Appendix 1 - Speaker profiles

Mr Richard Kneebone

Richard Kneebone is the Chairman of the Board of Directors of Therapeutic Guidelines Limited. He is a qualified lawyer and consultant on corporate governance and compliance and was formerly employed as Company Secretary for Orica Ltd, Company Secretary for BHP Billiton and subsidiaries, General Counsel and Company Secretary for Australian National Line, and Legal Advisor for Hong Kong Mass Transit Railway Corporation. Before that he was in private practice.

Dr Sue Phillips

Sue Phillips is the Chief Executive Officer of Therapeutic Guidelines Limited. She was awarded a Doctorate of Philosophy by the University of Oxford in 1985 for her research on cellular immune responses to developmental tumours. She was formerly employed as Director and Interim Executive Director at the National Health and Medical Research Council’s National Institute of Clinical Studies, Senior Policy Analyst at the Royal Australian College of General Practitioners, Director in various health policy positions within the Australian Government’s Department of Health and Ageing, and Post Doctoral Research Fellow at the Australian National University John Curtin School of Medicine and Monash University Biochemistry Department. In 2008, Sue was awarded an Australia Day Achievement Medallion for services that have made a significant contribution to the nation. Sue is a member of the Guidelines International Network Board of Trustees.

Professor Silvio Garattini

Silvio Garattini qualified in medicine in 1954. He was appointed as lecturer in chemotherapy and pharmacology.

He was the founder of the Mario Negri Institute for Pharmacological Research and was its director when it opened in 1961. The Institute now has a staff of more than 850 people in three locations and in its 50 years has published more than 12 000 scientific papers and more than 250 books, on topics such as cancer and its treatment, tumour immunology, neuropsychopharmacology, and cardiovascular and renal pharmacology.

Professor Garattini was a member of Commissione Unica del Farmaco (the Italian organisation that decides on the reimbursement of drugs) from 1993 to 1997, member of Committee for Medicinal Products for Human Use (European Medicines Agency) from 1997 to 2004, Chairman of the Committee for Clinical Research (Agenzia Italiana del Farmaco) from 2005 to 2010, and is currently a member of the National Committee on Bioethics. He was also a founder of the European Organisation for Research and Treatment of Cancer. He has received many awards for his work, including the French Legion d’Honneur for Scientific Merit, and the Grande Ufficiale della Repubblica Italiana, the Medaglia d’Oro al Merito della Sanità Pubblica granted by the Italian Ministry of Health.

Assistant Professor Barbara Mintzes

Barbara Mintzes is an Assistant Professor with the School of Population and Public Health at the University of British Columbia. The main focus of her research is on pharmaceutical policy, including the effects of direct-to-consumer advertising and physician-directed promotion on prescribing and medicine use decisions. She also carries out systematic reviews of the effectiveness and safety of new drugs with the university’s Therapeutics Initiative. These reviews are used as background information for provincial reimbursement decisions. Dr Mintzes has a PhD in Health Care and Epidemiology from the University of British Columbia, and holds a Michael Smith Foundation for Health Research Scholar Award.

Professor Paul Komesaroff

Paul Komesaroff is a physician, medical researcher and philosopher at Monash University in Melbourne, where he is Professor of Medicine and Director of the Centre for Ethics in Medicine and Society.

He is a practising clinician, specialising in the field of endocrinology; his scientific research work focuses on the effects of hormones on the cardiovascular system and the development of noninvasive techniques for assessment of cardiovascular risk.

Paul is the Director of the Clinical Ethics Service at the Alfred Hospital, Ethics Convener of the Royal Australasian College of Physicians and Chair of the Royal Australasian College of Physicians Expert Advisory Group on Ethics, Executive Director of Global Reconciliation and Chair of the International Health Workforce Society of Australasia.

Paul has been actively involved in numerous committees, including the Victorian Justice Health Advisory Committee, the Victorian Department of Human Service Genetics Advisory Committee, Australians Donate, the ethics committees of the US Endocrine Society and Australian Medical Association, and the Australasian Bioethics Association.

Associate Professor Ian Kerridge

Ian Kerridge is Director and Associate Professor in Bioethics at the Centre for Values, Ethics and the Law in Medicine at the University of Sydney, and Staff Haematologist/Bone Marrow Transplant physician at Royal North Shore Hospital, Sydney. He is the author of over 150 papers in peer-reviewed journals and five textbooks of ethics, most recently Ethics and Law for the Health Professions (Federation Press). He is a member of the Australian Health Ethics Committee, Chair of the Australian Bone Marrow Donor Registry Research Committee, and a member of the NSW Health Department’s Clinical Ethics Advisory Panel. His current research interests in ethics include public health ethics, the philosophy of medicine, stem cells, prescription drug policy, end-of-life care, synthetic biology, and organ donation and transplantation.

