Largest, most rigorous study to date confirms CBD oil helps some kids with epilepsy

"This is the first solid, rigorously obtained scientific data" that a marijuana compound is safe and effective for this problem, said one study leader

May 25, 2017

A medicine made from marijuana, without the stuff that gives a high, cut seizures in kids with a severe form of epilepsy in a study that strengthens the case for more research into pot’s possible health benefits.

“This is the first solid, rigorously obtained scientific data” that a marijuana compound is safe and effective for this problem, said one study leader, Dr. Orrin Devinsky of NYU Langone Medical Center.

He said research into promising medical uses has been hampered by requiring scientists to get special licenses, plus legal constraints and false notions of how risky marijuana is.

“Opiates kill over 30,000 Americans a year, alcohol kills over 80,000 a year. And marijuana, as best we know, probably kills less than 50 people a year,” Devinsky said.

The study was published Wednesday by the New England Journal of Medicine.

For years, desperate patients and parents have argued for more research and wider access to marijuana, with only anecdotal stories and small, flawed studies on their side. The new study is the first large, rigorous test — one group got the drug, another got a dummy version, and neither patients, parents nor doctors knew who took what until the study ended.

It tested a liquid form of cannabidiol, one of marijuana’s more than 100 ingredients, called Epidiolex, (eh’-pih-DYE’-uh-lehx). It doesn’t contain THC, the hallucinogenic ingredient, and is not sold anywhere yet, although its maker, GW Pharmaceuticals of London, is seeking U.S. Food and Drug Administration approval.

The company paid for, designed and helped run the study, and another doctor involved in the study has related patents.

Patients in the study have Dravet (drah-VAY) syndrome, a type of epilepsy usually caused by a faulty gene. It starts in infancy and causes frequent seizures, some so long-lasting they require emergency care and can be fatal. Kids develop poorly, and their mental impairment seems related to the frequency of seizures — from 4 to as many as 1,717 a month in this study.

Allison Hendershot’s 12-year-old daughter Molly was four months old when she had her first. It lasted an hour and a half, and emergency room doctors medically induced a coma to stop it. Molly, who lives in Rochester, New York, has tried more than half a dozen medicines and a special diet, but her seizures continued.

“We literally could not count how many” before she started in the study, her mom said.

It included 120 children and teens, ages 2 to 18, in the U.S. and Europe. They took about a teaspoon of a sweet-smelling oil twice a day (drug or placebo) plus their usual anti-seizure medicines for 14 weeks. Their symptoms were compared to the previous four weeks.

Serious seizures with convulsions dropped from around 12 a month to about six for those on the drug and did not change in the others. Three patients on the drug became seizure-free during the study.

It’s no panacea, though. Diarrhea, vomiting, fatigue, sleep problems and other issues were more frequent in the drug group. Twelve patients quit the study — nine on the drug and three in the placebo group.

Hendershot thinks her daughter got the dummy medicine because they saw no change in her seizures until the study ended and all participants were allowed to try the drug.

By the second day they saw a difference, and “she went seizure-free for two months. It was pretty remarkable,” Hendershot said.

The fact the drug came from marijuana “did not matter to me at all,” she said. “If it helps, we’re happy. I think people hear ‘cannabis’ or that it comes from marijuana and immediately there’s a stigma attached to it.”

For those who swear marijuana helped them, “anecdote has been confirmed by data,” Dr. Samuel Berkovic writes in a commentary in the medical journal. He is an epilepsy researcher at the University of Melbourne in Australia, where medical marijuana was legalized last year, and has worked with Devinsky in the past.

The drug is being tested in a second large study in kids with Dravet syndrome, and in studies of some other types of epilepsy.

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Cannabis firms in Colorado, Florida partner to provide pharma-quality medical marijuana products

Agreement between Wana Brands and AltMed bridges interstate expansion, targets growing markets of women and Baby Boomers

May 20, 2017

Cannabis products firms Wana Brands and Alternative Medical Enterprises LLC have inked a deal that’s one part national expansion play and another part investment in a growing trend: pharmaceutical-quality medical marijuana.

