{"id":7491,"date":"2017-06-21T16:59:30","date_gmt":"2017-06-21T16:59:30","guid":{"rendered":"http:\/\/www.denverpost.com\/?p=2691225"},"modified":"2017-06-21T16:59:30","modified_gmt":"2017-06-21T16:59:30","slug":"forbidden-medicine-caught-between-a-doctors-cbd-advice-and-federal-laws","status":"publish","type":"post","link":"https:\/\/cannitrol.com\/blog\/forbidden-medicine-caught-between-a-doctors-cbd-advice-and-federal-laws\/","title":{"rendered":"Forbidden medicine: Caught between a doctor\u2019s CBD advice and federal laws"},"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\/forbidden-medicine-caught-between-a-doctors-cbd-advice-and-federal-laws\/\" send=\"true\" layout=\"standard\" width=\"450\" show_faces=\"false\" font=\"arial\" action=\"like\" colorscheme=\"light\"><\/fb:like><\/div><div class=\"row\">\n<div class=\"large-10 large-centered small-12 columns\">\n<div class=\"entry-meta-date\">Published: Jun 20, 2017, 2:33 pm \u2022 Updated: Jun 20, 2017, 4:26 pm<span class=\"single-comments-link\"><a href=\"http:\/\/www.thecannabist.co\/2017\/06\/20\/cbd-medical-marijuana-new-york-cannabidiol-cbd-oil\/81926\/#disqus_thread\" class=\"commentsNameLink\" \/><\/span><\/div>\n<p class=\"byline\">By <span class=\"author\"><a class=\"url fn n\" href=\"http:\/\/www.thecannabist.co\/author\/awallace\/\" rel=\"author\">Alicia Wallace<\/a><\/span><em>, The Cannabist Staff<\/em><\/p>\n<p><em>Cannabidiol is a non-psychoactive cannabis compound touted for its medicinal promise\u2013but marijuana- and hemp-derived extracts rich in CBD and low in intoxicating THC are facing a future yet to be determined.<\/em><\/p>\n<p><em>The Cannabist\u2019s special report \u201cCBD, TBD\u201d explores a regulatory and legal landscape pockmarked by federal-state conflicts, national drug policy, pioneering research\u00a0efforts and disparate avenues toward the compound\u2019s full legalization. This is the first installment in an ongoing series.<\/em><\/p>\n<hr \/>\n<p>Seizures are a constant in Nancy Pasiecznik\u2019s life.<\/p>\n<p>In a typical month, they come by the dozen. In some months, they have come on the order of 100.<\/p>\n<p>Attempts to control the uncontrollable have been practically futile and, in some instances, nearly fatal for Pasiecznik, 59, who lives in a state-run facility in western New York.<\/p>\n<p>At one point, roughly five years back, the dosages on her medications were ratcheted up too high, hurtling her into a life-threatening, prolonged seizure.<\/p>\n<p>A different course of treatment had to be charted.<\/p>\n<p>Last October, her neurologist recommended that Nancy receive a daily half-milliliter dose of <a href=\"http:\/\/www.thecannabist.co\/2014\/02\/18\/charlottes-web-strain-aids-colorado-springs-kids-seizures-worries-doctors-children-medical\/4893\/\">Charlotte\u2019s Web<\/a>, a whole plant hemp extract oil <a href=\"http:\/\/www.thecannabist.co\/2016\/07\/22\/cw-hemp-boulder-cbd-extract\/59021\/\">formulated and developed by Colorado-based CW Hemp<\/a>. The oil is rich in cannabidiol (CBD), a non-psychoactive cannabis compound that has been highly touted for its potential medicinal benefits and attracted national attention for its claimed ability to reduce seizures for some patients.<\/p>\n<p>\u201c(Nancy) has been tried on multiple antiseizure medications without significant lasting improvement in her seizure control and\/or with intolerable side effects,\u201d Dr. Kenneth R. Murray, of the <a href=\"https:\/\/www.dentinstitute.com\/\" target=\"_blank\" rel=\"noopener\">Dent Neurologic Institute<\/a> in Buffalo, N.Y., wrote to the state of New York in a letter provided to The Cannabist. \u201cI feel it is imperative that she be afforded an opportunity for stabilization of her seizure disorder.\u201d<\/p>\n<p>But in the eyes of the federal government, CBD not only remains unproven, it\u2019s also an illicit cannabis derivative, creating a legal and ethical conundrum for doctors, patients and their families \u2014 even in states like New York that allow medical marijuana.<\/p>\n<p>To date, Nancy has yet to receive the recommended medicine.<\/p>\n<h3>Another treatment option from Colorado<\/h3>\n<p>Nancy has relied on a network of state and family support since age 18.<\/p>\n<p>Her developmental disabilities and epilepsy require her to be under constant care, and she resides at a state-run group home in Orchard Park under the purview of New York\u2019s Office for People With Developmental Disabilities.