{"id":62944,"date":"2022-02-02T04:03:17","date_gmt":"2022-02-02T04:03:17","guid":{"rendered":"http:\/\/www.mixedracestudies.org\/?p=62944"},"modified":"2022-02-02T04:03:18","modified_gmt":"2022-02-02T04:03:18","slug":"is-there-evidence-for-the-racialization-of-pharmaceutical-regulation-systematic-comparison-of-new-drugs-approved-over-five-years-in-the-usa-and-the-eu","status":"publish","type":"post","link":"https:\/\/mixedracestudies.org\/wp\/?p=62944","title":{"rendered":"Is there evidence for the racialization of pharmaceutical regulation? Systematic comparison of new drugs approved over five years in the USA and the EU"},"content":{"rendered":"<p><a href=\"https:\/\/doi.org\/10.1016\/j.socscimed.2021.114049\" target=\"_blank\" rel=\"noopener\"><em><strong>Is there evidence for the racialization of pharmaceutical regulation? Systematic comparison of new drugs approved over five years in the USA and the EU<\/strong><\/em><\/a><\/p>\n<p><a href=\"https:\/\/www.sciencedirect.com\/journal\/social-science-and-medicine\" target=\"_blank\" rel=\"noopener\">Social Science &amp; Medicine<\/a><br \/>\n<a href=\"https:\/\/www.sciencedirect.com\/science\/journal\/02779536\/280\/supp\/C\" target=\"_blank\" rel=\"noopener\">Volume 280, July 2021, 114049<\/a><br \/>\nDOI: <a href=\"https:\/\/doi.org\/10.1016\/j.socscimed.2021.114049\" target=\"_blank\" rel=\"noopener\">10.1016\/j.socscimed.2021.114049<\/a><\/p>\n<p><strong><a href=\"https:\/\/www.soc.lu.se\/en\/shai-mulinari\" target=\"_blank\" rel=\"noopener\">Shai Mulinari<\/a><\/strong>, Senior Lecturer<br \/>\nDepartment of Sociology, Faculty of Social Sciences<br \/>\n<em>Lund University, Sweden<\/em><\/p>\n<p><a href=\"https:\/\/portal.research.lu.se\/en\/persons\/andreas-vilhelmsson\" target=\"_blank\" rel=\"noopener\"><strong>Andreas Vilhelmsson<\/strong><\/a>, Associate Researcher<br \/>\nDivision of Social Medicine and Global Health, Department of Clinical Sciences Malm\u00f6<br \/>\n<em>Lund University, Malm\u00f6, Sweden<\/em><\/p>\n<p><strong><a href=\"https:\/\/researchportal.bath.ac.uk\/en\/persons\/piotr-ozieranski\" target=\"_blank\" rel=\"noopener\">Piotr Ozieranski<\/a><\/strong>, Senior Lecturer<br \/>\nDepartment of Social and Policy Sciences<br \/>\n<em>University of Bath, Bath, United Kingdom<\/em><\/p>\n<p><a href=\"https:\/\/liu.se\/en\/employee\/annbr25\" target=\"_blank\" rel=\"noopener\"><strong>Anna Bredstr\u00f6m<\/strong><\/a>, Senior Lecturer, Docent; Associate Professor of Ethnicity and Migration<br \/>\n<em>Institute for Research on Migration, Ethnicity and Society (REMESO)<\/em><br \/>\n<em>Link\u00f6ping University, Sweden<\/em><\/p>\n<p><a href=\"https:\/\/doi.org\/10.1016\/j.socscimed.2021.114049\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/ars.els-cdn.com\/content\/image\/1-s2.0-S0277953621X00111-cov200h.gif\" width=\"200\" border=\"0\" \/><\/a><\/p>\n<p><strong>Highlights<\/strong><\/p>\n<ul>\n<li>We compare race\/ethnicity labeling of hundreds of new drugs in the <a href=\"https:\/\/en.wikipedia.org\/wiki\/United_States\" target=\"_blank\" rel=\"noopener\">USA<\/a> and the <a href=\"https:\/\/en.wikipedia.org\/wiki\/European_Union\" target=\"_blank\" rel=\"noopener\">EU<\/a>.<\/li>\n<li>Many labels report race\/ethnicity demographics of trials, more often in the USA.<\/li>\n<li>Fewer labels report race\/ethnicity differences in response, more often in the EU.<\/li>\n<li>Racial\/ethnic taxonomy used in labels is variable and inconsistent.<\/li>\n<li>The racialization of pharmaceutical regulation differs between the USA and the EU.<\/li>\n<\/ul>\n<p>Recent decades have seen much interest in racial and ethnic differences in drug response. The most emblematic example is the heart drug <a href=\"https:\/\/www.sciencedirect.com\/topics\/medicine-and-dentistry\/hydralazine-plus-isosorbide-dinitrate\" target=\"_blank\" rel=\"noopener\">BiDil<\/a>, approved by the <a href=\"https:\/\/en.wikipedia.org\/wiki\/Food_and_Drug_Administration\" target=\"_blank\" rel=\"noopener\">US Food and Drug Administration<\/a> in 2005 for \u201cself-identified blacks.