Wana Brands, an edibles company in Boulder, Colo., on Wednesday announced it signed a reciprocal licensing agreement with Alternative Medical Enterprises LLC, or AltMed, a Sarasota, Fla.-based medical cannabis outfit.

The agreement allows for AltMed to manufacture and sell Wana’s product portfolio in Arizona, and Wana can manufacture and sell AltMed’s line of Müv medicinals — including metered dose inhalers, transdermal patches and topical products — in Colorado.

Financial terms were not disclosed in the deal between the two privately held firms.

“They’re high-growth categories. The topicals have been growing at a nice clip,” said Wana Brands co-owner Nancy Whiteman. “I think the products are a perfect fit for the up-and-coming demographics.”

Those demographic cohorts: women, Baby Boomers and senior citizens.

Although Wana is known for its gummies, caramels and “jewels” edibles, the venture with AltMed doesn’t stray too far from character.

Two years ago, Wana launched WanaCapsXR, extended release medical cannabis capsules. The products — which resemble standard pills and come in a childproof white pill bottle — were developed in partnership with Cannabics Pharmaceuticals Inc., a Bethesda, Maryland-based cannabis drug development firm with a research and development hub in Israel.

At the time, Wana co-founder John Whiteman said that his firm saw a need for a “professional product” with the dependability of Tylenol and Excedrin, according to the Boulder (Colorado) Daily Camera:

“Pretty much from the beginning, we realized that the biggest chunk of the market would be regular folks,” said co-founder John Whiteman. “We’ve stayed true to offering a product that is consistent and reliable and that you can trust.”

AltMed is a firm deeply ingrained in developing pharmaceutical-grade manufacturing facilities, practices and products, said Karen Quick, AltMed’s director of commercial operations. AltMed is in the process of qualifying for ISO 9001 certification for manufacturing facilities in Arizona.

“Most of our executives come from a pharmaceutical background, they bring with them a scientific approach to this industry — so it’s about purity, safety and testing and potency,” she said. “The reason we want this is we want safety for the patient. If it’s going to be a medicine, it’s dosed accurately, it’s safe, and it’s tested.”

And if the federal government and the U.S. Food and Drug Administration were to shift their stances on medical marijuana, AltMed wants to be prepared.

Expansion is a tricky endeavor for cannabis companies operating in a landscape in which their product remains illegal under federal law and is also banned from interstate commerce. That’s where licensing comes into play.

AltMed has signed similar deals to land its Müv products in five states, Puerto Rico and Canada. However, the Wana reciprocal licensing agreement will be the first to come to fruition as those past transactions are still in the planning stages, Quick said.

Wana met the mark because of its history in the industry, dedication to quality control, and its ability to adapt its manufacturing facility to produce items such as trans-dermal patches, Quick said. Representatives for both firms will make frequent visits to the other company’s facilities to both learn manufacturing practices and to ensure for product consistency.

“We’re representing each other’s products. It behooves me to work very carefully with (Wana Brands’) team to make sure we’re well-prepared,” Quick said.

AltMed could start selling Wana edibles in Arizona by the fourth-quarter of this year, Quick said. Wana Brands is targeting the end of this year as well for Müv, but the first quarter of 2018 may be more realistic, Whiteman said.

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Michigan OKs recreational marijuana ballot petition, opposition group emerges

The ballot committee must gather about 252,000 valid voter signatures within a six-month period to submit the bill to the Republican-led Legislature

May 20, 2017

LANSING, Mich. — Advocates of legalizing recreational marijuana use cleared a procedural step Thursday and will quickly begin collecting signatures needed to send the bill to lawmakers and potentially voters.

The Board of State Canvassers approved the form of the group’s petition. The ballot committee must gather about 252,000 valid voter signatures within a six-month period to submit the bill to the Republican-led Legislature.

Lawmakers likely would not act on the marijuana measure and instead let it go to a statewide vote in November 2018.

A new ballot committee, Keep Pot out of Neighborhoods and Schools, emerged Thursday to oppose the drive organized by the Coalition to Regulate Marijuana Like Alcohol, whose backers include marijuana advocacy groups. Spokesman Chris De Witt declined to say who is behind the opposition group and said law enforcement officials ultimately could join.

