Montana Chemists Bring Quality Control to Medical Cannabis

Montana Chemists Bring Quality Control to Medical Cannabis

In a Bozeman laboratory, Noel Palmer, a doctor in analytical chemistry and co-founder of Montana Botanical Analysis, located in the Bozeman Medical Arts Center, scribbles a series of acronyms and arrows on a whiteboard to show the biosynthetic pathway that’s been the focus of his work for the past year. Palmer’s detailed presentation, professional expertise and fully stocked lab—including the quietly buzzing liquid chromatographer in the corner—suggest the chemist works for a pharmaceutical company.

Not quite, but close.

Instead of test tubes, plastic bags containing cannabis cover the lab’s countertops. Palmer will analyze each one to identify and quantify its chemical compounds, giving Montana medical marijuana patients and caregivers who come to him something they’ve never had before: knowledge of exactly how strong their medicine is, and a better sense of how much patients should take.

It’s the dosing. That’s one area where I feel like our work has really impacted physicians and the general public. Those are concerns that seem to be fairly common. How do you dose this stuff? But you can. We’re here and we’re doing it right now…We can talk numbers. It’s not just some dude who makes cookies in a kitchen. – Noel Palmer – Montana Botanical Analysis

Palmer does indeed talk numbers. He thumbs through a stack of files and pulls out a printout of a recent analysis. The liquid chromatographer detected a handful of cannabinoids—the active constituents of cannabis—with the biggest blip on the chart corresponding to THC, or tetrahydrocannabinol, the main psychoactive and analgesic substance in cannabis.

Patients may have a hard time deciphering Palmer’s printout, but they’d have no problem reading the labels on the dozens of glass dropper bottles containing glycerin-based cannabis tincture on the counter. Just like a pill bottle from a pharmacy, each bottle’s contents are printed on the front. One, for example, contains 13.7 mg/mL of THC, less than 0.2 mg/mL of CBD (or cannabidiol), and 1.8 mg/mL of CBN (or cannabinol). Clients hire Montana Botanical Analysis to not only test samples, but also to create these tinctures—test, package and seal them—thus creating a chain of custody ensuring patients know exactly what they’re ingesting.

Measuring dosage shouldn’t be a lot to ask of a substance that’s been legalized for medical use in 14 states, but efforts to better quantify the makeup of medical marijuana are in their infancy. It’s an area of the industry that, beyond benefiting patients, helps allay concerns of medical marijuana opponents who say the plant isn’t regulated enough to be prescribed as medicine.

I think physicians are uncomfortable with the whole idea of ‘take two hits and call me in the morning. They want to know about dosing. And from a medical-legal point of view, I see where they’re coming from. What are we prescribing to these people? Every other medicine or supplement in the U.S. has a label on it except cannabis. Why? That’s what the inspiration for this was. If you’re going to call it a medicine, you need to treat it like a medicine. If you don’t call it a medicine, then don’t bring us into it. – Michael Geci, Physician

The company, along with Missoula-based CannabAnalysis, stand out as the first labs in the state working to bring scientific rigor to an industry that’s lacked it. And they hope what they’re discovering has the potential to convert even the staunchest opponents of medical cannabis.

Quantifying cannabis

Palmer and Geci bring impressive resumes to their work with Montana Botanical Analysis. Palmer studied ice cores from Antarctica using analytical and spectroscopic methods as part of his post-doctorate work at Montana State University, which he quit to help launch the company. Geci has practiced emergency and integrative medicine, mostly in New York, since the mid-’90s, and is a member of the American Academy of Cannabinoid Medicine.

I don’t think there’s anyone in the country that’s got the intellectual capital to do the kind of work that we do. – Michael Geci, Physician

Geci is referring to the company’s technology and he and his partner’s collective expertise, as well as their relationship with Dutch scientists who have decades of experience analyzing cannabis. The scientists, Geci says, have visited Montana Botanical Analysis a handful of times as part of what he calls an “international collaborative arrangement.” He’s tight-lipped about the proprietary information they’ve imparted, and goes so far as to limit what the Independent can photograph inside the lab.

While Montana Botanical Analysis may be on the cutting edge of cannabis science, similar labs are cropping up in other states with medical marijuana laws, most notably California and Colorado.

They’re absolutely increasingly popular. And they are for pretty commonsensical reasons, and that is that most of us, obviously, when we buy a medicine, [we want to know] it is safe, that it has gone through some degree of testing, some degree of quality control…[Testing] is standard fare for almost everything we consume whether it’s food or drugs. – llen St. Pierre, director of the National Organization for the Reform of Marijuana Laws (NORML)

Testing, though, doesn’t suddenly place cannabis alongside other drugs approved by the U.S. Food and Drug Administration (FDA). In fact, it’s far from comparable. Even if a patient knows exactly the percentages of cannabinoids in a strain, they can’t account for the various methods by which it can be ingested, nor, no matter the method of ingestion, what constitutes an appropriate dose.

