{"id":8353,"date":"2018-06-20T12:29:35","date_gmt":"2018-06-20T12:29:35","guid":{"rendered":"https:\/\/www.denverpost.com?p=3088371&amp;preview_id=3088371"},"modified":"2018-06-20T12:29:35","modified_gmt":"2018-06-20T12:29:35","slug":"some-parents-fear-changes-to-state-laws-as-fda-weighs-use-of-cbd-pharmaceuticals","status":"publish","type":"post","link":"https:\/\/cannitrol.com\/blog\/some-parents-fear-changes-to-state-laws-as-fda-weighs-use-of-cbd-pharmaceuticals\/","title":{"rendered":"Some parents fear changes to state laws as FDA weighs use of CBD pharmaceuticals"},"content":{"rendered":"<div id=\"wp_fb_like_button\" style=\"margin:5px 0 5px 5px;float:right;height:100px;\"><script src=\"http:\/\/connect.facebook.net\/en_US\/all.js#xfbml=1\"><\/script><fb:like href=\"https:\/\/cannitrol.com\/blog\/some-parents-fear-changes-to-state-laws-as-fda-weighs-use-of-cbd-pharmaceuticals\/\" send=\"true\" layout=\"standard\" width=\"450\" show_faces=\"false\" font=\"arial\" action=\"like\" colorscheme=\"light\"><\/fb:like><\/div><div class=\"media_block\"><\/div>\n<div><img src=\"https:\/\/cannitrol.com\/blog\/\/wp-content\/uploads\/2018\/06\/some-parents-fear-changes-to-state-laws-as-fda-weighs-use-of-cbd-pharmaceuticals.jpg\" class=\"ff-og-image-inserted\" \/><\/div>\n<p>COLORADO SPRINGS \u2014 Some American parents who for years have used cannabis to treat severe forms of epilepsy in their children are feeling more cautious than celebratory as U.S. regulators near a decision on whether to approve the first drug derived from the marijuana plant.<\/p>\n<p>The U.S. Food and Drug Administration is expected to issue a decision by the end of the month on the drug Epidiolex, made by GW Pharmaceuticals. It\u2019s a purified form of cannabidiol \u2014 a component of cannabis that doesn\u2019t get users high \u2014 to treat Dravet and Lennox-Gastaut syndromes in kids. Both forms of epilepsy are rare.<\/p>\n<p>Cannabidiol\u2019s effect on a variety of health conditions is frequently touted, but there is still little evidence to back up advocates\u2019 personal experiences. The U.S. Drug Enforcement Administration has long categorized cannabis as a Schedule I drug, a category with \u201cno currently accepted medical use and a high potential for abuse.\u201d That strictly limits research on potential medical uses for cannabis or the chemicals in it, including cannabidiol, or CBD.<\/p>\n<p>But for years, parents desperate to find anything to help their children have turned to the marijuana-based products made legal by a growing number of states.<\/p>\n<p>Meagan Patrick is among the parents using CBD to treat symptoms in their children. She moved from Maine to Colorado in 2014 so she could legally get CBD for her now-5-year-old daughter, Addelyn, who was born with a brain malformation that causes seizures.<\/p>\n<p>\u201cMy child was dying, and we needed to do something,\u201d Patrick said.<\/p>\n<aside class=\"related right\" \/>\n<p>As for the potential approval of a pharmaceutical based on CBD, she said fear is her first reaction.<\/p>\n<p>\u201cI want to make sure that her right to continue using what works for her is protected, first and foremost. That\u2019s my job as her mom,\u201d Patrick said.<\/p>\n<p>Advocates like Patrick became particularly concerned when GW Pharmaceuticals\u2019 U.S. commercial business, Greenwich Biosciences, began quietly lobbying to change states\u2019 legal definition of marijuana, beginning in 2017 with proposals in Nebraska and South Dakota.<\/p>\n<p>Some worried the company\u2019s attempt to ensure its product could be legally prescribed and sold by pharmacies would have a side effect: curtailing medical marijuana programs already operating in more than two dozen states.<\/p>\n<p>The proposals generally sought to remove CBD from states\u2019 legal definition of marijuana, allowing it to be prescribed by doctors and supplied by pharmacies. But the change only applies to products that have FDA approval.<\/p>\n<p>Neither Nebraska nor South Dakota allows medical use of marijuana, and activists accused the company of trying to shut down future access to products containing cannabidiol but lacking FDA approval.<\/p>\n<p>Britain-based GW Pharmaceuticals never intended for the changes to affect other marijuana products, but they are necessary to allow Epidiolex to be sold in pharmacies if approved, spokesman Stephen Schultz said.<\/p>\n<p>He would not discuss other places where the company will seek changes to state law. The Associated Press confirmed that lobbyists representing Greenwich Biosciences backed legislation in California and Colorado this year.