Medical Marijuana - the debate rages on

Medical Marijuana - The debate rages on.
Updates made on February 02, 2006

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New drug boosts 'brain's own cannabis
Publish Date: January 30, 2006

Jan 30 (HealthCentersOnline) - A new drug that elevates levels of marijuana-like chemicals in the brain may offer hope for safer treatment of pain and depression.

Researchers from McGill University in Canada and the University of California report discovering a drug they named URB597. They found that URB597 promoted creation of endocannabinoids, dubbed the "brain's own cannabis" (marijuana).

The brain releases endocannabinoids in certain situations, such as during exercise. These chemicals affect certain receptors in the brain that can promote positive feelings.

The scientists found that the increase in endocannabinoids sparked by URB597 improved mood in test subjects. They described their study as the first to show that an endocannabinoid-increasing drug can enhance mood.

"The results were similar to the effect we might expect from the use of commonly prescribed antidepressants, which are effective on only around 30 percent of the population," lead researcher Dr. Gabriella Gobbi reported. "Our discovery strengthens the case for URB597 as a safer, non-addictive, non-psychotropic alternative to cannabis for the treatment of pain and depression and provides hope for the development of an alternate line of antidepressants, with a wider range of effectiveness."

The study was published in the Proceedings of the National Academy of Sciences.

21 States Have Authorized Medical Marijuana Studies, But Only Six Implemented Programs

In the late 1970s and early 1980s, as interest grew in the medicinal value of marijuana, 20 state legislatures responded to the demands of patients and scientists for solid research on the drug. (Massachusetts began such an effort in 1991.) In order for officially sanctioned research programs to begin, legislation was needed to carve out exemptions under state marijuana laws for study participants, and processes and regulations were needed to guide implemenation.

Each of the states listed below passed comprehensive legislation designating agencies and/or universities to conduct medical marijuana research, and spelling out regulations, such as limitations on which diseases would be studied, and mandating cooperation with key federal agencies in designing and supplying the research projects.

Ultimately, six states got through all the red tape and began programs of varied duration. Many of these programs also studied synthetic THC capsules, once they were made available by the federal government. All of these programs are now complete, and about half the states on these lists have had the legislation repealed or expired.

Authorized AND implemented:

California (1979)
Georgia (1980)
Michigan (1979, 1982)
New Mexico (1978)
New York (1980)
Tennessee (1981)

Authorized but NOT implemented:

Alaska (1979, 1982)
Arizona (1980)
Colorado (1979)
Florida (1978)
Illinois (1978)
Maine (1979, 1983)
Massachusetts (1991, 1996)
Minnesota (1980) -- THC only
New Jersey (1981)
Nevada (1979)
Rhode Island (1980)
South Carolina (1980)
Texas (1980)
Washington (1979)
West Virginia (1979)

Canada Patients Get Government Marijuana Wed Aug 27, 2003
By TOM COHEN, Associated Press Writer

TORONTO - Jari Dvorak scored two ounces of pot Tuesday and lit up, but — unlike in the past — the deal involved no back alley exchange or hiding from police.

This time, the 62-year-old Dvorak went to a doctor to pick up his supply, making him one of the first patients to receive government-grown marijuana. He paid $245, tax included.

"I just smoked some and it's doing the trick," said Dvorak, one of several hundred Canadians authorized to use medical marijuana for pain, nausea and other symptoms of catastrophic or chronic illness.

The program announced last month by the federal health department provides marijuana grown by the government in a former copper mine turned underground greenhouse in northern Manitoba.

Dvorak described his new stash as light green and orange in color, resembling ground tobacco sealed in vacuum-packed bags. If he saw some lying around, he said, "I would say that's marijuana, especially if I sniff it."

Getting it has been a three-year struggle for Dvorak and other Canadian patients who have battled through the courts to make the government respond to what they call their need for a compassionate exemption from criminal law.

