Tag Archives: seizures

How GW Pharma Won CBD

By Cathleen Rocco
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As of this writing, the United States Food and Drug Administration (FDA) has approved GW Pharma’s CBD drug Epidiolex for treating profound refractory pediatric epilepsy syndromes (Dravet syndrome and Lennox Gastaut syndrome) as well as for treating seizures associated with tuberous sclerosis complex (TSC) in patients one year of age or older. The product is a very simple, orally-administered formulation comprised of 100mg/ml cannabidiol (CBD), dehydrated alcohol, sesame seed oil, strawberry flavor and sucralose – basically, an alcohol-based solution with sesame seed oil to help solubilize the CBD oil, flavoring and sweetener.

GW logo-2On April 6th, 2020 GW Pharma performed a regulatory miracle when they succeeded in convincing the Drug Enforcement Administration (DEA) to deschedule Epidiolex (i.e., remove it from the Schedule 1 and Schedule 5 lists of substances that the agency regulates due to concerns regarding safety, potential for abuse or both) for all indications – including indications for which it has not yet been approved by the FDA.1 The benefit to GW of having their product descheduled is incalculable. This status change removed potential barriers to insurance reimbursement and made the need to set up and administer an expensive REMS2 drug safety program less likely. In part because of this regulatory coup d’état, the drug recently posted yearly earnings of nearly $300 million.

It is important to note that the DEA descheduled the Epidiolex formulation and not cannabis-derived CBD itself. Thus, GW Pharma is now in the enviable position of being the only company that can legally sell cannabis-derived CBD. More importantly, because the DEA descheduled the formulation and not the active ingredient, other companies who wish to market cannabis-derived CBD pharmaceutical formulations will have to repeat whatever it is that GW did to get Epidiolex descheduled.3 The DEA effectively gave the company a huge head start with respect to competitors who are developing other cannabis-derived CBD formulations that would compete with Epidiolex. That advantage will remain in place unless and until cannabis-derived CBD itself is descheduled or cannabis is legalized at the federal level.

GW Pharma’s CBD drug Epidiolex, which is FDA-approved to treat profound refractory pediatric epilepsy syndromes

GW Pharma’s attorneys demonstrated considerable virtuosity in devising this approach. However, there is another aspect of the GW Pharma story – one that could have profound implications for the exploding CBD consumer packaged goods (CPG) industry. The Federal Food, Drug, and Cosmetics Act4 (FFDCA) prohibits the introduction into interstate commerce of any food to which has been added an approved drug or a drug for which substantial clinical investigations have been instituted and made public.5 Because CBD was and is still the subject of clinical trials run by GW Pharma and others, even hemp-derived CBD is currently illegal to use as a food additive or dietary supplement under the FDCA

The FDA has recently re-started the public commentary stage of a long process that will hopefully result in the creation of a regulatory pathway for CBD to be used as a food additive – something that would seemingly be a straightforward matter given the copious amounts of safety data being generated from all of GW Pharma’s clinical trials. However, as long as the FDA continues to drag its feet in providing a regulatory pathway for CBD CPG products, CBD, regardless of its source, will remain illegal to use as a food additive or supplement under either the CSA or the FFDCA despite the existence of safety data obtained through the Epidiolex clinical trials. If, as many people in the industry anticipate, the agency decides to begin enforcement action, this could have a hugely negative impact on the industry.

In addition to the potentially disastrous effect that federal law could have on an important new industry, the federal regulatory scheme introduces unnecessary regulatory complexity and cost by imposing two different regulatory schemes depending on the source of the CBD. CBD derived from hemp is chemically identical to CBD derived from cannabis. Despite that identity, the 2018 Farm Bill nonsensically exempts only hemp-derived CBD from the Controlled Substances Act. If a regulatory pathway is created for hemp-derived CBD, but the DEA insists on maintaining cannabis-derived CBD as a schedule 1 substance, then the same molecule will be subject to two different regulatory schemes. This scenario would require tracking and certifying CBD sources and thereby impose regulatory and economic burdens that are entirely unnecessary from a public health point of view.

FDAlogoAn alternative, economically disastrous scenario: given the pharmaceutical industry’s formidable lobbying power, it is entirely possible that the FDA could decide to limit the use of CBD exclusively in prescription drug formulations. This could kill the entire US hemp CBD CPG industry, currently estimated to reach $22 billion by 2022.6

Overall, the current state of affairs is unfair, expensive, uncertain and entirely unworkable over the long term. The CSA must be amended, ideally to deschedule both hemp and cannabis entirely, but at least in the short term, to deschedule CBD and preferably all non-THC cannabinoids regardless of their source. Further, the FDA must provide a regulatory pathway to allow the use of low doses of cannabinoids shown to be safe, either by existing clinical trial data or future testing pursuant to the NDIN submission process.

A 2019 Gallup poll found that 14% of Americans – 1 in 7 – use CBD products.7 The demand is there, the industry is thriving, and adequate safety data exists to justify a regulatory system that allows low-dose over the counter CBD products provided those products are produced using Current Good Manufacturing Practices (CGMPs) for food and dietary supplement manufacturing prescribed by the FDA and that such products undergo regular testing that demonstrates they are safe, unadulterated and accurately labeled. It is time for the industry to collectively fund a New Dietary Ingredient Notification (NDIN) submission that would provide safety data sufficiently compelling to force the FDA to either recognize CBD and other non-THC cannabinoids as being GRAS substances regardless of their source, or in the alternative create a regulatory path for CPG products containing low-doses of CBD and other non-THC cannabinoids.

