Tag Archives: synthetic

Epidiolex-GW

Epidiolex Gives GW Pharmaceuticals Boost In Global Markets

By Marguerite Arnold
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Epidiolex-GW

GW Pharmaceuticals scored a significant victory in the United States with its cannabis-based epilepsy drug Epidiolex in mid-April. The company received approval from a U.S. Food and Drug Administration (FDA) panel for its use in treating two forms of drug-resistant epilepsy.

The drug was granted “orphan drug” status in the EU a year ago.Will this be enough to move the conversation forward about cannabis as medicine in the United States? 

So what does the future hold for this drug and a company, which has visited this space before? Remember Sativex?. The Company now faces real competition from a raft of companies moving into this space from just about everywhere – both from Canada and of course Europe itself.

The FDA Might be on the Verge of Approving its First Cannabis-Based Drug

It is not like this is either the FDA’s or GW Pharma’s first discussion about the medical efficacy of cannabinoids. Sativex, a mouth spray containing THC, was never granted approval in the United States for the treatment of MS – although it received such approvals in Europe.

Epidiolex-GWIf the FDA approves Epidiolex (made from CBD), it will be the first cannabinoid-based drug approved in the United States by the federal agency.

Will this be enough to move the conversation forward about cannabis as medicine in the United States? What will happen in the EU?

A Divergent and Highly Different Drug Market

Will the FDA finally approve at least one form of a CBD-based drug? The chances are that Epidiolex might finally move the agency to approve. However,this is not, despite the hype that the company has made in the press about this, the first cannabinoid-based drug to be approved in the United States. It might be, however, the first drug based on actual natural cannabinoids rather than synthetic ones that it approves for some purpose. Both Cesamet and Dronabinol (or Marinol) are synthetic cannabinoid drugs approved for several conditions from chronic pain caused by chemo to Parkinson’s.

GW logo-2But those who are hoping that this drug approval might open the floodgates at the FDA for startersshould take a pew. While Sativex was not approved in the United States, it was made available after 2011 for MS patients, particularly in Germany, which has the highest rate of MS of any European country. The problem? It was just too expensive for most people to afford – since their insurance would not cover it. And doctors were even more resistant to prescribing than they are now. So even getting a prescription was almost impossible.

That conversation was different in Europe post-2013, and there were people who managed to get a doctor to write a prescription not to mention afford the eye-watering prices sans insurance coverage.

That said, given the choice between whole plant meds, most people still prefer bud cannabis to the spray variety. And in Europe right now, that is what is on the table.

What Will This Mean in the US vs Europe?

In the US, the first thing that FDA approval will mean is drug sales for only one branded drug. That is the cynicism at play here. Furthermore, it also neatly dodges the THC issue.

In Europe? Particularly Germany? This development is not likely to make much of a dent. GW is competing with every single Canadian producer with flower-based oil – and on both the medical and non-medical CBD front. That also now includes local producers. Further, this is a market which prizes genericized drugs over name brands. In France, the distribution of Sativex was held up, primarily because of the row over cost. And who would pay.

It is also unlikely that the FDA approval in the United States will change the discussion either in the US on a federal level – or in Europe.

The most important place this news already made a dent? GW Pharma’s stock price – at least temporarily. It is also a spot of good news the company really needs. In February, the company’s GWP42006 drug designed for focal seizures (drug resistant epilepsy) failed to outperform placebo results and wiped 5% off the company’s stock.

Dr. Allison Justice

What Does it Really Mean To Be Organic in Cannabis?

By Dr. Allison Justice
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Dr. Allison Justice

If you ask an organic chemist, it’s any molecule with a carbon attached. If you ask a consumer of USDA Certified Organic vegetables, they might say it is food produced without chemicals pesticides, that it is safer and cleaner and even more nutritious. Possibly another consumer will say it’s just a hoax to pay more for food, but what does the USDA Certified Organic Farmer say?

Most will agree it is a very rigorous process of record keeping, fees, rules and oversight. The farmers have limited choices for pesticides and fertilizers; they incur higher labor costs, suffer potentially lower yields and generally have higher input costs. However, at the end of the day the farmer does get a higher price point.

With so many misconceptions about organic food, it is difficult to know what is actually organic by definition. First let’s think about what the word pesticide means. A pesticide is “a substance used for destroying insects or other organisms harmful to cultivated plants or to animals.” By definition, a vacuum used to suck off spidermites is a pesticide, so instead we should say that no synthetic pesticides are used. These are pesticides that enter and reside for long periods of time within the plant, which are potentially harmful to the end consumer. Though organic food does not contain synthetic pesticides, the perception of the food being healthier is also not always accurate. Growers often use foliar applied teas or manures, which increase the chance of the product containing E. coli or other harmful microbes. In addition, certain sanitizing agents or gamma irradiation is not allowed, so the post-harvest cleaning is not always as thorough as for conventional foods. When cannabis is sold as a dried product, the consumer cannot wash the flower as they might do before eating an apple. As growers, we should make sure we are disinfecting the flower before harvest and keeping the plant/processes clean throughout curing.

I often hear cannabis growers saying they are producing an organic product, but this simply cannot be true. The term “organic” is a labeling term for agricultural products (food, fiber or feed) that have been produced in accordance to the federal government’s USDA organic regulations. Due to our (cannabis growers) ongoing disagreements with the federal government, this is not a term we can put on our product. However, we can still grow to the same standards as USDA-certified farmers. How can we do this? By using OMRI (Organic Materials Review Institute) approved products. OMRI is a third-party, nonprofit organization that lets growers know if a product can be used in certified Organic production. You can find this seal on many fertilizers or pesticides.

Next, if it is a pesticide product that is not OMRI approved, check to see if it is registered by the EPA (Environmental Protection Agency). The EPA will provide ingredients and crops that are approved, amounts which can be used safely and storage/disposal practices on the label. Products that are put through the EPA registration are evaluated for their environmental, human and residual risks. Companies pay a hefty fee for this process, and much research goes into providing this information – ALWAYS READ THE LABEL!

A couple of exceptions to an EPA registration are pesticides that are 25B-exempt and biological control. 25B-exempt pesticides are pesticides that pose minimal or no risk to humans. A complete list of these products can be found here. Examples of these pesticides include rosemary, garlic, spearmint, etc.

Biological control is a method for controlling pests by the use of natural enemies. Biological control agents are allowed in organic production. If you are still wondering which pesticides or fertilizer are OK to use in cannabis and you do not live in a state with already enforced regulation, check out allowed lists in states that do.

So we know we cannot be considered a USDA organic cannabis farmer, but we CAN strive to meet the same standards:

  • Follow your state’s regulations; they are there for a reason!
  • Use OMRI products, 25B-exempt products and BCAs.
  • Keep an eye out for upcoming third-party certification companies, such as Clean Green or MPS (beware of the ones that want you to only use their products), because we need more than the state to regulate what we put onto our crop.
  • Finally, always think about the microbial load you’ve put on your plants. Although many can be very beneficial and help to produce high quality crops, many species can be harmful to the end user.