Tag Archives: MIND

03/7/23

Marijuana Policy Has Run Ahead of Science

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Senate Bill 3 was signed into law by Governor Tom Wolf on April 17, 2016, legalizing medical marijuana in Pennsylvania. The Governor anticipated signing the bill “will improve the quality of life for patients and their families throughout Pennsylvania.” Information on the PA Medical Marijuana Program indicated it would include funding for research to study “the use of medical marijuana to treat serious conditions.” There will also be an advisory committee “that will view these research findings and make recommendations to the legislature for changes to the act.” I’d like to suggest they start with a Harvard-based researcher who is concerned that “policy has outpaced science” when it come to making public health decisions about recreational and medical marijuana.

Staci Gruber is an associate professor of psychiatry at Harvard Medical School and the director of the MIND program (Marijuana Investigations for Neuroscientific Discovery). She has done research on the effects of both recreational and medical marijuana. In an interview with The Harvard Gazette, Dr. Gruber said the science on the health effects of marijuana is not yet settled. “When we think about legalization we always like to have science inform policy. In this particular case, it seems to me that policy has outpaced science.”

She added there is a lot we don’t know about the effects of marijuana. Most of what we do know comes from studies of “chronic, recreational marijuana users.” There are differences between recreational and medical marijuana use, for example with regard to what they use, and how they use. She said there has been well-founded excitement about the potential for medical cannabis use. “[But] there’s a striking paucity of research on the use of medical cannabis.”

Dr. Gruber and her colleagues discussed the findings in a study of theirs, “Splendor in the Grass?” that looked at the impact of medical marijuana on executive functioning. They acknowledged how the growing body of evidence shows recreational marijuana use adversely effects brain function, especially during adolescence, the critical period of neurodevelopment. But they also theorized the use of medical marijuana (MMJ) may not lead to the same adverse neurocognitive effects. Recreational users, seeking a euphoric, mood altering effect, use products with a high THC content. In contrast MMJ users seek medical relief and use products with a markedly different chemical composition than common recreational products. “These MMJ products are often (but not always) high in other cannabinoids, such as cannabidiol (CBD) which has been touted for its therapeutic potential, and which is not psychoactive.”

The study found that after three months of medical marijuana use, patients (who had previously not been exposed to marijuana) experienced some improvement, rather than the well-documented deficits. “They showed some improvements in measures of executive functions. They also had some improvements in sleep quality and some measures of mood and quality of life.” A subset of people who were using MMJ for chronic pain also reported improvements. Although it was a small sample size, there was a 42% reduction in opiate use. When they analyzed samples of their patient’s products, a number of them were using products high in CBD (cannabidiol) and other non-psychoactive cannabinoids.

Gruber thought there was hope for at least adjunctive therapy, “if not substitution therapy,” for cannabinoids or cannabinoid-based products for individuals currently using opioids. “We’ve seen individuals who’ve stopped using opioids altogether.” That won’t work for everyone. “But that doesn’t mean it’s something that shouldn’t be exploited and explored.”

While future studies are needed to further examine the impact of MMJ, research is impeded by a number of federal and state restrictions. It is imperative, however, that sound research, including well-controlled clinical trials of MMJ products, many of which are already widely used by patients, are thoroughly examined. As the “green rush” pushes forward, gaining momentum as states continue to adopt less restrictive policies, we cannot afford for research to continue to lag behind.

Dr. Gruber said her goal as a scientist was to provide truthful information so all people, regardless of their recreational or medical status, can understand what is in their cannabis or medicine. In pursuit of this goal, Dr. Gruber and her colleague Kelly Sagar continued a discussion of their research with “Marijuana on the Mind?” in Policy Insights from the Behavioral and Brain Sciences. You can also watch an archived webinar by Gruber and Sagar on the same subject, “Marijuana on the Mind: A Primer for Policymakers” on the website Social Science Space, where there are also written answers to some of the questions from the webinar. The presentation exists as an independent YouTube video as well. The audio cuts out a few times, but returns if you continue with the video.

In “Marijuana on the Mind?” Gruber and Sagar gave a helpful review of the history of medical use of marijuana, noting how it was included in the U.S. pharmacopeia (a list of medicinal drugs with their effects and directions for their use) until 1942. They also documented several areas of concern with marijuana, including its adverse effects on cognition, especially executive function and memory; brain development among adolescents; and safety concerns related to the frequency and magnitude of marijuana use as well as its potency.

Marijuana (MJ) use negatively effects executive brain functions (EF) such as attention, decision making, risk taking, inhibition and verbal fluency. An earlier age of onset in using MJ appears to be related to greater impairment on EF. “Several investigations have also noted that lower EF appears to predict increased MJ use.” Several aspects of memory are negatively effects by MJ use. Some evidence suggests increased use and higher exposure to MJ are related to slower psychomotor/processing speed.

The formation of grey matter and whiter matter in the brain is adversely effected by MJ use. Grey matter is responsible for information processing and decision-making. White matter has a critical role in promoting efficient communication within and between regions of the brain. Adolescent MJ users are particularly vulnerable to grey matter reductions; minimal further damage seems to occur after early adulthood. Lower white matter integrity is related to higher impulsivity scores, particularly with early onset MJ users.

MJ users with early onset (prior to age 16) reportedly use MJ nearly twice as often and more than 2.5 times as much relative to late-onset users. Overall, frequency and duration of use appear to be key factors in determining the extent of MJ-related impairment.

Safety concerns with MJ use are on the rise due to the increased potency of marijuana and the use of MJ concentrates. The potency of marijuana has risen nearly 200% since 1995. The use of concentrated MJ products, such as dabs, shatter, wax, budder and others can exceed 60% THC. “Furthermore, these products may also contain residual amounts of solvents (i.e., butane, hexane), often used to make concentrates, which are potentially toxic.” There has been very little research done on cognitive performance or measures of brain structure and function in humans with MJ concentrates. “This raises concern that adverse consequences associated with MJ use may be worse now than in the past, particularly among young users.”

