Get your Kava submissions in

Thelema · May 25, 2009

Inviting submissions for the upcoming July meeting... from the pre gazette notice:

1.4 Piper methysticum (Kava) – consideration of scheduling, including a proposal to exempt the dried

root or rhizome from scheduling (see item 12.1.5 of the February 2009 Record of Reasons).

12.1.5:

12.1.5 PIPER METHYSTICUM (KAVA)

PURPOSE

The Committee considered a proposal to exempt Piper methysticum from scheduling

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 133

BACKGROUND

The active ingredients of Piper methysticum (kava), kava lactones (or kava pyrones), are

pharmacologically active compounds naturally present in the kava plant. Nineteen kava

lactones have been isolated from the kava root, of which six are the major constituents of

kava (kawain, dihydrokawain, methsticin, dihydromethsticin yangonin, and

demethoxyangonin). The proportions and potency of kava lactones vary according to the

plant variety and also the method of preparation. The kavalactone content varies from 3

per cent to 20 per cent dry weight, even within the same subspecies. The concentration

of kava lactones is generally highest in the lateral roots (approximately 15 per cent) and

decreases progressively toward the aerial part of the plant. The effects of kava may also

depend on how it is consumed in terms of whether it is used concomitantly with other

drugs, food, alcohol or physical activity.

The absorption of kava lactones in the gastrointestinal tract is poor and variable. Kava

lactones appear to be hydroxylated by the cytochrome P450 system and are eliminated by

the kidneys and in the faeces. Kava is known to have several actions; the primary action

is as a mild sedative. Other actions include local anaesthesia of the mouth and tongue,

analgesia, ocular effects, anticonvulsive effects and antimycotic properties. It has been

reported as an effective anti-anxiety treatment.

The October 2003 NDPSC Meeting noted a safety evaluation report prepared by the Kava

Evaluation Group/Office of Complementary Medicines on kava containing medicines and

decided there was a need to restrict the use of alcohol/acetone extracts of kava, including

those for bulk supply to health care practitioners, due to the potential risk of liver

toxicities.

The June 2004 NDPSC Meeting, agreed to include kava in Schedule 4 of the SUSDP, as

well as adopting the exemptions specified in the TGA Regulations 1990. The Committee

confirmed the decision at the October 2004 NDPSC Meeting. This decision made all

kava Schedule 4; except dried whole or peeled rhizome, its aqueous dispersions or

extracts, tablets of

125 mg or less of kava lactones per tablet, teabags of up to 3 g kava, and not more than

25 mg of kava lactones per dose, compliant with RASML and in topical or dermal

preparations when included on the ARTG.

At the February 2008 NDPSC Meeting, in the light of a policy decision by the former

Australian Government, the Committee reconsidered scheduling restrictions for kava and

concluded that the potential for abuse and the hazard to public health of the whole or

peeled rhizome meant that this form of kava should no longer be exempt from

scheduling. Thus the decision meant that only those products on the ARTG containing

kava were not Schedule 4.

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 134

DISCUSSION - SUBMISSIONS

Members noted that Piper methysticum (kava) was not included in the Government

Gazettal notice for the February 2009 NDPSC Meeting. The NDPSC received a single

submission, from XXXXX, requesting kava be rescheduled to its previous status of

exempt from scheduling, as it was prior to the recent scheduling change. The submission

dealt with kava as the traditional drink and as dried fresh or frozen rootstock. The

applicants’ claims against the scheduling criteria, Section 52E Matters to be taken into

account in exercising powers, (a) to (i), are summarised;

(a) Toxicity and Safety of the Substance

• LD50 of kava resin given by intra peritoneal injection to mice, rats and rabbits ranged

from 300 to 4000 mg/kg. With oral administration the LD50 in mice was 920mg.

Doses of 50mg dihydromethysticin, administered 3 times a week to rats produced no

evidence of chronic toxicity, however attempts to duplicate the findings have had

limited success.

• The applicant claimed that clinical trials of kava had not revealed any hepatoxicity,

but also stated that “kava has a tendency to have a toxic effect on the liver”.

( Risks and Benefits Associated with the Use of the Substance

• Kava is used traditionally to treat anxiety, sleep disorders and other complaints.

• The applicant claimed that kava lactones are shown to affect a range of

neurotransmitter systems, and that they have “dose dependent effects on the central

nervous system, including anti-epileptic properties”.

