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NEW STUDIES
Epidiolex Works:
If FDA Approves It, How Will It Affect
the Medical Marijuana Industry?
 

Most likely wipe it out, say specialists who treat epilepsy, cancer, and other diseases that advocates claim marijuana or its derivatives cure or help.
 
Epidiolex is cannabidiol (CBD) that GW Pharmaceuticals of Great Britain extracts from marijuana it grows without pesticides. The company has worked hard to ensure that Epidiolex contains no THC, the marijuana component that causes the high and that is neurotoxic to children’s brains. GW purifies the CBD extract and formulates it in consistent, reliable doses for treating rare forms of epilepsy.
 
This week, GW announced the results of the first-ever, placebo-controlled trial of a CBD product. To get there, it first showed that Epidiolex is safe and reduces seizures in animal studies. It demonstrated that the drug’s contents are measured by rigorous standards and are carefully monitored for contaminants. It proved that even the equipment used to make the drug meets rigorous industry standards. This evidence qualified the company to initiate FDA clinical trials a few years ago.
 
In this, the first of several FDA trials GW is conducting, 120 patients suffering intractable seizures from Dravet syndrome were randomly assigned to an experimental group which received Epidiolex or a control group which received a placebo. Patients’ average age was ten; 30 percent were younger than six. Those receiving Epidiolex experienced a 39 percent reduction in convulsive seizures compared to a 13 percent reduction among those receiving a placebo. The company plans to apply to FDA for approval of its drug based on these results.
 
Anecdotal claims made by seriously ill patients, advocates, and the press have motivated well-intentioned state legislatures to pass laws legalizing marijuana for medical use, including CBD oils for treating epilepsy. Doctors cannot prescribe these products, only recommend them because the products do not meet FDA standards of safety or efficacy. Many contain THC, the component that produces a high, and may be dangerous.
 
Medical marijuana products “are unregulated, highly variable artisanal preparations of cannabis oil prescribed, in most cases, by physicians with no training in pediatrics, neurology, or epilepsy,” writes Michael D. Privitera, MD, president of the American Epilepsy Society and director of the Epilepsy Center at the University of Cincinnati, in a letter to a Pennsylvania legislator. “As a result, the epilepsy specialists in Colorado have been at the bedside of children having severe dystonic reactions and other movement disorders, developmental regression, intractable vomiting, and worsening seizures that can be so severe they have to put the child into a coma to get the seizures to stop.”
 
Dr. Privitera notes that it is impossible to know whether these disastrous adverse reactions are caused by artisanal CBDs themselves or by contaminants found in the products. The lack of safety or proof of efficacy is why nearly all medical societies oppose medical marijuana laws. Medical doctors will not recommend something that has known harms and no known benefits. Now that a clinical trial has shown that Epidiolex is safe and effective for reducing seizures, doctors will almost certainly prescribe it for Dravet Syndrome, and perhaps other diseases, and the market for artisanal CBD products will dry up.
 
Concludes Dr. Privitera, “The well-intentioned law makers in the states that have passed CBD laws are now coming to grips with the substantial financial and administrative burdens of developing, maintaining, and running a CBD access program. In reality, these programs could be abandoned as quickly as they are established should an FDA approved drug be available within the next 18-24 months.”
 
Read the American Epilepsy Society letter here. Read the New York Times story here. Read GW Pharmaceuticals’ announcement here.
 
MARIJUANA INDUSTRY NEWS
A Purpose for Everything Under the Sun, Including Marijuana
 
The top producer of unregulated, highly variable artisanal preparations of CBD oils is CW Botanicals, owned by the Stanley Brothers, who make Charlotte’s Web oil. Featured in two CNN documentaries called "Weed" and "Weed II" by Dr. Sanjay Gupta, the brothers have created the Realm of Caring, a nonprofit organization that supports families who move to Colorado to obtain Charlotte’s Web oil for their children suffering from epilepsy.
 
Comment: Although they insist publicly that their CBD products contain less than three-tenths of one percent THC, the Stanley Brothers advocate much higher levels when lobbying legislators. Jesse Stanley persuaded Georgia legislators to allow 5 percent THC in its “Low” THC CBD bill passed last year. Street marijuana did not reach THC levels of 5 percent until 2000. Americans were getting high on pot with lower THC levels in the 60s, 70s, 80s, and 90s.
 
Read about the Stanley Brothers and Charlotte’s Web here.
 
Can Cousin of Marijuana Plant Ease NFL’s Concussion Problem?
 
CW Botanicals and the Realm of Caring are raising up to $100,000 to support a study at John Hopkins University medical school to see if artisanal CBD products such as Charlotte’s Web oil will treat brain injuries that result from repeated concussions many football players suffer. The team has enlisted former NFL players to appear in a YouTube video launched during Brain Injury Week to promote their cause.
 
Read ABC News story here. See YouTube video here.
 
MEDIA
 Weediquette: Could Marijuana 
Help Kids with Cancer?
 
Does the press promote artisanal marijuana products for curing diseases? The answer in a docu-series called Weediquette is a resounding yes. In this documentary, the moderator reports on children with cancer whose parents give them marijuana with extremely high levels of THC to “treat” their cancer. Some even forego chemotherapy, believing that pot will cure them.
 
Read Daily Beast story here. It contains a list to the documentary.
The Marijuana Report is a weekly e-newsletter produced by National Families in Action in partnership with SAM (Smart Approaches to Marijuana). Subscribe to The Marijuana Report and visit our website, The Marijuana Report.Org, to learn more about the marijuana story unfolding across the nation.

About National Families in Action (NFIA)
NFIA consists of families, scientists, business leaders, physicians, addiction specialists, policymakers, and others committed to protecting children from addictive drugs. Our vision is:
  • Healthy, drug-free kids
  • Nurturing, addiction-free families
  • Scientifically accurate information and education
  • A nation free of Big Marijuana
  • Smart, safe, FDA-approved medicines developed from the cannabis plant (and other plants) 
  • Expanded access to medicines in FDA clinical trials for children with epilepsy

About SAM (Smart Approaches to Marijuana) 

SAM is a nonpartisan alliance of lawmakers, scientists and other concerned citizens who want to move beyond simplistic discussions of "incarceration versus legalization" when discussing marijuana use and instead focus on practical changes in marijuana policy that neither demonizes users nor legalizes the drug. SAM supports a treatment, health-first marijuana policy. 

SAM has four main goals: 
  • To inform public policy with the science of today's marijuana.
  • To reduce the unintended consequences of current marijuana policies, such as lifelong stigma due to arrest.
  • To prevent the establishment of "Big Marijuana" - and a 21st-Century tobacco industry that would market marijuana to children.
  • To promote research of marijuana's medical properties and produce, non-smoked, non-psychoactive pharmacy-attainable medications.
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