Kevin Sabet, special adviser for policy in the White House’s Office of National Drug Control Policy, underlined that point when he spoke at the Montana Supreme Court Administrator’s annual drug court conference in Helena in September. Despite Montanans voting clearly in favor of medical marijuana in 2004, he said it is “not how we do medicine in this county.”

Marijuana cannot be the one exception in the history of the world that doesn’t go through a scientific process to be approved as medicine. It doesn’t make any sense. – Kevin Sabet

But Rose Habib, owner of CannabAnalysis, says FDA approval shouldn’t be the ultimate goal of cannabis proponents.

“The truth is, cannabis doesn’t fit into the FDA box,” she says.

Habib points to the fact that the pharmaceutical industry and government oversight is focused on single-compound pills, whereas cannabis, with its myriad cannabinoids, has a synchronistic effect.

Look at the number of cold relief medications on the market. Each one appeals to a different person. I don’t think it’s fair to say that cannabis needs to be in a very small box in order for people to be comfortable with it. People have found through using it that different strains, different methods of uptake, all these things treat their symptoms differently. And the people who are sick, and the people who are in a lot of pain, benefit tremendously from this product, and they have learned to adjust their dosage and adjust their method of intake to suit their needs. – Rose Habib

Habib believes cannabis is more appropriate for use in over-the-counter products or herbal supplements—”whenever it becomes legalized.”

In the meantime, Montana’s cannabis labs are focusing on how to raise the overall credibility of the drug.

Montana Botanical Analysis tests for more than a dozen cannabinoids—including THC, CBN and CBD—each with different therapeutic effects. According to Palmer, the company has handled more than 1,000 samples this year. Each test typically costs $79, or less for caregivers with fewer than five patients and patients who grow their own cannabis.

Missoula’s CannabAnalysis, which declined to give the Independent a tour of its lab citing a concern over client confidentiality, uses roughly the same liquid chromatography technology as Montana Botanical Analysis. Habib doesn’t put a number on how many tests she’s conducted since she started the company in January, but says she serves hundreds of clients. She charges $125 for cannabinoid profiles, or less for clients with multiple samples. CannabAnalysis, like Montana Botanical Analysis, also makes quantified tinctures. Habib says CannabAnalysis will begin pesticide screening and micro testing–tests for yeast and mold, total aerobic bacteria, and coliform—next week.

A lot of people are entering this industry who aren’t seasoned growers. And a lot of the product they may end up with has pathogenic mold in it, or they’ll use pesticides…and those things can harm patients in the long run. Since we’re dealing with a medical product, those things need to be tested and worked on so people are developing a safe, quality product. That’s my goal. That’s the whole business plan—a safe, quality product for patients. – Rose Habib

Habib counts a biology degree from SUNY College of Environmental Science and Forestry, and professional experience doing environmental remediation testing at the Midwest Research Institute in Kansas City, Mo., along with work in chemistry labs analyzing corn, margarine and nutraceuticals, among her qualifications to study cannabis. She says her work helps eliminate the guessing game patients too often play when they take their medicine.

I provide quantitatively dosed products so you know you’re getting exactly this many milligrams of THC when you eat this. In the beginning, patients didn’t know what that meant. They were like, ‘Well, is that an ounce, or a gram, or is that two grams, half a joint? What is that?’ Well, I don’t know. But you’re going to have to try it and find out and then you’ll come back and say, ‘Okay, I know what 10 milligrams feels like. Now I know I want 20, or only 5.’ They’re learning this process, and that gives them concrete numbers to work with. They’re becoming more educated and they’re using that knowledge. – Rose Habib

What Habib explains sounds like progress to one of the state’s leading medical marijuana opponents. Sen. Jim Shockley, R-Victor, who drafted a bill for the 2011 legislative session that would repeal Montana’s voter-approved Medical Marijuana Act, says the cannabis labs’ work makes him more likely to embrace the burgeoning industry.

“If somebody can quantify the dosage—maybe rationalizing it would be another way of putting it—I think that would certainly be a step forward,” he says.

Beyond THC

Cannabis scientists are helping to pinpoint something that may prove to be far more useful than cannabinoid quantification.

Palmer becomes giddy when his explanation of cannabis’ biosynthetic pathway reaches CBD, a cannabinoid with no psychoactive effects that, therapeutically, may be more promising than THC. He refers to it as “the silver bullet of the modern cannabis movement.”

“It’s not about THC anymore. It’s about everything, the blend. It’s all of these in there,” Palmer says, pointing to the cannabinoids written on his whiteboard. “We think of them working symbiotically.”

