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UK: Britain Poised to Approve Medicine Derived From Marijuana
Davis Tuller New York Times
Tuesday 27 Jan 2004 A marijuana-based medication for people suffering from multiple sclerosis and severe pain is expected to be approved for sale in Britain early this year, British officials say. The drug, Sativex, developed by GW Pharmaceuticals, a British company, is a liquid extract from marijuana grown by the company under license from the government. Developed to be sprayed under the tongue, it would be the first drug in recent decades to include all the components of the cannabis plant, advocates of medical marijuana say. The British agency that regulates pharmaceuticals does not like to discuss potential drugs before they are approved. The country's Home Office, which oversees laws and policies on controlled substances, has indicated that Sativex is likely to receive approval. Alan Macfarlane, a chief inspector at the Home Office, said the results of the clinical trials for Sativex looked promising. "I'm hoping it will be dealt with in the next two to three months, and I will be surprised if it doesn't succeed," he said. Bayer, the German pharmaceutical giant, signed a deal with GW last year to market Sativex in Britain and possibly other countries. "What's likely to happen is that the U.K. authorization will lead quite quickly to European Union authorization," Mr. Macfarlane said. "I think it's going to be a little troubling for the U.S. Drug Enforcement Administration, given the national climate about marijuana." GW also hopes eventually to obtain regulatory approval from the Food and Drug Administration. But the review process in the United States is expected to take much longer, and the policy against marijuana use, in any form, is much more prohibitive. Further, the Office of National Drug Control Policy says that marijuana abuse is associated with health problems as diverse as respiratory infections, impaired memory and learning, anxiety and panic attacks. Marijuana proponents challenge these claims, saying the plant is far less toxic than many of the medicines it would replace. In any event, they say, approval of medical marijuana in Britain should lead to broader acceptance of the plant's therapeutic uses. "If it turns out to be effective," said Dr. Jack Lewin, chief executive of the California Medical Association, "it's going to be a very positive development, akin in terms of medicine to moving from the crudeness of smoking opium to the use of Demerol and morphine." The Food and Drug Administration has allowed people to import personal supplies of pharmaceutical drugs that are not approved in the United States, and medical marijuana advocates are already planning to pressure the authorities to allow patients to obtain Sativex. But Will Glaspy, a spokesman for the Drug Enforcement Administration, said it was unlikely that someone could lawfully import an extract from a drug like marijuana, although he did not know specifically about Sativex. "If it's a controlled substance here, it would be illegal to bring it into the country," Mr. Glaspy said. But some advocates for overhauling marijuana laws say the British approval of Sativex will bolster their case. Dr. Rick Doblin, president of the Multidisciplinary Association for Psychedelic Studies, a research and education organization in Sarasota, Fla., said, "To the extent that GW gets approval, it supports the credibility of what we have been saying about the medical benefits of marijuana, and it causes people to question the credibility of the government." Others are concerned about the government's response. Bruce Mirkin, a spokesman for the Marijuana Policy Project, an advocacy group in Washington, said, "The government could use this as an excuse to say, `See, we have this fabulous pharmaceutical substitute; you don't need this nasty weed anymore.' " Drug companies have already developed a handful of drugs derived from isolated elements of the marijuana plant. The most widely known marijuana drug now available is Marinol, which the F.D.A. approved in capsule form in 1985. Marinol is essentially a synthetic version of THC, or tetrahydrocannabinol, the psychoactive component of marijuana, and is used to treat chemotherapy-associated nausea and AIDS-related wasting and appetite loss.
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