Based upon their discussion, policy recommendation given by Gruber and Sagar include:

  1. age restrictions based upon evidence highlighting the developmental trajectory of the adolescent brain;
  2. restrictions on targeting youths in advertisements;
  3. safe packaging guidelines to prevent the accidental ingestion of edible MJ products by children;
  4. place limits on THC potency as well as minimums for potentially beneficial cannabinoids in marijuana, like CBD;
  5. more research on the impact of medical marijuana, which will likely require a lessening of marijuana as a Schedule I substance

As the dialogue regarding legalization of recreational and MMJ continues, perceived risk of MJ use has fallen to an all-time low. Consequently, those with the highest neurodevelopmental vulnerability are using MJ more frequently than in previous years, posing a serious public health issue. A growing body of evidence indicates that relative to non-MJ users, heavy MJ users exhibit poorer performance on cognitive tasks, altered patterns of brain activity, and lower frontal WM coherence, which are highly moderated by age of onset of MJ use. Given the potential therapeutic benefits of MJ, however, it is important to weigh these risks with the benefits. Policy has outpaced science, and eased restrictions allowing citizens to use MJ, in some cases without the benefit of appropriate research. Additional investigation is warranted and necessary to guide informed policy decisions. As states consider legislation for MJ use, it is imperative to determine safe guidelines regarding the impact of MJ on the brain, particularly during critical periods of neurodevelopment.

Dr. Gruber’s research through the MIND program will be extremely helpful for the PA Medical Marijuana Program and state policy makers, such as members of the advisory committee, in making informed public policy decisions with the ongoing availability of medical marijuana in Pennsylvania. The review by Gruber and Sagar of the research relevant the influence of marijuana on cognition, brain structure and brain function in “Marijuana on the Mind?” can be helpful in making future public policy decisions with regard to medical marijuana in the state.

An article cited by Gruber and Sagar, “Cannabis for Medical Use,” should also be reviewed by policy makers, as it is a systematic review and meta-analysis of the benefits and adverse events of cannabinoids. The full text of the systematic review is available. What follows is from the article’s Discussion.

Most studies suggested that cannabinoids were associated with improvements in symptoms, but these associations did not reach statistical significance in all studies. Based on the GRADE approach, there was moderate-quality evidence to suggest that cannabinoids may be beneficial for the treatment of chronic neuropathic or cancer pain (smoked THC and nabiximols) and spasticity due to MS (nabiximols, nabilone, THC/CBD capsules, and dronabinol). There was low-quality evidence suggesting that cannabinoids were associated with improvements in nausea and vomiting due to chemotherapy (dronabinol and nabiximols), weight gain in HIV (dronabinol), sleep disorders (nabilone, nabiximols), and Tourette syndrome (THC capsules); and very low-quality evidence for an improvement in anxiety as assessed by a public speaking test (cannabidiol). There was low-quality evidence for no effect on psychosis (cannabidiol) and very low-level evidence for no effect on depression (nabiximols). There was an increased risk of short-term AEs with cannabinoid use, including serious AEs. Common AEs included asthenia, balance problems, confusion, dizziness, disorientation, diarrhea, euphoria, drowsiness, dry mouth, fatigue, hallucination, nausea, somnolence, and vomiting. There was no clear evidence for a difference in association (either beneficial or harmful) based on type of cannabinoids or mode of administration. Only 2 studies evaluated cannabis.There was no evidence that the effects of cannabis differed from other cannabinoids.

The authors noted there was moderate-quality evidence to support the use of cannabis to treat chronic pain and spasticity. However, the existing evidence suggesting improvements in nausea and vomiting due to chemotherapy, weight gain in HIV, sleep disorders, and Tourette syndrome was low quality evidence. Cannabinoids were also associated with an increased risk of short-term adverse events such as those noted in the above quote. Future studies with large random clinical trials were said to be needed in order to confirm the effects of cannabinoids with issues such as: weight gain in patients with HIV/AIDS, depression, sleep disorders, anxiety disorders, psychosis, glaucoma, and Tourette syndrome. Additionally, the lack of research into the effects and adverse events with cannabis point to the need of future studies in these areas.

Hopefully as medical marijuana becomes more widely available in Pennsylvania, the administrators of the Medical Marijuana Program and other state policy makers will pursue the recommendations suggested in the research reviewed here by Gruber and others who are concerned that “policy has outpaced science” when it comes to lawmakers making public health decisions about recreational and medical marijuana.

Originally posted on March 6, 2018.

01/21/20

From the Frying Pan Into the Fire with Recreational Marijuana in PA

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On September 25, 2019, Governor Tom Wolf announced he supports legalizing recreational marijuana. Wolf and Lt Gov. John Fetterman called for three specific actions at their press conference: 1) a bill to decriminalize non-violent and small cannabis-related offenses; 2) developing a way to expunge past convictions for non-violent and small cannabis-related offenses; and 3) consideration by the General Assembly of legalization of adult-use recreational marijuana. He said: “We now know the majority of Pennsylvanians are in favor of legalization, and that includes me.” He added that he looked forward to seeing what could be accomplished, especially the criminal justice reforms.

His endorsement represented an about-face from August of 2018, when he told KDKA Radio Morning News the time was not right to legalize marijuana for recreational use: “I don’t think the citizens of Pennsylvania are ready for it.” He recommended waiting on the longer-term results of legalization in states such as Colorado, Oregon, Washington, where their different approaches could be helpful as PA weighs its own options. Then in December of 2018, Wolf said in a tweet: “More and more states are successfully implementing marijuana legalization, and we need to keep learning from their efforts.” He added any change would require legislation. But he thought it was time for “Pennsylvania to take a serious and honest look at recreational marijuana.”

Wolf’s support for legalization came after the completion of Fetterman’s “Statewide Cannabis Listening Tour” on May 19, 2019. Key takeaways from those who attended the tour included: 65-70% approval for adult-use cannabis legalization; near unanimous support for decriminalization and mass expungement of non-violent and small cannabis-related offenses; if legalized, cannabis should be grown on Pennsylvania farms; the removal of cannabis from its current classification as a Schedule I drug; and a provision allowing for six to eight homegrown cannabis plants for personal use. More than 10,000 individuals attended Listening Tour meetings and the online portal received more then 44,000 comments. The September announcement of support for legalizing recreational marijuana was followed by the introduction of the “Adult-Use Cannabis Act,” Senate Bill 350, by Pennsylvania senators Daylin Leach and Sharif Street.

