Marijuana Law, Policy & Reform

Editor: Douglas A. Berman
Moritz College of Law

Tuesday, November 12, 2019

"A special exception for CBD in foods and supplements?"

X13596446The question in the title of this post is the headline if this notable new editorial in the journal Drug Discovery Today authored by Patricia Zettler and Erika Lietzan.  (Disclosure/humble brag: Professor Zettler is on the Ohio State College of Law faculty and a member of our Drug Enforcement and Policy Center.)  Here are excerpts from the start and end of the piece:

In the last two years the cannabidiol (CBD) market has exploded. Consumers can purchase CBD-containing oils, lotions, gummies, tea, coffee, water, popcorn, and cereal, on store shelves and online. Celebrities and athletes are touting the benefits of these products, and sales are forecast to exceed $20 billion in the next five years.  This market explosion has coincided with the U.S. Food & Drug Administration (FDA)’s 2018 approval of the first CBD drug (Epidiolex), for treating seizures associated with two rare and severe forms of epilepsy in children, as well as the 2018 Farm Bill, which removed cannabis with low levels of delta-9-tetrahydocannabinol (THC) — “hemp” — from the federal list of controlled substances.  And it comes on the heels of nearly 40 states enacting comprehensive laws to legalize cannabis for medical use (and sometimes recreational use) within their borders.

Yet significant questions remain about the legal status of these widely available CBD products.  Most sales of CBD-containing foods and supplements violate the “drug exclusion rules” in the Federal Food, Drug, and Cosmetic Act (FDCA).  But FDA has yet to enforce those rules, apart from sending warning letters to a few sellers.  The agency is instead considering what approach to take.  Several former agency officials — including former Commissioner Scott Gottlieb — have urged FDA to create a sensible, science-based path forward for consumer products.  The time is ripe for the agency, lawmakers, health care providers, the drug discovery community, and the public to consider the purpose of the drug exclusion rules and what a different approach — exempting CBD — might mean for consumer and patient access and safety, as well as innovation incentives....

As a practical matter, CBD-containing foods and supplements may be here to stay.  Lawmakers or FDA may decide that the drug exclusion rules are unwarranted for CBD, given the federal descheduling of hemp, state legalization of cannabis products, and (eventually) rigorous evidence that CBD products are relatively safe.  But FDA should not default into this position simply because a robust, albeit unlawful, market has already emerged.  A decision to give CBD special treatment should be made thoughtfully and with public participation, accounting for possible gains in consumer access and choice, as well as the lost opportunity to learn, and harness, CBD’s full therapeutic potential.

November 12, 2019 in Business laws and regulatory issues, Federal Marijuana Laws, Policies and Practices, Medical community perspectives, Medical Marijuana Commentary and Debate, Recreational Marijuana Commentary and Debate, Who decides | Permalink | Comments (0)

Wednesday, October 30, 2019

"The Impact of Medical Marijuana Laws and Dispensaries on Self-Reported Health"

S21946191The title of this post is the title of this notable new article authored by Elena Andreyeva and Benjamin Ukert published in the Forum for Health Economics & Policy. Here is its abstract:

Growing evidence suggests that medical marijuana laws have harm reduction effects across a variety of outcomes related to risky health behaviors.  This study investigates the impact of medical marijuana laws on self-reported health using data from the Behavioral Risk Factor Surveillance System from 1993 to 2013.  In our analyses we separately identify the effect of a medical marijuana law and the impact of subsequent active and legally protected dispensaries.

Our main results show surprisingly limited improvements in self-reported health after the legalization of medical marijuana and legally protected dispensaries.  Subsample analyses reveal strong improvements in health among non-white individuals, those reporting chronic pain, and those with a high school degree, driven predominately by whether or not the state had active and legally protected dispensaries.  We also complement the analysis by evaluating the impact on risky health behaviors and find that the aforementioned demographic groups experience large reductions in alcohol consumption after the implementation of a medical marijuana law.

October 30, 2019 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research | Permalink | Comments (0)

"Cannabinoids for the treatment of mental disorders and symptoms of mental disorders: a systematic review and meta-analysis"

Download (6)The title of this post is the title of this notable new article by multiple authors published in The Lancet Psychiatry. Here is its "Summary":

Background

Medicinal cannabinoids, including medicinal cannabis and pharmaceutical cannabinoids and their synthetic derivatives, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), have been suggested to have a therapeutic role in certain mental disorders.  We analysed the available evidence to ascertain the effectiveness and safety of all types of medicinal cannabinoids in treating symptoms of various mental disorders.

Methods

For this systematic review and meta-analysis we searched MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Clinical Trials, and the Cochrane Database of Systematic Reviews for studies published between Jan 1, 1980, and April 30, 2018.  We also searched for unpublished or ongoing studies on ClinicalTrials.gov, the EU Clinical Trials Register, and the Australian and New Zealand Clinical Trials Registry.  We considered all studies examining any type and formulation of a medicinal cannabinoid in adults (≥18 years) for treating depression, anxiety, attention-deficit hyperactivity disorder (ADHD), Tourette syndrome, post-traumatic stress disorder, or psychosis, either as the primary condition or secondary to other medical conditions.  We placed no restrictions on language, publication status, or study type (ie, both experimental and observational study designs were included). Primary outcomes were remission from and changes in symptoms of these mental disorders.  The safety of medicinal cannabinoids for these mental disorders was also examined. Evidence from randomised controlled trials was synthesised as odds ratios (ORs) for disorder remission, adverse events, and withdrawals and as standardised mean differences (SMDs) for change in symptoms, via random-effects meta-analyses.  The quality of the evidence was assessed with the Cochrane risk of bias tool and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.  This study is registered with PROSPERO (CRD42017059372, CRD42017059373, CRD42017059376, CRD42017064996, and CRD42018102977).

Findings

83 eligible studies (40 randomised controlled trials, n=3067) were included: 42 for depression (23 randomised controlled trials; n=2551), 31 for anxiety (17 randomised controlled trials; n=605), eight for Tourette syndrome (two randomised controlled trials; n=36), three for ADHD (one randomised controlled trial; n=30), 12 for post-traumatic stress disorder (one randomised controlled trial; n=10), and 11 for psychosis (six randomised controlled trials; n=281).  Pharmaceutical THC (with or without CBD) improved anxiety symptoms among individuals with other medical conditions (primarily chronic non-cancer pain and multiple sclerosis; SMD −0·25 [95% CI −0·49 to −0·01]; seven studies; n=252), although the evidence GRADE was very low.  Pharmaceutical THC (with or without CBD) worsened negative symptoms of psychosis in a single study (SMD 0·36 [95% CI 0·10 to 0·62]; n=24). Pharmaceutical THC (with or without CBD) did not significantly affect any other primary outcomes for the mental disorders examined but did increase the number of people who had adverse events (OR 1·99 [95% CI 1·20 to 3·29]; ten studies; n=1495) and withdrawals due to adverse events (2·78 [1·59 to 4·86]; 11 studies; n=1621) compared with placebo across all mental disorders examined.  Few randomised controlled trials examined the role of pharmaceutical CBD or medicinal cannabis.

Interpretation

There is scarce evidence to suggest that cannabinoids improve depressive disorders and symptoms, anxiety disorders, attention-deficit hyperactivity disorder, Tourette syndrome, post-traumatic stress disorder, or psychosis. There is very low quality evidence that pharmaceutical THC (with or without CBD) leads to a small improvement in symptoms of anxiety among individuals with other medical conditions.  There remains insufficient evidence to provide guidance on the use of cannabinoids for treating mental disorders within a regulatory framework.  Further high-quality studies directly examining the effect of cannabinoids on treating mental disorders are needed.

