Good News and Bad News

Is the tide finally turning for NHS whistleblowers?  Health Secretary Andrew Lansley has ordered the Care Quality Commission to keep its whistleblowing non-executive director Kay Sheldon on the board, despite CQC chair Dame Jo Williams asking for Sheldon to be sacked. Sheldon’s ‘crime’ was to speak up against the culture of the CQC at the Mid Staffordshire Inquiry last November, describing the strategy as “reactive” and driven by “reputation management and personal survival”.  Sheldon contacted the Inquiry herself, and told chair, Robert Francis QC:  “My main concern is the organisation is badly led with no clear strategy. The chair and the chief executive do not have the leadership or strategic capabilities required.” She was also concerned that the CQC kept repeating the same mistakes and did not consider whether it had sufficient capacity to do annual inspections.

Sheldon told the Inquiry that she had emailed chief executive Cynthia Bower with her concerns and received a phone call from a “quite angry” Williams, asking her whether she “knew what impact this email would have on Cynthia.” On the day Sheldon gave evidence, Williams wrote to Lansley asking for her removal. Instead, Bower handed in her notice and Williams must now consider her position after Lansley, following  lengthy consultation and legal advice, decided that Sheldon should stay.

Whether this represents a true change of culture in the treatment of whistleblowers, or is merely an arse-covering exercise from Lansley knowing that Francis praised Sheldon for her ‘great courage’ and his report is likely to call for more like her, remains to be seen. As for the CQC, new chief executive David Behan clearly has his work cut out. A survey of 63 NHS chief executives by the Health Service Journal found that 44% were either ‘not confident’ or ‘not at all confident’ that failures on the scale of Mid Staffs would currently be picked up.

This reflects poorly not just on the regulators, but also the trusts and their boards who often don’t know what’s going on under their noses and politicians like Lansley who keep restructuring and destabilising the service, rather than focusing relentlessly on quality and safety. When the Eye broke the Bristol heart scandal in 1992, MD criticised surgeons for ‘persistently refusing to publish their results in a manner comparable to other units’. Fast forward 20 years and the Safe and Sustainable review of child heart surgery didn’t base any of its recommendations on the outcomes of the individual units because ‘a meaningful analysis of outcome data was not possible due to the low volume of surgical procedures within centres.’

So twenty years after the Bristol scandal, we still have no outcome data to prove how safe the service is and no idea how much poor performance has been covered up in that time. Bristol was only picked up because its results were so bad, it was an extreme statistical outlier. Even then, it would have remained hidden if not for the extreme bravery of whistleblower Dr Stephen Bolsin, who lost his job.

The harm caused by the lack of action to make child heart surgery safe by reorganizing it into fewer centres that are properly staffed and do sufficient numbers of operations to train future surgeons and prove they get good results is hard to quantify. But following the entirely avoidable Oxford child heart scandal (Eye July 30^th 2010), a detailed analysis of results between 2000 and 2008 by Professor David Spiegelhalter uncovered more that 20 excess deaths at each of the Leeds, Leicester and Guy’s units (Eye June 2011). The number of excess deaths at Bristol was between 30-35.

Clearly something had to be done, and the reduction in the number of centres doing surgery from 11 to 7 is at least 10 years overdue. Several Eye readers have written to object about the proposed removal of surgery from Leeds (and to point out that Andy Burnham is not the constituency MP, as MD claimed) but on the evidence available, Leeds may not welcome having its outcomes over the last decade closely scrutinized. The Safe and Sustainable review was not perfect – making safety decisions without using outcome data is beyond ironic – but it has survived rigorous scrutiny by the Appeal Court and the current referral to the Independent Reconfiguration Panel supported by Burnham can only delay improvements to the service, something Labour did for a decade in office. Meanwhile, a father has written to MD about the death of his child following heart surgery in Leeds, asking if the unit is safe. Without comparative data, I have no idea. And neither does he.

The Coalition’s Creature

Well done Nick Timmins. The ex-FT public policy editor has written an insightful account of the Health and Social Care Act, from its Ken Clarke origins over 20 years ago to the incorporation of the Blair reforms and onto the political train crash it’s now become. And it’s free¹. Much is old news to Eye readers, except the extent to which Lansley was apparently gagged by George Osborne before the election.  As Lansley claims:  “I can remember it being said explicitly to me that ‘our presentation will be radical reform on education and reassurance on health’. And the reassurance was about spending.” According to some of his advisers, when Lansley protested that “he was not being allowed to set out his stall and that might lead to trouble,” he was over-ruled.

