The regulation of research by funding bodies: an emerging ethical issue for the alcohol and other drug sector?

1. The regulation of research by funding bodies: an emerging ethical issue for the alcohol and other drug sector? Peter Miller1, David Moore2 and John Strang1 1National Addiction Centre, Institute of Psychiatry, King's College London, UK 2National Drug Research Institute, Perth, Australia

2. “It is the job of science to advise, to be helpful to, and to support the policy process, but its inalienable responsibility is also to criticise, question, test and be awkward. Science has to have a larger vision of itself than its being merely a biddable management tool” . (Edwards, 1993: 13)

3. “FDA Scientists Pressured By Political , Commercial Interests” (Medical News Today, 2006) • N= 997 • 15% inappropriately excluded/altered technical information or conclusions • 17% provided incomplete, inaccurate or misleading information • 47% said they knew of situations where "commercial interests" improperly tried to have an FDA conclusion reversed, withdrawn or changed • 40% said FDA management did not consistently stand behind staff scientists whose "scientifically defensible positions" were potential causes of political controversy http://www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.html

4. Types of regulation • Direct censorship • Non publication • Limited access • Project funding • Inadequate/inappropriate researchers

5. Two areas of application • Academic journals • Ethics committees • Beneficence

6. “A submitted manuscript is the intellectual property of its authors, not the study sponsor. We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication.” (Davidoff et al., 2001b: 463)

7. Commentaries • 5 invited commentaries • Lenton and Midford • Khoshnood • Ashcroft • Hall • Hough and Turnbull • Hall (2006) Addiction editorial • ‘Ensuring that addiction science is deserving of public trust’

8. Current conflict of interest statements • ISAJE • “All sources of funding for the study, review, or other item should be declared in the final publication. Funding sources should be described in a way that allows an average reader to recognize potential conflicts of interest.” • Addiction • “The statement should declare sources of funding, direct or indirect, and any connection with the tobacco, alcohol, pharmaceutical or gaming industries.  Any contractual constraints on publishing imposed by the funder must also be disclosed. ”

9. Specific recommendations • Addictions journals should require: • Author statement of funding source published with each article • a positive statement that the lead author had complete control over the study data, analysis, decision to publish and preparation of the published report • A brief editorial in each journal to discuss and debate the issue • Prior registration with ICMJE approved clinical trials register as a pre-requisite for publication?

10. Thank you • References • Edwards, G. (1993). Substance Misuse and the Uses of Science. In G. Edwards, J. Strang & J. H. Jaffe (Eds.), Drugs, Alcohol, and Tobacco: Making the Science and Policy Connections (pp. 3-16). Oxford: Oxford University Press. • Hall, W. (2006). Ensuring that addiction science is deserving of public trust. Addiction, 101(9), 1223-1224. • International Committee of Medical Journal Editors (2005) Ethical Practice Guidelines in Addiction Publishing: http://www.isaje.net (accessed 14 April 2006). • Miller, P., Moore, D., & Strang, J. (2006). The regulation of research by funding bodies: An emerging ethical issue for the alcohol and other drug sector. International Journal of Drug Policy, 17(1), 12-16. • Room, R. (1993). The evolution of alcohol monopolies and their relevance for public health. Contemporary Drug Problems, 20(2), p169-187.