Appendix 2 - Speaker disclosures

Sue Phillips made the following disclosure:

  • Guidelines International Network board member and contributing author to the paper she quoted in her presentation: Qaseem A, Forland F, Macbeth F, Ollenschlager G, Phillips S, van der Wees P. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med 2012;156:525-31.

Silvio Garattini explained the Mario Negri Policy on Independence, which includes:

  • Independence from politics, industry, finance and ideology or religion
  • The Institute has many funding streams with no more than 10% of the total budget from a single source
  • No patent applications
  • Allow collaboration with industry but require ownership of data until publication
  • Insist on freedom of expression in all publications.

Barbara Mintzes made the following disclosures:

  • No conflicts of interest to declare
  • Associated with the Therapeutics Initiative, which hosts the Cochrane Hypertension review group
  • Publicly funded (Canadian Institutes of Health Research, Michael Smith Health Research Foundation, British Columbia Ministry of Health)

Paul Komesaroff made the following disclosures:

  • Clinician and researcher
  • Professor of Medicine, Monash University
  • Director of Centre for Ethics
  • Engaged in research into menopause and the cardiovascular effects of steroid hormones
  • Collaborative relationships in research projects, past and present, with pharmaceutical companies
  • Ethics convener of the Royal Australasian College of Physicians
  • Principal author of Royal Australasian College of Physicians ‘Guidance for Ethical Relationships Between the Medical Profession and Industry’ and other documents
  • Member or Chair of various ethics committees
  • Executive Director, Global Reconciliation

Ian Kerridge made the following disclosures:

  • Not employed (or reimbursed) by the pharmaceutical industry
  • Not a member of advisory group or engaged as a consultant for the pharmaceutical industry
  • Receives no travel or academic support from the pharmaceutical industry
  • Not a shareholder of any pharmaceutical industry
  • Contributes to enrolling patients into clinical trials sponsored by Roche, Pfizer, Cellgene, CSL, Onyx and Amgen
  • Chair of HPC Transplant Group and member of Haematology Group for NSW Cancer Institute
  • Member of Royal Australasian College of Physicians Ethics Committee and the Australian Health Ethics Committee

