Use, and I’m not even going to qualify it by typing “Medical and recreational use”, of cannabis has increased exponentially in recent years. However, extremely limited research creates scenarios where doctors are flying blind when it comes to safety, dosing, and effectiveness. It must change — and rapidly.
Why? Because every day, a hopeful mother asks her doctor if cannabis might help reduce her child’s seizures. A senior post-op joint replacement surgery patient requests a cannabis instead of opioids for pain. And a pregnant woman mentions to her obstetrician that a friend suggested a cannabis edible for her morning sickness.
How should a clinician or provider respond to these questions? With recommendations, a written prescription, or just a flat “No”? The truthful answer is that we don’t know, what we don’t know.
For the past 10-15 years, the legalization and marketing of cannabis for medical purposes have far outpaced the available science, especially in the United States. For doctors and providers to be able to effectively counsel patients about the safety, efficacy, and appropriate dosing of medical cannabis, we need peer reviewed evidence of the effects of cannabis on human health.
Today, more than 23 million people consume cannabis products without really knowing what risks they may be taking or what the true benefits might be. But even more importantly, without understanding how cannabis interacts with other pharmaceuticals and medicines. Today, we lack the traditional data to make the dosing and population indications possible.
Without a ready reference available, like the Physician’s Desk Reference, we unable to make reliable and replicable dosing and cannabinoid composition recommendations. For patients seeking cannabis as medicine, we are painfully ignorant of not only the side effects, but the contraindications of cannabis with the over 20,000 drugs approved by FDA to be marketed to patients, is unknown.
Case example: You are a 54-year male who takes Lipitor, Plavix, an OTC (over the counter) acid reducer and occasionally uses Cialis for ED. Can you take cannabis for anxiety or use a CBD topical daily for joint pain?
I challenge you to stop reading now and pick up the phone and ask any medical professional you know if this patient should, or should not, use cannabis or CBD. Chances are that your doctor, your pharmacist, or your uncle who is an ER Physician, will know.
And if you are lucky enough to find a cannabis professional doctor in your life, chances are that they came by their education through self-funded research via community acquired protocols, patient testimony, and trial and error. The last 10 years they probably attended offsite conferences and shared individual findings with colleagues to cobble together a semblance of a protocol for certain populations.
In the 33 states and the District of Columbia where medical cannabis is legal, legislatures are deciding which conditions warrant prescriptions without reliable evidence.
The National Academy of Sciences, Engineering, and Medicine (2017) report called limited understanding of the health effects of cannabis “a significant public health concern” and pointed to certain U.S. regulatory rules as a barrier to necessary research. Here we are in 2020, and the truth is, that the legalization and marketing of cannabis has simply outpaced the available science.
The reality of the problem stems from strict federal restrictions on cannabis research. Currently, researchers can only study a small variety of cannabis compounds, and as such, cannot possibly keep pace with the market. Unfortunately, funding is miniscule compared to the multitude of unknowns about cannabis. We desperately need major changes in rules, regulations, and research initiatives so we can effectively advise and protect patients, and consumers.
In the United States, federal law classifies cannabis as a Schedule I controlled substance, a category of drugs deemed to be of no medicinal value. The Drug Enforcement Administration (DEA) has long asserted that cannabis lacks the evidence to warrant changing that classification. The irony lies in the law; the same law that constrains researchers’ ability to do the science necessary to determine cannabis’s appropriate classification.
The hypocrisy is that the Food and Drug Administration (FDA) has approved several cannabis-related medications, including Sativex and Epidiolex for seizures and Marinol, indicated for nausea in cancer patients and appetite loss in AIDS patients — And even these obvious medicinal applications have not motivated the DEA to reconsider the classification.
The list of common unanswered questions about cannabis is long, and for uncommon applications, even longer. What are the effects of cannabis on an unborn child? Is CBD a dangerous anticoagulant? How does cannabis interact with opioids or other drugs? Which conditions might it alleviate, and which of the hundreds of varietals might work best for which conditions? How much cannabis should patients consume, and how often? What form factor is appropriate for what population? Is inhalation, ingestion, or transdermal application the best dosing strategy?
The failure of the institution to provide guidance, means that patients are left seeking advice from a budtender at a local dispensary based on what that person has surmised from other customers’ experiences. Basically hearsay. Furthermore, individual states also lack rules about educating budtenders to ensure that consumers receive consistent or accurate advice.
