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Article ; Online: Transparency at the EMA: More Evidence Is Needed.

Löfstedt, Ragnar E

Therapeutic innovation & regulatory science

2018 Volume 47, Issue 3, Page(s) 299–300

Abstract: 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 ... ...

Abstract	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.
Language	English
Publishing date	2018-09-19
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1177/2168479012469946
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Book: Risk management in post-trust societies

Löfstedt, Ragnar

(Earthscan risk in society series)

2017

Author's details	Ragnar E. Löfstedt
Series title	Earthscan risk in society series
Language	English
Dates of publication	2017-2005
Size	xxii, 165 Seiten, Illustrationen
Publisher	Earthscan
Publishing place	Abingdon, Oxon
Document type	Book
ISBN	9781138465725 ; 9781844077021 ; 1138465720 ; 1844077020
Database	ECONomics Information System

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Article ; Online: Communicating food risks in an era of growing public distrust: three case studies.

Lofstedt, Ragnar

Risk analysis : an official publication of the Society for Risk Analysis

2013 Volume 33, Issue 2, Page(s) 192–202

Abstract: The communication and regulation of risk has changed significantly over the past 30 years in Europe and to a noticeable but lesser extent in the United States. In Europe, this is partly due to a series of regulatory mishaps, ranging from mad cow disease ... ...

Abstract	The communication and regulation of risk has changed significantly over the past 30 years in Europe and to a noticeable but lesser extent in the United States. In Europe, this is partly due to a series of regulatory mishaps, ranging from mad cow disease in the United Kingdom to contamination of the blood supply in France. In the United States, general public confidence in the American government has been gradually declining for more than three decades, driven by a mix of cultural and political conflicts like negative political advertising, a corrosive news media, and cuts in regulatory budgets. While the former approach is based on an objective assessment of the risk, the latter is driven more by the perception of the risk, consumer sentiment, political will, and sectoral advocacy. In this article, the author examines three U.S.-based food case studies (acrylamide, bisphenol A, and artificial food colorings) where regulations at the local and state levels are increasingly being based on perceived risk advocacy rather than on the most effective response to the risk, be it to food safety or public health, as defined by regulatory interpretation of existing data. In the final section, the author puts forward a series of recommendations for how U.S.-based regulators can best handle those situations where the perceived risk is markedly different from the fact-based risk, such as strengthening the communication departments of food regulatory agencies, training officials in risk communication, and working more proactively with neutral third-party experts.
MeSH term(s)	Acrylamide/analysis ; Acrylamide/toxicity ; Benzhydryl Compounds/analysis ; Benzhydryl Compounds/toxicity ; Communication ; Europe ; Food Coloring Agents/analysis ; Food Coloring Agents/toxicity ; Food Contamination/legislation & jurisprudence ; Phenols/analysis ; Phenols/toxicity ; Public Relations ; Risk Assessment ; Trust ; United States
Chemical Substances	Benzhydryl Compounds ; Food Coloring Agents ; Phenols ; Acrylamide (20R035KLCI) ; bisphenol A (MLT3645I99)
Language	English
Publishing date	2013-02
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	778660-8
ISSN	1539-6924 ; 0272-4332
ISSN (online)	1539-6924
ISSN	0272-4332
DOI	10.1111/j.1539-6924.2011.01722.x
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Article ; Online: Anticipating or Accommodating to Public Concern? Risk Amplification and the Politics of Precaution Reexamined.

Wardman, Jamie K / Löfstedt, Ragnar

Risk analysis : an official publication of the Society for Risk Analysis

2018 Volume 38, Issue 9, Page(s) 1802–1819

Abstract: Regulatory use of the precautionary principle (PP) tends to be broadly characterized either as a responsible approach for safeguarding against health and environmental risks in the face of scientific uncertainties, or as "state mismanagement" driven by ... ...

