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Global cannabis powerhouse GW Pharmaceuticals has been successful in its talks with the U.K. health authorities and NHS patients can now access its drugs for two types of epilepsy and spasticity.
This should allow over 10,000 patients easier access to GW’s Sativex and Epidyolex cannabis medicines through the country’s National Health Service (NHS). The decision has been welcomed by U.K. firm GW, charities and campaigners whilst others say its a missed opportunity as the new recommendations ‘have not gone far enough’.
In August, the U.K.’s National Institute for Health and Care Excellence (NICE) interim report into the cost-effectiveness of Cannabis Based Medicinal Products (CBMPs) was unveiled.
It ruled GW’s Epidyolex and Sativex too expensive, but following months of talks GW Pharmaceuticals has learnt both drugs have now been approved for use by the NHS in England. Experts estimate the cost of Epidyolex at around £20,000 to £30,000 a year and GW’s chief operating officer Chris Tovey said, at the time, it was in discussions with NICE over pricing.
Responding to the latest news in a company press release, he said: “This is a momentous occasion for UK patients and families..(and)… proof that cannabis-based medicines can successfully go through extensive randomised placebo-controlled trials and a rigorous NICE evaluation process to reach patients.”
Doctors will now be able to prescribe Epidyolex, for children with two types of severe epilepsy – Lennox Gastaut syndrome and Dravet syndrome. An estimated 3,000 people with Dravet and 5,000 with Lennox Gastaut syndrome in England will benefit.
Sativex, a mouth spray that contains a mix of THC and CBD, has been approved for treating muscle stiffness and spasms, known as spasticity, in multiple sclerosis. However doctors will not be allowed to prescribe it to treat pain.
Prof Helen Cross, a consultant in pediatric neurology at Great Ormond Street Hospital, who led UK trials of Epidyolex, said it was ‘great news’. However the campaign group, End Our Pain, said the new guidelines are a massive missed opportunity.
The BBC report spokeswoman Millie Hinton saying: “This restrictive guidance is condemning many patients to having to pay for life-transforming medicine privately, to go without or to consider accessing illegal and unregulated sources.”
Genevieve Edwards, from the MS Society, said they had been campaigning for access to Sativex for years and ‘it was brilliant NICE has finally listened’. But, she hit out at the lack of recommendations on pain saying it is a common symptom of MS.
The NICE guide guidelines found a lack of evidence regarding the use of cannabis drugs in the management of chronic pain.
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Cannabis-based medical treatments will soon be available within the National Health Service in both England and Wales following a landmark decision this week.
In the guidelines published Monday, the National Institute for Health and Care Excellence outlined the circumstances under which such treatment would be appropriate, including childhood epilepsy, multiple sclerosis, and chemotherapy-induced vomiting and nausea.
The institute, a public body that provides guidance on health care matters in the United Kingdom, said that the initial cannabis prescription “must be made by a specialist medical practitioner,” and that the specialist “should also have a special interest in the condition being treated.” For children, “the initiating prescriber should also be a tertiary [pediatric] specialist,” the institute said.
The guidelines represent a milestone for Britain, where laws governing pot use are stricter than other countries in Europe, and where medical cannabis has been slow to roll out.
Turning a New Leaf
But attitudes are changing quickly among UK policymakers. British home secretary Sajid Javid said last year that physicians in the UK would be able to prescribe medical marijuana for patients, a decision that came after a long-running campaign inspired by two high-profile cases involving children who suffer from a form of epilepsy that is mitigated by the use of cannabis oil.
One such case centered around Billy Caldwell, a 12-year-old suffering from life-threatening seizures who had his medicinal marijuana confiscated at Heathrow Airport in 2018.
“Having been moved by heartbreaking cases involving sick children, it was important to me that we took swift action to help those who can benefit from medicinal cannabis,” Javid said last year.
But the treatment remained painfully elusive in the UK, and the rollout has been a slow-go, making the guidelines this week from the National Institute for Health and Care Excellence a watershed moment for the new policy.
Charlotte Caldwell, the mother of Billy, told Sky News on Monday that it was “an incredible day for the UK.”
The New York Times reported that the “that the recommendations [from the National Institute for Health and Care Excellence] could immediately be applied for England and Wales, with Northern Ireland expected to consider use on a case-by-case basis,” while they will not apply at all to Scotland, which has its own health care body.