A 2009 study in Trends of Pharmacological Sciences titled “Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb,” conducted by five European scientists, identified 18 non-psychotropic effects of CBD. It can treat muscle spasms, cancer, diabetes, nausea, inflammation and pain, among other conditions.

“CBD has an extremely safe profile in humans, and it has been clinically evaluated (albeit in preliminary fashion) for the treatment of anxiety, psychosis, and movement disorders,” reads the study. “There is good pre-clinical evidence to warrant clinical studies into its use for the treatment of diabetes, ischemia and cancer…

“The plant cannabis is a source of several other neglected photocannabinoids such as CBC and CBG,” the study continues. “Although the spectrum of pharmacological effects of these compounds is largely unexplored, their potential action…might make these compounds new and attractive tools for pain management.”

Geci summarizes CBD this way:

 

There’s no question in my mind that it’s a blockbuster chemical. – Michael Geci

What CBD doesn’t do is make you feel high.

So, without a lab—without somebody who can use the instrumentation—you’re almost never going to be able to identify this through living-room empirical studies. Some guy is not going to sit down in his kitchen and say, ‘Wow, my joints don’t hurt any more. I feel so good.’ They don’t do that. – Noel Palmer – Montana Botanical Analysis

But Palmer seldom finds CBD. In nearly a year of testing, he’s only analyzed three strains that contain a meaningful amount of it. Why? He says it’s because cannabis growers have for decades been so focused on breeding strains with high THC content that some of the other cannabinoids—the ones that don’t make you stoned—were disregarded.

“I hate to use this word,” Palmer says, “but cannabis in Montana—everywhere—is really boring. It’s almost all THC…because everybody’s been so good at breeding THC into their plants and not focusing on these other cannabinoids. There’s been no instrumentation and no science to help them identify unique strains. They smoke it a couple times and they don’t get as high, so they trash it; they cut it down and get rid of it.”

Palmer pulls out another printout of raw data and points to a big blip on the chart. It’s a test of “the most interesting strain” he’s seen yet in Montana.

“This one’s very interesting because CBD, that peak right there, usually you see nothing there,” he says.

He won’t name the strain because of a confidentiality agreement, but he says it was the ugly duckling of pot plants grown from a random bag of seeds. The grower nonetheless brought a sample to him and it contained the most CBD Palmer had ever seen.

“When we find it I go ape-shit,” Palmer says of CBD. “I call the client and say, ‘Give me more. I want to make sure you have it in there.'”

Developing cannabis strains with high CBD content—or isolating it in other forms—appeals to Palmer and Geci largely because it has the potential to make cannabis’ medical benefits more accessible.

THC in and of itself has some definite therapeutic benefits. It’s a cancer-fighting substance. But a lot of people find that the psycho-active aspects of THC are uncomfortable. Even for the casual user who enjoys catching a buzz now and then, if you give them too much it can be a very uncomfortable experience, very trippy. – Michael Geci – Physician

“What a shame it would be,” he continues, “for, say, a 50-year-old person who wants to use cannabis for pain relief and gets a strain that’s too potent. The caregiver doesn’t warn him about it, he takes a couple hits…and it can be a truly frightening experience. And then he says, ‘I don’t want to use this anymore.’ And all because the quality control methodologies that every other medicine and chemical and supplement in the country is mandated to do, cannabis isn’t. So that’s the mission here, to bring this to a different level.”

And there are many levels. In June, the UK became the first to approve Sativex, an oral spray consisting of extracts of THC and CBD developed to treat symptoms of multiple sclerosis (MS). Spain approved the spray in July, Canada approved it in August, and New Zealand approved it in early November. The ratio of THC to CBD is 2.7 mg to 2.5 mg per spray, ensuring a standardized dose.

GW Pharmaceuticals, the maker of Sativex, reports that over one third of MS patients in the UK may be using cannabis illegally for its medical benefits.

“If cannabinoid-based medicines can safely provide relief from any symptom of MS, they will not only improve the quality of life of people with the condition but also the people who care for them,” writes the UK’s MS Society. “The benefits of a drug that can restore some aspect of normal work and social life cannot be overestimated.”

In the U.S., Colorado Springs, Colo.-based Cannabis Science, a biotech company developing pharmaceutical cannabis products, is leading the push for FDA clinical trials, regardless of the drug’s legal status. (Incidentally, Cannabis Science announced in June it planned to acquire Missoula-based Montana Pain Management, but the deal fell through in August.)

Palmer says the science showing the therapeutic effects of cannabis, and especially CBD, has become undeniable.

“I think if you show this to physicians they can question some of the studies, but they can’t question the greater picture—that there’s something there. It’s real,” he says. “And it’s not just THC. It’s all these other things that are really the magic. THC is easy to find, but science is really going to unravel all of these other cannabinoids.”