Abstract	Regulatory use of the precautionary principle (PP) tends to be broadly characterized either as a responsible approach for safeguarding against health and environmental risks in the face of scientific uncertainties, or as "state mismanagement" driven by undue political bias and public anxiety. However, the "anticipatory" basis upon which governments variably draw a political warrant for adopting precautionary measures often remains ambiguous. Particularly, questions arise concerning whether the PP is employed preemptively by political elites from the "top down," or follows from more conventional democratic pressures exerted by citizens and other stakeholders from the "bottom up." This article elucidates the role and impact of citizen involvement in the precautionary politics shaping policy discourse surrounding the U.K. government's "precautionary approach" to mobile telecommunications technology and health. A case study is presented that critically reexamines the basis upon which U.K. government action has been portrayed as an instance of anticipatory policy making. Findings demonstrate that the use of the PP should not be interpreted in the preemptive terms communicated by U.K. government officials alone, but also in relation to the wider social context of risk amplification and images of public concern formed adaptively in antagonistic precautionary discourse between citizens, politicians, industry, and the media, which surrounded cycles of government policy making. The article discusses the sociocultural conditions and political dynamics underpinning public influence on government anticipation and responsiveness exemplified in this case, and concludes with research and policy implications for how society subsequently comes to terms with the emergence and precautionary governance of new technologies under conflict.
Language	English
Publishing date	2018-04-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	778660-8
ISSN	1539-6924 ; 0272-4332
ISSN (online)	1539-6924
ISSN	0272-4332
DOI	10.1111/risa.12997
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Article ; Online: Pharmaceutical Benefit-Risk Perception and Older Age: A Pilot Study.

Balog-Way, Dominic Hugo Patrick / Löfstedt, Ragnar Ernst

Therapeutic innovation & regulatory science

2020 Volume 54, Issue 3, Page(s) 645–657

Abstract: Background: Older age plays an important role in pharmaceutical benefit-risk perception. This creates challenges and opportunities, especially for regulatory authorities and advocacy groups seeking to communicate with patients of all ages. This study ... ...

Abstract	Background: Older age plays an important role in pharmaceutical benefit-risk perception. This creates challenges and opportunities, especially for regulatory authorities and advocacy groups seeking to communicate with patients of all ages. This study explored the pharmaceutical benefit-risk perceptions of older versus younger adults to identify age-related effects for further study. Methods: 80 face-to-face surveys were conducted with samples of older and younger respondents from Boulder, Colorado (USA), and Dublin (Ireland). Results: Older adults were more likely than their younger counterparts to view greater risk today than 20 years ago for 14 out of 16 items ranging from diabetes and Alzheimer disease, to patients taking prescription medicines. Both older and younger respondents perceived most medical treatments as high in benefit and low in risk. Older adults construed "risk" variably as (1) side effects, (2) dangers of inappropriate use, and (3) wider issues. Crucially, older adults' quantitative benefit-risk judgments were strongly influenced by personal experiences and the positive/negative feelings they most associated with different medicines, medical procedures and tests. While positive associations influenced high benefit perceptions, negative associations influenced high risk perceptions. Conclusion: Age-related effects on risk perception should be further explored to help improve the effectiveness of benefit-risk communication for adults of all ages.
MeSH term(s)	Aged ; Communication ; Humans ; Perception ; Pilot Projects ; Prescription Drugs ; Surveys and Questionnaires
Chemical Substances	Prescription Drugs
Language	English
Publishing date	2020-01-06
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1007/s43441-019-00099-x
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Article ; Online: The informal European Parliamentary Working Group on Risk--history, remit, and future plans: a personal view.

Löfstedt, Ragnar E

Risk analysis : an official publication of the Society for Risk Analysis

2013 Volume 33, Issue 7, Page(s) 1182–1187

Abstract: 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 ... ...

Abstract	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.
Language	English
Publishing date	2013-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	778660-8
ISSN	1539-6924 ; 0272-4332
ISSN (online)	1539-6924
ISSN	0272-4332
DOI	10.1111/risa.12065
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Article ; Online: Risk communication: the Avandia case, a pilot study.

Lofstedt, Ragnar

Expert review of clinical pharmacology

2010 Volume 3, Issue 1, Page(s) 31–41

Abstract: On 21 May 2007, the New England Journal of Medicine published Nissen and Wolski's article entitled 'Effect of rosiglitazone on the risk of myocardial infarcation and death from cardiovascular causes.' The publication of the article had immediate ... ...

