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Marijuana Extract May Help
Some Children With Epilepsy, Study Finds
 
NPR reports on the American Epilepsy Society’s annual meeting being held this week. Several papers about Epidiolex, a pharmaceutical version of CBD oil made by GW Pharmaceuticals, and childhood epilepsy are being presented.
 
The largest study started in 2014 with 313 children from 16 epilepsy centers across the country. Sixteen percent of participants withdrew from the three-month trial because the drug either was ineffective for them or they experienced adverse side-effects.
 
But 261 patients who continued in the trial experienced reductions in severe seizures by almost half. Many continued experiencing benefits after the trial ended, including 9 percent of all patients and 13 percent of those with Dravet syndrome who were seizure-free, many for the first time in their lives.
 
Until a full clinical trial with a placebo-controlled element is completed, however, it’s impossible to tell if Epidiolex is having a real effect on epilepsy, says Dr. Orin Devinsky.
 
“Full on, randomized clinical trials testing Epidiolex for epilepsy are already underway, but it will still take some time until the results are out,” he says.
 
Though he understands parents’ desperation, his advice is to wait for the results.
 
The American Epilepsy Society fully supports the clinical trials being carried out by GW Pharmaceuticals as well as a trial to begin with another pharmaceutical version of CBD developed by INSYS Therapeutics.
 
But the Society warns against using CBD products that states have legalized because they are not regulated for purity or uniformity.
 
“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,” writes Amy Brooks-Kayal, MD, president of the society in a July 13, 2015 letter to Idaho Governor Butch Otter.
 
Whether these distressing events are due to “artisanal” CBD products themselves or contaminants they may contain no one can say, she says. The society encourages states to fund research instead.    
 
Read NPR story here.
 
Cannabist Specialist GW Pharma
Ramps Up Capacity Ahead of Key Drug Approval
 
The Telegraph of the UK writes that GW Pharmaceuticals is ramping up its production capacity in the US in anticipation of FDA approval of Epidiolex sometime next year.
 
Production has already increased by 20 times this year and is expected to double in 2016 to meet the demand for Epidiolex if it is approved. Analysts believe approval may come by early 2017.
 
The scaling up will result in some 200 tons of raw material a year. GW makes Epidiolex from specially grown marijuana plants from which cannabidiol is extracted, purified and formulated. This level of production will result in 1.6 million 100mg bottles of Epidiolex, enough to supply 55,000 seriously ill children for a year.
 
GW expects to get the results of its US clinical trials of Epidiolex in the first half of 2016. The next step is to present data from the trials to FDA for approval of the drug.
 
Read The Telegraph story here.
 
Newspapers May Violate Federal Law by Carrying Marijuana Ads, Postal Service Warns
 
The US Postal Service warned newspapers in the northwest that it is illegal “to place an ad in any publication with the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule I controlled substance.” Marijuana is a Schedule I drug under federal law.
 
The warning added that if the ad advocates buying marijuana from a dispensary it does not comply with the law.
 
Many weeklies send some or all of their newspapers to subscribers through the mail.
 
The president and publisher of the Portland Tribune said this does not affect his paper because it made the decision not to accept marijuana ads. “We just want to adhere to the policies we think are promoting the health of Oregon,” he added.
 
Other publishers are seeking clarification of the ruling because there has been an explosion of pot shops in Oregon once medical marijuana dispensaries converted to recreational marijuana shops. They use billboards, websites, and news ads to showcase their products in a highly competitive market.
 
Read The Register Guard story here.
 
Minnesota Adds Pain
to Medical Cannabis Conditions List
 
The state’s health commissioner announced he will add intractable pain to the list of conditions that qualify for treatment with medical marijuana. This will breathe new life into the state’s medical marijuana industry, says the business publication.
 
The commissioner overruled a state panel’s recommendation not to add pain, “based on a lack of scientific evidence that cannabis helps alleviate pain.”
 
The commissioner said he was influenced by hundreds of Minnesotans who testified at public hearings in support of the move.
 
Read Marijuana Business Daily story here.  Read Health Commissioner’s press release here.
 

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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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