The Future of Medicine: How Tilray Medical’s Study Redefines Cannabis Therapy

Medical cannabis has come a long way in the past ten years. As states began to make doctor-supervised cannabis accessible to qualified patients, the stigma of cannabis created healthcare and legal obstacles. The leading cause of diminishing the therapeutic benefits of cannabis was a lack of evidence-based clinical studies showing how it could be beneficial for patients.

The problem was that acquiring evidence-based data was very difficult in the United States. Exploring the nexus between cannabis and human well-being has long posed a challenge because stringent regulations have historically been an impediment to research efforts. American policymakers have turned to other countries (with fewer restrictions) to gain data and clinical insights into the therapeutic potential of medical cannabis.

Among these pioneering nations, Israel emerged as a trailblazer, joining the ranks of the Netherlands and Canada in embracing medical cannabis at the federal level. Despite strides made in legalization at the state level, the American cannabis industry has grappled with the demand for evidence-backed data on the safety and efficacy of medical cannabis products.

Enter Tilray Brands Inc., known as Tilray Medical (traded on Nasdaq Tlry Tsx), based in Canada. On April 3, 2024, Tilray Medical unveiled the outcomes of a groundbreaking study titled “Age-Related Patterns of Medical Cannabis Use: A Survey of Authorized Patients in Canada.”

The findings from the research hold promise in fostering a deeper understanding of the nuanced relationship between age demographics, chronic pain management, and medical cannabis consumption, which may help facilitate informed decision-making between patients and healthcare providers.

Lessoning Obstacles to Cannabis Research in America

Why has the United States been so reliant on the data regarding medicinal cannabis use from other countries? Researching any Schedule I substance domestically is fraught with many steps, expenses, and obstacles to acquiring raw cannabis for clinical trials.

Until President Biden signed H.R.8454 – Medical Marijuana and Cannabidiol Research Expansion Act, researchers had an uphill climb through three federal agencies before being granted approval. These agencies govern and authorize research, cultivation, and distribution of raw cannabis used for each study.

Food and Drug Administration (FDA) Authorization

The Federal Food, Drug, and Cosmetic (FD&C) Act made the FDA responsible for ensuring that any new drug undergoes an approval process before being sold in the United States. That approval process includes controlled clinical studies and submission of an Investigative New Drug (IND) application to the FDA.

The protocols that must be followed before drug approval include:

• Review of the qualifications of researchers and investigators.
• Drug stability testing.
• Quality control testing (free of contaminants).
• Proof of informed consent (protecting the welfare of human subjects in the study).
• Proof of secure storage to prevent theft and unauthorized access to the test substance.

The sponsor or research team is required to submit the clinical summary of protocols to an institutional review board (IRB). Only after approval from the IND can the researchers apply for approval to market the new drug in the United States.

Duplicate Review by the Drug Enforcement Administration (DEA)

Under Section 823(f) of the Controlled Substances Act, researchers who wished to use marijuana for clinical studies had to apply for DEA registration. That required the IND information and approval, as well as details such as the qualifications of the investigators and the institution where the research would be conducted.

All Schedule I drug researchers were required to get separate approvals for protocols to demonstrate recordkeeping and secure the storage of cannabis materials against theft (or diversion). Approval from the DEA typically takes more than a year. At any step, the DEA can deny registration if it feels the study may pose a threat to public health and safety.

Problems With Sourcing Cannabis for Clinical Trials in the United States

Prior to the Medical Marijuana and Cannabidiol Research Expansion Act, researchers had one single grower in the country to source cannabis for clinical trials. For almost fifty (50) years, the National Center for the Development of Natural Products (located at the University of Mississippi) was responsible for providing cannabis to authorized researchers.

One of the great limitations of the NIDA Drug Supply Program was the potency of the cannabis provided for researchers. On average, the potency level was 7% or less, with a very limited number of strains available. Today, in the United States, there are over eight hundred documented strains of cannabis and many more hybrid strains sold in dispensaries.

Researchers were not able to acquire the same cannabis potencies or strains that were available to the public through licensed retailers. That limited the validity and scope of cannabis research for human health because the sample was not representative of what the majority of Americans were consuming on a regular basis.

Is It Easier to Conduct Cannabis Clinical Trials Now?

Many of the obstacles encountered by domestic cannabis researchers were removed with H.R.8454, Medical Marijuana, and Cannabidiol Research Expansion Act. The good news is that rather than relying on international sources, clinical trials in the United States could begin to provide more of that evidence-based data required by the FDA and DEA.

Some of the requirements that have changed as a result of Title I of the Cannabis Research Bill include:

• Elimination of duplicate reviews by the DEA. The Drug Enforcement Administration must accept an application now if it has been approved by the FDA (through the IND process), the National Institutes of Health (NIH), or another federal agency that provides funding for cannabis scientific research.
• There are new strict timelines for the DEA review of applications. Instead of taking over a year, the DEA is now required to complete the application or request more information within sixty (60) days. After supplemental information is received, the DEA has to approve or deny the application for clinical study in writing within thirty (30) days.
• Standardization of security controls for researchers. In the past, the DEA security requirements have been inconsistent and burdensome. The new protocols are stated, and the standards are easier to understand and comply with for clinical studies, applying to all Schedule I and II substances.
• Title II of the bill protects higher education (IHEs) from losing or reducing federal funding because of the Drug-Free Schools and Campuses Act (DFSCA).

