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IACM-Bulletin of 24 May 2009
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* UK/Europe: GW Pharmaceuticals files for approval of Sativex
for multiple sclerosis
* Science: THC improved symptoms of schizophrenia in a few
patients in a clinical case series
* Science: Moderate cannabis use was associated with improved
retention in naltrexone treatment for opiate-dependence

1.

UK/Europe: GW Pharmaceuticals files for approval of Sativex for
multiple sclerosis

The cannabis extract Sativex from the British company GW
Pharmaceuticals has been filed for approval for the treatment of
spasticity in multiple sclerosis in Europe, paving the way for its
potential approval at the end of 2009 or early in 2010. Since the
pivotal trial was designed largely by the British regulators there is
relatively low risk of a rejection. The spray contains equal
amounts of two natural cannabinoids, CBD (cannabidiol) and
THC (dronabinol). Following numerous delays, the submission to
regulators in Britain and Spain is a landmark for the British
company.

Clinical trials have shown Sativex, which is sprayed under the
tongue, reduces spasticity in multiple sclerosis patients who do not
respond adequately to existing therapies. If it is approved, Sativex
will be marketed in Britain by the German company Bayer and in
the rest of Europe by the Spanish company Almirall. Following the
filings in Britain and Spain, submissions for approval will be made
in other European countries during 2010. Further clinical trials
need to be completed before the medicine is ready for submission
for approval in the United States, where GW's partner is the
Japanese company Otsuka. Sativex was first approved in Canada
in 2005.

More at:
-
http://www.reuters.com/article/healthNews/idUSTRE54J1KI2009
0520
- http://www.gwpharm.com

(Sources: Press release of GW Pharmaceuticals of 20 May 2009,
Reuters of 20 May 2009)

2.

Science: THC improved symptoms of schizophrenia in a few
patients in a clinical case series

Scientists at the Rockland Psychiatric Center in Orangeburg, New
York, reported improvement of symptoms of schizophrenia in 4
patients who received oral THC (dronabinol). The study was
initiated after a dramatic improvement in one patient. The
researchers found that further 3 of 5 treatment-refractory patients
with severe chronic schizophrenia but who had a self-reported
history of improving with cannabis use improved also with THC.
They only selected patients whose severe, refractory condition
made the possible benefits outweigh the risks. From
approximately 200 patients with chronic psychosis, 5 patients met
the inclusion criteria. Dronabinol was initiated at 2.5 mg twice a
day and subsequently raised to 5 mg twice a day at the second
week and 10 mg twice a day at the just third week.

No significant adverse effects were observed. One of the patients
needed 8 weeks to reach significant improvement, while the
others responded within a shorter period of time. Researchers
noted that "this improvement seems to have been a reduction of
core psychotic symptoms in 3 of the 4 responders and not just non-
specific calming." The results would suggest "that the role of
cannabinoids in psychosis may be more complex than previously
thought. They open a possible new role for cannabinoids in the
treatment of schizophrenia."

(Source: Schwarcz G, Karajgi B, McCarthy R. Synthetic delta-9-
tetrahydrocannabinol (dronabinol) can improve the symptoms of
schizophrenia. J Clin Psychopharmacol 2009;29(3):255-8.)

3.

Science: Moderate cannabis use was associated with improved
retention in naltrexone treatment for opiate-dependence

According to clinical research at the Department of Psychiatry of
Columbia University in New York moderate cannabis use
improved retention in naltrexone treatment of patients suffering
from dependency on opiates such as heroin. 63 opioid dependent
patients, admitted for inpatient detoxification and induction onto
oral naltrexone accompanied by six months of behavioural therapy
were classified into three levels of cannabis use during treatment
based on biweekly urine toxicology: abstinent (0 per cent cannabis
positive urine samples); intermittent use (1 to 79 per cent cannabis
positive samples); and consistent use (80 per cent or greater
cannabis positive samples).

Naltrexone is an opioid receptor antagonist used primarily in the
management of alcohol dependence and opioid dependence.
Intermittent cannabis users showed superior retention in
naltrexone treatment (median days retained = 133), compared to
abstinent (median = 35 days) or regular users (median = 35 days).
Intermittent cannabis use was also associated with greater
adherence to naltrexone pill-taking. Researchers noted that
experimental studies are needed to directly test the hypothesis that
cannabinoid receptor agonists exert a beneficial pharmacological
effect on naltrexone maintenance and to understand the
mechanism.

