{"id":64,"date":"2005-06-07T16:23:19","date_gmt":"2005-06-07T21:23:19","guid":{"rendered":"http:\/\/blogs.law.harvard.edu\/nesson\/2005\/06\/07\/marijuana-volcano\/"},"modified":"2005-06-07T16:23:19","modified_gmt":"2005-06-07T21:23:19","slug":"marijuana-volcano","status":"publish","type":"post","link":"https:\/\/archive.blogs.harvard.edu\/nesson\/2005\/06\/07\/marijuana-volcano\/","title":{"rendered":"Marijuana Volcano"},"content":{"rendered":"<p><img decoding=\"async\" src=\"http:\/\/cyber.law.harvard.edu\/nesson\/blog\/wp-content\/volcano.jpg\" align=\"right\" alt=\"\" \/>  In many states of the USA the argument for Medical Marijuana has not yet prevailed. Though opinion against its medicinal use may be grounded in misinformation and prejudice, it is yet true that the Supreme Court has no reason to expend its valuable authority in preventing Congress from respecting and responding to what is still a dominant national sensibility. The Supreme Court&#8217;s decision forces Medical Marijuana advocates to move the focus of their educational efforts to the national legislature.  This may prove in the end to be a good thing, though in the mean time doctors and patients will feel the pressure of the law as an additional goad to present their case.<\/p>\n<p>***<\/p>\n<p>The FDA better close their eyes and cover their ears&#8230;.<\/p>\n<p>Clinical trial to be published in the Journal of Pharmaceutical Sciences<br \/>\ncalls the Volcano Vaporizer a &#8220;safe and effective&#8221; cannabinoid delivery<br \/>\nsystem:<\/p>\n<p>&#8220;The goal of this study was to evaluate the performance of the Volcano<br \/>\nvaporizer in terms of reproducible delivery of the bioactive cannabinoid<br \/>\ntetrahydrocannabinol (THC) by using pure cannabinoid preparations, so that<br \/>\nit could be used in a clinical trial.<\/p>\n<p>&#8220;Our results show that with the Volcano a safe and effective cannabinoid<br \/>\ndelivery system seems to be available to patients. The final pulmonal uptake<br \/>\nof THC is comparable to the smoking of cannabis, while avoiding the<br \/>\nrespiratory disadvantages of smoking.&#8221;<\/p>\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;-<\/p>\n<p>J Pharm Sci. 2006 Apr 24<\/p>\n<p>Evaluation of a vaporizing device (Volcano(R)) for the pulmonary<br \/>\nadministration of tetrahydrocannabinol.<\/p>\n<p>Hazekamp A, Ruhaak R, Zuurman L, van Gerven J, Verpoorte R.<\/p>\n<p>Division of Pharmacognosy, Institute of Biology, Leiden University, Leiden,<br \/>\nThe Netherlands.<\/p>\n<p>What is currently needed for optimal use of medicinal cannabinoids is a<br \/>\nfeasible, nonsmoked, rapid-onset delivery system. Cannabis &#8220;vaporization&#8221; is<br \/>\na technique aimed at suppressing irritating respiratory toxins by heating<br \/>\ncannabis to a temperature where active cannabinoid vapors form, but below<br \/>\nthe point of combustion where smoke and associated toxins are produced. The<br \/>\ngoal of this study was to evaluate the performance of the Volcano vaporizer<br \/>\nin terms of reproducible delivery of the bioactive cannabinoid<br \/>\ntetrahydrocannabinol (THC) by using pure cannabinoid preparations, so that<br \/>\nit could be used in a clinical trial. By changing parameters such as<br \/>\ntemperature setting, type of evaporation sample and balloon volume, the<br \/>\nvaporization of THC was systematically improved to its maximum, while<br \/>\npreventing the formation of breakdown products of THC, such as cannabinol or<br \/>\ndelta-8-THC. Inter- and intra-device variability was tested as well as<br \/>\nrelationship between loaded- and delivered dose. It was found that an<br \/>\naverage of about 54% of loaded THC was delivered into the balloon of the<br \/>\nvaporizer, in a reproducible manner. When the vaporizer was used for<br \/>\nclinical administration of inhaled THC, it was found that on average 35% of<br \/>\ninhaled THC was directly exhaled again. Our results show that with the<br \/>\nVolcano a safe and effective cannabinoid delivery system seems to be<br \/>\navailable to patients. The final pulmonal uptake of THC is comparable to the<br \/>\nsmoking of cannabis, while avoiding the respiratory disadvantages of<br \/>\nsmoking. (c) 2006 Wiley-Liss, Inc. and the American Pharmacists Association<br \/>\nJ Pharm Sci 95:1308-1317, 2006.