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  1. Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components. Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana and its components. Proponents of “medical marijuana” advertised its uses for a wide number of medical conditions, such as cancer, multiple sclerosis, post-traumatic stress disorder and anxiety – just to name a few of the touted conditions. The FDA has been supportive of research in this area for many years. But marijuana is a Schedule I compound with known risks. Research to demonstrate that marijuana or its components could be safe and effective in the treatment of medical disorders should be held to the same standard as other drug compounds. And certainly it should not be held to a lower standard, as some proponents would suggest. The FDA has an active program to assist drug developers who want to investigate marijuana or its components through properly controlled clinical trials, to demonstrate the potential for safe and effective uses. Today, the FDA approved a purified form of the drug cannabidiol (CBD). This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older. This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients. This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced. So today, in addition to celebrating this scientific achievement and the medical advance that it represents for these patients and their families, we should also reflect on the path that made this possible. It’s a path that’s available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs. That pathway includes a robust clinical development program, along with careful review through the FDA’s drug approval process. This is the most appropriate way to bring these treatments to patients. This process also includes a review of the purity of a new drug and manufacturing controls. Before a high-quality drug can be developed, evaluated, and eventually approved by the FDA; it’s critical that the necessary work is done to identify drugs of potential medical benefit and conduct rigorous scientific research through adequate and well-controlled clinical trials. This is true for all drugs, including ones derived from plant materials, like marijuana. And the FDA remains committed to collaborating with federal and state agencies, researchers and product developers on advancing this type of important and conscientious work. This research process – from early development through preclinical and clinical research – gives us a comprehensive understanding of a new drug. That includes an understanding of whether the new product is safe and effective for treating a particular medical condition, what the proper dosage is and for what populations it is safe and effective, how the new compound could interact with other drugs, or whether the new drug has side effects or other safety concerns. This work also helps product developers identify the appropriate dosage needed to achieve the desired therapeutic effect while minimizing toxicity and risk. Taken in totality, the scientific evidence generated by these studies forms the basis of the FDA’s evaluation of benefit versus risk. And it’s because of this careful, scientific and evidence-based evaluation by the FDA that health care providers can rely on having a quality product that delivers a consistent, uniform dose of an effective medication that is able to deliver a predictable treatment to patients. This is especially important when considering treatment for serious medical conditions that will be utilized in the clinical care of patients who may have any number of health vulnerabilities. The purified form of the drug CBD approved today by the FDA has been shown to meet these rigorous standards. Research on the therapeutic effects of marijuana and its components involves a number of federal agencies in addition to the FDA, including the National Institute on Drug Abuse, part of the National Institutes of Health, and the Drug Enforcement Administration. The FDA has taken several specific steps to support this research. We meet regularly with researchers as they plan and carry out their trials. We have also formed a Botanicals Team that provides scientific expertise on botanical issues for researchers developing drugs derived from plants, such as marijuana. That team published guidance for industry on clinical studies involving botanical drugs, as well as quality controls for lot-to-lot consistency. In recent years, the agency also has recommended to the DEA the approval of several hundred Schedule I research protocol licenses for research on marijuana or its constituent compounds. Additionally, the FDA also works with companies to provide patients access to experimental therapies while clinical trials are ongoing through expanded access provisions. These approaches help protect patients while also allowing for the collection of data necessary to support the FDA approval of safe and effective therapies for use in the broader population. Through this process, hundreds of children were able to get access to investigational CBD products while this product was being studied. Drugs derived from marijuana also are eligible for several programs that are intended to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions. Much of the work we’ve done to encourage research in this area has led to the approval action we took today. The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels. However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims. The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims. We’re especially concerned when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits. Today’s approval demonstrates our commitment to the scientific process and working with product developers to bring marijuana-based products to market. We remain committed to our gold standard for product development and review. Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality. And most importantly, that these products have been proven safe and effective for patients. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
