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  1. Article ; Online: The Safety of Anti-SARS-CoV-2 Vaccines

    Michel Goldman

    Journal of Clinical Medicine, Vol 11, Iss 1248, p

    Vigilance Is Still Required

    2022  Volume 1248

    Abstract: The opinion I put forward in this paper is that attention must continue to be paid to clinical observations compatible with a detrimental effect of anti-SARS-CoV-2 in certain diseases of immunological nature. Using the example of the atypical ... ...

    Abstract The opinion I put forward in this paper is that attention must continue to be paid to clinical observations compatible with a detrimental effect of anti-SARS-CoV-2 in certain diseases of immunological nature. Using the example of the atypical thrombocytopenic thromboses caused by adenoviral-vector-based vaccines, I argue that usual post-marketing pharmacovigilance programs may fail in identifying very rare vaccine-related disorders. Since the robust protective immunity induced by mRNA vaccines is related to their distinct capacity to induce strong stimulation of T follicular helper cells, I suggest that the safety of mRNA vaccines should be further assessed by appropriately designed epidemiological and mechanistic studies focusing on lymphoproliferative and autoimmune diseases in which T follicular helper cells were found to play a key role.
    Keywords COVID-19 ; SARS-CoV-2 ; vaccine ; mRNA lymphoma ; T cell ; autoimmunity ; Medicine ; R
    Language English
    Publishing date 2022-02-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Case reports as early safety signals

    Michel Goldman / Rebecca E. Chandler

    Frontiers in Medicine, Vol

    learning from the COVID-19 vaccination campaign

    2024  Volume 10

    Keywords safety ; vaccine ; adjuvant ; COVID-19 ; case report ; pharmacovigilance ; Medicine (General) ; R5-920
    Language English
    Publishing date 2024-01-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Thrombotic thrombocytopenia associated with COVID-19 infection or vaccination

    Michel Goldman / Cédric Hermans

    PLoS Medicine, Vol 18, Iss 5, p e

    Possible paths to platelet factor 4 autoimmunity.

    2021  Volume 1003648

    Abstract: Michel Goldman and Cédric Hermans discuss thrombotic mechanisms in COVID-19 and rare adverse ...

    Abstract Michel Goldman and Cédric Hermans discuss thrombotic mechanisms in COVID-19 and rare adverse reactions to SARS-CoV-2 vaccinations.
    Keywords Medicine ; R
    Language English
    Publishing date 2021-05-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Reflections on the Collaborative Fight Against COVID-19

    Michel Goldman / Mitchell Silva

    Frontiers in Medicine, Vol

    2020  Volume 7

    Abstract: Clinical trials to identify efficient treatments against COVID-19 flourish worldwide without much attention to patients' voice so far. As therapeutic interventions in the early phase of the disease are attracting more and more interest, we argue that now ...

    Abstract Clinical trials to identify efficient treatments against COVID-19 flourish worldwide without much attention to patients' voice so far. As therapeutic interventions in the early phase of the disease are attracting more and more interest, we argue that now is the time to involve patients' organizations in the design of clinical protocols in order to define the most relevant end-points and assess the risk-benefit balance of new therapies.
    Keywords patient ; trial ; partnership ; regulation ; COVID-19 ; Medicine (General) ; R5-920 ; covid19
    Language English
    Publishing date 2020-09-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Online Information on Probiotics

    Marie Neunez / Michel Goldman / Pietro Ghezzi

    Frontiers in Medicine, Vol

    Does It Match Scientific Evidence?

    2020  Volume 6

    Abstract: Probiotics are over-the-counter products marketed for enhancing human health. Online information has been key in promoting probiotics worldwide. However, only few rigorous clinical studies have met the stringent criteria required to establish the ... ...

