In part one of A Nation Addicted, we learned the opioid epidemic has grown exponentially worse over the last 15 years. For years, doctors and patients have continued the cycle of prescription-to-addiction with a cognitive dissonance that is astounding. While the nation is now painfully aware of the addictive and potentially fatal consequences of opiate painkillers, the trend of abuse and fatal overdose continues to snowball out of control.
How can we break the cycle of opioid addiction once and for all?
A surgeon from Hartford, Connecticut who is currently leading a groundbreaking research study on acute pain may have the answer.
In the Fall of 2016, Connecticut Governor Dannel Malloy signed new legislation for expanded medical marijuana research. Malloy also announced the Department of Consumer Protection would approve a revolutionary study at Hartford’s Saint Francis Hospital. The first-of-its-kind research would focus on medical marijuana’s ability to treat acute pain in patients with broken ribs, an injury that typically results in an extended prescription to oxycodone or other opioid painkillers.
St. Francis Hospital estimates the initial phase of the study will take roughly eight months, as the study requires 60 very specific patients. Hopeful participants in the study would need to have broken ribs and no history of heroin addiction or habitual cannabis use. Once the first phase of the study is complete, the research team will then conduct a randomized control trial with around 300 patients over the course of 18 months.
We spoke at length with Dr. James Feeney, the trauma surgeon leading the St. Francis marijuana study, to gain insight on the opioid painkiller crisis, marijuana’s viability as a replacement, and what this study could mean for the future of medicine.
Marijuana.com: Why patients with broken ribs?
Dr. James Feeney: Well, it’s a good, clean model for pain. We have a good idea of how to treat it, we know how much medication they technically require and for how long. So it’s a good way to treat something that we know is painful but doesn’t often masquerade as a different problem, and you know it’s painful for about six weeks.
Marijuana.com: How is the study going so far?
Dr. James Feeney: So far, it’s going great. I’d say we’re probably at around 10 patients right now. We’re looking to enroll a total of 60, and we had a couple more come in last night that might be candidates. But we have to wait and see, we’ll see.
Marijuana.com: Even in the event that medical marijuana wouldn’t be used as a replacement for opioid painkillers, could you see a scenario where it may be used as a supplemental treatment so that maybe fewer opioid painkillers could be prescribed?
Dr. James Feeney: That’s absolutely something that can happen and it’s actually one of the things that we’re looking at. We have to do this study in phases and the first phase of the study is: is it safe and effective? There’s very little quality data on acute pain and marijuana right now. There’s a fair amount of data for chronic pain, but not a ton for acute pain. The next phase is going to be, can we use it to supplementally replace or completely replace opioid pain medications? That will be the randomized control trial where people don’t really know what they are getting.
Marijuana.com: What consumption method is being used in the trial?
Dr. James Feeney: Right now, we are using a pill that’s 10mg of THC and 10mg of CBD. Then, we can escalate them from there to 20mg and 20mg. I don’t know that we have actually had to escalate anybody to 20/20 yet. But we’re following a very defined dose escalation protocol, so these are just pills at this point. We’re also using a sublingual spray for breakthrough pain.
Marijuana.com: What do you know about the source material the pills originated from, as far as where it was grown?
Dr. James Feeney: These are all being cultivated by the growers that have licenses in Connecticut to provide medical marijuana within the state. We have one producer that’s making the pill and a different one that’s handling the spray.
Marijuana.com: So the CBD is whole-plant derived versus a hemp-based alternative?
Dr. James Feeney: Correct.
In a study that aims to demonstrate the efficacy of medical marijuana in comparison to opioid painkillers, the distinction between using medicine sourced from whole-plant matter versus synthetically generated cannabis compounds is crucial.
The pharmaceutical community has tried to appease medical marijuana advocates for decades by parading out synthetic cannabis substitutes one after another with little success. Initially, scientists thought that isolating THC and delivering a lab-produced copy in pill form would allow patients to experience the same therapeutic effects reported by whole plant cannabis users.
Dr. Sanjay Gupta addressed this topic while explaining the origin of Marinol, an FDA-approved synthetic THC pill that was made available for patients undergoing chemotherapy.
“When the drug became available in the mid-1980s, scientists thought it would have the same effect as the whole cannabis plant,” Dr. Gupta told CNN. “But it soon became clear that most patients preferred using the whole plant to taking Marinol. Researchers began to realize that other components, such as CBD, might have a larger role than previously realized.”
Our own Dr. Bonni Goldstein also explained the importance of utilizing the whole plant in her recent book, Cannabis Revealed.
Not all of the phytocannabinoids have been thoroughly studied, but those that have are found to have their own medicinal effects when isolated from the other phytocannabinoids. When used together as they occur naturally in the whole plant, they balance each other in a synergistic action first called “the entourage effect” by Raphael Mechoulam, PhD. Dr. Mechoulam, an Israeli researcher, was the first to isolate THC and CBD in the early 1960s. The “entourage effect” means that the cannabinoids work better together than when isolated from one another. The synergy can enhance effects or modulate effects beneficially.