One of the most important changes was the expansion of sources to cultivate, harvest, process, and provide cannabis for clinical studies. This will mean a greater supply and variety of cannabis strains (and potencies) to provide more accurate research results.

Because the bill protects higher education institutions from losing federal funding, it may encourage more Universities to engage in cannabis health and wellness studies. More studies mean more American evidence-based data on cannabis use for human health.

Problems With Current Chronic Pain Management Therapies

Patients who suffer from severe chronic pain are often individuals who have been diagnosed with treatment-resistant conditions. Chronic pain patients include individuals diagnosed with neuropathic pain, chronic non-cancer pain, rheumatoid arthritis, multiple sclerosis, and other medical conditions.

Historically, treatment modalities have been focused on prescription medications for pain relief. However, medical studies published in the past five years have reported that chronic pain conditions can be exacerbated by long-term use of certain medications, specifically opioids.

Pain medications work by reducing inflammation and numbing down pain perception in the human body. The pain still occurs, but your ability to register it is impaired by taking prescription opioids, nonsteroidal anti-inflammatory drugs, or NSAID medications. Over time, many patients see an increase in pain intensity due to developing a tolerance for prescription pain medications, according to the American Medical Association.

While long-term use of cannabis may also cause patients to develop THC tolerance, responsible use of lower-potency products appears to help medical cannabis patients manage pain intensity. It has been supported in many studies for analgesic efficacy.

For people living with chronic pain (the majority of which are older Americans or elderly patients), doctor-supervised cannabis can restore quality of life.

Insights About Pain Relief from the Tilray Medical Report

Gleaning insights from “The Canadian Cannabis Patient Survey” (CCPS) conducted in 2021 formed the foundation of this groundbreaking study. A total of 2,697 patients participated, with an average age of 54.3 years. There are slightly more male participants (50.9% versus 49.1% female patients) who completed the survey.

In accordance with health privacy laws, patient identifying information was meticulously redacted or safeguarded throughout the study. Given the prevalence of respondents over fifty, a significant portion exhibited age-related ailments, notably chronic pain and neuropathic pain symptoms.

In the United States, chronic pain afflicts an estimated 1 in 5 adults over eighteen, as per the Centers for Disease Control and Prevention (CDC). Traditionally, prescription opioids and NSAIDs have been the go-to treatments for chronic pain.

However, the medical fraternity acknowledges the grave side effects associated with prolonged opioid use. Studies indicate that opioid medications may exacerbate pain sensitivity over time, prompting both patients and practitioners to explore alternative therapies for more effective symptom management.

What Did The Tilray Medical Report Discover?

Widely regarded as groundbreaking, the Tilray Medical report offers compelling evidence from medical cannabis research, suggesting a profound improvement in patients’ quality of life.

Key findings from the study include:

Chronic pain (27.8%) and arthritis (14.9%) emerged as the primary motivators for patients to explore medical cannabis. Anxiety (9%) ranked third among primary symptoms, while insomnia or sleep disturbances (34.6%) were prevalent secondary concerns, often comorbid with chronic pain.

A staggering 53.8% of adults reported a reduction in prescription opioid usage within the year preceding the study, attributing it to medical cannabis. Moreover, patients reported a decrease in the consumption of alcohol, tobacco, and other substances post-certification for medical cannabis use.

José Tempero, Tilray’s Medical Director, emphasized, “Our involvement underscores our dedication to medical research, edging us closer to unlocking the full therapeutic potential of medical cannabis.”

Help for Patients Suffering From Debilitating Symptoms

Tilray Medical stands as Canada’s premier medical cannabis brand, owing to its expansive distribution network and unparalleled production capabilities. The company remains at the forefront of the global cannabis landscape, spearheading medical trials worldwide and advocating for the integration of doctor-supervised medical cannabis into patient care.

With EU-GMP-certified cannabis products available in over twenty countries and a diverse portfolio encompassing THC and CBD brands, Tilray has conducted extensive medical trials spanning Europe, Canada, the United States, Australia, and Latin America. These trials have yielded insights into various conditions, including pediatric epilepsy, cancer-induced nausea, HIV, breast cancer, PTSD, and alcohol use disorder, among others.

Cannabis research serves as a catalyst for change, urging stakeholders—from patients and physicians to hospitals, pharmacies, and policymakers—to consider cannabis access as an integral component of quality healthcare. As a global leader, Tilray’s ongoing research initiatives and periodic reports contribute to destigmatizing medical cannabis and advancing the discourse surrounding its therapeutic potential.

By shedding light on the therapeutic potential of physician-monitored cannabis interventions, this study not only underscores the importance of evidence-based medicine but also advocates for wider access to regulated medical cannabis globally. In doing so, it paves the way for improved health outcomes and a more holistic approach to patient well-being.

Aaron Bloom

Aaron Bloom, an experienced healthcare attorney, serves as the CEO, overseeing the mission and growth of DocMJ and Medwell Health and Wellness Centers since 2016. Aaron’s passion for improving patients’ lives comes from his experience in healthcare. For more than 20 years, Aaron has owned, operated, and represented traditional healthcare organizations. This experience created a passion for finding improved ways to relieve suffering. His goal as CEO is to work daily to provide relief to all patients who seek better health and wellness through the medicinal benefits of medical cannabis and evidence-based alternative medicines.