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September, 2001 Edition
A publication of Ohio Patient Network (OPN). Contact Jean Taddie, Editor (editor@ohiopatient.net). |
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The following new items are included in this
month's OPNews:
* OPN WEB SITE KEEPS GROWING * OPN MEETING A SUCCESS * GW RELEASES PRELIMINARY DATA ON MEDICINAL CANNABIS TRIALS * MARIJUANA GOOD FOR THE BRAIN, STUDY SHOWS * MS PATIENTS SIGN FOR CANNABIS TRIALS * SIGN THE "IN DEFENSE OF FREEDOM" PETITION The following items are included in every OPNews: * YOU ARE INVITED TO OPN MEETINGS * HOW TO GET YOUR INFORMATION IN OPNews * HOW TO BE REMOVED FROM THE OPNews LIST * HOW TO CONTACT YOUR STATE REPRESENTATIVE AND SENATOR *************************************************** OPN WEB SITE KEEPS GROWING By Mary Jane Borden Keep checking the OPN Web site regularly. To better serve patients and caregivers, as well as to provide more useful information to the medical and legal communities, OPN plans to update and enhance its Web site frequently. Recent additions include an Events page that links to upcoming events sponsored by OPN and sister organizations and a section For Members Only from which members can be referred to legal services or ask a group of medical professionals questions concerning cannabis. With the goal of collecting the most extensive and best respected links to medical marijuana information, we have greatly enhanced the Web Links page to include categories specifically for the medical and legal communities. We could lead you directly to those new sections, but why not start out at our home page: http://www.ohiopatient.net. *************************************************** OPN MEETING A SUCCESS By Jean Taddie (Columbus, Ohio) On Saturday, September 15, OPN Board Members and a number of OPN members met in Columbus to discuss our organization's accomplishments and future goals. The warm sunny day provided the perfect backdrop for the meeting and potluck lunch. Special thanks go to Ken Schweickart for hosting the meeting, Secretary Kim Hayes for her endless pages of note taking, and Vice President Eleanor Ahrens for creating such a festive and delicious spread. One of the main goals that was discussed at the meeting - a goal that all of you can help with - is growing the Ohio Patient Network. To help our efforts, we ask each of you to encourage five (5) people to join the OPN. Ask your care providers, ask patients you know, ask concerned friends. Take them to the webform at http://www.ohiopatient.net/Become_an_OPN_member.htm where they can sign up for the private OPN discussion list and/or the monthly OPNews update. Recruit your friends to Join With Us! *************************************************** GW RELEASES PRELIMINARY DATA ON MEDICINAL CANNABIS TRIALS Source: GW Pharmaceuticals Press Release. September 10, 2001. Available at: http://www.gwpharm.com/news_pres_10_sep_01.html (England) GW Pharmaceuticals plc, the company developing a portfolio of prescription medicines derived from cannabis, announces the first release of preliminary safety and efficacy data from its Phase One and Two clinical trials. The data supports the very positive outcomes in patients reported by clinicians following administration of cannabis-based medicines by means of a sub-lingual spray. Of the first 53 patients in three trial centres, 41 derived clinically significant benefit. The data also confirms that GW's medicines have an excellent safety profile. GW also announces that, following detailed submissions to the Medicines Control Agency ("MCA") on patient progress in its trials covering 20 patient-years of data, the MCA has approved the extended use of its cannabis-based medicines (both THC and CBD containing materials) from 12 months to 24 months treatment. GW presented its first data to the American Academy of Pain Management in Arlington, Virginia, USA on Friday 7 September. The data relates to the effects of different formulations of cannabis-based medicines and placebo on patients suffering principally from Multiple Sclerosis or Spinal Cord Injury. The highlights are as follows: -Active treatments provide superior benefit to placebo in key outcomes (pain, overall symptom relief, sleep duration). -The data shows clear trends which support the clinical improvements experienced by patients whose conditions have been considered intractable in the face of standard therapy. In some cases, the improvements have been sufficient to transform lives. -Of the first 53 patients entering the studies in three centres, two remain in the acute phase of the study and 44 have completed this phase. Of these, 41 sustained a sufficiently beneficial response for them to opt to continue on active treatment long term. -The studies have generated over 20 patient-years of treatment. Adverse events have been predictable and generally well tolerated. -By careful self-titration (dose adjustment), most patients are able to separate the thresholds for symptom relief and intoxication. -Analysis of dosage levels over extended periods shows no evidence of tolerance, thereby avoiding the requirement for patients to progressively increase their dose. Commenting on the data, Dr Philip Robson, Medical Director, said, "This is the most comprehensive evaluation of cannabis-based medicines so far undertaken in patients suffering from multiple sclerosis and spinal cord injury. We are seeing definite trends indicating the superiority of active treatment over placebo. I have seen at first hand in the Oxford trial the very real clinical benefits that cannabis-based medicines can provide for these seriously ill patients. These encouraging early results fully justify the expansion of the clinical research programme