    Abstract Probiotics are over-the-counter products marketed for enhancing human health. Online information has been key in promoting probiotics worldwide. However, only few rigorous clinical studies have met the stringent criteria required to establish the efficacy and safety of probiotics. The present study was undertaken to assess the information quality of webpages referring to probiotics and to compare the recommendations available online with the information collected from trusted scientific sources. We evaluated 150 webpages returned by Google searching “probiotics” in terms of typology of website, health information quality based on the JAMA score and the HONcode certification, as well as completeness of the information based on the presence of four criteria: (1) links to scientific references supporting health claims, (2) cautionary notes about level of evidence for alleged benefits, (3) safety considerations, and (4) regulatory status. We then enumerated the health claims mentioned online and the corresponding clinical trials and reviews registered in the Cochrane library. Finally, the conclusions of Cochrane reviews were used to assess the level of scientific evidence of the information available through Google search. HON-certified websites were significantly more frequent in the top 10 websites than in the remaining websites. In terms of completeness of information, only 10% of webpages met all four criteria, 40% had a cautionary note on benefits, 35% referred to scientific literature, and only 25% mentioned potential side effects. The results of the content analysis led us to conclude that: (1) the most frequent typologies of webpages returned by Google are commercial and news, (2) commercial websites on average provide the least reliable information, and (3) significant numbers of claimed benefits of probiotics are not supported by scientific evidence. This study highlights important biases in the probiotics information available online, underlining the need to improve the quality and objectivity of ...
    Keywords probiotics ; safety ; regulatory ; health claims ; online ; evidence-based medicine ; Medicine (General) ; R5-920
    Subject code 302
    Language English
    Publishing date 2020-01-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Antibody-based therapies for COVID-19

    Michel D Kazatchkine / Michel Goldman / Jean-Louis Vincent

    PLoS Medicine, Vol 17, Iss 5, p e

    Can Europe move faster?

    2020  Volume 1003127

    Abstract: Michel Goldman and colleagues call on the European medical and scientific community to coordinate ...

    Abstract Michel Goldman and colleagues call on the European medical and scientific community to coordinate efforts on immunotherapy-based approaches to coronavirus.
    Keywords Medicine ; R ; covid19
    Language English
    Publishing date 2020-05-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Patient Preferences to Assess Value IN Gene Therapies

    Eline van Overbeeke / Brett Hauber / Sissel Michelsen / Michel Goldman / Steven Simoens / Isabelle Huys

    Frontiers in Medicine, Vol

    Protocol Development for the PAVING Study in Hemophilia

    2021  Volume 8

    Abstract: Introduction: Gene therapies are innovative therapies that are increasingly being developed. However, health technology assessment (HTA) and payer decision making on these therapies is impeded by uncertainties, especially regarding long-term outcomes. ... ...

    Abstract Introduction: Gene therapies are innovative therapies that are increasingly being developed. However, health technology assessment (HTA) and payer decision making on these therapies is impeded by uncertainties, especially regarding long-term outcomes. Through measuring patient preferences regarding gene therapies, the importance of unique elements that go beyond health gain can be quantified and inform value assessments. We designed a study, namely the Patient preferences to Assess Value IN Gene therapies (PAVING) study, that can inform HTA and payers by investigating trade-offs that adult Belgian hemophilia A and B patients are willing to make when asked to choose between a standard of care and gene therapy.Methods and Analysis: An eight-step approach was taken to establish the protocol for this study: (1) stated preference method selection, (2) initial attributes identification, (3) stakeholder (HTA and payer) needs identification, (4) patient relevant attributes and information needs identification, (5) level identification and choice task construction, (6) educational tool design, (7) survey integration, and (8) piloting and pretesting. In the end, a threshold technique survey was designed using the attributes “Annual bleeding rate,” “Chance to stop prophylaxis,” “Time that side effects have been studied,” and “Quality of Life.”Ethics and Dissemination: The Medical Ethics Committee of UZ KU Leuven/Research approved the study. Results from the study will be presented to stakeholders and patients at conferences and in peer-reviewed journals. We hope that results from the PAVING study can inform decision makers on the acceptability of uncertainties and the value of gene therapies to patients.
    Keywords preference ; instrument design ; hemophilia ; interviews ; survey ; gene therapy ; Medicine (General) ; R5-920
    Subject code 650
    Language English
    Publishing date 2021-03-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: Rapid Progression of Angioimmunoblastic T Cell Lymphoma Following BNT162b2 mRNA Vaccine Booster Shot

    Serge Goldman / Dominique Bron / Thomas Tousseyn / Irina Vierasu / Laurent Dewispelaere / Pierre Heimann / Elie Cogan / Michel Goldman

    Frontiers in Medicine, Vol

    A Case Report

    2021  Volume 8

    Abstract: Since nucleoside-modified mRNA vaccines strongly activate T follicular helper cells, it is important to explore the possible impact of approved SARS-CoV-2 mRNA vaccines on neoplasms affecting this cell type. Herein, we report and discuss unexpected rapid ...

