Tag Archives: chronic pain

June 29, 2020

Cannabinoid Research & Pharmacology: A Q&A with Dr. Linda Klumpers

By Cannabis Industry Journal Staff

Dr. Linda Klumpers has a Ph.D. in clinical pharmacology of cannabinoids. Originally from the Netherlands, she began much of her career in studying cannabis there. She now lives and works in the United States, where she has worked on a number of projects, started her own company and is continuing her research on cannabis as an effective medicine.

After studying neuroscience at the University of Amsterdam, she went on to train at the Centre for Human Drug Research and Leiden University Medical Center, where Dr. Klumpers obtained a clinical pharmacology degree and a Ph.D. in clinical pharmacology of cannabinoids. She has been researching cannabinoids in humans since 2006. Dr. Klumpers co-authored a number of peer-reviewed cannabinoid publications and she has received five honors and awards for her work, including the BJCP Prize from the British Journal of Clinical Pharmacology.

In 2016, she moved to the United States and founded Cannify, an online tool that helps patients and clinicians with product matching and providing legitimate cannabis education based in sound science. In 2018, Dr. Klumpers joined forces with Dr. Michael Tagen, another clinical pharmacologist, to launch Verdient Science, a consulting partnership. Their work at Verdient Science includes helping clients set up human studies, advise on FDA submissions, creating course materials, adjusting product pipelines and product development strategies, among other areas of focus.

Right now, Dr. Klumpers is waiting to hear back from a grant application they submitted to study THC and CBD ratios for medical efficacy in chronic pain patients. We sat down with Dr. Klumpers to hear her story, what she is working on now and how she hopes to continue researching cannabis as an effective medicine.

Cannabis Industry Journal: Tell us about your background as a research scientist. How did you get involved in cannabis?

Dr. Linda Klumpers: During my Ph.D. work, we studied the effects of so-called cannabinoid receptor antagonists that block the effects of THC – I prefer to say “we”, as research is always done by multiple people. The problem with studying these compounds in healthy volunteers is that you can’t observe acute effects, which means that you won’t measure any effect after a single dose. To circumvent this issue, we applied a trick and developed a ‘challenge test’: after you give the ‘invisible’ blocking compound, you stimulate the cannabinoid system by giving people THC. If the subjects don’t feel the effects of THC, you know that the blocker worked. One thing lead to another and we ended up studying various administration methods, such as intrapulmonal (via the lungs) with vaporization, oral and sublingual. We studied the behavior of cannabinoids in the body and how the body responded to them.

CIJ: Can you share some information on the projects you are working on? What is Cannify and what is Verdient Science?

Dr. Klumpers: Cannify was founded in 2016 after I saw that too many people had opinions about cannabis that were more based on emotion than fact. Besides, I noticed that a majority of the scientific literature on cannabis pharmacology was left unnoticed and unapplied to the people getting exposed to cannabis, such as patients, the cannabis industry – that was in a very different stage at that time – healthcare providers and regulators. With my Ph.D. in cannabis pharmacology, I wanted to add a level of objectivity to cannabis education and research. Cannify’s goals are to understand the science of cannabis, and share this with others.

The way we do this is multi-fold:

Cannify Quiz: Patients with an interest in cannabis often want to know the science about cannabis and their condition. Our quiz helps these people by asking in-depth questions and showing them relevant scientific literature in a personalized report. After that, an overview is given with products and product matching scores. Our account system allows users to track their progress over time. Product manufacturers, dispensaries and other companies can use the quiz for their websites and their stores to help out retail employees and save them time, and to receive insight with our analytics on customer desires and behavior. Needless to say, an educated customer is a better customer. It is important that customers come and leave stores well-informed.
Education: Speaking of education, our website contains educational articles about everything cannabis: from plant to patient and from product to mechanism of action. We regularly publish educational quizzes for people to test their knowledge level. With a free Cannify account, you can find all of our educational quizzes and save your results. We also provide customized courses, and have educated a wide audience varying from industry professionals to CME-accredited courses for healthcare providers. On top of that, our educational videos in dispensaries (in collaboration with our partner, Enlighten) reach customers and retail employees.
One of Cannify’s educational graphics, showing the difference between topical and transdermal product administration

Research: To expand the knowledge on cannabis, performing and especially sharing research is essential. We have already performed and published some of Cannify’s results on descriptive statistics and effect prediction during conferences, as well as a review paper on cannabis therapeutics in a peer-reviewed journal and a book chapter. This year, we expect to co-publish the results of a survey in different sleep patient groups. We collaborated with the Centre of Excellence for Epilepsy and Sleep Medicine in the Netherlands on a peer-reviewed paper from which we expect new research to follow to benefit these patients. We have also co-submitted a grant to study THC and CBD ratios in chronic pain patients: fingers crossed! Another important next step is to test a healthcare provider-specific version of Cannify’s quiz in the clinic once COVID dies down. I want to add that after working in a clinical lab for many years, it is important to combine the results of clinical trials to what people do in real life, which is what we do with Cannify.

