Tag Archives: medical

Sunrise Genetics Partners With RPC, Begins Genetic Testing in Canada

By Aaron G. Biros
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Sunrise Genetics, Inc., the parent company of Marigene and Hempgene, announced their partnership with New Brunswick Research & Productivity Council (RPC) this week, according to a press release. The company has been working in the United States for a few years now doing genomic sequencing and genetic research with headquarters based in Fort Collins, CO. This new partnership, compliant with Health Canada sample submission requirements, allows Canadian growers to submit plants for DNA extraction and genomic sequencing.

Sunrise Genetics researches different cannabis cultivars in the areas of target improvement of desired traits, accelerated breeding and expanding the knowledge base of cannabis genetics. One area they have been working on is genetic plant identification, which uses the plant’s DNA and modern genomics to create authentic, reproducible, commercial-ready strains.

Matt Gibbs, president of Sunrise Genetics, says he is very excited to get working on cannabis DNA testing in Canada. “RPC has a long track record of leadership in analytical services, especially as it relates to DNA and forensic work, giving Canadian growers their first real option to submit their plant samples for DNA extraction through proper legal channels,” says Gibbs. “The option to pursue genomic research on cannabis is now at Canadian cultivator’s fingertips.”

Canada’s massive new cannabis industry, which now has legal recreational and medical use, sales and cultivation, previously has not had many options for genetic testing. Using their genetic testing capabilities, they hope this partnership will better help Canadian cultivators easily apply genomic testing for improved plant development. “I’m looking forward to working with more Canadian cultivators and breeders; the opportunity to apply genomics to plant improvement is a win-win for customers seeking transparency about their Cannabis product and producers seeking customer retention through ‘best-in-class’ cannabis and protectable plant varieties,” says Gibbs. The partnership also ensures samples will follow the required submission process for analytical testing, but adding the service option of genetic testing so growers can find out more about their plants beyond the regular gamut of tests.

RPC is a New Brunswick provincial research organization (PRO), a research and technology organization (RTO) that offers R&D testing and technical services. With 130 scientists, engineers and technologists, RPC offers a wide variety of testing services, including air quality, analytical chemistry of cannabis, material testing and a large variety of pilot facilities for manufacturing research and development.

They have over 100 accreditations and certifications including an ISO 17025 scope from the Standards Council of Canada (SCC) and is ISO 9001:2008 certified. This genetic testing service for cannabis plants is the latest development in their repertoire of services. “This service builds on RPC’s established genetic strengths and complements the services we are currently offering the cannabis industry,” says Eric Cook, chief executive officer of RPC.

German Media Reports Dramatic Increase in Cannabis Patients Covered by Insurance

By Marguerite Arnold
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German media is now reporting that in the first 10 months of medical cannabis reform, over 13,000 applications for medical cannabis have been received by the largest three public health insurance companies. Most of the applications were received (and processed) by AOK who received 7,600 applications. Barmer received 3,200 applications. Krankenkassen Techniker (or TK as it is widely referred to here) received approximately 2,200 applications.

The reality is that most patients still rely on the black market.Between 62-64% of those who applied at the big three were also reimbursed. That means that there are already close to 10,000 patients, if not slightly more, covered under some kind of reimbursed cannabis scheme in Germany (where cannabis costs only $10 per month as a co-paid expense). When cannabis is not covered by health insurance, however, patients must pay out of pocket for the drug which can run as much as $3,000 for a single month’s supply.

This information is also being released, fascinatingly, not from the government, insurance companies or even advocacy groups. Instead it comes from a report produced by local media (the Rheinische Post in Dusseldorf). The media outlet surveyed the three top largest health insurance companies on the number of cannabis-as-medicine applications they have received since the cannabis law was reformed last year.

Home cultivation and recreational use, except in a few city trials now underway in places like Bremen, is still outlawed on a federal level. The new law also specifically prohibits patients from growing their own. And since the reform law passed last year, the prevailing story from patients is the difficulties they have had in not only finding a doctor willing to prescribe cannabis, but also getting their health insurers to reimburse them for huge out of pocket expenses that most of the chronically ill can never hope to afford.

The reality is that most patients still rely on the black market. It is still easier to get cannabis this way. And far cheaper – unless of course approved by health insurance.

What Does This Mean For The Bigger Picture?

Despite the fact that many in the mainstream German media are still highly sceptical of the medical efficacy of cannabis, the tide is turning here too, rather dramatically. According to recent polls, about 57% of the country is ready for recreational reform. That means in the last four to five years, the majority of public opinion has also shifted. It is also clear that medical cannabis cannot be as easily dismissed as it once was. Here or anywhere.

What makes this even more interesting is the impact this now moving situation will have on the debate, particularly domestically, but also internationally.

The first is that Germany clearly has a huge number of potential patients. Local advocates put the real number here north of 1 million for conditions the drug is commonly prescribed for in other places. At the present time, the only doctors who are allowed to prescribe the drug must also have a special license to dispense such restricted “narcotics” as cannabis is now classified auf Deutsch. And the only “on-label” condition for cannabis is still Multiple Sclerosis. That means that cancer, AIDS, chronic pain and movement disorder patients, along with those who manage to get approved for PTSD, ADD, depression and other “psychological” disorders only get the drug approved as a measure of “last resort.” In other words, after all other drugs fail. That is a high bar to pass.

