When listing off drugs you can snort up your nose, marijuana usually doesn’t make the list. But with cannabinoid-spiked nasal sprays, that’s now possible, though it might not be any different than smoking. Homemade cannabis nasal sprays have existed on the fringes of the medical weed market for years now, but a Colorado company recently…
A new study published by JAMA Neurology delivers a verdict on a long-debated theory that MS can be treated by opening blocked veins: it’s safe but “largely ineffective,” and so cannot be recommended.
The treatment didn’t reduce the patients’ disability and only restored brain blood flow in about half of patients, according to lead author Dr. Paolo Zamboni and a committee of neurologists based in Italy.
Dr. Zamboni was the originator of the theory. He first proposed in 2009 that blocked veins might lead to some of the symptoms of MS. That set off a firestorm of interest by patients and scientists about the possibility that the disease, long labelled an immune disorder, could be linked to vein abnormality a condition Dr. Zamboni dubbed Chronic Cerebrospinal venous insufficiency, or CCSVI.
The JAMA study, dubbed “Brave Dreams,” was designed to help answer the question: Could opening up those abnormal veins improve symptoms associated with MS?
The study was designed to be a large one, funded to treat 430 MS patients with either balloon angioplasty to open narrowed veins, or a placebo procedure.
However, after several years, researchers recruited only 115 patients.
The study reports that only six of the 15 MS clinics and centres that had agreed to participate in the study actually did.
Some patients in the study were reluctant to participate, unwilling to risk being in the placebo group and not receive the treatment.
“This was very tough for us,” Dr. Zamboni told CTV News.
“Really the neurological community, asked for a double-blinded study, but in the meantime the neurologists rarely supported the study.”
All of the patients in the study were diagnosed with CCSVI on ultrasound and with angiograms.
Balloon angioplasty corrected or restored blood flow in 53 per cent of patients treated for blocked veins. But it didn’t seem to work on the others.
When scientists compared the effects on disability scores and brain scans, they reported no differences between the placebo and treatment groups.
“It’s an unusual study,” said Dr. George Ebers, a now-retired Canadian neurologist from Oxford University, who was asked to comment on the paper.
“You’ve got a study designed for some 400 people only able to enroll about 100. So it means it was very much underpowered to answer the questions. Yet it came up with this conclusion.”
Despite the limitations in the study, he agreed with its conclusions.
“No one in the scientific world thought there were legs to this idea. I couldn’t see any rationale to support the idea that venous narrowing is linked to MS,” he said.
Dr. Maria Grazia Piscalgia, a neurologist in Ravenna, Italy, referred 28 of the 115 patients to the Brave Dreams study.
She told CTV News that eight of those patients received placebo angioplasty, while 20 were given the balloon angioplasty.
Of those 20 who received the treatment, 18 showed improvements in symptoms and fewer lesions on MRI scans for one year.
However, the data, when combined with all the other patients studied, showed no overall benefit.
“I believe that research in medicine, even if it leads to negative results, allows us to understand the diseases and care more precisely for the people who suffer from it,” Dr. Piscaglia said in an email.
While clearly the therapy doesn’t work on all patients, the study does note there appears to be a group of patients, who had fewer brain lesions, suggesting this group should be “further analyzed.”
That research that could potentially explain cases like Tammy Lynn Tremblay. She was diagnosed with MS in 2006, and began losing strength, balance and vision.
“I would end up in a wheelchair. It was scary — very scary,” she said.
When drugs didn’t stop her decline, the Ottawa scientist researched Zamboni’s theory and went to Poland in 2010 for angioplasty, to open up blocked veins.
“The great thing is that I have never had any other MS episodes since and this was 2010. So, after seven years, if this is a placebo effect, it’s a pretty good one.”
Tremblay still holds out hope for her future.
“There is no cure for MS,” she said. “I would still encourage them to pursue and investigate this possible avenue.”
New legislation will triple production and make medical cannabis free for all patients
By Anna Momigliano, Special To The Washington Post
MILAN – In Italy, as in most of western Europe, medical cannabis is legal. What sets the country apart is that cultivation of the plant is a de facto army monopoly.
The only place cannabis can be legally grown here is at a heavily guarded military facility in Florence where, this year, two greenhouses produced a yield of about 220 pounds.