And here’s some information on Verdient Science:

Verdient Science is a consulting partnership I have with clinical pharmacologist Dr. Michael Tagen. We provide clinical and translational pharmacology expertise to improve the quality of product development & clinical testing. While both working as independent consultants, we decided from 2018 to start working together to offer better services. Since then, our work has been very variable and includes helping clients set up human studies, advise on FDA submissions, creating course materials, adjusting product pipelines and product development strategies to make them more efficient and cheaper, performed scientific due diligence and much more. When clients want additional services that are beyond our expertise, we are typically able to introduce them to various people per expertise area, or refer them to our partner companies, Complex Biotech Discovery Ventures (CBDV) with Dr. Markus Roggen, and Via Innovations with Dr. Monica Vialpando. A benefit of working with the same partners includes smooth handovers and the feeling of a one stop shop.

CIJ: How does Cannify match available products to consumer needs? Is there an algorithm you developed that matches moods or feelings to cannabinoids or chemical profiles?

Dr. Klumpers: That is a great question and the core of what we do! So back to the Cannify quiz: there are three steps:

Users fill in questions;
A personalized report is generated with the relevant science;
The user gets a product overview with product matching scores.

Another Cannify educational graphic, showing THC distribution throughout the body over time

The report and the matching scores are generated using algorithms that are regularly updated. These algorithms are based on various data sources:

Literature: There is a lot of available literature, and we make sure to select the most relevant and reliable studies;
Raw data: There is only so much one can find in the literature, and lots is hidden in the raw data. Therefore, we piled up data from studies done at various research institutions, including the University of Kentucky and Johns Hopkins University, and used them in our algorithms;
Internal studies: From the thousands of users filling in their results, there is a lot of information that we should learn from. This feedback loop helps us to better understand how the lab relates to real life situations.

CIJ: The world of cannabis research has been historically stymied by red tape, DEA interference and a host of federal regulations. How have you managed to work through all that? Do you have a DEA license? What did it take to get it?

Dr. Klumpers: Luckily, a majority of our research was and is done outside of the US. You still need to obtain the appropriate licenses, but I was perhaps lucky to have filled in every form very thoroughly and we got the licenses within months. The process is quite meticulous, as you need separate licenses for almost every step from manufacturing to administration. An additional complication is that our cannabis is not stored in our own building, but in the hospital pharmacy across the street, involving transport via the public road. Despite the roadblocks, including a legal procedure about this matter that was going on in parallel, I had no major issues getting our work done. For our research in the US, we were lucky to have been working with partners that already have the required license.

Also with publishing, I have never had an issue with the cannabis stigma. Generally, in my field of science, good quality science is very much welcomed and appreciated, and this was even before the time that there were four different cannabis-related journals, as is the case nowadays.

CIJ: Looking to the future, where do you hope to focus your research efforts? Where do you think the cannabis community should be focusing their efforts in the next 5-10 years?

Dr. Klumpers: Besides continuing to analyze the data generated from Cannify, I keep my fingers crossed for the grant application I mentioned earlier on THC and CBD ratios in chronic pain patients. Although we know that CBD is able to influence THC-induced effects, it is not known at what dosages, which ratios and how the effects are related to each other. For example: is CBD able to decrease certain side-effects of THC without decreasing pain-relieving effects?

Whatever is done, wherever in the community: good quality data are keyNext to that, I am also interested in other neurological and psychiatric disorders, and, of course, my Ph.D. love: the cannabinoid antagonists. Sadly, all the research efforts on this compound group were halted more than a decade ago. However, there is a renewed interest. I would love to help turn these compounds into effective and safe medicines.

Regarding the cannabis community: 5-10 years sounds really far away for an industry that is relatively new to many, but a lot has already changed since I started cannabis research more than 14 years ago and time has flown by. Some changes have been positive and others less so. Whatever is done, wherever in the community: good quality data are key. Many companies gather data and even publish them in peer-reviewed journals, but that does not always mean that the data are useful or that the studies were done well. Only a few minor changes to how and which data are gathered, and so much more can be done. What can help with achieving this is to let the right people do the right thing: many call themselves a ‘cannabis scientist’ or ‘cannabis expert’, but that does not mean anything. What has someone truly achieved and what is their exact expertise? A Ph.D. in chemistry is not going to help you in setting up effect studies, neither will I be able to improve your product’s shelf life or extraction yield. Getting the right people in the right place is key. Lastly: the cannabis community should stay critical. The length of one article in Cannabis Industry Journal wouldn’t be enough to lay out all the misconceptions that people have about cannabis. Make sure that those misconceptions do not live on and do not be afraid to admit you don’t know something, irrespective of the branch you work in: only then, can the cannabis community progress to the benefit of all.

