Professor John Abraham (Department of Sociology, University of Sussex)
Key Challenges of Pharmaceutical Development, Regulation and Public Health
I begin by examining the distinction between the regulatory and policy definitions of pharmaceutical innovation with what public health needs from pharmaceuticals, namely, therapeutic advance. The response to the ‘innovation crisis’ in terms of shortening and loosening regulatory assessment within the standard approval process is discussed, including streamlining of safety standards. I then shift to examine regulatory provisions for drugs to treat serious or life-threatening conditions under ‘accelerated approval’ or ‘exceptional circumstances’ regulations. Specifically, the shift to use of non-established surrogate endpoints is scrutinised. Do these regulatory changes give us more confidence that new
drugs are efficacious and safe? Finally, I examine the question of the ‘independence’ of the regulatory agencies: funding, performance targets, and conflicts of interest of regulatory advisers.
Dr Kari Auranen (Department of Vaccination and Immune Protection
National Institute for Health and Welfare, Finland)
How uncertain should I be? – experiences from epidemiologic modelling
Models are increasingly used to predict outcomes of intervention programmes, e.g., to assess the likely effectiveness of large-scale vaccination. Although statistical modelling seems appropriate when addressing questions about such future outcomes, predictive models in epidemiology have defied formal requirements on coherent statistical reasoning. This is at least partly due to the need of causal inferences and more generally to uncertainties in choosing appropriate model structures. Luckily, when nature has spoken, predictive models become useless. Models may then serve as basis to address more scientific questions. In this talk I discuss different aspects of uncertainty in modelling infectious disease data for answering scientific questions on one hand, and for making predictions about intervention programmes on the other. The view will be a practical one, with examples from my recent work on modelling vaccination against pneumococcus and varicella.
Professor David Coggon (MRC Epidemiology Resource Centre, University of Southampton)
Chemical and Physical Hazards in the Environment
This presentation will introduce the contrasting challenges in
assessment, communication and management of scientific uncertainties
concerning possible risks to health from residential exposure to
pesticides and to radiofrequency radiation from mobile phone base
stations. It will also highlight the difficulties posed to risk
assessment and management by the possibility of nocebo effects, in
which (sometimes seriously disabling) illness arises through
psychological mechanisms, as a consequence of perceived hazardous
exposures.
Professor Christl Donnelly (Imperial College, London)
Collaborative research on the spread
of 2009 H1N1 pandemic influenza – the experience of the MRC Centre for
Outbreak Analysis and Modelling
The 2009 H1N1 pandemic influenza first emerged in Mexico in March 2009 and has now spread rapidly across the globe. Key questions arose about how to best use limited resources to mitigate the effects of the pandemic. Pre-pandemic modelling work had suggested that multi-faceted mitigation policies, including the use of antivirals and social distancing could have an important impact on overall and peak clinical attack rates. These assessments of intervention strategies, however, depended critically on the transmission potential, natural history of infection, antiviral effectiveness and age-related patterns of susceptibility for the pandemic strain. Real-time statistical analyses and mathematical modelling of transmission informed epidemic/pandemic responses in many settings and was a key component in scientific advice to governments and inter-governmental agencies. International collaborations contributed importantly to these efforts.
Professor Jonathan Wolff (University College London)
When is Cost-Benefit Analysis Morally Acceptable in Health Decision Making (And What Should We Do When It Isn't)?
The National Insititute of Health and Clinical Excellence (NICE) provides guidance on the use of new medicines and technologies on the basis of their cost-effectiveness, judging financial costs against health benefits. NICE is regularly criticised for the callousness or inhumanity of decisions reached on this basis. Yet while it may seem easy to criticise particular decisions, it is far less clear how a systematic alternative decision procedure is possible. In this talk I will review some criticisms and alternatives, briefly looking at modified forms of cost-benefit analysis incorporating equity and social
value weights, as well as considering more radical alternatives such as participatory decision-making, and professional judgement.
