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Legal Marijuana States Had Fewer Vaping-Related Lung Injuries, Study Finds

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People in states where recreational marijuana is legal were significantly less likely to experience vaping-related lung injuries than those in states where cannabis is prohibited, according to a new study published in an American Medical Association journal.

The finding seems to affirm what many reform advocates said during the peak of the e-cigarette or vaping product use-associated lung injury (EVALI) crisis last year. With thousands being hospitalized over EVALI, it became clear that contaminated vape cartridges were the source and that contamination was more common in illicit, unregulated markets where consumers can’t walk into retail stores and buy tested and labeled marijuana products.

By analyzing Centers for Disease Control and Prevention (CDC) data on EVALI cases, the prevalence of e-cigarette use and the population in each state from June 2019 to January 2020, researchers were able to confirm that.

The research letter, published by the JAMA Network Open on Monday, shows that states with recreational marijuana shops had 1.7 EVALI cases per million population compared to 8.1 cases per million in prohibition states. There was no statistically significant difference between criminalized and medical cannabis states, which experienced 8.8 cases per million population.

“The data suggest that EVALI cases were concentrated in states where consumers do not have legal access to recreational marijuana dispensaries,” the letter states. “This association was not driven by state-level differences in e-cigarette use, and EVALI case rates were not associated with state-level prevalence of e-cigarette use. One possible inference from our results is that the presence of legal markets for marijuana has helped mitigate or may be protective against EVALI.”

“Recreational marijuana states had among the lowest EVALI rates of all states.”

While the researchers said the reason for the association isn’t clear yet, they surmised¬†that it’s “possible that in recreational states, people tend to purchase marijuana products at legal dispensaries, which may be less likely to sell the contaminated products that are thought to cause EVALI.”

That has been the working theory of many industry observers, who have argued that legalization is an important safeguard to public health by ensuring compliance with quality control standards in cannabis products. It should be noted, however, that there are select reports of instances where people seemed to develop a lung injury after obtaining marijuana vaping products from licensed dispensaries in Oregon.

“It appears states that have legal access to marijuana have lower rates of EVALI cases, which is consistent with the hypothesis that people have demand for marijuana products, and in states where they don’t have access to them in this regulatory fashion, they end up purchasing them elsewhere,” study co-author Alex Hollingsworth told MedPage Today.

NORML Executive Director Erik Altieri said the findings “come as little surprise.”

“In jurisdictions where cannabis is legally regulated, consumers gravitate toward the above-ground retail marketplace where they can access lab-tested products manufactured by licensed businesses,” he said. “Just like alcohol prohibition gave rise to the illicit production of dangerous ‚Äėbathtub gin,‚Äô marijuana prohibition provides bad actors, not licensed businesses, the opportunity to fulfill consumers‚Äô demand‚ÄĒsometimes with tragic results.”

In a historical commentary on the new study also published by the American Medical Association Journal, a separate set of researchers drew a parallel to the era of alcohol prohibition‚ÄĒfrom which an underground industry of bootleggers emerged.

“Bootleggers fortified their distillates with methanol to increase apparent potency, causing blindness and death in unwary consumers,” they said, noting that industrial ethanol, which was exempt from prohibition, was sometimes used despite the fact that government officials directed it to be adulterated with poisonous substances to deter consumption. “The resulting concoctions, known as denatured alcohol, were responsible for thousands of deaths during the 14 years that Prohibition was in effect. The history of Prohibition thus serves as a cautionary tale about unintended and unforeseen consequences of legislation regulating substances that affect public health.”

“Bootlegging was rampant and criminal syndicates proliferated, fueling a wave of organized crime.”

EVALI similarly appears to be strongly associated with a specific contaminant in illicit markets, vitamin E acetate (VEA), which is used to dilute or stretch cannabis concentrates ‚ÄĒ”a scenario reminiscent of the unscrupulous bootleggers of the Prohibition era.”

“How could a state‚Äôs legalization of recreational marijuana inadvertently protect its citizens against EVALI? The obvious answer is that THC-containing vaping products in states where recreational marijuana is legal are uncontaminated with VEA. If so, another question follows: why would THC products in these states be less likely to be contaminated (ie, diluted) with VEA? One salient possibility is that there is less financial incentive to dilute THC concentrates in states where raw THC material is readily available without legal risk and compensatory markup.”