October 30, 2019 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research | Permalink | Comments (0)

Tuesday, October 1, 2019

"Contribution of Marijuana Legalization to the U.S. Opioid Mortality Epidemic: Individual and Combined Experience of 27 States and District of Columbia"

The title of this post is the title of this new forthcoming research article authored by Archie Bleyer and Brian Barnes.  Here is its abstract:

Background

Prior studies of U.S. states as of 2013 and one state as of 2015 suggested that marijuana availability reduces opioid mortality (marijuana protection hypothesis).  This investigation tested the hypothesis with opioid mortality trends updated to 2017 and by evaluating all states and the District of Columbia (D.C.).

Methods

Opioid mortality data obtained from the U.S. Centers for Disease Control and Prevention were used to compare opioid death rate trends in each marijuana-legalizing state and D.C. before and after medicinal and recreational legalization implementation and their individual and cumulative aggregate trends with concomitant trends in non-legalizing states.  The Joinpoint Regression Program identified statistically-significant mortality trends and when they occurred.

Results

Of 23 individually evaluable legalizing jurisdictions, 78% had evidence for a statistically-significant acceleration of opioid death rates after medicinal or recreational legalization implementation at greater rates than their pre-legalization rate or the concurrent composite rate in non-legalizing states.  All four jurisdictions evaluable for recreational legalization had evidence (p <0.05) for subsequent opioid death rate increases, one had a distinct acceleration, and one a reversal of prior decline.  Since 2009-2012, when the cumulative-aggregate opioid death rate in the legalizing jurisdictions was the same as in the non-legalizing group, the legalizing group′s rate accelerated increasingly faster (p=0.009).  By 2017 it was 67% greater than in the non-legalizing group (p<0.05).

Conclusions

The marijuana protection hypothesis is not supported by recent U.S. data on opioid mortality trends.  Instead, legalizing marijuana appears to have contributed to the nation′s opioid mortality epidemic.

October 1, 2019 in Medical community perspectives, Medical Marijuana Commentary and Debate, Recreational Marijuana Commentary and Debate | Permalink | Comments (1)

Thursday, September 5, 2019

"Oregon death is 2nd linked to vaping, 1st tied to pot shop"

The title of this post is the headline of this AP article, which started this way:

Public health officials in Oregon said Wednesday that a person who recently died of a severe respiratory illness had used an electronic cigarette containing marijuana oil from a legal dispensary, the second death linked to vaping nationwide and the first tied to a vaping product bought at a pot shop.

Officials have not determined what sickened the middle-aged adult, whether the product was contaminated or whether they may have added something to the liquid in the device after buying it, said Dr. Ann Thomas with the Oregon Health Authority.

Thomas declined to name the brand of the product or the dispensary during the investigation and said it's the only case of vaping-related illness or death in Oregon that authorities know about.  "Our investigation has not yielded exactly what it is in this product," Thomas said.  "At this point, some of the other states have more data than us."

As of last week, 215 possible cases of severe lung disease associated with the use of e-cigarettes had been reported by 25 states, according to the federal Centers for Disease Control and Prevention. The battery-powered vaping devices can be used to inhale a flavored nicotine solution or a solution infused with marijuana oil.

Illinois officials on Friday reported what they consider the first death in the nation linked to vaping after the person contracted a serious lung disease.  They didn't say if the e-cigarette contained marijuana oil or just nicotine. Health officials in some states have said a number of people who got sick had vaped products containing THC, the compound that gives marijuana its high.

That's a critical distinction in the Oregon case, according to the American Vaping Association, which has blamed the recent spate of lung illnesses on illegal vape pens that contain THC.

Wisconsin public health officials said late last month that 89% of the people they interviewed who became sick reported using e-cigarettes or other vaping devices to inhale THC.

In New York state, 32 cases of vaping-related illness have been reported, with a "vast majority" involving people who vape illicit marijuana.  None has involved medical marijuana products sold in compliance with state law.

New York officials are focusing their investigation on an additive used in black-market vape oils made from vitamin E.  A state health department spokeswoman said a lab has found "high levels" of vitamin E acetate in "nearly all" the marijuana samples involved.

September 5, 2019 in Medical community perspectives, Recreational Marijuana Commentary and Debate | Permalink | Comments (0)

Thursday, August 29, 2019

US Surgeon General issues new health advisory on "Marijuana Use and the Developing Brain"

Screen+Shot+2018-09-14+at+4.43.10+PMThis morning, the federal government weighed in on the health risks of marijuana reforms through this new extended US Surgeon General advisory headed "Marijuana Use and the Developing Brain."  Here is how it gets started and some key passages (with lots of cites to research removed):

I, Surgeon General VADM Jerome Adams, am emphasizing the importance of protecting our Nation from the health risks of marijuana use in adolescence and during pregnancy. Recent increases in access to marijuana and in its potency, along with misperceptions of safety of marijuana endanger our most precious resource, our nation’s youth.

Background

Marijuana, or cannabis, is the most commonly used illicit drug in the United States.  It acts by binding to cannabinoid receptors in the brain to produce a variety of effects, including euphoria, intoxication, and memory and motor impairments.  These same cannabinoid receptors are also critical for brain development.  They are part of the endocannabinoid system, which impacts the formation of brain circuits important for decision making, mood and responding to stress....

The risks of physical dependence, addiction, and other negative consequences increase with exposure to high concentrations of THC7 and the younger the age of initiation. Higher doses of THC are more likely to produce anxiety, agitation, paranoia, and psychosis.  Edible marijuana takes time to absorb and to produce its effects, increasing the risk of unintentional overdose, as well as accidental ingestion by children and adolescents.  In addition, chronic users of marijuana with a high THC content are at risk for developing a condition known as cannabinoid hyperemesis syndrome, which is marked by severe cycles of nausea and vomiting.

This advisory is intended to raise awareness of the known and potential harms to developing brains, posed by the increasing availability of highly potent marijuana in multiple, concentrated forms.  These harms are costly to individuals and to our society, impacting mental health and educational achievement and raising the risks of addiction and misuse of other substances.  Additionally, marijuana use remains illegal for youth under state law in all states; normalization of its use raises the potential for criminal consequences in this population.  In addition to the health risks posed by marijuana use, sale or possession of marijuana remains illegal under federal law notwithstanding some state laws to the contrary.

Marijuana Use during Pregnancy

Pregnant women use marijuana more than any other illicit drug.  In a national survey, marijuana use in the past month among pregnant women doubled (3.4% to 7%) between 2002 and 201712. In a study conducted in a large health system, marijuana use rose by 69% (4.2% to 7.1%) between 2009 and 2016 among pregnant women.  Alarmingly, many retail dispensaries recommend marijuana to pregnant women for morning sickness.

Marijuana use during pregnancy can affect the developing fetus. THC can enter the fetal brain from the mother’s bloodstream and may disrupt the endocannabinoid system, which is important for a healthy pregnancy and fetal brain development. Moreover, studies have shown that marijuana use in pregnancy is associated with adverse outcomes, including lower birth weight.  The Colorado Pregnancy Risk Assessment Monitoring System reported that maternal marijuana use was associated with a 50% increased risk of low birth weight regardless of maternal age, race, ethnicity, education, and tobacco use....

Marijuana Use during Adolescence

Marijuana is also commonly used by adolescents, second only to alcohol.  In 2017, approximately 9.2 million youth aged 12 to 25 reported marijuana use in the past month and 29% more young adults aged 18-25 started using marijuana.  In addition, high school students’ perception of the harm from regular marijuana use has been steadily declining over the last decade.  During this same period, a number of states have legalized adult use of marijuana for medicinal or recreational purposes, while it remains legal under federal law.  The legalization movement may be impacting youth perception of harm from marijuana.

The human brain continues to develop from before birth into the mid-20s and is vulnerable to the effects of addictive substances.  Frequent marijuana use during adolescence is associated with changes in the areas of the brain involved in attention, memory, decision-making, and motivation.  Deficits in attention and memory have been detected in marijuana-using teens even after a month of abstinence.  Marijuana can also impair learning in adolescents.  Chronic use is linked to declines in IQ, school performance that jeopardizes professional and social achievements, and life satisfaction.  Regular use of marijuana in adolescence is linked to increased rates of school absence and drop-out, as well as suicide attempts. 

