{"id":1778,"date":"2016-10-26T00:58:39","date_gmt":"2016-10-26T00:58:39","guid":{"rendered":"http:\/\/orionhealth-blog.local\/?p=1778"},"modified":"2023-07-26T02:11:04","modified_gmt":"2023-07-26T02:11:04","slug":"precision-medicine-demands-permissionless-innovation","status":"publish","type":"post","link":"https:\/\/orionhealth.com\/us\/blog\/precision-medicine-demands-permissionless-innovation\/","title":{"rendered":"Precision Medicine Demands &#8220;Permissionless Innovation&#8221;"},"content":{"rendered":"<h6 class=\"wp-block-heading\">Paul Howard and Peter Huber argued in the fourth chapter of their new book, \u201c<a href=\"http:\/\/www.manhattan-institute.org\/unlocking-precision-medicine\">Unlocking Precision Medicine<\/a>,\u201d that to realise what the&nbsp;<a href=\"https:\/\/www.nih.gov\/precision-medicine-initiative-cohort-program\">National Institutes of Health<\/a>&nbsp;calls an \u201capproach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person,\u201d our society should rely on the tech sector\u2014not the&nbsp;<em>government<\/em>\u2014to spur precision-medicine innovations. The authors asserted that the \u201ctech industry\u2019s network of \u2018permissionless innovation\u2019 flourishes because its companies don\u2019t have to navigate dense webs of federal regulations before launching new products&#8230;\u201d <\/h6>\n\n\n\n<p class=\"wp-block-paragraph\">Howard and Huber claimed that the tech industry\u2019s drive for relentless productivity is the very force that keeps its thumb firmly pressed on the pulse of organisations and individuals alike, which makes iteratively customising and improving subsequent products and services possible.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Compare that to the costly, constrained, multi-year approval cycle of the U.S. Food and Drug Administration (FDA), which must give its okay before anyone outside of clinical trials can benefit from a given treatment.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cThere is very little in the way of rapid or real-time feedback loops in the (healthcare) industry\u2014even though the technology for it is available today,\u201d wrote the authors.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Shockingly, Howard and Huber suggested that most drugs might not actually be failing the FDA\u2019s tests, and that, rather, the&nbsp;<em>drug-testing protocol<\/em>&nbsp;that the FDA uses is probably faulty:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">These trial designs were first used in the 1930s, and are built on the assumption that patients with similar clinical symptoms are suffering from the same disease. But that\u2019s an assumption that has been disproven by modern science over the past few decades\u2014especially after the deciphering of the human genome in 2000.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The authors praised new technologies that have revealed that \u201cmany seemingly common disorders\u2014so defined by their apparent clinical symptoms\u2014are in fact clusters of biochemically different diseases (breast cancer, for instance, is a combination of at least nine different diseases).\u201d Further, Howard and Huber noted that \u201ctraditional symptom-based definitions of singular diseases are still used to frame most FDA-approved clinical trials, leading to the testing of one drug at a time in patients that are assumed to have the same condition.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The authors suggested that the answer to this mishandling of data is precision medicine, and that its success \u201chinges on two deeply intertwined strategies.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The first is targeting. The companies creating the drugs need to be empowered to \u201ctarget disease-propelling molecular factors (\u2018biomarkers\u2019) and pathways.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The second is identification. Doctors must have the ability to use key tests to:<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>Single out \u201cpatients in whom those factors or pathways are present\u201d&nbsp;<\/li><li>Quickly match those patients with the right drug<\/li><li>Follow up with those specific patients and adjust their treatments, if necessary<\/li><\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cLeft to expert physicians with access to large patient databases that allow them to share reliable information quickly,\u201d wrote Howard and Huber, \u201cthis feedback strategy can produce a rapid-learning health system that improves care based on what we learn from every patient\u2019s response to treatment.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Purchase the full book&nbsp;<a href=\"http:\/\/www.manhattan-institute.org\/unlocking-precision-medicine\">here<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Learn about the genomics-health IT gap for precision medicine: read the Chilmark report now!<\/em><\/strong><\/p>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link\" href=\"https:\/\/orionhealth.com\/us\/knowledge-hub\/reports\/bridging-the-genomics-health-it-gap-for-precision-medicine\/\">Go to Report<\/a><\/div>","protected":false},"excerpt":{"rendered":"<p>Paul Howard and Peter Huber argued in the fourth chapter of their new book, \u201cUnlocking Precision Medicine,\u201d that to realise what the&nbsp;National Institutes of Health&nbsp;calls an \u201capproach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person,\u201d our society should rely on the tech sector\u2014not the&nbsp;government\u2014to [&hellip;]<\/p>\n","protected":false},"author":35,"featured_media":1122,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[1],"tags":[],"region":[28],"class_list":["post-1778","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","region-us"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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