The second, as a result, is that these numbers appear artificially low for another reason. The government claimed upon passage of the cannabis reform legislation last year that it expected only 10,000 new patients a year for the first few years (and before domestic cultivation began). As these results already prove, there are clearly far more patients who want the drug than those who can get it. There are also more patients whose doctors are willing to write prescriptions for the drug than are getting reimbursed by public health insurance.Bottom line? No matter how slow it is in getting started, the medical cannabis market has arrived in Germany. The numbers will only grow from here.

Third, this entire debate is now happening at a time when Germany is re-examining its own health insurance policies. While 90% of the country is on much cheaper public healthcare, 10% of the country, mostly the self-employed, foreigners and high earners, have private coverage. This is highly expensive, and ends up trapping even Germans in a system that is unaffordable as they age. In fact, the issue is a big one in Berlin right now as particularly the SPD is pushing Chancellor Merkel and the CDU to finally address a growing problem.

The law last year mandated that public health insurance must cover cannabis if prescribed under the right conditions. That means that private health insurers have to cover it too.

On the cannabis front specifically, what this may indicate, however, is that the public health insurers are being tasked to only approve a certain pre-identified number of patients nationally in the early part of the cannabis program. Especially as all of the medical cannabis in the country is still imported – and most of that is still coming from Canada.

What these numbers clearly show however, beyond all the caveats, is that demand is starting to pick up. Cannabis as medicine has not entirely caught on in the mainstream, although Germans are clearly interested in the idea. Especially given all the noise and news from abroad on this front.

It also means that no matter how “anaemic” these numbers may seem in early 2018, it is a respectable kick-off to what many in the industry view as one of the world’s most lucrative medical cannabis markets. Counting the approximately 1,000 patients who received medical cannabis before the law changed last year, it is safe to say that the market is now up and running.

Bottom line? No matter how slow it is in getting started, the medical cannabis market has arrived in Germany. The numbers will only grow from here.

How Does This Compare To Other Countries?

But how does the German patient ramp up compare to other countries after significant reform has been passed?

In Canada, the cannabis-as-medication discussion is clearly mainstream as the country prepares to launch its recreational program later this summer. The medical program began in 2014. The most recently released figures as of the beginning of January 2018, show that medical cannabis has clearly caught on. Health Canada’s most recent figures show that by September of last year, there were 235,621 registered cannabis patients in the country. Significantly, this is also up dramatically from 174,503 registered patients as of just April 2017. The previous year, the total number of cannabis patients literally tripled in 2016. To put this in “historical perspective,” as of Q1 2015, about a year into the new medical law in Canada, there were “only” 23,930 patients (or about twice the number in Germany as of now). This growth is all the more impressive when one considers that there is no mandate for insurance coverage of the drug in Canada. That said, cannabis is far cheaper in Canada. It is of course covered domestically. Plus the licensed producers can mail order it directly to patients.

Israel’s path to medical cannabis access has been slower off the ground in terms of overall numbers, but it is has still dramatically expanded over the past decade too. In 2012, there were about 10,000 cannabis patients in Israel. That number more than doubled by 2016 to over 23,000 patients. This will continue to increase too. Israel’s medical cannabis is covered under national health insurance and patients must pay about $100 a month for their meds.

What Is The Official German Government Response To This News?

Marlene Mortler, German drug commissioner for the federal government and affiliated with the CSU, has issued comments that seem to be supportive of the continued program in Germany. “The growing number of permits shows how important it was to launch this law last year,” she said, while warning that medical cannabis is not a panacea.

Microbiology 101 Part Two

By Kathy Knutson, Ph.D.
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Microbiology 101 Part One introduced the reader to the science of microbiology and sources of microbes. In Part Two, we discuss the control of microorganisms in your products.

Part 2

The cannabis industry is probably more informed about patients and consumers of their products than the general food industry. In addition to routine illness and stress in the population, cannabis consumers are fighting cancer, HIV/AIDS and other immune disorders. Consumers who are already ill are immunocompromised. Transplant recipients purposely have their immune system suppressed in the process of a successful transplant. These consumers have pre-existing conditions where the immune system is weakened. If the immunocompromised consumer is exposed to viral or bacterial pathogens through cannabis products, the consumer is more likely to suffer from a viral infection or foodborne illness as a secondary illness to the primary illness. In the case of consumers with weakened immune systems, it could literally kill them.Bacteria, yeast, and mold are present in all environments.

The cannabis industry shoulders great responsibility in both the medical and adult use markets. In addition to avoiding chemical hazards and determining the potency of the product, the cannabis industry must manufacture products safe for consumption. There are three ways to control pathogens and ensure a safe product: prevent them from entering, kill them and control their growth.

Prevent microorganisms from getting in

Think about everything that is outdoors that will physically come in a door to your facility. Control the quality of ingredients, packaging, equipment lubricants, cleaning agents and sanitizers. Monitor employee hygiene. Next, you control everything within your walls: employees, materials, supplies, equipment and the environment. You control receiving, employee entrance, storage, manufacturing, packaging and distribution. At every step in the process, your job is to prevent the transfer of pathogens into the product from these sources.