August 29, 2019 in Federal Marijuana Laws, Policies and Practices, Medical community perspectives, Recreational Marijuana Commentary and Debate, Who decides | Permalink | Comments (0)

Sunday, June 16, 2019

"Marijuana Damages Young Brains: States that legalize it should set a minimum age of 25 or older."

The title of this post is the headline of this new commentary in the New York Times authored by two doctors, Kenneth L. Davis and Mary Jeanne Kreek. Here are excerpts:

It’s tempting to think marijuana is a harmless substance that poses no threat to teens and young adults. The medical facts, however, reveal a different reality.

Numerous studies show that marijuana can have a deleterious impact on cognitive development in adolescents, impairing executive function, processing speed, memory, attention span and concentration. The damage is measurable with an I.Q. test. Researchers who tracked subjects from childhood through age 38 found a consequential I.Q. decline over the 25-year period among adolescents who consistently used marijuana every week. In addition, studies have shown that substantial adolescent exposure to marijuana may be a predictor of opioid use disorders.

The reason the adolescent brain is so vulnerable to the effect of drugs is that the brain — especially the prefrontal cortex, which controls decision making, judgment and impulsivity — is still developing in adolescents and young adults until age 25....

The risk that marijuana use poses to adolescents today is far greater than it was 20 or 30 years ago, because the marijuana grown now is much more potent. In the early 1990s, the average THC content of confiscated marijuana was roughly 3.7 percent. By contrast, a recent analysis of marijuana for sale in Colorado’s authorized dispensaries showed an average THC content of 18.7 percent.

The proposals for legalizing marijuana under consideration in New York and New Jersey allow for use starting at age 21. While society may consider a 21-year-old to be an adult, the brain is still developing at that age. States that legalize marijuana should set a minimum age of no younger than 25. They should also impose stricter limits on THC levels and strictly monitor them. Educational campaigns are also necessary to help the public understand that marijuana is not harmless.

Simply because society has become more accepting of marijuana use doesn’t make it safe for high school and college students. Cigarettes and alcohol, both legal, have caused great harm in society as well as to people’s health, and have ruined many lives. Marijuana may do the same. We must tightly regulate the emerging cannabis industry to protect the developing brain.

UPDATE: Interestingly, not long after blogging about this NY Times commentary, I came across this extended Washington Post piece headlined "Potent pot, vulnerable teens trigger concerns in first states to legalize marijuana." Here is a snippet:

As more than a dozen states from Hawaii to New Hampshire consider legalizing marijuana, doctors warn of an urgent need for better education — not just of teens but of parents and lawmakers — about how the products being marketed can significantly affect young people’s brain development.

The limited scientific research to date shows that earlier and more frequent use of high-THC cannabis puts adolescents at greater jeopardy of substance use disorders, mental health issues and poor school performance.

“The brain is abnormally vulnerable during adolescence,” said Staci Gruber, an associate professor of psychiatry at Harvard Medical School who studies how marijuana affects the brain. “Policy seems to have outpaced science, and in the best of all possible worlds, science would allow us to set policy.”

June 16, 2019 in Medical community perspectives, Recreational Marijuana Commentary and Debate | Permalink | Comments (0)

Wednesday, June 5, 2019

Americans For Safe Access releases detailed "Patient's Guide To CBD"

2CBD_Guide_GraphicThe leading medical marijuana advocacy group, Americans for Safe Access, has this terrific new resource titled "Patient's Guide To CBD."  Though the title of this nearly 50-page report is simple, the contents provide an intricate road-map to the complicated law and science surrounding the status and import of the cannabis-plant compound known as CBD. Here is a section of the publication's introduction:

The Patient’s Guide to CBD was created by Americans for Safe Access (ASA) for the benefit of patients, prospective patients, healthcare providers, consumers, and anyone interested in learning more about CBD.  The goal of this guide is to be an informative and useful reference document that will be shared with others so that patients, doctors, and regulators can make informed decisions regarding CBD....

Patients and consumers should also be aware of the legal and regulatory status of CBD products.  As of May 2019, 47 U.S. states have passed some type of legislation permitting the use of cannabis or cannabinoids such as CBD; nevertheless, cannabis with THC in excess of 0.3% by dry weight is a Schedule I controlled substance under U.S. Federal law.  Therefore, CBD-containing products that were produced from cannabis plants that exceed the federal threshold on THC may be legal at the state level, but are federally illegal.  Additionally, even CBD products that are derived from plants containing not more than 0.3% THC by dry weight may violate laws such as the Food, Drug and Cosmetics Act and create further legal challenges for patients and consumers.

The passage of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) will make industrial hemp (i.e., cannabis with no more than 0.3% THC by dry weight), including CBD-rich industrial hemp, an agricultural commodity in the United States, but the U.S. Department of Agriculture has yet to promulgate federal regulations or approve state regulations regarding the cultivation and processing of industrial hemp. Further, the U.S. Food & Drug Administration has yet to provide a pathway for the introduction of hemp-derived CBD products into the marketplace.  Therefore, it is not yet federally legal to market hemp-derived CBD as a drug, dietary supplement, food product, or cosmetic.  Patients and consumers are encouraged to stay up to date on these changing regulations to ensure that they, and their products, are in compliance with applicable laws.

Globally, the use of products containing CBD has risen dramatically as more and more people seek alternative ways to improve their health and their lives.  The data has shown an increase in the sales of products containing CBD every year, and sales are expected to continue to rise in the coming years.

June 5, 2019 in History of Marijuana Laws in the United States, Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research, Medical Marijuana State Laws and Reforms | Permalink | Comments (0)

Tuesday, May 21, 2019

New research suggests CBD can reduce craving and anxiety for those with heroin use disorder

Long-time readers know I have long been covering the (never-quite-clear) connection between modern marijuana reform and the modern opioid crisis.  (Just some of many, many prior posts on this front are linked below.)   Today brings notable research news on this front, which is already getting a lot of attention from the mainstream press in articles from CNN, from NBC News, from Newsweek, and from US News & World Report, among others.  All these stories are about a new study published in The American Journal of Psychiatry from multiple authors under this catchy title: "Cannabidiol for the Reduction of Cue-Induced Craving and Anxiety in Drug-Abstinent Individuals With Heroin Use Disorder: A Double-Blind Randomized Placebo-Controlled Trial."  Here is the study's abstract:

Objective:

Despite the staggering consequences of the opioid epidemic, limited nonopioid medication options have been developed to treat this medical and public health crisis. This study investigated the potential of cannabidiol (CBD), a nonintoxicating phytocannabinoid, to reduce cue-induced craving and anxiety, two critical features of addiction that often contribute to relapse and continued drug use, in drug-abstinent individuals with heroin use disorder.

Methods:

This exploratory double-blind randomized placebo-controlled trial assessed the acute (1 hour, 2 hours, and 24 hours), short-term (3 consecutive days), and protracted (7 days after the last of three consecutive daily administrations) effects of CBD administration (400 or 800 mg, once daily for 3 consecutive days) on drug cue–induced craving and anxiety in drug-abstinent individuals with heroin use disorder. Secondary measures assessed participants’ positive and negative affect, cognition, and physiological status.

Results:

Acute CBD administration, in contrast to placebo, significantly reduced both craving and anxiety induced by the presentation of salient drug cues compared with neutral cues. CBD also showed significant protracted effects on these measures 7 days after the final short-term (3-day) CBD exposure. In addition, CBD reduced the drug cue–induced physiological measures of heart rate and salivary cortisol levels. There were no significant effects on cognition, and there were no serious adverse effects.

Conclusions:

CBD’s potential to reduce cue-induced craving and anxiety provides a strong basis for further investigation of this phytocannabinoid as a treatment option for opioid use disorder.

