Image: Shutterstock.
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Do you foresee any problems with the DEA letting it go through?You never know. The only thing that the DEA could object to is that this is a study that is what’s called an outpatient study. Meaning that people are given a weeks' supply of marijuana, which means a half ounce. People are given a half ounce to take home and do at home. We didn’t choose to hospitalize patients for three months, which is how long this study takes.The DEA could claim that there is drug diversion possibility, with the outpatient nature of the study, but I don’t think they will. The FDA has a Controlled Substances Act and what we’ve proposed is that we give a video camera to every subject and every time they smoke it, they have to video tape themselves smoking it and video tape themselves putting the marijuana back in the little safe that they get. They bring in the video tape at the end of the week, when they want to get their new weeks’ supply. We have a staff member review the video tape to make sure that they used it and didn’t give it to somebody else.If your study does go through, how do you intend to fund it?The state of Arizona has collected about five or six million dollars in fees from medical marijuana programs, and they recently opened some of it up for grants. We submitted a grant about a month ago for this study, about $750,000. It’s kind of nerve-racking because we had to do all this work and we knew that if the study was rejected, they would of course not fund the study. And we weren’t sure when they would make the decision. If that doesn’t work, and they reject it, I’m not sure exactly where we’ll get the money from.I believe that there is such enormous, pent-up demand for FDA-regulated medical marijuana research and support from PTSD patients that will go to the marijuana industry probably. The medical marijuana industry, that would be my guess, or philanthropists.That’s only the first step. We’d need $15 or $20 million to make marijuana into a prescription medicine, approved by the FDA. That will probably take five to seven years. What does that $15 to $20 million go toward? This is just a Phase II pilot study, an exploratory study. We’re figuring out what the doses are, whether CBD helps, whether THC is effective on its own, what are the side effects. The money would go then to what is called the Phase III study, and those are the ones that are used to prove safety and efficacy. With that we’ll probably have to treat 400-500 people or more.This study will give us results and we’ll see how clear the signals that we get are. Is there marijuana helpful a lot or a little? If it’s helpful a lot, then you need fewer people for the bigger study.@thor_bensonThe changing political dynamic played a major role, the major role. But also, we made it very clear that if they were objecting to it, then it wasn’t for scientific reasons. It was an arbitrary decision.