  2. https://www.ncbi.nlm.nih.gov/pubmed/26800377 RESULTS: CBD treatment yielded a significant positive effect on seizure load. Most of the children (66/74, 89%) reported reduction in seizure frequency: 13 (18%) reported 75-100% reduction, 25 (34%) reported 50-75% reduction, 9 (12%) reported 25-50% reduction, and 19 (26%) reported <25% reduction. Five (7%) patients reported aggravation of seizures which led to CBD withdrawal. In addition, we observed improvement in behavior and alertness, language, communication, motor skills and sleep. Adverse reactions included somnolence, fatigue, gastrointestinal disturbances and irritability leading to withdrawal of cannabis use in 5 patients. CONCLUSIONS: The results of this multicenter study on CBD treatment for intractable epilepsy in a population of children and adolescents are highly promising. Further prospective, well-designed clinical trials using enriched CBD medical cannabis are warranted. Read the full study here http://www.seizure-journal.com/article/S1059-1311(16)00005-4/fulltext
  3. Published on Mar 1, 2018 Muskegon Mother finds non-toxic and safe Cannabidiol CBD from medical marijuana is a better treatment for epilepsy than liquid Valium. In phase 1 of the study, 3 mg/kg daily of cannabidiol (CBD) was given for 30 days to 8 health human volunteers. Another 8 volunteers received the same number of identical capsules containing glucose as placebo in a double-blind setting. Neurological and physical examinations, blood and urine analysis, ECG and EEG were performed at weekly intervals. In phase 2 of the study, 15 patients suffering from secondary generalized epilepsy with temporal focus were randomly divided into two groups. Each patient received, in a double-blind procedure, 200-300 mg daily of CBD or placebo. The drugs were administered for along as 4 1/2 months. Clinical and laboratory examinations, EEG and ECG were performed at 15- or 30-day intervals. Throughout the experiment the patients continued to take the antiepileptic drugs prescribed before the experiment, although these drugs no longer controlled the signs of the disease. All patients and volunteers tolerated CBD very well and no signs of toxicity or serious side effects were detected on examination. 4 of the 8 CBD subjects remained almost free of convulsive crises throughout the experiment and 3 other patients demonstrated partial improvement in their clinical condition. CBD was ineffective in 1 patient. The clinical condition of 7 placebo patients remained unchanged whereas the condition of 1 patient clearly improved. The potential use of CBD as an antiepileptic drug and its possible potentiating effect on other antiepileptic drugs are discussed.
  4. Medical marijuana for the treatment of epilepsy has been a controversial and intriguing topic for the last few years. Drawing upon both clinical experience and research findings, the panelists discuss the potential medical benefits and risks of using medical marijuana as a treatment for epilepsy. The panelists also review the legal and practical issues associated with medical marijuana use in Michigan. Panelists: Evangelos Litinas, MD, MBA – Om of Medicine; Gregory Barkley, MD – Henry Ford Comprehensive Epilepsy Center; Zahra Abbas – Adult with Epilepsy; Michael Komorn – Komorn Law, Michigan Medical Marijuana Association
  5. We've known for forty years that Cannabidiol (CBD) from the Cannabis Sativa aka Marijuana aka Hemp plant vastly reduces many different kinds of seizures and epilepsy in humans. It is a travesty that patients and parents of children with epilepsy are prohibited from using this non-toxic plant to prevent and stop seizures. Tens of thousands of epileptics have died because they were unable to access this life saving safe non-toxic medication. Abstract In phase 1 of the study, 3 mg/kg daily of cannabidiol (CBD) was given for 30 days to 8 health human volunteers. Another 8 volunteers received the same number of identical capsules containing glucose as placebo in a double-blind setting. Neurological and physical examinations, blood and urine analysis, ECG and EEG were performed at weekly intervals. In phase 2 of the study, 15 patients suffering from secondary generalized epilepsy with temporal focus were randomly divided into two groups. Each patient received, in a double-blind procedure, 200-300 mg daily of CBD or placebo. The drugs were administered for along as 4 1/2 months. Clinical and laboratory examinations, EEG and ECG were performed at 15- or 30-day intervals. Throughout the experiment the patients continued to take the antiepileptic drugs prescribed before the experiment, although these drugs no longer controlled the signs of the disease. All patients and volunteers tolerated CBD very well and no signs of toxicity or serious side effects were detected on examination. 