There has long been speculation that Big Pharma is angling to wipe out the cannabis industry and make all consumers – even those who consume cannabis just for fun – into people who have to get their weed over the counter or via prescription. But is there any truth to it? Is Big Pharma coming for weed?
Who Is Big Pharma?
According to consumer advocacy organization Drug Watch, Big Pharma is a term used to refer to the global pharmaceutical and medical device industry. Publicly traded and incredibly powerful, the global revenue for pharmaceuticals was north of $1 trillion in 2014, and has only grown since. As a surprise to exactly no one, the majority of the top 10 pharmaceutical companies are headquartered in the U.S. and include Gilead, Amgen, AbbVie, Johnson & Johnson, Pfizer, and Merck.
With their massive pile of profits, Big Pharma has little trouble finding their way into the halls of power. It is estimated that they employ nearly 1,400 lobbyists on Capitol Hill, and contribute about two-thirds of the FDA (Food and Drug Administration) budget through applications — or user fees — for new products.
Anyone who watches TV or video knows that these pharma companies also spend a ton of money on promoting their products; for every $1 spent on research, $19 goes to marketing and advertising. The United States and New Zealand are the only countries in the world that allow drug makers to market directly to consumers.
If Big Pharma was to replace a holistic cannabis industry and monopolize the cannabis marketplace, they would have to work very closely with the FDA. How would that work?
Cannabis and the FDA
For as fast as the cannabis industry moves and for the many studies showing the potential therapeutic benefits of cannabis, the FDA is, for the most part, one slow moving behemoth.
They have approved exactly one cannabis-derived drug, Epidiolex (from the non-intoxicating CBD) for the treatment of intractable epilepsy for pediatric patients. They recently approved another condition for Epidiolex – tuberous sclerosis complex. Epidiolex is a subsidiary of UK-based Jazz Pharmaceuticals, formerly GW Pharmaceuticals.
FDA Approved Synthetic Cannabinoids
There are other synthetic cannabinoid medicines that are FDA-approved:
- Marinol (dronabinol) – a subsidiary of AbbVie and used in the treatment of vomiting and nausea from cancer treatment
- Syndros (dronabinol) – a subsidiary of Texas-based Benuvia, to treat anorexia in adults with AIDS and for chemotherapy-related nausea and vomiting
- Cesamet (nabilone) – subsidiary of Canadian company Valeant pharmaceuticals, another treatment for nausea and vomiting related to cancer treatment.
The FDA does note, “Importantly, the FDA has not approved any other cannabis, cannabis-derived or cannabidiol (CBD) products currently available on the market.”
From what we’ve seen here, the FDA-approved cannabis medicines available to consumers are very narrow. And that could be at least in part due to the onerous process a pharmaceutical company has to undergo to get a drug approved.
Before a drug actually gets to the application process with the FDA, it has to go through an extensive, typically years-long clinical trial process: testing is performed first in laboratories then on animals to ensure its safety before clinical trials are performed on humans. Then it goes through three clinical trial phases and must ultimately be studied on thousands of people to show that the benefits of the drug outweigh its risks.
Once a company clears that final hurdle, the application and approval process can, bureaucratically speaking, be quite brief. The FDA can approve or deny a medicine in six months or less.
What is Synthetic Cannabis?
It’s safe to assume that if Big Pharma is looking to “medicalize” cannabis, they would have to design and formulate products that act and perform just like medicine. Specifically dosed, repeatable, and uniform. Doing this with cannabis flower is notoriously difficult, but synthetic cannabis is made in a lab via a multistep process called chemical synthesis. This makes for a much simpler, accurate, and efficient manufacturing process.
In Cannabis Science and Technology, Professor Edvinas Orentas, Department of Organic Chemistry, Vilnius University, Lithuania and Head of Research at Sanobiotec, explained in an interview the difference between “natural” and “synthetic” cannabinoids.
Professor Orentas said:
“The natural cannabinoids are typically defined as the ones separated from natural sources, in this case the C. sativa plant and all the variations of the species. The fully synthetic cannabinoids are made in the laboratory from scratch, using simple chemical precursors via a multistep process called chemical synthesis. In special cases, you might as well have semi-synthetic cannabinoids, where the starting material comes from the plant and is further elaborated in the lab to another compound.”Continue Reading Below
So, hold on a second. If cannabinoids can be made from scratch in a lab, then Big Pharma doesn’t even really need cannabis plants at all. Theoretically, pharmaceutical companies could make synthetic cannabis right now and stuff the shelves of CVS with it. Right?
Cannabis is Still a Schedule I Drug
Come with me into the weeds, if you will, for a talk about substances, analogue substances, and chemicals. According to the federal government, cannabis is still a Schedule I drug, meaning that it has “no currently accepted medical use and a high potential for abuse.” In addition to cannabis, other drugs on this list include heroin, LSD, ecstasy, and peyote.
Just because a pharmaceutical company could make a synthetic cannabis medicine from scratch doesn’t mean they can.
While we tend to think of cannabis as a whole plant, the government thinks about drugs as chemicals —they see cannabis as delta-9-tetrahydrocannabinol and cannabidiol.
(5α,6α)-7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol diacetate? That’s opium. N-(4-Hydroxyphenyl)acetamide is acetaminophen, more famously known as Tylenol.
The government has also staked its claim on the ability to outlaw “any substance which is intended for human consumption and is structurally or pharmacologically substantially similar to or is represented as being similar to a Schedule I or Schedule II substance and is not an approved medication in the U.S.”
In other words, if a drug even thinks about pretending to be another drug, that’s illegal, too.
The Wrap Up
In the long term, it could make sense for Big Pharma to move toward synthetic cannabis. After all, it can be made cheaply and efficiently, no plant needed, and its results could be reliable and replicable.
But to the question of Big Pharma wiping out the cannabis industry? I’d bet no. If they did, it would take billions of dollars and decades worth of effort and lawsuits. As it currently stands, they can’t make any significant dent anyway, at least not until the federal government moves to reschedule or legalize the chemicals of the cannabis plant.
Frequently Asked Questions
How Many Synthetic Cannabinoid Pharmaceuticals Are There?
Three synthetic cannabis medicines have been approved by the FDA: Marinol, Syndros, and Cesamet.
How is Synthetic CBD Made?
Synthetic CBD is created in a lab from base materials, not cannabis plant material.
What Schedule Are Synthetic Cannabinoids?
Synthetic cannabinoids, like K2 for example, are considered to be a controlled substance analogue and are treated as schedule I substances.
Is K2 Still Sold in Stores?
It shouldn’t be. But if you see it, please don’t buy it.