Bringing Medicine To Cannabis, Not Cannabis To Medicine MD 420 May 1, 2019 Medical, Political In 2014, I was hired by a new medical cannabis company as a consultant to help them create more of a “healthcare friendly” cannabis line to be recommended by doctors. At the time, I knew very little about the medical cannabis industry which helped me bring fresh eyes into a very non- medical industry. I had to do some serious market research and aggressively review the clinical data to get caught up to speed, fast. I remember thinking “If this is really medicine, it will disrupt everything!” For the first thirty days, I devoured medical research about the endocannabinoid system (ECS), cannabinoids, terpenes, dosing administration (smoking, gel-caps, sublingual, topical, edible, suppository), raw material sources (flower, distillate oil concentrates, purified powdered isolates). I also dug deep in the comparison to FDA approved synthetic drugs, as well as to recreational “drugs” like alcohol, tobacco, narcotics and other hallucinogens. On-site market research consisted of going door to door, dispensary after dispensary, day after day just to see what products were being offered to patients in a medical (actually more recreational) manner. I was very disappointed at the entire “medical dispensary” model and quickly understood why doctors were so skeptical of the entire medical cannabis industry. These products looked like someone was making this stuff in the kitchen sink and licking a label on them. The branding was “hippyish”, there was no quality control and the bud-tenders looked like something out of Wayne’s World. Almost every dispensary looked like a pot smokers head shop with bongs everywhere. It was definitely NOT a medical setting! I realized that the entire “cannabis culture” lacked any experience as to how “medical cannabis” should represent medical standards with pharmaceutical quality control, professional branding, accurate labeling, standardized dosing, and proper instructions. Then it hit me – “Cannabis is trying to break into medicine, but NOBODY is bringing medicine to cannabis!” In my opinion, Texas is in a unique position to become the first “legitimate” medical cannabis program in the US. If we learn from the mistakes of other medical marijuana states, and make use of good ‘ol fashioned Texas ingenuity to bring a different model other states have not used, then we are primed and ready to lead the country with the first legitimate medical cannabis program. I discovered four major problems that could cause stress related migraines (something cannabis can treat by the way) to both politicians and doctors that would make them hesitate moving forward with medical cannabis in Texas. PROBLEM #1: WHY OTHER MEDICAL CANNABIS STATES FAILED: In California and Colorado, state residents were approved by their doctors to qualify for a medical cannabis card allowing them to walk into any dispensary and purchase medical cannabis – which was part of the reason why the medical model failed and forced the recreational dispensary model. Legislators approved medical cannabis laws for doctors to be involved with “doctor run programs”, but missed a major step – nobody told the doctors! Doctors in general know NOTHING about cannabis. Not only that, medical cannabis is still classified a Schedule-1 drug on a federal level, and if the doctors were to recommend or prescribe it for a patient, doctors were concerned that they would be breaking federal law and the DEA could come knock on their office door, put them in handcuffs, and take their medical license. I don’t know if you know this or not, but doctors are very skittish “anti-liability” creatures. It wasn’t hard to figure out that doctors were avoiding cannabis because of legal concerns, especially in the early years when nobody knew what was going to happen next. Therefore, the states “opened shop” expecting doctors to approve patients and send them to medical dispensaries, but doctors were not participating. Millions of dollars were spent to open the cannabis market, open grow facilities, start processing labs, begin product development, and set up dispensaries for product sales… all with very little doctor participation. The next obvious step was to go “recreational” and bypass the doctors all together. Once that happened, states started cranking out sales, generating crazy amounts of tax revenue, and patients started witnessing miraculous recoveries from cancer, pain, MS, epilepsy, Alzheimers, Autism, PTSD… and nobody was tracking these medical results because doctors were not involved. This is why there are so many patients on YouTube preaching how cannabis has saved their son, mother, daughter, dog… which doctors consider anecdotal evidence and not able to take seriously – no matter how accurate, amazing or miraculous the result is. Solution: See Problem 2. PROBLEM #2: LACK OF QUALITY MEDICAL CANNABIS TRAINING FOR DOCTORS: As more states add to the ever growing “green list” for legalizing medical cannabis, the marijuana movement is quickly outpacing the medical profession’s understanding of it. In a study published in the fall of 2017, researchers found that fewer than 10% of the medical schools included any kind of medical marijuana in their curricula. Two-thirds of medical school deans reported that their graduates “were not at all prepared to prescribe medical marijuana,” and a quarter reported that their graduates “were not at all prepared to answer questions about medical marijuana.” Even more concerning, the survey demonstrated that almost 90 percent of physicians in the final stages of their training — residents and fellows — felt they weren’t at all prepared to prescribe medical marijuana, and more than one-third felt they were not able to accurately answer questions about it. Almost 85% reported receiving no education about medical marijuana during medical school or residency. This means there is a huge gap between “what doctors actually know” vs “what doctors should know”; especially in a state, like Texas, that is still very apprehensive about legalizing it. Given the fact that medical marijuana is now a legitimate therapeutic option for patients in 33 other states, doctors need to be informed enough to guide their patients in an evidence-based manner and discern which patients might benefit from medical marijuana in states where it’s legal. In Texas, only cannabidiol (CBD) is legal, which means doctors still need the proper knowledge base on how to intelligently answer questions