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Charlotte Figi, Who Helped Popularize CBD for Medical Use, Dies at 13

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Her mother said members of the family had been sick with what they believed was Covid-19, reports New York Times.*

Charlotte Figi, whose use of cannabidiol, or CBD, to treat her epilepsy helped popularize its medicinal use, died on Tuesday April, 07. She was 13.*

Her death was confirmed by her parents, Paige and Steven Figi, who said the cause was most likely complications related to Covid-19, the disease caused by the new coronavirus.*

Charlotte became the face of the medicinal CBD movement when she was 5 years old, after it appeared that taking CBD eased the symptoms of her epilepsy.*

She had her first seizure when she was 3 months old. Soon after, her parents were told that she had Dravet syndrome, a rare form of epilepsy that starts in infancy.*

By age 5, Charlotte was having over 300 seizures a week, about one every 30 minutes, Ms. Figi said. Charlotte was in a wheelchair and used a feeding tube because she could not swallow, her mother said. On several occasions, she was resuscitated after her heart stopped.*

The family tried dozens of medications but they did not work. “We were told by the doctor there was nothing left to try pharmaceutically,” Ms. Figi said.*

Ms. Figi began to research CBD, a nonintoxicating, nonpsychotropic compound found in cannabis. The cannabinoid was being used overseas to treat epileptic patients. She found a grower who agreed to grow the hemp needed to extract CBD oil for Charlotte.*

“I didn’t think it was going to work,” Ms. Figi said.*

But it did. Charlotte did not have any seizures for seven days after starting the treatment, Ms. Figi said.*

“She started talking, making eye contact, walking, and we removed her feeding tube,” her mother said. The seizures were reduced to about one a month.*

Dr. Sanjay Gupta, the chief medical correspondent on CNN, interviewed Charlotte for his 2013 documentary special “Weed,” and later advocated the use of CBD to treat epilepsy.*

Charlotte’s story made national headlines, and soon other epileptic patients followed her lead. Many saw similar results, Ms. Figi said.*

In 2011, Charlotte’s Web CBD was founded by Joel Stanley, the hemp grower who helped Charlotte. The company was named after her.*

“What began as her story, became the shared story of hundreds of thousands,” Mr. Stanley wrote on the company’s Facebook page. “Her story built communities, her need built hope, and her legacy will continue to build harmony.”*

In 2018, the Food and Drug Administration approved a cannabidiol medication, Epidiolex, to treat the seizures caused by Dravet syndrome. It was the first drug to be approved by the F.D.A. for the condition.*

Ms. Figi said the members of her family experienced an illness in early March that she believes was Covid-19, but they did not meet the requirements to be tested.*

“I’ve never been that sick in my entire life,” Ms. Figi said on Thursday. “We are a very healthy family.”*

While the rest of the family was recuperating, Charlotte’s condition worsened and she was taken to Children’s Hospital in Colorado Springs on April 3, her mother said. Charlotte tested negative for the virus and was discharged two days later.*

On Monday, Ms. Figi said, Charlotte was feeling better. She painted Charlotte’s toenails and they sat in the sun for a while. But early Tuesday morning, Charlotte had a seizure and became nonresponsive, her mother said.*

“It was the last moment she was alive, I feel,” she said.*

Charlotte was resuscitated by paramedics and rushed to the hospital. She had a seizure that led to her going into cardiac arrest, her mother said.*

Ms. Figi said that Charlotte’s test for the coronavirus came a month too late. (False negatives are a known problem with the current coronavirus tests.)*

In addition to her parents, Charlotte is survived by her twin sister, Chase; her brother, Maxwell, 16; and her mother’s husband, Greg Iafeliece.*

For nine years, thanks to CBD, Charlotte had the opportunity to live a life with a close resemblance to that of any young girl, her mother said.*

Charlotte was adventurous. She liked to hike and ride on the front of a tandem bike with her mother, and she enjoyed riding horses with her sister. But what was most important, Ms. Figi said, is that Charlotte was oblivious to the movement she started.*

“She found incredible resolution from cannabis but she didn’t know,” Ms. Figi said. “She had a good life.”*

* article original

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*** editor’s note.: our condolences to the Figi family and their loved ones. A starlight has faded away.

