01/30/24

Continue to Keep Marijuana Medical in PA

Photo by Alesia Kozik: https://www.pexels.com/

Medical marijuana has been available in Pennsylvania since February of 2018. Fortunately, progress to the legalization of recreational marijuana has not occurred yet. I’ve been urging for almost six years that we wait for the research into the risks and benefits of marijuana use can be reliably researched. Here are three recently published research articles to reflect on that suggest going ‘full Colorado’ in Pennsylvania may not be a good idea.

In August of 2023, The British Medical Journal (BMJ) published “Balancing risks and benefits of cannabis use” by Solmi et al. Their research was an umbrella review of 101 meta-analyses that have reported on the safety of cannabis, cannabinoids or cannabis-based medicines. According to the 2019 Global Burden of Disease Study, Solmi et al said more than 23.8 million people have cannabis use disorder (CUD). In the U.S., the prevalence of CUD was estimated at around 6.3% in a lifetime. In Europe, around 15% of people aged 15 to 35 reported using cannabis in the past year.

In Europe, over the past decade, self-reported use of cannabis within the past month has increased by almost 25% in people aged 15-34 years, and more than 80% in people who are 55-64 years. Cannabis or products containing tetrahydrocannabinol (cannabinoids) are widely available and have increasingly high tetrahydrocannabinol content. For instance, in Europe, tetrahydrocannabinol content increased from 6.9% to 10.6% from 2010 to 2019. Evidence has suggested that cannabis may be harmful, for mental and physical health, as well as driving safety, across observational studies but also in experimental settings. Conversely, more than a decade ago, cannabidiol was proposed as a candidate drug for the treatment of neurological disorders such as treatment-resistant childhood epilepsy. Furthermore, it has been proposed that this substance might be useful for anxiety and sleep disorders, and even as an adjuvant treatment for psychosis. Moreover, cannabis-based medications (ie, medications that contain cannabis components) have been investigated as putative treatments for several different conditions and symptoms.

There was converging evidence of an increased risk of psychosis in adolescents and adults, and with psychosis relapse in people with a psychotic disorder. There was an association between cannabis and general psychiatric symptoms such as depression and mania; and detrimental effects on memory, verbal delayed recall, verbal learning and visual immediate recall. “Across different clinical and non-clinical populations, observational evidence suggests an association between cannabis use and motor vehicle accidents.” There was also evidence of an association with somnolence (drowsiness) with cannabinoids and cannabidiol. Cannabis-based medicines were associated with visual impairment, disorientation, dizziness, sedation and vertigo.

In addition to the association of cannabis and psychosis, cannabis use is associated with a worse outcome after onset, including poorer cognition, lower adherence to antipsychotics and a higher risk of relapse. “In other words, use of cannabis when no psychotic disorder has already occurred increases the risk of its onset, and using cannabis after its onset, worsens clinical outcomes.” Mood disorders have their peak of onset close to that for cannabis use, raising concern because of the associations noted in this study between cannabis and depression, mania and suicide attempt. High THC content cannabis is thought to serve at a gateway to other substances, especially in younger people.

With regard to the therapeutic potential of cannabis-based medicines, cannabidiol was beneficial in reducing seizures in certain forms of epilepsy. They were also beneficial for pain and spasticity in multiple sclerosis, as well as for chronic pain in various conditions. In patients with chronic pain, the effects of prolonged use of cannabinoids needs to be tested “because current findings only come from short term randomized controlled trials.” Active comparisons between cannabidiol and available options for epilepsy, cannabis-based medicines and other pain medications, other treatments for muscle spasticity in multiple sclerosis are needed with a focus on efficacy and safety to inform future guidelines.

In conclusion, Solmi et al said converging and convincing evidence supported the association of marijuana use with poor mental health and cognition and the increased risk of car crashes. Cannabis use should be avoided in adolescents and young adults when neurodevelopment is still occurring, when mental health disorders begin and cognition is important for optimizing academic performance and learning. Cannabidiol could be considered as a potential treatment option in epilepsy. Cannabis-based medicines could be considered for chronic pain across different conditions, and for nausea and vomiting and for sleep in cancer.

Law and public health policy makers and researchers should consider this evidence synthesis when making policy decisions on cannabinoids use regulation, and when planning a future epidemiological or experimental research agenda, with particular attention to the tetrahydrocannabinol content of cannabinoids. Future guidelines are needed to translate current findings into clinical practice.

The 2022 National Survey on Drug Use and Health (NSDUH) released in November of 2023, 22% of people 12 or older reported using marijuana in various ways (smoking, vaping, dabbing, eating or drinking, lotion or cream, taking pills or some other way). The percentage was highest among young adults, 18 to 25 (38.2% or 13.3 million people), followed by adults over 26 (20.6%, 45.7 million people), then adolescents 12 to 17 (11.5%, 2.9 million people). Among people 12 or older in 2022, 6.7% or 19 million people, has a CUD (cannabis use disorder) in the past year. The percentage of young adults 18 to 25 with CUD was 16.5% or 5.7 million people. Adolescents aged 12 to 17 with CUD was 5.1%, or 1.3 million people. These figures were higher than the data reported in the following article, “Cannabis-Related Disorders and toxic Effects,” perhaps reflecting more recent data.

In December on 2023, The New England Journal of Medicine published “Cannabis-Related Disorders and Toxic Effects” by Daniel Gorelick. The article reviewed the seven cannabis-related disorders defined in the DSM-5-TR. The author said worldwide, an estimated 209 million persons between 15 and 64 used cannabis in 2020. In the U.S., an estimated 52.4 million people 12 and older used cannabis in 2021, representing 18.7% of that age group. And 16.2 million persons met the diagnostic criteria for CUD.

Cannabis use disorder occurs in all age groups but is primarily a disease of young adults. The median age at onset is 22 years (interquartile range, 19 to 29). In the United States, the percentage of 18-to-25-year-old persons with current (past-year) cannabis use disorder in 2021 was 14.4%. Younger age at initiation of cannabis use is associated with faster development of cannabis use disorder and more severe cannabis use disorder.

The major risk factors for developing CUD are the frequency and duration of cannabis use. And the core feature is loss of control, reflected in persistent use despite adverse consequences. The potency and amount of cannabis are also risk factors, but they have not been well studied because of the difficulty in quantifying the amount and potency of the THC content of products. “The potency of cannabis has doubled over the past 2 decades, according to analyses of samples seized by U.S. law enforcement, which may contribute to the increased risk of cannabis use disorder and cannabis-induced psychosis.” The risk of CUD increases with the frequency of use: 3.5% prevalence of CUD with yearly use (less than 12 days per year); 8.0% with monthly use (up to 4 days per month); 16.8% with weekly use (up to 5 days per week); and 36% with daily or near daily use.

