The Cannabis Conundrum

GW's drug-development strategy is based on the belief that various components of the plant work to treat specific illnesses, and it is breeding plant strains in which different cannabinoids predominate. In addition to its THC variety, GW is cultivating a strain that consists almost entirely of cannabidiol, or CBD, which moderates the THC high and possesses no psychoactive effect of its own. CBD may be useful in treating neuropathic pain, inflammation, and central-nervous system conditions such as epilepsy. To date, three drugs have been tested in clinical trials: GW's high-THC variety, high-CBD, and Sativex, which is a 50-50 mix of the two.

Geoffrey Guy's goal--to cultivate medical-grade pharmaceutical plants that produce a specific cannabinoid--has required him to raise the art of cannabis-breeding to a spectacular level. Guy's CBD-producing plant strain is unique. And every one of Guy's plants--whether it's a THC, CBD, or one of several other varieties--is completely uniform, with absolutely no genetic variation between each plant. In that respect, the greenhouse resembles a living factory, where the product takes exactly 14 weeks, from planting to harvest, to move down the assembly line.

"Our job is to find out, ahead of everyone else, what the cannabinoids do," says Guy. "To accomplish that, we grow into the plant the exact profile of the chemicals we want. We control our finished product by controlling the plant."

Dressed Better Than a Banker

Geoffrey Guy is a physician and a maverick entrepreneur who has previously launched two publicly traded pharmaceutical companies. On one day in his office in a high-security compound south of London, he was decked out in a double-breasted business suit, complete with a white handkerchief peeking above the breast pocket--people in the legal-cannabis business tend to dress better than bankers. Guy cracks that his favorite mind-altering drug is rugby. He claims never to have smoked anything, least of all pot: "I've brought 14 different drugs to market, and I've never taken any of those, either."

Guy might be the only man in England who has the know-how and the political connections necessary to launch a cannabis-based pharmaceutical company and shepherd its products through the British regulatory system. Nineteen years ago, he founded Ethical Holdings, a pharmaceutical company that developed morphine products, which gave him real-world experience in winning controlled-drug licenses from Britain's Home Office. In 1990, he founded Phytopharm, a company that specialized in developing medicines from Chinese herbal remedies.

Starting in the mid-1990s, patient groups in the UK--particularly the powerful Multiple Sclerosis Society--began lobbying for changes in the drug laws that would allow sick people to receive prescribed cannabis. Guy, who had been devouring the medical literature on marijuana, thought that if he could get dispensation from the government, he had the science-and-business wherewithal to develop an approved medicine from an illegal plant. His hunch paid off. In June of 1998, after months of meetings with Guy, the British government granted GW the license to cultivate and supply cannabis for research and drug development.

Still, had Guy failed to come up with an alternative to smoking cannabis, regulators never would have allowed him to proceed. For Sativex, GW has devised a delivery device that looks like a breath spritzer: Patients spray the drug onto the lining of the mouth; it takes effect within 20 to 45 minutes. The device allows patients to determine how many doses they need to relieve their symptoms. They tend to settle out at relatively modest levels--on average, 8 to 10 sprays of Sativex a day--which appear to be enough to relieve their symptoms without incurring an intoxicating effect. "These people are suffering from a terribly debilitating disease," says Guy. "They're just looking for a safe, efficacious medicine that will help them get on with their lives."

For the U.S., a Missed Market?

While the United Kingdom seems to be on the verge of approving Sativex--and countries from Canada to Australia are permitting the compassionate use of marijuana for seriously ill people--medical marijuana research remains mired in politics in the United States. California has established the Center for Medicinal Cannabis Research at the University of California at San Diego, and the National Institute on Drug Abuse has implemented a mechanism for supplying marijuana to the center's investigators. (Scientists outside of California who aspire to investigate medical marijuana face a torturous regulatory approval process.) Thus far, federal regulators have approved 14 of the center's studies. One such study is investigating the short-term effects of cannabis on spasticity in 30 MS patients. Meanwhile, GW has just completed phase III clinical trials on more than 1,000 patients--the largest program of clinical research on cannabis ever.