If passed, the bill would legalize adult-use cannabis for individuals 21 years of age and older, and establish a permitting process for growers, processors, and dispensaries; the current measure would not place a limit on the number of permits that could be issued. The bill would also allow for cannabis delivery, consumption (i.e., “bring your own” or BYO) lounges, and home grow. Under the proposed legislation, the Pennsylvania Department of Agriculture would oversee the adult-use program.

Two days after the Adult-Use Cannabis Act was introduced, Governor Wolf met with governors from New York, New Jersey and Connecticut at a “marijuana summit,” where they agreed to a set of core principles for legal cannabis programs they would pursue. This seems to be part of a continuing strategy for legalizing recreational marijuana in Pennsylvania that I said was like eating an elephant one bite at a time (See “Eating the Elephant of Marijuana Legalization in PA”). Let’s see if we can digest some of what we are hearing from the “Statewide Cannabis Listening Tour,” the Adult-Use Cannabis Act, and what we can learn from the states who have gone before PA in legalizing recreational marijuana.

The first key takeaway in the Executive Summary of the Listening Tour was that 65-70% of those who attended tour stops approved of adult-use cannabis legalization. This seems to be the source of Governor Wolf’s statement that “We now know the majority of Pennsylvanians are in favor of legalization.” We know that 65-70% of those who attended tour stops approved of adult-use cannabis legislation, not that 65-70% of Pennsylvanians approve of legalization. The 10,000 or so individuals who went to the Listening Tour stops are not representative of the Commonwealth as a whole, and surveys of them should not haven been presented as “the majority of Pennsylvanians” by the governor. The Executive Summary made the distinction, saying a majority of attendees supported legalization—why didn’t the governor?

The Adult-Use Cannabis Act would issue permits to applicants seeking to legally become a Grower, Homegrower, Microgrower, Processor, open a Dispensary to sell cannabis retail to consumers, become a Deliverer of cannabis from a dispensary to consumers, or operate “use lounges,” where individuals may use cannabis which they have brought to the space. Cannabis use in public, except use in these consumption lounges, would be prohibited. See the “Adult-Use Cannabis Act” link for a further description of these permits. There would be a 17.5 percent tax rate imposed at the point-of-sale on cannabis by dispensaries.

There was “near-unanimous” support for decriminalization and mass expungement of non-violent and small cannabis-related offenses, and for removing cannabis from its current classification as a Schedule I drug. These social justice concerns and the rescheduling of cannabis are laudable and can be legislated independent of legalizing adult-use of recreational marijuana. Were they bundled into the Adult-Use Cannabis Act in order to garner support in the General Assembly for legalizing recreational marijuana?

There was concern expressed for an anticipated increase of people driving under the influence of cannabis, which has in fact happened in other states. The National Institute on Drug Abuse said several meta-analyses found the risk of being involved in a crash increased significantly and in a few cases doubled or more than doubled. “Two large European studies found that drivers with THC in their blood were roughly twice as likely to be culpable for a fatal crash than drivers who had not used drugs or alcohol.”

A 2009 article in The American Journal on Addictions said detrimental effects of cannabis use varied in a dose-related fashion and were more pronounced with highly automatic driving functions than with more complex tasks that required conscious control. Impaired drivers tend to compensate effectively when driving, but combining alcohol and marijuana eliminates the ability to use such strategies “and results in impairment even at doses which would be insignificant were they of either drug alone.”

In Colorado, where recreational marijuana has been legal since 2012, there has been a sharp increase in the number of marijuana-related automobile fatalities each year from 2013 to 2016. There were 77 marijuana-related fatalities in 2016, 51 of those drivers had levels of THC above the threshold for cannabis impairment under Colorado law. According to a survey by the Colorado Department of Transportation, over half of marijuana users said they had got behind the wheel of a vehicle in the last 30 days within two hours of using the drug.

After recreational marijuana was legalized in Washington in 2012, the proportion of marijuana-positive drivers involved in fatal crashes increased from 8 percent to 17 percent in 2014, according to AAA. The majority of drivers who had detectable levels of THC also had alcohol and/or other drugs in their blood at the time of the crash. “Of all THC-positive drivers involved in fatal crashes over the study period, an estimated 34.0% were positive for THC only, 39.0% were positive for both THC and alcohol.” 16.5% were positive for both THC and one more other drug, but not alcohol; and 10.5% were positive for THC, alcohol, and one or more other drugs.

Research from the Insurance Institute for Highway Safety (IIHS) and Highway Loss Data Institute (HLDI) showed that crashes were up as much as 6 percent in Colorado, Nevada, Oregon and Washington when compared with neighboring states that haven’t legalized marijuana for recreational use: Idaho, Montana, Utah and Wyoming. IIHS-HLDI President David Harkey said legalizing marijuana was having a negative impact on the safety or our roads. “Despite the difficulty of isolating the specific effects of marijuana impairment on crash risk, the evidence is growing that legalizing its use increases crashes.”

The Adult-Use Cannabis Act seeks to take an illegal drug away from the black market and regulate its distribution through legislation and regulation. And hopefully develop a new revenue source for Pennsylvania. PA Auditor General Eugene DePasquale estimated legalizing marijuana would produce approximately $581 million in annual tax revenue. After funding a grant program ($2 million) and an interest-free loan program ($2 million) and $9 million to the Department of Agriculture to oversee the adult-use program, 95% of the remaining revenue would be distributed to school districts. Ironically, one of the top concerns noted in the “Statewide Cannabis Listening Tour” was the potential of negative effects on the development of youth and students.

The New York Times featured an article in April of 2019 on how the illegal marijuana market was booming in California despite legalization. The governor of California redeployed National Guard troops stationed on the border with Mexico to go after illegal cannabis farms in Northern California because the problem was getting worse, not better. In wildland areas, the California Department of Fish and Wildlife more than doubled its seizures of illicit marijuana in 2018, the first year recreational cannabis was legal.

