Cannabis is authorized for medical use in France

On October 25, 2019, the members of France’s Assemblée Nationale (its legislative branch of government), during their consideration of the 2020 national budget authorized, with only a public vote of “hands up”, the medical use of Cannabis for an initial trial period of two years. The amendment was based on a report prepared by the researcher Olivier Learn, from the LREM, and then submitted for approval to the Agence du Medicament (ANSM), the French regulatory agency for drugs.

The therapeutic forms of Cannabis were only approved for those patients that are in what they dubbed as an “impasse thérapeutique” with clinical variants of Epilepsy that are resistant to traditional treatments, neuropathic pain after amputations, secondary effects of the chemotherapy and the involuntary muscular contractions of Multiple Sclerosis. The Cannabis will be provided in liquid or inhalator presentations by physicians that will be especially trained with stringent regulatory protocols by the government. Even thought its recreational use is still prohibited, this is a previous step in that direction.

During the past few years the elected officials of the European countries have been pressured by their peers in Holland, which is the only EU nation that has decriminalized the personal use of Cannabis. The small progressive country has been swarmed by busloads of eager buyers of pot for multiple reasons, including medical and recreational ones. The Dutch authorities claim that they can control what goes on in front of the counters but not in the back of them as the industry has been taken over by criminal gangs. If the other members of the European Community start to legalize and control the use of Cannabis, then the Dutch authorities could count on pan-European enforcement.

Even though it has not been legally approved yet in Macedonia—a small European country tucked between Serbia and Greece—its northern territory—with plenty of sunshine and little rain—has thousands of square kilometers with marijuana plants. A report of France Internationale (RFI) on the issue stated that many investors are already courting the Macedonian authorities to distribute their stocked tons of harvested pot. This schizophrenic negation of the reality by authorities of the European Community (EU) is reminiscent of what happens in the USA. A confused/confusing message.

Only the strict federal regulation and control of Cannabis will pave the way for the needed scientific research and protection of consumers in both the USA and the EU.

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Cannabinoid research is stalled by red tape  

How can you soar like a majestic eagle in azure skies if your take-off is blocked by turkeys? That is precisely the gut feeling many medical and pharmaceutical investigators have at present when they have to confront the varied bureaucratic hurdles set by a tone-deaf US administration. Believe it or not, the critical clinical research on the potential value of Cannabinoids in severe chronic illnesses like Epilepsy, Parkinson’s Disease, Post-Traumatic Stress disorder, etc., is being haunted by the sorely outdated Marijuana Tax Act of 1937, which had  banned its use and sales.

At present it is legal to prescribe—with varying limitations—marijuana and the active components for medical use in all the American states except four of them; however, it remains in the Class I of the Drug Enforcement Administration (DEA) registrar of controlled substances, which makes it illegal to possess, cultivate, distribute it, according to the Federal statutes, Only in the handful of states that have approved its recreational use (including our state of Florida) have these rules being somewhat put in a “legal limbo” in order to allow the personal consumption of the drug.

In the February 2019 Senate hearing on the Opioid Crisis, many prestigious medical researchers decried that the fuzzy, confusing legal status of the drug has impeded the full deployment of academic resources to fully design and carry out comprehensive clinical trials for its usage. That has left many patients in dire need of relief with unanswered questions about the reliability and usefulness of many commercial preparations that might not have met stringent quality standards. Only the drug Epidiolex, a CBD derivative, was approved by the FDA in June 2018 for the treatment of Lennox-Gastaut and Drayet syndromes , two severe forms of Epilepsy affecting the very young,

Investigators emphasized the lack of a proper supply of consistent research-grade marijuana to conduct the necessary clinical trials as there is only one US facility, the University of Mississippi, approved to cultivate it; some researchers have openly criticized the quality of its samples, with several of them being contaminated by mold. According to the US Attorney’s office, twenty applications have been filled to cultivate marijuana but none of them have been approved so far. In spite of the talk pour la gallerie of politicians of all stripes in Washington, D.C. the reality sur-le-champ is that the Federal government might be effectively impeding the set-up of experimentation.

