U.S. researcher discusses challenges in studying medical marijuana

In Feature Stories by KentM

According to a medical marijuana researcher in the U.S., marijuana studies have already proven why the plant requires a new drug classification. He says studying marijuana effectively is hampered by the U.S. labeling the plant an illegal drug.

Dr. Sunil Aggarwal, a New York–based medical resident involved in medical marijuana research and policy reform, told The Medical Marijuana Review the FDA needs to wise up to traditional medicines cannabis.

We spoke to Dr. Aggarwal about his take on medical marijuana’s future. A graduate of the the University of Washington, Dr. Aggarwal has published a number of papers on the subject of marijuana as medicine.  He is the author of a review article “Cannabinergic Pain Medicine: A Concise Clinical Primer and Survey of Randomized Controlled Trial Results” featured on the the cover of the February 2013 issue of The Clinical Journal of Pain.

He also sits on the boards of numerous organizations, including the Americans for Safe Access Foundation, Patients Out of Time, and the Center for the Study of Cannabis and Social Policy.

MMR: How hard is it to study medical marijuana in the U.S.?

Aggarwal: Doing a clinical trial with cannabis is really difficult. But there are a large number of clinical trials that have been done, despite the hurdles. People are thinking, “Oh, if I publish that one more trial, maybe the government will reschedule marijuana then.”

The truth is, we already have the information available to change the drug’s classification. Once you do that, you’ll open up more research avenues. But right now, the type of funding you can get, the type of questions you can ask, and access to the substance are all very limited.

MMR: What type of research do you think needs to be done?

Aggarwal: What has to happen in order to push the issue forward is to have cannabis of many varieties available locally that people are familiar with, [and] which have been tested in terms of their constituents, like THC and CBD ratios, and various modes of administration.

Only in these kinds of settings can you really start to follow patients over a long time, observe if their conditions improve, and identify the most appropriate dosages and preparations of the medicine.

You can set up a huge trials program like this. But this is not to change the drug’s classification or to prove that it has medicinal use. The drug has already been proven to have medical uses. The question is, how many more are there, what is the exact dose, etc.

MMR: What about FDA approval?

Aggarwal: Marijuana is more of a traditional medicine, and the FDA in the U.S. has a different relationship with traditional medicines like ginseng or tea tree oil. When there’s a history of use, you don’t have to give the FDA every possible pre-clinical toxicity study. And often you’re not really making medical claims, so you’re in a different zone.

Cannabis can exist in multiple different zones. You can have it in the pharmaceutical pipeline, but you can have it in the herbal pharmacopeia and the folk homemade medicine category as well. But I think you have to apply regulations to it that are proportionate to its toxicity.

The only reason cannabis, or anything else, goes through the FDA process is because it’s an investigational new drug. But cannabis was never new; cannabis is far older than the FDA.

MMR: Have you heard anything about Canada’s new laws? What’s your reaction?

Aggarwal: I recently did a two-hour radio show with 3 or 4 Canadian [medical marijuana] patients. It was really interesting to hear about all the things going on there from the perspective of the patients.

One of them still has a grower’s license, and the cost that she quoted per gram versus what another guy had to pay from a federal distributor was really something. Less than 3 cents a gram, she said, with no pesticides and produced in her yard – I was blown away by that.

But when the new rules come into effect, she calculated a cost of $50,000 a year for her exemption amount. So she’s just simply not going to be able to afford it.

I also heard that they’re changing the language of the medical documentation to more of a prescription, which I thought was a positive step.

We talked about different legal issues that patients were facing as well, including John Conroy’s case that is trying to preserve grower rights for patients. I think that grower rights is a critical issue, and I don’t think it’s going to just disappear like that.

MMR: What do you see as the main goal for medical marijuana advocacy?

Aggarwal: There’s a lot of work that needs to be done with making cannabis available and better understanding it. The main goal, in terms of the medical world, really is to depoliticize the thing as much as possible.

Even though there’s a lot of politics to get it into the medical sphere, once you recognize something as a medicine, then it should be apolitical. If you need it, and if it’s helpful for you, then you talk to your doctor about it and that’s it.

To get to that point would be great, but it’s going to take a lot of public discourse and undoing policy changes to get to that place. Unfortunately, there’s always going to be a political role because, even once something like cannabis is legal, people will still want to make money off of it.

 

Photo courtesy Sunil Aggarwal