Of the roughly 14 million pounds of marijuana grown in California annually, only a fraction — less than 20 percent according to state estimates and a private research firm — is consumed in California. The rest seeps out across the country illicitly, through the mail, express delivery services, private vehicles and small aircraft that ply trafficking routes that have existed for decades.This illicit trade has been strengthened by the increasing popularity of vaping, cannabis-infused candies, tinctures and other derivative products. Vape cartridges are much easier to carry and conceal than bags of raw cannabis. And the monetary incentives of trafficking also remain powerful: The price of cannabis products in places like Illinois, New York or Connecticut are typically many times higher than in California.

Politico also wrote about “How Legal Marijuana Is Helping the Black Market.” It said when Oregon legalized marijuana in 2014, the state tried to stifle its black market by making the path into the legal market was as easy as possible. “It did not limit licenses and it simplified regulations, creating a program with one of the lowest barriers to entry in the United States.” The strategy worked. An Oregon State Police Sergeant estimated there are more illicit marijuana growing in Southern Oregon than before legalization, with most of it going out of state. He said law enforcement is just inundated with illegal marijuana and exportation.

Now, Oregon is an easy place to find high-quality, cheap, legal marijuana. There are more than 650 licensed marijuana dispensaries in the state, or three times the number of McDonald’s restaurants (205). If you’re an Oregonian living in a town or county with legal pot and you want to buy marijuana, there is no reason to shop illegally.

Even The Motley Fool weighed in with “5 Reasons the Marijuana Black Market Won’t Go.” They noted how the legalization of recreational marijuana in Canada and U.S. states has not stopped black market cannabis, as initially expected. “In California, the largest legal weed market in the world by annual sales, illicit marijuana sales are projected to outpace legal pot sales in 2019 by a significant margin: $8.7 billion to $3.1 billion.” Estimates by Scotiabank are that the black market would be responsible for 71% of total cannabis sales in Canada in 2019. The problem noted by the Motley Fool included supply issues in Canada, tax issues in select US states, a slow dispensary approval process, jurisdiction issues, and spotty regulatory enforcement.

Staci Gruber, who is the director of the MIND (Marijuana Investigations for Neuroscientific Discovery) project, has published a series of studies that confirmed the heavy use of marijuana lowers the level of white matter in the corpus callosum region of the brain; and the earlier the age of marijuana use was associated with lower levels of white matter. White matter affects learning and brain functions, modulating the distribution of action potentials and acts as a relay and coordinates communication between different brain regions. Not surprisingly, marijuana smokers were also found to have higher levels of impulsivity. Adolescent marijuana users are also vulnerable to reduction in grey matter, which is responsible for information processing and decision making. See “Listening to Marijuana Research,” “Marijuana Policy Has Run Ahead of Science” and “Double Whammy of Teens Vaping Marijuana” for more on these concerns.

The Motley Fool noted where cannabis had been one of the fastest-growing industries on the planet. After sales more than tripled worldwide between 2014 and 2018, Wall Street forecasted a 5-fold to 18-fold increase in global annual revenue by 2030. But since May of 2019, many marijuana stocks have seen their share price cut in half or worse. Our neighbor to the north, Canada, hasn’t stomped out the black market as expected and supply shortages have been a persistent problem. And the regulatory enforcement designed to drive the black market out of business hasn’t been working. “Based on data from the United Cannabis Business Association, via an audit that was recently turned into California Gov. Gavin Newsom (D-Calif.), 2,835 of the 3,757 listings of marijuana sellers in California on website WeedMaps were unlicensed.”

Hopefully the core principles for legal cannabis programs the governors of Connecticut, New York, New Jersey and Pennsylvania agreed they would pursue at the so-called “marijuana summit” included a continued “wait and see” option. Legalizing recreational marijuana does not seem to have solved problems it was predicted to solve and seems to have generated new ones that weren’t anticipated or predicted. Let’s follow Governor Wolf’s older advice about waiting to see the longer-term consequences of marijuana legalization in Washington, Oregon, Colorado and California. If we acted on his endorsement in favor of legalization now, wouldn’t we be jumping from the frying pan into the fire?

01/14/20

Eating the Elephant of Marijuana Legalization in PA

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On December 19, 2018, PA Governor Tom Wolf tweeted more and more states were successfully implementing marijuana legalization, and PA needed to keep learning from their efforts. Change would take legislation. “But I think it is time for Pennsylvania to take a serious and honest look at recreational marijuana.” Then on January 3, 2019 Pittsburgh state Representative Jake Wheatley proposed the commonwealth legalize recreational marijuana, saying House Bill 50 would provide for social justice reforms, incentivize cannabis businesses to partner with PA farmers, and well as invest in student forgiveness, after school programs and affordable housing. We need to do what is best for the people of Pennsylvania and legalize cannabis this Legislative Session.”

Governor Wolf said: “I’m just trying to be a realist, that this is something we really ought to be taking a look at in a way that maybe we haven’t before.” But he didn’t intend to make it a priority of his second term. However, he also thought Pennsylvania shouldn’t hide her head in the sand and say things aren’t happening in other states in the region.

I’m just saying I’m going to look at what’s going on in the neighboring states and see if we can continue to learn from them and other states that have, through referendum and legislative action, legalized it, and see what maybe we ought to be doing. I’m just keeping my eyes open.

The Republican-controlled chambers of the General Assembly are opposed to the bill. Senate Majority Leader Jake Corman called the idea “reckless and irresponsible,” while his counterpart in the House, Majority Leader Bryan Cutler, opposed the medical marijuana passed in 2016.  Corman said, “As long as I as leader, I will do everything in my power to prevent legalization of recreational marijuana.” He added that it gives the wrong message to our youth.

