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| 'Resuscitation drug adrenaline questioned in cardiac arrest' | |
| (about 17 hours later) | |
| Approval has been given for a study where some cardiac arrest patients will be given a dummy drug, rather than adrenaline to kick-start their heart. | |
| There are concerns that adrenaline, used for more than 50 years as a key part of resuscitation, can do more harm than good. | |
| But the study will mean some patients across England and Wales being given a placebo without their consent. | But the study will mean some patients across England and Wales being given a placebo without their consent. |
| Experts say the research throws up a number of ethical challenges. | Experts say the research throws up a number of ethical challenges. |
| 'Critical time' | 'Critical time' |
| More than 50,000 people suffer cardiac arrests outside of hospitals each year in the UK. | More than 50,000 people suffer cardiac arrests outside of hospitals each year in the UK. |
| During arrests their hearts stop beating completely and most people do not survive. Currently only 8% leave hospital alive. | During arrests their hearts stop beating completely and most people do not survive. Currently only 8% leave hospital alive. |
| Paramedics follow a protocol for anyone found without a heartbeat - this involves chest compressions, shocking the heart with a defibrillator and giving a shot of adrenaline if shocks don't work. | Paramedics follow a protocol for anyone found without a heartbeat - this involves chest compressions, shocking the heart with a defibrillator and giving a shot of adrenaline if shocks don't work. |
| But over the past decade some scientists have suggested adrenaline could do more harm than good. | But over the past decade some scientists have suggested adrenaline could do more harm than good. |
| There is some evidence it may damage the brain by reducing blood supply to the head and could diminish the chances of survival. | There is some evidence it may damage the brain by reducing blood supply to the head and could diminish the chances of survival. |
| The Warwick University study will involve 8,000 people in London, Wales, the West Midlands, and the South Coast and north-east of England who have a cardiac arrest. | The Warwick University study will involve 8,000 people in London, Wales, the West Midlands, and the South Coast and north-east of England who have a cardiac arrest. |
| Half the patients will receive the dummy medicine and half will get adrenaline - but as they will be unconscious there will be no consent gathered as the drug is administered. | |
| Paramedics will also not attempt to get consent from relatives or passers-by as the researchers emphasise that time is critical during resuscitation. | Paramedics will also not attempt to get consent from relatives or passers-by as the researchers emphasise that time is critical during resuscitation. |
| But they say local residents will be given information on the trial and details about how to opt out. | But they say local residents will be given information on the trial and details about how to opt out. |
| Depending on local arrangements, this could involve ringing their ambulance service and being put on a computerised register - but details are yet to be finalised. | Depending on local arrangements, this could involve ringing their ambulance service and being put on a computerised register - but details are yet to be finalised. |
| 'No active consent' | 'No active consent' |
| After the arrest, relatives will not be told whether their family members received the drug or the dummy version. | |
| Dr Daniel Sokol, a medical ethicist and barrister who is not involved in the study, said: "A challenging aspect of this research is the lack of informed consent regarding a life-and-death intervention. | Dr Daniel Sokol, a medical ethicist and barrister who is not involved in the study, said: "A challenging aspect of this research is the lack of informed consent regarding a life-and-death intervention. |
| "The question then is: 'Is this research sufficiently potentially beneficial that we can forego proper consent?'" | "The question then is: 'Is this research sufficiently potentially beneficial that we can forego proper consent?'" |
| ANALYSIS: Ethics of life-and-death research | ANALYSIS: Ethics of life-and-death research |
| There will always be a drive to update conventional medical practice as science advances. And at the heart of modern trials is the idea of informed consent - all participants must agree to take part and be told about the risks. | There will always be a drive to update conventional medical practice as science advances. And at the heart of modern trials is the idea of informed consent - all participants must agree to take part and be told about the risks. |
| But gaining consent for studies looking at life-and-death situations is difficult. People who are unconscious - either after a cardiac arrest or in intensive care, for example, will not be able to give consent while a study is taking place. | But gaining consent for studies looking at life-and-death situations is difficult. People who are unconscious - either after a cardiac arrest or in intensive care, for example, will not be able to give consent while a study is taking place. |
| This raises questions about how to ethically advance treatment for cardiac arrest - which has extremely poor survival rates. The results of the trial could save many lives. But the researchers feel the only way to get these answers involves testing on a group of patients who cannot be part of the decision-making process. | This raises questions about how to ethically advance treatment for cardiac arrest - which has extremely poor survival rates. The results of the trial could save many lives. But the researchers feel the only way to get these answers involves testing on a group of patients who cannot be part of the decision-making process. |
| And scientists will have grappled with the question of whether to inform relatives about the trial - whether the patient survives or not. | And scientists will have grappled with the question of whether to inform relatives about the trial - whether the patient survives or not. |
| Researchers stress they have had lengthy discussions with the Oxford research ethics committee that granted approval for the study. | Researchers stress they have had lengthy discussions with the Oxford research ethics committee that granted approval for the study. |
| Prof Peter Weissberg, of the British Heart Foundation, said: "It is important to remember we don't actually know whether this routine use of adrenaline is a safe and effective practice. | Prof Peter Weissberg, of the British Heart Foundation, said: "It is important to remember we don't actually know whether this routine use of adrenaline is a safe and effective practice. |
| "The concern is it could be doing patients more harm than good. The only way to answer this crucially important question is to do a well-designed clinical trial | "The concern is it could be doing patients more harm than good. The only way to answer this crucially important question is to do a well-designed clinical trial |
| "It is always difficult to conduct a trial in situations where people are too ill to give their consent. But there are well established ethical guidelines for undertaking such studies. | "It is always difficult to conduct a trial in situations where people are too ill to give their consent. But there are well established ethical guidelines for undertaking such studies. |
| "What is unacceptable is to continue giving a treatment that could be doing more harm than good." | "What is unacceptable is to continue giving a treatment that could be doing more harm than good." |
| The study will start in the autumn. | The study will start in the autumn. |