into larger scale Phase Three pivotal trials. This Phase Three programme is now well underway. "The data also suggest an excellent safety profile for these medicines and I welcome the MCA's decision to allow patients to extend their maintenance treatment into a second year." Dr Geoffrey Guy, Executive Chairman, commented, "Our clinical trials programme is moving ahead in a most satisfactory manner. We remain confident of being able to present data on quality, safety, and efficacy to the UK regulatory authorities in 2003, and - subject to approval - bring the first cannabis-based prescription medicine to market in early 2004." *************************************************** MARIJUANA GOOD FOR THE BRAIN, STUDY SHOWS Source: High Times, Special to HighWitness News. September 13, 2001. Available at: http://www.hightimes.com/News/2001_09/potgood.tpl By Paul Armentano (Arlington, Virginia) Hundreds of the nation's top neurologists, clinicians and pain specialists obtained a sorely needed education on the therapeutic value of cannabis at last week's annual meeting of the American Academy of Pain Management (AAPM) in Arlington, Virginia. Highlighting the four day conference-which included one full day devoted to pot's analgesic properties-was Friday's keynote address by Geoffrey Guy, head of GW Pharmaceuticals' world-renowned medi-pot greenhouse. "This plant isn't broken; let's not take it apart," Guy told an initially cynical crowd, many of whom had likely never before heard the term marijuana unless it was in reference to Cheech and Chong. However, by the conclusion of Guy's speech, during which he announced that nearly 80 percent of all patients administered GW's sublingual cannabis extracts in clinical trials have attained significant benefits, no one was snickering. "I'd like to thank Geoffrey Guy for his informative presentation," declared one attendee. "I see we need to get over our 1960s and 70s attitudes toward marijuana." Friday's daylong workshop, entitled "The Role of Cannabinoids in Pain Management," was the brainchild of Montana neurologist and editor of The Journal of Cannabis Therapeutics, Ethan Russo. Russo praised the AAPM for agreeing to address the pot for pain issue head on. "This body is unique for having recognized the role of medical cannabis for people with chronic pain," he said. "The reality is that there's a great deal of interest in this subject and today's [presentations are] are a manifestation of that interest." Speakers at the conference included Russo, MS specialist Denis Petro, Jon Gettman (who announced that oral arguments regarding his petition to force the federal government to reschedule marijuana will begin before the US Court of Appeals next March), patient activist and former Cannabis Cup "Goddess" Kitty Tucker, Kevin Zeese, Patients Out of Time co-founder Mary Lynn Mathre, and Institute of Medicine (IOM) researcher Janet Joy, co-author of the report: Marijuana As Medicine: Assessing the Science Base*. Joy's presentation offered both good and bad news for medi-pot proponents. On the positive front, Joy announced that the National Institute on Drug Abuse (NIDA) recently approved three separate clinical trials examining the efficacy of marijuana in the treatment of MS and AIDS-related neuropathy (severe pain). All three studies, pending final approval from the Drug Enforcement Administration (DEA), will be performed at California's newly created Center for Medicinal Cannabis Research. (Though it remains to be seen whether DEA-chief and monumental medi-pot hater Asa Hutchinson will allow these or similar trials to go forward.) However, aside from NIDA's sudden change of heart-for nearly 15 years the agency refused to allow any investigations into the therapeutic potential of whole smoked cannabis, Joy admitted that little has changed at the federal level since the release of the IOM's 1999 report. When asked what specific actions the federal government has taken to implement the IOM's recommendations, including the initiation of compassionate, single-patient (so-called "n-of-1") trials, Joy responded "essentially nothing." Regarding the possibility that pot could one day become a legal FDA-approved medication, Joy expressed little enthusiasm. "It's a botanical product," she said, "and [they] don't generally meet modern FDA standards." Given the ignorance and recalcitrance of US drug policy, it's no wonder America lags some "five to eight years" behind other industrialized nations when it comes to unlocking pot's therapeutic potential, according to Geoffrey Guy, who described the US as "out of kilter with the entire rest of the Western world with respect to cannabinoids." Further illustrating this point, Guy said that although his company has been "welcomed with open arms by the rest of the world," - GW is set to begin numerous Phase III human studies in England and Canada this fall - they have received only a tepid reaction from US officials. "The United States has a very particular way of viewing these materials (cannabis and cannabis-based extracts), and it doesn't have to do with the materials or how they help the patients," he said. Nevertheless, Guy's presentation made it apparent that medi-pot is alive and well internationally. Recently, England's Medicine! s Control Agency (MCA), the equivalent of our FDA, affirmed the safety of GW's cannabis extracts, and extended the duration for which they can provide medical pot to patients from 12 to 24 months. According to Guy, 41 of the 53 patients enrolled in GW's first three clinical trials sustained therapeutic benefits - including relief from pain, spasticity, bladder-related symptoms and tremor, as well as a 50 percent average reduction in their use of opiates - and have elected to continue their medi-pot