Several clinical and sociodemographic factors are associated with an increased risk of cannabis use disorder, including the use of other psychoactive substances such as alcohol and tobacco; having had adverse childhood experiences (such as physical, emotional, or sexual abuse); having a history of a psychiatric disorder or conduct problems as a child or adolescent; depressed mood, anxiety, or abnormal regulation of negative mood; stressful life events (such as job loss, financial difficulties, and divorce); and parental cannabis use. These significant associations do not necessarily indicate a direct causal influence on cannabis use disorder, because many of these factors are also highly associated with both cannabis use and frequent cannabis use.

Gorelick told Medical Xpress almost 50% of people with CUD have another diagnosable psychiatric disorder such as major depression, PTSD or generalized anxiety disorder. He said: “There is a lot of misinformation in the public sphere about cannabis and its effects on psychological health with many assuming that this drug is safe to use with no side effects.” About 1 in 10 people who use cannabis will become addicted and if you start using before the age of 18 the risk rises to one in six. Cannabis use accounts for 10% of all drug-related emergency room visits and is associated with a 30 to 40 percent increased risk of car accidents.

He concluded that CUD and heavy or long-term cannabis use have clear adverse effects on physical and psychological health. He thought research on the endocannabinoid system is needed to better explain the pathophysiology of these effects and to develop treatments. In other words, continue to keep marijuana medical in PA until we have reliable research to determine whether or not recreational marijuana should be legalized. So far, it’s not looking to be a wise move.

For more information on marijuana and the concerns with legalization, search for “marijuana” or “cannabis” on this website or see, PREPARING to Legalize Cannabis.” For more information on marijuana legalization in Pennsylvania, see “Keep Marijuana Medical in PA,” “Waiting Before Pennsylvania Goes ‘Full Colorado’” and others.

03/7/23

Marijuana Policy Has Run Ahead of Science

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:

age restrictions based upon evidence highlighting the developmental trajectory of the adolescent brain;
restrictions on targeting youths in advertisements;
safe packaging guidelines to prevent the accidental ingestion of edible MJ products by children;
place limits on THC potency as well as minimums for potentially beneficial cannabinoids in marijuana, like CBD;
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.

01/14/20

Eating the Elephant of Marijuana Legalization in PA

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 25^th 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 15^th, 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 16^th, 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.

age restrictions based upon evidence highlighting the developmental trajectory of the adolescent brain;
restrictions on targeting youths in advertisements;
safe packaging guidelines to prevent the accidental ingestion of edible MJ products by children;
place limits on THC potency as well as minimums for potentially beneficial cannabinoids in marijuana, like CBD;
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?”

05/18/18

Marijuana Stepping Stone in PA?

Frank Glover / Stepping stones over the Wharfe / CC BY-SA 2.0

As medical marijuana began to be sold in Pennsylvania I speculated that a prediction by a co-sponsor of Senate Bill 3, that dry leaf marijuana would be sold in PA dispensaries sometime in 2018, was more bluster than reality. But it seems I was wrong. On April 16^th, 2018 Governor Wolf announced that he supported changes to the existing state medical marijuana program that would allow dispensaries to sell dry leaf marijuana. Regulations to enact the recommendations will be available in the Pennsylvania Bulletin on May 12. Were the state legislators who voted for Senate Bill 3 aware a provision in it would permit an advisory board to approve the sale of dry leaf marijuana at a later date, even though the initial bill did not permit it? And were they aware there would be a move to sell dry leaf in dispensaries so quickly? Would they have voted for the Bill if they knew that was the goal?

Rachael Levine, the PA Health Secretary, announced on April 16^th that she approved recommendations from the state’s medical marijuana advisory board to permit the sale of dry leaf “for patients with a qualifying medical condition.” The rationale to permit access to dry leaf marijuana was said to offer a lower-cost option to the concentrate forms. Allegedly the flower form is believed to be more effective in treating some medical conditions with better dosage control than the concentrate form ( a statement made without any supporting evidence). PA law still prohibits smoking medical marijuana or using it in edible form, but plant matter can be legally vaporized, meaning it can be heated, but not burned.

It’s not clear how that rule would be enforced once the marijuana is purchased and taken home. Dr. Levine said patients would be urged to follow the prescribed methods for administering the medical marijuana. “We are not looking for an intoxicating effect. We are looking for a medical effect.”

The Cannabist wrote about the proposed changes to allow the sale of dry leaf or flower marijuana in Pennsylvania. A cannabis consumer advocate said no state law would prevent certified medical marijuana users from buying the dry leaf product and smoking it legally, instead of vaporizing it. “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.”

In all, there were 21 proposed changes to Pennsylvania’s medical marijuana program. Additional changes included allowing physicians participating in the program to choose to not have their name listed in the public registry to encourage more physicians to participate. The number of qualifying medical conditions is to increase from 17 to 21. One of those additional medical conditions was “the use of medical marijuana as a substitute for treating opioid addiction.” This change barely passed, with six of the 12 voting advisory board members voting in favor and at least one person abstaining (More on this issue later). Another proposed change that would limit a practitioner’s ability to specify the form and dose of medical marijuana a patient should get was not approved. Governor Wolf’s statement said:

My administration is committed to ensuring patients who need and would benefit from this medicine have access to it. The final report of the Medical Marijuana Advisory Board continues to put patients first and will improve the program to give greater access to patients by breaking down financial and administrative barriers. Allowing dry leaf for vaporization will shorten the time it takes to get medication to dispensaries, expand options for the growing number of patients, and hopefully make the program less cost-prohibitive for some patients.

But is this just political rhetoric? Are Pennsylvania’s elected officials being maneuvered into a path toward the eventual legalization of recreational marijuana?

State Senator Daylin Leach predicted at the World Medical Cannabis Conference & Expo, held in Pittsburgh on April 21 and 22 of 2017, that medical marijuana in plant form would be available in dispensaries sometime in 2018. During a panel discussion at the Expo held at the David L. Lawrence Convention Center, he noted State Bill 3 had a section permitting the advisory board to make recommendations by April 2018 about changing the permitted forms of the drug. “But they will, because we’re appointing people to do that.” He believes that full legalization of recreational marijuana in Pennsylvania is inevitable.

State Senator Mike Folmer was another of the primary sponsors of State Bill 3. He said he’s not opposed to legalizing recreational marijuana, but he can’t “politically advocate” for it at this time. WESA said he recalled “how difficult it was to get enough Republicans on board with the medical marijuana program.” I wonder if those unnamed Republicans were aware that their approval of State Bill 3 had a loophole section permitting the advisory board to approve changes to the permitted forms of marijuana? Are they feeling manipulated into approving what was presented as a bill that would restrict the dispensing of dry leaf cannabis?

