Pharmaceutical Benefit-Risk Perception and Age Differences in the USA and Germany.

INTRODUCTION: Understanding how patients of all ages perceive the benefits and risks of medical treatments is vitally important. Yet, the role of older age on pharmaceutical benefit-risk perceptions has hardly been empirically investigated as a central focus of study. OBJECTIVE: This study tested the generalizability of recent pilot findings to explore benefit-risk perception age differences between adults aged 65 years old and over (older group) and those aged 18-64 years old (younger group). METHODS: An online survey representative for age, sex, and education was conducted in Ohio, USA (N = 1520) and Germany (N = 1536). A combination of benefit, risk, and affect questions measured respondents' perceptions of 18 medicines, tests, vaccines, and procedures. Further questions investigated general perceptions of side effects and effectiveness, as well as respondents' reliance on different sources of medicines information. RESULTS: Clear age differences were found that strongly support recent pilot findings. Older adults perceived prescription medicines significantly more positively than their younger counterparts. They had significantly higher benefit and lower risk perceptions for most, but not all, medical treatments investigated. Older adults' benefit-risk perceptions were more strongly correlated with positive/negative affect, that is, their positive/negative experiences and feelings of "goodness" or "badness" they associated with each medical treatment investigated. They also perceived doctors and pharmacists as more competent and trustworthy. Contrary to popular belief, both age groups ranked their reliance on 15 different medical (e.g. doctors), societal (e.g. social media), industry (e.g. pharmaceutical company websites), and governmental (e.g. regulatory agencies) sources of medicines information remarkably similarly. CONCLUSION: Age has an important role in patients' pharmaceutical benefit-risk perceptions. Findings show that, when designing messages, benefit-risk communicators should incorporate age differences. This includes older patients' positive perceptions of pharmaceuticals, greater reliance on affect, and information seeking versus scanning behaviour. Field experiments are now needed to test the effectiveness of such changes for improving benefit-risk communication practice.

The informal European Parliamentary Working Group on Risk--history, remit, and future plans: a personal view.

On September 5, 2012 the inaugural meeting of the European Parliamentary Working Group on Risk (WGR) took place in the European Parliament in Brussels. It is chaired by Mrs. Julie Girling (U.K. Conservative), Member of the European Parliament (MEP), and involves some 10-12 other MEPs representing a wide array of European political parties from across the EU member state countries, including Sweden, the Netherlands, and Hungary. The WGR is supported by a small secretariat reporting directly to Julie Girling MEP. In this background article of WGR, I discuss the background to why WGR was set up, the remit of the committee, and some of its possible future plans. I do this very much in a personal capacity, having suggested the formation of the committee in the first place and persuaded Mrs. Girling to chair it.

Transparency at the EMA: More Evidence Is Needed.

Ever since its establishment in 1995, the European Medicines Agency (EMA) has been committed to transparency. That said, as of late the Agency has been criticized for lacking it. To address this criticism, the Agency is attempting to become even more transparent. In this commentary the author argues that the EMA is now moving almost too quickly toward complete transparency. Before launching a number of new transparency initiatives, it should consider arranging some workshops on the topic as well as pretesting its communication messages before they are put in the public domain.

Nanotechnology risk communication past and prologue.

Nanotechnologies operate at atomic, molecular, and macromolecular scales, at scales where matter behaves differently than at larger scales and quantum effects can dominate. Nanotechnologies have captured the imagination of science fiction writers as science, engineering, and industry have leapt to the challenge of harnessing them. Applications are proliferating. In contrast, despite recent progress the regulatory landscape is not yet coherent, and public awareness of nanotechnology remains low. This has led risk researchers and critics of current nanotechnology risk communication efforts to call for proactive strategies that do more than address facts, that include and go beyond the public participation stipulated by some government acts. A redoubling of nanotechnology risk communication efforts could enable consumer choice and informed public discourse about regulation and public investments in science and safety.

Nano risk analysis: advancing the science for nanomaterials risk management.

Scientists, activists, industry, and governments have raised concerns about health and environmental risks of nanoscale materials. The Society for Risk Analysis convened experts in September 2008 in Washington, DC to deliberate on issues relating to the unique attributes of nanoscale materials that raise novel concerns about health risks. This article reports on the overall themes and findings of the workshop, uncovering the underlying issues for each of these topics that become recurring themes. The attributes of nanoscale particles and other nanomaterials that present novel issues for risk analysis are evaluated in a risk analysis framework, identifying challenges and opportunities for risk analysts and others seeking to assess and manage the risks from emerging nanoscale materials and nanotechnologies. Workshop deliberations and recommendations for advancing the risk analysis and management of nanotechnologies are presented.