<\/p>\n<p>\u201cAs a company, we understand there\u2019s a significant business building up,\u201d Schultz said. \u201cAll we want to do is make sure our product is accessible.\u201d<\/p>\n<p>Industry lobbyists in those states said they take company officials at their word, but they still insisted on protective language ensuring that recreational or medical marijuana, cannabidiol, hemp and other products derived from cannabis plants won\u2019t be affected by the changes sought by GW Pharmaceuticals.<\/p>\n<p>Patrick Goggin, an attorney who focuses on industrial hemp issues in California, said the company would run into trouble if it tried to \u201clock up access\u201d to marijuana-derived products beyond FDA-approved drugs.<\/p>\n<p>\u201cPeople need to have options and choices,\u201d he said. \u201cThat\u2019s the battle here.\u201d<\/p>\n<p>Legal experts say the changes are logical. Some states\u2019 laws specifically prohibit any product derived from the marijuana plant from being sold in pharmacies. The FDA has approved synthetic versions of another cannabis ingredient for medical purposes but has never approved marijuana or hemp for any medical use.<\/p>\n<p>A panel of FDA advisers in April unanimously recommended the agency approve Epidiolex for the treatment of severe seizures in children with epilepsy, conditions that are otherwise difficult to treat. It\u2019s not clear why CBD reduces seizures in some patients, but the panel based its recommendation on three studies showing significant reduction in children with two forms of epilepsy.<\/p>\n<p>Denver-based attorney Christian Sederberg, who worked on the GW Pharmaceuticals-backed legislation in Colorado on behalf of the marijuana industry, said all forms of marijuana can exist together.<\/p>\n<p>\u201cThe future of the industry is showing itself here,\u201d Sederberg said. \u201cThere\u2019s going to be the pharmaceutical lane, the nutraceutical (food-as-medicine) lane, the adult-use lane. This shows how that\u2019s all coming together.\u201d<\/p>\n<p>Alex and Jenny Inman said they won\u2019t switch to Epidiolex if it becomes available, though their son Lukas has Lennox-Gastaut syndrome.<\/p>\n<p>Alex, an information technology professional, and Jenny, a preschool teacher, said it took some at-home experimentation to find the right combination of doctor-prescribed medication, CBD and THC \u2014 the component that gives marijuana users a high \u2014 that seemed to help Lukas with his seizures.<\/p>\n<p>\u201cWhat makes me a little bit nervous about this is that there\u2019s sort of a psyche amongst patients that, \u2018Here\u2019s this pill, and this pill will solve things,\u2019 right? It works differently for different people,\u201d Alex Inman said.<\/p>\n<p>The Inmans moved from Maryland to Colorado in 2015 after doctors recommended a second brain surgery for Lukas\u2019 seizures. The couple and other parents and advocates for CBD said children respond differently to a variety of strains.<\/p>\n<p>The Realm of Caring Foundation, an organization co-founded by Paige Figi, whose daughter Charlotte\u2019s name is attached to the CBD oil Charlotte\u2019s Web, said it maintains a registry of about 46,000 people worldwide who use CBD.<\/p>\n<p>For Heather Jackson, who said her son Zaki, now 15, benefited from CBD and who co-founded the foundation, Epidiolex\u2019s approval means insurers will begin paying for treatment with a cannabis-derived product.<\/p>\n<p>\u201cThat might be a nice option for some families who, you know, really want to receive a prescription who are going to only listen to the person in the white coat,\u201d Jackson said.<\/p>\n","protected":false},"excerpt":{"rendered":"<div class=\"media_block\"><\/div>\n<p>Some American parents who for years have used cannabis to treat severe forms of epilepsy in their children are feeling more cautious than celebratory as U.S. regulators near a decision on whether to approve the first drug derived from the marijuana plant. <\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[531,52,330,7153,7827,6892,6813,77,5667,56,9,6855,5019,441,1,3,18,61,1736],"tags":[3105,2632,2908,7155,7828,6893,6818,2655,5673,2636,6856,5022,3015,2622],"_links":{"self":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/8353"}],"collection":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/comments?post=8353"}],"version-history":[{"count":0,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/8353\/revisions"}],"wp:attachment":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/media?parent=8353"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/categories?post=8353"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/tags?post=8353"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}