Canada becomes Sativex country

GW's plant-based medicine approved for pharmacies

Sativex inhaler prototypeSativex inhaler prototypeCanada is the first country in the world to license a plant-based cannabinoid pharmaceutical medicine, Sativex, created by GW Pharmaceuticals and marketed in conjunction with Bayer.
Sativex is a combination of plant-derived delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The ratio of THC to CBD in Sativex is 2.7 mg to 2.5 mg per spray, which ensures a standardized dose is delivered each time it is used. It's administered via a spray pump which places Sativex spray under the tongue or on the inside of the cheek.

The spray formulation allows for more specific dosing than oral tablets, well-suited to the variable nature of neuropathic pain experienced by people with Multiple Sclerosis (MS), which is the main target patient audience for Sativex.

GW Pharmaceuticals is still waiting for regulatory approval of Sativex in England, where the product was developed and where it was first submitted for approval two years ago.

Canadian approval, which took less than a year, is expected to expedite UK approval. Sativex is expected in Canadian pharmacies by June, 2005.

MS is a disease of the central nervous system- the most common neurological disease affecting young adults in Canada. Approximately 50,000 Canadian men and women have MS, and approximately three more people are diagnosed each day, mostly in people between the ages of 20 to 40 years of age.

Pain is a common symptom of MS occurring in up to 86 per cent of people with MS. Neuropathic or nerve pain occurs spontaneously or can be provoked by touch, temperature or movement. Half the people with MS suffer from chronic neuropathic pain, which is described by patients as freezing cold or burning sensations in the limbs, most often in the legs.

"It's hard to explain to someone who has never felt this type of pain. It's like being plugged into an electric socket all the time," said Steve Walsh, who used Sativex in clinical trials and who suffers from MS. "At times, putting on clothes or anything touching me can be too much to take."

According to Dr. Allan Gordon, Director of the Wasser Pain Management Centre in Toronto, "Effective pain control and management are extremely important in a disease like MS. The approval of Sativex in Canada reflects the urgent need for additional treatment options in the field of neuropathic pain in MS."

Dr. Geoffery GuyDr. Geoffery GuyA happy Guy

Dr. Geoffrey W. Guy is the pioneering physician and pharmaceutical developer who created GW and Sativex. When the Canadian approval of Sativex was announced on April 19, 2005, Guy breathed a sigh of relief.

Ever since he embarked on his quest to make a plant-based cannabis medicine, his company has come under attack from marijuana activists who asserted that he was seeking a medical cannabis monopoly.

The same activists attacked Guy for partnering with Bayer, a German company which some criticize because it was an industrial participant in Nazi Germany, along with thousands of other companies such as BMW and IBM.

GW also faced a copycat syndrome. After his company had spent millions of dollars researching natural cannabinoids and cannabinoid medicines, and finding out how hard it was to get chemically-oriented regulators to approve them, other companies began to adopt or modify his approach, hoping to cash in on the naturally-derived, controlled dose, pharmaceutical cannabinoid medicine market at his expense.

Among the copycatters are Canadian company Cannasat, configured in 2004 and which has yet to create its own medicine, and Solvay Pharmaceuticals, which sought to market a single synthetic cannabinoid, Dronabinol, as an inhaler-delivered medicine.

Single molecule synthetics like Dronabinol, which is marketed as Marinol, have been found to be ineffective by many medical pot patients, who say they'd rather smoke cannabis than use Marinol pills.

In some cases, the side effects of Marinol have caused serious problems for patients, and many researchers say that the single-cannabinoid approach, especially when the cannabinoid is a synthetic one, does not work well for most patients.

Guy began his quest to develop natural cannabis medicines in 1998, when the British physician and pharmaceutical products developer became the first person in recent memory to receive a UK government license to grow marijuana.

Guy enthusiastically contacted Cannabis Culture to announce Canadian approval for Sativex.

To create Sativex, Guy grew massive amounts of totally-organic marijuana. In 1999, he began growing 25,000 plants in specially-built, well-guarded greenhouses in southern England.

Since then, he has grown more than 300,000 "numbered, registered plants," most of which have been selectively bred to produce unusually high percentages of one of many active ingredients in whole marijuana- cannabinoids- that Guy extracts for use in his pharmaceutical cannabis medicines.

Guy's plants are proprietary strains of cannabis originally procured from Dutch marijuana research company Hortapharm. Dr. Guy doesn't personally use marijuana, booze or coffee, but his company cultivates more marijuana than anyone else in the world.