“We do everything in-house,” said the facility’s director, Col. Antonio Medica. “We grow the plants, harvest them, dry and grind the leaves, sanitize the final product with gamma rays, then ship it to pharmacies and hospitals.”
Now the army’s involvement in the therapeutic marijuana business is set to expand. Under a new budget law moving through Parliament, the cannabis program at the Military Chemical Pharmaceutical Plant is to receive an additional $2 billion in public funding. If the bill is approved as anticipated, military officials say, they expect production to triple within a year.
The bill will also make medical cannabis free for all patients, with the cost covered by the government. Until now, local governments have covered the cost in just 11 of Italy’s 21 provinces.
Not everyone is happy with the army’s role, however. Some say they believe that even with the new funding, the quantity and the quality of Italian-grown cannabis will fall short.
To understand how the army ended up growing pot, one has to understand the country’s health policy – and the way its implementation has, at times, been delegated to the military.
Italy legalized cannabis for medical use in 2007, with many caveats. To grow the plant legally requires special authorization from the Health Ministry’s narcotics office, which means dealing with the country’s infamous bureaucracy. As a result, no private entrepreneur managed to set up a business, and the drug had to be imported from abroad, making it prohibitively expensive.
Since access to medical care here is considered a constitutional right, in 2014 the government assigned the task of growing medical-grade cannabis to the military. The army was already responsible for the production of “orphan drugs,” medications that cure rare diseases and are not produced in the market economy.
“Producing medicines is a standard part of what the Defense Industries Agency does, because health is a matter of national security,” Medica said.
Problems with the decision soon became apparent, according to critics.
One difficulty is that the army makes only one strain of cannabis, called FM2, which is low in THC, one of marijuana’s main active substances, when compared to imported strains.
Andrea Trisciuglio, a 39-year-old multiple sclerosis patient from Foggia in southern Italy, said he has been using medical marijuana for the past 10 years to mitigate his symptoms but has found the local supply ineffective.
“The FM2 just doesn’t work for patients like me,” he said. “I have to use Bedrocan” – a variety of cannabis with about 22 percent THC, compared to FM2’s 8 percent. Trisciuglio said that his local hospital imports Bedrocan from the Netherlands but that he sometimes he has to wait as long as a month for it.
The trouble with importing cannabis from the Netherlands is that it “is expensive, which also makes it slow,” said Carlo Valente, a lawyer in the southern city of Lecce who is representing Trisciuglio and other patients. Dutch medicines, he said, reach Italy through intermediary agencies, which raises their price.
“This is making doctors, who already struggle with the social taboo associated with cannabis, even more reluctant to prescribe it and hospital pharmacies less cooperative,” he said.
According to an investigation by the magazine Internazionale, imported cannabis can cost up to $84 a gram. By contrast, the army-produced cannabis costs $7 a gram, Medica said. “We are a nonprofit.”
But to critics of the system, affordability does not cancel out the homegrown product’s other shortcomings. In addition to quality issues, they say, the army lacks the capability to produce all the therapeutic cannabis that Italy needs.
National consumption of the drug is between 880 and 1,000 pounds a year, according to military estimates. This means that even if the military succeeds in tripling its annual production to the anticipated 660 pounds, it will not meet the country’s need, and imports from the Netherlands will still be necessary.
To Trisciuglio, the army monopoly is not in patients’ best interest. “The army alone is just not enough,” he said. “We need to make it easier for others to grow medical cannabis.”
In 2012, Trisciuglio and other patients petitioned the local government for authorization to grow their own marijuana, under supervision, but never received a green light.
Medica, however, is confident that the army can meet – and keep up with – the demand, perhaps even to the point of sending its own cannabis abroad.
“We are working around the clock to increase the production and are experimenting with a new variant, for patients who are not satisfied with FM2,” he said. “In the near future, we hope to export to San Marino and the Vatican.”
Medical marijuana may help reduce opioid addiction in patients suffering from chronic pain, according to a new study published in the open access journal PLOS ONE.
Lead by Drs. Jacob Miguel Vigil and Sarah See Stith, researchers observed 37 patients suffering chronic pain who both habitually used opioids and chose to enroll in New Mexico’s medical marijuana program between the years 2010 and 2015.
For that same period of time, researchers also observed 29 similar patients that chose not to enroll in the state’s medical marijuana program and compared the two groups using the state’s Prescription Monitoring Program opioid records for a 21-month observation period.