“Now is not the time for the recreational use of pot to be foisted upon Michigan and this proposal definitely puts our kids at risk,” the committee said in a statement that cited flaws in the initiative such as “unchecked” marijuana growing in homes.

Proponents say allowing the recreational use of marijuana — Michigan already allows its use for medical reasons — would boost tax collections, help the industry and save some of the money spent incarcerating people for marijuana-related crimes. They began circulating petitions immediately.

Under the legislation, adults 21 and over could legally possess up to 2.5 ounces of marijuana and grow up to 12 plants at home. A 10 percent tax on marijuana would be assessed, in addition to the 6 percent sales tax.

Gary Gordon, an attorney for the group opposing the drive, said it is “misleading” because people who grow their own marijuana could “do anything they want with the plants.”

Josh Hovey, spokesman for the committee organizing the initiative, said the opposition’s claims are “laughable” and “untrue,” and the provision allowing home growing mirrors what is in the voter-approved medical marijuana law.

Follow David Eggert on Twitter at https://twitter.com/DavidEggert00 . His work can be found at https://apnews.com/search/David%20Eggert

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Infused with Chef Hosea Rosenberg: Tuna poke bowl

The "Top Chef" winner shares his recipe for a fresh and healthy cannabis-infused entrée

May 20, 2017

Editor’s note: The Cannabist’s debut video recipe series “Infused” with award-winning chef Hosea Rosenberg is sponsored by Binske, purveyors of marijuana-infused cooking oil, honey and chocolate.

Marijuana-Infused Tuna Poke Bowl

Serves: 4

“The Binske spicy chili oil is the secret ingredient to make this extra special.”
–Chef Hosea

Ingredients
2 cups sushi rice, rinsed well in cold water

2 cups water

1 tablespoon sesame oil

2 tablespoons soy sauce

Pinch of salt

1 teaspoon sugar

2 tablespoons mirin (Japanese sweet rice wine)

3 tablespoons rice vinegar

2 tablespoons lemon juice

2 tablespoons lime juice

1 tablespoon fresh ginger, minced

2 teaspoon sriracha sauce

4 servings cannabis-infused chili oil (20mg THC total)–chef Hosea uses Binske Crushed Chile Oil

No. 1 grade ahi tuna, diced

1 ripe avocado, diced

½ English cucumber, diced

2 scallions, sliced very thin

1 jalapeno, sliced very thin

2 tablespoons dried hijiki (a type of seaweed), soaked in cold water and drained

1 tablespoon sesame seeds, toasted

Instructions
1. Combine rice, water and pinch of salt in small pot. Bring to simmer. Cover and let cook for about 15 minutes, or until done. Remove from heat and allow to sit for 10 minutes. Fluff with fork.

2. Combine tuna, avocado, cucumber and jalapeno in bowl, set aside in refrigerator.

3. Combine sesame oil, soy, salt, sugar, rice wine, rice vinegar, lemon juice, lime juice, ginger, sriracha, and Binske chili oil in bowl. Set aside.

4. Toss tuna, avocado, cucumber and jalapeno with dressing and allow to sit for ten minutes.

5. Divide rice between four serving bowls.

6. Top rice with tuna mixture. Garnish with scallions, hijiki and sesame seeds. Serve immediately.

Chef Hosea Rosenberg prepares a gourmet marijuana-infused tuna poke bowl. (The Cannabist)
Chef Hosea Rosenberg prepares a gourmet marijuana-infused tuna poke bowl. (The Cannabist)

Tips from Chef Hosea
• You must find the freshest fish available for a dish like this. If you can’t find good tuna, salmon is a great substitute.
• Make sure the knife is very sharp before cutting fish or veggies.
• Keep all ingredients cold until using.
• Serve this dish fresh — don’t toss with dressing until you’re ready to eat.

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A frantic push for medical marijuana in Texas, bureaucratic heartbreak and renewed resolve

Following the life and death of Texas House Bill 2107: Advocates' concerted efforts yield surprising results before an ultimate letdown.

