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Are pharmaceutical policies in Australia based on evidence or influence?ÌýWe answer this question collaborating with consumers and medical professionals to research on policy, evidence and influence related to drug therapies for obesity, diabetes, cardiovascular disease, cancer, ageing and mental health.Ìý

Our goal is to inform policy debates with high quality evidence in order to develop solutions for optimizing treatment for patients affected by chronic disease. We give evidence-based responses to controversial aspects of drug-therapies such as: influence on health consumers and medical professionals by the pharmaceuticals industry, equal access to medications, and over-prescribing.Ìý

• Industry sponsorship of patient groups: A series of studies on funding of health consumer organisations in Australia and internationally, including: funding patterns, transparency, conflicts of interest.Ìý
• Commercial influences on professional practice: Creation of publicly available, usable databases of industry funding of health professionals in Australia.ÌýÌýso far at the Charles Perkins Centre.Ìý
• Effective warnings for clinicians and the public on harmful effects of medicines:ÌýA comparison of the Therapeutic Goods Administration (TGA)’s safety advisories on medicines with those of US, Canadian and European regulators over the last decade.

The project node works to improve treatment, with or without drugs, for patients affected by chronic disease, as well as increase transparency in pharmaceutical policies. Examples include: analysis of the role of drug therapies for obesity, evaluation of the increased access to insulin analogues in low-income countries, examination of the warnings by regulators about newly discovered harmful effects of medicines.

Funding

• NHMRC and Canadian Institues of Health Research (AUD $2 million 2017-2022) How best to protect public health: a comparative analysis of regulatory safety warnings on medicines in Australia, Canada the European Union and the United States.

Publications

Consolidation of a research team including University of Sydney, University of New South Wales, University of South Australia, Harvard, University of Copenhagen, Utrecht University, Kings College London, University of British Columbia, York University, Dalhousie University has resulted inÌý8 publications thus far, along with 3 under submission and an additional 6-8 expected. Highlights include:

• Parker, L., Fabbri, A., Grundy, Q., Mintzes, B., Bero, L. (2019). "Asset exchange" - Interactions between patient groups and pharmaceutical industry: Australian qualitative study.ÌýBMJ, 367, 1-12.
• Perry, L., Bhasale, A., Fabbri, A., Lexchin, J., Puil, L., Joarder, M., Mintzes, B. (2019). Comparative Analysis of Medicines Safety Advisories Released by Australia, Canada, the United States, and the United Kingdom.ÌýJAMA Internal Medicine, 179(7), 982-985
• Lau, E., Fabbri, A., Mintzes, B. (2019). How do health consumer organisations in Australia manage pharmaceutical industry sponsorship? A cross-sectional study.ÌýAustralian Health Review, 43(4), 474-480.

Research database

We have developedÌýÌýon pharmaceutical industry payments to health professionals and consumer organisations in Australia.ÌýThese have been used as a resource by journalists and led to media coverage on undue influence on health care via sponsorship of educational events for health professionals, consumer health organisations, individual professional financing for speaking engagements, advisory boards, travel, conference attendance, and contracts.Ìý

Pharmaceutical regulatory policy issues

Submissions to consultations on pharmaceutical regulatory policy issues include:

• Prescrire, France, AIDES France, AIM – International Association of Mutual Benefit Societies, et al.Ìý. Dec 19, 2019.ÌýÌý
• Lexchin J, Gagnon MA, Graham J, Grundy Q, Herder M, Kohler JC, Mintzes B. Submission to consultation on: Health Canada’s Draft Guidance: Accelerated Review of Human Drug Submissions. June 1, 2019
• Bhasale A, Lexchin J, Bero L, Perry L, Karanges E, McEwin E, Fabbri A, Mohammad A, Puil L, Torca M, Mintzes B. Submission to consultation on:ÌýÌý(GVP) Module XV - Safety communication (Rev 1). April 29, 2019

Internal collaborators

• Professor
• Professor
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• Associate Professor
• Professor
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• Dr
• Dr
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• Professor
• Dr
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• ProfessorÌýÌý(Project Node Leader)
• Associate Professor
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• Dr Lisa Parker
• Dr
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• Dr Edwin TanÌý(Project Node Leader)
• Dr
• Professor

Advisory committee members

• Emeritus Professor
• Professor
• Emeritus Professor

External collaborators

• Dr Sharon Batt, Dalhousie University
• Associate Professor Marc-Andre Gagnon, Carleton University
• Professor Janice E. Graham, Dalhousie University
• Professor David Henry, Bond University
• Dr Michael Law, University of British Columbia
• Emeritus Professor Joel Lexchin, York University
• Dr Ruth Lopert, Centre for Global Development
• Professor Steve Morgan, University of British Columbia
• Dr Ray Moynihan, Bond University
• Professor Libby Roughead, University of South Australia
• Professor Ingrid Sketris, Dalhousie University
• Dr Paulina Stehlik, Bond University
• Dr Agnes Vitry, University of South Australia