{"id":3292,"date":"2016-04-30T16:41:43","date_gmt":"2016-04-30T16:41:43","guid":{"rendered":"http:\/\/interactif.com\/enfold\/?p=3292"},"modified":"2022-05-03T18:26:07","modified_gmt":"2022-05-03T18:26:07","slug":"the-muscular-dystrophy-duchenne-community-meets-the-fda-1","status":"publish","type":"post","link":"https:\/\/laforcedmd.com\/en\/the-muscular-dystrophy-duchenne-community-meets-the-fda-1\/","title":{"rendered":"The Duchenne muscular dystrophy community meets the FDA &#8211; Part-1"},"content":{"rendered":"<p>On April 25, two representatives from the Force traveled to Washington, DC, to attend the <a href=\"http:\/\/www.fda.gov\/AdvisoryCommittees\/default.htm\" target=\"_blank\" rel=\"noopener noreferrer\">AdCom Conference of the Food &amp; Drug Administration (FDA)<\/a>, which focused on the approval of new treatments for DMD.<\/p>\n<p>The following is what they wanted to communicate to the DMD community on their return to the US capital.<\/p>\n<h3>\u00a0<em>\u201cFDA, please don\u2019t let me die early \u2026\u201d<\/em><\/h3>\n<p>This was the amazing conclusion of the advocacy speech by <strong>Billy Ellsworth, 15<\/strong>, who stood \u2013 in every sense of the term \u2013 in front of the United States Food &amp; Drug Administration (FDA) members who were present the event. At 15, he is still able to stand on two legs, which quite unusual given the course Duchenne muscular dystrophy (DMD) normally takes: this is because, for several years, Billy has benefited from <em><a href=\"https:\/\/en.wikipedia.org\/wiki\/Eteplirsen\" target=\"_blank\" rel=\"noopener noreferrer\">Eteplirsen<\/a>\u00a0<\/em>treatments.<\/p>\n<p>Out of the corner of my eye, I gaze at Marie-Catherine, my friend, and partner in <em>La Force<\/em> Foundation, and I wonder how she manages to hold out, listening to all those testimonials presented by children currently living with more advanced stages of dystrophy muscular dystrophy. Last year, we managed to obtain special access to another treatment, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Ataluren\" target=\"_blank\" rel=\"noopener noreferrer\"><em>Ataluren<\/em> (Translarna)<\/a> for her son Anakin; efforts have also benefited four other families in Canada; but now, just as with <em>Eteplirsen<\/em>, this medication is under threat of not being approved and may be lost, despite having shown immediate results (after 3 months) in Anakin\u2019s case.<\/p>\n<p>At the big Monday conference, it was as if the <em>Eteplirsen<\/em> treatment was being brought before the \u201cFDA court\u201d. In the morning, <a href=\"http:\/\/www.sarepta.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Sarepta<\/a>, the pharmaceutical company, was first filed its evidence, followed by the FDA, which made its argument using graphics and PowerPoint presentations galore; this was followed in the afternoon by 51 testimonies on the treatment of children, families, and researchers, who made their case in front of the committee that will subsequently be making recommendations to the FDA. The FDA will then debate the matter and decide whether or not to approve the treatment.<\/p>\n<h3>DOMINO EFFECT<\/h3>\n<p>In the world of rare diseases, it\u2019s virtually impossible to have access to the same kind of data as for diseases with a larger pool of patients. In the case of DMD, each child develops the disease at his own pace and each case is unique, so it\u2019s very difficult to measure the impact of treatment on a small group of patients. Each treatment in development can only apply to approximately 13% of a given population (in the United States, for example, this represents 15 000 afflicted children). When it comes to rare diseases, approval standards must be more flexible and progressive,<em> otherwise, it\u2019s virtually impossible to develop a treatment and hope to get approval<\/em>. Some scientists believe that a combination of treatments could well constitute a cure, <strong><em>but if no treatment is approved, it will discourage other biotechnology companies from developing other treatments<\/em><\/strong>, since these two can only handle one mutation and are bound to meet the same type of obstacle.<\/p>\n<p>You may be asking yourself what are the consequences of a positive or negative decision by the FDA for Canadians? You won\u2019t be surprised to hear that, historically, Health Canada\u2019s decisions have been influenced by those of our neighbors to the South.