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As customers hoard pot brownies, North American weed firms see lockdown boost*

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Cannabis sales are touching new highs as customers across the United States and Canada stockpile weed to prepare for long spells of isolation because of the coronavirus pandemic, reports Reuters.*

Between March 16 and March 22, sales of recreational cannabis across key U.S. markets, including California, Colorado, Oregon and Alaska, were up 50% and medical marijuana sales rose 41% from the same period last year, figures obtained from cannabis point of sale and data platform Flowhub show.*

Several U.S. states and Canadian provinces have taken steps to curb the fast-spreading coronavirus by issuing stay at home orders, restricting business operations, or closing down borders as death toll in both countries approaches 600.*

While many businesses have been ordered shut, cannabis stores have been listed as essential services and allowed to remain open.*

In Ontario, Canada’s most populous province, online sales on the government-run Ontario Cannabis Store’s (OCS) website have soared over the last two weeks, OCS director of communications Daffyd Roderick, said. For example, last weekend’s orders were more than twice as high as only two weeks ago.*

In Nova Scotia, which on Sunday became the latest province to declare coronavirus emergency, cannabis sales spiked 76% last week, according to the province’s liquor commission, which controls sales of cannabis there.*

Fears of months of supply disruptions were boosting Canadian sales, Stuart Titus, CEO of California-based Medical Marijuana Inc (MJNA.PK) told Reuters.*

“We have seen stockpiling in Canada by consumers who have snapped up products from LPs (licensed producers).”*

The surge in demand may offer pot producers a welcome respite after investors sold off cannabis stocks throughout much of last year as profits in the sector remained elusive.*

Jamie Pearson, CEO of California-based Bhang Inc BHNG.CD, which makes cannabis-infused beverages, chocolates and other products, said sales were booming and should boost revenue and profits this quarter.*

Pearson said edibles such as gummies, brownies, and chocolates, were most popular, probably because they were easier to store and eat, even with gloves on.*

Still, Titus and others recommended caution, saying the long-awaited reversal of fortune could prove not much more than a short-lived relief.*

“The cannabis industry is showing itself to be recession-proof but at times like this, it’s important to understand that the spike in consumer demand is probably not going to last long,” Avis Bulbulyan, CEO of cannabis consulting firm Siva Enterprises, said.*

* original article

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Long lines at San Francisco area cannabis stores exempt from coronavirus lockdown

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Millions of California’s Bay area residents can still legally light up as cannabis facilities are exempt from a cornonavirus lockdown that has shuttered most businesses in San Francisco and nearby cities, reports Reuters*.

Cannabis store managers say they have lines longer than local grocery shops and waiting room only. Most staff at a dozen stores reached Tuesday evening said they were too busy to talk to Reuters. *

“Oh man, we’re flooded. As soon as people heard we were still open, they started lining up,” said Anthony Barajas, the general manager of Cana Culture in San Jose. *

“Once all the toilet paper got sold out, they knew they needed some relief,” he said. *

Bars, clubs, gyms and other businesses all closed Monday under one of the strictest orders made so far in the United States aimed at stemming the coronavirus pandemic. Around 7 million people reside in the area affected by the orders. *

Cannabis stores and vendors join the short list of “essential” places that can stay open along with grocery stores, pharmacies and doctors offices, the San Jose Mercury News and other media reported, citing the state’s Bureau of Cannabis Control and local officials. *

California has more than 500 confirmed cases of coronavirus and at least 12 people have died. *

Cana Culture is following strict rules, such as no more than 10 people in the facility at a time, either shopping or relaxing in a smoking area. Outside, the store’s security officers enforce a store rule that everyone has to stand about an arm’s length away from each other. *

“We’re a necessary service,” said Barajas. “People need this for medical purposes and recreation. The public still needs access to lab-tested medicine.” *

“It’s been steady from the time we open right up until we close, with people still waiting outside,” Barajas said. “And we’re still allowed to do curb-side service.” *

He added: “I guess the state still needs some tax revenue while everything else is closed.” *

* original article

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Malawi legalises cannabis for medicine and industrial fibres*

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Malawi has become the latest country in southern African to relax laws against growing and selling cannabis, making it legal for use in the production of medicines and hemp fibres used in industry,

Malawi’s parliament passed a bill on Thursday that makes it legal to cultivate and process cannabis for those two uses, but stops short of decriminalising recreational use. Agriculture Minister Kondwani Nankhumwa tabled the bill. *

A growing number of countries around the world are either legalising or relaxing laws on cannabis, also known as marijuana, as attitudes towards the drug change. They include several in southern Africa, most recently Zambia, which in December legalised production for export. *

They follow Lesotho, which became the first country in the region to legalise cannabis, for medicinal purposes, in 2017, and Zimbabwe. South Africa meanwhile has decriminalised domestic personal use, and is in the process of lifting a ban on commercial cultivation of the plant. *

“We are very happy that finally we’re taking the right steps to move the country’s economy forwards,” Chauncy Jere, a director of Ikaros Africa, one of the two companies conducting industrial hemp trials in Central Malawi, told Reuters. *