At the end of the observation period, researchers found that patients using medical marijuana were 17 times more likely to cease their opioid prescriptions, five times more likely to reduce their daily opioid dosage and on average saw a 47% reduction in their daily opioid dosage, compared to a 10% increase in the group that chose not to use medical marijuana.
“Current levels and dangers of opioid use in the U.S. warrant the investigation of harm-reducing treatment alternatives,” Vigil said in a statement.
“Our results highlight the necessity of more extensive research into the possible uses of cannabis as a substitute for opioid painkillers, especially in the form of placebo-based, randomized controlled trials and larger sample observational studies.”
Secondo un nuovo studio pubblicato dalla rivista BioMed Research International , il tetraidrocannabinolo (THC) potrebbe essere “un potenziale nuovo bersaglio per il trattamento delle malattie cardiovascolari indotte dal diabete”.
“Lo scopo di questo studio era di determinare se la somministrazione cronica di basse dosi di un agonista del recettore cannabinoide non specifico potesse fornire effetti cardioprotettivi in un modello di diabete mellito di tipo I”, afferma l’abstract dello studio.
“Il diabete è stato indotto in ratti Wistar-Kyoto maschi di otto settimane.
A seguito dell’induzione del diabete, il 9- tetraidrocannabinolo è stato somministrato mediante iniezione intraperitoneale (0,15 mg kg -1 giorno -1 ) per un periodo di otto settimane fino a che gli animali hanno raggiunto sedici settimane di età. ”
Al termine del trattamento, sono state effettuate “valutazioni della reattività vascolare e della funzione ventricolare sinistra ed elettrofisiologia, come pure marcatori sierici di stress ossidativo e perossidazione lipidica”. Secondo i ricercatori, “la somministrazione di Δ 9 -Tetraidrocannabinolo a animali diabetici ha ridotto significativamente la glicemia e le concentrazioni e le alterazioni patologiche attenuate nei marcatori sierici dello stress ossidativo e della perossidazione lipidica.
Cambiamenti positivi agli indici biochimici negli animali diabetici hanno migliorato la funzione miocardica e vascolare.
Questo studio dimostra che “la somministrazione cronica di basse dosi di Δ 9-tetraidrocannabinolo può provocare effetti anti-iperglicemici e antiossidanti negli animali diabetici, portando a miglioramenti nella funzione degli organi terminali del sistema cardiovascolare. ”
L’abstract si conclude affermando che “Le implicazioni di questo studio suggeriscono che i recettori dei cannabinoidi potrebbero essere un potenziale nuovo bersaglio per il trattamento delle malattie cardiovascolari indotte dal diabete”.
Lo studio completo, condotto dai ricercatori della Central Queensland University in Australia, può essere trovato sul sito Web del National Institute of Health degli Stati Uniti cliccando qui .
A diet rich in vegetables and low in protein reduced inflammation in multiple sclerosis (MS) patients by modulating the gut microbiome and promoting bacteria that helps control a hyper-reactive immune system.
The study reporting the findings, “Immunological and Clinical Effect of Diet Modulation of the Gut Microbiome in Multiple Sclerosis Patients: A Pilot Study,” was published in the journal Frontiers in Immunology.
An increasing amount of data supports the idea that changes to the natural flora of microorganisms within the gut, known as the gut microbiome, plays a role in MS.
As antibiotics are known to alter the microbiome composition, so does diet, and both can change the interaction between the microbiome and the immune system. For example, one study with the established mouse model for MS – the so-called experimental autoimmune encephalomyelitis (EAE) mice – showed that a low-calorie diet had a beneficial effect in EAE, while a salt-rich diet increased disease severity by increasing the activity of immune cells called Th17 cells.
Now, a team of researchers tested the hypothesis that MS disease activity can be affected by dietary patterns.
The team conducted a small pilot study with relapsing-remitting multiple sclerosis (RRMS) patients attending the Multiple Sclerosis Rehabilitation Unit of the Don Carlo Gnocchi Foundation in Milan, Italy.
Researches analyzed the participants’ gut microbiome together with additional clinical parameters, including their immune system, at the time of recruitment. They then compared the results after patients had followed two different diets – a Western diet (WD) and a high vegetable/low-protein diet (HV/LP) – for at least one year.
The WD was characterized by the “regular consumption of red meat, processed meat, refined grains, sweetened food, salt, and an overall high intake of saturated and omega-6 fatty acids,” the researchers wrote.