Abstract	On 21 May 2007, the New England Journal of Medicine published Nissen and Wolski's article entitled 'Effect of rosiglitazone on the risk of myocardial infarcation and death from cardiovascular causes.' The publication of the article had immediate ramifications. The producer of rosiglitazone (under the trademark Avandia(®)); GlaxoSmithKline, saw its share price fall 8% on the day of the publication, and it led to front-page headlines in national newspapers in Europe and North America. This article evaluates the risk-communication strategies of the various actors involved in the Avandia case from the time of the Nissen and Wolski article to the present day. The evaluation is based on a content analysis of a number of USA and UK newspapers from the period January 2007 to May 2008, interviews with GlaxoSmithKline staff, drug regulators (EMEA, Medicines and Healthcare Products Regulatory Agency and US FDA), journalists at the Wall Street Journal and the Financial Times, and advisors to US politicians (Congressional staffers).
Language	English
Publishing date	2010-01
Publishing country	England
Document type	Journal Article
ISSN	1751-2441
ISSN (online)	1751-2441
DOI	10.1586/ecp.09.49
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: The precautionary principle in the EU

Löfstedt, Ragnar

Risk management : an international journal Vol. 16, No. 3 , p. 137-163

why a formal review is long overdue

2014 Volume 16, Issue 3, Page(s) 137–163

Author's details	Ragnar Lofstedt
Keywords	precautionary principle ; communication ; Europe ; European commission
Language	English
Publisher	Palgrave Macmillan
Publishing place	Basingstoke
Document type	Article
ZDB-ID	2227982-9 ; 2180561-1
ISSN	1743-4637 ; 1460-3799
ISSN (online)	1743-4637
ISSN	1460-3799
Database	ECONomics Information System

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Article ; Online: Pharmaceutical Benefit-Risk Perception and Older Age: A Pilot Study.

Balog-Way, Dominic Hugo Patrick / Löfstedt, Ragnar Ernst

Therapeutic innovation & regulatory science

2019 , Page(s) 2168479019870761

Abstract	Background: Older age plays an important role in pharmaceutical benefit-risk perception. This creates challenges and opportunities, especially for regulatory authorities and advocacy groups seeking to communicate with patients of all ages. This study explored the pharmaceutical benefit-risk perceptions of older versus younger adults to identify age-related effects for further study. Methods: 80 face-to-face surveys were conducted with samples of older and younger respondents from Boulder, Colorado (USA), and Dublin (Ireland). Results: Older adults were more likely than their younger counterparts to view greater risk today than 20 years ago for 14 out of 16 items ranging from diabetes and Alzheimer disease, to patients taking prescription medicines. Both older and younger respondents perceived most medical treatments as high in benefit and low in risk. Older adults construed "risk" variably as (1) side effects, (2) dangers of inappropriate use, and (3) wider issues. Crucially, older adults' quantitative benefit-risk judgments were strongly influenced by personal experiences and the positive/negative feelings they most associated with different medicines, medical procedures and tests. While positive associations influenced high benefit perceptions, negative associations influenced high risk perceptions. Conclusion: Age-related effects on risk perception should be further explored to help improve the effectiveness of benefit-risk communication for adults of all ages.
Language	English
Publishing date	2019-09-17
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1177/2168479019870761
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Pharmaceutical Benefit-Risk Perception and Age Differences in the USA and Germany.

Balog-Way, Dominic H P / Evensen, Darrick / Löfstedt, Ragnar E

Drug safety

2020 Volume 43, Issue 11, Page(s) 1141–1156

Abstract: 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 ... ...

Abstract	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.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aging ; Data Collection ; Female ; Germany ; Health Knowledge, Attitudes, Practice ; Humans ; Male ; Middle Aged ; Ohio ; Prescription Drugs/adverse effects ; Prescription Drugs/therapeutic use ; Risk Assessment ; Young Adult
Chemical Substances	Prescription Drugs
Language	English
Publishing date	2020-07-23
Publishing country	New Zealand
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1018059-x
ISSN	1179-1942 ; 0114-5916
ISSN (online)	1179-1942
ISSN	0114-5916
DOI	10.1007/s40264-020-00977-6
Database	MEDical Literature Analysis and Retrieval System OnLINE

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