use long-term. "These are mostly patients whose conditions were previously considered intractable," Guy said, adding that many also reported that medical pot profoundly improved their sleep, mood and overall sense of well-being. "Somehow a million years of evolution between cannabis and humans have come up with an amazing medicine," Guy said to close Friday's workshop. For those in attendance, the day marked the beginning - but hopefully far from the end - of a long-overdue education in the use of marijuana as medicine."THC ... and CBD ... are potent anti-oxidants, effective neuroprotectants because of their ability to reduce toxic forms of oxygen (free radicals) that are formed during cellular stress." *Marijuana As Medicine: Assessing the Science Base, National Academy of Sciences Institute of Medicine (IOM), 1999. *************************************************** MS PATIENTS SIGN FOR CANNABIS TRIALS Source: BBC News (UK Web). Thursday, September 06, 2001 (View this article at http://www.mapinc.org/drugnews/v01/n1651/a03.html?2216) (Plymouth, England) Two hundred people have signed up for the first national study into the effects of cannabis on multiple sclerosis. The research will investigate whether cannabis and related chemicals help to reduce muscle stiffness and improve mobility in multiple sclerosis patients. Multiple sclerosis is a degenerative disease of the central nervous system. Initially it causes loss of balance, reduced vision and bouts of localized paralysis. Eventually, patients may become totally paralysed and wheelchair-bound. The £1.2 million research, funded by the Medical Research Council, is being co-ordinated between the Plymouth Hospitals NHS Trust and the University of Plymouth's Postgraduate Medical School. Helpful Dr John Zajicek, who is leading the project, said: "Many patients with MS and their doctors believe that cannabis is helpful in treating some of its symptoms. "This trial is recruiting enough patients to prove scientifically whether cannabis is indeed helpful, as we believe." In January the first recruits were signed up in Plymouth and from June the trial was extended nationwide. In total 660 people are needed for the three-year programme, which will involve 38 hospitals across Britain. Patients are accepted onto the study for only one year and are randomly given one of three treatments. Some are given cannabis oil, others a constituent of cannabis called tetrahydrocannabinol, and the remainder receive placebo capsules. Every few weeks, those taking part in the trial are assessed for muscle stiffness and mobility and are also asked to take part in a postal survey about their disability and quality of life. Neither the patients nor the doctor will know which form of treatment each is being given until after the study. The results are expected by summer 2003. *************************************************** SIGN THE "IN DEFENSE OF FREEDOM" PETITION By Mary Jane Borden** The recent tragic events have troubled us all, and certainly we want action. But if you care about our cause, if you want to retain the ability to speak your mind, please sign the "In Defense of Freedom" petition at http://www.indefenseoffreedom.org/. It has already obtained the endorsement of more than 150 organizations, 300 law professors, and 40 computer scientists. Please add your voice. **OPN respects individual freedom of expression of all members, including board members, and members are free to express their opinions as desired on our lists. OPN will take official positions on issues directly related to the medical cannabis issue. *************************************************** *************************************************** The following items are included in every OPNews: *************************************************** OPNews DISCLAIMER OPNews, a publication of Ohio Patient Network (OPN), provides medical cannabis news that affects Ohio patients, caregivers, and health professionals. Articles are intended for information purposes and do not reflect an official position by OPN or the OPN Board of Directors. For more information, contact Jean Taddie, Editor (editor@ohiopatient.net). *************************************************** YOU ARE INVITED TO OPN MEETINGS The OPN Board of Directors invites you to participate in the OPN planning meetings. Electronic voice/text meetings are held at the OPN chatroom in PalTalk. To receive PalTalk and meeting room instructions, as well as date and time information, contact info@ohiopatient.net. *************************************************** HOW TO GET YOUR INFORMATION IN OPNews OPNews is published monthly. To have your information considered for publication, submit your story to editor@ohiopatient.net. PLEASE DO NOT SEND ATTACHMENTS. Please do not boldface or italicize text. Include a contact name with a phone number and/or e-mail address with submissions. *************************************************** HOW TO BE REMOVED FROM THE OPNews LIST You may sign off this list at any time by using the webform at www.ohiopatient.net. *************************************************** HOW TO CONTACT YOUR STATE REPRESENTATIVE AND SENATOR Find your Representative in the Ohio House at http://www.house.state.oh.us/jsps/Representatives.jsp Find your Ohio Senator at http://www.senate.state.oh.us/senators/ Write to your officials care of their district office, or send your letter to their Columbus office at: The Honorable (name) Ohio House of Representatives 77 South High Street Columbus, Ohio 43266-0603 -or- The Honorable (name) Ohio Senate Building Columbus, Ohio 43215 Telephone calls and emails are also persuasive, especially when the constituent contacts the district office.
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