August 24, 2019

Robert VanVaren enquires about cannabis treatment for his mother in effort to lessen her reliance on prescribed opiates.

 


Natalia Lopez assists Joseph Cover who says medicinal marijuana helped him overcome his opiate addiction.

 


Eduardo Amezquita, a retired veteran, waits for his medicinal marijuana prescription for his 11th back surgery, which he says helps minimize his need for prescription opiates.

 

Medical marijuana: A Catch-22 for Florida residents, researchers

Ask nearly any scientist in Florida who wants to conduct clinical research on cannabis, and expect to hear echoes of a similar strain: The status of medical marijuana in the Sunshine State is currently hazy -- ask again later. 

But for thousands of chronically ill patients who rely on the relief they insist cannabis provides, waiting on science is not an option when quality of life is at stake.

Dr. Karen Forsythe Monroe, a Pinellas County physician who is licensed to recommend medical cannabis to qualified adults in Florida, maintains morning hours at her St. Pete office. She spends her afternoons making home visits with patients who are housebound by chronic illness or pain.

"I look at the patient, and I ask: Are they really suffering? ... They're old and they're sick. That's what I'm seeing. The people who are coming to me -- they don't want to get high. They just want their pain to go away," Monroe says.

A supermajority of Florida voters approved legalizing marijuana for medical use when they voted in favor of Amendment 2 in 2016. But as of today, the state's doctors and researchers say they're still waiting for the smoke to clear before cannabis can make concrete clinical progress.

Here's an abridged recap of medical marijuana's recent history in Florida: 

  • 2016: Floridians vote in favor of the Florida Medical Marijuana Initiative. The amendment requires a supermajority (60%) to pass; it receives over 71% voter approval.
  • 2017: Florida Legislature, under former Governor Rick Scott, writes medical cannabis into law, but places a strict ban on smoking it. Qualified patients may use vaporizers, pills, edibles, suppositories, and topical cannabis products. The smoking ban is challenged in circuit court.
  • 2018: The Florida Department of Health reports 65,310 patients in the Office of Medical Marijuana Use (OMMU) registry at the beginning of the year. In its last weekly report of the year, the OMMU reports 167,211 qualified patients. Hillsborough, Pinellas, and Palm Beach counties account for more than 30% of all registered medical marijuana patients in Florida.
  • 2019: The Florida Legislature, under Gov. Ron DeSantis, votes in favor of repealing Scott's smoking ban. Senate Bill 182 permits qualified patients to receive up to 2.5 ounces of whole flower (smokable) cannabis every 35 days. As of May 31, the OMMU reports 224,815 qualified patients and 2,293 physicians. As of June 14, the OMMU reports 231,438 qualified patients and 2,321 physicians.


The numbers indicate medical cannabis is a blooming industry in Florida. However, for doctors who seek strong scientific literature and patients who desire clinically tested relief in regulated doses: The path to answers is still a trek through the weeds.

Studies stall for decades

With the passing of Amendment 2 and the subsequent Senate Bill 8A in 2017, Florida legalized medical cannabis for 10 qualifying conditions: cancer, epilepsy, glaucoma, HIV, AIDS, Post Traumatic Stress Disorder (PTSD), Amyotrophic Lateral Sclerosis (ALS), Crohn's Disease, Parkinson's Disease, and Multiple Sclerosis (MS), as well as "medical conditions of the same kind or class as or comparable to the above qualifying conditions," such as Generalized Anxiety Disorder.

Tasked by state law to furnish the OMMU with research that supports her cannabis recommendation for each patient, Dr. Monroe notes that anecdotal and observational evidence of cannabis' efficacy in treating conditions including but not limited to appetite loss, nausea, pain, and anxiety is abundant, but digging up existing science that meets what she calls the "Research Gold Standard" -- the double-blind, randomized, placebo-controlled study -- is like looking for a needle in a hemp stack. 

The problem with tracking down solid research on medical cannabis in the United States? It hardly exists. Why? Because doing the research is a felony. 

Superseding state law, federal restrictions on the Cannabis sativa plant paint a murky landscape for patients, doctors, and scientists. The Marihuana Tax Act of 1937 and the Controlled Substances Act of 1970 placed cannabis' long-standing medicinal claims at odds with the plant's legal status: Since the Nixon administration, the Cannabis sativa plant is classified alongside heroin and LSD on the federal list of Schedule 1 Controlled Substances. 

In other words: as of June 1, 2019, Florida is among 33 states and the District of Columbia, where qualifying patients may, according to state law, purchase and use cannabis products for medicinal purposes. Eleven additional states permit recreational cannabis. However, as of June 1, 2019, the U.S. Drug Enforcement Agency (DEA) classifies cannabis by its Schedule 1 definition: a drug with high potential for abuse and zero medical value.