CBD vs. THC

Another issue with the approval of selling cannabis dry leaf in the dispensaries is making a clear distinction of the kinds of marijuana that will be sold. There seems to be very little effort made when discussing medical marijuana in Pennsylvania—either by the media or government officials—to distinguish cannabis with high levels of THC from strains with high levels of CBD. Tetrahydrocannabinol (THC) is psychoactive, while cannabidiol (CBD) is not. A helpful overview of the differences between THC and CBD can be found in: CBD vs. THC: Main Differences.

Both THC and CBD are present in mature cannabis flower. But different cannabis strains produce different amounts of the compounds. So what strains of cannabis will be sold for medical reasons in Pennsylvania and will they have high concentrations of THC or CBD? Will there be more high THC strains?

Cannabinoids like THC and CBD effect the endocannabinoid system (ECS), which is “named for the plant that inspired its discovery.” Until recently the ECS was an unknown part of the human body’s functions. It helps ensure the proper running of the body’s immune and central nervous system. Its discovery came about through the research efforts of Lisa Matusuda and her team at the National Institute of Mental Health (NIMH) in the early 1990s, where they first identified a THC-sensitive receptor in the brains of lab rats. “The endocannabinoid system is responsible for regulating balance in our body’s immune response, communication between cells, appetite and metabolism, memory, and more.” The cannabinoids in cannabis like THC and CBD interact with the ECS to produce their effects.

Another researcher team was able to identify two of the body’s naturally produced endocannabinoids, anandamide and 2-arachidonoyglycerol (2-AG). 2-AG is a full agonist of both CB₁ and CB₂ receptors. Anandamide is a partial agonist of both receptors and as a result, doesn’t trigger as powerful a physiological response. Cannabinoids like THC and CBD mimic the behavior of endocannabinoids like 2-AG and anandamide. THC activates CB₁receptors, producing the high effect. Although THC also activates CB₂receptors, there it is a partial agonist, meaning it does not have as strong of a physiological effect.

“CBD causes chemical changes by blocking receptors. It tends to have low affinity for both CB₁and CB₂receptors, and instead acts as an indirect antagonist of agonists.” In other words, CBD blocks other chemicals like THC from binding and activating the receptors, as shown in the following graphic in: CBD vs. THC: Main Differences:

By modulating the endocannabinoid system, several diseases and conditions could possibly be treated, including: pain, inflammation, multiple sclerosis, anorexia, epilepsy, cancer, glaucoma, cancer, obesity, schizophrenia, cardiovascular disorders, Parkinson’s disease, Huntington’s disease, Alzheimer’s disease and Tourette’s syndrome.

One of the main obstacles to the acceptance and use of cannabis as a medicine is its potential for psychoactivity from THC. BUT “this issue does not arise in a number of possible approaches to the regulation of the endocannabinoid system.” One way is when a non-psychoactive cannabinoid like CBD is used for therapeutic reasons. Another is when an antagonist to the CB₁ receptor blocks THC from activating it. Are the cannabis strains and medical marijuana products being distributed in Pennsylvania formulated to minimize the euphoric activation of the CB₁ receptor by THC?

Benefits of CBD

Josh Axe, a wellness physician, has listed “8 Proven Benefits of CBD.” On his list are 1) that CBD relieves pain and inflammation; 2) it has antipsychotic effects; 3) it reduces anxiety; 4) helps to fight cancer; 5) relieves nausea; 6) it may treat seizures and other neurological disorders; 7) it could lower the incidence of diabetes; and 8) it promotes cardiovascular health. Dr. Axe cited multiple references to support these claims. He acknowledged several health benefits with THC, including its antispasmodic, analgesic, anti-tremor, anti-inflammatory and appetite stimulating properties. However, there are multiple adverse effects from marijuana use that have been documented in studies primarily of recreational marijuana, which is high in THC. See “Marijuana Research Findings” for more information.

Approving “medical marijuana as a substitute for treating opioid addiction” is a broad and vague addition to the list of approved medical uses of marijuana in Pennsylvania. Does that mean an individual could use medical marijuana as a MAT (medication-assisted treatment) for an opioid misuse disorder? There is reliable evidence for marijuana (THC and CBD) to relieve pain, but that is different than treating opioid addiction.

According to the Chicago Tribune the Illinois Senate recently passed a bill that would allow patients to take an opioid prescription and a signed doctor’s note to a medical marijuana dispensary in order to substitute marijuana for pain relief. “The dispensary must verify approval from a doctor and ensure a patient is not already receiving medical marijuana through another means.” One of the bill’s sponsors said: the bill “keeps people from getting strung out and spiraling down.” The Chicago Tribune commented where that state Senator received at least $8,000 in campaign contributions from medical marijuana interests.

Opponents to the bill said lawmakers were helping medical marijuana dispensaries become profitable businesses by expanding the number of people who can use the drug. One lawmaker said: I just want to make note and remind people that the medical marijuana program was lobbied by people who now own it.” If support for the bill in Illinois was motivated by individuals looking to profit from it, that should be known. However, note again that it was directed to patients with an opioid prescription substituting medical marijuana for the prescription and not the vaguely defined use “as a substitute for treating opioid addiction.”

There was a report on the NPR program All Things Considered on April 2, noting: “Opioid Use Lower In States That Eased Marijuana Laws.” The article highlighted two studies published in JAMA Internal Medicine showing there was a decrease in Medicare and Medicaid prescriptions for opioids in states with liberal marijuana laws. One study found a 14% reduction in opioid prescriptions in states allowing easy access to medical marijuana. The finding was a correlation and thus doesn’t prove marijuana use would result in a reduction in the use of opioids. Nevertheless, “the findings suggest that expanding access to medical marijuana could help ease the opioid epidemic.” Again, this is not vaguely defined use as a substitute treatment for opioid addiction. One of the researchers said:

Like any drug in our FDA-approved pharmacopeia, it can be misused. There’s no question about it. So I hope nobody reading our study will say ‘Oh, great, the answer to the opiate problem is just put cannabis in everybody’s medicine chest and we are good to go.’ We are certainly not saying that.

The authors of the second study said while laws permitting marijuana use have the potential to reduce opioid prescribing in a population segment with a high risk for chronic pain use disorder and opioid overdose, “Nevertheless, marijuana liberalization alone cannot solve the opioid epidemic.”

Another study cited in the NPR report, “Cannabis Use and Risk of Prescription Opioid Use Disorder,” found cannabis use appeared “to increase rather than decrease the risk of developing nonmedical opioid use.” The lead author of the study said there was likely a role “for medical marijuana in reducing the use of prescribed opioids for the management of pain.” But it is a question of balancing risks and benefits, which is hard to do when the current studies are based on broad populations and not the at-risk populations as a whole. And once again, the potential is for individuals with pain issues to benefit from marijuana, not for it to be used as a substitute for treating opioid addiction.

