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  • by NORML Canada October 15, 2019

    Legal Marijuana Sales Being in Canada

    NORML Canada launches official Post-Legalization platform to focus advocacy efforts on reforming Canada’s legal Cannabis system.

    In light of the first year of legalization, NORML Canada has monitored the Canadian cannabis landscape closely, to determine the next steps for crafting achievable and functional reform of cannabis regulations.

    The five key “pillars” established by NORML Canada are designed to help focus organizational resources to support our ongoing government and public outreach.

    1) Increased Access 
    Our goal is to ensure consumers have ease of access to legal cannabis products, access to medical dispensaries, access to world-class product options, as well as access to affordable legal options.

    2) Transitioning “Unregulated Market” into the legal framework
    Creating avenues for the current unlicensed market to be welcomed as part of the legal cannabis industry in order to achieve the government’s stated goal of disincentivizing the illicit market.

    3) Social discrimination protections
    Putting in place protective regulations that remove stigma barriers and consequences for consumers in the workplace, housing, and family.

    4) US relations – border & banking
    Ensuring international respect for Canada’s sovereign laws. Removal of any unnecessary international banking/travel barriers for legal business and cannabis entrepreneurs.

    5) Expungement, apologies, reparations & beyond
    Government must acknowledge the fact that cannabis laws were historically unjust and discriminatory in the first place.

    NORML Canada invites the public and press to join us at the historic Hotbox Lounge on Oct 17th, from 4-7pm to launch the new official platform, and to discuss the year-to-date. 

    NORML Canada proudly welcomes our sister chapter to the South – NORML Michigan, to share insights on Michigan’s newly passed legal recreational cannabis bill. Our combined goals are to understand how we can learn from and collaborate with one another.

    For additional information please contact Info@norml.ca

  • by David Holland, Executive Director of Empire State NORML October 9, 2019

    There has been some confusion and misinformation circulating about what New York’s latest expansion of marijuana decriminalization means and what impact it will have on criminal prosecutions going forward. 

     

    The Short Synopsis of the Offenses and Sentences 

    There are 2 provisions of New York’s Penal Law that relate marijuana-related offenses. Penal Law 220 relates to “controlled substances” offenses which include possession of “concentrated cannabis” which is defined as being more than 2 1/2% by volume of the total volume of cannabis seized. PL 220 then imposes escalating grades of punishment depending on the weight of concentrated cannabis. Simple possession of a very small amount of ‘concentrated cannabis’ is an A misdemeanor punishable by up to a year in jail. But, possession of just 1/4 ounce of concentrated cannabis is a D Felony and punishable by up to 7 years imprisonment. 

    Penal Law 221 is far more lenient as it specifically relates to cannabis flower penalizing possession based on the pure weight of the flower (minus root balls, stems, stalks, seeds, etc), not its chemical potency like PL 220 does. It too has escalating grades of punishment, but as of August 28, 2019, now permits much greater amounts to be possessed up to 2 ounces before a misdemeanor crime is actually committed. Possession of flower does not become a felony offense unless the defendant is in possession of more than 8 ounces with a corresponding maximum jail term of 4 years. 

    As of August 28, 2019, public consumption and possession of up to two ounces of cannabis flower is punishable as a marijuana possession violation (not a crime) and the sentence of that offense is a monetary fine up to $200 under Penal Law 221. However, possession or public consumption of wax, shatter, hashish, and/or cannabis oil which is more than 2 1/2% THC by volume, otherwise possessed in any amount, is still punishable as a “controlled substances” crime under Penal Law 220 which results in dramatically different consequences. 

    In addition to the potential length of incarceration, a significant difference between those two penal provisions under which marijuana-related offenses may be charge is that when charged under Penal Law 221, the criminal defendant may, over the objection of the prosecutor, request pursuant to Criminal Procedure Law 170.55 or 170.56 asking the court to adjourn the case in contemplation of dismissal (“ACD” or “MACD”). That means that if the person is not rearrested in a 6-12 month period, then the charges will automatically dismiss and all the records sealed as if the case never happened. 

