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: Pharmacovigilance plays a consequential role in the surveillance of adverse drug reactions, which is provoked by the drugs used to cure diseases. Adverse drug reactions (ADRs) produce detrimental or undesirable effects to the body after administration of drugs. It has been reported that the number of patients dying because of contrary effects of drugs per year increased upto 2.6-fold. Moreover, rates of hospitalization of patients are increasing owing to adverse effects of drugs. Thus, it becomes challengeable for physician, health care providers, WHO and pharmaceutical industries to resolve the associated problem of ADRs. During the clinical trial of a novel drug, it is prominent to explore the dependability of drug. In this review, we documented the details required to identify the ADRs in patients along with reported banned drugs.
    SpringerPlus 11/2014; 3:695. DOI:10.1186/2193-1801-3-695
  • BMJ Clinical Research 11/2014; 349:g7197. DOI:10.1136/bmj.g7197 · 14.09 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Ticagrelor, a potent antiplatelet, has been shown to be beneficial in patients with acute coronary syndromes in a randomised controlled trial published in a highly ranked peer reviewed journal. Accordingly it has entered guidelines and has been approved for clinical use by authorities. However, there remains a controversy regarding aspects of the PLATO trial, which are not immediately apparent from the peer-reviewed publications. A number of publications have sought to highlight potential discrepancies, using data available in publicly published documents from the US Food and Drug Administration (FDA) leading to disagreement regarding the value of open science and data sharing. We reflect upon potential sources of bias present in even rigorously performed randomised controlled trials, on whether peer review can establish the presence of bias and the need to constantly challenge and question even accepted data.
    International Journal of Cardiology 05/2014; 176(3). DOI:10.1016/j.ijcard.2014.05.034 · 6.18 Impact Factor


Available from