EXPERT ADVISORY COMMITTEE ON DRUGS
Thursday 3 May 2007, 9.30am – 2.30pm
Terrace Room 3, Terrace Conference Centre, Level 2, St John House,
114 The Terrace, Wellington

    EACD MEMBERS PRESENT

Dr Ashley Bloomfield
Dr Geoffrey Robinson
(Chair)
Dr Helen Moriarty
Professor Doug Sellman
Dr Keith Bedford
Adrienne Fruean
Paul Campbell
Rajesh Chhana

EACD SECRETARIAT PRESENT

Olivia Tuatoko
Martin Woodbridge
Bruce Atmore
Mark Heffernan

INVITED GUESTS/EXPERTS

Win van der Velde
Dave Potaka
Una Jagose

1 & 2 WELCOME AND APPOLOGIES

Apologies were received from Clinical Associate Professor Tim Maling and Gavin Jones.
Rajesh Chhana gave apologies for lateness.

Acting Assistant Commissioner Gavin Jones has been appointed as the New Zealand
Police representative on the EACD.  Detective Superintendent Win van der Velde
attended the meeting on behalf of Commissioner Jones.

Dave Potaka, Detective Senior Sergeant from the National Drug Intelligence Bureau and
a member from Crown law also attended the meeting. The Crown Law representative
provided legal  advice  on the issues considered by the EACD during its discussion of
BZP.

3.  DECLARATION OF CONFLICTS OF INTEREST

Dr Geoffrey Robinson advised the Committee that he is employed by for the Medicine
Research Institute of New Zealand (MRINZ)  and was involved  with the study “The
benzylpiperazine (BZP) / trifluoromethylphenylpiperazine (TFMPP) and alcohol safety
survey” Thompson et al (2006), Medicine Research Institute of New Zealand (MRINZ).

Dr  Helen  Moriarty  also advised that she was an external advisor for the study “Legal
Party Pil s and their use by young people: summary report of findings” Sheriden and
Butler (2006), University of Auckland.

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The Committee considered that Dr Moriarty posed no conflict of interest, and agreed that
Dr Geoffrey Robinson should  step down from the discussion on  the  MRINZ  research
project.

4.  MINUTES OF THE EACD MEETINGS:  29 NOVEMBER 2006 & 15 FEBRUARY 2007

The minutes  from the 29  November  2006 meeting were  confirmed  as a true and
accurate record of that meeting.  The minutes are currently on the National Drug Policy
website.

The minutes from the 15 February 2007 meeting were confirmed as a true and accurate
record of that meeting. The minutes are currently on the National Drug Policy website.

The Committee agreed to wait until the Minister has received advice before the Minutes
of this meeting are placed on the website.

5.  MATTERS ARISING

5.1    Report on Actions Arising from the 29 November 2006 EACD Meeting

Please refer to the minutes of the 29 November 2006 EACD meeting.

5.1.2 General Business – Indan(e)s and Aminoindan(e)s. Item 5.4
Issue:  Secretariat to provide an assessment of indan(e)s and aminoindan(e)s for
discussion at a future meeting.

Outcome: This topic is not on the current agenda as the National Drug Policy team’s
resources  had been directed towards preparing the BZP  update and additional
documents.  However, indan(e)s and aminoindan(e)s wil  be considered by the
Committee under agenda item 9 when members review the list of substances scheduled
to be discussed at future meeting dates.

5.1.3 General Business – Thalidomide. Item 5.5

Issues: Secretariat to prepare a paper for the Committee on Thalidomide for discussion
at a future meeting.

Outcome: Thalidomide is to be discussed under agenda item 9.

5.1.4 BZP Update. Item 6

Issue: Implications of classifying BZP as a Class C1 controlled drug in the Misuse of
Drugs Act 1975 on enforcement agencies and also the potential for increasing controls
through the implementation of regulations.



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Discussion:  One  Commit ee  member expressed disappointment at  not  being able to
attend the meeting held on 29 November 2006. He was surprised that the Committee felt
the pressure to make a conclusion on partial data. Now that the EACD recommendation
from the 29 November meeting  has been made public, this member believed  that  it
would be difficult for the Committee to re-consider their recommendation.

The Chair advised that the Committee will be reviewing the 29 November 2006 EACD
recommendations  at the current meeting, along with additional information.  The Chair
commented that the Committee wil  need to ensure that the process used to formulate
the advice is robust.

The Commit ee agreed that there was no pressure to make a recommendation at the 29
November 2006 meeting,  even thought there was plenty of public interest. The
Committee also considered that there were a variety of issues that led the Committee to
make their recommendations. Members were aware that the current status quo was not
acceptable and therefore the main options were further regulation or classification as a
controlled drug.