    By contrast, a criminal defendant charged with a controlled substances offense for possession of “concentrated cannabis” (hash, oil, wax, shatter, etc) under Penal Law 220 cannot ask the Court to adjourn the charges in contemplation of dismissal and the court cannot do so without the consent of the Prosecutor. So, the criminal defendant is really at the mercy of the Assistant District Attorney who is handling the case. Worse, if convicted of the controlled substances misdemeanor under PL 220, in addition to the risk of incarceration, there are mandatory fines and surcharges as well as DNA fees and sample collections that can be imposed. Such convictions may not be subject to the newly enacted expungement provisions as they are “controlled substances” offenses and not “marijuana” offenses which were the sole targets for expungement under the new decriminalization law. 

     

    Legal Provisions

    New York Penal Law defines all of the violations and crimes that are punishable in New York State. Drug-related offenses fall under those provisions of the penal code that considered offenses against Public Health and Morals. Those controlled substances which constitute drug offenses are defined and identified in the Public Health Law. 

    Under the Public Health Law 3302(4) “Concentrated Cannabis” is defined as: 

    (a) The separated resin, whether crude or purified, obtained from a plant of the genus Cannabis; or 

    (b) a material, preparation, mixture, compound or other substance which contains more than two and one-half (2 1/2%) by weight of delta-9 THC… 

    Under PHL 3302(5) a “Controlled Substance” means any substance listed in section 3306 of the PHL. “Marihuana” is a Schedule I controlled substance under PHL 3306(d)(13). Under PHL 3302(21) “Marihuana” means all parts of the plant of the genus cannabis, whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. It does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, mixture, or preparation of the mature stalks (except extracted resin therefrom), fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination. 

    The distinguishing feature between “marihuana” and “concentrated cannabis” is greater than 2 1/2% concentration by volume requirement. Once that concentration threshold is exceeded, the arrestee may be charged with misdemeanor possession of either a controlled substance offense under PL 220 or the more lenient weight-based provisions of PL 221 that specifically pertain to marijuana. 

    The 2 1/2% potency threshold is by volume, so unlike other drugs, the medium in which it is contained, ie, the glass vial, pipe, etc., should not be weighed to raise the potential penalty since the inclusion of the weight of the medium may in fact reduce the potency determination as the wax, oil, etc, thereby reducing the concentration calculation. 

    While the Public Health Law 3306 and Penal Law 220 and 221 each address cannabis oil derived from the stalks and stems (but not the seeds), and resin, the determining feature is the 2 1/2% by volume threshold of demarcation to constitute a controlled substances offense. With the passage of the 2018 Farm Bill, any oil or flower with less than 0.3 THC by volume , is now deemed to be legal and that determination will be binding on the states due to Congress’ ‘commerce clause’ and power to regulate interstate commerce. 

    That means that in New York State, personal possession of any flower or oil which falls between 0.3% THC and 2 1/2% THC by volume should be prosecutable only under the more lenient provisions of Penal Law 221. 

    The sentences for each provision of the Penal Law are found in Penal Law 70.00 et seq. 

  • by Justin Strekal, NORML Political Director September 25, 2019

    Members of the House of Representatives voted 321 to 103 in favor of HR 1595: The SAFE Banking Act, which amends federal law so that explicitly banks and other financial institutions may work directly with state-legal marijuana businesses. 

    Two-hundred and twenty-nine Democrats and 91 Republicans cast ‘yes’ votes in favor of the measure.

    This historic vote marks the first time ever that a chamber of Congress has ever held a successful floor vote on a stand-alone piece of marijuana reform legislation. 

    Today’s vote is a significant victory for the cannabis reform movement and here’s why: for the first time ever, a supermajority of the House voted affirmatively to recognize that the legalization and regulation of marijuana is a superior public policy to prohibition and criminalization. 

