Tag: marijuana

Medical cannabis could soon get the green light in France after unprecedented trial

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During a years-long experiment that ended on Tuesday, French health authorities gave patients suffering from serious illnesses the chance to use prescribed medical cannabis. As France prepares to put cannabis-based medicines on the market, patients look back at their experience of the trial.

Patience is a virtue. But when faced with indescribable pain on a daily basis, being virtuous is not the priority. At least it isn’t for Valérie Vedere, who was diagnosed with HIV in 1992 and then throat cancer in 2012.

“To appease the burning sensation I get from radiotherapy, I use cannabis therapeutically,” the 58-year-old living in Bordeaux says. “But I also experience pain from antiretroviral treatments for HIV.”

“It’s as if my hands and feet are being squeezed in a vice, which can lead to extreme burning and tingling sensations. I also have muscle spasms that generally take place at the end of the day,” Vedere explains. Her chronic pain is something that can’t be treated with painkillers like tramadol or other opioids. “It’s not suitable for the long-term,” she says.

When France launched a nationwide experiment to test the use of medical cannabis for patients with serious illnesses three years ago, Vedere was determined to participate.

“I had already been using cannabis to ease my symptoms illegally. Now, I would be able to use it legally and have consistent follow-ups with my doctor,” she says. After persuading her doctor that she was a perfect candidate for the trial, she finally became a participant in May 2021 – two months after the experiment was launched.

A leap in the direction of legal medical cannabis

The first results of the trial came trickling in two years later, in 2023. Patients felt their symptoms had improved significantly, with no unexpected side effects. No cases of substance abuse or addiction had been reported.

“Our evaluations show that between 30 and 40 percent of symptoms like pain, spasms, quality of life or epileptic seizures for example, have improved significantly,” says Nicolas Authier, a doctor specialised in pharmacology, addiction and pain who is also the president of the scientific committee tasked with monitoring the medical cannabis trial.

Preparations to make prescribed cannabis-based medicines more readily available, including in pharmacies, are now under way for 2025.

Read moreFrance launches public consultation on legalising cannabis

“Cannabis-based medicines are currently dispensed in hospitals or in hospital pharmacies, but in the long-run, most of them will become available in regular pharmacies much like any other drug,” says Authier.

The French National Agency for the Safety of Medicines and Health Products (ANSM) has until the end of the year to authorise approved cannabis-based products for medicinal use. Those products will then be granted temporary approval for five years – with scope for them be renewed indefinitely – pending a decision by European authorities to market the drugs.

Until then, the patients who were part of the trial will continue to have access to cannabis-based medicines. But as of Wednesday March 27, no new participants are able to join the trial.  

A total of 3,035 people took part in the unprecedented experiment and 1,842 are still receiving treatment today.

An unprecedented experiment

Before the trial was first launched across 275 health facilities in the country, a committee of interdisciplinary scientists – consisting mostly of healthcare professionals and patients – was set up. Together, they defined the conditions under which the experiment would be rolled out, what medicines would be used, the training pharmacists and doctors would receive, how patients would be monitored and the information they would receive.

Health authorities then allowed limited prescriptions for people suffering from five specific conditions: neuropathic pain, some drug-resistant forms of epilepsy, intense oncology symptoms related to cancer or cancer treatment, palliative situations and pathologies that affect the nervous system, like multiple sclerosis.

Patients were only prescribed cannabis-based medicines if available treatment was found to be insufficient, or if they presented an aversion to existing drugs.

Mylène, who is 26 and lives in Paris, has tried a cocktail of medications to combat her cephalgia – a condition that results in recurring and extremely painful headaches. “They are brutal. The pain is permanent, seven days a week. I haven’t had a break since they started in 2014,” she says. “And sometimes I get a particularly painful attack, and it’s as if two cinder blocks are being pressed against my head.”

“I tried all kinds of treatment. Paracetamol, ibuprofen, opioids like tramadol and even morphine. Either the medicine wouldn’t have an effect on me or the side effects were too intense,” the young radiologist explains. “I joined the trial in late December 2023 and started taking medical cannabis droplets morning and night. It’s almost been three months and I am already starting to feel relief. I feel a change that’s really starting to take effect.”

