All posts tagged: Science

The FDA Approved its First Cannabis Drug. What Next?

June 28, 2018 Mary Jane Blog

Five years ago, I bought a safe for my son’s doctor to store drugs. It was blue, about three feet square, and weighed 965 pounds—like the Acme safes Wile E. Coyote used to try to drop on Road Runner. My family and I had evidence the drugs might cure our 11-year-old son of his relentless seizures. But because the drugs contained a derivative of a cannabis plant known as cannabidiol, or CBD, the drugs had to be handled like they were heroin, or any other so-called Schedule 1 drugs. Every few months when a new shipment arrived, I or my wife Evelyn would appear at UCSF doctor Roberta Cilio’s office door. She’d open the safe, make us sign some papers, and give us Sam’s medicine in a brown paper bag to take home.

The medicine did help our son, and a whole lot more. Sam’s seizures dropped from 100 a day to about five a day—and GW Pharmaceuticals, the manufacturer, was so encouraged by his response that it started talking to epilepsy doctors about clinical trials. On Monday, the Food and Drug Administration approved the drug, now known as Epidiolex, for sale in the US. It will likely be available via prescription at pharmacies in the fall.

Like any new drug, we won’t know whether it lives up to its hype for a while. What’s clear is that it will permanently change the way we talk about cannabis in America. Cannabis is as legal as alcohol in Washington, DC and eight states, including the entire West Coast. But doctors, scientists, and hospital administrators are governed by federal, not state law, which makes studying cannabis a risky, time-consuming endeavor. That’s about to permanently change.

Early evidence suggests CBD could be useful not just for epilepsy, but a broad spectrum of neurological diseases like Parkinson's, Alzheimer's, multiple sclerosis, and some brain cancers. “There are neuroscientists who are drooling to work on this,” said Elizabeth Thiele, director of the pediatric epilepsy program at Massachusetts General Hospital and one of the lead investigators in the GW trials. Once the DEA reschedules Epidiolex, they finally will be able to.

The approval also enables GW itself to accelerate its own internal cannabis research. GW is already testing Epidiolex for the treatment of tubular sclerosis, a disease other than epilepsy that often causes seizures. Beyond that, GW now has political capital with US regulators that it plans to use to get approval for Sativex, a THC and CBD mouth spray for cancer pain and multiple sclerosis, which has been available in the UK since 2010 and in other European countries like Germany since 2011. If that product is approved, American scientists will finally have a relatively easy, legal way to test the effects of dosed THC for many disorders.

For the moment, the biggest unknown is how insurance companies will decide to cover Epidiolex. The double blind, placebo-controlled trials required for FDA approval only covered two rare brain-destroying pediatric types of epilepsy—Dravet Syndrome and Lennox Gastaut Syndrome. About 50,000 patients are affected by these two illnesses. But there is already evidence that Epidiolex could help with dozens of different types of seizures and epilepsy syndromes.

Indeed, two-thirds of the 1,756 patients who have tried Epidiolex in the past five years didn’t have Dravet or LGS—including Sam. Demand for Epidiolex was so high among drug-unresponsive patients like Sam that GW allowed neurologists at more than four dozen hospitals that weren’t part of the formal trials to conduct their own so-called open label trials. It helped GW learn more about how Epidiolex worked in a broader population, and it allowed a lot of sick patients to get access to medicine that might help them.

That parallel research should make it easier for doctors to prescribe the drug for other illnesses, a practice known as “prescribing off label.” It just means that in a doctor’s professional opinion a certain drug is worth trying, and it happens a lot with epilepsy drugs, Thiele says.

The reason that pharmaceutical firms focus on rare diseases like Dravet and LGS—at least for seizure drugs—is driven as much by business and bureaucratic considerations as medical ones, doctors and pharmaceutical executives have told me. It’s difficult to get permission to do drug trials in children unless those kids have illnesses like Dravet and LGS. In addition, companies can get FDA approval faster and have patent protection for longer if they develop drugs for rare diseases like Dravet or LGS.

What all this means is that GW will need to ensure that patients already taking Epidiolex for other forms of epilepsy don’t suddenly wake up in the fall and become compelled to pay full price for medications that work for them. It also means that doctors will need to marshal their expertise and the data that already exist.

Thiele says that insurance companies eventually decide to cover epilepsy drugs for many more kinds of seizures than they were originally prescribed. The only question in her mind is how long that will take. The one thing she does know is that the public pressure for insurance companies to cover Epidiolex broadly will be intense. “Every epileptologist I know says that patients have been asking when they can get Epidiolex for a year now,” she adds.

As for Sam, he wants to be a neurologist when he grows up. Two and a half years ago, when we combined Epidiolex with another drug, Sam’s seizures stopped completely. Sam, now 17, has medical permission to drive a car, something along with—well, everything—that seemed impossible to imagine five years ago.

