A new drug derived from marijuana just became the first of its kind to get the green light from the US government.
Called Epidiolex, the drug is designed to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD).
British-based GW Pharmaceuticals makes the drug. It does not contain THC, the well-known psychoactive component of marijuana responsible for the drug’s characteristic high.
The federal thumbs-up comes on the heels of several months of promising research results and a positive preliminary vote from the Food and Drug Administration this spring. Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds.
“This approval serves as a reminder,” Scott Gottlieb, the FDA commissioner, said in a statement on Monday, “that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”
In three large clinical trials which the FDA considered before giving Epidiolex the official green light, researchers presented strong evidence that the pharmaceutical-grade CBD in the medicine had the power to significantly curb some of the worst symptoms of two of the hardest-to-treat forms of epilepsy, known as Lennox-Gastaut syndrome and Dravet syndrome.
“This is clearly a breakthrough drug for an awful disease,” John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.
But although the green light means that patients will soon be able to access Epidiolex with a doctor’s prescription, many will also likely turn to less expensive sources of CBD, such as those sold in marijuana dispensaries. Researchers and advocates cautioned against this, however, with the caveat that it’s impossible to verify that what’s in those products is actually pharmaceutical-grade CBD.
Starting last spring with a study presented at the American Academy of Neurology’s yearly meeting in Boston, GW Pharmaceuticals has consistently presented strong clinical studies that appear to support Epidiolex.
“There’s a boatload of evidence to show for this drug at this point,” Orrin Devinsky, a lead author on one of those studies and a neurologist at NYU Langone Health.
A month after the Neurology meeting, Devinksy and his colleagues published a positive study of the drug in children with Dravet syndrome in the New England Journal of Medicine. Roughly 43% of the children in that study who got the drug saw their number of seizures cut in half, and 5% stopped having seizures entirely. In comparison, children who got a placebo had barely any noticeable change in their symptoms.
Almost exactly a year later, Devinksy and his team followed up those results with another favorable study in the same journal using a smaller dose of the drug in patients with Lennox-Gastaut. Devinsky said that low dose might be “the sweet spot” where most patients can achieve relief from symptoms without any unwanted side effects, such as drowsiness.
Also, although Epidiolex is designed to treat only two types of epilepsy, medical professionals and Florida marijuana doctors can technically prescribe it “off-label” for other conditions as well. (The anesthetic ketamine, for example, is prescribed this way for some hard-to-treat forms of depression.)
“We would expect that once this is approved as a drug it’s quite likely this will be tried in other populations off-label so it has a big opportunity to affect others,” Lubbers said.
Epidiolex vs. other CBD products
Scientists and advocates representing families of patients with epilepsy are hailing Epidiolex’s arrival as a long-awaited treatment. But they are also aware that desperate patients — especially parents of young children — may actively seek alternate sources of CBD that may be cheaper and don’t require a doctor’s prescription.
In states where marijuana is legal (or in states with laws legalizing CBD on its own), oils and salves made with CBD are widely available. But experts caution that these products may not be what they seem.
“What’s different with [Epidiolex] is that this is a well-studied and well-controlled product,” Laura Lubbers, the chief scientific officer of a nonprofit called Cure that funds epilepsy research.
But most dispensary-grade CBD products are not well-studied or well-controlled.
For a 2017 study published in the Journal of the American Medical Association, researchers tested 84 products purchased from 31 different online CBD sellers. Roughly seven out of 10 items had different levels of CBD than what was written on the label. Of all of the items they tested, roughly half of the items had more CBD than was indicated; a quarter had less. And 18 of the samples tested positive for THC, despite it not being listed on the label.
“The main thing is that CBD as approved by the FDA is pharmaceutical-grade CBD. It’s manufactured under stringent standards, the same as other FDA-approved drugs,” Shlomo Shinnar, the president of the American Epilepsy Society and a professor of neurology and epidemiology at the Albert Einstein College of Medicine. “That’s not the same as when people tell you, ‘Oh, I’ve got marijuana and it’s high in CBD,’ or ‘Oh, I’ve got a CBD product.'”
Epidiolex’s approval could also be a powerful catalyst for deeper research into other marijuana-derived medicines. Cannabis has more than 400 compounds, of which CBD and THC are only two, and researchers think the others could hold promise as well.
The drug’s green light also means that the Drug Enforcement Agency now has 90 days to reschedule CBD, which it listed in January of last year as a “marijuana extract” separate from “marijuana” or THC.