March 21, 2019

The Rise of The Cannabis Clinic Model In Europe

By Marguerite Arnold

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The opening of the UK’s first cannabis clinic is certainly cause for cheer. The effort, backed by a growing UK powerhouse that includes European Cannabis Holdings, has just opened its first private cannabis clinic in the UK, with two more on the way, including one in London by the end of the year.

The clinic will see patients who can afford to pay, in other words those who are privately insured and not covered by the NHS. The clinics will also serve those with chronic illnesses including chronic pain and epilepsy.

This development will also undoubtedly begin to increase the number of actual legal British cannabis patients, which is significant in and of itself. That count now, close to five months after cannabis became technically available via Schedule II prescription last year, is a shocking four patients. This is not a typo.

Presumably, this means that patients who enter the market this way will also be able to access newly imported Dutch cannabis which has just started to enter the country in bulk. Not to mention be able to find pharmacies who stock the drug.

For the backers of ECH (which include SOL Global), these are strategic moves indeed, which also bode well for those who can afford access.

But does this herald a new shift in the way that cannabis will be prescribed for the mainstream in the UK if not across Europe? That is not so clear.

The History of Cannabis Clinics… In Israel and Beyond

From the medical side of the world, it has been cannabis specialty pain clinics that have moved the conversation forward and served patients in places like Israel. In the latter part of the last decade, Israel slowly began to liberalize access not via dispensaries, as in the American model, but rather via specialty pain clinics paid for by the government. It was only when patient attendance at such prescription and dispensation points became flooded by applicants that the government, just a few short years ago, began to allow regular doctors to prescribe the drug and regular pharmacies to carry it.

What does this say about a British market where reform has just come, and only four patients?There are currently various initiatives sprinkled around Europe- mostly in the form of collectives of doctors who try to help get their patients cannabinoid treatments. See, for example, Kalapa Clinic in Spain. Or the “self help” group of patients in Germany loosely associated with Dr. Grotenhermann (one of the country’s best-known cannabinoid doctors).

Yet in Germany, the first country in Europe to liberalize medical use, there are as yet no cannabis clinics of either the private or public kind (although there have also been several unsuccessful attempts to do just this since 2017 in cities like Berlin and Munich). Part of the reason for the failure of the model in Germany at least is due to the fact that while specialty doctors are needed to help guide patients through the complicated approvals process, the payment for the same from the insurance companies (even private insurers) is so low it is not yet economically feasible to set up a clinic based on this model.

That said, it is clearly an idea that has occurred to more than a few entities. In Germany, however, land of (at least) 40,000 patients, this model has yet to take off. What does this say about a British market where reform has just come, and only four patients? Even as early as spring 2017, when the German government changed the law mandating insurance coverage, there were 800 German patients in the system.

Why The UK Is Likely To Be Different

Cannabis patients may actually be some of the best situated patients to ride out the Brexit crisis that will hit all drugs. Why? From the start, the strange classification of the drug is requiring bespoke solutions for niche patients. While it may not be fair, this in turn will at least start to create a core group of medical users.

Creating at least that first critical mass is also unbelievably important for greater access and reform, if not speeding it on its way. And the backers of the new clinics are well aware that impetus on this front will not come from the much-beleaguered NHS but rather private initiatives like the ones now being launched in the UK.

Disclaimer: ECH is a sponsor of the MedPayRx go to market pilot trial.

November 10, 2017

Soapbox

Poland Legalizes Medical Cannabis

By Marguerite Arnold

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Poland has now legalized cannabis for medical purposes.

That said, it will be some time before patients have access to the drug. While Poles can now technically access medical pot, the scheme approved by the Polish Parliament that went into effect on November 1^st is regressive, to say the least. Certainly compared with even other countries in Europe that are now finally admitting that cannabis is a drug with medical efficacy, the Polish experiment looks “old-fashioned.”

What Does Medical Cannabis Reform Look Like in Poland?

Like most conservative countries, Poland is sticking with a highly restrictive approach that still puts patients in the hot seat. In addition to getting a doctor’s prescription, the chronically ill must be approved by a state authority – a regional pharmaceutical inspector. They must get a license first, in other words. They must then find about $500 a month to pay for cannabis. To put this in perspective, that is roughly the total amount such patients get from the state to live on each month.

