Dr. Ethan Russo is one of the nation’s leading researchers in medicinal cannabis—but he still has to go through innumerable hoops with the FDA to legally get materials for his research.
He was a clinical neurologist in Missoula, Montana for 20 years in a practice focusing on a chronic pain. His early work revolved around clinical studies of cannabis and migraines—but he was refused material for a study by the National Institute on Drug Abuse due to its schedule one classification, despite the study being approved by the Food and Drug Administration.
After authoring and editing several books and numerous materials on medicinal cannabis—and working on trials for a cannabis-based mouth spray Sativex, for multiple sclerosis patients— Dr. Russo is currently a medical director at American biotech company Phytecs.
Dr. Russo’s work with Phytecs focuses on the development of therapies targeting the endocannabinoid system which is involved in the regulation of a variety of physiological processes including appetite, pain-sensation, mood and memory.
Russo will be one of the speakers Friday, May 12 , at the Cultivation Classic—the world's only cannabis competition and event exclusively for pesticide-free product grown in Oregon. We talked to him about his research in advance of the competition.
What is Phytecs research focused on right now and what are your priorities as medical director?
It varies. One of our people is Rafael Mechoulam, the father of cannabis-based medicine. He has developed some semi-synthetic analogs of cannabidiols. These are like cannabidiols but have a chemical change. These could potentially be developed as prescription medicine, so we’re investigating those.
Additionally we’re investigating cannabis in different forms of what are called chemical varieties, or chemovars, that can be focused on being used for a particular kind of ailment.
We’re also interested in non-cannabis approaches to the endocannabinoid system, so this would include various herbal agents that are not cannabis, and are not scheduled, that modulate this system in our bodies. We have a reactive program screening plants for this kind of biochemical activity that could be harnessed from a therapeutic standpoint, and that wouldn’t necessarily get into the whole pandora’s box of trying to do research with cannabis.
Do laws in the United States hinder progress in this particular science?
Various countries have legalized, Canada is in the process, but you have medical access in Chile, Israel, Germany, the Czech Republic, Mexico. The United States is surrounded by countries that have more liberal policies.
As it stands, if material is developed by a company in a foreign country, it can be imported into the U.S. for clinical trials. It has to go through a variety of hoops in conjunction with both the Food and Drug Administration and the Drug Enforcement Agency, but it can be done. It has been done.
In comparison, a company in the U.S. that is developing a cannabis-based medicine has no ability to use that in clinical trials. They can’t cross state lines, all the material has to be funneled through the National Institute on Drug Abuse (NIDA). That is the catch 22 in which we find ourselves.
It seems like in 2017 the United States would be a world leader in the development of medicinal cannabis. Why are we not?
Most of it has to do with the laws in the U.S., so on the one hand cannabis is a schedule one drug, that means according to the government it is dangerous, addictive and has no recognized medical use.
That’s obviously untrue at this point. We’ve seen reports of efficacy and safety in a variety of different conditions. It’s no longer and never was a scientific basis for it being forbidden. It’s actually a leftover from 1970 when the controlled substances act was passed.
At the time cannabis was placed in schedule one as a place holder pending the results of an appointed commission called the Schafer Commission. They came out with findings that cannabis should be decriminalized and should be available medically, but that was rejected by President Nixon. Subsequently, cannabis has remained mired, 70 years later, in this forbidden classification. That’s one part.
The second is NIDA has a stranglehold on the supply of cannabis. It can only be obtained through them, and the system is setup in a way that using material that’s not standardized means that it’s not consistent enough to be developed as a pharmaceutical drug.
If you had a successful clinical trial, you couldn’t get the same material again.
Additionally all the studies that have been approved for cannabis with therapeutic indication in this country have been small scale, very limited duration and really have not advanced the science the way it has been possible for foreign companies to do, and even bring that material into the U.S.
Basically, the industry of developing cannabis as a medicine has been totally roadblocked by these policies. Basically we’ve seeded this research and development to other nations in the world.
Has the emergence of recreational legalization over the past few years helped or hurt scientific pursuits surrounding medicinal cannabis?
I guess on the one hand there’s a more general acceptance that these substances can be used safely. We have not seen massive increases in accidents or admissions to treatment programs, but overall, it’s not necessarily helpful.
The best example is in Washington state. Prior to the legalization of cannabis in Washington, there was a very viable, working medical program, such that patients had very liberal allowances on what they could hold.
Additionally, there was a good availability of often organically grown material with good quality control available for dispensaries. In the state’s efforts to fold that program into the legal market, all that went by the wayside. We’ve seen the disappearance of the chemovars of cannabis that people had used medicinally, and what we see now is a market that’s dominated by recreational strains, or chemovars that tend to be very high in THC.
Additionally, there have been huge problems. We did a huge study last year in which we took a bunch of samples from the legal market, sent them to a state approved lab to test for pesticides and showed gross contamination in about 85 percent of the samples. This is because the market was not regulated with respect to mandating this kind of testing take place.
I’m all about safety. On one hand this is a situation that should never occur. We know the dangers of cannabis. Relatively they’re quite low compared to other medicines, but it should never be the case that because of a lack of oversight or lack of regulation you end up with a product that is more dangerous just because nobody is testing.