4 of the 8 CBD subjects remained almost free of convulsive crises throughout the experiment and 3 other patients demonstrated partial improvement in their clinical condition. CBD was ineffective in 1 patient. The clinical condition of 7 placebo patients remained unchanged whereas the condition of 1 patient clearly improved. The potential use of CBD as an antiepileptic drug and its possible potentiating effect on other antiepileptic drugs are discussed. https://www.ncbi.nlm.nih.gov/pubmed/7413719 Abstract A high dose of Δ⁹-tetrahydrocannabinol, the main Cannabis sativa (cannabis) component, induces anxiety and psychotic-like symptoms in healthy volunteers. These effects of Δ⁹-tetrahydrocannabinol are significantly reduced by cannabidiol (CBD), a cannabis constituent which is devoid of the typical effects of the plant. This observation led us to suspect that CBD could have anxiolytic and/or antipsychotic actions. Studies in animal models and in healthy volunteers clearly suggest an anxiolytic-like effect of CBD. The antipsychotic-like properties of CBD have been investigated in animal models using behavioral and neurochemical techniques which suggested that CBD has a pharmacological profile similar to that of atypical antipsychotic drugs. The results of two studies on healthy volunteers using perception of binocular depth inversion and ketamine-induced psychotic symptoms supported the proposal of the antipsychotic-like properties of CBD. In addition, open case reports of schizophrenic patients treated with CBD and a preliminary report of a controlled clinical trial comparing CBD with an atypical antipsychotic drug have confirmed that this cannabinoid can be a safe and well-tolerated alternative treatment for schizophrenia. Future studies of CBD in other psychotic conditions such as bipolar disorder and comparative studies of its antipsychotic effects with those produced by clozapine in schizophrenic patients are clearly indicated. (PsycINFO Database Record (c) 2016 APA, all rights reserved) http://psycnet.apa.org/record/2006-05687-001 Abstract BACKGROUND The Dravet syndrome is a complex childhood epilepsy disorder that is associated with drug-resistant seizures and a high mortality rate. We studied cannabidiol for the treatment of drug-resistant seizures in the Dravet syndrome. METHODS In this double-blind, placebo-controlled trial, we randomly assigned 120 children and young adults with the Dravet syndrome and drug-resistant seizures to receive either cannabidiol oral solution at a dose of 20 mg per kilogram of body weight per day or placebo, in addition to standard antiepileptic treatment. The primary end point was the change in convulsive-seizure frequency over a 14-week treatment period, as compared with a 4-week baseline period. RESULTS The median frequency of convulsive seizures per month decreased from 12.4 to 5.9 with cannabidiol, as compared with a decrease from 14.9 to 14.1 with placebo (adjusted median difference between the cannabidiol group and the placebo group in change in seizure frequency, −22.8 percentage points; 95% confidence interval [CI], −41.1 to −5.4; P=0.01). The percentage of patients who had at least a 50% reduction in convulsive-seizure frequency was 43% with cannabidiol and 27% with placebo (odds ratio, 2.00; 95% CI, 0.93 to 4.30; P=0.08). The patient’s overall condition improved by at least one category on the seven-category Caregiver Global Impression of Change scale in 62% of the cannabidiol group as compared with 34% of the placebo group (P=0.02). The frequency of total seizures of all types was significantly reduced with cannabidiol (P=0.03), but there was no significant reduction in nonconvulsive seizures. The percentage of patients who became seizure-free was 5% with cannabidiol and 0% with placebo (P=0.08). Adverse events that occurred more frequently in the cannabidiol group than in the placebo group included diarrhea, vomiting, fatigue, pyrexia, somnolence, and abnormal results on liver-function tests. There were more withdrawals from the trial in the cannabidiol group. CONCLUSIONS Among patients with the Dravet syndrome, cannabidiol resulted in a greater reduction in convulsive-seizure frequency than placebo and was associated with higher rates of adverse events. (Funded by GW Pharmaceuticals; ClinicalTrials.gov number, NCT02091375.) http://www.nejm.org/doi/full/10.1056/NEJMoa1611618 Muskegon mom hopes medical pot will save daughter, 5 Nina DeSarro, WZZMPublished 9:08 a.m. ET March 1, 2018 Can medical marijuana save Michigan girl? Could something so taboo, something the federal government doesn't recognize as containing medicinal value, be the cure for a 5-year-old girl in Muskegon? (Photo: WZZM) LeAnne Parker is a supermom. Between caring for her two daughters, her dogs and keeping up with her career, she does it all. “For four years my life was normal. My kids were normal. I knew nothing was wrong,” Parker said. That is until January 7, 2017 when her five-year-old daughter, Lily became unresponsive. “Her eyes