backissues -> CC26 -> UK doc grows pharmaceutical pot
by Pete Brady (19 Jun, 2000)
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British scientist grows thousands of potent buds, to extract their resins for medical
research.
For hundreds of years, merry olde England was friendly to marijuana. In the 17th and 18th centuries, British physicians used cannabis to treat depression, infections, coughs, sexual diseases, and inflammation. In the 1800's, the British East India Company's surgeon, Dr William O'Shaughnessy, reported that cannabis relieved pain and relaxed tense muscles. Later that century, cannabis was prescribed for England's grande dame, Queen Victoria.
Cannabis extracts and tinctures were legally available to researchers and physicians in England until 1971, when pressure from the World Health Organization, the United Nations Commission on Narcotic Drugs, and the United States caused the British government to pass the Misuse of Drugs Act, which placed cannabis in "Schedule I" status. The island nation then followed the lead of prohibitionist America, denying cannabis had medical efficacy and warring against recreational use.
In the mid-90's, British doctors, patients and researchers rediscovered the plant's healing powers. UK clinicians found that synthetic and natural cannabinoids helped patients with multiple sclerosis (MS), anorexia, HIV/AIDS, and chronic pain. In 1995, the Royal Pharmaceutical Society (RPS) advocated medical use of cannabinoids and study of their effectiveness. In 1998, the British House of Lords recommended that cannabis be reclassified as a Schedule II drug to facilitate medical research and prescription.
"We have seen enough evidence to convince us that a doctor might legitimately want to prescribe cannabis to relieve pain, or the symptoms of multiple sclerosis (MS), and that the criminal law ought not to stand in the way," a House of Lords spokesman said, noting that 85,000 people suffer from MS in the UK.
The British Home Office, which is responsible for law enforcement policies, rejected the Lords' recommendation, saying cannabis won't be rescheduled until extensive clinical tests have been conducted. So in 1999, the RPS launched clinical tests to determine if cannabis could decrease the amount of morphine needed to reduce surgical pain, and if cannabis reduced muscle spasms in MS patients.
But these tests, important as they are, have been overshadowed by pioneering cannabis research conducted by GW Pharmaceuticals, a UK-based pharmaceutical company founded by medical doctor, entrepreneur and maverick Dr Geoffrey W Guy.
In 1998, Dr Guy received Home Office licenses that allowed GW Pharmaceuticals to cultivate cannabis, and to store and dispense cannabis preparations.
Although the Laboratory of the Government and the University of London already had licenses to grow cannabis, Guy's plans for massive pot farms and innovative medical marijuana experiments put GW on the map, and it has not been lost on marijuana advocates that Guy is legally allowed to do something the rest of us would be sent to prison for.
Thus, we have the ironic happenstance that a 45-year-old businessman, father, and physician, who claims to have never used pot, is growing thousands of super-potent pot plants.
Guy works incessantly, but recently took time from his busy schedule to provide Cannabis Culture with an exclusive interview.
Why?
"There's a lot of misinformation about what we are doing, and why we do it," Guy said, at his home in Southern England. "That's why I am willing to do an interview with an activist publication such as yours. I want people to know the truth."
Growmaster Guy
Mild-mannered Geoffrey Guy heads what is probably the biggest, most professional commercial marijuana growing operation in the universe. Hidden away in southeastern England between London and Bristol are GW's space-age glasshouses, guarded by electrified razor wire, cameras, spotlights, motion sensors, round the clock security guards and other James Bond measures recommended by the spooks at Scotland Yard, and required by the Home Office.
Guy spent considerable amounts of money to retrofit and lease the $8 million glasshouses.
"These are state of the art horticulture facilities," he says proudly. "Like a cross between a spaceship and an operating theater. There are only three or four as good as this in all of Europe. We can create any environment we want to – temperate, maritime, or tropical. Light, temperature and humidity are all controlled by computers. We have three massive air conditioning units, so the air is completely rotated every four minutes. The glasshouses have 14-foot ceilings with banks of metal halide lights. The lighting array is designed by computer to give absolutely even lighting. Temperature control is plus or minus one degree. Energy is our greatest expense: it costs $180,000 a year."
Since Guy planted his first cannabis crop in the summer of 1998, he and his team of 20 pharmaceutical researchers and botanists have grown 40,000 plants; 30,000 have been harvested. The secret glasshouses are a living factory.
