WILLY NOTCUTT thinks that one of Geoffrey Guy's shrewdest moves was his choice of multiple sclerosis patients as the first population on which to test Sativex. With its myriad symptoms and variable progression, Notcutt says, MS is a very difficult disease to study. "So why use it? Nothing to do with logic. It has everything to do with politics." MS patients were already "screaming and shouting and writing about it," Notcutt told me. Using them "was opportunistic. It could have been the hemophiliacs with pain from AIDS. It could have been the gay AIDS lobby. But the perception of the young mother struck down by MS was powerful. There was no taint of any recreational use nor any prejudice over sexuality."
Whatever the spin, John Ross is glad to have his Sativex. A 66-year-old former truck driver, Ross has had multiple sclerosis for 25 years, and he lost his driver's license to it 15 years ago. Since then, it's gotten bad enough to put him in a wheelchair some of the time (including this morning), racked with pain that he likens to being plugged into a wall socket and muscle spasticity that makes it hard for him to keep his balance. But he's chipper and ramrod straight in the chair and there's a glint in his blue eyes when he tells me that since he's been on Sativex—which he, like all Notcutt's cannabis patients, calls "The Spray"—he's even gotten back onto the golf course.
Ross' story is much like the accounts of the other MS patients I encountered at Paget: a nightmare descent, as the sheaths around their nerves unraveled, into a world of pain and debilitation, frustrating attempts to find relief through various drug cocktails, and finally the suggestion, made by a doctor in Ross' case, to "get your hands on cannabis." Ross was surprised, but he dutifully rounded up some pot, rolled it with tobacco into a cigarette (the usual method of recreational users in England), and got nearly instant relief. He avoided the black market by growing his own in the little greenhouse attached to his home, but the fear of being busted was never far away. (Nor was mishap, like the time he dried his plants in the oven and his wife came home to a house full of smoke and a too happy husband.) So when his doctor referred him to Notcutt's trials, Ross was pleased to discover that the spray was not only legal and cleaner than smoking, but also just as effective as his homegrown. "I was brilliant," he says, "on 28 sprays a day." (Notcutt estimates that five or six shots of Sativex is "very roughly speaking" the equivalent of one joint.) Now he generally takes six sprays before bed, usually drinking it mixed into milk because, he says, the spray gave him mouth ulcers and it "tastes vile."
Ross says that Sativex doesn't get him high, a claim repeated by most patients I spoke to at Paget—and by medical marijuana users generally. This isn't as far-fetched as it sounds, says GW spokesman Mark Rogerson, echoing the long-accepted principle that a drug's effects depend on the mindset and environment of the user as much as on chemistry. "In general the aim of the recreational user is to achieve intoxication, while the aim of the medicinal user is to avoid it—because they want to go on with their lives." The company uses this claim to further distinguish its product from pot—GW calls intoxication a "side effect"—but in fact it is nearly impossible to disentangle cannabis' medicinal effects from its side effects. According to Notcutt, Sativex users do not avoid euphoria so much as they become experts in finding the "borderland" between disabling pain and disabling intoxication, to learn how to "go up to the point where that was enough, thank you very much. If I go much further, I start to feel kind of funny and I don't want to be there." Notcutt thinks that Sativex patients can safely find their own dose, and points out that no one has ever died from an overdose of cannabis in any form. And he's sure this method will work, in part because it's been working for years: "A group of people [can be] passing a joint around, and one will take a puff and get a bit too high and the next time pass on it. Smoking a joint in a group is a patient-controlled analgesia device."
John Ross has found that borderland, and he is pleased to be allowed to be there. (His reward for participating in clinical trials is a free supply of Sativex by prescription.) "Yesterday, I fell in my garden," he told me. "I came straight indoors and took four sprays, and I knew it would keep me calm and in control, and out of pain. And even if I did have the pain, it's easier to contend with." Ross is a satisfied customer, and he wants me to spread the word. "Anyone in the States got the MS," he says as he wheels himself out of Notcutt's office, "you tell them to get on The Spray."
AT LEAST ONE PERSON in the States would like to do exactly that. Julie Falco, a Chicagoan who has had MS for half of her 40 years, bakes an ounce of pot into a pan of brownies ("I like a little chocolate with my cannabis," she says) every 10 days or so and eats a small square every morning for pain and spasticity. She sees Sativex as "another option in the arsenal," one that can provide quicker relief than eating pot and can be used in public. But getting Sativex from Canada is not as easy as hopping on a bus and buying Prilosec. Even if she could get a prescription, U.S. Customs and Border Protection would, according to a spokesman, seize and destroy Sativex on the grounds that cannabis is illegal in this country. So Falco has applied to the FDA for permission to obtain Sativex under the Compassionate Use program, which allows patients for whom there is no other treatment to obtain drugs still considered experimental by the U.S. government. (More than 40 medical marijuana patients once got pot directly from the government under this program, but in 1992 the FDA stopped considering Compassionate Use applications for the plant.)