May 17, 2017

AUSTIN, Texas — On the afternoon of Tuesday, May 9, Jax Finkel, the executive director of Texas NORML, was frantically trying to find a bill. Somewhere, deep in the catacombs of the Texas state Capitol, House Bill 2107, the first comprehensive medical marijuana bill to clear a committee in the state’s history, was getting shuttled around. It needed to be located immediately. She says, “I was literally walking between offices looking for the cart.”

Just days before, HB 2107 had passed out of the House’s Health Committee by a vote of 7-2. From there, it was a five-step process to move the bill through the system to the Calendars Committee, which would then schedule the bill for a debate and vote on the House floor. Finkel says this process “usually takes three business days, but it can be done in a matter of hours.” At this point, hours were all they had left.

The Calendars Committee met at 5:30 p.m. for a quick five-minute roll call of approved bills, which Finkel livestreamed on Facebook in the hopes HB 2107 would be on the list. It wasn’t. Finally, at 7:30 p.m., the bill arrived, ready for approval. But if the Calendars Committee didn’t reconvene to schedule by 10 p.m., then the bill would crash. And the Legislature wasn’t going to meet again until 2019. Actual human lives hung in the balance of a minor bureaucratic procedure.

It was a political miracle that Texas had even reached this point. In 2015, against most predictions, Gov. Greg Abbott signed into law the Compassionate Use Act, a limited and highly restrictive bill that allowed a small number of children with intractable epilepsy access to low-THC cannabis medicine containing non-psychoactive cannabidiol (CBD). But not only did the law exclude the vast majority of potential medical marijuana patients, and not only did it keep patients from having access to any cannabis products containing THC, it still has yet to be fully implementedStory after story continue to appear in the local and national news about Texas medical marijuana “refugee” families, forced to leave their homes and head to states where medical marijuana is legal so their children could get the treatment they needed.

When it came to medical, most advocates in the Texas marijuana-rights movement didn’t expect much from this legislative session, which ends May 29. They instead turned their attention to decriminalization legislation (HB 81 and companion SB 170) that would establish a system of civil penalties for weed possession, which cleared committee early but then later died on the House floor without a vote.

In the state Senate, José Menendez filed a comprehensive medical bill last November, SB 269, but it has sat dormant in committee as the GOP-dominated body pursued other legislative priorities, like banning sanctuary cities and telling transgendered teens which bathroom to use.

In the House, Rep. Eddie Lucio III, a Democrat from Brownsville, saw a political opportunity, and a chance to do some good. After watching a heartwrenching YouTube video in which the Zartlers, a North Texas family, treat their teenage daughter’s severe autism with vaporized cannabis, Lucio III checked to see if a companion medical bill had been filed in the Texas House. It hadn’t. Thus HB 2107 was born. “We filed it right away,” Lucio III tells The Cannabist. “Just based on what I had read, I knew it was the right thing to do.”

Lucio III reached out to Rep. Jason Isaac, a Republican from Dripping Springs who had shown sympathy toward medical-marijuana reform, to sign on as cosponsor to HB 2107. But it languished in the House for months after it was first filed in mid-February. With the end of the legislative session on the horizon, activists decided that something had to be done quickly.

Speaking to lawmakers’ minds, hearts

In the last week of April, they hastily put together a press conference on the Capitol steps, emphasizing testimony from conservative Christian mothers and veterans with PTSD. “It is God’s plant and he gave it to us for good,” one mom said. Others held signs that said, “Cannabis saves lives.”

Behind the scenes, advocates were also working the phones. The bill’s fate lay in the hands of Walter T. “Four” Price, an outspoken Christian Republican who serves as chairman of the House Committee on Public Health. Three families from his district in Amarillo pressed his office with phone calls, including relatives of a teenager with Crohn’s disease and another family that had recently been forced to move to Trinidad, Colorado, to take care of a young child with epilepsy.

Growing fields of hemp
Legislation to allow patients access to whole-plant medical marijuana progressed further than it ever had in Texas in 2017. (Denver Post file photo)

Says Heather Fazio, the Texas political director of The Marijuana Policy Project: “We wanted him to see that it’s not just Austin that wants medical marijuana. There are even people in Amarillo.” On April 27, Price scheduled HB 2107 for a hearing.

