Tag Archives: patient

August 3, 2017

Is There a Medical Cannabis Crisis Brewing in Germany?

By Marguerite Arnold

There is a great deal to be happy about with medical cannabis legalization in Germany. This is the first country that has mandated insurance coverage of the drug – at least at the federal legislative level.

However, as the government evaluates the finalists in the first tender bid for domestically grown and regulated cannabis, a real crisis is brewing for patients on the ground. And further one that the industry not only sees but is trying to respond to.

Spektrum Cannabis GmbH, formerly MedCann GmbH began trying to address this problem when they obtained the first import license for Canadian cannabis last year. They are also one of the apparent five finalists in the pending government bid to grow the plant domestically for medical purposes. According to Dr. Sebastian Schulz, head of communications for Spektrum, “Shortly after the new cannabis law was reformed we experienced a huge increase in demand from the side of patients. We had prepared for that. The German population is very curious about cannabis as a medicine and in general very open to natural remedies.”

People are curious here. But like other places, the law in Germany has evolved slowly. Much like Israel, the government has allowed a trickle of patients to have access to cannabis by jumping through multiple, time consuming hoops. The process of getting cannabis prescribed, much less getting a pharmacy to stock it, was difficult. Patients had to pay out of pocket – a monthly cost of about $1,700. While that is expensive by American standards, to Germans, this is unheard of. The vast majority of the population – 90% – is on public health insurance. That means that most Germans get medications for $12 a month, no matter what they are. Allegedly, German patients were supposed to get about 5oz a month for this price. At least that is what the law says.

People are curious here. But like other places, the law in Germany has evolved slowlyAs in other countries, no matter what Germans think about recreational reform, the clear majority of them at this point support medical use. And at this point, both legislatively and via the courts, the government has said and been required to provide the drug to Germans patients at low cost.

Unintended Effects & Consequences

Since the law went into effect in March of this year however, things have suddenly turned very dire for patients.

The handful of people who had the right to grow at home – established under lawsuits several years ago – were suddenly told they could no longer do so. They had to go to a doctor and regular pharmacy. Even regular patients in the system found that their insurance companies, allegedly now required to pay, are refusing to reimburse claims. Doctors who prescribed the drug were abruptly informed that they would be financially responsible for every patient’s drug cost for the next two years (about $50,000 per patient).

To add a final blow to an already dire situation, German pharmacies that carried the drug, then announced an additional fee. It is about $9 extra per gram, added at the pharmacy, pushing the price of legitimate cannabis north of $20 dollars per gram. This is justified as a “preparation fee.” Cannabis bud is technically marked as an “unprocessed drug.” This means the pharmacies can charge extra for “processing” the same. In reality this might be a little bud trimming. If that. The current distributors in the market already prep and pre-package the drug.

What this bodes for a future dominated by infused products, oils and concentrates is unclear. However the impact now is large, immediate and expensive in a country where patients also must still go to the pharmacy in person for all prescription drugs.

There is no mail order here, by federal law. Online pharmacies are a luxury for Auslanders.

At minimum, this could mean that without some relief, German patients will go right back into the black market and home grow.While nobody has challenged this situation yet en masse, it is already a sore point not only for patients but across the industry. It means that an already expensive drug has gotten even more expensive. It also means that the government regulations are not working as planned.

At least not yet. For the large Canadian companies now coming into the market with multimillion-dollar investments already sunk in hard costs, Germany will be a loss-leader until the system sorts itself out.

According to Schulz, whose company is now in the thick of it, the new law is very vague. “Currently, there are almost no cannabis flowers available in German pharmacies because companies like us are not allowed to sell them,” says Schulz. “Various different regulatory demands come up that seemed to change on a monthly basis. We are ready to deliver even large amounts of cannabis for a market that might well explode soon – but we first need to overcome the regulatory nightmare that leads to the suffering of so many patients here these days.”

At minimum, this could mean that without some relief, German patients will go right back into the black market and home grow. Black market costs for cannabis are about $10-15 a gram. In other words, exactly the situation the government was hoping to avoid.

What Is Causing The Situation?

The intended effect of the legislation was twofold, according to industry insiders: To legalize cannabis in such a way to meet a rising public demand and, in the face of a court decision, to limit the home grow movement. The latter of which, despite federal regulations, is thriving here. Germans like to grow things, and cannabis is a rewarding plant to nurture.

High attendance at the Mary Jane Grow Expo in Berlin in June is just one sign that the genie is out of this particular bottle. BfArM – the federal agency in charge of regulating narcotics and medical devices – cannot stuff it back.Patients are going back to the way things were

However home grow does not build a professional, high volume cannabis market, much less a highly regulated medical one make. The government also made clear that it is going to have strict inspections and quality controls, and will technically buy all the cannabis produced, per the terms of the bid application process.

However, it is not entirely clear when the government will start actually doing the buying. And why the buying has not started yet. If insurance companies are refusing to pay, this means the government is not reimbursing them. The same government, which has also agreed to do so, as of March 2017.

What Gives On Good Old German Efficiency?

