Ted Simons: A director of the Arizona department of health services has decided no to the expand the state's medical marijuana program to cover new medical conditions. The department was petitioned to add migraines, depression, anxiety and posttraumatic stress disorder, but citing lack of scientific data about benefits and risks the department denied those requests last week. Here to explain that decision is state health director will humble and in opposition, Dr. Sue Sisley. She's part-time faculty for U.A. College of medicine where she is trying to start a study using marijuana to treat PTSD. It was your decision. Why not include PTSD, stress disorder, anxiety and migraines?
Will Humble: I'm a big believer in using scientific evidence to help drive decisions like this. So that's pretty much what we did. We looked at the scientific literature, the published works of scientists around the world, and we looked at the evidence. We hired UofA to do some work for us as well. They looked at the series of studies out there and I had my medical review team at the department of health services, physicians in the department, look at that evidence. They gave me a recommendation. I reviewed the studies and bottom line, I just didn't see the kind of scientific evidence that I need to add those medical conditions to the list. By the way, it's a permanent add. When a director adds something like PTSD to the list, it's there for good. There's no way of pulling it back if later scientific evidence suggests in fact it's harmful. Or doesn't help at all. So there was just a lack of evidence.
Ted Simons: Lack of evidence, not enough evidence. Why is that not a good enough reason?
Dr. Sue Sisley: I think bottom line is that the federal government stymies all this marijuana research. So by setting up a standard saying that you only will accept randomized controlled trials as the ultimate guideline of whether to add conditions sets an unattainable standard for our community. I take care of these patients every day. I'm sitting with patients and their families who are trying to put their lives back together, dealing with PTSD, and most of my patients are combat vets, first responders. Police and fire who have been injured in the line of duty. These folks are going to be -- they are not going to have legal protection under the medical marijuana program. I think that's very disappointing.
Ted Simons: What about the idea that you're looking for the kind of research that no one does because there are so many restrictions?
Will Humble: Well, so in the world of science there's a gradient of studies. At the top, really the top of the pyramid are these randomized controlled clinical trials which is the gold standard for public health and medicine. If there were data in that category that would be the best. If there was data, randomized trial, controlled for compounders, you could say, I can hang my hat on that. But that's not the only kind of study that’s out there. There are things called observational studies which I know it's inside baseball to most viewers but in the world of science there's observational studies which don't meet the same standard as that sort of gold standard study but still can provide really valuable information. We looked at the evidence like I said, looked at the published works and there's not much in that observational category either. Those are much easier to do. Because there are sixteen or so states that have medical marijuana programs. that's your cohort.
Dr. Sue Sisley: I'm focused on PTSD because I participated in that petition. I can tell you that, because these patients are not afforded legal protection it's impossible to recruit patients in to an observational study where we're asking them to come out of the shadows and declare they are using this drug illegally. They live in fear every day of arrest and prosecution. So to ask them to be recruited into a study even if you say it's confidential, if you can guarantee, maybe you can talk to the governor, ask her to guarantee legal protection for these patients so they can participate in an observational study I would welcome it. We would help you. Maybe you could fund the study. Director Humble has done such a good job managing the program, he's accumulated over a $5 million surplus. That could easily be used to sponsor these legitimate trials that he's requesting from the community.
Ted Simons: What about that?
Dr. Sue Sisley: Well, the fund is limited by law. Voter approved language says to implement the program. So we can use the money to implement the program. That means when we get the dispensaries coming online we're going to hire an accountant to look inside their books to make sure they are truly nonprofit. There's a series of things we can do with it. Research at least the way it's defined right now under the law really crosses that boundary. But it could be changed. Takes three-quarters in the legislature. It could be changed but right now the way the law reads we're kind of restricted.
Ted Simons: Without that research, any kind, whatever the strata of research we're talking about here, without that is there not a concern that there could be a placebo effect? Is there not a concern that in some cases you could be doing more harm than good having some of these folks being prescribed marijuana?
Dr. Sue Sisley: Absolutely. There's no question that we need more research and that's why I think -- we do have things to look at. We have, for instance, two states who have already approved PTSD. In New Mexico, they have had it on the books since 2009. The sky hasn't fallen. All the dire predictions have gone unfulfilled. I think what's interesting is that marijuana has remarkably low toxicity. It's much safer than many of the drugs that we physicians prescribe every day. An example is the fact that our own poison center, the manager of the Arizona poison and drug information center in 2010 reported that of 65,000 calls that they received, only 26 concerned marijuana. You can see that when people have a reaction it's minimal and generally I think that what we are here to advocate for is more research. I would really welcome the opportunity to partner with director humble to go to the DEA, to our elected officials and stand shoulder to shoulder with us so we can urge them to eliminate the barriers to legitimate high level rigorous scientific study.
Ted Simons: Before the decision you heard from a lot of folks, a lot of patients, a lot of doctors, a lot family members. They are convinced placebo or otherwise, convinced that this helps them. Did you not totally believe them?
Dr. Sue Sisley: No, yeah. We had a bunch of folks that came to a public hearing. I believed all of them. They looked really sincere. Their stories were compelling. But with a job like mine, you're in charge of making policy decisions like that, you -- I feel like I really need to look at the full scope of scientific evidence. You know, individual testimony is one kind of evidence, a case report is one kind of evidence. But to me, it doesn't cross that line at least for me professionally to say, okay, I'm going to make that leap, add this to the list for good in the absence of good, solid studies. So your point is well taken that there is this absence of studies. It is true that by virtue of the fact marijuana is on schedule 1, the top category most restrictive category, that the federal government is restricting studies and it’s not a high priority for NIH. So there are barriers in place. They are federal barriers, not really an Arizona thing.
Ted Simons: With those barriers in place, it is what it is, to coin the phrase, you still have things like migraines, chronic pain is covered by medical marijuana. I know anxiety an amorphous, PTSD with be vague, but can you not find ways to deal with those patients with what is already covered?
Dr. Sue Sisley: Well, the struggle is that we have worked so hard to make this an exemplary medical program and we're trying to train physicians who participate in the program to strive for the highest ethical standards. So I don't want to then encourage docs to maybe be vague about the diagnosis or fudge it in a way to fit into a category. We want these people to perform in the most exemplary way.
Dr. Sue Sisley: You brought up migraines. And that’s a good one to bring up. That was the one that was really stood out as different than the others in the sense that migraines by their very definition are severe. In order to qualify as a condition, any condition can qualify if it causes severe and chronic pain. Not “or” but “and”. So if a clinician believes that the migraine is causing severe and chronic pain, that's an appropriate treatment for that patient, migraines are a fine diagnosis. My challenge was to add questions to add migraines per-se in the absence of severe or chronic pain and just the data wasn't there.
Ted Simons: With that in mind, last question for you, why not err on the side of the patients, the side of those in pain?
Dr. Sue Sisley: You know what? By using science you are er ring on the side of patients. That's my opinion. The scientific method has gotten us to where we are today in public health and in medicine. I'm not going to abandon the basic principles of using research to make decisions because of stories you might have heard at a hearing.
Ted Simons: Last question for you. Why not wait until more data comes in, until the state and whoever makes the decision is ready to say, we are willing to make this commitment? They are not saying no forever, just for now.
Dr. Sue Sisley: Well, we have to wait now because the petition has been rejected. In the meantime I hope director Humble will step up as a result of this discussion and go arm and arm with us down to our congressional delegation and help us eliminate those barriers to the very research that you're demanding from this community.
Ted Simons: All right, we have to stop there. Great discussion. Thanks for joining us.
Will Humble: Thank you.