Marijuana possession remains a crime in Canada, though the government has proposed making small amounts — less than half an ounce — punishable by a citation and fine similar to a traffic ticket. U.S. officials have warned of tighter border security if Canada takes that step.

Last month, Health Minister Anne McLellan announced the program to sell the government-grown weed, satisfying an Ontario court order for the government to make a legal supply available to authorized patients. The court ruling said current laws made "seriously ill, vulnerable people deal with the criminal underworld to get medicine."

Under the program, qualified patients can get just over an ounce of dried pot for about $105, well below street prices. Authorized growers can buy packs of 30 seeds once a year for $15.

Dvorak's supply came with something he never had seen — a content analysis. He noted the THC content was 10.2 percent, compared to the range of 3 percent to 18 percent in most street marijuana. Tetrahydrocannabinol, or THC, is the psychoactive chemical in marijuana.

He smokes pot in the morning to soothe nausea from the HIV drugs he has taken for 15 years.

"I'm so happy the government is coming through with it," Dvorak said. "Are they going to carry on with it? We'll see."

McLellan has called the initial program an interim measure to satisfy the court order while the government appeals the ruling.

Canada unveiled plans for medical marijuana in 2000 and began growing a supply in the abandoned mine shaft in Flin Flon, Manitoba. New regulations took effect on July 30, 2001, expanding the number of Canadians allowed to use medical marijuana and allowing people to grow their own or designate someone to grow it for them.

The regulations also cleared the way for distribution of the government-grown pot, but McLellan's department later announced it needed further tests on the effects of medicinal marijuana and the quality of its pot before making any available.

That brought last year's court ruling ordering the government to offer a legal supply instead of making patients buy off the street.

Medical marijuana users complain the Canadian system has been a bureaucratic maze intended to stifle the issue instead of providing pot to those who need it. While hundreds have received federal exemptions to grow and possess marijuana, others say it is hard to find doctors to sign off on their requests.

Dvorak described himself as lucky because his "compassionate" doctor understands the need. He refused to give the doctor's name.

Nine U.S. states allow limited use of marijuana for medical purposes under the direction of a doctor: Alaska, Arizona, California, Colorado, Hawaii, Maine, Nevada, Oregon and Washington.

The Bush administration has asked the Supreme Court to decide whether the government can strip a doctor's license to prescribe drugs if medical marijuana is prescribed. It also has appealed a 9th U.S. Circuit Court of Appeals (news - web sites) ruling that blocked the federal government from punishing doctors who prescribe medical marijuana.

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GW PHARMACEUTICALS STARTS MEDICINAL CANNABIS TRIALS IN CANADA

4 August 2001 GW Pharmaceuticals plc ("GW or "the Company")

GW Pharmaceuticals plc, the company developing a portfolio of
prescription medicines derived from cannabis, is commencing clinical
trials in Canada. This is the first trial undertaken outside the
United Kingdom by GW, and is believed to be the only trial of its
kind in North America.

The start of this first trial in Canada follows the grant to GW
earlier this year of an Investigational New Drug (IND) by Health
Canada, the Canadian regulatory authority. The Phase Two trial, in
which patients will take cannabis-extract by means of a sub-lingual
(under-the-tongue) spray, will include sufferers of Multiple
Sclerosis, Spinal Cord Injury and other forms of chronic pain, and
will be under the supervision of Dr Daniel DeForge, of The
Rehabilitation Centre, Ottawa Hospital. The trial will be randomised
and double-blind - that is, neither doctors nor patients will know
whether drug or inactive placebo is being taken.

In addition to providing useful data on GW's non-smoked
cannabis-based medicines, the Canadian trial will provide GW with a
platform from which to expand further research in Canada.

The commencement of trials in North America follows the rapid
progress of GW's European programme. Following a series of Phase Two
trials involving 75 patients that have been underway in the UK since
May 2000, GW started its first Phase Three clinical trial in Multiple
Sclerosis in the UK in May 2001. Recruitment for this trial is now
well underway.

