FDA Chief: Marijuana Not Likely Recognized for Medical Value, But Will be Legalized

FDA Chief: Marijuana Not Likely Recognized for Medical Value, But Will be Legalized

[Editor’s Note: There must be strong rumblings in DC about Federal cannabis legalization. This mixed assessment doesn’t mean rescheduling is off the table either. ]

Many members of the American cannabis community have been holding their breath for decades in hopes that the U.S. Food and Drug Administration might wave its magic wand and hocus pocus, alakazampoof: marijuana is all of sudden considered safe and effective medicine in the eyes of the federal government. If you are one of those people who fall into this cohort, we’re going to go out on a limb and say it’s okay to breathe. Not because all of your oxygen-deprived brains had some bizarre, occult-like influence on the FDA’s negative outlook on weed –  they certainly didn’t. Marijuana, at least in smokable forms, will probably never be acknowledged for its ability to treat a single health condition.

However, this does not mean the herb will not be made legal soon for recreational use. In fact, officials with the FDA are sure that it will.

Just last week, FDA commissioner Scott Gottlieb said federal marijuana legalization was destined to happen “soon.” The head of Uncle Sam’s gatekeeper to pharmaceutical commerce told CNBC on Friday that the day of the doobie is swiftly approaching. “I think there’s an inevitability that it’s going to happen at the federal level at some point soon,” Gottlieb said.

Unfortunately, the big cheese of the FDA refused to elaborate on just how close the nation is to legal weed. All he was willing to say is that his agency, for better or worse, is not supportive of the pot products that claim to have healing powers for everything from the common cold to cancer.

“We do regulate compounds that are making drug claims and we regulate botanical use of marijuana,” Gottlieb told the news source. “We have approved compounds derived from marijuana, but there is no demonstrated medical use of botanical marijuana. That’s the bottom line.”

The approved compound of which the FDA chief spoke is cannabidiol (CBD), specifically when used in a drug called Epidiolex. The FDA put its seal of approval on the pharmaceutical earlier last year, making it the first cannabis-based medicine ever to be cleared for distribution in the United States. But this action had absolutely no impact on the legality of other CBD products.

While the U.S. Drug Enforcement Administration classified Epidiolex a Schedule V, all other CBD products derived from the cannabis plant remain a Schedule I dangerous drug on the agency’s Controlled Substances Act. The overall message is the federal government will only give cannabis medicinal clearance when a drug company puts it through a rigorous approval process, which includes years of clinical trials. Otherwise, marijuana cannot and will not be labeled medicine.

But even if some diehard cannabis purists still have faith that the FDA will one day revere the cannabis plant for all of its therapeutic benefits, Gottlieb says that is unlikely as long as it is presented in smokable forms.

“I prescribed blood pressure pills and all kinds of other things to my patients when I was a practicing physician not too long ago,” Gottlieb said back in May. “I never told a patient to go home, crush up a pill, roll it in a piece of paper and smoke it. Using a lung as a drug delivery vehicle isn’t optimal. That’s not to say that we wouldn’t evaluate it if it came in; it just wouldn’t be an optimal way to deliver an active ingredient.”

But this should in no way be viewed as bad news. Considering the head of the FDA feels confident marijuana will be federally legalized in the near future, it appears the entire cannabis community — not just a small percentage — will come out as winners in the end. There is a lot of talk that Congress will get the ball rolling on nationwide legalization at the beginning of the next session. Perhaps Gottlieb knows something that we don’t?

Many predict the United States will legalize cannabis no later than 2020, so it is critical for the discussions surrounding this level of reform to begin soon on Capitol Hill. And when legalization takes hold, it will not matter if a person wants to use marijuana to ease pain or just to provide them with some squinty-eyed perception. Toss out the labels, marijuana will be for everyone.

TELL US, do you think you’ll see cannabis legalized on the federal level?

FDA Chief: Marijuana Not Likely Recognized for Medical Value, But Will be Legalized was posted on Cannabis Now.

Come On, How High Can a Person Really Get?

Come On, How High Can a Person Really Get?

Ed Note: The question is, why rank cannabis ranked solely on the amount of THC-A. This is like judging a wine solely on alcoholic strength. Read this article to better understand cannabis and your buzz.

