I recently had the pleasure of speaking to a 46-year-old British physician and pharmaceutical developer who has organically grown tens of thousands of specially-bred marijuana plants in Southern England with the blessing of the British government.
Dr Geoffrey Guy, the mild-mannered founder of GW Pharmaceuticals, was eager to update Cannabis Culture readers about his company's successful efforts to use raw, blended cannabis extracts in GW's proprietary "medical delivery devices" to treat a variety of medical conditions.
The last time CC spoke with Dr Guy, in early 2000, he was just beginning clinical trials designed to test the effectiveness and safety of his cannabis-based medicines (CC#26, UK doc grows pharmaceutical pot).
Guy and his team of professional pot growers raise cannabis plants from seeds developed by Dutch company Hortapharm. These plants are remarkable because they consistently produce extraordinarily high percentages of target cannabinoids, such as THC and CBD (cannabidiol), which Guy uses in medicines aimed at treating multiple sclerosis, spinal cord injury, neural injuries, cancer, arthritis, and chronic pain.
GW's miracle pot may soon be among the first cannabis plants ever patented. Although some industrial hemp genetics have been copyrighted as intellectual property, Guy is seeking to register marijuana varietals distinguished by specific morphological characteristics, such as color, leaf size and shape, and smell.
These characteristics are indicative of plant cannabinoid profiles developed for GW; some varieties contain 90% of their total cannabinoids as THC, while others predominantly contain CBD. Guy is focusing on these two primary cannabinoids, but he's also optimistic about other constituents, such as CBC, THC-V, and CBG.
The doctor is seeking patents for the way he extracts cannabinoids from plants, for extract composition and formulations, and for GW devices that deliver extracts to patients.
According to preliminary information provided exclusively to Cannabis Culture, GW's medical devices will revolutionize the way cannabis is ingested. Cannabis extracts blended in precise ratios will be packaged in a "canister" that joins to an electromechanical device that delivers controlled aerosolized doses of plant-derived cannabinoids without delivering harmful combustion by-products.
The canisters and delivery devices will be dispensed by pharmacists, and closely monitored by pharmacists, doctors, and GW itself.
"Pharmaceutical companies spend hundreds of millions of dollars researching and producing medicines, but as soon as those medicines are given to patients, they can be improperly used," Guy explains. "Patients might use too much, too little, or they might divert their medications to other people. For medications like cannabis that are controlled substances, it's essential that medical personnel be able to monitor dosage patterns. Our devices are like a digital camera that records details of time, date and other particulars every time it is used."
"Physicians will be able to monitor patient usage remotely," continued Guy. "People won't be able to tamper with our devices, even though they are portable and easy to use. You'd need a metal saw or a blowtorch to get into one of them. These controls answer concerns of those who worry that our extracts will be used inappropriately. And, these devices can be adapted for other medicines, ensuring patient safety and medical efficacy."
Although politics shouldn't influence medical services, Guy's research and product development has been affected by differing political realities in Europe and North America.
Guy says the United Kingdom has defied United Nations' opposition to medical use of controlled substances, and that many countries, such as the Netherlands, are eagerly awaiting expected approval and commercial availability of GW cannabis medical products by 2004.
"Home Secretary David Blunkett has been out front on this, saying he would recommend approval by our Medicines Control Agency if the clinical trials continue to be favorable," Guy said. "Many countries are inviting us to give presentations about our projects. They are as excited as we are about the results of our studies."
Blunkett's support is welcome and somewhat unusual, Guy acknowledges. He speculates that Blunkett's stance is influenced in part because the Home Secretary suffers from blindness.
"He knows what it is like to have a serious medical condition," Guy says. "I suspect this makes him especially compassionate, and willing to help us alleviate the suffering of patients by providing them with cannabis-based medicines."
Guy says that the Canadian government will accept GW's "European-Commonwealth medical dossier" and grant approval to the company's cannabis medications when the UK does so.
Health Canada and GW are conducting a small medical study, Guy says, and he hopes to expand clinical trials in Canada within a year.
No way USA
The US government's position on medical marijuana is a daunting barrier for American patients hoping to use GW's products. Backed up by a zero tolerance Congress and executive branch that apparently sees no difference between hemp, cannabis, and medical marijuana products, federal officials and allied agencies have generally blocked all studies planned by researchers hoping to determine the plant's medical efficacy.
Dr Guy and his representatives have engaged in high level discussions with the DEA, FDA, the Office for National Drug Control Policy (ONDCP), National Institute for Drug Abuse (NIDA) and senior state officials in California and Maine.
"We've made some progress in the US," Guy says. "We've commenced pre-clinical research in laboratories and other research in a university. This research is aimed at cell protection properties, general pharmacology, and the enhancement of effects afforded by beneficial synergy created when cannabinoids are blended together rather than isolated. The DEA has approved importation of our extracts into the US. They haven't said no to us on anything we've asked so far. They are playing it by the book. We look forward to continued progress."
After spending close to $80 million on product research and development, and almost single-handedly convincing the UK government to grant approval for his innovative plan to prove that individual and combination medicines made from raw plant extracts are superior to single molecule synthetic THC medicines like Marinol, Geoffrey Guy is understandably proud of what he has achieved.
"Our medicines have produced clinically significant improvements in a number of symptoms, including pain, muscle spasm, spasticity, sleep duration and quality, and overall improvements in quality of life," Guy says. "In some cases, the improvement has transformed lives. Given the previously intractable nature of patients' symptoms, that's all the more remarkable. By careful self-titration, most patients are able to get symptom relief while avoiding intoxication. Analysis of dosage levels over extended periods shows no evidence of tolerance, meaning that patients don't have to progressively increase their dose."
"GW occupies a lead position world-wide," concludes Guy. "We are uniquely placed to become the first company to achieve regulatory approval for prescription cannabis-based medicines."