The World Health Organization (WHO) has declared in February 2019 that marijuana should not be considered as a controlled substance in international treaties, paving the way for governments to take a fresher look at their legislation. Sadly, the USA has a long history of ignoring the call of international organizations and stubbornly insisting on a pernicious attitude of “father knows best.” There are two countries that have approved the use of marijuana for medicinal and recreational purposes—Uruguay and Canada—and it seems that a few others will follow the lead very soon. When will our do-nothing representatives in Washington D.C. finally wake up to the need of implementing the proper clinical research trials on Cannabinoids and is derivatives for medical use ?

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Cannabis in Epilepsy – Part II

Recently there have been several large, well-controlled studies of the use of Cannabidiol in children and adolescents but it was used as an adjunctive therapy, not in a standalone way. What would happen if patients were only taking a cannabinoid as some activists for the legalization of Cannabis are vociferously demanding in many American state capitals?

Emily Stockings et al., researchers at the National and Alcohol Research Centre at the University of South Wales in Sydney, reviewed the data of several clinical trials of Cannabidiol, focusing on 36 studies that studied the use of the drug in drug-resistant Epilepsy. Two double blind studies on the use of CBD—one with 120 patients with the Drayet syndrome and the other with 171 patients with Lenox-Gastaut syndrome—showed that CBD was 75% more likely than the placebo to reduce the number of seizures by more than half. In the largest pool of almost a thousand patients that were observed, almost half of them got some significant reduction of their seizure frequency.

The researchers admitted that the quality of the data was mixed as there is no reliable evidence of which preparation of Cannabis—either Cannabis sativa or CBD-THC extracts or oral cannabis extracts—is more suitable. Three randomized clinical trials studied the possibility of seizure-free by just taking CBD compared to placebo; even though they found an encouraging six-fold increase in the number of patients that ended up seizure-free, their data is not completely reliable. Half of the patients treated with CBD reported that the quality of their daily activities had improved. The overall data suggested that almost half of the patients reported some significant improvement.

The greatest gains were observed in patients with Drayet syndrome or Severe Myoclonic Epilepsy of Childhood (SMEC), a tragic condition that begins in the first year of life and produces constant seizures; we can understand the relief experienced by those parents when they noticed a change. However, all the studies with Drayet syndrome were case series with a 100% response, which should be interpreted with extreme caution. The Sydney researchers also studied the number of participants that dropped off the study, which could be an indicator of their tolerance to the drug; they found no real difference between the participants receiving CBD and those with placebo.

There was a significant increase in the rate of adverse events in patients receiving CBD compared to placebo, including the dangerous status epilepticus and elevated aminotransferase levels. The most common adverse effects were drowsiness, diarrhea, fatigue and lack of appetite. This fact should make clinicians ponder whether the addition of CBD is warranted in the med schedule. The use of Cannabis should not be taken lightly or “to see what happens. What’s there to lose anyway?”

Many policy pundits and media charlatans are jumping in the bandwagon of the medical benefits of Cannabis in the American states that have long approved it like Colorado and those like Florida that are just beginning to regulate its use. We should fund serious studies in prestigious centers; moreover, the parents of children with grave, chronic neurological diseases should have priority access to them. There is a fine blue line between the medical benefits of Cannabis and its purely recreational use. But sick children should not be taken as hostages by the perpetrators of this media driven-frenzy.

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Farmacia Homeopatica Italiana

When the dirt-poor, half-literate and dazed Italian immigrants arrived at the ports of entry of Montevideo and Buenos Aires in the beginning of the Twentieth Century they found two very prosperous (due to their commodities’ export bonanza) yet sparsely populated countries that needed their arms to work in the fields, storage silos, meatpacking plants, leather factories and even in their offices and homes. But the native population was not really interested in their social welfare and health. So these savvy survivors decided to band together in “mutual associations” that provided some basic social services, primary health care facilities, temporary lodging for new arrivals, labour placement, legal advice and even funeral services for the long-term residents.

My dear grandfather Morizio arrived as a child with his whole family from Piemonte and prospered as a winemaker in Uruguay; but he never made it back to his “piccolo paese” in Ricaldone. Neither did the parents from my dear grandmother Yolanda who aldo arrived with their whole families from Salerno in Campania. Their humungous sacrifice enabled their descendants to live, work and study in the host countries.

