into the practice of scientific research it is of advantage to use subsidizing market makers, and to keep markets aligned with current publication practice.     

A Method for Measuring the Efficiency Gap between Average and Best Practice Energy Use: The ENERGY STAR Industrial Energy Performance Indicator

A common feature distinguishing between parametric/statistical models and engineering economics models is that engineering models explicitly represent best practice technologies, whereas parametric/statistical models are typically based on average practice. Measures of energy intensity based on average practice are of little use in corporate management of energy use or for public policy goal setting. In the context of companyor plant‐level indicators, it is more useful to have a measure of energy intensity that is capable of indicating where a company or plant lies within a distribution of performance. In other words, is the performance close to (or far from) the industry best practice? This article presents a parametric/statistical approach that can be used to measure best practice, thereby providing a measure of the difference, or “efficiency gap,” at a plant, company, or overall industry level. The approach requires plant‐level data and applies a stochastic frontier regression analysis used by the ENERGY STAR^TM industrial energy performance indicator (EPI) to energy intensity. Stochastic frontier regression analysis separates energy intensity into three components: systematic effects, inefficiency, and statistical (random) error. The article outlines the method and gives examples of EPI analysis conducted for two industries, breweries and motor vehicle assembly. In the EPI developed with the stochastic frontier regression for the auto industry, the industry median “efficiency gap” was around 27%.     

Greatness and tribulations of Zeiss and Leitz, two famous German optic companies III. Zeiss Ikon and elimination of Emanuel Goldberg

Gathering archival documents to trace the history of the Zeiss company presents no difficulty : they are abundant… except for a period from 1932 to 1945, systematically ignored, and that corresponds to the Nazi period. On the website Zeiss Historica, among the outstanding personalities of the Zeiss company, we note that, for Professor Emanuel Goldberg, the web page ? is still under development but an early picture of the professor is available. ?. But fortunately, Mickael Buckland, a Professor at the UC Berkeley School of Information brought the life and the work of Emanuel Goldberg to light. Thanks to him, his works and innovations, who had disappeared from our cultural and scientific heritage, return to light after being erased during fifty years. Goldberg had published dozens of articles, obtained patents, developed cameras, microdots, movie cameras, and he designed what he called a "Statistical Machine ", the first electronic document retrieval machine. In France, if this rediscovery was made known to the world of information science, it has not had the impact it deserved in the scientific world. Therefore it is time to reconstruct his career and his work, and to analyse the reasons why some attempted to erase definitively his name and memory.     

Guidelines for medical practice: 1. The reasons why.

Various external special interest groups are promoting attempts to better measure and control the performance of the medical profession, primarily to restrain costs. We can neither afford to ignore the rising costs nor reject efforts by provincial licensing authorities to improve supervision of the quality of care. Furthermore, there is increasing public interest in the outcome of medical treatment and a suspicion that some care may be unnecessary or inappropriate. Much of what physicians do is not based on impeccable or complete scientific evidence, and we have not established a method whereby science can consistently be translated into practice. Optimal practice patterns must be defined to improve the quality of care and to maximize the efficiency with which scarce resources are used. Careful scientific evaluation of data is particularly necessary with the arrival of new drugs and technology. Sensible, flexible guidelines produced by appropriate panels will help promote improved practice. Rigid standards must be avoided to allow for individual consideration and scientific innovation. The recognized difficulties of influencing clinical practice by precept or education and the problems imposed by rapidly changing scientific knowledge are two hurdles to be overcome. Licensing bodies must identify and enforce minimal standards, but optimal practice patterns are better devised by a broader segment of the profession. Intervention by third-party payers, as is prevalent in the United States, intrudes upon physician autonomy and reduces access to care. Physicians must support the development of guidelines for optimal medical practice based on the best existing data and focused on improving the quality of care.     

An online tutorial for helping nonscience majors read primary research literature in biology

Using primary literature is an effective tool for promoting active learning and critical thinking in science classes. However, it can be challenging to use primary literature in large classes and in classes for nonscience majors. We describe the development and implementation of an online tutorial for helping nonscience majors learn to read primary literature in biology. The tutorial includes content about the scientific process and the structure of scientific papers and provides opportunities for students to practice reading primary literature. We describe the use of the tutorial in Biology of Exercise, a course for nonscience majors. Students used the tutorial outside of class to learn the basic principles involved in reading scientific papers, enabling class sessions to focus on active-learning activities and substantive class discussions.     

