Marijuana Law, Policy & Reform

Editor: Douglas A. Berman
Moritz College of Law

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)

Friday, December 28, 2018

"Alcohol Use and Risk of Related Problems Among Cannabis Users Is Lower Among Those With Medical Cannabis Recommendations, Though Not Due To Health"

DownloadThe title of this post is the headline of this encouraging article recently published in the Journal of Studies on Alcohol and Drugs authored by Meenakshi Subbaraman and William Kerr.  Here is its abstract:

Objective:

A small body of work has started developing cannabis use “typologies” for use in treatment and prevention. Two potentially relevant dimensions for classifying cannabis use typologies are medical versus recreational cannabis use and the co-use of cannabis and alcohol. Here we compare alcohol use and related problems between cannabis users with and without medical cannabis recommendations.

Method:

Data come from a larger general population study in Washington State conducted between January 2014 and October 2016.  All participants in the analytic sample (n = 991) reported using both alcohol and cannabis in the past 12 months.  The primary exposure was having a medical recommendation for cannabis.  Outcomes were past-30-day drinking (drinks/day, frequency of 5+ drinks, and maximum number of drinks in a day) and past-12-month Alcohol Use Disorders Identification Test (AUDIT) scores.

Results:

Compared with those without medical cannabis recommendations, cannabis users with medical cannabis recommendations had 0.59 times fewer drinks/day, 0.44 times fewer occasions drinking 5+, and 0.78 times the average maximum number of drinks in one day (all ps < .05).  Those with a recommendation also had 0.87 times lower AUDIT total scores (p < .05) and 0.57 times lower AUDIT problem scores (p < .01).

Conclusions:

Cannabis users with medical cannabis recommendations drink less and have fewer alcohol-related problems than those without recommendations, even after adjusting for health status. Future studies should examine non-health reasons regarding how medical and non-medical users use cannabis differently.

December 28, 2018 in Medical community perspectives, Medical Marijuana Data and Research | Permalink | Comments (0)

Tuesday, July 3, 2018

Big new Australian study throws cold water on marijuana as an effective pain reliever

Download (18)The huge 2017 National Academies of Sciences report titled "The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research" came to this encouraging conclusion in Chapter 4 of the report concerning the medicinal potential of marijuana: "There is substantial evidence that cannabis is an effective treatment for chronic pain in adults."

A big new study out of Australia, however, now throws some cold water on anyone getting to hot about marijuana's potential as an effective pain reliever. This Business Insider Australia article reports on the study under the headline "A 4-year Australian study of 1500 people finds no evidence that cannabis helps to treat pain." Here are excerpts:

A long term study by the University of NSW — one of the world’s longest in-depth community studies on pharmaceutical opioids and non-cancer pain — has found little evidence to support the use of cannabis in the treatment of chronic pain.

The four-year study of more than 1,500 Australians prescribed opioids for non-cancer pain suggest that there is a need for caution in using medicinal cannabis. Those in the study who used cannabis, and there were many among those with chronic non-cancer pain who had been prescribed opioids, actually had greater pain, anxiety and were coping less....

“Chronic non-cancer pain is a complex problem,” says Dr Gabrielle Campbell at the University of NSW, the lead author in the latest study. “For most people, there is unlikely to be a single effective treatment. In our study of people living with chronic non-cancer pain who were prescribed pharmaceutical opioids, despite reporting perceived benefits from cannabis use, we found no strong evidence that cannabis use reduced participants’ pain or opioid use over time.”

The Pain and Opioids IN Treatment (POINT) study, published today in the journal Lancet Public Health, looked at the effect of cannabis on pain, on the extent to which this interfered with everyday life, and on prescribed opioid use.

In the study, funded by the National Health and Medical Research Council and led by the National Drug and Alcohol Research Centre at UNSW Sydney, participants were recruited through community pharmacies and completed comprehensive assessments of their pain, physical and mental health, medication and cannabis.

Participants had been in pain for a median of 10 years and taken prescribed opioids for for four years. There were very high rates of physical and mental health problems. At each assessment, participants who were using cannabis reported greater pain and anxiety, were coping less well with their pain, and reported that pain was interfering more in their life, compared to those not using cannabis.

There was no clear evidence that cannabis led to reduced pain severity or pain interference or led participants to reduce their opioid use or dose. However, the users thought otherwise. Those who used cannabis, despite the study finding no evidence, reported that cannabis was effective (mean score of 7 out of 10). One possibility is that cannabis improves sleep, which in turn improves well-being, say the researchers.

The researchers say double-blind randomised placebo-controlled clinical trials are needed to better understand the impact of cannabis.

The full study being reported on is titled "Effect of cannabis use in people with chronic non-cancer pain prescribed opioids: findings from a 4-year prospective cohort study," and it is available at this link.  Reading the abstract makes clearer that this study was entirely observational in that participants were acquiring and using marijuana on their own and reporting that use rather than being giving marijuana in a controlled setting.

Among other reactions, this new study reinforces my sense that we need a lot more studies to really get a handle on the possible value of marijuana to help address the "complex problem" of chronic pain.  I am also struck by the line I emphasized above that indicate that a significant majority of marijuana users in the study believed that they were helped by marijuana when the evidence suggested otherwise.  A real interesting philosophical issue arises, for the medical profession and for governments, if it turns out that marijuana does not really help many chronic pain problems, but many users think that it does and are eager to have access to the drug because others report that it provides them relief.

