❓ WA Parliamentary Question on Notice regarding drug and research trials involving involuntary mental health patients since 2000. The response details the number of trials, ethical guidelines, and financial aspects, primarily within the North Metropolitan Health Service.
AnsweredQoN 177Legislative Council
QuestionView source ↗
(1) How many drug and/or research trials has the Western Australian Mental Health Service conducted since 2000 which included involuntary patients as the subject(s)? (2) What were the trials for, what drugs were involved and when were the trials conducted? (3) Are there particular ethical guidelines for running drug trails on patients who cannot refuse treatment (i.e. involuntary patients)? (4) If so, what are they? (5) Were they complied with in all trials? (6) If not, for each of these trials, what breaches were there? (7) What hospital(s) undertook each of these trials? (8) Which doctor was responsible for each of these trials? (9) Was the informed consent of involuntary patients obtained to participate in these trials? (10) What payments were made in connection with these trials (please provide details of payers, payees, amounts, dates and methods of payment)? (11) What was the total income from each of these trials? (12) What accounts were the payments directed to?
AnswerView source ↗
Answered
11 September 2013
Responded by
Minister for Mental Health
Response time
76 days
(1)
North Metropolitan Health Service (NMHS): There have been 56 trials (48 not involving medication and 8 involving medication), for 2002 onwards.
South Metropolitan Health Service (SMHS): Nil.
WA Country Health Service (WACHS): Nil.
Child & Adolescent Health Service (CAHS): Nil.
(2)
NMHS: The eight trials involving medication were:
Study of safety and effectiveness of
intramuscular psychotropic medication
in patients who are acutely agitated (2002).
Study examining cardiovascular risk reduction in patients with schizophrenia recently changed to
Risperdal
(2003).
Study of intramuscular (IM) antipsychotic medications -
Olanzapine v's alternative IM medications
(2004-2005).
Study of Effectiveness of
Olanzapine
in Tablet and Wafer Forms on improving negative symptoms in the treatment of Inpatients with Schizophrenia (2003-2005).
Study of Electronic Schizophrenia Treatment Adherence Registry Protocol
(Risperdal Consta)
(2006).
Trial of
Risperdal Consta
versus oral atypical antipsychotics in poorly adherent subjects with schizophrenia in a routine care setting (2006-2009).
Risperdal Consta
Observation Study After SwiTching (COAST) (2006).
Study looking at the efficacy and safety assessment of
Org 5222
and
Olanzapine
in the treatment of patients with schizophrenia or schizoaffective disorder (2003-2004).
The other 48 projects mentioned were research such as de-identified data analysis and data collection.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(3)
NMHS, SMHS, WACHS and CAHS: Yes.
(4)
NMHS, SMHS, WACHS and CAHS: The
National Statement on the Ethical Conduct in Human Research
chapter 3.3 outlines the ethical considerations specific to projects which are "interventions & therapies, including clinical and non clinical trials and innovations".
The
National Statement on the Ethical Conduct in Human Research
chapter 4.5 outlines the ethical considerations specific to "people with a cognitive impairment, an intellectual disability or a mental illness".
(5)
NMHS: Yes.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(6)
NMHS: Not applicable.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(7)
NMHS: Graylands Hospital, Inner City Community (Adult) Mental Health Service and Osborne Park Community (Adult) Mental Health Service.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(8)
NMHS: Names of specific doctors will not be disclosed due to the doctor's right to confidentiality.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(9)
NMHS: Yes.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(10) Please see tabled papers [...]
(11)
NMHS: Unable to answer this question as information regarding total income is incomplete or not held by the service.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(12)
NMHS: Two Special Purpose Accounts (0402000 and 0402006) operate for all drug trials undertaken by NMHS MH.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
North Metropolitan Health Service (NMHS): There have been 56 trials (48 not involving medication and 8 involving medication), for 2002 onwards.
South Metropolitan Health Service (SMHS): Nil.
WA Country Health Service (WACHS): Nil.
Child & Adolescent Health Service (CAHS): Nil.
(2)
NMHS: The eight trials involving medication were:
Study of safety and effectiveness of
intramuscular psychotropic medication
in patients who are acutely agitated (2002).
Study examining cardiovascular risk reduction in patients with schizophrenia recently changed to
Risperdal
(2003).
Study of intramuscular (IM) antipsychotic medications -
Olanzapine v's alternative IM medications
(2004-2005).
Study of Effectiveness of
Olanzapine
in Tablet and Wafer Forms on improving negative symptoms in the treatment of Inpatients with Schizophrenia (2003-2005).
Study of Electronic Schizophrenia Treatment Adherence Registry Protocol
(Risperdal Consta)
(2006).
Trial of
Risperdal Consta
versus oral atypical antipsychotics in poorly adherent subjects with schizophrenia in a routine care setting (2006-2009).
Risperdal Consta
Observation Study After SwiTching (COAST) (2006).
Study looking at the efficacy and safety assessment of
Org 5222
and
Olanzapine
in the treatment of patients with schizophrenia or schizoaffective disorder (2003-2004).
The other 48 projects mentioned were research such as de-identified data analysis and data collection.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(3)
NMHS, SMHS, WACHS and CAHS: Yes.
(4)
NMHS, SMHS, WACHS and CAHS: The
National Statement on the Ethical Conduct in Human Research
chapter 3.3 outlines the ethical considerations specific to projects which are "interventions & therapies, including clinical and non clinical trials and innovations".
The
National Statement on the Ethical Conduct in Human Research
chapter 4.5 outlines the ethical considerations specific to "people with a cognitive impairment, an intellectual disability or a mental illness".
(5)
NMHS: Yes.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(6)
NMHS: Not applicable.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(7)
NMHS: Graylands Hospital, Inner City Community (Adult) Mental Health Service and Osborne Park Community (Adult) Mental Health Service.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(8)
NMHS: Names of specific doctors will not be disclosed due to the doctor's right to confidentiality.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(9)
NMHS: Yes.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(10) Please see tabled papers [...]
(11)
NMHS: Unable to answer this question as information regarding total income is incomplete or not held by the service.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
(12)
NMHS: Two Special Purpose Accounts (0402000 and 0402006) operate for all drug trials undertaken by NMHS MH.
SMHS: Not applicable.
WACHS: Not applicable.
CAHS: Not applicable.
Explore WA Government Data
Search the full archive in the free dashboard, or query programmatically via API.
Explore more
Government Gazette
Appointments, regulatory notices, planning changes.
Hansard
Debates, questions, speeches and sentiment.
Tabled Papers
Reports and documents tabled in Parliament.
Committees
Committee profiles and recent reports.
Regulations
Subsidiary legislation with filters and summaries.
Bills
Proposed laws and parliamentary progress.
Acts
Current WA legislation and summaries.
Explanatory Memoranda
Bills with EMs (text/PDF) available.
Members
MP profiles, party breakdown and rankings.
Pollie Rankings
Data-driven rankings across 19 categories.
Amendment Chains
Track how schemes and regulations evolve over time.