Governor Wolf said he is committed to seeing that citizens of Pennsylvania who need medical marijuana get it. Secretary Levine said: “We are not looking for an intoxicating effect. We are looking for a medical effect.” Hopefully that means cannabis strains and medical marijuana products that are high in CBD and low in THC will be sold in Pennsylvania dispensaries while high THC products will be limited. It is also alarming that such a vague expansion of the permitted treatments, namely to use “medical marijuana as a substitute for treating opioid addiction,” could be included in the revised regulations. Let’s hope the government officials and regulators work to keep marijuana medical in Pennsylvania. But it is also apparent that there are others, perhaps including some of the sponsors of Senate Bill 3, who see the state’s approval of medical marijuana as a stepping stone towards recreational marijuana.

Documents detailing multiple revisions to Pennsylvania’s Medical Marijuana Program were posted online on May 12, 2018. They include permitting the sale of “dry leaf or plant form for administration by vaporization.” This can be smoked like recreational marijuana, although it is illegal in PA to do so. However, there is no clear way to enforce the restriction. As noted above, a pro cannabis activist acknowledged individuals would smoke, not vaporize the dry leaf product saying, “This is how humans have used cannabis for 10,000 years and it’s how people should have access to it in Pennsylvania.”

Also, opioid use disorder is now an approved medical condition to receive medical marijuana. The new regulation is vague and subjective. It seems to provide a loophole for individuals who have an opioid use disorder diagnosis to qualify for a medical marijuana card. The new regulation permitting medical marijuana for opioid use disorder reads: “Opioid use disorder for which conventional therapeutic interventions are contraindicated or ineffective, or for which adjunctive therapy is indicated in combination with primary therapeutic interventions.” The documents describing the amended regulations are available here: http://cannabislawpa.com/updates-resour…/regulatory-updates/

Please share this information with others who may be concerned with the revised regulations so they can voice their concerns. Anyone troubled by these noted changes, or any others within the new guidelines can submit written comments, suggestions or objections regarding these amended temporary regulations to John J. Collins, Office of Medical Marijuana, Department of Health, Room 628, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120, (717) 547-3047. The given email address for John Collins was invalid. I will update it here if I locate a valid one.

02/13/18

Keep Marijuana Medical in PA

Western Pennsylvania is about to see medical marijuana sales begin. Two dispensaries are scheduled to open on February 15^th, 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 15^th. 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 1^st. 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 7^th 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.

04/25/17

Pesticides, Fungi and Pot

In 2015, two Colorado marijuana users sued the state’s largest marijuana grower, claiming it used a dangerous agricultural fungicide on its pot plants. The fungicide, Eagle 20, contains the chemical myclobutanil, which becomes poisonous when ignited. The allegations were that while Eagle 20 is approved for certain edible products, it is not approved for smokable products like marijuana and tobacco. The lawsuit said: “Persons who smoke cannabis that has been sprayed with Eagle 20 inhale … poisonous hydrogen cyanide.” The company, LivWell, maintained its plants are safe.

The two individuals alleged they were not aware of LivWell’s use of Eagle 20 on their cannabis when they bought it. Had they known, they would not have smoked LivWell’s cannabis. They were asking for a monetary reimbursement for their unused product and were also demanding that LivWell stop using the Eagle 20 fungicide on its cannabis. The plaintiff’s lawyer said that to his knowledge, this was the first product liability action filed against the legal marijuana industry. LivWell’s owner said: “Testing of our finished product by an independent, state-licensed lab approved by the City of Denver showed that our products are safe – as we have always maintained.”

In the end, the lawsuit was dismissed. The Denver judge who heard the case said the plaintiffs couldn’t sue because they were not actually harmed. They bought and then consumed the pot without any repercussions. The written opinion noted there were no allegations that the cannabis did not perform as it was supposed to; and both consumers smoked it without harm. LivWell’s owner said this had been a ploy intended to smear the company’s name. “The people behind this case do not want the commercial cannabis industry to succeed and will try anything to bring down the industry.”

Setting aside the rhetoric from the lawyers on both sides of the dismissed lawsuit and LivWell’s owner, the use of pesticides on marijuana is a growing concern for the industry. The marijuana website The Cannabist has an archived page on marijuana pesticides with fourteen articles published between December 4, 2015 and July 29, 2016. Their titles range from: “Check Your Stash: Are you consuming pesticide-peppered pot? Full recall list” to “State releases hundreds of recalled pot batches after they tested pesticide-free.”

Ricardo Baca and others, writing for The Cannabist, said Denver’s Department of Environmental Health has issued 26 recalls of marijuana and pot products since September of 2015. The Colorado Marijuana Enforcement Division has issued 26 recalls in the form of administrative holds between February and July of 2016. The recalls originated from an executive order issued by the governor of Colorado in November of 2015. Within the order, the governor said: “Until scientific assessment establishes which additional pesticides can be safely applied to marijuana, marijuana contaminated by an Off-Label Pesticide shall constitute a threat to the public safety.”

At the core of legal cannabis’ pesticide problem in Colorado is the state’s lack of a pesticide certification for marijuana testing labs. So while cannabis testing facilities are certified by the state’s health department to test for potency and contaminants, the Colorado Department of Public Health and Environment is still working with other agencies, labs and industry to develop proficiency standards and testing certification requirements for pesticide tests.

Reporting originally for The Denver Post, David Migoya and Ricardo Baca, noted how The Post revealed in its own testing that a number of marijuana-infused products contained high levels of pesticides that shouldn’t be used on cannabis. The Catch-22 is that there is no pesticide specifically approved for use with marijuana, because pesticide chemicals are regulated by the EPA. And since cannabis is illegal under federal law, there are no federal standards. “As a result, there have been no tests to show how pesticides used on marijuana could affect consumers or whether their use is safe.” Colorado state agriculture officials have allowed certain pesticides to be used on marijuana as long as it does not violate the restrictions of the product’s label.

Ron Kammerzell, a senior director in the Colorado Department of Revenue, which oversees the state Marijuana Enforcement Division (MED), said the state’s responsibility was to make sure the marijuana is safe for the consumer and not contaminated by pesticides. The top priority is to keep pesticide-contaminated products from getting to consumers. He added that pesticides were a challenging area fro testing, so they wanted to be sure they did it right. “Once we have mandatory testing for pesticides, that will be a game-changer in terms of making sure that we’re minimizing these types of contaminations.” Kammerzell hopes to have the state’s pesticide testing certification program implemented sometime in 2017.

Writing for Slate, Rachel Gross noted how cannabis vendors are pitching healthier, organic marijuana to their customers. “Like wine aficionados, certain weed smokers have always had a reputation for being connoisseurs.” The U.S. legal cannabis industry was projected to bring in almost $7 billion in 2016. The founder of Clean Green, a marijuana-certifying program, said: “These are sophisticated buyers, the same people who are buying organic food and organic coffee.” The industry is becoming more industrialized and corporate and the fear is that industrial pot is laced with pesticides.