On the streets, patients are going back to the way things were. Many are used to fighting for the only drug that makes them feel better. The euphoria in May, for example, has been replaced with weary acceptance that things might get a bit worse before they really improve.

That said, there is also a realization that more activism and lobbying are required on just about every front. If an extrapolation of data from say Colorado or California is applied to Germany, there are already at least a million eligible patients here, based on the qualifying conditions. The government is planning for an annual increase in medical patients of about 5-10,000 a year, including in the amount of cannabis they are planning on buying from the licensed producers they choose. The numbers, however, are already not matching.Even existing patients are literally being forced into the black market again.

Added to this wrinkle is the other reality that is also looming, particularly now.

With one exception, all of the firms now apparently in contention as finalists for the German government bid will also be supplying a domestic market in Canada that is going rec next summer. One year, in other words, before the German companies even begin producing.

What Is The Upshot For Patients?

Guenther Weiglein is one of the five patients who sued for home grow rights in 2014. He is now suing again for the right to extend home grow privileges until the government figures out its process. He is not the only one. Earlier this year he was told he had to stop his home grow and integrate into the “mainstream” system. So far, he, along with other patients who are suing, including for insurance coverage, have not been able to get cannabis easily through the system, although they are starting to make progress.

Weiglein’s situation is made even more frustrating by the fluidity of the situation. As of late July, he had finally gotten agreement from his insurance company to cover the drug. But now he cannot find a doctor willing to accept the financial risk of prescribing it to him. And in the meantime he has no access to medication.

Talk to any group of advocates right now, and there is one ongoing story. Even existing patients are literally being forced into the black market again.

And those that can’t afford it? They are out of luck. Some patients say a tragedy like someone dying will create the impetus to move this into public eye. A hunger strike here by a leading cannabis doctor earlier this summer has so far not had much impact on policy. There is a great deal of pessimism here, as promised change earlier this year has turned into a long and drawn out multiyear question mark.

If this sounds like a bubbling and untenable situation, especially before a national election, it is. The prospect of another four years of Angela Merkel does not bode well for fast cannabis reform.

That said, the German government is now in an interesting situation. The law has now clearly changed to say that sick Germans are allowed to use cannabis as a drug of choice for chronic diseases when all else fails. Further, the national government has bound the insurance industry to cover it. So far, every patient who has sued for coverage has won. That has not, however, moved the insurance industry altogether. Nor has it solved the problem with doctors prescribing the drug.

Many now ask what will? It is clear, however, that it will change. The question is when, how fast, and in what situations.

The problem will undoubtedly ease by 2019, when the first German crops are finally ready, although it will be far from completely solved.

July 27, 2017

Soapbox

Cannabis Industry Needs Leadership, Not Pesticides

By Ben Ward

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The medical cannabis sector is currently attracting increased attention, as patients, doctors, regulators and investors take a closer look at our industry. There is a lot for them to learn and to benefit from as our industry matures under the glare of the proverbial spotlight. And there’s a lot for those of us in the industry to be proud of. We’re helping patients manage pain, for example. We’re helping them get their lives back.

But that same spotlight is also revealing some problems in our industry.

Take ingredients for example. When I look at the ingredient list in my natural medicines, I don’t expect to see Myclobutanil, Piperonyl Butoxide, Pyrethrin, Bifenezate, and Avermectin listed. Yet, that’s exactly what some licensed producers of cannabis in Canada and some cultivators in California have been selling to their patients. You have to ask yourself why, when pesticides are the only toxic substances released intentionally into our environment to kill living things. Patients don’t take cannabis to harm themselves. They do it to improve their quality of life.

Yet some cannabis companies have violated their patients’ trust in supplying them with something that could harm them. Indeed, recalls for cannabis, unfortunately, are now becoming somewhat commonplace on both sides of the border. These licensed producers – audited and approved by government – are entrusted to produce safe, reliable, consistent medicine for patients. They are entrusted to put safety at the core of their business at all times. But that is clearly not the case in certain circumstances.

In the past year, a few of the 52 licensed producers in Canada have been found to have pesticide contamination in their cannabis products. From what I can see, the explanations given for the presence of these pesticides don’t make sense. Pyrethrin, for instance, has been found on some medical cannabis products shipped out of certain growing facilities. However, pyrethrin does not naturally appear on plants. It has to be intentionally applied, accidentally or otherwise.

That means, in cases where this pesticide has been found on products after they left the growing facility, two things had to have happened. First, someone introduced it onto the plants to deal with an insect infestation. And second, lax quality control standards – perhaps influenced by a short-term focus on profits over patients – allowed infected products to enter their supply chain and, in many cases, to be consumed by patients.

When revealed, those responsible for companies using pesticides such as pyrethrin say they are “shocked”, publicly declaring that they have no clue as to how these toxic substances entered their cultivation processes. The fact is, if you don’t test your inputs, if you fail to test your outputs, and if you manage your business for short-term profits, you shouldn’t be producing cannabis.

