We all knew the pharmaceutical industry would step into the world of Medicinal Cannabis and take over with a bang, but we did not expect it to happen with a whirlwind of professionals voicing concerns globally. Questions are looming about dosing, increased seizures in patients, a death in the trials to seizures, and even other epilepsy drugs that combined with this one can be life threatening. Even the likes of Professor Raphael Mechoulam, the Israeli organic chemist and professor of Medicinal Chemistry at the Hebrew University of Jerusalem in Israel who first isolated and identified THC in the 1960’s and discovered the Endocannabinoid System 3 decades later, created panels and meeting from across the Atlantic to here in California this coming week, and will address this at the huge CannX conference he hosts every year in his country. Dr. David Bearman of the American Academy of Cannabinoid Medicine has been invited to give his input there.
Liz Minda, cannabis advocate and nurse, the mother of Jadyn with Severe Intractable Epilepsy stated, “Epidiolex was the last pharmaceutical we tried and it failed for seizure cessation. Full spectrum cannabis oil stopped seizures and gave her a brighter cognitive and physical ability every day. The best Leap of Faith I have ever taken. Currently, for the last 12 months Jadyn is on CBD only, not Epidolex!” I was part of her compassion crew that helped wean Jadyn from GW’s CBD to the plant – and it’s nowhere near the same. It seems that many are quite upset at the fact that Pharmaceutical CBD will be compared to Hemp derived and Cannabis Flower derived CBD products that do not cause the problems nor carry side effect warnings such as GW Pharmaceuticals has been forced to put on it’s product by the F.D.A., take a look – you decide. Would you take this drug as a replacement for pharmaceuticals? Would you consider it a ‘good representation’ of the ‘dangers’ of Cannabis products? How many of us want these type of warnings blasted out on TV advertisements for the drug creating a new “Reefer Madness 2019” in which people that are considering cannabis as medicine will then change their mind. Approval of a drug, or a way to scare consumers away?
WARNINGS AND PRECAUTIONS (From FDA Website) Hepatocellular Injury: EPIDIOLEX can cause transaminase elevations. (LIVER DAMAGE) Concomitant use of valproate and higher doses of EPIDIOLEX increase the risk of transaminase elevations. See Full Prescribing Information for serum transaminase and bilirubin monitoring recommendations. (5.1) Somnolence and Sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX. (5.2) Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts. (5.3) Hypersenstivity Reactions: Advise patients to seek immediate medical care.(5.4) Withdrawal of Antiepileptic Drugs: EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.
LET ME INTERRUPT: Status epilepticus (which kills nearly 50,000 people per year, Olympian “FloJo” died of seizures/status in her sleep) is caused by discontinuing a cannabis product? Since when does stopping a cannabis created product CAUSE the problem you’re treating? Since when is CBD addictive? Never… but when does a pharmaceutical cause us problems? When are they addictive? Daily.
(5.5) ADVERSE REACTIONS: The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) are: somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder, and poor quality sleep; and infections. (6.1).
(ALL of the above will be ‘disclaimed’ in Television and print advertisements, and quickly the world will liken CBD itself to Big Pharma’s version)
USE IN SPECIFIC POPULATIONS: Pregnancy: Based on animal data, may cause fetal harm.
I’m not sure how you’re deciding on this one but for me this is quite obvious. It’s not CBD that does these things to people, it’s pharmaceuticals. It’s not the plant that would ever cause these problems – it’s pharmaceuticals. Leave it to that industry to dirty the name of a plant that saves and changes lives daily. We as a movement to legalize nature should not step back and watch, once again, as Big Pharma creates a cannabis medicine and it’s scheduled way down the list like Marinol (Synthetic THC) which has been a Schedule 3 since 1985. Epidolex proposal is at Schedule 4. How possibly can our country’s leadership sleep at night with the plant these drugs came from still schedule 1 while our citizens fight death defying illness and fight to gain access to a plant to become “Illegally Healed”?
Mike Robinson, Medicinal Cannabis Patient, Director of Communications American Academy of Cannabinoid Medicine. Founder, ICCRI & Domestic Animal Research Institute