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Doctors Speak
JAMA Says Little Evidence Supports
Marijuana for Medical Use. 
Epilepsy Society President Says Side Effects of Artisanal CBD Oils Can Be So Severe No Colorado 
Pediatric Neurologist Will Recommend Them.
JAMA Says Little Evidence Supports
Marijuana for Medical Use

Evidence does not support medical marijuana use for most of the diseases and conditions states are permitting, says an editorial in this week’s issue of the Journal of the American Medical Association (JAMA).
 
“First, for most qualifying conditions, approval has relied on low-quality scientific evidence, anecdotal reports, individual testimonials, legislative initiatives, and public opinion,” say the editorial’s authors. “The US Food and Drug Administration (FDA) requires evidence from at least two adequately powered randomized clinical trials before approving a drug for any specific indication,” and evidence for most conditions fails to meet FDA standards.   
 
Second, there are inconsistencies between states about which conditions qualify for medical marijuana. Some states legalize medical marijuana for PTSD or sickle cell anemia, for example, while others do not. Such differences reflect inconsistencies in applying current evidence to legislative decision-making.
 
Third, most FDA-approved  drugs have just one or two active ingredients. Marijuana contains more than 400 compounds whose interactions with each other are poorly understood. In addition, the amounts of some marijuana compounds in various strains vary so widely that precise dosing is difficult, which means doctors cannot give patients proper guidance.
 
Fourth, some individual marijuana components are available commercially (dronabinol and nabilone) and published data exists to guide dosing. Few data exist to guide dosing of smoked [or eaten] marijuana for medical use.
 
Fifth, while short-term adverse effects of marijuana are quite well known, the effects of long-term use need further study. Tolerance and dependence occur with repeated exposure to marijuana, meaning that dosages will have to be increased when the drug is used medically to be effective, increasing the risk of addiction and other problems.
 
Finally, “there is also a small but definite risk of psychotic disorder associated with marijuana use, as well as a significant risk of symptom exacerbations and relapse in patients with an established psychotic disorder,” say the authors. Those with schizophrenia, bipolar disorder, or substance dependence must be identified and measures must be taken to protect them from medical marijuana.
 
“Perhaps US states should establish clinical follow-up programs to monitor long-term outcomes prospectively, especially negative outcomes (e.g. new cases of psychosis) in patients with contraindications.”
 
In addition to this editorial, JAMA also publishes several research articles concerning medical marijuana this week.
 
Read editorial
here.
Read “Medical Marijuana for Treatment of Chronic Pain and Other Medical and Psychiatric Problems, A Clinical Review” here.
Read “Cannabinoids for Medical Use, A Systematic Review and Meta-Analysis” here.
Read “Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products” here.
 
American Epilepsy Society President Says Side Effects of Artisanal CBD Oils Can Be So Severe No Pediatric Neurologist in Colorado Will Recommend Them

Two years ago, the Georgia Legislature tried but failed to legalize artisanal cannabidiol (CBD) oils for children suffering from epilepsy. Artisanal CBD oils are products marijuana growers are making in states that have legalized marijuana for medical use. No grower in these states has submitted its CBD product to FDA for approval as a safe or effective medicine.
 
In contrast, two pharmaceutical companies, GW Pharmaceuticals of Great Britain and Insys Therapeutics of the US, are developing pharmaceutical-grade CBD oils. GW’s version, Epidiolex, is in FDA Phase III clinical trials and Insys Therapeutics is about to undergo FDA testing. The Insys drug is 100% synthesized CBD, meaning it is an exact chemical duplicate of cannabidiol found in the marijuana plant but is made of pure chemicals to eliminate impurities and contaminants. Epidiolex is an extract of marijuana that has been purified to remove impurities and contaminants and is 98% CBD with trace amounts of THC and other cannabinoids. Both drugs must be tested 
 
 in animals to ensure safety before companies can apply to FDA for permission to test their drugs in humans.
Artisanal CBD oils offer no such protections to patients. Random tests have shown that many contain THC, which can cause seizures, contaminants, and in some cases little to no CBD.
 