Dr. Kevin Sneed, founding Dean of the University of South Florida College of Pharmacy and Senior Associate VP of USF Health, hopes to attain DEA approval to conduct clinical cannabis trials at the university. 

"Most of what's out in the medical literature is either anecdotal or observational -- or, in most cases, it's just not a well-done or credible study. Here at USF, we are making attempts to work directly with the DEA," says Sneed.

Even in states where cannabis is legal for medical as well as recreational use, such as Colorado, researchers who wish to perform clinical trials on the plant must apply for a Schedule 1 DEA research license. Once approved, scientists are permitted to study only cannabis that is sourced from the federal crop located at the University of Mississippi and overseen by the National Institute for Drug Abuse (NIDA).

Dr. Sneed says USF aims to achieve "very coherent, very well-done clinical trials" on the safety and effectiveness of compounds found in the Cannabis sativa plant -- specifically, those compounds' effects on what Sneed calls "bio-inflammatory pathways in the body" -- and new, non-euphoric formulations for their delivery. Sneed notes, however, that until USF researchers receive a green light from the DEA, achieving clinical results is not worth risking doctors' careers or patients' safety.

"We want to make sure we're going through every legal pathway to protect the patient, our researchers, and the integrity of what we're doing," says Sneed.

"As it stands, we're being patient. We have not engaged in any [cannabis research] because we are not authorized to do it. But we understand what needs to be done, we know why it needs to be done, and when the time comes -- we're ready to do it," he adds.

Cannabinoid conundrum: To CBD or not to CBD? What about THC?

More than 100 chemical compounds make up the Cannabis sativa plant. The plant’s two most buzzed-about cannabinoid compounds, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), dominate most of the conversation surrounding medical marijuana. 

Although conventional science is limited, current evidence indicates that THC is the cannabinoid responsible for cannabis' psychoactive effects -- in other words, it's what gets people "high." Although THC is largely implicated for the psychoactive properties that give cannabis its dodgy reputation and Schedule 1 classification, there are scores of unanswered questions, or inadequately researched theories and observations, about the possible benefits this cannabinoid could offer, in what dosages, and by what delivery.

Scientists are interested in how THC might help reduce nausea and wasting in HIV and AIDS patients, or those undergoing chemotherapy for cancer, as well as its possible role as an anti-inflammatory, and the ways the cannabinoid may interact with or replace opioids as a treatment for chronic pain. 

A separate cannabinoid, CBD, exhibits demonstrable success in treating severe forms of childhood epilepsy -- and possibly also includes powerful anti-inflammatory and anxiety-reducing benefits yet to be defined in a lab. But CBD comes to the table without any of the psychoactive side effects attributed to THC. 

CBD and THC are just two among at least 113 compounds that comprise the Cannabis sativa plant, but CBD may be the first to show up to traditional medicine -- namely, in pediatrics -- with some solid pharmaceutical receipts.

In 2018, Epidiolex, the first FDA-approved pharmaceutical formulation of plant-derived CBD, hit the market to treat two rare and severe forms of childhood epilepsy: Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome. 

Epidiolex exists in pharmacies today, largely thanks to Colorado parents Paige and Matt Figi who in 2013 tried oil derived from a CBD-dominant, low-THC cannabis strain in a desperate, last-ditch effort to reduce the frequency of severe epileptic seizures suffered by their 5-year-old daughter Charlotte. Charlotte's seizures began when she was 3-months-old. By age 5, she was having 300 grand mal seizures a week. The seizures were reduced to just twice monthly, on average, when the Figis introduced the CBD oil.

Originally nicknamed "Hippie's Disappointment" because of the "disappointing" lack of psychoactive effects due to its scarce THC content, the CBD-dominant strain that helped soothe Charlotte Figi's seizures later became known as "Charlotte's Web." It opened the door for clinical research on CBD, and ultimately, the first FDA-approved, plant-derived prescription CBD pharmaceutical Epidiolex. 

In spite of CBD's budding promise, the lack of available research on this cannabinoid and on THC means there remain more unknowns than there are understandings about the role of Cannabis sativa as medicine.

Re-scheduling hemp: Will the Federal Farm Bill change the playing field?

Consumer Reports found that an estimated 64 million Americans have taken CBD, and that 63% find it effective for the condition they were trying to treat. In a telephone survey of 4,355 adults, 40% said they receive their CBD from a dispensary and 25% purchase it online. Most respondents report price as their main concern. Only 13% of respondents report safety as a high-ranking concern, and more than half are confident there are regulations in place on CBD.

There are not -- yet.

The Agricultural Improvement Act of 2018, also known as the Farm Bill, removes hemp as a Schedule 1 substance and re-classifies it as an "agricultural commodity.” By removing federal restrictions on hemp that date back to 1937, the Farm Bill authorizes states to create hemp programs beyond university settings. It also both clarifies and complicates the conversation surrounding medical applications of Cannabis sativa by legally defining what is "medical marijuana" and what is "hemp" -- both of which derive from the same plant. 

