Source: Los Angeles Times (CA)
Author: Eric Bailey, Times Staff Writer
Published: February 1, 2004
Copyright: 2004 Los Angeles Times
Contact: [email protected]
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."
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