about CBD, or even THC, without feeling like they are authorizing their patients to commit a crime. However, recent changes in CBD legalization was made possible on a national level when President Trump signed the Hemp Farm Bill in December 2018 making CBD officially legal across the country – but possibly putting the FDA in charge of it. Even more recently, Texas removed CBD off of the Schedule-1 status by approving commercial hemp, and supported by Texas Farmers and State Representative Tracy King. SOLUTION: STATE CERTIFICATION & TRAINING WITH CMES The best way to encourage doctors to get more involved in alternative therapies like cannabis is to offer state approved training and education. If Texas had a state approved CME certification program on medical cannabis, and had a state approved pharmacy/GMP manufacturer model for cannabinoid quality control, Texas could be leading the medical cannabis agenda with the only true “Medical Model” in the United States. LoneStar Life Sciences is currently building such a training platform with the largest and most experienced medical cannabis certification program in the US and establish a Texas program under the LoneStar Life Sciences Academy banner. With this program, we will be able to track all doctors and pharmacists in Texas who want to get involved with medical cannabis, as well as their patients, on behalf of the state of Texas. PROBLEM #3: DISPENSARY VS PHARMACY The one thing that seems to scare the crap out of Texas Politicians regarding medical cannabis is NOT being able to control who gets access to what product and from where. Healthcare has a fix for that. Keep in mind the medical dispensary model is not built for healthcare. Doctors currently have electronic health record (EHR) systems to track patients, including all of their prescriptions. If Texas allowed the cannabis pharmacy model, doctors would be able to prescribe cannabis knowing exactly what the patient is going to get – and track the results through the EHR. The Texas politicians and law enforcement see the medical dispensary model an easy and obvious step into the eventual “recreational” dispensary model – and they are correct. However, this concern could be addressed with NOT opening dispensaries, by using pharmacies – a model already in place and is considered the standard way to dispense medications. Medical professionals, and patients for that matter, are more familiar and comfortable with the established Patient-Doctor-Pharmacy “triad” relationship. Doctors do not consider the dispensary equal to the pharmacy model for four major reasons: • Control: Doctors want to have a certain amount of control over what their patients are taking so they can manage their outcome better. With a dispensary model, doctors have no control of what the patient will be sold at a dispensary. However, prescriptions written from a doctor and sent to a pharmacy gives doctors the proper control of what their patient should get. • Patient Compliance: In a dispensary, most patients have no clue as to what to get and could be “sold” something completely different from what the doctor intended. If it is “flower” to smoke, what kind is it? If we were talking edibles, what’s the standardized dose per item? Prescriptions from a compound pharmacy would allow doctors to be very specific on milligram dose, type of concentrate used (indica, sativa or hybrid), and choose the proper delivery system that would be best for that patient and their specific medical problem. • Quality Control: Cannabis companies have very little oversight in product development and quality control like pharmacies do. Compound pharmacies or registered GMP manufacturers, for example, are inspected by the State to ensure product quality from professionally trained, board certified pharmacists and pharmacy technicians, or PhD chemists. All records are inspected and tracked to make sure the pharmacy or manufacturer is following all established medical protocols. • Professional Personnel: Dispensary bud- tenders lack medical training and have no medical certifications. In a dispensary, it is common for tattooed bud-tenders with nose rings and ear loops typically handle a patient’s medical cannabis recommendations instead of a trained medical professional. Solution: Choose Pharmacy over Dispensary Prescribing cannabis products through an approved cannabis pharmacy could solve the paranoia Texas medical professionals and politicians have about the cannabis industry. Texas is definitely not ready to go recreational any time soon, and by keeping the cannabis control in the hands of doctors with a pharmacy model, the recreational market can be delayed (at least for now). This would allow the state board of pharmacy to maintain management and quality control of products made like any compound pharmacy. Special Note: Just so everyone is on the same page, as far as CBD is concerned, there is no psychoactive effect and is non-toxic when using it, and therefore harmless to consumers if it is processed with proper quality control and lab reports. If we follow the same pharmacy model – imagine CBD as “over the counter” version of cannabis medicine, and the THC would be “behind the counter” version requiring a prescription. PROBLEM 4: HOW DO YOU TRACK IT ALL? Tracking everything from the seed production to the grower, to the processor, to the laboratory, to the product manufacturer, to the pharmacy, and from the doctor to the patient – everything needs to be tracked. If you add medical schools for clinical trials and medical researchers, they should all be using the same software to make sure everything can be tracked from source to user. The only way to keep track of every link in the chain is with new technology called “Blockchain”. SOLUTION: LONESTAR INFOTECH With LoneStar InfoTech Blockchain based software, we will be able to track all data from the seeds all the way through to the patient for feedback. The system I just described to you can be developed on a single secure database, but with multiple users with “keys” along the way. As for medical cannabis purposes, this system would also allow the State of Texas to track all tax revenue, track certified doctors trained to prescribe medical cannabis responsibly, track all patients using cannabis products, track all pharmacists or supplement companies making or selling cannabis based products, and track responsive feedback on a smart phone app from patients about how the cannabis products are helping improve their health or quality of life.