{"id":24677,"date":"2022-01-30T15:05:45","date_gmt":"2022-01-30T15:05:45","guid":{"rendered":"https:\/\/evaggelatos.com\/?p=24677"},"modified":"2022-01-30T15:05:45","modified_gmt":"2022-01-30T15:05:45","slug":"%ce%bf-reiner-fulmich-%ce%ad%cf%87%ce%b5%ce%b9-%ce%b4%ce%af%ce%ba%ce%b9%ce%bf-%ce%bf%cf%8d%cf%84%ce%b5-%cf%83%cf%84%ce%bf-fda-%ce%bf%cf%8d%cf%84%ce%b5-%cf%83%cf%84%ce%bf%ce%bd-who-%cf%80%ce%bf%ce%bb","status":"publish","type":"post","link":"https:\/\/evaggelatos.com\/?p=24677","title":{"rendered":"\u039f Reiner Fulmich \u03ad\u03c7\u03b5\u03b9 \u03b4\u03af\u03ba\u03b9\u03bf \u03bf\u03cd\u03c4\u03b5 \u03c3\u03c4\u03bf FDA,  \u03bf\u03cd\u03c4\u03b5 \u03c3\u03c4\u03bf\u03bd WHO \u03c0\u03bf\u03bb\u03cd \u03c0\u03b5\u03c1\u03b9\u03c3\u03c3\u03cc\u03c4\u03b5\u03c1\u03bf \u03bf\u03cd\u03c4\u03b5 \u03c3\u03c4\u03b7 Pfizer \u03ba\u03b1\u03b9 \u03c4\u03b1 \u03b3\u03b5\u03bd\u03b5\u03c4\u03b9\u03ba\u03ac \u03c4\u03b7 \u03c3\u03ba\u03b5\u03c5\u03ac\u03c3\u03bc\u03b1\u03c4\u03b1 \u03bc\u03c0\u03bf\u03c1\u03b5\u03af\u03c2 \u03bd\u03b1 \u03ad\u03c7\u03b5\u03b9\u03c2 \u03b5\u03bc\u03c0\u03b9\u03c3\u03c4\u03bf\u03c3\u03cd\u03bd\u03b7. \u03c4\u03b1 \u03c0\u03ac\u03bd\u03c4\u03b1 \u03be\u03b5\u03c0\u03bf\u03c5\u03bb\u03ae\u03b8\u03b7\u03ba\u03b1\u03bd \u03c3\u03c4\u03bf \u0394\u03b9\u03b5\u03c5\u03b8\u03c5\u03bd\u03c4\u03ae\u03c1\u03b9\u03bf \u03c4\u03b7\u03c2 \u03c0\u03b1\u03b3\u03ba\u03bf\u03c3\u03bc\u03b9\u03bf\u03c0\u03bf\u03af\u03b7\u03c3\u03b7\u03c2."},"content":{"rendered":"<div class=\"hero\">\n<div class=\"panel-pane pane-highwire-article-citation\">\n<div class=\"pane-content\">\n<div id=\"node1057575\" class=\"highwire-article-citation highwire-citation-type-highwire-article\" data-node-nid=\"1057575\" data-pisa=\"bmj;375\/nov02_8\/n2635\" data-pisa-master=\"bmj;bmj.n2635\" data-apath=\"\/bmj\/375\/bmj.n2635.atom\">\n<h1 id=\"page-title\" class=\"highwire-cite-title\">Covid-19: Researcher blows the whistle on data integrity issues in Pfizer\u2019s vaccine trial<\/h1>\n<p><cite class=\"highwire-cite highwire-citation-bmj-article-top\"><span class=\"highwire-cite-journal\">BMJ<\/span> <span class=\"highwire-cite-published-year\">2021<\/span>; <span class=\"highwire-cite-volume-issue\">375<\/span> <span class=\"highwire-cite-doi\"> doi: <a href=\"https:\/\/doi.org\/10.1136\/bmj.n2635\">https:\/\/doi.org\/10.1136\/bmj.n2635<\/a><\/span> <span class=\"highwire-cite-date\">(Published 02 November 2021)<\/span> <span class=\"highwire-cite-article-as\"> Cite this as: <span class=\"italic\">BMJ<\/span> 2021;375:n2635 <\/span> <\/cite><\/p>\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"row\">\n<div class=\"left-content col-xs-12 col-sm-8 col-md-8 col-lg-8\">\n<article>\n<div class=\"panel-pane pane-custom pane-1\">\n<div class=\"pane-content\">\n<div class=\"non-ajax-article-tabs\">\n<ul class=\"nav nav-tabs inline\">\n<li class=\"active\"><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"panel-separator\"><\/div>\n<div class=\"panel-pane pane-node\">\n<div class=\"pane-content\">\n<div class=\"node node-highwire-comment node-promoted clearfix\">\n<div class=\"row rr-header\">\n<div class=\"rr-left-column\">\n<h2>Rapid Response:<\/h2>\n<h3>Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer\u2019s vaccine trial<\/h3>\n<div class=\"response-title\">\n<h3><\/h3>\n<\/div>\n<div class=\"content\">\n<div class=\"response-body\">\n<p><span style=\"font-size: 18pt;\">Responses to BMJ investigation<\/span><\/p>\n<p><span style=\"font-size: 18pt;\">In September, Brook Jackson contacted The BMJ about problems she had encountered while employed at Ventavia Research Group. The BMJ commissioned freelance investigative reporter Paul Thacker to write up the story. The resulting article [1] was subject to The BMJ\u2019s usual high level editorial oversight and review. After publication, The BMJ wrote to Ventavia, Pfizer and the U.S. Food and Drug Administration (FDA) to better clarify the scope and implications of the problems identified at Ventavia, as well as what corrective measures were taken.<\/span><\/p>\n<p><span style=\"font-size: 18pt;\">To date, Ventavia has not responded to The BMJ\u2019s repeated requests for information. However, in statements to other media outlets, <strong>Ventavia has claimed that its former employee Jackson did not work on Pfizer\u2019s covid-19 vaccine clinical trial.<\/strong> <strong>This claim is not true. Jackson has contacted media organisations that have published these false allegations, sharing documentation that shows her work on the trial, and asking for corrections.<\/strong> At the time of writing, MedPage Today has updated its article.