By Carmel Barrau, M.D., Violina Bhattacharyya, M.D., Jeffrey Block, M.D., Julie Kantor, M.D., Jorge Pardo, M.D., Smith Joseph, D.O.

Dade County Medical Association’s 2021 Physician Leadership Academy

Address correspondence to: Jeffrey S. Block, M.D. Phone: 305-793-9222

Email: DocBlock@BellSouth.net

Conflict of Interest: The authors have no conflicts of interest to disclose

Florida’s previous decade concerning legal Schedule 2 (controlled) substances demonstrated systemic failure controlling a proliferation of “oxycontin pill mills” that resulted in tragic patient outcomes throughout the United States. Responsible guidance from the Florida Medical Association (FMA) prompted legislation to establish standards for pain

management clinics. This resulted in more stringent licensure requirements, established a limit on the amount that could be prescribed when patients pay cash, and required tamper-resistant prescription forms.1 The authors respect Federal Controlled Substances Act2 laws designating Cannabis as an illegal Schedule 1 (prohibited) substance and recognize how Cannabis’ recent legal availability has expanded in Florida to now include in excess of half a million of our citizen-patients.3 Physician leaders are rightfully concerned with how the past four years generated such dramatic increases of medical marijuana patients to become the fastest growing Cannabis program in the nation.

At this particularly formidable time, the authors maintain that the FMA should proactively address Cannabis-related issues. Key recent systemic failures that collectively compromise the rendering of safe and effective healthcare impacting Florida physicians’ practice of medicine have been identified.

Medical Cannabis as a new industry in Florida has significantly advanced unabated largely because:

  • The Florida Legislature has been unable to address constraints on Cannabis products,A 4

and

  • The Florida Department of Health has not produced required rules impacting physician practice standards.

A Florida’s 2021 legislative initiatives were unable to regulate medical marijuana through either identical bills SB1958 or HB1455 The bills died in the Senate Judiciary Committee, and the House Health and Human Services Committee respectively on April 30, 2021.   https://www.flsenate.gov/Session/Bill/2021/1958 and   https://www.myfloridahouse.gov/Sections/Bills/billsdetail.aspx?BillId=72700&SessionId=90

Despite rapidly changing parameters concerning medical marijuana, the COVID-19 pandemic has understandably forced physicians to acutely focus on healthcare’s most urgent needs. Policy positions have essentially remained unchanged over the past five years. The authors seek organizational solutions in 2021 that will optimally inform and guide the education of colleagues, patients, and legislators; and have accordingly focused on two key issues in need of organizational development:

  1. Consistent Updates to the FMA Policy Positions – This initiative’s purpose is intended to evolve proactive healthcare policies that reflect current scientific knowledge and current legal parameters impacting Florida physicians’ goal to render safe and effective patient care.
  • Optimizing the Education of Florida Physicians – Endorsing high-quality physician educational content responsibly provides Florida’s consumer-patients with unbiased and vetted information to facilitate their independent healthcare knowledge and decision- making.

The FMA Public Policy Compendium currently provides consensus opinions involving five medical marijuana statements. These consensus opinions originated in response to Florida’s evolving legislative5 proposals that contrasted with prevailing federal law; and were established beginning in 2012 as cited in P307.001-005.6

The authors are concerned that currently neither Florida’s legal access to medical Cannabis or the supporting evidence-based science are acknowledged within the existing FMA policy positions. Because outdated FMA policies do not reflect the realities of contemporary patient care or the basis of Florida law, the authors support and emphasize frequent revisions. The authors also firmly believe that Florida expert physicians’ opinions deserve more timely input to help advance inextricably connected societal healthcare issues.

The growing body of evidence-based data and changing Florida laws, rules, and regulations that surround Cannabis presents a moral imperative for its duly licensed healers to provide responsible guiding leadership as required by and expected from licensed physicians in Florida.

The authors recognize that “marijuana” is a complex subject extending beyond rendering basic healthcare. Marijuana additionally involves societal issues that necessarily include legal, agricultural, and industrial considerations. Whereas Florida law specifically allows qualified citizens to receive restricted access to medical marijuana; the authors understand that Florida’s licensed medical doctors are uniquely qualified to provide such societal leadership. Because the medicalization of Cannabis is currently incomplete, the ideal solution is an enduring platform to evolve policy initiatives from which Florida’s expert physicians should proactively respond to evidence-based data, future research, and changing state and federal legal constraints.

This ultimately helps physicians develop standards of care that favorably impact patient outcomes.

