Debate over medical ethics

Enrolling unconscious patients in medical trials is not unethical, and should probably happen more, a University of Otago philosopher says.

Associate Prof Andrew Moore, the founding chairman of the National Ethics Advisory Committee, was asked to comment about revelations yesterday that thousands of critically ill or unconscious hospital patients had been enrolled for antibiotics research in Auckland and Christchurch.

''It's important not to insist on consent from people who aren't able to give it.''

Propertrial designprovided safeguards for people who could not give consent, and New Zealand's regulatory framework was strong.

''Consent makes sense and is required for people who are able to give it. But there are people who aren't able to give it, and who need help, basically.

''The advances in medicine come from research, and actually the people who aren't able to consent are some of the sickest people, so they're the people who most need better treatments.

''Because some people are inclined to insist on consent whether or not people are able to give it, it's in fact some of the sickest people who tend to miss out on the research and, therefore, on the benefits.''

Researchers feared controversy arising from research on unconscious patients, which limited potential for medical advances.

''I think it would be a good thing if there was more research in this area.''

Auckland Women's Health Council co-ordinator Lynda Williams, whose newsletter this month raised the alarm about the research, said when contacted New Zealand's regulation of medical research had become ‘‘slushy''.

Patients receiving the trial antibiotics were not getting the treatments they would have otherwise, so there was likely to be little benefit for them as individuals.

Unconscious patients should not be used for research in which they were used to gain evidence for drugs under development, she said.

''This is all about money,'' she said.

Otago University professor of medical ethics Grant Gillett disagreed that non-consensual clinical trials were a case of‘‘doctor knows best''.

''It's actually opposed to the idea that your own doctor can do what he or she thinks is best for you,'' he said.

''It's aligned with the idea that your own doctor has to give you the best available, widely accepted treatment, as a default position and with your consent, but if you need that treatment and cannot give consent, then the doctor has a duty to give it to you.''

Prof Gillett said the measure had to be predicated on the fact that what was being offered as a trialled treatment had to be at least as good as, and no more risky, than what would be given anyway.

Prof Gareth Jones, of Otago University's bioethics centre, said retrospective consent also set a dangerous precedent.

- additional reporting The New Zealand Herald

Duty of care comes first

It is misleading to imply a level chance of future gain exists for research participants, and particularly so when vulnerable unconscious patients are involved. We cannot assume new drugs still in trial phase will lead to better treatments. When we don’t know if they will be as good as current treatments (non-inferiority trials) it is arguable there is a duty of care to ensure the sickest patients continue to get the best current treatment.
Scaremongering claims that without ongoing research we won’t have new or better treatments to offer in future are unhelpful. It’s a slippery slope to enrol unconscious patients without their consent in drug trials; even more so in the existing environment where study sponsors are not required to make all the trial data publicly available. The public good is never fairly served when big pharma withhold data that is contrary to their profit-making priorities.