FROM

Leslie Hamilton

Cardiac (adult and transplant) surgeon Freeman Hospital, Newcastle

Past President SCTS

Vice chair Safe+Sustainable Steering Group

 

Subject: “Safe and Sustainable”: the Jarman data
Date: Mon, 5 Nov 2012 20:40:58 +0000
From: Leslie.Hamilton

Dear Phil

 

We met at the very first national “Stakeholders”meeting when the review started. I have always enjoyed your MD column in Private Eye and have very much appreciated your support for the principles of the review. Your column in the current issue (Eye 1326) is no exception.

Nonetheless, I have significant reservations about Professor Jarman’s analysis of the outcome (mortality) data. I know he was a member of the panel for the Bristol Inquiry and am aware of his work through the Dr Foster organisation.

 

It would seem obvious to use outcome data to assess the quality of care when deciding which units to designate as the surgical units for the future. However the clinical Steering Group (who advised the JCPCT) was very clear that the data should not be used in this way.

 

In adult cardiac surgery we have a well established, internationally accepted risk stratification system (EuroSCORE) which was developed using a robust statistical analysis of a database containing tens of thousands of patients undergoing a small range of operations – this enables us to allow for patient and operation factors to give a predicted mortality so that outcomes can be compared in a fair manner. Indeed we have shown that mortality has fallen steadily over the years so that the score has had to be recalibrated – EuroSCORE 2 was presented at the annual meeting of the European Association for Cardiothoracic Surgery last week in Barcelona (http://www.euroscore.org/calc.html).

In paediatric cardiac surgery, we have long recognised that we needed a similar process to enable outcomes to be compared. However we have the opposite situation – a small number of children undergoing a large range (149 on the database but only the 50 commonest shown on CCAD) of procedures (with sometimes several procedures combined in an individual child). Also some of the higher risk procedures currently performed do not have a specific code in HES data.

 

Several international groups (including the one at UCL / NICOR) have been working to develop a scoring system which would allow for both case complexity and patient factors in paediatric cardiac surgery:

 

• · The Aristotle Complexity Score (http://www.aristotleinstitute.org/aboutScore.asp). I was involved with this group – it allows for most of the factors influencing outcomes but surgeons felt it was too complex! (http://ejcts.oxfordjournals.org/content/25/6/911.abstractand http://ats.ctsnetjournals.org/cgi/content/full/84/6/2027

 

• · The RACHS score (http://www.ncbi.nlm.nih.gov/pubmed/18377539) which divides the operations into 6 categories of technical difficulty and is similar to the Aristotle Basic Score (http://jtcs.ctsnetjournals.org/cgi/content/full/133/4/865)

 

• · More recently there has been further work between the American (STS) and European (EACTS) societies to produce a “STAT”score (http://www.chop.edu/service/cardiac-center/cardiac-outcomes/volumes-mortality-rates-complexity.html) but this is not too far away from RACHS.

 

Ultimately though these are empirical scores based on professional opinion. It was for this reason that the Steering Group advised the JCPCT not to use outcome data to assess units. We are currently seeing challenges to the decision making process used by the JCPCT – if outcome data had been used, dissatisfied units would have had endless ammunition with which to challenge the decision! It was felt better to ask Sir Ian Kennedy to assess the units against their ability to meet the standards proposed for the future (which he and his team did).

 

We know that there is significant variation in the complexity of cases undertaken by the current units. We know that neonates have the more complex operations and have the highest mortality – so using age up to 5 years (as Prof Jarman has done) does not make sense. We also know that primary repair at a young age is usually better but an initial palliative operation (a shunt?) will have a lower mortality risk initially – so initial outcome may look better. We also know that the hazard risk for surgery probably goes out to 90 days so using 30 day mortality can be misleading.

 

One of the strong arguments for having bigger centres with a higher volume of cases is that they will do a similar range of cases and the statistical analysis will be more robust. And we can look at outcomes other than mortality (parents are especially interested in neurological injury). Work needs to continue on producing a score which is helpful to parents and fair to surgical teams.

 

My real concern about the Jarman analysis and your conclusion is that parents will be mislead – if my grandchild needed heart surgery I would have no hesitation in going to Birmingham or Guys/St Thomas’s. So I think the JCPCT got it right. I can say this with no vested interest – I stopped doing paediatric cardiac surgery 5 years ago when the physical, emotional and mental pressures of a 1 in 2 rota got to me. Which is why I feel so strongly about seeing this through.