5.1.5 UK Criteria on Drug Scheduling. Item 9
Issue: It was agreed that the Secretariat would revise this paper for consideration at the
3 May 2007 EACD meeting to include information on the Australian Risk Management
standards.  The UK publication “Drug classification: making a hash of it?” would also be
made available to EACD members.

Outcome:  This will be considered under agenda  item  8:  Rational  drug classification
systems.

5.1.6 Zopiclone. Item 10
Issue: The Committee agreed to maintain a watching brief regarding any updates on the
classification of zopiclone by the World Health Organization.  It was agreed that no
further action would be taken to recommend the classification of zopiclone under the
Misuse of Drugs Act 1975 in New Zealand at this stage. The Chair was to inform the
Minister and the Secretariat to write to manufacturers and inform them that no further
action wil  be taken.

Outcome: Chair has informed Minister that the EACD advised that no further action is
required. The Secretariat has advised manufacturers of this outcome.

5.1.7 Legal Status of 2C-T-7. Item 11
Issue:  That the Commit ee recommend to the Minister that the definition of
amphetamine analogues in Schedule 3, Part 7 of the Misuse of Drugs Act 1975 be
amended to include “and/or alkylthio radicals” after “alkylamino radicals”.  It was agreed
that the recommended amendment would be brought to the attention of the Minister for
his direction on appropriate legislative action.

Outcome: This was brought to the attention of the Minister.

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5.1.8 General Business – Gateway Theory. Item 12
Issue:  It was agreed that the Secretariat  would  provide the EACD with a paper
summarising evidence on the gateway theory, drawing in particular on work conducted in
the UK.

Outcome: The Committee was interested in commissioning someone to undertake this
piece of work for future EACD consideration.  The Secretariat would investigate options.

5.1.9 Next Meeting. Item 13
Issue: Dr Robinson would provide a copy of his paper assessing alcohol against the
EACD criteria for the information of EACD members at the next meeting.

Outcome:  The paper wil  be considered by the Committee under agenda Item 7:
Assessment of alcohol harm.

5.2  Report on Actions Arising from the 29 November 2006 EACD Meeting

5.2.1  Discussion on options for the presumption for supply of BZP and related
piperazines. Item 4
Issue: The EACD would recommend five grams or 100 tablets, capsules, or other drug
forms each containing some quantity of the drug as the level for the presumption for
supply of BZP, phenylpiperazine and related substances in Schedule 5 of the Misuse of
Drugs Act 1975.

Outcome:  A summary of the EACD discussion  has been approved  by members and
advice has been provided to the Associate Minister of Health.

6.  BZP

Issue: The Committee was to review and determine what additional advice the EACD
might want to give to the Minister in light of receiving further documents relating to BZP.

Background:  On  4  December 2006, the EACD provided the Minister with their
recommendation to classify BZP and related substances as Class C1 controlled drugs
under the Misuse of Drugs Act 1975.  The Minister announced this advice in December
and a public consultation on this proposal closed on 23 March 2007.

Two of the key studies that informed the Committees discussion during the 29 November
meeting have since been peer reviewed. There was also a review on the MRINZ study
that was commissioned by the Social Tonics Association of New Zealand by two leading
Australian commentators on drug issues. This review has been given to MRINZ for a
response.
The Committee noted that  the studies reviewed by the Committee used the term
seizures to refer to anything from a small twitch to a grand seizure. Members agreed
that this term was too broad and that some studies did not explain if the seizures were
experienced because of withdrawal effects.  However, it  was also noted that the Gee
paper had clearly documented three grand mal-type seizures.

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Reference:  Peer Review  of the study entitled:  The benzylpiperazine (BZP) /
trifluoromethylphenylpiperazine (TFMPP) and alcohol safety survey by Thompson et al
(2006) from the Medical Research Institute of New Zealand.

This study has been peer reviewed by Andrew Jull, University of Auckland,  Associate
Professor Michael Dawson, & Dr Alex Wodak, accessUTS, University of Technology,
Sydney

Dr Robinsons  stepped down from the discussion but remained present in the
room to clarify issues as they arose.
Discussion: One Commit ee member noted that the MRINZ study was not a study
designed to look at the side effects of BZP. Its purpose was to look at  driving
performance under an intoxicating dose of BZP with or without alcohol  and the study
results  should be used to inform the primary goal  of the study.  With regards to side
effects, the Commit ee member commented that the researchers  were  right to
discontinue the study when they  did,  and that the Committee should take into
consideration that in the members view, the side effects were most likely heightened as
participants endured at least 6 hours of fasting and the substance was taken when it is
not normally taken. The Committee noted a discrepancy that needed to be explained
between the subjects’  prior experiences when taking BZP in comparison to  their
experiences under the study’s circumstances.