My Son Pioneered an Epilepsy Drug Derived From Marijuana. An FDA Panel Just Approved It

June 24, 2018 Mary Jane Blog

Yesterday morning a tall, lanky 16-year-old boy in a red polo shirt stood at a podium in front of a roomful of doctors, scientists, and regulators and told them about how a drug they were considering for approval had changed his life. “I had seizures for 10 years,” he said. “My parents tell me there were times I had seizures 100 times a day.” Now, he said, he has been seizure free for nearly two and a half years.

“I can understand what goes on at school,” he said. “And I can have adventures that never would have been possible before.” He told them about how seizure freedom enabled him to study to be a Bar Mitzvah in 2016. He told them about a school trip he’d just taken without his parents to South Africa—12,000 miles from home. And he said that he hoped to become a neurologist one day so that he could help other people with epilepsy. The audience, despite being told not to applaud speakers until the end, clapped anyway.

About an hour later, after about a dozen parents of epileptic children spoke of their struggles with the disease, the Food and Drug Administration panel of scientists and doctors voted 13-0 to recommend approval. The FDA is expected to render a final decision on the drug, Epidiolex, by June. One of the panelists John Mendelson, an addiction treatment executive and a UCSF professor said, “This is clearly a breakthrough drug for an awful disease.”

The whole event, which I watched on a live stream from my home office in Berkeley, was one of the thrills of my life. Sam is my son. He and my wife Evelyn both testified because Sam was the first person in the US to take Epidiolex back in December 2012. After trying more than two dozen medications, a crazy sounding diet, and corticosteroids that made Sam look like a cancer patient, Epidiolex—which didn’t even have a name when Sam tried it—was truly our last option to help him.

The author’s son, Sam Vogelstein, testified Thursday in Washington DC before the FDA’s advisory committee.

Evelyn Nussenbaum

I should mention that Epidiolex is derived from cannabis. Its active ingredient is cannabidiol, aka CBD, which is a chemical in the plant that doesn’t make you high.

The manufacturer, GW Pharmaceuticals, knew little about epilepsy back then. But Sam’s response was so extraordinary, their executives decided they needed to learn more about the disease, and quickly embarked on clinical trials. Sam actually tried the medicine in London under a doctor’s supervision. Such a trial in the UK was straightforward, whereas conducting it in the US would have been impossible because of our cannabis laws. Since then nearly 1,800 patients have tried it at US hospitals, with about 40 to 50 percent seeing greater than 50 percent reductions in seizures. That sounds small until you consider that admission to the trials required patients to have exhausted all other medicinal options. Officially, Epidiolex will be approved only to treat two of the most severe types of epilepsy, Dravet and Lennox Gastaut syndromes. But doctors will likely have the flexibility to prescribe it for other epilepsies too. Many epilepsy drugs are prescribed this way, known as off label. (Many patients, including Sam, are on more than one drug.)

The pending approval of Epidiolex isn’t just a big deal for me and my family. It’s a big deal for 3 million people in the US who have epilepsy, and, if approved elsewhere, 73 million people worldwide. Epilepsy affects about one percent of the world’s population, more than Parkinson’s and Multiple Sclerosis combined. And yet for all humanities’ scientific prowess, only about two-thirds of people who take epilepsy medicines become seizure free. The imminent approval of a medication that might shrink the number of unresponsive patients is a major, even historic, development.

It’s also a big deal for cannabis research and by extension the cannabis legalization discussion. Epidiolex will be the first FDA approved drug derived from a cannabis plant. It can’t get anyone high because the manufacturer extracts all the THC during production.

To manufacture CBD, GW maintains tens of thousands of cannabis plants in hothouses all over the UK. It extracts the CBD from the plants in a lab, ending up with a 100 milliliter bottle of strawberry flavored sesame oil that it ships to the US.

A common refrain from cannabis opponents has long been that there is no scientific evidence that anything associated with cannabis can be medicine. And that’s been true because regulators and police worldwide make studying illegal substances like cannabis nearly impossible.

But to get this far in the FDA approval process, GW had to marshal the same scientific evidence of safety and efficacy that every other drug manufacturer must present. It created a medicine that was consistent from dose to dose, bottle to bottle, and batch to batch. It conducted all the required placebo controlled trials, administered by doctors in hospital settings. And those doctors published peer reviewed research in top medical journals like the New England Journal of Medicine. “It’s an honor to be participating in a (cannabis) decision based on science instead of politics," said panelist Mark Green, professor of neurology and anesthesiology at the Icahn School of Medicine in New York, after the vote.

Indeed, it doesn’t require too much imagination to see how Epidiolex’s pending approval forces a public reckoning on how we think about cannabis nationally. Attorney General Jeff Sessions has made no secret of his virulent opposition to the legalization of cannabis in any form. He has said that “good people do not smoke marijuana.” Yet, assuming Epidiolex gets formal FDA approval, he will have to weigh in through his supervision of the Drug Enforcement Administration.