• The applicant claimed that the World Health Organisation (WHO) found only 2

reports of possible adverse reactions to kava use. The applicant claimed that this

figure was out of over ‘12 billion discreet doses prepared in the traditional way over

20 years’. The source of the 12 billion figure was not cited, nor could one be found in

the WHO article. The applicant also claimed that when kava was taken in doses from

100 to 210 mg of kava pyrones (or kava lactones) per day the users had few adverse

reactions. Adverse reactions are described including kava dermopathy of the hair

nails and skin, rare allergic reactions including hearing loss and anorexia and possible

extrapyramidal side effects such as involuntary oral and lingual reflexes and twisting

movements of the head and trunk.

• The applicant reported that liver function tests can be elevated after 3 to 8 weeks of

use, and may be followed by hepatomegaly; that kava can exacerbate hepatitis, but

that this spontaneously resolves on cessation.

(d) Extent and Patterns of Use of a Substance

• The traditional use of kava was described.

• The inappropriate use of kava by NT remote indigenous communities was mentioned.

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 135

(e) Dosage and Formulation of a Substance

• Aqueous extract/suspension consumed in 100ml measures.

(f) Need for Access to the Substance, Taking into Account its Toxicity Compared with

Other Substances Available for a Similar Purpose

• The applicant claimed that the scheduling of kava denied Australians of Pacific

Islander origin their traditional and cultural use of kava. The Committee noted that it

was the ban imposed by the Australian Customs Service on all kava imports, except

those under medical or scientific research licence, which denied free access to kava.

• The applicant claimed that kava’s closest alternative is alcohol with its related antisocial

behaviour and associated health risks and that no deaths have been attributed to

kava consumption.

• Fewer than 350 people in the NT were identified as being at risk of abusing kava.

• The applicant reiterated the argument that because the number of abusers of this

substance was “insignificant” that it is not right to restrict the use of the substance to

others.

(g) Purpose for which the Substance is to be used

• The applicant reiterated the original use of the substance in the Pacific Islands.

(h) Additional Matters; Economic and Trade Considerations

• The applicant reported that kava was a primary cash crop for Vanuatu, Tonga and

Samoa, accounting for up to 30 per cent of their GDP, and inferred that the ban

imposed by Australia may influence other countries to “harmonise’ their policy to

kava in line with Australia’s. They noted that Australia is a signatory to the

Agreement on Technical Barriers to Trade (World Trade Organisation), and may be

subject to legal challenges (from kava producing countries) to remove technical

barriers to the kava trade.

The application contained an extensive bibliography including fifteen articles by Alan R

Clough. The articles were selected to present a picture of kava use in the remote NT;

however, they pointed to a growing problem. The fact that some of these references

countered the applicant’s own position suggested that the applicant had not fully

considered these when including them as supporting materials. The following summaries

are from the three Clough papers included in the application as attachments;

• ‘Health effects of kava use in eastern Arnhem Land Aboriginal Community’ (Internal

Medicine Journal, 2003, 33:336-340), examined the links between various health

effects including sudden cardiac arrest and heavy kava use, in a cross-sectional study

within a kava using community in Arnhem Land. Health effects of kava use such as

abnormal liver function, kava dermopathy and decreased lymphocytes were observed

in the study. The author stated, “The general increase in IgE and IgG levels and CRP

reflect the burden of infectious pathogens associated with the continuing

socioeconomic disadvantage of those living in remote Aboriginal communities.

Elevated CRP is increasingly recognized as a marker of risk for cardiovascular

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 136

disease, and the generally high levels of CRP and homocystine across all groups in

this Aboriginal community are of great concern.” Markers for cardiovascular disease

were higher in the indigenous population, but not higher in kava users. In effect the

conclusions drawn in this paper did not support a relaxation of the current restrictions.

• ‘Case-control study of the association between kava use and pneumonia in eastern

Arnhem Land Aboriginal communities Northern Territory, Australia’ (Epidemiol

Infect, 2003, 131, 627-635). Kava, consumed in Arnhem Land since 1982, may be a

risk factor for infectious disease including pneumonia. A case–control study (n=115

cases; n=415 controls) was conducted in 7001 Aboriginal people (4217 over 15

years). Odds ratios were calculated by conditional logistic regression with substance

use and social factors as confounders. Pneumonia was not associated with kava use.

The author found statistically significant associations between pneumonia admission

and alcohol use, cannabis use and with petrol sniffing suggested that the effects of

other substances, or combinations, may compound kava’s effects in ways not yet

understood. He postulated that if Aboriginal people continued to drink kava it would

be prudent for them to moderate consumption even though an association with

pneumonia has not been shown. Again, this paper did not provide evidence to refute

current scheduling arrangements.

