Vital Signs » Winter 2018
In less than a year, medical marijuana will be legal in the state of Ohio. There are those who support the move, made by the state legislature, and those who don’t. But no matter their position on the issue, much of the debate among those with opinions centers on what’s best for patients. The most discernible difference comes in defining what “best for patients” actually means. It’s not an easy question, and the reality is that the answer varies depending on who is asked. Further reducing clarity, there has been little research into the effectiveness of marijuana for most illnesses because of its federal designation as a Schedule I drug by the Drug Enforcement Administration.
So even though a patient may find personal benefit for symptoms, in most cases there are few supporting scientific studies. And that is where some see a common belief — that those using medical marijuana are just abusing the system so they can get high legally.
“A lot of progress has been made, but there is still a weird stigma,” said Shaughnessy O’Brien, 33, of Seattle. Once a research associate at Indiana University, he suffers from Crohn’s disease with chronic abdominal pain and diarrhea. “I don’t get that from anyone who knows me or knows how sick I have been, but I notice it more from people in states that don’t have medical marijuana and who have a limited frame of reference for it."
O’Brien has used marijuana to help treat his symptoms for years, and it has helped immensely. Before moving to Washington, he had to use fentanyl patches to continuously manage his pain.
“As a long-term solution, marijuana has given me better results with fewer side effects across the board,” O’Brien said. “It’s not physically addictive, it isn’t as mentally incapacitating, and it actually helps the underlying conditions responsible for my symptoms.” Crohn’s is one of 21 qualifying medical conditions laid out in the Ohio bill legalizing medical marijuana, House Bill 523. Like most on the list, including the likes of Alzheimer’s, cancer, glaucoma, and multiple sclerosis, there aren’t proper double-blind, large-sample studies with controls for standards of care that prove marijuana’s effectiveness in treatment.
The lack of data is the focal point of much debate surrounding its legal use. Physicians struggle with this ethical question: can it be called medicine if it hasn’t been thoroughly tested, studied, and approved for use in humans by the federal government?
“As a physician, when I have something that’s called medicine in the United States, it’s a product that the Food and Drug Administration has evaluated and looked at research that looks at the safety and efficacy and says that these are better than somebody taking a placebo or essentially a sugar pill,” said Glen Solomon, M.D., professor and chair of internal medicine and interim chair of neurology at the Boonshoft School of Medicine. “So when I prescribe an antibiotic for you — if I were to give you penicillin to treat your infection, I know that penicillin has been studied in that infection and that it works, that it’s safe to give or at least we know what the side effects are. And third, that the manufacturer has met with the requirements such that when it says penicillin on the bottle, you’re not getting something else."
O’Brien believes that what he purchases in Washington is pure because of “hands-on and transparent” production. Dried or cured flowers work best for his condition, and so quality standards are not nearly as complex as those for pharmaceutical drugs. He credits competition among vendors and quality controls such as marking each bag with a grower identifier, batch number, and harvest date, for ensuring quality issues are addressed.
Solomon’s interest in the subject has recently increased because his patients keep asking about it. As a physician who specializes in treating headache, he knows that these conversations will only become more common and wants to prepare medical students and other doctors to give the best advice possible.
He’s helping to launch the Medical Marijuana Task Force in the Department of Internal Medicine. It will educate medical students, residents and physicians about the evidence concerning medical marijuana so they can decide if they want to recommend it to their patients. And that is all they can do — it can’t be prescribed in Ohio because of its federal status.
“It was something we decided we needed to put together. The patients are going to ask,” Solomon said. “Either you work from knowledge or you work from ignorance. It’s usually a lot better to work from knowledge.” He notes that the positive experiences of a few users are essentially testimonials. There’s not much evidence there, outside of personal opinion, to sufficiently prove the effectiveness of marijuana for medical use. How, then, can physicians confidently recommend it to patients? To the best of his knowledge, the only disease that marijuana has been clinically proven to treat is Dravet’s disease, a seizure disorder.
“They may have seizure disorder on the list. That is the only disease that it has been shown to work better than a placebo, in children, and it’s rare,” Solomon said. “There is no other disease in which there’s been a study to show that marijuana is effective. So, obviously I have problems with calling this stuff medicine."
O’Brien doesn’t have much of an opinion on the medicine designation. He can only speak from his experience.
“We consider corticosteroids and opiate-based pain management to be medicine, but marijuana has allowed me to avoid both of those for years now while providing a considerably more livable quality of life for me,” O’Brien said.Steve Huffman, M.D., ’95, the Ohio state representative who sponsored House Bill 523, is more concerned with giving patients the option to use the drug for their ailments.
Huffman completed his family medicine residency at Wright State University and now works as an emergency room physician. He is the first person with an M.D. degree to be elected to the Ohio General Assembly. The achievement gave him the ideal platform for sponsoring the bill. “Being a physician and with my background, I wasn’t the one who went out and said, ‘Look, I want to do this or I’m the big marijuana doctor,’” Huffman said. “After studying this as a group, the House said, ‘Hey, look, you’re the guy to do this because we’ll get more traction from a doctor than somebody else.’"
The bill was passed less than a year after Ohio voters rejected a statewide ballot initiative seeking to legalize recreational and medical marijuana. The measure would have granted a few growers a monopoly on producing marijuana in the state. The circumstances of its passage appear suspect to Solomon and others who believe the state is only seeking more tax revenue.
“The state charges a very large sum of money for people applying to run a dispensary or be a grower of marijuana,” Solomon said. For growers, of which there will be 18 in the state, the licensing fee is $200,000 each, payable in cash because of federal banking restrictions, to the Ohio Department of Taxation. “The state will make a very large amount of money and I think that was probably the driving force behind this."