Dr Geoffrey Guy, GW's Executive Chairman, will be providing a
progress report on the company's UK Phase Two trials in a keynote
speech at the American Academy of Pain Management in early September.
GW has previously noted that patients in these trials are clearly
gaining benefit with clinically significant improvements in a range
of symptoms, including pain, muscle spasms, spasticity, bladder
related symptoms, tremor and overall improvements in quality of life.

Canada allows sufferers from chronic conditions such as Multiple
Sclerosis and Arthritis to apply to possess and to cultivate cannabis
for medical purposes legally. The Canadian Medical Association and
other organisations have expressed concern over this development in
that smoked cannabis does not offer physicians and patients a
solution which fits the norms of medical practice. GW's programme is
designed to provide an appropriate long term solution for Canadian
patients by providing a non-smoked prescription medicine which
harnesses the medical benefits of cannabis and which is of proven
quality, safety and efficacy and approved as a prescription medicine
by Health Canada.

Dr Geoffrey Guy, Chairman of GW Pharmaceuticals said, "The start of
clinical trials in Canada is the first phase of our international
trials programme. The Canadian health authorities have recognised the
potential contribution of cannabis-based medicines in the treatment
of many different conditions. GW has been in discussion with Health
Canada for some time and has developed a close and positive working
relationship over that period. We remain committed to the view that a
non-smoked form of cannabis-medicine developed in full accordance
with the standards of modern pharmaceuticals offers the best solution
for patients."

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Study Shows Cannabis Spray Helps Ease Chronic Pain

Updated: Mon, Sep 03 10:28 AM EDT By Patricia Reaney

GLASGOW, Scotland (Reuters) - A cannabis spray used under the tongue
helps to relieve the suffering of multiple sclerosis patients and
people suffering from chronic pain, a British doctor said Monday.

The spray contains extracts from the drug and allows doctors to
control dosage effectively and measure the effects.

So far the results have been encouraging.

"We are finding it is useful for a lot of patients," Dr. William
Notcutt of James Paget Hospital in Great Yarmouth in eastern England
told a science conference in Glasgow.

An estimated one person in 12 experience chronic pain.

Notcutt tested the spray, which was developed and supplied by the
British company GW Pharmaceuticals, in patients with experience of
cannabis and in others who were not familiar with the drug.

The spray totally relieved pain in some patients while it helped
others get a good night's sleep, which Notcutt said is a blessed
event for many chronic pain sufferers.

In addition to providing valuable information about the effectiveness
of the drug in easing chronic pain, Notcutt told the British
Association for the Advancement of Science Conference that the study
was also providing data on the best dosage and side effects.

"We need much more basic information on how to use this," he said.

Although the use of cannabis is illegal in most countries, patients
with diseases such as cancer and multiple sclerosis have been
lobbying to use cannabis for medicinal purposes.

Only three patients out of the 23 in the two groups said they
received no benefit from the spray. Side effects included a high
level of euphoria, or "high," panic attacks and fainting.

Notcutt refused to be drawn on whether his research would provide
further support to those seeking to legalese cannabis.

"Our goal has been to return people to an active life," he said,
adding that one patient had returned to work and others had resumed
driving.

GW Pharmaceuticals, set up in 1997, operates under licenses from the
British Home Office (interior ministry) to cultivate, possess and
supply cannabis for medical research.

It grows cannabis in secure, computer-controlled glasshouses in
southern England. The plants used in the trials were grown to
maximize the benefits of cannabinoids, the active ingredient in
cannabis.

Notcutt said the use of cannabis extracts for pain could pave the way
for the drug to be used for other conditions including rheumatoid
arthritis, surgical premedication, epilepsy and eating disorders.

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Drug Delivery Technologies

Cannabis can be taken by a variety of routes of administration. Smoking, according to patients who take cannabis for the relief of spasm and pain associated with Multiple sclerosis is a very effective method of drug delivery. However, smoking delivers carcinogenic tars and particulates into the bronchial tree, and is not seen by GW as an appropriate method of drug delivery for a prescription product.