• ‘Emerging Patterns of Cannabis and other substance use in Aboriginal Communities

in Arnhem Land, Northern Territory: A study of two Communities’ (Clough, AR,

Menzies School of Health Research and Charles Darwin University, Darwin, NT)

This study examined the effects of a variety of substances including kava, cannabis,

alcohol, tobacco and petrol sniffing. The research focussed on cannabis and made

only brief mention of kava. The conclusion was that action was required to reduce

cannabis use especially in relation to other drugs. The paper did not state a position

on current access arrangements to kava.

In Appendix A of the Supporting Data, the applicant stated that a disproportionate

“amount” of papers on kava had come from Dr Alan Clough during the past 20 years. It

was claimed that because Dr Clough was responsible for this research ‘the body of

research has been skewed’. The applicant made this statement even though fifteen of

Clough’s papers are listed in the supporting evidence section of the application. The

following summaries of other articles listed by the applicant in the bibliography, but not

attached to the application;

• ‘Case-control study of the association between kava use and ischaemic heart disease

in Aboriginal communities in eastern Arnhem Land (Northern Territory) Australia’

(Clough, AR et al, 2004, J Epidemiol Community Health, 58(2): 140-141). Provided

statistical evidence of the potential damage to cardiovascular system caused by

misuse/addiction of kava.

• Letters to the Editor (Clough AR et al, 2006, eMJA, 184 (2):91-92). Alan R Clough

et al wrote to the Medical Journal of Australia (MJA) reporting their concern that the

NT’s introduced regulations for kava supply control were not working (under the

Kava Management Act 1998) in that;

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 137

− Kava licence areas permitted retailers to sell more than double the safe weekly

limit of kava per person

− The illegal trade added perhaps $2 million per annum.

− The social, economic and health effects were unknown in the long term and had

lead to a decline in participation in traditional ceremonies.

− Kava was the psychoactive substance with the greatest impact on the financial

resources of communities and individuals in Arnhem Land.

− Kava’s health effects include seizures and extreme weight loss, resulting in

immunosuppressive effects, possible cardiovascular disease and potential fatal

hepatotoxicity.

The letter recommended that the kava supply and its outlets be reduced, the amount of

kava per person be reduced by half, quantities imported be limited, kava prices be

reviewed, illegal sale of kava be rigorously enforced and that the Kava Management

Act 1998 be reviewed to facilitate the proposed changes. Competing interests: Alan

Clough declared that he had been a member of the Northern Territory Licensing

Commission, the body responsible for licensing kava in the Northern Territory.

• ‘Enough! or too much. What is excessive kava use in Arnhem Land?’ (Clough AR

2003 Drug Alcohol Rev, 22:43-51). The study described parameters for use in

monitoring health, social and economic effects of kava use in Arnhem Land

Aboriginal communities in the Northern Territory. Interview data combined with

health worker assessments were compiled. Kava, supplied illegally, was still being

used in Arnhem Land in 2001-02. In 2000, cases of dermopathy, abnormally low

body mass index, low blood lymphocytes and abnormally high y-glutamyl

transferase, characteristic of heavy use, occurred more frequently with increased kava

use. Acute effects emerged at average consumption levels of from 310-440 g/week of

kava powder. When kava users in one community began to consume it at an average

of 240-425 g/week from mid-1990, 19 per cent of available cash resources were spent

on kava with 11 per cent of cash resources leaving the local community economy.

The proportion of men drinking kava reached 70 per cent and women 62 per cent

from mid-1990, with 20 per cent of the population spending unprecedented amounts

of time (14 + hours/week) in activities where kava was consumed. Their association

with increased kava use suggested that approaches to minimizing harm from its abuse

began with controlling supply. The article supported the banning of kava from

Australia because of the negative health, economic and social effects on indigenous

communities.

• ‘Kava in Arnhem Land: a review of consumption and its social correlates.

Comprehensive Review’ (Clough, AR 2000, Drug and Alcohol Review, 19, 319-328).

The paper stated that the way Aboriginal people drink kava has been confounded by

claims, based on anecdotes of imputed health effects. Anecdotes and comments had

promoted the perception that dosage levels among Aboriginal people were much

greater than in Pacific island societies. This paper reviewed published data about kava

consumption, and evaluated it with respect to information collected from observation

of one Aboriginal community in Arnhem Land where people tended to consume kava

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 138

at a steady tempo; 37 g of kava powder containing around 3800 mg of kava lactones

in 670 ml of water in an hour. The highest levels of consumption in Arnhem Land

had been reported to be up to 900g/week of kava powder with heavy consumers

drinking at least 610 g/week, levels comparable to estimates for Pacific-island

societies. Results of the research included the finding that heavy users of kava in Fiji

may consume over 701 and 1800 g/week, far more than in Arnhem Land. This paper

questioned the anecdotal information that Aboriginal people were high consumers of

kava, and placed their consumption in perspective compared to South Pacific

countries, recommending that assumptions about usage need to be revisited. It did

not support the continuation of the practice of drinking kava in indigenous

communities.