 

Yours sincerely

 

Leslie Hamilton

 

Cardiac (adult and transplant) surgeon Freeman Hospital, Newcastle

Past President SCTS

Vice chair S+S Steering Group
MY RESPONSE

Thanks Leslie

 

Ever since the Bristol Inquiry, UK experts have told me that it is too difficult to collect properly risk adjusted mortality in paediatric cardiac patients, that the heterogeneity of the population make it not worthwhile, that the numbers are too small, that there is no validated model and so on and so forth.

Odd then that New York state have been collecting and publishing this pooled data in 3 yearly batches since 1997, with the latest report published in October 2011 (see http://www.health.ny.gov/statistics/diseases/cardiovascular/index.htm, and scroll down to ‘Pediatric Congenital Cardiac Surgery in New York State’near the bottom (where paediatrics always is)).

 

I have already corresponded with David Cunningham on this, and put the correspondence up on my website where I shall put your response too. My own view is that first we need to get the data, models and analysis as good as they possibly can be – and that means sharing CCAD data with Brian Jarman, Paul Aylin and their team to allow them to contribute to this process. I think it is appalling that their request for the data has been denied – had it not been, there may well have been a more complete analysis, and Guys and Birmingham may have had a lower mortality ratio. But they can only work with the data and codings that they have. Professor Jarman has sent his data to Bruce Keogh and the DH twice, with no response. Time to converse and share, please.

 

Although the final analysis of pooled data may not be perfect and there may be mitigating factors, I believe it should be in the public domain – as per New York – over an agreed period of time, say three years. How else will you spot another Bristol? Or Oxford? And be sure to act on it? In Bristol and Oxford, the data simply was not acted on – it took whistleblowers to expose the scandals. You could argue that publication of data alone is not enough – the Mid Staffs scandal tells us that. You may have good arguments for Birmingham and Guys being high – and you should share them with Professor Jarman. I believe parents have a right to see this data and have it explained to them. But if CCAD won’t share the data with DFI, you shouldn’t be surprised if the analysis isn’t as complete as it could be.

 

I understand why the Steering Group advised the JCPCT not to use outcome data to assess units for the Safe and Sustainable review, but I won’t agree with it until I’ve seen the best statistical analysis of the pooled data. Do we have any idea how many excess deaths there have been in the 11 years since the Bristol inquiry? Have there been any significant statistical outliers over that time? HMSRs aren’t perfect either, but I feel a lot safer knowing they’re out in the public domain.

 

Yours Sincerely

 

Phil Hammond

How to choose a child heart surgeon

One key recommendation of the Bristol Inquiry 11 years ago was that ‘patients must be able to obtain information as to the relative performance of the trust and the services and consultant units within the trust.’ The Inquiry concluded that between 30 and 35 more children had died after heart surgery between 1991 and 1995 in Bristol compared to a typical unit in England at that time. So how are England’s child heart surgeons performing now?

The official figures for 2010-2011 look superficially reassuring. Over fifty procedures are listed and if you know which one you child is having, you can look at the results in your hospital and compare it to other units on a graph. If you look at, say, the results for the arterial shunt operation, you’ll see that half the units are above average, half are below average but none of them breach the ‘significant statistical outlier’ line that would trigger an investigation. The same is true of pretty much all of the procedures, but the problem is that for many operations, the numbers per hospital are so small as to be statistically meaningless and you’d have to be truly shocking to trigger an investigation.

Generally, the more of an operation you do, the better you get at doing it and teaching it, and the easier it is to statistically prove your competence, which is why the Bristol Inquiry recommended a reduction in centres performing surgery. The fact that we still haven’t managed this 11 years after the inquiry and over 20 years since the Eye broke the Bristol scandal is, in the words of NHS Medical Director Bruce Keogh ‘a stain on the soul of the specialty.’

Health secretary Jeremy Hunt has just ordered a review into the current review. So the Independent Reconfiguration Panel (IRP) will now decide if the Joint Committee of Primary Care Trusts (JCPCT) has made the correct choices in its proposed reduction in the number of surgical centres from 11 to 7, each with a critical mass of 400 operations a year (Eyes passim). Just about everyone agrees that child heart surgery in England would be safer if expertise, resources, research and training were concentrated in fewer centres, but no-one wants their local centre to close.