"It's quite eerie to be in there in the summer – when the sun comes out the daylight shades are drawn across by the computer to give exactly the right light intensity on the plants," Guy explains. "The shades withdraw automatically when the sun goes away. We can go from full sun to pitch black in five minutes. We have 14 different cubicles and can produce microclimates in each one. Pest control is achieved by natural methods. We have no funguses or molds because of our filtering mechanisms and because our humidity is kept below 50%."
Guy admits that hydroponic growing mediums and nutrients might be easier to use than organic methods, but he's proud that marijuana produced in his glasshouses is 100% organic.
"Our plants are medical-grade pharmaceutical plants, so we can have absolutely no pesticides, herbicides, or chemicals involved," Guy says. "We use a compost mix that we adapted from research done in Holland, and add a small amount of nitrogen. The entire growing operation is a laboratory experiment; we have already conducted 25 complete botanical and horticultural research programs. Every input – watering regimes, compost formulas, light intensity, plant densities on the rolling benches, climate, flowering, vigor, growth rates – is recorded and evaluated."
Guy's biography is characterized by boundless zeal, energy, and achievement. His father was a hospital administrator and his mother was a nurse. The young Guy's teachers generally acknowledged him to be something of a genius; he put himself through medical school by working as a truck driver and motorcycle courier, and was a fully qualified physician by age 25. He also earned an additional medical degree in pharmaceutics.
At age 30, he created Ethical Holdings, a company specializing in pharmaceutical research and morphine products. By the time Guy left the company in 1997, it was worth nearly $170 million. In the interim, he'd founded a yacht manufacturing and design company and produced computerized respiratory machinery.
Guy became involved with a French company specialized in developing plant-based medicines, and later founded his own natural medicines company, which he called Phytofarm. The company specialized in developing medicines from Chinese herbal remedies.
"I think it's good business to be open-minded about the healing potential of plants," he explained, "but I don't come from any cultural cannabis background. The first cannabis plant I ever saw was at the start of this GW program. When I was in medical school, the mind-altering drugs were beer and rugby. I am not into smoking anything, and I gave up alcohol several years ago. My interest in this comes from my desire to make drugs more amenable and more useful for patients, and my background in plant medicine, in addition to my training in Western pharmaceuticals."
Guy says he first became aware of marijuana's medicinal potential about ten years ago:
"And about seven or eight years ago, I thought cannabis-based medicines could be delivered through a skin patch; I have since realized that it probably won't absorb through skin. I had already worked with the Home Office in getting other controlled drug licenses, and had tried a number of years ago to see if we could research cannabis. They said, 'No, certainly not.'
"But after that, patient groups were beginning to articulate medical cannabis benefits, and medical users were going to court and not being sentenced, because nobody wanted to see people in jail for trying to heal themselves. These patient groups have credibility; they are a different demographic profile than many of the cannabis users in the US. The people over here didn't already use cannabis or other illicit drugs, and somehow got to cannabis and found it helped them medically. They were not social, countercultural or recreational users. They did not have a positive correlate for prior cannabis use, or other recreational drug use. They are what we call 'Middle England.' It would be like 'Mom and Pop America' using it.
"In 1997, I took in a UK conference on medical cannabis. I found myself looking at a very respectable group of clinicians, government officials, care groups, patients groups, researchers. I realized that my notion of medical cannabis from four years earlier had now become acceptable. It seemed clear that a lot of good people supported therapeutic cannabis, but people were asking how to get research done. 'It's a schedule I drug, so we can't do it,' they said. 'Isn't there a pharmaceutical company that can get this approved?'
"So I stood up and explained how it could be researched. You'd need a special dispensation from the government, but you could apply the normal rules of drug development. I think that this energized people, created a bit more optimism and pragmatism.
"In December, '97, the Alliance for Cannabis Therapeutics, headed by Clare Hodges, led a parliamentary delegation to the Home Office to ask for rescheduling. That delegation contained very respectable people. The Home Office was opposed to rescheduling, but they encouraged us to go see their civil servants. I had by that time worked 15 years in pharmaceuticals, and I knew that if a government official says, 'Go see the civil servants,' then we should go see them.
"The cannabis patients and other advocates continued to ask who could conduct the research if permission for doing it was granted. I looked at my situation; I had just stood down from two companies, my wife and I had just had children. It seemed like a good time for a new adventure, and I had a belief that cannabis might work, so I went to the Home Office officials and said, 'Well I have to grow tons of this material, standardize it, test it, retest it, grow tons more, formulate it, grow more, etc.' They said, 'Yes, of course you do.' I then lined out the basic requirements I would need approval for. Again they said yes.
