To the Editor:
Will the 10 recommendations developed by the pharmaceutical industry and the publishing representatives close the credibility gap in reporting industry-sponsored clinical research?1 The guidance lacks targets and commitments. The recommendation on data disclosure does not even require companies to allow authors to have unrestricted access to all data. What's the timeline for the guideline's recommendations? What are the milestones? What are the concrete actions? Who will independently monitor the guidance implementation, which will require money and time?
Too many companies still exhibit poor records of ethics. GlaxoSmithKline recently agreed to pay $3 billion to settle civil and criminal investigations into its sales practices for numerous drugs, its fourth such case since April 2008, surpassing the previous record of $2.3 billion by Pfizer in 2009.2 In addition, Daniel W. Coyne just disclosed the saga of Amgen's incomplete report on the early major trial of epoetin that misled the medical community about the anemia drug's risks and benefits, which helped make Amgen rich.3 Should physicians be tempted to blindly accept general statements from recidivists?
The guidance promoted by Mansi et al1 is marked by a major conflict of interest. Publishers highly rely on publication of industry-supported trials, and thus these trials are associated with an increase in journal impact factors. Moreover, drug advertising and sales of reprints provide them with a substantial income.4
References
- 1.Mansi B.A., Clark J., David F.S. Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012;87(5):424–429. doi: 10.1016/j.mayocp.2012.02.009. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Braillon A. Drug industry is now biggest defrauder of US government. BMJ. 2012;344:d8219. doi: 10.1136/bmj.d8219. [DOI] [PubMed] [Google Scholar]
- 3.Coyne D.W. Opinion: Misleading drug trials. The Scientist. May 14, 2012 the-scientist.com/2012/05/14/opinion-misleading-drug-trials/ Accessed May 18, 2012. [Google Scholar]
- 4.Lundh A., Barbateskovic M., Hróbjartsson A., Gøtzsche P.C. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue: cohort study. PLoS Med. 2010;7(10):e1000354. doi: 10.1371/journal.pmed.1000354. [DOI] [PMC free article] [PubMed] [Google Scholar]