Ted Simons: Research on how marijuana might help treat veterans with post-traumatic stress disorder has been approved by the federal government, but state money to conduct that research at the University of Arizona is blocked at the capitol. Joining us now Dr. Sue Sisley, who received federal permission to conduct the study. It's good to have you here. Thanks for joining us. What exactly does your study look at? Or will your study look at?
Sue Sisley: It's a randomized control trial looking at 70 veterans who have treatment resistant post-traumatic stress disorder. So that means they failed at least two different medication trials and failed psychotherapy. We're going to be providing basically they'll be randomized into 5 dosage option and they'll also be randomizing to a smoking group or a vaporizer group.
Ted Simons: There this is a three-year study?
Sue Sisley: Yes.
Ted Simons: What kind of marijuana are we talking about? Smoking, vapor, extracts?
Sue Sisley: It's actually whole plant medicine that's purchased from the national institute on drug abuse. They're the sole supplier for any marijuana for any FDA approved studies. So we have to buy it from them and it gets mailed out to investigators in these rolled cigarettes and we teach the patients how to utilize it according to a very strict scientific protocol.
Ted Simons: The FDA and NiDA both on board with this?
Sue Sisley: Yes. FDA, NiDA, public health service and the University IRB, institutional review board.
Ted Simons: Post-traumatic stress disorder is not qualified for medical marijuana in Arizona. Why?
Sue Sisley: Well, there's really not enough of the high level data that the health department needed to persuade them this was worthy. So this trial, our trial would be the first randomized control trial of its kind looking at the use of marijuana in treating post-traumatic stress disorder. So we're hoping that once the study gets implemented it will be able to answer these questions that the health department has, our medical community is struggling and certainly to help patients.
Ted Simons: Are there similar studies in the pipeline elsewhere around the country?
Sue Sisley: Not very many. The progress on research has been stymied by a lot of different federal regulations that require a lot of red tape, particularly the public health service review. Marijuana is the only schedule one drug that has the second review by public health service. So after FDA approval, any other schedule one drug like LSD or ecstasy just moves to be implemented. But marijuana has the second redundant review nobody can really explain why it's there, it seems to be evidence of science being trumped by politics.
Ted Simons: So now you've got the study all set to go, you've got the feds saying give it a shot, how much would the study cost?
Sue Sisley: It's looking like it will be about a million dollars at this point. Because you have to purchase that study drug from NiDA that's very expensive to manage all the regulatory oversight that's required. It's going to be -- The budget looks to be a million.
Ted Simons: $300,000 a year?
Sue Sisley: Yes.
Ted Simons: With that in mind, this research, the money for the research is being blocked at the capitol. What's going on there?
Sue Sisley: The funds we're talking about is a surplus fund that is voter protected. It was generated by selling medical marijuana I.D. cards to patients, and collecting licensing fees from dispensary owners, and the money, it can't be swept by the legislature, and so it's been accumulating for years, and it's up to almost I think $7 million. We've been asking the Arizona medical association has been asking for the last two years to allow that money to be utilized for marijuana research. Our argument is it's negligent for our state to sell 50, 60, 100,000 cards to our patients and not actively conduct medical marijuana research simultaneously.
Ted Simons: And it is being blocked by one particular lawmaker?
Sue Sisley: Sure. Senator Yi was the chair of the education committee that had the opportunity to hear the bill. But because she chose not to put it on the agenda, the bill never was able to proceed and so this is frustrating for a medical community, we're stuck as gate keepers for a medical marijuana program and we have no data to understand how this drug is absorbed, how the to counsel patients.
Ted Simons: If the study is a million dollars and you have $300,000 a year, whatever the case may be, are there other ways to fund it, just say forget the state money?
Sue Sisley: We have tried to apply to private foundations, talk to private donors, but nothing has come up yet. And I think this is the most sensible fund to utilize, because it's generated by the people who were actually actively using this plan. And I think they're desperate to have access to this data, the patients want high level science to understand how this medicine should be dosed, what strains are best for what illnesses, so there's really a big outcry in the public and I think that's what you're seeing at the legislature.
Ted Simons: I know senator Yi says that she -- And I think she sponsored a marijuana study on campus last year, so it's not like she's not immune to the problem or doesn't understand it, but she says it should not be a priority for state funds.
Sue Sisley: Well, and we were proud of her, she championed that bill last year that enabled marijuana research to be legal on campuses, which is tremendous. But for some reason this -- Things have changed since our last legislative session, and unfortunately -- I'm hoping we can persuade her that this is a surplus fund that is voter protected. It's not part of the state general fund in the theoretical way. So the support for proceeding with marijuana research is so prominent at this point. Our veteran community has been -- There's a huge groundswell of veteran support for this, and I think that's really what enabled the study to get green lighted by the federal government in the first place, was this veteran outcry saying, look, we're suffering. We're not able to be functional, none of the meds we have available through the V.A. or otherwise are working for us, or they have terrible side effects.
Ted Simons: As a scientist, a as a doctor, are you ready to do this study and are you prepared if the study says, huh-uh. This may -- Initially maybe X, but later down the road this may not be the best thing for PTSD.
Sue Sisley: Absolutely. That's the beauty of FDA approved protocol. There is -- This is objective data we're generating. I'm a blinded investigator, I don't know what patients are getting. None of the people participating in the study will have any information about that. So all the data collected will be in the most objective fashion. There's internal and external controls, and auditing that's very severe. So to allay concerns about -- From the extremists who are afraid this research is somehow going to promote legalization, we invite them to come over to the university and see just how rigorous this reserve is and how it's conducted.
Ted Simons: 30 seconds. What's next?
Sue Sisley: I think the DEA permit comes up next, and then the U of A has done a great job of shoring up all the logistics, finding us a site. And so we're looking forward to launching this summer. We're going to put out our publicity to let veterans know, hey, the study is available to you, come get screened.
Ted Simons: All right. We got to stop it there. It's good to have you here.
Sue Sisley: Thank you, sir. Appreciate it.
Ted Simons: That is it for now. I'm Ted Simons. Thank you so much for joining us. You have a great evening.