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IACM-Bulletin of 26 December 2004

Canada: GW Pharmaceuticals will get approval for Sativex by Canadian regulators

The cannabis extract Sativex of the British firm GW Pharmaceuticals received Qualifying Notice for approval by the Canadian health ministry (Health Canada). Sativex will initially be indicated in Canada for the relief of neuropathic pain in multiple sclerosis.

The news comes just weeks after British regulators said they wanted more evidence about the benefits of the drug. In the UK the firm had applied for a different indication, for the treatment of spasticity in patients with multiple sclerosis.

Sativex is a whole plant cannabis extract containing the cannabinoids THC and CBD as its principal components. The medicine is administered by means of a spray into the mouth. It will be exclusively marketed in Canada by Bayer HealthCare. Health Canada has confirmed that Sativex qualifies to be considered for approval. GW is required to respond and accept conditions within 30 days. If the response is acceptable, the regulator will proceed to finalize the marketing authorization.

Analysts said the Canadian system for drug approval meant the rest of the process was little more than a formality. GW said it expected full approval by early next year.

(Sources: Reuters of 21 December 2004, press release of GW Pharmaceuticals of 21 December 2004)

USA: Drug authority rejects request by the University of Massachusetts to grow cannabis

A request to grow cannabis at the University of Massachusetts so it can be tested in clinical studies has been turned down by the Drug Enforcement Administration (DEA). The decision was faxed to the university on 10 December.

A spokeswoman for the DEA said the agency would have no comment beyond its order, which gave the university 30 days to appeal. In its order, the drug agency said the only government-licensed marijuana farm, operated by the University of Mississippi, grew enough for researchers. It said that 18 medical studies using the drug had been approved since 2000. But Dr. Lyle E. Craker, the professor of plant biology at the University of Massachusetts who applied for the license three years ago, said researchers complained that the government's marijuana was weak and that it was hard to get permission to use it.

"We wanted to have a source independent from the government and with a known potency so doctors can run clinical trials," he said. Researchers would still need DEA permission to work with the drug.

(Source: New York Times of 14 December 2004)

News in brief

USA: Older Americans support medical use
According to a poll done for the nation's largest advocacy group for seniors, AARP, 72 percent of older Americans support the legalisation of cannabis for medical uses. 1706 Americans were asked whether they agree that "Adults should be allowed to legally use marijuana for medical purposes if a physician recommends it." AARP has 35 million members. "The use of medical marijuana applies to many older Americans who may benefit from cannabis," said Ed Dwyer, an editor at AARP The Magazine. (Source: Associated Press of 17 December 2004)

USA: Hawaii
The number of people in Hawaii who have registered to use cannabis for medical purposes continues to grow, reaching almost 2,000 since the state Legislature created the program four years ago. And the number of patients signed up has increased steadily every year, according to Keith Kamita of the state drug authority. (Source: Honolulu Advertiser of 20 December 2004)

Europe: EU drugs strategy
With a narrow margin of 285 votes in favour, 273 against with 23 abstentions, the EURopean Parliament adopted a recommendation on 15 December to the EURopean Council on the EURopean strategy on fighting drugs. The members of the EURopean Parliament adopted a strategy which differs considerably from the U.S. strategy. It says that it wants to "lay much greater stress on harm reduction, information, prevention, care and attention to protecting the lives and health of people with problems caused by the use of illicit substances, and define measures to prevent them from being marginalised, rather than implementing repressive strategies which verge on and have frequently led to violations of human rights." (Sources: Press release of 15 December 2004, text of the resolution)

USA: Montana
Montanans who want to use cannabis to treat serious illness can begin registering with the Department of Public Health and Human Services immediately, state officials announced on 21 December. The office has already received more than 30 requests for application forms. (Source: Ravalli Republic of 22 December 2004)

Science: Adherence to antiretroviral therapy
U.S. researchers investigated the effects of cannabis use on continuation of antiretroviral therapy (ART) in HIV positive patients. 252 patients completed the interview, 175 (69 per cent) were on ART and 168 (67 per cent) provided ART adherence data. 41 of these 168 (24 per cent) used cannabis. There was no association between ART adherence and cannabis use. However, among HIV positives who suffered from nausea those who used cannabis were three times more likely to continue their ART therapy than non-users. (Source: De Jong BC, et al. J Acquir Immune Defic Syndr 2005;38(1):43-46.)

USA: Wisconsin
A woman who was arrested for possession of cannabis in Wisconsin was acquitted since she possessed a prescription by a Californian doctor. The medical use of cannabis is illegal in Wisconsin. However, the law says you can possess a controlled substance as long as you have a valid prescription. The patient suffers from chronic pain and got a prescription card while living in California. She was arrested after she had moved to Wisconsin. (Source: Americans for Save Access of 17 December 2004)

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