The Committee’s interest in and response to this research was because the study was a
randomised controlled trial, and the pattern of adverse events were seen entirely in the
group that took BZP.  The  Committee assumed that the  randomisation  process was
designed to minimise  differences between the participant  groups  who did and did not
consume BZP.  The trial clearly showed a difference between the groups in the rates of
adverse events. However, some Commit ee members agreed that the effect of an empty
stomach and possibly  caffeine  withdrawal  may  have  brought a  heightened  sensitivity
and reaction to the ingestion of BZP.
The  Committee  noted that the level of side effects reported from the participants’
previous use of BZP  was  consistent with other studies, with the most significant
symptoms including a dry mouth, loss of appetite, nausea, and palpitations.

The SHORE study “Legal party pil  use in New Zealand: Prevalence of use, availability,
health harms and ‘gateway effects’ of benzylpiperazine (BZP) and
trifluoromethylphenylpiperazine (TFMPP),  and Auckland University study “Legal Party
Pil s and their use by young people: summary report of findings” showed users reporting
similar effects at a high rate. The Committee noted that some of the participants who
experienced side effects during the study reported that their symptoms were much worse
than they had experienced previously and considered these symptoms quite debilitating.

Members discussed the small sample size of only 16 people in the intervention group.
As a research cohort this is a small number and this issue was raised by one of the peer
reviewers.  Overall, the reviewer was very critical of the study  and some of the issues
raised in the review were unanswered by the authors of the study.

The Committee discussed the potential risk of harm from BZP, noting that people who
take BZP tablets  to get a ‘quick buzz’  wil  increase the amount of BZP taken in one
session if they do not obtain  the effect they were wanting with one dose. One member

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noted that there has been a reduction in BZP-related hospital admissions and reports of
decreased sales of BZP.  Following the release of the EACD advice documenting safety
issues.

One member, who hadn’t been able to attend the November EACD meeting, expressed
the opinion that the Committee placed too much emphasis on the finding of the MRINZ
study. The members view was that stopping the trial early, because of the harm to the
subjects, may have created an emotional  overtone  that influenced the Committee’s
decision.

Other members stated this study was not the catalyst for the decision nor did it dominate
the thinking of the group,  but  it  was a significant study that deserved an  appropriate
amount of consideration along with other evidence.

The Committee discussed the dosage given to subjects for the study and agreed that
this  was not an unreasonable amount, based on the doses  recommended by the
manufacturers and the user reports.

References:  Theron et al (2007) “Benzylpiperazine based party pil s’ impact on the
Auckland  City hospital  emergency Department Overdose database (2002-2004)
compared with ecstasy (MDMA or methylenedioxymethamphetamine), gamma-
hydroxybutyrate (GHB), amphetamines, cocaine, and alcohol”.

Discussion: The Commit ee discussed this study and found it very interesting; it also
received publicity when released. The description of cases and co-ingestants  was
slightly variable and there were slightly lower rates of co-ingestant use than shown in the
SHORE study. The study reported only one BZP-related  hospital admission, although
this was not serious.

Committee members made the following observances. Firstly, BZP was deemed to be
the  main cause of hospital admissions,  although no prior checks were done on the
people that were administered before the study to know if the patients were heavy takers
of BZP prior to being admit ed. Secondly, it was unclear if the increase of presentations
to the emergency department over the 3 years was because of the use of party pills or
because clinicians’ maybe more aware of BZP.. Thirdly, the study showed that the use
of alcohol and amphetamine-related hospital admissions have been steady, which does
not fit with the theory that BZP should be replacing amphetamines as a stimulant. Lastly,
there was a lack of toxicology data in this study.

Reference: ESR Testing of “Torque”

Discussion: The Committee noted that “Torque” contained a relatively low level of BZP.
It was also noted that there have been no  deaths in New Zealand or internationally
related to the use of BZP without other substances.

Reference: Consumer Link Survey (2007) Comparative risks of legal party pil s, alcohol
and il egal drugs.

Discussion:  The  Commit ee discussed the Consumer Link Survey  commissioned by
STANZ,  which surveyed 200 young New Zealanders on  a range of issues related to
BZP. Members found it hard to place the findings without knowing full details of the
methodology.