In total, 20 patients participated in the study and they were equally divided: 10 in the Western diet group and 10 in the HV/LP group.
The microbiome of patients changed in a diet-specific manner: Those fed with a HV/LP diet saw their microbiome enriched in Lachnospiraceae bacteria and showed a decrease in their pro-inflammatory profile.
Lachnospiraceae bacteria produce a compound called butyrate, which has been suggested to promote immunotolerance while reducing inflammation.
Also, “in the HV/LP diet group alone, the relapse rate during the 12 months follow-up period and the Expanded Disability Status Scale score at the end of the study period were significantly reduced,” the team wrote.
In contrast, patients fed a Western diet were seen to have an increase in bacteria belonging to the phylum Euryarchaeota, previously shown to be associated with shorter time to disease relapse in pediatric MS patients.
Overall, these results “support the possibility that diet could possibly be used as a tool to modulate the immune system in an anti-inflammatory way as a consequence of changes in the gut microbiota,” the team concluded.
“It will be important to replicate these results in ampler cohorts of MS patients and to expand these observations in inflammatory diseases other than MS,” researchers added.
In late 2008, Barry Lauder started to see double in one eye. By 2009, with a collection of doctor’s appointments, tests, and unanswered questions lining his patient file, the Maryland native was diagnosed with nystagmus—a condition marked by uncontrollable shaking of the eyes. That same year, he was hit with a multiple sclerosis (MS) diagnosis.
Then, he learned he had a second eye condition known as optic neuritis, which caused him to lose the ability to see color in his right eye. As Lauder’s health deteriorated on every front, shades of red bled into grays and whites, and vibrant landscapes faded to muted scenes.
Despite this rapid erasure of a life in rainbow, Lauder was hesitant to start a medication regime to correct the neuritis and his other maladies. “I didn’t take traditional medicine at first,” he recalled. “I was freaked out by it—the pills, the warnings, the injections. Side-effects lists were unending—it was daunting.”
Lauder began to consider holistic methods of pain management, which included medical cannabis. Those treatments ultimately led him on a journey from Maryland to Colorado and back again, giving him a unique perspective on the dramatic differences in state MMJ programs. Moving from one of America’s most cannabis-restrictive states (Maryland) to its most open (Colorado) led him to view cannabis as a needed and essential factor in his daily life.
Cannabis as a Medicinal Option
It’s not uncommon for MS patients to ingest a variety of pills every day—including multiple opioids—to manage their symptoms. The National MS Society provides a list of symptoms commonly associated with MS, and the medications commonly used to address them. The list is enormous, and patients who express multiple symptoms may be prescribed one pill or more per symptom category. The story of Jabe Couch, an MS patient who weaned himself off 15 MS-related medications (and whose story can be found here) with the help of cannabis, is not atypical of the many who’ve discovered healing and comfort outside of the standard pharmaceutical options.
Cannabis and Multiple Sclerosis (MS) Treatment
But Lauder was a Baltimore resident at the time of his diagnosis, and in 2009 Maryland law did not allow medical patients to buy or use cannabis. To obtain it, Lauder was forced to phone up connected friends and ask them to access the illicit market. The cannabis—of unknown origin and potency—provided sporadic relief, but gradually his symptoms began to overlap and worsen. He grew depressed and desperate. “With my optic neuritis,” he recalls, “I wouldn’t say I got close to ending it, but I knew I wasn’t very happy and I made a point not to get near or collect guns. It was getting that bad.”
Lauder’s uneasiness about aggressive medicinal intervention ran into the hard reality of his condition: His eyes were deteriorating and causing him excruciating pain. “It felt like someone was in my head with a steel-toed boot trying to kick my eye out,” he says. “It’s hard to cope when you don’t have the relief and medicine you’re used to. It was unbearable.” He began a routine of Copaxone, an immunotherapy drug which required a self-administered shot, to address his intense and growing symptoms. It became a daily ritual for almost four and a half years.
During that time, cannabis became a supplementary tool that allowed him to bring down the aggravating discomfort. “When I was in Baltimore, I got in the habit of taking my syringe out and I would put a record on”—his record player hummed with personal favorites from Sigur Rós to Okkervil River—“and I’d pack a bowl, take my injection, then light up to soothe the burn from the shot … [cannabis] was something that helped me on all levels. It helped the pain, the processing of the fact that I had to do it. I never knew if [Copaxone] worked—I never felt better—but I knew cannabis helped.”