"It wasn't that they were being particularly innovative or courageous. The polls showed that most people believed medical cannabis should be legalized. The Home Office had found that applying the Misuse of Drugs Act to medical users was problematic. They wanted a way to separate these people from recreational cannabis users. I prepared a development plan that detailed how we would go from growing the plant all the way to making and marketing a medical product.
"The Home Office sent the proposal to the Medicines Control Agency, which approves drug trials for new drugs. Within about a month, they said they were prepared to approve our request. On 6-8-98, the licenses were issued."
 | | Dr Guy, scientist-gardener. | The road to Wellville
Although many people lionize Guy for winning authorization for the biggest government-sanctioned pot research project ever, the doctor himself shies away from the pot-hero label.
"How did I help make this happen?" he asked rhetorically. "I suppose I have always had a drive and very intense focus. I don't take no for an answer. Once I got interested in cannabis as a medicine, I kept pushing on doors that kept opening in front of me, and being an adventurous sort of person, I kept on pushing open the doors. And then patients started writing to me about how cannabis helped them, and the problems resulting from criminal penalties, and the full horror, the full realization of the conditions that some of these patients had to deal with, began to hit me. My original conviction that this was a worthy project was strengthened by the clear indication that a number of needy patients were benefiting from these materials."
But the road to medical cannabis is long and winding, even for someone who doesn't take no for an answer, especially for someone who had never seen or grown cannabis in his life.
One of Guy's biggest challenges was to find a reliable source of plant genetics and horticultural assistance so he could produce stabilized cannabis varieties containing predictable amounts of cannabinoids, which are among the most important medically-useful ingredients found in marijuana.
Guy met this challenge by teaming up with HortaPharm, a marijuana research and growing facility located near Amsterdam. GW Pharmaceuticals purchased all rights to HortaPharm's impressive catalog of proprietary cannabis genetics, including the rights to varieties developed in the future.
HortaPharm is a secretive organization that carries security-consciousness to a level that has been described by other Dutch marijuana breeders as "needless paranoia." Dr. Guy mentioned HortaPharm in an interview he gave in Issue # 8 of the British pro-pot journal Red Eye Express.
"HortaPharm is a Dutch company run by expatriate Americans," Guy told Red Eye. "Mr David Watson founded the company nearly ten years ago to carry out botanical research and breeding of medicinal varieties of cannabis. Their principal botanist is Robert Connell Clarke, author of Marijuana Botany and HASHISH!. HortaPharm carried out much of their research under license from the Dutch government, and lacking any pharmaceutical development capability had sought drug company partners to take on the challenge. GW was the only company prepared to make the commitment needed to take their varieties all the way through [medical products] development."
I contacted HortaPharm to arrange for a visit and an interview, but a HortaPharm rep told me the only way I'd get cooperation from his company was if I agreed to allow my GW article to be reviewed and possibly edited by HortaPharm before publication. Although such requests are usually dismissed out of hand, my respect for HortaPharm's work led me to agree to the review conditions. I forwarded a series of questions to HortaPharm director David Watson, but Watson sent an email saying he wouldn't help with my article, because he did not want articles about HortaPharm to appear in any magazines other than scientific publications.
Thus, it surprised me to find that Watson had granted a September, 1998 interview about HortaPharm and GW to the Independent on Sunday, a mainstream British newspaper that sponsored a cannabis legalization campaign in 1997 and '98.
"[HortaPharm's] research farm is no paradise for the pleasure-seeking puffer," the article says. "'It looks like dope, but really it's hope,' explains the proprietor, American entrepreneur David Watson. What he means is that many of these plants have been specifically bred not to produce an intoxicating resin or hashish. Indeed, HortaPharm hopes to thwart the aims of the average recreational user."
Rec-pot vs med-pot?
Thwarting the aims of recreational users is one of the most controversial motivations attributed to GW's research.
When I visited England a few months ago, most cannabis activists I spoke with had mixed feelings about Guy's med-pot efforts. Pot advocates are glad that scientists and doctors have recognized what they've been saying for years – that marijuana is medicine – but many believe there's no need to have marijuana validated by expensive tests or diced and spliced to ensure conformity to pharmaceutical standards designed for laboratory-created medicines.