That means instead of being listed alongside marijuana as a Schedule 1 drug with “no currently accepted medical use,” CBD will soon be categorized as either a Schedule 2 or 3 drug, much like the popular ADHD medication Adderall.
Once that happens, it’ll unleash what Carreno called a “sea change” for CBD manufacturers and the industry as a whole, which up until this point has existed in a legal grey area.
Apart from CBD, researchers are also actively studying THC and other marijuana compounds for a range of potential medical uses, from relieving pain to soothing severe nausea. Although Epidiolex is the first marijuana plant-based drug to land FDA approval, the agency has already given the green light to drugs whose active ingredient is a lab-made version of THC, for example.
In the meantime, experts look forward to seeing Epidiolex made available to patients in need.
Florida Marijuana Doctors are seeing more patients than expected. There are now over 210,000 patients in the Florida medical marijuana registry with many many more coming.
Yet marijuana’s official designation in the US as a Schedule 1 drug something with “no currently accepted medical use” — means it has been pretty tough to study.
Despite that, a growing body of research and numerous anecdotal reports link cannabis with several health benefits, including pain relief and the potential to help with certain forms of epilepsy. In addition, researchers say there are many other ways marijuana might affect health that they want to better understand.
Along with several other recent studies, a massive report released last year by the National Academies of Sciences, Engineering, and Medicine helps sum up exactly what we know— and what we don’t — about the science of weed.
One of weed’s active ingredients, tetrahydrocannabinol, or THC, interacts with the brain’s reward system, the part primed to respond to things that make us feel good, like eating and sex.
When overexcited by drugs, the reward system creates feelings of euphoria. This is also why some studies have suggested that excessive marijuana use can be a problem for some people — the more often you trigger that euphoria, the less you may feel during other rewarding experiences.
Within a few minutes of inhaling marijuana, your heart rate can increase by between 20 and 50 beats a minute. This can last anywhere from 20 minutes to three hours, according to the National Institute on Drug Abuse.
The NASEM report found insufficient evidence to support or refute the idea that cannabis might increase the overall risk of a heart attack. The same report, however, also found some limited evidence that smoking could be a trigger for a heart attack.
In August, a study published in the European Journal of Preventive Cardiology appeared to suggest that marijuana smokers face a threefold higher risk of dying from high blood pressure than people who have never smoked — but the study came with an important caveat: it defined a “marijuana user” as anyone who’d ever tried the drug.
Research and many Fort Lauderdale Marijuana Doctors suggests this is a poor assumption — and one that could have interfered with the study’s results. According to a recent survey, about 52% of Americans have tried cannabis at some point, yet only 14% used the drug at least once a month.
Other studies have also come to the opposite conclusion of the present study. According to the Mayo Clinic, using cannabis could result in decreased— not increased — blood pressure.
So while there’s probably a link between smoking marijuana and high blood pressure say Lakeland Marijuana Doctors, there’s not enough research yet to say that one leads to the other.
Pot contains cannabidiol, or CBD, a chemical that is not responsible for getting you high but is thought to be responsible for many of marijuana’s therapeutic effects. Those benefits can include pain relief or potential treatment for certain kinds of childhood epilepsy.
The new report also found conclusive or substantial evidence — the most definitive levels — that cannabis can be an effective treatment for chronic pain, which could have to do with both CBD and THC. Pain is also “by far the most common” reason people request medical marijuana, according to the report.
One of the ways scientists think marijuana may help with pain is by reducing inflammation, a component of illnesses like rheumatoid arthritis.
A preliminary 2005 study of 58 patients with RA, roughly half of whom were given a placebo and roughly half of whom were given a cannabis-based medicine called Sativex, found “statistically significant improvements in pain on movement, pain at rest, quality of sleep” for patients on Sativex says Tampa Marijuana Doctors.
Other studies testing other cannabinoid products and inhaled marijuana have shown similar pain-relieving effects, according to the report.
Some people with inflammatory bowel diseases like Crohn’s and ulcerative colitis could also benefit from marijuana use, studies suggest.
A 2014 paper, for example, describes two studies of people with chronic Crohn’s. Half were given the drug and half got a placebo. That study showed a decrease in symptoms in 10 of 11 subjects using cannabis, compared with just four of 10 on the placebo. But when the researchers did a follow-up study using low-dose CBD, they saw no effect in the patients.
sarasota marijuana doctors say that, for now, we need more research before we’ll know whether cannabis can help with these diseases.
