TGA and Cannabis

[luciddreaming]

I checked back on this pdf someone sent me a while ago. And finally found the bit on Cannabis. It's quite interesting.

 

Here's an exceprt

A PubMed search of the literature relating to cannabinoids and multiple sclerosis

undertaken by the Secretariat, uncovered the following papers.

 

‘A tale of two cannabinoids: The therapeutic rationale for combining

tetrahydrocannabinol and cannabidiol’ (Russo, E et al 2006, Medical Hypotheses

Volume 66, Issue 2, p234-246) examined the current knowledge of physiological and

clinical effects of tetrahydrocannabinol (THC) and cannabidiol (CBD). The paper is

of relevance because:

− CBD was demonstrated to antagonise some undesirable effects of THC including

intoxication, sedation and tachycardia, while contributing analgesic, anti-emetic,

and anti-carcinogenic properties in its own right.

− A rationale for combination of THC and CBD in pharmaceutical preparations is

presented.

− Cannabinoid and vanilloid receptor effects as well as non-receptor mechanisms

were explored, such as the capability of THC and CBD to act as anti-

inflammatory substances independent of cyclo-oxygenase (COX) inhibition.

− Combination therapy has permitted the administration of higher doses of THC,

providing evidence for clinical efficacy and safety for cannabis based extracts in

treatment of spasticity, central pain and lower urinary tract symptoms in multiple

sclerosis, as well as sleep disturbances, peripheral neuropathic pain, brachial

plexus avulsion symptoms, rheumatoid arthritis and intractable cancer pain.

− Prospects for future application of whole cannabis extracts in neuroprotection,

drug dependency, and neoplastic disorders are further examined.

− The hypothesis that the combination of THC and CBD increases clinical efficacy

while reducing adverse events was supported.

 

‘Meta-analysis of cannabis based treatments for neuropathic and multiple sclerosis-

related pain’ (Iskedjian, M et al, January 2007, Current Medical Research and

Opinion. 23(1):17-24):

− Stated that debilitating pain, occurring in 50-70 per cent of multiple sclerosis

(MS) patients, was poorly understood and infrequently studied.

− Summarized efficacy and safety data of cannabinoid-based drugs for neuropathic

pain.

− Focused on baseline-endpoint score differences where the cannabidiol/THC

buccal spray decreased pain 1.7 +/- 0.7 points (p = 0.018), cannabidiol 1.5 +/- 0.7

(p = 0.044), dronabinol 1.5 +/- 0.6 (p = 0.013), and all cannabinoids pooled

together 1.6 +/- 0.4 (p < 0.001).

− Noted that placebo baseline-endpoint scores did not differ (0.8 +/- 0.4 points, p =

0.023).

− Noted that at endpoint cannabinoids were superior to placebo by 0.8 +/- 0.3

points (p = 0.029).

− Dizziness was the most commonly observed adverse event in the

cannabidiol/THC buccal spray arms (39 +/- 16 per cent), across all cannabinoid

treatments (32.5 +/- 16 per cent) as well as in the placebo arms (10 +/- 4 per cent).

− The meta-analysis concluded that cannabinoids including the cannabidiol/THC

buccal spray are effective in treating neuropathic pain in MS, although the review

was based on a small number of trials and patients.

− Pain related to MS was assumed to be similar to neuropathic pain.

 

In regards to the current classification of cannabidiol in relation to the Convention on

Psychotropic Substances 1971 and the Single Convention on Narcotic Substances 1961,

XXXXX has advised that cannabidiol, as such, is not under international control.

However, XXXXX did point out that as the pharmaceutical product THC+CBD contains

cannabis extracts and cannabis extracts are included in Schedule I of the Single

Convention on Narcotic Drugs of 1961, then this convention would apply to THC+CBD.

According to Article 2 of the Single Convention, drugs included in Schedule I are subject

to all control measures applicable to drugs under the Single Convention, including the

mandatory submission of annual estimates and statistical returns as well as the control of

international trade. That is to say, the obligations upon signatories for substances

included in Schedule I relate to mandatory reporting of movement of these substances

and these do not necessarily translate to mandatory restrictions on access. It was also

pointed out that the substance delta-9-tetrahydrocannabinol in its isolated (synthetically

manufactured) form is contained in Schedule II of the Convention on PsychotropicSubstances of 1971.

 

....