There’s no place in healthcare for people who disregard a patient’s well being, because – from a patient’s perspective – what you don’t know could hurt you. No one who grows something can absolutely guarantee that a mistake will never be made, granted. But as the cannabis sector expands, experienced cannabis firms know there’s a direct correlation between attention and leadership: as the world pays more attention to our sector, the onus on us to be stewards in and for our industry also rises.

That means putting patient safety at the centre of everything we do. And that means ensuring patients are consuming safe cannabis produced by licensed companies that are committed to the long-term health and prospects of our growing industry.

July 11, 2017

Greenhouse Ventures, Thomas Jefferson University’s Lambert Center Launch Education Series

By Aaron G. Biros

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Greenhouse Ventures, a startup accelerator for ancillary businesses in the cannabis space, announced today the launch of a series of educational events throughout Pennsylvania, partnering with The Lambert Center for the Study of Medicinal Cannabis and Hemp at Thomas Jefferson University. According to the press release, the series of talks will be focused on Pennsylvania’s legislation regarding medical cannabis.

“The PA Medicinal Cannabis Education Tour seeks to rectify the current lack of education on medicinal cannabis by providing current, reliable information on medicinal marijuana and its uses,” reads the press release. The events come at an opportune time: Pennsylvania recently announced qualifying permit applications for growers and dispensaries. As the state moves forward with their plan to fully implement a medical cannabis program by 2018, those looking to learn more about the regulations can attend these talks throughout the state.

The PA Medicinal Cannabis Education Tour will make stops in six cities, one for each of the regions set by the Department of Health: Tuesday, July 25^th in Philadelphia; Wednesday, July 26^th in Allentown; Tuesday, August 1^st in Pittsburgh; Wednesday, August 2^nd in Erie; Tuesday, September 26^th in Harrisburg and Wednesday, September 27^th in State College. The educational content is developed by the Lambert Center at Thomas Jefferson, the only such program dedicated to cannabinoid therapy. “These programs will educate healthcare professionals on the basic science underlying the pharmacologic and therapeutic options associated with medical cannabis in patient care, clinical insights on the use of medicinal cannabis, and provide information on legislative measures of Pennsylvania state law on the use, recommendation and dispensing of medical marijuana for medical conditions,” reads the press release.

Charles V. Pollack, Jr., MD, director of the Lambert Center

Last year, The Lambert Center hosted an accredited CME course as part of Greenhouse Ventures’ industry conference, Innovation in the Cannabis Industry: Future Outlook. “The Lambert Center for the Study of Medicinal Cannabis and Hemp at Thomas Jefferson University is proud to support and participate in the PA Medicinal Cannabis Education Tour,” says Charles V. Pollack, Jr., MD, director of the Lambert Center. “The Lambert Center is the only comprehensive academic resource for education, research, and practice for the therapeutic use of cannabinoids to be based in a US health sciences university. We view the PA Tour as an essential education piece to prepare Pennsylvania doctors and assist in a smooth rollout of Pennsylvania’s Medical Cannabis industry.”

Sara Jane Ward, PhD, is an assistant professor at the Center for Substance Abuse and Research at the Lewis Katz School of Medicine at Temple University and one of the course instructors on the education tour. She says a large part of the event series is to settle old misconceptions about cannabis. “There are a lot of misconceptions and misunderstandings on cannabis as a medicine in the medical community, because historically medical students are not taught about cannabis and the endocannabinoid system,” says Ward. “I’m looking forward to working with Greenhouse Ventures and The Lambert Center for the Study of Medicinal Cannabis and Hemp, to educate healthcare professionals across Pennsylvania on the health benefits of cannabis.”

“A common setback for states that are implementing medical cannabis regulations is the lack of interest and sign ups from doctors and patients,” says Kevin Provost, executive officer of Greenhouse Ventures. “With reputable medical institutions like Thomas Jefferson University providing entry level education on medicinal cannabis and the endocannabinoid system, hopefully healthcare professionals across the state will realize this is real medicine, that can bring significant medical benefits to thousands of patients, and that now is the time for them to learn, before the industry is open in Pennsylvania.”

The first event in the educational series will be in Center City, Philadelphia on Tuesday, July 25^th in the Bluemle Life Sciences Building at Thomas Jefferson University.

June 29, 2017

European Cannabis News Roundup- Summer 2017

By Marguerite Arnold

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Obstacles to American cannabis reform are creating a quirky if valuable market. Cannabis is still a “Schedule I” drug. From a practical perspective, this has created a multi-billion dollar industry that as of yet, cannot get reliable banking services. It also means that patients cannot get the drug covered under health insurance. There are no national safety requirements for growing, packaging, labelling or consumption.

This is certainly not the case elsewhere. Other countries are rapidly outpacing the U.S. in such regards even if their commercial markets are not (yet) of the same size. Outside of Canada right now, Europe is the place where most of these things are happening.

Just as in the U.S., however, there is no one single path to reform.

Who Is Interesting In Europe?

This is an evolving question, but here, for the moment are the market leaders and what is going on locally:

Germany. Cannareform auf Deutsch currently underway makes this the most exciting country in Europe right now. The country is basically the “California of the EU” as it were, with about 20 million more people.