Kill microorganisms

Colorized low-temperature electron micrograph of a cluster of E. coli bacteria.
Image courtesy of USDA ARS & Eric Erbe

The combination of raw materials to manufacture your product is likely to include naturally occurring pathogens. Traditional heat methods like roasting and baking will kill most pathogens. Remember, sterility is not the goal. The concern is that a manufacturer uses heat to achieve organoleptic qualities like color and texture, but the combination of time and temperature may not achieve safety. It is only with a validated process that safety is confirmed. If we model safety after what is required of food manufacturers by the Food and Drug Administration, validation of processes that control pathogens is required. In addition to traditional heat methods, non-thermal methods for control of pathogens includes irradiation and high pressure processing and are appropriate for highly priced goods, e.g. juice. Killing is achieved in the manufacturing environment and on processing equipment surfaces after cleaning and by sanitizing.

If you have done everything reasonable to stop microorganisms from getting in the product and you have a validated step to kill pathogens, you may still have spoilage microorganisms in the product. It is important that all pathogens have been eliminated. Examples of pathogens include Salmonella, pathogenic Escherichia coli, also called Shiga toxin-producing E. coli (STEC) and Listeria monocytogenes. These three common pathogens are easily destroyed by proper heat methods. Despite steps taken to kill pathogens, it is theoretically possible a pathogen is reintroduced after the kill step and before packaging is sealed at very low numbers in the product. Doctors do not know how many cells are required for a consumer to get ill, and the immunocompromised consumer is more susceptible to illness. Lab methods for the three pathogens mentioned are designed to detect very low cell numbers. Packaging and control of growth factors will stop pathogens from growing in the product, if present.

Control the growth of microorganisms

These growth factors will control the growth of pathogens, and you can use the factors to control spoilage microbes as well. To grow, microbes need the same things we do: a comfortable temperature, water, nutrients (food), oxygen, and a comfortable level of acid. In the lab, we want to find the pathogen, so we optimize these factors for growth. When you control growth in your product, one hurdle may be enough to stop growth; sometimes multiple hurdles are needed in combination. Bacteria, yeast, and mold are present in all environments. They are at the bottom of the ocean under pressure. They are in hot springs at the temperature of boiling water. The diversity is immense. Luckily, we can focus on the growth factors for human pathogens, like Salmonella, pathogenic E. coli, and Listeria monocytogenes.

The petri dishes show sterilization effects of negative air ionization on a chamber aerosolized with Salmonella enteritidis. The left sample is untreated; the right, treated. Photo courtesy of USDA ARS & Ken Hammond

Temperature. Human pathogens prefer to grow at the temperature of the human body. In manufacture, keep the time a product is in the range of 40oF to 140oF as short as possible. You control pathogens when your product is at very hot or very cold temperatures. Once the product cools after a kill step in manufacturing, it is critical to not reintroduce a pathogen from the environment or personnel. Clean equipment and packaging play key roles in preventing re-contamination of the product.

Water. At high temperatures as in baking or roasting, there is killing, but there is also the removal of water. In the drying process that is not at high temperature, water is removed to stop the growth of mold. This one hurdle is all that is needed. Even before mold is controlled, bacterial and yeast growth will stop. Many cannabis candies are safe, because water is not available for pathogen growth. Packaging is key to keep moisture out of the product.

Nutrients. In general, nutrients are going to be available for pathogen growth and cannot be controlled. In most products nutrients cannot be removed, however, recipes can be adjusted. Recipes for processed food add preservatives to control growth. In cannabis as in many plants, there may be natural compounds which act as preservatives.

Oxygen. With the great diversity of bacteria, there are bacteria that require the same oxygen we breathe, and mold only grows in oxygen. There are bacteria that only grow in the absence of oxygen, e.g. the bacteria responsible for botulism. And then there are the bacteria and yeast in between, growing with or without oxygen. Unfortunately, most human pathogens will grow with or without oxygen, but slowly without oxygen. The latter describes the growth of Salmonella, E. coli, and Listeria. While a package seals out air, the growth is very slow. Once a package is opened and the product is exposed to air, growth accelerates.

Acid. Fermented or acidified products have a higher level of acid than non-acid products; the acid acts as a natural preservative. The more acid, the more growth is inhibited. Generally, acid is a hurdle to growth, however and because of diversity, some bacteria prefer acid, like probiotics which are non-pathogenic. Some pathogens, like E. coli, have been found to grow in low acid foods, e.g. juice, even though the preference is for non-acidic environments.

Each facility is unique to its materials, people, equipment and product. A safe product is made by following Good Agricultural Practices for the cannabis, by following Good Manufacturing Practices and by suppressing pathogens by preventing them coming in, killing them and controlling their growth factors. Future articles will cover Hazard Analysis and Critical Control Points (HACCP) and food safety in more detail.

California Rolls Out Licensing For Cannabis Businesses

By Aaron G. Biros
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Last week, the Bureau of Cannabis Control issued the first licenses for California’s new market. The first license went to Moxie, a cannabis distribution company out of Lynwood.

The search feature for the list of licenses issued so far

As of the publication of this article, the Bureau, the state authority tasked with leading the regulation of the industry, has issued 43 temporary licenses. So far, four laboratories have received licenses, along with a number of retailers, distributors, microbusinesses in both medical and adult-use markets.

The labs to receive their temporary licenses so far are pH Solutions, Steep Hill Labs, Pure Analytics and ORCA Cannalytics. Judging by the number of temporary medical and adult-use licenses awarded so far, it appears the Bureau is trying to issue a similar amount for each sector, distributing the number of licenses between the two equitably.

