Source: Los Angeles Times (CA)
Author: Eric Bailey, Times Staff Writer
Published: April 20, 2005
Copyright: 2005 Los Angeles Times
Contact: [email protected]
Canada became the first nation Tuesday to approve a pharmaceutical
prescription spray derived from the cannabis plant, a move that could
shift the medical marijuana debate in the U.S.
The drug, called Sativex, is being produced by GW Pharmaceuticals of
Britain and is expected to be available in Canadian pharmacies within
weeks, principally for the treatment of pain from multiple sclerosis.
"I think the Canadian approval will change an awful lot of things," said
Geoffrey Guy, GW Pharmaceuticals executive chairman. In particular, it
should help "create momentum" for approval in other countries, including
the U.S., he said.
The company isn't expected to apply in the United States until late this
year. An examination of the drug's merits could take three to five
But the Canadian approval of Sativex, announced by GW Pharmaceuticals at
the opening of the London stock exchange, is causing ripples in the U.S.
Bush administration officials declined to comment but have privately
said approval of a prescription form of cannabis in the U.S. might draw
a bright line between its use by patients and by recreational users.
Some medical marijuana activists, meanwhile, see approval of Sativex as
proof that cannabis is a worthy medicine.
"Sativex is for all practical purposes liquid marijuana, so the question
of whether marijuana is medicine has been settled," said Bruce Mirken of
the Marijuana Policy Project. "The only question is what form people
use, and that's best left to doctors and patients."
Meanwhile, a few activists have promised to travel north of the border
to get Sativex instead of waiting for the drug's approval in the U.S.
"It's not the fault of MS patients that the U.S. is so far behind in
medical marijuana research and development," said Steph Sherer of
Americans for Safe Access, a Berkeley-based medicinal marijuana advocacy
California and nine other states allow medical marijuana, but the
federal government maintains strict prohibitions. The U.S. Supreme Court
is expected to soon decide a case involving two California women who
smoke marijuana to alleviate their illnesses.
Guy and his colleagues began research into prescription forms of
marijuana in 1997 at the behest of the British government, reacting to
the emotional and heavily publicized arrests of multiple sclerosis
patients medicating themselves with illegal cannabis.
In a remote corner of England, GW Pharmaceuticals set up high-security
greenhouses capable of producing 30 tons of cannabis a year. Sativex
gives physicians more consistent quality and the ability to set
"I think physicians will feel a lot more comfortable with this," said
Dr. David Bearman, a Santa Barbara internist who specializes in medical
marijuana. "One of the reasons cannabis fell out of favor was a lack of
The spray, laced with a peppermint flavoring, contains no carcinogenic
smoke, Guy said, and patients in trials reported that they could avoid
the drug's intoxicating effects once they discovered what dose worked
best for them. Patients are given Sativex through a spray under the
tongue or on the inside of the cheek.
Although his fledgling pharmaceutical company expected to win approval
in Britain last year, government officials said in December that they
wanted more evidence about the benefits of the medicine. GW
Pharmaceuticals has launched a new series of tests and expects approval
by late this year or in 2006.
Guy said the company, which has teamed up with Bayer to market Sativex
in Canada, hopes for approval in Europe, China, Southeast Asia and the
U.S. within five years.
"The U.S. has one of the best regulatory systems in the world, but it
requires a lot of effort and the generation of an awful lot of data,"
To help win U.S. approval, the firm has hired U.S. drug experts as well
as Andrea Barthwell, former medical director for federal drug czar John
"Having this product available will certainly slow down the dash to make
the crude plant material available to patients across the country," said
Barthwell, an addiction medicine specialist.
Some medical marijuana activists suggested that Sativex could help spur
efforts to legalize medicinal use of leafy marijuana.
"In practical terms," said Mirken, of the Marijuana Policy Project, "Sativex
is to marijuana as a cup of coffee is to coffee beans."
Barthwell drew a different comparison.
"Comparing crude marijuana to Sativex is like comparing a raging forest
fire to the fire in your home's furnace," she said. "While both provide
heat, one is out of control."
Note: The drug will be used to treat pain from multiple sclerosis.
Medicinal marijuana advocates see decision as furthering their cause in
Related Articles & Web Sites:
Marijuana Policy Project
The Lesson of Sativex
Canada Approves GWs Cannabis Drug for MS
GW Clears Cannabis Hurdle
Cannabis Spray Gets Go-Ahead