<\/p>\n<figure class=\"figure wp-caption aligncenter\"><img loading=\"lazy\" class=\"size-full wp-image-81667\" src=\"https:\/\/cannitrol.com\/blog\/\/wp-content\/uploads\/2017\/06\/forbidden-medicine-caught-between-a-doctors-cbd-advice-and-federal-laws.jpg\" alt=\"CBD status still TBD: Cannabist report\" width=\"1000\" height=\"632\" \/><figcaption class=\"wp-caption-text\">Nancy Pasiecznik is shown in a family photo circa 1972. Seizures have been a constant in Nancy\u2019s life. Now 59, she lives in a state-run group home in western New York. (Mike Roy, Special to The Denver Post)<\/figcaption><\/figure>\n<p>Intellectually, Nancy functions at about a 10-year-old level. She loves eating pizza, going on walks with her brother and legal guardian, Paul Pasiecznik, 74, and hearing tales about other people\u2019s dogs.<\/p>\n<p>For more than eight months, Paul has waged a battle on behalf of his sister so that she could follow her doctor\u2019s orders.<\/p>\n<p>The conversation about adding Charlotte\u2019s Web to Nancy\u2019s treatment plan began last fall when Murray, who sought out cutting-edge therapies in areas such as epilepsy, told Paul that he saw potential in an emerging area of cannabis compounds, <a href=\"http:\/\/www.thecannabist.co\/2017\/06\/19\/cbd-oil-epilepsy-child-fda\/80781\/\">specifically CBD<\/a>.<\/p>\n<p>Murray explained to Paul how <a href=\"http:\/\/www.thecannabist.co\/2017\/05\/25\/cannabidiol-cbd-oil-epilepsy-medical-study\/80258\/\">Epidiolex, a possible breakthrough CBD drug<\/a> developed by U.K.-based GW Pharmaceuticals, was making its way through clinical trials. Dr. Orrin Devinsky, the principal investigator of the Epidiolex study, <a href=\"https:\/\/www.gwpharm.com\/about-us\/news\/gw-pharmaceuticals-announces-second-positive-phase-3-pivotal-trial-epidiolex\" target=\"_blank\" rel=\"noopener\">recently presented positive findings<\/a> from <a href=\"https:\/\/www.gwpharm.com\/epilepsy-patients-caregivers\/patients\" target=\"_blank\" rel=\"noopener\">late-stage trials<\/a> about the drug\u2019s potential in treating seizures associated with certain types of epilepsy.<\/p>\n<p>Knowing it could take years for Epidiolex to make it to market, Nancy\u2019s doctor presented another treatment option: Charlotte\u2019s Web, the brand name for a whole plant hemp CBD extract grown and processed in Colorado by CW Hemp.<\/p>\n<p>Since it legalized medical marijuana in 2000 and adult-use marijuana in 2012, Colorado has developed into a hub for anecdotal evidence about CBD\u2019s ability to treat symptoms of seizure disorders and other ailments. Charlotte\u2019s Web <a href=\"http:\/\/www.thecannabist.co\/2015\/05\/29\/dateline-charlottes-web-medical-marijuana-new-lourdes\/35549\/\">gained national media attention<\/a> for its seemingly otherworldly ability to reduce seizures in a <a href=\"http:\/\/www.thecannabist.co\/2014\/02\/18\/charlottes-web-strain-aids-colorado-springs-kids-seizures-worries-doctors-children-medical\/4893\/\">local girl named Charlotte Figi<\/a>.<\/p>\n<p><a href=\"http:\/\/extras.denverpost.com\/stateofhope\/\">Scores of medical marijuana refugees have flocked to the state and proclaimed success of CBD oil<\/a> as an alternative care option. News reports about Figi and many other patients buoyed CW Hemp, formerly known as CW Botanicals, to national prominence.<\/p>\n<p>After learning about Charlotte\u2019s Web from Nancy\u2019s doctor, Paul began furiously researching CBD \u2014 querying New York state officials, lawmakers and lawyers; scouring the internet for information; and cold-calling The Cannabist\u2019s Colorado offices in a quest to learn what could and could not be done for his sister while she was in the care of her group home.<\/p>\n<h3>A tangled web of regulatory and legal uncertainty<\/h3>\n<p>In the letter penned to state officials recommending Charlotte\u2019s Web for Nancy, Murray referred to it as a dietary supplement \u201cclassified as hemp and thus legal to ship to all 50 states.\u201d But Paul soon learned that others didn\u2019t view CBD extracts in that same light.<\/p>\n<p>The <a href=\"http:\/\/www.thecannabist.co\/2016\/12\/15\/dea-cbd-new-rule-marijuana-extracts\/69550\/\">federal government considers CBD oil and other cannabis-derived extracts<\/a> to be Schedule I substances \u2014 the strictest of the classifications in the U.S. Controlled Substances Act.