Then on September 25th Governor Wolf announced that he was now in favor of legalizing marijuana for recreational use. Lt. Governor John Fetterman, who had spent months on a statewide recreational marijuana listening tour, stood beside him. Governor Wolf said, “I think it’s time for the General Assembly to sit down and craft a bill that actually recognizes that Pennsylvania is ready for this, and also takes advantage of what we’ve learned from other states in terms of what to do and what not to do.” On October 15th, 2019, two state senators introduced Senate Bill 350, which would allow for home delivery and the expungement of many previous criminal convictions related to marijuana. See the link for key high lights of the Bill.

Some have doubts that the proposed Adult-Use Cannabis Act will pass this year, especially in its current form, as there are no Republican co-sponsors at this time. The bill also faces an uphill battle in Pennsylvania’s Republican-controlled Senate, although Senators Leach and Street have indicated that they are optimistic the bill will pass and that many of their Republican colleagues will end up supporting the measure. Generally, the legislation is thought to stand a better chance than prior efforts in light of the Lt. Governor’s listening tour and the Governor’s recently announced support of legalization. With that said, in response to Gov. Wolf’s comments promoting legalization, House Republican leaders issued a statement less than one month ago criticizing Gov. Wolf’s position and stating that “[o]ur caucus has no plans or interest in legalizing recreational marijuana.” It is also worth noting that Senator Leach also co-sponsored Pennsylvania’s medical cannabis legislation, which reportedly also lacked any Republican co-sponsors initially.

Pennsylvanians are facing a purposeful and strategic scheme to get recreational marijuana legalized in their state. It began with Governor Wolf signing Senate Bill 3, legalizing medical marijuana on April 17, 2016. Initially, the approved conditions were limited to 17 “serious medical conditions.” Those conditions have expanded from 17 to 23 since then, as seen on the PA website, under Qualifying Conditions. Anxiety, Dyskinetic and spastic movement disorders, opioid use disorder, terminal illness and Tourette syndrome have been added; and a few have been relaxed, such as Cancer now has added “including remission therapy.”

At first, dried leaves, plant material and edibles were strictly prohibited. Only those forms of medical marijuana listed in Act 16 were permitted. They included: 1) a form medically appropriate to administer by vaporization or nebulization; 2) pills; 3) topical forms, including gels, creams or ointments; 4) tinctures; 5) liquids; or 6) oils. Also, a licensed practitioner or medical professional determined which form is appropriate for the patient.

At the World Medical Cannabis Conference & Expo held in Pittsburgh in April of 2017, Daylin Leach said he expected medical marijuana would be available in plant form (dry leaf, flower) in 2018. He said a section of Senate Bill 3 authorized an advisory board to make recommendations about whether to change the permissible forms of the drug. During a panel discussion at the Expo, he said the following about the advisory board:

But they will [approve sale of the plant form of marijuana], because we’re appointing people to do that,” Leach said as the crowd laughed. “They will recommend that at latest by April 17 (2018), which means when dispensaries open, it is likely that they will have whole plant on their shelves from day one.

On April 16th, 2018 Governor Wolf announced he supported changes to the existing state medical marijuana program that would allow dispensaries to sell dry leaf marijuana or “flower,” and the PA Health Secretary, Rachael Levine, announced she approved the recommendation from the state’s advisory board to permit the sale of dry leaf “for patients with a qualifying medical condition.” The rationale was their desire to offer a lower-cost option to the forms permitted in Act 16. PA law still prohibited smoking medical marijuana or using it in edible form, but it was unclear how that rule would be enforced once the marijuana was purchased and taken home. Cannabis consumer advocate Chris Goldstein said: “I’m sure patients are going to go home and smoke it, and there’s nothing wrong with it. . .  This is how humans have used cannabis for 10,000 years and it’s how people should have access to it in Pennsylvania.”

Now there are six forms of medical marijuana available for consumption in PA: pills, extracts, liquids, topicals, patches, and flower. “Dry leaf/flower” went on sale at PA dispensaries on August 1, 2018. Daylin Leach was off on his time table, but accurate on his prediction that flower would be for sale in the first year.

In its first full year, Pennsylvania collected $2 million in tax revenue from growers and processors. Dispensaries reported $132 million in sales. Dr. Rachael Levine said: “Our goal for the next year and beyond is to increase the number of grower/processors and dispensaries operating, to register even more physicians and to continue the growth of our scientific, medically based program.” There are currently an estimated 72 medical marijuana dispensaries in Pennsylvania, with around 283 more applications for potential dispensaries as of the end of November, 2019. Writing for Law.com, Patrick McKnight said:

Pennsylvania’s medical marijuana program is noteworthy for its promotion of scientific testing. As part of the program, the state certifies eight academic clinical research centers. The mission of the clinical program is to conduct, “Research on the therapeutic or palliative efficacy of medical marijuana limited to the serious medical conditions defined by the act and the temporary regulations.” The state also has four approved laboratories for quality testing and sampling.

There are some serious researchers, like Staci Gruber, who are investigating the medical benefits of cannabis. She is an associate professor of psychiatry at Harvard Medical School and the director of MIND (Marijuana Investigations for Neuroscientific Discovery). She has done research on the effects of both recreational and medical marijuana. In an interview with The Harvard Gazette, Dr. Gruber said the science on the health effects of marijuana is not yet settled. “When we think about legalization we always like to have science inform policy. In this particular case, it seems to me that policy has outpaced science.”

Gruber said there is a lot we don’t know about the effects of marijuana. Most of what we do know comes from studies of “chronic, recreational marijuana users.” There are differences between recreational and medical marijuana use, with regard to what they use and how they use. She said there has been well-founded excitement about the potential for medical cannabis use. “[But] there’s a striking paucity of research on the use of medical cannabis.”

Dr. Gruber said her goal as a scientist was to provide truthful information so all people, regardless of their recreational or medical status, can understand what is in their cannabis. In pursuit of this goal, Dr. Gruber and her colleague Kelly Sagar continued a discussion of their research with “Marijuana on the Mind?” in Policy Insights from the Behavioral and Brain Sciences. You can also watch an archived webinar by Gruber and Sagar on the same subject, “Marijuana on the Mind: A Primer for Policymakers” on the website Social Science Space, where there are also written answers to some of the questions from the webinar. The presentation exists as an independent YouTube video as well. The audio cuts out a few times, but returns if you continue with the video.