Consider the gram of weed you can buy, right now, in the four states (Washington, Oregon, Colorado, and Alaska) and Washington, D.C., where recreational marijuana is legal (or the 24 states where it’s available for medical purposes). Before it was sealed in that baggie, it was a plant. That plant likely got sprayed with fungus-, insect-, and disease-killing chemicals. Before it was a plant, it was a seedling. That seedling may have sat in soil that had been fumigated with even more pesticides. And before that seedling got planted, the grow room that would one day be its home was probably bug-bombed and lined with pest strips, which are laced with chemicals that linger in enclosed spaces.

Thanks to the series of recalls, like those noted above in Colorado, consumers are becoming more aware of the pesticide issues in the marijuana industry. The Oregonian found abnormally high levels of pesticides in nearly half the products sold in state dispensaries. “Those pesticides included a common roach killer, half a dozen human carcinogens, and a fungicide [myclobutanil] that allegedly turned into hydrogen cyanide when heated.” The dose is the issue. Even a toxic substance like hydrogen cyanide could be harmless in a small enough dose. Oregon is working closely with the state of Washington and Colorado to coordinate which pesticides should be tested for in cannabis.

Researchers at UC Davis recently announced a study that found medical marijuana contained “multiple bacterial and fungal pathogens that may cause serious and even fatal infections.” Smoking, vaping or inhaling aerosolized marijuana may pose a serious health risk to individuals, especially those with impaired immune systems. George Thompson, one of the study’s authors, noted where patients with impaired immune systems are routinely advised to avoid exposure to plants and certain raw foods because of the risk of infection. “But at the same time, they are increasingly turning to medical marijuana to help them with symptom control. Because microorganisms known to cause serious infections in immunocompromised patients were found to be common on marijuana, we strongly advise patients to avoid it.”

They publically voiced their concerns in a letter to the editor of the journal Clinical Microbiology and Infection. There is a copy of the letter here. The news media also picked up on the study. Claudia Black, writing for The Sacramento Bee, said the uneasy news comes as a majority of states have eased laws on medical and recreational marijuana, and a majority of U.S. doctors support the use of medical marijuana for symptoms such as pain, nausea and loss of appetite during chemotherapy and other treatments. George Thompson was quoted as saying it was a big oversight to not warn patients with compromised immune systems to avoid marijuana. “It’s basically dead vegetative material and always covered in fungi.”

The study gathered marijuana from 20 Northern California growers and dispensaries. The analysis of marijuana for the study was done by Steep Hill Labs, a cannabis testing company. “The analysis found numerous types of bacteria and fungi, including organic pathogens that can lead to a particularly deadly infection known as Mucor.” There is a misconception that if it is from a dispensary, the marijuana must be safe. But that’s not the case, according to Joseph Tuscano, another one of the researchers. “This is potentially a direct inoculation into the lungs of these contaminated organisms, especially if you use a bong or vaporization technique.” You can watch a CBS Sacramento news video on the study posted on YouTube here.

So it’s not just that the anti-pot people are out to sink the industry. Its customers are concerned about the presence of pesticides in their pot. Researchers are finding that some marijuana contains common bacteria and fungi that poses a danger to individuals with compromised immune systems. The marijuana industry is going through some serious growing pains. But the question begs to be asked, did the states that legalized recreational and medical marijuana run ahead of the regulatory and bureaucratic changes needed to support it?

02/20/17

Listening to Marijuana Research

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.

11/29/16

Marijuana & Adverse Health Effects

In the 2016 election there was another political milestone met besides the presidential election of Donald Trump—four more states voted to legalize recreational marijuana. California, Maine, Massachusetts, and Nevada joined Alaska, Colorado, Oregon, Washington and the District of Columbia. However, the public use of marijuana—recreational or medical—is still not permitted anywhere. Arkansas, Florida and North Dakota approved medical marijuana initiatives and Montana loosened restrictions on an existing medical marijuana law. The executive director of the Drug Policy Alliance was quoted in The Washington Post as saying: “The end of marijuana prohibition nationally, and even internationally, is fast approaching.”

Given the election of Donald Trump and the international position on marijuana, this may be more optimism than reality. Within the U.S. there has been clear momentum towards legalization of some kind, as there are now eight states and the District of Columbia where recreational marijuana is legal; and 28 states and the District of Columbia where medical marijuana is permitted. However, because of the ongoing federal classification of marijuana as a Schedule I drug, reliable research into the benefits and adverse health effects from marijuana use is hard to come by. The public needs to be more aware of the scientific research into the potential adverse effects and medical benefits from marijuana as the U.S. continues to move toward a complicated, patchwork quilt of varied state laws and regulations regarding marijuana.

A good place to start is with an article written by the current director of the National Institute on Drug Abuse (NIDA), Dr. Nora Volkow and three others, “Adverse Health Effects of Marijuana Use.” Volkow et al. reviewed the current state of the scientific findings on the adverse health effects related to the recreational use of marijuana. Their review focused on the areas where the evidence was the strongest. In a table summarizing their confidence in the evidence for adverse effects of marijuana on health and wellbeing, they gave the following assessment of marijuana use, particularly with heavy or long-term use that starts in adolescence.

Effect	Overall Level of Confidence
Addiction to marijuana or other substances	High
Diminished lifetime achievement	High
Motor vehicle accidents	High
Symptoms of chronic bronchitis	High
Abnormal brain development	Medium
Progressive use of other drugs	Medium
Schizophrenia	Medium
Depression or anxiety	Medium
Lung cancer	Low

Long-term marijuana use can lead to addiction; there’s no real doubt. About 9% of those who experiment with marijuana will develop dependence, according to the criteria for dependence in the DSM-IV. This increases to one in six (16.7%) among those who started using marijuana as teens. Daily smokers have a 25% to 50% risk of developing an addiction to marijuana. There is also a cannabis withdrawal syndrome, with symptoms such as: irritability, sleep difficulties, dysphoria (a state of being unhappy or unwell), cravings, and anxiety.

Since the brain remains in a state of active development until around the age of 21, individuals under 21 who use marijuana are more vulnerable to adverse long-term effects from marijuana use. Adults who smoked marijuana regularly during adolescence have impaired neural connectivity (fewer fibers) in certain brain regions.

The impairments in brain connectivity associated with exposure to marijuana in adolescence are consistent with … findings indicating that the cannabinoid system plays a prominent role in synapse formation during brain development.

While regular use of marijuana is associated with anxiety and depression, causality has not been established. Marijuana is also regularly linked to psychosis, especially among people with a predisposition. Heavy marijuana use, greater drug potency, and exposure at a young age can all negatively effect the experience of psychosis or schizophrenia, accelerating the time of a first psychotic episode by 2 to 6 years.