    Now we look to the Senate, where we are cautiously optimistic. Given the strong bipartisanship of the House vote, coupled with Senate Banking Chairman Mike Crapo’s recent pledge to hold a markup on this issue, we believe that Congress’ appetite to resolve this important issue has never been greater.

    But we are not done. In fact, we’re just getting started. 

    Why NORML Supports Passage of HR 1595: The Safe Banking Act:

    Federal law currently defines all marijuana-related endeavors as criminal enterprises, including those commercial activities that are licensed and legally regulated under state laws. Therefore, almost no state-licensed cannabis businesses can legally obtain a bank account, process credit cards, or provide loans to small businesses and entrepreneurs. 

    In this environment, the rapidly growing multi-billion dollar cannabis industry must operate largely on a cash-only basis, which makes businesses more susceptible to theft and more difficult to audit. This ongoing federal prohibition also places the safety and welfare of these businesses’ customers at risk, as they must carry significant amounts of cash on their persons in order to make legal purchases at retail facilities. For these reasons, NORML has long advocated that federal lawmakers vote “yes” on The SAFE Banking Act.

    What’s Next?

    Today’s vote is a significant first step, but it must not be the last. Much more action will still need to be taken by lawmakers. In the Senate, we demand that lawmakers in the Senate Banking Committee hold true to their commitment to move expeditiously in support of similar federal reforms. And in the House, we anticipate additional efforts to move forward and pass comprehensive reform legislation like The MORE Act — which is sponsored by the Chair of the House Judiciary — in order to ultimately comport federal law with the new political and cultural realities surrounding marijuana.

    Now Is the Time to Demand Congress Do MORE.

    Now that House members have overwhelmingly shown their support for HR 1595, it is time for them to address more comprehensive reform legislation, namely The Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act.

    Introduced by House Judiciary Chairman Jerry Nadler (D-N.Y.), the MORE Act is bipartisan legislation that removes the marijuana plant from the Controlled Substances Act, thereby descheduling the substance at the federal level and enabling states to set their own regulatory policies absent the threat of federal interference.

    But, perhaps most importantly, the MORE Act seeks to address many of the past wrongs of marijuana criminalization. Specifically, it would appropriate a portion of the federal taxes collected from the legal industry to pay for the expungement of past criminal records and to partially fund reentry services, job training, and community improvements in jurisdictions that have been most disproportionately impacted by war on marijuana. Furthermore, the MORE Act additional allocates a portion of the federal taxes collected to the Small Business Administration to support small businesses and entrepreneurs who seek to engage in the emerging legal marketplaces. 

    Strike while the iron is hot and send a message to your lawmakers in support of ending prohibition NOW!

    Take time today to tell your members of Congress that their work is far from over. Nearly one in four Americans now reside in a jurisdiction where the adult use of cannabis is legal and it is time for members of Congress to stand up for their rights and liberties. 

    Thank you again for your support for NORML and for being on the right side of history. We could never have gotten this far without you, and with your continued support we know that we can ultimately secure cannabis freedom in our time. 

     

    Our educational and advocacy efforts are supported by thousands of people throughout the country as we work to advance marijuana reform in all 50 states and the federal level. Can you kick in $5, $10 or $20 a month to help us keep going?

  • by Stephen M. Komie, NORML Legal Committee September 23, 2019

    On June 25, 2019, Governor JB Pritzker signed into law a revision of the Illinois Cannabis Control Act, 720 ILCS 550.1 et seq. Commencing January 1, 2020, Illinois residents will be authorized to possess up to 30 grams of cannabis for usage as they desire.  Non-residents do not have the same exception from the criminal penalties. Non-residents are limited to 15 grams. Between now and January 1, 2020 the law remains in effect prohibiting possession of marijuana except for persons who have Illinois Medical Marijuana Cards.  

    Illinois has an estimated 770,000 marijuana related criminal records which are now eligible for clemency by Governor Pritzker. Prior to January 1, 2020 expungements remain in effect for persons who received court supervision, or were not convicted, or had their case dismissed after a motion to suppress, or the prosecution declined to proceed.  Those expungements remain available in the normal manner.

