From the Frontlines: Taking the Guesswork Out of Medical Cannabis

These were the words spoken by the doctor treating my husband, Stewart Smith, for his debilitating back pain. It was 2008, and we were living in Colorado, where cannabis medicine had been legal since 2000 through passage of Amendment 20.¹

During this period, I was making monthly visits to my own pain management doctor for refills of the cocktail of opioids prescribed for severe back and neck pain that included fentanyl, methadone, and Norco—plus 23 other pharmaceuticals, most of which were to compensate for side effects of the opioids. My life had been reduced to doctor visits, trips to the pharmacy, and struggling to stay awake. At 49, I was living the life of an aged, disabled woman.

Upon our return to California in 2010, it became apparent that Stewart would require extensive surgery to repair his broken back. Without it, the doctors warned, he would quickly be confined to a wheelchair, and he was taking high doses of nonsteroidal anti-inflammatory drugs (NSAIDs)² to cope. California legalized cannabis medicine in 1996 through Proposition 215,³ but not one physician we visited even mentioned cannabis as a pain treatment option.

A friend mentioned that she made pot brownies for her fiancé to deal with his chronic neck pain. My immediate reaction was skepticism as I recalled the “brownies” of my youth. Besides, wasn’t marijuana illegal? For me, marijuana was no different than cocaine. My entire education about cannabis was based on the propaganda of Marijuana Prohibition.

After further investigation, and reinforced by our shared desperation for relief, we decided to give cannabis a try. The first step was to find a doctor willing to write a recommendation for both of us to use cannabis legally. We found a local doctor who was writing “215” recommendations.⁴ We had a brief consultation and he agreed we should try cannabis, but he was unable to give us any direction as to what flower materials to take or how much to take. Instead, he gave us a sheet of paper with several dispensary names and a general remark to look for an “indica.” He did whisper “one of the listed dispensaries was better” than the others. He shared this limited information while acting as though the DEA was listening in and he was risking his medical license by sharing this.

The young man behind the dispensary counter was congenial, but of little help in educating us on what cannabis materials to buy. He suggested a brownie, a Rice Krispies treat, and a package of caramel corn—all infused with various cannabis products. There was no labeling to indicate what was in the product—no ingredients list, no milligrams of cannabinoids, and no indication of what chemotype (or strain) was used to produce it. The Rice Krispies treat was wrapped in plastic wrap, and had a piece of masking tape that read “5–20 doses” written with a pen. What was a “dose”? How would we know how much to take? Was this square to be divided into five pieces or 20?

Discovering a System

As a former process engineer, it is in my nature to look for patterns and specificity. I weighed each piece, recorded times taken, time until onset, hours slept, and how we felt in the morning. It was clear from the beginning that nothing was predictable or consistent using this sort of unidentified and unquantified “medicine.”

The same woman, who first told me about pot brownies, introduced us to her friend who grew cannabis on a mountaintop. The grower was happy to provide us with a reduced granny price, and sold us two ounces of XXX ChemDawg. The only instructions we received were to grind up the flowers, mix with an oil (safflower, olive, medium-chain triglyceride (MCT), etc.), and slowly heat. There were no recommended times or temperatures, and the online forums were confusing and contradictory. I was able to learn at what temperature tetrahydrocannabinolic acid (THCA) became tetrahydrocannabinol (THC),⁵ but that was about it.

In searching for a baked good that utilized a lot of oil (instead of butter), I came across my Aunt Zelda’s carrot cake recipe. It was ideal, because I knew how much oil had been used, and by weighing the entire cake and then each piece, it was a simple calculation to see how strong a piece would be. However, we still had no method of measuring the milligrams of cannabinoids in each piece to enable the notion of dosing, as there was no lab testing for quality verification.

Over a short time, friends began commenting on the health improvements they were seeing in us. When we shared our new pain control method, we were frequently asked to help these friends or their loved ones. In exchange, we only asked that they provide feedback as to how much they were taking and how they were feeling.

