Thousands of critically ill or unconscious patients have been
enrolled without their consent in clinical trials to test
treatments in New Zealand hospitals.
A medical ethics committee delayed approving a drug company's
application in March for an antibiotics trial at Auckland and
Christchurch hospitals so it could obtain legal advice from
The lead researcher for the trial told the health and
disability ethics committee that, in line with similar
applications approved in the past, the aim was to get
permission from relatives of the patient and then
"retrospective" consent once they had recovered.
Provisional approval for the new trial has since been granted
but a patient rights' advocate says the DHBs involved have
forgotten the lessons of the Cartwright Inquiry which
established the current system of informed consent for
healthcare and research.
One of the aims of the trial is to help widen the range of
medicines available to deal with the worsening problem of
antibiotic-resistant "superbugs". The latest case involves a
proposed trial at the Auckland and Christchurch hospitals of
a new antibiotic. In a global trial, sponsored by United
States-based Cubist Pharmaceuticals, intensive care
specialists want to see if the new medicine is as good as the
The 20 trial participants will be patients who have picked up
pneumonia in hospital while on mechanical ventilation for
breathing. They will be legally unable to give consent
because they will be fully unconscious, sedated or have a
breathing tube in their throat which will prevent them from
A health and disability ethics committee, chaired by Brian
Fergus, has provisionally approved the trial after initially
deferring a ruling until it had received advice from Crown
Law on the legal basis for enrolling unconscious patients
into research trials.
Dr Shay McGuinness, Auckland cardiothoracic intensive care
specialist, told the committee that as in similar
applications approved by ethics committees, the aim was to
obtain "assent from relatives and then retrospective consent"
from patients when they had recovered, according to minutes
of a March meeting.
"The researcher explained he and colleagues were operating on
the basis of previous discussions with Crown Law dating back
to around 2005. [He] was of the view that this process dated
back to the 1990s and several thousand people had gone
through the process."
Auckland Women's Health Council co-ordinator Lynda Williams,
who attends the committee's public meetings, said she was
outraged that district health boards were forgetting the
lessons of the Cartwright Inquiry.
"This is pre-Cartwright stuff. It shows that the patient
protections put in place following the 1988 Cartwright Report
and the Code of [Health and Disability Consumers'] Rights are
not being adhered to."
The code states that when patients are not competent to give
consent, they can be treated or enrolled in research if it
would be in their best interests and satisfies other
Ms Williams said she would complain to the Health and
Disability Commissioner over the consent process.
"We need to do something about it because it is not okay to
be enrolling unconscious patients in research, she told
"We cannot go back to this idea that the doctor knows best."
Health Minister Tony Ryall referred Herald inquiries to the
ethics committee, saying: "Ministers are not consulted on
specific cases such as this."
Dr Colin McArthur, the Auckland District Health Board
clinical adviser on research, said that in virtually all of
the earlier trials the comparisons were between two different
kinds of standard care.
Up to 4000 New Zealand patients participated in those trials,
said Dr McArthur, who is the head of the transtasman
Intensive Care Society's clinical trials group.
In the antibiotic trial, which was low risk, participants
would be diagnosed earlier and receive extra medical
attention. While it was not known if this would improve
outcomes, Dr McArthur said this "extra benefit" underpinned
the contention the trial was ethical.
"The legal question hasn't been tested in court [or by the
Health and Disability Commissioner] about exactly how best
interests should be defined."
He said the DHB complied with the code requirement to act
Dr McArthur said there was not usually time to consult family
members when patients arrived in an intensive care unit. No
more than 5 per cent of patients retrospectively - and
families, when the patient died - withheld consent for
participation in ICU trials.
- Martin Johnston of the New Zealand Herald