    Executive clemency is not an expungement.  Executive clemency is the power of the governor to exonerate or forgive persons who have committed crimes. Persons who have had arrests for 30 grams or less will have the Illinois State Police and local police agencies examine their arrests over a 6-month period after January 1, 2020.  The police agencies will have 6 months to find those records. For all who were convicted of 30 grams or less, the state and local police are required to send those records within 6 months to the Governor’s Prisoner Review Board.  The law charges the Prisoner Review Board with the obligation to review each case for eligibility for clemency. The criteria to be employed is 1) is it the same person as reported arrested; 2) is the record a correct record; and 3) there must be an absence of any violent offense involved with the arrest.  Once cleared by the Prisoner Review Board, the Prisoner Review Board will make a recommendation to Governor Pritzker.  

    It is expected that Governor Pritzker is most likely to issue hundreds of thousands of pardons during the remainder of his four-year term in office. The Governor has announced that it will be a very streamlined process. This, of course, remains to be seen. After a pardon is issued, Attorney General of Illinois Kwame Raoul, acting on behalf of the Prisoner Review Board, will appear before a circuit judge to seek expungement for the cases where clemency is granted by the Governor.  It is expected that hundreds of thousands of persons will be relieved of their criminal record which prevented them from receiving government benefits such as housing and welfare.  

    For people who were arrested with 30 to 500 grams the expungement process remains in effect. Except for the first-time offenders, those persons may request the court to vacate their conviction and expunge the records. 

    This reform is unprecedented in Illinois law and will be a first.  The arresting police agency can object to the request to vacate the conviction and expunge the record. The law directs the court to consider the defendant’s age at the time of the offense, the current age of the defendant, and any adverse consequences which would accompany denial of the expungement.  

    As with all developments in the law, every person’s case is different and requires the advice of a skilled attorney who is knowledgeable in the area of criminal law and expungement. I would urge all members of NORML who have criminal records for zero to 30 grams and 30 grams to 500 grams to consult with your local member of the NORML Legal Committee to determine your eligibility for clemency and/or expungement.

  • by Randy Robinson, MERRY JANE September 20, 2019

    We also spoke with her attorneys, who explained why they believed the DEA broke the law by holding up long-promised medical marijuana research licenses.

    Dr. Sue Sisley

    Dr. Sue Sisley

    I first met Dr. Sue Sisley in person when she spoke in Las Vegas a few years ago. Back then, Dr. Sisley just entered the national spotlight, known as the research doctor who’d been unfairly fired from the University of Arizona for simply trying to study medical marijuana. 

    But at the Vegas event, she brought good news: She announced that other universities would host her research, and she recently applied for a third-party cultivation license from the DEA, the only federal agency that can legally provide cannabis for clinical study in the US. 

    At the time, the DEA said it would begin accepting applications for third-party marijuana growers after scientists had, for decades, complained about the highly restricted, low-quality cannabis the feds provided for research purposes. Since marijuana is federally illegal, the National Institute of Drug Abuse (NIDA), the FDA, and the DEA have only allowed one man, Dr. Mahmoud ElSohly at the University of Mississippi, to grow cannabis for clinical studies. Essentially, the federal government has monopolized cannabis research, and ElSohly’s product, according to some scientists who’ve seen it, is unsuitable for clinical trials. 

    Dr. Sisley’s announcement in Vegas was a big deal, since it meant her research group could one day grow its own high-quality cannabis, the kind that medical marijuana get from dispensaries and home growers. And time was an issue, since her research projects involved suicidal combat veterans with PTSD and stage 4 cancer patients who didn’t have long to live.

    Later that night, everyone celebrated at a hotel bar. In hindsight, however, the celebration in Vegas was extremely premature.