You can find the list of licensees here, and search between the dates of 12/15/17 to 1/2/18 to get the most up-to-date list of licenses awarded. “Last week, we officially launched our online licensing system, and today we’re pleased to issue the first group of temporary licenses to cannabis businesses that fall under the Bureau’s jurisdiction,” says Lori Ajax, Bureau of Cannabis Control Chief. “We plan to issue many more before January 1.”

According to the press release, temporary licenses are only issued to applicants with prior local authorization in the form of a license or permit from the jurisdiction where the business is. Those licenses will become effective on January 1, 2018. The temporary licenses will work for 120 days, or May 1, 2018, after which businesses will need to have a permanent license to continue operating.

More than 1,900 users have registered with the Bureau’s online system, and more than 200 applications have been submitted, according to the press release.

The various regulatory bodies in California have worked diligently for months now to roll out proposed emergency regulations, setting strict requirements for manufacturers, growers, retailers and testing labs. Manufacturing regulations, including specific labeling, packaging and processing requirements, give a good snapshot of how regulators plan to move forward. Testing requirements could also be significantly firmer, with rules for documentation, sample sizes, sampling procedures, storage and transportation.

Yet when the adult-use sales become fully legal on January 1, 2018, those regulations will not be fully implemented.

Donald Land, a UC Davis chemistry professor and chief scientific consultant at Steep Hill Labs Inc., told The Associated Press, “Buyer beware.” There will be a six-month range where existing inventory will be allowed on the shelves, products that might not meet the standards of the new rules. So dispensaries will get half a year of sales before all products have to meet the new, stricter testing requirements.

Tikun Olam Expands to Washington, D.C.

By Aaron G. Biros
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Today, Tikun Olam announced their expansion into the Washington, D.C. market. Partnering with the cultivator, Alternative Solutions, they will license them to grow, manufacture and distribute Tikun-branded products.

Tikun Olam is an international cannabis company with roots in Israel, where they are working in clinical trials to produce strains targeting a handful of medical conditions. The company has made serious investments in the United States market previously, with operations in Delaware, Washington and Nevada, and has plans to enter the Rhode Island, Maryland, Massachusetts and Illinois markets in 2018.

cannabis close up
The Tikun Olam strain Avidekel being grown in Israel.

The five-year licensing deal signed with Alternative Solutions is the latest development in their expansion plans in North America. They also have similar partnerships developing around the world, including in Canada, Australia, United Kingdom and South Africa.

Tikun plans on having their full line of products ready for distribution with Alternative Solutions in the Washington, D.C. market some time in 2018. “Alternative Solutions is thrilled to be Tikun Olam’s exclusive partner in DC,” says Matt Lawson-Baker, chief operating officer of Alternative Solutions. “We look forward to making Tikun’s products available at all DC dispensaries, giving access to these clinically proven strains to the more than 5,600 registered MMJ patients in Washington DC.”

Bernard Sucher, chief executive officer of Tikun Olam, says he is excited to get working with Alternative Solutions. “Its cultivation and manufacturing operations will make it possible for Tikun to serve every single patient in a single jurisdiction–a first for us and something we hope to accomplish within every U.S. state. “

Total Yeast & Mold Count: What Cultivators & Business Owners Need to Know

By Parastoo Yaghmaee, PhD
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Editor’s note: This article should serve as a foundation of knowledge for yeast and mold in cannabis. Beginning in January 2018, we will publish a series of articles focused entirely on yeast and mold, discussing topics such as TYMC testing, preventing yeast and mold in cultivation and treatment methods to reduce yeast and mold.

Cannabis stakeholders, including cultivators, extractors, brokers, distributors and consumers, have been active in the shadows for decades. With the legalization of recreational adult use in several states, and more on the way, safety of the distributed product is one of the main concerns for regulators and the public. Currently, Colorado1, Nevada and Canada2 require total yeast and mold count (TYMC) compliance testing to evaluate whether or not cannabis is safe for human consumption. As the cannabis industry matures, it is likely that TYMC or other stringent testing for yeast and mold will be adopted in the increasingly regulated medical and recreational markets.

The goal of this article is to provide general information on yeast and mold, and to explain why TYMC is an important indicator in determining cannabis safety.

Yeast & Mold

Photo credit: Steep Hill- a petri dish of mold growth from tested cannabis

Yeast and mold are members of the fungi family. Fungus, widespread in nature, can be found in the air, water, soil, vegetation and in decaying matter. The types of fungus found in different geographic regions vary based upon humidity, soil and other environmental conditions. In general, fungi can grow in a wide range of pH environments and temperatures, and can survive in harsh conditions that bacteria cannot. They are not able to produce their own food like plants, and survive by breaking down material from their surroundings into nutrients. Mold cannot thrive in an environment with limited oxygen, while yeast is able to grow with or without oxygen. Most molds, if grown for a long enough period, can be detected visually, while yeast growth is usually detected by off-flavor and fermentation.

Due to their versatility, it is rare to find a place or surface that is naturally free of fungi or their spores. Damp conditions, poor air quality and darker areas are inviting environments for yeast and mold growth.

Cannabis plants are grown in both indoor and outdoor conditions. Plants grown outdoors are exposed to wider ranges and larger populations of fungal species compared to indoor plants. However, factors such as improper watering, the type of soil and fertilizer and poor air circulation can all increase the chance of mold growth in indoor environments. Moreover, secondary contamination is a prevalent risk from human handling during harvest and trimming for both indoor and outdoor-grown cannabis. If humidity and temperature levels of drying and curing rooms are not carefully controlled, the final product could also easily develop fungi or their growth by-product.

