{"id":1442,"date":"2010-02-20T18:41:43","date_gmt":"2010-02-20T23:41:43","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/senators-and-fda-officials-attack-avandia\/"},"modified":"2011-07-19T17:45:03","modified_gmt":"2011-07-19T21:45:03","slug":"senators-and-fda-officials-attack-avandia","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/02\/20\/senators-and-fda-officials-attack-avandia\/","title":{"rendered":"Senators and FDA Officials Attack Avandia"},"content":{"rendered":"<p><a href=\"http:\/\/www.nytimes.com\/2010\/02\/20\/health\/policy\/20avandia.html?pagewanted=1&amp;hp\">A front page story in the <em>New York Times<\/em><\/a> reports that U.S. Senators and FDA officials are raising new questions about Avandia (rosiglitazone). A soon-to-be-released Senate report asks whether it is ethical to continue the ongoing 16,000 patient TIDE trial, while several FDA officials recommend that the drug should be removed from the market.<\/p>\n<p>In response to the <em>Times<\/em>&nbsp;story, the US Senate posted <a href=\"http:\/\/finance.senate.gov\/press\/Gpress\/2010\/prg022010a.pdf\">the full 334 page staff report<\/a> and an accompanying (and much shorter) <a href=\"http:\/\/finance.senate.gov\/press\/Gpress\/2010\/prg022010.pdf\">press release<\/a>. GlaxoSmithKline, the manufacturer of Avandia, rejected the attacks and issued its own <a href=\"http:\/\/us.gsk.com\/html\/media-news\/pressreleases\/2010\/2010_us_pressrelease_10016.htm\">press release<\/a>.<\/p>\n<p>(See the <a href=\"http:\/\/content.nejm.org\/cgi\/content\/short\/357\/1\/28\">RECORD interim analysis<\/a> on cardiovascular risk with rosiglitazone in NEJM from 2007, a <a href=\"http:\/\/content.nejm.org\/cgi\/content\/short\/356\/24\/2457\">related meta-analysis<\/a> by Nissen and Wolski, and this <a href=\"http:\/\/general-medicine.jwatch.org\/cgi\/content\/full\/2007\/1228\/4\">summary of the research<\/a> from Journal Watch General Medicine.)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A front page story in the New York Times reports that U.S. Senators and FDA officials are raising new questions about Avandia (rosiglitazone). A soon-to-be-released Senate report asks whether it is ethical to continue the ongoing 16,000 patient TIDE trial, while several FDA officials recommend that the drug should be removed from the market. In [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1442","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1442","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=1442"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1442\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=1442"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=1442"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=1442"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}