\u201d Previous social science research has explored this \u201cracialization of pharmaceutical regulation\u201d in the <a href=\"https:\/\/en.wikipedia.org\/wiki\/United_States\" target=\"_blank\" rel=\"noopener\">USA<\/a>, and discussed its implications for the \u201cpharmaceuticalization of race\u201d in terms of reinforcing certain taxonomic schemes and conceptualizations. Yet, little is known about the racialization of <a href=\"https:\/\/www.sciencedirect.com\/topics\/medicine-and-dentistry\/pharmaceuticals-regulation\" target=\"_blank\" rel=\"noopener\">pharmaceutical regulation<\/a> in the USA after BiDil, and how it compares with the situation in the <a href=\"https:\/\/en.wikipedia.org\/wiki\/European_Union\" target=\"_blank\" rel=\"noopener\">EU<\/a>, where political and regulatory commitment to race and ethnicity in <a href=\"https:\/\/www.sciencedirect.com\/topics\/medicine-and-dentistry\/pharmaceutical-medicine\" target=\"_blank\" rel=\"noopener\">pharmaceutical medicine<\/a> is weak. We have addressed these gaps by investigating 397 product labels of all novel drugs approved in the USA (<em>n<\/em> = 213) and the EU (<em>n<\/em> = 184) between 2014 and 2018. Our analysis considered statements in labeling and the racial\/ethnic categories used. Overall, it revealed that many labels report race\/ethnicity demographics and subgroup analyses, but that there are important differences between the USA and the EU. Significantly more US labels specified race\/ethnicity demographics, as expected given the USA&#8217;s greater commitment to race and ethnicity in pharmaceutical medicine. Moreover, we found evidence that reporting of race\/ethnicity demographics in EU labels was driven, in part, by statements in US labels, suggesting the spillover of US regulatory standards to the EU. Unexpectedly, significantly more EU labels reported differences in drug response, although no drug was restricted to a racial\/ethnic population in a manner similar to BiDil. Our analysis also noted variability and inconsistency in the racial\/ethnic taxonomy used in labels. We discuss implications for the racialization of pharmaceutical regulation and the pharmaceuticalization of race in the USA and EU.<\/p>\n<p>Read the entire article in <a href=\"https:\/\/doi.org\/10.1016\/j.socscimed.2021.114049\" target=\"_blank\" rel=\"noopener\">HTML<\/a> or <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0277953621003816\/pdfft?md5=faa404129482a059bd4f8b8db763f399&amp;pid=1-s2.0-S0277953621003816-main.pdf\" target=\"_blank\" rel=\"noopener\">PDF<\/a> format.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>We discuss implications for the racialization of pharmaceutical regulation and the pharmaceuticalization of race in the USA and EU.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12,28,2039,8,20],"tags":[32891,32893,2771,21905,32894,32892,31716,32890,3743],"class_list":["post-62944","post","type-post","status-publish","format-standard","hentry","category-articles","category-europe","category-health-medicine","category-media-archive","category-usa","tag-andreas-vilhelmsson","tag-anna-bredstrom","tag-bidil","tag-european-union","tag-isosorbide-dinitrate-hydralazine","tag-piotr-ozieranski","tag-race-based-medicine","tag-shai-mulinari","tag-social-science-medicine"],"_links":{"self":[{"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=\/wp\/v2\/posts\/62944","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=62944"}],"version-history":[{"count":1,"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=\/wp\/v2\/posts\/62944\/revisions"}],"predecessor-version":[{"id":62945,"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=\/wp\/v2\/posts\/62944\/revisions\/62945"}],"wp:attachment":[{"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=62944"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=62944"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mixedracestudies.org\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=62944"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}