 What is TYMC?

TYMC, or total yeast and mold count, is the number of colony forming units present per gram of product (CFU/g). A colony forming unit is the scientific means of counting and reporting the population of live bacteria or yeast and mold in a product. To determine the count, the cannabis sample is plated on a petri dish which is then incubated at a specific temperature for three to five days. During this time, the yeast and mold present will grow and reproduce. Each colony, which represents an individual or a group of yeast and mold, produces one spot on the petri dish. Each spot is considered one colony forming unit.

Why is TYMC Measured?

TYMC is an indicator of the overall cleanliness of the product’s life cycle: growing environment, processing conditions, material handling and storage facilities. Mold by itself is not considered “bad,” but having a high mold count, as measured by TYMC, is alarming and could be detrimental to both consumers and cultivators. 

Aspergillus species niger
Photo: Carlos de Paz, Flickr

The vast majority of mold and yeast present in the environment are indeed harmless, and even useful to humans. Some fungi are used commercially in production of fermented food, industrial alcohol, biodegradation of waste material and the production of antibiotics and enzymes, such as penicillin and proteases. However, certain fungi cause food spoilage and the production of mycotoxin, a fungal growth by-product that is toxic to humans and animals. Humans absorb mycotoxins through inhalation, skin contact and ingestion. Unfortunately, mycotoxins are very stable and withstand both freezing and cooking temperatures. One way to reduce mycotoxin levels in a product is to have a low TYMC.

Aspergillus flavus on culture.
Photo: Iqbal Osman, Flickr

Yeast and mold have been found to be prevalent in cannabis in both current and previous case studies. In a 2017 UC Davis study, 20 marijuana samples obtained from Northern California dispensaries were found to contain several yeast and mold species, including Cryptococcus, Mucor, Aspergillus fumigatus, Aspergillus niger, and Aspergillus flavus.3 The same results were reported in 1983, when marijuana samples collected from 14 cannabis smokers were analyzed. All of the above mold species in the 2017 study were present in 13 out of 14 marijuana samples.4

Aspergillus species niger, flavus, and fumigatus are known for aflatoxin production, a type of dangerous mycotoxin that can be lethal.5 Once a patient smokes and/or ingests cannabis with mold, the toxins and/or spores can thrive inside the lungs and body.6, 7 There are documented fatalities and complications in immunocompromised patients smoking cannabis with mold, including patients with HIV and other autoimmune diseases, as well as the elderly.8, 9, 10, 11

For this reason, regulations exist to limit the allowable TYMC counts for purposes of protecting consumer safety. At the time of writing this article, the acceptable limit for TYMC in cannabis plant material in Colorado, Nevada and Canada is ≤10,000 CFU/g. Washington state requires a mycotoxin test.12 California is looking into testing for specific Aspergillus species as a part of their requirement. As the cannabis industry continues to grow and advance, it is likely that additional states will adopt some form of TYMC testing into their regulatory testing requirements.

References:

  1. https://www.colorado.gov/pacific/sites/default/files/Complete%20Retail%20Marijuana%20Rules%20as%20of%20April%2014%202017.pdf
  2. http://laws-lois.justice.gc.ca/eng/acts/f-27/
  3. https://www.ucdmc.ucdavis.edu/publish/news/newsroom/11791
  4. Kagen SL, Kurup VP, Sohnle PG, Fink JN. 1983. Marijuana smoking and fungal sensitization. Journal of Allergy & Clinical Immunology. 71(4): 389-393.
  5. Centre for Disease control and prevention. 2004 Outbreak of Aflatoxin Poisoning – Eastern and central provinces, Kenya, Jan – July 2004. Morbidity and mortality weekly report.. Sep 3, 2004: 53(34): 790-793
  6. Cescon DW, Page AV, Richardson S, Moore MJ, Boerner S, Gold WL. 2008. Invasive pulmonary Aspergillosis associated with marijuana use in a man with colorectal cancer. Diagnosis in Oncology. 26(13): 2214-2215.
  7. Szyper-Kravits M, Lang R, Manor Y, Lahav M. 2001 Early invasive pulmonary aspergillosis in a leukemia patient linked to aspergillus contaminated marijuana smoking. Leukemia Lymphoma 42(6): 1433 – 1437.
  8. Verweii PE, Kerremans JJ, Voss A, F.G. Meis M. 2000. Fungal contamination of Tobacco and Marijuana. JAMA 2000 284(22): 2875.
  9. Ruchlemer R, Amit-Kohn M, Raveh D, Hanus L. 2015. Inhaled medicinal cannabis and the immunocompromised patient. Support Care Cancer. 23(3):819-822.
  10. McPartland JM, Pruitt PL. 1997. Medical Marijuana and its use by the immunocompromised. Alternative Therapies in Health and Medicine. 3 (3): 39-45.
  11. Hamadeh R, Ardehali A, Locksley RM, York MK. 1983. Fatal aspergillosis associated with smoking contaminated marijuana, in a marrow transplant recipient. Chest. 94(2): 432-433.
  12. http://apps.leg.wa.gov/wac/default.aspx?cite=314-55-102

European Cannabis News Roundup 2017 And Predictions For 2018

By Marguerite Arnold
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Europe saw big developments on the cannabis front all year. This includes country-by-country developments that include legalization of medical use and even plans to begin domestic production, no matter how delayed such plans have turned out to be.