As of January 19, the lower house of the German parliament voted unanimously to legalize cannabis for medical use. Further, they voted to cover it under public health insurance which covers 90% of Germans. Yes, this is a system in process. Yes, there are problems. Health insurance companies appear to have launched a tepid attempt to slow this down, but just as in Canada, they are already facing court challenges. It is a losing battle here. Both legal and legislative mandate are very clear.

This is an industry that will also begin to grow, per government estimates, at between 5-10,000 patients per year for the next couple of years. It could grow faster than that. With over 1 million potential patients already, and a high interest in plant-based and natural medicine, this is a market more than ready for cannabis products. There are now up to ten growing bids up for grabs here and those who have applied are waiting anxiously as the government is set to announce the winners this summer. The big push right now on the ground is doctor and patient education as well as getting patients signed up for trials.

Recreational reform is also far from dead here. The medical question, in fact, has only inspired activists to redouble their efforts to get recreational reform finalized sooner than later. Especially given developments elsewhere, including locally.

Bern, the capital of Switzerland
Photo: martin_vmorris

Switzerland. The Swiss are approaching the question of legalization in another unique way not seen anywhere else. That said, they are clearly inspired by events in other places. Since 2011, low-THC cannabis has been for sale in regular shops. However in the last quarter of 2016 and into the first of this year, the market all of a sudden seems to have woken up. There are now over 160 shops either selling the drug or applying to sell it. This is all product that is taxable.

Thanks to this, reformers are now pushing a bill federally that would legalize and tax the sales of all THC products – no matter their concentration. In effect, in other words, the Swiss are looking at tax revenue first. If they succeed, they will be the first country to enter the market this way. It will also push other countries, starting with their closest neighbours, to examine the question of legalization just on this front. The economic justification alone is compelling. Expect Austria to also look at the problem this way.

Spain. The country is widely billed as the “next Holland.” Why? Cannabis reform has been very similar procedurally. Due to loopholes in the current law, the Spanish have been able to establish a thriving “cannabis club” market. These clubs are member-driven and non-profit. However locals who are over the age of 21 can sign up and smoke in “semi-private.” Legislation now pending in the Spanish legislature would focus on better regulation of both the clubs and the existing grows that support them. The way the Spanish seem to be approaching the issue is to give larger cities and regions direct control over regulation of the industry. However for now, this is a market that is steadfastly resistant to commercial development on the scale seen in other places. Investors – especially from overseas, are avoiding the market because of this uncertainty.

De Wallen (Red Light District) in Amsterdam, where a number of cannabis shops are.
Photo: Bert Kaufmann

Holland. Generation X reformers are used to the idea of the grey market created by the unique nature of Dutch culture and the plant. For the better part of 40 years, the entire industry here has been based on a unique market of seed producers and growers. That, in turn, supports the coffee shop culture. There are many proposals to change the law here, and the industry will probably begin to better regulate – starting with cultivation, as the rest of Europe turns its attention to this issue. It was Holland after all, that started this. What is next for Holland 2.0? It is likely that regional developments will also shape this market too. It is still part of the EU.

Italy. While a bit of an outlier, the Italians are also in the game now. How further reform will proceed here, however is anyone’s guess. The Italian military began growing and distributing cannabis to pharmacies last year. The first medically focused canna café has now opened in Rome.

The Eastern Bloc

Eastern European countries are all over the map on legalization – although most are approaching this as a medical issue. In Czech Republic, legalization has moved forward here steadily in large part because of existing national drug policy. Croatia began importing from Canada last year in the form of cannabis concentrates. Both of those countries have digital prescription systems to integrate with medical cannabis, as part of the legislation legalizing medical use in 2015. This digital dispensation system is also unique so far in Europe, although other countries will be entering this area quickly. Even Turkey has begun to implement reform, allowing producers to begin to grow the plant domestically for local medical use.

April 12, 2017

Pennsylvania Temporary Rules for Doctors Released

By Aaron G. Biros

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Pennsylvania Department of Health Secretary Dr. Karen Murphy recently released a draft of temporary regulations for physicians, asking for feedback via a survey from the medical community. “The process for a patient to obtain medical marijuana will begin with the physician, so it’s vital to ensure that our regulatory process for those physicians is open and transparent,” says Secretary Murphy. “Our focus remains to implement a patient-focused medical marijuana program that gives help to those who need it, and these temporary regulations mark an important step forward in achieving that goal.” The temporary rules, published on April 11^th, outline physician and practitioner registration, patient certifications, physician training and other key regulations.

Steve Schain, Esq. practicing at Hoban law Group

In the temporary rules lie some stipulations for doctors, which seem intended to limit corruption or financial conflicts of interest. According to Steven Schain, Esq., consumer finance litigation, banking law and cannabis law expert practicing with Hoban Law Group, the market’s growth will hinge on doctor participation. “The entire program will rise and fall based on the speed in which we involve doctors,” says Schain. “If the doctors don’t certify for medical conditions and make recommendations, the market won’t go anywhere.” Pennsylvania’s program, under the current language, requires doctors to issue patient certifications, similar to what other states might call a doctor recommendation or prescription.

