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IACM-Bulletin of 14 March 2004

Germany: An administrative court rejects law suits against the Federal Institute for Pharmaceuticals and Medical Products

On 3 March the Cologne administrative court rejected law suits of 5 patients who tried to achieve a certificate of exemption for the medical use of cannabis, as it is possible for example in Canada. They suffer from multiple sclerosis, Crohn's disease and HIV.

In Germany the Federal Institute for Pharmaceuticals and Medical Products (Bundesinstitut fuer Arzneimittel und Medizinprodukte) is responsible for the regulation of exemptions for narcotics, which are limited by the law to "scientific and other purposes of public interest". But many persons applied for an exemption, since in 2000 the Constitutional Court indicated that the medical supply of the population is also of public interest. However, all applications were rejected.

Five of them filed law suits against this rejection before the Cologne administrative court and now lost. The administrative court indicated that the concerned could take dronabinol (THC) to treat their diseases. But the health insurances had refused to reimburse the costs of the drug for these patients, while several other insurances pay for it.

In 1999 the plaintiffs handed in a constitutional complaint at the Constitutional Court. The court did not accept it on formal grounds, since they should have tried other legal means before, including applications to the Federal Institute for Pharmaceuticals and Medical Products. Supported by the German Association for Cannabis as Medicine (ACM) some of the plaintiffs will appeal before the Higher Administrative Court in Muenster. They finally aim at handing in again their constitutional complaint at the Constitutional Court.

(Sources: Press release of the administrative court of Cologne of 9 March 2004, ACM)

Science: Cannabinoid receptor blocker Rimonabant effective against obesity and smoking

First results of two phase III studies of Rimonabant (SR141716), a cannabinoid receptor antagonist, were presented at the 53rd annual scientific meeting of the American College of Cardiology in New Orleans on 9 March. The drug was shown to help to reduce weight in obese persons and to help smokers quit smoking. The drug, which is made by Sanofi-Synthelabo, could be available by late 2005.

Rimonabant blocks the cannabinoid-1 receptor. This receptor is activated by THC and other cannabinoids, which causes appetite. Both overeating and tobacco overstimulate the cannabinoid system in the brain, which is reduced by rimonabant.

In the tobacco study, more than 700 smokers were given either 5 milligrams or 20 mg of rimonabant or a placebo. About a quarter of the persons, who received 20 mg of rimonabant, stopped smoking in 10 weeks, which was about twice the quit rate seen in the placebo group. In the second study with more than 1,000 obese subjects more than 70 percent of the subjects in the 20 mg group lost more than 5 percent of total body weight and 44 percent lost more than 10 percent during the year.

(Sources: Press release of Sanofi-Synthelabo of 9 March 2004, UPI International of 9 March 2004)

News in brief

Science: Neuropathic pain
An open study with eight patients suffering from severe neuropathic pain that was refractory to all other therapies was conducted in France. Patients suffered from spinal cord injury, poststroke pain and peripheral nerve injury. They received up to 25 mg THC daily for 4 months. The dose was increased every week by 5 mg starting with 2 x 2.5 mg. Mean achieved dose was 16.6 mg (range 7.5-25 mg). In seven patients there was no relevant decrease in pain intensity. In one patient spontaneous pain decreased by 60 percent. At 4 weeks there was a tendency to a reduction in number of painful attacks from 9.8 daily before the treatment to 3.2 daily, but this effect disappeared after 2 months. (Source: Attal N, et al. EUR J Pain 2004;8:173–177)

USA: Oregon
A doctor who signed about 40 percent of all the medical marijuana cards in Oregon was suspended from practicing medicine on 4 March. He had two offices in Portland and traveled frequently to mass meetings in hotel conference rooms with patients seeking the card. Leveque said he had signed thousands of cards because other doctors were reluctant to give patients the medicine they needed. Oregon's Medical Marijuana Act, approved by voters in 1998, allows residents to grow and use cannabis for medical purposes with a doctor's recommendation. About 1,200 doctors signed these recommendations for more than 7,000 patients. (Source: Associated Press of 5 March 2004)

USA: Conference on Cannabis Therapeutics
Patients Out of Time will co-host along with the University of Virginia School of Nursing and other institutions the Third National Clinical Conference on Cannabis Therapeutics to be held on 20-22 May 2004 in Charlottesville, Virginia. (Source: www.medicalcannabis.com)

Science: THC powder
Dutch researchers at the University of Groningen developed a dry powder formulation of THC, that rapidly dissolves in water. THC was incorporated in a matrix of inulin, a fructose sugar. Dissolution experiments showed that THC and inulin dissolved at the same rate. On this base they produced tablets, that could be used for sublingual administration. (Source: Van Drooge DJ, et al. EUR J Pharm Sci 2004;21(4):511-8)

Science: THC and morphine
The effects of a combination of THC and morphine and of THC and cannabidiol (CBD) were investigated in a rat model of inflammatory pain. A combination of THC and morphine increased pain reduction and side effects compared to both drugs alone. CBD had no effect. (Source: Finn DP, et al. EUR J Neurosci 2004;19(3):678-86)

Switzerland: Council of States supports decriminalisation
The Council of States (Upper House of Parliament) supports a revision of the narcotics act for the second time. The bill intended to decriminalise the use of cannabis and to restrict the obligation of prosecution for cultivation and trading in 2001. However, the National Council (Swiss Lower House of Parliament) rejected the bill in September 2003 shortly before the elections. On 2 March the Council of States decided once more to revise the narcotics act, so that the National Council has to vote on it again. (Source: Neue Zuercher Zeitung of 2 March 2004)

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