"I think it's a bit presumptuous of people to think that they can improve on God's handiwork," commented Free Rob Cannabis, the courageous UK activist who provides medical cannabis to sick people and changed his name to honor his favorite plant. "Why spend millions to find out what anybody who smokes it can find out by smoking it – that it helps people? All of us need to respect each other's use of this plant. Those of us who enjoy marijuana's entheogenic, religious and recreational values argue for the right of medical users to benefit from its medical values. Medical users should likewise demand that this miracle plant be legalized for all its uses – medical, recreational, spiritual and industrial."
But some medical activists, scientists and government officials advocate using science to isolate marijuana's medically useful ingredients, and seem indifferent to people who endure criminal penalties for non-medical use.
The UK's drug czar also fueled legalizers' suspicions in 1999, when he said med-pot research made the issue of whole plant legalization a moot point. Indeed, most med-pot scientists oppose recreational use and "unsupervised" medical cannabis use. They aim to determine which cannabinoids treat specific medical conditions, and then to extract or synthesize those cannabinoids and sell them to patients in delivery systems that are "safer" than smoked marijuana. And some of their research is funded by anti-marijuana organizations, intended to help governments and prohibitionists use chemistry to defeat marijuana's psychoactive effects.
Lorna Layward, a researcher and spokesperson for England's MS Society, recently asked drug companies to develop compounds that mimicked cannabis but avoided the "side-effects" experienced by cannabis smokers.
"We are going to get away from the plant," Layward said.
Free Rob and other marijuana activists see entheogenic plants like marijuana, peyote, and psilocybin as sacred, practical tools that connect us to earth, spirituality, inner peace, and physical healing. They note that people could freely gather and produce botanicals until the 20th century, when medicines and medical care were taken out of the hands of traditional healers, shamans, midwives, and individuals, and transferred into the control of licensed elites, corporations, and government agencies.
In this context, homegrown medical marijuana symbolizes self-reliance and freedom. Some people are willing to breed and grow their own medicine, ingest it, monitor its effects, and make necessary adjustments. That's exactly what I did after a botched surgery in 1994, and it worked well. Opponents of whole plant legalization claim I hurt myself by smoking marijuana, but whatever negative effect pot may have had on me, it was safer than the effects of prescription painkillers I kicked by using marijuana. And pot is far safer than jail.
 | | `The entire growing operation is a laboratory experiment.` | No view?
Dr Guy responded candidly, and with a degree of weariness, when I mentioned the controversies surrounding his research.
"I'm fully aware of these thoughts about our research," he said. "Some of this is just paranoia. People were spreading rumors that we were an arm of the government deliberately growing low-potency marijuana so we could prove that marijuana had no usefulness. That's preposterous. I have spent plenty of my money and my wife's money on this company; do you think we're going to do that so we can fail?
"People have to understand that we are producing pharmaceuticals. Doctors have to have adequate information as to its effects, its counterindications, which other drugs patients can take safely with cannabis. Patients should be able to be reimbursed for cannabis medicines by insurance or health services. There are international standards for medicines that can be prescribed by doctors. If we went to standards boards and said 'This is a plant, can't you treat this differently?' they would laugh at us.
"We want to spread cannabis to a large market, not just those people today who benefit from it, but to a lot more patients. I don't believe that this clashes with the aims of the people who are suspicious of us. A program that leads to a whole extract of cannabis being approved by regulatory authorities around the world can only help more people believe in the medical benefits of this plant. Recreational pot people don't have too much to worry about with our programs. There might be other programs they do have to worry about."
I asked Guy if people should be able to use and grow cannabis without medical supervision.
"It is inadvisable for patients to undertake a program of medication either on its own or in conjunction with prescribed medicines without their doctor's supervision," he replied.
"I don't have a view on recreational use," he added. "I run a pharmaceutical company and make medicines. My only comment on recreational use is that that issue is between the groups that want to promote it and the plebiscite. Nobody on that side has anything to worry about from our program."
Breeding medicine
The Dutch government used to be very tolerant of its burgeoning marijuana industry, but times have changed for the worse, and Netherlands' officials are less friendly toward the herb. Holland would not let HortaPharm export clones to Dr Guy, so he had to develop his original crop of marijuana varieties (he calls them chemovars) from stabilized HortaPharm seeds.
When photographs of GW's initial crop of seed-grown plants were released to the media, the doctor found himself accused of being a novice grower mistakenly producing leafy plants with long internodes and no flowering tops.