In “Marijuana on the Mind?” Gruber and Sagar gave a helpful review of the history of medical use of marijuana, noting how it was included in the U.S. pharmacopeia (a list of medicinal drugs with their effects and directions for their use) until 1942. They also documented several areas of concern with marijuana, including its adverse effects on cognition, especially executive function and memory; brain development among adolescents; and safety concerns related to the frequency and magnitude of marijuana use as well as its potency. Based upon their discussion, policy recommendations given by Gruber and Sagar include:

  1. age restrictions based upon evidence highlighting the developmental trajectory of the adolescent brain;
  2. restrictions on targeting youths in advertisements;
  3. safe packaging guidelines to prevent the accidental ingestion of edible MJ products by children;
  4. place limits on THC potency as well as minimums for potentially beneficial cannabinoids in marijuana, like CBD;
  5. more research on the impact of medical marijuana, which will likely require a lessening of marijuana as a Schedule I substance

PA medical marijuana research would do well to partner with researchers like Gruber and her organization. Let’s allow research and not rhetoric guide the medical uses of the cannabinoids in cannabis. But is Pennsylvania’s commitment to scientific testing real or just window dressing?

Over four years ago in “Marijuana Peek-a-Boo” I suggested a strategy for legalizing recreational marijuana would eat the elephant one bite at a time. Keep the battles going state-by-state and simultaneously keep the federal government out of the fight. Legislatures within the states where marijuana is not yet approved should hear about the income and health benefits of legalizing marijuana, but not the existing problems where it has been approved. Information on the different kinds of cannabinoids in marijuana and their varying medical benefits—some greater than others—needs to be suppressed. Let them think the medical benefits are all or nothing with marijuana and not contingent upon specific cannabinoids within marijuana. The known health problems from smoking marijuana should be minimized or ridiculed.

Gruber and Sagar’s policy recommendations should be seriously considered and implemented by Pennsylvania. Lawmakers should read “Marijuana on the Mind?” and/or watch “Marijuana on the Mind: A Primer for Policy Makers.” They could also read, “Marijuana Policy Has Run Ahead of Science,” which is a discussion of Gruber and Sagar’s article. The scientific testing and research of marijuana by the Commonwealth needs to be seriously and aggressively pursued. The benefits and problems with cannabinoids like THC and CBD need to be researched and described. So far it seems there are limited health benefits from THC. See “Listening to Marijuana Research”  or “Marijuana & Adverse Health Effects” for more information on this. Then there are two previous articles I wrote on marijuana legalization in Pennsylvania: “Keep Marijuana Medical in PA” and “Marijuana Stepping Stones In PA?”

02/13/18

Keep Marijuana Medical in PA

© Jonathan Weiss | 123rf.com

Western Pennsylvania is about to see medical marijuana sales begin. Two dispensaries are scheduled to open on February 15th, 2018. It’s been almost two full years since Governor Tom Wolf signed Senate Bill 3, legalizing medical marijuana on April 17, 2016. As the Governor signed the bill, he said: “I am proud to sign this bill that will provide long overdue medical relief to patients and families who could benefit from this treatment.” At the time, the press release expected implementing the state’s Medical Marijuana Program to take between 18 and 24 months, making it right on schedule. Let’s hope that what’s coming sets PA on a different path than California’s original legalization of medical marijuana did in 1996—despite the hopes of two of the sponsors of the new PA law.

When Proposition 215 was about to be approved in California, Senator Diane Feinstein said: “you’ll be able to drive a truckload of marijuana through the holes in it.” The devil is in the details, and she said that particular bill lacked details. A significant difference between Proposition 215 and the Pennsylvania Medical Marijuana Program is that in PA, dried leaves, plant material and edibles are strictly prohibited. Grower/processors can only manufacture the forms of medical marijuana listed in Act 16. These include: 1) a form medically appropriate to administer by vaporization or nebulization; 2) pills; 3) topical forms, including gels, creams or ointments; 4) tinctures; 5) liquids; or 6) oils. A licensed practitioner or medical professional determines which form is appropriate for the patient.

Cannabis products as they are to be sold in PA will provide medical relief to patients and families within the state without the patent medicine aura in dispensaries hocking different kinds of edibles or plant material for what “ails” you, as in states with less restrictive medical marijuana laws (like California). A medical professional (physician, physician assistant or certified registered nurse) has to be present during all hours a facility is open and offering to dispense or consult with a patient. Additionally, they all have to complete a required four-hour training and be registered with the PA Department of Health. Significantly, “a practitioner or physician may not issue a patient certification at the dispensary facility.”

Patients wanting to participate in the medical marijuana program have to visit the online Patients and Caregivers Registry and create a profile in the Department of Health’s patient and caregiver registry. Then they have to obtain a physician’s certification they suffer from one of the 17 serious medical conditions listed in the graphic below. Returning to the Patients and Caregivers Registry, they pay $50 a year for a medical marijuana ID card. Caregivers for minors or patients unable to travel to a dispensary themselves can also participate in the medical marijuana program. Registered caregivers can have up to five patients. See the YouTube video, “Overview of Medical Marijuana in Pennsylvania” on the webpage for more information on the Pennsylvania Medical Marijuana Program linked above.

Look on the website for other resources such as a list of approved practitioners by state region and county, the Patient and Caregiver Registry, and an Information for Patients Brochure. Under certain guidelines, a parent, legal guardian or caregiver may administer medical marijuana to students with serious medical conditions while on school property. See the website for more information on what is required for this process.

The initial guidelines described above will give patients in Pennsylvania access to marijuana for legitimate medical reasons. If the guidelines are followed as described above, they will help the state avoid its new medical marijuana program morphing into what has happened in California since the approval of Proposition 215 in 1996. But Pennsylvania citizens and government officials need to be vigilant. At least two of the cosponsors of the legislation itself want to see the plant form of marijuana available for sale in dispensaries and to eventually to see the state move towards legalizing recreational marijuana.