The peasants from the Mezzogiorno (despectively nicknamed “terrones” by the more wealthy Italians up North) had “fame di terra” and ventured en masse to the hinterlands where they toiled in the fertile plains, the grain storage facilities, the meatpacking and fish processing plants, the cargo facilities in the ports of Rosario and Bahia Blanca. The city of Mar del Plata is located in the Atlantic coastline in the state of Buenos Aires, close to the agricultural centers and with a good harbor to host a fishing fleet. They worked tirelessly for long hours and started large families in that blessed city. But initially they did not have spare money to seek medical care for their families, let alone medication.

The “Farmacia Homeopatica Italiana” was founded in 1914 by concerned professionals that had studied the herbal medicine and natural products that the nascent Homeopathy was promoting at the time. Even with the present worldwide controversies swirling around that healing school, the natural products of this pharmacy have continued to sell very well as their customers value them. When you enter their cozy, downtown location , you are immediately transported into another more genteel age as you gawk at the shelves filled with glass flasks containing natural products and potions. We have been a loyal customer for many years and at present we are using three of their products.

In the mornings we take a solution of “Magnesium Chloride” mixed with some orange juice, before leaving for work we rub either the cream or liquid form of “Arnica” on the knees, and if we happen to eat too much meat or a hearty meal, we take a lemon tea with a few drops of the “Liver Drainer.” This is not a commercial or professional endorsement of their products but the honest testimony of a satisfied customer that values their work.

In our next blogging season we will discuss some of these marvelous natural products plus some others from the milennary Chinese and Ayurvedic Medicine as well; we will take advantage of the upcoming summer break to study in earnest before writing. If you happen to be in Mar del Plata, please do not forget to visit this place and chat with the informed pharmacists who are always ready to discuss the indications for their products.

Farmacia Homeopatica Italiana

20 de Setiembre 1678, Mar del Plata

Tel.: (0223) 473-0178, 473-4845, 473-8354

farmaciahitaliana@yahoo.com.ar

 

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Pain and Mindfulness in Multiple Sclerosis

Chronic pain is one of the most crippling, and oftentimes intractable to treatment, symptoms of patients with Multiple Sclerosis, many of them young people in the prime of their lifetimes. Given that most pharmacological schedules eventually bring collateral effects that intoxicate or limit the wakefulness of patients with good jobs, paths in Alternative Medicine have been explored.

Almost two thirds of MS patients experience some kind of severe pain in their daily demeanor. Patients experience different types of pain, which can be grouped in the following categories:

  1. Central neuropathic pain: dysesthetic extremity pain, tonic muscle spasm, trigeminal neuralgia.
  2. Musculoskeletal pain: cervical or lumbar radiculopathies.
  3. Mixed Neuropathies and nonneuropathic forms of pain: headaches.

Jon Kabat-Zinn initiated the practice of “mindfulness” in 1982 as a behavioral cure for pain. He wrote that it constitutes as “paying attention in a particular way; on purpose, in the present moment, and non-judgmentally.” It is as if the patient could detach himself/herself from the suffering condition and observe it in “an objective way” without expressing any judgements. It strives to let go of natural defensive mechanisms and to start the process of acceptance of pain. Various meditation practices like focused attention or open monitoring are being used, which activate some unique neural networks that modify the pain experience integrated in the CNS.

Angela Senders et al. designed a cross-sectional survey of MS patients followed in the outpatient clinic of the Oregon Health and Science University that completed several questionnaires during one study visit; patients that had a relapse or exacerbation in the previous 90 days were excluded. As a measurement device they use “pain interference”, which is “how much pain” limits the patient’s ability to perform the occupational and social tasks; they used the “Patient-reported Outcomes Measurement Information System (PROMIS) as the dependent variable in the study.

One hundred and fifty patients participated in the study, the majority were women (78%) and the mean age was 50.45 +/- 12.85 years; the majority of patients had the relapsing-remitting variant of the disease (74%) and two-thirds of them were taking MS DMT like interferon beta-1b. in the study model for every 18-point increase in the mindfulness score, the Pain-interference score was expected to decrease by 2.88 points. Six demographic features (age, sex, level of disability, type of MS, DMT and education) were studied for their interaction with mindfulness.