Depending on their condition, patients were given medical cannabis either in oil or dried flower form. Oil droplets were generally taken orally, while dried flowers were inhaled in vaporisers to prevent the potential health risks from burning the plant.

Cannabis-based medicines can have varying degrees of THC and CBD, the two main compounds unique to the cannabis plant, known as cannabinoids. While THC is its primary psychoactive compound, responsible for the typical weed high consumers can feel, it is most efficient in tackling pain. CBD, the second most prevalent compound in cannabis or cannabinoid, is still psychoactive but doesn’t have the same intoxicating effect as THC.

“The majority of patients were given cannabis-based medicines in oil form, which is the treatment that has the longest lasting effect,” Authier explains. “But oil droplets don’t prevent peaks of severe pain that can only be relieved by fast-acting medication … so sometimes we added dried cannabis flowers that patients could inhale using a vape. The effects don’t last very long but are very rapid.”  

However, in February 2024 the ANSM decided to stop prescribing medical cannabis in flower form.

“I wasn’t at the mediation meeting when the decision was taken so I can’t say for certain why,” says Authier. “It seems that the medical cannabis flower looks too similar to the illicit cannabis flower consumed for [recreational] purposes. So that could cause confusion and perhaps spark fears of a potential black market.”

“It’s all very debatable,” Authier adds, unconvinced.

For Vedere, both the oils and flowers are “indispensable”. Angered with the decision to stop prescribing medical cannabis in this form, she wrote an open letter to the French health ministry demanding an explanation.

“I don’t want to take opioids. And when I have sudden attacks of pain, the flowers are the only thing that relieve me,” says Vedere. “So I will just have to continue using the oil that I’m prescribed. As for the flowers, I’ll buy them illegally.”

Based on the five medical conditions that warrant this type of treatment, Authier estimates that between 150,000 and 300,000 people in France could be prescribed cannabis-based medicines, meaning that an entire industry has been holding its breath for the roll-out of the drugs.

While suppliers of the cannabis-based medicines used in the years-long trial were Israeli, Australian and German companies – those tasked with distribution were French.

Along with Germany, France could become the biggest market for medical cannabis in Europe, according to French daily Le Monde.

But despite the promise of a booming market, introducing these drugs to the French market and even getting the trial off the ground has been anything but a bed of roses.

The bad rep of cannabis in France

A few days ago, while attending a Senate hearing on the impact of drug trafficking in France, Finance Minister Bruno le Maire reiterated his position that the decriminalisation of cannabis was a no-go.

“Cannabis is cool and cocaine is chic. That is the social representation of drugs,” he said. “But in reality, the two are poisons. They are both destructive and contribute to the undermining of French society as a whole.”

Despite France being one of the biggest cannabis consumers in Europe, it also has some of the toughest laws against the drug. THC is still classified as a narcotic in France, with the maximum level permitted in any cannabis plant limited to 0.3 percent. CBD is legal as long as the cannabis plant does not exceed the permitted levels of THC.

There is still a lot of stigma around cannabis in France, even though public opinion on its medical use is hugely encouraging. According to a 2019 survey by the national Observatory for Drugs and Addictive Tendencies, 91 percent of French people say they are in favour of doctors prescribing cannabis-based medicines “for certain serious or chronic illnesses”.

Read moreCannabis in France: Weeding out the facts from the fiction

Still, attitudes around the plant are difficult to shift. “It’s impossible to completely shake off the stigma attached to the word cannabis, which is associated with narcotics. So we had to make a real effort to reassure [the medical community] throughout the experiment,” says Authier.

When it comes to medicinal cannabis, politicians and public health officials in France have expressed their concerns through two key arguments. First, that the roll-out of these medicines would be too expensive. And second, that the legalisation of medicinal cannabis will inevitably lead to the legalisation of its recreational use.

“Our objective has always been accessibility. Ensuring that patients have access to these medicines and that doctors prescribe them,” Authier counters. “It was never, as some like to believe, a Trojan horse move to then legalise recreational cannabis. That has absolutely nothing to do with our trial. Opium-based medicines exist without heroin being legalised.”

“We had to deal with some rather dogmatic opinions and deconstruct a lot of beliefs or language to be taken seriously,” he confesses.