Why are we Here?
Several variables have led to the current situation. For one, scientists sometimes are reluctant to pursue cannabis research because of onerous federal requirements associated with Schedule I substances: registering with the DEA, undergoing background checks, tracking, and discarding the drug, and more. Then there can be numerous state requirements as well.
The bureaucratic hurdles aren’t the biggest problem, though. In an attempt to limit the amount of cannabis that could be diverted for illicit use, the DEA forbids research using cannabis from anywhere other than an agency-approved source. Researchers therefore can’t use cannabis from a local dispensary even though the state has approved it and its products. Failure to follow DEA rules comes with serious risks. Rogue researchers face potential criminal sanctions and fines, and the institutions they work for could lose millions of dollars in federal research and student-aid funding. Most universities and research institutions generally will not turn to the cannabis industry to fund their work. That’s because accepting industry funding could be deemed money laundering or aiding and abetting a criminal activity.
There is a substantial, and likely successful, court case pending against the FDA for lack of access to quality cannabis for research. As it stands, there is only one DEA-approved source for cannabis allowed to be used in research: The National Institute on Drug Abuse program at the University of Mississippi. And while dispensaries sell more than 700 strains of higher quality cannabis, the Mississippi facility offers an extremely limited variety of cannabis. Sometimes, researchers can get a license to import products from another country, but those instances are rare.
Meanwhile, growers have been waiting more than four years for DEA review of their applications to grow cannabis for research. The DEA has said it plans to increase the number of such manufacturers. However, this will be delayed by the development of new regulations the DEA says it needs to ensure that the program meets relevant laws and that applications are evaluated under the applicable legal standards.
Solving the problem
In the United States, we have unwittingly hobbled our research progress through opposing narratives and juxtapositioned legal tenants when it comes to this plant. There are several ways to cut through the current obstacles to cannabis research.
Certainly, reclassification of cannabis from a Schedule I to a Schedule III drug would solve the access problems. Unlike Schedule I and II drugs, substances in this category are available to researchers from several facilities licensed by states or the federal government. Researchers would still be required to register with the DEA and report on purchases, distribution, and destruction of the cannabis used in their studies.
If the DEA remains unwilling to reclassify cannabis, one significant advance would be to quickly approve more growers. In addition, the DEA needs to allow the growers to expand the varieties of cannabis available for research — and those need to be varieties that can be inhaled, ingested, or applied to the skin. Researchers also need to be able to purchase medical cannabis from cultivators, growers, and dispensaries so they can study the actual products that consumers are buying and using.
Assuming that all the administrative and access obstacles are addressed, we still won’t be able to close the critical knowledge gap without additional funding. In 2017, for example, out of its $33 billion budget, the National Institutes of Health (NIH) provided only $140 million for cannabis research. This may sound like a lot of money, but it’s less than .0042% of the NIH budget — or approximately $3.50 for each individual in the United States who is currently using cannabis without knowing its potential risks or benefits.
The Real Losers
Patients. Consumers. Caregivers. Providers. Doctors.
The Wild West attitude that has previously defined the business of cannabis is no longer accepted by the longstanding professionals in the industry. And more importantly, the “Green Rush” that is currently featured on every financial report and media trend, is not the future of cannabis. Cannabis as medicine is the future and treating it, and its individual compounds, as a consumer-packaged goods and pharmaceutical is the way forward.
We need dollars and research focus funneled towards every step of the supply chain, from the grower to the packaging. We must have indoctrinated education and verifiable curriculum for providers, clinicians, and doctors. But the very first thing we must do, is to discover the negative side effects of cannabis, in all its forms and methods of administration.
Patients deserve information. The first step to incorporating cannabis into any regimen, is understanding the possible downsides, the side effects, and the contraindications to other medicines. Collection of data, in all its forms, is the only way this will happen. I encourage every advocate, retailer, grower, extractor, and processor to endeavor to participate in every way possible. Correlating the compounds responsible for symptom relief and change of disease course is necessary to prove efficacy. Every patient, provider and caregiver should have access to this information.
No matter how someone feels about that issue, it’s clear that we need a much better understanding of the potential risks and benefits of a product that is already so widely used. Health care providers across the country need to be able to look patients in the eye when asked urgent questions and offer evidence-based answers.