Some (of many) prior related posts:

May 21, 2019 in Medical community perspectives, Medical Marijuana Data and Research | Permalink | Comments (0)

Wednesday, May 1, 2019

Shouldn't every major marijuana investor make major investments in marijuana research?

Research-data-analysisThe question in the title of this post is prompted by this notable story out of Boston headlined "Harvard, MIT share $9 million gift to study marijuana's health effects." Here are the interesting details:

An investor in the cannabis industry has donated $9 million to Harvard and MIT to study the drug’s health effects, in what the institutions describe as the largest private gift to support marijuana research in the United States.  The Broderick Fund for Phytocannabinoid Research, announced Tuesday morning, will be shared equally by Harvard Medical School and the Massachusetts Institute of Technology, with the goal of filling vast gaps in the understanding of how marijuana affects the brain and behavior.

“The lack of basic science research enables people to make claims in a vacuum that are either anecdotal or based on old science,” said the donor, Charles R. “Bob” Broderick, an alumnus of both universities. “For generations we haven’t been able to study this thing for various sorts of societal reasons. That should end now, as well as the prohibitions that are falling around the world.”

Broderick has invested heavily in the booming marijuana business, starting in Canada in 2015 and more recently the United States, through his family-run Uji Capital. Although Broderick stands to profit if the studies find benefits from marijuana, the universities and the researchers said the donor will have no say in the work process or its results. They also pledged to publish their findings even if they find marijuana doesn’t help or causes harm.

Broderick recalled the first time he raised the idea of funding cannabis research with a Harvard development officer: “There was silence on the other end. Then she said, ‘I don’t think we do it.’ And I said, ‘That’s the problem.’ ” The official soon called back to say that Harvard researchers studying brain chemicals would be interested in examining marijuana’s effects.

Dr. Igor Grant, a longtime California marijuana researcher who is not involved with the Harvard-MIT project, said the grant “will really let them move forward with research that has been difficult to fund.”

“The work in this area has been very, very slow coming,” said Grant, director of the Center for Medicinal Cannabis Research at the University of California San Diego.

“This is exactly the type of research we need,” said Dr. Peter Grinspoon, a Massachusetts primary care doctor and board member of Doctors for Cannabis Regulation, a group promoting legalization and regulation of marijuana. Whether for or against marijuana, Grinspoon said, “Everybody wants more research.” The marijuana studies to date vary in quality, often have conflicting results, and typically involve either purified extracts or smoked marijuana — not the gummies, cookies, vapor, oils, or highly potent buds that people consume today....

Until recently researchers could work only with marijuana grown at a federal farm in Mississippi, whose plants are less potent than those purchased at dispensaries in states where the drug is legal. But John Gabrieli, a professor of brain and cognitive sciences at MIT and one of the grant recipients, said “a fast-changing regulatory environment” is allowing access to better material.

The MIT researchers intend to use extracts from the plants to tease out the effects of marijuana in people with schizophrenia — about half of whom are heavy cannabis users, Gabrieli said. The researchers want to pursue intriguing evidence that a component in marijuana known as tetrahydrocannabinol, or THC, improves cognitive function in people with schizophrenia. They will look at how THC as well as another key component — cannabidiol, or CBD — affect cognition alone and in combination.

Another MIT researcher will study how chronic exposure to THC and CBD may alter the cell types implicated in schizophrenia, potentially shedding light on why teens who use cannabis are at greater risk of developing schizophrenia and why the drug may be more dangerous for teens than adults.

Other studies at MIT will examine whether marijuana ingredients can help people with autism and with Huntington’s disease, and will study the effects of cannabis ingredients on attention and working memory. It’s been “incredibly hard” to get funding for marijuana research, Gabrieli said. “It’s been illegal all over the place until very recently. Without the philanthropic boost, it could take many years to work through all these issues.”

At Harvard, the $4.5 million gift establishes the Charles R. Broderick Phytocannabinoid Research Initiative, involving some 30 basic scientists and clinicians at the medical school and its affiliated hospitals. The Harvard team plans to study the effects of marijuana ingredients on brain cell function and the connections between brain cells, testing purified ingredients on mice and rats.

Researchers at Harvard have been studying natural brain chemicals known as endocannabinoids, which are involved in a variety of functions, including memory, appetite, and stress response. The grant will enable them to expand that research to encompass cannabinoids derived from plants. “Marijuana has about 100 different cannabinoid compounds. We understand very little about the specific effects of each of them on the nervous system,” said Bruce Bean, Harvard neurobiology professor and one of the project’s researchers....

The research, however, is funded by someone who could profit if the findings are favorable or lose money if new dangers are discovered.  Could knowing this somehow, even unconsciously, bias the results?  Josephine Johnston, director of research at the Hastings Center, a think tank concerned with bioethics, said such conflicts of interest are commonplace. “In a pure world, you wouldn’t have a situation like this.  But it’s pretty much a fact of life of biomedical research in the United States that you have interested parties funding research,” said Johnston, co-editor of a book on conflicts of interest in biomedical research. Institutions can enact safeguards to ensure both that the research is unbiased and that it’s perceived as trustworthy.

Both MIT and Harvard said they have such policies in place, requiring that gifts come without strings attached and that researchers have control over their work and its publication.  Grant, the California marijuana researcher, agreed that conflict of interest is an important concern. But, he added, if people profiting from the marijuana boom invest in science, “maybe that’s not a bad thing. They could just as easily buy yachts or do something else.”

Because I am a kind of marijuana researcher (focused on law and social science, rather than medical science), I realize I have a bias when suggesting that everyone involved in the marijuana industry ought to be funding academic marijuana research.  Also, as a director of the Drug Enforcement and Policy Center at The Ohio State University, I am sensitive to the concern that research funded by the marijuana industry or investors carries real conflict risks that can come with any private funding of public research. 

All that said, this article helps highlight just some of the many reasons why a lot more private funding (and a lot more public funding) is needed for all sorts of marijuana research.  There are many times I end up feeling truly overwhelmed by all the important research questions that arise in this space and all the formal and informal barriers to conducting all the needed research.   And especially with so many legal and social changes in this space, this period seems like an "all hands on deck" moment.  And I do not think it is misguided to believe that everyone involved in the marijuana industry and especially its investors ought to be swabbing the deck as best they can.

May 1, 2019 in Business laws and regulatory issues, Medical community perspectives, Medical Marijuana Data and Research, Recreational Marijuana Data and Research, Who decides | Permalink | Comments (0)

Monday, March 25, 2019

"The Effect of Marijuana Use on American Veterans with PTSD, and How the U.S. Department of Veterans Affairs Ought to Respond"

The title of this post is the title of a presentation to be made by one of my students in my Marijuana Law, Policy & Reform seminar this coming week.  Here is part of his explanation of his topic and links to some background reading:

Because the U.S. Department of Veterans Affairs (VA) is required to follow all federal laws, the VA is prohibited from prescribing, recommending, or assisting veterans in obtaining marijuana.  While veterans may discuss marijuana use with VA providers, VA doctors cannot help their patients participate in a state medical marijuana program and veterans cannot obtain reimbursement funding through the VA when they seek medical marijuana from state programs.

The inability of the VA to prescribe or recommend marijuana to American veterans with PTSD denies former service members an opportunity to receive treatment that many veterans not only want, but which also has the potential to be safer than the VA’s history of doling out addictive prescription drugs such as opioids, antidepressants, and anti-anxiety pills.  PTSD is a serious disease that is relatively common among combat veterans — it causes varying symptoms such as flashbacks, nightmares, severe anxiety, and uncontrollable thought about a triggering event.

The medical research in this arena has reached mixed findings.  While some researchers have found that the use of medical marijuana by veterans with PTSD has positive results, other studies suggest that marijuana use by those with PTSD may actually make symptoms worse.  There simply has not been enough controlled studies to conclusively state whether marijuana is beneficial for those with PTSD.  Nonetheless, there is plenty of anecdotal evidence by veterans suggesting that their use of marijuana has improved, or in some cases eliminated, symptoms associated with their PTSD.  Fortunately, the first clinical trial of marijuana for American veterans with PTSD is currently underway in Colorado.  My presentation will suggest that we need more controlled clinical trials such as this to further identify whether marijuana could (or should) truly be used as a remedy for veterans with PTSD.