Marijuana may throw off your balance, as it influences activity in the cerebellum and basal ganglia, two brain areas that help regulate balance, coordination, reaction time, and posture.
Feeling as if time is sped up or slowed down is one of the most commonly reported effects of using marijuana. A 2012 paper sought to draw some solid conclusions from studies on those anecdotal reports, but it was unable to do so.
“Even though 70% of time estimation studies report overestimation, the findings of time production and time reproduction studies remain inconclusive.
In a 1998 study that used magnetic resonance imaging (MRI) to focus on the brains of volunteers on THC, the authors noted that many had altered blood flow to the cerebellum, which most likely plays a role in our sense of time.
Limitations on what sort of marijuana research is allowed make it particularly difficult to study this sort of effect.
Since weed makes blood vessels expand, it can give you red eyes.
A case of the munchies is no figment of the imagination — both casual and heavy marijuana users tend to overeat when they smoke.
Marijuana may effectively flip a circuit in the brain that is normally responsible for quelling the appetite, triggering us to eat instead, according to a recent study of mice.
It all comes down to a special group of cells in the brain that are normally activated after we have eaten a big meal to tell us we’ve had enough. The psychoactive ingredient in weed appears to activate just one component of those appetite-suppressing cells, making us feel hungry rather than satisfied says orlando marijuana doctors.
Marijuana can mess with your memory by changing the way your brain processes information, but scientists still aren’t sure exactly how this happens. Still, several studies suggest that weed interferes with short-term memory, and researchers tend to see more of these effects in inexperienced or infrequent users than in heavy, frequent users.
Unsurprisingly, these effects are most evident in the acute sense — immediately after use, when people are high.
Scientists can’t say for sure whether marijuana causes depression or depressed people are simply more likely to smoke. But one study from the Netherlands suggests that smoking weed could raise the risk of depression for young people who already have a special serotonin gene that could make them more vulnerable to depression.
Those findings are bolstered by the NASEM report, which found moderate evidence that cannabis use was linked to a small increased risk of depression.
The NASEM report also found substantial evidence of an increased risk among frequent marijuana users of developing schizophrenia — something that studies have shown is a particular concern for people at risk for schizophrenia in the first place says Bradenton Marijuana Doctors.
Researchers think it’s possible that CBD might be a useful treatment for anxiety disorders, and that’s something that several institutions are currently trying to study.
The recent report suggested that evidence of a link between marijuana and an increased risk of most anxiety disorders was limited.
However, the authors wrote that there is moderate evidence that regular marijuana use is connected to an increased risk of social anxiety. As in other cases, it’s hard to know whether marijuana use causes that increase or people use marijuana because of an increased risk of social anxiety says lake mary marijuana doctors.
The THC content of marijuana across the US has tripled since 1995, according to a large recent study in which researchers reviewed close to 39,000 samples of cannabis. While THC levels hovered around 4%, on average, in 1995, they skyrocketed to roughly 12% in 2014.
Meanwhile, the CBD content in marijuana — the part that’s responsible for many of the drug’s therapeutic effects— has dropped, the researchers found, shifting the ratio of THC to CBD from 14:1 in 1995 to about 80:1 in 2014.
Still, tracking THC potency over time can be tricky. The older a weed sample gets, the more its THC appears to degrade. How it is stored matters too. These two barriers could be interfering somewhat with the metrics on pot’s potency.
In a recent study, scientists used MRI brain scans to get a better picture of the brains of adults who have smoked weed at least four times a week for years.
Compared to people who rarely or never used the drug, the long-term users tended to have a smaller frontal cortex, a brain region critical for processing emotions and making decisions. But they also had stronger cross-brain connections, which scientists think smokers may develop to compensate.
Still, the study doesn’t show that smoking pot caused certain regions of the brain to shrink; other studies suggest that having a smaller orbitofrontal cortex in the first place could make someone more likely to start smoking.
Most researchers agree that the people most susceptible to brain changes are those who begin using marijuana regularly during adolescence.
Some athletes, especially in certain endurance and adventure sports, say marijuana use can boost their athletic performance. This may be because of anti-inflammatory or pain-relieving effects that make it easier to push through a long workout or recover from one.
At the same time, there are ways that marijuana could impair athletic performance, since it affects coordination and motivation, and dulls the body’s natural recovery process.
Without more research, it’s hard to know how marijuana affects athletic performance.