Navigating Legal and Banking Challenges

Being in legal compliance—as much as is possible when dealing with a Schedule I drug—was very important to us. An attorney who was attempting to make a name for himself as a “cannabis attorney” was recommended to us. He set up Aunt Zelda’s as a mutual benefit nonprofit corporation (MBNPC), so we could legally have on hand more product than what is allowable for personal use. Each patient who joined our collective empowered us to have on hand the equivalent of six more mature plants (half a pound of raw material) per patient. The regulations were very clear that no cannabis could be sold. Instead, we donated medicine to patients and they in turn made a donation in cash back to Aunt Zelda’s. There are no tax advantages to an MBNPC, but we were still saddled with many of the restrictions associated with nonprofit status. The federal tax laws do not allow for conventional deductions for items as straightforward as labor. Only the raw product (and its associated cultivation costs—nonlabor) can be deducted.

Banking was also an immediate problem and remains a challenge. Cultivators demanded large cash payments. Employees required payroll with associated FICA, worker’s compensation, etc., and sales tax had to be paid by check or credit card. Patients were required to pay in cash, as there was no way for us to deposit a check. This continues to be problematic.

As of December 2016, we have been literally kicked out of three banks. This included when opening an account for a medical practice that was limited to advising cannabis patients. It is not necessary to “touch the plant” to be excluded. Simply the use of the word “cannabis” or “marijuana” on a website can be enough to frighten away the banks. As a result, approximately 75 percent of all cannabis-related businesses in California are operating on a cash-only basis. FinCEN, the Department of Treasury’s agency that deals with money laundering, has issued a memorandum to legally service cannabis-related businesses (CRBs);⁶ however, the state banks remain leery.

From the Prohibition Ages to Alchemy to Science

A new testing lab opened in Davis, California, operated by a biochemist who was able to determine the cannabinoid and terpene content of cannabis products. Some products remained crude, like baked goods that were not easily tested, but we were getting closer to knowing the actual active medical ingredients like milligrams of cannabinoids and terpenes in our product. Now we could determine the actual dose being consumed, which would help us to help others with similar diagnoses—theoretically. What we actually found was that no two cannabis patients are alike, and that we would have to ask a lot of health and personal questions in order to find patterns that would predict a therapeutic dose. In this early period, we began work on a Cannabis Desk Reference that would inform and empower the medical community about various diseases and their associated cannabinoid treatment protocols.⁷

In mid-2011, a businessman who was kind enough to meet with us suggested that instead of “building everyone a house, that we supply the lumber.” Our carrot cake was very popular, but wasn’t scalable. If we were to supply patients with the infused oils, they could consume cannabis however they chose—whether in a marinara sauce, a salad dressing, a baked good, or just straight under the tongue. This was an excellent strategy to scale our business and help a larger patient population. We shifted to providing the oils with known cannabinoid and terpene dosages to the milligram level that had been lab tested so patients would be empowered to dose themselves.

Disease-Specific Products and Collecting Data

When the first cancer patient approached us, our initial reaction was abject fear. Who were we to advise a cancer patient? What qualified us to provide the appropriate medicine? Nothing. The reality was there was nowhere else for him to go. No doctor was offering guidance in treating disease with cannabis. The Internet had many stories of individuals “curing” their cancers with cannabis using something known as Rick Simpson Oil (RSO), but the crude technique for making the oil and the dosing instructions of a “gram a day” were untenable for most people. We agreed to help the patient as long as a primary physician was aware of the cannabis use and remained in charge of the health care. Shortly afterward, a family came to us with a six-year-old girl suffering with a glioblastoma multiforme (GBM), a form of brain cancer known as the Terminator.⁸

Cultivating, Educating, and Empowering

A nurse we knew was on long-term disability because of a car accident. I asked her if she was interested in learning about cannabis as an alternative to her opioid use. She was interested, so I suggested that she could help others with their cannabis use once she was trained in the endocannabinoid system. She spent two years interning with us, and has gone on to start her own practice. We then found a physician who had heard me speak a couple of times and wished to learn our techniques. Though he had written recommendations for thousands of patients, he did not have the luxury of following up to see what they used and how it worked. With us, he was able to have a more conventional relationship with patients. In order to protect medical professionals’ licenses, we formed a separate company, Calla Spring Wellness, which does not in any way “touch the plant,” so doctors and nurses are insulated.

