Re: Forty years of sports performance research and little insight gained
To the Editor of the British Medical Journal
Dear Editor,
The nefarious effect that the activities of many prominent pharmaceutical companies have had on clinical research is now widely recognised, and has caused Marcia Angell recently to comment that "[i]t is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine" [1]
Heneghan and his colleagues have done valuable work in showing the dubious scientific basis of the marketing claims of sports drinks manufacturers that their products enhance sporting performance [2]. Their findings are perhaps unsurprising, as at last one of the pharmaceutical companies criticised by Angell – Glaxo-Smith-Kline – is deeply involved in the sports drinks promotion. Part of the problem which Angell describes involves the abuse of confidentiality agreements in university research contracts by parts of the pharmaceutical industry [3,4,5]. This has become such a scandal that the late Pope was moved to criticise their practices, warning that "The very ethics of research can be undermined .... when financial groups claim the right to permit the publication of research data depending on whether or not such data are in the interests of the groups themselves" [6]. The secrecy over industry/university research contracts described in the present sports drinks study, and the readiness of industry-funded academics to attack its conclusions, suggests that similar abuse may occur in this field.
The editors of medical journals (including that of the BMJ) have taken a strong lead to address the abuse of confidentiality agreements to suppress results and to bias conclusions. Through the requirements of the International Committee of Medical Journal Editors [7], authors of research papers have to give details of potential conflicts of interest aimed at restoring public trust in the credibility of published articles. Most medical journals now adhere to this protocol, but few of the journals cited as supporting the claims of sports drinks manufacturers appear to do so [8].
The response of British universities to this abuse seems to have been less impressive, with a reluctance to adopt effective safeguards [9, 10]. The Economics and Social Research Council (ESRC) in its 2005 Research Ethics Framework insisted that the independence and impartiality of researchers whom it funds must be clear, and any conflicts of interest or partiality must be made explicit [11]. If strictly interpreted, these would go some way to preventing abuses associated with confidentiality agreements. However it is far from clear that universities in general have adopted such safeguards with respect to other sources of funding. For example, the University of Bath only requires that conflicts of interest be discussed with the head of department, and does not insist that they are made explicit in publications. Similarly, "funding sources and significant collaboration and all commercial, financial or other 'interest' relating to the work" may be kept secret if "anonymity has been agreed" [12].
The privileged position of universities in society is because they are supposed to be devoted to the disinterested pursuit of knowledge. Olivieri [4] relates a number of instances where the integrity of North American universities has been seriously compromised by entering into financially rewarding, but intellectually fraught, research contracts with industry. Let no one suppose that this could not happen in the U.K. [13, 14, 15].
David Packham,
Materials Research Centre,
University of Bath,
Claverton Down, Bath, BA27AY.
Competing interests: none.
References
1. Angell, Marcia, Drug Companies & Doctors: A Story of Corruption, New York Review of Books, January 15, 2009].
2. Heneghan Carl, Perera Rafael, Nunan David, Mahtani Kamal, Gill Peter, Forty years of sports performance research and little insight gained, BMJ 2012;345:e4797
3. Thompson, J., Baird, P. and Downie, J.: The Olivieri Report, J. Lornier & Co., Toronto, 2001.
4. Olivieri, Nancy: Patients' health or company profits? The Toronto story, Science Eng Ethics, 2003 9, 29.
5. Washburn, Jennifer: Rent-a-Researcher: Did a British university sell out to Procter & Gamble? Slate (an online Newspaper owned by Washington post) posted Thursday, Dec. 22, 2005, at 2:38 PM ET http://www.slate.com/id/2133061/
6. Pope John-Paul II: Science Eng Ethics, 8, 263(2002).
7. ICMJE, International Committee of Medical Journal Editors http://www.icmje.org/
8. ICMJE list of journals http://www.icmje.org/journals.html#J
9. Evans, G.R. & Packham, D.E., Ethical issues at the university-industry interface: a way forward? Science Eng Ethics, 2003 9, 3.
10. Evans, G.R., Ethical Issues at the University/Industry Interface---a decade on. J. Biol. Phys. Chem. 11 (2011) 125—128.
11. Economic and Social Research Council: Research Ethics Framework http://www.gold.ac.uk/media/ESRC_Re_Ethics_Frame_tcm6-11291.pdf
3.2.6 The independence and impartiality of researchers must be clear, and any conflicts of interest or partiality must be explicit The research should be conducted so as to ensure the professional integrity of its design, the generation and analysis of data, and the publication of results, while the direct and indirect contributions of colleagues, collaborators and others should also be acknowledged. In addition, this principle requires that investigators ensure that there is no undeclared conflict of interest (which may be personal, academic or commercial) in their proposed work and that the relation between the sources of funding and researchers’ control over results is made clear, specifically in relation to the ownership, publication and subsequent use of research data.
12. University of Bath, Code of Good Practice in Research Revised framework 30th Nov 2011 http://www.bath.ac.uk/opp/resources.bho/Code_of_Good_Practice_in_Researc... para. 4.1 and 7.3 http://www.bath.ac.uk/opp/research/
13. Baty P., MP calls for probe into Sheffield's relationship with the drug industry, Times Higher Education Supplement, 16.12.05
14. Health Care Renewal The Blumsohn Case: "Rent-a-Researcher?" Friday, December 23, 2005, http://hcrenewal.blogspot.com/2005/12/more-summary-and-much-documentatio...
15. Corbyn Zoë, Times Higher Education Supplement, 15 April 2010, http://www.timeshighereducation.co.uk/story.asp?storycode=411229
Competing interests:
No competing interests
22 August 2012
David E. Packham
Academic - largely retired
none
University of Bath
Materials Research Centre, University of Bath, Claverton Down, Bath, BA" 7AY, U.K.