When the Georgia bill failed last year, Governor Nathan Deal formed a partnership with GW to conduct clinical trials of Epidiolex in Georgia as well as a statewide FDA expanded access program for children not able to enroll in the clinical trials. Both programs are up and running.
 
Despite this, the legislature came back with a bill this year to legalize artisanal CBD oils not only for childhood epilepsy but also for seven other diseases. Moreover, this bill permits possession of up to 20 ounces of CBD oil containing up to 5% THC. The bill passed and the governor signed it in April. It provides immunity from prosecution to those who possess CBD and calls for a special commission to recommend how best to grow marijuana, process it into CBD oils, and distribute it to patients.
 
Like the researchers whose work is published in JAMA today, specialists who treat epilepsy also are beginning to speak out. The NBC-TV affiliate in Atlanta interviewed several this week. Dr. Yong Park, who is helping run the clinical trials in Georgia, says doctors don’t know what the drug interactions are or what the side effects might be because they don’t have the evidence yet. Nor do they know how many pesticides artisanal CBD oils may contain nor what the long-term effects of daily exposure on the brain might be.
 
Under the new state law, when doctors sign a letter approving patients for the state registry that allows them to possess CBD oils, says Atlanta pediatrician Cynthia Wetmore, M.D., Ph.D., "they are required to keep track of the patients. But how do we know what dose to recommend? The oil patients have access to is not standardized. Each batch can be different. There's a lot of variability in each batch. What side effects is it causing, if any? We have to report to the state on each patient, quarterly. It will be hard to know if it's helping or hurting."
 
Perhaps the most haunting concerns come from Dr. Amy Brooks-Kayal, a Colorado pediatric neurologist and president of the American Epilepsy Society. The Atlanta NBC-TV affiliate published her letter to a Pennsylvania representative who held hearings a few months ago on a similar bill in his state. In part, she writes:
 
The families and children coming to Colorado are receiving unregulated, highly variable artisanal preparations of cannabis oil prescribed, in most cases, by physicians with no training in pediatrics, neurology, or epilepsy. 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. Because these products are unregulated, it is impossible to know if these dangerous adverse reactions are due to the CBD or because of contaminants found in these artisanal preparations. The Colorado team has also seen families who have gone into significant debt, paying hundreds of dollars a month for oils that do not appear to work for the vast majority. For all these reasons not a single pediatric neurologist in Colorado recommends the use of artisanal cannabis preparations. Possibly of most concern is that some families are now opting out of proven treatments, such as surgery or the ketogenic diet, or newer antiseizure medications because they have put all their hope in CBD oils.
 
All three epilepsy specialists want parents to know that giving artisanal CBD oils to children exposes them to risks that cannot be defined. They urge parents instead to enroll their children in clinical trials or expanded access programs that are testing pharmaceutical-grade CBD where doctors can monitor the children closely.

Read Atlanta story and full text of Dr. Brooks-Kayal’s letter
here.

To Our Subscribers
 
With this issue, we welcome many new subscribers. We hope you find our e-newsletter will keep you up to date on the marijuana story. Nearly 24,000 readers have clicked through now to read the health report from Colorado featured in the February 4th issue of The Marijuana Report. Many of you shared that issue with others and apparently so did they. More than 11,000 readers have clicked through to the Colorado public safety report featured in our February 11th issue. Thank you for being such effective, committed networkers. For those who missed the Colorado health report, click here (note new link); the public safety report, click here.
National Families in Action and partners, Project SAM and the Treatment Research Institute, welcome our new readers. We hope you enjoy this weekly e-newsletter to keep up-to-date with all aspects of the marijuana story. Visit our website, The Marijuana Report.Org, and subscribe to the weekly e-newsletter The Marijuana Report to learn more.

National Families in Action is a group of families, scientists, business leaders, physicians, addiction specialists, policymakers, and others committed to protecting children from addictive drugs. We advocate for:
  • 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
What is our call to action?
  • Ask your leaders to establish FDA expanded access to Epidiolex® for children with epilepsy.
  • Ask your leaders to find a middle road between incarceration and legalization of addictive drugs.
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