Appendix 3 - Participants

Name Role Organisation Location
Ms Jo Allardice Editor Therapeutic Guidelines Limited Melbourne
Professor Chris Baggoley Chief Medical Officer Department of Health and Ageing Canberra
Mr Martin Basedow Lecturer, Health Care Management Flinders University Adelaide
Dr Margaret Beavis General practitioner Melbourne
Dr Phil Bergen Lecturer Centre for Medicine Use and Safety, Monash University Melbourne
Ms Marion Berry Manager, Melbourne Office NHMRC Melbourne
Ms Alice Bhasale Consumer Team Leader NPS MedicineWise Sydney
Professor Frank Bowden Principal Medical Advisor ACT Health Directorate Canberra
Professor Jo-anne Brien Professor of Clinical Pharmacy St Vincent’s Hospital,
University of Sydney
Sydney
Ms Siobhan Brophy Communications Manager National Asthma Council Australia
Dr Heather Buchan Director, Implementation Support Australian Commission on Safety and Quality in Health Care Sydney
Professor Rachelle Buchbinder Director Monash Department of Clinical Epidemiology, Cabrini Hospital Melbourne
Professor and NHMRC Practitioner Fellow Department of Epidemiology and Preventive Medicine, Monash University
Joint Coordinating Editor Cochrane Musculoskeletal Group
Ms Nicki Burridge Publications Pharmacist Society of Hospital Pharmacists of Australia Melbourne
Professor Terry Campbell Senior Associate Dean Faculty of Medicine, University of New South Wales Sydney
Dr Shane Carney Physician John Hunter Hospital Newcastle, New South Wales
Professor John Condon Professor of Psychiatry Flinders University, Daw Park Repatriation Hospital Adelaide
Mr Glen Cormick Manager, Business Development Baker IDI Heart and Diabetes Institute Melbourne
Ms Karen Crawford Health Professional Training Coordinator Diabetes Australia
Dr Marilyn Cruickshank Healthcare Associated Infection Program Manager Australian Commission on Safety and Quality in Health Care Sydney
Dr Sladjana Cvetkovic Medicines Information Manager NPS MedicineWise Sydney
Dr Jonathan Dartnell Executive Manager, Innovation and Learning NPS MedicineWise Melbourne
Ms Susan Daskalakis Editor Therapeutic Guidelines Limited Melbourne
Dr Janice Davies Consultant Whole Systems Work Melbourne
Ms Janette Donovan Consumer representative Melbourne
Dr John Dowden Medical Editor Australian Prescriber Canberra
Mr Geraint Duggan Assistant Director, Guidelines Program National Health and Medical Research Council Melbourne
Ms Leia Earnshaw Acting Assistant Director National Blood Authority
Mr Peter Francis Lawyer Maddocks Melbourne
Professor Silvio Garattini Director Mario Negri Institute for Pharmacological Research Milan, Italy
Professor Alastair Goss Professor, Oral and Maxillofacial Surgery University of Adelaide Adelaide
Professor Lindsay Grayson Professor/Director, Infectious Diseases Austin Health and University of Melbourne Melbourne
Dr Peter Greenberg Physician Department of General Medicine, Royal Melbourne Hospital Melbourne
Dr Robert Grenfell National Director, Cardiovascular Health Heart Foundation Melbourne
Mr Stephan Groombridge Program Manager Royal Australian College of General Practitioners Melbourne
Ms Natalie Hannaford Research Fellow University of South Australia Adelaide
Dr Ken Harvey Melbourne
Dr James Hayes Emergency Physician Northern Hospital Melbourne
Ms Mary Hemming Consultant Therapeutic Guidelines Limited Melbourne
Mr Kelvin Hill National Program Manager, Clinical Issues National Stroke Foundation Sydney
Dr Suzanne Hill Chair, Pharmaceutical Benefits Advisory Committee Department of Health and Ageing Canberra
Dr Ingrid Hopper Clinical Pharmacologist Alfred Hospital Melbourne
Ms Susan Huckson Manager, Centre for Outcome and Research Evaluation Australian and New Zealand Intensive Care Society Melbourne
Professor Alan Husband Health Professional Team Leader, Medicines Information NPS MedicineWise Sydney
Professor Garry Jennings Director Baker IDI Heart and Diabetes Institute Melbourne
Ms Melanie Jeyasingham Editor Therapeutic Guidelines Limited Melbourne
Dr Jane Johnson Research Fellow, Department of Philosophy Macquarie University Sydney
Mrs Jenny Johnstone Editorial Director Therapeutic Guidelines Limited Melbourne
Dr Sarina Kempe Clinical Pharmacology Registrar Alfred Hospital Melbourne
Associate Professor Ian Kerridge Director Centre for Values, Ethics and the Law in Medicine, University of Sydney Sydney
Ms Benafsha Khariwala Editor Therapeutic Guidelines Limited Melbourne
Miss Carol-Anne Kilkenny Medical Writer NPS MedicineWise Sydney
Ms Georgina Kilroy Editor Therapeutic Guidelines Limited Melbourne
Mr Richard Kneebone Chair, Board of Directors Therapeutic Guidelines Limited Melbourne
Professor Paul Komesaroff Director Monash Centre for the Study of Ethics in Medicine and Society Melbourne
Ms Catherine Lavars Assistant Director, Clinical Adviser Department of Health and Ageing Canberra
Ms Kerry Lavery Project Officer Australian and New Zealand Intensive Care Society Melbourne
Ms Rebecca Lee Project Officer Heart Foundation Melbourne
Ms Anne Leversha Senior Lecturer Monash University Melbourne
Ms Emma Lourey Senior Program Officer, Health Professional Learning NPS MedicineWise Melbourne
Dr Liz Marles President Royal Australian College of General Practitioners Sydney
Ms Catherine Marshall Independent Guideline Adviser
and Health Consultant
New Zealand
Professor Christine McDonald Director Department of Respiratory and Sleep Medicine, Austin Hospital Melbourne
Dr Aidan McElduff Endocrinologist Northern Sydney Endocrine Centre Sydney
Ms Angela Melder Clinical Effectiveness Senior Consultant and Manager Quality Unit, Monash Medical Centre Melbourne
Associate Professor David Menkes Associate Professor of Psychiatry University of Auckland New Zealand
Assistant Professor
Barbara Mintzes
Assistant Professor School of Population and Public Health, University of British Columbia Vancouver, Canada
Ms Deborah Monk Director, Innovation and Industry Policy Medicines Australia Canberra
Ms Georgia Morris Senior Policy Advisor Australian Medical Association Sydney
Professor Rob Moulds Medical Advisor Therapeutic Guidelines Limited Melbourne
Ms Carol Norquay Electronic Production Editor Therapeutic Guidelines Limited Melbourne
Mr Mark Olszewski Communications Project Officer National Asthma Council Australia Melbourne
Ms Ali Patterson Publishing Director Therapeutic Guidelines Limited Melbourne
Associate Professor Christopher Pearce Clinical Design Lead National E-Health Transition Authority Sydney
Dr Sue Phillips Chief Executive Officer Therapeutic Guidelines Limited Melbourne
Dr Jane Robertson Senior Lecturer, Clinical Pharmacology University of Newcastle Newcastle,
New South Wales
Dr Susie Rogers Editor Therapeutic Guidelines Limited Melbourne
Dr Philipa Rothfield Senior Lecturer, Philosophy Program La Trobe University Melbourne
Ms Sandy Scholes Pharmacist Melbourne
Dr Ian Scott Director Internal Medicine and Clinical Epidemiology, Princess Alexandra Hospital Brisbane
Ms Vanessa Simpson Medical Writer NPS MedicineWise Sydney
Ms Lishia Singh Coordinator, Business Development Baker IDI Heart and Diabetes Institute Melbourne
Associate Professor Jane Smith Associate Professor of General Practice Bond University Medical School Gold Coast, Queensland
Dr Kay Sorimachi Director, Policy and Regulatory Affairs Pharmaceutical Society of Australia Melbourne
Ms Janet Struber Coordinating Editor Centre for Remote Health Alice Springs,
Northern Territory
Professor Martin Tattersall Professor of Cancer Medicine Department of Medicine, Central Clinical School, University of Sydney Sydney
Professor John Tiller Director Therapeutic Guidelines Limited Melbourne
Dr Janet Wale Consumer representative Melbourne
Dr Judith Walker Senior Policy Officer, Policy and Advocacy Unit The Royal Australasian College of Physicians Sydney
Dr John Waterston Consultant Neurologist Alfred Hospital and Cabrini Medical Centre Melbourne