<\/p>\n<p>***<\/p>\n<p>Medical marijuana<br \/>\nReefer madness<\/p>\n<p>Apr 27th 2006<br \/>\n&gt;From <a href=\"http:\/\/www.economist.com\/science\/displaystory.cfm?story_id=6849915\">The Economist<\/a> print edition<\/p>\n<p>Marijuana is medically useful, whether politicians like it or not<\/p>\n<p>IF CANNABIS were unknown, and bioprospectors were suddenly to find it in<br \/>\nsome remote mountain crevice, its discovery would no doubt be hailed as<br \/>\na medical breakthrough. Scientists would praise its potential for<br \/>\ntreating everything from pain to cancer, and marvel at its rich<br \/>\npharmacopoeia\u2039many of whose chemicals mimic vital molecules in the human<br \/>\nbody. In reality, cannabis has been with humanity for thousands of years<br \/>\nand is considered by many governments (notably America&#8217;s) to be a<br \/>\ndangerous drug without utility. Any suggestion that the plant might be<br \/>\nmedically useful is politically controversial, whatever the science<br \/>\nsays. It is in this context that, on April 20th, America&#8217;s Food and Drug<br \/>\nAdministration (FDA) issued a statement saying that smoked marijuana has<br \/>\nno accepted medical use in treatment in the United States.<\/p>\n<p>The statement is curious in a number of ways. For one thing, it<br \/>\noverlooks a report made in 1999 by the Institute of Medicine (IOM), part<br \/>\nof the National Academy of Sciences, which came to a different<br \/>\nconclusion. John Benson, a professor of medicine at the University of<br \/>\nNebraska who co-chaired the committee that drew up the report, found<br \/>\nsome sound scientific information that supports the medical use of<br \/>\nmarijuana for certain patients for short periods\u2039even for smoked marijuana.<\/p>\n<p>This is important, because one of the objections to marijuana is that,<br \/>\nwhen burned, its smoke contains many of the harmful things found in<br \/>\ntobacco smoke, such as carcinogenic tar, cyanide and carbon monoxide.<br \/>\nYet the IOM report supports what some patients suffering from multiple<br \/>\nsclerosis, AIDS and cancer\u2039and their doctors\u2039have known for a long time.<br \/>\nThis is that the drug gives them medicinal benefits over and above the<br \/>\nmedications they are already receiving, and despite the fact that the<br \/>\nsmoke has risks. That is probably why several studies show that many<br \/>\ndoctors recommend smoking cannabis to their patients, even though they<br \/>\nare unable to prescribe it. Patients then turn to the black market for<br \/>\ntheir supply.<\/p>\n<p>Another reason the FDA statement is odd is that it seems to lack common<br \/>\nsense. Cannabis has been used as a medicinal plant for millennia. In<br \/>\nfact, the American government actually supplied cannabis as a medicine<br \/>\nfor some time, before the scheme was shut down in the early 1990s.<br \/>\nToday, cannabis is used all over the world, despite its illegality, to<br \/>\nrelieve pain and anxiety, to aid sleep, and to prevent seizures and<br \/>\nmuscle spasms. For example, two of its long-advocated benefits are that<br \/>\nit suppresses vomiting and enhances appetite\u2039qualities that AIDS<br \/>\npatients and those on anti-cancer chemotherapy find useful. So useful,<br \/>\nin fact, that the FDA has licensed a drug called Marinol, a synthetic<br \/>\nversion of one of the active ingredients of<br \/>\nmarijuana\u2039delta-9-tetrahydrocannabinol (THC). Unfortunately, many users<br \/>\nof Marinol complain that it gets them high (which isn&#8217;t what they<br \/>\nactually want) and is not nearly as effective, nor cheap, as the real<br \/>\nweed itself.<\/p>\n<p>This may be because Marinol is ingested into the stomach, meaning that<br \/>\nit is metabolised before being absorbed. Or it may be because the<br \/>\nmedicinal benefits of cannabis come from the synergistic effect of the<br \/>\nmultiplicity of chemicals it contains.