just slowly start going to the right, almost like poltergeist, to the point where she turned her whole body until she was facing the shower which was behind her,” Parker said. In a panic, Parker immediately called an ambulance. “I didn’t know what to do, I just sat there and cried, I thought I was losing her, I just had the door open and I was just screaming for somebody to please help,” Parker remembered. Lily was taken to the hospital where doctors couldn't figure out what had happened. “They just said, 'if it happens again call us' and sent me home with no answers so we came home with no answers,” Parker said. Two weeks later, it happened again. And then again. “She did testing and testing and everybody said ‘I don’t know, just the brain is…welcome to the brain,’” Parker said. Finally in February, Lily received a diagnosis of epilepsy. “With two seizures that are unprovoked, you get the diagnosis of epilepsy.” She was immediately put on prescription medication, but the seizures continued. Lily had reached the maximum dosage possibly. “Now she’s failed all pharmaceuticals,” Parker said. Not only were the medications ineffective, her physical and mental state began to deteriorate. Five-year-old Lily was high, every day, her mom said. “I sent her to school the other day, and they called me and they said that she was tired. She was passing out. She fell asleep during circle,” Parker said. She picked Lily up from school after her teachers told her she was walking into walls. The only other option for Lily was brain surgery, if she would even qualify. “I thought, there has to be something else,” Parker said. Brain surgery could mean a loss of Lily’s peripheral vision. “And there’s a chance that it wouldn't even work, so then my daughter is partially blind and still has seizures, how do you make that choice for your kid, I don’t know,” Parker said. She would never be able to drive, never be able to play sports, that’s a really, really hard decision to make as a parent.” Desperate for another solution, Leanne found out about CBD, Cannabidiol. “I started doing my research so instead of doing all of my research about epilepsy, now I was doing all of my research about CBD oil and learning everything I possibly could to learn about the benefits of it,” Parker said. She went to a meeting in Grand Haven about medical marijuana’s use in treating epilepsy and from that point forward, she was going to give CBD a try. “It’s my daughter, so you can judge me. I feel like we live in a culture where it’s okay to pop Oxycontin, Vicodin and pain killers but we look at CBD oil like it’s awful, I don’t understand that,” Parker said. Nervous, Leanne approached her daughter’s neurologist with the idea. “I brought it up to my doctor hoping and praying that he was on board with it and a lot of people aren’t I’m lucky that I found a doctor that is, because if he wasn’t, I’d have to do it behind his back,” Parker said. Weeks later, she received Lily’s medical marijuana license in the mail. “The sad part is, there’s no doctor to talk to and that is the most frustrating part with me, because I’m like ‘okay I’m on board I want to do this, how, where, what do I do, how do I go about it and how do I even know how to dose my daughter?’” Parker said. Through her research, she found Bloom. The Ann Arbor based medical marijuana facility that offers doctor/patient consulting. “I wish this was option one before the pharmaceuticals, I wish I would have tried this first,” Parker said. It’s still a little too early today, but it’s been 25 days seizure free for Lily. “I am not hopping on a bandwagon of medical marijuana, I’m jumping off of the pharmaceutical bandwagon,” Parker said. So far, this is the longest Lily has gone without having a seizure since July of 2017. https://www.freep.com/story/news/local/michigan/2018/03/01/muskegon-medical-marijuana-leanna-parker/384280002/
  6. FDA Moves Forward With Marijuana-Based Drug To Fight Childhood Epilepsy The Food and Drug Administration has granted orphan drug designation for a cannabis-based drug developed to treat childhood-onset epilepsy, GW Pharmaceuticals announced last week. Although not full FDA approval -- its maker still must demonstrate the efficacy of the drug in clinical trials -- the orphan drug designation represents a tremendous step forward for cannabis-based medicine. The drug, called Epidiolex, contains a highly purified, plant-derived form of cannabidiol (CBD), a non-psychoactive compound found in marijuana that doesn't produce the "high" sensation associated with THC, the plant's main psychoactive ingredient. CBD has long been used as a treatment for Dravet syndrome, a rare and severe form of epilepsy in children, and GW Pharmaceuticals sees Epidiolex as useful in treating both Dravet and Lennox-Gastaut syndrome (LGS), another rare form of childhood epilepsy. The FDA grants the orphan drug designation to drugs intended to treat rare disorders. It qualifies the maker of the drug for certain tax incentives related to clinical testing as well as an exclusive marketing period for the drug. Currently, the federal government classifies marijuana as a Schedule I substance, but its compounds, like CBD and THC, can be reclassified at a lower level of risk if approved for medical use by the FDA. The agency's approval of the