Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Trials of Medications

School of Health Policy and Management, York University, 4700 Keele St., Toronto, ON, M3J 1P3, Canada.
Science and Engineering Ethics (Impact Factor: 1.52). 02/2011; 18(2):247-61. DOI: 10.1007/s11948-011-9265-3
Source: PubMed

ABSTRACT 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.

Download full-text


Available from: Joel Lexchin, Jul 21, 2014
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across popu-lations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.
    Public Health Ethics 01/2015; DOI:10.1093/phe/phu049 · 1.27 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: This study explored how disclosure of financial conflicts of interest (FCOI) influences naïve or "lay" individuals' perceptions of the ethicality of researcher conduct. On a between-subjects basis, participants read ten scenarios in which researchers disclosed or failed to disclose relevant financial conflicts of interest. Participants evaluated the extent to which each vignette represented a FCOI, its possible influence on researcher objectivity, and the ethics of the financial relationship. Participants were then asked if they had completed a college-level ethics course. Results indicated that FCOI disclosure significantly influenced participants' perceptions of the ethicality of the situation, but only marginally affected perceptions of researcher objectivity and had no significant influence on perceptions of the existence of FCOIs. Participants who had previously completed a college-level ethics course appeared more sensitive to the importance of FCOI disclosure than those who lacked such background. This result suggests that formal ethical training may help individuals become more critical consumers of scientific research.
    Science and Engineering Ethics 07/2014; DOI:10.1007/s11948-014-9572-6 · 1.52 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Drug companies aggressively market their products to increase sales and economic rewards. Different countries have different regulatory regimes for controlling promotion. In the United States control rests directly with the Food and Drug Administration whereas Canada relies on a mixture of voluntary self-regulation and an autonomous agency. Each method has significant weaknesses. We examine these weaknesses by analyzing the promotion of OxyContin (the time release version of the opioid oxycodone) by Purdue in Canada and the United States. We then look at the association between promotion and the misuse and abuse of OxyContin in both countries. Finally, we advance specific recommendations for regulating promotion for drugs that may have a high abuse potential.
    The International journal of risk & safety in medicine 01/2011; 23(4):233-40. DOI:10.3233/JRS-2011-0539

Similar Publications