July 3, 2018 in Medical community perspectives, Medical Marijuana Data and Research | Permalink | Comments (0)

Tuesday, June 26, 2018

SCOTUS provides a good new First Amendment precedent for doctors interested in recommending marijuana

Supreme-court-marijuanaThe modern state medical marijuana laws owe part of their structure to critical lower federal court rulings about the First Amendment's protection of doctors who wish to discuss marijuana use with patients.  In the late 1990s after California voters passed the nation's first medical marijuana law, the federal government threatened physicians who recommended or prescribed a Schedule I drug with possible revocation of DEA registration and exclusion from Medicare and Medicaid reimbursements.   But this threat was thwarted through litigation which culminated in a ruling by the U.S. Court of Appeals for the Ninth Circuit holding that physicians’ First Amendment freedom of speech rights under the privileged doctor-patient relationship permitted them to issue medical marijuana recommendations.  The Ninth Circuit's ruling in Conant v. Walters, 309 F.3d 629 (9th Cir. 2002), has provided a key foundation for modern medical marijuana regimes, but the firmness of that foundation could be questioned because the US Supreme Court has never addressed this issue directly.

As of this morning, the Supreme Court still has not addressed this issue directly, but it has now ruled in National Institute of Family and Life Advocates v. Becerra, available here, that the First Amendment limits what states can tell doctors and other health professional to say or not say.  Here is part of a fascinating passage (which even mentions medical marijuana, with my emphasis added) extolling the importance of broad constitutional protections in this realm:

As with other kinds of speech, regulating the content of professionals’ speech “pose[s] the inherent risk that the Government seeks not to advance a legitimate regulatory goal, but to suppress unpopular ideas or information.” Turner Broadcasting, 512 U. S., at 641.  Take medicine, for example. “Doctors help patients make deeply personal decisions, and their candor is crucial.” Wollschlaeger v. Governor of Florida, 848 F.3d 1293, 1328 (CA11 2017) (en banc) (W. Pryor, J. concurring).  Throughout history, governments have “manipulat[ed] the content of doctor-patient discourse” to increase state power and suppress minorities:

“For example, during the Cultural Revolution, Chinese physicians were dispatched to the countryside to convince peasants to use contraception. In the 1930s, the Soviet government expedited completion of a construction project on the Siberian railroad by ordering doctors to both reject requests for medical leave from work and conceal this government order from their patients.  In Nazi Germany, the Third Reich systematically violated the separation between state ideology and medical discourse. German physicians were taught that they owed a higher duty to the ‘health of the Volk’ than to the health of individual patients.  Recently, Nicolae Ceausescu’s strategy to increase the Romanian birth rate included prohibitions against giving advice to patients about the use of birth control devices and disseminating information about the use of condoms as a means of preventing the transmission of AIDS.” Berg, Toward a First Amendment Theory of Doctor-Patient Discourse and the Right To Receive Unbiased Medical Advice, 74 B. U. L. Rev. 201, 201– 202 (1994) (footnotes omitted).

Further, when the government polices the content of professional speech, it can fail to “‘preserve an uninhibited marketplace of ideas in which truth will ultimately prevail.’” McCullen v. Coakley, 573 U. S. ___, ___–___ (2014) (slip op., at 8–9).  Professionals might have a host of good-faith disagreements, both with each other and with the government, on many topics in their respective fields.  Doctors and nurses might disagree about the ethics of assisted suicide or the benefits of medical marijuana; lawyers and marriage counselors might disagree about the prudence of prenuptial agreements or the wisdom of divorce; bankers and accountants might disagree about the amount of money that should be devoted to savings or the benefits of tax reform.  “[T]he best test of truth is the power of the thought to get itself accepted in the competition of the market,” Abrams v. United States, 250 U. S. 616, 630 (1919) (Holmes, J., dissenting), and the people lose when the government is the one deciding which ideas should prevail.

Given the modern politics of marijuana reform, I was not that worried that the Ninth Circuit's work in Conant v. Walters would be undermined anytime soon. But it would not be too hard to imagine Attorney General Jeff Sessions or other state or federal officials resistant to marijuana reform trying to heavily regulate how medical professionals can talk to patients about marijuana. This new SCOTUS precedent would seem to limit such efforts.

June 26, 2018 in Court Rulings, History of Marijuana Laws in the United States, Medical community perspectives, Medical Marijuana Commentary and Debate, Who decides | Permalink | Comments (0)

Monday, June 25, 2018

Formal FDA approval for Epidiolex means some part of the federal government finds some part of cannabis plant has "accepted medical use"

Download (1)This new CNN piece, headlined "FDA approves first cannabis-based drug," reports on the big news from the federal government concerning a very specific form of medical marijuana. Here are the details:

The US Food and Drug Administration approved a cannabis-based drug for the first time, the agency said Monday. Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision.

The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begin in early childhood, usually between 3 and 5.

"This is an important medical advance," FDA Commissioner Dr. Scott Gottlieb said in a statement Monday. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery."

The drug is the "first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs," according to a statement Monday from GW Pharmaceuticals, the UK-based biopharmaceutical company that makes Epidiolex....

The FDA has approved synthetic versions of some cannabinoid chemicals found in the marijuana plant for other purposes, including cancer pain relief. Justin Gover, chief executive officer of GW Pharmaceuticals, described the approval in the statement as "a historic milestone." He added that the drug offers families "the first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies."

"These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care," Gover said. Epidiolex will become available in the fall, Gover told CNN.  He would not give any information on cost, saying only that it will be discussed with insurance companies and announced later....

It's an option for those patients who have not responded to other treatments to control seizures.  According to the Epilepsy Foundation, up to one-third of Americans who have epilepsy have found no therapies that will control their seizures. Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well." She has not used Epidiolex in her own clinical practice and was not involved in the development of the drug but said she's not sure it will live up to "all of the hype" that has surrounded it....

As part of the FDA's review of the medication, the potential for abuse was assessed and found to be low to negative, according to Gover. Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use. Gover said the approval signals "validation of the science of cannabinoid medication."

