BRITISH FIRM HOLDS HOPE FOR USERS OF MEDICAL POT

Some Say Prescription Marijuana Spray Could Defuse A Legal Standoff.

Carol Rosenfield hurts. Pain and fatigue smother her, arriving without
warning. Sometimes, the 58-year-old West Hollywood woman says, symptoms of
her multiple sclerosis strike so hard she feels as if she's melting, "like
the Wicked Witch of the West."

What she wants - what she says she needs - is Dr. Geoffrey Guy's medicine.

On the far side of the Atlantic, Guy and his fledgling British
pharmaceutical company are poised to release a prescription drug packed
with equal parts potential and controversy. Contained in a tiny spray
bottle, the drug developed by GW Pharmaceuticals is named Sativex. Most
know it by its street name: marijuana.

Even in advance of its expected approval in Britain, the medication is
roiling anew the long and bitter standoff over medical marijuana in
America, a conflict that has knotted California since 1996, when voters
approved cannabis as medicine.

Despite the U.S. government's long resistance to marijuana for the ill, the
Bush administration is privately voicing a cautious interest in Guy's
medication. Apart from the drug's potential benefits to patients, some
administration officials see it as a step toward ending the emotionally
charged duel between the nine states that have legalized medical cannabis
and the federal government, which stands by its unbending ban on marijuana
for any use.

Instead of hitting the street-corner drug dealer, medical marijuana
patients could get a doctor's prescription filled at the neighborhood
pharmacy. The sick who stick with smoked cannabis would risk seeing
sympathy ebb, sparking a new wave of raids on the dozens of cannabis
dispensaries that have survived to serve California patients.

Though such potential pitfalls aren't lost on pot activists, some see a
different future. By vaulting a long-demonized substance from the fringe to
the pharmacy, they contend, prescription elixirs such as Sativex could help
reshape public opinion about a drug maligned by federal officials as Cheech
and Chong medicine.

Rosenfield doesn't plan to stand on the sidelines and wait. She doubts the
U.S. Food and Drug Administration and federal Drug Enforcement
Administration will give Sativex a green light any time soon. If it gets
into British pharmacies and receives good reviews, Rosenfield vows, she
will find a way to obtain the marijuana extract, crossing the Atlantic
herself if necessary.

"Oh my god, yes," said Rosenfield, who uses marijuana to control her
symptoms but would trade it for a prescription drug that works better. "If
this Sativex is released in England, I will find a way to get it."

Sativex, which is sprayed in the mouth and absorbed by the mucus membrane,
has undergone extensive clinical trials and is expected to be marketed in
the United Kingdom, initially for treatment of multiple sclerosis and
certain types of chronic pain.

Guy, a stout and energetic man who wears owlish glasses and professes to
have never smoked marijuana despite his company's singular focus on the
plant, believes further research might eventually prove cannabis-based
medicines effective against many other illnesses, from cancer pain and
rheumatoid arthritis to migraine headaches and Parkinson's disease.

"We haven't suffered any of the scoffing about the medical possibilities of
cannabis as you have in the U.S.," Guy said. "The U.S. psyche has a great
deal of difficulty getting past the notion of this as a demon drug."

GW Pharmaceuticals has generated skepticism in some quarters of the British
press, with one broadsheet suggesting that Sativex rests on a flimsy
premise advanced by Guy, the company's cheerleader in chief. But for most
of last year GW's stock rocketed, particularly after the feisty start-up
signed an agreement with Bayer, the pharmaceutical giant, to market the
drug in Britain and Canada.

The company's creation was something of a happy accident for Guy.

In 1997, government officials were aghast at heavily publicized arrests of
MS patients who had been medicating themselves with marijuana. British
officials made it clear that they had no intention of legalizing smoked
cannabis as medicine. But through side channels, they collaborated with Guy
to launch research toward a prescription drug.

"We insisted they develop a proper medicine," said Alan Macfarlane, the
British Home Office's chief drug branch inspector. "It had to be textured
like a medicine, look like a medicine, behave like a medicine and be
delivered like a medicine."

Guy, 49, set out on a bit of historical sleuthing to see how cannabis was
used during the late 1800s, its heyday in the British pharmacopeia. (Queen
Victoria is said to have used cannabis to ease menstrual pain.) The
pharmaceutical firm focused on MS and neuropathic pain, the most common
uses of medical cannabis in Britain today.