At the moment, CBD is a Schedule 1 drug like cannabis. Its medical use—except in the specially approved trials that proved its effectiveness—is not allowed. The DEA must reschedule it before it can be sold. Technically, the DEA could refuse. But it would have to explain how it—a police agency—was in a better position to make that call than the FDA, an agency of scientists and doctors. An explanation would also be needed for neurologists, and the parents of millions of very sick children. The DEA can’t delay its decision either. By law it must rule within 90 days.

All that maneuvering would be moot, of course, if Congress decides to pass a law legalizing cannabis entirely, as Senate Minority Leader Chuck Schumer proposed last night. He is not the first senator to propose such a law, but he is by far the most influential to do it. “If smoking marijuana doesn’t hurt anybody else, why shouldn’t we allow people to do it and not make it criminal" he told Vice News.

By now you are probably wondering what a family from California like us was thinking when it traveled to the UK to have their kid try a drug derived from a cannabis plant. Remarkably, that’s where you had to go to get pharmaceutical grade CBD back then. We tried to procure it from artisanal producers here for six months. Everything we tried turned out to be ineffective and sometimes fraudulent. Getting the CBD out of cannabis plant is complicated, expensive, and time consuming.

The artisanal CBD market is more robust today. There are some good, reliable preparations that are helping epilepsy patients who could not get into the GW trials. Hopefully they will force GW to keep Epidiolex affordable. But many parents have told me that in a perfect world they'd just go to the pharmacy to treat their kids' seizures. They have complicated lives, but simple needs. They want the same experience they get when they fill a penicillin prescription: a cure.

All of this made yesterday one of the best days in Sam's young life. Other parents thanked him for speaking for all the kids who were too sick to speak for themselves, and he felt like he was part of something bigger than himself. “And when I suggested that we made a good team as speakers," Evelyn said, “he said with a big grin, ‘You set ’em up. And I knock ’em down.’ ”

Read more: http://www.wired.com/

All eyes on Canada as first G7 nation prepares to make marijuana legal

June 10, 2018 Mary Jane Blog

From crime to health to business, Canadas decision to legalize marijuana is a grand progressive experiment that promises to answer a host of questions

When Canopy Growth opened its first cannabis factory in an old chocolate plant near Ottawa four years ago, it did so predicting a bright future. Canada had already legalized medical marijuana, and Canopy predicted full legalization for recreational use to be next.

What the company hadnt predicted, however, was the sudden flood of foreign visitors. Politicians and police authorities from Jamaica, Germany, Denmark, the Netherlands, Greece and Australia have all come knocking, as well as doctors from New Zealand, Brazil and Chile, along with groups of corporate investors and bankers so many that Canopy now sometimes splits up the groups according to their birthdays.

We knew wed have to give a lot of tours, so we just cut a window into the wall, said the company spokesman, Jordan Sinclair. We put windows in all of the doors.

Canada will be thrust even more directly under the international microscope on Thursday, when a vote in the Senate is expected to ratify Bill C-45, effectively making Canada the first G20 nation to legalize recreational marijuana.

Its going to be a bit of a science fiction experience for a while, said Benedikt Fischer, an expert on substance use at Torontos biggest psychiatric hospital. Its unique in the world, because its happening for the first time in a wealthy country. Its not like in the US, where there are these state experiments. Most people kind of ignore Uruguay. And so the world is really looking at this.

Governments, researchers and business leaders around the world all have their own reasons for keeping tabs. Legalization could affect Canadas crime patterns, health and countless other factors but exactly how, no one yet knows.

Each Canadian province plans to roll out its newly legalized market in a slightly different way, creating about a dozen mini-laboratories within one massive test case.

Even places that have already taken the legalization plunge are hoping Canada will solve some mysteries. After Colorado legalized marijuana five years ago, for example, organized crime reacted by ramping up supplies of black tar heroin, opiates and harder drugs, said Dr Larry Wolk, the states top public health official.

But Wolk says he is interested to watch that process unfold on a bigger scale in Canada, where the new law is expected to deal a much more significant blow to the black market. Any new mix of illicit drugs in the country could have new effects on public health.

Whats the impact of marijuana legalization on the opioid crisis? he asked as an example. Does it actually act as a substitute so that people can get off opiates for chronic pain? Is there a positive impact? Or is it a negative impact, because as a result theres more opiates in the black market? Is [pot] a gateway? We dont really have an answer.

One delicate balance for Canadian authorities has been guessing at what kind of pricing will be low enough to eradicate illicit sales yet not so low as to entice new users. Canadas finance minister, Bill Morneau, recently said the goal is keeping cannabis out of the hands of kids and out of the black market. That means keeping the taxes low so we can actually get rid of the criminals in the system.