Substance use and abuse issues frequently challenge a physician’s ability to effectively treat pain as an intolerable symptom of physical, psychological, or spiritual nature. Bioethical considerations can be shared through organized medicine’s proactive leadership. In contrast to medical-legal ethical guidance often selectively championed by doctors and lawyers  respectively, bioethical leadership’s perspectives involve a full community’s meaningful discussion that intentionally includes patients, clergy, and law enforcement among others. Such a broad conversation is universally helpful to render impactful healthcare that ultimately seeks to not simply improve an individual patient’s outcome, but also societal outcomes as well.

Physicians as caring individuals always strive to “do the right thing,” even as complicated societal situations challenge clinical acumen. This passage from the textbook ‘Advanced Therapeutics in Pain Medicine’ (CRC Press 2020) articulates a dilemma with how physicians manage pain:

“Primum non nocere” (first do no harm) is a guiding maxim for clinicians, and concern for balancing risk with benefit is central to treatment decisions in patient care. Most responsible clinicians will not advise their patients to pursue a particular treatment regimen without conclusive clinical evidence and peer review confirmation regarding the relative safety and efficacy of a given treatment. Yet the compassionate physician will also be mindful of the ethical obligation to ease suffering with whatever tools might be available, and wherever possible. In this context, the medicinal use of Cannabis currently presents a conundrum in need of bioethical rationale.

The clinician faced with a patient in intolerable pain has an obligation to not just feel compassion, but to do what is possible to alleviate that suffering without causing harm. As the limitations of opioid options become more evident, the search for safe and effective solutions has rightfully included cannabinoid medicines. Despite barriers to research, randomized clinical trials provide substantial evidence of the analgesic potential of cannabinoids that confirm animal experiments, laboratory science, and what is known about the purpose of the endocannabinoid receptor system.

As clinicians consider how to apply these discoveries, we may do well to heed the ethical standards which physicians have historically promised to uphold, whether the Hippocratic oath to “apply for the benefit of the sick all measures that are required,” or that of Maimonides to seek the strength, time and opportunity to correct acquired beliefs and extend the domain of knowledge.”7

Responsible health professionals require high-quality education to help transition patients’ use away from existing practices of self-titration-oriented medical Cannabis consumption.

Physicians deserve to be provided with necessary information to help guide their patients’ limited Cannabis use for safe and well-understood purposes; and as a means of understanding contraindications, drug interactions, and dosing guidelines that account for the wide diversity of bioactive plant chemical standards that bring potential for inconsistent effects. While there is evolving research designed to discern and demonstrate medical Cannabis’ safe dosing and control protocols, the current limitations of evidence-based data concerning Cannabis when used as a medicine signal a significant need for additional ongoing research.8

Floridians presently consume Cannabis regardless of legality, and regardless of a clear legal distinction between medical and recreational Cannabis use. Florida’s citizen-patients not only currently use legally dispensed medical Cannabis products as permitted under Florida law, but also continue to use illicit-market products. Of note is that immediately before the COVID-19 pandemic perilously compromised the availability of intensive care unit ventilators, news reports throughout the United States featured previously healthy individuals, predominately youth, who inhaled vaporized Cannabis oil products and developed chemical burns resulting in life- threatening reactive-airway pneumonitis. The Centers for Disease Control and Prevention determined that this resulted from illegal Cannabis oil concentrates that were contaminated with harmful cutting agents.

If a Florida physician recognizes that their patient might have a medical condition that — within reasonable medical judgment — could potentially benefit from carefully supervised medical Cannabis regimens, only when policy follows clinical research to ensure safety and efficacy, and when regulations are present that discourage misuse and ensure accountability, that physician should consider their citizen-patient’s informed consent access to Cannabis plant- derived chemicals’ use for medical purposes.

Organized medicine has a practical obligation to promote public health awareness and education concerning the expanding legalization of Cannabis by clearly acknowledging current scientific research regarding its non-medical use. We believe the FMA should continue to work with policy makers to avoid broadening access to the recreational use of Cannabis, especially among youth. The FMA should encourage opportunities to participate in clinical evaluations of legitimate medical Cannabis use provided that they are consistent with how patients are actually using it. The FMA should continue to oppose resolving issues of Cannabis consumption — medicinally or recreationally — through citizens’ ballot initiatives; and the FMA should oppose all related legislation not accompanied by a process of FMA approval. Because the ever- increasing numbers of Floridians using either legal or illegal Cannabis products understandably will expect to receive physicians’ non-discriminatory comprehensive healthcare, the urgency of Dade County and Broward County physicians’ compassionate patient guidance concerning Cannabis is readily apparent.