Appendix 4 - Further reading

The following list of background references was provided to Independence Forum participants.

Independence: what’s the point? ISDB General Assembly. Melbourne; 14 September 2005. [cited 2013 Aug 12]

Avraham R. Clinical practice guidelines: the warped incentives in the U.S. healthcare system. Am J Law Med 2011;37:7-40.

Boyd EA, Bero LA. Improving the use of research evidence in guideline development: 4. Managing conflicts of interests. Health Res Policy Syst 2006;4:16.

Gale EA. Between two cultures: the expert clinician and the pharmaceutical industry. Clin Med 2003;3:538-41.

Gale EA. Conflicts of interest in guideline panel members. BMJ 2011;343:d5728.

Guyatt G, Akl EA, Hirsh J, Kearon C, Crowther M, Gutterman D, et al. The vexing problem of guidelines and conflict of interest: a potential solution. Ann Intern Med 2010;152:738-41.

Hirsh J, Guyatt G. Clinical experts or methodologists to write clinical guidelines? Lancet 2009;374:273-5.

Ioannidis JPA. Why most published research findings are false. PLoS Med 2005;2:e124.

Johnson AJ, Rogers WA. Conflict of interest guidelines for clinical guidelines. Med J Aust 2012;196:244-5.

Mintzes B. New UK guidance on industry-health professional collaboration. BMJ 2012;344:e3952.

Norris SL, Holmer HK, Ogden LA, Burda BU. Conflict of interest in clinical practice guideline development: a systematic review. PLoS One 2011;6:e25153.

Robertson J, Moynihan R, Walkom E, Bero L, Henry D. Mandatory disclosure of pharmaceutical industry-funded events for health professionals. PLoS Med 2009;6:e1000128.

Roseman M, Turner EH, Lexchin J, Coyne JC, Bero LA, Thombs BD. Reporting of conflicts of interest from drug trials in Cochrane reviews: cross sectional study. BMJ 2012;345:e5155.

Roseman M, Milette K, Bero LA, Coyne JC, Lexchin J, Turner EH, et al. Reporting of conflicts of interest in meta-analyses of trials of pharmacological treatments. JAMA 2011;305:1008-17.

Williams MJ, Kevat DAS, Loff B. Conflict of interest guidelines for clinical guidelines. Med J Aust 2011;195:442-5.

Zuiderent-Jerak T, Forland F, Macbeth F. Guidelines should reflect all knowledge, not just clinical trials. BMJ 2012;345:e6702.