 

The Committee confirmed that tetrahydrocannabinol was captured by the current

Schedule 8 entry for ‘dronabinol’ (delta-9-tetrahydrocannabinol) and agreed to

foreshadow consideration of the scheduling of cannabidiol in Schedule 8 when prepared

and packed for therapeutic use at the June 2009 NDPSC Meeting.

 

Here's the link for it. I'm still not quite sure whether we even have Dronabinol in Aus....

Apparently it is an extract, not synthetic.

 

Go to page 142

http://www.tga.gov.au/ndpsc/record/rr200902.pdf

 

I just sent a letter to the TGA asking them about it.

Edited May 30, 2009 by luciddreaming

[Frazz]

these articles are hard to understand and i guess that is to make it so difficult for uneducated stoners like myself to sort the double-dutch from the intelligible, simple english and arrive at some sort of meaning contained within these papers ..

 

the last paragraph i cannot fully understand , but i give my take on it here

quoted here again but broken down in 2 parts;

 

The Committee confirmed that tetrahydrocannabinol was captured by the current

Schedule 8 entry for ‘dronabinol’ (delta-9-tetrahydrocannabinol)

 

ok Schedule 8 is a listing of Drugs of Addiction e.g. S8 medicines , so ‘dronabinol’ (delta-9-tetrahydrocannabinol) is 'captured' within the definitions of Schedule8 , that is the view of the 'Committee'

 

The Committee agreed to foreshadow

consideration of the scheduling of cannabidiol in Schedule 8 when prepared

and packed for therapeutic use at the June 2009 NDPSC Meeting.

 

'The Committee' (reminds me of Communist Party mettings ) will think about considering Cannabidol, when prepared and packed for therapeutic use ', (presumably by a Pharmaceutical Company) for inclusion to Schedule 8

 

what a mob of bumbling clowns, it would be a bloody shame if they ever decided to do something definite, something positive, something real ...

 

thanks for posting it all the same lucid d.

[Radic]

thanx for the link dreamer

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009

page148

 

DISCUSSION – RELEVANT MATTERS UNDER 52E

 

Some jurisdictional Members noted that XXXXX it has been difficult for jurisdictions to

approve access to these products as cannabidiol was considered a Schedule 9 substance.

It was noted that access would be facilitated if cannabidiol was a Schedule 8 substance.

 

thats why

 

RESOLUTION 2009/55 - 26

The Committee confirmed that tetrahydrocannabinol was captured by the current

Schedule 8 entry for ‘dronabinol’ (delta-9-tetrahydrocannabinol) and agreed to

foreshadow consideration of the scheduling of cannabidiol in Schedule 8 when prepared

and packed for therapeutic use at the June 2009 NDPSC Meeting.

 

resechedule cannabis now

people are suffering

how do they sleep at night???????

[loylty gets u nothing]

resechedule cannabis now

people are suffering

how do they sleep at night???????

 

 

with a gut full of taxed alcohol

thats my suspicions

take care

bil

[luciddreaming]

Thanks for the help understanding this shit guys

I got this reply.

 

Thank you for your email regarding the status of Dronabinol in Australia.  I am from the Office of Prescription Medicines in the Therapeutic Goods Administration (TGA) and in response to your enquiry I offer the following information.

 

Essentially, any product  for which therapeutic claims are made must be included on the Australian Register of Therapeutic Goods (ARTG) before it can be commercially supplied in Australia. In order for a therapeutic good to appear on the ARTG, a sponsor (i.e. the individual or company intending to supply the goods) must lodge an application with the TGA.  This application is  accompanied by data which must show evidence of the safety, quality and effectiveness of the product.  This submission is evaluated by the TGA and if  approved, the therapeutic good is  added to the ARTG and can be commercially supplied in Australia for an approved indication.

 

Dronabinol does not appear on the ARTG.  It has not been approved for use by the TGA and therefore cannot be commercially supplied in Australia.

 

The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) places Dronabinol into Schedule 8 (Controlled Drug).  While the SUSDP is not uniformly adopted in Australia by all States and Territories, legislative arrangements are such that in essence, the same prohibitions are in place. Each State and Territory has its own 'Drugs Misuse Act' that captures these types of substances.   In additiion the SUSDP also places Dronabinol into Appendix D "Additional controls on possession or supply of Poisons included in Schedule 4 or 8".  

 

Dronabinol (delta-9-tetrahydrocannabinol) is the sole entry under Item 3 in Appendix D which states:

 

"Poisons available only from or on the prescription or order of a medical

 practitioner authorised by the Secretary of the Commonwealth

 Department of Health and Ageing under section 19 of the Therapeutic

 Goods Act 1989."