* Medical journal article, "Post-Traumatic Stress Disorder" (discussing what PTSD is and various treatment options, including cannabis).

* Medical journal article, "Use and effects of cannabinoids in military veterans with posttraumatic stress disorder"(reviewing several studies and noting that while there is a need for more randomized and controlled studies, some PTSD patients report benefits in terms of reduced anxiety and insomnia and improved coping ability).

* Medical journal article, "Posttraumatic Stress Disorder and Cannabis Use Characteristics among Military Veterans with Cannabis Dependence" (exploring the negative effects of treating PTSD with marijuana and finding that individuals with PTSD may have a particularly difficult experience when attempting to quit marijuana).

* Medical journal article, "Marijuana and other cannabinoids as a treatment for posttraumatic stress disorder: A literature review" (explaining that conclusions cannot yet be drawn about the therapeutic effects of marijuana and related cannabinoids for PTSD; suggesting that rapidly changing legal landscape will permit promising clinical research).

* Medical journal article, "A review of medical marijuana for the treatment of posttraumatic stress disorder: Real symptom re-leaf or just high hopes?" (finding some positive data for use of marijuana for PTSD but also noting conflicting findings and limits of studies conducted thus far).

* Report on study, "Marijuana for Symptoms of PTSD in U.S. Veterans" (first clinical trial of marijuana for PTSD in American veterans underway).

* Recent Weedmaps article, "Marijuana Study Findings Could Hold Promise for Veterans With PTSD" (noting that MAPS study mentioned above could pave the way toward an FDA-approved prescription medicine; anecdotal evidence of veteran using black market rather than expensive medical marijuana program in CA)

March 25, 2019 in Federal Marijuana Laws, Policies and Practices, Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research, Medical Marijuana State Laws and Reforms, Who decides | Permalink | Comments (0)

Tuesday, March 19, 2019

"The contribution of cannabis use to variation in the incidence of psychotic disorder across Europe (EU-GEI): a multicentre case-control study"

The title of this post is the title of this important new study appearing in The Lancet Psychiatry.  Here is its summary:

Background

Cannabis use is associated with increased risk of later psychotic disorder but whether it affects incidence of the disorder remains unclear.  We aimed to identify patterns of cannabis use with the strongest effect on odds of psychotic disorder across Europe and explore whether differences in such patterns contribute to variations in the incidence rates of psychotic disorder.

Methods

We included patients aged 18–64 years who presented to psychiatric services in 11 sites across Europe and Brazil with first-episode psychosis and recruited controls representative of the local populations.  We applied adjusted logistic regression models to the data to estimate which patterns of cannabis use carried the highest odds for psychotic disorder.  Using Europe-wide and national data on the expected concentration of Δ9-tetrahydrocannabinol (THC) in the different types of cannabis available across the sites, we divided the types of cannabis used by participants into two categories: low potency (THC <10%) and high potency (THC ≥10%). Assuming causality, we calculated the population attributable fractions (PAFs) for the patterns of cannabis use associated with the highest odds of psychosis and the correlation between such patterns and the incidence rates for psychotic disorder across the study sites.

Findings

Between May 1, 2010, and April 1, 2015, we obtained data from 901 patients with first-episode psychosis across 11 sites and 1237 population controls from those same sites.  Daily cannabis use was associated with increased odds of psychotic disorder compared with never users (adjusted odds ratio [OR] 3·2, 95% CI 2·2–4·1), increasing to nearly five-times increased odds for daily use of high-potency types of cannabis (4·8, 2·5–6·3).  The PAFs calculated indicated that if high-potency cannabis were no longer available, 12·2% (95% CI 3·0–16·1) of cases of first-episode psychosis could be prevented across the 11 sites, rising to 30·3% (15·2–40·0) in London and 50·3% (27·4–66·0) in Amsterdam.  The adjusted incident rates for psychotic disorder were positively correlated with the prevalence in controls across the 11 sites of use of high-potency cannabis (r = 0·7; p=0·0286) and daily use (r = 0·8; p=0·0109).

Interpretation

Differences in frequency of daily cannabis use and in use of high-potency cannabis contributed to the striking variation in the incidence of psychotic disorder across the 11 studied sites. Given the increasing availability of high-potency cannabis, this has important implications for public health.

March 19, 2019 in Medical community perspectives, Recreational Marijuana Data and Research | Permalink | Comments (0)

Tuesday, February 26, 2019

Two interesting new articles about the early operation of Ohio's medical marijuana program

OHIO-HERBAL-CLINIC-DOCTORS-OFFICE-OHIO-MEDICAL-MARIJUANA-CARD--300x300Two Ohio papers had two interesting new article about early developments in the operation of Ohio's still-new medical marijuana program.  Here are headlines, links and excerpts:

From the Akron Beacon Journal, "Ohio medical marijuana recommendations coming from clinics, not family doctors"

If you know someone who has received a recommendation to use medical marijuana, odds are the recommendation didn’t come from a family doctor or primary-care physician. The vast majority of recommendations in Ohio come from clinics that employ doctors solely to evaluate patients for medical marijuana, say people familiar with the industry....

“Marijuana-specific clinics fill a huge need,” said Dr. Joel Simmons, who runs the Ohio Herbal Clinic, a Near East Side cannabis clinic. While the clinics, many of which have out-of-state owners, have some critics, patient advocates say primary-care doctors are the ideal source for marijuana recommendations.

Those doctors better understand a patient’s needs and medical history, said Mary Jane Borden, co-founder of the Ohio Rights Group, which advocates for users of medicinal cannabis. When Ohio lawmakers wrote the state’s medical-marijuana law, they hoped that family physicians would be writing most recommendations, Borden said....

Clinics charge between $125 and $200 for an evaluation, which insurance won’t cover.  Because the clinics don’t negotiate with insurance companies, they clinics can charge whatever they want, said Emilie Ramach, founder and CEO of Compassionate Alternatives, a Columbus-based nonprofit agency that helps patients pay for medicinal cannabis.  Several clinic doctors, including Simmons, said they do their best to keep their prices reasonable.

From the Columbus Dispatch, "High prices keep many Ohioans out of legal cannabis market"

As Ohio’s medical marijuana industry finally takes off, some patients and advocates are griping about costs that put it out of reach for many people.  A steep price tag stems partly from the lack of competition, as Ohio only has seven dispensaries spread throughout the state, mostly in rural areas, experts said.  Costs are expected to drop as more dispensaries open and the industry finds its footing.

In the meantime, patients openly acknowledge buying the drug on the black market while they wait for prices to come down.  And without insurance to cover the expense, some worry that low-income people might never be able to afford medical cannabis....

Several local patients said using marijuana has improved their quality of life, but they must stretch their budgets to pay for it or buy it on the street.  “I’m not using as much as I probably need to be using,” said Mary Alleger, 31, of Reynoldsburg, who said she uses cannabis to treat post-traumatic stress disorder (PTSD) and ongoing pain from a botched medical procedure.

Katherin Cottrill, 33, of Newark, has worked with the patient advocacy organization Ohio Rights Group to acquire a medical marijuana card, but said current costs keep her from even getting started.  “I would have to pay $200 to $250 (just to get a recommendation),” Cottrill said.  “And then I have to drive to a dispensary and pay $50. It’s unreasonable for me to even try.”...

Just under 3 grams of medical marijuana costs about $50. Cannabis clinics charge between $125 and $200, and the state charges $50 in fees.  Marijuana is cheaper on the street, patients said.

“On the black market you can buy an ounce for $200,” said Robert Doyle, 61, of Newark, who has a medical marijuana card but still buys the drug on the street due to the cost.  There are about 28 grams in an ounce.  Doyle said he’s visited dispensaries in Michigan with prices comparable to the black market, making him confident that Ohio’s costs will eventually fall....