According to Schain, other states with similarly worded regulations experience a lack of physician participation, and tepid market growth at best. “If you look at New York, New Jersey or Maryland, they run into issues where there just is no incentive for doctors to participate,” says Schain. “If you look at the existing language of the regulations, there is no financial incentive for doctors to get involved, they can’t charge for a recommendation, which is good and bad.”

“The good part is it reinforces that doctors can’t really be a financial backer of a grow operation or a dispensary,” says Schain. Under the current language, physicians can’t solicit, accept or offer any form of compensation from any patient, prospective patient, caregiver or anyone involved in a medical cannabis business if they intend to register with the Department to issue patient certifications for cannabis. “Some doctors thought this would be a cottage industry for them, it’s not.” Doctors are also not allowed to advertise as a practice issuing patient certifications for cannabis. “Another benefit of the language in the proposed regulations is the continuing care of a physician,” says Schain. “They want the people doing the bulk of referring or recommendations to be primary care physicians. Those are the people doing most of the recommendations, as it should be.”

Those rules contrast starkly with what many are familiar with in California’s regulations where doctors could advertise freely and charge fees without the need for ongoing care. “Looking at previous regulations in a state like California, where there were no requirements for ongoing care, we saw doctors making a business out of writing recommendations for cannabis,” says Schain. “The PA regulations are much stricter, which I think is great.”

In addition to those preventative measures, the temporary rules require physicians to actively use the Prescription Drug Monitoring Program. This means doctors must consider a patient’s history of controlled substance prescriptions to see if that might impact their medical cannabis use. Doctors have to take this into account before issuing or modifying a patient certification. The rules also provide for a 4-hour training course, required for all physicians seeking to register as a practitioner who can certify patients for medical cannabis use. The Department of Health expects the program will be fully implemented by 2018.

March 31, 2017

Opening a Dispensary on an Island: Overcoming a Barrier to Business

By Aaron G. Biros

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Martha’s Vineyard is renowned for its beautiful beaches, quaint whaling towns and picturesque rolling countryside. The island is well known as a popular vacation spot for the rich and famous, including the Obamas, the Clintons and Larry David. The movie Jaws was filmed there and the infamous Ted Kennedy-Chappaquiddick incident took place there in 1969. Its summer population of 115,000 drops to about 17,000 as the island slows down for the winter. It is also home to roughly 120 registered medical cannabis patients and a dispensary that will have to deal with the complexities of operating on an island.

In 2012, Massachusetts became the eighteenth state to legalize medical cannabis and in 2016, the state legalized adult use of cannabis. Geoff Rose, co-founder of Our Island Club, a local organization that offers discounts to full-time residents, saw a great need for a medical cannabis dispensary. Rose was granted a provisional license to both cultivate and dispense, as required by the state, on the island. Rose’s nonprofit that received the licenses, Patient Centric of Martha’s Vineyard, plans to operate in West Tisbury, a small town located in the center of the island.

Travel to and from the island is restricted to either boat or plane with the vast majority of traffic occurring on ferries operated by the Steamship Authority. But Rose cannot transport any cannabis on the ferries or even a smaller, non-commercial vessel because the waters are under the jurisdiction of the Coast Guard, a federal agency tasked with enforcing The Controlled Substances Act. The same goes for aircraft under FAA jurisdiction. Transporting cannabis products on the ferries, or any vessel for that matter, would be a felony.

Coast Guard vessel conducting training exercises off the Vineyard

Martha’s Vineyard is not just a physical island, but also a jurisdictional island where all cannabis growing, lab testing and dispensing must occur on the island. Currently, those 120 medical cannabis patients living on the island have no legal method of obtaining medical cannabis, unless they grow it themselves. Rose and his nonprofit, Patient Centric, hope to change that. We sat down with Geoff Rose to learn more about his mission to bring medical cannabis to the Vineyard and some of the legal implications associated with running a cannabis business on an island.

Cannabis Industry Journal: How did you get started with the idea to open a dispensary on the island?

Geoff Rose: Well I moved here almost sixteen years ago and as I have often said, when you move here you have three options: you can contribute to the community, you can hide and stay reclusive or you can leave. It is a very unique community and I chose to contribute. We started Our Island Club, which is a service program for year-round residents that helps them save on essential products and services as a means to cope with the high cost of living here. Clearly there is a need as there are 7,000 year round residents participating in that program. We have donated over a half-million dollars to 175 or more charitable organizations on the island. In addition to that, because of the membership fee, anyone who can’t afford it can still receive the membership.

I have come to launch the dispensary in the same manner. There is a need. [Legal medical cannabis] has now been law since November of 2012. Over four years later and still no dispensary on the island- I have continued to persevere because I know that there is a need.

CIJ: It is a pretty tight-knit community; did you meet any local opposition?

Geoff: Dukes County (the Vineyard) voted in favor of medical marijuana by a wide margin and 82% of West Tisbury voted in favor of medical marijuana, one of the highest in the state. Well I am currently waiting on my special permit application that I am required to apply for in West Tisbury. It has been sent to the Martha’s Vineyard Commission (MVC) for review.