The first place to ever legalise medical cannabis was California, in 1996. Colorado followed suit four years later in 2000, then Canada in 2001, the Netherlands in 2003, Israel in 2006, Italy in 2013 and Germany in 2017. To date, around 20 countries in Europe have joined the list, each with their own set of rules and restrictions.

In France, it wasn’t until 2018 that serious discussions around medical cannabis emerged in the public sphere. And it took another three years before the trial began, in 2021.

Now that it looks like medical cannabis is here to stay in France, at least for the next five years, Mylène feels relieved.

“When I was accepted as a participant a few months ago, I thought ‘finally’,” she sighs. “I can see a real step forward and I hope it continues. I hope that it can become more readily available so that as many people as possible can be treated.”



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Potentially dangerous doses of melatonin and CBD found in gummies sold for sleep | CNN

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CNN
 — 

Testing of over two dozen melatonin “gummies” sold as sleep aids found some had potentially dangerous amounts of the hormone that helps regulate sleep, according to a new study.

“One product contained 347% more melatonin than what was actual listed on the label of the gummies,” said study coauthor Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts.

A jar of gummies might also contain ingredients you didn’t count on, Cohen said: “One of the products that listed melatonin contained no melatonin at all. It was just cannabidiol, or CBD.”

According to the US Food and Drug Administration, “it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.” Yet several of the tested products containing CBD in the study openly advertised the addition of that compound to their melatonin product, Cohen said.

“Four of the tested products contained levels of CBD that were between 4% and 18% higher than on the label,” Cohen said.

The use of CBD in over-the-counter aids is particularly concerning because parents might purchase gummy products to give to their children to help them sleep, said Dr. Cora Collette Breuner, a professor of pediatrics at Seattle Children’s Hospital at the University of Washington.

“There’s no data that supports the use of CBD in children,” said Breuner, who was not involved in the study. “It’s currently only recommended for a very specific use in children over 1 with intractable seizure disorders.”

Aside from CBD, consuming a gummy that unknowingly contains extremely high levels of melatonin — well over the daily 0.5 to 1 milligram per night that has been shown to induce sleep in kids — is also dangerous, said Breuner, who serves on the integrative medicine committee of the American Academy of Pediatrics, which is currently writing new guidelines on supplements in children.

Side effects of melatonin use in children can include drowsiness, headaches, agitation, and increased bed-wetting or urination in the evening. There is also the potential for harmful interactions with medications and allergic reactions to the melatonin, according to the National Center for Complementary and Integrative Health, a department of the National Institutes of Health.

The agency also warns supplements could affect hormonal development, “including puberty, menstrual cycles, and overproduction of the hormone prolactin,” which causes breast and milk development in women.

In the study, published Tuesday in the journal JAMA, researchers sent 25 products labeled as melatonin gummies to an outside lab that tested for levels of melatonin and other substances.

However, the research team didn’t pick products “willy-nilly” off the internet, Cohen said. The scientists carefully chose the first 25 gummy melatonin products displayed on the National Institutes of Health database, which the public can check to see labels of dietary supplements sold in the United States.

“We choose gummies over other products because we thought parents would chose edibles to give to their children,” Cohen said. “”We also wanted to take a closer look at those products after last year’s report that poison centers have had over a quarter million calls about pediatric ingestion, thousands of hospitalizations, ICU visits, even some deaths.”

A 2022 report by the US Centers of Disease Control and Prevention found calls to poison control about melatonin ingestion by children rose 530% between 2012 to 2021. The largest spike in calls — 38% — occurred between 2019 and 2020, the report said.

Most of the calls were about children younger than 5 years old who had accidentally eaten gummies caregivers had not properly locked away.

“Gummies are enticing to young children, who see them as candy,” Cohen said. “We wondered if there was something going on with the products that might be contributing to the calls to the poison control centers.”

The new study found 88% of the gummies were inaccurately labeled, and only three contained a quantity of melatonin that was within 10% of what was listed on the label, said Cohen, who has studied invalid labeling of supplements for years.

“The regulatory framework for supplements is broken,” he said, “The manufacturers are not complying with the law, and the FDA is not enforcing the law. So what that means is that we have a lot of poor-quality products out there.”