As the title of this post highlights, this news serves as still further proof of the misguided placement of marijuana as a Schedule I drug under the Controlled Substances Act defined as having "no currently accepted medical use in treatment in the United States." But, it should also be realize that this news serves as proof that the federal government, even without any reform to the CSA, can and will approve a cannabis-based medicine which has been "thoroughly studied in clinical trials [and] manufactured to assure quality and consistency."  Thus, the catch-22 comes from the fact that marijuana's placement on Schedule I precludes US-based companies from doing the types of clinical trials that the FDA demands.  (If we had a well-functioning federal government, marijuana surely would have been at least re-scheduled to Schedule II or III under the CSA many years ago.  But I digress....)

June 25, 2018 in Business laws and regulatory issues, Federal Marijuana Laws, Policies and Practices, History of Marijuana Laws in the United States, Medical community perspectives, Medical Marijuana Commentary and Debate, Who decides | Permalink | Comments (0)

Monday, June 4, 2018

Medical marijuana news nationwide, in states large and small, developing and debated

There are so many interesting developments, some small and some big, in medical marijuana states that I cannot come close to keeping track of it all.  Having seen a lot of notable stories in a lot of states in recent days, I figured it might be time to do a round-up of stories that caught my eye.  So, though this is not in any sense comprehensive, here goes in alphabetical order:

From Arkansas here, "Arkansas Supreme Court to hear dispute over medical marijuana rollout"

From Connecticut here, "With booming medical marijuana program, some fear shortages"

From Georgia here, "Georgia couple loses custody of son after giving him marijuana to treat seizures"

From Florida here, "As marijuana dispensaries open their doors, Florida registers 5,400 new users per week"

From Maryland here, "Overwhelmed computer system stalls medical marijuana sales over weekend in Maryland

From Ohio here, "Ohio announces 56 sites where medical marijuana will be sold"

From Oklahoma here, "Oklahoma's medical marijuana law would be unique"

From Utah here, "Unofficially, many Utah law enforcement groups are lining up to oppose the medical marijuana initiative"

June 4, 2018 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research, Medical Marijuana State Laws and Reforms | Permalink | Comments (1)

Sunday, May 27, 2018

"Could medical marijuana help fight opioid abuse? It’s complicated"

MarijuanavopioidsThe title of this post is the thoughtful headline of this article from Illinois thoughtfully discussing the issues surrounding the relationship between opioid use and marijuana access.  Here are excerpts:

Tom Utley says medical marijuana allowed him to reduce his use of prescription painkillers by 98 percent over the past year and a half. “It has given me control of my life,” said Utley, 42, a Mason County resident whose chronic pain after a car crash 27 years ago used to require him to swallow Vicodin and OxyContin pills four times a day.  Now he takes prescription opioids only a few times each month.

Utley, who works part time running a gymnastics tumbling program, has found relief in marijuana-infused topical lotions and patches, as well as smokable cannabis, from Springfield’s HCI Alternatives dispensary. Unlike prescription opioids, marijuana doesn’t come with the unwanted side-effects of constipation, cravings and cloudy thinking, he said....

Utley is among those who see expanded access to medical marijuana for people in pain as one solution for the nationwide epidemic of addiction to legal opioid painkillers and illegal opioids such as heroin and fentanyl.  There were about 2,000 fatal and 14,000 nonfatal opioid overdoses in Illinois last year. “I think it would be a way-better alternative,” Utley said of medical cannabis....

The Illinois General Assembly is considering a bill that could vastly expand the number of people qualifying for the state’s medical marijuana pilot program.  Senate Bill 336 would allow people who have been or could be prescribed opioids to apply for acceptance into the program.  The science surrounding the therapeutic benefits of marijuana is far from conclusive. But those shades of gray are missing from descriptions of both the benefits of cannabis from supporters of SB 336, and the drawbacks cited by opponents.

“Public policy is light years ahead of the science right now,” said Ziva Cooper, a research scientist who is associate professor of clinical neurobiology in psychiatry at Columbia University in New York. “There seems to be this nationwide experiment on the effects of cannabis that is happening in the absence of rigorous studies.”

SB 336 passed the Illinois Senate on a 44-6 vote April 26.  The bill is expected to receive a vote from the full House by the end of the week....  A spokeswoman for Gov. Bruce Rauner, a Republican, didn’t respond when asked the likelihood that Rauner would sign the bill into law if it reaches his desk.

Supporters of the legislation cite studies that have documented a correlation between a reduction in opioid-related fatalities and opioid prescriptions in states that allow the use of marijuana for medical or recreational purposes.  “The science is generally supportive of the concept,” said state Sen. Don Harmon, D-Oak Park, the bill’s chief Senate sponsor. “People don’t die from cannabis. I don’t feel like we’re doing much harm.”

But those studies, as well as numerous anecdotal reports from patients, don’t necessarily prove that expanding medical marijuana use leads to positive outcomes for the general population, Cooper said.  Results also aren’t conclusive when it comes to the negative implications of cannabis use reported in other legitimate but non-definitive studies, she said.  Those studies, publicized by Springfield-based Illinois Church Action on Alcohol and Addiction Problems, suggest marijuana is associated with an increased risk of prescription opioid misuse and addiction, and actually may contribute to the opioid epidemic....

Cooper said, “There is correlational evidence on both sides of the argument.” ...  The studies do make a compelling argument that more and more-rigorous follow-up studies are needed, she said while declining to comment on SB 336. “It’s just going to take time for us to do the studies that will yield the actual data that support some of these things we’re hearing about in the media,” she said.

Cooper was a member of a committee convened by the National Academies of Sciences, Engineering and Medicine that issued a report in January 2017 on the current state of evidence surrounding the health effects from cannabis and chemicals in cannabis known as cannabinoids.  The report said there is “conclusive” or “substantial” evidence that cannabis or cannabinoids are effective for the treatment of chronic pain in adults. “But there are a couple of caveats,” she said.  For example, she said, the report didn’t say there’s conclusive evidence that cannabis is more effective than opioids in helping patients deal with pain....

