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IACM-Bulletin of 03 October 1999

USA: Study with smoked marijuana in migraine approved

After almost three years of effort, the Food and Drug Administration (FDA) has granted approval to Dr. Ethan Russo, a neurologist in Missoula, Montana, to study the effects of smoked cannabis (marijuana) in the treatment of migraine.

Cannabis will be compared to oral dronabinol (Marinol) and injected sumatriptan, the current "gold standard" in the acute treatment of the disease. The study will enrol 40 patients with severe migraine, and employ a double-blind, double-dummy crossover design, using cannabis, herb devoid of THC, Marinol (synthetic THC) or placebo capsules.

Barriers to Russo's study remain. The National Institute on Drug Abuse (NIDA) currently holds a monopoly on the domestic supply of marijuana. NIDA will only sell the drug to researchers who will pass an additional internal Public Health Service review.

Russo notes, "NIDA has thrown up a new and unnecessary barrier to this research. Their review panel has not been selected or seated, and there are no guarantees that members will have any
expertise in migraine treatment. (...) There will be additional unnecessary delays. In the meantime we cannot properly raise funding for the study." The Cannabis in Acute Migraine Treatment Protocol has a projected cost of $250,000, to be raised from private sources.

Should the current problems with NIDA continue, Dr. Russo has considered a foreign source of supply, "The British government is fully supporting current cannabis research. Dr. Geoffrey Guy is already recruiting multiple sclerosis patients for clinical trials. His material is true medical grade cannabis, three to four times as potent as the best that NIDA says that it can supply."

(Source: Personal communication of Ethan Russo)
E-mail of Dr. Ethan Russo: ptm5739@montana.com

Australia: Calls for legal access to medical use of cannabis

Legal and doctors' groups joined forces on 30 September to call for the legalization of prescription marijuana for people with severe medical conditions. In a joint call the Australian Medical Association (AMA) of New South Wales (NSW) president, Dr Kerryn Phelps, and the president of the Law Society, Ms Margaret Hole, urged the NSW Government to change its drug laws to allow cannabis to be prescribed.

Marijuana would have to be grown legally to support any such move, the convenor of the Australian Committee for Medical Cannabis, Timothy Moore, said. The NSW Law Society and the Australian Medical Association said cannabis for medical use had been legalized in parts of the US and there was no reason this should not happen in Australia. Most State law societies and AMA branches were supporting the move.

Dr. Phelps said many doctors already encouraged patients who used marijuana to relieve their symptoms to continue using the drug. "Common sense dictates that we already have enough evidence for this," Dr Phelps said. "We think there should be exemptions for such people immediately. If marijuana doesn't work for them, they won't use it, and if it has some side effects they won't continue using it. As far as I can see, legalizing prescription marijuana is a win win situation."

"This yields enormous quality of life benefits for some individuals who suffer from diseases or disease treatments that produce impaired appetite or nausea," said Dr. Macdonald Christie, head of pharmacology at the University of Sydney.

NSW Law Society president Margaret Hole said she could see no reason why the law could not be changed to exempt people who needed marijuana for their conditions. "Drug use and abuse is primarily a health and social issue not a criminal one and it should be addressed as such," Ms Hole said. The illegality of cannabis for people for whom it was the only workable palliative treatment was "a human rights issue", Ms Hole said. "If I have a disease, I have a human right to be treated with the best medicine possible."

The NSW Government indicated it would not immediately rule out any move that would decriminalize marijuana for medical use.

(Sources: AAP of 30 September 1999, The Australian of 1 October 1999, Sydney Morning Herald of 1 October 1999)

USA: FDA regarding designation of marijuana as an Orphan Drug

On 25 May the Food and Drug Administration (FDA) wrote a letter that an application of the Multidisciplinary Association for Psychedelic Studies (MAPS) to designate marijuana as an Orphan Drug in the treatment of AIDS wasting had finally been accepted.

Two and a half years ago MAPS submitted its first application to FDA's Office of Orphan Drug Products. The Orphan Drug program was created by Congress to facilitate development of drugs for rare diseases, defined as fewer than 200,000 patients per years. Drugs for such rare diseases have not been considered sufficiently profitable for pharmaceutical companies and research has been minimal. Marinol, the oral THC pill, was approved for AIDS wasting under the Orphan Drug program.

MAPS' application had been rejected five times until its acceptation now. "This final designation is a demonstration of good faith on the part of FDA and represents a major milestone in MAPS' efforts to support research into the medical uses of marijuana," Rick Doblin, President of MAPS, said.

MAPS began working in 1992 with Dr. Donald Abrams, University of California in San Francisco, in an effort to obtain permission for his study of the use of marijuana in AIDS patients. Dr. Abrams' study was eventually approved in 1997 and began in 1998. The purpose of the ongoing study is to determine whether or not marijuana therapy is safe for patients taking the new protease inhibitor drugs. Dr. Abrams will complete the dosing phase of the study in early 2000.

