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Cannabidiol in Epilepsy Treatment: Understanding CBD’s Role

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By: Juan Sebastian Chaves Gil

The therapeutic use of cannabidiol (CBD) is a subject of controversy. While its application to treat various conditions such as anxiety, stress, insomnia, or certain chronic pains is on the rise, scientific and clinical evidence regarding the effects of this component of cannabis remains limited. In 2017, the World Health Organization (WHO) concluded that CBD has only been proven effective in some types of epilepsy after clinical trials, as research for other diseases is less advanced.

Several studies have shown the positive effects of cannabidiol in the treatment of refractory epilepsies, those that do not respond to conventional antiepileptic medications. However, neurologist Ángel Aledo Serrano warns about the need for caution and the importance of using it under the prescription and supervision of a neurologist.

There is a positive perception of CBD due to its natural origin, but Dr. Aledo emphasizes that it is crucial to adjust expectations, as it is not a universal remedy or healthier than other medications just because it comes from a plant.

In Spain, the only scientifically endorsed medication for certain epilepsies and authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS) is Jazz Pharmaceuticals’ Epidyolex. This medication is indicated for Dravet Syndrome, Lennox-Gastaut Syndrome, and Tuberous Sclerosis, all of which are rare epileptic syndromes that are difficult to control with conventional medications.

Dravet Syndrome, a common genetic epilepsy, was the first to demonstrate the beneficial effects of CBD. Its application began ten years ago with the case of Charlotte Figi, an American girl with this syndrome, whose epileptic seizures significantly improved with a CBD-rich and low-THC cannabis treatment.

 

Despite the proven efficacy in Dravet Syndrome, Epidyolex has recently obtained approval in Spain to treat epileptic seizures associated with tuberous sclerosis, a rare genetic disease.

Regarding administration, cannabidiol can be used in children and adults of various ages, although its effectiveness is not as supported in children under 2 years old due to a lack of research. Epidyolex is presented in syrup form and is taken twice a day, with precautions regarding dosage to avoid adverse effects. Dr. Aledo highlights that the use of CBD is not as common as other antiepileptics due to its specific indication for rare and severe epilepsies.

Additionally, he underscores that its high cost, approximately 1,000 euros per bottle of Epidyolex, also contributes to its limited use.

As for the effects, cannabidiol improves the quality of life by reducing the frequency and intensity of epileptic seizures, although it rarely eliminates them entirely. Moreover, it can have a positive impact on cognition and behavior.

However, potential adverse effects, such as drowsiness, dizziness, diarrhea, and blood abnormalities, especially in liver transaminases, should be considered and monitored regularly.

Although Epidyolex is the only scientifically endorsed cannabidiol for epilepsy and is only available in hospital pharmacies, CBD is legally sold in parapharmacies in various forms and brands not scientifically tested. This poses risks as it lacks the necessary medical supervision, as the amount of cannabidiol and other components is not guaranteed and can vary, leading to intoxication or insufficient doses. Dr. Aledo emphasizes the importance of caution and consultation with a specialist in refractory epilepsies before resorting to products without scientific endorsement.



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Andrew Cooper

The Future Of Cannabis After Rescheduling

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The Cannabis world is going through another big change with the potential of rescheduling – but what does it really mean?”

The Fresh Toast – The cannabis world is going through another major change, so what is the future of cannabis after rescheduling?

The Drug Enforcement Administration (DEA) is moving for cannabis to be rescheduled. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August 2023 recommendation, based on scientific support for the rescheduling from the FDA, that cannabis be rescheduled under Schedule III of the Controlled Substances Act. Cannabis has remained a Schedule I substance since it was originally “temporarily” classified as such by the Controlled Substances Act of 1970. Schedule I drugs are defined as having no currently accepted medical use and a high potential for abuse, with other Schedule I drugs including heroin and LSD (despite cocaine, fentanyl, and other potentially dangerous drugs being in less restrictive drug schedules). The status of cannabis as a Schedule I drug has long been criticized, particularly as more and more U.S. states legalized cannabis for medical and recreational use.