But even if prices drop, clinic costs and fees will remain a barrier for some, Cottrill said.  “What about low-income people who are desperately seeking medication?” she said. “They can’t even afford to pay $50 to get their card registered.”

February 26, 2019 in Business laws and regulatory issues, Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research, Medical Marijuana State Laws and Reforms, Who decides | Permalink | Comments (1)

Wednesday, February 13, 2019

"Association of Cannabis Use in Adolescence and Risk of Depression, Anxiety, and Suicidality in Young Adulthood: A Systematic Review and Meta-analysis"

Download (24)The title of this post is the title of this notable new article which just today is published online in JAMA Psychiatry.  Here is its front matter:

Key Points

Question

Is adolescent cannabis consumption associated with risk of depression, anxiety, and suicidality in young adulthood?

Findings

In this systematic review and meta-analysis of 11 studies and 23 317 individuals, adolescent cannabis consumption was associated with increased risk of developing depression and suicidal behavior later in life, even in the absence of a premorbid condition. There was no association with anxiety.

Meaning

Preadolescents and adolescents should avoid using cannabis as use is associated with a significant increased risk of developing depression or suicidality in young adulthood; these findings should inform public health policy and governments to apply preventive strategies to reduce the use of cannabis among youth.

Abstract

Importance

Cannabis is the most commonly used drug of abuse by adolescents in the world. While the impact of adolescent cannabis use on the development of psychosis has been investigated in depth, little is known about the impact of cannabis use on mood and suicidality in young adulthood.

Objective

To provide a summary estimate of the extent to which cannabis use during adolescence is associated with the risk of developing subsequent major depression, anxiety, and suicidal behavior.

Data Sources

Medline, Embase, CINAHL, PsycInfo, and Proquest Dissertations and Theses were searched from inception to January 2017.

Study Selection

Longitudinal and prospective studies, assessing cannabis use in adolescents younger than 18 years (at least 1 assessment point) and then ascertaining development of depression in young adulthood (age 18 to 32 years) were selected, and odds ratios (OR) adjusted for the presence of baseline depression and/or anxiety and/or suicidality were extracted.

Data Extraction and Synthesis

Study quality was assessed using the Research Triangle Institute item bank on risk of bias and precision of observational studies. Two reviewers conducted all review stages independently. Selected data were pooled using random-effects meta-analysis.

Main Outcomes and Measures

The studies assessing cannabis use and depression at different points from adolescence to young adulthood and reporting the corresponding OR were included. In the studies selected, depression was diagnosed according to the third or fourth editions of Diagnostic and Statistical Manual of Mental Disorders or by using scales with predetermined cutoff points.

Results

After screening 3142 articles, 269 articles were selected for full-text review, 35 were selected for further review, and 11 studies comprising 23 317 individuals were included in the quantitative analysis. The OR of developing depression for cannabis users in young adulthood compared with nonusers was 1.37 (95% CI, 1.16-1.62; I2 = 0%). The pooled OR for anxiety was not statistically significant: 1.18 (95% CI, 0.84-1.67; I2 = 42%). The pooled OR for suicidal ideation was 1.50 (95% CI, 1.11-2.03; I2 = 0%), and for suicidal attempt was 3.46 (95% CI, 1.53-7.84, I2 = 61.3%).

Conclusions and Relevance

Although individual-level risk remains moderate to low and results from this study should be confirmed in future adequately powered prospective studies, the high prevalence of adolescents consuming cannabis generates a large number of young people who could develop depression and suicidality attributable to cannabis. This is an important public health problem and concern, which should be properly addressed by health care policy.

February 13, 2019 in Medical community perspectives, Recreational Marijuana Data and Research | Permalink | Comments (5)

Monday, February 4, 2019

"Should Physicians Recommend Replacing Opioids With Cannabis?"

Download (3)The title of this post is the title of this short new "Viewpoint" piece authored by Keith Humphreys and Richard Saitz and published in the Journal of the American Medical Association.  I recommend the full piece, and here are excerpts:

Recent state regulations (eg, in New York, Illinois) allow medical cannabis as a substitute for opioids for chronic pain and for addiction.  Yet the evidence regarding safety, efficacy, and comparative effectiveness is at best equivocal for the former recommendation and strongly suggests the latter — substituting cannabis for opioid addiction treatments is potentially harmful.  Neither recommendation meets the standards of rigor desirable for medical treatment decisions.

Recent systematic reviews identified low-strength evidence that plant-based cannabis preparations alleviate neuropathic pain and insufficient evidence for other types of pain.  Studies tend to be of low methodological quality, involve small samples and short-follow-up periods, and do not address the most common causes of pain (eg, back pain).  This description of evidence for efficacy of cannabis for chronic pain is similar to how efficacy studies of opioids for chronic pain have been described (except that the volume of evidence is greater for opioids with 96 trials identified in a recent systematic review).

The evidence that cannabis is an efficacious treatment for opioid use disorder is even weaker.  To date, no prospective evidence, either from clinical trials or observational studies, has demonstrated any benefit of treating patients who have opioid addiction with cannabis.

Substituting cannabis for opioids is not the same as initiating opioid therapy.  There are no randomized clinical trials of substituting cannabis for opioids in patients taking or misusing opioids for treatment of pain, or in patients with opioid addiction treated with methadone or buprenorphine.  In addition to surveys of patients who use medical cannabis, the other types of studies prompting a move to cannabis to replace opioids are population-level reports stating that laws allowing medical cannabis use are followed by fewer opioid overdose deaths than expected.  The methodological concern with such studies is that correlation is not causation.  Many factors other than cannabis use may affect opioid overdose deaths, such as prescribing guidelines, opioid rescheduling, Good Samaritan laws, incarceration practices, and availability of evidence-based opioid use disorder treatment and naloxone....

For opioid use disorder, there is concern that the New York State Health Commissioner has defined opioid addiction to include people being treated with US Food and Drug Administration – approved, efficacious, opioid agonist medications, as a qualifying condition for medical cannabis.  Methadone and buprenorphine treatment reduces illicit opioid use, blood-borne disease transmission, criminal activity, adverse birth outcomes, and mortality.  Discontinuing such medications increases the risk of return to illicit opioid use, overdose, and death.  The suggestion that patients should self-substitute a drug (ie, cannabis) that has not been subjected to a single clinical trial for opioid addiction is irresponsible and should be reconsidered....

Cannabis and cannabis-derived medications merit further research, and such scientific work will likely yield useful results.  This does not mean that medical cannabis recommendations should be made without the evidence base demanded for other treatments. Evidence-based therapies are available.  For chronic pain, there are numerous alternatives to opioids aside from cannabis.  Nonopioid medications appear to have similar efficacy, and behavioral, voluntary, slow-tapering interventions can improve function and well-being while reducing pain.

For the opioid addiction crisis, clearly efficacious medications such as methadone and buprenorphine are underprescribed.  Without convincing evidence of efficacy of cannabis for this indication, it would be irresponsible for medicine to exacerbate this problem by encouraging patients with opioid addiction to stop taking these medications and to rely instead on unproven cannabis treatment.

February 4, 2019 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana State Laws and Reforms, Who decides | Permalink | Comments (0)

Sunday, January 20, 2019

"If Weed Is Medicine, So Is Budweiser: Legalize marijuana, but don’t pretend it’s therapeutic."

Bach-peter_1The title of this post is the headline of this provocative Wall Street Journal commentary authored by Peter Bach, "a pulmonary physician at Memorial Sloan Kettering Cancer Center in New York [who] directs the Center for Health Policy and Outcomes."  Here are excerpts:

Ten states and the District of Columbia have legalized recreational marijuana use, and another eight look likely to do so in 2019.  I favor the move but am troubled by the gateway to it: All these jurisdictions first passed laws permitting the use of “medical” marijuana.  We should set the record straight, lest young people (and old ones) think marijuana is good for you because it is wrongly labeled a medication.