His plants grow in massive, pristine greenhouses segregated into computer-controlled micro-climates containing virtually mono-cannabinoidic plants that produce high percentages of these target cannabinoids: THC, CBD, THC-V, CBC, CBD-V, CBG or CBN. Currently, these cannabinoids are the ones thought to possess the most significant medical value.

Guy says he produces many tons of totally-organic, inspected, quality-controlled dried buds each year, and has amassed a comprehensive horticultural-pharmaceutical cannabis database while also extracting and testing cannabinoids. He is an expert on cloning techniques, soil, plant pests (thrips and spider mites are the worst pests, he says), humidity, and other technical factors that make commercial pot growing a science and an art.

Guy's publicly-traded company has developed three types of medicine made from cannabis extracts: a high-THC extract called Tetranabinex, a mostly-CBD extract called Nabidiolex, and the 51-49% mixture of CBD and THC, called Sativex.

These drugs are the results of medical research GW began in 1998. Almost single-handedly, GW's scientists and doctors have proven to skeptical scientists and regulators that marijuana's medical benefits- described derisively as "merely anecdotal" and "unproven" by drug warriors- are scientifically verifiable.

The extracts give unusually safe and effective relief for patients with MS, chronic pain, and other serious conditions. In some cases, GW proved, cannabinoids are the ONLY medicine that provides relief. The company is elated on getting approval for Sativex, but is also seeking approval for natural cannabinoid medicines that will treat arthritis, schizophrenia, appetite disorders, nerve damage, and glaucoma.

Guy's scientific team includes the world's top cannabis researchers, including Dr. Raphael Mechoulam and Dr. Roger Pertwee.

Bayer the bear?

In May, 2003 Guy sold marketing rights for Sativex to Bayer, a major German pharmaceutical company. Guy viewed Bayer's interest as proof that cannabis medicines had finally become legit.

Guy's critics, especially Pot-TV host and writer-activist David Malmo-Levine, saw it otherwise, alleging Bayer is an unethical company, and impugning GW because it affiliated with Bayer.

Malmo-Levine or other GW critics believe smoked cannabis is safe, effective medicine, that cannabis pharmaceutical products are not needed, and that cannabis pharmaceutical research, patents and products are part of a capitalist-prohibitionist conspiracy that will eventually prevent cannabis market growers and users from having access to raw cannabis for self-medication.

Dr. Guy views Malmo-Levine's criticisms as "one-sided attacks" rather than "fair reporting."

"It must be noted that [Malmo-Levine] never talked to me before he started publishing articles accusing us of being an evil company," Guy said. "That is not how a professional journalist operates, is it? Our company created medicines that work for patients who had no relief from other medicines. We submitted a strong dossier to the Medicines and Healthcare Products Regulatory Agency (MHRA) in England, so patients can finally get effective cannabinoid products from their pharmacists, and be reimbursed by their health insurance. We hope to have MHRA approval very soon, and we now have Canadian approval. We are working on getting approval in America, a very tough place due to their prejudice against recreational cannabis, but we will do it. We are helping thousands and potentially millions of patients. How many patients are our critics helping?"

GW is not alone in the race to develop cannabis medicines, but Guy says his company's use of organically-produced natural cannabis extracts is innovative, proprietary and medically efficacious.

Other companies, such as Solvay, create and market synthetic products like Marinol, a chemical THC analog, which has long been criticized because its synthetic "single cannabinoid" approach can produce negative side-effects while failing to relieve symptoms it is prescribed for. Guy says Sativex has side effects that are very minor and easily controlled with proper dosing and medical supervision.

In regards to critics' assertion that Guy exploits prohibition and that if marijuana was totally legal patients would grow and smoke their own cannabis instead of taking Sativex, Guy says bona fide medical marijuana patients, and patients who as yet have never tried marijuana medicines, and those who have tried them and found them inferior, have far different needs and motivations than recreational users or medpot patients who smoke whole marijuana.

"It may be hard for some advocates to believe, but there are millions of people who are quite satisfied with the way their consciousness works, but who want safe, symptomatic relief from a medical condition so they can get on with their life by working, taking care of their children, and being productive members of society," Guy says. "They aren't looking to get ?stoned,' quite the opposite. Our products will extend the reach of cannabis to people who would never have been comfortable smoking a joint, bong or vaporizer."

To further the goals of people who want to medicate without getting high, Guy's research team developed precise cannabinoid combinations and dosage methods that allow patients to self-medicate with precise control and with zero risk of harming their lungs.

