Report of the Working Party Use of Cannabis for Medical Purposes

[Chronmasta]

I`ve only just flicked through this, but im sure you`ll all find it quite interesting

 

 

http://www.druginfo.nsw.gov.au/__data/page/1222/volume2.pdf

 

 

 

[dani]

I`ve only just flicked through this, but im sure you`ll all find it quite interesting

 

 

http://www.druginfo.nsw.gov.au/__data/page/1222/volume2.pdf

 

 

 

 

loving your threads Chron.. Will save this one for good read tonight.

[Chronmasta]

cheers mate

im n ot sure how many have read this article....im skimming through it whenever i got a spare 5 mins, and every time i do, i find something interesting

 

here`s a couple quotes from in the article that i thought might interest a few

 

they`re only a small part of whats in it and i advise anyone to read the lot b4 using any quotes......

 

7.4.1 PSYCHIATRIC DISORDERS

There is disagreement in the literature about whether cannabis use can produce an acute psychosis

or not, but most commentators agree there is little evidence of a persistent cannabis-induced

psychosis117. The association between cannabis and schizophrenia is not well understood. The

scientific literature indicates general agreement that heavy cannabis use can precipitate

schizophrenic episodes but not that cannabis use can cause the underlying disorder. People with

schizophrenia or with a family history of schizophrenia are likely to be at greater risk for adverse

psychiatric effects from the use of cannabis118.

 

7.8 SUMMARY: THE RISKS OF CANNABIS USE

§ Most of the evidence on cannabis’ harmful effects is based on smoked cannabis. Except for the

psychoactive effects of cannabis (which are due to THC), it is not possible to distinguish the

drug effects from the effects of inhaling smoke;

§ The primary acute adverse effect of cannabis use is impaired psychomotor performance, which

affects a persons’ ability to safely drive or operate complex equipment;

§ The immunosuppressive effects of cannabis are not well established. If they exist at all, they

are probably not great enough to preclude medical use.

§ The acute side effects of cannabis use are within those tolerated for other medications;

§ The chronic effects of cannabis are of greater concern for medical use:

o Chronic cannabis smoking increases the risk of cancers, lung damage and poor

pregnancy. Smoking is not a safe route of administration for any chronic medical

condition;

o There is a small risk of dependence on THC. People most at risk are those with

psychiatric disorders (including substance dependence) and adolescents with

conduct or substance use problems; they should be advised against using cannabis;

§ Cannabis cigarettes are not ideal delivery systems in that they deliver a variable mixture of

cannabinoids as well as a variety of other biologically active substances (including possible

contaminants such as fungi or bacteria);

§ The available data suggest that medical use of cannabis would not be a problem if it was as

closely regulated as the use of other medications with abuse potential (e.g. the opioids);

§ Three factors influence the safety of cannabis or cannabinoid drugs for medical use: the

delivery system, the use of plant material, and the side effects.

o Smoking as a delivery system for cannabis is undesirable as it is clearly harmful,

especially in people with chronic conditions;

o Cannabis plant material, because of its uncertain composition and hence equally

uncertain effects, is an undesirable form of medication.

o Side effects of cannabinoid drugs are within the acceptable risk associated with

approved medications – in fact, some of the side effects, such as anxiety reduction

and sedation, might be desirable for some patients. As with many medications

there are people for whom they would probably be contraindicated.

§ Studies of the individual health risks of smoking cannabis should be conducted, particularly

among populations in which cannabis use is prevalent.

 

8.5.2 FUTURE POSSIBILITIES

A number of companies that produce innovative dosage forms of drugs have been asked for their

views on possibility of developing a cannabinoid preparation that would retain the benefit of

rapid absorption offered by smoking without its adverse effects. Most believed that such a

development was possible but that it would take a considerable time, especially if new

cannabinoids were involved. They were not convinced that the financial incentives were sufficient

to undertake the development work without significant seeding funds.