Easing Symptoms in Colorado
Cannabis’s potential to soften symptoms associated with epilepsy, PTSD, cancer, MS, and myriad other medical conditions is no secret. And with 2.3 million people affected by MS worldwide (an estimated 400,000 of them living in the US), some patients from states where cannabis is still illegal are willing to uproot their lives for the opportunity to alleviate their symptoms.
Though there’s no hard data on the number of medical cannabis refugees that have come to Colorado since legalization was implemented, countless stories have surfaced in mainstream outlets and on social media, particularly highlighting parents who have moved their whole families to Colorado solely to ensure medical cannabis access for their children. CNN followed Kim and Rich Muszynski, who moved from Florida to treat their daughter’s seizures with cannabis oil—a decision that followed their research on Charlotte Figi, the famous namesake of the high-CBD strain Charlotte’s Web. In 2016, Today estimated that 200 families had moved to Colorado as medical refugees, many with stories similar to the Muszynskis’. However, that number could easily reach to the thousands, as Colorado doesn’t keep track of which products are bought for MMJ patients and which are for adult-use consumers.
By 2013, Barry Lauder had come to realize how critical the effects of cannabis were to his overall well-being, but Maryland’s laws still made his medicine hard to come by. So after much thought and planning, he joined the ever-growing number of medical cannabis refugees and set out for Colorado. Living first in Pueblo County, he eventually found an apartment in Denver’s Holly Ridge neighborhood, and discovered a dispensary, Sacred Seed, whose budtenders worked to set him up with appropriate strains and consumption methods.
He was amazed by the ease with which patients could obtain medical cannabis in Colorado—and also the acceptance that existed around the general subject of consuming. “A lot of the reason why I moved was for the cannabis, and not just the cannabis but the mindset and the lifestyle that came with it,” Lauder says. “I didn’t feel like I was hiding something dirty or looking over my shoulder. It’s hard to describe how nice that was, just a huge relief.”
Cannabis and Overall Mental Health
When Lauder finally approached the last day of his Copaxone injections—having completed that round of pharmaceuticals by doctor’s orders—his vision had not improved and the nystagmus had begun to affect both of his eyes. “My eyes just—I don’t know, they just stopped,” he recalls. “Both started to move rapidly, so I’ve dealt with almost three years of my eyes in constant motion.”
Lauder has not made eye contact with another person in roughly two years, usually faking it to make others feel more comfortable and to project an impression of normalcy. Because his eyes are in constant motion, Lauder often feels extreme nausea and disorientation, which he placates with heavy indicas. When he feels a touch of melancholy cloud his mind, he reaches for well-rounded sativas to help him take his first steps out the door.
‘I didn’t feel like I was hiding something dirty or looking over my shoulder.’
Barry Lauder, on cannabis in Colorado
In Colorado, even as his vision deteriorated and MS continued to plague him, Lauder was able to maintain his independence and passion for helping others. He signed up for classes at the University of Denver, and in 2015 he obtained a degree in social work—a feat that would have been impossible, he says, without medical cannabis. “In Colorado, the patches and the edibles were really helpful to me,” he notes. “I could focus in class; I wouldn’t be [distracted by] the deep pain affecting my legs.”
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 1st 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.
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.
Its government has estimated sales abroad would rake in $1.1 billion a year for the Middle Eastern country.
Bio-tech companies based there are preparing to expand production of the drug to meet rising global consumer demand.
One is Breath of Life Pharma (BOL), which is about to open the world’s largest medical marijuana grow-house and research centre in central Israel.
The one-million-square-foot facility will allow the firm to store enough medical cannabis to supply the entire US, according to its chief executive Dr Tamir Gedo.
He estimates that BOL will produce 80 tons – more than 175,000 pounds – per year, according to a news statement on its website.
It comes after Israel’s government gave the go-ahead in February to legislation permitting export of the drug.
Agriculture Minister Uri Ariel has previously said that by next year the country will join the Netherlands and Canada as global cannabis suppliers.
BOL is not alone in its ambitions – it is one of eight licensed firms seeking to position Israel as a global hub for medical cannabis research.
Israel was among the first countries to legalise medical marijuana, although it remains illegal for recreational use.