<br \/>\nJust what have you been smoking?<\/p>\n<p>THC is the best known active ingredient of cannabis, but by no means the<br \/>\nonly one. At the last count, marijuana was known to contain nearly 70<br \/>\ndifferent cannabinoids, as THC and its cousins are collectively known.<br \/>\nThese chemicals activate receptor molecules in the human body,<br \/>\nparticularly the cannabinoid receptors on the surfaces of some nerve<br \/>\ncells in the brain, and stimulate changes in biochemical activity. But<br \/>\nthe details often remain vague\u2039in particular, the details of which<br \/>\nmolecules are having which clinical effects.<\/p>\n<p>More clinical research would help. In particular, the breeding of<br \/>\ndifferent varieties of cannabis, with different mixtures of<br \/>\ncannabinoids, would enable researchers to find out whether one variety<br \/>\nworks better for, say, multiple sclerosis-related spasticity while<br \/>\nanother works for AIDS-related nerve pain. However, in the United<br \/>\nStates, this kind of work has been inhibited by marijuana&#8217;s illegality<br \/>\nand the unwillingness of the Drug Enforcement Administration (DEA) to<br \/>\nlicense researchers to grow it for research.<\/p>\n<p>Since 2001, for example, Lyle Craker, a researcher at the University of<br \/>\nMassachusetts, has been trying to obtain a licence from the DEA to grow<br \/>\ncannabis for use in clinical research. After years of prevarication, and<br \/>\npressure on the DEA to make a decision, Dr Craker&#8217;s application was<br \/>\nturned down in 2004. Today, the saga continues and a DEA judge (who<br \/>\npresides over a quasi-judicial process within the agency) is hearing an<br \/>\nappeal, which could come to a close this summer. Dr Craker says that his<br \/>\nsituation is like that described in Joseph Heller&#8217;s novel, \u00b3Catch 22\u00b2.<br \/>\n\u00b3We can say that this has no medical benefit because no tests have been<br \/>\ndone, and then we refuse to let you do any tests. The US has gotten into<br \/>\na bind, it has made cannabis out to be such a villain that people<br \/>\nblindly say \u0152no\u00b9.\u00b2<\/p>\n<p>Anjuli Verma, the advocacy director of the American Civil Liberties<br \/>\nUnion (ACLU), a group helping Dr Craker fight his appeal, says that even<br \/>\nif the DEA judge rules in their favour, the agency&#8217;s chief administrator<br \/>\ncan still decide whether to allow the application. And, as she points<br \/>\nout, the DEA is a political organisation charged with enforcing the drug<br \/>\nlaws. So, she says, the ACLU is in this for the long haul, and is<br \/>\nalready prepared for another appeal\u2039one that would be heard in a federal<br \/>\ncourt in the normal judicial system.<\/p>\n<p>Ms Verma&#8217;s view of the FDA&#8217;s statement is that other arms of government<br \/>\nare putting pressure on the agency to make a public pronouncement that<br \/>\nconforms with drug ideology as promulgated by the White House, the DEA<br \/>\nand a number of vocal anti-cannabis congressmen. In particular, the<br \/>\nfederal government has been rattled in recent years by the fact that<br \/>\neleven states have passed laws allowing the medical use of marijuana. In<br \/>\nthis context it is notable that the FDA&#8217;s statement emphasises that it<br \/>\nis smoked marijuana which has not gone through the process necessary to<br \/>\nmake it a prescription drug. (Nor would it be likely to, with all of the<br \/>\nharmful things in the smoke.) The statement&#8217;s emphasis on smoked<br \/>\nmarijuana is important because it leaves the door open for the agency to<br \/>\napprove other methods of delivery.<br \/>\nHigh hopes<\/p>\n<p>Donald Abrams, a professor of clinical medicine at the University of<br \/>\nCalifornia, San Francisco, has been working on one such option. He is<br \/>\nallowed by the National Institute on Drug Abuse (the only legal supplier<br \/>\nof cannabis in the United States) to do research on a German nebuliser<br \/>\nthat heats cannabis to the point of vaporisation, where it releases its<br \/>\ncannabinoids without any of the smoke of a spliff, and with fewer<br \/>\ncarcinogens.