Two issues were raised: the preferred drug for delivery; and the mode of delivery. The preferred

drug on present knowledge is THC. The best route of administration (and thus relevant

formulation) is less certain.

Some companies have developed sophisticated forms of transpulmonary delivery using breath

activated systems that allow rapid titration of dose to response. However, these require aqueous

drug solutions, which precludes THC. An alternative technology could be used to generate

aerosol by ultrasonic or jet energiser using cannabinoids in suspension or dispersed in an aqueous

matrix. Even if such a development plan was successfully undertaken by a major company, the

end cost of such a sophisticated device is likely to be too high for the target patient population.

Sublingual and buccal drug administration could be developed pharmaceutically from drug

suspension or nonaqueous medium, although models for these dosage forms are normally based

upon solutions. Both rectal and passive transdermal administration are unlikely ever to fulfil the

need for rapid titration of dose to effect. Active (iontophoretic or electroporation) transdermal

systems may be successful as these have been used with large molecules, including hydrophilic

proteins.

Although there is still much work to be done, success could lead to the development of new

methods for administering cannabinoids to patients for therapeutic purposes and to significant

gains in intellectual property.

At this stage there are no feasible, reliable and inexpensive methods for delivering cannabinoids

and effectively titrating dose to response.

In terms of future long-term development, further experimentation is needed into:

76

§ making cannabinoids more water soluble;

§ determining the intrinsic pharmacological and cannabinoid receptor binding actions of any

new derivatives;

§ determining whether the actions of the derivatives is due to biodegradation to their parent

cannabinoids;

§ examining their potential for innovative delivery, e.g. by aerosols into the lungs or by

iontophoresis, using relevant animal models,

§ evaluating any promising new cannabinoids and their routes of delivery in human subjects

under controlled conditions, in the usual manner for early drug development.

This would require a significant program of experimentation that would require major

sponsorship from the National Health and Medical Research Council with a pharmaceutical

industry partnership.

For the immediate future, it would seem that an ultrasonic nebulizer, invented locally, has great

promise. Any development-application from government sources would be well-placed in this

area, especially if they also funded local development of more water soluble cannabinoids.

Relatively inexpensive research could also be done into formulating cannabinoid suspensions into

solid lozenge dosage forms that might be suitable for buccal or sublingual routes. Appropriate

research skills are available locally and the requisite funding is within the reach of the State

government sources with or without pharmaceutical industry partnership. In any event,

monitoring of international research and collaboration with groups working on these issues in

other countries should be fostered.

 

PART THREE: LEGAL AND REGULATORY OPTIONS

This section explores the legal issues raised by the report’s recommendations concerning the use

of cannabis or cannabinoids for medical purposes in New South Wales. The question of medical

use is quite separate from issues such as decriminalisation or legalisation for non-medical use; these

were not considered by the Working Party.

Decisions concerning the medical use of cannabis and cannabinoids must be based on sound

scientific evidence of their therapeutic value. The first part of this report has provided the basis

upon which such decisions can be made. This second part considers various legal and regulatory

models for facilitating both the therapeutic use of cannabis and the performance of therapeutic

trials for selected medical conditions. The objective was to explore and develop models, which

would permit the use of cannabis and cannabinoids for therapeutic purposes and scientific trials in

New South Wales, without contravening any existing legislative and regulatory requirements.

9 INTRODUCTION

Cannabis is a prohibited drug in all States and Territories in Australia. Before examining in detail

the various proposals for regulating the medical use of cannabis, it is first necessary to consider

what legal constraints might be imposed upon such action by international law. Australia’s

domestic drug laws are influenced, and to some extent determined, by the obligations set out in

international conventions to which Australia is a party. This is why the requirements of

international drug conventions can limit the range and scope of legal strategies available for

dealing with the medical use of cannabis.

This section of the report identifies the key international drug conventions to which Australia is a

party, as well as the obligations and limitations these conventions place on our drug related laws.

The underlying assumption is that it is desirable for any legislative scheme dealing with the use of

cannabis or cannabinoids for medical purposes in New South Wales to comply with Australia’s

obligations under international law.