A growing chorus of British lawmakers would like to go even further and make recreational marijuana use legal, as well. Several members of UK parliament (MPs) made an exploratory visit this summer to Canada, where pot has been legal for a little more than a year, and returned motivated to end prohibition in Britain.
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Patients in over 30 European countries could soon be able to get access to GW Pharmaceuticals Epidyolex cannabis medicine after it was approved by the European Commission.
Since its launch in the U.S last year GW’s sales have rocketed with Epidiolex (as it is known in America) boosting its revenues by over $30m in its first quarter, with more than 7,600 patients accessing the drug.
Now the European Medicines Agency has approved marketing authorisation in the 28 member states of the European Union, for its use for two conditions associated with childhood epilepsy; Lennox‑Gastaut syndrome and Dravet syndrome.
The medicine – a strawberry-flavoured oral CBD with the anti-seizure drug clobazam – can now be launched across Europe. Up to 50,000 children and young adults in Europe have one of the two syndromes, reports The Guardian newspaper.
GW was formed in the 1990s and and created one of the first medical cannabis medicines with Sativex – a one to one combination of CBD and THC – used to treat muscle spasms caused by MS and other conditions. In its market statement on the EC approval GW said it had stemmed from the results of four randomised, controlled Phase 3 trials, incorporating data from more than 714 patients.
In GW’s press release Isabella Brambilla, Chairman, Dravet Syndrome European Federation said: “The approval of cannabidiol oral solution is an important milestone for patients and families whose lives are significantly impacted by these rare, complex and life-long forms of epilepsy.”
In an earlier market statement GW said it was looking at five European markets to initially launch Epidyolex: France, Germany and the U.K. with the other two unnamed countries to follow. Justin Gover, GW’s Chief Executive Officer said the approval is the realisation of ‘many years of dedication and collaboration between GW, physicians and the epilepsy community’.
He added: “We are delighted to be the first to offer this solution to the epilepsy community.”
The E.C. decision is valid in all 28 countries of the European Union, alongside Norway, Iceland and Liechtenstein. However, despite this good news GW has still to convince the U.K. medical authorities to approve both Epidyolex and Sativex.
In the last few weeks, the U.K. deemed both to be too costly at around £30,000 a year. GW’s chief operating officer, Chris Tovey, said the company was in discussions with the UK’s National Institute for Health and Care Excellence (NICE) about making the drug available on the NHS.
He said: “The feedback [in the US] has been incredibly positive.” He said it is ‘very optimistic’ that NICE would agree to fund Epidiolex. We are hoping for a relatively rapid decision from NICE and we are hoping to make it available for U.K. patients in the next couple of months,” he said in a press release.
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The European Union has approved a CBD-based medicine as a treatment for seizures associated with two severe forms of epilepsy. The move by regulators with the European Medicines Agency (EMA) marks the first time a drug derived from cannabis has been approved for use in Europe. The medication, Epidyolex, is an oral solution rich in cannabidiol, or CBD.
“The approval of EPIDYOLEX® marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy,” said Justin Gover, the CEO of GW Pharmaceuticals, in a press release.
“This approval is the culmination of many years of dedication and collaboration between GW, physicians and the epilepsy community,” Gover added. “We believe patients and physicians deserve access to rigorously tested and evaluated cannabis-based medicines, manufactured to the highest standards and approved by medicines regulators, and we are delighted to be the first to offer this solution to the epilepsy community.”
Drug Offers New Hope
The drug was approved as an adjunct therapy for patients with Dravet syndrome and Lennox-Gastaut syndrome, two severe forms of epilepsy that usually appear early in life and can cause up to hundreds of seizures per day. The medication is approved for use by patients two and older in conjunction with clobazam, an existing treatment for epilepsy.
Professor Elinor Ben-Menachem of the University of Goteborg’s Sahlgren Academy and Hospital in Sweden said that the approval of the drug offers patients and families hope for better seizure control and improved quality of life.
“LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy, with few patients achieving adequate seizure control,” said Ben-Menachem.
Isabella Brambilla, the chairman of the Dravet Syndrome European Federation, said that the approval of the drug is an exciting achievement for patients and families eager for a new treatment option.
“The approval of cannabidiol oral solution is an important milestone for patients and families whose lives are significantly impacted by these rare, complex and life-long forms of epilepsy,” said Brambilla.
Drug Also Available in U.S.
