"WHO CARES?" IN THE BRITISH NHS

The murdering doctor below will almost certainly suffer no penalty. Even Roy Meadow got off the hook eventually. In the USA, the galoot below would be sued to oblivion

A mother died after being given penicillin before a minor operation despite telling doctors that she was allergic to the drug, an inquest was told yesterday. Teresa Innes, 38, was wearing a red allergy band on her wrist and her medical notes stated that she should not be given the antibiotic. However, a doctor at Bradford Royal Infirmary prescribed it as she was about to undergo routine surgery to drain an abscess on her thigh. She suffered anaphylactic shock which stopped her heart for 35 minutes resulting in brain damage and a persistent vegetative state from which she never recovered. The former care worker died two years later, in 2003, after Dame Elizabeth Butler-Sloss, then President of the High Court Family Division, gave the hospital permission to withdraw her artificial feeding.

At her inquest yesterday, Bradford Coroner's Court was told that Ms Innes had been for a week's holiday to Corfu in September 2001 with her son Scott, 17, and noticed an infection on her left thigh when she returned, thought to have come from an insect bite. She developed an abscess on her leg and was prescribed non-penicillin antibiotics by her GP. A week later, when there was no improvement, she returned to her GP who referred her to Bradford Royal Infirmary.

On arrival at the hospital, at least four members of staff were told of her allergy and it was logged in her notes, the inquest was told. However, during a ward round at the hospital that evening, Ms Innes was prescribed penicillin by John Griffith, a doctor, before the minor operation to drain the abscess on her thigh scheduled for that night. Her medical notes, the inquest was told, recorded that she was allergic to the drug and that she was wearing a bright red allergy band on her wrist. The operation was later postponed to the next morning, when she was given a drip containing Magnapen, a form of penicillin.

A statement by Marlene Greaves, a close friend of Ms Innes who accompanied her to hospital, was read to the inquest. Ms Greaves, who has since died, explained how Ms Innes first had an allergic reaction to penicillin in 1997, after giving it to her nephew and then licking the spoon. She took two days to recover. Ms Greaves recalled how Ms Innes was assessed in the accident and emergency department before being transferred to a ward. "Teresa made a point of telling this doctor she was allergic to penicillin but he said he already knew because it was in her notes," Ms Greaves said.

She said that Ms Innes was in pain and that it was "all she could do to lift one leg". Ms Greaves, who had been named as Ms Innes's next of kin, was called early the next morning and told that her friend was seriously ill. Ms Greaves said: "I couldn't believe what they had done and pointed out how many times they had been told about her allergy." She said she was angry at the time and did not realise how serious the situation was. "I feel in many ways Teresa was like a daughter to me. I think and hope if she was alive today she would feel the same about me," she said. "It was just at a time in her life when things were looking up for Teresa. Her life was lost through such a needless mistake."

Post-mortem examinations found that Ms Innes, whose upbringing was described as "something of a struggle", died from brain damage due to a lack of oxygen brought on by anaphylactic shock and leading to an irrecoverable persistent vegetative state. The inquest was told how, in a meeting between Ms Innes's relatives and hospital staff, Dr Griffith admitted to writing the prescription but said he had not seen the wristband. Nicholas Clarke, a doctor, who assessed her condition on arrival at the accident and emergency department, said Ms Innes came with a letter from her GP, Ian Stinson, which noted her allergy. He said he also noted the condition in her notes in "block capital letters" before handing them over to another member of staff.

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ANOTHER BRITISH REGULATORY FAILURE

Experts knew that drugs similar to the one that nearly killed six men at a London hospital last week could have dangerous side effects. Trials last year in the US of a similar "monoclonal antibody" caused severe toxic reactions in patients. But the British study went ahead after the regulatory authority failed to consult outside specialists who would have warned against proceeding.

Angus Dalgleish, a world expert on immunology, said at the weekend he was amazed the trial had been allowed to proceed. "The previous studies which caused similar severe side effects were in patients already suffering from cancer, but (the researchers) should have known they would get a meltdown because this drug was hitting exactly the same immune response pathways," Professor Dalgleish said.

Last week six healthy young male volunteers, who were to be paid pound stg. 2000 ($4800) for the trial, suffered catastrophic side effects within minutes of receiving an experimental drug called TGN1412, which was being tested as a potential treatment for leukemia, rheumatoid arthritis and multiple sclerosis. Two of those given the drug are still in a coma at Northwick Park Hospital, northwest London. The other four have regained consciousness and spoken to relatives.

But doctors said the four men could face months of slow recovery. The monoclonal antibody they were given can linger in the system for months, unlike most conventional drugs that are flushed out in days.

The two others were critically ill in intensive care, and relatives of one of them, Ryan Wilson, said they had been told he could be in a medically induced coma for up to a year. Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said an advisory panel was meeting regularly and developing a more detailed understanding of what had happened to the volunteers.

Professor Dalgleish said the Medicines and Healthcare Products Regulatory Agency (MHRA), which approves such drug trials, should have consulted a specialist before approving the study. "I can't understand it. They are normally super-cautious. I would have told the people doing this trial not to do it because the dangers were so great," he said. The data that should have raised the alarm were presented at a meeting of the American Society of Clinical Oncology in May last year. Professor Dalgleish -- a professor of cancer at St George's Hospital medical school, south London -- said an engineered antibody using the same pathway as TGN1412 had produced severe side effects in about half of a group of patients who were dying of cancer.

British experts told The Times last week it had been a mistake to give the drugs to six volunteers at the same time, but MHRA has defended the trial. A spokesman said the MHRA had reviewed the dossier of data that the drug's developer, TeGenero, had produced and confirmed that all was in order. Given the same data, the agency would approve the trial again, he said. "We have (since) given the trial protocol to a new set of assessors and they came to the same conclusions. There was nothing wrong with it."

In Germany, where the drug was developed, prosecutors said they were examining whether to start an investigation into the biotech company TeGenero. And the body responsible for licensing trials, the Paul-Ehrlich-Institut, hinted changes would be needed in the way trials were run. Their spokeswoman told German radio: "We are all going to think about whether to start off with a single person for studies where there is a risk of this kind."

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

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