{"id":7487,"date":"2017-06-19T15:33:11","date_gmt":"2017-06-19T15:33:11","guid":{"rendered":"http:\/\/www.denverpost.com?p=2688587&amp;preview_id=2688587"},"modified":"2017-06-19T15:33:11","modified_gmt":"2017-06-19T15:33:11","slug":"people-are-desperate-parents-doctors-place-epileptic-children-in-trials-to-get-fda-approval-of-medical-marijuana","status":"publish","type":"post","link":"https:\/\/cannitrol.com\/blog\/people-are-desperate-parents-doctors-place-epileptic-children-in-trials-to-get-fda-approval-of-medical-marijuana\/","title":{"rendered":"\u201cPeople are desperate\u201d: Parents, doctors place epileptic children in trials to get FDA approval of medical marijuana"},"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\/people-are-desperate-parents-doctors-place-epileptic-children-in-trials-to-get-fda-approval-of-medical-marijuana\/\" 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 19, 2017, 7:51 am \u2022 Updated: Jun 19, 2017, 9:14 am<span class=\"single-comments-link\"><a href=\"http:\/\/www.thecannabist.co\/2017\/06\/19\/cbd-oil-epilepsy-child-fda\/80781\/#disqus_thread\" class=\"commentsNameLink\" \/><\/span><\/div>\n<p class=\"byline\">By <strong>Vinny Vella<\/strong>, <em> The Hartford Courant<\/em><\/p>\n<p>HARTFORD, Conn. \u2014 There are good days for West Tarricone. Days when she can laugh and live like any other 9-year-old. Days when she can play with her brother, Blake, and watch \u201cThe Ellen DeGeneres Show\u201d on her iPad.<\/p>\n<p>But there are also bad days. Days when her body weathers 100 seizures. Days when it has closer to 1,000 \u2014 some lasting more than 90 minutes.<\/p>\n<p>Lately, she\u2019s been having more good days thanks to Connecticut\u2019s new experiment with medical marijuana.<\/p>\n<p>Doctors diagnosed West just after her first birthday, not long after her mother Cara Tarricone<br \/>noticed she had been jerking oddly. Two weeks before they learned West had intractable epilepsy, she had a grand mal seizure.<\/p>\n<p>In the years since, West has tried a battery of nearly two dozen medicines, but just one has brought her some comfort \u2014 cannabis oil, which is derived from the marijuana plant.<\/p>\n<h3>Medical marijuana<\/h3>\n<p>\u201cWithout it, we\u2019d be in the hospital, we\u2019d just live there because we\u2019d have to be controlling bigger seizures all the time,\u201d Tarricone said.<\/p>\n<p>West takes the cannabis oil daily, in addition to four pharmaceutical medications. Tarricone says she\u2019s \u201cpleased\u201d with the daily medication, and has seen a decrease in some seizure activity.<\/p>\n<p>But the medicine\u2019s most profound effect comes when West\u2019s seizures flare beyond control. When that occurs, Tarricone rubs a different concentration of the oil into her daughter\u2019s gums as a \u201crescue medicine.\u201d Within a minute, the more intense symptoms subside. Her tightened muscles slacken. Her breathing regulates.<\/p>\n<p>Before the oil, the family had to rely on pharmaceutical rescue medicines. When they didn\u2019t show signs of working right away, Tarricone would have to call for an ambulance.<\/p>\n<p>During intense seizures, they usually didn\u2019t work.<\/p>\n<p>\u201cI said immediately, this is a natural option, and I want this for my child,\u201d Tarricone said. \u201cSomething that could eliminate a lot of extra pharmaceutical medication in her system and be so simple and straightforward? This is something we needed for our daughter.\u201d<\/p>\n<p>The state legislature passed a bill approving cannabis as a palliative treatment for childhood seizure patients in May 2016, but the medicine didn\u2019t become available until October, when the law went into effect.<\/p>\n<p>The Tarricones received their first batch for West in March. She is currently one of less than 50 children in Connecticut utilizing the medicine, according to the state Department of Consumer Protection.<\/p>\n<p>Getting the medicine was a victory for the family, one of the more vocal advocates for legalizing cannabis oil.<\/p>\n<p>And as they begin using it, they hope their story inspires a greater understanding and wider acceptance of a substance that could improve the lives of other children.<\/p>\n<p><strong><em>Story continues below photo gallery<\/em><\/strong><\/p>\n<div id=\"gslideshow\" class=\"gss-container\">\n<div class=\"gss-info\">\n<div class=\"gss-long-cap\">In this April 19, 2017 photo, West Tarricone sits in the exam room with her Neurologist Dr. Madan Cohen, the medical director of the Epilepsy Center and Clinical Neurophysiology Lab at Connecticut Children&#8217;s Medical Center in Hartford, Conn. West sees her neurologist approximately every three months. At these appointments, West receives a check up and Dr. Cohen and West&#8217;s mother, Cara, discuss West&#8217;s medications, seizures and assess if any changes to her treatment need to be made. After trying nearly two dozen medications, her family sought out medical marijuana to better control her seizures. (Lauren Schneiderman, Hartford Courant via AP)<\/div>\n<\/p><\/div>\n<\/div>\n<h3>Fighting for medicine<\/h3>\n<p>West\u2019s condition is so unstable that Tarricone had to give up her job to care for the girl. Her wife, Diane, works three jobs to support the family.