Data from the state indicate that 3 million Illinoisans obtained an opioid prescription in 2016, according to Chris Stone, chief executive officer of HCI Alternatives.  Even if just 10 percent of those patients sought temporary access to the state’s medical marijuana program under the provisions of SB 336, up to 300,000 people would join a program currently serving 36,800 people, he said....

Illinois, unlike most states with medical marijuana programs, doesn’t allow a general diagnosis of pain to qualify patients for the program, Cassidy said.  The Illinois Department of Public Health is appealing a Cook County judge’s January ruling ordering the department to add “intractable pain” to the list of qualifying conditions for medical marijuana.

IDPH director Dr. Nirav Shah has said there was a lack of “high-quality data” to justify adding pain to the list of more than 30 conditions, which include cancer, AIDS, spinal cord injury, seizures and fibromyalgia. SB 336 isn’t designed to add pain patients to the program for the rest of their lives. “This is really about folks who are looking at a six-month period of time of needing these medications or a three-month time period — for those folks who are very much at risk of addiction,” Cassidy said.

Some (of many) prior related posts:

May 27, 2018 in Medical community perspectives, Medical Marijuana Commentary and Debate | Permalink | Comments (0)

Monday, April 30, 2018

Lots of new medical marijuana coverage via CNN

Last night CNN aired the fourth installment of Chief Medical Correspondent Dr. Sanjay Gupta's programming about marijuana.  This Special Report was titled "Weed 4: Pot vs. Pills," and CNN has has a number of stories in recent days related to its work in this space.  Here are links to just some of its recent coverage:

April 30, 2018 in History of Marijuana Laws in the United States, Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research | Permalink | Comments (0)

Friday, April 20, 2018

"Does medical marijuana decrease opioid use or boost it?"

The title of this post is the title of this effective new WonkBlog piece by Keith Humphreys, which makes these important points:

Studies conducted at the state level show that expanding access to medical marijuana is correlated with lower rates of opioid misuse and overdose.  Yet studies of individuals show that using medical cannabis is correlated with higher rates of using and misusing opioids.  This set of conflicting research has revealed less about the relationship between marijuana and opioids than it has about how science is misunderstood and misused in political debates....

The math underlying why many such apparent contradictions exist across scientific research areas is complicated, but the underlying point is simple: We can’t know what’s happening to individuals by looking just at state data (or county or city data), and we can’t know what is happening to states just by looking at individuals. Thus there isn’t any logical contradiction between marijuana and opioid use having opposite relationships at the state and individual level.

The other statistical point of relevance here is more widely understood: Just because two things are correlated doesn’t prove there’s a causal relationship between them. However, in this particular domain, people tend to apply that rule only to the subset of studies that conflict with their views on marijuana.  Sometimes this is a conscious decision by people who want to spin the evidence, but more often it reflects unconscious, built-in flaws in human reasoning that make us more prone to attend to and trust evidence that confirms what we already believe or deeply want to believe.  That is, people who hold anti-marijuana views will be more likely to accept the individual correlational studies as proving that medical cannabis is harmful and dismiss the state-level studies as “merely correlational.”  Those with positive views of marijuana will do the reverse.  (If you want to see this phenomenon in action, watch how this article is discussed on Twitter today!)

Being human, scientists also sometimes fall prey to the same problem, being too critical of marijuana studies that don’t accord with their beliefs and not critical enough of those that do.  But at their best, scientists design rigorous studies of important questions and then accept the answers whether they (or anyone else) likes them or not.

Solving the puzzle of whether and how medical cannabis and opioids interact will require laboratory experiments and randomized clinical trials in which researchers can control exposure to both drugs rather than relying on correlational data. In one recent such study, Ziva Cooper of Columbia University found initial evidence that marijuana may modify both the pain-relieving effects and abuse liability of oxycodone.

More studies like Cooper’s are needed and should become more common if Congress is wise enough to loosen restrictions on medical marijuana research. In the meantime, the medical marijuana debate will rage on, with many people on each side citing as authoritative whichever study suits their purposes.

April 20, 2018 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research | Permalink | Comments (0)

Monday, April 2, 2018

Two new papers provide further evidence of marijuana reform aiding with opioid crisis

180402-imd-ec-800As reported via this CNN article, headlined "Marijuana legalization could help offset opioid epidemic, studies find," this weeks bring the publication of notable new research suggesting a link between marijuana access and reduced use of opioids. Here are the basics:

Experts have proposed using medical marijuana to help Americans struggling with opioid addiction. Now, two studies suggest that there is merit to that strategy. The studies, published Monday in the journal JAMA Internal Medicine, compared opioid prescription patterns in states that have enacted medical cannabis laws with those that have not. One of the studies looked at opioid prescriptions covered by Medicare Part D between 2010 and 2015, while the other looked at opioid prescriptions covered by Medicaid between 2011 and 2016.

The researchers found that states that allow the use of cannabis for medical purposes had 2.21 million fewer daily doses of opioids prescribed per year under Medicare Part D, compared with those states without medical cannabis laws. Opioid prescriptions under Medicaid also dropped by 5.88% in states with medical cannabis laws compared with states without such laws, according to the studies....

In order to evaluate whether medical marijuana could function as an effective and safe alternative to opioids, the two teams of researchers looked at whether opioid prescriptions were lower in states that had active medical cannabis laws and whether those states that enacted these laws during the study period saw reductions in opioid prescriptions.

Both teams, in fact, did find that opioid prescriptions were significantly lower in states that had enacted medical cannabis laws. The team that looked at Medicaid patients also found that the four states that switched from medical use only to recreational use -- Alaska, Colorado, Oregon and Washington -- saw further reductions in opioid prescriptions, according to Hefei Wen, assistant professor of health management and policy at the University of Kentucky and a lead author on the Medicaid study. "We saw a 9% or 10% reduction (in opioid prescriptions) in Colorado and Oregon," Wen said. "And in Alaska and Washington, the magnitude was a little bit smaller but still significant."...

