Britain Poised to Approve Medicine Derived From Marijuana
January 26, 2004
David Tuller, New York TimesA 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.
But THC is only one of dozens of cannabinoids, the substances that invest the marijuana plant with its properties. And because Marinol must be absorbed through the digestive system, it takes longer to begin working than smoked marijuana. Many patients also say that Marinol is far less effective in easing their symptoms.
Sativex has been designed to overcome those shortcomings. Because it is sprayed under the tongue, the drug is absorbed through mucus membranes, a quicker and more reliable route of action than swallowing a pill.
Moreover, Sativex includes not only THC but substantial levels of the cannabinoid cannabidiol, which is believed to have anti-anxiety and other therapeutic properties -- as well as dozens of other marijuana ingredients that GW researchers believe augment the drug's medicinal benefits. The company also maintains that Sativex, when taken properly, does not cause the kind of intoxication that people routinely experience from smoking marijuana.
In clinical trials, Sativex provided some relief from symptoms of multiple sclerosis and from pain caused by nerve damage. The company is also testing Sativex and other marijuana products for treatment of schizophrenia, head injuries, epilepsy, rheumatoid arthritis and other conditions.
Dr. Geoffrey Guy, the chairman of GW, said he had founded the company to develop marijuana-based medicines after realizing in the 1990's how many ordinary people with serious illnesses were being charged with marijuana possession. 'This was Middle England showing up in court,' he said.
Dr. Lester Grinspoon, a retired psychiatry professor at Harvard Medical School and a longtime marijuana proponent, said Sativex would be an improvement over Marinol. 'But many or quite possibly most people would still find smoking marijuana to be quicker, more effective and cheaper,' he said.
Dr. Grinspoon worries that what he calls the pharmaceuticalization of marijuana -- the advent of Sativex and related drugs -- could weaken public support for easing laws on the possession and use of the plant.
But the executive director of the Drug Policy Alliance, a New York-based group that seeks to overhaul drug laws, sees any increase in awareness of the benefits of marijuana as likely to advance the debate.
'What's happening is that people are appreciating the broader value of cannabis in human society,' said Dr. Ethan Nadelmann, the alliance's executive director. 'It's a remarkable plant with remarkable properties.'