Toss a couple of cannabis growers into a room together and they’ll go at each other like wild, rabid dogs, marking their territory every step of the way. Perhaps it’s pride, a twinge of insecurity or pure unadulterated ego, but anyone with a passion for growing weed has the unwavering attitude that their creation, their strain, their breed of stoned delights is vastly superior to any other version of the plant ever produced. It can be a rather humorous display to watch two seemingly adult humans arguing over specs like, “My plant produces better yields… mine will get you higher,” and all sorts of other puffed up, brolicious sass gab.

It’s the potency factor that really gets some of the more uptight growers taking trash. As you read this article from the comforts of your home, just know that we are watching you. No, not really. Just know that a gang of deranged cultivators is out there right now trying to devise some of the most powerful, knock you in the dirt strains known to humankind. The goal of this gnarly cultivation crusade, or so it seems, is to unleash a species of weed upon the planet that mimics the savage blast of a sledgehammer to the face. These radicals, my dear friends, are the mad science forces dedicated to Getting America Stoned Again.

All of this focus lately on the potency of weed begs the question: Is it necessary to create stronger strains to drag the cannabis culture into the modern age? Seriously, how high do we need to be? After all, humans have been getting stoned for thousands of years on moderately okey dokey, no-frills bud, never once complaining (at least as far as we know) that the weed they were smoking didn’t catapult them into some feral dimension of space and time where the kitchen appliances speak in tongues. Yet, cannabis consumers today are driven by marijuana that registers a THC content of 25 percent and over. The more, the better. These people are the dedicated potronauts of stoned society who need to trip out at a near dysfunction to feel like they got their money’s worth. They, of course, are some same hotshot binge tokers who end up on a full-fledged freak out after a fiendish canna-panic sets in.
THC potency chart

Although we have limited knowledge regarding the science behind the elusive pot buzz, most experts agree that susceptibility to the potency of some strains is really more about the person’s tolerance than the purported THC-levels. The idea is that the more marijuana a person consumes on a regular basis, the less likely he or she is to be slashed to bits by some mega-strain referred to as The Kevorkian packing a THC punch of 99.99 percent. But for the weekend weed warrior, it’s a different story altogether. These folks should prepare to watch their faces melt off in the streets. “It’s really dependent on the history of use in that individual,” Richard Miller, a professor of pharmacology at Northwestern University’s Feinberg School of Medicine, told Mashable.

There is some basic science behind to getting high. Since every person is equipped with an endocannabinoid system, our brains have receptors that allow tetrahydrocannabinol (THC) to cling them and produce buzzed effects. But the more these receptors are used, the less effective they become in generating a high.

“They tend to work a little better or worse depending on how much they’re used,” Miller said. “If you flood them [receptors] with lots and lots of cannabis there might be a tendency for them to work less well.”

If tolerance is the determining factor for how strong a person’s buzz is going to be, some of the high potency strains are sort of wasted on regular users. But that’s okay, no need to change up your buying habits or anything. Some studies have suggested that it doesn’t matter how much THC is contained in a particular strain, all of them are relatively the same. Researchers at the University of British Columbia say the differences in the buzz that each strain produces is associated with varying levels of other non-intoxicating cannabinoids. “A high abundance compound in a plant, such as THC or CBD, isn’t necessarily responsible for the unique medicinal effects of certain strains,” said lead study author Elizabeth Mudge in an interview with Science Magazine.

There is more to creating a strain of marijuana than churning out massive THC levels. Most experienced cannabis growers understand the importance of the “entourage effect” –  cannabinoids, terpenes, flavonoids – all working together to provide the user with a unique buzz and are not just obsessing over THC levels. But the consumer is. Some reports show that some growers are being forced to produce more high potency strains because less potent products aren’t selling. Consumers in legal states like Alaska are all about the strong stuff (anything over 20 percent) rather than average strains testing at 14 percent. But this is happening everywhere. Some of America’s favorite strains (Blue Dream, GG#4, Durban Poison) contain at least 20 percent THC. This is where it necessary for budtenders (and the cannabis media) to educate.

So, how high can a person really get? Pretty high. But this has less to do with THC levels than most are programed to think.

TELL US, do you buy cannabis based on its THC levels?

The post Come On, How High Can a Person Really Get? appeared first on Cannabis Now.

Come On, How High Can a Person Really Get? was posted on Cannabis Now.