• ‘Brain dysfunction associated with petrol sniffing and kava drinking in Arnhem Land

Aboriginal Communities’ (Cairney, S 2003, unpublished Doctor of Philosophy thesis,

La Trobe University, Victoria). In this article, Cairney reported that despite

collecting data from reportedly the heaviest users of kava in the world, no impairment

in saccade or cognitive function in individuals who were currently heavy users and

had been for up to 18 years, nor in users who been heavy users, but had abstained for

longer than 6 months; had been found. Current and ex-users showed a higher rate of

kava dermopathy, lower body mass index, lowered blood lymphocytes and, in

addition kava users showed elevated liver enzymes. This paper supported the need

for further research into the health effects of kava.

• ‘Saccade and Cognitive Function in Chronic Kava Users’ (Cairney, S 2003,

Neuropsychopharmacology 28). The author’s findings mirrored those of the previous

paper: that current and ex users showed a higher rate of kava dermopathy, lower body

mass index, lowered blood lymphocytes and, in addition kava users showed elevated

liver enzymes. The author concluded that, despite health consequences such as an

increased risk of serious infection, potentially fatal liver damage, and loss of body fat

and dermopathy, these data suggested that chronic kava use caused no disruption to

human saccade and cognitive processes. The paper supported the need for further

research into the effects of kava on liver function.

• Kava extract versus placebo for treating anxiety (Pittler, MH and Ernst, E 2003,

Cochrane Database of Systematic Reviews Issue 1). Compared with placebo, kava

extract was an effective symptomatic treatment for anxiety although, the size of the

effect seemed small. The effect lacked robustness and was based on a relatively small

sample. The data available from the reviewed studies suggested that kava was

relatively safe for short-term treatment (1 to 24 weeks), although more information

was required. The author concluded that trials with large sample sizes and long term

safety studies were needed to clarify the resultant effects of kavas consumption. The

paper’s findings did not provide evidence supporting a rescheduling application.

• ‘Hepatitis associated with Kava, an herbal remedy for anxiety’ (Escher, M &

Desmeules J 2001, BMJ vol.322). This article presented a case reported to the Swiss

Pharmacovigilance Centre in Berne It described the history of a patient, in previous

good health, with no pattern of drug or alcohol use, through a rapid onset of liver

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 139

failure, to a liver transplant. The patient took 3 to 4 capsules of kava extract daily for

2 months, to treat slight anxiety. He presented with jaundice, and dark coloured

urine, and a ‘tanned’ skin colour. The patient's condition deteriorated within 48

hours. He developed stage IV encephalopathy and had to be intubated. This paper

provided evidence to support further clinical studies on effects of kava on the liver

and potential risks of liver disease resulting from kava ingestion are needed.

• ‘The risk-benefit profile of commonly used herbal therapies: ginkgo,St John’s wort,

ginsent, Echinacea, saw palmetto and kava’ (Ernst, E 2002 American College of

Physicians – American Society of Internal Medicine, Annals of Internal Medicine,

136: 42-53). The author provided a clinically oriented overview of the safety and

efficacy of kava and other herbs. He reported that kava was an efficacious short term

treatment for anxiety, but not without side effects. Serious adverse effects had been

reported but seem to be rare. Two post marketing surveillance studies involving more

than 6000 patients found adverse effects in 2.3 per cent and 1.5 per cent of patients

taking 120 to 240 mg of standardized extract. The author reported that problems arose

when kava was self administered and when taken with other medications that act on

the central nervous system or with alcohol. It did not support the potential for kava to

be safely used in indigenous communities.

The applicant disagreed with the findings of the paper ‘Kava and After in the Nhulunbuy

Hinterland’ (Hughes, H 8 October 2007, Issue Analysis, No.88, Centre for Independent

Studies No.88) previously presented to the Committee at the February 2008 NDPSC

Meeting. Members noted that Emeritus Professor Helen Hughes is a senior fellow at the

Centre for Independent Studies in Sydney and had authored papers on economic and

social issues in the South Pacific and Australia. The applicant claimed that the paper by

Hughes was ‘misleading’ in that it cited the WHO as recommending that kava be

available on prescription only.’ In particular the applicant felt that the Committee relied

too heavily on this reference in its February 2008 deliberations.