<\/p>\n<p>New York <a href=\"http:\/\/www.thecannabist.co\/2014\/06\/19\/new-york-lawmakers-agree-medical-marijuana\/14356\/\">legalized medical marijuana in 2014<\/a>, but the state\u2019s program is <a href=\"http:\/\/www.thecannabist.co\/2017\/01\/20\/new-york-medical-marijuana-program-concerns\/71361\/\">among the most prohibitive in the nation<\/a>. Dispensaries are sparse \u2014 fewer than 20 are scattered throughout the state \u2014 and the law prohibits the smoking of cannabis and a select few medical conditions qualify for the program.<\/p>\n<p>Murray could not be reached for comment. His letter to New York state officials was among several letters of correspondence provided by Paul to The Cannabist.<\/p>\n<p>As New York navigated the choppy waters of medical marijuana legalization, the Dent Neurologic Institute in which Murray practices has positioned itself as a resource for potential medical marijuana patients and the broader medical community, said Dr. Laszlo L. Mechtler, Dent medical director and chief of neuro-oncology at the Roswell Park Cancer Institute.<\/p>\n<p>Mechtler formed the\u00a0<a href=\"https:\/\/www.dentinstitute.com\/for-patients\/nys-medical-marijuana.php\" target=\"_blank\" rel=\"noopener\">Dent Cannabis Clinic<\/a>, which serves 1,000 patients and has another 1,000 on the waiting list. His wider aim is to have Dent land a Schedule I research license to conduct prospective clinical studies involving medical marijuana.<\/p>\n<p>Without studies, he and his colleagues have to rely on their clinical experience and the results that they\u2019re seeing in patients \u2014 much like a physician would do 200 years ago, he said.<\/p>\n<figure class=\"figure wp-caption aligncenter\"><img loading=\"lazy\" class=\"size-full wp-image-81668\" src=\"https:\/\/cannitrol.com\/blog\/\/wp-content\/uploads\/2017\/06\/forbidden-medicine-caught-between-a-doctors-cbd-advice-and-federal-laws-1.jpg\" alt=\"CBD legal status cannabidiol \" width=\"1000\" height=\"733\" \/><figcaption class=\"wp-caption-text\">Paul Pasiecznik, 74, and his sister Nancy Pasiecznik, 59, prepare to take a walk at Chestnut Ridge Park on June 8, 2017, in Orchard Park, N.Y. The elder Pasiecznik has run into roadblocks in his efforts to try an alternative medical treatment for Nancy\u2019s epilepsy: a whole plant hemp CBD extract manufactured in Colorado. (Mike Roy, Special to The Denver Post)<\/figcaption><\/figure>\n<p>In trying to learn how to help his sister receive CBD oil while in the care of the state-run group home, Paul butted up against a bureaucratic system that itself was trying to understand and unravel a tangled web of regulatory and legal uncertainty.<\/p>\n<p>Paul\u2019s initial correspondence with the clinical director for <a href=\"https:\/\/www.csdd.net\/\" target=\"_blank\" rel=\"noopener\">New York\u2019s Community Services for the Developmentally Disabled<\/a>, the office that oversees Nancy\u2019s group home, left him optimistic.<\/p>\n<p>While the office sought clarification from the state about what was permissable, officials made suggestions for helping Nancy get Charlotte\u2019s Web in the interim. Among the solutions floated was that Paul could transport Nancy, who is a registered medical marijuana patient, to his personal residence where he could administer the recommended medication himself.<\/p>\n<p>Before a temporary treatment plan could be developed, the state came back with its clarification:<\/p>\n<p>Under New York state law, the act of nurses administering, supervising or tracking any marijuana product \u2014 even CBD oil low in the psychoactive compound THC \u2014 would constitute the committal of a crime and, thus, personal misconduct, state officials wrote in a Jan. 31, 2017, letter to Paul.<\/p>\n<p>Although Paul and his lawyer balked at the Schedule I classification, claiming the hemp-derived extract was legal under protections offered by the <a href=\"http:\/\/www.thecannabist.co\/tag\/2014-farm-bill\/\">2014 U.S. Farm Bill<\/a>, the state stood firm.<\/p>\n<p>The letter didn\u2019t just put the kibosh on the possibility of integrating Charlotte\u2019s Web with Nancy\u2019s medical treatment \u2014 it also chilled Paul\u2019s plans to transport her to his home so that he could personally administer the oil to Nancy.<\/p>\n<p>Earl Cohan, director of clinical services for New York\u2019s Community Services for the Developmentally Disabled, could not be reached for comment.<\/p>\n<h3>\u2018Absolutely no relief\u2019<\/h3>\n<p>Paul doesn\u2019t want to have to look over his shoulder to administer a potential medicine that he thinks could help his sister.