IACM-Bulletin of June 24, 2007

Germany — The Federal Institute for Pharmaceuticals and Medical Products concedes an exemption for the medical use of cannabis to some patients

In letters of June 2007 to some patients the Federal Institute for Pharmaceuticals and Medical Products (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte), an institution of the Federal Health Ministry, in principle concedes their right to use cannabis for medicinal puposes. The presented medical documents would show, that a treatment with the available medicinal drugs "turned out not to be successful so that the use of cannabis can be recommended from a clinical point of view" and that "an approved drug that would at least be as effective as cannabis for the treatment of your illness is currently not available," respectively.

The BfArM suggested to the patients to use a cannabis extract to be manufactured by a pharmacy designated by the patient. So far, it is unknown how expensive the extract will be and if the health insurances will reimburse the costs of the treatment. The applicants were asked by the BfArM to drop their application for an import of medicinal cannabis from the Netherlands and to accept the alternative proposed by the BfArM. "For reasons of precaution" the institute pointed out that in case of retention of their application they have to anticipate a dismissal. Although the cannabis produced by the Dutch company Bedrocan is standardized on THC and CBD the BfArM justifies it’s attitude with the "unknown and variing" concentrations of active agents, respectively.

(Sources: Letters of the BfArM to applicants for an approval of exemption for the medical use of cannabis)

Canada — Cannabis extract receives a qualifying notice for approval for use in cancer pain

According to a press release by GW Pharmaceuticals and Bayer HealthCare Pharmaceuticals, the Canadian Health Ministry has issued a Qualifying Notice for the approval of their cannabis extract Sativex in the relief of cancer pain. Sativex is already approved and marketed in Canada for the symptomatic relief of neuropathic pain in multiple sclerosis.

The approved indication will be “adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain”. Sativex has been developed by UK-based GW Pharmaceuticals and is exclusively marketed in Canada by Bayer. The issue of a Qualifying Notice confirms that Sativex qualifies to be considered for approval. Final approval of Sativex for this indication is expected within 60 days.

GW has completed a positive Phase III study in Europe in 177 patients with cancer pain. The trial was a multi-center double-blind, placebo-controlled study. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine).

(Source: Press release by GW Pharmaceuticals of 19 June 2007)

Switzerland — Patients with amyotrophic lateral sclerosis in a clinical study with THC are not allowed to continue to use the drug after completion of the study

Until summer 2007 a clinical study on the use of THC in patients with amyotrophic lateral sclerosis is conducted at a hospital of St. Gallen. Study leader Dr. Markus Weber noted that patients suffering from this degenerative disease of the nerve system profit from the treatment, but is not allowed to continue the treatment his patients after completion of the study.

Weber fears that the patients' muscle spasms, which have been reduced due to the treatment, will come back after the end of the THC application. Many of his patients already asked him to continue the treatment even if doctor and patient break the law in doing so. The high costs of a therapy with sythetic THC are affordable only by a few patients. Markus Weber is not the only doctor who questions the prohibition of cannabis for medical use. Dr. Thomas Cerny, professor for oncology at the hospital in St. Gallen, regards the issue simply as a political absurdity.

More at:

http://www.tagblatt.ch/index.php?artikelxml=1334614

(Source: St. Galler Tagblatt of 2 May 2007)

News in brief

USA — Rimonabant

The weight-loss pill Acomplia (rimonabant) should not be approved in the USA because Sanofi-Aventis has not shown that the benefits outweigh the risk of suicidal thoughts among those taking the drug, an advisory panel said. Sanofi did not get a single vote on 13 June in favour of the cannabinoid receptor antagonist from a committee of outside advisers to the FDA (Food and Drug Administration), the US agency for approval of medicinal drugs. The panel found that the company's safety data were insufficient and that the weight lost in clinical trials did not justify the danger of psychiatric or neurological side effects. (Source: www.bloomberg.com)

USA — Connecticut

After struggling with what was described as one of the most difficult decisions in her three-year tenure, Governor M. Jodi Rell on 20 June vetoed a measure that would have legalized the use of cannabis for certain medical conditions. In a statement, Mrs. Rell said, “I completely sympathize with the well-intentioned goal of alleviating pain and suffering, but legal alternatives are available.” (Source: New York Times of 20 June 2007)

Science — Inflammation of the airways

Research with cells of the human bronchial mucous membrane shows that a synthetic cannabinoid (CP55,940) reduced the concentration of certain molecules (cytokines) that promote inflammation. The scientists of the University of Groningen, the Netherlands, concluded that cannabinoids exert anti-inflammatory properties in airways by modulating cytokine release. (Source: Gkoumassi E, Br J Pharmacol 2007 Jun 11; [Electronic publication ahead of print])

Science — Trigeminal pain

In a rat model of trigeminal neuropathic pain it was demonstrated that a synthetic cannabinoid (WIN55,212-2) was effective in reducing this kind of pain. This pain reduction was caused by activation of CB1 receptors. (Source: Liang YC, et al. Neuropharmacology 2007 May 13; [Electronic publication ahead of print])

Science — Growth of hair

It was demonstrated that the growth of human hair follicles was inhibited by endocannabinoids and THC. This effect was mediated by the CB1 receptor. Researchers concluded that CB1 receptor agonists "may therefore help to manage unwanted hair growth, while CB1 antagonists might counteract hair loss." (Source: Telek A, et al. FASEB J 2007 Jun 12; [Electronic publication ahead of print])

Science — Schizophrenia

Earlier research by scientists of the University of Cologne had demonstrated that levels of anandamide were elevated in the cerebrospinal fluid of untreated people with schizophrenia. The new research shows that untreated patients with newly diagnosed schizophrenia who used cannabis had no elevated levels of this endocannabinoid. (Source: Leweke FM, et al. Schizophr Res 2007 Jun 11; [Electronic publication ahead of print])

Germany — Delta 9 Pharma

One of the two companies that produce dronabinol for medical purposes was renamed on 15 June 2007. Delta 9 Pharma, a subsidiary company of the phytopharmaceutical company Bionorica, is now named Bionorica Ethics. (Source: www.bionorica-ethics.de)