<\/p>\n<p>Moving to another state, like California, where medical marijuana is more readily available, was not an option. Their son, for one, couldn\u2019t bear the thought of leaving his friends and school, she said.<\/p>\n<p>Besides, the Tarricones are attached to their neurologist at Connecticut Children\u2019s Medical Center, Dr. Jennifer Madan Cohen.<\/p>\n<p>Attached to the point where leaving her care was a risk they wouldn\u2019t take. So if they couldn\u2019t go to the drug, they\u2019d find a way to bring it to them.<\/p>\n<p>Tarricone lent her voice to the movement of parents seeking medical marijuana for their children. It was a fledgling group in 2015, when the first bill failed in the state legislature.<\/p>\n<p>But a year later, they were ready, Tarricone said, adding their testimony to a groundswell of support for the legislation.<\/p>\n<p>\u201cWe shared stories and made it personal, how it would affect us, how it would affect our children,\u201d she said. \u201cI truly think that gave us the momentum. In that year, we had enough opportunity to educate legislators personally as to what the medication is, how it worked, how effective it could be, and that parents should really be the ones making that decision with their medical care providers.\u201d<\/p>\n<p>But when they initially broached the subject with Madan Cohen and the other members of West\u2019s medical team, they were somewhat skeptical, Tarricone said.<\/p>\n<p>\u201cThey just didn\u2019t know that this was something parents were pursuing, and moving to other states to pursue,\u201d she said. \u201cBut I kept saying, \u2018This is what\u2019s happening, let\u2019s talk about this more, I want to continue this conversation.&#8217;\u201d<\/p>\n<p>\u201cAnd I didn\u2019t let it go,\u201d she added.<\/p>\n<p>Madan Cohen has treated West since her diagnosis. In that time, she\u2019s seen her try a bevy of medicines for the seizures that plague her.<\/p>\n<p>\u201cYou name it, she\u2019s been on it,\u201d Madan Cohen, the medical director of the hospital\u2019s epilepsy center and clinical neurophysiology lab, said in her office recently. \u201cIf there\u2019s a medicine I\u2019ve had, she\u2019s tried it.\u201d<\/p>\n<p>Because of that, she doesn\u2019t see the Tarricones\u2019 interest in medical marijuana as \u201cirrational.\u201d<\/p>\n<p>\u201cThey\u2019ve seen their child have pretty severe seizures and not have control with the various treatments they have,\u201d she said. \u201cSo I\u2019ve never discouraged a family\u2019s want to try this treatment, but we have to decide when it\u2019s the right time to try something.\u201d<\/p>\n<p>She acknowledged that West was at a point in her life where trying medical marijuana was an attractive option.<\/p>\n<p>But when it comes to the treatment\u2019s effectiveness, Madan Cohen is unable to give a definite answer. And it\u2019s not just because the utilization of the oil is still relatively new for the adolescent.<\/p>\n<h3>Trials and error<\/h3>\n<p>Medical marijuana is unique in the way it\u2019s dispensed. Normally, medication requires FDA approval before it can be prescribed to patients. However, because individual states are legalizing marijuana for medicinal purposes, patients seeking the drug are circumventing that approval process, receiving a substance that the federal government considers illegal \u2014 and largely untested as a drug.<\/p>\n<p>Still, within the medical community, there\u2019s a body of evidence supporting the benefits of using cannabidiol, a chemical compound found in marijuana, in treating seizures. Evidence like clinical trials sponsored by pharmaceutical companies with deep pockets. Madan Cohen herself is involved in one such trial, the goal of which is to accumulate enough evidence to one day seek FDA approval.<\/p>\n<p>But the products available in Connecticut are not purely cannabidiol. They also contain tetrahydrocannabinol, another chemical component found in marijuana known to be psychoactive, in various concentrations.<\/p>\n<p>Trials studying the effectiveness of THC, or any other component of marijuana, can be difficult to get clearance for, according to Dr. William Zempsky, a pediatrician with Connecticut Children\u2019s Medical Center who sits on the board of physicians for the state\u2019s medical marijuana program.<\/p>\n<p>For one, limited availability means that different physicians work with different strains of the plant. And there seem to be multiple variants for every study: how the marijuana is consumed and the conditions it\u2019s used to treat, for example.