The details of the medical cannabis laws were found to have a significant impact on opioid prescription patterns, the researchers found. States that permitted recreational use, for example, saw an additional 6.38% reduction in opioid prescriptions under Medicaid compared with those states that permitted marijuana only for medical use, according to Wen.

The method of procurement also had a significant impact on opioid prescription patterns. States that permitted medical dispensaries -- regulated shops that people can visit to purchase cannabis products -- had 3.742 million fewer opioid prescriptions filled per year under Medicare Part D, while those that allowed only home cultivation had 1.792 million fewer opioid prescriptions per year.

"We found that there was about a 14.5% reduction in any opiate use when dispensaries were turned on -- and that was statistically significant -- and about a 7% reduction in any opiate use when home cultivation only was turned on," Bradford said. "So dispensaries are much more powerful in terms of shifting people away from the use of opiates."...

This is not the first time researchers have found a link between marijuana legalization and decreased opioid use. A 2014 study showed that states with medical cannabis laws had 24.8% fewer opioid overdose deaths between 1999 and 2010. A study in 2017 also found that the legalization of recreational marijuana in Colorado in 2012 reversed the state's upward trend in opioid-related deaths.

Here are links to the JAMA Internal Medicine articles referenced here, as well as a companion commentary:

Medical and Adult-Use Marijuana Laws and Opioid Prescribing for Medicaid Enrollees by Hefei Wen & Jason Hockenberry

Association Between US State Medical Cannabis Laws and Opioid Prescribing in the Medicare Part D Population by Ashley C. Bradford et al

The Role of Cannabis Legalization in the Opioid Crisis by Kevin Hill & Andrew Saxon

 

Some (of many) prior related posts:

April 2, 2018 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research, Medical Marijuana State Laws and Reforms, Recreational Marijuana Data and Research | Permalink | Comments (0)

Wednesday, March 28, 2018

Notable efforts to expand reach and application of New Jersey's medical marijuana program

Nj-mmj-e1522187420449The great state of New Jersey has been the focal point for a lot of interesting debate over recreational marijuana reform this year.  But as that debate continues, the state's new Governor has announced here a new effort to "expands patient access to medical marijuana."  Here are some details:

Governor Phil Murphy [Tuesday] announced major reforms to New Jersey’s Medicinal Marijuana Program. Reforms include the addition of medical conditions, lowered patient and caregiver fees, allowing dispensaries to add satellite locations, and proposed legislative changes that would increase the monthly product limit for patients, and allow an unlimited supply for those receiving hospice care.

“We are changing the restrictive culture of our medical marijuana program to make it more patient-friendly,” Governor Murphy said. “We are adding five new categories of medical conditions, reducing patient and caregiver fees, and recommending changes in law so patients will be able to obtain the amount of product that they need. Some of these changes will take time, but we are committed to getting it done for all New Jersey residents who can be helped by access to medical marijuana.”

More than 20 recommendations are outlined in a report that New Jersey Department of Health Commissioner Dr. Shereef Elnahal submitted to Governor Murphy in response to Executive Order 6, which directed a comprehensive review of the program within 60 days. “As a physician, I have seen the therapeutic benefits of marijuana for patients with cancer and other difficult conditions,” said Dr. Elnahal. “These recommendations are informed by discussions with patients and their families, advocates, dispensary owners, clinicians, and other health professionals on the Medicinal Marijuana Review Panel. We are reducing the barriers for all of these stakeholders in order to allow many more patients to benefit from this effective treatment option."

In the report, the Department submitted three categories of recommendations: those that are effective today, regulatory changes that will go through the rulemaking process, and proposals that require legislation. In addition, there are recommendations for important future initiatives to allow home delivery, develop a provider education curriculum, and expedite the permitting process. Effective today, five new categories of medical conditions (anxiety, migraines, Tourette’s syndrome, chronic pain related to musculoskeletal disorders, and chronic visceral pain) will be eligible for marijuana prescription. Currently, 18,574 patients, 536 physicians, and 869 caregivers participate in the program – a far smaller number than comparably populated states. The Commissioner will also be able to add additional conditions at his discretion.

Other immediate changes include lowering the biennial patient registration fee from $200 to $100 and adding veterans and seniors -- 65 and older -- to the list of those who qualify for the $20 discounted registration fee. Those on government assistance, including federal disability, already receive the reduced fee.

The report prepared by the New Jersey Department of Health is available at this link.

March 28, 2018 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research, Medical Marijuana State Laws and Reforms | Permalink | Comments (0)

"Enforcing Federal Drug Laws in States Where Medical Marijuana Is Lawful"

Jama-logoThe title of this post is the title of this  new Viewpoint commentary authored by Lawrence Gostin, James Hodge, and Sarah Wetter published earlier this week on line at JAMA. Here is how it concludes:

Toward Rational Medical Marijuana Policies

Although public opinion and state action have trended strongly toward permitting use of marijuana, especially for medical purposes, controversy continues to exist.  The specter of federal prosecution could refrain physicians, patients, and dispensaries from providing marijuana in states where the drug is lawful and dissuade additional jurisdictions from legalizing marijuana.  Public policy formed and implemented in the context of inconsistent federal and state laws, unpredictable legal enforcement, and insufficient scientific evidence is unsustainable.  Rational policies should follow a 3-pronged agenda.

A Solid Research Foundation

Sound policy requires a strong evidence base.  Scientific studies could quell ongoing disagreements about marijuana’s medical effectiveness, harms, and status as a gateway drug.  Yet limited funding and restrictive access to uniformly high-quality cannabis have sharply curtailed longitudinal studies on a drug already in wide use. Physicians require rigorous evidence to inform prescribing practices and counseling of patients.  At present, wide regional variations in prescribing practices exist, and patients do not have access to consistently high-quality, uncontaminated cannabis — where the purity, potency, and dosage can be ensured.  Health officials, moreover, rarely conduct careful surveillance of marijuana use incidence, prevalence, and outcomes.  Public policy on a potentially hazardous psychotropic drug is difficult when short- and long-term effects across populations are underreported, insufficiently studied, and poorly funded.

