ITEM 6
ADVICE TO
THE EXPERT ADVISORY COMMITTEE ON DRUGS
ON:
An overview of BZP
May 2007
Executive Summary
This paper provides members with further documents relating to BZP. These
documents provide an opportunity for the Commit ee to review and determine
what additional advice the EACD might want to give to the Minister in light of
such developments.
Background
BZP was considered by the EACD in a previous meeting held 29 November
2006. The Committee reviewed a number of documents and gave advice to
the Associate Minister of Health that evidence now indicated BZP posed a
‘moderate risk of harm’ and BZP, phenylpiperazines and related substances
would be appropriately classified as class C1 drugs in the Misuse of Drugs
Act 1975.
The Minister announced this advice in December and a public consultation
closed on April 23. The Ministry of Health has analysed these submissions
and a draft report of this analysis is enclosed. Also enclosed are peer reviews
of the studies by The Medical Research Institute of New Zealand and the
University of Auckland as well as new research by Theron et al, Consumer
Link and results from the ESR’s testing of “Torque.”
Papers
1. 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”.
This research (Attached) reviewed Auckland City Hospital’s Emergency
Department’s overdose database for the years 2002, 2003 and 2004, for
‘herbal ingestions’ and ‘party pills.’ The study compared the number of
presentations for BZP based ‘party pil s’ to the number of presentations for
alcohol, and also the il icit drugs MDMA, GHB and cocaine. The study
recorded one BZP presentation in 2002 (0.07% of total overdoses), 4 BZP
presentations in 2003 (0.29% of total overdoses) and 21 BZP presentations in
2004 (1.58% of total overdoses). Data is not currently available for
presentations during 2005 and 2006.
The study shows an increasing trend of BZP related hospital presentations as
would be expected with an increasing prevalence of BZP use. Of note
however is that even in 2004 when the highest number of presentations was
recorded, the presentation rate (1.58%) was still considerably lower than
alcohol (60.87% of total overdoses), GHB (6.4% of total overdoses) and
amphetamines (3.69% of total overdoses). The authors of the study note that
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“With a consumption of 200,000 tablets/month, a presentation of 21 patients
to the emergency department in a year [2004] is relatively small.”
The authors also note that of those presenting for a BZP related condition, the
most common symptoms were anxiety, palpitations, nausea, and vomiting
and that 38% of those presenting required only reassurance, 46% were
treated with IV fluids and 23% were given diazepam for anxiety. While data
was not given for the treatment requirements of other drugs it might be
assumed that more intensive methods would have been required for treating
adverse reactions to such substances.
The authors of this study note that their findings contrast that of Gee et al
(2005), where presentations to Christchurch hospital appeared to be more
common and threatening. With 15 out of 60 people suffering ‘toxic seizures’
as a result of ‘party pil ’ use. An explanation for this discrepancy is offered
that Auckland city retailers and manufacturers of ‘party pil s’ are/were more
likely to adhere to the voluntary code of practice provided by STANZ than
those in Christchurch. STANZ members self regulate to a maximum of
200mgs per dose. The Committee has previously noted products with up to
500mgs of BZP per pil /capsule commonly available in Christchurch.
STANZ has submitted on the proposed classification of BZP and related
substances, noting that this research puts into context the Christchurch
reports and indicates a low risk of harm. STANZ has also alleged that the
adherence by Auckland city distributors to a code of practice including limiting
BZP to 200mgs per pil /capsule justifies the discrepancy in presentations and
harms between Auckland and Christchurch hospitals and evidences this
argument as a basis for further regulation, rather than classification under the
Misuse of Drugs Act 1975.
Dr Chris Wilkins, SHORE, Massey University was approached to provide
analysis on harms between Auckland and Christchurch using data from the
National Household Survey 2006. Due to restrictions in sample size it was
considered unfeasible to compare responses from the two cities and instead a
comparison was made between the North and South islands. It was found
that:
•
Statistical analysis did not suggest South Islanders were more at risk
than north islanders
•
There were differences between the islands in terms of the ‘party pil ’
most commonly used; “Charge” was the most popular product in both
islands while “Kandi” was the second most popular in the North and
“Frenzy” in the South.
•
North Islanders (16%) were more likely to have used party pills in the last
year than South Islanders (12%)
•
There were no differences between the islands in terms of having used
‘party pills’ for 24 hours or more continuously, the amount of pil s used on
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a typical occasion and the greatest amount of pil s used on a single
occasion.