Because marijuana use impairs critical cognitive functions during acute intoxication and for days after use, many students may be functioning below their natural capabilities for long periods of time. “The evidence suggests that such use results in measurable and long-lasting cognitive impairments, particularly among those who started to use marijuana in early adolescence.” A failure to learn at school, even for short or sporadic periods of time because of acute intoxication, will interfere with the capacity to achieve educational goals. This seems to explain the association between marijuana use and poor grades.

Heavy marijuana use has been linked to lower income, greater need for socioeconomic assistance, unemployment’s, criminal behavior, and lower satisfaction with life.

There is also a relationship between THC levels in blood and performance in controlled driving-simulation studies. These studies have been a good predictor of real-world driving ability. “Recent marijuana smoking and blood THC levels of 2 to 5 mg per milliliter are associated with substantial driving impairment.” The overall risk of involvement in an accident increases by a factor of 2 when someone drives soon after using marijuana. Not surprisingly, combining marijuana and alcohol seems to result in greater risks than the use of either drug alone.

The authors noted that most of the long-term effects of marijuana use in the article have been seen among heavy or long-term users. Yet the presence of multiple confounding factors, including the frequent use of marijuana with other drugs, detracts from their ability to establish causality.

They also noted there is a need to improve our knowledge on the potential medical benefits of the marijuana plant. A report by the Institute of Medicine sees the benefits for stimulating appetite and in combating chemotherapy-induced nausea and vomiting, severe pain and decreasing intraocular pressure in the treatment of glaucoma. “Nevertheless, the report stresses the importance of focusing research efforts on the therapeutic potential of synthetic or pharmaceutically pure cannabinoids.” With all of its problems, the existing structure for the approval of new medicines through the FDA is better than the current lack of any safety and regulatory apparatus with medical marijuana. The ongoing failure to confirm or refute the plethora of health and medicinal claims with marijuana use is progressively taking us back to the days of patent medicine claims in state-by-state approval. In conclusion they summarized the results of their review of the literature on adverse effect from marijuana use as follows:

Marijuana, like other drugs of abuse, can result in addiction. During intoxication, marijuana can interfere with cognitive functions (e.g. memory and perception of time) and motor function (e.g. coordination), and these effects can have detrimental consequences (e.g. motor-vehicle accidents). Repeated marijuana use during adolescence may result in long-lasting changes in brain function that can jeopardize educational, professional, and social achievements. . . . . As policy shifts toward legalization of marijuana, it is reasonable and probably prudent to hypothesize that its use will increase and that, by extension, so will the number of persons for whom there will be negative health consequences.

A German review study by Hoch et al., “Risk Associated with the Non-Medical Use of Cannabis,” also sought to summarize the current state of knowledge regarding the physical and mental adverse effects of intensive recreational cannabis use. They came to conclusions similar to the Volkow et al. study. Hoch et al. noted the potential for addiction and withdrawal, mild negative effects on learning capacity, neurocognitive impairments with adolescents, an increased risk of psychosis, and others. “Further research is required to clarify the causal nature of the links between cannabis consumption patterns and adverse events.”

Empirical data have now clearly shown that starting early in life and regularly using high amounts of cannabis for a long period of time increases the risk of various mental and physical disorders and endangers age-appropriate development. Because many studies have failed to control properly for confounding variables, it still cannot be stated beyond doubt that there is a causal connection between cannabis consumption patterns and cognitive damage or the development of comorbid psychic or somatic disorders. The worldwide increase in the THC content of cannabis may increase the health risks, particularly for adolescent users. Further research is required to determine why some people are more affected than others by the unfavorable consequences.

On the other hand, another long-term study of chronic marijuana use among young adult men by Bechtold et al., was published in the journal, Psychology of Addictive Behavior. The study used data from The Pittsburgh Youth Study, a longitudinal study that followed seventh grade students until they were 36. The study found that chronic marijuana users were no more likely than other groups to experience several physical or mental health problems, including early onset psychosis and heart problems. Some limitations in applying the findings of this study would include the fact that participants were only followed until the age of 36, perhaps too early for many of the health problems to become evident. Another difference was that the heaviest use category for marijuana was “more than 3 times per week,” while Volkow et al. seems to have been looking at daily or almost daily use.

In a postscript addition to the above studies, a 2016 study by Columbia researchers found evidence of a compromised dopamine system in heavy marijuana users. Dopamine levels were lower in the striatum, an area in the brain involved in working memory, impulsive behavior and attention. Previous studies have found addiction to other drugs of abuse, like cocaine and heroin, have similar effects on dopamine release. This was the first such evidence for marijuana.

A press release by the Columbia University Medical Center quoted the lead author as stating that in light of the increasing use and acceptance of marijuana, especially by young people, it is important to look more closely at the potentially addictive effects of cannabis on key regions of the brain. The study was small, with 11 adults who were severely dependent upon marijuana and 12 matched healthy controls. The average age of onset among the marijuana users was 16, with dependence occurring by 20. In the month before the study, all users in the study had smoked daily.

“Compared with controls, the cannabis users had significantly lower dopamine release in the striatum, including subregions involved in associative and sensorimotor learning.” The investigators also explored the relationship between dopamine release in the striatum and cognitive performance on learning and working memory tasks. The bottom line was that long-term, heavy marijuana use could impair the dopaminergic system, which in turn could have a series of negative effects on learning and behavior.

I talked with someone who had been to California a few weeks after the 2016 election when recreational marijuana use was legalized. She reported how employees of her hotel were gathering outside on their break to smoke pot, similar to what cigarette smokers do. If legal recreational use becomes more widespread in the U.S., the adverse physical and mental adverse effects from heavy, regular use will also become more evident. Then marijuana use will take a place beside alcohol use and tobacco use as a public health problem.

07/29/16

Be Careful of Where You’re Going

On July 9, 2015 eight Senators sent a letter to the Department of Health and Human Services (HHS), Office of National Drug Control Policy (ONDCP), and the Drug Enforcement Administration (DEA) asking for information on their efforts to facilitate scientific research into the benefits of medical marijuana. The Senators asked for answers to a series of questions, stating that relevant federal agencies had to play a leadership role in coordinating and facilitating research into medical marijuana. This began a process culminating in the administrators of the three agencies sending a detailed reply to their questions in an April 4, 2016 response … 26 pages long. And so speculation began that the DEA would decide whether or not to change the controlled substance status of marijuana “in the first half of 2016.”

This was part of the inquiry made by the Senators’ letter, in noting the need to remove “extraneous regulatory barriers for researchers who wish to perform scientific studies on the sue of marijuana for various diseases.” They pointed to the need of the federal government to make a concerted effort to understand how marijuana works and what the appropriate doses and methods of treatment are, “like any prescribed medicine.” Within Appendix C of the HHS, ONDCP, DEA response, was the following graphic and text delineating the process to schedule or re-schedule any drug.

