Legislation Denies Drugs to Patients Unable to Give Consent; Doctors Warn Scottish Executive Is Putting Lives at Risk with New Law

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THE lives of thousands of patients have been put at risk by a controversial law preventing them being treated with new drugs, doctors warned last night.

Accident and emergency teams across Scotland have been forced to halt routine clinical trials of promising treatments because they are now required to get permission from patients' families first.

Doctors have traditionally used new trial drugs in the critical moments following a heart attack, stroke or head injury because they frequently offer the best chance of saving lives.

But under the Scottish Executive's Adults With Incapacity Act, which came into force at the start of this month, they must get consent from next-of-kin.

Family members now have responsibility for life-or-death decisions about the care of patients who are too ill to consent to treatment themselves.

But Professor Stuart Cobbe, head of cardiology at Glasgow Royal Infirmary, said the rule was unrealistic in an emergency. He warned: 'If improvements in patient care can't be tested then it will have a very bad effect on their outcomes and lives.

'Only about 6 per cent of heart attack patients respond successfully when doctors shock the heart so there is enormous scope for improvement.

'But the only way to improve outcome is to show the benefits of new treatments in trials, comparing the new treatment drug with the traditional treatment.

'We have had to stop all trials.' He warned that in emergency wards doctors must treat the patient within seconds, making the notion of being able to contact next-of-kin 'unrealistic'. 'It just can't be done. As it stands, Scotland cannot take part in new research and must rely on the trials being undertaken in other countries,' he said.

The Act is aimed at improving care for mentally ill patients but it also applies to the thousands of patients brought into emergency wards each year who have temporarily lost their mental faculties through a stroke, heart attack, epileptic seizure, brain injury or who are simply unconscious.

Dr Richard Lindley, a senior lecturer at Edinburgh University's department of clinical neurosciences, said he had been forced to stop trials of a clot-busting stroke drug, RTPA, because his patients could not give consent.

Before July 1, one quarter of his patients were receiving the drug.

The treatment is already being used in the U.S. and it has ethical approval for use in UK trials.

He said: ' This new law is a threat to future improvements in the treatment of emergency patients. If nothing is done we will be stuck at 2002 standards for these dreadful conditions.

'It means emergency doctors cannot compare the effectiveness of a traditional treatment with a trial treatment because it is illegal.

'We warned the Scottish Executive about this problem and suggested that they implement a waiver of consent in the law but they refused to do that. It really represents amazing doublestandards.

'We are well aware of the need for safeguards but we feel that the bureaucrats, in their enthusiasm, have created rules that fail to recognise certain emergency trials and procedures.' Their worries were backed last night by the British Heart Foundation. A spokesman said: 'It is only through research that we will fully understand the conditions we are fighting.' The measure complies with a European Directive to be put in force by 2004 but Scotland is the only country in the UK which has implemented the move as law.

An Executive spokesman said: 'All doctors are empowered to undertake the appropriate treatment necessary to keep their patients alive or prevent serious deterioration in their condition.

'This position has not changed.

Research involving such patients is also allowed under strict regulation, where this will benefit them. …