One sign of success will be if Canada not only discourages underground sales, but converts illicit sellers to the new system, said Tim Boekhout van Solinge, a Dutch criminologist.

What I am mainly following is who will be the new legal growers, and whether authorities manage to get some of the illegal growers to become legal growers, he said.

Lots of Doctors Recommend Weed Without Understanding It

May 14, 2018 Mary Jane Blog

If you go to a doctor and ask them to recommend you medical marijuana, don’t expect them to fully understand how the drug works, both for you as an individual patient and in general as a therapy. Because no one really does.

With more and more states legalizing marijuana for medical or recreational use, cannabis is shedding its stigma and entering the mainstream. That means folks who’ve shied away from the stuff are getting better access, and exploring cannabis as a non-addictive treatment for ailments like pain. But that new interest is running smack dab into a big problem plaguing medical cannabis: The research on what marijuana can actually treat, what components of the plant matter, and how different patients respond to them, is severely lacking.

Just how much doctors are struggling with it becomes clear today in the Journal of Clinical Oncology. A study reveals that half of surveyed oncologists say they recommended marijuana to patients in the last year. But half of those didn’t think they actually had sufficient knowledge to make those recommendations.

The biggest question for oncologists is what cancer symptoms cannabis can really treat. The survey found respondents split when it comes to the treatment of pain: A third of oncologists said cannabis is equally or more effective than standard pain treatments, a third said it was less effective, and a third didn’t know. “But there seemed to be clear consensus that medical marijuana is a good adjunct to standard pain treatment, so a good add-on medication,” says Ilana Braun, lead author and chief of Dana-Farber Cancer Institute's Division of Adult Psychosocial Oncology. In fact, two-thirds of respondents said it’d be a good supplemental treatment.

According to the National Academies of Sciences, Engineering, and Medicine—which last year published a massive, big-deal review of cannabis research—“there is substantial evidence that cannabis is an effective treatment for chronic pain in adults.” It’s also been shown to help control nausea and vomiting.

Now, doctors have long prescribed a synthetic THC called dronabinol, aka marinol, for the treatment of nausea and weight loss. Problem is, side effects include paranoia and “thinking abnormal.” Beyond that, you wouldn’t want to try to get high on it because it’s missing the galaxy of other active compounds in cannabis. “If it worked—it rarely does work—but if it really did work it would be abused on the streets,” says physician Allan Frankel, a pioneer in medical cannabis. “For 15 cents a pill? That's how bad marinol is.”

The reason, Frankel says, is the so-called entourage effect, the interaction of dozens of other cannabinoids in marijuana like CBD (which is an extremely effective treatment for seizures, by the way) that may produce different therapeutic effects. So by that logic, with marinol, patients aren’t getting the full effect of the cannabis plant.

And that full effect would be? Well, nobody really knows—in part because the US government makes the stuff very, very difficult to study. In the eyes of the feds, it’s still a very illegal schedule I drug, the most tightly controlled category, and the DEA decides who gets crop to research. Researchers don’t have access to a variety of strains that might produce a variety of benefits, given different levels of CBD and THC and other compounds.

Even if you could study lots of different strains, it’s not always possible to tell what a patient is going to get at the dispensary. Flowers can be mislabeled, and the THC content of oils doesn’t always match what’s on the label. “Composition standardization is a giant mess,” says Jeff Raber, CEO of the Werc Shop, a lab that tests cannabis. “So for an ultra traditional doctor, I can understand where they're like, Man, we don't really know what that is, is that OK? It's not standardized like a pharmaceutical product.”

A doctor can’t just say, Take two marijuana pills and call me in the morning. And on a physiological level, we all handle cannabis differently. “Even if I tell everybody, go inhale a tenth of a gram, their inhalation depths and absorption rates are going to be different,” says Raber.

“Unfortunately, we are going a little bit blind,” says physician Bonni Goldstein, medical director of the Canna-Centers, which provides cannabis consultations for patients. “But what I'm finding in clinical experience is I learn from every patient, and so we try to use the scientific research that we do have.”

So doctors like Goldstein try to tailor cannabis as best they can for a patient’s needs. Her patients have the luxury of attentive, personalized cannabis consultations. “Someone retired who has cancer who doesn't have to get up in the morning and get somewhere may be able to take bigger doses during the day,” says Goldstein, “versus a mom of four who has kids in and out of activities, who has breast cancer.”

But your typical oncologist isn’t going to sit down with a patient for an hour to walk through their lifestyle and needs. So patients are left to experiment with dosages on their own, or consult with their local dispensary.

Because it turns out that dispensaries have some experience dosing cannabis. “Some of the top dispensaries that have been doing this for a while know this better than anybody else,” says Rob Adelson, president and CEO of Resolve, which makes a smart inhaler for medical marijuana patients. “There's still so much about the pharmacokinetics of this plant that we just don't know yet. So asking a doctor to come in to try to solve the problem without any more data than the dispensary has is hard.”

