Dr. Geoffrey Guy, Chairman of GW Pharmaceuticals plc, will make the following comments at Annual General Meeting:

“In 2008, we have started to build on the achievements of 2007, a year of important progress for GW. The licence agreement signed in 2007 with Otsuka secured the future of our lead product, Sativex®, in the United States, the world’s largest pharmaceutical market, by providing funding for the US development plan aimed at securing regulatory approval from the FDA. Separately, the global cannabinoid research collaboration signed with Otsuka later in 2007, enabled us to accelerate the development of our pipeline of new cannabinoid medicines. During 2007, we also secured a further approval for Sativex in Canada for the treatment of cancer pain and achieved clarity from the European regulators as to their requirements to gain approval.

“2008 is a pivotal year in GW’s development with the results expected from three separate late stage trials for Sativex in Europe and the US. The first of these is the MS neuropathic pain Phase III trial in Europe which includes a total of 339 patients. This study is complete and on track for database lock shortly with headline results due in the coming weeks. Separately, the Phase III MS spasticity trial requested last year by the UK regulatory authority commenced on time and is recruiting on schedule. These two trials provide us with separate regulatory filing opportunities for Sativex in Europe over the coming year.

“Progress is also being made under both elements of the Otsuka collaboration. The Sativex US Phase IIb/III cancer pain study commenced towards the end of 2007 as planned. Other aspects of the Sativex US development plan agreed with the FDA are also progressing well. Under the cannabinoid research agreement, promising pre-clinical data is already starting to emerge on a range of novel cannabinoids within the CNS and oncology fields.

“Separately, our in-house research programme in the field of type 2 diabetes and related metabolic disorders is also making progress. We recently announced highly promising results in both pre-clinical pharmacology studies and a Phase I trial of a new potential cannabinoid treatment, delta-9-tetrahydrocannabivarin (THCV). Following on from this first study, GW is now preparing to start a Phase IIa multiple dose study in type 2 diabetic patients in 2008.

“With Sativex now in the regulatory endgame in Europe and in late stage development in the US, and the wider field of cannabinoid medicines continuing to grow, we look forward to reporting news of our progress during 2008.

“As announced in the preliminary results, Dr Brian Whittle, Scientific Director and co-founder, at the age of 75, has chosen not to seek re-election at the AGM and therefore retires today. Although Brian has gradually decreased his working time over the last few years, he played an instrumental role in the development of GW and will be greatly missed. I would like to express on behalf of the Board my sincere gratitude for his contribution to the company.”

Source: GW Pharmaceutical

The lung cancer study was the scariest. Since cigarettes are a known lung cancer risk, it seems plausible that marijuana might carry similar risks. In fact, most of the scientific evidence tends in the opposite direction - though one would never know it from reading either the study or the Reuters wire story that got the heaviest circulation.

Conducted in New Zealand, this was what is called a "case-control" study, in which researchers looked at a group of patients who had lung cancer and compared them to a group without cancer - the controls - matched for age and other demographics. All were asked about various factors that might increase their lung cancer risk, including smoking cigarettes or marijuana. After running the data on 79 cancer cases and 324 controls through myriad equations and mathematical analyses, the researchers proclaimed that one joint packed a cancer risk roughly equal to 20 cigarettes - an assertion that became Reuters' lead.

What was downplayed in the study, published in the European Respiratory Journal, and missing entirely from most media reports was context - context that strongly suggests that its alarming conclusion is wrong.

For one thing, the new conflicts with other, much larger studies. In a study published in 1997, Kaiser-Permanente researchers followed 65,000 patients for 10 years and saw no sign of marijuana use increasing the risk of lung cancer or other smoking-related cancers. And a UCLA study similar in design to this one, published in 2006, found a trend toward lower lung cancer rates among marijuana smokers. Instead of 79 cancer cases, the UCLA team looked at 1,212. The result was so striking that they speculated that it "may reflect a protective effect of marijuana."

That's right: Marijuana might protect from cancer. Piles of published studies going back to the mid-1970s document the cancer-fighting properties of marijuana's active components, THC and other chemicals called cannabinoids. Anticancer activity has been shown in many types of malignant cells, including lung cancer cells. So even though marijuana smoke contains tars and other potentially carcinogenic compounds, it is entirely plausible that cannabinoids counter any harmful effects.

But even without such context, a closer look at the New Zealand data raises questions that should have been asked by reporters. For example, most marijuana smokers in the study actually didn't show an increased risk of cancer. The only group that did was those whose marijuana use equaled at least 10.5 "joint-years" (one joint-year equals smoking a joint every day for one year). That group constituted a whopping 14 people. All those complicated mathematical models leading to the "20 times the risk" assertion, and contradicting reams of published research, rest on exactly 14 people.

Concord, NH - A House subcommittee yesterday approved a bill to reduce the consequences of possessing small amounts of marijuana.

The Criminal Justice and Public Safety subcommittee voted 3-1 to reduce to a violation, punishable by a $200 fine, possession of less than one-quarter ounce of marijuana. It is not clear when the full committee will vote on the bill.

Current law makes possession of marijuana a misdemeanor, which carries a fine and criminal record upon conviction. A violation would not mean a record, Rep. David Welch, R-Kingston, said.

"Young folks who aren't always making intelligent choices could screw up their chances at a Pell Grant for college later on," under current law, he said. A quarter ounce is the equivalent of seven or eight joints, Welch said, referring to marijuana cigarettes.

The subcommittee set a lower limit than the original version of House Bill 1623, which would have decriminalized holding up to one and a quarter ounces. It also corrected a drafting error in the bill that would have removed penalties for selling small amounts of marijuana.

Rep. John Tholl, R-Whitefield, who is the Dalton police chief, voted with Welch and Rep. Ellen Nielsen, D-Claremont, for the amended bill. Tholl said possession of a quarter-ounce is "far less onerous than an ounce." He said it's not clear how far the full Criminal Justice committee, with its high percentage of retired law enforcement officers, will view the bill.

Matt Simon of the N.H. Coalition for Common Sense Marijuana Policy said he was happy to see the bill advance. Current penalties are "unnecessarily harsh," he said.

"These representatives have taken an honest look at the facts and they've agreed to support punishments which come closer to fitting the offense." Rep. Delmar Burridge, D-Keene, opposed the bill, sponsored by Reps. Jeffrey Fontas, D-Nashua, Andres Edwards, D-Nashua, and Charles Weed, D-Keene.

Copyright: 2008 The Union Leader Corp.

Source: Union Leader (Manchester, NH), Union Leader - Front Page News