Academic analysis of the Institute of Medicine report: The Future of Drug Safety.

This paper analyzes the influential September 2006 Institute of Medicine (IOM) report entitled The Future of Drug Safety. It also analyzes the US FDA's and the politicians' FDA Amendments Act (FDAAA) response to it from a risk-communication perspective. This article begins with an extensive background discussion as to why the IOM report was commissioned. Then, it outlines and analyzes, from a risk-communication perspective, a number of the IOM's suggested recommendations. In the third section, a number of overarching critiques of the IOM report are provided and, in the final section, a similar analysis is provided for the FDA's and politicians' (FDAAA) responses to the IOM report. Overall, the IOM's report is an intelligent, well-structured document that provides a number of very useful recommendations. That said, the report is comparatively weak with regard to its recommendations associated with risk communication. Medical and drug risk communication is currently in its infancy.

The impact of the cox-2 inhibitor issue on perceptions of the pharmaceutical industry: content analysis and communication implications.

The field of risk communication has its roots in the environmental, chemical, space, and nuclear arenas. As a number of these sectors have now vastly improved their communication strategies, attention is being placed on sectors that have been more problematic as of late. Examples of such sectors, include the food industries and the pharmaceutical/health sector. This article focuses on how large, multinational pharmaceutical companies can better communicate risks by analysis of one specific case, namely, that of the Cox-2 controversy.(1) For purposes of this article, risk communication is best described as "the flow of information and risk evaluations back and forth between academic experts, regulatory practitioners, interest groups and the general public," and "big pharma" refers to the more traditional R & D-based, innovative pharmaceutical companies.

Science communication and the Swedish acrylamide "alarm".

On April 24, 2002 the Swedish National Food Administration along with a group of researchers at the University of Stockholm raised an alarm regarding potential health risks associated with eating fried and baked foods such as potatoes and bread. Scientists had found high levels of acrylamide (up to 500 times more acrylamide than that allowed in drinking water by the World Health Organisation), a substance widely believed to cause cancer, in cooked high starch foods. The outcomes of this "alarm" were immediate. In Sweden sales of chips fell by 30-50 percent over a 3-day period following the press conference, and share prices among several fried food manufacturers fell substantially, as stock analysts were fearful that consumption of fried foods would decrease significantly. Four days after the press conference, however, consumers began eating fried food as normal and a number of researchers and journalists in Sweden and elsewhere took the view that the alarm had been both exaggerated and ill placed. In this study, I evaluate the science communication process associated with the scare, based on a content analysis of a select group of Swedish broad sheets from just previous to the April 2002 press conference to the present time (December 2002). In addition, the study is based on interviews with the various Swedish regulators involved in the process itself (in particular at the Swedish National Food Administration) as well as with the scientists responsible for the study at Stockholm University and relevant journalists and politicians.

Swedish chemical regulation: an overview and analysis.

This article begins with a review of the regulation of chemicals in Sweden over the past 30 years, focusing particularly on the 1997 Government Environmental Quality Bill, which called for a toxic-free society by the year 2020. The second part of the article analyzes why Sweden has taken this route. The third and final section discusses Sweden's present role in formulating present EU chemical regulation, such as the recent EU Chemical White Paper, and hypothesizes future impacts of Swedish chemical regulations on the EU itself.

Use of risk assessment and life cycle assessment in decision making: a common policy research agenda.

Quantitative risk assessment (RA) and life cycle assessment (LCA) are both analytical tools used to support decision making in environmental management. They have been developed and used by largely separate groups of specialists, and it is worth considering whether there is a common research agenda that may increase the relevance of these tools in decision-making processes. The validity of drawing comparisons between use of the tools is established through examining key aspects of the two approaches for their similarities and differences, including the nature of each approach and contextual and methodological aspects. Six case studies involving use of each approach in public decision making are described and used to draw out concerns about using RA and LCA in this context. The following categories of concern can be distinguished: philosophical approach of the tools; quantitative versus qualitative assessment; stakeholder participation; the nature of the results; and the usefulness of the results in relation to time and financial resource requirements. These can be distilled into a common policy research agenda focusing on: the legitimacy of using tools built on a particular perspective in decision making; recognition and role of value judgments in RA and LCA; treatment of uncertainty and variability; the influence of analytical tools in focusing attention on particular aspects of a decision-making situation; and understandability of the results for nonspecialists. It is concluded that it is time to bring together the experiences of RA and LCA specialists and benefit from cross-fertilization of ideas.