“If THC concentrates are transported from states where they are legal and can be relatively cheaply mass produced (like industrial ethanol stocks during Prohibition) to other states where they are illegal and must be guarded jealously as a rare and precious commodity, there may be a strong economic inducement to dilute them, thereby increasing profits. Thus, legalization of marijuana may have protective local effects but untoward collateral effects.”

President Trump also seemed to pick up on the failure of prohibition during a meeting on the vaping crisis last year. He acknowledged that simply banning the products wouldn’t work, as people would simply move on to the illicit market, where there aren’t regulations.

What’s worse, the conflict between state and federal marijuana laws actually inhibited research into how to address EVALI cases, complicating shipments of vaping specimens, a top CDC official said.

The same official also suggested that federal cannabis regulations could mitigate the vaping problem. Former Food and Drug Administration Commissioner Scott Gottlieb made a similar argument.

CBD Prescription Drug Is No Longer A Federally Controlled Substance, DEA Says

This story was updated to include comment from NORML.

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

Politics

New FDA Guidance Will Make It Easier To Approve CBD-Based Medicines

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The Food and Drug Administration (FDA) is releasing new draft guidelines that are meant to streamline approvals for generic oral CBD medications.

In a notice published in the Federal Register on Wednesday, the agency said it is soliciting public feedback on its guidance to researchers who are interested in submitting abbreviated new drug applications (ANDAs) for CBD solutions.

To expedite the approval process, FDA said applicants can request a waiver of an in vivo bioequivalence study if they meet certain requirements. This guidance comes two years after the agency approved the brand-name CBD-based epilepsy medication Epidiolex from GW Pharmaceuticals.

Going forward, if a drug company wants to produce generic versions of that 100 mg/mL cannabidiol solution, they could follow specific rules to skip the in vivo bioequivalence study step if the draft guidance is finalized. The drug would have to be derived from Cannabis sativa L, contain no more than 0.1 percent THC and have “no inactive ingredient or other change in formulation from the [reference listed drug] that may significantly affect systemic availability.”

Researchers must use “appropriate analytical methods” such as macroscopic or microscopic analysis or DNA bar-coding methods to determine that the solution is being made from cannabis sativa.

“Due to the many cultivars within this species, identification and authentication of plant species should be conducted at the cultivar(s) level if the potential cultivar(s) will be used as a natural source of the [botanical raw material],” FDA said.

Further, when collecting that raw cannabis, the agency said applicants must follow “established good agricultural and collection practices (GACP) procedures to minimize variations in BRM and eventually ensure the batch-to-batch consistency of the drug substance.”

A public comment period on FDA’s draft guidance will last until November 23. FDA also recently closed a comment period on separate draft guidance on developing cannabis-derived medications. However, three other federal agencies are currently accepting input on a variety of other proposed cannabis- and drug-related regulations.

While this latest document isn’t the separate comprehensive CBD guidance that advocates and industry stakeholders have been waiting for, it’s another example of how the scientific landscape around cannabis is changing, with a federal agency helping to facilitate the production of cannabidiol-based drugs.

Separately, FDA announced on Tuesday that it will be hosting a public meeting in November to discuss gender and sex differences in the effects of CBD and other cannabinoids.

The agency also recently held a meeting to help inform cannabis researchers and cultivators about opportunities to protect their proprietary information and promote studies into the plant.

It also recently submitted¬†draft guidance on CBD enforcement¬†to the White House Office of Management and Budget‚ÄĒa long-anticipated move that comes after hemp legalization.

The agency was mandated under appropriations legislation enacted late last year to¬†provide an update on its regulatory approach to CBD, and it did so in March. The update stated that ‚ÄúFDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.‚ÄĚ

FDA has been using enforcement discretion for CBD in the years since hemp became legal.

The agency has continued to issue warnings to cannabis businesses in certain cases‚ÄĒsuch as instances in which companies claimed CBD could treat or cure coronavirus‚ÄĒand¬†provide public¬†notices about recalls.

In July, FDA also submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.

Also that month, a congressional¬†spending bill for FDA was released that includes a provision¬†providing ‚Äúfunding to develop a framework for regulating CBD products.‚ÄĚ

The agency is also actively looking to award a contract to help study CBD as the agency develops regulations for products containing the non-intoxicating cannabinoid.

Read FDA’s draft guidance on developing CBD medications below:¬†

FDA CBD guidance by Marijuana Moment

FDA Explains Effects Of CBD And Marijuana Compounds Based On Sex And Gender Differences

Photo by Kimzy Nanney.