The Controlled Substance Act requires eight factors as part of its scientific review: 1) the actual or relative potential for abuse; 2) the scientific evidence of its pharmacological effect; 3) the state of current scientific knowledge regarding the substance; 4) the history and current pattern of abuse; 5) the scope, duration and significance of abuse; 6) the risk to the public health; 7) the psychic or physiological dependence liability; and 8) the immediate precursor of a substance already controlled.

Writing for the Huffington Post in April 2016, Matt Ferner noted the FDA completed its review of the medical evidence of the safety and effectiveness of marijuana, and forwarded it to the DEA. But the FDA recommendations are still not public. In the Washington Post, Christopher Ingraham interviewed John Hudak of the Brookings Institution, who said the small amount of researchers currently working with marijuana is not due to the government turning down applications to do the research. Rather, it is a function of the application process itself. “People just aren’t applying because of all the headaches involved. . . . It’s a huge disincentive for the academic community.”

The bureaucratic hurdles also mean that colleges and universities are often hesitant to fund marijuana research for fear of running afoul of complex federal regulations. One ongoing study on the use of marijuana to treat veterans with PTSD has been struggling to get off the ground for more than five years, for instance.

There was an unconfirmed rumor by an “anonymous” DEA attorney that the DEA planned to reschedule marijuana as a Schedule II controlled substance and make medical marijuana legal with a doctor’s prescription in all 50 states. This is simply not true. Rescheduling would merely make it easier to get permission to do research with marijuana, not make it legal for doctors in all 50 states to prescribe marijuana. If that were the case, why can’t doctors prescribe cocaine legally? It is a Schedule II Controlled Subtance. Writing for The Fix, McCarton Ackerman noted the skepticism about the validity of the source.

In response to the rumors, DEA staff coordinator Russ Baer would not confirm the rumored rescheduling by August 1st in an interview with aNewDomain. Baer pointed out the complexity of what is referred to as “medical marijuana.” While THC and CBD are the two main cannabinoids, there are an estimated 480 compounds in cannabis. “What is under-reported right now is how complex the marijuana plant is.”

Baer said the DEA wants to remove the roadblocks to further research into the effectiveness of medical marijuana. However, he said the DEA doesn’t support decisions made on anecdotal evidence.

We want there to be research on marijuana and its component parts, there needs to be (more) studies about both the benefits and the adverse effects about marijuana. . . . We want to know more about cannabis— we need rigorous scientific research — the DEA stands behind the scientific process.

He added that safe medical cannabis requires rigorous peer-reviewed studies. He singled out current research into the benefits of cannabinol (CBD). “We are told by NIDA, also, that there are medical studies out there also preliminarily indicate CBD is beneficial.” But the opioid crisis has captured most of the DEA’s attention. “Marijuana is important, but our efforts are mainly focused on the nation’s growing opioid crisis. . . . We’re focusing on fentanyl, fentanyl compounds and on preventing the deaths caused by opioid addiction.”

A June 24th article by Kate O’Keeffe for the Wall Street Journal said Baer didn’t expect an answer by June 30th, but the agency was in the final stages of deciding whether to reschedule marijuana. He added that a decision is expected sometime soon.

On July 13, 2016 Dr. Douglas Throckmorton of the FDA appeared before the Judiciary Subcommittee on Crime and Terrorism. In his written statement to the committee, he reiterated its standing 2006 recommendation that marijuana remain as a Schedule I controlled substance because of a high potential for abuse; no currently-accepted medical use; and that it lacks accepted safety for use under medical supervision. However, “DEA is currently in the process of evaluating a number of other Citizen Petitions regarding the scheduling of marijuana.”

He noted there are three drugs approved for human use that contain active ingredients present in or similar to those in botanical marijuana: Marinol Capsules, Syndros and Cesamet Capsules. These products have undergone the FDA’s approval process and have been determined to be safe and effective for their respective indications. The future of medical marijuana lies in “classical drug development.”

If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives. Isolated cannabinoids will provide more reliable effects than crude plant mixtures. Therefore, the purpose of clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug but rather to serve as a first step toward the development of nonsmoked rapid-onset cannabinoid delivery systems.

Throckmorton pointed to three Fast Track designations for Savitex (April 2014), Epidiolex (June 2014) and a CBD formulation of Insys Therapeutics to treat Dravet syndrome (February 2015). All three are drugs derived from marijuana. He said the FDA is working with researchers who are conducting studies on the development of potential new drugs derived from marijuana.

FDA encourages and supports medical research into the safety and effectiveness of marijuana products through adequate and well-controlled clinical trials conducted under an IND [Investigational New Drug] and consistent with DEA requirements for research on Schedule I substances. FDA has provided scientific advice to representatives from several states considering support for medical research of marijuana and its derivatives, including CBD, to help ensure that their research is rigorous and appropriate.

Another date floated on the rumor pond for a DEA decision on rescheduling marijuana was August 1st, which is fast approaching. Will there be an answer? Who knows? According to Russ Baer, the DEA is not bound to give its answer within some artificially determined timeframe. So I suggest those anxious for an announcement by the DEA (senators and marijuana activists alike) apply a mash up of a famous Yogi-ism here: “Marijuana ain’t re-scheduled till it’s rescheduled.” Perhaps the DEA is just trying to be careful in its decision making process about the rescheduling. Yogi Berra has some further words of wisdom to apply there: “You’ve got to be very careful if you don’t know where you are going, because you might not get there.”

08/10/15

Marijuana Peek-a-Boo

On Friday, July 10th, the House of Representatives passed H.R. 6, the 21st Century Cures Act (244-183). The bill is now in the Senate for consideration. There had been an amendment proposed that would have rescheduled marijuana and its derivatives under a new 1-R schedule, which would have facilitated research. Marijuana could then have been rescheduled further, after that research was completed and further reclassification was warranted. The National Institute of Health (NIH) and the Drug Enforcement Agency (DEA) were also directed in the amendment to study the benefits and risks of medical marijuana. But the bipartisan amendment was defeated. The irony is that both critics and supporters of legalizing marijuana put forth the failed amendment.

Reporting for the Washington Post, Aaron Davis said that House Republicans have consistently defended their opposition to marijuana laws, saying there is no evidence that such action would do anything “but destroy the brains of the nation’s adolescents.” But the lack of evidence can be traced to Congressional resistance to fund federal agencies to do objective testing on the effects of marijuana. This “Catch 22” led to the support of the amendment by critics and supporters of legalization.