Oklahoma Official Charged With Felonies After Fake Marijuana Terrorist Threats

Oklahoma Official Charged With Felonies After Fake Marijuana Terrorist Threats

It began as a scam seemingly built on good intentions. The Oklahoma State Department’s leading legal eagle, 37-year-old Julie Ezell, was simply going to create a digital boogeyman, of sorts, in hopes of convincing state regulators to back down on their willingness to ban smokeable forms of marijuana. But, these days, not only does it take guts and nerves of steel to pull off the perfect felonious capper, but it also requires the technological aptitude to prevent investigators from tracking down the true culprit. None of these qualities Ezell possessed enough of to bring longevity to the hoax.

At the beginning of July, Ezell was threatened by a terrorist group with a seemingly violent passion for seeing the state’s medical marijuana program unleashed without being marred by overregulation. She began receiving nasty emails from supposed cannabis advocates that included personal information, such as the description of her car, her home address and messages such as “We will watch you.” But this was just the prequel to the terror. Additional emails came later, one of which said, “We will stop YOU and you’re [sic] greed. Any way it takes to end your evil and protect what is ours.” Another message read, “We would hate to hurt a pretty lady. You will hear us. We are just the beginning.”

The overall message from the would-be terrorists was let us smoke weed or you will die.

As anyone would in this situation, Ezell reported the aggressive emails to the authorities. But she didn’t count on the authorities sending in the experts to trace the messages back to their original source. This is where it all hit the fan. A forensic investigation of her phone determined that the terrorist group threatening Ezell was actually Ezell herself. Come to find out, she had been using the phony email address “MaryJameprotonmail.com” to send menacing threats to her government-assigned email account. It was upon this discovery that state investigators dragged Ezell in for questioning. Of course, as any inexperienced fraudster does when the heat comes down, she buckled, confessing to the whole ridiculous plot.

Ezell resigned from her position last Friday. In an email to Interim Commissioner of Health Tom Bates, she wrote, “I am so sorry.” But in the eyes of the state, sorry wasn’t enough. Earlier this week, Ezell was slapped with two felonies and a misdemeanor for being the mastermind behind the threatening emails and trying to pull the wool over the eyes of the Oklahoma State Bureau of Investigation. Still, her attorney, Ed Blau, suggests that her heart was in the right place and that “these charges do not reflect who she is as a person, nor do they reflect the type of advocate she had been for the people of the state of Oklahoma.”

But exactly what kind of advocate was she? What was her motive in conjuring up a hoax pertaining to the state’s marijuana laws? At the very core of this scam was a woman seemingly working to ensure that the will of the people was respected. Once the voters approved medical marijuana back in June, Ezell was part of the crew charged with drafting the rules for the state’s medicinal cannabis program. Other parties wanted to ban smoking and put a state-licensed pharmacist on staff at every dispensary. However, her version of how the regulatory affairs should shake out did not include these provisions. Both of these rules were eventually adopted by the state anyway.

But why did Ezell care enough about medical marijuana freedoms to risk legal repercussions as a result of fraudulent terrorist threats? A report from the Oklahoma City-based publication, NonDoc, suggests that Ezell “attempted to use the threats as leverage during an inter-agency political fight about the medical marijuana rules.” But this still does not answer the question why. The crime doesn’t appear to be financially motivated. In fact, reports indicate that she was offered a bribe by Oklahoma State Board of Pharmacy director Chelsea Church that promised her a new job and a guaranteed pay raise if “you get me a pharmacist in dispensary.”

But she did not accept. In a text to Church, Ezell cited a “threatening email” as an excuse for not including the pharmacist requirement in the final draft. This texting situation has sparked a separate investigation.

TELL US, do you think Oklahoma is overregulating cannabis?

The post Oklahoma Official Charged With Felonies After Fake Marijuana Terrorist Threats appeared first on Cannabis Now.

Oklahoma Official Charged With Felonies After Fake Marijuana Terrorist Threats was posted on Cannabis Now.

Medical Marijuana Struggles to Survive Recreational Markets

Medical Marijuana Struggles to Survive Recreational Markets

In the beginning, the concept of marijuana for medicinal purposes was the only way the cannabis advocacy community could effectively further legalization movements. This is how California became the first legal state in the nation more than two decades ago. But there has been a shift in recent years in the plot to bring weed to the mainstream. Now, nine states and the District of Columbia allow adults 21 and older to use pot recreationally in a manner similar to beer. This is not to say that marijuana doesn’t still have the same therapeutic powers that once allowed people all over the Golden State to purchase weed for a variety of aches and pains to the full-blown, devastating effects of cancer and chemotherapy. But under the recreational laws, it is no longer necessary for “patients” to conjure up health problems to keep a surplus of weed on hand at all times. They can simply walk into their local dispensary, flash an ID, hand the clerk some money and head back home to relish in the feel-good effects of pot. No medical marijuana card required. No questions asked.