Tom Daubert, founder of Patients and Families United, a group that lobbies for marijuana patients’ rights in Helena, says caregivers are beginning to identify and breed strains with a greater diversity of cannabinoids.

“I have no idea how many of the producers are aware of these nuances,” he says. “Certainly the better ones are and are taking it seriously.”

Palmer, Geci and Habib all say the entire industry is beginning to catch on.

“Patients are definitely becoming more and more savvy, and it’s moving at an exponential pace,” Habib says. “The labs are offering these services, the caregivers are starting to learn that [quantification gives them] an edge, and immediately patients are starting to learn [about the benefits of cannabinoids besides THC]. And now that it’s not a back-alley transaction, where you go into a storefront…and you’re treated like a normal citizen, it’s improved their access to what they actually need, and that’s been great for them.”

Adds Geci: “We’re starting to get some variability, and we’re responsible, I think, for the reorientation for a lot of providers that this really is a medicine for beyond just chilling somebody out on the couch.”

Legal ambiguity

The science behind medical marijuana is still evolving, as is state’s legal approach to the industry. The Montana Legislature is expected to address the Medical Marijuana Act when it convenes in January, with a particular focus on the law’s many ambiguities. Some opponents are calling for the law’s outright repeal, while others believe simple clarifications can address alleged abuses.

Rep. Diane Sands, D-Missoula, chair of the Children, Families, Health and Human Services Interim Committee, has led the effort over the past six months to draft a bill to help rein in an industry that’s seen the number of patients on the state’s rolls jump from 7,339 on Jan. 1 to 26,429 by the end of November. The industry becomes increasingly contentious with every dispensary that opens its doors, but Sands believes giving legal cover to cannabis labs—cover they currently lack—is something most legislators should agree on.

“The people running the labs have scientific degrees and they’re doing really important work,” Sands says, “and I think that’s absolutely critical as this goes forward.”

Shockley, who would prefer no medical marijuana program at all, agrees with Sands.

“If we decide to not totally do away with medical marijuana and we’re going to keep it in existence, reputable and licensed laboratories seem to be a good idea to let them test it to see what people are using,” Shockley says. “That makes sense to me.”

Habib, who plans a major lab expansion next summer, points out that the current law fails to take into account secondary service providers—couriers, bakers, chemists, horticulturists, etc. Only patients and caregivers can legally possess marijuana, which means that she and Palmer can legally possess and analyze their clients’ medicine only if they’re patients or caregivers themselves. Habib lobbied Sands’ committee over the summer to acknowledge secondary service providers, but she’s pessimistic her appeals will materialize in whatever legislation is passed in 2011.

I think the patients are only going to benefit the more above board it becomes, the more other professionals are allowed to participate in this industry without fear of prosecution. I need microbiologists, I need chemists, I need professional kitchen people. I need all these people just for my business alone, and they all benefit patients in the long run. – Rose Habib

Advances in cannabis quantification may not just affect the law, but law enforcement. Currently, law enforcement considers, for example, cannabis tincture weighing an ounce to be an ounce of cannabis, even if that tincture only contains 1/8 of an ounce of actual cannabis and the rest glycerin. The interpretation puts patients who would rather not smoke at risk, since a few bottles of tincture could put them over the ounce they’re legally allowed to possess.

Palmer says he’s approached law enforcement with a proposal on how to quantify cannabinoid content in edibles and relate it to plant material, but the discussion didn’t go far. Law enforcement lacks the appropriate instrumentation, he says, and it faces barriers to outsourcing forensics to private labs.

“Law enforcement needs a clear protocol,” Palmer says.

More to the point, law enforcement needs a medical marijuana law that better reflects how medical marijuana is being used. Mark Long, chief of the Montana Narcotics Bureau, points out that cannabinoid quantification matters little to his colleagues because the law defines usable marijuana only as its dried weight.

“If the law said you can’t sell a product with more than X amount of THC in it, well then it would be important for law enforcement, and these labs would be more critical,” Long says. “But right now it doesn’t say anything about THC, so really, if we have somebody with a cookie, it doesn’t matter to us how much THC is in there… If the THC content of that cookie is two percent or if it’s 60 percent it doesn’t matter, because the current law just goes by weight, which is goofy. It’s just goofy, but that’s the way it is.”

Long does make clear, however, that he’s encouraged by the potential for labs to make medical marijuana safer for patients.

“I think it is an issue with anybody using medical marijuana not knowing what’s in it,” he says. “That’s a sticking point with law enforcement, too, and I think other medical people. It’s a product with a lot of variability in what’s in it.”

Credit the cannabis labs then for at least providing a service it appears most Montanans, no matter their position on medical marijuana, can support. As the Legislature will surely prove when it tackles the topic in January, consensus ends there.

By Matthew Frank, published in Missoula Independent