In order to meet the needs of patients who want cannabinoid medical benefits but don't want to be stoned, the company's research has uncovered the inner workings of the subjective feeling of being "high," and how this feeling is related to medical effects and unwanted side-effects.

Guy says patients are advised to use small amounts of medicine so blood levels of cannabinoids build slowly. Patients seek relief from pain, muscle spasms and other symptoms, but they do not want to be "high," he says.

During clinical testing, some patients experienced panic when they perceived that they had become "intoxicated." Other unwanted effects included dizziness, dry mouth, and increased heart rate. Most of these problems are solved when patients self-adjust dosage, or when GW provides gentler formulations or regimens.

"The incidence of side-effects is very minor; cannabis has lived up to its reputation of being one of the safest drugs humans can use," Guy says. "We have seen our cannabis medicines provide better relief than traditional medicines that are far more dangerous for patients than cannabis ever could be."

Safety is a key factor in GW's research and product development, and this has led the company to develop a way to administer cannabinoids without relying on the combustion of cannabis.

"We are not working on only one formulation or only one way of administering cannabis drugs," Guy said. "Some of our patients will use a pressure-activated oral spray; others will inhale a pure vapor of the drug that is generated without flame. We are perfecting special methods that will ensure the pharmacokinetic properties of cannabinoids, including terpenoids, which are volatile at room temperature. The end result will be that patients and their doctors can exactly monitor the relief and lift they get from our drugs, so that a patient who needs instantaneous relief from an acute symptom will get it, whereas somebody who needs to build their dose gradually so that the relief lasts for several hours will be able to do so as well, all with complete control."

Guy says his company's system of sprays, inhalers, and vaporizers will take harm reduction and cannabis delivery to new levels.

"People currently believe that using one of the many models of vaporizer that are on the market will provide them with fully-utilized, totally-clean cannabis vapors, but this is not true," Guy says. "Cannabinoids cannot be properly vaporized using the kinds of heat sources and chambers that we see on the market right now. There is still some burning of plant material taking place, people are still inhaling carcinogens, and there are irregularities in the quality and design of these vaporizers that prevents people from getting what they think they are getting."

GW is pleased that its inhaler device has been well-received by regulators, but the company is also developing a medical grade professional vaporizer that will provide truly smoke-free cannabis medicines.

Dr. Guy says all vaporizers currently available are amateur devices that lack the precision and quality needed to truly vaporize target cannabinoids in a 100% safe and effective manner.

"If we create the vaporizer we envision, patients will dial in the exact relief they want, push a button, and get a controlled dose that will provide safe, effective relief for a variety of conditions," Guy promises. "There will be no smoke. Patients will get 98% volatilization of the cannabinoids they need in doses just high enough to achieve the medical effects they seek."

Big bad GW?

When the deal uniting Bayer and GW was announced, GW's critics jumped all over it, alleging that Bayer is an evil company and that GW's embrace of Bayer indicated bad intent.

David Malmo-Levine said: "Bayer is arguably the worst corporation on earth. They are the inventors and propagators of Aspirin, Heroin, Mustard Gas, forced labor, the Nazi party, Zyklon B, death labor, Tabun and Sarin nerve gas, parathion, Codex, Cipro, Baycol, Baygon, Fenthion, Baysiston, TDI Olaqunidox, PPA's, PCB's and other such wonders. Bayer has the worst ethical track record of any company this author knows of."

Dr. Ethan Russo, a long-time cannabis researcher who now works for GW, says Malmo-Levine "seems to be against the entire system of intellectual property, corporations, scientific research, medical progress, and patents."

"In almost every area of human endeavor, from journalism to medicine to the music industry, individuals and corporations create unique ideas and products and then seek to protect their work through copyrights and patents," Russo explains. "Even if marijuana was totally legal, most people would not conduct the kind of scientific research that GW is conducting. This research uses cannabinoids to extend lives, cure diseases, and relieve disease symptoms. GW has helped legitimize cannabis medicines, and the company has a right to protect its discoveries and its investments."

What about Malmo-Levine's charges that Bayer worked with Hitler's government and continues to be an unethical company?

"I'm Jewish," Russo responds, "and I am as horrified by the Holocaust and Hitler as anyone would be, but this is not 1940. Dr. Guy was courted by several pharmaceutical companies, and he chose Bayer as his partner because Bayer is a leading pharmaceutical company committed to getting cannabis medicines to as many people as possible."

Guy defended his decision to partner with Bayer, and also dismissed charges that his company has created a plant-patents monopoly that will be used against commercial black market marijuana growers, home growers, and medpot growers.

