First baby in the world to join cannabis therapy trial (UK)

A baby was delivered by emergency caesarean section at a Norwich hospital in March. The same baby became the first baby to join a cannabis treatment trial. The trial aiming at finding out if cannabis medicine are efficient in helping babies at risk of seizures and brain injury.

Oscar Parodi, was born, on 11 March in Norfolk, and encountered difficulties. “The baby was diagnosed with neonatal hypoxic-ischemic encephalopathy (HIE), a condition caused by a lack of oxygen or blood flow from the placenta to the developing baby.” He was then transferred to the neonatal intensive care unit, where he received cooling therapy for 72 hours.

What is HIE and the cooling treatment?

Cooling therapy is the only treatment for HIE in conventional medicine. Researchers believe that medicinal cannabis can be beneficial as protection. It might be useful for babies that are suffering from bran injury or seizures.

Babies that are diagnosed with HIE have higher risks of brain injury. Oscar’s mother was happy to participate in the trial program at the hospital. She accepted because it is a way to perfect cannabis derived medicine and do the most she can for her son. Also to see if it is efficient in dealing with neonatal care in babies with seizures and brain injury.

“Participating patients will be given a dose of either the trial medication, or a placebo, as soon as possible following birth. In addition, the babies also receive routine HIE cooling therapy to bring their body temperature down to 33.5C.”

“This is the first time a cannabis-derived medicine has been tested intravenously in human babies. It is hoped that it will be good for preventing seizures and protecting the brains of newborn babies with HIE.” said Prof Paul Clarke, a consultant neonatologist at NNUH, to The Guardian.

“We have always had good support from families wanting to take part in research on our [unit] and they often do it from an altruistic point of view to help benefit future babies. One of the attractions of this trial for parents is the closer brain monitoring babies get as part of the study, because a more advanced brainwave monitor is used for the trial babies. This gives parents more reassurance that any seizures will be picked up.”

epidiolex
Read our article about The first FDA approved cannabis-derived medicine here: https://cannah.net/articles/the-first-cannabidiol-based-medicine-gets-fda-approval/

The clinical trial is progressing

Along with Oscar, there is another baby that was born in April which is participating in the trial too. The babies that participate are receiving the standard cooling therapy. Along with that, a single dose of the study drug or placebo followed by blood tests. Babies that are taking part in the trial receive only a 30th of the usual dose to minimize the risks. Furthermore, a single dose or a placebo was gave to them as soon as possible withing 12 hours of birth.

The producing process of the drug is under controlled conditions to ensure that the amount of THC, the psychoactive substance, is minimal.

Prof. Paul Clarke concluded saying: “As with any study of a new medicine there may be unexpected side effects and unknown risks. With this in mind the trial has been carefully designed to make it as safe as possible, and so we are only giving the babies a minuscule dose at the beginning, and we monitor them even more closely than usual.”

epidiolex

The first Cannabidiol based medicine gets FDA approval

On April 6 2020 GW Pharmaceuticals and it’s US Subsidiary Greenwich Biosciences Inc. announced that their cannabidiol based medicine EPIDIOLEX, which is a oral solution, is no longer a controlled substance. While there are no other CBD medicines with FDA approval, this announcement places EPIDIOLEX as the first cannabidiol based medicine that gets FDA approval.

The DEA also confirmed the non- controlled status of the medicine, fully establishing that the medicine is no longer a controlled substance under the federal Controlled Substances Act.

Epidiolex is a cannabidiol based medicine that gets FDA approval for the treatment of seizures associated with Lennox-Gausetaus Syndrome or Dravet syndrome in patients two years of age or older. As explained before on this page, CBD is the non-psychoactive cannabinoid from the cannabis sativa plant, and it has several beneficial effects while not producing any high. Epidiolex contains a pure form of the cannabinoid derived from marijuana plants.

What is Epidiolex good for?

medicinal hemp

In the official FDA press release it is mentioned:

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.

Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

In terms of testing the efficiency of the medicine prior to it’s approval: “Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo. The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.”

What changed for the cannabidiol based medicine?