<\/p>\n<p>During the 11-hour conference, I often watched my friend Marie-Catherine with an anxious eye, knowing that it\u2019s extremely difficult for her to hear these testimonials and having to face a reality which is not yet hers since her son is only 8 years old.<\/p>\n<p>I look at all these people around the room \u2013 many of which are directing a foundation in addition to caring for their child (or children: some have three!\u2026) \u2013, and all I see is courage. Some of them, like Pat Furlong, founder of PPMD, is part of the first generation \u2013 their children died of Duchenne muscular dystrophy \u2013 but they continue the fight.<\/p>\n<p><strong>Personally, I can tell you that this long day forever changed my perception of life\u2019s problems. I feel sad for these parents, but I know will never really understand the pain they endure every day.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<h3>Read more<\/h3>\n<p><a href=\"http:\/\/www.forbes.com\/sites\/kenkam\/2016\/04\/29\/sarepta-fda-policy-forced-adcom-to-vote-against-patients-interests\/?utm_campaign=yahootix&amp;partner=yahootix#12c8e7de36ad\" target=\"_blank\" rel=\"noopener noreferrer\">Forbes Market<\/a>\u00a0 \u2013 \u00a0<a href=\"https:\/\/www.change.org\/p\/united-states-congress-the-fda-should-be-made-to-approve-eteplirsen-by-the-u-s-government?recruiter=533882114&amp;utm_source=share_petition&amp;utm_medium=facebook&amp;utm_campaign=share_page&amp;utm_term=mob-xs-share_petition-custom_msg&amp;fb_ref=Default\" target=\"_blank\" rel=\"noopener noreferrer\">Change.org (petition)<\/a> \u00a0\u2013 \u00a0<a href=\"http:\/\/www.bizjournals.com\/boston\/blog\/bioflash\/2016\/04\/fda-chief-lays-out-rationale-for-duchenne-drug-to.html\" target=\"_blank\" rel=\"noopener noreferrer\">Boston Business Journal\u00a0<\/a>\u00a0 \u2013 \u00a0<a href=\"http:\/\/www.cbsnews.com\/videos\/fda-panel-rejects-drug-that-could-combat-rare-terminal-illness\/\" target=\"_blank\" rel=\"noopener noreferrer\">CBS News<\/a><\/p>\n<p><a href=\"https:\/\/www.bostonglobe.com\/business\/2016\/04\/25\/fda-panel-weighs-sarepta-experimental-drug\/UlsqTHKthFw376EyF3PuYN\/story.html\" target=\"_blank\" rel=\"noopener noreferrer\">Boston Globe<\/a> \u00a0\u2013 \u00a0 <a href=\"https:\/\/www.statnews.com\/pharmalot\/2016\/04\/25\/fda-panel-sarepta-muscular-dystrophy\/\" target=\"_blank\" rel=\"noopener noreferrer\">Austin Leclaire<\/a>\u00a0 \u2013 \u00a0<a href=\"http:\/\/community.parentprojectmd.org\/profiles\/blogs\/the-eteplirsen-ad-comm-a-paradigm-shift\" target=\"_blank\" rel=\"noopener noreferrer\">PPMD<\/a> \u00a0\u2013 \u00a0\u00a0<a href=\"http:\/\/www.fda.gov\/AdvisoryCommittees\/default.htm\" target=\"_blank\" rel=\"noopener noreferrer\">FDA AD-COMM<\/a>\u00a0 \u2013 \u00a0<a href=\"http:\/\/hc-sc.gc.ca\/dhp-mps\/acces\/index-eng.php\" target=\"_blank\" rel=\"noopener noreferrer\">Health Canada PAS<\/a><\/p>\n<p><a href=\"http:\/\/jettfoundation.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">The Jett Foundation<\/a>\u00a0 \u00a0\u2013 \u00a0 <a href=\"http:\/\/www.parentprojectmd.org\/site\/PageServer?pagename=nws_index\" target=\"_blank\" rel=\"noopener noreferrer\">PPMD<\/a> \u00a0\u2013 \u00a0<a href=\"http:\/\/duchennealliance.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">Duchenne Alliance<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On April 25, two representatives from the Force traveled to Washington, DC, to attend the AdCom Conference of the Food &amp; Drug Administration (FDA), which focused on the approval of new treatments for DMD. The following is what they wanted to communicate to the DMD community on their return to the US capital. \u00a0\u201cFDA, please [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":3293,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12],"tags":[],"class_list":["post-3292","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The Duchenne muscular dystrophy community meets the FDA - Part-1 - La Force dmd<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/laforcedmd.com\/en\/the-muscular-dystrophy-duchenne-community-meets-the-fda-1\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Duchenne muscular dystrophy community meets the FDA - Part-1 - La Force dmd\" \/>\n<meta property=\"og:description\" content=\"On April 25, two representatives from the Force traveled to Washington, DC, to attend the AdCom Conference of the Food &amp; Drug Administration (FDA), which focused on the approval of new treatments for DMD. 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