The Hughes’ paper said:

− “The study found mixed evidence of liver damage from the use of kava in

medications, but WHO recommended that kava products should only be

available on prescription.” (p3)

The WHO paper said:

− “It would seem advisable that all kava products, prepared as pharmaceuticals,

be available on prescription only in order to better monitor the use and apply

necessary controls.” (p5, Recommendations, under Conditions of use)

• The quoted texts purveyed essentially the same meaning, which made the claim of

Hughes’ paper seeking to mislead the reader, spurious to the argument.

• The applicant argued that the paper by Hughes had not addressed 52E. This paper

was written by the researcher on behalf of The Centre for Independent Studies (CIS).

CIS is the leading independent public policy 'think tank' within Australasia. The

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 140

paper was not intended to be an application to the NDPSC. There was therefore no

expectation that it address matters under 52E.

• The Issues Analysis by Helen Hughes was used as a reference by the OCS. Points

made by Hughes were; that the available limit of kava for legal consumption had been

twice the safe limit per week of between 240 g and 400 g per week; that the

interaction of kava with the other drugs of addiction was a known health risk; that due

to the negative social and health outcomes of kava abuse, that the Commonwealth

Government had no choice but to ban its use allowing limited imports for medical and

scientific research and 2 kg per person as accompanied baggage; that commercial

interests in kava promotion were the protagonists of perpetuating the sale of kava in

the NT and Australia wide.

The Committee recalled XXXXX submission considered at the October 2007 NDPSC

Meeting. The submission stated that there was a potential for abuse of the substance and

thus hazards to public health exist if the whole or peeled rhizome of this substance is

exempted from Schedule 4. The following is an overview of the points discussed:

• Kava was found to have the potential for abuse and misuse, resulting in both adverse

health and social hazards in these remote indigenous communities. The previous

exemption from the requirements of scheduling opened a pathway for diversion of

legitimate kava products for illicit purposes in some communities.

• It was stated that it was unlikely that the tablet, capsule or teabags currently listed on

the ARTG would be abused and, thus, the scheduling for these should not be altered.

It was noted that XXXXX supported the proposed change to a Schedule 4 entry for kava.

From June 2006, the previous Australian Government had serious concerns about abuse

of kava in the NT following abuse in remote indigenous communities. Kava was

consumed by some indigenous communities at up to 100 times the usual rate. At least

eight communities in Arnhem Land, comprising about 7,700 people, identified significant

kava use as a problem. Heavy use of kava caused weight loss, malnutrition, liver

damage, hypertension and skin disorders. These health issues represented a real concern

to the then Government and to the jurisdictional health departments. The following

points list the restrictions which came into force under the Australian Customs Service as

a result of the previous Australian Government’s decision to restrict access to kava:

• The importation of kava without a permit issued by the Office of Chemical Safety,

Treaties and Compliance Section, is now an offence under the Customs Act of 1901

and subject to prosecution.

• Consistent with the existing regulations set out in the Customs (Prohibited Imports)

Regulations 1956, the importation of kava is now only permitted for medical or

scientific purposes.

• Importation of 2 kg of dried or root kava per adult is now permitted with

accompanied baggage in recognition of cultural significance of kava use by people of

South Pacific Islander descent.

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 141

• The Customs Act 1901 and Statutory Rules 1956 as amended, contains the listing;

Schedule 4, 112B Kava, Customs (Prohibited Imports) Regulations 1956.

The Committee noted information from Food Standards Australia and New Zealand

(FSANZ). The current status of kava in terms of the FSANZ Food Standard for kava is;

• The Australia New Zealand Food Standards Code (the Code) included a specific

standard for kava i.e. Standard 2.6.3

• FSANZ was aware of recent changes to the SUSDP and to the Customs (Prohibited

Imports) Regulations 1956.

XXXXX

The New Zealand Food Safety Authority (NZFSA) had issued a ‘Privileged Statement’,

under delegated authority from the Director General of Agriculture and Forestry pursuant

to Section 37 of the Food Act 1981, on the 16 August 2002. The statement advised New

Zealanders that they should consider carefully when using dietary supplements

containing kava; following the TGA’s recall of all complimentary medicines containing

kava, after the death of a woman from liver failure. The statement pointed out those

traditional forms of the substance was not associated with serious liver damage, as was

the concentrated form. It was stated that international evidence of adverse reactions to

kava in dietary supplements had resulted in the Minister of Health’s Medicines Adverse

Reaction Committee addressing the issue.