“There’s no denying that cannabis would be a lucrative industry and its demand is huge,” said Jere, who is spokesman for the Hemp Association of Malawi. *

Tobacco, a drug scientists say is far more addictive and ruinous to health than cannabis, has been Malawi’s chief foreign currency earner since independence from Britain in 1964. *

* article original

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Increasing numbers of older Baby Boomers are using marijuana: study*

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In just four years, marijuana use grew by 75% among Americans aged 65 and older, according to a new study, and researchers expressed concern over a lack of information on the potential health implications, reports Reuters.*

The increase was most pronounced in women, those with higher incomes and more education, according to a report published on Monday Feb 24th, in JAMA Internal Medicine. *

The findings continue a trend seen over the last decade, said the study’s lead author, Benjamin Han, an assistant professor of geriatric medicine and palliative care at the New York University School of Medicine. *

“Consider that not even 10 years ago 0.4% of adults 65 and older said they had used marijuana in the past year, and now it’s 10 times that at 4%,” Han said. *

The trend is concerning, Han said, because of the lack of research on the effects of cannabis on older people. Some prescription and even over-the-counter medicines, such as Benadryl, affect older people differently, he said. *

It was not known whether the trend is tied to marijuana becoming legally available in a growing number of U.S. states, or if people had been using the drug for many years before turning 65. *

Although researchers initially suspected medical issues might have driven the rise in marijuana use among seniors, most appeared to be in relatively good health, Han said. *

Researchers looked at four recent years of data from the National Survey on Drug Use and Health. Among 14,896 respondents to the nationally representative survey who were 65 or older, marijuana use increased from 2.4% to 4.2% from 2015 through 2018. *

In men, the percentage rose from 3.6% to 4.2%, while for women it jumped from 1.5% to 2.9%. Among college educated seniors, marijuana use over age 65 rose from 2.9% to 6.2%, and in those making $75,000 a year or more, from 2.4% to 5.5%. *

The findings underscore the importance of monitoring marijuana use in this growing population, said Ziva Cooper, research director at the UCLA Cannabis Research Initiative, who was not involved with the study. *

“Without these data, we wouldn’t know what was going on in this age group,” she said. “It’s the fastest growing one and it’s important to study.” *

It also points to the need for additional research. *

“You want to know about the frequency of use, what percentage are using daily, weekly, monthly, and what are the consequences of use in this age group,” Cooper said. “Another question is are these people newly initiating use or are they ones who were smoking marijuana in the ‘60s and ‘70s and are going back to it now.” *

* original article

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*** ed: Professor Han’s studies are frequently funded by the National Institute on Drug Abuse (NIDA). NIDA-funded studies are known to be essentially negative or to create distrust of all kinds of substances, including cannabis.

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Access to medical marijuana tied to reduced workers’ comp claims*

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Legalizing access to medical marijuana may lead to fewer workers’ compensation claims, a U.S. study suggests, reports Reuters.*

In states with laws allowing medical marijuana, researchers tied the accessibility of cannabis to a nearly 7% decline in workers’ comp claims. When there were claims, they were for shorter periods of time, on average, after medical marijuana was legalized, according to the analysis in Health Economics

“We think there is a lot of overlap between conditions for which medical marijuana can be used in managing symptoms and the types of illnesses that lead people to file workers’ compensation claims,” said study coauthor, Catherine Maclean, an associate professor in the economics department at Temple University in Philadelphia.*

For instance, medical marijuana can be used to reduce chronic pain symptoms. While cannabis use isn’t going to cure the condition causing the pain, it can allow the individual to mitigate the symptoms, said Maclean, who is also a research associate at the National Bureau of Economic Research and a research affiliate at the Institute for Labor Economics.*

“When a state adopts medical marijuana legalization there is a modest decline in the propensity to file claims and a reduction in the (overall average) income people receive from workers’ compensation,” Maclean said.*

In some of her earlier research, Maclean found that after legalization of medical marijuana, older workers experienced a reduction in pain and an increase in the number of hours worked.*

To look at the potential impact of medical marijuana legalization on workers’ comp claims, Maclean and her coauthor turned to data from the Census Bureau’s Annual Social and Economic Supplement to the Current Population Survey in 1990-2013. Each year between February and April, the survey interviews 150,000 U.S. residents aged 15 and older.*

When the data were analyzed, the researchers found a 6.7% decrease in claims when medical marijuana was legally available. In addition, the dollar amount of claims decreased by 0.8%.*

The new study provides a window on the possible impact of medical marijuana legalization on people’s ability to work even when in pain, said David Powell, a senior economist at the RAND Corporation in Arlington, Virginia.*