Although these conventions aim to eliminate the use of illicit drugs, they also recognise that some

of these drugs can be useful for medical and scientific purposes. Further, to use cannabis for

research and clinical purposes would not place Australia in breach of any its international treaty

obligations. In some participating States, for example the UK, it is lawful to possess cannabis and

most of its derivatives for the purposes of medical research. The definition of “medical and

scientific purposes†may be considered sufficiently broad to allow the prescription of

cannabinoids and/or the certification of cannabis use for the treatment of certain medical

conditions.

 

Medical Necessity Defence

The defence of “medical necessity†was first established in 1975 when a man was arrested for

cultivating cannabis for the treatment of severe glaucoma.230 Defendants must satisfy the following

criteria in order to use it:

· That they did not intentionally bring about the circumstances that precipitated the unlawful

act;

· That they could not accomplish the same objective using a less offensive alternative available;

· That the evil sought to be avoided was more heinous than the unlawful act perpetrated to

avoid it.231

Courts in at least three states have allowed, since 1976, the medical necessity defence in medical

cannabis cases: Washington, Florida and Idaho. However, courts in the states of New Jersey,

Georgia, Massachusetts, Minnesota and Alabama have refused to allow this defence.

“The medical necessity defence does little to allow access to a legal and regulated supply of medical

cannabis and the prohibitive court costs involved in arguing the defence may often preclude

defendants from using it. In Australia, the defence would apply to situations of imminent peril,

but would not normally be applied to cases of therapeutic use of cannabis or other unlawful

substancesâ€.232

 

 

there`s HEAPS more in there

 

 

 

Chron

[gottagrow]

Only half way through it

Choice link Cheers chron

[dani]

cheers mate

im n ot sure how many have read this article....im skimming through it whenever i got a spare 5 mins, and every time i do, i find something interesting

 

here`s a couple quotes from in the article that i thought might interest a few

 

they`re only a small part of whats in it and i advise anyone to read the lot b4 using any quotes......

 

7.4.1 PSYCHIATRIC DISORDERS

There is disagreement in the literature about whether cannabis use can produce an acute psychosis

or not, but most commentators agree there is little evidence of a persistent cannabis-induced

psychosis117. The association between cannabis and schizophrenia is not well understood. The

scientific literature indicates general agreement that heavy cannabis use can precipitate

schizophrenic episodes but not that cannabis use can cause the underlying disorder. People with

schizophrenia or with a family history of schizophrenia are likely to be at greater risk for adverse

psychiatric effects from the use of cannabis118.

 

7.8 SUMMARY: THE RISKS OF CANNABIS USE

§ Most of the evidence on cannabis’ harmful effects is based on smoked cannabis. Except for the

psychoactive effects of cannabis (which are due to THC), it is not possible to distinguish the

drug effects from the effects of inhaling smoke;

§ The primary acute adverse effect of cannabis use is impaired psychomotor performance, which

affects a persons’ ability to safely drive or operate complex equipment;

§ The immunosuppressive effects of cannabis are not well established. If they exist at all, they

are probably not great enough to preclude medical use.

§ The acute side effects of cannabis use are within those tolerated for other medications;

§ The chronic effects of cannabis are of greater concern for medical use:

o Chronic cannabis smoking increases the risk of cancers, lung damage and poor

pregnancy. Smoking is not a safe route of administration for any chronic medical

condition;

o There is a small risk of dependence on THC. People most at risk are those with

psychiatric disorders (including substance dependence) and adolescents with

conduct or substance use problems; they should be advised against using cannabis;

§ Cannabis cigarettes are not ideal delivery systems in that they deliver a variable mixture of

cannabinoids as well as a variety of other biologically active substances (including possible

contaminants such as fungi or bacteria);

§ The available data suggest that medical use of cannabis would not be a problem if it was as

closely regulated as the use of other medications with abuse potential (e.g. the opioids);

§ Three factors influence the safety of cannabis or cannabinoid drugs for medical use: the

delivery system, the use of plant material, and the side effects.

o Smoking as a delivery system for cannabis is undesirable as it is clearly harmful,

especially in people with chronic conditions;

o Cannabis plant material, because of its uncertain composition and hence equally

uncertain effects, is an undesirable form of medication.

o Side effects of cannabinoid drugs are within the acceptable risk associated with

approved medications – in fact, some of the side effects, such as anxiety reduction

and sedation, might be desirable for some patients. As with many medications

there are people for whom they would probably be contraindicated.