Maryland Representative Andy Harris, a doctor and outspoken critic of legalization over the past two years, co-sponsored the amendment. Before the House Rules Committee sidelined the amendment, he said: “We need science to clearly determine whether marijuana has medicinal benefits and, if so, what is the best way to gain those benefits.” Harris reportedly doesn’t think that research will find medical benefits, but another Republican, H. Morgan Griffith of Virginia, thinks there are limited circumstances in which marijuana has medical benefits. He said: “This amendment would have answered the question one way or the other. I think it would have shown it is a valuable medical substance, but now we don’t have the evidence.”

The failed effort put advocates for marijuana legislation in the odd position of having to praise Harris, who had become a nemesis of their cause. Michael Collins, the policy manager for the pro-marijuana Drug Policy Alliance, said: “To Mr. Harris’s credit, he thinks there are benefits to researching marijuana, whether you support it or not.” Opponents to legalization of marijuana also see research as a logical step forward. Sue Rusche, head of the National Families in Action, a drug prevention organization, said: “Right now we really don’t know what you’re getting. What we need is research to show us what level of CBD and THC should be given and what’s safe.”

Back in January of 2014, President Obama said it was up to Congress, not his administration, to reschedule marijuana. Steven Nelson, reporting for US News and World Report, said that marijuana advocates said that wasn’t entirely accurate. Representative Earl Blumenauer from Oregon said the law actually permits the current administration to reclassify marijuana. “I don’t dispute that Congress could and should make the change, but it’s also something the administration could do in a matter of days and I hope they will consider it.” Rep. Blumenauer is one of 17 cosponsors of other legislation aimed at reclassifying marijuana, the “Regulate Marijuana Like Alcohol Act.” There has been no action reported on the bill at this point. Govtrack.us said the bill had a 3% chance of getting past committee, and a 1% chance of being enacted. Blumenauer has introduced “The Marijuana Tax Act,” also listed as having a 1% chance of being enacted by Govtrack.us.

Tom Angell, chairman of the group, Marijuana Majority, said it was unfortunate that President Obama “passed the buck” to Congress on marijuana. Dan Riffle, the director of federal policies for the Marijuana Policy Project, said that rescheduling marijuana “is not a ‘job for Congress,’ as the president says.” Riffle said that scheduling decisions are handled by the DEA. In June of 2014, Anna Edney for Bloomberg Business reported that the FDA had been asked by the DEA to review marijuana’s status. This is the third time since 2001. In 2001 and 2006 the FDA recommended that marijuana remain a Schedule 1 Controlled Substance.

Douglas Throckmorton, the Deputy Director for Regulatory Programs at the FDA, acknowledged the FDA was once again conducting an analysis, but could not say when the FDA would complete its analysis or whether it would recommend a change. His testimony before a House subcommittee described the FDA’s role in potentially approving marijuana as a prescription drug. Dr. Throckmorton affirmed the FDA’s belief that its drug approval process was “the best way to ensure that safe and effective new medicines from marijuana are available as soon as possible for the largest numbers of patients.” He added that it was important to apply these scientific standards to the development and assessment of any alleged therapeutic uses of marijuana.

One of the considerations with establishing the safety and efficacy of a drug is a manufacturer’s ability to demonstrate an ability to consistently manufacture a high-quality drug product. This presents a special challenge with botanically derived drugs like marijuana, including the consistency of lot-to-lot potency. Another consideration is the need to identify a method of consistently providing a specific drug dose. Citing a report from the Institute of Medicine (IOM), Throckmorton noted problems associated with getting consistent dosing from smoked products such as marijuana. The IOM recommended that clinical trials involving marijuana be conducted to find a safe, alternative delivery system.

If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives. Isolated cannabinoids will provide more reliable effects than crude plant mixtures. Therefore, the purpose of clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug but rather to serve as a first step toward the development of nonsmoked rapid-onset cannabinoid delivery systems.

Throckmorton then cited two drugs approved for human use that contain active ingredients that are present or similar to those in botanical marijuana: Marinol and Cesamet.

These products have undergone FDA’s rigorous approval process and have been determined to be safe and effective for their respective indications, and reflect the views of the IOM that the future of marijuana as a potential medicine lies in classical pharmacological drug development. As a result, patients who need medication can have confidence that any approved drug will be safe and effective for its indicated uses.

So here’s what I’m thinking. When the 21st Century Cures Act is reviewed by the Senate, it needs a provision that will add the changes proposed by the Griffth-Harris-Blumenauer-Farr amendment. This would bring future research into medical marijuana under the authority of the FDA. Effective regulations for the safety and efficacy of medical marijuana can be developed. All states, those who have already approved the use of medical marijuana and those in the future who may approve it, would benefit from the standardization of FDA regulation. The existing problems with medical marijuana (see “Let’s Not Get Ahead of Ourselves”) such as biological and chemical contaminants, accurate labeling, overmedication, and consistent dosing in products could be worked out. The at times outrageous claims for exactly what marijuana DOES medically treat can be examined systematically and scientifically.

But I’m also thinking that isn’t what some legalization advocates want, because it will take time; and the momentum towards recreational marijuana legalization could be lost. The best path to legalization is to let the political infighting in Congress and federal agencies like the FDA and the DEA continue to neutralize any federal regulation of medical marijuana while marijuana activists continue their state-by-state battle. If I wanted to develop a strategy for national legalization of marijuana, I’d suggest the following.

The strategy for eventual national legalization of recreational marijuana is to eat the elephant one bite at a time. Keep the battles going state-by-state and keep the federal government out of the fight. Legislatures within the states where medical marijuana is not yet approved should hear about the income and health benefits of legalizing medical 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. If I wanted a sound national policy toward medical marijuana, I’d look for the following developments.

The best strategy to slow and perhaps stop the growth of state-by-state legalization of recreational marijuana is to be proactive about the legalization of medical marijuana at the federal level. Quality research that showed the medical benefits of specific cannabinoids, like CBD and THC, the psychoactive cannabinoid in marijuana needs to be done. A more efficient delivery system for medical marijuana than smoking an herbal product of varying potency, with possible biological and chemical contaminants could be developed. The sideshow of existing medical marijuana “treatment” as an excuse to legally medicate (and overmedicate) with THC to get high would stop. Individuals who could benefit from legitimate medicinal marijuana products would get the help they need. And the recreational advocates couldn’t hide behind the medical marijuana movement anymore.

Faith Seeking Understanding

Charles Sigler, D.Phil.

Tag: medical marijuana

Continue to Keep Marijuana Medical in PA

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Eating the Elephant of Marijuana Legalization in PA

Marijuana Stepping Stone in PA?

CBD vs. THC

Benefits of CBD

Keep Marijuana Medical in PA

Pesticides, Fungi and Pot

Listening to Marijuana Research

Marijuana & Adverse Health Effects

Be Careful of Where You’re Going

Marijuana Peek-a-Boo