DOCTORS in casualty departments in the US will soon be able to test experimental life-saving treatments on unconscious patients. Under new federal regulations which could be finalised next month, doctors will be able to assume that their patients would have agreed to participate in such trials had they been conscious.
Most medical researchers welcome the move. 鈥淎s things stand right now, we can鈥檛 develop any new drugs or treatments for people in emergency situations,鈥� says Robert Levine of Yale University鈥檚 School of Medicine in New Haven, Connecticut. But others warn that the change may set a dangerous precedent for vulnerable groups of patients.
In the hours after a head injury, the brain can be susceptible to further harm. Free radicals released around the injury, for example, can damage neighbouring tissue. Drug treatment may slow or prevent this damage, physicians believe. But in most cases, the drugs need to be given soon after injury, and it may be impossible to trace the victim鈥檚 relatives in time to seek their consent.
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The new rules will end a two-year ban on experimental treatments in unconscious people. Until 1993, American doctors were allowed to test therapies on such patients and ask for their consent afterwards. But the practice stopped when the National Institutes of Health and the Food and Drug Administration decided that this did not constitute informed consent. The difference in the new system is that planned trials will be widely publicised and the public invited to comment. In effect, the public will give consent for the trials, not the individual.
The regulations, to be issued by the FDA, aim to protect patients without hindering research. They require that all permissible treatments for the life-threatening condition must be 鈥渦nproven or unsatisfactory鈥� before an experimental treatment can be tried. The trial must be approved by the institutional review board, the ethics panel of the university or hospital. An independent 鈥渄ata and safety monitoring board鈥� must supervise the trial, and the results must be published.
As with any other clinical trial, researchers will be entitled to assign patients at random to receive either the experimental therapy or a placebo. As soon as patients regain consciousness, or when family members can be traced, researchers must tell them about the trial and give them a chance to withdraw.
The regulations would put research into emergency treatments under more stringent control than most other types of biomedical research. For trials of routine treatments, institutional review boards rarely, if ever, ask the public to comment on their plans. 鈥淚 think it鈥檚 completely appropriate that such research should be held to a higher standard than other forms of research,鈥� says Roger Lewis, a physician at the University of California, Los Angeles, and chairman of the research committee of the Society for Academic Emergency Medicine. The extra safeguards are needed because emergency trials take away a person鈥檚 right to say no to an experiment.
But others warn that the changes could have unwanted side effects. The public may be appalled to learn that half the patients in a trial would be given placebos instead of a potentially lifesaving treatment, says Jason Karlawish of the University of Chicago Medical Center. He fears their reactions may make placebo-controlled trials impossible.
Adil Shamoo of the University of Maryland Medical School in Baltimore fears that removing a person鈥檚 right to give consent is a dangerous precedent that could leave other patients, such as the cognitively impaired, open to abuse. 鈥淚n ten years, we鈥檒l have had some abuses, and people will start rethinking the rules,鈥� he says.