§ Studies of the individual health risks of smoking cannabis should be conducted, particularly

among populations in which cannabis use is prevalent.

 

8.5.2 FUTURE POSSIBILITIES

A number of companies that produce innovative dosage forms of drugs have been asked for their

views on possibility of developing a cannabinoid preparation that would retain the benefit of

rapid absorption offered by smoking without its adverse effects. Most believed that such a

development was possible but that it would take a considerable time, especially if new

cannabinoids were involved. They were not convinced that the financial incentives were sufficient

to undertake the development work without significant seeding funds.

Two issues were raised: the preferred drug for delivery; and the mode of delivery. The preferred

drug on present knowledge is THC. The best route of administration (and thus relevant

formulation) is less certain.

Some companies have developed sophisticated forms of transpulmonary delivery using breath

activated systems that allow rapid titration of dose to response. However, these require aqueous

drug solutions, which precludes THC. An alternative technology could be used to generate

aerosol by ultrasonic or jet energiser using cannabinoids in suspension or dispersed in an aqueous

matrix. Even if such a development plan was successfully undertaken by a major company, the

end cost of such a sophisticated device is likely to be too high for the target patient population.

Sublingual and buccal drug administration could be developed pharmaceutically from drug

suspension or nonaqueous medium, although models for these dosage forms are normally based

upon solutions. Both rectal and passive transdermal administration are unlikely ever to fulfil the

need for rapid titration of dose to effect. Active (iontophoretic or electroporation) transdermal

systems may be successful as these have been used with large molecules, including hydrophilic

proteins.

Although there is still much work to be done, success could lead to the development of new

methods for administering cannabinoids to patients for therapeutic purposes and to significant

gains in intellectual property.

At this stage there are no feasible, reliable and inexpensive methods for delivering cannabinoids

and effectively titrating dose to response.

In terms of future long-term development, further experimentation is needed into:

76

§ making cannabinoids more water soluble;

§ determining the intrinsic pharmacological and cannabinoid receptor binding actions of any

new derivatives;

§ determining whether the actions of the derivatives is due to biodegradation to their parent

cannabinoids;

§ examining their potential for innovative delivery, e.g. by aerosols into the lungs or by

iontophoresis, using relevant animal models,

§ evaluating any promising new cannabinoids and their routes of delivery in human subjects

under controlled conditions, in the usual manner for early drug development.

This would require a significant program of experimentation that would require major

sponsorship from the National Health and Medical Research Council with a pharmaceutical

industry partnership.

For the immediate future, it would seem that an ultrasonic nebulizer, invented locally, has great

promise. Any development-application from government sources would be well-placed in this

area, especially if they also funded local development of more water soluble cannabinoids.

Relatively inexpensive research could also be done into formulating cannabinoid suspensions into

solid lozenge dosage forms that might be suitable for buccal or sublingual routes. Appropriate

research skills are available locally and the requisite funding is within the reach of the State

government sources with or without pharmaceutical industry partnership. In any event,

monitoring of international research and collaboration with groups working on these issues in

other countries should be fostered.

 

PART THREE: LEGAL AND REGULATORY OPTIONS

This section explores the legal issues raised by the report’s recommendations concerning the use

of cannabis or cannabinoids for medical purposes in New South Wales. The question of medical

use is quite separate from issues such as decriminalisation or legalisation for non-medical use; these

were not considered by the Working Party.