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Reference: Analysis of Submissions

Discussion:  The Commit ee noted that  one of the key concerns raised from the
analysis of submissions was the potential for BZP use to lead to permanent damage but
the analysis does not provide any evidence that would support this hypothesis.  There
have been no reported BZP related deaths, or evidence of date rape. The Committee
noted that BZP could lead to harm if taken with illicit drugs and/or alcohol, and poses a
particular risk of harm if taken on an empty stomach or if the person who takes it has
schizophrenia.

The Committee discussed the difficulty of ensuring the quality  of BZP products. If
regulations were  strengthened,  then the quality of the products would be assured, as
long as monitoring was in place.  Ironically, food has to be known to be safe before it is
marketed and Members felt that there should also be an obligation on BZP importers to
prove that the product does not pose a risk of harm to the public.  Some submissions
requested a ban on BZP sold in powder form.

The Committee discussed the use of BZP as an alternative to other illicit drugs, noting
that the analysis of submissions showed  that  some users  state that they use  BZP
instead of Methamphetamine. One Commit ee member noted that the majority of heavy
il icit drug users would not contemplate using BZP as an alternative. With regards to
moving to a stronger substance from BZP, the submissions suggested the shift more
likely towards ecstasy rather than methamphetamine.

Some submitters considered that the EACD relied on research where the researchers
could be viewed as having been compromised by the need to bid for funds or having a
conflict of interest because of funding source.

A submission that requested a public representative  on the EACD  was discussed.
Members noted that the public can comment on EACD discussion once the Minutes of
meetings has been placed on the NDP website. Any change to the framework of the
committee would have to go through the Minister as the EACD is a statutory body.

The Commit ee raised other matters for consideration to be placed in the advice to the
Minister, these included;
•  reports of an apparent reduction in use of BZP, reflected by the decline of number of
cases presenting to Christchurch hospital, where there is a high degree of awareness
of this substance.
•  issue of the il egal drug market and the combination of substances in tablets and
capsules appearing, although no evidence to date that legal party pil  retailers are
selling products with il egal substances in them.
•  manufacturers seeking  to market alternative products that aren’t captured by a
classification if a decision is made to classify BZP.
The Committee noted that Piperazine has been defined in the United Kingdom as a
medicine. There has been an issue with importation into the UK, as it was not effectively
controlled (although classified as a medicine), and UK suppliers were using New
Zealand addresses to supply UK consumers ordering over the internet.

A Committee member noted that of greater interest than how the drug is accessed and
abused by users is who the target user group is. None of the studies asked the user why

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they took BZP.  This member considered that once  this question  is answered further
problems may be able to be solved.

The committee revisited the previous recommendations given to the Minister to see if
any changes needed to be made now that further evidence was given. The Committee
agreed that the conclusions from November meeting will stay substantially the same but
some of the details should be changed.  These changes were agreed, and are reflected
in the recommendations.

Recommendation: The Committee noted  that BZP creates dependence in  very few
people.  Once taken,  some users no longer wanted  to take it again.  As users usually
take an overdose of substances such as BZP when they have their judgement impaired,
usually by alcohol.

The Committee noted placing responsibility for proving safety on those supplying these
substances in New Zealand is key to progress efforts to take a measured and evidence-
based approach to drug classification and, importantly, reducing drug-related  harm.
This would require legislative change separate from any decision about scheduling BZP

Having discussed the new information available, the Commit ee reconsidered the
recommendations contained in its December 2006 advice to the Minister. As in earlier
discussions, there were different views among Committee members as to the potential
risk of harm posed by BZP.  Two Committee members considered that BZP poses a low
risk of harm.  A further Commit ee member considered that BZP poses a low-to-
moderate risk of harm. Five Commit ee members present at this meeting held the view
that BZP poses a moderate risk of harm.  The two Committee members unable to attend
this meeting and who attended the November 2006 meeting held the view at that time
that BZP poses at least a moderate risk of harm.

7.  Assessment of alcohol harm

Reference:
Should Ethanol be scheduled as a Class B1 drug under the Misuse of Drugs Act (1975)
in New Zealand? D Sellman JD, Robinson GM, Beasley R, National Addiction Centre,
University of Otago and Medical Research Institute of New Zealand.
  Issue:  This paper provided an analysis and discussion of the harms of ethanol by
utilizing the nine criteria used by the EACD in considering new and potentially harmful
substances. This paper was written to make people aware of ethanol and its harms.
  Discussion: The paper has been submitted for publication.

Outcome:  Paper was noted by the Committee

As the meeting ran over time Items 8 and 9 wil  be discussed at the next meeting,
the Chair thanked members for their attendance and closed the meeting.

10:   Dates of Future EACD Meetings

The date for the next EACD meeting was confirmed to be held on Thursday 28 June 07.

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