Because of scheduling conflicts, that hearing didn’t begin until almost 10 p.m. on Tuesday, May 2, and it ran into the early hours of the morning. Yet the Public Health Committee stayed riveted as advocates ran through an extraordinary series of testimonies. Doctors and medical researchers testified about marijuana’s vast potential as a medicine. One after another, constituents presented a series of tragic stories that would have broken Scrooge’s heart. The politicians heard from disabled veterans, desperate mothers and fathers, the sick, the sad, the dying, people in pain. At one point, HB 2701 cosponsor Isaac, who’s not on the committee but was there in support, had to step off the dais to grab some tissues. Few dry eyes were left in the room by the time the hearing ended.

Word got around the House fast. “Some hearts were changed on that night because of the reality of what families and veterans were going through,” says Terry Franks, Isaac’s chief of staff. “It hit them hard. I don’t think they realized what an important issue this is for folks.”

Early the next day, Lucio III and Isaac were on the House floor, looking for support. It was easy to find. When they started, the bill had five cosponsors. By the time they were done, it had 77, including 28 Republicans. A majority of the House now not only supported medical marijuana, but they supported it so wholeheartedly that they wanted their names on the bill. In an absurdly partisan political season, only medical cannabis had been able to bring people together.

Lucio III credited the activists, who have been working tirelessly to change people’s minds. “These advocates have been reaching out to these members, sharing their hearts, talking about the difference in quality of life,” he says. “People had already been educated. I was just the one to execute it.”

Then Price, even though he’d voted against the Compassionate Use Act in 2015, scheduled HB 2107 for a committee vote for Friday, May 5. He voted against this bill, too, but it sailed out of committee on a 7-2 vote. “Allowing that to happen makes Representative Price a hero,” Fazio says. “He demonstrated incredible professionalism, and we value that.”

The nail-biting began. Could HB 2107 make it through the bureaucratic process in time? “We don’t see anyone on the Calendars committee who would have an opposition to this bill,” Lucio III says in a phone call from the House floor after the bill cleared the committee. “But the timing is not our friend.”

Over the weekend, advocates were in overdrive, calling, emailing, pleading. Out of nowhere, whole-plant medical cannabis had an upset chance to become the law in Texas, prompting an early response: “Rejoice!” Finkel posted on the Texas NORML Facebook page.

At 7:30 p.m. on May 9, as HB 2107 officially arrived at the Calendars Committee office, Isaac desperately called for a point of order on the House floor, asking that the committee quickly convene. The House, which was busy debating (and eventually approving) a bill to allow state-funded adoption agencies to reject applications from LGBT, Jewish, and Muslim families, didn’t hear his plea. By 10 p.m., the dream was dead.

“We will continue to fight”

A visibly disappointed Lucio III and Isaac recorded a hasty video (watch below), saying that they would continue to fight on for the families and veterans of Texas. “In this time of divisive politics,” they wrote in a letter to grieving supporters, “we have found bipartisan agreement that the well-being of our loved ones suffering from debilitating conditions should rise over the fray of Left and Right. … We will continue to fight for the patients suffering in Texas who could benefit from medical cannabis.”

Lucio III and Isaac both stressed that in 2019, a medical cannabis law would be their top priority from Day One of the legislative session, which could prevent further bureaucratic tragedy. This assumes that they’re re-elected, as every Texas House member has to run every two years. In an interview, Lucio III says: “My level of commitment has grown significantly. It’s become a labor of love. My wife keeps saying, ‘This should be your legacy work, to help these families.'”

Meanwhile, activists are going to have to spend another legislative session looking to gain rights that, by 2019, likely will be commonplace throughout much of the country. Heather Fazio says it’s “going to be a campaign issue.”

“People want someone’s head on a pitchfork,” Texas NORML’s Finkel said after the bill’s demise. “They are frustrated and angry. And you know what? They should be. They are dying. It’s awful. But they’re going to have to get involved during the full cycle…We finally find this bipartisan bill that so many people could agree on, and it was too late.”

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