AMBULANCE authorities have been accused of ‘playing god’ and putting lives at risk by taking part in a trial which gives cardiac arrest victims a placebo instead of adrenaline.

The study by five ambulance trusts including South Central Ambulance Service (SCAS), called PARAMEDIC-2, will eventually be rolled out to every ambulance in the county.

Current guidelines recommend routinely giving adrenaline during the resuscitation of patients who have suffered cardiac arrest.

However researchers say a clinical trial has never been done and believe it could cause more deaths than it saves.

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Chairwoman of Oxford health group Patient Voice Jacquie Pearce-Gervis, said: “What they are doing is basically playing god by enrolling people into this trial.”

Some concerns have been raised about the trial, in which patients could be given a salt solution instead, because patients will not be able to consent to take part, only opt out of it.

But the ambulance service said the ethics had been approved, based on European law, and that funding had been given by the National Institute for Health Research (NICE).

The trial has been designed to test this belief but Abingdon GP Dr Prit Buttar said it could lead to deaths that might have been prevented.

He said: “If a small number of people survived after being given adrenaline, and fewer survived when given the placebo, you could argue that several people who had died may have not died if they were given adrenaline.

“If you asked members of the public whether they wanted adrenaline or whether they wanted salt water after suffering a cardiac arrest, I’m sure most would say adrenaline.

“You could be causing preventable deaths with this trial.”

The trial will be rolled-out to Hampshire in April but eventually every ambulance in Oxfordshire will take part in the trial, which is managed by the University of Warwick and taking place at four other ambulance trusts.

Paramedics and doctors will not know if they are administering the placebo or adrenaline.

Pregnant women, people suffering from an allergic reaction and people who have been given adrenaline before ambulance crews attend will not be enrolled in the trial.

Everyone else is automatically registered unless they choose to opt-out by requesting a silver “no study” bracelet that must be worn at all times.

Chairwoman of Oxford health group Patient Voice Jacquie Pearce-Gervis, said: “What they are doing is basically playing god by enrolling people into this trial.

“I think it’s a very worrying trial. I’m highly suspicious when healthcare services don’t publicise trials.

“The ambulance service needs to inform patients about this and how they can opt-out.”

SCAS refused to comment on whether patients’ lives could be put at risk in the drug trial, which will run until August 2018.

In a joint statement, the trust and the University of Warwick said they will be publicising the trial through the local press and community noticeboards in the coming months.

They added recent studies suggested although adrenaline does restart the heart, it could possibly worsen survival rates in cardiac arrest patients.

The statement said: “The real risk would be to continue to give treatments that may have been used for decades, but have not been properly tested to modern scientific standards.”

It added: “The ethics of the study have been approved at a national level based on European law. We do not know whether adrenaline is beneficial or harmful in treating our patients in cardiac arrest. The best treatment for cardiac arrest is good cardiopulmonary resuscitation and early defibrillation and this will remain unchanged throughout the trial.

“The need for this trial has also been recognised by NICE which has provided the funding for this study. As part of the funding process they carefully appraised the need for the study.”

Director of the Oxford-based centre for evidence-based medicine Professor Carl Heneghan, said: “Importantly there are areas of clinical practice where the effects of what we do are uncertain and drugs like adrenaline may cause more deaths.

“Previously we used antiarrhythmic drugs to treat heart attacks but after a trial in the 1980s, the CAS trial, it was found that it increased mortality and in fact killed more Americans than the number of Americans that died in the Vietnam War.”

Labour MP for Oxford East Andrew Smith added: “The key and rather surprising thing here is that there is no medical evidence that giving adrenaline actually helps survival, so it does seem to me a vital thing to investigate. It is right that such trials have to satisfy stringent medical and ethical standards.”

To read more about the trial or opt-out visit southcentralambulance.nhs.uk


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