A spokesperson for the FDA told CNN the agency would review the findings of the study, adding that the FDA generally doesn’t comment on specific studies, but “evaluates them as part of the body of evidence to further our understanding about a particular issue.”

“It’s important to underscore that under current law, the FDA does not have the authority to approve dietary supplements before they are marketed, and firms have the primary responsibility to make sure their products are not adulterated or misbranded before they are distributed,” the spokesperson said via email.

Steve Mister, president and CEO of the Council for Responsible Nutrition, a trade association for the dietary supplement industry, released a statement saying that manufacturers may add additional melatonin to be sure the product remains at the levels on the label as degradation naturally occurs over time.

“While there may be some variability in overages as companies adhere to the FDA’s requirements regarding shelf life and potency, it does not mean there is a risk in taking these products as intended,” Mister said.

People often view melatonin as an herbal supplement or vitamin, experts say. Instead, melatonin is a hormone that is made by the pineal gland, located deep within the brain, and released into the bloodstream to regulate the body’s sleep cycles.

Studies have found that while using melatonin can be helpful in inducing sleep if used correctly — taking a small amount at least two hours before bed — but the actual benefit is small, Breuner said.

In six randomized controlled trials on melatonin treatment in the pediatric population, she said, melatonin decreased the time it took to fall asleep, ranging from 11 minutes to 51 minutes.

“However, these were very small studies with widely variable results,” Breuner said. “So I say to the parents, ‘You’re really looking at as little as 11 minutes in decreasing the amount of time it takes your child to fall asleep.’”

Anyone considering melatonin should be sure that the bottle has the stamp of the United States Pharmacopeia (USP), which manufacturers hire to test and verify products.

“If it has a USP stamp on the label, you can be sure the product is accurately labeled,” Cohen said. “However, that doesn’t mean melatonin products are going to work or they’re a good idea to take.

“That’s not what the USP is about,” he said. “But at least the verification of the label should eliminate the problems we’re seeing here in our study.”

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Marijuana may make sleep worse, especially for regular users, study finds | CNN

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Editor’s Note: Sign up for CNN’s Sleep, But Better newsletter series. Our seven-part guide has helpful hints to achieve better sleep.



CNN
 — 

It’s a common assumption among marijuana users: Using weed will help you fall asleep and stay asleep. Scientists, however, aren’t so sure that’s true.

“This is an understudied but important area, as many people are increasingly turning to cannabis products as sleep aids,” said sleep specialist Wendy Troxel, a senior behavioral scientist at Rand Corp., who was not involved in the study.

“But we really lack solid evidence demonstrating whether cannabis helps or hurts sleep,” Troxel added.

Use of weed may actually harm sleep, a December 2021 study has found. The research, published in a BMJ journal, revealed adults who use weed 20 or more days during the last month were 64% more likely to sleep less than six hours a night and 76% more likely to sleep longer than nine hours a night.

Optimal sleep for adults is defined by the US Centers for Disease Control and Prevention as seven to eight hours a night.

Moderate consumption — using weed less than 20 days during the past month — didn’t create short sleep problems, but people were 47% more likely to snooze nine or more hours a night, the study also found.

Why is short and long sleep a problem?

“Large population-based studies show that both short sleep and long sleep are associated with an increased risk of heart attacks and strokes, as well as the long-term progression of things like atherosclerosis, diabetes, coronary artery disease and any of the major cardiovascular diseases,” said lead study author Calvin Diep, who is resident of anesthesiology and pain medicine at the University of Toronto.

“It seems with sleep there’s kind of this ‘Goldilocks phenomenon’ where there’s an amount (that’s) ‘just right,’” Diep said.

One in three Americans don’t get enough sleep, according to the CDC. In addition, 50 million to 70 million Americans struggle with sleep disorders such as sleep apnea, insomnia and restless leg syndrome, which can ruin a good night’s shut-eye.

The CDC calls that a “public health problem,” because disrupted sleep is associated with a higher risk of conditions, including high blood pressure, weakened immune performance, weight gain, a lack of libido, mood swings, paranoia, depression, and a higher risk of diabetes, stroke, cardiovascular disease, dementia and some cancers.

The December 2021 study analyzed use of marijuana for sleep among 21,729 adults between the ages of 20 and 59. The data was gathered by the National Health and Nutrition Examination Survey, and is considered representative of over 146 million Americans.

