NHS HEADS CANNOT STOMACH THE POLITICAL DECEITS AND BUNGLES

The management crisis in the health service has worsened with the resignation of a senior director who accused ministers of “deceit over reform”. Professor Aidan Halligan, director of clinical governance, stood down this week, leaving another vacancy at the top of the NHS, The Times has learnt. Nine senior positions are filled at present by temporary replacements or new appointees for staff who have resigned. The news came as the problems over jobs in the NHS increased, with another health trust announcing yesterday that it was losing 600 posts.

Professor Halligan shocked ministers last month when he condemned their failure to overhaul the NHS as they poured in billions of pounds of extra cash. His remarks were used in the Commons by David Cameron, the Conservative leader, to embarrass Tony Blair. The resignation of Professor Halligan comes two months after the sudden departure of Sir Nigel Crisp, the chief executive of the NHS and Permanent Secretary at the Department of Health. Andrew Foster, another senior department figure, also recently announced that he was leaving.

Andrew Lansley, the Shadow Health Secretary, said: “The Department of Health is a department without leadership, without direction and without any effective financial control. It is not surprising in the context of Mr Blair’s failing Government. “The ministers must take responsibility. There is a crisis of confidence between NHS staff on the one hand and the ministers and Department of Health on the other, because of the latter’s failure to articulate a clear and effective policy.”

It remains unclear why Sir Nigel resigned at a time of increasing pressure on the NHS caused by worsening deficits. But within weeks of the announcement it emerged that Mr Foster, the head of workforce planning at the department and another figure central to its reform programme, was stepping down. The department said that Mr Foster had chosen to leave to pursue other health service interests.

Professor Halligan, who was until last year the country’s second-most senior doctor when he served as deputy Chief Medical Officer, has decided to leave public service altogether. In a letter on Monday to Sir Liam Donaldson, the Chief Medical Officer, Professor Halligan thanked him for all his “support, encouragement and many kindnesses over the years”. Professor Halligan, a former lecturer in obstetrics, used an interview in a health service journal last month to criticise what he said was a failure to reform the NHS. “We have learnt that throwing money at the problem only allows us to do more of what we have always done,” he said. “Any suggestion of real reform has been a deceit. Working patterns, practice and custom are at the heart of many capacity issues [in the NHS] and have never been challenged.”

Oxford Radcliffe Hospitals confirmed plans yesterday to cut 600 jobs in an attempt to save 33 million pounds. The trust said that it could not rule out compulsory redundancies, although it has 600 vacancies

The Times





U.K. Regulators slam drug trial firm

Drug regulators have heavily criticised the firm which carried out the drug trial which left six men seriously ill. Parexel - who deny any wrongdoing - failed to follow proper procedures the Medicines and Healthcare products Regulatory Agency have reported. But the agency said the adverse reaction, which left the men with multiple organ failure, was the result of an "unexpected biological effect".

Experts slammed the conclusion, saying the outcome could have been predicted. At the time of the trial, Professor Herman Scholtz, from Parexel, said the clinical research organisation had followed regulatory, medical and clinical research guidelines during the study.

All six previously healthy men who took part suffered multiple organ failure after being given TGN1412, which is designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis. One is still in Northwick Park hospital, and is said to be making steady progress. The solicitor representing two of the men has called the MHRA report "totally inadequate" and said it was "a whitewash".

The MHRA found the drug was given in correct doses and there was no sign of contamination or manufacturing errors. But it lists a catalogue of administrative errors. Parexel failed to complete the full medical background of a trial subject and the medical history of one of the volunteers was not updated. There was also no contract in place between TeGenero, the makers of the drug, and Parexel at the beginning of the trial. In addition, the MHRA reported one of the doctors involved did not have adequate training or experience. And two of the volunteers were allowed to leave before it was confirmed they had received the placebo

The German manufacturers of the drug TeGenero have maintained that the men's reactions were "completely unexpected" and did not reflect the results obtained from the earlier laboratory studies.

Dr David Glover, an independent consultant and industry expert on the development of antibody and other biological drugs said: "Today's report is inadequate and completely misses the point. "The report concluded the problem was due to an unexpected biological effect, but this is absolute nonsense. "The trial volunteers' response was predictable from preceding literature and data supplied by the company and should not have come as a surprise."

But Professor Kent Woods, MHRA Chief Executive told the BBC other monoclonal antibodies, like TGN1412, had been tested safely before, and there had been substantial safety measures built in to the study's development." However he admitted: "The number of volunteers is something that has to be reconsidered. "But even if one volunteer had been affected, it would have been a disastrous outcome." He added: "We are satisfied that the adverse incidents which occurred were not as a result of any errors made in the manufacture of TGN1412, its formulation, dilution or administration to trial participants."

It its interim report last month, the MHRA said it would take a "precautionary approach" to future trials of drugs like TGN1412. But Ann Alexander, the lawyer representing the two most seriously affected victims of the drug trial, condemned the report as "totally inadequate". "Today's report is a whitewash and leaves many questions unanswered. It gives no detailed information about the pre-clinical trials, about which there has been conflicting information." Ms Alexander, of Irwin Mitchell solicitors, questioned the finding that the reaction produced by the drug was unpredictable and called for an independent enquiry.

She added that a Health Select Committee report published last year had found a lack of transparency in the MHRA. "The concerns of the select committee seem to have been confirmed by the MHRA's investigations. "I now have little faith in the MHRA's ability to seek, obtain or make public detailed and relevant information about the clinical history of this trial or the manner in which it was conducted," she added.

The Department of Health has said the expert group will produce an interim report within three months of starting work. It will provide advice on how future trials of monoclonal antibodies should be designed.

Source

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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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