{"id":36931,"date":"2013-05-31T13:00:10","date_gmt":"2013-05-31T17:00:10","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=36931"},"modified":"2013-05-31T13:00:10","modified_gmt":"2013-05-31T17:00:10","slug":"two-fda-officials-quarrel-over-safety-of-angiotensin-receptor-blockers","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/05\/31\/two-fda-officials-quarrel-over-safety-of-angiotensin-receptor-blockers\/","title":{"rendered":"Two FDA Officials Quarrel Over Safety of Angiotensin-Receptor Blockers"},"content":{"rendered":"<p>Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to\u00a0<a href=\"http:\/\/online.wsj.com\/article\/SB10001424127887324682204578515172395384146.html?mod=WSJ_hps_LEFTTopStories\">a story by Thomas Burton in Friday&#8217;s\u00a0<em>Wall Street Journal<\/em>.<\/a><\/p>\n<p>One official, Thomas Marciniak, contends that ARBs may increase the risk for cancer. Marciniak has been a vocal critic of FDA&#8217;s efforts to assess drug \u00a0safety. In the past he has raised questions about other major drugs, including prasugrel, rosiglitazone, and rivaroxaban.\u00a0But Marciniak&#8217;s boss,\u00a0Ellis Unger, who is the acting director of the office of new drugs, told the\u00a0<em>WSJ\u00a0\u00a0<\/em>that Marciniak&#8217;s concerns are a &#8220;diversion.&#8221;<\/p>\n<p>In 2010 the FDA\u00a0<a href=\"http:\/\/cardiobrief.org\/2010\/07\/15\/fda-announces-safety-review-of-arbs-and-cancer\/\">announced<\/a>\u00a0it was reviewing the safety of ARBs following a study that raised the possibility that the popular drugs might cause a small but significant increase in the risk for cancer. One year later the FDA\u00a0<a href=\"http:\/\/cardiobrief.org\/2011\/06\/02\/fda-arbs-dont-increase-risk-of-cancer\/\">said<\/a>\u00a0that it had concluded its review and found no evidence of an increased risk for cancer.\u00a0&#8220;We have no reason to tell the public anything new,&#8221; Unger told the\u00a0<em>WSJ<\/em>.<\/p>\n<p>Burton reports:<\/p>\n<blockquote><p>In a rare rebellion by an FDA reviewer, Dr. Marciniak has clashed with his bosses over his desire to spend time on\u00a0ARB\u00a0safety, instead of just on new-drug applications.<\/p><\/blockquote>\n<p>Marciniak claims that the FDA review was not sufficiently rigorous because it relied on summary data provided by drug companies. On his own initiative, Marciniak analyzed patient-level data and concluded that ARBs were associated with a 24% increase in the risk for lung cancer. Marciniak, \u00a0reports Burton, &#8220;sent a memo to senior FDA officials, saying: &#8216;The FDA needs to inform patients and physicians about the\u00a0ARB\u00a0lung-cancer risks. The FDA must act now.'&#8221;<\/p>\n<p>But Unger disagreed with Marciniak&#8217;s analysis and told Burton that it was not reliable. Burton reports that Unger discouraged Marciniak from working on the topic, but Marciniak refused to discontinue his investigation.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to\u00a0a story by Thomas Burton in Friday&#8217;s\u00a0Wall Street Journal. One official, Thomas Marciniak, contends that ARBs may increase the risk for cancer. Marciniak has been a vocal critic of FDA&#8217;s efforts to assess drug \u00a0safety. In [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[647,1520,196],"class_list":["post-36931","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-arbs","tag-cancer-risk","tag-fda"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/36931","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=36931"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/36931\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=36931"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=36931"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=36931"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}