"That caused a bit of snickering," Guy admitted. "What we were doing, of course, was growing out these initial plants as mothers so that we could easily make clones, which are put into jiffy pots under 24 hour lights for two to three weeks, and then transferred to larger pots. Through testing and research, we developed a basic set of chemovars that reliably produce identical generations of plants that contain specific ratios of cannabinoids. We now grow very beautiful sinsemilla buds, and we have a yield and leaf ratio that is probably comparable to the best growers in the world."
Guy's chemovar program has raised cannabis breeding to an awesome level; his horticultural and pharmacological assistants monitor the tiniest details of the growing process. Guy knows where and when individual cannabinoids develop in different plants, even in different parts of a plant. He knows with scientific accuracy, plus or minus one percent, when cannabinoids are at their peak, and their ratios. He knows how nutrients, compost, plant density, lighting, and climate factors affect cannabinoid development and plant vigor. He knows the best harvesting, drying and curing techniques, and how they affect cannabinoid profiles and longevity.
Guy likens marijuana to wine grapes.
"It becomes obvious, as you study this plant, that it has the same breadth of genetic and environmental expression as grapes do, if not more," Guy said. "We're finding the factors that influence cannabinoid profiles, ripening, and production of other constituents, such as aromatic terpenes. These can be manipulated to assist our medicinal research."
Guy and HortaPharm developed stable lines of plants containing consistently predictable percentages of THC and other cannabinoids. In GW's "THC plants," for example, 90% or more of the cannabinoids present are in the form of THC. Other GW chemovars are rich in cannabidiol (CBD), which Guy believes may be an unheralded and increasingly important medical cannabinoid that does not produce acute psychotropic effects. His plants also produce other cannabinoids, such as cannabichromene (CBC) and cannbigerol (CBG), about which little is known.
Guy and his pharmaceutical chemists are especially intrigued by "propyl analogues" of THC and CBC, which are called THC-V and CBC-V.
"Southeast Asian, tropical and equatorial cannabis seem to contain higher amounts of THC-V and CBC, which could be responsible for reports that these varieties produce clearer, more transparent effects, and less of the unwanted effects, such as drowsiness," he explained. "Varieties grown in temperate and maritime climates have more THC and CBD. We are excited about testing the pharmacology of each cannabinoid."
Whole, raw, or synthetic?
The scientific debate about cannabinoids and their effects, which Dr Guy's research will help settle, spills over into the debate about whether synthetic cannabis-based medicines, such as Marinol, work as well as smoked cannabis or whole cannabis extracts.
Many experts assert that THC is responsible for all marijuana's effects. They believe there are no pharmacological differences between cannabis varieties. They claim that laboratory-produced THC (such as Marinol) is exactly the same as THC created by nature inside marijuana plants. Many scientists say that people who claim to experience different psychoactive effects from different types of marijuana are fooling themselves.
Other experts say that Dr Guy's "whole plant extract" approach, which avoids reliance only on THC, and seeks to extract different cannabinoids from plants and recombine them for use with specific medical aliments, is a misguided waste of time.
"They're entitled to their opinion, but I think the facts are on my side," Guy commented. "Plant THC is different from synthetic THC. It has to do with the number of optical isomers produced by plants in comparison to THC produced in a laboratory. But very few clinical experiments could distinguish the difference between synthetic and plant-derived THC as it relates to patient care.
"The truly important comparison is between the effects of the single molecule approach, using only THC, and multiple molecule approaches utilizing cannabinoids in combination. At GW we have advanced analytical techniques which tell you quite precisely which cannabinoids appear in plants, and we have been breeding a truly wide range of plants with different cannabinoid profiles, identifiable varieties that consistently give us different ratios.
"It is ridiculous to assert that there are no pharmacological differences between cannabis varieties. North American viewpoints are influenced by the types of cannabis there, which are mostly high THC varieties developed primarily for recreational use. In Europe and the UK, the more predominant illicit material is resin [hashish] from Morocco and other such regions, which are very high in CBD, in some instances more than 50%. It's a different mix of cannabinoids than those in the US, and many researchers suspect that CBD has its own effects and may also moderate the effects of THC.
"North American researchers focus on the single molecule approach, concentrating on THC to the exclusion of other cannabinoids, so the scientific literature is the literature of THC, because most researchers have concentrated on THC. But if THC is so effective, why are so few patients happy with Marinol? Why do they report so many negative effects? Why is it still only a $20 million drug, which is a very small market share? It is partially because Marinol takes too long to absorb because it is ingested orally, which subjects it to being metabolized by the liver into a different, and more potent, analogue of THC. But it is also possible that other cannabinoids moderate the effects of THC.