A Harmonized Legal Environment

Substantial variability of legal approaches to marijuana use exists across jurisdictions and between states and the federal government.  Individuals in certain jurisdictions can lawfully access marijuana for medical use, recreational use, or both, whereas individuals in other jurisdictions cannot do so.  Conditions under which physicians can prescribe (or patients can access) marijuana fluctuate extensively.  Federal law is inconsistent with policy in virtually all states.  The CSA should be revised to operate harmoniously with prevailing state law. Model legislation for medical use of marijuana, based on scientific evidence, could help reconcile activities across jurisdictions.

Federal Law Enforcement Respectful of States’ Sovereignty

Under US constitutional design, states and localities are laboratories for innovation, with state sovereignty and local home rule respected and preserved.  This requires federal prosecutorial discretion to hew to the legal environment of states that have legalized marijuana use.  Respecting marijuana laws is essential in states where cannabis is prescribed and used for medical purposes.  On an issue as consequential as marijuana, the nation needs consistent legal norms based on the best available scientific evidence.

March 28, 2018 in Criminal justice developments and reforms, Federal Marijuana Laws, Policies and Practices, Medical community perspectives, Medical Marijuana Commentary and Debate | Permalink | Comments (0)

Sunday, March 25, 2018

"Unique treatment potential of cannabidiol for the prevention of relapse to drug use: preclinical proof of principle"

Npp201754f1The title of this post is the title of this notable new research just published on-line from the journal Neuropsychopharmacology.  Here is the abstract:

Cannabidiol (CBD), the major non-psychoactive constituent of Cannabis sativa, has received attention for therapeutic potential in treating neurologic and psychiatric disorders. Recently, CBD has also been explored for potential in treating drug addiction.  Substance use disorders are chronically relapsing conditions and relapse risk persists for multiple reasons including craving induced by drug contexts, susceptibility to stress, elevated anxiety, and impaired impulse control.  Here, we evaluated the “anti-relapse” potential of a transdermal CBD preparation in animal models of drug seeking, anxiety and impulsivity.  Rats with alcohol or cocaine self-administration histories received transdermal CBD at 24 h intervals for 7 days and were tested for context and stress-induced reinstatement, as well as experimental anxiety on the elevated plus maze.

Effects on impulsive behavior were established using a delay-discounting task following recovery from a 7-day dependence-inducing alcohol intoxication regimen.  CBD attenuated context-induced and stress-induced drug seeking without tolerance, sedative effects, or interference with normal motivated behavior.  Following treatment termination, reinstatement remained attenuated up to ≈5 months although plasma and brain CBD levels remained detectable only for 3 days.  CBD also reduced experimental anxiety and prevented the development of high impulsivity in rats with an alcohol dependence history.  The results provide proof of principle supporting potential of CBD in relapse prevention along two dimensions CBD: beneficial actions across several vulnerability states, and long-lasting effects with only brief treatment. The findings also inform the ongoing medical marijuana debate concerning medical benefits of non-psychoactive cannabinoids and their promise for development and use as therapeutics.

I found this research via this press article with a headline that provides a crisp accounting of what this research means: "Cannabis drug may help alcohol and cocaine addicts overcome their cravings, study finds." Here is how one of the researchers explained the findings in the press account:

Speaking of the findings, lead author Dr Friedbert Weiss said: 'The efficacy of the CBD to reduce reinstatement in rats with both alcohol and cocaine -- and, as previously reported, heroin -- histories predicts therapeutic potential for addiction treatment across several classes of abused drugs.

'The results provide proof of principle supporting the potential of CBD in relapse prevention along two dimensions: beneficial actions across several vulnerability states and long-lasting effects with only brief treatment.

'Drug addicts enter relapse vulnerability states for multiple reasons. Therefore, effects such as these observed with CBD that concurrently ameliorate several of these are likely to be more effective in preventing relapse than treatments targeting only a single state.'

Results further suggest CBD is completely cleared from such rats' brains just three days after the treatment ends.

March 25, 2018 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research | Permalink | Comments (0)

Friday, March 23, 2018

Estimates of extraordinary health-care savings in research paper on medical marijuana laws and tobacco use

I just saw this notable research paper authored by Anna Choi, Dhaval Dave and Joseph Sabia under the title "Smoke Gets in Your Eyes: Medical Marijuana Laws and Tobacco Use." The last line of the abstract merits placement in bold because it is such a bold finding:

The public health costs of tobacco consumption have been documented to be substantially larger than those of marijuana use.  This study is the first to investigate the impact of medical marijuana laws (MMLs) on tobacco cigarette consumption . First, using data from the National Survey of Drug Use and Health (NSDUH), we establish that MMLs induce a 2 to 3 percentage-point increase in adult marijuana consumption, likely for both recreational and medicinal purposes.  Then, using data from the NSDUH, the Behavioral Risk Factor Surveillance System (BRFSS), and the Current Population Survey Tobacco Use Supplements (CPS-TUS), we find that the enactment of MMLs leads to a 1 to 1.5 percentage-point reduction in adult cigarette smoking.  We also find that MMLs reduce the number of cigarettes consumed by smokers, suggesting effects on both the cessation and intensive margins of cigarette use.  Our estimated effect sizes imply substantial MML-induced tobacco-related healthcare cost savings, ranging from $4.6 to $6.9 billion per year.