Example of synergistic enhancement: both THC and CBD, when given separately, have been found to have pain-relieving properties, but studies show that CBD enhances pain relief when used together with THC, compared to THC used by itself.
Example of opposing effects: CBD can decrease psychoactivity, memory loss and the increased heart rate THC can induce.
Marijuana.com: Piggy-backing off of the recent Center for Disease Control study, what are your thoughts on the shift of opioid painkiller use to more harmful variants and how it’s prescribed?
Dr. James Feeney: Yes, I’m looking at that study right now, it is pretty interesting. I started medical school in 1996 and when I was in my first and second year, they introduced us to what was at the time a pretty new concept, pain as the 5th vital sign. It was just around this time when doctors were starting to take a real interest in a patient’s pain levels at all times. There was more of an emphasis on treating pain appropriately, but over the years of my training, what I’ve seen is that idea that pain is the 5th vital sign become more and more institutionalized; to the point where one of the questions nurses ask when a patient is admitted to the floor is, “what’s your pain score?” and patients all know exactly what that question means.
That probably started around the mid to late-90s and then turned into a line item on the patient’s bill of rights which was the patients have the right to adequate pain control. You have to think about that for a second because signs are something that doctors measure. In those intervening years, we completely took away the role of the physician to say to a patient, “I understand that you’re having a little bit of pain. I can’t take your pain completely away, but I can take the edge off.” My goal is to take the edge off a little bit so that you can function a little better in your daily life. Instead, we said, “you get to now decide if the pain control I’m giving you is enough,” and if the answer is “no,” then I have to give you more because it is a construct that we’ve developed in the patient’s bill of rights.
Over the last 10 or 15 years, we started tying physician compensation to how well they perform on patient satisfaction surveys. After a patient takes a survey, about 60 to 70% of those questions asked have to do with pain control. We really put ourselves into a corner when it came to pain control and the only thing we really have at our disposal to treat pain is opioid medication.
Marijuana.com: What role does Big Pharma play in that construct? We are one of only two countries that can do direct to consumer drug advertising, so where does the cycle start and end?
Dr. James Feeney: I think Big Pharma plays two very important roles, that’s a great question. The first one is that they have a stranglehold on this market. No one else can produce or market the medication we need for pain control, so every tiny bit that is sold is profit for these organizations. The other reason is they have a very sophisticated lobbying group within the federal government and within state government that really helps control law and policy.
If this study demonstrates a benefit that marijuana is effective in acute pain control, and states start changing their laws to allow marijuana to be used for pain control in acute situations like broken bones, postoperative situations, that’s a huge profit loss for the Big Pharma corporations that right now have a corner on the market.
This is ‘Who Killed the Electric Car’ all over again.
While medical marijuana legislation has made immense progress in recent years, it still isn’t legal for all Americans, and some states that have medical marijuana laws do not include pain as a qualifying condition for acceptance into the program.
Take a look at the states with the most opioid painkiller prescriptions per 100 people and you’ll see that the highest concentration occurs in places with the most outdated cannabis laws on the books.
Places like Kentucky, Ohio, West Virginia, and Tennessee not only dole out the most prescription painkillers but also experience some of the highest rates of overdose fatalities.
Marijuana has long shown its viability as a combatant to chronic pain, but the Hartford study aims to prove it can provide therapeutic relief to patients with more intense acute pain as well.
Marijuana.com: Is the future of medicine, however far off, homegrown marijuana — at least for acute and chronic pain?
Dr. James Feeney: I don’t know if that will ever happen but it’s kind of a fascinating concept that, if we’re going to do this, the first thing is we have to do this with good, strong science. I think that’s the best way to do it. And good, strong science is not that far off.
In order to fund this study, we have to provide the medication. All of the organizations that we’ve gone to in search of funding, they’ve all said, “No thank you.” So what we did at St. Francis is our own surgeons, who care for people with broken bones and big trauma operations, are funding this project out of their own pockets.
Marijuana.com: In October, Governor Malloy signed new legislation that expanded research for medical marijuana. How important is it that, going forward, bureaucracy doesn’t impede what could be good medicine?
Dr. James Feeney: There’s really only one state in the Union that we can do this research in and that’s Connecticut. First of all, we’re the only state that has a medical marijuana program that is medicalized enough to allow us to do the randomized controlled trials that we need to do. Second, Connecticut has a state licensing system in place that allows researchers to apply for a license to do this research so that we can legally, at least via the state, look at expanding the role of medical marijuana. It’s the only place in the country we can do this research.
Marijuana.com: You said your fellow surgeons at St. Francis were supporting this research financially. Have you had this strong show of support from the get-go or did you have to convince a lot of people?
Dr. James Feeney: When I first heard the call for research, it was late Summer, early Autumn. I went to my business partner, sat down in his office and said, ‘Hey David, what do you think about this idea?’ and he laughed at me and said, ‘The hospital is never going to go for it, it’s a Catholic hospital. They’re never going to go for that.’ I replied, ‘listen to this for a second, just think about this. What a hot button topic this is, what a huge problem opioid addiction is and we can end it right here in St. Francis Hospital in Hartford, Connecticut and take the first step in ending this epidemic.’ He kind of laughed at me and said, ‘that’s never going to fly’ and walked away. Then he came back a couple of hours later and said, ‘I couldn’t stop thinking about your idea. I went on the internet, I did a little bit of reading and you know what? Damnit, you’re right. I think we should at least run it up the flagpole and see who salutes it.’