References:

  1. Centers for Disease Control and Prevention. Drug overdose deaths – Florida 2003-2009. MMWR Morb Mortal Wkly Rep. 2011 Jul 8;60(26):869-72.
  • Physician Certification Pattern Review Panel, Board of Medicine, Board of Osteopathic Medicine. Physician Certification Pattern Review 2021 Annual Report. Tallahassee (FL): Department of Health; 2020 Sep 30-2019 Oct 1. 33 p.
  • Roach S. The fight to save Florida’s medical marijuana program. Florida Politics. 2021 Apr 7.
  • Florida Medical Association Public Policy Compendium. Tallahassee (FL); 2019 Oct, updated 2020 Jan 14. Part 307, Medical Marijuana; p. 98.
  • Swidan S, Bennett M. Advanced Therapeutics in Pain Medicine. Boca Raton: CRC Press; c2020. Chapter 4, Endocannabinoid Receptors and Medical Cannabis; 30 p.
  • Hemingway K, Martorella G, Schluck G, et al. Medical Marijuana in Florida: The Knowledge, Practices, and Attitudes of Providers. Cannabis Clinical Outcomes Research Conference. 2021 Apr; Gainesville, Florida.

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By Dr. Jeff G. Konin

It is likely a safe assumption that if you are reading this edition of Cannabis News Florida that you take up some space in the cannabis world. Perhaps you come from the business angle, or the agricultural space, possibly analytical chemistry, healthcare, or many others. We make up an extremely diverse group of individuals who collaborate in one shape or another to achieve one of many common goals: understanding, achieving, and disseminating cannabis efficacy.

Each of our unique disciplines view “research” slightly differently. For example, in the medical and healthcare professions, we lean toward a commonly and possibly overused term called “evidence-based” research. This simply means that to be able to validate that something works, it has undergone the highest levels of clinical studies and has shown a statistical significance. We throw out terms such as meta-analysis, systematic reviews, and double-blind clinical trials just to name a few. By contrast, research knowledge such as those presented in a case study format, or by an expert opinion, are viewed to represent a lower level of acceptance. Additionally, such studies may be viewed differently if they were performed in a lab, on animal models, or proposed in theory as compared to human studies.

When one looks up the definition of “business research”, results yield a common theme that acquiring information in an effort to “make wise decisions, “maximize sales and profits”, or “interpreting market trends” just to name a few. In such cases, statistics may or may not be as important as the bottom line. This in no way minimizes the importance of the information. It simply involves a different process and/or approach and applies the data in a way to meet business-related goals.

Is there a connection or a disconnect with such different approaches and perception of cannabis-based research? More than likely the answer to these questions is “yes” to both. There is clearly a connection that should occur between research grounded in business as well as research grounded in science. For example, if medical researchers find a statistical difference in favor of a positive intervention using a combination of or an isolate of a cannabinoid, the effective use for patients will only be successfully conveyed and disseminated through effective measures learned through marketing the product, identifying price points and margins, and ongoing improvements and findings. However, regardless of how good a product appears to demonstrate positive findings, if this is not conveyed in a professional business-like manner, it will not reach its potential from either a healthcare or a business perspective.

Where the majority of the industry to date has found itself is the polar opposite of what was just described. Though certainly not the case with all cannabis-based companies, many have in fact found successful business practices based upon their own internal research. The outcome has been positive, some finding greater success than others. However, few of the numerous cannabis-based businesses that manufactur and sell product to consumers have actually conducted the clinical research previously described to the standards expected in the medical and healthcare industry. Additionally, of those that have conducted product efficacy research, the majority have done so in-house. There is truly nothing wrong with this approach, as it does make sense to test one’s own product. In fact, most would argue that it is an essential step that needs to take place to be able to stand behind a product and sell it to a consumer base. However, such findings and any statements claimed from one’s own research will be viewed as being biased in opinion from those in the medical and healthcare industry. Think about it, have you ever seen a cannabis company put out information that they tested their own product, and it wasn’t good? Of course not, so the expectation of any self-published or even just self-promoted “evidence” will be expected to state nothing but positive claims of one’s own product. This is typically referred to having a conflict of interest – that is, those doing the testing have a financially vested interested in reporting positive results.

There is no shortage of business research in the cannabis space. In fact, as noted, many credible companies are performing their own-house product research as it relates to consumer benefits. In fact, some could argue that in a relatively new area of fast-growing interest that ample research already exists. For example, a simple National Library of Medicine search solely using the word “cannabis” yields over 27,000 published research articles. However, most healthcare providers do not read where these studies are being published: Plant Science, Molecules, or Nature as a few examples. Some do read journals like Addiction, and slowly more are paying attention to the Journal of Cannabis Research and Cannabis and Cannabinoid Research. It is a process. The area of research that could be served well is continued product research performed by 3rd party, independent testing researchers with results being published in journals that focus and emphasize clinical application. In particular, journals of specialized areas such a sports medicine, geriatrics, pediatrics, neurology and others would benefit from contemporary cannabis-based findings.

