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  1. 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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  2. 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
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    Lofstedt, Ragnar E

    Expert review of clinical pharmacology

    2008  Volume 1, Issue 5, Page(s) 617–625

    Abstract: 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. ... ...

    Abstract 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.
    Language English
    Publishing date 2008-09
    Publishing country England
    Document type Journal Article
    ISSN 1751-2433
    ISSN 1751-2433
    DOI 10.1586/17512433.1.5.617
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    Lofstedt, Ragnar E

    Journal of health communication

    2007  Volume 12, Issue 5, Page(s) 471–491

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Advertising as Topic ; Communication ; Cyclooxygenase 2 Inhibitors/adverse effects ; Drug Industry ; Drug-Related Side Effects and Adverse Reactions ; Government Regulation ; Health Policy ; Humans ; Perception ; Pilot Projects ; Public Relations ; Risk ; United States ; United States Food and Drug Administration
    Chemical Substances Cyclooxygenase 2 Inhibitors
    Language English
    Publishing date 2007-07
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1427988-5
    ISSN 1081-0730
    ISSN 1081-0730
    DOI 10.1080/10810730701438724
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Book ; Online: Social Trust and the Management of Risk

    Cvetkovich, George / Lofstedt, Ragnar E

    (Earthscan Risk in Society)

    2013  

    Abstract: Social trust is a crucial issue to many aspects of modern society. Policy makers continually aspire to winning it and corporations frequently run the risk of losing it. The 'trust deficit' raises vital questions and problems to which until recently there ...

    Series title Earthscan Risk in Society
    Abstract Social trust is a crucial issue to many aspects of modern society. Policy makers continually aspire to winning it and corporations frequently run the risk of losing it. The 'trust deficit' raises vital questions and problems to which until recently there have been few answers or solutions.Experts from both sides of the Atlantic explore the importance for trust of various influences, from individual perceptions to organizational systems, and consider the conditions involved in building or undermining trust. Several authors examine practical hazard management issues, including medical vaccinatio
    Language English
    Size Online-Ressource (438 p)
    Publisher Taylor and Francis
    Publishing place Hoboken
    Document type Book ; Online
    Note Description based upon print version of record
    ISBN 9781853836046 ; 1853836044
    Database Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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  7. Book ; Online: Risk Management in Post-Trust Societies

    Lofstedt, Ragnar E E

    2012  

    Abstract: A thought-provoking and invaluable book for anyone who cares about risk communication and management in the 21st century?Anna Jung, Director General, European Food Information Council?Professor Ragnar L?fstedt has once again produced a most interesting ... ...

    Abstract ?A thought-provoking and invaluable book for anyone who cares about risk communication and management in the 21st century?Anna Jung, Director General, European Food Information Council?Professor Ragnar L?fstedt has once again produced a most interesting book on risk management and trust, well-based on theory and built on empirical findings?Mikael Karlsson, President, Swedish Society for Nature Conservation?Highlights the difficult balancing task facing risk regulators. Regulatory inaction against real risks can undermine public trust. However, exaggerated responses to risks can also jeopardize
    Language English
    Size Online-Ressource
    Publisher Earthscan
    Publishing place Hoboken
    Document type Book ; Online
    Note Description based upon print version of record ; 4 Risk Management in the United States: The Case of International Paper's Hydro-Dam Re-Licensing ProcedureIntroduction; History of the adversarial style of regulation; Negotiated rule-making: the dams on the Androscoggin river; Regulatory negotiation within the hydropower sector; Negotiated rule-making and the Androscoggin case; Outcome of the process; Analysis of the risk factors; 5 Sweden: Barsebäck, Risk Management and Trust; Overview; Sweden's overall risk management approach; Historical background; Adversarial as opposed to consensus decision-making; Introduction to the Barsebäck case
    ISBN 9781849772457 ; 1849772452
    Database Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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  8. Article: Science communication and the Swedish acrylamide "alarm".

    Lofstedt, Ragnar E

    Journal of health communication

    2003  Volume 8, Issue 5, Page(s) 407–432

    Abstract: 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. ... ...

    Abstract 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.
    MeSH term(s) Acrylamides/blood ; Acrylamides/classification ; Acrylamides/toxicity ; Carcinogens/classification ; Communication ; Cooking/methods ; Dietary Carbohydrates ; Fear ; Female ; Food Analysis/standards ; Humans ; Mass Media ; Public Health Administration/standards ; Risk Assessment/standards ; Solanum tuberosum ; Sweden
    Chemical Substances Acrylamides ; Carcinogens ; Dietary Carbohydrates
    Language English
    Publishing date 2003-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1427988-5
    ISSN 1081-0730
    ISSN 1081-0730
    DOI 10.1080/713852123
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Swedish chemical regulation: an overview and analysis.

    Löfstedt, Ragnar E

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

    2003  Volume 23, Issue 2, Page(s) 411–421

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Chemical Industry/history ; Chemical Industry/legislation & jurisprudence ; Conservation of Natural Resources/history ; Conservation of Natural Resources/legislation & jurisprudence ; European Union ; History, 20th Century ; History, 21st Century ; Humans ; Public Policy ; Risk Assessment/history ; Risk Assessment/legislation & jurisprudence ; Sweden
    Language English
    Publishing date 2003-04-08
    Publishing country United States
    Document type Historical Article ; Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 778660-8
    ISSN 1539-6924 ; 0272-4332
    ISSN (online) 1539-6924
    ISSN 0272-4332
    DOI 10.1111/1539-6924.00321
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Nanotechnology risk communication past and prologue.

    Bostrom, Ann / Löfstedt, Ragnar E

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

    2010  Volume 30, Issue 11, Page(s) 1645–1662

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Nanotechnology ; Risk Assessment
    Language English
    Publishing date 2010-10-29
    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/j.1539-6924.2010.01521.x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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