Actual medicines have research behind them, enumerating their benefits, characterizing their harms, and ensuring the former supersedes the latter.  Marijuana doesn’t.  It’s a toxin, not a medicine.  It impairs judgment and driving ability.  It increases the risk of psychosis and schizophrenia.  Smoking it damages the respiratory tract.  A 2017 report from the National Academy of Medicine called the evidence for these harms “substantial.”

Claims that marijuana relieves pain may be true.  But the clinical studies that have been done compare it with a placebo, not even a pain reliever like ibuprofen.  That’s not the type of rigorous evaluation we pursue for medications.  What’s more, every intoxicant would pass that sort of test because you don’t experience pain as acutely when you are high.  If weed is a pain reliever, so is Budweiser.

Some advocates say marijuana is better than opiates for pain.  Yet while opiates have risks, there are no studies comparing them to marijuana, and untested claims in medicine don’t get the benefit of the doubt.  Testing such a hypothesis often disproves it.

Decades ago, several studies suggested that marijuana might relieve nausea in chemotherapy patients.  But again most compared it with a placebo, while a few compared it with older nausea treatments not used today. None were very convincing. More important, no study has compared marijuana to today’s Neurokinin-1 antagonists. While such treatments are sometimes ineffective, that shortcoming doesn’t impart efficacy on marijuana either.

In writing medical-marijuana laws, state lawmakers and initiative authors have gone well beyond pain and nausea control, lauding the plant as an effective treatment for a long list of conditions, including hepatitis, Alzheimer’s and Parkinson’s.  Beyond the lack of data, what these conditions have in common isn’t biology, but modern medicine’s failure to treat them satisfactorily.  Heartbreaking as that is, marijuana isn’t the answer....

Marijuana belongs in the same category as alcohol and tobacco — harmful products that adults can choose to enjoy....  Decades passed before we took on smoking and drinking with education, labeling and other forms of regulation.  But it worked, and deaths from lung cancer, heart disease and alcohol-associated accidents are in sharp decline. We need this same approach with marijuana.  Acknowledging that it is not a medicine is a necessary first step.

I think it valuable and important to highlight ways in which many of the forms of the plant cannabis, at least right now, is not comparable to the kinds of medicines we access at a drug store.  But it is also important to highlight ways in which medical marijuana laws do not treat marijuana as comparable to other medicines. For starters, public and private health insurance systems general do not help cover the cost of marijuana used medicinally and there are all sorts of distinctive limits on the whos and hows of medical marijuana access.  In many ways, all modern medical marijuana laws are still just elaborate variations on the original law created by California in 1996, which simply created a limited exception to marijuana prohibition for those eager to try marijuana for various therapeutic purposes. Had marijuana never been criminalized, there would have been no need to seek exceptions from prohibition for medical uses (and, it bear recalling, there was much discussion and special laws around alcohol access for medical use during the Prohibition era).

January 20, 2019 in History of Alcohol Prohibition and Temperance Movements, History of Marijuana Laws in the United States, Medical community perspectives, Medical Marijuana Commentary and Debate, Who decides | Permalink | Comments (2)

Sunday, January 13, 2019

Maryland Medical Cannabis Commission report explores treatment of opioid use disorder by using medical cannabis

MJIN_Maryland-MMJ-Logo-Web-500x281The debate over the relationship between the opioid crisis and marijuana reforms is so very interesting and, of course, so very important.  Advocates for and against marijuana reform seem ever eager to leverage the opioid crisis (and everything else) to support their prior conclusions about the virtues or vices of marijuana reform.  Against this backdrop, I think  information from non-partisans is especially valuable, and thus I was pleased to see this notable new report from the Maryland Medical Cannabis Commission titled "Treatment of Opioid Use Disorder with Medical Cannabis."  I recommend the full report, which mostly just reports on the state of the law in many jurisdictions and research on these topics.  Here are excerpts:

Since 2016, at least nine states have considered legislation or regulations to allow medical cannabis as an opioid replacement therapy to help ease withdrawal symptoms and aid in relapse prevention....  In 2018, Pennsylvania, New Jersey, and New York became the first states to expressly allow medical cannabis for the treatment of OUD. Each state permits the use of medical cannabis to treat OUD, but with significant restrictions....

From 2016-2018, at least seven state legislatures considered bills that would expressly add OUD to the list of medical cannabis qualifying conditions.  Of these, the majority rejected the legislation seeking to add OUD to the list of qualifying conditions.  [T]hree states – Hawaii, Maine, and New Mexico – passed legislation authorizing the use of medical cannabis to treat OUD; however, the State’s Governor vetoed the legislation in each instance following significant pressure from health care providers, health care organizations, and addiction specialists....

Data suggest that cannabis legalization reduces prescription opioid use by serving as an alternative pain treatment. Medical cannabis laws may also have downstream policy effects on reducing opioid-related hospitalizations, overdose deaths, and traffic fatalities. The following section examines existing literature on the association between medical cannabis and opioid use, including as a treatment for opioid use disorder....

[But] a study was published in the “To the Editor” section of JAMA Internal Medicine in September 2018, which found that the opioid-related overdose death rate was accelerating in states where medical and/or adult use cannabis laws had been implemented. Moreover, the death rate surpassed that of nonlegalizing states. The study reviewed opioid-related overdose death data from 2010 to 2016, and determined that the age-adjusted death rate was higher in states with cannabis legalization and that the age-adjusted death rate was increasing at a faster rate than in non-legalizing states. While several researchers have challenged the methodology of this study – including the inaccurate assessment of states that have legalized medical and adultuse cannabis – the results call attention to the need for further investigation of the association between cannabis legalization and opioid-related overdose deaths....

In December 2018, the Commission received two petitions requesting the addition of OUD to the list of medical cannabis qualifying conditions. If the Commission determines that either or both of these petitions are “facially substantial” then it must conduct a public hearing within the next 12 months to evaluate whether the medical condition or disease should be included in the list of qualifying conditions.  The Commission’s Research Committee, which includes two physicians, a scientist, addiction specialist, and horticulturist, is currently evaluating the petitions to determine whether they are facially substantial and require a public hearing. The Commission will provide the General Assembly with updates on the status of the OUD petitions, including information on any public hearings to consider adding OUD as a qualifying medical condition.

January 13, 2019 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research, Medical Marijuana State Laws and Reforms, Who decides | Permalink | Comments (0)

Saturday, January 12, 2019

"Marijuana needs warning labels like tobacco for associated mental, physical health risks"

Download (3)The title of this post is the headline of this recent commentary in USA Today authored by DJ Jaffe, who is the executive director of Mental Illness Policy Org.  Here is an excerpt:

Before legislators legalize marijuana, they should require bold and direct warning labels to be placed on the packaging as is done with tobacco products. If the states fail to act, then the Food and Drug Administration should step in and require it.

In early 2017, after exhaustive review, the National Academies of Sciences, Engineering, and Medicine found that there are significant health risks associated with using cannabis and cannabinoids. Yet none of the 33 states that have legalized medical marijuana, or the 10 states that have legalized recreational use, gives adequate warnings of those risks.

The situation is similar to when cigarettes first became extensively marketed. The health risks were known but not disclosed, leading to disease and lives being lost. In addition to appearing on the packaging, the warning labels should be displayed prominently wherever the product is sold, in advertising and in mandated public service announcements funded by the marijuana industry.

The academies, founded by Congress, comprise the country’s leading researchers. They have become the nation’s most reputable arbiters of the science that should guide policy. The findings of the report, "The Health Effects of Cannabis and Cannabinoids," were particularly disturbing for people prone to mental illness and those who have a mental illness.

The report found either substantial or moderate evidence of an association between cannabis use and the development of schizophrenia or other psychoses; increased symptoms of mania and hypomania in individuals diagnosed with bipolar disorders; increased risk for the development of depressive disorders; and increased incidence of suicidal ideation, attempts and completions.