The Committee noted that as this item had not been gazetted, there was no public

comment.

The applicant suggested possible wording, should the Committee have wished to amend

current scheduling.

DISCUSSION – RELEVANT MATTERS UNDER 52E

The Committee agreed that this matter be gazetted before it is considered as per

established process protocols. Thus, the Committee agreed to include this matter in the

pre-meeting Gazette Notice for the June 2009 NDPSC Meeting and to therefore

foreshadow consideration of the scheduling of kava at that Meeting.

RESOLUTION 2009/55 – 25

The Committee decided to foreshadow consideration of the scheduling of kava at the

June 2009 NDPSC Meeting.

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 55 – February 2009 142

12.1.6

Darklight · June 16, 2009

This decision made all kava Schedule 4; except dried whole or peeled rhizome, its aqueous dispersions or extracts, tablets of 125 mg or less of kava lactones per tablet, teabags of up to 3 g kava, and not more than 25 mg of kava lactones per

OK, am not doing long documents without extreme difficulty atm, but does this mean the cold water extract powder would be exempt from scheduling? Have been extremely impressed with it's anti-anxiety reducing qualities during some hard times and would hope that it is available to others who wish to make a qualified choice as to treatment options

And is it too late to make a representation on those same qualities before the next meeting? Again, my apologies if this is redundant and I've missed something posted above or avail elsewhere. Is it even worth me putting in a submission as an individual who has benefited from availability?

FWIW- recommended dose where legal- Klin Kava cold water extract- cap it up into 000's and take 1-3 in the morning when it looks all too hard. Take another one or two during the day. Don't drink alcohol within 6 hours also works for me. Take as required situationally, rather than regularly

Teotzlcoatl · June 16, 2009

Holy shit the get technical with it!

piper678 · August 5, 2009

This decision made all kava Schedule 4; except dried whole or peeled rhizome,

No. Now kava roots (techincally not a rhizome) are Scedule 4, unless people on this board can help out.

I am only one person and had put in one submission to overturn this, it delayed the inevitable for quite a while, but more support is now, urgently, needed. There is only until August 19th to register a flood of protests.

If anyone wants to actively do something, details below and I can always be contacted if more information is required.

Members generally agreed that the submission had not established a case for overturning

the previous decision to restrict access to kava products. A Member noted that support

for Pacific Island economies was not a relevant consideration under section 52E.

RESOLUTION 2009/56 - 10

The Committee decided that the current scheduling for Piper methysticum remains

appropriate.

From http://www.tga.gov.au/ndpsc/record/rr200906.pdf

1. POST-JUNE 2009 NDPSC MEETING GAZETTE NOTICE

The post-meeting gazette notice for the June 2009 meeting of the NDPSC is now available on the NDPSC website. Please note that interested parties have until close of business on 19 August 2009 to lodge post-meeting public submissions with the Secretariat in relation to the scheduling changes listed in Part A or B of the post-meeting gazette notice.

Follow this link to access the post-meeting gazette notice for the June 2009 meeting of the NDPSC.

http://www.tga.gov.au/ndpsc/ndpscgan.htm

Thelema · August 7, 2009

For those who can't find it [it's not in the post-meeting record, it's in the reasons, at the wrong page]:

also, piper, if you are the only one who made a pre-meeting submission, then you said this, and I quote:

"Only one pre-meeting submission was received. XXXXX supported the current

scheduling due to public health and safety issues. It also fully supported the World

Health Organisation (WHO) position that kava be a prescription substances in order to

better monitor its use and to apply necessary controls."

Why would you support full prescription of the substance?

11.5 PIPER METHYSTICUM (KAVA)

PURPOSE

The Committee considered the scheduling of Piper methysticum (kava).

BACKGROUND

The active ingredients of kava are kavalactones (or kava pyrones) which are

pharmacologically active compounds naturally present in the kava plant. Nineteen

kavalactones have been isolated from the kava root, of which six are the major

constituents of kava (kawain, dihydrokawain, methsticin, dihydromethsticin yangonin,

and demethoxyangonin). The kavalactone content varies from 3 to 20 per cent dry

weight, even within the same subspecies.

Kava’s primary action is as a mild sedative. Other actions include local anaesthesia of

the mouth and tongue, analgesia, ocular effects, anticonvulsive effects and antimycotic

properties. It has been reported as an effective anti-anxiety treatment.