Per the Farm Bill, Cannabis sativa plants containing more than 0.3% of the psychoactive cannabinoid THC are considered "medical marijuana." Cannabis sativa plants containing less than 0.3% THC are "hemp." 

CBD may be sourced, by a variety of methods, from Cannabis sativa plants that are classified as medical marijuana as well as those that are classified as hemp. Currently, the lion's share of CBD products sold in Florida dispensaries contains THC levels that are slightly or significantly above the 0.3% limit -- thus requiring an OMMU license to acquire. 

"Hemp-derived" CBD products that can be purchased over-the-counter, for instance in Florida gas stations or online, claim to contain less than 0.3% THC. However, consumers have no way of knowing whether this is the case -- or what other ingredients may lurk within -- because there is currently zero regulation on hemp oils and no federal lab standard for testing CBD products in the United States.

The only lab-verified CBD products on the Florida market are those sold in state-licensed dispensaries operated by Medical Marijuana Treatment Centers (MMTCs) -- who also operate their own laboratories. 

On May 31, 2019, in the FDA's historic first-ever public hearing on CBD, DEA-approved Schedule 1 researcher, Elise Weerts of Johns Hopkins University, underscored scientists' cannabinoid conundrum: 

"My 21-year-old son can walk into a store and buy [any cannabis product] and I cannot purchase, store, or test that product. It is illegal for me to do so."

As a Schedule 1 controlled substance, it is also a felony for medical marijuana (cannabis containing more than 0.3% THC) to cross state lines. 

This means that all cannabis products sold in Florida dispensaries and consumed by qualified Florida patients must be cultivated in-state by licensed, private MMTC grow operations. How cannabinoid profiles in these dozens of MMTC-grown strains on the Florida market compare with that of the NIDA crop in Mississippi -- which celebrated its 50th anniversary in 2018 --  is, and will remain, indefinitely, under current federal restrictions, unknown. 

Where does this leave research efforts to verify any of the CBD and THC-containing cannabis products that are currently being smoked, vaped, swallowed, or applied topically or sublingually by thousands of medical cannabis patients, as well as countless people who purchase over-the-counter hemp and CBD in the state of Florida today? 

The answer is currently hazy. Ask again later. 

Oh, and -- head's up, hemp-derived CBD users in Florida: Until Senate Bill 1020 (the State Hemp Program approved by Tallahassee lawmakers in May) goes into law on July 1, possession of hemp is still a criminal act. It's been that way since 1937.

Reaching around the restrictions to do the research

One way scientists working within the public university system in Florida are able to collect data on medical cannabis, without touching the plant, is simply by asking patients. 

In 2017, University of Florida Professor in Epidemiology Dr. Robert Cook, Director of the Southern HIV and Alcohol Research Consortium (SHARC) and Chair of the Florida Consortium for HIV/AIDS Research (FCHAR), was awarded a $3.2 million NIDA grant to conduct a 400-person longitudinal cohort study of persons living with HIV who report using cannabis.

"In terms of restrictions on research, I certainly can't use federal research money to purchase marijuana products, and I can't ask people to bring products onto campus. This grant was written to find out what people are doing on their own -- self-medicating," says Dr. Cook.

The study, held in collaboration with USF and FIU, aims to collect data on patients' self-dosing habits and to identify relationships between cannabis consumption and HIV symptoms, HIV viral suppression, markers of chronic inflammation, and cognitive or behavioral aspects of health. 

Participants can self-report what type of cannabis products they are consuming, how much, and document their anecdotal experiences via questionnaires. They also undergo blood and urine tests to determine markers of inflammation, as well as toxicology reports that break down the specific components in the cannabis the individual is using.

"Some of the trickiness [of studying medical cannabis] is that the marijuana plant has all of these components together -- some call it a potential 'entourage effect.' The traditional medical community that is interested in evaluating whether a drug works has to have that drug tested in a specific dose and condition. But people in the real world are using marijuana off the street, some are getting it from dispensaries, and many say they're self-treating things like sleep or pain -- so the purpose of our grant is to try to describe what people are doing on their own," Cook says.

While the study doesn't offer the controlled laboratory precision that researchers like Dr. Sneed at USF hope to achieve with a Schedule 1 DEA research license, Cook says, longitudinal, survey-based studies like his provide opportunities to develop insights about real-world cannabis use.

"If we follow people for three to four years, we do think some will start using, and that some will stop, and those will be opportunities for us to see how changes in marijuana use impact changes in health," Cook says. 

Cook notes there are benefits as well as pitfalls to researching cannabis through federal channels.