It is this hassle-free approach to maintaining a cannabis lifestyle that is starting to put the screws to medical marijuana programs. States that began their journey into legal weed by passing Compassionate Use laws, and have since adopted deeper reforms by legalizing the leaf for recreational use, are now seeing fewer patients and more customers, according to a recent report from Marijuana Business Daily. Colorado, Oregon and Nevada, have all experienced diminished medical marijuana sales as a result of fully legal markets. Patients are simply buying less of the “medical” stuff now that they lean on the recreational sector. It is a trend that seems destined to cripple medical marijuana programs nationwide as more states move to eliminate prohibition.

But is this really a problem?

The answer really depends on who is being asked. There are some folks who consider the cannabis plant is the most sacred plant on Earth and therefore it should not be consumed for recreational purposes. It is this group of zealots, the ones who believe God put cannabis here for us to remedy all of the devastating ailments that come our way, that remain the most passionate about maintaining their respective statewide medical marijuana programs. There are even some who protest the recreational movement because they fear it puts them at risk for losing access to actual “medical marijuana.” But there really is very little difference between medical and recreational weed. There are no super secret labs in legal states dedicated to growing special strains of cannabis for people purporting to have legitimate health conditions.

If there is any difference at all between the medical and recreational offerings distributed in part of the United States, it is that some of the medical strains are higher in the non-intoxicating compound of the cannabis plant known as cannabidiol (CBD). While these strains are better than some might imagine, they are not as popular as higher THC versions, like Blue Dream and Durban Poison. The only other difference is taxes. Some medical marijuana programs do not charge patients tax (or have reduced tax rates), while weed purchased on the recreational sector is levied big time. For some patients, like those on fixed incomes, high tax rates are enough to keep them from leaving the world of medical marijuana. But for the more functional breed of patients, those who can still maintain gainful employment, it is just easier to get all of their “medicine” from the recreational side. This is starting to happen more.

Oregon experienced the biggest drop, with patient counts down 42 percent since recreational sales began in 2015. In Nevada, which just celebrated its one-year anniversary for recreational sales, patient numbers have declined by 32 percent since last October. Colorado, the first state in the nation to go fully legal, experienced the lowest drop in medical marijuana patients (22 percent). This is likely due to the low cost associated with its medicinal program, the report says.

In spite of the controversy surrounding medical and recreational weed, the United States should probably prepare for the eventual demise of medical marijuana. Once the federal government finally brings prohibition to an end nationwide, allowing adult citizens all across the country to use cannabis however they see fit, the medicinal concept is going to come crashing down… and hard. No question. All one has to do is examine America’s history with alcohol to see that “medicinal purposes” cannot exist in a recreational climate.

During the days of alcohol prohibition, booze was still legal for medicinal purposes. Doctors were prescribing hard liquor to patients suffering from a variety of conditions ranging from depression to cancer. Interestingly, doctor’s orders on prescription booze sometimes read, “Take three ounces every hour for stimulant until stimulated.” In other words, drink until happy. But as it was pointed out in a piece from The Smithsonian, “medicinal alcohol” was a “mostly bogus” way for citizens to drink legally. Doctors didn’t mind this ruse because they earned more money. But the second alcohol prohibition was repealed, giving the people legal access to booze, once more, for recreational consumption there was no reason for anyone to ask their doctors for permission to drink. In 2018, most people laugh when it is suggested that alcohol has medicinal properties. Still, decades ago, medical whiskey was no laughing matter for alcohol enthusiasts caught up on the wrong side of prohibition.

Some medical marijuana purists might argue that the situation with alcohol and cannabis is different because the plant has actually been proven to have some medical value. Even the federal government now says that CBD is safe and effective medicine for some forms of epilepsy. This might be true. After all, I have never claimed to be a scientist, a medical expert of any kind, nor do I even like to visit the dentist to get my teeth cleaned on occasion. All I have is the history books as a basis for this hypothesis. And if any part of the prohibition chapter is coming around again — rest assured medical marijuana will not survive.