What Adelson sees cannabis promoting is a new paradigm of medical care. “We've heard this from many doctors, that they might not know about medical cannabis, might not want to promote it, and that a patient comes in and says, ‘I'd like to try it,’” he says. “And patients bring studies with them." That inversion of responsibility has its downsides: An elderly patient might not be aware of side effects like dizziness, for example. But at the same time, it's impossible to overdose. For better or worse, if doctors don't feel they have the knowledge to appropriately prescribe a drug, patients will fill that void.

More cannabis science

Another big unknown with cannabis is the issue of safety. Namely, the stuff that's grown in the wilds of California can be very, very dirty.
Take a deeper dive into why it's so hard to properly dose marijuana.
Again, please never drive stoned, ever, even if it's currently impossible to determine just how intoxicated you are.

Read more: http://www.wired.com/

Why It’s So Hard to Dose Weed

April 29, 2018 Mary Jane Blog

Cannabis is a notoriously finicky drug. Take the right amount and you get relaxation or euphoria, but take too much and it’s a long ride of paranoia. Which makes marijuana tricky for casual users, and potentially problematic for new users who want to use cannabis to treat ailments like pain.

It's difficult to quantify just how much of the drug you’re inhaling through a bong or vaporizer—especially because marijuana contains some 500 chemicals that interact in ways scientists are just beginning to understand. And really, how you end up feeling depends as much on your physiology and state of mind as it does on the plant.

But, some good news. For one, science only has more to learn about how marijuana works on the human body. And two, companies making cannabis devices are figuring out ways to tackle the dosing problem.

Take the Resolve One smart inhaler (formerly known as Breeze) for medical marijuana users who also happen to be data nerds, coming out in May. Think of it like the Keurig of cannabis: Insert a “Smart Pod” of marijuana and the device administers a precise blast of vapor. The device pairs with a smartphone app, where users begin by inputting their pain level. The inhaler calculates the right dose, followed by a drag. Ten minutes later, once the cannabis has kicked in, the app pings them to rate their pain again. This helps the user determine how effective the dose was.

And it helps Resolve One's maker, Resolve Digital Health, do the same: By gathering more and more data, it can build pain profiles. Some folks wake up in pain, for instance, while for others the pain builds throughout the day. So how might cannabis help mitigate these different experiences? How might the drug interact with other medications the person is taking? (Users are encouraged to log these in the Resolve One app.) How do other medical conditions factor into the pain problem? (You log these too.)

More cannabis science

Resolve’s goal is to use data from Resolve One to help not only individual users, but to build a better understanding of how cannabis can treat pain. “I think patients of the future, and we're seeing it right now with cannabis patients, are data-empowered patients,” says Rob Adelson, president and CEO of Resolve. “They want information, they want to collect it, they want to share it, they want to compare it.”

Now, it’s clear that accumulating more and more data hasn’t cured cancer or helped humans figure out how to stop aging. But in the case of cannabis, scientists have so little detailed information about user responses that it makes sense to start looking. Especially because the effects of cannabis can vary wildly from user to user. Some people, for instance, can handle higher THC content than others without having a conniption. And how marijuana affects you can even vary based on how much food you’ve had that day, especially if you’re consuming edibles.

“It's going to take a long time for us to get to the level of knowledge that we all need to be at to understand how this plant works, specifically for very specific health conditions,” says Adelson. “But what we'll do is collect that data, and then put some of those insights and findings into clinical studies where we can go deeper into it.”

dosist

The uncertainty is especially challenging given how potent cannabis has become. One study found that THC levels have gone up three-fold since 1995, thanks to selective breeding. But patients may be more interested in high levels of CBD, the non-psychoactive component that could help treat ailments like epilepsy.

“Our focus is on mitigating the intoxicating effects of cannabis, which is a very different mindset than a lot of cannabis brands,” says Gunner Winston, CEO of Dosist, which makes dose pens. “A lot of people don't want to be intoxicated.”

The trick may be something called the entourage effect, the idea that the plant’s various compounds interact with one another to put a check on the psychoactive effects on THC. Specifically, you’d want a lot of CBD in there. Yet science hasn’t proved out this effect.

“I think the anecdotal mountain of evidence says that it does exist,” says Jeff Raber, CEO of the Werc Shop, a lab that tests cannabis. “But we don't know why or how or which ones are doing what.”

And that’s just when it comes to ingesting and inhaling cannabis. “We actually know very little about other modes of administration,” says UC San Diego researcher Igor Grant, who studies cannabis. “People talk about having skin patches and various kinds of gels. The work just hasn't been done to show whether that actually delivers the cannabis in the way that you would want in an effective dose.”