•
There were no differences in the average potency of ‘party pills’ between
the islands
•
The analysis did not indicate there was any difference between the
islands in terms of experiencing negative events through the use of ‘party
pills.’
Initially these statistics show little variation in use and harms between the two
islands. However, the Ministry understands that a more popular product in
the North Island (“Kandi”), is a STANZ product, while the more popular
product in the South Island (“Frenzy”) is not. When the Ministry arranged for
testing of “Kandi” it was found that the level of BZP did not deviate above the
stated dose of 90mgs. “Frenzy,” however, stated 85mg of BZP but the actual
quantity found ranged up to 157mgs.
The EACD has previously expressed concern in regard to the robustness of
the results of this testing which were undertaken by the pharmaceutical
division of ESR, therefore the results in this paper may need to be treated with
caution. However when taken at face value the testing indicates that STANZ
members are producing more consistent products. While the data above note
that there were “no differences in the potency of the pil s between the islands”,
the deviation between stated content and actual content of a product may
result in South Islanders taking a larger dose of BZP than North Islanders,
due to discrepancies in the manufacturing between two prominent products in
each island.
2. ESR Testing of “Torque”
There has been recent heightened media interest in BZP related harm
concerning the admission of Greymouth ‘disk jockey’ Ben Rodden to
Christchurch hospital after he collapsed at a dance party. It was initially
alleged that Mr Rodden had consumed a BZP based ‘party pil ’ called ‘Torque’
and that this ‘party pil ’ may have been the cause of his collapse. There was
also speculation in the media that the ‘party pil ’ may have contained
controlled substances such as MDMA. The Ministry of Health contracted ESR
to test a sample of ‘Torque’ for the presence of illicit substances, and also to
assess the consistency of BZP levels between doses of the product. Results
from the testing which are attached to this paper indicated that “Torque” did
not contain any il icit substances and the BZP content was low with a range of
20-40mgs per pil . The ESR also noted that there were comparatively very
high levels of caffeine present although were unable to quantify this finding.
3.
Consumer Link survey (2007) Comparative risks of legal party pil s,
alcohol and il egal drugs.
This study commissioned by STANZ employed a survey of 200 individuals
aged between 18 and 29 years with 60% of responses received from
Auckland, 20% of responses received from Wel ington and 20% of responses
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received from Christchurch, New Zealand. The rational for the survey was to
contrast adverse effects from ‘party pills’ with that of alcohol and il icit drugs.
Key findings from the survey allege that ‘party pills’
•
produce fewer adverse health effects than alcohol
•
are less likely to result in physical injury
•
are much less likely to provoke aggressive behaviour
•
are not identified with traffic accidents
•
create far fewer issues of dependency of loss of control.
When interpreting these findings it may be appropriate to consider the
possibility of bias or leading questions. Firstly this survey concludes that
‘party pills’ produce fewer adverse health effects than alcohol. This appears
to be cantered around an analysis of questions relating to vomiting, memory
loss, physical injuries and visits to accident and emergency. The survey does
not take into account the possibility of seizures as noted by Gee et al (2005)
going unnoticed, nor does it consider that despite party pil s being legal, they
are stil stigmatised and viewed unfavourably by some. As such,
presentations to hospital or even admit ance of harm in general are arguably
less likely to be disclosed in relation to the consumption of ‘party pills’ that in
comparison to use of alcohol. This may bias an accurate comparison of
negative effects between the two substances.
This study also notes that ‘50% of respondents believed il egal drug use
would increase should party pil s be banned.’ In interpreting this finding it
should be noted that respondents believing this increase would happen, and
respondents disclosing that they would use more il icit drugs themselves, are
separate issues. With the potential classification of BZP gaining such
widespread coverage in the media, a common rebuttal by the ‘party pil ’
industry has been to publicise the likely hood of a shift towards the use of il icit
stimulants should a classification occur. The finding that 50% of respondents
believed illegal drug use would increase may not indicate any potential for this
trend, instead it shows that the respondents surveyed have potentially been
influenced by ongoing debate in the media.
4. Analysis of Submissions
The Ministry of Health received 64 submissions regarding the potential
classification of BZP, phenylpiperazine and related substances. One of the
submissions included a petition with over 9000 signatures and three petitions
were considerably complex. The submissions have been analysed by Al en
and Clark and a draft report is attached to this paper. The Ministry intends to
bring a final version of this summary to the table for this meeting.