"I have spent 16 years researching drug delivery. I founded a drug delivery company. A large number of the constituents that enhance the acceptability of a chemical formulation are plant extracts and materials. So some of the constituents of cannabis might enhance absorption of other active components. There is the distinct possibility that interactions of components increase their bioavailability or how they are metabolized.
"Recent research in California in mice studied the effects of pre-treatment of CBD and how that affected their brain THC levels. Mice pre-treated with CBD had brain THC levels that were increased significantly over mice that had not been pre-treated. CBD by itself is an extremely potent anti-inflammatory agent.
"It's true that THC on its own, provided it's delivered in the right way, provides relief of acute neurogenic pain and neurogenic dysfunction, such as spasms. We are designing clinical programs to explore cannabinoids' effects on these conditions. But I don't accept that the activity of a whole plant can be represented by a single molecule of THC. It may do some of the things that a whole plant can do, but it is probably not as well tolerated by the patient; it probably has a less acceptable toxicity profile than whole plant extracts will have."
Pausing to take a breath, and to make sure that I understood what he was saying, Guy continued:
"My hypothesis, that cannabis medicines should be based on a combination of whole extracts from the plant, is not based on a belief system. I've worked in pharmaceutical medicine for 20 years. It's always struck me as odd that anyone believes there are many pathological systems in the body that would rely on, or be corrected by, alteration of a single chemical.
"Most illnesses are complexes of symptoms. There are series of mechanisms going wrong, and in some cases, cascades of reactions involving multiple factors. In head injury and stroke, many reactions occur in the brain; they are multi-factorial. So why would people insist that single chemical treatments are useful for such complex problems?
"Over millions of years, man, god and nature contrived to identify plants that have beneficial values, beneficial combinations of components that provide benefits to people. Concerning cannabis, I suspect there are a multiplicity of constituents inside the plant that work together to minimize the negative effects of individual components.
"When a patient is given THC alone, it produces all the adverse effects of a single chemical. It is very possible that the other compounds in cannabis may limit those adverse effects. It shouldn't be difficult for educated people to understand the concept of synergy between two or more molecules.
"Another factor is that some constituents of cannabis are potent antioxidants. If you want to make a drug and keep it in good condition with a decent shelf life, you need these antioxidants in the mix.
"To sum it all up, I think we'll find that THC as part of an extract of whole cannabis has different effects than administering it on its own."
 | | `People have to understand that we are producing pharmaceuticals.` | Seeking approval
Last year in Jamaica, I interviewed another medical cannabis pioneer who had conducted a pharmaceutical products design process. Dr Manley West, a professor at the University of the West Indies in Kingston, has already developed ganja-based medicines utilizing raw plant extracts. West claims to have removed the "psychoactive constituents" from his ganja-extract medicines, which are used to treat glaucoma, asthma and motion sickness. West's medicines have been pharmaceutically approved by medical review agencies in the Caribbean, Europe and elsewhere.
Dr Guy has now embarked on the same journey; he's committed to creating, funding and supervising an arduous process that starts with marijuana plants and ends up with marketable pharmaceutical medicines.
There are no guarantees that Guy's efforts will pay off. Government regulations, competition, and scientific hurdles ensure that he will spend at least $20 million creating cannabis-based medicines that he hopes will be approved and ready for mass marketing in England and elsewhere by 2003.
It is conceivable that he could succeed at every step of the way, only to find his products accepted by European regulators but frozen out of the lucrative US market due to drug war politics. Dr West was a victim of American drug war and scientific imperialism: the US Food and Drug Administration (FDA) refused to accept the validity of West's clinical testing programs, insisting that he spend millions of dollars to prove in the US what he'd already proven in Jamaica!
There are rumors that Guy met with US drug czar Barry McCaffrey, trying to get the obstinate general to OK fair clinical trials in America. The American government has managed to block all but a handful of the med-pot research proposals that have been put forward by US researchers.