Society is at an International tipping point toward its views of cannabis. In some places, scientific research is leading the way. In others, business research is leading the way. Yet in other places, a disconnect remains that connects the two worlds absent any perceived or real conflicts of interest. Identifying models that address such concerns will be a key to the future success of any efficacious findings that cannabis intervention may play in the well-being of individuals. Likewise, studies without bias can produce true understandings of any concerns related to short or long-term adverse effects, unknown drug interactions, and potentially findings that haven’t yet even been considered.

This is an opportunistic time to define cannabis research in a collaborative way that is inclusive of all those vested in the industry. Private business partnering with research Universities is one reputable method of achieving this goal. It is a process. It takes time, it takes educating, and it requires patience from the beginning to the end. The process is something University researchers excel in and are prepared for the many hurdles, and oftentimes one that private business is not prepared for. Building teams and working together on realistic timelines, having a solid strategic plan in place, and recognizing funding amounts necessary to achieve study goals are all essential building blocks toward unbiased research. Doing so then allows the findings of studies to be reported and presented to all stakeholders in the highest and most professional manner possible.

Cannabis research is ripe for ideas, partnerships, sharing of findings, and product efficacy. Consumer demand will drive apportion of acceptance and reputable research will drive the rest!

Dr. Jeff G. Konin is a Clinical Professor in the Department of Athletic Training in the Nicole Wertheim College of Nursing and Health Sciences at Florida International University (FIU) where he directs the Global Initiative for Cannabinoid Research and Education. To learn more about FIU’s cannabinoid research and education initiative you can visit their website at https://go.fiu.edu/GlobalCannabis. Views represented in this column do not reflect that of Florida International University and are solely attributed to Dr. Jeff G. Konin.



PūrWell launches PūrRelēf, a first-of-its-kind organic gummy that provides a safe and effective alternative to NSAIDs (Non-Steroidal Anti-Inflammatory Drugs.) Millions of people rely on NSAIDs to control symptoms of chronic pain and inflammation, however, NSAIDs come with some risk. Studies have shown they may cause toxicity to one’s liver, kidneys, and upper GI-tract. PūrRelēf combines powerful flavonoids from Skull Cap and Green Tea to provide extraordinary anti-inflammatory support, while added benefits of Boswellia and Turmeric supercharge the anti-inflammatory action. CBG and Delta-8 isolate round out the overall analgesic effects. Unlike NSAIDs that may cause undesirable side effects, PūrRelēf is a combination of GRAS (Generally Regarded As Safe) ingredients, that have shown no toxicity over periods of long-term use. It is a COX-1, COX-2 and 5-LOX inhibitor. PūrRelēf’s convenient form makes it easy to consume, and the Appleberry flavor is derived from organic fruit extract.



Steve White named President after Harvest Acquisition

Trulieve Cannabis Corp. announced several new executive appointments including; President, Steve White; Vice President & General Counsel, Nicole Stanton; Director of Investor Relations, Christine Hersey; and Executive Director of Corporate Communications, Rob Kremer.

The White, Stanton and Hersey appointments follow the Company’s October 1, 2021, closing of the acquisition of Harvest Health and Recreation Inc.

“We are thrilled to officially announce the appointment of several members of the legacy Harvest team to key roles within our organization,” said Kim Rivers, Trulieve’s Chief Executive Officer. “The addition of talent and experienced leadership was a key component of the Harvest acquisition and further advances our strategy of expansion through the addition of regional assets and teams within our hub model. We also are adding to our leadership team as the company continues to experience significant growth.”

These leaders deliver a breadth of experience from multiple industries to Trulieve’s leadership team:

Steve White, President – Mr. White co-founded Harvest Health & Recreation in 2011 and served as Chief Executive Officer until the acquisition of the company by Trulieve. As an early pioneer in the U.S. legal cannabis industry, Mr. White led the company as it grew from a single dispensary to become one of the top multi-state operators with cultivation, manufacturing, and retail operations in several markets. Mr. White spearheaded one of the industry’s most successful license application teams, paving the way for rapid growth through organic license awards and capital efficient expansion. As a former litigator, Steve White successfully navigated the complex patchwork of different regulatory regimes across various U.S. markets while advocating for expanded access to cannabis for patients and adult use consumers. Steve White serves as a member of the boards of the Arizona Dispensary Association and charitable organization Harvesting Hope. Mr. White graduated from Arizona State University Honors College summa cum laude with a B.S. in Political Science and earned a Juris Doctorate from Washington & Lee University, School of Law.

