MEDICAL MARIJUANA GETS BACKING IN CANADA 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: cannabis. 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.