At the October 2003 meeting, the Committee noted a report prepared by the Kava

Evaluation Group from the TGA’s Office of Complementary Medicines on kava

containing medicines and decided there was a need to restrict the use of alcohol/acetone

extracts of kava, including those for bulk supply to health care practitioners, due to the

potential risk of liver toxicities.

At the June 2004 meeting, the Committee agreed to include kava in Schedule 4, as well

as adopting exemptions as specified in the TGA Regulations 1990. The decision made all

kava Schedule 4 except dried whole or peeled rhizome, its aqueous dispersions or

extracts, tablets of 125 mg or less of kavalactones per tablet, teabags of up to 3 g kava,

and not more than 25 mg of kavalactones per dose.

At the February 2008 meeting, in light of an Australian Government kava policy

decision, the Committee reconsidered the restrictions for kava and concluded that the

potential for abuse and the hazard to public health of the whole or peeled rhizome meant

that this form of kava should no longer be exempt from scheduling. The Committee

therefore amended the Schedule 4 entry so that only some products on the ARTG were

not captured.

At the February 2009 meeting, the Committee noted a request from XXXXX that kava be

rescheduled to its pre-February 2008 status. The Committee noted that this matter had

not been gazetted. Members expressed concern that the public had not had the chance to

make a comment. The Committee therefore agreed that the issue be foreshadowed for

consideration at the June 2009 Meeting to allow gazettal and public comment.

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 56 – June 2009 68

DISCUSSION - SUBMISSIONS

Pre-meeting Submission

Only one pre-meeting submission was received. XXXXX supported the current

scheduling due to public health and safety issues. It also fully supported the World

Health Organisation (WHO) position that kava be a prescription substances in order to

better monitor its use and to apply necessary controls.

February 2009 submission

The Committee particularly recalled the following from the XXXXX submission:

(a) Toxicity and Safety

• LD50 of kava resin given by intra peritoneal injection to mice, rats and rabbits ranged

from 300 to 4000 mg/kg. With oral administration the LD50 in mice was 920 mg.

Doses of 50 mg dihydromethysticin, administered 3 times a week to rats produced no

evidence of chronic toxicity, however attempts to duplicate the findings have had

limited success. The applicant claimed that clinical trials of kava have not revealed

any hepatoxicity, but also state that ‘kava has a tendency to have a toxic effect on the

liver’.

( Risks and Benefits

• Kava is used traditionally to treat anxiety, sleep disorders and other complaints. The

applicant claimed that kava lactones have been shown to affect a range of

neurotransmitter systems, and that they have ‘dose dependent effects on the central

nervous system, including anti-epileptic properties’.

• The applicant claimed that the WHO has found only two reports of possible adverse

reactions to kava use. The applicant claimed that this figure was out of over ‘12

billion discreet doses prepared in the traditional way over 20 years’ (the source for

this figure was not cited). The applicant also claimed that when kava was taken in

doses from 100 to 210 mg of kava lactones per day the users had few adverse

reactions. Adverse reactions included kava dermopathy of the hair nails and skin,

rare allergic reactions including hearing loss and anorexia and possible

extrapyramidal side effects such as involuntary oral and lingual reflexes and twisting

movements of the head and trunk.

• The applicant reported that liver function tests could be elevated after 3 to 8 weeks of

use, and may be followed by hepatomegaly; that kava can exacerbate hepatitis, but

that this spontaneously resolves on cessation.

(d) Extent and Patterns of Use

• The traditional use of kava was described and the inappropriate use of kava by NT

remote indigenous communities was mentioned.

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 56 – June 2009 69

(e) Dosage and Formulation

• Aqueous extract/suspension consumed in 100 mL measures.

(f) Need for Access

• The applicant claimed that the scheduling of kava denied Australians of Pacific

Islander origin their traditional and cultural use of kava.

− The Committee noted that the ban was imposed by Customs on all kava imports,

except those under medical or scientific research licence.

• The applicant claimed that kava’s closest alternative was alcohol with its related antisocial

behaviour and associated health risks and that no deaths have been attributed to

kava consumption.

• Fewer than 350 people in the NT have been identified as being at risk of abusing

kava.

• The applicant reiterated the argument that the number of abusers of kava was

‘insignificant’ that it was not right to restrict the use of kava for others.

(h) Purpose for which the substance is to be used

• The applicant reiterated the original use of the substance in the Pacific Islands.

Additional Matters: – Economic and Trade Considerations

• The applicant reported that kava is a primary cash crop for Vanuatu, Tonga and

Samoa, accounting for up to 30 per cent of their GDP, and infer that the ban imposed

by Australia may influence other countries to ‘harmonise’ their policy to kava in line

with Australia’s. It was noted that Australian is a signatory to the Agreement on

Technical Barriers to Trade (World Trade Organisation), and may be subject to legal

challenges (from kava producing countries) to remove technical barriers to the kava

trade.