March 23, 2018 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research | Permalink | Comments (0)

Wednesday, March 7, 2018

"America Is Giving Away the $30 Billion Medical Marijuana Industry"

800x-1The title of this post is the headline of this notable lengthy new Bloomberg Businessweek article.  I am tempted to politicize this post by saying that a true "America First" President ought to be quite concerned about the sub-headline of this piece: "Why? Because the feds are bogarting the weed, while Israel and Canada are grabbing market share."  I recommend the piece in full, and here are excerpts:

Lyle Craker is an unlikely advocate for any political cause, let alone one as touchy as marijuana law, and that’s precisely why Rick Doblin sought him out almost two decades ago. Craker, Doblin likes to say, is the perfect flag bearer for the cause of medical marijuana production—not remotely controversial and thus the ideal partner in a long and frustrating effort to loosen the Drug Enforcement Administration’s chokehold on cannabis research. There are no counterculture skeletons in Craker’s closet; only dirty boots and botany books. He’s never smoked pot in his life, nor has he tasted liquor. “I have Coca-Cola every once in a while,” says the quiet, white-haired Craker, from a rolling chair in his basement office at the University of Massachusetts at Amherst, where he’s served as a professor in the Stockbridge School of Agriculture since 1967, specializing in medicinal and aromatic plants. He and his students do things such as subject basil plants to high temperatures to study the effects of climate change on what plant people call the constituents, or active elements....

In June 2001, Craker filed an application for a license to cultivate “research-grade” marijuana at UMass, with the goal of staging FDA-approved studies. Six months later he was told his application had been lost. He reapplied in 2002 and then, after an additional two years of no action, sued the DEA, backed by MAPS. By this point, both U.S. senators from Massachusetts had publicly supported his application, and a federal court of appeals ordered the DEA to respond, which it finally did, denying the application in 2004.

Craker appealed that decision with backing from a powerful bench of allies, including 40 members of Congress, and finally, in February 2007, a DEA administrative law judge ruled that his application for a license should be granted. The decision was not binding, however; it was merely a recommendation to the DEA leadership. Almost two years later, in the last week of the Bush administration, the application was rejected. Craker threw up his hands. He firmly believed marijuana should be more widely grown and studied, but he’d lost any hope that it would happen in his lifetime. And he had basil to attend to.

Then, in August 2016, during the final months of the Obama presidency, the DEA reversed course. It announced that, for the first time in a half-century, it would grant new licenses. Doblin, who has seemingly endless supplies of optimism and enthusiasm, convinced the professor there was hope—again. So Craker submitted paperwork, again, along with 25 other groups. The university’s provost co-signed his application, and Senator Elizabeth Warren (D–Mass.) wrote a letter to the DEA in support of his effort. He’s still waiting to hear back. “I’m never gonna get the license,” Craker says.

Pessimism isn’t surprising from a man who’s been making a reasonable case for 17 years to no avail. Studies around the world have shown that marijuana has considerable promise as a medicine. Craker says he spoke late last year at a hospital in New Hampshire where certain cannabinoids were shown to facilitate healing in brain-damaged mice. “And I thought, ‘If cannabinoids could do that, let’s put them in medicines!’ ” He sighs. “We can’t do the research.”

Another sigh. “I’m naive about a lot about things,” he says. “But it seems to me that we should be looking at cannabis. I mean, if it’s going to kill people, let’s know that and get rid of it. If it’s going to help people, let’s know that and expand on it. … But there’s just something wrong with the DEA. I don’t know what else to say. … Somehow, marijuana’s got a bad name. And it’s tough to let go of.”....

Many people expect the Republican-controlled Congress to follow its recent tax overhaul by looking for ways to slash costs in Medicaid and Medicare. Legitimate research into the medicinal properties of marijuana could help. Studies show that opioid use drops significantly in states where marijuana has been legalized; this suggests people are consuming the plant for pain, something they could be doing more effectively if physicians and the FDA controlled chemical makeup and potency. A study published in July 2016 in Health Affairs showed that the use of prescription drugs for which marijuana could serve as a clinical alternative “fell significantly,” saving hundreds of millions of dollars among users of Medicare Part D....

Among those who’ve advised Craker is Tony Coulson, a former DEA agent who retired in 2010 and works as a consultant for companies developing drugs. Coulson was vehemently antimarijuana until his son, a combat soldier, came home from the Middle East with post-traumatic stress disorder and needed help. “For years I was of the belief that the science doesn’t say that this is medicine,” he says. “But when you get into this curious history, you find the science doesn’t show it primarily because we’re standing in the way. The NIDA monopoly prevents anyone from getting into further studies.”

Coulson blames the Obama administration for not acting sooner, creating a situation in which the decision on granting new growing licenses was passed down to Attorney General Jeff Sessions, who has publicly declared his belief in the dangers of marijuana. The NIDA monopoly is now his to change. “Sessions has a 1930s Reefer Madness view of the marijuana world,” Coulson says. “It’s not realistic, and it’s not what rank-and-file DEA really are concerned about. DEA folks have moved beyond this.”

“I guess I take a nationalist approach here,” says Rick Kimball, a former investment banker who’s raising money for a marijuana-related private equity fund and is a trustee for marijuana policy at the Brookings Institution. “We have a huge opportunity in the U.S.,” he says, “and we ought to get our act together. I’m worried that we’re ceding this whole market to the Israelis.”

March 7, 2018 in Business laws and regulatory issues, Federal Marijuana Laws, Policies and Practices, Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research, Who decides | Permalink | Comments (0)

Monday, March 5, 2018

Encouraging research from Minnesota on success of medical marijuana in the treatment of "intractable pain"

Download (9)This recent press release from the Minnesota Department of Health, headlined "Medical cannabis study shows significant number of patients saw pain reduction of 30 percent or more," provides a summary of this encouraging lengthy report titled "Intractable Pain Patients in the Minnesota Medical Cannabis Program: Experience of Enrollees During the First Five Months." Here is the start of the press release:

Forty-two percent of Minnesota’s patients taking medical cannabis for intractable pain reported a pain reduction of thirty percent or more, according to a new study conducted by the Minnesota Department of Health. “This study helps improve our understanding of the potential of medical cannabis for treating pain,” said Minnesota Health Commissioner Jan Malcolm. “We need additional and more rigorous study, but these results are clinically significant and promising for both pain treatment and reducing opioid dependence.”