“The literature studying medical marijuana laws is constantly trying to understand whether these policies provide additional opportunities for pain management,” Powell said in an email. “This study takes a very clever look at whether medical marijuana policy affects workers’ compensation claiming behavior, an interesting proxy for the ability to work with reduced pain that this literature has not studied before.” *

Overall, the study is very carefully done and provides convincing evidence, he said. “The estimates are relatively small in terms of workers’ compensation claiming behavior but possibly hint at bigger effects on other labor-supply margins.”*

SOURCE: bit.ly/374dNw9 Health Economics, online February 4, 2020.*

* article original

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Aurora Cannabis to take C$1 billion in charges, cuts 500 jobs as CEO exits*

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Aurora Cannabis said Chief Executive Terry Booth will retire and Executive Chairman Michael Singer become interim CEO as the beleaguered marijuana producer announced C$1 billion ($752.79 million) in impairment charges on Thursday Feb 6, reports Reuters.*

The company also cut about 500 jobs, including about 25% of corporate positions.*

Aurora’s U.S.-listed stock fell 13% in after-hours trading. The shares were halted earlier on Thursday.*

Aurora expects impairment charges of as much as C$225 million on assets and as much as C$775 million on goodwill in the second quarter, it said. Net revenue will be between C$50 million and C$54 million, compared with C$54.2 million a year ago.*

Aurora also said on Thursday it had made amendments to its secured credit facilities, including removal of some covenants, giving it options to refinance at maturity. Analysts have warned the company may not be able to meet the covenants of a C$360 million loan due in August 2021.*

Aurora’s expenses in the most recent quarter were almost four times its sales, and it holds less than two quarters’ worth of cash and short-term investments.*

Singer takes the helm as Aurora faces criticism for its aggressive global expansion amid uncertain demand. Aurora has stopped estimating when it will become profitable after missing its own guidance.*

The executive change makes Aurora the latest in a string of Canadian cannabis companies, including Canopy Growth, Aphria, Supreme Cannabis and Sundial Growers to change leadership as soaring costs and disappointing sales prompt concern from investors sitting on billions of dollars in losses.*

Singer has been on the board of the Alberta-based company since May 2016 and was named executive chairman nearly a year ago.*

Booth, a co-founder of the company, will remain on Aurora’s board and will become a strategic adviser to the company, Aurora said, confirming an earlier Reuters story.*

“I don’t think we’re going to see some sort of major strategic change, because Singer has been involved with the company and they’re keeping Booth on as an adviser,” said Andrew Kessner, an analyst at William O’Neill in New York. “This is to signal to the market that they are making changes.”*

Aurora has begun a formal search for a permanent CEO, Booth said in the memo without providing a time frame, adding that details would be shared once the process is complete.*

Booth’s departure follows the abrupt exit of Chief Commercial Officer Cam Battley in December.*

* original article

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Tilray cuts 10% of workforce to reduce costs*

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Tilray Inc (TLRY.O) has cut 10% of its 1,443-strong workforce as part of a global restructuring effort to reduce costs, the Canadian cannabis producer said on Tuesday Feb 2, report Reuters.*

“By reducing headcount and cost, Tilray will be better positioned to achieve profitability and be one of the clear winners in the cannabis industry,” the company said in an e-mailed statement. “The tough decision to eliminate roles has not been taken lightly.”*

With costs that are multiples higher than revenues, Canadian cannabis companies face bleak prospects for turning profits as sales lag and investors flee the sector, analysts have warned.*

“I expect to see many (licensed producers) announce significant job cuts in the near future,” Jason Sandberg, research analyst at PI Financial, said by email. “Too many companies had been relying on capital infusions, which have dried up, and not internally generated cash flow.”*

Tilray’s adjusted quarterly loss before interest, taxes, depreciation and amortization in the September quarter tripled to $23.5 million, as sales and marketing costs spiked nearly five-fold. The company has said it expects to achieve positive EBITDA in the December quarter.*

Tilray shares closed up 5.2% in New York, compared with a 2% gain in the Horizons Marijuana Life Sciences Index ETF (HMMJ.TO).*

* original article

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NICE refuses GW Pharma’s cannabis-based Epidyolex for treatment-resistant epilepsy

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« The often distressing and life-limiting nature of these very difficult to control epilepsies mean that we should all welcome new treatment options. Cannabidiol is a promising treatment for people with these types of epilepsies. »

Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE

UK-based GW Pharma has suffered a setback in its home country after drug watchdog NICE chose not to recommend NHS reimbursement of Epidyolex (cannabidiol/CBD) in combination with clobazam for people with Dravet or Lennox-Gastaut syndrome (LGS), two forms of treatment-resistant epilepsy, report Pharmafile.com.*

