HTTP/1.0 200 OK Content-Type: text/html Medical Marijuana Gets Backing in Canada
Pubdate: Tue, 08 Feb 2005
Source: Wall Street Journal (US)
Page: D7
Copyright: 2005 Dow Jones & Company, Inc.
Author: Jeanne Whalen, Staff Reporter
Cited: GW Pharmaceuticals
Bookmark: (Cannabis - Medicinal - Canada)
Bookmark: (Cannabis - Medicinal)
Bookmark: (GW Pharmaceuticals)


Mouth Spray Wins Preliminary Approval

U.K. and U.S. Tests Loom

As some popular painkillers come under fire for causing dangerous side 
effects, an often-shunned alternative is gaining legitimacy in pain relief: 

Medical marijuana has been winning legal endorsement through the efforts of 
a British pharmaceutical firm. GW Pharmaceuticals of Salisbury, England, 
has spent years developing and promoting a cannabis-based mouth spray that 
the company claims eases severe pain and muscle stiffness without causing a 
psychotropic high. Winning the backing of health authorities has been an 
uphill battle, but Canadian officials recently gave it preliminary approval 
for treatment of neuropathic pain in multiple sclerosis sufferers. Studies 
concluded not long ago also showed the product effective at treating severe 
cancer pain.

Now GW is aiming for approval in the United Kingdom, and longer-term, in 
the U.S., where medical marijuana is likely to come up against greater 
resistance. "The deepness and polarity of the [marijuana] debate in the 
U.S. is unique," acknowledges Geoffrey Guy, executive chairman of GW. GW 
hopes the Canadian approval "will force the U.S. to address this issue once 
and for all and make a decision," says Managing Director Justin Gover. If 
the product is approved in more markets, GW believes it one day could be 
used by a million patients suffering from pain associated with MS, cancer 
and other ailments.

The treatment, called Sativex, is an extract of a hybrid form of cannabis 
grown by GW. The company says the plants are specially bred to remove most 
of the psychotropic agents and to increase the presence of helpful 
properties such as cannabidiol. The company, which won a special license 
from the U.K. to breed cannabis and carry out research, grows 50,000 plants 
every year in greenhouses in a location it keeps secret so as to avoid 
curiosity seekers, protesters and potheads.

Founded in 1998 to research the medicinal uses of cannabis, GW is traded on 
the London Stock Exchange. The company has a few other cannabis-derived 
products in early development.

Richard Payne, a 56-year-old Briton with multiple sclerosis, began taking 
Sativex three years ago as part of a clinical trial and says the medicine 
helps relieve his muscle stiffness and gives him better bladder control. It 
also has alleviated the violent muscle spasms that used to keep him awake 
at night.

Finding the Right Dosage

"When I was finding a level that suited me I did get in an intoxicated 
state once," he says, but he's since decreased the dosage, as he believes 
most pain sufferers would. "If you took all your eight-week supply in a few 
days you'd probably be very high," he says. "But I think people who suffer 
MS would rather have a better quality of life for eight weeks than have a 
couple of days where you don't know what's going on in the world."

In late December, Canada's health agency issued what it calls a "qualifying 
notice" for the approval of Sativex to treat neuropathic pain in MS 
patients. The de facto approval will become official once GW submits extra 
forms agreeing to certain conditions, including an obligation to carry out 
additional clinical trials with the product. GW says it expects its 
partner, Bayer AG, to begin marketing Sativex within a few months in 
Canada, where 50,000 people have MS.

Canadians, who legalized smoked marijuana for those with "grave and 
debilitating illnesses" in 2001, have a fairly accepting attitude toward 
the cannabis plant. The fact that British officials gave GW permission to 
grow and test its product in Britain gives the company hope that it may win 
approval there, too, possibly as soon as this summer.

The U.S. will be a harder sell. Under the classification system of the 1970 
Controlled Substances Act, marijuana is listed as having "no currently 
accepted medical use." That hasn't stopped gravely ill patients from 
smoking it on the sly, and in recent years 11 states have defied federal 
law by making marijuana legal for medicinal use. California was the first, 
passing its 1996 Compassionate Use Act after heavy lobbying by AIDS 
patients and others. Last year, Montana and Vermont became the latest 
states to pass similar laws.

The Bush administration says the state laws interfere with federal efforts 
to combat illegal drugs and has sought to overturn them. In 2002, Federal 
Bureau of Investigation agents raided the home of a California woman who 
was growing marijuana to treat her lower-back pain. The woman and a 
colleague filed a lawsuit against the federal government, a case that has 
worked its way up to the Supreme Court. The court began hearing the case, 
Ashcroft v. Raich, last year, and is expected to rule in July.

Doesn't Give a High

GW hopes Sativex will avoid similar controversy because it isn't smoked 
and, when used properly, doesn't give a high. The company has spent several 
years explaining its product in meetings with key U.S. officials and says 
it hopes to open discussions with the Food and Drug Administration in the 
coming months. As a first step, GW is aiming to win FDA permission to carry 
out a clinical trial of Sativex on American patients.

An FDA spokeswoman declined to comment on Sativex's prospects for approval. 
Last summer, Robert J. Meyer, a director of the FDA's office of drug 
evaluation, told a congressional committee that the FDA would "continue to 
be receptive to sound, scientifically based research into the medicinal 
uses of botanical marijuana and other cannabinoids" and would "facilitate 
the work of manufacturers interested in bringing to the market safe and 
effective products."

Sativex's approval in Canada won't make the product easily available to 
Americans driving over the border. The medicine will be available only by 
prescription in Canada and will be illegal back in the U.S.

Several years ago, the FDA approved a medicine called Marinol that is made 
from a synthetic copy of a compound found in cannabis. The medicine, sold 
by Solvay SA of Belgium, is used to treat appetite loss and weight loss in 
AIDS patients. Other drug companies also are working on synthetic compounds 
that mimic cannabis, including Indevus Pharmaceuticals, which is testing 
such a product in late-stage human trials. Because Sativex is made from 
pure cannabis extract, it will be a harder sell. 
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