The pot used by MS patients in England is a type of Moroccan hashish
characterized by lower levels of psychoactive tetrahydrocannabinol, or THC,
than the potent cannabis prized in America. Instead, the weed contained
higher quantities of cannabidiol, or CBD in scientific shorthand.

Though THC has long been the focus of recreational pot connoisseurs as well
as scientists hunting down marijuana's therapeutic value, Guy considers CBD
a sort of underappreciated kin with far more therapeutic promise. He has
nicknamed CBD his "Cinderella molecule."

In a remote corner of England, GW set up high-security greenhouses capable
of producing 30 tons of pot a year. By mixing different strains, the firm
hopes to tailor cannabis-based drugs to various illnesses.

Sativex shares the jigsaw puzzle of roughly 425 chemicals found in leafy
marijuana, but gives physicians more consistent quality and the ability to
set standardized dosages. The peppermint-tasting spray contains no
carcinogenic smoke, and Guy said patients rarely feel intoxicated after
they discover which dose works well for them.

The only current cannabis-based medicine in the U.S., a prescription pill
containing synthesized THC, takes longer to react, isn't easily stomached
by patients suffering nausea, and leaves some zonked out.

"Patients don't want to replace one disability for another," Guy said.
"They don't want to get high."

Richard Payne, a former British Telecom manager with MS who participated in
clinical trials of Sativex, said, "You never get that buzz. You just notice
your legs moving a bit freer. It certainly has changed my life."

The UK health products agency is expected to finish its review of GW's
50,000-page drug application and rule on Sativex sometime in the next few
months. Macfarlane, the Home Office drug inspector, said he would be
surprised if it didn't get a green light.

"I shall be extremely disappointed if it isn't approved," he said. "The
occasions when people suffering MS have been prosecuted have been difficult
for me personally."

The firm hopes to have the drug on the market in at least three European
countries fairly quickly, as well as in Canada, where medical marijuana has
been legalized.

That wave might then wash up on U.S. shores.

GW has been conducting talks for the last four years with the FDA and the
DEA, which plays a role in the review of drugs that present a risk of abuse.

To circumvent the worries of anti-drug warriors, GW has developed a small,
computer-aided metering device for potential use in the U.S. The hand-held
contraption, about the size of a TV remote control, meters dosages to
ensure that a patient isn't overusing the spray.

Federal regulators won't discuss their talks with GW, but didn't express
qualms that Sativex represented a rare foray in the prescription drug
business: a whole-plant medicine. "Lots of products are derived from
plants," said Brad Stone, an FDA spokesman. "We're not biased against
herbals." Moreover, the mass of data presented by GW in Britain could help
with approval.

Officials at the White House, meanwhile, see possibilities in Sativex.

"A product like this, if effective, would separate the people genuinely
seeking medicine from those who are trying to advance a Trojan horse
drug-legalization agenda," one administration official said. "It would end
the charade of smoked marijuana as medicine."

Such talk worries some activists, who believe the government would use
Sativex to divide patients and legalization proponents, the medical
marijuana movement's driving force. Valerie Corral, founder of a Santa Cruz
medical marijuana cooperative fighting the federal government in court,
called it "a way to further promulgate the drug war."

Other critics say Sativex could prove medically inferior to smoked
cannabis. Dr. Lester Grinspoon, a longtime marijuana researcher at Harvard
Medical School, said in a journal article last year that a cannabis mouth
spray is slower to act than inhaled pot, more expensive than the home-grown
product and probably less effective.

But some medical marijuana activists see more than just health benefits
from Sativex. Daniel Abrahamson, legal affairs director at the Drug Policy
Alliance, said it could help demystify cannabis and encourage discussion
about easing strict criminal penalties for recreational use.

It remains uncertain how warm an embrace Sativex would receive from U.S.
doctors.

Dr. Melvyn Sterling, medical director for an Orange County hospice program,
sometimes recommends marijuana to cancer patients suffering weight loss.
But he can't tell them where to get it, worries about the legal risk
they're taking on and can't gauge the quality of the pot or how much they
should take.

Sativex would help on all those fronts, Sterling said. "I've been looking
forward to having this stuff available to us."

Many other physicians, however, remain dubious about U.S. approval any time
soon, and even then want to see Sativex prove itself in the real world.

"When we see them in action, every drug has its upside and downside," said
Dr. Scott Fishman, a UC Davis professor of medicine conducting research on
marijuana's effect on pain. "It's almost as if these drugs never enjoy as
much support as the day they're introduced."