Last year, the drug was approved for use in the United States by the Food and Drug Administration under the trade name Epidiolex. The Drug Enforcement Administration subsequently relisted Epidiolex under Schedule 5 of the nation’s list of controlled substances, but the relisting did not apply to other forms of cannabidiol.
CBD derived from hemp was legalized in the U.S. with the passage of the 2018 Farm Bill in December. The FDA is currently in the process of formulating regulations for the use of CBD as a supplement or an ingredient in foods.
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I first met Mike Robinson when discussing a previous High Times article on cannabis use and depression and was amazed by what he shared about his own life and the power that the plant had on him.
The former civil rights lobbyist and law professional has always had a passion for children, especially those in need. Robinson’s lobbying and legal work saw him advocating for children with different needs for over 20 years. He has also volunteered for charities aiding children and animals. Robinson also suffers from epilepsy himself and understands the limitations it can put on a person.
In recent years, Robinson has become the director of communications for the American Academy of Cannabinoid Medicine and is the founder of the Global Cannabinoid Research Center.
It was his work as the founder, director and in-person provider for the American Cannabis Compassion Alliance, which went to families across California and provided them with cannabis medication when in need. Robinson himself would travel the state from his Los Angeles by train to meet with patients. Due to his epilepsy, he was not able to drive himself.
Robinson’s work left him fielding calls and messages all day and night. Often, he would have his two phones on silent when going to bed. By chance, this one night in 2016 would be different.
While trying to sleep for a long train ride in the morning for work, he received a frantic message from a mother, Anne Mari, who found Robinson’s information through a Facebook search CBD and epilepsy. She was calling about her daughter, Genevieve.
Genevieve’s story extends beyond epilepsy and involves a painful misdiagnosis at age two. Anne Mari explained that she had taken her daughter to the doctor several times out of concern, but was turned away, with the doctor telling her she had nothing to worry about. However, when Genevieve suffered her first grand mal seizure at two years old, doctors said treatment would not reverse the brain damage she experienced due to frequent seizures.
After some time on medications, she began to be weaned off in 2015. However, things would not be positive for too long.
That night, Anne Mari messaged Mike and told him that she had been given a gram of CBD by a friend and wasn’t sure how to give it to her daughter, who has severe autism, epilepsy and O.C.D. Additionally, Genevieve suffered from frequent grand mal seizures and excessive “digging” into her own skin, among other awful side effects.
The results were so debilitating that she would only be allowed back in school if UCLA medical professionals signed off.
“Genevieve was going to be held back even in 8th grade after over a year of using oils, but the entire educational and therapy team made the decision with us that it was time to get her into high school,” Anne Mari explained.
Robinson fit the family into his schedule the next day.
“I was very concerned because the medication she was taking directly contradicted with CBD and could actually cause more seizures….They were psychotropic medications that an autistic child doesn’t need to be on. So I wanted to be there immediately, you know, to see what would happen,” Robinson recalled.
The next day, he arrived to find Anne Mari distressed as her daughter suffered another grand mal seizure. “When he got here that day,” Anne Marie recalled, “we had already been to the doctor that morning because she was so bad. A doctor was so troubled by Genevieve. She went to her purse, that of her own personal money. She took a $50 pill because she knew I was very financially strapped since her father died and she said, ‘I want you to get this kid to UCLA immediately and get a second opinion.’”
This dire situation led Robinson to feel a sense of urgency he had never felt before. He saw that the CBD Anne Mari had been given was around 80% potent and would be too strong to administer to a child orally.
Instead, Robinson went to his car and got a THC “rescue oil.” He gave the mother the standard warning that he is not a medical professional and that risks were present. In need of relief for her daughter, Anne Mari approved. They both said she responded immediately and was back on her feet.
What happened next brought tears to the whole house: Genevieve got up and walked to her room with an iPad. Mike turned to see Anne Mari crying. “I actually asked her not to call the police,” he recalled with a laugh. She was crying because Genevieve could barely stand, much less walk to her room, on the cocktail of drugs she had been prescribed.
Not only that, she was humming as well. Robinson learned that it was the sound Genevieve made when she was happy; a sound the family had not heard in ages. After losing her father at a young age and having to take numerous medications, Genevieve was finally humming her happy tune again.
Robinson checked in the next day and stayed in touch with the family, as he did with other families he worked with. But something connected deeper with Genevieve than other clients. The same would be said for him and Anne Mari, who slowly began to form a deeper bond.