"We will indeed be taking out ?plant variety rights' on a number of strains that we developed as part of our R&D program. These rights prevent other parties using our specific strains to produce plant extracts without our permission. GW has only sought patent protection for strains we created; there are plenty of other varieties for people to use, they just can't use strains we developed," Guy said. "If people get into trouble for growing cannabis plants, it will be from the police for breaking the law, not from us. If somebody stole our genetic material or our products, that would be breaking the law, but our patents and commercial interests in no way further the drug war."

Guy allegedly made recent statements that were perceived as threatening by a few Canadian medical marijuana activists who told him they were designing raw plant spray extracts similar to Sativex, but Guy insists that he has no interest in using prohibition to further his marketing or harm people who work on their own with marijuana.

Dr. Geoffery GuyGreen gold rush

Whether or not Guy's intentions, patents and business interests pose imminent monopolistic or plant patent threat to cannabis users and growers in general, there's evidence that GW is only one of many companies seeking to cash in on the cannabis "gold rush."

For example, Canadian marijuana growers and users who possess coveted Health Canada cultivation and possession licenses are being courted by a myriad of individuals, companies, and advocacy groups, including marijuana fertilizer companies.

When asked about rumors that GW and Bayer were also wooing Canadian licensed medpot patients, Guy and other GW spokespersons acknowledged that his company had contacted "numerous federal exemptees" who "expressed interest in utilizing Sativex as soon as it would be legally available."

Some Canadian medical marijuana advocacy groups have been contacted by rival companies seeking to co-opt their patients for medical cannabis research. Such medical marijuana advocacy services often advise people how to obtain Health Canada medpot licenses, usually providing them with logistical support, names of sympathetic doctors and other assistance. Some of these service providers charge fees. Others expect would-be licensees to remain under the service's umbrella while the advocacy service markets them, their licenses, their medical records, their medical grow rooms, or their marijuana to third parties such as pharmaceutical companies or pot nutrients companies.

In the final analysis, criticisms of Dr. Guy and pharmaceutical marijuana research by marijuana activists contain interesting ironies and inconsistencies.

Recreational marijuana smoking became very popular in Western countries beginning in the 1960's. Medical marijuana has been increasing in popularity since the 1980's.

From the 1960's until the mid-1990's, the only source for marijuana was Dutch cannabis coffeeshops, and the black market, comprised of smuggling cartels, clandestine dealers, commercial growers, and home growers.

In a reverse echo of Malmo-Levine's allegation that GW benefits from prohibition, most marijuana industry insiders admit that prohibition benefits black market growers and dealers because prohibition is the artificial price support that makes marijuana so profitable for them. If it wasn't for prohibition, a lot of people would have trouble growing $400 an ounce pot to help pay their mortgages.

The cannabis black market, cultivators, and Dutch coffeeshops could accurately be described as a "monopoly" that has until now controlled the supply and price of marijuana. But now, that underground monopoly has competition. The Dutch government is trying to close cannabis coffeeshops while at the same time growing its own medical marijuana and supplying it to pharmacies. The scheme appears to have failed, because the Dutch government's cannabis is lower quality and higher priced than coffeeshop cannabis.

Health Canada grew its own marijuana and has been trying to sell it (along with pot seeds) to patients. The scheme appears to have failed because the Canadian government cannabis is low quality, poorly-packaged, and less potent than black market cannabis.

GW Pharmaceuticals and other companies grow marijuana and market its active ingredients to patients. Individuals, compassion clubs and consortiums are trying to cash in on Health Canada medical marijuana licenses by getting licensed patients to grow and sell large amounts of cannabis, and by selling cannabis to licensed patients who can't grow their own. More and more compassion clubs are opening; retailers like Bud Buddy and Jay's Joints are selling marijuana on the Internet.

Far from being an increasingly monopolistic industry, as Malmo-Levine alleges, it appears that Dr. Guy, Bayer, GW, Solvay, Bud Buddy and others are just part of a growing group of people and companies who are creating a vanguard of anti-monopolistic increased production and expansion of marketing, selling and producing varying cannabis products and methods of cannabis use.

Gone is the day when marijuana users only had two choices: to grow their own cannabis, or procure it on the black market. Gone is the day when marijuana users could either smoke cannabis or ingest it in home-brewed tinctures, oils, and foods. They now have an ever-wider range of choices for procuring and using marijuana, thanks in part to medical marijuana laws, and to companies like GW.Dr. Geoffery Guy

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