    Abstract Since nucleoside-modified mRNA vaccines strongly activate T follicular helper cells, it is important to explore the possible impact of approved SARS-CoV-2 mRNA vaccines on neoplasms affecting this cell type. Herein, we report and discuss unexpected rapid progression of lymphomatous lesions after administration of a BNT162b2 mRNA vaccine booster in a man recently diagnosed with AITL.
    Keywords mRNA vaccine ; T cell ; lymphoma ; COVID-19 ; angioimmunoblastic ; follicular ; Medicine (General) ; R5-920
    Language English
    Publishing date 2021-11-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Public‐private partnerships as driving forces in the quest for innovative medicines

    Michel Goldman / Carolyn Compton / Barbara B Mittleman

    Clinical and Translational Medicine, Vol 2, Iss 1, Pp n/a-n/a (2013)

    2013  

    Abstract: Abstract Background Despite progress in translational research, we are still falling short in developing the innovative medicines required to address major public health needs. Furthermore, the failure rate, time, and cost required for registration of a ... ...

    Abstract Abstract Background Despite progress in translational research, we are still falling short in developing the innovative medicines required to address major public health needs. Furthermore, the failure rate, time, and cost required for registration of a new drug are pushing the economics of the industry to the breaking point. New models of drug development based on collaborative endeavours are badly needed to improve this dire situation. Findings In 2004, the US Food and Drug Administration (FDA) introduced the Critical Path Initiative with the intent of modernizing drug development by implementing public‐private partnerships (PPP) to share data, expertise, and resources. In response to FDA's initiative, in the following year the non‐profit Critical Path Institute (C‐Path) was formed. At the same time, the National Institutes of Health (NIH) Public‐Private Partnership program was established. In Europe, the Innovative Medicines Initiative (IMI) supported jointly by the European Union and the European Federation of Pharmaceutical Industries and Associations was launched in 2008. These independent efforts have a common long‐term objective, namely to facilitate the emergence of innovative medicines by developing new tools for drug discovery, new indicators for drug efficacy or safety, and new approaches for patient stratification. Herein, we present evidence that PPP already exert a positive impact on the drug development process. Conclusions Public‐private partnerships represent attractive means to leverage resources dispersed across industry, academia, and voluntary health organizations in order to address multiple challenges of drug development in an era of constrained resources and increased regulatory pressure.
    Keywords Drug development ; Drug efficacy ; Drug safety ; Pre‐competitive research ; Knowledge management ; Public‐private partnership ; Medicine (General) ; R5-920
    Subject code 360
    Language English
    Publishing date 2013-12-01T00:00:00Z
    Publisher Wiley
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: Online Information of Vaccines

    Pietro Ghezzi / Peter G. Bannister / Gonzalo Casino / Alessia Catalani / Michel Goldman / Jessica Morley / Marie Neunez / Andreu Prados-Bo / Pierre R. Smeesters / Mariarosaria Taddeo / Tania Vanzolini / Luciano Floridi

    Frontiers in Medicine, Vol

    Information Quality, Not Only Privacy, Is an Ethical Responsibility of Search Engines

    2020  Volume 7

    Abstract: The fact that Internet companies may record our personal data and track our online behavior for commercial or political purpose has emphasized aspects related to online privacy. This has also led to the development of search engines that promise no ... ...

    Abstract The fact that Internet companies may record our personal data and track our online behavior for commercial or political purpose has emphasized aspects related to online privacy. This has also led to the development of search engines that promise no tracking and privacy. Search engines also have a major role in spreading low-quality health information such as that of anti-vaccine websites. This study investigates the relationship between search engines' approach to privacy and the scientific quality of the information they return. We analyzed the first 30 webpages returned searching “vaccines autism” in English, Spanish, Italian, and French. The results show that not only “alternative” search engines (Duckduckgo, Ecosia, Qwant, Swisscows, and Mojeek) but also other commercial engines (Bing, Yahoo) often return more anti-vaccine pages (10–53%) than Google.com (0%). Some localized versions of Google, however, returned more anti-vaccine webpages (up to 10%) than Google.com. Health information returned by search engines has an impact on public health and, specifically, in the acceptance of vaccines. The issue of information quality when seeking information for making health-related decisions also impact the ethical aspect represented by the right to an informed consent. Our study suggests that designing a search engine that is privacy savvy and avoids issues with filter bubbles that can result from user-tracking is necessary but insufficient; instead, mechanisms should be developed to test search engines from the perspective of information quality (particularly for health-related webpages) before they can be deemed trustworthy providers of public health information.
    Keywords search engines ; vaccines ; health information ; information quality ; privacy ; misinformation ; Medicine (General) ; R5-920
    Subject code 303
    Language English
    Publishing date 2020-08-01T00:00:00Z
    Publisher Frontiers Media S.A.
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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