But as far as inhaled marijuana is concerned, companies like Resolve Digital Health and Dosist are starting to tackle the quantification problem, the former catering to patients and the later to a more general audience. And they’re betting that demand for a more predictable cannabis experience is only going up.

“People are asking for this,” says Winston of Dosist. “We can debate all day how much science has been done and should be done, but when you look across the country people are demanding cannabis for therapeutic purposes.”

Remember: Until there’s a fool-proof system for accurately dosing inhaled cannabis—and there may never will be—go low and slow. Your brain will thank you.

Read more: http://www.wired.com/

My Son Pioneered an Epilepsy Drug Derived From Marijuana. An FDA Panel Just Approved It

April 24, 2018 Mary Jane Blog

The author’s son, Sam Vogelstein, testified Thursday in Washington DC before the FDA’s advisory committee.

Evelyn Nussenbaum

I should mention that Epidiolex is derived from cannabis. Its active ingredient is cannabidiol, aka CBD, which is a chemical in the plant that doesn’t make you high.

Read more: http://www.wired.com/

The Dirty Secret of California’s Cannabis: It’s Dirty

April 9, 2018 Mary Jane Blog

This is a story about marijuana that begins in a drawer of dead birds. In the specimen collections of the California Academy of Sciences, curator Jack Dumbacher picks up a barred owl—so named for the stripes than run across its chest—and strokes its feathers. It looks like a healthy enough bird, sure, but something nefarious once lurked in its liver: anticoagulant rodenticide, which causes rats to bleed out, and inevitably accumulates in apex predators like owls. The origin of the poison? Likely an illegal cannabis grow operation in the wilds of Northern California.

Wired

“It's a mess out there,” says Dumbacher. “And it costs taxpayers millions of dollars to clean up the sites.”

Marijuana doesn’t just suddenly appear on the shelves of a dispensary, or the pocket of a dealer. Someone’s gotta grow it, and in Northern California, that often means rogue farmers squatting on public lands, tainting the ecosystem with pesticides and other chemicals, then harvesting their goods and leaving behind what is essentially a mini superfund site. Plenty of growers run legit, organic operations—but cannabis can be a dirty, dirty game.

Morgan Heim/BioGraphic/California Academy of Sciences

As cannabis use goes recreational in California, producers are facing a reckoning: They’ll either have to clean up their act, or get out of the legal market. Until the federal prohibition on marijuana ends, growers here can skip the legit marketplace and ship to black markets in the many states where the drug is still illegal. That’s bad news for public health, and even worse news for the wildlife of California.

If you’re buying cannabis in the United States, there’s up to a 75 percent chance that it grew somewhere in California. In Humboldt County alone, as many as 15,000 private grows churn out marijuana. Of those 15,000 farms, 2,300 have applied for permits, and of those just 91 actually have the permits.

Researchers reckon that 15 to 20 percent of private grows here are using rodenticide, trying to avoid damage from rats chewing through irrigation lines and plants. Worse, though, are the growers who hike into rugged public lands and set up grow operations. Virtually all of them are using rodenticide. “At very high doses the rodenticides is meant to kill by basically stopping coagulation of blood,” says Dumbacher. “So what happens is if you get a bruise or a cut it you would you would literally bleed out because it won’t coagulate.”

And what’s bad for the rats can’t be good for the barred owl. How the poison might affect these predators isn’t immediately clear, but researchers think it may weaken them.

Scientists are used to seeing rodenticides in owl livers—but usually, those animals are picking off rats in urban areas. Not so for these samples. “When we actually looked at the data, it turned out that some of the owls that were exposed were from remote areas parts of the forest that don't have even roads near them,” says Dumbacher. When researchers took a look at satellite images of these areas, they were able to pick out illegal grow operations and make the connection: Rodenticides from marijuana cultivation are probably moving up the food chain.

The havoc that growers are wreaking in Northern California is worryingly similar to the environmental bedlam of the past. “We can't just take exactly the same historical approach that California did with the Gold Rush,” says Mourad Gabriel, executive director of the Integral Ecology Research Center and lead author of the study with Dumbacher. It was a massive inundation of illegal gold and mining operations that tore the landscape to pieces. “150 years down the road, we are still dealing with it.”

And Northern California’s problems have the potential to become your problem if you’re buying marijuana in a state where it’s still illegal. “We have data clearly demonstrating the plant material is contaminated, not just with one or two but a plethora of different types of pesticides that should not be used on any consumable product,” says Gabriel. “And we find it on levels that are potentially a threat to humans as well.”

Lab Rats

Across from an old cookie factory in Oakland, California sits a lab that couldn’t look more nondescript. It’s called CW Analytical, and it’s in the business of testing marijuana for a range of nasties, both natural and synthetic. Technicians in lab coats shuffle about, dissolving cannabis in solution, while in a little room up front a man behind a desk consults clients.