 

If a medical practitioner wishes to treat a patient with this product  they must apply under Category B of the Special Access Scheme (SAS) for approval to supply their patient with this unapproved therapeutic good.  I have attached a link to our website that explains the Special Access Scheme.  The Category B form can be downloaded from this site.

 

http://www.tga.gov.au/hp/sas.htm

 

These products are also prohibited under Customs Legislation and therefore a import permit must be issued by the Office of Chemical Safety prior to importation of this product.  

 

It is also necessary to comply with State or Territory legislation and seek approval through relevant health departments for supply and posession of these products.

 

I trust this information is of assistance.

 

Clearly NOBODY is going to go to that much fucking trouble, can you imagine how much it would cost and how long it would take! Just go to the fucking street corner and get some weed. In fact, that reminds me. My mum was saying that her friend had cancer and the doctors actually told her where to go to get Medicinal Cannabis. Which leads me to believe there must be some compassion clubs around Aus.

[bufo marinus]

"Poisons available only from or on the prescription or order of a medical

practitioner authorised by the Secretary of the Commonwealth

Department of Health and Ageing under section 19 of the Therapeutic

Goods Act 1989."

 

This lil snippit of info shouldn't be passed over too quickly.

Get the right forms filled out and hey presto! your smoking or doing research on your own imported Cannabis, only problem is, you and I would probably never get the correct paper work approved.

Main thing is their is an avenue to move on this point, this is why medical Cannabis has such an excellent chance of becoming reality and why you see it talked up, as it should, these days.

The case on The Sunshine Coast involving the guy with severe burns, the magistrate pointed him in this direction, as I'm guessing, he thought he would get approval.

Reschedule Cannabis? With all the mounting government funded propaganda reports it is a David and Goliath size problem to tackle, I think it'd be easier passing a referendum than challenging the credibility of an entire species of middle class welfare recipients which we happily do here hehe

Compassion Clubs? Someone told me that fine upstanding citizen WallyDuck is involved with one in Canberra, why not call Wally and ask, I'm sure he'd be only too happy to help out,... at a reduced fee of course

imo Compassion Club scenario like Canada is not quite the way to go either, what would be more accountable is a system of licensed growers reporting to a central body, just like the Barley Growers or Wheat Growers Board, the Cannabis could be graded and assessed properly

[luciddreaming]

This is not for Cannabis, although I suppose it could be. Unapproved medicine must include cannabis. But then it has to get to schedule 8 first.

But this is for Dronabinol. Extracted THC + CBD (I think) Which I think is or will be Schedule 8 soon.

Plus you don't just have to full out the right forms. You need approval from all these pollies.

i.e You'd have to be dying. And then it's just quicker and easier to get bud.

 

Yep I think compassion clubs are not the way to go. But it's what we have at the moment.

WallyDuck ey? I think I've seen him around here a couple of times. Unfortunately I'm nowhere near Canberra hehe

Edited June 2, 2009 by luciddreaming

[bufo marinus]

Yes it is a different schedule than Droabinol but same procedure for access.

I have read where a researcher filled in the appropriate forms and the Cannabis was then imported to do research on.

[Pangaea]

This is not for Cannabis, although I suppose it could be. Unapproved medicine must include cannabis. But then it has to get to schedule 8 first.

But this is for Dronabinol. Extracted THC + CBD (I think) Which I think is or will be Schedule 8 soon.

Plus you don't just have to full out the right forms. You need approval from all these pollies.

i.e You'd have to be dying. And then it's just quicker and easier to get bud.

 

Yep I think compassion clubs are not the way to go. But it's what we have at the moment.

WallyDuck ey? I think I've seen him around here a couple of times. Unfortunately I'm nowhere near Canberra hehe

 

Have found the same in Canberra

[lightning]

Actually the SAS can be used for importing both schedule 8 & 9. substances.

We got the form and then asked both State and Fed Health Ministers for a list of medical

practitioners authorised by the Secretary of the Commonwealth

Department of Health and Ageing under section 19 of the Therapeutic

Goods Act 1989." and a List of Governmant Authorised Suppliers in order to be able to fill out the form....

 

We are still waiting for a reply to that question from any of them.

 

We made a point about that in our brief as it shows the system is unworkable and there fore in breach of the obligations under the treaty.

 

I love how they list THC and CBD as "poisons" when they are actually less toxic than water!!