synthetic THC-based drug Marinol in 1985, for example, resulted in THC becoming a Schedule III substance. The classification of marijuana as Schedule I puts the plant into "the most dangerous" category of illegal substances "with no currently accepted medical use." The Schedule I status is why the Obama administration continues to raid medical marijuana dispensaries and prosecute their owners and workers. It's also part of the problem scientists have in obtaining cannabis, and funding, to conduct legal research on the drug in the U.S. If marijuana were reclassified as Schedule III -- like THC -- it would be officially recognized as having an accepted medical use and presenting less potential for abuse. Universities and labs that receive federal funding would find it much easier to conduct research on its potential benefits. According to the National Institutes of Health, Dravet syndrome typically appears in children within their first year of life. Along with frequent seizures, those affected often exhibit poor language development, hyperactivity and difficulty relating to others. Seizures for children affected by Lennox-Gastaut syndrome usually begin before the age of four. The majority of children with the syndrome also experience some degree of impaired intellectual functioning or information processing as well as behavioral disturbances, according to NIH. Currently, there is no cure for either disorder, and FDA-approved medications to treat epilepsy can cause children to become nauseated and develop rashes or, in some cases, depression or hyperactivity. Those drugs may not even effectively treat the seizures the children suffer from. "We are now in active discussions with the FDA regarding the US regulatory pathway for Epidiolex and believe that this medicine has the potential to meet the significant unmet need of children suffering with severe seizures where all options to control those seizures have been exhausted," GW Pharmaceuticals CEO Justin Gover said in a statement after the orphan drug announcement. "GW is responding to this need with the goal of providing an FDA-approved prescription CBD medicine that physicians have confidence in prescribing and parents can trust for quality, consistency and access." Marijuana has a long history of effectively treating seizures. In 1843, British Army doctor William O'Shaughnessy documented his use of cannabis oil to stop an infant's near-constant convulsions. Today, in the 20 U.S. states with legal medical marijuana, many families have been experimenting with a high-CBD, low-THC strain of cannabis to help treat their children who have debilitating seizures. The popular "Charlotte's Web" strain, named after 7-year-old Charlotte Figi and developed by non-profit medical marijuana group Realm of Caring, is being used to treat more than 300 patients suffering from epilepsy in Colorado. Charlotte, who used to suffer from hundreds of seizures a week, was the first child in Colorado to be legally treated with cannabis since medical marijuana was legalized. Her recovery has been miraculous, her mother, Paige Figi, told The Huffington Post. "She is getting a re-do of all the years she was robbed by epilepsy," Figi said. Charlotte's Web and similar medical strains are administered in liquid or capsule form and, according to doctors, produce little to no side effects. Because of the low THC count, users don't experience the high associated with traditional marijuana. In recent years, a number of studies have shown the medical promise of marijuana. Purified forms of cannabis can be effective at attacking some forms of aggressive cancer and may help slow the spread of HIV. Legalization of the plant for medical purposes may even lead to lower suicide rates. Although marijuana appears to be helping many people, some doctors remain cautious. “I worry that we just don’t know enough about it,” Dr. Sharon Levy, of the Boston Children’s Hospital at Harvard Medical School, told NBC News. “I think they’re putting their child at risk of long-term consequences of marijuana use that we don’t fully understand.” Down the road, FDA approval of Epidiolex may produce a cannabis-based drug that skeptical doctors would be comfortable prescribing to their patients. This isn't GW Pharmaceuticals' first foray into marijuana-derived drugs. The company has been developing and testing multiple cannabinoid drugs, including the world's first cannabis plant-derived prescription drug, Sativex, which is used for the treatment of spasticity due to multiple sclerosis in 25 countries. Sativex is not approved by the FDA but is in clinical trials in the U.S. http://www.huffingtonpost.com/2014/0...n_4906832.html