RELATED: Beer Sales Flatten Thanks To Marijuana

From a consumer standpoint rescheduling will not actually legalize cannabis. At least not in a way forcing States in which cannabis is currently prohibited to immediately change course as a direct result of rescheduling. Instead, those States are likely to continue cannabis prohibition (though this momentous step may influence further states to legalize). Similarly, states with state-legal cannabis programs will likely not immediately change from a consumer perspective, although further regulation or even a reduction in product pricing due to cannabis no longer being subject to section 280E of the Internal Revenue Code (discussed in detail below) may soon follow.

Photo by 2H Media via Unsplash

There is more going on the business side with rescheduling. Falcon Rappaport & Berkman LLP has reviewed the process and outcomes.

Taxes

The most significant consequence of cannabis rescheduling will be the immediate removal of cannabis from the reach of I.R.C. Section 280E, which is arguably the greatest burden on state-legal cannabis operators. Section 280E prohibits cannabis businesses from writing off many business expenses when calculating their net profit, which has resulted in vastly higher taxes as compared to similar non-cannabis businesses. Instead, section 280E only permits a deduction for the Cost of Goods Sold (COGS) for any business trafficking in any controlled substances (i.e., drugs listed on Schedule I or Schedule II). Despite cannabis businesses operating under state-legal programs, they are considered “trafficking” and cannot take ordinary business deductions. Allowing cannabis businesses to deduct all ordinary and necessary business expenses, and not just COGS, will help to even the playing field with nearly every other legal business.

Federal Illegality

As discussed from a consumer standpoint, rescheduling cannabis does not affect the overall federal illegality of cannabis. This means that state-legal cannabis businesses will not automatically be federally legal, as their federal illegality will continue under Schedule III. While Schedule III drugs may be legally prescribed and sold under federal law, the various restrictions (such as requiring FDA approval of any such Schedule III drug and DEA registration of a distributor) mean that your average dispensary, even medical dispensaries, will still be federally non-compliant.  For these same reasons, the reclassification to Schedule III does not mean that marijuana grown pursuant to state programs can be sold in interstate commerce. Marijuana products, even under Schedule III, are only federally legal if they are federally approved and there are only three FDA-approved cannabis-based drugs developed to date (Marinol, Epdiolex, and Syndros).

RELATED: Cannabis Industry Employs The Same As These Companies

Intellectual Property & Cannabis Trademarks

The United States Patent and Trademark Office (USPTO), the agency tasked with examining federal trademark applications, has generally required use of a mark to be lawful under federal law in order to receive federal trademark registration under the U.S. Trademark Act (see Examination Guide 1-19). The federal illegality of cannabis has thus prevented trademark registration in connection with most cannabis products. Unfortunately, cannabis rescheduling will not remedy this issue. Even in Schedule III, cannabis products would have to be federally lawful, with lawful use of a Schedule III drug requiring FDA approval.

Entitlement to Federal Bankruptcy Protection 

Currently, plant-touching cannabis companies are not entitled to federal bankruptcy protection. That is because the U.S. Bankruptcy Code requires that bankruptcy plans are “proposed in good-faith and not by any means forbidden by law.” Since even state-regulated cannabis companies violate the federal Controlled Substances Act (CSA), they are disqualified. Unfortunately, rescheduling to Schedule III of the CSA alone will not likely solve that barrier to bankruptcy. While some have argued otherwise, the fact is that to manufacture, distribute, or dispense a Schedule III Controlled Substance, businesses must be registered with the Drug Enforcement Administration (“DEA”). Any business or person not registered with the DEA is not authorized to manufacture, distribute, or dispense it. Meaning that violations would likely constitute an unlawful act under the CSA. Consequently, an attempt by the non-complying business to commence a voluntary petition seeking federal bankruptcy protection will likely result in a motion to dismiss the case by the U.S. Trustee’s Office.

However, in light of a recent trend among bankruptcy court’s in allowing ‘one-step-removed’ distribution of cannabis-related assets, federal rescheduling may very well result in a more liberalized approach to administering bankruptcy cases so that bankruptcy judges will be more willing to look past the issue of marijuana’s federal illegality.

