How to turn cannabis into a legal drug
Posted on November 12, 2014 | By Henry | Leave a response
Turning cannabis into a legal drug
GW Pharmaceutials has been making medicine from cannabis for more than a decade
Confused & perplexed about how a British drug maker can legally sell a drug made from cannabis in several countries around the world?
We reveal it all here…
Step One: Get a scientific theory
Scientists believe that the cannabis plant contains hundreds of compounds, or cannabinoids, that hold medicinal properties. To date, around 60 of these have been identified.
GW works with several university research labs to understand the chemical make-up of each cannabinoid and from there to identify potential therapeutic applications. This research provides GW with a scientific basis to look into the therapeutic effects of a specified combination of cannabinoids in a particular ailment.
Step Two: Grow the right kind of cannabis
Plants have extremely complex chemical make-ups and cannabis is no different. No two plants contain quite the same blend of cannabinoids.
This presents GW with two challenges.
First, it must breed cannabis that has the right blend of cannabinoids for the purposes of the treatment it is looking to develop.
For example, the plants used to make Sativex, its mutiple sclerosis medicine, must contain high levels of both tetrahydrocannabinol (THC) and cannabidiol (CBD). However it needs a high-CBD, low-THC strain for its epilepsy drug Epidiolex.
GW does not use genetic modification so it creates new breeds the old-fashioned way – by crossing different types of plants.
Second, it must make sure every single bottle of medicine that rolls off the production line contains an identical cocktail of cannabinoids. This means that once it has developed a breed that contains the right blend of compounds, it must only use exact clones of this plant for future development. So once it has hit on the right breed, it will grow generation after generation of the same plant in a separate greenhouse to avoid accidental breeding with other strains.
Step Three: Refine your extract
GW has a very specific blend of cannabinoids in mind for each experimental drug it develops.
Sometimes it can achieve this by breeding alone, when the extract of a specific plant contains the target levels of cannabinoid.
But most of the time GW will want its medicine to contain just a single cannabinoid or just a small number of them. So it will breed a plant with high levels of these particular cannabinoids and then purify the resulting extract by removing the unwanted compounds.
This bit takes years.
To get regulatory approval for a particular drug, GW must gather an enormous amount of clinical data demonstrating both its safety and effectiveness in humans – and that’s after it has already run tests in animals.
First, it will test the drug in a small group of patients with the target disease to make sure it does not have any harmful side effects. These trials will probably only involve tens of people.
Then it must run trials on several hundred patients to get enough proof that its medicine has a meaningful effect.
Regulators place high scientific standards on these trials. This means GW must test its drug against a placebo and neither the patient nor the doctor must know which is being used in any given case. This helps avoid bias in recording results.
Step Five: Record your medicine’s fingerprint
For any given medicine, GW must prove to regulators that each batch it produces is identical.
So once it has extracted the oil from its chosen cannabis plant, it uses a powerful computer to compile a very precise chemical profile.
It puts all subsequent batches through the same process to prove that each batch of oil is identical.
To get permission to sell a drug in any given country, the regulator in charge must give the official nod.
Once GW has gathered enough evidence to demonstrate that its drug works, it must submit an enormous file to whichever regulator patrols the region it wants approval in. regulators. For US approval, it goes to the FDA, for EU approval, it goes to the EMA, and so on.
The regulator spends several months going through the evidence with a fine-toothed comb before deciding whether to give the medicine the final nod.