<\/p>\n<p>That is encouraging. But it does not address the wider question of which<br \/>\ncannabinoids are doing what. For that, researchers need to be able to do<br \/>\ntheir own plant-breeding programmes.<\/p>\n<p>In America, this is impossible. But it is happening in other countries.<br \/>\nIn 1997, for example, the British government asked Geoffrey Guy, the<br \/>\nexecutive chairman and founder of GW Pharmaceuticals, to come up with a<br \/>\nprogramme to develop cannabis into a pharmaceutical product.<\/p>\n<p>In the intervening years, GW has assembled a \u00b3library\u00b2 of more than 300<br \/>\nvarieties of cannabis, and obtained plant-breeder&#8217;s rights on between 30<br \/>\nand 40 of these. It has found the genes that control cannabinoid<br \/>\nproduction and can specify within strict limits the seven or eight<br \/>\ncannabinoids it is most interested in. And it knows how to crossbreed<br \/>\nits strains to get the mixtures it wants.<\/p>\n<p>Nor is this knowledge merely academic. Last year, GW gained approval in<br \/>\nCanada for the use of its first drug, Sativex, which is an extract of<br \/>\ncannabis sprayed under the tongue that is designed for the relief of<br \/>\nneuropathic pain in multiple sclerosis. Sativex is also available to a<br \/>\nmore limited degree in Spain and Britain, and is in clinical trials for<br \/>\nother uses, such as relieving the pain of rheumatoid arthritis.<\/p>\n<p>At the start of this year, the company made the first step towards<br \/>\ngaining regulatory approval for Sativex in America when the FDA accepted<br \/>\nit as a legitimate candidate for clinical trials. But there is still a<br \/>\nlong way to go.<\/p>\n<p>And that delay raises an important point. Once available, a<br \/>\nwell-formulated and scientifically tested drug should knock a herbal<br \/>\nmedicine into a cocked hat. No one would argue for chewing willow bark<br \/>\nwhen aspirin is available. But, in the meantime, there is unmet medical<br \/>\nneed that, as the IOM report pointed out, could easily and cheaply be<br \/>\nmet\u2039if the American government cared more about suffering and less about<br \/>\nposturing.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In many states of the USA the argument for Medical Marijuana has not yet prevailed. Though opinion against its medicinal use may be grounded in misinformation and prejudice, it is yet true that the Supreme Court has no reason to expend its valuable authority in preventing Congress from respecting and responding to what is still [&hellip;]<\/p>\n","protected":false},"author":370,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2177],"tags":[],"class_list":["post-64","post","type-post","status-publish","format-standard","hentry","category-rhetorical-space","p1","y2005","m06","d07","h11"],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/archive.blogs.harvard.edu\/nesson\/wp-json\/wp\/v2\/posts\/64","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/archive.blogs.harvard.edu\/nesson\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/archive.blogs.harvard.edu\/nesson\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/archive.blogs.harvard.edu\/nesson\/wp-json\/wp\/v2\/users\/370"}],"replies":[{"embeddable":true,"href":"https:\/\/archive.blogs.harvard.edu\/nesson\/wp-json\/wp\/v2\/comments?post=64"}],"version-history":[{"count":0,"href":"https:\/\/archive.blogs.harvard.edu\/nesson\/wp-json\/wp\/v2\/posts\/64\/revisions"}],"wp:attachment":[{"href":"https:\/\/archive.blogs.harvard.edu\/nesson\/wp-json\/wp\/v2\/media?parent=64"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/archive.blogs.harvard.edu\/nesson\/wp-json\/wp\/v2\/categories?post=64"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/archive.blogs.harvard.edu\/nesson\/wp-json\/wp\/v2\/tags?post=64"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}