(Source: Raby WN, Carpenter KM, Rothenberg J, Brooks AC,
Jiang H, Sullivan M, Bisaga A, Comer S, Nunes EV. Intermittent
marijuana use is associated with improved retention in naltrexone
treatment for opiate-dependence. Am J Addict 2009;18(4):301-8.)

4.

News in brief

***USA: Rhode Island
Three years after legalizing cannabis for medicinal purposes in
Rhode Island, the House of Representatives on 20 May adopted a
plan to create dispensaries that would sell the drug to patients.
The Senate in April overwhelmingly approved an identical version
of the bill. Governor Carcieri, a long-time critic of medical
cannabis, is expected to veto it. But the House of Representatives
approved the legislation in a 63-to-5 vote, which should allow to
easily override a veto later. (Source: Providence Journal of 21
May 2009)

***USA: Minnesota
A bill that would have legalised the medicinal use of cannabis in
Minnesota was approved by the state House of Representatives
and the Senate on 18 May. However, the bill was vetoed by
governor Tim Pawlenty on 22 May. (Source: Minneapolis Star-
Tribune of 18 May 2009, MPP of 22 May 2009)

***Canada: Department of Veterans Affairs
The Department of Veterans Affairs of the Canadian government
will cover the costs of medical cannabis. A letter from the
department to a veteran said the costs of medical cannabis
provided by the health ministry (Health Canada) may be covered
if it is proven to be needed for medicinal reasons. (Source: Comox
Valley Record of 12 May 2009)

***USA: End of war on drugs
Gil Kerlikowske, the new head of the White House Office of
National Drug Control Policy, says the United States should not
see itself as fighting a "war on drugs." He questioned the use of
the popular "war" term, saying such an idea is actually standing in
the way of positive movement regarding the country's drug
problems. "Regardless of how you try to explain to people it's a
'war on drugs' or a 'war on a product,' people see a war as a war
on them," Kerlikowske said on 13 May. (Source: UPI of 14 May
2009)

***USA: California
The Supreme Court won't hear another challenge to California's
law permitting cannabis use for medical purposes. On 18 May the
high court refused to hear appeals from San Diego and San
Bernardino counties. Representatives of the two counties had
sued to overturn the state law after it was approved by voters in
1996, but lower courts have ruled against them. (Source:
Associated Press of 18 May 2009)

***Science: Amyotrophic lateral sclerosis
According to basic research with an animal model of amyotrophic
lateral sclerosis (ALS), the sensitivity of cannabinoid-1 receptors
controlling the transmission of the neurotransmitters glutamate and
GABA was remarkably potentiated in ALS mice. Researchers
noted that this may indicate that adaptations of the
endocannabinoid system might be involved in the pathophysiology
of ALS and that CB1 receptors might be potential therapeutic
targets for this disease. (Source: Rossi S, et al. Amyotroph
Lateral Scler 2009 May 19:1-8. [Electronic publication ahead of
print])

***Science: Tobacco and cannabis
Researchers of Columbia University in New York investigated
differences between the effects of cannabis cigarettes mixed with
tobacco and cannabis-only cigarettes in 24 cannabis users. On six
different occasions they smoked cannabis cigarettes with three
different THC concentrations (0, 1.8 and 3.6 per cent) with or
without tobacco. Cannabis-only cigarettes resulted in higher THC
blood concentrations and stronger psychic effects, while cannabis
cigarettes mixed with tobacco produced similar increases in heart
rate and higher carbon monoxide levels in the blood. (Source:
Cooper ZD, et al. Drug Alcohol Depend 2009 May 13.
[Electronic publication ahead of print])

5.

ONE YEAR AGO:
- USA: Barack Obama might stop federal prosecutions in states
with a medical cannabis law, if elected president
- Science: Dronabinol effective in the treatment of vocal tics and
dystonia in a patient with multiple sclerosis

TWO YEARS AGO:
- Science: Cannabis smoking worsens breathing problems in
cigarette smokers
- IACM: In commemoration of Tod Mikuriya

(More at the IACM-Bulletin archives: http://www.cannabis-
med.org/)

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