Status Quo

There are several aspects of the existing cannabis industry which would not be immediately changed by rescheduling cannabis to Schedule III. Ongoing banking issues including the lack of access to standard commercial bank loans and lines of credit would likely persist; difficulties in processing cannabis transactions due to the reality that major credit card companies like Visa, Mastercard and others will likely still not service marijuana businesses; general federal illegality; and the criminalization of cannabis (and continued incarceration of certain offenders) in prohibitive states would remain following rescheduling.

While many had hoped for the de-scheduling of cannabis, the change in stance of the DEA, a longstanding adversary of cannabis reform, is no small feat.

Terran Cooper is a regular contributor to The Fresh Toast.  He is part of Falcon Rappaport & Berkman LLP. This article was developed in part with the help of Andrew Cooper and Matthew Foreman.



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Bob Groesbeck

What Can Consumers Expect From Marijuana Rescheduling

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Most of the industry has been thrilled with the progress of rescheduling.  But for the 40+ million who consume – what does it mean in real world terms?

The federal government took a big step toward rescheduling marijuana from a Schedule 1, which is a dangerous drug with zero medical benefits, to to Schedule III such as ketamine, Tylenol with codeine, and anabolic steroids.  The industry is excited at the progress, the benefits will include the ability to have simple tax write off like any other normal mom and pop business.  But what can consumers expect from marijuana rescheduling.

RELATED: Beer Sales Flatten Thanks To Marijuana

Two longer term benefits. With a Schedule III classification, medical researchers may find it easier to obtain the necessary approvals and funding for studies.  With existing work, scientist have just began uncovering how the plant can help the body.  By better understanding of the compound’s potential, better treatments will be available for a variety of health issue. The pharmaceutical industry, the major leader in research, stands to gain from increased research opportunities.

It also will move the medical industry closer into viewing cannabis as a legal, useful tool in treating patients. This could play a part in weaning physicians from using opioids for pain and using something developed from cannabis which is much less addictive.

a black and white photo of a machine

Another benefit is it allows legal businesses a bit more breathing room and some expansion, even in the short term. The hope is to push out the grey players who are causing issues. One which is the flow of premade products from maker to seller to consumer, currently – some cut corners and products are not quite the same as on traditional store shelves. Rescheduling will allow more oversight and safer products.

“Legalization represents a pivotal shift towards a safer, more accessible, and consumer-friendly cannabis market,” said, Bob Groesbeck, Co-CEO Planet 13. “Legalization would not only have significant economic implications but would also greatly benefit cannabis consumers. “With legal status ensuring that products undergo rigorous testing for safety and quality, consumers can confidently access products that meet stringent standards.

RELATED: Cannabis Industry Employs The Same As These Companies

One benefit not seen in the near horizon is a lowering of prices. As a growing industry, most mom and pop need the extra cash to stabilize and grow. So while sales may happen, the benefit for the consumer is a healthy shop/product maker which will be around longer.

“Cannabis policy is a burning question with a small minority of the public but data show that in congressional campaigns, the vast majority (nearly 90% of candidates) never mention cannabis policy in public. That suggests that most voters are focused on different issues. Despite that, the current cannabis rescheduling petition before the federal government, and initiated by President Biden, is moving at lightning speed compared to every other cannabis rescheduling petition before it.” shared John Hudak,  Director, Maine Office of Cannabis Policy.



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“A big deal”: What the feds’ move to reclassify marijuana means for Colorado cannabis

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Cannabis advocates in Colorado cheered the Biden Administration’s reported move to reclassify marijuana and said the decision likely would reduce businesses’ tax burden significantly.

Industry leaders cautioned that such a move — if finalized — would not resolve some major challenges facing the industry, such as limited access to banking. But they pointed to the symbolic importance of preparations by the U.S. Drug Enforcement Administration to downgrade the substance’s drug classification.

A man pours cannabis into rolling papers as he prepares to roll a joint the Mile High 420 Festival in Civic Center Park in Denver, April 20, 2024. (Photo by Kevin Mohatt/Special to The Denver Post)

Read the rest of this story on DenverPost.com.



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