Spanish health authorities already allow medical use of cannabis extract Sativex, and recently released the good clinical results obtained with it so far. Consider the impact it can have regarding the therapeutic use of cannabis itself.

Health authorities have not authorized the medical use of joint by bronchial irritation produced by the smoke of her burning, not for lack of medical benefits such

I recently attended as a guest to a conference organized by the University of Cadiz, Algeciras on cannabinoids as new therapeutic tools. Orgado Dr. Antonio Martinez, who works at the Hospital of Alcorcón in its neuroprotective effects in neonatal ischemic encephalopathy, I made the following comment: Now that studies are showing the effectiveness of cannabis extract, not the one its agonists isolated left out all the arguments against therapeutic joint and open the door to its legalization, is not it?. With positive results in clinical trials in chronic pain 65% of patients and considering that, in fact, Sativex is not nothing but "pure cannabis" might be questioned:

Facilitate Sativex medicinal cannabis the way ...

There is reason to think, indeed. It has long been known that the consumption of this plant has, in certain circumstances, therapeutic efficacy. Health authorities have not authorized the medical use of joint by bronchial irritation produced by the smoke of her burning, not by lack of such medical benefits. We also know that it is not a good route of administration is the digestive effects being erratic and irregular because the active ingredients must pass through the liver, where they undergo metabolism determined before reaching their sites of action. Investigations since then have been directed toward the development of a cannabis extract, which requires neither the digestive tract or inhaled, and containing a certain amount of tetrahydrocannabinol (THC) and cannabidiol (CBD), main responsible for the cannabinoid therapeutic effects, the general consensus among scientists

Extract or tincture is all kinds of pharmaceutical preparation to facilitate the administration of a drug, usually plants. Do not think that the use of herbal extract is rare in Spain. Although there are neighboring countries with long experience in their jobs, such as Germany, the Spanish pharmaceutical legislation contemplates and here long, have been prescribing more. As an example we recall the famous plant extract capsules marketed by a Pygeum africanum laboratory known for the treatment of prostate hypertrophy (Pronitol ®), or extracts intended for inhaled administration in colds, eucalyptus and mint (Sinus ®) .

With the cannabinoids are multiple routes of administration tested alternatives to inhaled and digestive, suppositories, transdermal patches, injections, eye drops ... So far he has achieved higher levels of popularity has been a nebulizer absorption through the buccal mucosa, Sativex, developed by GW Pharmaceuticals. From a legal cultivation of cannabis produced a solution introduced into a spray to spray the inside of the mouth, similarly to those designed for bad breath. Health authorities to support the extract as a drug, they have only demanded that its composition is constant and that the amount of THC and CBD are quantified, considering the other components of the herbal extract as excipients without effects on the body.

Authorize the use of Sativex is, on one hand, support the effectiveness of the plant as such and, second, to normalize from a pharmacological point of view and administrative use of the extract. One could similarly consider any kind of dye. There would be no grounds to deny a patient with the same clinical profile than those authorized to use the statement said, using the plant itself in any form, any extract manufactured by himself too.

... Or, conversely, kill him?

There are reasons for that may occur. For some time, as you reminded us Gaspar Fraga in a recent editorial Hemp, the path of the demand for recreational use, recreational cannabis has kept pace with its use as medicine. The reasons are complex and, as our director felt, sometimes not at all beneficial. Among other things has made some public sector and health professionals believe that such a claim could not be more therapeutic than an excuse for self-authorization of the use of cannabis. While the struggle for medical use has been sued by those who did it for recreational use, health authorities have given no answer.

It was not until recently that our politicians had no choice but to respond to such information: Agate Group of patients with breast cancer in Catalonia, knowledgeable about the medical benefits of consumption of the plant, filed a formal request for legal access . The answer was the facilitation of these patients Cesamet tablets. It is a drug composed exclusively of nabilone, a cannabinoid agonist and, therefore, alleged the same effects as THC. The Cesamet was not in our pharmacies, but could save the problem using the rules on foreign drugs: if a medicine does not have the backing of some powerful laboratory that can circulate in our country and a doctor deems it appropriate to use, health authorities should responsible for purchasing and distribution outside the patient. The response of the patients, and the supporting scientific knowledge, preferring the joint was therapeutic: it is better for its composition and its route of absorption. The demand continued.

With the appearance on the scene of Sativex, therapeutic joint demand could suffer another serious, perhaps fatal, setback. The advantages are evident from the first point of view of accessibility: the patient wants to get rid of the symptoms (vomiting, pain) as soon as you cross the street and buy the medicine at the corner drugstore. As with the joint, avoiding the dreaded first-pass metabolism but also bronchial irritation is avoided by maintaining the same therapeutic effect as it contains the entire plant. Furthermore, any of the offers available now seem to me more complex, from the self-cultivation of the plant until its acquisition in the black market.

It is clear that the answer to a new joint claim of treatment may be the facilitation of access to Sativex patients. In order to quell the demand for raw plant, as in his day made with nabilone, health authorities can draw now two ways: in addition to the description of foreign medication from Canada, where it is marketed for multiple sclerosis and soon also for cancer pain, known as the Compassionate Use. Spain is one of the countries participating in clinical trials that are currently performed with Sativex for other indications (neurological pain, nausea and vomiting from chemotherapy, stimulating appetite) and the Clinical Trials Act provides that any doctor can prescribe a drug listed at the time still under study, before they end and outside of them, relying on the Compassionate Use, as is being done in Catalonia. In addition, the powerful laboratory has purchased the rights to their European distribution is precisely Spanish.

Epilogue

Once approved Sativex is it just tip the balance toward it or even to any other cannabis extract, manufactured by the same patient as well? If a doctor has requested access to the nebulizer to a patient and not get hit, what if it turns to self-cultivation and preparation of your own statement? There are not scientific and legal arguments to prevent it. The future looks interesting, no doubt.

Dr. Ricardo Navarrete
Member of the IACM