GW is using three drug delivery technologies in the development of its products, specifically:

* Sub-lingual (under the tongue) spray - This spray technology is being utilised for the Group's lead product which is now in Phase III trials and is being supplied by a leading spray technology provider. The spray pump is already approved by the Medicines Control Agency (MCA) in the UK and similar agencies elsewhere for use with specific medicines.

* Sub-lingual tablet - These tablets, which are intended to dissolve under the tongue rather than be swallowed by patients, have been developed in-house by the GW team. They have been used in one of the Group's Phase II trials.

* Inhaler - GW is developing an innovative inhalation device for the delivery of its medicines. GW expects that this device will enable patients to benefit from the rapid relief associated with inhaled delivery but without exposure to the carcinogens produced when cannabis is smoked. GW has entered into a partnership with a major UK electronics company to support this project. Intellectual proprietary rights relating to this technology will be owned exclusively by GW. This device has potential for use in the administration of non-cannabis products and GW will also be exploring its wider commercial applications during the course of its development. The development of this device is being partly funded by a grant of approximately �150,000 under the UK Government's SMART award scheme.

GW is also developing specialist security technology which can be applied to all of its drug delivery systems. The aim of this anti-diversionary technology is to prevent any potential abuse of cannabis-based medicines. In addition, this technology is being designed to enable the recording and remote monitoring of patient usage. The technology should recognise and prevent any abnormal use that differs from expected prescribed usage. Such data would itself have intrinsic value and would also allow for efficient monitoring in clinical trials. The first set of prototypes for the technology as applied to the sub-lingual spray pump has been developed and two patent applications have been filed.

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Marijuana-Like Medications May Ease Anxiety By Jacqueline Stenson
NEW YORK (Reuters Health) - Seeking to induce the anxiety-reducing effects of marijuana without causing mental stupor or the munchies, scientists have identified two experimental drugs that appear to do just that in lab rats.

The research might eventually lead to an entirely new class of medications to combat anxiety and depression, said study author Daniele Piomelli, a professor of pharmacology at the University of California at Irvine.

The active component in marijuana, THC, acts similarly to naturally occurring neurotransmitters in the brain called cannabinoids, which can play a role in mood, he told Reuters Health.

The new drugs, URB532 and URB597, work by inhibiting an enzyme that breaks down the cannabinoid known as anandamide, he explained.

And as evidenced by his animal research, reported in the advance online publication of the January issue of Nature Medicine, the result is higher brain levels of anandamide, which in turn ease anxiety in rats. When given the drugs, the animals squeaked less when subjected to isolation and were less tentative when placed in a maze with exposed spaces. In the wild, such spaces put the animals at risk of predator attack.

However, the rats did not experience typical THC side effects such as increased appetite, reduced body temperature or loss of motor function, all of which would signal cannabinoid intoxication in the animals. That's probably because THC acts directly on cannabinoid receptors on brain cells, whereas the new drugs work in a different, more subtle way, Piomelli said.

The effect of the experimental drugs is similar to antidepressants like Prozac, which boost brain levels of another neurotransmitter, serotonin, he said. "Some people have low levels of serotonin, and maybe there are some people who have low levels of anandamide," he said.

The new drugs show promise as novel ways to treat anxiety and depression in people, Piomelli said. Human studies with the new drugs could begin within a year, he added. SOURCE: Nature Medicine 2002;10.1038/nm803.

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Marijuana as medicine? An online book.

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Medicinal Cannabis Research
GW Pharmaceuticals plc is the company licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked prescription cannabis-based medicines. We hope to bring to market our first prescription medicine in early 2004. This will provide sufferers of multiple sclerosis and other neurological disorders with a medicine which allows them to experience the medical benefits of cannabis without unwanted psychoactive side effects, and without the health dangers associated with smoking.