By far the most interesting market developments were in Germany all year. The Teutonic state has entered some interesting territory – even if its potential is still in the development rather than rollout status.

Elsewhere, however, medical acceptance is clearly starting to bloom across the continent in a way that is more reminiscent of American state development than what is about to happen in Canada.

One of the most interesting aspects of European reform however, that is in marked difference to what has happened in the U.S., is that grow facilities are being slowly established with federal authorization, even before further reform comes (see Turkey, Slovenia, Germany and even Denmark).

How reform will continue to roll out and shape the discussion however, is still a matter very much left up to individual European states. Cannabis legalization may become the first uniting issue of the new Deutsch ruling parliamentary coalition, whatever that is. In Spain, the cannabis question might yet be a play in simmering separatist tensions. Across the continent, legislatures are, for the first time in two generations, reconsidering what cannabis is, how it should be used, and what the penalties should be for those who use the drug either medicinally or recreationally.

Change is still all over the map. And it is still very, very slow.

Germany

The country’s federal legislators voted unanimously to mandate medical coverage of cannabis under public health insurance (which covers 90% of the population) on January 19th. Since then, however, forward movement has been stymied by a combination of forces and politics. While the legislation became law in March and the government established a cannabis agency, other developments have not been so clear cut. Yes, import licenses are being issued. And yes, there is a pending tender bid. However announcements of the finalists have been delayed since August due to lawsuits over qualifications of the growers, among other things. The new German government (whatever it will be) plus apparent CETA (EU-Canada Comprehensive Economic and Trade Agreement)-related complications have all added to the drama. That said, when the cannabis opera moves into its next act, as of probably early next year, expect to see domestic medical grow go forward. Importing medical supplies, even from across the continent (which is what is happening now) is ludicrously expensive. Rumours are already flying out of Berlin that further cannabis reform is one of the few things that all parties can agree to as a new government forms.

Holland

Sadly, the biggest cannabis-related “development” this year was the decision by all major health insurers to stop covering the drug, just as the German government changed its mind about the issue. Greater regulation of coffee shop grows coupled with this lack of insurance coverage means that patients are being forced into a coffee shop culture which is also commoditizing and commercializing into a high-volume affair, particularly in Amsterdam. While this might just be the new face of an old business, the laid back “coffee shop” culture of yore is an endangered species.

Barcelona, capital of Catalonia
Photo: Bert Kaufmann

Spain

Catalonian independence made headlines globally this year. So did the associated bid for other freedoms of a cannabis sort – particularly in Barcelona. Club grows were set to become more regulated as of this summer. However the massive Catalonian bid for independence has further muddied the waters. Given the fact that cannabis reform appears to be at the forefront of finding political compromise elsewhere in Germany, perhaps givebacks about taxes for this industry might be one way to temper down the still-raging separatist forces afoot.

Poland

The Polish government surprised everyone this fall, and legalized the drug for medical purposes (at least in theory) in November. What this actually means for patients is another story. There are no plans to cultivate on the radar. Patients under the new law are allowed to travel to other countries to seek their medical cannabis. How they might afford it is another question. Not to mention how they will escape prosecution from personal importation if checked at a border.

Warsaw, Poland
Image: Nikos Roussos, Flickr

Polish pharmacists will however be trained on how to make medicaments from imported cannabis. They will have to be registered with the Office for the Registration of Medical Products. This means that pharmacists must be pre-registered with the government – in a move much like the early days of the Israeli medical program. The medicine is expected to cost about $460 a month. How well this will work in serving the country’s more than 300,000 already eligible patients is another story.

Greece

Cannabis economists have long said that what the Greeks really need to heal their economy is a vibrant cannabis injection. And as of mid-November early investors in the nascent market had already staked close to $2 billion in cultivation opportunities. Senior ministers in the government have also publicly backed plans to move Greece into a strategic position to claim a piece of a global cannabis market estimated to reach 200 billion dollars a year by the end of the next decade. It means jobs. It means capital infusions. Exactly, in other words, what the Greek economy desperately needs. Expect to see further formalization of the grow program here in 2018 for sure.

Lithuania

It appears that quite a few countries in Europe are pushing for real cannabis reform by the end of the year, and this little EU country is joining the list. With a unanimous agreement in Parliament already to change the country’s drug policy, Lithuania’s legislators could vote to legalize the drug on December 12th of this year. All signs look promising.

Slovenia

MCG, an Australian-based company, made news in the fall by announcing a new cannabinoid extraction facility in the country, on track for completion this year. The company also ramped up domestic production operations in August. Real reform here still has a long way to go. However with domestic production underway, greater medical use looks promising.

Denmark

The country signed a production agreement to open a new facility in Odense, the country’s third largest city with Spektrum Cannabis, the medical brand of one of the largest Canadian producers (Canopy Cannabis) now seeking a foothold in Europe late this fall. What this means for ongoing reform in Denmark is also positive. The company will import cannabis via Spektrum Denmark until all the necessary approvals are ironed out for cultivation.

Portugal

While “reform” here is less of an issue than it is elsewhere (since all drugs are decriminalized), Portugal might yet play an interesting role in cross-European legalization. Tilray, another large Canadian-American firm with interests in Europe, announced the construction of a large medical cannabis facility in the country earlier this year. That plant could easily ship medical supplies across Europe as new countries legalize but do not implement grow facilities.

