Will 2010 be the decisive year for new legislation? Multiple Sclerosis and pain sufferers find relief in cannabis spray.
“We now have reasonable evidence that cannabis is a promising treatment in selected pain syndromes caused by injury or diseases of the nervous system, and possibly for painful muscle spasticity due to multiple sclerosis”. This was the conclusion of a report written by the Center for Medicinal Cannabis Research (CMCR) of the University of California, that was presented to the public on 18 February of this year. It is available on the CMCR web site.
“We focused on illnesses where current medical treatment does not provide adequate relief or coverage of symptoms,” explained CMCR director, Igor Grant, MD, Executive Vice-Chair of the Department of Psychiatry at the UCSD School of Medicine. “These findings provide a strong, science-based context in which policy makers and the public can begin discussing the place of cannabis in medical care.”
The conclusions reached by the CMCR are based on the results of clinical tests, conducted following rigid methodological criteria in which the efficacy of cannabis was found to be “very significant”, and its effects on pain to be “comparable to the best existing treatments”. The report states that “These results are particularly important as some of these studies used cannabis as a supplementary treatment for patients who were not receiving sufficient benefit from a wide range of standard medicines for pain. This suggests that cannabis could be a therapeutic option for those patients who do not respond or who respond only partially to traditional therapies”.
The side effects that the patients complained of (coughing, nausea, dizziness, sedation and altered mental state) were found to be only marginally important and which disappeared rapidly after the treatment.
This news is just the latest in a series arriving from the USA which has given the debate on medicinal cannabis a shot in the arm. First, last Autumn, President Obama announced the end of the persecution by the FBI and DEA of sick patients who were using cannabis while abiding by legislation in individual states. Second, the American Medical Association, the largest US medical association requested, officially that “the classification of marijuana in Schedule 1 of controlled substances be reassessed so as to facilitate the carrying out of clinical research, the development of medicines based on cannabinoids, and alternative methods of administering the medicine” link to www.ama-assn.org article.
On 12 January, the New Jersey legislature approved a measure which makes New Jersey the 14th state that allows the use of marijuana to help patients with chronic illnesses, link to New York Times article.
The debate on medicinal cannabis seems destined to be re-ignited in Europe too.
The Ministry of Health in the Netherlands, a country that has traditionally had a more liberal outlook as regards the issue of drugs, has already for some time begun the production and sale of cannabis inflorescence with a standard content of tetrahydrocannabinol and cannabidiol (the two main active ingredients of the plant). Production is managed by a special government agency www.cannabisbureau.nl , which also controls its export to other countries in the EU. This is still today the only legal European source of supply for therapeutic cannabis.
Another potential producer ready to enter the market is GW Pharmaceuticals (http://www.gwpharm.com), a small company based in the UK. that is developing a “”portfolio” of cannabinoid medicines, of which the lead product is Sativex, an oromucosal spray for the treatment of multiple sclerosis symptoms, cancer pain and neuropathic pain. GW, has already registered Sativex on the Canadian market in 2005, and formally presented a request for registration, in May 2009, for the European market. An outcome of this submission is expected around early 2010.
In Italy for some years now, the therapeutic use of cannabis has been considered legal, but the supply of the medicine is only possible through a complex (and expensive!) import procedure.
Last January the Senate approved an order of the day presented by MPs from the Radical Party, Donatella Poretti and Marco Perduca which committed the government to consider the validity and feasibility, (an evaluation to be carried out by the Ministry of Health along side the Cabinet’s Department for Anti-Drug policy), of the production in Italy of cannabis medicines, through the Centro di ricerca per le Colture industriali in Rovigo and the stabilimento farmaceutico militare of Florence. This order of the day proposes that Cannabis sativa, currently being grown for research purposes at the Centro di ricerca per le Colture industriali in Rovigo, should not be destroyed, as currently happens, but sent to the Stabilimento chimico farmaceutico militare in Florence so as to start the production of a cannabis medicine “Made in Italy”.
If this were to happen, this supply could avoid the importing of these medicines from abroad, with significant savings for the National Health Service and this would also simplify life for doctors who choose to prescribe it. The ACT (Associazione per la Cannabis Terapeutica) while being in favour of the approval of the measure, emphasised that with the adoption of such a measure “patients would be spared the tiresome and lengthy bureaucratic procedure which they are currently subject to when they try and obtain cannabinoid medicines, as well, they would save hundreds of euros every month (almost all related to import costs)”.
Currently, the situation in the different regions of Italy is not standardised, with some Local Health Authorities (ASL in Italian) paying the cost of the medicine, and others who make the patients pay for it. There exists therefore a paradoxical situation where people suffering from serious pathologies such as tumours, neuropathic pain, epilepsy, multiple sclerosis, paraplegia and others, and for whom the usual therapy is not effective, find themselves virtually denied the ability to cure themselves with cannabinoids.
A case of this sort was recently brought to the attention of the courts in the town of Avezzano (Region of Abruzzo) . The case involved a patient of limited financial means, suffering from multiple sclerosis, who had asked the Local Health Authority if it was possible to obtain the administration of a cannabis based medicine produced abroad for free, a medicine that has shown itself to be the only effective medicine for alleviating the pain but which the patient could not afford.
Faced with a rejection of the request by the Local Health Authority, the patient referred his case to the legal authorities which in a sentence dated 2 February 2010, recognised the patient’s right to have the medicine in question administered for free. “The sentence reached”, explained Judge Elisabetta Pierazzi, “relates to the treatment of serious pathologies, in cases where other medicines taken by patients have been found not to be effective. The medicine is not produced in Italy, it is imported on a sporadic basis in small quantities and so it has to be administered and paid for by the patient at a very high price”. The decision was based on an interpretation of Article 32 of the Italian Constitution which enshrines the right of citizens to health. The danger of serious and irreparable damage exists, in the opinion of the judge, in the fact that the cost of the only effective medicine, and bearing in mind the chronic nature of the pathology, could compromise the ability to satisfy, with one’s own financial means, the minimum requirement to live a life as a patient. “I am delighted with this victory”, said the patient, “which is a victory for all people suffering from illnesses who are obliged to live without the only cure that can relieve their suffering, as a result of laws which are both irrational and which are contrary to fundamental human and civil rights”.
Tato Grasso MD is a founding partner of the Associazione Cannabis Terapeutica (ACT), Italy
1st March 2010