Decisions concerning the medical use of cannabis and cannabinoids must be based on sound

scientific evidence of their therapeutic value. The first part of this report has provided the basis

upon which such decisions can be made. This second part considers various legal and regulatory

models for facilitating both the therapeutic use of cannabis and the performance of therapeutic

trials for selected medical conditions. The objective was to explore and develop models, which

would permit the use of cannabis and cannabinoids for therapeutic purposes and scientific trials in

New South Wales, without contravening any existing legislative and regulatory requirements.

9 INTRODUCTION

Cannabis is a prohibited drug in all States and Territories in Australia. Before examining in detail

the various proposals for regulating the medical use of cannabis, it is first necessary to consider

what legal constraints might be imposed upon such action by international law. Australia’s

domestic drug laws are influenced, and to some extent determined, by the obligations set out in

international conventions to which Australia is a party. This is why the requirements of

international drug conventions can limit the range and scope of legal strategies available for

dealing with the medical use of cannabis.

This section of the report identifies the key international drug conventions to which Australia is a

party, as well as the obligations and limitations these conventions place on our drug related laws.

The underlying assumption is that it is desirable for any legislative scheme dealing with the use of

cannabis or cannabinoids for medical purposes in New South Wales to comply with Australia’s

obligations under international law.

Although these conventions aim to eliminate the use of illicit drugs, they also recognise that some

of these drugs can be useful for medical and scientific purposes. Further, to use cannabis for

research and clinical purposes would not place Australia in breach of any its international treaty

obligations. In some participating States, for example the UK, it is lawful to possess cannabis and

most of its derivatives for the purposes of medical research. The definition of “medical and

scientific purposes†may be considered sufficiently broad to allow the prescription of

cannabinoids and/or the certification of cannabis use for the treatment of certain medical

conditions.

 

Medical Necessity Defence

The defence of “medical necessity†was first established in 1975 when a man was arrested for

cultivating cannabis for the treatment of severe glaucoma.230 Defendants must satisfy the following

criteria in order to use it:

· That they did not intentionally bring about the circumstances that precipitated the unlawful

act;

· That they could not accomplish the same objective using a less offensive alternative available;

· That the evil sought to be avoided was more heinous than the unlawful act perpetrated to

avoid it.231

Courts in at least three states have allowed, since 1976, the medical necessity defence in medical

cannabis cases: Washington, Florida and Idaho. However, courts in the states of New Jersey,

Georgia, Massachusetts, Minnesota and Alabama have refused to allow this defence.

“The medical necessity defence does little to allow access to a legal and regulated supply of medical

cannabis and the prohibitive court costs involved in arguing the defence may often preclude

defendants from using it. In Australia, the defence would apply to situations of imminent peril,

but would not normally be applied to cases of therapeutic use of cannabis or other unlawful

substancesâ€.232

 

 

there`s HEAPS more in there

 

 

 

Chron

 

Hi Chron,

Still flicking thru' myself

Did you check Grace's posts?.. Injecting reality and the one in artificial happiness and the 1 on the guy who is taking his case to US Fedeeral court, based on medical necessity??

All put together makes you feel like their might be hope.. at least in our grandchildren's lifetime with the current bunch of idiots we have on both sides of politics here in OZ..

[Chronmasta]

good chit mate

yeah i wouldnt know a half of the law stuff if it wasnt for grace

 

[headhigh]

You're on fire mate!

 

keeping me entertained! I love info like this.

[ashka]

This was most interesting and also most disappointing. When I read section 6.5 on glaucoma it said that the ammount of cannabis I need to smoke to mantain eye pressure would not make it a viable option as the risk would outweigh the benefit. Well try and tell me that living in a blind world would be preferable to facing possible risk of future illnesses. That is crap. I just saw a you tube video on a full on medical study of the long term medical cannabis compassion people who have used for 25 years and every test from brain, lung, liver, kidney were all normal. Noticed the quote was from a British medical document who have blantantly lied about this in the past whereas American documents have much more positive and open research of recent times.