<\/p>\n<p>\u201cWe\u2019re dealing with a different combination of drugs that people study,\u201d Zempsky said. \u201cIt\u2019s really hard to take all that information and go forth and say \u2018Medical marijuana works for x condition,\u2019 because we\u2019re not talking about the same thing, and to drill it down to an individual patient is more complex.\u201d<\/p>\n<p>Connecticut has a history of such studies. St. Francis Hospital and Medical Center sought to study marijuana as an alternative to opioid painkillers. Yale University has sponsored similar trials in the past, according to Zempsky.<\/p>\n<p>And Connecticut Children\u2019s is laying the groundwork for a study of its own, using data from its patients to see the long-term effects of medical marijuana.<\/p>\n<p>The medications that West uses, for example, are low doses of THC. Just enough to treat her seizures and keep her comfortable.<\/p>\n<p>The family initially tried cannabidiol medication, Tarricone said. It made West\u2019s seizures even worse.<\/p>\n<p>Still, THC\u2019s effectiveness hasn\u2019t been proven clinically, Madan Cohen said. Instead, physicians rely on anecdotal evidence, like the Tarricones\u2019 positive experience, when informing prospective patients.<\/p>\n<p>\u201cI think there\u2019s enough people who reported it that that\u2019s some level of data,\u201d Madan Cohen said. \u201cBut it\u2019s just not the same level of data as <a href=\"http:\/\/www.thecannabist.co\/2017\/05\/25\/cannabidiol-cbd-oil-epilepsy-medical-study\/80258\/\">a randomized, controlled trial<\/a> and the things the FDA requires to get a medicine approved as a treatment.\u201d<\/p>\n<p>Trials help determine crucial medical information, like the drug\u2019s side effects, dosing recommendations and interactions with other medicines.<\/p>\n<p>Without them, physicians treating patients with medical marijuana have to undergo some trial and error, seeing what works best in their individual case.<\/p>\n<p>\u201cMy advice to parents \u2014 and this is what I told West\u2019s parents as well \u2014 is that you have to think of it as you\u2019re doing your own clinical trial on your child,\u201d she said. \u201cWe don\u2019t know what the outcome is going to be, we don\u2019t know if they\u2019re going to respond, we don\u2019t know what the side effects are.<\/p>\n<p>\u201cBut there are some families who feel that risk is acceptable compared to what is going on in the child\u2019s life medically at the current time,\u201d she added.<\/p>\n<h3>A family\u2019s choice<\/h3>\n<p>FDA approval would have the additional benefit of making the medicine more affordable: All approved drugs have to be covered at least partially by medical insurance.<\/p>\n<p>If for no other reason than that, Madan Cohen is encouraging more trials, more testing from policymakers both here and in Washington.<\/p>\n<p>\u201cNow, people are desperate, and they feel like the government is just getting in their way, as opposed to the idea that the government is protecting them from potential harm,\u201d she said. \u201cAnd I think the intentions are good to make sure that something doesn\u2019t have a lot of side effects.\u201d<\/p>\n<p>Zempsky said he understands the frustrations that some parents may feel, especially if they see medical marijuana as an effective alternate remedy. But, still, he cautioned against universal adoption of the drug too early.<\/p>\n<p>\u201cWhile I\u2019ve seen a lot of impressive outcomes with medical marijuana, it\u2019s not as good as everyone says it is,\u201d Zempsky said. \u201cWe have to be careful of letting things get out too far ahead of us, because we don\u2019t know long-term risks, especially for child patients.\u201d<\/p>\n<p>He\u2019s not outright opposed to prescribing the drug for children suffering from certain conditions, like epilepsy. He simply argues that there isn\u2019t enough data out there to know how adolescent use of medical marijuana affects patients later in life.<\/p>\n<p>\u201cIf you give medical marijuana to someone who\u2019s 13, you need to know what they\u2019re like when (they\u2019re) 40,\u201d he said. \u201cThat takes time, and there\u2019s no way to expedite that. So we won\u2019t be comfortable for years in the pediatric world to open the floodgates, even if we\u2019re comfortable in the adult world.\u201d<\/p>\n<p>But research is needed. And Rep. Gail Lavielle understands that.<\/p>\n<p>The Republican from Wilton became a vocal supporter last spring for medical marijuana in the state \u2014 both as an elected official and a mother.<\/p>\n<p>\u201cWhen you\u2019re a parent, you want to do everything you can to help your child. You\u2019re not going to put your child in danger voluntarily,\u201d she said. \u201cSo you must be pretty desperate to try and find something to help them if you\u2019re willing to consider something that you\u2019re not totally sure of the risks of.