{"id":6061,"date":"2014-03-07T12:33:00","date_gmt":"2014-03-07T12:33:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/fdas-crimean-referendum-putsched-aveed\/"},"modified":"2019-02-21T01:16:48","modified_gmt":"2019-02-21T01:16:48","slug":"fdas-crimean-referendum-putsched-aveed","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-crimean-referendum-putsched-aveed\/","title":{"rendered":"FDA&#8217;s &#8220;Crimean Referendum&#8221; Putsched Aveed Through the Approval Process"},"content":{"rendered":"<p>The FDA recently approved Endo Pharmaceuticals&#8217; testosterone replacement therapy drug Aveed (testosterone undecanoate), &#8220;ignoring a petition submitted last week by a consumer group that claimed the agency should first conclude a safety review of alternative products,&#8221; reports Alexander Gaffney (&#8220;<a href=\"http:\/\/forums.pharma-mkting.com\/showthread.php?t=90872\">Endo&#8217;s Aveed Approved by FDA, Drawing Anger from Consumer Group<\/a>&#8220;).<\/p>\n<p>The approval &#8220;will likely greatly expand the use of testosterone, now found to increase the risk of heart attacks and other cardiovascular diseases,&#8221; wrote Sidney Wolfe, founder of Public Citizen&#8217;s Health Research Group (see &#8220;<a href=\"http:\/\/www.citizen.org\/hrg2189\">Letter to the FDA Protesting Aveed<\/a>&#8220;).<\/p>\n<p>&#8220;Public Citizen also raised the prospect that FDA&#8217;s approval of the drug, based in part on the findings of its advisory committee, might have reached a different conclusion had the advisory committee known about the potential cardiovascular risks associated with the drug.&#8221;<\/p>\n<p>&#8220;It is likely, if not certain, that the vote against safety would have been even greater had there been a presentation and discussion of the cardiovascular risks known at that time,&#8221; Wolfe wrote.<\/p>\n<p>You know what this reminds me of?<\/p>\n<p>It&#8217;s like Putin stacking the deck in the upcoming Crimean &#8220;referendum.&#8221; Here&#8217;s how a Soviet-era propagandist might depict the FDA Aveed advisory committee vote:<\/p>\n<p><a name='more'><\/a><\/p>\n<div class=\"separator\" style=\"clear: both; text-align: center;\">\n<a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2014\/03\/FDA-Aveed-Referendum.png\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2014\/03\/FDA-Aveed-Referendum.png\" height=\"223\" width=\"400\" \/><\/a><\/div>\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA recently approved Endo Pharmaceuticals&#8217; testosterone replacement therapy drug Aveed (testosterone undecanoate), &#8220;ignoring a petition submitted last week by a consumer group that claimed the agency should first conclude a safety review of alternative products,&#8221; reports Alexander Gaffney (&#8220;Endo&#8217;s Aveed Approved by FDA, Drawing Anger from Consumer Group&#8220;). The approval &#8220;will likely greatly expand [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11490,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[493,44,294,411,386],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA&#039;s &quot;Crimean Referendum&quot; Putsched Aveed Through the Approval Process - Pharma Marketing Network<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-crimean-referendum-putsched-aveed\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA&#039;s &quot;Crimean Referendum&quot; Putsched Aveed Through the Approval Process - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"The FDA recently approved Endo Pharmaceuticals&#8217; testosterone replacement therapy drug Aveed (testosterone undecanoate), &#8220;ignoring a petition submitted last week by a consumer group that claimed the agency should first conclude a safety review of alternative products,&#8221; reports Alexander Gaffney (&#8220;Endo&#8217;s Aveed Approved by FDA, Drawing Anger from Consumer Group&#8220;). 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