    It’s been nearly three years since the DEA announced its revolutionary cultivator program. The only problem is, the program doesn’t actually exist. The agency still hasn’t doled out any third-party grower licenses, even though 33 legitimate research groups, of which Dr. Sue Sisley’s Scottsdale Research Institute (SRI) is only one, have submitted applications. In fact, the DEA hasn’t processed the applications, though it gladly raked in about $100,000 total in fees for all 33 submissions. And again, the applications were submitted three years ago. For more information on this situation, see NORML Deputy Director Paul Armentano’s op-ed here.

    Dr. Sisley isn’t just trying to study medical marijuana; she’s trying to get cannabis flowers approved by the FDA as tried-and-true medicine. “American research is so crucial because it’s the only way health insurance companies would be able to pay for cannabis the same way they pay for pharmaceuticals,” she told MERRY JANE over the phone. “It needs FDA approval.”

    Fed up with the feds’ stonewalling of potentially life-saving marijuana research, in July, Dr. Sisley and the Scottsdale Research Institute filed a lawsuit against the DEA with two Texas-based attorneys, Matt Zorn and Shane Pennington. Since Zorn and Pennington reside in a prohibition state, neither of them has clients in the cannabis industry, nor are they affiliated with any cannabis activist or legalization groups. Further, Zorn and Pennington took on Dr. Sisley’s case pro bono. Read NORML’s coverage of the litigation here.

    The court gave the DEA 30 days to respond to Dr. Sisley, SRI, and the other researchers who filed suit. But that window has passed, and the DEA still hasn’t explained why it didn’t process the cultivator applications for three years. Instead, the DEA said it would take public comments and establish new rules for handing out the licenses, even though dozens of researchers have already paid heavy application fees for their submissions. As Dr. Sisley and her attorneys play the bureaucratic waiting game, it looks as if the DEA is finding new ways to stall further while a court simultaneously has ordered it to explain why it’s stalling.

    What caused the DEA’s three-year hold up? How has the federal government traditionally stalled cannabis research? What can cultivation applicants such as Dr. Sisley do now? To find out more, MERRY JANE spoke with Dr. Sisley and her attorneys about why she and over 30 other research groups don’t want the federal government’s bunk buds.

    NIDA marijuana

    Photo courtesy MAPS

     MERRY JANE: Dr. Sisley, you’re one of the few people who’s actually seen the federal government’s cannabis products. Can you explain how it’s prepared for shipping at the University of Mississippi and how it comes packaged?

    Dr. Sue Sisley: Basically, it comes in these generic batches of either high-THC, high-CBD, or placebo cannabis. You have a very limited menu there, and they come in these ziplock bags. When you open it, it’s a greenish powder filled with extraneous plant material. So, there’s some flower; there’s some mixed stems and leaves, just ground-up fragments of the plant. It’s not just the tops of the plant — the flower — which is what we’d like to study.

    Did the DEA, FDA, or University of Mississippi provide any lab results for the cannabis powders, so you know what you’re actually giving to patients?

    Dr. Sisley: That’s one of the problems, and one of our legal arguments: There’s no transparency. Normally, when you do clinical trials — and for years I did trials for Big Pharma — you get a complete drug master file that would give you all the details about the drug: its properties, how it was manufactured, et cetera. There’s none of that available. 

    Even though the DEA takes millions of dollars of taxpayer money, they provide zero transparency. You’re not allowed access to the drug master file, which would be normal operation procedure in any other FDA trial. 

    The only other federal agency who has access to file is the FDA, and they refuse to share that with the public, which is already an abomination in my opinion. It should be challenged. 

    Many people have tried to FOIA that information, and they haven’t gotten it. Maybe you could try? [laughs]

    So, as a responsible scientist, I’m guessing you went ahead and tested the DEA’s ground-up weed powder yourself instead?

    Dr. Sisley: We did. We were the first scientists to do independent secondary testing [on the DEA’s cannabis]. We sent it out to other DEA-licensed labs and did three independent rounds of testing, just to confirm that it was even cannabis.