Rapid Response:
Re: Forty years of sports performance research and little insight gained
To the Editor of the British Medical Journal
Dear Editor,
The nefarious effect that the activities of many prominent pharmaceutical companies have had on clinical research is now widely recognised, and has caused Marcia Angell recently to comment that "[i]t is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine" [1]
Heneghan and his colleagues have done valuable work in showing the dubious scientific basis of the marketing claims of sports drinks manufacturers that their products enhance sporting performance [2]. Their findings are perhaps unsurprising, as at last one of the pharmaceutical companies criticised by Angell – Glaxo-Smith-Kline – is deeply involved in the sports drinks promotion. Part of the problem which Angell describes involves the abuse of confidentiality agreements in university research contracts by parts of the pharmaceutical industry [3,4,5]. This has become such a scandal that the late Pope was moved to criticise their practices, warning that "The very ethics of research can be undermined .... when financial groups claim the right to permit the publication of research data depending on whether or not such data are in the interests of the groups themselves" [6]. The secrecy over industry/university research contracts described in the present sports drinks study, and the readiness of industry-funded academics to attack its conclusions, suggests that similar abuse may occur in this field.
The editors of medical journals (including that of the BMJ) have taken a strong lead to address the abuse of confidentiality agreements to suppress results and to bias conclusions. Through the requirements of the International Committee of Medical Journal Editors [7], authors of research papers have to give details of potential conflicts of interest aimed at restoring public trust in the credibility of published articles. Most medical journals now adhere to this protocol, but few of the journals cited as supporting the claims of sports drinks manufacturers appear to do so [8].
The response of British universities to this abuse seems to have been less impressive, with a reluctance to adopt effective safeguards [9, 10]. The Economics and Social Research Council (ESRC) in its 2005 Research Ethics Framework insisted that the independence and impartiality of researchers whom it funds must be clear, and any conflicts of interest or partiality must be made explicit [11]. If strictly interpreted, these would go some way to preventing abuses associated with confidentiality agreements. However it is far from clear that universities in general have adopted such safeguards with respect to other sources of funding. For example, the University of Bath only requires that conflicts of interest be discussed with the head of department, and does not insist that they are made explicit in publications. Similarly, "funding sources and significant collaboration and all commercial, financial or other 'interest' relating to the work" may be kept secret if "anonymity has been agreed" [12].
The privileged position of universities in society is because they are supposed to be devoted to the disinterested pursuit of knowledge. Olivieri [4] relates a number of instances where the integrity of North American universities has been seriously compromised by entering into financially rewarding, but intellectually fraught, research contracts with industry. Let no one suppose that this could not happen in the U.K. [13, 14, 15].
David Packham,
Materials Research Centre,
University of Bath,
Claverton Down, Bath, BA27AY.
Competing interests: none.
References
1. Angell, Marcia, Drug Companies & Doctors: A Story of Corruption, New York Review of Books, January 15, 2009].
2. Heneghan Carl, Perera Rafael, Nunan David, Mahtani Kamal, Gill Peter, Forty years of sports performance research and little insight gained, BMJ 2012;345:e4797
3. Thompson, J., Baird, P. and Downie, J.: The Olivieri Report, J. Lornier & Co., Toronto, 2001.
4. Olivieri, Nancy: Patients' health or company profits? The Toronto story, Science Eng Ethics, 2003 9, 29.
5. Washburn, Jennifer: Rent-a-Researcher: Did a British university sell out to Procter & Gamble? Slate (an online Newspaper owned by Washington post) posted Thursday, Dec. 22, 2005, at 2:38 PM ET http://www.slate.com/id/2133061/
6. Pope John-Paul II: Science Eng Ethics, 8, 263(2002).
7. ICMJE, International Committee of Medical Journal Editors http://www.icmje.org/
8. ICMJE list of journals http://www.icmje.org/journals.html#J
9. Evans, G.R. & Packham, D.E., Ethical issues at the university-industry interface: a way forward? Science Eng Ethics, 2003 9, 3.
10. Evans, G.R., Ethical Issues at the University/Industry Interface---a decade on. J. Biol. Phys. Chem. 11 (2011) 125—128.
11. Economic and Social Research Council: Research Ethics Framework http://www.gold.ac.uk/media/ESRC_Re_Ethics_Frame_tcm6-11291.pdf
3.2.6 The independence and impartiality of researchers must be clear, and any conflicts of interest or partiality must be explicit The research should be conducted so as to ensure the professional integrity of its design, the generation and analysis of data, and the publication of results, while the direct and indirect contributions of colleagues, collaborators and others should also be acknowledged. In addition, this principle requires that investigators ensure that there is no undeclared conflict of interest (which may be personal, academic or commercial) in their proposed work and that the relation between the sources of funding and researchers’ control over results is made clear, specifically in relation to the ownership, publication and subsequent use of research data.
12. University of Bath, Code of Good Practice in Research Revised framework 30th Nov 2011 http://www.bath.ac.uk/opp/resources.bho/Code_of_Good_Practice_in_Researc... para. 4.1 and 7.3 http://www.bath.ac.uk/opp/research/
13. Baty P., MP calls for probe into Sheffield's relationship with the drug industry, Times Higher Education Supplement, 16.12.05
14. Health Care Renewal The Blumsohn Case: "Rent-a-Researcher?" Friday, December 23, 2005, http://hcrenewal.blogspot.com/2005/12/more-summary-and-much-documentatio...
15. Corbyn Zoë, Times Higher Education Supplement, 15 April 2010, http://www.timeshighereducation.co.uk/story.asp?storycode=411229
Competing interests: No competing interests