<\/p>\n<p>\u201cSo I listened to this, and I decided it wasn\u2019t up to me to decide, that it would be supreme and egregious arrogance to think otherwise,\u201d she added.<\/p>\n<p>Lavielle stresses that she\u2019s not \u201cpro marijuana,\u201d especially when it comes to recreational use. But in conversations with her constituents who have epileptic children, she realized the government shouldn\u2019t create unneeded roadblocks.<\/p>\n<p>\u201cMy stance is that it\u2019s not up to me as a legislator, as a member of the government, or to the legislature itself to tell people whether they can try something that they think might work when their child has a very grave disease,\u201d she said.<\/p>\n<p>Her colleagues agreed: The bill passed 129-13 in the House and 23-11 in the Senate in May 2016.<\/p>\n<h3>Doing everything possible<\/h3>\n<p>Meanwhile, away from the Capitol and long-winded debates over policy, children like West Tarricone live the reality of that decision, their families hoping for continued success with treatment.<\/p>\n<p>The 9-year-old from Windham doesn\u2019t let anything slow her down. Her personality is bright and bubbly. She\u2019s affectionate, grabbing the hands of new acquaintances as she leads them around her living room.<\/p>\n<p>Tarricone says her daughter loves to laugh, especially at the pratfalls and tumbles her twin brother makes while they play.<\/p>\n<p>The levity helps, Tarricone said. It takes the family\u2019s collective attention away from the epilepsy. So does the cannabis oil.<\/p>\n<p>What started as a seeming long shot, an idea that Tarricone first had three years ago, now sits in the family\u2019s medicine cabinet, ready to soothe the seizures when they overtake her daughter.<\/p>\n<p>\u201cIf you were in our position and you were running out of all pharmaceutical options, and here\u2019s this hope at the end of a really bad tunnel for a child who\u2019s going to prematurely die, you\u2019re going to know,\u201d Cara Tarricone said.<\/p>\n<p>\u201cBecause when you look in your child\u2019s eyes, you know you have to do everything possible to help them.<\/p>\n<p><em>Via Associated Press Member Exchange. Information from: <a href=\"http:\/\/cour.at\/2qQ86BL\">Hartford Courant<\/a><\/em><\/p>\n<div class=\"entry-meta-tags\">\n<div class=\"entry-tags\">Topics: <a href=\"http:\/\/www.thecannabist.co\/tag\/cannabidiol\/\" rel=\"tag\">cannabidiol<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/cannabis-kids\/\" rel=\"tag\">cannabis kids<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/cbd\/\" rel=\"tag\">cbd<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/cbd-oil\/\" rel=\"tag\">cbd oil<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/connecticut\/\" rel=\"tag\">Connecticut<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/education\/\" rel=\"tag\">education<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/epilepsy\/\" rel=\"tag\">epilepsy<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/fda\/\" rel=\"tag\">fda<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/food-and-drug-administration\/\" rel=\"tag\">Food and Drug Administration<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/medical-marijuana\/\" rel=\"tag\">medical marijuana<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/medical-marijuana-research\/\" rel=\"tag\">medical marijuana research<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/parenting\/\" rel=\"tag\">parenting<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/pot-and-parenting-2\/\" rel=\"tag\">pot and parenting<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/research\/\" rel=\"tag\">research<\/a>, <a href=\"http:\/\/www.thecannabist.co\/tag\/seizures\/\" rel=\"tag\">seizures<\/a><\/div>\n<\/div><\/div>\n<\/p><\/div>\n<p><!-- .row --> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>HARTFORD, Conn. &#8212; There are good days for West Tarricone. Days when she can laugh and live like any other 9-year-old. Days when she can play with her brother, Blake, and watch &#8220;The Ellen DeGeneres Show&#8221; on her iPad. But there are also bad days. Days when her body weathers&#8230; <a href=\"http:\/\/www.thecannabist.co\/2017\/06\/19\/cbd-oil-epilepsy-child-fda\/80781\/\"><\/a> <\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[531,330,5104,7153,6892,6813,77,5667,56,9,5019,7154,1777,1,3,61,1736],"tags":[3105,2908,5109,7155,6893,6818,2655,5673,2636,5022,7156,4345],"_links":{"self":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/7487"}],"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=7487"}],"version-history":[{"count":0,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/posts\/7487\/revisions"}],"wp:attachment":[{"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/media?parent=7487"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/categories?post=7487"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannitrol.com\/blog\/wp-json\/wp\/v2\/tags?post=7487"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}