IACM-Bulletin of May 25, 2003

UK — Bayer to market cannabis based medicine Sativex in the UK

German drugs and chemicals group Bayer AG said on 21 May it had agreed with GW Pharmaceuticals to market a cannabis-based multiple sclerosis and pain drug from the British company.

Bayer said in a statement it had received exclusive rights to market the drug in the United Kingdom and had the option for a limited period of time to negotiate rights in the European Union, as well as Canada. The United States, however, is not part of the deal and a launch in the world's largest pharmaceuticals market is at least two or three years away. The company said it had paid GW a signature fee and would later pay additional fees on regulatory approval in the United Kingdom for treatment of multiple sclerosis, neuropathic pain and cancer pain, totalling 25 million pounds (41 million US dollars, 35 million Euros).

GW will supply the product, which is sprayed into the mouth, and get a share of product revenues. Bayer will market the drug under the name Sativex. GW Pharmaceuticals had submitted its medicine for approval by the responsible agency (Medicines Control Agency) in March. UK approval of the drug was likely by the end of the year, a spokesman of GW said.

(Sources: Reuters of 21 May 2003)

Germany — First acquittal for medical user of cannabis

On 15 May a patient who used cannabis for medicinal purposes was acquitted for the first time by a German court. Following the hearing of two medical experts, judge Bauer of the District Court of Mannheim declared that the situation constituted a state of emergency and that the use of cannabis was justified under the given circumstances.

In 1999, 200 grams and three years later 400 grams of cannabis with a THC content of about 3 percent had been confiscated from Michael F., who uses the drug to treat symptoms of multiple sclerosis.

The medical experts Dr. Zvonko Mir, head physician of an MS clinic in the town of Sundern where the accused had been treated, and Dr. Hans-Michael Meinck, professor at the neurological department of the University of Heidelberg, supported the use of cannabis mainly because of the patient's severe ataxia (dysfunction of motion sequence).

The accused was among the patients who filed a complaint against the prohibition of cannabis for medicinal purposes with the Supreme Court in 1999. However, the court required the plaintiffs to first pass through all normal legal channels before the highest German court would address the subject. The court further pointed out the possibility of an application for a certificate of exemption from the Federal Institute for Drugs and Medical Products. However, the institute which belongs to the Federal Health Ministry later categorically refused all applications regarding the medical use of cannabis.

Michael F. had also tried to obtain cost reimbursement from his health insurance carrier for a treatment with dronabinol (THC), the main active agent of cannabis. Some health insurance carriers pay for this treatment, others do not. Consequently, His lawyer, Robert Wenzel

of Hamburg, called the ruling "consistent and correct". However, the public prosecutor filed an appeal with the next higher District Court.

Dr. Franjo Grotenhermen, Chairman of the IACM, noted that while dronabinol is available on prescription and a cannabis extract is said to be available on prescription soon, without a commitment by health insurances to reimburse treatment costs, many patients will still be

forced to use the less expensive illegal cannabis and will be threatened by prosecution.

Australia — New South Wales plans to allow medical use of cannabis

Australia's most populous state plans to allow seriously ill people to use cannabis as a medicine.

However, a proposal for a four-year trial period by New South Wales state premier Bob Carr provoked outrage among anti-drug campaigners even though he vowed to maintain the state's tough stance on recreational use. "When it comes to marijuana this is not a social revolution," Carr, of the centre-left Labour party, said on 21 May. "This is a method of us doing something compassionate for someone living with multiple sclerosis or receiving massive chemotherapy treatment."

Under the scheme, expected to be approved and begin by year's end, those suffering cancer, AIDS, multiple sclerosis and other serious illnesses can register to use marijuana for pain relief. In what form it will be distributed has to be decided.

(Source: Reuters of 21 May 2003)

News in brief

USA — Maryland

Republican Governor Robert Ehrlich signed a bill on 22 May that drastically reduces criminal penalties for seriously ill people who use cannabis. The Bush administration had pressed him to veto the measure. Until now patients faced a maximum penalty of a year in jail and a $1,000 fine. Now those who can convince a judge that they use marijuana to relieve symptoms of a chronic or life-threatening illness will have to pay a fine of no more than $100. (Source: Associated Press of 22 May 2003)

Science — Heartburn

New animal research shows that THC play a role in a reflex that can result in reflux of stomach acid into the esophagus. This reflex was significantly attenuated by THC. Thus, THC may be beneficial in the so-called "gastro-oesophageal reflux", which is characterised by heartburn, regurgitation of stomach acid, and inflammation of the esophagus. (Quelle: Partosoedarso ER, et al. J Physiol 2003 May 16; [electronic publication ahead of print])

Science — Neuropathic pain

Neuropathic cancer pain and pain due to inflammation was induced in mice. A synthetic cannabinoid (WIN55,212-2) attenuated tumour-evoked pain approximately 50% and was more potent at reducing pain in the inflammatory model. In the cancer model the cannabinoid effect was partially blocked by pre-treatment with a CB1 receptor antagonist, in the inflammation by a CB1 and a CB2 antagonist. (Source: Kehl LJ, et al. Pain 2003 May;103(1-2):175-86)

Science — Neuropathic pain

Demyelinating diseases such as multiple sclerosis can be associated with painful sensory phenomena such as tactile pain and hyperalgesia. Demyelination is the term used for a loss of myelin, a substance in the white matter that insulates nerve endings. In a model of demyelination a cannabinoid that binds to the cannabinoid receptor was shown to decrease this neuropathic pain. (Source: Wallace VC, et al. J Neurosci 2003 Apr 15;23(8):3221-33)

Science — Early cannabis use

An Australian study shows that weekly cannabis use by pupils was associated with significantly increased risk of early school-leaving. This association was strongest at the youngest ages of below 15 years and diminished progressively with age. (Source: Lynskey MT, et al. Addiction 2003 May;98(5):685-692)

USA — Connecticut

A bill that would have legalized cannabis for medical purposes in Connecticut was defeated in the House of Representatives on 21 May by a 79-64 vote. (Source: Associated Press of 21 May 2003)