The first-of-its-kind research study is based on the experiences of the initial 2,245 people enrolled for intractable pain in Minnesota’s medical cannabis program from August 1, 2016 to December 31, 2016. Of this initial group, 2,174 patients purchased medical cannabis within the study’s observation period and completed a required self-evaluation before each purchase.

As part of the self-evaluation, patients completed the PEG (pain, enjoyment and general activity) screening tool. On a scale of 0 to 10 (with 0 being no pain and 10 being the highest pain), patients rated their level of pain, how pain interfered with their enjoyment of life and how pain interfered with their general activity.

Using the PEG scale data, 42 percent of the patients who scored moderate to high pain levels at the beginning of the measurement achieved a reduction in pain scores of 30 percent or more, and 22 percent of patients both achieved and maintained a reduction of 30 percent or more over four months. The 30 percent reduction threshold is often used in pain studies to define clinically meaningful improvement. Health care practitioners caring for program-enrolled patients suffering from intractable pain reported similar reductions in pain scores, saying 41 percent of patients achieved at least a reduction of 30 percent or more.

The study also found that of the 353 patients who self-reported taking opioid medications when they started using medical cannabis, 63 percent or 221 reduced or eliminated opioid use after six months. Likewise, the health care practitioner survey found that 58 percent of patients who were on other pain medications were able to reduce their use of these medications when they started taking medical cannabis. Thirty-eight percent of patients reduced opioid medication (nearly 60 percent of these cut use of at least one opioid by half or more), 3 percent of patients reduced benzodiazepines and 22 percent of patients reduced other pain medications.

The safety profile of medical cannabis products available through the Minnesota program continues to appear favorable. No serious adverse events (life threatening or requiring hospitalization) were reported for this group of patients during the observation period. 

Here is a portion of the executive summary from the full report:

Among respondents to the patient (54% response rate) and health care practitioner (40% response rate) surveys, a high level of benefit was reported by 61% and 43%, respectively (score of 6 or 7 on a seven-point scale). Little or no benefit (score of 1, 2, or 3) was reported by 10% of patients and 24% of health care practitioners.

The benefits extended beyond reduction in pain severity, though that was the benefit mentioned most often (64%). The benefit described second most often was improved sleep (27%), which likely has a synergistic relationship with reduction in pain severity. In some cases improved sleep, reduction of other pain medications and their side effects, decreased anxiety, improved mobility and function, and other quality of life factors were cited as being the most important benefit. The pattern of described benefits was similar in the patient and the health care practitioner survey results....

A large proportion (58%) of patients on other pain medications when they started taking medical cannabis were able to reduce their use of these meds according to health care practitioner survey results. Opioid medications were reduced for 38% of patients (nearly 60% of these reduced at least one opioid by ≥50%), benzodiazepines were reduced for 3%, and other pain medications were reduced for 22%. If only the 353 patients (60.2%, based on medication list in first Patient Self-Evaluation) known to be taking opioid medications at baseline are included, 62.6% (221/353) were able to reduce or eliminate opioid usage after six months.

March 5, 2018 in Medical community perspectives, Medical Marijuana Commentary and Debate, Medical Marijuana Data and Research, Medical Marijuana State Laws and Reforms | Permalink | Comments (0)

Wednesday, February 28, 2018

Americans for Safe Access releases its latest analysis and report card on medical marijuana programs across United States

Asa_default_social_thumbnail2The advocacy group Americans for Safe Access regularly produces reports on the state of state medical marijuana laws, and this latest 2018 version of ASA's “Medical Marijuana Access in the United States: A Patient-Focused Analysis of the Patchwork of State Laws” now runs almost 200 pages.  I recommend the report in full for everyone interested in medical marijuana information, and here is part of the report's preface:

For over fifteen years, Americans for Safe Access (ASA) has engaged state and federal governments, courts, and regulators to improve the development and implementation of state medical cannabis laws and regulations.  This experience has taught us how to assess whether or not state laws meet the practical needs of patients. It has also provided us with the tools to advocate for programs that will better meet those needs. Passing a medical cannabis law is only the first step in a lengthy implementation process, and the level of forethought and advance input from patients can make the difference between a well-designed program and one that is seriously flawed.  One of the most important markers of a well-designed program is whether or not all patients who would benefit from medical cannabis will have safe and legal access to their medicine without fear of losing any of the civil rights and protections afforded to them as American citizens....

Today, we have a patchwork of medical cannabis laws across the United States.  Thirty states, the District of Columbia, Guam, and Puerto Rico have adopted laws that created programs that allow at least some patients legal access to medical cannabis.  Most of those thirty states provide patients with protections from arrest and prosecution as well as incorporate a regulated production and distribution program.  Several programs also allow patients and their caregivers to cultivate a certain amount of medical cannabis themselves.  While it took a long time for states to recognize the importance of protecting patients from civil discrimination (employment, parental rights, education, access to health care, etc.), more and more laws now include these explicit protections.

However, as of 2017, none of the state laws adopted thus far can be considered ideal from a patient’s standpoint.  Only a minority of states currently include the entire range of protections and rights that should be afforded to patients under the law, with some lagging far behind others.  Because of these differences and deficiencies, patients have argued that the laws do not function equitably and are often poorly designed, implemented, or both.  As production and distribution models are implemented, hostile local governments have found ways to ban such activity, leaving thousands of patients without the access state law was intended to create. Minnesota, for example, despite setting up a regulatory system for the production, manufacturing, and distribution of cannabis oil extracts, prohibits qualified patients from using the actual plant.  These laws include sanctions for qualified patients who seek to use their medicine in whole plant form, unnecessarily eliminating clinically validated routes of administration used by hundreds of thousands of patients.  Some states have taken years to implement their medical cannabis laws leaving patients waiting years before their medicine is available. 

February 28, 2018 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)