TELL US, do you think medical marijuana is doomed?

The post Medical Marijuana Struggles to Survive Recreational Markets appeared first on Cannabis Now.

Medical Marijuana Struggles to Survive Recreational Markets was posted on Cannabis Now.

FDA Approves Cannabis-Based Medicine for Seizures

FDA Approves Cannabis-Based Medicine for Seizures

Although marijuana remains illegal at the federal level, that hasn’t stopped one drug company from bringing its cannabis-based seizure medicine to the American market.

For the first time ever, the U.S. Food and Drug Administration (FDA) has put its seal of approval on an oral cannabidiol (CBD) solution that will be prescribed to patients suffering from rare and severe cases of epilepsy. This is a giant leap forward in the grand scheme of cannabis acceptance in the United States, especially since the federal government still refuses to acknowledge that any part of the cannabis plant has therapeutic properties.

On Monday, the FDA gave Britain’s GW Pharmaceuticals permission to begin legally distributing its CBD syrup Epidiolex in the United States. The drug is derived from the cannabis plant and not synthetic in nature like prescription THC drugs (Marinol and Syndros) available as an appetite enhancer for people with HIV/AIDS.

This solution has been shown to lessen seizure frequency in children with Lennox-Gastaut syndrome and Dravet syndrome without providing the intoxicating effects often associated with marijuana. It is a development that FDA Commissioner Scott Gottlieb said, “serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.”

This means Epidiolex, which will require a prescription from a doctor, will soon be available in pharmacies all across the nation. From Walmart to CVS to the Mom-n-Pop drugstores still kicking it Smalltown, USA — legitimate cannabis medicine will be available in the same way as other prescription drugs.

Although marijuana is legal in 20 states for medicinal use, not all of these programs provide epileptic children with access to cannabis-based treatments. And even the ones that do are far from having the blessing of the federal government, and therefore are not covered through any insurance network. As for Epidiolex — the drug falls right in line with those FDA approved medications paid for through most American healthcare plans. And thank for ganja gods for that — a report from the Associated Press indicates that patients could spend in upwards of $25,000 per year on this medicine.

While this move will undoubtedly increase profits for GW Pharmaceuticals, predicting annual sales eventually reaching $1 billion, it could also bring some much-needed relief to hundreds of thousands of children afflicted with more complex variations of epilepsy for which traditional treatments have been mostly ineffective.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Doctor Billy Dunn, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement accompanying a press release. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”

More patients could eventually benefit.

Along with Epidiolex receiving FDA approval comes some work for the U.S. Drug Enforcement Administration (DEA). The agency now has 90 days to reschedule CBD from its rank as a Schedule I drug on the Controlled Substances Act. The non-intoxicating compound currently falls in line with marijuana, which has “no currently accepted medicinal use” in the eyes of Uncle Sam. But now, considering that Gottlieb and company have deemed CBD an official medicine, it cannot remain a Schedule I.

“It absolutely has to become Schedule 2 or 3,” DEA spokesperson Barbara Carreno told Business Insider.

This reschedule should make it easier for researchers to study CBD for its potential health benefits. Unfortunately, it will continue to be a bureaucratic nightmare for anyone in the scientific community to explore the therapeutic possibilities of the primary psychoactive compound of the cannabis plant known as tetrahydrocannabinol (THC). This compound will remain in the same ranking as heroin. What’s more is this part of the plant may never find FDA approval in smokeable form.

It is important to point out that GW Pharmaceutical’s CBD solution Epidiolex is higher-quality medicine than the majority of the CBD products sold on the Internet and through various health food stores. GW’s product is made with “pharmaceutical-grade CBD,” explained Shlomo Shinnar, the president of the American Epilepsy Society and a professor of neurology and epidemiology at the Albert Einstein College of Medicine, while those CBD oils and lotions found in shopping malls and smoke shops are made from hemp seed. High-quality CBD products, like the newly approved medicine GW is peddling, can contain up to 30 percent CBD or more. Hemp versions of this product are lucky to hit 3.5 percent CBD.

GW Pharmacueticals is expected to announce the U.S. launch for Epidiolex as soon as the DEA reclassifies CBD.

TELL US, do you think the government will reschedule CBD?

The post FDA Approves Cannabis-Based Medicine for Seizures appeared first on Cannabis Now.

FDA Approves Cannabis-Based Medicine for Seizures was posted on Cannabis Now.

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