The application included an extensive bibliography, including fifteen articles by Alan

Clough. The articles were selected to present a picture of kava use in the remote NT.

Members noted that some of these references actually appeared to argue against the

applicant’s position. The following summaries are from the three papers included in the

application as attachments:

• Clough, AR 2003, ‘Health effects of kava use in eastern Arnhem Land Aboriginal

Community’, Internal Medicine Journal, vol 33, pp. 336-340: examined the links

between various health effects including sudden cardiac arrest and heavy kava use, in

a cross-sectional study in Arnhem Land. Health effects such as abnormal liver

function, kava dermopathy and decreased lymphocytes were observed. The author

stated ‘the general increase in IgE and IgG levels and CRP reflect the burden of

infectious pathogens associated with the continuing socioeconomic disadvantage of

those living in remote Aboriginal communities. Elevated CRP is increasingly

recognized as a marker of risk for cardiovascular disease, and the generally high

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 56 – June 2009 70

levels of CRP and homocystine across all groups in this Aboriginal community are of

great concern. Markers for cardiovascular disease were higher in the indigenous

population, but not higher in kava users’.

• Clough, AR 2003, ‘Case-control study of the association between kava use and

pneumonia in eastern Arnhem Land Aboriginal communities Northern Territory,

Australia’, Epidemiol Infect., vol 131, pp. 627-635. Kava, consumed in Arnhem Land

since 1982, may be a risk factor for infectious disease including pneumonia. The

author found statistically significant associations between pneumonia admission and

alcohol use, cannabis use and with petrol sniffing suggested that the effects of other

substances, or combinations, may compound kava’s effects in ways not yet

understood. He postulated that if Aboriginal people continue to drink kava it would

be prudent for them to moderate consumption even though an association with

pneumonia has not been shown.

• Clough, AR, ‘Emerging Patterns of Cannabis and other substance use in Aboriginal

Communities in Arnhem Land, Northern Territory: A study of two Communities’.

This study examined the effects of a variety of substances including kava, cannabis,

alcohol, tobacco and petrol sniffing. The research focussed on cannabis and made

only brief mention of kava. The conclusion was that action was required to reduce

cannabis use especially in relation to other drugs.

Members also recalled that in the applicant’s supporting data, it was claimed that a

disproportionate ‘amount’ of papers on kava have come from Dr Clough during the past

20 years. It was claimed that because Dr Clough was responsible for this research, ‘the

body of research has been skewed’. The following are summaries of other relevant

articles listed by the applicant in the bibliography, but not attached to the application:

• Clough, AR et al., 2006, ‘Letters to the Editor’, eMJA, vol 184 (2), pp. 91-92. Clough

and colleagues reported their concern that the NT’s introduced regulations for kava

control (under the Kava Management Act 1998) were not working in that:

− Kava licence areas permitted retailers to sell more than double the safe weekly

limit of kava per person.

− The illegal trade added up to perhaps $2 million per annum.

− The social, economic and health effects were unknown in the long term and had

lead to a decline in participation in traditional ceremonies.

− Kava is the psychoactive substance with the greatest impact on the financial

resources of communities and individuals in Arnhem Land.

− Kava’s health effects include seizures and extreme weight loss, resulting in

immunosuppressive effects, possible cardiovascular disease and potential fatal

hepatotoxicity.

− The letter recommended that the kava supply and outlets supplying kava be

reduced, the amount per person be halved, quantities imported be limited, kava

prices be reviewed, illegal sale of kava be rigorously enforced and that the Kava

National Drugs and Poisons Schedule Committee

Record of Reasons of Meeting 56 – June 2009 71

Management Act 1998 be reviewed. Clough also disclosed that he had been a

member of the NT Licensing Commission, the body responsible for licensing

kava in the NT.

• Clough, AR, 2003, ‘Enough! or too much. What is excessive kava use in Arnhem

Land?’, Drug Alcohol Rev, vol 22, pp. 43-51. The study described parameters for use

in monitoring health, social and economic effects of kava use in Arnhem Land

Aboriginal communities in the Northern Territory. Interview data combined with

health worker assessments were compiled. Kava, supplied illegally, was still being

used in Arnhem Land in 2001-02. In 2000 cases included dermopathy, abnormally

low body mass index, low blood lymphocytes and abnormally high y-glutamyl