There have been concerns, including from the local school. But state law requires that a dispensary be located beyond 500 feet from a school. The current location that I am asking for approval is over seven times that distance. There is a perceived concern about that. The first round of applications in 2013 included a score-based application process and while there were four competitors, none of us met the minimum score. In the second round, it moved to a compliance-based application process, and I was the only one who kept the effort alive and was awarded the license.

CIJ: There is a bit of an opioid problem on the vineyard, and multiple scientific studies have suggested a causal relationship between cannabis legalization and a reduction in opioid overdose-related deaths; do you see this as part of the solution?

Geoff: I have seen studies, particularly one by Johns Hopkins that does show a correlation between medical cannabis and the reduction of the use of opioids. I think it is a byproduct of opening the dispensary, so yes. I shared these findings with the Superintendent of Schools. I think education is the key to really develop awareness. The state has mandated that schools are required to develop a drug education program, it’s part of the school curriculum, and I see that as a critical component in our outreach effort to the community. We have a responsibility to the community in many ways, whether it’s law enforcement or education.

I recently announced that we would allocate a percentage of our net profits for grant money to programs involved in drug education. Community outreach and education are very important. There also needs to be some positive education. There is a clear understanding that children need to be educated about the misuse of cannabis, which is true. But they also need to be educated about the medical value of cannabis. For example, many in the medical community will acknowledge the benefits of cannabis as it relates to cancer patients, whether it is helping nausea, appetite, pain management or being used as a sleep aid. This is an important message that needs to be disseminated to children. How does it help your family member, friend or neighbor who is suffering from the effects of cancer? That is one of the messages that would be helpful for children to receive. We can address the impact of all drugs including cannabis on the developing brain; I understand and agree, and publicly support that in an educational context. I want to be part of the solution.

CIJ: What problems do you run into trying to open a cannabis business on the island?

Geoff: I received my provisional cultivation license in September of last year. Part of the issue is the fact that cultivation has to occur on the island. The Coast Guard regulates everything surrounding the island including all the ferries, or any watercraft.

As part of my provisional license, I am required to have an independent cannabis-testing laboratory on the island that will perform the requisite testing mandated by the state. I am currently in conversations with Ph.D. chemists consulting for the laboratory. I have had numerous conversations with lab directors in other parts of the state, including Proverde Labs and MCR Labs. The Coast Guard has stated that cannabis is a Schedule One substance and therefore any transport is illegal. Unfortunately the law is very specific and not exactly written with Martha’s Vineyard in mind.

Editor’s Note: If you have further questions relating to Patient Centric of Martha’s Vineyard, you can reach Geoff Rose at geoff@patientcentricmv.org

March 20, 2017

New York Adds Chronic Pain to List of Qualifying Conditions

By Aaron G. Biros

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The New York State Health Department announced last week a series of changes in their medical cannabis program that is expected to increase patient access in more rural parts of the state. The news comes after reports earlier this month highlighting the lackluster state of the market.

The press release announces that the state’s Health Department will add chronic pain as a qualifying condition, effective March 22^nd. That rule change came after the Health Department’s two-year report, which recommended conducting a review of evidence for using medical cannabis to treat patients suffering from chronic pain.

In addition to that, physician assistants may now register with the Health Department to certify patients for medical cannabis, given the supervising physician is registered as well. In November of last year, the Health Department announced they would allow nurse practitioners to certify patients. By increasing the number of eligible practitioners, the state hopes to improve patient access across the state, and particularly in rural areas where there are fewer physicians. “Improving patient access to medical marijuana continues to be one of our top priorities, as it has been since the launch of the program,” says Health Commissioner Dr. Howard A. Zucker. “These key enhancements further that goal. Medical marijuana is already making a difference for patients across New York State, and we are constantly evaluating the program to see how we can make it better.”

Speaking with The Buffalo News earlier this month, Ari Hoffnung, president of Vireo Health of New York told reporters that companies are having a hard time getting by in New York’s cannabis industry. “Our company is not close to break-even yet,” says Hoffnung. “And based on my understanding, no one has made a dime here in New York.’’ It is possible that the recent move by the Health Department could increase the size of the market, according to Matt Karnes, founder and managing partner of GreenWave Advisors, based in New York City. “Expanding the list of qualifying conditions to include chronic pain and to allow for nurse practitioners to make a recommendation will serve to jumpstart the fledgling medical marijuana market in New York State,” says Karnes. “Assuming similar chronic pain conditions apply to New York as is the case in other states, we could expect a large increase in the total number of patients.”

At this time, it is unclear exactly how the new regulations will affect the market size, but they can undoubtedly benefit patients seeking medical treatment. Dr. Scott Gottlieb, board-certified anesthesiologist and pain management specialist from Pearl River, New York, is optimistic this will help more patients get the treatment they need. “Having chronic pain added as a diagnosis is tremendously helpful,” says Dr. Gottlieb. “There are a lot of patients that don’t meet the current criteria for a qualifying condition and this will be very beneficial for them.” From his own experience, Dr. Gottlieb says he has found cannabis to be helpful in treating neuropathy (nerve-related pain.) “As a pain management physician we have a large population of patients with recent spinal cord surgery that do require continuous medications,” says Dr. Gottlieb. “It will be nice to have another option as a feasible medical treatment.”