It is one of just three, along with Canada and the Netherlands, to have a government-sponsored cannabis program. Israel is already a global leader in research and development into the drug for medical use.
The Ministry of Health has approved 150 research proposals, 35 of them clinical trials. More than 50 US companies are doing medical marijuana research in the country.
Trials are currently underway at Jerusalem’s Shaare Zedek Medical Center to test the effects of cannabinoids on 120 autistic children and young adults, the first of its kind worldwide.
Earlier this month, it was announced Hebrew University will investigate the benefits of non-psychoactive cannabis components for treating asthma and other respiratory conditions.
There are about 140 cannabinoids in the cannabis plant, with THC (the psychoactive component) and CBD, which has anti-inflammatory properties, of most interest to researchers.
CBD is the focus of much of Israel’s flourishing medical cannabis research on diabetes, heart disease, autism, fracture healing and inflammatory bowel disease.
The Israelis have also been investigating the drug’s ability to treat epilepsy, post-traumatic stress, cancer tumours, the side effects of chemotherapy, multiple sclerosis, Parkinson’s and Tourette’s syndrome, among others.
‘The Ministry of Health in Israel has channelled a lot of energy here in order to examine all the evidence based medicine, and is willing to take that approach,’ Dr Gedo told The Times of India.
‘Other ministries of health around the world are hesitant.’
BOL’s new centre has a 35,000-square-foot plant, an 8,000-square-foot storage room, 30,000 square feet of grow rooms and labs, and a million square feet of cultivation fields.
With its moat, wall, barbed wire, armed guards and security cameras, the facility could be mistaken for a military base if it weren’t for the pungent odour of marijuana in the air.
Like newborns in an incubator, hundreds of unique strains of plants will be monitored around the clock in computer-controlled, camera-patrolled, password-secured greenhouses.
Here the firm is able to break down the cannabis plant to extract different chemical compounds, called cannabinoids, for use in research and medicine.
There are about 140 of these, the most well-known ingredients are cannabidiol (CBD) and tetrahydrocannabinol (THC).
There are few facilities that can carry out the extraction process worldwide, Dr Gedo said, and most can only do it on a small scale.
Medical marijuana, while still controversial, has garnered increasing support in the medical community. But biotechs will be held back from fully capitalising on the global demand, given that the drug is still illegal in most countries.
There are currently just 29 that recognise some form of medical cannabis.
In the US, the use, possession, sale, cultivation, and transportation of marijuana is illegal under federal law. However 29 states, have legalised some form of medical use and allow doctors to prescribe the drug to patients.
BOL plans to apply for ‘investigative new drug’ status from the Food and Drug Administration (FDA) next year. Such approval would open up a huge market.
However, earlier this month, the FDA cracked down on marijuana products marketed as cancer cure.
The agency has sent a letter to four companies, slamming their claims that patients can treat life-threatening tumours – and even prevent Alzheimer’s – by using cannabis oils and creams.
In the UK, cannabis is still illegal in the UK, but its drug’s watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), last year ruled CBD should be classed as medicine.
It had looked at the ingredient because a number of manufacturing companies had been making ‘overt medicinal claims’ about products.
Now products used for medical purposes that contain CBD must be licensed before they can legally be supplied in the UK.
Meanwhile, medical marijuana producers and pharma companies are attempting to stay ahead of the game and make their mark overseas by scrambling to form collaborations and lobbying governments.
However, drug firms hoping to break into markets say cautious authorities in the US and Britain are too slow to act.
Israel-based pharma company iCAN held CannaTechUK, the UK’s first ever cannabis medical conference, in London last month, in a bid spark further interest and debate around the issue.
Founder Saul Kaye told Mail Online: ‘Much of the US and especially the UK are woefully behind the curve in helping patients who could greatly benefit from using cannabis based products for numerous ailments such seizure disorders, MS, PTSD, chronic pain, Parkinson’s, crohn’s disease, and to mitigate the effects of nausea from chemotherapy.
‘Israel is a place where the science of cannabis is forward looking not looked down upon.
‘Israel’s Ministry of Health has approved well over 100 research proposals and has tens of clinical trials now happening.
‘More than 50 US companies are doing medical cannabis research in Israel because they simply can’t do them in the US but they do not want to miss out in the incredible financial opportunities that await in this burgeoning industry.’