Drugs tested on critically ill, coma patients

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 Crown Law.

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.

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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 standard antibiotic.

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 speaking.

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."

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 Newstalk ZB.

"We cannot go back to this idea that the doctor knows best.''

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 conditions.

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 reasonably.

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.

Read the Ethics Committees' minutes from the meeting:

Read the Auckland Women's Health Council Newsletter on the issue:

A medical law expert has questioned whether researchers can lawfully rely on the claim that enrolling unconscious patients into a drug trial is in their best interests.

Associate Professor Joanna Manning, of Auckland University, said: "It's questionable whether the researcher could rely on ... the code to proceed to trial on unconscious patients because the question mark is over whether giving the person this medication would be in their best interests, when the purpose of the trial is only to prove it is not inferior to current standard care."

The Code of Health and Disability Services Consumers' Rights permits patients who are not legally competent to give informed consent - and for whom no one is available who is entitled to consent on their behalf - to be treated and involved in research as long as this is in the person's best interests.

Reasonable steps must also have been taken to ascertain and follow the person's views or, if they haven't been ascertained, to take into account the views of "other suitable persons who are interested in the welfare of the consumer and available to advise the provider".

"Arguably, the only body who could legally authorise a person to participate in this trial would be a court ... and it might be difficult to convince a court that participation in this trial is in the best interests of this person given it's a non-inferiority trial," said Dr Manning.

"I would be unsure about relying on a patient's retrospective consent."

A court could appoint a welfare guardian and grant authority to consent to medical treatment, but for experimental treatment the authority only included treatment to save the person's life or prevent serious harm to their health.

The same restrictions applied to those who held an enduring power of attorney for another person.