October 17, 2016

Steep Hill Labs Expands to Pennsylvania, Washington, D.C.

By Aaron G. Biros

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Last week, Steep Hill Labs, Inc. announced plans to expand on the East Coast, including licensing for laboratories in Washington, D.C. and Pennsylvania. The cannabis testing company now is operating or developing in seven states, the District of Columbia along with an official arrangement with a research university in Jamaica, according to Cathie Bennett Warner, director of public relations at Steep Hill.

The same team of physicians that oversees the Steep Hill laboratory in Maryland will operate the Pennsylvania and D.C. labs. Heading that team is chief executive officer Dr. Andrew Rosenstein, chief of the division of Gastroenterology at University of Maryland Saint Joseph Medical Center and assistant clinical professor of Gastroenterology and Hepatology at the University of Maryland Medical Center. Dr. Rosenstein has been recognized by Baltimore Magazine as a top doctor in the Baltimore area, according to a press release.

Dr. Andrew Rosenstein, CEO of Steep Hill Maryland, PA and D.C.

According to Dr. Rosenstein, they want to provide accurate clinical results for trials with patients using cannabis. “All clinical trials will require a competent, credible and reliable lab partner and that is what we are bringing to the field- and that is why we are working with Steep Hill,” says Dr. Rosenstein. With team members having backgrounds in pathology, molecular diagnostics, clinical chemistry, microbiology and genetics, it should come as no surprise that they plan to participate in clinical research.

Dr. Rosenstein’s vested interest in cannabis safety stems from prior experience with his patients using cannabis. “Over the past five years, we have seen an increased number of patients using cannabis, particularly for managing the side effects of Crohn’s disease and cancer treatment,” says Dr. Rosenstein. “They would bring it up to us and at the time I didn’t know much about it, but anecdotally it’s really clear that a lot of patients have great responses to it.” Not knowing much about the preparation or safety of cannabis at the time led Dr. Rosenstein to advise patients to be very careful if they are immunocompromised.

Examination of cannabis prior to testing- credit Steep Hill Labs, Inc. — Examination of cannabis prior to testing- credit: Steep Hill Labs, Inc.

“When a patient is immunocompromised, a bacterial or fungal infection can be lethal, so because we had patients using cannabis, we wanted to make sure it was safe,” says Dr. Rosenstein. So when Maryland legalized medical cannabis, Dr. Rosenstein and his team saw the need to protect patient safety and Steep Hill was a perfect fit. “We really didn’t want to reinvent the wheel so we looked for someone to partner with,” says Dr. Rosenstein. “Steep Hill has the best technology and the best credibility and we didn’t want to compromise on quality and safety issues. They felt the same way so we partnered with them and culturally it has been a great fit.”

Steep Hill Express in Berkeley, CA- MD,PA and D.C. will have a similar offering of instant potency analysis

The new laboratories plan to offer a similar range of services that are offered at other Steep Hill labs, such as rapid potency testing for THC-A, ∆-9-THC, CBD, CBD-A and moisture. But Dr. Rosenstein sees clinical opportunities in the East Coast medical hubs. “We want to provide the testing component for studies, providing clinical reproducibility and consistency, and those are the things as a top-notch lab that we are interested in doing.”

A petri dish of mold growth from tested cannabis- Photo credit: Steep Hill- — A petri dish of mold growth from tested cannabis- Photo credit: Steep Hill Labs, Inc.

With a physician-led group that has experience in molecular diagnostics, partnering with Steep Hill is about being medically focused, according to Dr. Rosenstein. “First and foremost, this is about patient safety.” Because of that, he emphasizes the need for required microbiological contaminant testing, particularly because of his experience with patients. “If you’re a cancer patient and you get a toxic dose of salmonella or E. coli, that can kill you, so testing for microbiologic contamination is of the highest priority.”

According to Warner, bridging the medical cannabis science gap with Steep Hill’s professionalism and experienced doctors practicing medicine is a big deal. “We are working very closely with their medical team to make sure these standards are medically superior,” says Warner. “To have these doctors with such a high level of knowledge in medicine working with us in cannabis analytics is a breakthrough.”

September 6, 2016

Adam Jacques and Team Launch Sproutly, Dispensary in Eugene, Oregon

By Aaron G. Biros

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Adam Jacques and his team officially launched the newest arm of their business last week, Sproutly, a dispensary located in Eugene, Oregon. “This is an extension of what the Grower’s Guild Gardens does and what the Microgrower’s Guild was,” says Jacques. The Grower’s Guild Gardens, Jacques’ award-winning cultivation business, is known for their high-CBD genetics and patient-focused work, most notably with Leni Young, which helped lead to the passing of legislation in Alabama called Leni’s Law, decriminalizing the possession of cannabis oil for patients in the state.