    The testing did confirm that the [batch sent by NIDA] has cannabinoids, some very minute quantities of terpenes in it, and that it was cannabis. It was just diluted with a lot of extraneous plant material. So, that’s one way that they can really sabotage your study outcomes because the study drug is issued to patients by weight. 

    How is issuing cannabis to patients by weight a way to sabotage a medical marijuana study?

    Dr. Sisley: In the last study we just completed, each patient got 1.8 grams [of cannabis] per day. So, if half of the weight of the study drug isn’t just the flower, then it’s all this other plant material — stems sticks, leaves — that’s weighing it down. And you can imagine how that would harm your efficacy data, because suddenly the patient may need to smoke two bowls just to get any therapeutic benefit, and by then they’ve developed so much bronchial irritation that they often can’t reach that therapeutic threshold.

    We noticed that a lot of patients, after just a few inhalations, the mucosal irritation was so harsh from smoking that [marijuana] – which is not normal, right? If people are just smoking the flowering tops of the plants, they can easily tolerate much more, but most people could only tolerate a few puffs [of the government’s cannabis], and they’d have to stop. That’s why I’m concerned that the efficacy data is not accurate. It’s not reflective of real-world cannabis.

    NIDA marijuana

    Photo courtesy MAPS

    Why is Dr. ElSohly grinding up the weed into an unrecognizable powder? Providing full, trimmed buds would help with the harsh smoke.

    Dr. Sisley: If you look at the quotes from Dr. ElSohly, he said that he’s not trying to make real-world cannabis. He’s trying to simply standardize this plant material for research, and that’s clear from what we’re getting. He may be achieving that, and he may be meeting whatever standards the FDA has set up, but if you look at FDA.gov, you’ll see how they define GMP, and it mentions things like “free from mold,” and, clearly, they’re already in violation of that. 

    You found mold in the DEA’s ‘research-grade cannabis’?!

    The secondary testing we did showed ostensibly high levels of mold in all the batches. With these excessive mold counts, you’d very likely have mycotoxins present. We believe mycotoxins are harmful to health — and we don’t have all the details yet — but scientists suspect that [mycotoxins are] carcinogenic. How do I knowingly hand out contaminated study drugs to cancer patients — to sick people? It’s totally unethical. It puts me in a terrible position.

    And the federal government has no qualms with American doctors dispensing moldy marijuna to patients? Cannabis dispensaries aren’t allowed to stock moldy cannabis, much less sell it.

    I shared with my attorneys this ridiculous document that the DEA forced me to sign. It said I can’t receive [the government-grown weed] to conduct research unless I sign a paper declaring that I accept all liability for any harmful outcome from the study.

    They won’t ship you the [plant material] without that — a contract that states that I’m finding the federal government harmless, that they’re not responsible for anything bad that comes from [their product].

    Then, when they ship [it], it comes with a disclaimer that says, “By the way, this plant material is contaminated with mold and should be irradiated prior to use.” It’s just an unbelievable process that they’ve been able to get away with for so many decades. That’s why it’s so imperative that the government license other growers immediately, so we can start to put flower through the FDA process.

    Now, here’s a question for the attorneys: According to your suit, the DEA’s inaction on these cultivator applications was unlawful and possibly unconstitutional. Can you explain your reasoning?

    Matt Zorn: It is not our position that we argued that it was unconstitutional. We do think that it’s unlawful, though.

    Shane Pennington: In 2016, the DEA said that it recognized, and held to be important, the due process interest of applicants who would respond to its cultivation licensing announcement by spending thousands of dollars and doing the work necessary to get an application in to the agency. Due process here is referring to the due process of law and amendments to the US constitution. Our point was that the agency’s delay had reached a point that it was unlawful under administrative law principles and the Administrative Procedure Act. That’s what made it unlawful. 

    Apart from that, we were emphasizing the government’s own statements, in its own public documents, recognizing that when it asked the public for applications, then charged them money to process those applications, there’s a due process interest in actually seeing that the law is followed and that the applications are processed. But to be clear, we weren’t bringing a constitutional challenge.

