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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.
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."
Pubdate: Tue, 27 Jan 2004
Source: New York Times (NY)
Copyright: 2004 The New York Times Company
Contact: letters@nytimes.com
Website: Breaking News, World News & Multimedia
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."
Pubdate: Tue, 27 Jan 2004
Source: New York Times (NY)
Copyright: 2004 The New York Times Company
Contact: letters@nytimes.com
Website: Breaking News, World News & Multimedia