Sproutly’s shelves boast over 75 strains of cannabis from Jacques’ farm.

Sproutly is a medical and recreational dispensary that boasts a wide variety of high-CBD strains, a reflection of the team’s focus in the past. “We are extremely medically focused with a variety of unique CBD strains in stock,” says Jacques. “First and foremost are the patients, but entering the recreational market means we will be carrying a wider variety.” The opening of the dispensary is well timed as the team received their Tier II cultivation license, allowing them to grow cannabis up to 20,000 square feet in an outdoor space and 5,000 square feet indoor. So in addition to the handful of brands they carry, including Lunchbox Alchemy edibles, Northwest Kind and Marley Naturals, they also carry over 75 strains from their own Grower’s Guild Gardens.

Adam Jacques in front of a display shelf at Sproutly.

Adam and Debra Jacques pride themselves in rigid standards for quality in sourcing, so it should be no surprise that they plan on supplying their dispensary with over 150 strains coming from more than 1,200 plants on their farm. “We really only take products from people we know and trust,” says Jacques. “That is why most of the flower in the dispensary is coming from our farm, so we know exactly what is going into it.” Jacques points to third-party certifications such as Clean Green, for other vendors to find reputable growers. “I need to know where it is coming from and that requires a personal relationship to trust the quality of their products.” The value of trust and personal relationships is also why they go through extensive training of their staff, using their own expertise for in-house training.

The team includes Chris West, Elton Prince and John De Kluyver, all of whom have a decade or more of experience cultivating cannabis and working with patients. “We take our bud tenders through training classes, they get tested on their knowledge of products and the science of cannabinoids and terpenes and how the combinations affect people differently,” says Jacques. By leveraging that high level of in-house expertise, the team prides themselves on customer service, helping patients and customers find the right strain or product that suits them best.

In the front of the dispensary, a receptionist greets patients or customers, checking identification and showing you to a bud tender. As you walk into the retail space, you immediately notice the professionalism of the staff, taking time to personalize each customer’s experience without making him or her feel rushed. The clean aesthetics, product selection and knowledgeable staff provide for a friendly retail culture without the common ‘stoner culture’ that usually follows.

Jacques and his team will not be trading in their overalls and work boots just yet as they are inching toward harvesting their 1,200 outdoor cannabis plants soon. Grinning ear-to-ear, Jacques showed off his Tier II cultivation license on the farm, and with it came a glimpse into their exciting growth.

April 12, 2016

Soapbox

Bridging the Gap: Doctors, Education and Compliance

By Aaron G. Biros

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Doctors are still very hesitant to recommend cannabis in medical treatment of their patients. A key aspect missing from the medical cannabis industry is participation from physicians and the medical community. Cannabis’ Schedule I drug status blocks medical research and leaves a stigma in the medical community. Doctors are concerned with the implications of recommending cannabis, the possibility of losing their license to practice and most lack any formal education in prescribing cannabis. The DEA’s recent announcement to consider rescheduling cannabis this year could dramatically impact doctor’s willingness to work with the drug.

The DEA’s plan to release a decision on the matter represents a major shift in attitude toward treating patients with medical cannabis. This could very possibly culminate in the rescheduling of cannabis, which would allow for more medical research, including clinical trials. Dr. Scott Gottlieb, board-certified anesthesiologist and pain management specialist from Pearl River, New York, believes the bigger obstacles for doctors prescribing cannabis include the stigma associated with it, legal concerns and physicians’ lack of education. Dr. Gottlieb has practices in both New York and New Jersey where he recommends patients cannabis. He believes there should be some type of recourse to help physicians circumvent legal issues. “Some of the bigger legal concerns regarding cannabis surround complying with state regulations,” says Gottlieb. “That sort of compliance includes confirming the diagnosis of the patient with thorough documentation, making sure it is an approved condition to treat with cannabis, documenting continued treatment of the illness and clearing the patient of any contraindications.”

Dr. Gottlieb believes it should be a collaborative effort on behalf of states, dispensaries and patients working to help educate doctors on the legal concerns surrounding the recommendation of cannabis. “Physicians are not taught anything in medical school about dosing or the medical effects of cannabis,” says Gottlieb. “With more education we can get rid of the stigma and get physicians aware of the potential benefits for their patients and the ability to control dosage in medication.”

Currently, there is very little communication between doctors and dispensaries in New York. A collaborative effort to educate all stakeholders involved could help get more doctors involved and streamline the entire process. “Doctors want patients to feel comfortable and know what to expect in receiving treatment with cannabis,” continues Gottlieb. “Which will come with a more transparent system, involving patients, doctors and dispensaries in a conversation about education.”

Pointing to the success of doctors actively recommending cannabis could also facilitate doctor participation. “The number one reason why I recommend cannabis is that I have a number of patients that use it to successfully treat their conditions and completely eliminate their opioid regiment,” says Gottlieb. That kind of success in a treatment should grab the attention of physicians as what could possibly be best for their patients. With more education and research, doctors will gradually feel more comfortable recommending cannabis to their patients.