California Manufacturing Regulations: What You Need To Know

By Aaron G. Biros
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In late November, California released their proposed emergency regulations for the cannabis industry, ahead of the full 2018 medical and adult use legalization for the state. We highlighted some of the key takeaways from the California Bureau of Cannabis Control’s regulations for the entire industry earlier. Now, we are going to take a look at the California Department of Public Health (CDPH) cannabis manufacturing regulations.

According to the summary published by the CDPH, business can have an A-type license (for products sold on the adult use market) and an M-type license (products sold on the medical market). The four license types in extraction are as follows:

  • Type 7: Extraction using volatile solvents (butane, hexane, pentane)
  • Type 6: Extraction using a non-volatile solvent or mechanical method
    (food-grade butter, oil, water, ethanol, or carbon dioxide)
  • Type N: Infusions (using pre-extracted oils to create edibles, beverages,
  • capsules, vape cartridges, tinctures or topicals)
  • Type P: Packaging and labeling only

As we discussed in out initial breakdown of the overall rules, California’s dual licensing system means applicants must get local approval before getting a state license to operate.

The rules dictate a close-loop system certified by a California-licensed engineer when using carbon dioxide or a volatile solvent in extraction. They require 99% purity for hydrocarbon solvents. Local fire code officials must certify all extraction facilities.

In the realm of edibles, much like the rule that Colorado recently implemented, infused products cannot be shaped like a human, animal, insect, or fruit. No more than 10mg of THC per serving and 100mg of THC per package is allowed in infused products, with the exception of tinctures, capsules or topicals that are limited to 1,000 mg of THC for the adult use market and 2,000 mg in the medical market. This is a rule very similar to what we have seen Washington, Oregon and Colorado implement.

On a somewhat interesting note, no cannabis infused products can contain nicotine, caffeine or alcohol. California already has brewers and winemakers using cannabis in beer and wine, so it will be interesting to see how this rule might change, if at all.

CA Universal Symbol (JPG)

The rules for packaging and labeling are indicative of a major push for product safety, disclosure and differentiating cannabis products from other foods. Packaging must be opaque, cannot resemble other foods packaged, not attractive to children, tamper-evident, re-sealable if it has multiple servings and child-resistant. The label has to include nutrition facts, a full ingredient list and the universal symbol, demonstrating that it contains cannabis in it. “Statute requires that labels not be attractive to individuals under age 21 and include mandated warning statements and the amount of THC content,” reads the summary. Also, manufacturers cannot call their product a candy.

Foods that require refrigeration and any potentially hazardous food, like meat and seafood, cannot be used in cannabis product manufacturing. They do allow juice and dried meat and perishable ingredients like milk and eggs as long as the final product is up to standards. This will seemingly allow for baked goods to be sold, as long as they are packaged prior to distribution.

Perhaps the most interesting of the proposed rules are requiring written standard operating procedures (SOPs) and following good manufacturing practices (GMPs). Per the new rules, the state will require manufacturers to have written SOPs for waste disposal, inventory and quality control, transportation and security.

Donavan Bennett, co-founder and CEO of the Cannabis Quality Group

According to Donavan Bennett, co-founder and chief executive officer of the Cannabis Quality Group, California is taking a page from the manufacturing and life science industry by requiring SOPs. “The purpose of an SOP is straightforward: to ensure that essential job tasks are performed correctly, consistently, and in conformance with internally approved procedures,” says Bennett. “Without having robust SOPs, how can department managers ensure their employees are trained effectively? Or, how will these department managers know their harvest is consistently being grown? No matter the employee or location.” California requiring written SOPs can potentially help a large number of cannabis businesses improve their operations. “SOPs set the tempo and standard for your organization,” says Bennett. “Without effective training and continuous improvement of SOPs, operators are losing efficiency and their likelihood of having a recall is greater.”

Bennett also says GMPs, now required by the state, can help companies keep track of their sanitation and cleanliness overall. “GMPs address a wide range of production activities, including raw material, sanitation and cleanliness of the premises, and facility design,” says Bennett. “Auditing internal and supplier GMPs should be conducted to ensure any deficiencies are identified and addressed. The company is responsible for the whole process and products, even for the used and unused products which are produced by others.” Bennett recommends auditing your suppliers at least twice annually, checking their GMPs and quality of raw materials, such as cannabis flower or trim prior to extraction.

“These regulations are only the beginning,” says Bennett. “As the consumer becomes more educated on quality cannabis and as more states come online who derives a significant amount of their revenue from the manufacturing and/or life science industries (e.g. New Jersey), regulations like these will become the norm.” Bennett’s Cannabis Quality Group is a provider of cloud quality management software for the cannabis industry.

“Think about it this way: Anything you eat today or any medicine you should take today, is following set and stringent SOPs and GMPs to ensure you are safe and consuming the highest quality product. Why should the cannabis industry be any different?”

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Medical Cannabis & The Vernacular Of Maturity

By RJ Starr
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Marijuana. Mary Jane. Pot. Reefer. Ganja. Weed. Joint. Grass.

The variety of terms used to describe cannabis are as diverse as the potentials of the plant itself – as well as the opinions of its proper nomenclature. A quick web search came up with a number of articles about how we should refer to cannabis, and opinions can be just as annoying and stinging as mosquitoes in the Everglades at the peak of season. Each of these words has an origin with which, having all the facts, you might not choose to align yourself. Words matter, and whether born from racism, xenophobia, or just plain ignorance, one will never go wrong following one simple piece of advice: “Never use a word or a phrase unless you know its meaning.” That said, it is not my intention here to add another opinion, but rather to present the topic from a different vantage. I’ll leave it up to you to decide whether or not it is worth your while to learn what you are saying, and in so doing, empower yourself to consider your audience as you consider your slang, just as you would with any other word.

