There was not a dry eye in the house. “Stop the cameras,” muttered Dr. Heather Carone, as she reached for a Kleenex to dry her eyes. “Please give me a moment …,” a telling plea from an ER physician, who has probably seen everything. As if tears were contagious, others at the video shoot could be heard quietly choking back emotions that cut to the core of every parent. But Paige Frate didn’t notice, as she played with her mother’s blond hair. Three-year old Paige has her blond locks lightly tied into a pert ponytail. She wiggles as if to say she wants down and then waddles toward a puzzle, giggling as she greets the dog. But what appears on the surface to be normal is far from it. Paige has been diagnosed with Dravet Syndrome, a rare genetic form of epilepsy that begins in infancy and afflicts an estimated 5,400 American children. A neurological disorder, epilepsy is characterized by recurrent, unprovoked seizures. Current treatments are comprised of pharmaceutical drugs, many of which have debilitating side effects. Some forms of epilepsy do not respond to treatment, and when the seizures continue despite medication, the cases are termed “intractable.” These recurrent and so-far incurable seizures leave their young victims developmentally disabled and their parents fearing for their very lives. Paige’s mother speaks forthrightly about these scares. The emergency surgery that saved Paige’s life after a 67 minute seizure shut down her heart and lungs. The myriad of side effects from the pharmaceuticals: rashes, nausea, anemia, sedation and even more seizures. It was when her mother voiced her deepest fear – “Honestly, when I tuck Paige into bed at night, I don’t know if she will be with us in the morning.” – that the tears welled in Dr. Carone’s eyes. A game changing moment for children like Paige came this past summer when the famed Dr. Sanjay Gupta observed the transformative effects of CBD (cannabidiol) on six-year old Charlotte Figi, who was also stricken Dravet Syndrome. After beginning a regimen of CBD oils, the child’s grand mal seizures dropped from 300 per week to only one or two per month, causing the good doctor to reverse his thinking about marijuana; CBD is a non-smoked, non-psychoactive component of this controversial plant. The plant’s controversy largely lies in its 40-year classification as a Schedule I drug, placing it off limits for research or use by even the most gravely ill. Doctors such as Heather Carone and Sanjay Gupta have been taught to embrace these policies and shun the plant’s therapeutic value, lest they lose their medical licenses or prescription privileges. Children such as Charlotte and Paige are changing their minds. Medicinal use of the cannabis plant has been traced back at least 5,000 years. A 1977 study in The Journal of Pharmacology and Experimental Therapeutics concluded, that “CBD is an effective anticonvulsant with a specificity more comparable to drugs clinically effective in major than minor seizures.” A search of, the library of clinical research, produces dozens of articles about CBD and its mechanism of action. Fundamentally, “endogenous” cannabinoids similar to CBD exist in every person. "Receptors" in the brain and elsewhere in the body bind specifically with these internal cannabinoids, as well as with plant-based and lab synthesized ones, thereby triggering the therapeutic effects. The human endogenous cannabinoid system unequivocally establishes the medicinal properties of cannabis. The federal government may be slowly getting the message. In October, the U.S. Food and Drug Administration designated cannabidiol an “Orphan Drug” and began to permit the enrollment of children with intractable epilepsy into two Investigational New Drug (IND) studies to test an oral liquid containing CBD. The trials have the singular purpose of treating these children, but if the drug proves successful in reducing their seizures, the FDA could expedite it to the Phase III clinical trials necessary for formal drug approval. Unfortunately, the proverbial devil is the details, for drug approvals can be lengthy, costly and politically unpalatable. The Compassionate IND Program serves as a case in point. Begun in the late 1970s, the program made medical marijuana available to about 30 patients, including those diagnosed with the newly discovered AIDS virus. However, in a political move, the Bush administration closed the program in 1992, grandfathering in the existing patients, three of whom still receive cannabis from the feds. Never once in the last 35 years did this IND lead to the formal drug approval process, nor were clinical trials conducted on the cannabis used in the program. In addition, the FDA reports that, “To date, more than 1,700 drugs and biologics have been designated as orphan drugs, with more than 300 achieving marketing approval.” But that’s a batting average of only 17 percent. In 2013, only two Orphan drugs were approved for genetic diseases like Dravet Syndrome. Further, The Journal of the American Medical Association asserts that the price structure developing for novel orphan drugs is becoming unsustainable. Aimed at limited patient populations, some of these drugs carry price tags as high as $300,000 per year, despite the significant role played by their own patient advocacy groups in bringing them to market. The process to legislatively unlock cannabis is obviously fraught with political obstacles as well. At a Youngstown roundtable discussion, Ohio Representative Bob Hagan lamented the legislative inaction on five medical marijuana bills that have languished in Ohio legislature over the past 12 years. The mantra of those in opposition to cannabis has always been, what about the children? In light of Paige and the thousands of children like her, advocates for this controversial plant now ask the same question. What about the children with intractable epilepsy, cancer and a host of other deadly childhood illnesses? Is prohibition so sacrosanct that they become collateral damage? Is it right for them to languish as their parents live in daily fear of their very survival? Enter the Ohio Cannabis Rights Amendment. One of the quickest and least expensive ways for Ohioans to permit these children to benefit from cannabis-based treatments is the passage of this measure by Ohio voters. The amendment contains specific provisions that would make those under age 18 with debilitating medical conditions like epilepsy eligible to use cannabis therapeutically with the prior written consent of a parent or guardian. These regulations could be in place this time next year. Thousands of voters from across the state are saying no to prohibition, and yes to the potential medicinal, therapeutic and industrial uses of the cannabis plant. Paige’s mother and the families of other sick children have joined forces with the Ohio Rights Group to get the Amendment on the ballot. They are collecting signatures, raising funds, participating in forums and lobbying their state legislators. And leading the way are children like Paige, who deserve the right to have their lives transformed at home here in Ohio. Upon drying her eyes, Dr. Carone summed up the emotions that caused her to stop the cameras, “It is inhumane for me to not offer my patients this safe and effective option.”

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