"One downside to that kind of research is that the marijuana needs to stay on campus -- but in the real world, people are getting up to seven months of product at a time. There are certain types of questions that are good to ask with the [cannabis] that comes from Mississippi -- and one benefit is that it's a standardized dose. But is that what people are actually doing? A lot of people are nervous that if someone uses a [MMTC grown] product, will it be the same?"

When state legislation tangles with scientific endeavors

Dr. Jenny Wilkerson, Research Assistant Professor at the UF College of Pharmacy, admits to feeling burned by the conflict between medical cannabis research efforts and recent legislative decisions in Florida. 

Prior to joining the University of Florida in 2017, Wilkerson most recently completed a postdoctoral fellowship at Virginia Commonwealth University, where her research emphasized the endocannabinoid system -- the system in the body that interacts with cannabis.

Following the passing of Amendment 2, the Florida Legislature in 2016 established the Medical Marijuana Research and Education (MMRE) board, which was to be funded by taxes levied against licensed medical marijuana growers in Florida, and operated through the Moffitt Cancer Center. 

Wilkerson applied for the first MMRE monies available to researchers outside Moffitt in the 2018-2019 funding cycle, and received notification in June 2018 that she was recommended to receive $200,000 to fund her medical marijuana research project, titled "De-hazing the Role of the Immune System in Cannabinoid-Mediated Mitigation of Chemotherapy Side Effects."

"Here, I was going to look at THC in a mouse model of chemotherapy-induced pain and examine if THC’s mechanism of action is via the immune system. I was also going to examine respiratory depression due to opioids. We know that opioids are commonly prescribed for cancer pain. However, there is a little bit of evidence that suggests that chemotherapy increases susceptibility to opioid-induced respiratory depression. However, this hasn’t been systematically studied," Wilkerson explains. 

A $200,000 grant "would have been huge," she says. "This would have allowed me to start my independent research at a competitive level -- paying the salary for two full-time research laboratory technicians, as well as all related costs of my proposed research."

The operative phrasing, of course, is "would have been ..." 

"This grant by the state of Florida would have kick-started my career as a young scientist. It's partially why I chose to come to UF as opposed to going to an industry job in Boston … But then [our MMRE funding] got pushed back -- apparently via pushback from lobbyists in Tallahassee who thought the tax on growers was too high," Wilkerson says.

She then notes, "in January, our new governor signed a bill to basically dissolve the entire MMRE program. I've never seen the money I was supposed to get."

The new Florida Legislature under Gov. DeSantis dissolved Moffitt's medical professional-led MMRE board in early 2019 and passed along the appropriation of MMRE research monies -- including that previously awarded to Wilkerson -- to the oversight of the Florida Board of Governors. 

In addition to shuffling pre-allocated funds, the new MMRE board, the Consortium for Medical Marijuana Clinical Outcomes and Research, also states that its sole focus on clinical cannabis research should be on humans, meaning cannabis research using animals, such as Wilkerson's chemotherapy lab mice, will not be funded. 

It leaves Wilkerson in a tight and frustrating spot -- and puts what she believes to be valuable research on hold, indefinitely.

"I put in for a grant from the NIH, but unfortunately the criteria to get a grant from the NIH is very high. To get $200,000 [MMRE funding] for a year would have allowed me that extra money and time to put together a much stronger research portfolio -- one that I believe would be very compelling for the NIH."

In the meantime, working under UF Professor and Chair of the Department of Pharmacodynamics, Lance McMahon, Wilkerson plugs away at what research she is able to conduct -- mostly, she says, using McMahon's own startup money to fund CBD studies. 

"I've had to be more creative, and I've had to not answer some of those questions I think are so important -- like the respiratory depression issues. I've had to scale down my research endeavors significantly," Wilkerson says.

When might Wilkerson be able to pursue the cannabis research she deems vital to create guidelines for safe and responsible medical marijuana use in the state of Florida? Ask lawmakers in Tallahassee and Washington D.C. 

As for now, you can predict a familiar response: The status of medical marijuana is currently hazy. Ask again later.

Author's Note: On June 13, 2019, the Board of Governors selected the University of Florida to lead the Consortium for Medical Marijuana Clinical Outcomes Research, stating:

"The purpose of the consortium is to conduct rigorous scientific research and disseminate such research. The consortium shall include both public and private universities and research must include tracking clinical outcomes, certification standards, dosing standards, routes of administration, efficacy, and side effects; and the study of the effects of smoking marijuana to treat debilitating medical conditions (section 1004.4351, Florida Statutes)."

As the lead institution, UF will receive $1.5 million in recurring funding from the state of Florida to build a data repository known as the Medical Marijuana Clinical Outcomes Repository (MEMORY), develop a clinical research core, and establish a competitive grants program offering $600,000 annually from the state appropriation to participating institutions.

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