Schizophrenia and bipolar disorders are two of the most devastating neurobiological disorders and the ones that are often associated with homelessness and incarceration. If there is an association with using legalized marijuana, shouldn’t the public be warned?...

Washington and Colorado were the first states to legalize recreational marijuana. While both warn pregnant mothers not to use it, the only other significant warning on the packaging is that there “may be health risks,” a watered-down mealy mouthed warning that fails to give consumers the concrete information they need to avoid danger.

While the National Academies found "association," association is not the same as causality. Perhaps the increased risk of schizophrenia developing is because those who are prone to schizophrenia also are prone to use these products.

But until we know the chicken-or-egg answer, we should not follow the example of the tobacco regulation where the product was allowed to be marketed unencumbered by warnings, leading to more than 480,000 deaths a year, and subsequently the spending of millions of dollars re-educating consumers who had been misled in the first place.

January 12, 2019 in Business laws and regulatory issues, Medical community perspectives, Recreational Marijuana Commentary and Debate | Permalink | Comments (0)

Tuesday, January 8, 2019

Malcolm Gladwell rightly highlights how much we do not know about marijuana (but still ignores what we know about prohibition)

Gladwell-malcolmMalcolm Gladwell has this new extended essay in The New Yorker asking "Is Marijuana as Safe as We Think?".  The piece is somewhat focused on the forthcoming book by Alex Berenson (whose recent commentaries I have covered here and here), but it is most effective when it highlights that research on the public health consequences of marijuana remains incomplete and inconclusive.  Here is how the piece starts:

A few years ago, the National Academy of Medicine convened a panel of sixteen leading medical experts to analyze the scientific literature on cannabis. The report they prepared, which came out in January of 2017, runs to four hundred and sixty-eight pages. It contains no bombshells or surprises, which perhaps explains why it went largely unnoticed. It simply stated, over and over again, that a drug North Americans have become enthusiastic about remains a mystery.

For example, smoking pot is widely supposed to diminish the nausea associated with chemotherapy. But, the panel pointed out, “there are no good-quality randomized trials investigating this option.” We have evidence for marijuana as a treatment for pain, but “very little is known about the efficacy, dose, routes of administration, or side effects of commonly used and commercially available cannabis products in the United States.” The caveats continue. Is it good for epilepsy? “Insufficient evidence.” Tourette’s syndrome? Limited evidence. A.L.S., Huntington’s, and Parkinson’s? Insufficient evidence. Irritable-bowel syndrome? Insufficient evidence. Dementia and glaucoma? Probably not. Anxiety? Maybe. Depression? Probably not.

Then come Chapters 5 through 13, the heart of the report, which concern marijuana’s potential risks. The haze of uncertainty continues. Does the use of cannabis increase the likelihood of fatal car accidents? Yes. By how much? Unclear. Does it affect motivation and cognition? Hard to say, but probably. Does it affect employment prospects? Probably. Will it impair academic achievement? Limited evidence. This goes on for pages.

We need proper studies, the panel concluded, on the health effects of cannabis on children and teen-agers and pregnant women and breast-feeding mothers and “older populations” and “heavy cannabis users”; in other words, on everyone except the college student who smokes a joint once a month.

Gladwell later provides some context for how we should approach modern marijuana reform in light of all this uncertainty:

Drug policy is always clearest at the fringes. Illegal opioids are at one end.  They are dangerous.  Manufacturers and distributors belong in prison, and users belong in drug-treatment programs.  The cannabis industry would have us believe that its product, like coffee, belongs at the other end of the continuum. “Flow Kana partners with independent multi-generational farmers who cultivate under full sun, sustainably, and in small batches,” the promotional literature for one California cannabis brand reads.  “Using only organic methods, these stewards of the land have spent their lives balancing a unique and harmonious relationship between the farm, the genetics and the terroir.”   But cannabis is not coffee.  It’s somewhere in the middle.   The experience of most users is relatively benign and predictable; the experience of a few, at the margins, is not.  Products or behaviors that have that kind of muddled risk profile are confusing, because it is very difficult for those in the benign middle to appreciate the experiences of those at the statistical tails. Low-frequency risks also take longer and are far harder to quantify, and the lesson of “Tell Your Children” and the National Academy report is that we aren’t yet in a position to do so.  For the moment, cannabis probably belongs in the category of substances that society permits but simultaneously discourages.  Cigarettes are heavily taxed, and smoking is prohibited in most workplaces and public spaces.  Alcohol can’t be sold without a license and is kept out of the hands of children.  Prescription drugs have rules about dosages, labels that describe their risks, and policies that govern their availability. The advice that seasoned potheads sometimes give new users — “start low and go slow” — is probably good advice for society as a whole, at least until we better understand what we are dealing with.

I am not inclined to dispute much of what Gladwell has to say in this piece especially when he stresses uncertainty, but I am again eager to highlight what he ignores about the certain harms of prohibition. Notably, we still send a whole lot of drug users to prison rather than to treatment programs because of the "drug war" approach to criminalizing drug prohibitions, and we still arrest a whole lot of marijuana users. Moreover and even more importantly, the certain harms of marijuana prohibition are borne disproportionately by people of color and the poor.

I am supportive of a "start low and go slow” approach to the commercialization of marijuana based on all the uncertainty that Gladwell is eager to stress. But given the certain harms of prohibition and who is disproportionately subject to them, I do not think we can end the criminalization of marijuana soon enough.

January 8, 2019 in Medical community perspectives, Recreational Marijuana Commentary and Debate, Recreational Marijuana Data and Research, Who decides | Permalink | Comments (0)

Tuesday, January 1, 2019

Two deep dives into health research and social justice in modern age of marijuana reform

NBC News has two new lengthy articles exploring the state of marijuana research and debate over social justice in this era of marijuana reform.   Both pieces are worthwhile reads, and here are links to the pieces with extended headlines and a brief excerpt:

"The year in pot: States embrace legalization, but questions persist; Marijuana, the most widely used illegal drug in the U.S., is winning approval state by state and impressing investors. But researchers still caution against its use."

The wave of legalization is taking place as the latest polls show that nearly two-thirds of Americans endorse it, double the rate in 2000. Investors are noticing too, pouring an estimated $10 billion into the industry in North America this year.

Still, medical researchers continue to caution against its use because little is known about its effects on health. Here is a review of what we’ve learned about marijuana and marijuana-based products in 2018.

"Legal marijuana made big promises on racial equity — and fell short; 'Time is really up on selling your business dream as a social justice movement,' said the president of the Minority Cannabis Business Association."

While marijuana arrests have declined and tax revenue has begun to flow in most states that have legalized pot, the gains have accrued most heavily to white residents, even though black Americans paid the drug war’s biggest costs, according to a statistical analysis conducted by the Drug Policy Alliance, a nonprofit group that advocates drug policy reform.

The results in Colorado, the District of Columbia and the nine other states where recreational marijuana became legal from 2012 to 2018 have left some lawmakers and even marijuana legalization advocates skeptical of broad social-justice claims. For that reason, lawmakers in New Jersey and New York — two of the three states expected to legalize marijuana in 2019 — are now pushing for detailed criminal justice and business equity measures as part of any legalization package....

The efforts in New Jersey and New York come as the inequities in other states have grown clearer. In Colorado, the Drug Policy Alliance found, the number of black juveniles arrested on marijuana charges grew after legalization. In 2016, a Colorado Department of Public Safety analysis found that black people living in that state remained three times more likely than white people to be arrested for selling or possessing marijuana. In Washington state, an ACLU analysis found that in 2014, the first year in which marijuana became available in legal retail stores, a black adult remained three times more likely to face low-level marijuana charges than a white adult.

January 1, 2019 in Criminal justice developments and reforms, Medical community perspectives, Medical Marijuana Commentary and Debate, Race, Gender and Class Issues, Recreational Marijuana Commentary and Debate | Permalink | Comments (0)