In April of 2017 at the World Medical Cannabis Conference & Expo held in Pittsburgh, one of the sponsors of Senate Bill 3 (SB 3), State Senator Daylin Leach, said he expected medical marijuana would be available in plant form in dispensaries sometime during 2018. He noted a section of the bill authorizes an advisory board to make recommendations by April of 2018 about whether to change the permissible forms of the drug. During a panel discussion at the Expo, Margaret Sun for WESA reported Leach said the following about the advisory board:

“But they will [approve sale of the plant form of marijuana], because we’re appointing people to do that,” Leach said as the crowd laughed. “They will recommend that at latest by April 17 (2018), which means when dispensaries open, it is likely that they will have whole plant on their shelves from day one.”

Leach’s statement went over well with his listeners, but his ability to make good on his promise is more bluster than reality. What follows is a description of the members of the Medical Marijuana Advisory Board within the State Department of Health are supposed to include. I don’t see him being able to stack this deck:

Members include the Secretary of Health; the Physician General; State Police Commissioner; Chair of the State Board of Pharmacy; Commissioner of Professional & Occupational Affairs; President of the Pennsylvania Chiefs of Police Association; President of the Pennsylvania District Attorneys Association; members to be appointed by the Governor and the four legislative caucuses who are knowledgeable and experienced in issues relating to care and treatment of individuals with a serious medical condition, geriatric or pediatric or clinical research. One member appointed by the Governor shall be a patient, a family or household member of a patient or a patient advocate.

Also, the Department of Health has the final approval on whether to add the smokeable plant form to the program, but as SB 3 is written—and as it is now described on the website—dried leaves, plant material and edibles are not approved. Leach’s words suggest his intentions in sponsoring the medical marijuana legislation was at least partly as a stepping stone to his intent to pursue full legalization of recreational marijuana. Both Leach and another sponsor of SB 3, State Senator Mike Folmer, said they thought full legalization was inevitable in Pennsylvania. Folmer stated he couldn’t politically advocate for legalization just now, as it was difficult enough getting Republicans on board with the medical marijuana program. He said:

I’d like to see our first dispensaries up, I’d like to see the first grower/processors going, and I think then, on my side, we’ll see that the sky isn’t going to fall, dogs won’t sleep with cats, and the sun will still set in the West and civilization will not crumble.

Civilization won’t crumble with the implementation of the existing PA Medical Marijuana Program. But our inability to trust disingenuous politicians who pragmatically use public sympathy for suffering individuals to further their political agendas will crumble our civilization. SB 3 was apparently a backdoor strategy for these two PA State Senators towards their desire to eventually legalize recreational marijuana. Was there ever any real concern for the needs of medical marijuana patients, or was it just rhetoric to get closer to recreational legalization? Leach is a Democrat from Montgomery County and Folmer is a Republican representing Dauphin, Lebanon and York Counties. Remember this if you live in the areas they represent as their term expires.

The Pennsylvania Medical Marijuana Program as it now exists will provide for suffering individuals within the state. And that is a good thing. Other than THC (the psychoactive cannabinoid in cannabis), there seems to be a significant medicinal potential with CBD (cannabidiol). Further research is needed and the federal classification as a Schedule I substance hampers that research from being done. That needs to change.

There are some serious researchers, like Staci Gruber, who are investigating the medical benefits of cannabis without being blinded to its potential adverse psychoactive harms. PA medical marijuana research would do well to partner with researchers like Gruber and her organization, MIND (Marijuana Investigations for Neuroscientific Discovery). Let’s let research and not rhetoric guide the medical uses of the cannabinoids in cannabis. So far it seems there are limited health benefits from THC. See “Listening to Marijuana Research” for more information on this.

Solevo Wellness is set to open its doors for business in the Squirrel Hill section of Pittsburgh on February 15th. The dispensary’s first shipment is coming from the grower-processor Cresco Yeltrah in Brookville, Jefferson County. Visitors will be greeted by a receptionist and show their necessary legal paperwork to gain access to products and then visit with a pharmacist. “Then they’ll head to a showroom, where cannabis product samples are kept inside glass cases, make a purchase and continue with their day.” The Solevo Wellness dispensary is constantly monitored by security cameras.

CY+ opened its doors with a ribbon cutting ceremony in Butler PA on February 1st. It will begin selling its products on the fifteenth as well. Larry Clark, the Pennsylvania Deputy Director of Medical Marijuana was there. He said: “It’s a medical experience”; not the head shop approach. Kimberly Geyer, the Butler County Commissioner, said: “It defies all the traditional stereotypes associated with this industry.” CY+ is owned by Cresco Yeltrah, which seems to be a subsidiary of Cresco Labs, a company out of Chicago. Charlie Bachtell, the cofounder of CY+, was at the opening in Butler. Bachtell is the CEO and Cofounder of Cresco Labs. They hope to open their second Western Pennsylvania facility in the Strip district by mid-April.

That’s just around the time Daylin Leach thought the state advisory board could approve the sale of plant product in stores. Given the difficulty it seems there was in getting SB 3 passed not only does that seem unlikely, but it would be political suicide for medical marijuana activists. Dispensing marijuana as a medical product in an environment that has the feel of a medical practice or medicine shop rather than a head shop sets the right tone. Trying to force the so-called progressive cause of legalizing recreational marijuana on the back of the recent approval of medical marijuana could sink them both in PA. But Leach may have other things on his mind since his brash claim last year at the World Medical Cannabis Conference & Expo.

Daylin Leach had an event-filled 2017. He temporarily moonlighted as a lawyer for a Philadelphia law firm that lobbies for the marijuana industry from shortly after Governor Wolf signed SB 3 until he announced a run for Pennsylvania’s 7th Congressional District in July of 2017. He then announced the suspension of his campaign in December of 2017 in the midst of accusations of a pattern of inappropriate behavior with several former female staffers. He took this step after a story in the Philadelphia Inquirer appeared in which a series of former campaign and legislative staffers accused him of inappropriate behavior. He said he was taking a step back to focus on his family and work with Senate leaders to address these allegations. “I will continue to do all that I can to advance progressive causes in the Senate and represent my constituents with honor.”