Warsaw, Poland
Image: Nikos Roussos, Flickr

The multiple steps mean that only patients with financial resources– and an illness which is chronic but still allows them to negotiate the many government hurdles, including cost –will now be able to access medical cannabis. Unlike Germany which makes no such distinctions, Polish law now recognizes the drug as an effective form of treatment only for chronic pain, chemo-induced nausea, MS and drug-resistant epilepsy.

The heavily amended legislation also outlaws home growing. And while 90% of pharmacies will be able to dispense the drug, this is again, a technicality. Where will the pharmacies get the cannabis in the first place?

So the question remains: will this step really mean reform? There is no medical cultivation planned. And no companies (yet) have been licensed to import the drug.

This is what is clear. Much like the conversation in Georgia and other southern American states several years ago, legislators are bowing to popular demand if not scientific evidence, to legalize medical use. But patients still cannot get it – even if they jump through all the hoops.

In Poland, patients who cannot find legal cannabis in the country (which is all of them at this point) now do have the right to travel to other EU countries in search of medicine. But the unanswered question in all of this is still present. How, exactly is this supposed to work? Patients must come up with the money to pay for their medical cannabis (at local prices) plus regular transportation costs. Then they must pay sky high fees to access local doctors (if they can find them) at “retail cost” uncovered by any insurance.

The issue of countries legalizing cannabis on paper, but not in action, is a problem now facing legalization advocates in the EUThe most obvious route for Polish patients with resources and the ability to travel is Germany. The catch? Medical cannabis costs Just on this front, the idea of regular country hopping for script refills – even if “just” across the border – is ludicrous. And who protect such patients legally if caught at the border, with a three month supply?

Poland, in other words, has adopted something very similar to Georgia’s regulations circa 2015. Medical cannabis is now technically legal but still inaccessible because of cost and logistics. Reform, Polish-style, appears to actually just be more window-dressing.

And while it is an obvious step for the country to start issuing import licenses to Canadian, Israeli and Australian exporters, how long will that take?

The Next Step Of Reform – Unfettered Patient Access

While things are still bad in Poland, right across the border in Germany where presumably Polish patients could theoretically buy their medical cannabis, all is still not copacetic. Even for the “locals.” Germany’s situation remains dire. But even before legalization in March, Germany was importing bud cannabis from Holland and began a trickle of imports last summer from Canada. That trickle has now expanded considerably with new import licences this year. And presumably, although nobody is sure, there will be some kind of domestic cultivation by 2019.

At Deutsche Hanfverband’s Cannabis Normal activist’s conference in Berlin held on the same weekend as Poland decided to legalize medical cannabis, a Gen X patient expressed his frustration with the situation of legalization in general. Oliver Waack-Jurgensen is now suing his German public insurer. He expects to wait another year and a half before he wins. In the meantime, he is organizing other patients. “They [political representatives] are bowing to political expediency but completely ignoring patient needs,” says Waack-Jurgensen. “How long is this conversation going to take? I am tired of it. Really, really tired of this.”

The issue of countries legalizing cannabis on paper, but not in action, is a problem now facing legalization advocates in the EU and elsewhere who have achieved legislative victories, but still realize this is an unfinished battle. Germany is the only country in Europe with a federal mandate to cover the drug under insurance (for Germans only). And that process is taking time to implement.But even in Germany, patients are having to sue their insurance companies

Germany, Italy and Turkey are also the only countries in Europe as of now with any plans to grow the drug domestically under a federally mandated regulation scheme. Import from Holland, Canada and even Australia appears to be the next step in delaying full and unfettered reform in Europe. See Croatia, Slovenia and Bosnia. How Spanish or Portuguese-grown cannabis will play into this discussion is also an open question mark. Asking Polish patients suffering from cancer to “commute” to Portugal is also clearly unfeasible.

Unlike the United States, however, European countries do have public healthcare systems, which are supposed to cover the majority of the population. What gives? And what is likely to happen?

A Brewing Battle At The EU Human Rights Court?

While the Polish decision to “legalize” medical use is a step in the right direction, there is still a long way to go. If the idea is to halt the black market trade, giving patients real access is a good idea. But even in Germany, patients are having to sue their insurance companies. And are now doing so in large numbers. In a region where lawsuits are much less common than the U.S., this is shocking enough.

But the situation is so widespread and likely to continue for some time, that class action lawsuits – and on the basis of human rights violations over lack of access to a life-saving drug – may finally come to the continent and at an EU (international) level court.

Patients are literally dying in the meantime. And those who aren’t are joining the calls for hunger strikes and other direct civil action. Sound far-fetched? There is legal precedent. See Mexico.

And while Poland may or may not be the trigger for this kind of concerted legal action, this idea is clearly gathering steam in advocacy circles across Europe.

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.”