Despite concluding that the combo therapy effectively reduced the total number of the most prominent seizure types associated with these conditions compared to standard of care, the institute pointed to the lack of definitive long-term efficacy data, given that trial data submitted covered just 14 weeks.*

It also voiced scepticism in the reliability of economic models provided by the manufacturer on the drug combo’s cost-effectiveness, arguing that they failed to adequately account for all key aspects that would affect those with treatment-resistant epilepsy and their caregivers and families.*

“The often distressing and life-limiting nature of these very difficult to control epilepsies mean that we should all welcome new treatment options. Cannabidiol is a promising treatment for people with these types of epilepsies,” commented Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE. “Even though the committee accepted that the evidence shows that cannabidiol with clobazam reduces seizure frequency, its long-term efficacy is unknown, and the committee was not convinced about the way the company had modelled the effect on people living longer or having a better quality of life.*

“Based on the evidence presented to it, the committee could not recommend cannabidiol with clobazam as an effective use of NHS resources. However, we are committed to working with the company to resolve the economic modelling issues identified by the committee, and to help them understand what they may need to do to mitigate the cost of cannabidiol to the NHS. Patients, carers and their families deserve no less.”*

A spokesperson for GW Pharma responded: “We are committed to working with NICE to address the technical questions it has raised, with the aim of ensuring patients can access the medicine on the NHS as soon as possible following regulatory approval. We remain hopeful that NICE will recommend cannabidiol oral solution at the end of its appraisal process.”*

The therapy was approved by the FDA in June last year under the slightly different moniker Epidiolex, while EU approval is expected by October this year following a positive CHMP recommendation in July.*

Matt Fellows*

* original article

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*** ndlr. : –.

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Otsuka, GW announce Sativex fails in Phase III cancer pain trials

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« While the results overall have been disappointing, and not necessarily wholly consistent with clinical experience, nonetheless they suggest that Sativex may have a useful role in the treatment of certain subgroups of patients with advanced cancer pain who have exhausted opioid treatments. »

Dr Marie Fallon, professor of palliative care at the University of Edinburgh

Otsuka and GW Pharmaceuticals cannabis-based drug Sativex failed to show superiority over placebo in two Phase III trials, report Pharmafile.com.*

The studies were testing Sativex (nabiximols) in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimised chronic opioid therapy.*

In a previously-reported Phase III trial earlier this year, Sativex also failed to meet the primary endpoint in the additional two trials. The first involved 397 patients from the US, Mexico and Europe, and the second was conducted entirely outside the US and used a different clinical design.*

However, a pre-specified pooled analysis of patients across the two Phase III trials in the US did show a statistically-significant improvement for Sativex compared with placebo, with several secondary efficacy endpoints reaching statistical significance.*

In this study, the US was the largest single recruiting country and represented 30% of the overall trial population. The efficacy data from US sites alone showed more positive trends than those in non-US sites, which the companies say is consistent with data from the first Phase III trial and the Phase IIb trial.*

GW Pharmaceuticals and Otsuka say these more positive US results have led them to request a meeting with the FDA, to discuss the clinical relevance of these data and determine potential paths forward.*

Justin Gover, GW’s chief executive, says: “In light of the missed primary endpoint in the first trial earlier this year, these additional results are not a surprise. Nevertheless, we are encouraged by data across the trials which consistently show positive outcomes for US patients when analysed as a separate cohort. We believe that this finding may provide important guidance in determining the optimal target patient population for Sativex and look forward to a discussion with the FDA on a potential path forward.” *

Dr Marie Fallon, professor of palliative care at the University of Edinburgh and a principal investigator in the Phase III program, comments: “While the results overall have been disappointing, and not necessarily wholly consistent with clinical experience, nonetheless they suggest that Sativex may have a useful role in the treatment of certain subgroups of patients with advanced cancer pain who have exhausted opioid treatments.”*

“In particular, the US patients enrolled in this program showed a useful therapeutic benefit whereas results in European patients were generally not favourable. These US patients were less frail, hence the Sativex intervention was subjected to less ‘noise’, providing clearer results and valuable guidance in determining the optimal target patient population for Sativex. This is a patient population with a significant unmet need and I believe that this important observation for Sativex warrants further investigation.”* 

Sativex, usually used in the treatment of multiple sclerosis, was developed by GW with the Japanese company Otsuka acting as a licensing partner in the US. It was the world’s first plant-derived cannabinoid prescription drug.* 

Joel Levy

* original article

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*** ndlr. : –.