In early 2013, actress and producer Ricki Lake approached us asking us to participate in her documentary Weed the People, which would follow us as we produced the medicine and worked with patients. Doctors want to learn how to work with the endocannabinoid system, but they want to be paid while they train. There is a perception that everyone in the cannabis industry is making truckloads of money. The reality is quite different. If we had chosen to go the less medical route, and created products that are in demand by the recreational market, the profits are astounding. However, understanding the specific needs of immunocompromised individuals required a much higher level of quality and consistency. Trimmed cannabis from cutting room floors may be good enough for a vaporizer cartridge or a gummy bear, but not for a cancer patient. The same quality of flowers that sell for top dollar at dispensaries is what we use for extraction and infusion. To this end, we accepted investment from a group that was to help us continue to expand from R&D into full-scale production.

Navigating the Legal Maze

Stewart and I are committed to being of service to others. Unfortunately, much of the cannabis investment world appears more interested in quick returns on investment and exit strategies. Our investors have been no different. Many of the most innovative companies in this space have been created by individuals with entrepreneurial spirit and vision. That does not necessarily coincide with extensive business acumen. We may understand the best uses of the cannabinoids and terpenes, but reading a cap table or pro forma is a foreign language. Legal representation is expensive, and with the regulations being in flux, there are very few attorneys with the experience needed to guide small business owners through the maze of changing regulations. This has left many companies—ours included—to enter into predatory agreements. The instances of founders being pushed out of their own companies is growing far too rapidly. Small family farms and manufacturers are being squeezed out by corporate growers and processors. Mass production does not result in a quality medicine for patients. However, as long as green rush investors are driving vision, that won’t change.

With the implementation of the Medical Cannabis Regulation and Safety Act there are now at least 17 different license types for all aspects of the industry, from cultivation to distribution. Each county and city in California can decided whether it wishes to allow cannabis businesses to operate. This has caused a land grab in areas such as Santa Rosa (Sonoma County), where “green zones” have been designated. The prices of appropriate properties are skyrocketing, much as we saw during the dotcom bubble.

Our Focus and the Future

Our vision for treating patients is clear: start with organic material that has been accurately tested for cannabinoid and terpene content; process in a good manufacturing practice (GMP) facility utilizing organic ethanol to create high-quality medicines (each batch tested) so it can be dosed at the milligram level; have patients consult with medical professionals who are educated in the endocannabinoid system; understand dosing for different diagnoses; ensure budtenders and dispensaries have access to proper information when recommending products; and conduct clinical trials. To this end, in harmony with traditional medical care, we continue to be committed to all patients who can benefit from optimal treatment with cannabis.

We hope in our lifetime that cannabis medicine will be available to all Americans who are in need without regard to where they live. ◆

Endnotes

1. See Colo. Const. art. XVIII, § 14.

2. For a basic description of NSAIDs, see What Are NSAIDs?, OrthoInfo, http://orthoinfo.aaos.org/topic.cfm?topic=a00284 (last reviewed Jan. 2009).

3. See Cal. Health & Safety Code § 11362.5.

4. See Cal. Med. Ass’n, Physician Recommendation of Medical Cannabis: Guidelines of the Council on Scientific Affairs Subcommittee on Medical Marijuana Practice Advisory (2011), available at http://www.mbc.ca.gov/Licensees/ Prescribing/medical_marijuana_cma-recommend.pdf.

5. See Decarboxylation, Skunk Pharm Res. LLC, https://skunkpharmresearch.com/decarboxylation/ (last visited Apr. 19, 2017).

6. Press Release, Fin. Crimes Enf’t Network, FinCEN Issues Guidance to Financial Institutions on Marijuana Businesses (Feb. 14, 2014), https://www.fincen.gov/news/news-releases/fincen-issues-guidance-financial-institutions-marijuana-businesses.

7. See CDRMed, https://portal.cdrmed.org/ (last visited Apr. 19, 2017).

8. See Eric C. Holland, Glioblastoma Multiforme: The Terminator, 97 Proc. Nat’l Acad. Sci. 6242 (2000).