    What was the application fee?

    Dr. Sisley: I think we paid $3,100 to apply for the Schedule I license to grow. Back in 2016, when we submitted our application, they immediately processed my credit card, but they never processed the application, interestingly. Usually that goes hand-in-hand. 

    What was the DEA’s explanation for the hold-up? Or have they provided one yet?

    Pennington: No, they haven’t explained it. The court ordered them to respond to our petition. That was back in July. There’s an order from the court that says responds to the petition within 30 days. That put them on the clock, and of course we’re all waiting around for what the explanation is. As the lawyers representing [Scottsdale Research Institute], we were particularly eager to see that explanation because we knew that there couldn’t have been a reasonable explanation under the circumstances. 

    But then, the day before the response is due, all of this other stuff happened: The DEA said it “noticed” all these applications – read NORML’s coverage here – they launched all this new rule making, and President Trump donates $100,000 of his salary to facilitate an announcement from the US Surgeon General warning about marijuana and the need for research because of the risks to pregnant women and children.

    There’s just this huge media roll-out on the eve of this deadline to explain themselves. And of all of that talk, there wasn’t a single word explaining the delay. Nor was there an acknowledgement from the government that what it was doing was unreasonable, that it was legally obligated to process these applications quickly or within a particular time period. None of that. That kind of slipped past a lot of people. 

    A lot of doctors and medical organizations don’t view cannabis flower as a medicine because it can’t be accurately dosed when smoked or vaporized. What’s your response to those critics?

    Dr. Sisley: I’m a physician, so I understand. I trained in the same paradigm as them, that you don’t view anything as medicine unless it’s been through the FDA approval process. That’s where the dosing gets established. But with botanical medicine, we’re trying to persuade the FDA that it needs a different paradigm. We’ve actually managed to have some real breakthroughs with the FDA as evidenced by our last study, where the FDA allowed self-titration. [Editor’s note: Self-titration is when a patient administers their own dose based on what gives them a therapeutic effect at the time, rather than following a strictly set dosing regimen based on a mathematical formula.]

    I would argue that rapid self-titration is an appropriate method of dosing, and it’s the only right way of handling smoked or vaporized cannabis flower. You can’t force cannabis patients into dosing models. We showed that over and over again in our studies: The variations in dosing are so wide from one patient to the next that you can’t push people into it. 

    Patients have to start with the lowest amount, and if they don’t get an effect, they can repeat it until they reach their therapeutic range. That’s the most optimal way of dosing [with cannabis], and physicians need to learn to embrace that, or they need to learn to get out of the way. 

    Other countries, like Israel, are leading the way on groundbreaking medical marijuana research. Why is it important for America to join this research movement?

    Dr. Sisley: That research is important, and thankfully other countries have a more permissible environment where they have multiple growers. Our country is the only one holding out on this single-supplier model and claiming international treaty obligations, yet there are all these examples of other countries that have multiple growers. That’s why you’re seeing a renaissance of cannabis research in these other countries. 

    And sure, we can use their data — we often cite it — but the point is: In this country, we pride ourselves on being at the forefront of the most important medical research in the world. So why are we relegating this [cannabis research] to other countries? We’re so far behind now that we may never be able to catch up. The more the DEA continues to delay this, the more our chances to be competitive in that arena is sabotaged.

    Why do we even need other data if other countries are doing this? We’re trying to do non-profit drug development research at SRI. We’re trying to put flower through the entire drug development process. We just finished this FDA Phase II trial, and typically we’d be moving into Phase III now, but we don’t have a federally legal drug supplier for Phase III that can be sold as a prescription medicine.

    American research is so crucial because it’s the only way health insurance companies would be able to pay for cannabis the same way they pay for pharmaceuticals: Our cannabis needs FDA approval. The FDA won’t consider clinical trials from other countries. 

    You can catch more of Randy Robinson’s writing at MERRY JANE’s website.

     

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