In addition to issues with short and long sleep, people in the study who used weed within the last 30 days were also more likely to say they have trouble falling asleep or staying asleep, and were more likely to say they have discussed sleep problems with a health care provider, Diep said.

“The problem with our study is that we can’t really say that it’s causal, meaning we can’t know for sure whether this was simply individuals who were having difficulty sleeping, and that’s why they use the cannabis or the cannabis caused it,” he added.

Prior studies have also found a connection between the two components of marijuana, CBD and THC, and poor sleep. CBD, or cannabidiol, is a key component of medical marijuana, while THC, or tetrahydrocannabinol, is the main psychoactive compound in cannabis that produces the high sensation.

A 2018 randomized, double-blind, placebo-controlled study — the gold standard — found no benefit from CBD on sleep in healthy volunteers. Other studies have also found high rates of insomnia when withdrawing from nightly use of marijuana.

“At this time there still isn’t any clear evidence that cannabis is helping sleep,” said Dr. Bhanu Prakash Kolla, a sleep medicine specialist in the Center for Sleep Medicine at the Mayo Clinic in Rochester, Minnesota, who was not involved in any of the studies.

“We know that when people initiate use there is some benefit in the immediate short term, but there is quick tolerance to this effect,” Kolla said. “There currently is no good quality evidence to suggest that cannabis will help improve sleep quality or duration.”

Still, people continue to believe that weed is helping their sleep. Surveys of marijuana users show they do indeed rely on the drug for better sleep.

“The issue is that there’s a disconnect between these anecdotal reports of people reporting therapeutic benefits and the evidence behind it in terms of the data,” Diep said.

One possible reason, Kolla said, is that when people stop using cannabis after a period of regular use, the withdrawal effects from weed can cause sleep disruptions. That leads people to believe “the cannabis was in fact helping (sleep), while what they are actually experiencing are withdrawal symptoms.”

Another factor to consider is the increased potency of weed today as compared with when many of the studies on cannabis and sleep were conducted, said Dr. Karim Ladha, staff anesthesiologist and clinician-scientist of anesthesiology and pain medicine at the University of Toronto.

“A lot of the older data related to cannabis is based on lower doses of THC than what patients are using now, and there’s very little research related to CBD,” Ladha said.

“Studies tell us about what happens at a population level, but on an individual level that discussion is much more personal,” he said. “The studies just give us the possibilities that (marijuana) could hurt your sleep, but it may help and so we just don’t know until you try it.”

That’s why additional studies need to be done, he added.

“Patients are spending money and time and resources to obtain cannabis right now to help with sleep,” Ladha said. “I think as the medical community, we need to do everything we can to make sure that we enable our patients to make the best possible decisions for their health.”

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On ‘weed day,’ our medical analyst urges caution on recreational marijuana use | CNN

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CNN
 — 

As some people mark 4/20 as “weed day,” a day of celebration of marijuana use, I don’t want to bum you out — but I might.

Over the past decade, there has been a trend toward legalizing marijuana in the United States. Currently, at least 37 states, plus Washington, DC, have a comprehensive medical cannabis program. A growing number of states, currently at 21, have legalized recreational marijuana use.

I wanted to learn about the research around marijuana use, including the effects it has on the user and the medicinal uses for cannabis. I turned to CNN Medical Analyst Dr. Leana Wen, who has many concerns about recreational cannabis use, especially for certain populations such as young people and pregnant people.

Wen, who urged users and would-be users to be cautious, is an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She previously served as Baltimore’s health commissioner and as chair of Behavioral Health System Baltimore, where she oversaw policy and services around substances that can cause addiction, including marijuana.

CNN: What are the physiological effects of marijuana?

Dr. Leana Wen: Marijuana is a plant that has many active ingredients. One of the principal ones is a psychoactive compound called tetrahydrocannabinol. Often called THC, it’s similar to compounds that are naturally occurring in the body called cannabinoids and can mimic their function by attaching to cannabinoid receptors in the brain. In so doing, THC can disrupt normal mental and physical functions, including memory, concentration, movement and coordination.

