All Cannabis is Not Created Equal! If you disagree, take it up with Tetra Bio-Pharma.
I
By Dr. Guy Chamberland, Ph.D.
f you or someone you know suffers from any one of several diseases or health conditions, you may be searching Google daily hoping to find a company somewhere in the world doing research to show that cannabis will help. Those who experience chronic pain, cancer pain, fibromyalgia, PTSD, depression, anxiety, epilepsy, ocular pain to name a few, are watching and waiting, and the list of potential therapies comprising cannabinoids goes on. The question that needs to be asked is whether a doctor will authorize it, and if not, then why? One explanation might be the lack of scientific evidence or that the Canadian Medical Association does not endorse it. While cannabis has been used for thousands of years as a remedy, Health regulators say that cannabis is a drug and our Canadian biopharmaceutical company agrees. Tetra Bio-Pharma is in the business of discovering, developing and commercialising cannabinoid-derived products by taking a unique pharmaceutical pathway so that these drugs will become incorporated into the medical system. It’s a tall and painstaking order but Tetra knows that without scientific evidence, health regulators will not approve, physicians will not prescribe and insurance companies will not cover a product that has not been proven safe and effective in the exact same way as any other
10
drug for human use. Health Canada only approves drugs once they have successfully gone through a formal drug review process. This process, which can take anywhere between six months and two years, is the way a drug application is reviewed by scientists in the Health Products and Food Branch (HPFB) of Health Canada, and, as required, outside experts to assess the safety, efficacy and quality of a drug.1 So, what differentiates cannabis medicine from the medical cannabis currently available can be summed up in two words – scientific evidence. Because all pharmaceuticals used by humans go through rigorous clinical trials, they meet the standards required by regulators like Health Canada, the Food and Drug Administration in the US and the European Medical Authority. The Drug Identification Number (DIN) that comes along with this validation is what allows a drug to earn its coveted place as a prescription drug. While most doctors have limited knowledge and clinical experience in treating their patients with cannabis, they know about the importance of scientific data. They get that medicines approved by regulators establish a drug’s effectiveness and safety, the best dosing and usage in humans, any negative drug reactions and have compared results to existing treatments or a placebo when no treatment currently exists.2 This
Cannabis Prospect Magazine | June 2019
gold standard is also something that private and public insurers look at when it comes to reimbursement. Treatment with cannabis can cost a patient between $4,000 to $12,000 annually, an amount that could be significantly reduced with insurance coverage. Currently, the dosing and consistency of medical cannabis is almost impossible to achieve. Although our company is singularly focused on developing cannabis medicine backed up by science, we are not a cannabis company and it would be a mistake to see us other than through the lens of a pharmaceutical company. Tetra is one of a few companies working with Health Canada and the Food and Drug Administration (FDA) on clinical trial programmes with cannabinoid-derived products. These trials have led to a significantly improved understanding of the safety, pharmacokinetics and pharmacodynamics of cannabinoid-based drugs targeted for the treatment of pain. Tetra is already considered a global biopharmaceutical leader in cannabinoid-based drug discovery and development, a reputation that formed quickly as a result of our accelerated regulatory achievements, clinical programmes and cost management which is nothing less than remarkable by industry standards. That’s why I’m concerned, even worried, about the lack of understanding on