Frankly, I think he’s done enough and needs to move on to another progressive cause besides legalizing marijuana. But I suspect the financial lure of cannabis might be too strong for him to resist. So let’s make other PA state legislators aware of wanting to keep marijuana medical in PA.

02/20/17

Listening to Marijuana Research

© Mohammed Anwarul Kabir Choudhury

Would it surprise you to know that only .6% of all participants in medical marijuana programs are getting any ongoing medical oversight? Williams et al. assessed medical marijuana programs for Health Affairs according to seven components of traditional medical care and pharmaceutical regulation. The authors found that of the initial 23 states and the District of Columbia who had approved medical marijuana, 14 programs were nonmedical, according to those standards. These fourteen programs collectively enrolled 99.4% of all nationwide participants in medical marijuana programs.

One of the study’s coauthors, Dr. Silvia Martins said: “When you’re allowing someone to have access to a certain product as a medication, it needs to be overseen by good medical practices and medical rules.” And that is necessarily based on a clear understanding of the risks and benefits of any medicinal product.

With that in mind, the MIND project at McLean Hospital in Boston is researching medical marijuana (MMJ).  MIND stands for: Marijuana Investigations for Neuroscientific Discovery. Currently MIND is conducting a longitudinal study of MMJ. The first phase of the MIND project assesses subjects at baseline, before beginning their MMJ treatment. They then track their use of marijuana (MJ) and are in touch with researchers biweekly. Follow up visits occur every three months for two years in order to assess the potential impact of MMJ on cognitive function and related brain and quality of life measures.

The second phase is an FDA-approved clinical trial of high-CBD sublingual tincture for treating anxiety. A third and final phase will examine the clinical state and cognition in veterans who are using cannabinoids to treat various conditions, including PTSD, insomnia and pain. The MIND website noted how policy has gone too far ahead of science, so there is little data available on the impact of MMJ on cognitive functioning.

Given the considerable difficulty with cognitive function and disrupted mood experienced by patients with severe medical disorders, the addition of MJ, which has shown promise in alleviating a range of symptoms, could potentially improve cognitive performance. Equally critical, data showing a loss or impairment of cognitive function following the use of MMJ could inform alternative courses of treatment, staggered dosing, and ultimately prevent unjustified exposure to harm. As the number of states who have passed MMJ laws continues to grow, the ‘need to know’ has never been more important, relevant or timely, and has significant implications for public health policy.

Staci Gruber, who is the director of the MIND project, has been doing research into the effects of MJ since the early 1990s and has documented some interesting neurological effects from MJ. She led a 2013 study that found there were differences in the brain’s white matter and impulsivity between teenagers and young adults smoked an average of 25.5 joints of MJ per week and a control group who did not smoke MJ. Their research suggested that in some individuals who begin smoking MJ at an early age, differences in brain function and structure emerge during development. The study sample was small and it was not clear if the brain changes resulted from MJ use or predated MJ use. The changes could have occurred as the result of either chronic MJ use or reflect a delay in brain development in MJ smokers.

These data represent the first report of significant alterations in frontal white matter fiber tract integrity that are associated with self-report measures of impulsivity in chronic, heavy MJ smokers, and appear to be related to age of onset of MJ use. . . . Future investigations should include additional measures of behavioral impulsivity and their relationship to age of onset of MJ use to more fully explore the potential neurodevelopmental aspects of white matter changes in MJ smokers. Findings from this study suggest that changes in white matter microstructure may be predictive or associated with increased impulsivity, and may ultimately contribute to the initiation of MJ use or the inability to discontinue use.

A follow up study done by Gruber and others was published that same year, 2013. The study confirmed that heavy MJ smokers had lower levels of white matter in the corpus callosum region of the brain; and that earlier age of MJ use was associated with these lower levels of white matter. MJ smokers also had higher levels of impulsivity.

Taken together, these findings reinforce the idea that early onset of MJ use negatively impacts white matter development and is associated with behavioral impulsivity, a combination that may have enduring negative effects, particularly on the developing brain. Data from this study highlight the importance of early identification of MJ use among emerging adults and the need for efforts aimed at delaying or preventing the onset of MJ use.

Then a third study by Gruber and her research team at MIND published in the March 2016 issue of the Journal of Studies on Alcohol and Drugs found that MJ smokers had poorer executive brain function than the control group. The difference seemed to be primarily the result of early onset of MJ use, before the age of 16. The differences remained even after the frequency and amounts of MJ used were controlled. Additionally, the early MJ use and the greater amounts of MJ used predicted poorer performance and errors on the Wisconsin Card Sorting Test (WCST), which is used to assess abstract thinking. “The WCST is also considered a measure of executive function because of its reported sensitivity to frontal lobe dysfunction.”

These findings underscore the impact of early onset of marijuana use on executive function impairment independent of increased frequency and magnitude of use. In addition, poorer performance on the WCST may serve as a neuropsychological marker for heavy marijuana users. These results highlight the need for additional research to identify predictors associated with early marijuana use, as exposure to marijuana during a period of developmental vulnerability may result in negative cognitive consequences.

STAT News highlighted Dr. Gruber’s research with MIND in an August 2016 article. She commented there on the commitment of some of her research participants, how they drive two to three hours to be part of the MIND study. “They’re really committed. They really want to know what effect this will have on them.”

After reviewing some of the comments on the STAT article, it seemed to me that several of the pro marijuana readers either missed or ignored a few of her comments in the article. One of her comments was: “There’s a lot we don’t know about long-term effects, and that’s what I’m here to find out.” In a second remark Gruber pointed out that the cannabinoids she studies aren’t the ones that get you high. “But whether you’re for medical marijuana or against it, what we really need is information.”

SAMA (Science and Management of Addictions) president, Kim Bracket, said Staci Gruber has a talent for translating scientific information so that non-scientists can understand. This leads to a third and telling comment by Gruber in the article: “In science, you can have all the findings in the world, but if you can’t communicate them, what good are they?” So far, I think she is communicating her findings clearly and concisely to scientists and non-scientists, legalization activists and opponents to legalization. And we need to continue to listen to what she says.