The study showed that the relationship between pain and mindfulness was very significant (t=-5.52, P less than .0001) For every 18-point increase in the mindfulness score, the pain interference score decreased by 3.96 points (Beta=-0.227, P less than .0001) In sum, there is a significant correlation between the practice of mindfulness and the amelioration of MS pain.

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Cannabis in Lennox-Gastaut Syndrome

One of the most painfully frustrating events in our practice of Neurology since the times of residency training has been the encounter with a refractory Epilepsy syndrome in a young patient. Not only we witness the suffering of the disgraced patients, who are losing intellectual capacity and the promise of a fruitful future, but also the terrible frustration of their parents and loved ones. Lenox-Gastaut syndrome is exactly that: an epilepsy variant that attacks young patients with “drop seizures” that are resilient to effective, long-term and non-toxic pharmacologic treatment.

A multi-center study that enrolled 171 patients form 24 clinical centers form the United States, the Netherlands and Poland studied the effects of the administration of Epidiolex, a CBD purified drug that does not contain any of the psychoactive components of Cannabis. Patients from the age of 2 and 55 years old who had failed to show improvement with at least two anti-epileptic drugs were eligible to participate; their mean age was 15 years old with six drug failures. They all had to have slow (less than 3 hertz) spike and wave patterns in their electroencephalogram, more than one type of seizure for at least six months and at least two drop seizures per week.

The participants were randomized to receive 20 mg/kg purified CBD oil daily (divided twice daily) or a matched placebo for 14 weeks. Their families actively participated as they helped them record the number of drop seizures and related events during the study. They were evaluated four times in their respective medical clinics and twice with a special telephone interview. The investigators studied the percentage change of drop seizures during the treatment period of 86 patients that received the drug and the 85 patients who were part of the placebo group. We must point out that all patients continued to receive their properly prescribed anti-epileptic treatment.

The median percent reduction in monthly drop seizures from baseline to the end of the study was 43.9% in the group receiving Epidiolex compared to 21.8% in the placebo group. Some patients receiving the drug even had a 50% reduction in seizures and three patients were even seizure-free during the whole study; nobody in the placebo group had a seizure-free period. There were some adverse events in both groups, including diarrhea, fatigue, fever and vomiting. Amongst the noted drug interactions, the patients taking Clobazam had an increase in its active metabolite, which led to higher sedation. Thirty-six treated patients that were also taking Valproic Acid had an increase in liver enzymes, which resolved after the CBD was stopped.

After the study was stopped in October 2015, an open-label extension study was started.

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Clinical challenges in Transitioning

There is a dearth of clinical knowledge and expertise in the slowly yet surely evolving field of Transgender Medicine as only lately most practicing physicians have honestly  acknowledged that they know little or next to nothing about Transitioning for these patients. But many enthusiastic and honest professionals are starting to study the clinical challenges posed by these patients and trying some specific, practical steps.

Considering that Transgender people are usually receiving treatment with exogenous hormones that alter their metabolism, the established treatment protocols might not be entirely appropriate and they must be adjusted. Moreover since the hormonal schedules are often changed in composition and dosage, the treatment of chronic ailments must be adjusted accordingly.

The use of Testosterone in the female to male transitioning schedule could worsen a previously existing endometrial neoplasia. The use of estrogens in the male to female transitioning schedule can stimulate the appearance of blood clots. The use of hormones can affect chronic neurological diseases like Epilepsy. Some studies have suggested that there is negative interaction of Estrogen with antiepileptic drugs but its extent has not been established. The control of seizures becomes more difficult as new hormones are added.Transgender people have a higher rate of HIV infections and use retro-viral medication, which can interact with the hormones in still unforeseen ways.

Sadly one of the commonest reactions of clinicians who encounter treatment difficulties in their Transgender patients is that they must immediately stop the use of hormones until further notice. The subconscious in their minds still resists the idea that Transgender people are different and they need their hormonal treatments to become fully identified with their gender of choice. The only way to surpass this obstacle is to maintain good communications between the clinicians and the experts managing the hormonal treatments. Trans patients occasionally complain that some drugs are promoting a faster metabolic degradation of the hormones in their livers, for which they cannot benefit from their full metabolic effects in their Transitioning protocols. Instead of just dismissing those complaints, physicians should find solutions.

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