The declaration of marijuana as an Orphan Drug will make it easier to continue to research the medical use of the drug for AIDS wasting, if the data gathered by Dr. Abrams demonstrates that marijuana can be administered safely to AIDS patients. Another benefit of having marijuana declared an Orphan Drug by FDA is that it will theoretically be easier for MAPS to obtain a DEA license to establish a domestic medical marijuana production facility to produce high-quality marijuana for FDA-approved research.

(Source: Personal communication of Rick Doblin, MAPS)
URL of MAPS: htttp://www.maps.org

USA: Washington D.C. voted in favour of medical use of marijuana

District of Columbia voters would overwhelmingly allow marijuana to be used for medical purposes. The city's elections board says results from last November's ballot initiative show 69 percent of the 110,000 who voted would allow marijuana for pain relief and other medical purposes.

The results were released on 20 September 1999 by the city elections board, almost a year after the vote. Congress initially blocked the counting of the ballots until a U.S. District Court judge ordered the vote be counted, released, and certified.

U.S. District Judge Richard W. Roberts ruled on 17 September that the votes should be counted and announced. A ban attached to the District budget had kept everything on hold. The appropriations bill for the fiscal year beginning on 1 October approved by Congress contains a provision sponsors say would allow the vote tally but prohibit the change in law. However, that bill was vetoed by President Clinton on 28 September.

President Clinton vetoed because Congress added numerous " unacceptable" restrictions " that prevent local residents from making their own decisions about local matters," he said in a statement. Among others it would have prevented the city from allowing the use of marijuana for medical purposes despite the 1998 referendum.

(Sources: Associated Press of 20 and 28 September 1999)

USA: Sale of Marinol increased

There is a "significant increase" in prescriptions of the THC capsule Marinol in the states that recently passed pro-marijuana initiatives, according to associate product manager of Roxane Laboratories, Inc, David Querry. The roster now includes Alaska, Arizona, California, Colorado, Nevada, Oregon and Washington. As a result of the new laws, more patients ask for marijuana, but doctors have responded by prescribing Marinol first.

Marinol is a registered trade mark of Unimed Pharmaceuticals, Inc., and is marketed by Roxane Laboratories, Inc. It was introduced to the market in 1985 and approved by the FDA for the treatment of nausea caused by anti-cancer drugs and later against loss of appetite and cachexia in AIDS patients.

Standard practice dictates that doctors prescribe all conventional medications before offering an experimental drug as a treatment of last resort. But Roxane presents Marinol as a solution, not an option, for physicians who are "torn" when patients ask for marijuana. "What do they do?" asks Querry. "Honour the patients' wishes and recommend a medication that doesn't have identified medical studies to prove its safety and efficacy - or fall back on an FDA-approved product with fourteen years of history on the market?"

Only time will tell whether Marinol can capture the medical-marijuana market. But Roxane isn't taking any chances. Since 1996, when Californians first endorsed medical marijuana, the company has been waging a high-powered PR campaign. According to Querry, the company retained Hill & Knowlton "to educate the physicians and the public and the legislatures" about Marinol, because the drug is often mischaracterized by advocates of medical marijuana.

(Source: The Nation of 20 September 1999)

News in brief

Germany:
The General Meeting of the Association for Cannabis as Medicine (ACM) of this year will take place in Reutlingen near Stuttgart on 9 October. In the evening there will be public lectures on cannabis and cannabinoids by Dr. Peter Hess, Dr. Martin Schnelle and Dr. Franjo Grotenhermen.
(Source: ACM)

Canada:
A Montreal store will test open sale of marijuana to people with chronic illnesses. "It won't be just anyone who can come here," said Louise-Caroline Bergeron, director of the Compassion Club, slated to open on 30 September. "It's very controlled," Bergeron said. Its supporters in Quebec hope to have the same relationship that a similar business in Vancouver has with police. "People will have to have a doctor's note recommending cannabis," she said. The Montreal police department was consulting legal and medical authorities before deciding how to react to the club, said Const. Alain Lefrancois.
(Source: The Vancouver Sun of 29 September 1999)

USA:
Roughly 40,000 people packed the Boston Common on 18 September for the 10th annual rally in support of the legalization of marijuana. Police said they arrested 72 people at the rally, most on drug possession charges. Activists used this year's gathering to collect signatures for a proposed November 2000 ballot question that would decriminalize the possession of marijuana.
(Source: AP of 18 September 1999)

Japan:
Koichi Maeda, author of "Marijuana Seishun Ryoko" (A Young Man's Marijuana Travels), announced the foundation of a group that wants cannabis to be legalized for medical use, the Japan Medical Marijuana Association (JAMMA).
(Source: Personal communication of Koichi Maeda)

Germany:
During the conference "Cannabis - a Plant with Many Facets" on 29 September at the Technical School of Munster, organized by the Medical Association of Westphalia-Lippe and other organizations, Prof. Kleiber from Berlin said, that about every forth German had taken cannabis at least once. According to a large survey of more than 1,400 actual and former cannabis users the dependency rate among the actual users was about 2 percent. Cannabis would not be a gateway drug and would not decrease performance.
(Source: dpa of 29 September 1999)

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