After receiving the first FDA approval, Epidiolex was in Schedule V of the CSA, GW was than got a post-approval supplement with FDA to remove Schedule V designation for the medication.

This approval from the FDA along with the letter from the DEA means that all federal contralled-substance restrictions have need removed. The changes take place immediately and the company starts to implement the changes at state level in the entire distribution network. Once each state is ready, prescriptions for EPIDIOLES wil be valid for one year making it much more accessible. More doctors will now be able to prescribe this medicine without the requirements of state prescription drug monitoring programs.

CBD is now in the spotlight giving a chance for researchers to examine it’s effects. Furthermore, this are good news for the cannabis community and a glance of hope that more research about the properties of cannabinoids will be made and new medicine will appear and have a chance at approval for prescription.


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Legal cannabis resulted in a decrease in opioid prescription

A new study analyzed a database of 1.5 billion people with opioid prescriptions between 2011 and 2018. The publishing date was on Dec. 14 2019 in Journal of Health Economics. The study concluded that, there were reductions of 11.8 percent and 4.2 percent of opioid prescription.

Another study, which examined 2011 to 2016 Medicaid data had similar conclusion. “In this population-based, cross-sectional study using the all-capture Medicaid prescription data for 2011 to 2016, medical marijuana laws and adult-use marijuana laws were associated with lower opioid prescribing rates (5.88% and 6.38% lower, respectively).” In addition, the study from December examines all type of prescriptions not only the Medicaid. The conclusion, that Legal cannabis resulted in opioid prescription decrease, is similar to previous studies.

How can cannabis help with the opioid crisis?

CBD cannabis

Since pain began to be a common affection, doctors are treating it more aggressively. As a result, the number of opioid prescriptions quadrupled in the firstfifteen years of the new millennium. “Opioids are used to treat both chronic and acute pain, though their efficacy in treating chronic, non-cancer pain is limited (Boudreauet al., 2009; Chou et al., 2015, 2009).”. In addition to them not being efficient, they have severe side effects and sometimes destabilize patients even more.

As mentioned on the Harvard page, the most common use of medicinal marijuana is for pain control! Also there are several studies out there showing the benefits of CBD and THC for pain management. Because of those reasons, cannabis becomes one of the solutions for reducing the abuse of opioids.

There is common ground

Due to legalization in several states, more research could be conducted. More and more of the benefits of cannabis are now surfacing in the academical world. Even though research advances, it is difficult to introduce cannabis in nowadays medicine. Doctors also could have a difficult time in prescribing anything else than what the FDA approves. Because of political interest, it is difficut to get a cannabis based medicine to be FDA approved. This seems like ignoring several previous studies for personal gain. This makes it difficult even for the doctorss who advocate cannabis use to actually prescribe it. Doctors prescribe opioids which can have many side effects and can more addictive than medicinal cannabis.

legalize it

The study from the Journal of Health Economics suggests that Recreational and Medicinal access to cannabis are reducing opioid prescriptions. The results also fall in line with previous research on smaller populations. The authors also suggest that Recreational access has a more influential effect on the reduction than Medicinal access. This can be because of the wider access that recreational use gives and also not having to fulfill medicinal requirements. Legal cannabis resulted in opioid prescription decrease due to patients being able to manage their pain with cannabis.

Intersection with other pain medication

The article also mentions that prescribing NSAIDs, such as Advil or Aleve, decreases also by the passing of the recreational and medicinal cannabis laws. Those non-steroidal anti inflamatory drugs are less dangerous than opioids but can still be a difficult to use for people with kidney problems or ulcers. The reason why the laws decrease the consumption of NSAIDs and opioids is because patients get access to use cannabis products to treat pain. Furthermore, the patient are even more inclined towards using cannabis which is a plant, in comparison to the synthetic alternatives.

Conclusion

While cannabis proves more and more efficient in pain management, it is slowly replacing other alternatives that produce unwanted side effects. The risks of using cannabis are there, but they still are much lighter than those of opioids. By conducting more research it will be possible to know how to use this plant and minimize it’s side effects, while maximizing the therapeutic effects. It was too long that this plant was in the shadow, and it is time for humanity to stop hiding it and start using it to it’s entire potential!