  7. Utah Doctors Endorse Medical Marijuana Tinctures This week, three Utah physicians wrote a letter to the state Controlled Substances Advisory Committee to endorse the use of medical marijuana for patients, including the use of marijuana tinctures for children suffering from debilitating illnesses, such as epilepsy. The letter was written by pediatric neurologist Dr. Francis Filloux. Filloux and his colleagues join a recent push by a Utah mother to change the state law to allow the use of cannabis oil extract. “The substance is not psychoactive or hallucinogenic,” Filloux said in his letter, which was co-signed by two other university doctors. “It has absolutely no abuse potential.” By not allowing the cannabis oil in Utah, “we would be making the decision to limit access of our children to a potentially life-improving therapy,” Filloux wrote. The Controlled Substances Advisory Committee, which is comprised of physicians, pharmacists, and law enforcement, does not have the power to simply allow any form of medical marijuana. However, they can provide recommendations about legislation to the state legislature. Utah Representative Gage Froerer has already announced that he plans to introduce a bill in January that would allow hemp products, including marijuana tinctures. Tinctures can be considered a hemp product due to their extremely low THC content. [Source]
  8. Compound in cannabis may help treat epilepsy, researchers say http://www.latimes.c...0,1908600.story By Lee Romney Los Angeles Times September 14, 2012, 12:41 p.m. British researchers have determined that a little-studied chemical in the cannabis plant could lead to effective treatments for epilepsy, with few to no side effects. The team at Britain’s University of Reading, working with GW Pharmaceuticals and Otsuka Pharmaceuticals, tested cannabidivarin, or CBDV, in rats and mice afflicted with six types of epilepsy and found it “strongly suppressed seizures” without causing the uncontrollable shaking and other side effects of existing anti-epilepsy drugs. According to the findings, reported this week in the British Journal of Pharmacology, CBDV also delayed and reduced seizures when used in conjunction with two common anti-convulsant drugs. “There is a pressing need for better treatments for epilepsy,” said Dr. Ben Whalley, the lead researcher. “It’s a chronic condition with no cure and currently, in around one third of cases, the currently available treatments do not work, cause serious side-effects and increase fatalities.” The study, he added, highlights “the potential for a solution based on cannabinoid science. It has shown that cannabidivarin is the most effective and best tolerated anticonvulsant plant cannabinoid investigated to date.” The casual use of marijuana -- or cannabis -- to control seizures dates back to ancient times. Its most prominent component, THC, is among those shown in animal studies to have strong anti-convulsant properties, but its mind-altering effects have made it unsuitable for pharmaceutical development. A number of the plant’s more than 100 cannabinoids are non-psychoactive, however. The most studied among them is cannabidiol, or CBD, which has shown promise for multiple sclerosis spacticity, nausea, epilepsy and schizophrenia. Animal studies with CBD have also shown it to be effective as a neuoroprotectant and cancer-fighting agent. In recent years, California’s medical marijuana proponents have begun to breed plants for higher CBD content and develop customized tinctures for patients with a range of ailments. Those treatments combine high doses of CBD with smaller amounts of THC. Yet CBD’s widely known structure and well-studied uses mean that the pharmaceutical industry has less of an opportunity to protect patents on its use and profit from any drug development, said Whalley and Raphael Mechoulam, the Israeli researcher who first identified the structure of the compound nearly half a century ago and has conducted many key CBD studies. CBDV is a closely related chemical compound. While it was discovered in 1969, the research made public this week was the first conducted in animals, said Whalley, and only two small in vitro studies have been published, neither of them related to epilepsy. “The commercial protection can be good even if the compound itself was identified some time ago, as long as the proposed use is novel,” he said. “The better described the ‘new use’ is, the stronger the protection.” Medical marijuana proponents largely dismiss pharmaceutical industry efforts as too profit-driven, and say that encourages researchers to find a “magic bullet” compound rather than work with the complex benefits that the whole plant provides. Yet Whalley countered that “to make a cannabis-based medicine available and accessible to a global patient community, the only viable route is via conventional drug development, which is dictated by governmental legislation [and] regulation.” Dr. Stephen Wright, research and development director for GW Pharmaceuticals, which already markets a drug outside the U.S. that is half THC and half CBD for multiple sclerosis patients, said the company hoped to advance the CBDV research on epilepsy to human trials by next year. Epilepsy affects about 1% of people worldwide, and is caused by excessive electrical activity in the brain, which leads to seizures that can be fatal. Michael A. Komorn Attorney and Counselor Law Office of Michael A. Komorn 3000 Town Center, Suite, 1800 Southfield, MI 48075 800-656-3557 (Toll Free) 248-351-2200 (Office) 248-357-2550 (Phone) 248-351-2211 (Fax) Email: michael@komornlaw.com Website: www.komornlaw.com Check out our Radio show: http://www.blogtalkr...lanetgreentrees CALL IN NUMBER: (347) 326-9626 Live Every Thursday 8-10:00p.m. PLANET GREENTREES w/ Attorney Michael Komorn The most relevant radio talk show for the Michigan Medical Marijuana Community. PERIOD.
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