The justification for this lack of political honesty and mandate is beautifully encapsulated by an (unnamed)  senior health department official:  “Talking about reform almost seals its fate. The public hate this discussion. Going on the Today programme to talk about commissioning or economic regulation of health, is a) fundamentally boring, and b) not what people want to hear … people don’t want you to talk about the wiring.”

The extent of the subsequent public and professional opposition to the Bill suggest this was a bad call, as voters don’t enjoy having the largest structural changes in NHS history forced on them when the pre-election pledges were to end um pointless top-down reform. Again, Timmins argues that the massive disruption of the reforms isn’t entirely Lansley’s fault. His white paper became a victim of the coalition, as Danny Alexander and Oliver Letwin – neither of whom have the faintest idea how the NHS works – rewrote key pieces of it while Lansley was too loyal/ cowardly/ arrogant to protest.

Unlike Bevan’s Baby, the Health Bill had many fathers, each with a different agenda and caring more  about their party’s survival  than the NHS.  Primary Care Trusts and Strategic Health Authorities are being abolished with indecent haste, huge health responsibilities are being handed over to local authorities and GPs, many of whom lack the resources, desire and expertise to cope, and some very good NHS managers who might make sense of it all have instead decided to take very generous redundancy packages than stay to pick up the pieces. The Commissioning Support Groups (CSGs) who sit above Clinical Commissioning Groups (as SHAs do to PCTs) have struggled to attract talented managers with NHS experience – hardly surprising since CSGs didn’t even feature in the Health Bill and have been invented by chief executive David Nicholson to ‘catch’ senior managers rather than pay the exorbitant redundancy costs. But most are taking the exit money.

Timmins interviewed everyone bar Cameron and Clegg (too busy, apparently) and the consensus view is the reforms will fail, and at many levels. Politicians often claim to want to stand back from the day to day running of the NHS, but never do. Shadow health secretary Andy Burnham has already gone on BBC Look North ² to argue the decision to stop child heart surgery in Leeds is wrong. His ignorance and naked self interest is trumping the safety of babies. There isn’t the staff to keep all of the units open ³ and expertise needs to be concentrated in fewer centres. After extensive consultation, the one near Burnham’s constituency is earmarked to close. He should grow up and support the change. Similarly, Lansley will find it hard not to over-react to save his political skin when Mid Staffs reports.

The NHS has to make impossible savings to break even and the money, corporate memory and expertise already lost  from unnecessary restructuring will take years to recover. GPs in Clinical Commissioning Groups are waking up to the vast complexity of legislation they have to master on a management shoestring, while trying to cope with the increasing demand in their own practices. The government is wrong. Patients care  passionately how Bevan’s Baby became the Coalition’s Creature and although it will probably survive, it won’t be the NHS we’d hoped for.

1 http://www.kingsfund.org.uk/publications/never_again.html

2 http://www.bbc.co.uk/iplayer/episode/b01knp6b/Look_North_(Yorkshire)_12_07_2012/

3 http://www.rcpch.ac.uk/news/rcpch-president-outlines-challenges-paediatric-workforce

It’s the culture, stupid

Culture, according to Henry ford, eats strategy for breakfast. No amount of regulation or reform can protect patients from harm if the culture remains sick. Healthcare staff, politicians, civil servants, regulators and the pharmaceutical industry have to want to be open and accountable, rather than ordered to be. Which means owning up to and learning from mistakes when they happen, not burying them for years and being retrospectively contrite when an inquiry finally pushes them out into the open.

GlaxoSmithKline (GSK) agreed to pay a fine of $3billion last week, the largest healthcare fraud fine in US history, but just the latest in a long line (Ely Lilly $1.42 billion, Pfizer $2.3 billion, Astra Zeneca $.52 billion, Merck $.95 billion, Abbot $1.5 billion). GSK was found guilty of mis-selling the antidepressant Paxil to children, making claims about a diabetes drug (Avandia) unsupported by evidence, failing to disclose safety data about Avandia and lavishing hospitality on doctors to influence their opinions and prescribing. The company claimed that these various frauds were a decade old and had been sorted. In 2003, they promised to make outcome and safety data from all their clinical trials freely available. But safety data on Avandia was still withheld up until 2007.