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Politics

CDC Meets With Medical Marijuana Patients To Discuss Cannabis As Alternative Pain Therapy

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The Centers for Disease Control and Prevention (CDC) has recently been hosting meetings with medical marijuana patients as part of a broader series of listening sessions on alternative pain treatments.

Dustin McDonald, who uses cannabis to treat Lyme disease and also serves as policy director with Americans for Safe Access (ASA), told Marijuana Moment last week that his conversation with the federal agency was productive, with representatives listening attentively as he explained his personal experiences as well as the advocacy work that ASA is involved in.

Beyond simply getting an audience with a main federal health agency, McDonald said what especially stood out to him was that the CDC representatives told him that his wasn’t the first meeting they’ve had with someone who uses medical marijuana as an alternative pain management option. In fact, they said “a lot of the folks that they had spoken with were using cannabis for chronic pain.”

“In addition to my interview and my testimony discussing my experience utilizing medical cannabis for chronic pain and acute pain, there was a large population of people that they spoke with that were doing something similar,” McDonald said, adding that the CDC officials “seemed fairly open-minded” about the subject despite the ongoing federal prohibition of marijuana.

The ASA activist was especially encouraged by the last question the agency put to him, which he said asked “what could CDC do to assist in it advancing the conversation on additional research into medical cannabis applications to human health and health disorders, in talking to the lawmakers about the need to dive more deeply into researching all of these applications.”

ASA wants to take advantage of the opportunity to work with CDC and other related agencies to advocate for “removing roadblocks to research and pushing federal dollars towards combined grant programs for federal government agencies and academic institutions to really take a look at what’s going on with medical cannabis as a medicine,” McDonald said.

While it’s not clear what steps, if any, CDC will take to advance that conversation, McDonald said the fact that the agency heard from a multitude of voices about the therapeutic potential of marijuana could push them to take some action. At the very least, he expects medical marijuana to be discussed at some length in CDC’s forthcoming updated Guideline for Prescribing Opioids for Chronic Pain.

Marijuana Moment reached out to CDC to find out how often cannabis has been brought up in its meetings with stakeholders, but a representative was not immediately available.

The agency said in a notice about the pain management meetings published in the Federal Register in July that the conversations “will help inform CDC’s understanding of stakeholders’ values and preferences related to pain and pain management and will complement CDC’s ongoing work” on updating that guideline.

This comes months after CDC closed a public comment period on pain management that saw over 1,000 submissions advocating for marijuana and kratom as pain relief options.

But while there’s widespread interest in research cannabis as an opioid alternative, federally authorized research has been slow-going because of tight restrictions on who can access the plant for studies and where they can get it. Currently, there’s only one registered manufacturer at the University of Mississippi, and the marijuana they cultivate has been described as chemically closer to hemp than cannabis available in commercial markets.

A House committee last week approved key piece of marijuana research legislation that, among other things, would allow scientists to finally study cannabis from state-legal dispensaries.

In July, the House approved separate legislation that also called for letting researchers study marijuana purchased from businesses in state-legal markets instead of only letting them use government-grown cannabis. The intent of the provision, tucked into a 2,000-plus-page infrastructure bill, was to allow the interstate distribution of such products even to scientists in jurisdictions that have not yet legalized marijuana.

During an Energy and Commerce Subcommittee on Health hearing in January‚ÄĒwhich was¬†requested by four GOP lawmakers last year‚ÄĒfederal health and drug officials, including from the Drug Enforcement Administration (DEA), acknowledged that the current supply of cannabis for research purposes is inadequate and that scientists should be able to access a wider range of marijuana products.

DEA said four years ago that it would be taking steps to expand the number of federally authorized cannabis manufacturers, but it has not yet acted on applications.

Last year, scientists sued the agency, alleging that it had deliberately delayed approving additional marijuana manufacturers for research purposes despite its earlier pledge.

A court mandated that DEA take steps to make good on its promise, and that case was dropped after DEA provided a status update.

In March, DEA finally unveiled a revised rule change proposal that it said was necessary due to the high volume of applicants and to address potential complications related to international treaties to which the U.S. is a party.

The scientists behind the original case¬†filed another suit against DEA, claiming that the agency used a ‚Äúsecret‚ÄĚ document to justify its delay of approving manufacturer applications.

That was born out when the Justice Department Office of Legal Counsel document was released in April as part of a settlement in the case, revealing, among other things, that the agency feels that its current licensing structure for cannabis cultivation has been in violation of international treaties for decades.