<\/p>\n<p>If a nurse were to see him deliver the oil to Nancy, Paul wondered if they would call the police and have him arrested. Worse yet, it could threaten Nancy\u2019s medical benefits with the state, he said.<\/p>\n<p>\u201cHere is a doctor prescribing it to a patient, and the state is the inhibiting factor,\u201d he said. \u201cThere is absolutely no relief from the state-provided oversight.\u201d<\/p>\n<p>The New York State Department of Health provided the following statement:<\/p>\n<blockquote>\n<p>New York State\u2019s Medical Marijuana Program regulates the manufacture, sale and use of medical marijuana in New York State. Approved medical marijuana products sold by organizations registered with the State\u2019s Medical Marijuana Program (ROs) often contain CBD. However, products purchased outside of the ROs that claim to be \u201cCBD oil\u201d or \u201chemp-derived plant extracts\u201d are outside the purview of the State\u2019s Medical Marijuana Program and may be of unknown content and quality.<\/p>\n<\/blockquote>\n<p>Department of Health officials did not respond to follow-up questions about the policies of state-run special and developmental needs facilities.<\/p>\n<p>Separately, officials with New York\u2019s Office for People With Developmental Disabilities did not provide a response to The Cannabist\u2019s multiple emails and calls seeking an interview and information about the office\u2019s policy toward medical marijuana and CBD oil.<\/p>\n<p>Paul considered trekking across New York to purchase another brand of CBD extract, but the percentages of cannabidiol did not align with that of Charlotte\u2019s Web, he said. He also didn\u2019t know whether the extracts at a dispensary 20 minutes away in Buffalo or 200 miles away in Binghamton matched up to the ingredients, formulation, testing, safety and potency Nancy\u2019s neurologist referenced to him about Charlotte\u2019s Web.<\/p>\n<p>\u201cI trust the experts for recommendations,\u201d Paul said. \u201cPlus, there are some good stories coming out of Colorado.<\/p>\n<p>In the absence of federal legalization of medical cannabis and its related products, it\u2019s up to the states to advance research and provide access, said Mechtler, the head of the Dent Cannabis Clinic.<\/p>\n<p>And if the state or a facility is a hindrance, that could be grounds for a challenge, he added.<\/p>\n<p>\u201cEspecially in a state where it\u2019s legal, I would find myself an attorney and fight them,\u201d he said.<\/p>\n<p>Paul said he considered legal action on behalf of his sister, \u201cif it didn\u2019t cost me a car or two.\u201d<\/p>\n<p>He said he just wants the opportunity to see if this doctor-recommended supplement could help his sister.<\/p>\n<p>\u201cWill it work for Nancy? I don\u2019t know,\u201d he said. \u201cWithout a doubt, I would want to try it (for her).\u201d<\/p>\n<div class=\"entry-meta-author\">\n<div class=\"authorimage\"><a class=\"url fn n\" href=\"http:\/\/www.thecannabist.co\/author\/awallace\/\" rel=\"author\"><img src=\"https:\/\/cannitrol.com\/blog\/\/wp-content\/uploads\/2017\/06\/forbidden-medicine-caught-between-a-doctors-cbd-advice-and-federal-laws-2.jpg\" class=\"authormug\" \/><\/a><\/div>\n<p class=\"author-desc\">Alicia Wallace joined The Cannabist in July 2016, covering national marijuana policy and business. She contributes to the Denver Post&#8217;s beer industry coverage. In her 14 years as a business news reporter, her coverage has spanned topics such as the&#8230;<\/p>\n<\/div><\/div>\n<\/p><\/div>\n<p><!-- .row --> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cannabist Special Report: CBD, TBD &#124;&#124; In New York, a man on a quest to help his epileptic sister with cannabidiol from Colorado, is stymied by the system. <\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[6811,6892,6813,77,5667,9,6833,5019,1,3,61,1736],"tags":[6816,6893,6818,2655,5673,6835,5022],"_links":{"self":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/7491"}],"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=7491"}],"version-history":[{"count":0,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/7491\/revisions"}],"wp:attachment":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/media?parent=7491"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/categories?post=7491"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/tags?post=7491"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}