Phase Three of our UK trials programme, currently underway, is the largest such study undertaken to date by GW and involves over 500 patients. Our aim is to prepare data for Product Licence Approval by the Medicines Control Agency. In the event of a Licence being granted, the Home Secretary has confirmed that he would be willing to amend the Misuse of Drugs Act 1971 to allow the prescribing of a cannabis-based medicine.

Patients in our various trials are taking different formulations of cannabis-based medicines by means of a sub-lingual spray device - it is sprayed under the tongue and absorbed, rather than swallowed. This device is designed to deliver the drug principally to the mucosa for rapid effect. The patients also take an inactive 'placebo'. Neither the researchers nor the patients know whether they are using the active substance or the placebo at any given time.

Our results to date appear to show significant reduction in pain, muscle spasm and bladder dysfunction as well as improved neurological function. In addition, patients are able to self-titrate (adjust) their dose so as to provide the suitable level of medical benefit without incurring unwelcome side effects.

All our medicines are derived from extracts of plants which we grow ourselves. GW benefits from more than 10 years research expertise on cultivation and analysis of the cannabis sativa plant. Our plants are grown in a highly secure glasshouse facility. All aspects of the growing climate – temperature, humidity, air changes and photoperiod – are controlled by computer.

As far as Fibromyalgia is concerned, no specific clinical data exists on cannabis' ability to combat the symptoms of the condition. However, some patients report anecdotally that the drug benefits them. In Iowa, USA, a court judge has allowed a Fibromyalgia patient to use cannabis while on probation to effectively treat his chronic pain.

It does seem likely that cannabis alleviates some symptoms of Fibromyalgia. Cannabis' potential as an analgesic and anti-inflammatory have been documented by the Institute of Medicine, National Institute of Health, and others.

Additionally, cannabis has a long history as a sleep-inducing drug. One study of fifteen insomniac patients reported that over a five-week period "sleep quality was significantly influenced by 160 mg of cannabidiol (a non-psychoactive cannabinoid) as two-thirds of the subjects slept more than seven hours and … most subjects had few interruptions of sleep." An Italian research team reported that subjects who had inhaled cannabis within the last half-hour had significantly higher melatonin levels than those who abstained. Melatonin, a hormone produced by the pineal gland, is widely used to treat insomnia.

So there is evidence there to be considered. At the same time, there are a significant number of potential uses of cannabis-based medicines, and as a small young research company with limited resources, we have been forced to make choices as to the number of medical conditions we can research. Throughout our short history, this has been a difficult issue for us since we would, of course, wish to explore all potential uses of cannabis-based medicines as soon as we are able. Over the years, we have received letters from over 3,500 patients suffering from a very wide range of conditions, including Fibromyalgia. We have used this correspondence as an indicator of the priorities which we should attach to our research. Hence, for the time being, we have focused on patients suffering from multiple sclerosis, spinal cord injury and general neuropathic pain. In due course, as research in one area comes to a conclusion, we will broaden the scope of our research, and Fibromyalgia is certainly a condition we will consider.

Right now, our over-riding priority is to ensure that the first cannabis-based medicine is approved by the Medicines Control Agency as soon as possible so that it can be prescribed by doctors to patients. This will be the first cannabis-based medicine approved anywhere in the world. It is worth noting that although this cannabis-based medicine will be approved at that time for a specific use, it will be possible for the medicine to be prescribed by doctors (at their own discretion) for patients with other conditions.

At GW, we are all too aware that there are a large number of patients suffering from a broad range of medical conditions who may benefit from cannabis-based medicines. We are dedicated to finding a means for as many of such patients as possible to have access to these medicines in the shortest possible timeframe.

(This area of research will be worth monitoring for its success and possible future research funding here in the UK for use with fibromyalgia. Editor)

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Medicinal use of cannabis for fibromyalgia sufferers; written by a spokesman for GW Pharmaceuticals -the leading UK company involved in this research.

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Marijuana: Can it relieve pain?

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Court to decide what you and your doctor can say about medical marijuana.

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