So we went and had a meeting with our regional director and we went and had a meeting with our chief medical officer and we sat down with the president of the hospital. I prepared maybe a five-minute spiel on why this was a problem and how marijuana as a solution to the opioid epidemic might work. Before I even got halfway through, everybody was like, ‘oh my God, what a great idea.’ We couldn’t even believe we were not doing this already, how could we not be doing this already? And that was all it took and when I threw out the idea to my partners, they were all like, ‘This is fantastic’ and they all started making extra donations to a foundation. Everybody was on board pretty much from the start.
Marijuana.com: Do you think, on the government side of this, the simplest first step could be just taking a more common sense approach to the Controlled Substances Act and descheduling marijuana to make it easier to conduct meaningful research on it?
Dr. James Feeney: That is precisely what needs to happen and that is precisely why Connecticut is allowed to research medical marijuana, because that’s Schedule I. The federal government refuses to schedule marijuana as Schedule II because they say, ‘Well there’s no data for any efficacy and because there’s no data, we won’t change the schedule.’ I always say we want to research it and get the data and they say, ‘You can’t, it’s schedule one.’ So they use that vicious cycle and I am reasonably sure that Big Pharma is at least part of that decision. These big foundations that will support medical research won’t support this. So we are supporting this ourselves.
Marijuana.com: Are you limited in where you can source funding, or is it open to anyone?
Dr. James Feeney: We’re opening it up to anybody, I mean, we are essentially crowdfunding it right now by ourselves. We don’t really have an infrastructure to put up a GoFundMe page, that’s why we’re doing it through the St. Francis Foundation. We just set up a research foundation and donated to it ourselves to be able to do this project.
Marijuana.com: What are your thoughts on insurance embracing marijuana?
Dr. James Feeney: That would be fantastic. The medical marijuana for our project is costing about $600 per patient. We’re going to do 60 patients, so do the math — it’s going to be about $36,000 just for the marijuana, give or take. When it comes to the control arm, which is just opiates, patients get those covered through their insurance company. We don’t really have the option to say, ‘We’re going to submit this bill to your insurance company and they’re going to cover marijuana.’
Marijuana.com: The VA has had its fair share of issues as far as overprescribing opioids for a wide range of ailments. What are your thoughts on the VA and their refusal to accept medical marijuana even where it’s legal?
Dr. James Feeney: Personally, I know many of the men and women who work in the VA and the physicians and the people who are employed by the VA to try to take care of vets. They, to a person, every single one of them to my knowledge, always have the best interests of their patients at heart. They are physicians, nurses, nurse practitioners, physician’s assistants, etc., who care deeply for their patients and they want the best for their patients. Just like anybody else, they work in the system and there are certain rules they are obliged to follow. I understand that and I can’t hold that against the people who are doing it.
What I would suggest is that of all the medical institutions in this country, not one, not Harvard, not The Cleveland Clinic, not The Mayo Clinic, not Kaiser, not one organization that has a more robust research institution within their medical institution than the VA. The VA has access to hundreds of thousands of patients and has access to their entire system, if the VA wanted to do this study looking at the efficacy of medical marijuana they can do it better, easier, with larger numbers, quicker than just about any other organization I can think of. I’m a level 2 trauma center in the middle of Hartford, Connecticut, I get about 3,000 trauma patients a year. Of those 3,000 trauma patients a year, maybe 160 to 200 have isolated rib fractures. That’s about it. The VA can do this study in six weeks, maybe 12 weeks if they implement it across the nation. What’s going to take me a year, they can do in three months if they wanted to. That would be my request to the VA, to put their research prowess to work on this question.
Marijuana.com: Do you attribute that primarily to the monetization of pharmaceuticals in this country?
Dr. James Feeney: I do. I really do. I may sound like a little bit of a conspiracy theorist, but I really do — I believe that’s exactly what it is. I think it’s Big Pharma and their lobbying efforts trying to keep these medications from being studied properly. What we’re using instead of medical marijuana is really heroin. This is schedule II and we can see it.
Marijuana.com: When I was looking at the CDC study, it’s unbelievable to think there are all of these drugs that cause a significant percentage of overdose deaths in America, but most of them are scheduled below marijuana. It’s unreal.
Dr. James Feeney: Right. This is not what’s best for our patients and as a medical community, we kind of made a mess for ourselves. I don’t think anybody was trying to make a mess, I don’t think there was anything nefarious going on. We are genuinely trying to do a better job of taking care of patients. But, we did it with incomplete tools and we put ourselves in a position where we’ve at least added to an epidemic across the country of opioid abuse and overdose deaths.
If you would like to contribute to the trailblazing research being done at Saint Francis Hospital by Dr. Feeney and his team, email Traumaresearch@stfranciscare.org. Any contributions are greatly appreciated by the research team and patients involved.