GSK is a UKfirm and the Medicines and Healthcare products Regulatory Agency (MHRA) spent four years investigating the criminal charges in the case of Paxil (Seroxat, paroxetine). But whistleblowers were central to the exposure and the fact that the cases were all judged in America, rather than the UK, is in no small part due to the fact that the US takes whistleblowing seriously, has its own National Whistleblower Centre offering advocacy and advice, and gives whistleblowers a share of the fine (in this case 20% of $3 billion). Why? Because there is good evidence that whistleblowing is more effective than the regulatory authorities and saves vast sums of public money and many lives. And theUK should follow suit (Shoot the Messenger, Eye…)

But it won’t. Last week, the Today programme ‘broke’ the story of the super-gag of whistleblower Gary Walker, the former chief executive of the United Lincolnshire Hospital Trust, a story comprehensively covered by the Eye in July and November last year (Shoot the Messenger and Eye 1303 The Gagging Wars). Walker blew the whistle about the danger to patients of being forced to hit simplistic targets to both NHS chief executive David Nicholson (also in the dock over the Mid Staffordshire scandal) and his director of commissioning (and former SHA chief executive) Dame Barbara Hakin.

Walker was sacked on the trumped up charge of swearing and –  without a job, effectively unemployable in the NHS and facing the loss of his home – accepted a settlement of over £300,000 that contained a gagging clause preventing him from making his safety concerns public, and warning his colleagues and supporters not too. The settlement and legal fees for the gag were paid for out of the public purse in the full knowledge of the Department of Health and the Treasury. Now some of his supporters have decided to breach the gag and release documents to the media (including the Eye) which need to be analysed in public in a way that protectsWalkerfrom further persecution. Such is the seriousness of the allegations against Hakin – a former GP – that the Eye has passed them onto the GMC. Nicholson – as with the Mid Staffs inquiry – is unlikely to be held to proper account.

On a brighter note, the (hopefully) safe reorganization of child heart surgery has now been completed, just 20 years after the Eye broke the story of theBristolheart scandal and Professor Steve Bolsin sacrificed his NHS career to blow the whistle. Professor Bolsin has never been officially thanked (now would be a good time) and the structural reorganization can only work if units grow up, put their institutional loyalties behind them and work together to ensure the outcomes, research and training are the best in the world. It’s doable, but the staff have got to want to do it, and the politicians, managers and media must let it happen.

Eye success

In 1997, the Eye first exposed the wide variation in quality of care in the UK for the treatment of children with cleft lip and palate, with large numbers of centres doing relatively few operations with poor cosmetic results. A North West of England audit had found that 48% of children required major and often multiple reconstructive surgery, largely because of failure of the original surgery. In addition, Royal College of Surgeons guidelines were being flouted and a petty turf war was being fought out by plastic surgeons and maxillo-facial surgeons to the detriment of patients (Eye 937). Four months’ later, the Clinical Standards Advisory Group of the Department of Health (CSAG) echoed the Eye’s warnings. After investigating 297 children aged 5 and 277 aged 12 who had all undergone cleft repair in Britain, they found that 40% had poor dental bite, less than a third had a good lip appearance at the age of 12 and under half could speak with normal intelligibility at that age.

The CSAG stated that of the 57 centres carrying out the operation, only 6-8 provided good to
excellent care and the overall results were 5-12 times poorer than in the six European centres examined. And the key factor causing poor training and poor results from “specialists” (sic) doing one or two operations a year was “competition between plastic and maxillo-facial surgeons.” This report found that not only are many surgeons continuing to perform operations they are not competent to do, but they were failing to keep adequate records or perform proper audit. A further factor in this incompetence was the financial pressure from trust managers to do the operations locally, cheaply, occasionally and badly, rather than refer to a more expensive specialist centre.

CSCAG recommended that the number of centres undertaking cleft work should be reduced from 57 to between 8 & 15 “so that expertise and resources are concentrated”. Fast forward 15 years and the thousand children born each year with cleft lip and/or palate all now get operated on in one of just 11 centres of excellence. Complication rates have more than halved and success rates for alveolar bone grafting have risen from 58% to 85%. The standard of audit has improved dramatically and centralisation has enabled coordinated research that will further improve treatment in the UK and worldwide¹. The long overdue centralisation of child heart surgery should reap similar benefits.

Another Eye success

Following the exposure of shocking failures in the treatment of breast cancer patient Debbie Westwick, who now has metastatic disease, (Eye March 2012) the GMC finally got around to judging  that oncologist  Howard Smedley was guilty of serious misconduct. A Fitness to Practice Panel found ‘Dr Smedley’s misconduct involved a significant failure to follow establish guidelines in relation to the treatment of breast cancer. He has the opportunity to reflect on the appropriateness of his treatment plan but failed to do so. In failing to obtain DW’s properly informed consent Dr Smedley breached the guidelines of Good Medical Practice and Seeking Patient’s consent, and this is, in the Panel’s judgement, serious misconduct in the circumstances of the case.’