Huffman says the state will see benefits from taxing marijuana growers and dispensaries. They will be taxed as any other business in Ohio, he argues, paying things like property and income tax. The sale of medical marijuana itself will not be taxed because the state constitution forbids taxing medicine. For some background, O’Brien has seen recreational marijuana taxed as high as 37 percent in Washington. Ohio will not see tax rates that high, at least in the near future. And Huffman makes the case that the new law achieves a more ideal outcome for Ohio voters.
“A lot of passing House Bill 523 was to keep recreational marijuana out of the state of Ohio,” Huffman said. Just a few days after the bill was voted on in the Ohio senate, he noted that a major marijuana legalization advocacy group ended its push for recreational approval. “If you look at what’s happened in other states, they will get recreational and medical approved. And many people only want medical, but when they can only vote on one thing, medical and recreational, they vote to keep both of them. And so House Bill 523 was to prevent the two from getting lumped together and getting approved."
The infrastructure that it puts in place is extensive. The bill sets up a medical marijuana system from the ground up, taking into consideration the legalization efforts that have already taken place in around half of all American states. The bill establishes, among other things, the list of qualifying medical conditions, definitions for what is medical marijuana — the smoking of marijuana doesn’t make the list, though vaping does — and medical education requirements for physicians.
“The bottom line is you need to have a license in good standing and you need to take two hours of medical education about the use of medical marijuana. These are not real stringent requirements to put it mildly,” Solomon said. He questions how state lawmakers came up with the list of qualifying conditions.The bill also establishes quality standards for growing medical marijuana, which other states don’t have. This includes restrictions on pesticides used and standards for drying it out to avoid mold. It requires that all marijuana sold in Ohio be grown in Ohio, sets up protections so that businesses relying on government contracts can continue drug-free workplaces, and also lays out the steps patients will have to take to get it.
“Washington state’s medical program is limited to certain conditions, such as cancer, glaucoma, Crohn’s disease, intractable pain, PTSD, etc.,” O’Brien said. “If you have one of these qualifying conditions, you ask your general practitioner or a specialty clinic doctor to fill out an authorizing form for you. You take that form to a medically endorsed dispensary, and they will help you find products that work for you.” It took O’Brien a while to figure out the right ratio of THC, the compound providing most of marijuana’s psychological effects, to CBD, a compound believed to have medical benefits. He has had the most luck with a higher level of CBD about five times that of THC. “I am better able to absorb nutrients from food with less pain,” O’Brien said.
The steps he goes through to obtain marijuana are similar to what patients will do in Ohio. But only physicians who have an ongoing, primary care relationship with the patient will be able to make the recommendation to use medical marijuana. Nurse practitioners, physician assistants, and other health care workers outside of those with M.D. or D.O. degrees will not be able to make recommendations. Huffman won’t be recommending medical marijuana to anyone.
“I do not plan to be someone who recommends it because I practice emergency medicine,” Huffman said.
“By definition, you don’t really have an ongoing relationship with the patient in the emergency room. So I don’t plan to. I have never recommended it or done any research into medical marijuana.” It’s not a recommendation that Solomon can make with confidence. It’s not clear that it’s the best option for patients, and there are side effects to using marijuana. Since it’s not well studied, what they are isn’t clear. Besides, there are experimental treatments in development that could possibly work better.
“There will be people who choose to use something that’s never been shown to work instead of medications that have been shown to work for these conditions,” Solomon said. “And so people will suffer needlessly because they’re not getting the appropriate treatment because they’re choosing medical marijuana. Or people will have a limited budget and they’ll decide, ‘I’d rather do marijuana gummies than fill my prescription.’"
O’Brien is most concerned with alleviating his pain. “If I had to choose between gummies or opioid pain meds, gummies win hands down,” he said. “I think people might actually be smart enough to make that determination for themselves."
All patients who obtain a medical recommendation will have to register with the state and will receive a medical marijuana card. Their green light to use marijuana to treat their ailments will last one year, after which they will have to get another recommendation. There are also limits on the amount of marijuana one can get depending on the strength of whatever marijuana mix they’re buying: oil, patches, ingestibles, etc.
“So what happens if you have a recommendation for using marijuana and you get arrested for marijuana possession? You have an affirmative defense if you’re registered and have a physician’s recommendation,” Solomon said. “That’s really what this is about. This is a legal defense in court that says you won’t get arrested for marijuana possession.” The bill has flaws, but Huffman believes that the Ohio approach will be the model for the last half of states to legalize medical marijuana.
“We had a lot of experts from those other states come in and say, ‘We screwed it up here or this is what we’ve done well.’ And we kind of patterned Ohio after that,” Huffman said. “I don’t think it’s perfect. Some people say that we’re too restrictive. Some people say we’re not. But I think we have found a good balance to keep it what it is truly about, the patients and the medication."
In 2018 or 2019, he thinks that there will be an additional bill to fill in the gaps where House Bill 523 has not succeeded. This “cleanup bill” could attempt to solve the banking problem through a digital currency, such as bitcoin, or provide a way for dispensaries to transfer licenses between cities.Still elusive is reclassifying the drug at the federal level so that it can be researched as fully as needed. Without abundant and clear scientific evidence regarding its effectiveness in treatment, it’s not possible to determine what’s best for patients. And the debate on what’s best for patients will still likely continue.
“It’s possible that this might lead to research. But there’s nothing in any of the bills that promote research, nor is there funding for research as part of this,” Solomon said. “So I do think there will probably be more research because we’re legalizing this, but that certainly was never in the bill as a goal."
Huffman wishes more research could be undertaken, as has been done in Europe where he says medical marijuana is approved for the treatment of seizures and multiple sclerosis. But he notes that federal restrictions are in the way.
— Daniel Kelly