Nicole Stanton, Vice President and General Counsel – Ms. Stanton served as Vice President, General Counsel and Secretary of Harvest since 2019, overseeing the legal department and compliance program. She received the Public Company General Counsel of the Year award by the Arizona Corporate Counsel in April 2021. That same year, the Harvest legal department was nominated for Legal Department of the Year. Prior to joining Harvest, Ms. Stanton was employed by the national law firm of Quarles & Brady LLP for nearly 20 years. She served as the office managing partner of the firm’s Phoenix office from 2013-2018, as well as the firm’s assistant general counsel from 2009-2019. While managing partner, she was responsible for overseeing more than 100 lawyers and 75 professional legal staff, covering 11 different legal practice areas. She is a veteran litigation and legal ethics counsel. Her success as defense counsel garnered her an established and credible reputation across business practices including awards as one of the Top 100 Lawyers in Arizona from AZ Business Magazine (2015-2108) and Phoenix Business Journal’s Most Admired Leaders (2014). Ms. Stanton holds a Bachelor of Science in Communication from the University of Utah and a Juris Doctorate from the University of Arizona, College of Law. She has taught legal ethics at Arizona State University’s Sandra Day O’Connor College of Law and is a member of the prestigious American Law Institute.

Christine Hersey, Director of Investor Relations – Ms. Hersey served as Director of Investor Relations at Harvest since June 2019. She has over 20 years’ experience in corporate, buy-side and sell side roles working in and covering a variety of sectors including biotech, cannabis, cleantech, and consumer retail at Durant Partners, Efficacy Capital, M.S. Howells, Savitr Capital, and Wedbush Securities. Ms. Hersey previously covered global securities traveling throughout the U.S., Europe and Asia. Prior to her career in finance, Christine worked as an environmental engineer and project manager. Ms. Hersey earned a B.S. in Civil Engineering from Worcester Polytechnic Institute, M.S. in Civil Engineering from Northeastern University, and an MBA and M.S. in Finance from Boston College.

Rob Kremer, Executive Director of Corporate Communications – Mr. Kremer has nearly 30 years of experience in both corporate and agency settings. In his role at Trulieve, he will oversee both internal and external communications. Kremer spent the past 10 years as a partner at Rhythm Communications where he developed and implemented successful programs and campaigns. Client leadership includes Chick-fil-A, General Mills, Mizuno, as well as celebrities such as Champ Bailey, Ludacris and Ray Lewis, among many others. Previously, he served as in-house PR at both Coca-Cola and Aetna U.S. Healthcare, as well as an internal communications consultant at Hewitt Associates. Several campaigns under his stewardship have been recognized for regional and national awards. Mr. Kremer is a graduate of the Henry W. Grady School of Journalism at the University of Georgia and serves on numerous philanthropic boards.



By Vanessa Orr

One of the most important aspects of medical care is having a doctor you can trust who understands your health conditions before providing recommendations. This holds true in the case of medical marijuana certification and recertification as well.

“What distinguishes me and my practice is that I’m available, accessible, and I believe it’s important to educate people to empower them to make better choices,” said Daphnee Moise-Johnson, M.D., Vivant Medical Group. “Medical marijuana is a medicine, and it needs to be treated as such.”

Dr. Moise-Johnson has been an emergency room physician for 20 years and opened Vivant Medical Marijuana in Tampa six months ago to provide more a preventative type of care to patients.

“I wanted to get into more functional, integrative medicine to better help people find answers to their health problems before they find themselves at the ER in the middle of the night,” she said.

While Dr. Moise-Johnson believes strongly in the benefits of medical marijuana, she wants to ensure that the medicine is used the right way.

“I’ve seen quite a lot of improvement in patients’ health; many are no longer taking any kind of antidepressants or benzodiazepines or drinking alcohol, and they are sleeping better and going back to work,” she said. “But it’s important that they understand how the medicine works and find the right balance to make it a positive experience.”

When patients call, Dr. Moise-Johnson spends a minimum of 45 minutes educating them on the benefits of medical marijuana; the different illnesses it treats and why; the endocannabinoid system and the importance of terpenes.

“By understanding the different terpenes, you can find something more customized to your needs,” she said. “It’s also important to understand how these products work and how to take them so that patients don’t just go into the dispensary blindly.

“At Vivant, they are always going to have that exclusive doctor-patient relationship.”

To learn more, visit Vivant at www.vivantmedicalmarijuana.com or call (800) 574-9491.