Amongst themes raised in the analysis of submissions there were concerns
regarding the EACD process, including that the Committee:
•
recommendation relied on unpublished and un-replicated
research/reports that had not been under a robust peer review process
(7, 37, 44, 54, 61/61a)
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•
has not defined moderate risk and has not undertaken a formal risk
assessment (37)
•
was asked only to evaluate harm not potential benefits (42, 54)
•
has not evaluated other harm minimisation options such as tighter
regulation (19, 54)
•
has relied on information from two sources (letter from the National
Poisons Centre and report form the MRINZ) that are subject to serious
challenge (7, 37, 54)
•
has formed conclusions from results of recent studies in which there has
been inaccuracies as well as misinterpretation and misrepresentation of
the facts. (7, 37, 54)
•
has 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 (35, 55)
•
does not appear to have considered and provided recommendations, as
required by legislation, on the practicalities of imposing restrictions or the
ability to enforce those restrictions and requirements (61/61a).
•
A drug policy/law reform agency (42) recommended change to the
makeup of EACD to include lay people.
The full draft report of the analysis of submissions is 100 pages long. The
Ministry of Health expects to receive a final report by 30 April inclusive on an
executive summary detailing the main findings and recommendations in the
analysis. This summary wil be made available to commit ee members for
consideration and comment at the meeting on 3 May.
5. Peer review of studies
“Legal Party Pil s and their use by young people: summary report of findings”
Sheriden and Butler (2006), University of Auckalnd.
Since this study was considered by the Commit ee on 29 November 2006,
peer reviews have been conducted by Dr Marc Wilson, Deputy Head of
School of Psychology, Victoria University and Melissa Girling and Lanuola
Asiasiga, qualitative researchers at SHORE, Massey University. The
Reviews are generally supportive of the methodology used in this study
however some feedback is given relating to;
•
Screening of participants
•
Recruitment techniques
•
Interview methods, and
•
Reporting style
These peer reviews are attached to this paper. Comment has also been
sought on these reviews by the authors of this study, and is expected to be
made available to the Committee at the meeting on 3 May.
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“The benzylpiperazine (BZP) / trifluoromethylphenylpiperazine (TFMPP) and
alcohol safety survey” Thompson et al (2006),Medical Research Institute of
New Zealand.
This study was also considered by the Committee at the 29 November 2006
meeting. The Ministry of Health has recently received a peer review of this
study by Andrew Jull, research fellow and doctorial candidate at the Clinical
Trials Research Unit, University of Auckland. The review raises a number of
issues with the study relating to:
•
Reporting style
•
Sample size calculation
•
Definition of serious adverse events
•
Early stopping of the trial
•
Fasting, Tobacco and Caffeine abstinence
The study concludes that ‘given the many concerns noted about the design,
conduct and analysis of the trial the conclusion reached by the authors that
party pil s commonly cause severe adverse reactions cannot be supported’
and ‘there are insufficient grounds for drawing any conclusions wither in
support of the hypothesis that party pil s cause adverse events, or against it.’
The review is attached to this paper.
Another peer review of this study was supplied by STANZ in their submission
on the proposed classification of BZP. The review is conducted by Associate
Professor Michael Dawson, Head of Department Chemistry, Materials and
Forensic Science, University of Sydney and Dr Alex Wodak Director, Alcohol
and Drug Service, St Vincent’s Hospital. The review notes methodological
flaws relating to:
•
Co administration of BZP and TFMPP
•
Time of study
•
The unnecessary insertion of a venous cannula
•
Fasting of participants
•
Use of commercial ‘party pil ’ products
The review concludes that ‘the design of the study is fundamentally flawed to
the extent that it is incapable of establishing that BZP poses a moderate risk
of harm and should not be relied on by the EACD and/or the Minister as basis
for making any scheduling changes.’ The review is attached to this paper.
The Ministry of Health is also awaiting a peer review of this study by Dr Peter
Black, Department of Pharmacology University of Auckland. It is expected that
all peer reviews and comment from the authors wil be made available to the
Committee at the meeting on 3 May.
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References
Theron, L, Jansen, K, Miles, J (2007).,
Benzylpiperizine-based party pills’
impact on the Auckland City Hospital Emergency Department Overdose
Database (2002–2004) compared with ecstasy (MDMA or methylene
dioxymethamphetamine), gamma hydroxybutyrate (GHB), amphetamines,
cocaine, and alcohol.
Accessed 24 April 2007 from
http://www.nzma.org.nz/journal/120-1249/2416.
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Document Outline
