Prescription Pot: More Than a Pipe Dream?


That Supreme Court ruling against the medical use of marijuana wasn't a total downer for those who want the weed made legal for treating pain and other ailments. GW Pharmaceuticals, a British company that's developing medications derived from marijuana, says it's pushing ahead with plans to start clinical trials in the U.S., with an eye toward bringing the world's first cannabis-based prescription drug onto the market as early as 2003. In fact, the company announced plans for an initial public offering on May 14, only hours before the high court issued its decision.

Geoffrey Guy, founder and chairman of GW Pharmaceuticals, says the ruling won't affect his company because it's developing "legal pharmaceutical products" that will be reviewed by government regulators. The Supreme Court struck down a California law that let marijuana "buyers' cooperatives" provide the drug to seriously ill people whose doctors say they could benefit from smoking it. The Court said there was no proof of marijuana's medical effectiveness -- and Guy agrees. "The 'evidence' has yet to be proved," he says. "That is why we are having clinical trials."

"POLITICALLY SENSITIVE." Under license from the British government, GW grows about 15 tons of marijuana a year at secret locations around the country, then processes it into medicines intended to provide relief from pain and other symptoms. Advanced clinical trials are already under way in Britain for one marijuana-based preparation that has shown promise in early trials for treating symptoms of multiple sclerosis. Canadian regulators recently approved clinical trials there, too. And Guy says GW is in talks with the U.S. Food & Drug Administration and Drug Enforcement Agency to begin trials in the U.S. Although he expects to get the go-ahead, Guy recognizes, "it's more politically sensitive in the United States."

A movement to legalize marijuana for medical use has gained momentum in recent years as doctors and patients have reported that the drug eases pain, tremors, and muscle spasms caused by nervous-system diseases such as multiple sclerosis, as well as nausea caused by chemotherapy and AIDS. Voters in eight U.S. states have passed ballot initiatives allowing patients to obtain marijuana legally if their doctors certify that it's medically necessary. The California law struck down by the Supreme Court, for example, allowed state-regulated buyers' cooperatives to distribute the drug.

But researchers still aren't certain if tetrahydrocannabinol (THC), the active ingredient in marijuana, actually relieves symptoms -- or if people simply care less about them when they get high. For now, the Supreme Court ruled, marijuana "has no currently accepted medical use in treatment in the United States." The FDA has approved Marinol, a drug based on a synthetic version of THC, the active ingredient in marijuana. But Marinol's only approved use is for treating nausea, and its effectiveness is limited because it comes in pills, which nauseated patients often have trouble keeping down.

EARLY PROMISE. Enter GW Pharmaceuticals. The preparations it's developing are sprayed under the tongue, so they're absorbed directly into the body without the patient having to swallow anything. And the drugs are made from processed marijuana, so it doesn't produce a high. Early clinical trials over the past two years in Britain have shown effectiveness in treating symptoms of multiple sclerosis, arthritis, and cancer.

GW has already raised nearly $15 million from investors since its founding in 1997. The company is planning a London stock market listing in late June that could value it as high as $240 million. Proceeds will be used to fund clinical trials and step up cannabis production to as much as 100 tons a year. GW says it expects to be profitable as early as 2004. And it's way ahead of the competition: Guy says it's the only company in the world legally producing the weed for pharmaceutical uses. So, at least investors may be able to get a buzz. But for now, medical-marijuana use awaits the outcome of clinical trials. By Carol Matlack, who writes about business issues for BusinessWeek in Paris


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