As in many other situations, I will say that cannabis is not the fix to everything. BUT, it has many beneficial effects on humans and if we do not explore them we will never be able to understand the power of this plant entirely. Legal cannabis can help decrease opioid prescription and abuse. Here is a quote from the end of the article:

“While the results here do not suggest that cannabis access laws are the only tool to address prescription opioid use, they do suggest that cannabis access laws could play a meaningful role in addressing the opioid epidemic”


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NFL Negotiation to End Cannabis Suspensions

Great news for the National Football League players! The players might soon be able to use the herb for their pain relief and recreationally. There will be less NFL cannabis suspensions and the policy would become less strict. Team owners approve the agreement so it was shown to players on Thursday. The NFL Players association still needs to respond to it.

If the agreement is going to be succesful, the drug policy of the league would face changes for the use of cannabis. The penalties for testing positive for THC, like suspensions, would reduce drastically, according to the CBA Fact Sheet.

Decreased penalties and less NFL cannabis suspensions

The new agreement would increase the limit for THC metabolites in a drug test from 35 ng/L to 150 ng/L. It would also reduce the window during which players may receive a test from four months to two weeks. This would lead to less penalties and NFL cannabis suspensions happening only for extreme events and repetead disregard of the rules.

In the agreement there are mentions of an increase in the minimum salaries and benefits for active and retired players. An announcement on last Thursday from the league, confirms that the owners were positive with the agreement at a meeting in New York City.

Player Union still to decide

Several conference calls in recent week between the members of the Players Union to decide if they should continue with the agreement. If they don’t take a stand soon it could mean another year with strict penalties. Two thirds of the members have to agree to the proposal prior to the start of the new year on March 18.

“We shall see now if the players do approve the proposal,” Garafolo said Thursday. “There is no word on a timeline, but it seems like from this statement and from what we heard, that the owners believe that this will be the final offer until we go forward to next year if the players do not approve this current proposal.” (Source)

The Major League of Baseball has also mentioned in December that they are planing to remove cannabis from the list of prohibited substances for players.

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CBD infused drinks are investgated by The Coca-Cola Company

Cannabidiol (CBD) is drawing in a legitimate interest from huge corporate companies. The American Coca-Cola Company has recently mentioned that they are reviewing the advancement of CBD infused drinks. Maybe there is a posibility for a CBD Coca-Cola beverage?

CBD could be the eventual fate of “wellbeing drinks”

In an official statement from Coca Cola, an official mentions that they are “considering a move into the market in order to use CBD as an ingredient in “wellness” products”. While CBD is the non-psychoactive ingredient of the cannabis plant and has no intoxicating effect. Furthermore it’s use for a number of medical purposes. “This sector is changing rapidly but no decision has yet been made”. Even though the decision has not been taken, there is some interest for the CBD infused Coca-Cola.

Coca-Cola’s announcement comes as a response. Reports referencing talks among them and the Canadian company Aurora Cannabis to make drinks mixed with cannabidiol (CBD) were previously made. Coca-Cola accentuates that they are “not inspired by cannabis” but by CBD, which is the non euphoric part of the plant.

hemp plant

Manufacturers are expecting legalization!

The cannabis plant is producing a new phenomenon among the big stakeholders of the cousine business, a significant number of them wagering that pot will be legalized in numerous countries around the world in the coming years. Cannabis use is already legal in Canada, Jamaica, Uruguay, The Netherlands and other coutries and states in the USA.

Even Constellation Brands (!) the owner of Corona lagers, Modelo lagers, and Svedka vodka, as of late put a few billion USD in the Canadian organization Canopy Growth.

Coca-Cola and Constellation Brands enthusiasm for the cannabis business is simply one more sign and huge advance for the industry. The acknowledgment of the plant and it’s future as a legal item in the market can be improved this way. Maybe in the future we will be able to see a CBD infused Coca-Cola beverage.

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