Morgan Heim/BioGraphic/California Academy of Sciences

Running this place is a goateed Alabama native named Robert Martin. For a decade he’s risked the ire of the feds to ensure that the medical marijuana sold in California dispensaries is clean and safe. But in the age of recreational cannabis, the state has given him a new list of enemies to test for. If you're worried about consuming grow chemicals like the owls are doing, it's scientists like Martin who have your back.

“We're trying to do it in legitimate ways, not painting our face or putting flowers in our hair,” says Martin. “We're here to show another face of the industry." Clinical. Empirical.

Labs like these—the Association of Commercial Cannabis Laboratories, which Martin heads, counts two dozen members—are where marijuana comes to pass the test or face destruction. Martin’s team is looking for two main things: microbiological contaminants and chemical residues. “Microbiological contaminants could come in the form of bacteria or fungi, depending on what kind of situation your cannabis has seen,” says Martin. (Bad drying or curing habits on the part of the growers can lead to the growth of Aspergillus mold, for instance.) “Or on the other side, the chemical residues can be pesticides, herbicides, things like that.”

The biological bit is pretty straightforward. Technicians add a cannabis sample to solution, then spread it on plates that go into incubators. “What we find is of all the flowers that come through, about 12 to 13 percent will come back with a high level of aerobic bacteria and about 13 to 14 percent will come back with a high level of fungi and yeast and mold,” says laboratory manager Emily Savage.

With chemical contaminants it gets a bit trickier. To test for these, the lab run the cannabis through a machine called a mass spectrometer, which isolates the component parts of the sample. This catches common chemicals like myclobutanil, which growers use to kill fungi.

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Starting July 1 of this year, distributors and (legal) cultivators have to put their product through testing for heavy metals and bacteria like E. coli and chemicals like acephate (a general use insecticide). That’s important for average consumers but especially medical marijuana patients with compromised health. One group of researchers has even warned that smoking or vaping tainted marijuana could lead to fatal infections for some patients, as pathogens are taken deep into the lungs.

“This is why we have to end prohibition and regulate and legalize cannabis, so that we can develop the standards that everybody must meet,” says Andrew DeAngelo, director of operations of the Harborside dispensary in Oakland.

After testing, a lab like CW has to report their results to the state, whose guidelines may dictate that the crop be destroyed. If everything checks out, the marijuana is cleared for sale in a dispensary. “That gives the public confidence that these supply chains are clean for them and healthy for them,” says DeAngelo.

That safety comes at a price, though. To fund the oversight of recreational marijuana, California is imposing combined taxes of perhaps 50 percent. “They're too high,” says DeAngelo. He’s worried that the fees will push users back into the black market, where plants don’t have to hew to the same strict safety standards. “This shop should be a lot fuller than it is right now.”

And the black market gets us right back to the mess we started off in. Illegal cultivation is bad for consumers and bad for the environment. The only real solution? The end of prohibition. At the very least, the owls would appreciate it.

Read more: http://www.wired.com/

Why No Gadget Can Prove How Stoned You Are

April 2, 2018 Mary Jane Blog

If you’ve spent time with marijuana—any time at all, really—you know that the high can be rather unpredictable. It depends on the strain, its level of THC and hundreds of other compounds, and the interaction between all these elements. Oh, and how much you ate that day. And how you took the cannabis. And the position of the North Star at the moment of ingestion.

OK, maybe not that last one. But as medical and recreational marijuana use spreads across the United States, how on Earth can law enforcement tell if someone they’ve pulled over is too high to be driving, given all these factors? Marijuana is such a confounding drug that scientists and law enforcement are struggling to create an objective standard for marijuana intoxication. (Also, I’ll say this early and only once: For the love of Pete, do not under any circumstances drive stoned.)

Sure, the cops can take you back to the station and draw a blood sample and determine exactly how much THC is in your system. “It's not a problem of accurately measuring it,” says Marilyn Huestis, coauthor of a new review paper in Trends in Molecular Medicine about cannabis intoxication. “We can accurately measure cannabinoids in blood and urine and sweat and oral fluid. It's interpretation that is the more difficult problem.”

You see, different people handle marijuana differently. It depends on your genetics, for one. And how often you consume cannabis, because if you take it enough, you can develop a tolerance to it. A dose of cannabis that may knock amateurs on their butts could have zero effect on seasoned users—patients who use marijuana consistently to treat pain, for instance.

The issue is that THC—what’s thought to be the primary psychoactive compound in marijuana—interacts with the human body in a fundamentally different way than alcohol. “Alcohol is a water-loving, hydrophilic compound,” says Huestis, who sits on the advisory board for Cannabix, a company developing a THC breathalyzer.¹ “Whereas THC is a very fat-loving compound. It's a hydrophobic compound. It goes and stays in the tissues.” The molecule can linger for up to a month, while alcohol clears out right quick.