The GMC did not explain why it took three years from Debbie’s first complaint to pronounce, nor why they didn’t act sooner to protect patients. Unbeknown to Debbie, Smedley was subject to ‘supervision undertakings’  imposed by the GMC when she was originally referred in 2006, for reasons that they refuse to reveal. Four fundamental errors occurred whilst he was under GMC supervision but weren’t flagged up.  Her surgeon, Mr Jackson, was then suspended in the middle of her treatment, subsequently sacked and referred to the GMC. The CQC and local cancer network also don’t seem to have acted swiftly to protect patients for harm. But at least Debbie now has a measure of justice. And Dr Smedley has voluntarily removed himself from the medical register.

1 British Dental Journal 212, 525 (2012)

Lansley Vs Nicholson Round 12

Any health secretary hoping to force untested free-market health reforms on a resistant NHS needs a chief executive with a similar ideology to push them through. Unfortunately for Andrew Lansley, he’s got David Nicholson, a command and control former member of the Communist party. At this year’s Patient Safety Congress, MD asked Nicholson whether he supported Lansley’s reforms. He said: ‘I lack the imagination to have come up with them.’ Even more damning was that not a single one of 700 delegates thought the Health and Social Care Act would make the NHS safer for patients, and a majority thought it would make it less safe.

Massive structural change at a time of massive debt creates a perfect storm in the NHS for Mid Staffs type disasters, as staff take their eyes off patients to balance the books whilst endlessly reorganising. In August 2009, David Cameron promised : ‘We will not persist with the top-down re-structures and reorganisations that have dominated the last decade in the NHS.’  In government he has done the opposite, implementing reforms that Nicholson says ‘are so big, you can see them from space.’

Nicholson remains in office to oversee the NHS debt crisis – £20 billion must be saved over 5 years – but it’s given him a golden opportunity to scupper Lansley’s reforms. Lansley promised GPs they could organise themselves into groups of any size and reshape the NHS by innovating, closing down unprofitable hospitals and developing services closer to patients. Bullish GP consortia of all shapes and sizes popped up with corporate brands like Bexley Clinical Cabinet, the Red House, the Fortis Group, Cumbria Clinical Senate and Principia.

Fast forward 2 years and these clinical commissioning groups (CCGs) have been rounded up by Nicholson and forced to merge until they’re the same size as the Primary Care Trusts (PCTs) they replaced. They have been given a measly running cost allowance that will minimise their chances of commissioning locally. The new National Commissioning Board is starting to enforce top down financial targets and micro manage GPs, just as the Department of Health currently does. The GPs have been forced to accept centralised commissioning support advice from new organizations that are almost identical in size and personnel to the Strategic Health Authorities they replaced. And the CCGs have been ordered to abandon their lovingly chosen names to become identikit PCTs. So Principia will become NHS Rushcliffe CCG.

The battle between Lansley and Nicholson has ensured vast amounts of time, money, stress and anxiety have been expended dismantling organizations to rebuild them under another name. Clearly one of them has to go, but who? Both could both be undone by the Mid Staff’s inquiry report, due in the autumn. Its recommendations could strongly contradict Lansley’s reforms. Nicholson has his fingerprints on Mid Staffs – he was chief executive of Shropshire and Staffordshire SHA – and has overseen an NHS culture where whistleblowers have been repeatedly suspended, sacked and silenced, senior NHS managers protected and bad news buried under a pile of legal threats. (See Shoot the Messenger).  Two of the Eye’s ‘cussed quartet’ – Dr Jayne Collins, chief executive of Great Ormond Street and Cynthia Bowyer, chief executive of the CQC, have now resigned from their jobs and DH director of commissioning Barbara Hakin might have to follow suit if the Health Select Committee takes evidence from the gagged former Lincolnshire chief executive Gary Walker.

The noose is tightening on Sir David Nicholson but he’s sure to leave with a gold-plated pension. Meanwhile, Lansley can only bully doctors into ill-advised industrial action over theirs, and hope that when he leaves office he’ll be rewarded with some lucrative directorships and consultancies for opening up the NHS market. Back on earth, the proportion of patients waiting more than four hours in A&E has increased by more than a quarter over the last year, reaching its highest level since 2004.

Shoot the Messenger has been shortlisted for the Martha Gellhorn Prize for Investigative Journalism