IACM-Bulletin of November 13, 2005

Germany — Federal Administrative Court paves the way for certificates of exemption for the medical use of cannabis

In a ruling dated 19 May 2005 that was made public this week, the Federal Administrative Court indicates that the Federal Institute for Pharmaceuticals and Medical Products cannot globally deny applications for the medical use of cannabis. It confirmed the decision of the Federal Constitutional Court (German High Court, Bundesverfassungsgericht) of 20 January 2000 that medical treatment of ill people is of public interest and that therefore a certificate of exemption according to the paragraph 3 of the German Narcotics Act is possible in relation to therapeutic use of cannabis. The ruling pertains to the case of a 56 year old advocate suffering from multiple sclerosis who benefits from cannabis medicinally.

In December 1999, eight patients had registered complaints before the Federal Constitutional Court and demanded permission for the medical use of otherwise illegal cannabis. The court did not accept the complaints for decision and pointed out that the applicants had not exhausted all available legal avenues. They could previously made application to the Federal Institute for Pharmaceuticals and Medical Products. The German Narcotics Act allows the use of illegal drugs only for "scientific and other purposes of public interest". In their statement the judges of the Federal Constitutional Court wrote: "The medical supply of the population serves a public purpose that may justify an approval in individual cases."

Subsequently, more than 100 persons submitted applications that were defeated by the Federal Institute for Pharmaceuticals and Medical Products on the grounds that the treatment of a single patient did not represent a scientific or other purpose of public interest. Supported by the German Association for Cannabis as Medicine, a number of patients then sued the Institute before the Administrative Courts.

In its ruling, the Federal Administrative Court wrote: "The medical supply of the population is not a global act referred to a mass of undifferentiated subjects. Rather, it always results from the supply of single individuals that have a need thereof." The Federal Administrative Court emphasised the high value of the right to life and physical integrity based on the constitution (Grundgesetz). "The right to physical integrity cannot only be impaired when governmental organs themselves create an assault, or when their action cause pain. The protective boundary of the constitution rather is also reached if the government takes actions that inhibit that illnesses are cured or alleviated, and if physical suffering is continued and adhered without affliction as a result."

Physicians are not currently allowed to prescribe cannabis. However, that would "not prevent them from looking after and following a patient medicinally, who on the basis of a permission according to § 3 of the Narcotics Act uses such means him- or herself in the course of a pain therapy." With regard to the argument, patients could be prescribed dronabinol (THC) by a physician even if this drug is expensive and is not always paid by health insurance, the Federal Administrative Court wrote: "The reference to a medical drug that is neither readily available nor affordable by normal citizens is no alternative to achieve the public interest in the use of cannabis to combat illness."

(Source: Ruling of the Federal Administrative Court of 19 May 2005, available at www.cannabis-med.org/german/BVerwG.pdf)

Science — Cannabis extract effective in the treatment of rheumatoid arthritis

A clinical study published in the journal Rheumatology found that Sativex, a cannabis extract containing equal amounts of THC and CBD, was superior to placebo in 58 patients with rheumatoid arthritis over 5 weeks of treatment. In the double-blind trial 31 patients received cannabis and 27 placebo. Participants could take up to 6 doses, one dose of Sativex containing 2.5 mg THC and 2.5 mg CBD. Mean doses achieved in the final treatment week was 13,5 mg THC in the cannabis group.

The researchers found that patients who had taken Sativex had significant improvements in pain on movement, pain at rest, quality of sleep, and inflammation. There was no effect on morning stiffness but baseline scores were low. The large majority of adverse effects were mild or moderate, and there were no adverse effect-related withdrawals or serious adverse effects in the active treatment group.

Researchers concluded that "a significant analgesic effect was observed and disease activity was significantly suppressed following Sativex treatment. Whilst the differences are small and variable across the population, they represent benefits of clinical relevance and show the need for more detailed investigation in this indication."

(Sources: Blake DR, Robson P, Ho M, Jubb RW, McCabe CS. Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoid arthritis. Rheumatology 2005, November 9 [Electronic publication ahead of print]; Press release of GW Pharmaceuticals of 9 November 2005)

Holland — Government wants to stop the medical cannabis program and to restrict the sale of cannabis in coffee shops to the Dutch

The conservative government intends to get rid of the image of a "drug paradise". From January 2006 on only citizens of the Netherlands will have access to coffee shops. It is intended to prohibit the sale of cannabis in coffee shops to foreigners. According to the Austrian newspaper "Der Standard" the Dutch embassy in Austria informed the Austrian government, which will take over the presidency of the European Union in January 2006, and representatives of the United Nations about these plans.