Even if Falco is successful, most patients will have to wait for Sativex to run the FDA's gauntlet—notoriously difficult and unpredictable even for drugs without political baggage. But there is precedent for FDA approval of cannabinoids. In 1985, the agency approved Marinol, a synthetic form of THC, as a treatment for AIDS-related wasting and chemotherapy-induced nausea, but it has proved unpopular with patients, who complain that the drug takes too long to work, which makes the dosage hard to adjust, and that it is ineffective. (Some scientists believe that pot's medicinal effects depend on the interaction among all its chemicals, not just on THC.) Drug policymakers had hoped Marinol would be "a godsend," according to Mark Kleiman, director of the Drug Pol-icy Analysis Program at UCLA's School of Public Affairs. "It wasn't any fun and made the user feel bad," Kleiman says, "so it could be approved without any fear that it would penetrate the recreational market, and then used as a club with which to beat back the advocates of whole cannabis as a medicine." Kleiman thinks that Sativex might succeed where Marinol failed, not only because evidence from GW's clinical trials might convince regulators that it works, but also because GW is poised to "persuade the drug warriors that getting Sativex approved fast is the best way to block the medical marijuana movement."
But this kind of maneuvering could have unintended consequences. "The approval of Sativex will show that the drug warriors have been lying all along about medical marijuana," says Rob Kampia, head of the Marijuana Policy Project, an organization that has spearheaded several state ballot initiatives. It will also, Kampia thinks, vastly complicate law enforcement efforts. "If Sativex is approved in the U.S., and a patient is arrested for whole marijuana and they go to court, they're now going to be able to say, 'Hey, we know that liquid marijuana has medical value as declared by the FDA, therefore I shouldn't go to prison for having nonliquid marijuana.'"
UCLA's Kleiman points out other complications for drug warriors: "If the word gets out that in fact it can be used to get high, then there might be a substantial demand for it among those who want to get stoned while remaining within the law, especially since it could be prescribed for relatively nonspecific indications such as pain and anxiety. And the one thing this is going to do for sure," he adds, "is wreck the drug-testing industry."
GW refuses to comment on these possibilities, calling drug policy "a matter for law- yers and governments." But drug-war politics matter to the company, if for no other reason than that prohibition would make Sativex the only legal cannabis in the marketplace. ("I wouldn't want to comment on that particular statement," says Rogerson.) Indeed without prohibition, GW might not have a market, which may be why, in addition to its larger population, the United States holds more appeal to the company than Canada and Europe, with their relatively lax laws.
A couple of GW hires indicate that the company is not nearly so apolitical as it claims: John Pastuovic, a campaign spokes- man for George W. Bush in 2000 who was part of an effort to derail medical marijuana legislation in Illinois earlier this year, and Andrea Barthwell, who, as a deputy drug czar from 2002 to 2004, led the campaign to brand medical marijuana as a hoax. Both can be expected to enforce message discipline. As soon as I told him I was writing about medical marijuana, Pastuovic interrupted. "Sativex is not medical marijuana," he said. "What you have out [in California], that's medical marijuana. Sativex is medi- cine." For her part, Barthwell has refused to publicly comment about her turnaround, except to say to the Los Angeles Times that "comparing crude marijuana to Sativex is like comparing a raging forest fire to the fire in your home's furnace. While both provide heat, one is out of control."
GW even offers a high-tech way to control the fire that is bound to appeal to drug warriors: the Advanced Dispensing System, a thumbprint-activated, computerized dispenser that limits the dosage to what a doctor (through a cell-phone link) authorizes, preventing Sativex from being overused for its "side effects." Rogerson says that GW can certainly make the device—originally designed for methadone users—available to the U.S. government. "We can say, 'Here is your motorcar, sir. Would you like the standard version or the armor-plated version?'" Either way, Kampia says, "Sativex fits the niche that the drug warriors have created." And they seem to agree. "It is entirely possible that there are elements of the cannabis plant that have medicinal value," says Tom Riley, spokesman for the drug czar's office, echoing an Institute of Medicine report that his office commissioned in 1999. "If such elements were developed into safe, effective medicines, they could theoretically be prescribed and distributed like all the other drugs that have dependency-producing side effects."
Sativex also fits a niche that Kampia's movement has created, if inadvertently, by seeking to legitimize pot as a medicine even as it remains otherwise illegal. In a society that relies on a profit-driven, science-based industry to supply drugs and on government regulators to approve them, a raw herb that grows like a weed and has been vilified for nearly 70 years is a tough sell as a medicine. A patented liquid that you can pick up at Walgreens along with your Prozac, on the other hand, may be precisely the formula for bringing cannabis in out of the cold, especially if it has a carefully crafted reputation as something other than pot.
It is, of course, way too early to tell, but within two days of the Canadian approval, U.S. newspapers were already reporting that Sativex consisted of a "type of cannabinoids that have been isolated and purified [to] work specifically at the targeted pain receptors," and that the drug "does not intoxicate users." That, according to Willy Notcutt, "is a load of bollocks. But why," he asked me, "correct such misapprehensions at the current time?"