Federal Workplace Drug Testing Proposal Could Discriminate Against People Of Color

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New Psychedelics Research And Education Center Launched At UC Berkeley As Reform Movement Grows

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The University of California at Berkeley announced on Monday that it is launching a new center dedicated to psychedelics research and education.

Scientists at the center will use psychedelic substances to “investigate cognition, perception and emotion and their biological bases in the human brain,” according to a press release. At the same time, the new entity will be putting resources toward informing the public about “this rapidly advancing field of research.”

To start, the UC Berkeley Center for the Science of Psychedelics will look at psilocybin, the main psychoactive component of so-called magic mushrooms. This research is being partially funded by an anonymous $1.25 million donation.

‚ÄúThere‚Äôs never been a better time to start a center like this,‚ÄĚ Berkeley neuroscientist David Presti, a founding member of the center, said. ‚ÄúThe renewal of basic and clinical science with psychedelics has catalyzed interest among many people.‚ÄĚ

The research is meant to complement studies being conducted at other psychedelics-focused institutions, such as a similar center that launched at Johns Hopkins University last year.

‚ÄúSome of these studies have produced striking results in cases that are otherwise resistant to more conventional medical treatment,” Berkeley neuroscientist Michael Silver, directer of the new center, said. “This suggests that psychedelic compounds may offer new hope for people suffering from these disorders.”

The researchers will also be partnering with the Graduate Theological Union to create “an immersive learning program on psychedelics and spirituality.” That will involve training individuals to be “facilitators” for psychedelic ceremonies. The training program will look at the “cultural, contemplative and spiritual care dimensions of psychedelics.”

‚ÄúThe training of facilitators is an indispensable part of this project,‚ÄĚ Sam Shonkoff, an assistant professor at the Graduate Theological Union, said.

Researchers at the center will attempt to discover potential therapeutic applications of psychedelics for mental health by studying the fundamental mechanisms that go into a psychedelic experience. They plan to explore how visual hallucinations work in the brain, as well as the long-term effects of taking these substances on “social and political attitudes, identity and resilience to stress.”

‚ÄúPsychedelic medicines can open a doorway to seeing one‚Äôs psyche and connection with the world in new and helpful ways,‚ÄĚ Presti said. ‚ÄúThat‚Äôs been appreciated by shamanic traditions for thousands of years. Science is now exploring new ways to investigate this.‚ÄĚ

Journalism professor Michael Pollan, author of “How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression and Transcendence,” will also be involved.

‚ÄúWe‚Äôre really interested in what psychedelics can teach us about consciousness, perception, creativity and learning,‚ÄĚ Pollan said. ‚ÄúPsychedelics have a particular value later in life, because that is when you are most stuck in your patterns. They give you the ability to shake them loose.”

This center’s foundation comes in the midst of a national psychedelics reform movement, with activists across the country pushing to end criminalization of entheogenic substances.

In May 2019, Denver became the first U.S. city to decriminalize psilocybin, with the approval of a local ballot measure. Soon after, officials in Oakland, California, decriminalized possession of all plant- and fungi-based psychedelics. The City Council in Santa Cruz, California, voted to make the enforcement of laws against psychedelics among the city’s lowest enforcement priorities in January.

Last month, Canada’s health minister granted exemptions allowing certain cancer patients to legally use psilocybin for end-of-life care.

The Canadian government will have to¬†officially respond to a petition calling for the decriminalization of psychedelics¬†after it recently garnered nearly 15,000 signatures‚ÄĒand there‚Äôs legislation in the works that could make the reform happen.

Rep. Earl Blumenauer (D-OR) is formally throwing his support behind an Oregon initiative to legalize psilocybin mushrooms for therapeutic purposes and is helping to raise money for the campaign.

A measure to decriminalize a wide range of psychedelics will appear on the Washington, D.C. ballot‚ÄĒand recent polling indicates that it has strong support.

The Multidisciplinary Association for Psychedelic Studies announced last month that it raised $30 million in donations‚ÄĒincluding from several notable business leaders outside the drug policy realm‚ÄĒthat will enable it to complete a¬†study on using MDMA to treat post-traumatic stress disorder.

Meanwhile, Oregon voters will also see a separate measure on their November ballots to decriminalize drug possession and fund treatment services.

Federal Workplace Drug Testing Proposal Could Discriminate Against People Of Color

Photo elements courtesy of carlosemmaskype and Apollo.

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