Furthermore, the Dutch government considers to schedule cannabis as a hard drug if an ongoing investigation comes to the conclusion that the increase in THC concentration of cannabis during the past years is responsible for the increasing number of personality disorders in cannabis users, said Ton Cramer of the Health Ministry.

The medical cannabis programme under which cannabis was delivered by pharmacies for medical purposes will be stopped as well. According to the Dutch Health Ministry the program was unprofitable. Since September 2003 patients with a doctor's prescription can obtain standardized cannabis in pharmacies.

(Source: Der Standard of 3 November 2005)

Spain — Sativex will be available for selected patients

According to a press release by GW Pharmaceuticals of 8 November the company has reached agreement with the Health Department of The Regional Government of Catalonia to supply their cannabis extract, Sativex, which is sprayed under the tongue to 600 patients suffering from multiple sclerosis and a number of other conditions under a compassionate access programme. The programme will include an evaluation of safety and tolerability of the drug and an assessment of impact on quality of life.

This will be the first ever use of Sativex in Spain, and the first time that patients in Europe have had access to Sativex outside a clinical trial. An initial batch is due to be shipped to Spain in the next few weeks and further batches will be sent next year. The Catalan Health Department will finance the programme. It will be coordinated by the Catalan Institute of Pharmacology and six Catalan hospitals will participate.

130 of the patients will be people with multiple sclerosis, a further 130 will be patients suffering from neuropathic pain arising from a range of medical conditions, 40 will be suffering from anorexia and malnutrition caused by AIDS, and the remaining 300 will be cancer patients undergoing chemotherapy and suffering from nausea and vomiting. Those undergoing chemotherapy will begin six months later than the others.

(Sources: Press release of GW Pharmaceuticals of 8 November 2005, personal communication by Marta Duran)

News in brief

USA — Colorado and Michigan

Voters in two cities of Michigan, Ferndale and Traverse City, endorsed medical cannabis initiatives. Similar measures were supported in 2004 in Detroit and Ann Arbor. In another referendum 54 per cent of citizens of Denver, Colorado, voted in favour of a bill that allows adults to legally possess up to one ounce (28 grams) of cannabis. A similar measure won by a wide margin in Oakland, California, in November 2004. (Sources: Associated Press of 2 November 2005, press releases of the Marijuana Policy Project)

USA — California

On 8 November the city council of Santa Cruz, California, passed an ordinance paving the way for the nation's first-ever government-run medical cannabis distribution program. Under the measure, the Santa Cruz city government will set up an Office of Compassionate Use that will handle procuring and storing cannabis and dispense it to "qualified patients" under California's nearly ten-year-old medical cannabis law. (Source: NewStandard of 9 November 2005)

Science — ICRS 2006 Meeting

The 16th Symposium on the Cannabinoids of the International Cannabinoid Research Society (ICRS) will be held in Tihany, Hungary, from 25-28 June 2006. More information at www.cannabinoidsociety.org.

USA — Poll on legalization

A poll by Gallup of October 2005 found that 36 per cent of citizens of the United States support the legalization of the personal use of cannabis. Support steadily increased since Gallup posed this question for the first time in 1969. In 1995 25 per cent supported legalization. (Source: The Gallup Poll of 1 November 2005)

Canada — CMPA

In a letter to physicians of October 2005 the Canadian Medical Protective Association (CMPA) recommends that physicians who assist patients in their application for the medical use of cannabis to the Health Ministry that they ask applicants to sign a release from liability. Patients who seek legal access to the medical use of cannabis need a medical declaration from their physician. The regulations require the applicant to declare that he or she has discussed the risks with the physician who signs the medical declaration. The CMPA has developed a form of release, which may be downloaded from their website (www.cmpa-acpm.ca). The CMPA is a physicians' organization that provides legal defence, risk management and other services to their members. (Source: CMPA)

Science — Cannabis and driving

A study in Sweden found that the introduction of zero-concentration limits for THC and other drugs in the blood of drivers did not result in a reduction of driving under the influence of drugs (DUID). Researcher also noted that "the spectrum of drugs identified in blood samples from DUID suspects has not changed much since the zero-limit law was introduced". Zero-concentration limits were introduced in Sweden on 1 July 1999. (Source: Jones AW. Traffic Inj Prev 2005;6(4):317-22)

Science — Bioavailability of THC

Finish researchers increased the bioavailability of sublingual THC by using a THC/beta-cyclodextrin complex. Bioavailability of THC after sublingual administration of a powder of this complex was much higher as an alcohol THC solution. (Source: Mannila J, et al. Life Sci 2005 Oct 30; [Electronic publication ahead of print])