What have we learnt from Vioxx?

Department of Medicine, Yale University School of Medicine, 333 Cedar Street, PO Box 208088, New Haven, CT 06520-8088, USA.
BMJ (online) (Impact Factor: 16.38). 02/2007; 334(7585):120-3. DOI: 10.1136/bmj.39024.487720.68
Source: PubMed

ABSTRACT In October UK patients who had cardiovascular events while taking rofecoxib lost the right to fight Merck in the US for compensation. But researchers and journals can still benefit from this case if they learn from the mistakes, write Harlan Krumholz and colleagues

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: This article discusses how ethical and political issues affect contemporary research relationships. It focuses on the responsibilities of researchers studying organisations and elites, and the discussion draws upon the author’s experience of researching NHS primary health care services. The paper reviews the spread of “ethical guidelines” from medical to social research. Such guidelines primarily address ethical problems relating to individual researcher-researched relationships. Sociologists have criticised the application of medically-based guidelines to social research, while often accepting an ethical framework based on the researcher-researched dyad. But this limited conception of ethical responsibilities leaves complex organisational power hierarchies and their effects under-theorised. Researchers may then be vulnerable and lack guidance where organisational loyalties and market mechanisms have undermined the traditional supports of academic independence and professionalism. Sociologists could learn from critical medical scientists’ responses to some related ethical dilemmas, as some medical researchers have experienced these issues more acutely and for longer. Published (author's copy) Peer Reviewed
    Sociology 10/2008; 42(5). DOI:10.1177/0038038508094568 · 1.35 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The occurrence of sometimes life-threatening adverse drug reactions (ADRs) jeopardizes patients’ health during drug treatment and additionally imposes an increased financial burden on the healthcare system. The withdrawal of already marketed drugs because of ADRs furthermore erodes public confidence in the way drugs are approved. In this chapter the development and current status of drug monitoring systems will be discussed and the future of pharmacovigilance, the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem will be outlined.
  • [Show abstract] [Hide abstract]
    ABSTRACT: The safety profile of a drug evolves over its lifetime on the market; there are bound to be changes in the circumstances of a drug’s clinical use which may give rise to previously unobserved adverse effects, hence necessitating surveillance postmarketing. Postmarketing surveillance has traditionally been carried out by systematic manual review of spontaneous reports of adverse drug reactions. Vast improvements in computing capabilities have provided opportunities to automate signal detection, and several worldwide initiatives are exploring new approaches to facilitate earlier detection, primarily through mining of routinely-collected data from electronic healthcare records (EHR). This paper provides an overview of ongoing initiatives exploring data from EHR for signal detection vis-à-vis established spontaneous reporting systems (SRS). We describe the role SRS has played in regulatory decision making with respect to safety issues, and evaluate the potential added value of EHR-based signal detection systems to the current practice of drug surveillance. Safety signal detection is both an iterative and dynamic process. It is in the best interest of public health to integrate and understand evidence from all possibly relevant information sources on drug safety. Proper evaluation and communication of potential signals identified remains an imperative and should accompany any signal detection activity.
    Drug Safety 03/2013; 36(3). DOI:10.1007/s40264-013-0018-x · 2.62 Impact Factor


Available from