Editor’s Note: The opinions expressed in this publication are those of its author. They do not purport to reflect the opinions or views of the Cannabis Industry Journal, its editorial staff or its employees.


References

  1. Clincialtrials.gov lists 256 different clinical trials in which Epidiolex has been, is being or will be tested for a wide variety of other indications, including but not limited to opioid use disorder, several types of prostate cancer, alcohol use disorder, musculoskeletal pain, and a host of others.
  2. REMS – risk evaluation and mitigation strategy – are drug safety programs that the FDA requires in cases where mediations pose serious safety concerns with respect to potential abuse and other adverse effects.
  3. Exactly what they did isn’t clear, and won’t be for a long while given the snail’s pace at which FOIA requests are filled.
  4. Title 21 United States Code Chapter 9
  5. Title 21 United States Cod Chapter 9, Sections 331(ll), 342(a)(1) and Section 342(d)(f)(1)
  6. “Exclusive: New Report Predicts CBD Market Will Hit $22 Billion by 2022” Rolling Stone Magazine, September 11, 2018, citing cannabis industry analysis from the Brightfield Group.
  7. Gallup poll on American CBD product usage
adamplants

Adam Jacques: Award-Winning Grower, Pioneer and Medical Cannabis Provider

By Aaron G. Biros
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adamplants

Walking into one of the grow rooms on Adam Jacques’ farm outside of Eugene, Oregon, you will find dozens of cannabis plants and a whiteboard on the wall with the note “Do it for Frank” across the top. This is a reminder of why Jacques and his team are growing medical marijuana: To help people.

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Above some notes is their daily inspiration: “Do it for Frank”

Frank Leeds, one of Jacques’ cannabis patients, lost his battle with cancer in early January.

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A view of the grow room where they have 48 plants in flowering..

Jacques was working with Frank for the past five years to develop “Frank’s Gift,” a high-cannabidiol (CBD) strain with a slew of potential medical benefits. Deeply saddened by the loss of his patient and close friend, Jacques continues to run his grow operation, Grower’s Guild Gardens, where he and his wife, Debra, work to get high-quality, safe medicine to their patients.

His patients and other publications have repeatedly referred to Jacques as a “legend.” Jacques previously won Canna Magazine’s award for Most Influential Grower in the Northwest.

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Adam Jacques looking over his plants in their vegetative stage.

On their farm, strain testing is currently underway for the upcoming changes in the recreational program in Oregon. “With the way the medical laws are now, I have 48 plants for my patients, including multiple high-CBD genetics, and any excess flower will be sold to recreational dispensaries to cover our overhead costs,” says Jacques. When the Oregon Liquor Control Commission (OLCC) grants them their recreational grow license, he will take some of those trial strains to an outdoor crop estimated to be in the thousands of plants on his 42-acre farm.

Presenting at the Dispensary Next Conference a few weeks ago, Jacques said to a crowded room of industry professionals: “The biggest reward is helping people.” Jacques and his team’s work exemplifies the good that smaller grow operations can do for the industry.

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This plant is roughly four weeks from harvest, currently in the flowering stage.

Jacques’ recent work has taken him to help Leni Young, a four-year-old girl originally from Alabama who suffers from debilitating seizures. Her parents became medical refugees when she was not selected for an Alabama study involving cannabis oil. As a result, the Young’s took their daughter to Eugene, where with the help of Jacques and his team, they could get her customized cannabis oil with high doses of CBD and tetrahydrocannabinolic acid (THC-A) that could help treat her seizures.

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Left to right: Wayne Young with his daughter, Leni Young, and son, Thomas Young, alongside Debra Jacques.

The cannabis oil that Jacques created has brought Young’s seizures down from multiple occurring every day to just one every six weeks. “One-strain solutions like ‘Charlotte’s Web’ are no longer the answer for treating medical conditions,” says Jacques. “We create something custom designed for individual patients, and it is working.” CBD and THC-A, the main active ingredients in Leni’s medicine, are two of the non-psychoactive compounds in cannabis believed to have extraordinary medical benefits.

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Jacques inspecting some of the different strains they are testing for the recreational program.

Less than three weeks ago, a bill was introduced to the Alabama legislature that would decriminalize the possession of and allow patients to get high-CBD oil. The bill is called “Leni’s Law.”

Jacques’ goal in the long term is to get clinical trials with peer-reviewed studies to connect the dots between his patients, cannabis and evidence-based medicine. “I am working with a laboratory in Arizona and a doctor from Israel to perform a peer-reviewed study,” he adds. “Getting peer-reviewed will allow me to provide legitimate scientific evidence for my claims and get the knowledge into the hands of my patients.”

Looking into the immediate future, Jacques is wary of different regulations coming to Oregon. “Once you go recreational with your business, you lose the ability to provide any sort of a medical recommendation,” says Jacques. “I do not want to see the recreational program and the desire for profits push out our ability to help patients.”

Jacques and his team represent the idea that embodies the cannabis legalization movement, which is to help people get the medicine they need. “The money is not really important any more,” says Jacques.