The legalized cannabis industry has opened a plethora of professional opportunities. Thoughtfully considered, these opportunities can lead to new heights of professional accomplishment and financial earning capability. For those with the good fortune to have such opportunity in legalized cannabis, congratulations! You are a member of a very small group of pioneers who have the potential to shape an entire industry (remember that what Henry Ford did by creating the assembly line brought benefit, not just to the automotive industry, but to all industry.)

In this industry we are not just creating medical cannabis dispensaries, cultivation and processing facilities, we are creating new ideas and platforms for compliance, security, financial planning, quality assurance, botany, agriculture, sustainability, packaging, retail, inventory control, human capital – the list is as endless as the imagination – with the potential to influence capacity in every aspect of all types of industry, around the world. In the course of your career as a cannabis professional you will have a chance to interact with legal and healthcare professionals, legislators, regulators and investors. You may attend high profile events, hobnob with those who inspire social change and exchange dialog with thought leaders from all walks of life. As you represent your particular cannabis company, you will recognize that you also represent yourself, and in that very recognition will your thoughtfully chosen vernacular reveal your personal level of professionalism, eloquence and dignity; and irrespective of what, or from whom, any opinion originates, these core values are irreplaceable. Simply put, adults speak like adults.

A colleague reflected that we are not winning a long and drawn out struggle to divest ourselves from outdated prohibitions against the use of medical cannabis because of the words we are using, but because of education. While I agree with that assessment, the use of slang in professional discourse has a tendency to discredit the speaker and narrow the audience receptive to his message. As the scientific community and cannabis industry continues to re-educate society, our efforts will be bolstered by reaching as broad an audience as possible. Education presented professionally, eloquently, and with maturity engenders respect, goodwill and understanding. And that makes for fertile ground upon which to plant new ideas.

The Hiring Dilemma Facing The Cannabis Industry

By Gilbert J. Carrara, Jr., MD
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The business of cannabis is starting to mature and the industry as a whole is gearing up for rapid expansion. This means that pharmaceutical companies, dispensaries and other cannabis-focused businesses are starting to expand their executive teams. However, finding qualified candidates is proving to be an incredibly challenging task, due to the shallow talent pool of leaders with cannabis-related experience, the volatility of the industry and its lingering public perception problems. Companies must therefore dip into other, related talent pools. Here are some factors to consider when beginning the hiring process:

Desired Experience

The ideal candidate to fill an executive role in the medical cannabis industry needs to possess a unique skill set and extensive experience. One obvious source of candidates are peopleIt is important to be resilient in the face of intense criticism and have a thick skin. Diplomatic strength is required. who have hands-on leadership credentials in the pharmaceutical industry, given the highly regulated nature of both the business and consumer sectors. Other good talent sources are the tobacco industry and consumer healthcare services (such as hospitals and other kinds of medical centers).

Due to the evolving nature of the cannabis industry and the intense scrutiny it is under, executives will need to be well acquainted with how to manage compliance with governmental regulations and keep up-to-date on upcoming rule changes and potential legislation. This is especially true for dispensaries, as they are often arriving right after a state vote occurs, leaving no room for error when it comes to knowing and adapting to a state’s unique rules and regulations.

It is also important for a candidate to possess both business and consumer experience, not only on the medical and regulatory side of the business, but also the sales process. A large part of what medical executives do is indirect marketing through their interactions with people — both business affiliates and consumers. Having an executive with poor communication skills could prove to be costly down the line. 

Recommended Personality Characteristics

Due to the controversial nature of the business, a potential executive needs to possess a number of characteristics or personality traits. As with other industry sectors that face similar public approbation, including the tobacco industry, it is not a job for the thin-skinned or easily discouraged. Important traits to look for include:

Flexibility: Due to the evolving nature of the industry and its rapid growth, you cannot possibly control everything and everyone. Remaining flexible is the only way to remain sane and successful during this phase of industry expansion.This ability to easily communicate with diverse audiences is a strong indicator of success.

Resiliency: The cannabis industry is often vilified, and as a result so are the businesses and employees who work in it. It is important to be resilient in the face of intense criticism and have a thick skin. Diplomatic strength is required.

Adaptability: A candidate should be comfortable and credible talking about scientific and business issues one minute, and consumer issues the next. This ability to easily communicate with diverse audiences is a strong indicator of success.

Passion: If a candidate possesses passion for the cause and the medical and therapeutic value of cannabis, there is a much greater chance that they will weather the storm. Having someone who genuinely cares will show in every facet of the way they conduct business — from discussing quality of life to discussing the scientific background to relating to patients.

Hiring at an executive level is never easy and in the case of the cannabis industry, it is infinitely more challenging than most. It is imperative to never “settle” on a candidate simply because time is an issue. Having someone on your recruiting staff, or using a professional recruiter who has deep experience in the medical, pharmaceutical or consumer healthcare industries is also helpful, as they can “speak the language” of recruits and thoroughly answer their questions. Their credibility can help a candidate determine if the cannabis industry is right for them. Finding a quality candidate who understands the industry, the regulations and has a passion for their work will serve your business well as the cannabis industry matures.