But while THC may hang around in tissues, it starts diminishing in the blood quickly—really quickly. “It's 74 percent in the first 30 minutes, and 90 percent by 1.4 hours,” says Huestis. “And the reason that's important is because in the US, the average time to get blood drawn [after arrest] is between 1.4 and 4 hours.” By the time you get to the station to get your blood taken, there may not be much THC left to find. (THC tends to linger longer in the brain because it’s fatty in there. That’s why the effects of marijuana can last longer than THC is detectable in breath or blood.)

So law enforcement can measure THC, sure enough, but not always immediately. And they’re fully aware that marijuana intoxication is an entirely different beast than drunk driving. “How a drug affects someone might depend on the person, how they used the drug, the type of drug (e.g., for cannabis, you can have varying levels of THC between different products), and how often they use the drug,” California Highway Patrol spokesperson Mike Martis writes in an email to WIRED.

Accordingly, in California, where recreational marijuana just became legal, the CHP relies on other observable measurements of intoxication. If an officer does field sobriety tests like the classic walk-and-turn maneuver, and suspects someone may be under the influence of drugs, they can request a specialist called a drug recognition evaluator. The DRE administers additional field sobriety tests—analyzing the suspect’s eyes and blood pressure to try to figure out what drug may be in play.

The CHP says it’s also evaluating the use of oral fluid screening gadgets to assist in these drug investigations. (Which devices exactly, the CHP declines to say.) “However, we want to ensure any technology we use is reliable and accurate before using it out in the field and as evidence in a criminal proceeding,” says Martis.

Another option would be to test a suspect’s breath with a breathalyzer for THC, which startups like Hound Labs are chasing. While THC sticks around in tissues, it’s no longer present in your breath after about two or three hours. So if a breathalyzer picks up THC, that would suggest the stuff isn’t lingering from a joint smoked last night, but one smoked before the driver got in a car.

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This could be an objective measurement of the presence of THC, but not much more. “We are not measuring impairment, and I want to be really clear about that,” says Mike Lynn, CEO of Hound Labs. “Our breathalyzer is going to provide objective data that potentially confirms what the officer already thinks.” That is, if the driver was doing 25 in a 40 zone and they blow positive for THC, evidence points to them being stoned.

But you might argue that even using THC to confirm inebriation goes too far. The root of the problem isn’t really about measuring THC, it’s about understanding the galaxy of active compounds in cannabis and their effects on the human body. “If you want to gauge intoxication, pull the driver out and have him drive a simulator on an iPad,” says Kevin McKernan, chief scientific officer at Medicinal Genomics, which does genetic testing of cannabis. “That'll tell ya. The chemistry is too fraught with problems in terms of people's individual genetics and their tolerance levels.”

Scientists are just beginning to understand the dozens of other compounds in cannabis. CBD, for instance, may dampen the psychoactive effects of THC. So what happens if you get dragged into court after testing positive for THC, but the marijuana you consumed was also a high-CBD strain?

“It significantly compounds your argument in court with that one,” says Jeff Raber, CEO of the Werc Shop, a cannabis lab. “I saw this much THC, you're intoxicated. Really, well I also had twice as much CBD, doesn't that cancel it out? I don't know, when did you take that CBD? Did you take it afterwards, did you take it before?”

“If you go through all this effort and spend all the time and money and drag people through court and spend taxpayer dollars, we shouldn't be in there with tons of question marks,” Raber says.

But maybe one day marijuana roadside testing won’t really matter. “I really think we're probably going to see automated cars before we're going to see this problem solved in a scientific sense,” says Raber. Don’t hold your breath, then, for a magical device that tells you you’re stoned.

¹ UPDATE: 1/29/18, 2:15 pm ET: This story has been updated to disclose Huestis' affiliation with Cannabix.

Read more: http://www.wired.com/

This Pot Company Posts Record Sales as CEO Eyes Deals

March 19, 2018 Mary Jane Blog

Medical-marijuana company Aphria Inc. posted a 39 percent jump in second-quarter revenue to C$8.5 million ($6.8 million), exceeding the most recently reported figures of larger peer Aurora Cannabis Inc. and giving it the second-highest quarterly revenue of pot-specialty companies globally. Aphria remains upbeat, even as the increased legalization of marijuana is called into question after a move by U.S. Attorney General Jeff Sessions to revoke policies that allowed its spread and warnings of a possible de-listing. At a conference in Toronto on Wednesday, Chief Executive Officer Vic Neufeld stated plans for several acquisitions that will target expansion in four more states.

Why It’s So Hard to Dose Weed

February 27, 2018 Mary Jane Blog

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dosist

Remember: Until there’s a fool-proof system for accurately dosing inhaled cannabis—and there may never will be—go low and slow. Your brain will thank you.

Read more: http://www.wired.com/

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