Using marijuana can cause impaired thinking and interfere with someone’s ability to learn, according to the National Institute on Drug Abuse. Smoking cannabis can also impair the function of the parts of the brain that regulate balance, posture and reaction time. And THC stimulates the neurons involved in the reward system that release dopamine, or the “feel-good” brain chemical, which contributes to its addictive potential.

CNN: Marijuana is thought to have some positive and medicinal benefits. How can it be used for therapeutic purposes?

Wen: Short-term, many users report pleasant feelings, including happiness and relaxation. As a result, some people use marijuana to self-treat anxiety or depression. This is not a recommended use. What often ends up happening is that the person develops tolerance, requiring more and more of the drug to get the same effect.

There are some approved medicinal uses of marijuana for very specific indications. The US Food and Drug Administration has approved THC-based medications that are prescribed in pill form for treatment of nausea in patients with cancer undergoing chemotherapy and to stimulate appetite in patients with AIDS. There are several marijuana-based medications that are undergoing clinical trials for conditions like neuropathic pain, overactive bladder and muscle stiffness.

I think it’s really important for these and many more studies to continue. Researchers should continue to look not just at marijuana itself but its specific chemical components, since botanicals in their natural form can contain hundreds of active chemicals and obtaining the correct dosages may be challenging. In the meantime, users should use caution in evaluating supposed medicinal claims and clearly understand the risks of cannabis use.

CNN: What are the risks of marijuana use, and who may be particularly vulnerable to them?

Wen: The main concern about marijuana use is its impact on the developing brain. As the US Centers for Disease Control and Prevention states on its website, “Marijuana affects brain development. Developing brains, such as those in babies, children, and teenagers, are particularly susceptible to the harmful effects of marijuana and tetrahydrocannabinol.”

Numerous studies have linked marijuana use in women during pregnancy to a variety of cognitive and behavioral problems in their children. The CDC even warns against secondhand marijuana smoke exposure, and it also encourages breastfeeding individuals to avoid marijuana use.

Marijuana affects young people throughout adolescence and young adulthood. Much research has shown how marijuana use in childhood impacts memory, attention, learning and motivation. Regular cannabis use in adolescence is associated with higher likelihood of not completing high school and even lower IQ later in life. The negative impacts persist beyond the teen years. Some studies of university students have found that the regularity of marijuana use is correlated with lower grade point average in college.

I want to emphasize here that there is still a lot that we don’t know about the effects of marijuana, in particular long-term consequences. A recent study found that in adults, daily use of regular marijuana can increase the risk of coronary artery disease by as much as one-third. That’s the point, though; all the unknowns are exactly why I and many other clinicians and scientists urge caution.

To be clear, there are many reasons to support policy changes of decriminalizing marijuana, including to rectify the decades-long injustices of disproportionately incarcerating minority individuals for marijuana possession. However, supporting decriminalization should not be equated with believing that marijuana is totally safe. It’s not. Marijuana has the potential to cause real and lasting harm, especially to young people.

CNN: Could someone become addicted to marijuana?

Wen: Yes. There is a condition known as marijuana use disorder. Signs of this disorder include trying but failing to quit using marijuana;, continuing to use it even though it is causing problems at home, school or work;, and using marijuana in high-risk situations, including while driving. Some individuals, especially those who use large amounts, experience withdrawal symptoms when they try to stop.

As many as 3 in 10 people who use marijuana have marijuana use disorder, according to the CDC. The risk of developing marijuana use disorder is greater among those who use it more frequently and for those who started earlier in life.

CNN: Some people say that marijuana is no big deal, especially in comparison with other substances like alcohol and opioids. Would you agree that cannabis use is at least better than using those substances?

Wen: I wouldn’t frame it that way. It is true that marijuana doesn’t cause liver damage the way that high amounts of alcohol does, and it doesn’t have the lethality of opioids. If an adult is using marijuana once in a while, and not while driving, it’s probably not going to have lasting consequences.

However, there are harms associated with more frequent use of marijuana and in particular its use in children. In my opinion, the legalization movement has shifted the conversation so much towards acceptance of cannabis that we are neglecting the fact that it is a drug and, I believe, should be regulated just like alcohol, tobacco and opioids.

There should also be much more messaging and education so that people, including young people and their parents or guardians, can be aware of the harms of marijuana — just as they are aware of the harms of other drugs.

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