Making British cortisone: Glaxo and the development of corticosteroids in Britain in the 1950s-1960s

Following the announcement in 1949 in the USA that cortisone offered rheumatoid arthritis sufferers effective treatment for their crippling disease, the Ministry of Health came under considerable pressure from the medical profession and the public to make cortisone available in Britain. The Ministry, therefore, urged British companies to start manufacturing cortisone. Among the several pharmaceutical firms responding to the Ministry's request, Glaxo's expertise in the field of vitamins gave them a head start. This paper describes the varied and flexible strategy that enabled Glaxo to maintain this head start, and the scientific and technical capabilities which the company subsequently built up, enabling them to dominate the market for corticosteroids in Britain. Among the drugs to emerge out of the Glaxo project to manufacture cortisone, which began in 1950 and later became a wider R&D programme on steroids, was the topical steroid Betnovate, launched in 1963, which remains a best-seller today. However, although it led to successful new products, Glaxo's programme had limitations. The paper identifies a missed opportunity, in the shape of the biosynthetic route to steroid drugs, often considered as a milestone in the development of the new biotechnology. Whether or not this missed opportunity proved costly to the company is uncertain. However, it illustrates the role of technological path-dependence, and the importance of the integration between different scientific disciplines, in this case chemistry and biology, in pharmaceutical innovation.     

On the Use of Published Demographic Data for Population-Level Risk Assessment in Birds

As the practice of using population models for wildlife risk assessment has become more common, so has the practice of using surrogate data, typically taken from the published scientific literature, as inputs for demographic models. This practice clearly exposes the user to inferential errors. However, it is likely to continue because demographic data are expensive to gather. We review potential errors associated with the use of previously published demographic data and how those errors propagate into the endpoints of demographic projection models. We suggest methods for inferring bias in model endpoints when multiple and opposing biases are present in the demographic input data. We provide an example using Eastern Meadowlarks (Sturnella magna), a common songbird in Midwestern grasslands and agro-ecosystems. We conclude with a brief review of methods that could improve inference made using published demographic data, including methods from life-history theory, meta-analysis, and Bayesian statistics.     

Decoding the genetics debate: hype and hope in Icelandic news media in 2000 and 2004

The attraction of human genetics is rooted in optimistic projections of possible futures, where present-day problems are to be solved by technologies-to-come. But hyperbolic optimism with its consequent cycles of expectations, investment and disappointment is a threat to users, investors, and the ethical reputation of the biotechnology field. We report a study of the entire news coverage of genetics in Icelandic mass media in 2000 and 2004. All media promoted optimistic industry-based information largely without critical questions concerning scientific uncertainty, health benefits, or ethical challenges. Criticism and deliberation were thematically narrowed down, in 2000 to the issue of “presumed consent” for nationwide participation in a database proposed by the company Decode genetics, and in 2004 to topics concerning Decode's finances. In a discourse of monetary gain and loss, sustained exploration of scientific, moral and cultural issues has little appeal.     

An unethical trial and the politicization of the COVID-19 pandemic in Brazil: The case of Prevent Senior

The Brazilian Federal Senate created a Parliamentary Inquiry Commission (CPI) to investigate the Bolsonaro government's irregularities in the management of the COVID-19 pandemic. One of the cases that drew attention was the research conducted by Prevent Senior, a private health insurance company, on the early treatment of COVID-19. The article analyzes the scientific validity of the research and the ethical problems related to its implementation. It is based on analysis of Prevent Senior's report of the clinical study, the Brazilian and USA clinical trial registries, the Senate's CPI report, and on the information reported by the media. This case of scientific fraud and political-ideological bias exemplifies how Prevent Senior, using a questionable protocol to enhance its reputation and gain government support, was instrumental in building the “early treatment” narrative for COVID-19, and shows how it served as a basis for a government public policy that promoted the use of ineffective drugs.     

Checks and balances: the welcomed tension between philosophy and science

There is a tension between science and philosophy, but this tension need not engender enmity or derision. Scientists and philosophers can work together, and we argue that working together is beneficial to both, even if it is sometimes uncomfortable. We offer examples of how philosophy can autonomously and effectively inform scientific practice. Science and philosophy share certain methodological concerns and practices; therefore, scientists who disregard philosophy are vulnerable to critical conceptual mistakes. If our arguments are correct, and if it can also be shown that science informs philosophy, then, while it is possible for both disciplines to operate autonomously, each should welcome the checks and balances that each provides for one another in the investigation and explanation of reality.