{"id":6901,"date":"2010-02-08T17:18:00","date_gmt":"2010-02-08T17:18:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/fda-blasts-lillys-pah-ecommunity-videos\/"},"modified":"2019-02-21T01:22:08","modified_gmt":"2019-02-21T01:22:08","slug":"fda-blasts-lillys-pah-ecommunity-videos","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-blasts-lillys-pah-ecommunity-videos\/","title":{"rendered":"FDA Blasts Lilly&#8217;s PAH eCommunity Videos!"},"content":{"rendered":"<p>In a Notice of Violation letter to Lilly (<a href=\"http:\/\/www.forums.pharma-mkting.com\/showthread.php?p=25084#post25084\">see here<\/a>), FDA cited two videos supposedly submitted by patients who take ADCIRCA, Lilly&#8217;s drug approved for the treatment of Pulmonary Arterial Hypertension (PAH).<\/p>\n<p>The patient videos present statements made by Adcirca users, \u201cTraci\u201d and \u201cCarolyn&#8221; who make the following claims among others:<\/p>\n<ul>\n<li>\u201cI can walk, and stairs don\u2019t bother me [after Adcirca treatment] . . . . Bending over used to make me breathless, picking up my cat used to make me breathless and it doesn\u2019t affect me anymore.\u201d<\/li>\n<li>\u201cExercising and stairs and heat used to bother me and it didn\u2019t bother me anymore [after Adcirca treatment].\u201d<\/li>\n<li>&#8220;Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience,&#8221; said the FDA letter. <\/li>\n<li>\u201cI could walk a block without stopping and having to take a deep breath [after taking Adcirca]. I don\u2019t have to drag my oxygen tank with me as many places as I used to.\u201d<\/li>\n<li>\u201cI am exercising again . . . and I couldn\u2019t exercise [before Adcirca], now I am walking on the treadmill. You know and I am walking along the beach, slowly I am beginning to do a lot more of the exercising that I used to be able to do\u201d<\/li>\n<\/ul>\n<p>FDA said:<\/p>\n<p>First, \u201cTraci\u2019s\u201d and \u201cCarolyn\u2019s\u201d statements misleadingly imply that patients treated with Adcirca will greatly increase their walking time and distance (e.g., \u201cfrom . . . five minutes . . . to one hour,\u201d \u201cspending all night at the mall\u201d, \u201cnow I am walking on the treadmill,\u201d and \u201cwalking along the beach\u201d). These statements significantly exaggerate what was demonstrated in the clinical trials for Adcirca. As stated above, the placebo-adjusted mean change increase in 6-MWD was 33 meters. Thus, there is only data to support that study subjects can increase their walking distance by 33 meters in six minutes.<\/p>\n<p>Does the FDA really believe that Traci and Carolyn are real patients? I don&#8217;t think so &#8212; FDA is careful to put their names in parantheses, ie, &#8220;Traci&#8221; and &#8220;Carolyn.&#8221; Maybe if Lilly and other drug companies used actual patient video testimonials, there would not be so many misleading statements.<\/p>\n<p>When you try to access the videos of the Adcirca Web site, this is what you get:<\/p>\n<div class=\"separator\" style=\"clear: both; text-align: center;\"><a href=\"http:\/\/2.bp.blogspot.com\/_ZiPiXEv_Q_g\/S3BFXIO7_ZI\/AAAAAAAAC2s\/r2NssgtBv9Q\/s1600-h\/AdcircaMsg.jpg\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"246\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2010\/02\/AdcircaMsg.jpg\" width=\"640\" \/><\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>In a Notice of Violation letter to Lilly (see here), FDA cited two videos supposedly submitted by patients who take ADCIRCA, Lilly&#8217;s drug approved for the treatment of Pulmonary Arterial Hypertension (PAH). The patient videos present statements made by Adcirca users, \u201cTraci\u201d and \u201cCarolyn&#8221; who make the following claims among others: \u201cI can walk, and [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":9767,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[304,878,385,167,70],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Blasts Lilly&#039;s PAH eCommunity Videos! - 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\/fda-blasts-lillys-pah-ecommunity-videos\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Blasts Lilly&#039;s PAH eCommunity Videos! - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"In a Notice of Violation letter to Lilly (see here), FDA cited two videos supposedly submitted by patients who take ADCIRCA, Lilly&#8217;s drug approved for the treatment of Pulmonary Arterial Hypertension (PAH). 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