[2]<\/span><\/p>\n<p><span style=\"font-size: 18pt;\">During the course of this investigation, Jackson has provided The BMJ with dozens of documents, photos, audio recordings, and emails. These include evidence of her involvement in the clinical trial, and communications in which senior Ventavia employees discuss concerns that the FDA might show up at their clinical sites. These records were reviewed by The BMJ\u2019s editors, and the story was externally peer reviewed before publication.<\/span><\/p>\n<p><span style=\"font-size: 18pt;\">At the time of Jackson\u2019s complaint to the FDA, Ventavia had already enrolled more than 1000 participants across its three clinical trial sites and was still actively enrolling participants. Among the full trial\u2019s 44,000 participants, the total number recruited by Ventavia is still unknown. Another former Ventavia employee has told The BMJ that Ventavia ultimately recruited many more participants to Pfizer\u2019s clinical trial than those reported to the FDA by Jackson. However, <strong>neither Pfizer nor Ventavia will respond to questions from The BMJ to help clarify this matter.<\/strong><\/span><\/p>\n<p><span style=\"font-size: 18pt;\">Pfizer responded to The BMJ stating that it had received an anonymous complaint about Ventavia in September 2020. \u201cActions were taken to correct and remediate where necessary. <strong>Pfizer\u2019s investigation did not identify any issues or concerns that would invalidate the data or jeopardize the integrity of the study.\u201d<\/strong><\/span><\/p>\n<p><span style=\"font-size: 18pt;\">Pfizer added that the FDA and the study\u2019s Institutional Review Board (IRB) were \u201cproactively notified.\u201d Pfizer did not clarify whether it was Pfizer or Ventavia that notified the FDA and the IRB.<\/span><\/p>\n<p><span style=\"font-size: 18pt;\">Pfizer did not respond to our question of whether the data from the Ventavia sites were incorporated into the trial\u2019s safety and efficacy analyses.<\/span><\/p>\n<p><span style=\"font-size: 18pt;\"><strong>The BMJ also posed several questions to the FDA including why it had failed to inspect any of Ventavia\u2019s sites following Jackson\u2019s report, and whether the agency had received other complaints about the conduct of the Pfizer trial.<\/strong> An FDA spokesperson responded that the agency cannot comment further on this as it is an ongoing matter. <strong>\u201cFDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval.\u201d (\u03a3.\u03b3.: \u0391\u03bd \u03b8\u03ad\u03bb\u03bf\u03c5\u03bc\u03b5 \u03c3\u03b5 \u03c0\u03b9\u03c3\u03b5\u03cd\u03bf\u03c5\u03bc\u03b5 FDA).<br \/>\n<\/strong><\/span><\/p>\n<p><span style=\"font-size: 18pt;\">References<\/span><br \/>\n<span style=\"font-size: 18pt;\">[1] <a href=\"https:\/\/www.bmj.com\/content\/375\/bmj.n2635\">https:\/\/www.bmj.com\/content\/375\/bmj.n2635<\/a><\/span><br \/>\n<span style=\"font-size: 18pt;\">[2] <a href=\"https:\/\/www.medpagetoday.com\/special-reports\/exclusives\/95484\">https:\/\/www.medpagetoday.com\/special-reports\/exclusives\/95484<\/a><\/span><\/p>\n<\/div>\n<div class=\"response-competing\">\n<p><span style=\"font-size: 18pt;\"><strong>Competing interests: <\/strong> No competing<\/span> interests<\/p>\n<p><span style=\"font-size: 18pt;\"><strong>Source:https:\/\/www.bmj.com\/content\/375\/bmj.n2635\/rr-41<\/strong><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/article>\n<\/div>\n<p><span style=\"font-size: 18pt;\"><strong>\u00a0<\/strong><\/span><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Covid-19: Researcher blows the whistle on data integrity issues in Pfizer\u2019s vaccine trial BMJ 2021; 375 doi: https:\/\/doi.org\/10.1136\/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635 Rapid Response: Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer\u2019s vaccine trial Responses to BMJ investigation In September, Brook Jackson contacted The BMJ about &hellip; <\/p>\n<p><a class=\"more-link btn\" href=\"https:\/\/evaggelatos.com\/?p=24677\">\u03a3\u03c5\u03bd\u03ad\u03c7\u03b5\u03b9\u03b1 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[85,10],"tags":[90],"class_list":["post-24677","post","type-post","status-publish","format-standard","hentry","category-85","category-10","tag-90","item-wrap"],"_links":{"self":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/24677","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=24677"}],"version-history":[{"count":1,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/24677\/revisions"}],"predecessor-version":[{"id":24678,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/24677\/revisions\/24678"}],"wp:attachment":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=24677"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=24677"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=24677"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}