The regulation of research by The regulation of research by

funding bodies: an emerging funding bodies: an emerging

ethical issue for the alcohol and ethical issue for the alcohol and

other drug sector?other drug sector?

Peter Miller1, David Moore2 and John Strang1

1National Addiction Centre, Institute of Psychiatry, King's College London, UK2National Drug Research Institute, Perth, Australia

““It is the job of science to advise, to It is the job of science to advise, to be helpful to, and to support the be helpful to, and to support the

policy process, but its inalienable policy process, but its inalienable responsibility is also to criticise, responsibility is also to criticise, question, test and be awkward. question, test and be awkward.

Science has to have a larger vision Science has to have a larger vision of itself than its being merely a of itself than its being merely a biddable management tool” .biddable management tool” .

(Edwards, 1993: 13)

““FDA Scientists Pressured By Political , FDA Scientists Pressured By Political , Commercial Interests”Commercial Interests”

N= 997N= 997 15% inappropriately excluded/altered technical 15% inappropriately excluded/altered technical

information or conclusions information or conclusions 17% provided incomplete, inaccurate or misleading 17% provided incomplete, inaccurate or misleading

information information 47% said they knew of situations where 47% said they knew of situations where

"commercial interests" improperly tried to have an "commercial interests" improperly tried to have an FDA conclusion reversed, withdrawn or changedFDA conclusion reversed, withdrawn or changed

40% said FDA management did not consistently 40% said FDA management did not consistently stand behind staff scientists whose "scientifically stand behind staff scientists whose "scientifically defensible positions" were potential causes of defensible positions" were potential causes of political controversypolitical controversy

(Medical News Today, 2006)(Medical News Today, 2006)

http://www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.htmlhttp://www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.html

Types of regulationTypes of regulation

Direct censorshipDirect censorship

Non publicationNon publication

Limited accessLimited access

Project fundingProject funding

Inadequate/inappropriate Inadequate/inappropriate

researchersresearchers

Two areas of applicationTwo areas of application

Academic journalsAcademic journals

Ethics committeesEthics committees BeneficenceBeneficence

““A submitted manuscript is the A submitted manuscript is the intellectual property of its authors, intellectual property of its authors, not the study sponsor. We will not not the study sponsor. We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publication.”withhold publication.”(Davidoff et al., 2001b: 463)

CommentariesCommentaries

5 invited commentaries5 invited commentaries Lenton and MidfordLenton and Midford KhoshnoodKhoshnood AshcroftAshcroft HallHall Hough and TurnbullHough and Turnbull

Hall (2006) Hall (2006) AddictionAddiction editorial editorial ‘‘Ensuring that addiction science is Ensuring that addiction science is

deserving of public trust’deserving of public trust’

Current conflict of interest statementsCurrent conflict of interest statements ISAJEISAJE

““All sources of funding for the study, review, All sources of funding for the study, review, or other item should be declared in the final or other item should be declared in the final publication. Funding sources should be publication. Funding sources should be described in a way that allows an average described in a way that allows an average reader to recognize potential conflicts of reader to recognize potential conflicts of interest.”interest.”

AddictionAddiction ““The statement should declare sources of The statement should declare sources of

funding, direct or indirect, and any funding, direct or indirect, and any connection with the tobacco, alcohol, connection with the tobacco, alcohol, pharmaceutical or gaming industries.  Any pharmaceutical or gaming industries.  Any contractual constraints on publishing imposed contractual constraints on publishing imposed by the funder must also be disclosed. ”by the funder must also be disclosed. ”

Specific recommendationsSpecific recommendations Addictions journals should require:Addictions journals should require:

Author statement of funding source Author statement of funding source published with each articlepublished with each article

a positive statement that the lead author a positive statement that the lead author had complete control over the study had complete control over the study data, analysis, decision to publish and data, analysis, decision to publish and preparation of the published reportpreparation of the published report

A brief editorial in each journal to A brief editorial in each journal to discuss and debate the issuediscuss and debate the issue

Prior registration with ICMJE approved Prior registration with ICMJE approved clinical trials register as a pre-clinical trials register as a pre-requisite for publication?requisite for publication?

Thank youThank you ReferencesReferences

Edwards, G. (1993). Substance Misuse and the Uses of Edwards, G. (1993). Substance Misuse and the Uses of Science. In G. Edwards, J. Strang & J. H. Jaffe (Eds.), Science. In G. Edwards, J. Strang & J. H. Jaffe (Eds.), Drugs, Alcohol, and Tobacco: Making the Science and Drugs, Alcohol, and Tobacco: Making the Science and Policy ConnectionsPolicy Connections (pp. 3-16). Oxford: Oxford (pp. 3-16). Oxford: Oxford University Press.University Press.

Hall, W. (2006). Ensuring that addiction science is Hall, W. (2006). Ensuring that addiction science is deserving of public trust. deserving of public trust. Addiction, 101Addiction, 101(9), 1223-(9), 1223-1224.1224.

International Committee of Medical Journal Editors International Committee of Medical Journal Editors (2005) (2005) Ethical Practice Guidelines in Addiction Ethical Practice Guidelines in Addiction PublishingPublishing: http://www.isaje.net (accessed 14 April : http://www.isaje.net (accessed 14 April 2006).2006).

Miller, P., Moore, D., & Strang, J. (2006). The Miller, P., Moore, D., & Strang, J. (2006). The regulation of research by funding bodies: An emerging regulation of research by funding bodies: An emerging ethical issue for the alcohol and other drug sector. ethical issue for the alcohol and other drug sector. International Journal of Drug Policy, 17International Journal of Drug Policy, 17(1), 12-16.(1), 12-16.

Room, R. (1993). The evolution of alcohol monopolies Room, R. (1993). The evolution of alcohol monopolies and their relevance for public health. and their relevance for public health. Contemporary Contemporary Drug ProblemsDrug Problems, 20(2), p169-187., 20(2), p169-187.