Guy won't confirm or deny that he met with McCaffrey, but admitted that, "In the pharmaceutical business, one cannot afford to develop a drug just in one country. It's a global activity. If we want to develop a scheduled drug in the US, for example, we have to secure safe passage for our research material into the US, but the DEA and General McCaffrey's Office of National Drug Control Policy (ONDCP) have an influence on that. The main people we'd work with would be the FDA, but we have an extra hurdle in trying to get past the DEA/ONDCP, and other hurdles because this is a cannabis-based product. And after all that, the steps for getting approval are the same as they would be for any other drug."
Guy isn't sure if American officials will wake up to the therapeutic potential of cannabis, but he's optimistic about prospects in Canada and other countries.
"We've engaged in a dialogue with Canadian officials for more than a year," he said. "They came to our grow site, and had discussions with the Home Office. GW made proposals to them in May '99, and has offered to provide them with materials for clinical research programs since that time. Political and judicial events, such as the approval of Canadian patients to smoke cannabis under a Section 56 exemption, have overshadowed what we are doing in some ways, but we are continuing discussions with Health Canada. They have been very helpful indeed.
"GW has already set up a Canadian subsidiary company. We're also in touch with a wide range of investigators in Canada; we anticipate that our research proposals may be approved and clinical trials may start in Canada in summer, 2000. These trials, funded by the Canadian government, would be the first international expansion of GW's research and development program."
Waiting to inhale
GW Pharmaceuticals was created in late 1997, and Guy is well on his way toward meeting his initial goal: to extract cannabinoids from plants, test them for purity, toxicity and longevity, and configure them in ratios and delivery devices suitable for medical testing. Next, he'll go through three experimental phases involving human test subjects.
Phase One finds healthy volunteers who sample GW extracts while being monitored for physiological and psychological effects. Phase Two gives GW extracts to people with medical conditions. In this phase, Guy determines what doses and cannabinoid profiles are safe and have therapeutic value. In Phase Three, Guy gives cannabinoids to a larger group of patients, perhaps numbering in the thousands, perhaps comprising an international patient test group. He'll find out how his extracts affect specific groups of patients. For example, will a younger MS patient be affected by cannabinoids in a different manner than an older patient?
"By mid summer we will be doing primary studies in three areas: multiple sclerosis, spinal cord injuries and phantom limb pain," Guy predicted. "We're very excited by what we hear. A doctor in London, for example, studied a patient who has uncontrollable movement of the eye, related to MS, and cannabis is the only thing that helps him – no drug in the world gets rid of it except smoking cannabis resin. Oral cannabis doses, up to 30mg THC, didn't help him, so we suspect that the resin is effective because it can contain as much as 50% CBD. It's very enlightening to look into the different uses for cannabinoids and to find endpoints where no other drug works like cannabis."
Guy is recruiting patients for all phases of his trials via his website. He's received nearly 2,000 inquiries and patient histories; most of them confirm his belief that cannabis medicines are "among the most exciting biopharmaceutical opportunity I've seen in years."
He says he sympathizes with patients who say they already know cannabis helps them, and that they don't like the slowness of the required pharmaceutical approval process.
"We're working as hard as we can to get prescription medicines approved and ready for the patients within four years," Guy says. "In the meantime, they'll have the opportunity to utilize these medicines by participating in our clinical trials."
Guy predicts he'll be conducting Phase Three trials by the end of this year. If GW's extracts provide safe, timely, efficient relief for patients, he'll submit massive dossiers to England's Medicines Control Agency (MCA), the British equivalent of the FDA. If the MCA approves his products, he says, the British government has assured him that they will be placed on Schedule Two or lower, so that they can be prescribed by doctors.
Before that happens, however, Guy has to figure out the best way to get cannabis extracts into his patients.
"We've changed our minds about the delivery devices several times," he admits. "I can basically rule out the gastrointestinal tract as a method of ingestion. There are big problems when cannabis is taken that way: THC becomes a different metabolite in the liver, one that is three to five times more potent, and with a different effects profile. There's a slower onset, which delays relief, but the effects last longer, and some people become groggy. Marinol is not a very well designed drug.
"So we need a mucosal route – mucosa is red, wet, shiny surfaces – but that doesn't necessarily mean inhalation, and we cannot have people smoking the drug, because smoking has unacceptable negative health effects. You could administer extracts sublingually [below the tongue], or through the rectal or vaginal route. Obviously, there are limiting factors with these approaches. Suppositories aren't popular with some cultures; if we went the vaginal route, we would basically cut our potential number of patients in half! We're doing Phase One trials now, and the volunteers have reported that the sublingual route worked quite well; it was similar to what they expected from smoked cannabis. We've also worked on inhaler designs, and continue to be interested in that possibility."
 | | `There are international standards for medicines that can be prescribed by doctors` | Anti-euphoric ideology
Guy's cannabis delivery choices are limited and complicated by the reductionistic ideology underlying pharmaceutical regulations, Western medicine, and the drug war. This ideology distrusts nature, inserts a class of paid intercessors – doctors, corporations, pharmacists – between people and their health needs, and criminalizes entheogenic substances. It's an ideology that classifies cannabis-induced euphoria as a "negative side-effect."