The two took it slow at first. After three months of dating in 2016, Robinson visited for Christmas. He didn’t leave until the 10th of January.
“I came in and stayed for those two weeks and that’s when we became a family,” he said.
A few days after leaving, Anne Mari and Genevieve’s older sister, Fatima, would tell Robinson that Genevieve wanted him around. This was made clear by the videos of her referring to him as “Daddy.”
While California’s Prop 64 ended Robinson’s compassion service, there is plenty of good news to celebrate. Three years since the first meeting, the entire family now puts their faith in cannabinoids to treat their various conditions. Robinson reported, “Genevieve is off all pharmaceuticals. I’ve quit opioids. Anne Mari used to drink, and she just celebrated two years sober…all using cannabinoid medicine.”
In addition to excellent health news, Genevieve is in school and will turn 16 in August. Meanwhile, Mike and Anne Mari have gotten engaged.
Robinson explained how the family is doing much better these days. “We’re growing as a family. I think the love is just incredible.” He added, “It shines through because every element, as much as we have flaws and defects, we just shower with compassion and love from the inside. This whole family started with love. So, every time we have a problem, that’s what steps in and solves it.”
Today, the family continues to advocate for children in need and for education about the benefits of cannabinoid treatment. To learn more about Mike Robinson, Genevieve, and others using cannabinoid treatments, visit Mike’s Medicines, the blog Robinson operates.
The post Genevieve’s Journey: How Cannabis Helped Save a Life and Create a Family appeared first on High Times.
A hospital in Florida has diagnosed one of its patients with drug abuse after he admitted to his doctors he uses cannabis to treat his epilepsy, according to a report in local media. The diagnosis came while Michael Morell of Homestead, Florida was undergoing treatment after having a grand mal seizure in June.
Morell, who had been previously diagnosed with epilepsy, says that on the morning of June 20 he woke up to his alarm clock, rose in bed to hit the snooze button but then was unable to lie back down. His muscles had become rigid, to be followed soon by violent convulsions.
“It’s weird because I didn’t feel like there was anything wrong in that moment, but I was confused as to why I was in an upright position,” Morell told the Miami New Times. “The next thing I remember is being in the hospital bed with my family surrounding me.”
Morell’s wife Tania Gonzalez had been wakened by Morell’s spasms and became alarmed when he was unable to respond. She quickly called 911 and he was rushed to Homestead Hospital.
Once he arrived at the emergency room, Morell was given morphine and had another seizure in the hospital. The physician on duty ordered a series of medical tests including a CT scan, MRI, EKG, and toxicology screening. The MRI revealed that Morell had a 4-millimeter cyst on the mesial temporal lobe of his brain.
Doctors Question Medical Use of Cannabis
A few hours later, a psychiatrist by the name of Daniel F. Mandri came to talk to Morell in his hospital room.
“At first, I didn’t think anything was off, but then he started asking me weird questions,” Morell said.
Eventually, the psychiatrist got to the point and asked Morell directly if he “did cannabis.” Morell replied that he used a medical marijuana nasal spray with the recommendation of his doctor to treat his epilepsy and occasionally smoked a joint to relax.
According to consultation notes provided by Morell, the psychiatrist had been “asked to see patient for ‘drug abuse and seizures.’” The following day, Morell’s attending physician, Dr. Jimena Amparo Blandon, came to see Morell, who was told he had cannabis abuse disorder.
“Yes, I smoke weed,” Morell said later. “But I have a medical marijuana license and a full green light to do this legally.”
Morell was also told that cannabis could actually exacerbate his seizures and might cause schizophrenia. After the visit from Blandon, Morell asked to be released from the hospital. Upon his discharge, he was given a four-page guide on cannabis abuse disorder and was told he should seek help at a drug treatment facility.
Citing doctor-patient confidentiality, Homestead Hospital declined to comment on Morell’s experience at the facility. Blandon and Mandri failed to answer requests for comment.
Cannabis Stigma Alive and Well
Although the medical use of cannabis was approved by Florida voters in 2016, patients who choose the option continue to face the stigma associated with marijuana. The state legislature attempted to outlaw smokable forms of cannabis, a move that was eventually ruled unconstitutional and repealed. Subsequently, ways to limit the amount of THC in cannabis have also been considered.
Other attempts to tightly control access to medical marijuana, such as a limit on licenses available for marijuana businesses and a requirement that all providers be vertically integrated, have also been challenged in the courts.
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