Dr Guy is a businessman trying to operate within a system that slows down his efforts to market cannabis medicines. Understandably, the system requires GW's products to be targeted, effective and easy to use, but it also requires draconian security measures, such as electronic codes that prevent non-patients from utilizing Guy's products. Some observers, noting that smoked cannabis is safer and more effective than many prescription drugs it competes with, believe cannabis medicines are being held to a higher standard than the laboratory pharmaceuticals they'd replace.
And finally, GW is asked to design cannabis products that lack the main feature many marijuana users value most: the ability to produce euphoria and altered consciousness.
When I asked Guy if marijuana's mind-altering properties might inherently be linked to its medicinal effects, he responded, "I don't know. We have plenty of patient evidence to say the high is not necessary for their symptom relief, with many considering the high an unwanted side effect. I am also aware of claims that some patient groups may have additional effects at doses likely to cause a high. This will be closely investigated in our research programs."
I tried probing him in different ways about the irony of trying to remove psychoactivity from cannabis, when it's obvious that psychoactivity is a key feature of the plant's evolution. He denied he was in league with people using scientific research to eliminate psychoactive marijuana or prevent people from getting high by pre-treating them with chemicals that shut down cannabinoid receptors in the brain.
This was the only time in the interview when I felt I was getting a political answer rather than a candid one. Instead of telling me whether he opposed or supported peoples' right to use cannabis for altered consciousness, mood elevation and recreation, he said he had no opinion on the issue.
That rang hollow for me: Dr Guy is a very opinionated person.
"That's a political debate, not a scientific one," he said carefully. "In America they're either totally for or totally against [cannabis]. It's difficult to establish a balanced middle ground approach that says we have a marvelous drug that can make a lot of people feel much better, but it does have some problems, like any effective drug would have. To say here's an excellent drug without any negative effects is too much to ask medical community to believe.
"In the UK we're not as fervent or fanatic on this subject as in the US. The debate in the UK is not when we will use medical cannabis, but how. We don't have the type of law enforcement in the UK, or even in Europe, like you have in the US. I have debated heads of anti-drug squads over here, and they all, to a person, have said that if it's going to benefit patients then they fully agree with it. There's a kind of objectivity over here that seems to be lacking elsewhere. A lot of people over here knew nothing about marijuana. Now they are hearing about cannabis, and to them it means a medicinal plant, not something you smoke at a rock concert. They don't have any connection of it to marijuana.
"In the US, the medical use and recreational use seems to be confused and often there's an overlap, and it makes it harder to convince people that cannabis can produce legitimate medicines."
Our kind of guy?
So how should those of us who believe that marijuana should be totally legal for all uses feel about Dr Guy and his research? Is he a hero, a genius businessman, or an unwitting agent of Babylon?
I'm reminded of a conversation I had inside the famed Alchemy Head Shop on Portobello Road in London. A middle-aged Brit, visibly suffering from a nerve disorder that caused his hands to shake and his facial muscles to twitch, was furtively buying a glass pipe.
We talked about Dr Guy.
"I want to be one of his patients," the man said. "He's a solid chap. Very clever. Very tough. The kind who can knock heads in the Home Office and stand down [Prime Minister] Tony Blair. He's doing God's work."
Wouldn't it be better for you, I asked, if the government allowed you to grow your own medicine at home?
"I'm not much of a gardener," he responded, "and I'd rather just buy it from a chemist."
I asked him if he enjoyed getting high, if he agreed with the goal of making cannabis medicines that lack mind-altering properties.
"I like the effect, I admit it," he said. "It calms me down and puts a little color into a dreary day. I saw Dr Guy on television. He doesn't use cannabis. Never has, he says. So isn't it marvelous that a man who has never enjoyed it is doing so much for it? Someday, after he has everything going well and can relax, I hope he'll sample a bit and feel that special feeling. It's better than lager. But not to worry, we're grateful for him just the way he is."
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