Meanwhile, expertise is spread too thinly and units are buckling under the strain. The Care Quality Commission (CQC) has investigated after a recent child cardiac death and other safety concerns in Bristol, has issued a formal warning to University Hospitals Bristol FT and concluded the post-operative ward is understaffed.

The JPCT chose not to use any outcome data in reaching its decisions because the numbers were too small. But if you add together the data for four or more years you get a much better idea of which units are performing best.  Last year, Professor Sir Brian Jarman, who heads the Imperial College Dr Foster Intelligence Unit, did a comparative analysis using the best data available to him and the same techniques that uncovered Bristol. He sent it to Keogh but got no response. He has just repeated the analysis for 2006-2012, sent it to Keogh and put it on his website. For open heart surgery in the under 5’s over the last 6 years, there are six units that have lower than the expected mortality ratio of 100: Leicester (45), Bristol (47), Brompton (65), Southampton (67), Newcastle (68) and Great Ormond Street (73). Leicester and the Brompton are marked for closure despite being in the top 3 for overall survival. Of the others chosen by the JCPCT, Birmingham has a mortality ratio of 110, Alder Hey 120 and Guys and St Thomas’s 128. Leeds (120) has not been chosen and Oxford (160) has been stopped from operating. The JCPCT argues that when (if) their proposals go through in 2014, the amalgamated expertise in the 7 units should ensure excellent results whatever the hospital site (if the staff work together and put their rivalries behind them). But if I could choose where my child went for open heart surgery tomorrow, I’d check out the staffing levels in Bristol but otherwise opt for any of the top six.

E mail correspondence post publication

From:david.cunningham@ucl.ac.uk

To: hamm82@msn.com Subject:

RE: Outcomes of heart surgery in children

Date: Wed, 31 Oct 2012 15:43:01 +0000

Hi Phil,

Enjoyed your article in Eye 1326 about Childrens’ Heart Surgery. In the CCAD Portal you can, as you say, observe data for each year. However the funnel-plot graphs (which are just about to be updated) show a THREE year view of the data, not just a single year – because, as you say, numbers get just too small. We thought three year was a good compromise between avoiding small numbers and using data that was too old to reflect current practice. Brian Jarman has chosen two cuts of the HES data, 6-year and 4-year. The casemix adjustment, or lack of it due to the inadequacies of HES codings, may explain some of the apparent differences. For instance Brimingham and Guys do most of the Norwood procedures for hypoplastic left heart syndrome, which may explain their relatively high SMRs. In our non-casemix adjusted analysis of the same 6 year period, inclusion or exclusion of Norwood ops for HLHS made a difference of 20 to the SMRs of Guys and Birmingham.

It is extremely difficult to risk adjust properly for congenital heart surgery – there is no adequate risk model existing in the world – but we are actively working on that with the Clinical Outcomes Research Unit (CORU) at UCL. Early results look fairly promising and the work is ongoing. In the meantime that is why we display results for over 50 relatively common procedures.

Brian mentions that they have applied for CCAD data, which is correct. The audit commissioning body, HQIP, rejected the application and offered DFI advice on how to reapply successfully for the data. We currently await the revised application. I would personally like to work with DFI in achieving an optimal analysis and would welcome discussions with them. It is really important this is done correctly – since Bristol there have been some false trails which have taken a long time to sort out and they perhaps could have been avoided without compromising the public interest, in my view.

I cannot comment on the wisdom of the choices made by the JCPCT but I understand at least some of the recommendations are being reviewed by the new Health Secretary. It is always going to be difficult, and highly emotive for so many people, to make these difficult choices. I hope this makes some sense. Rgds David Cunningham

Dr A D Cunningham Senior Strategist for National Cardiac Audits 07753 682686 . david.cunningham@ucl.ac.uk NICOR . Centre for Cardiovascular Prevention and Outcomes . University College London 3rd Floor . 170 Tottenham Court Road . London W1T 7NU

From:Jarman, Brian [mailto:b.jarman@imperial.ac.uk] Sent: 31 October 2012 17:43

To: Cunningham, A Cc: Phil Hammond

Subject: RE: Outcomes of heart surgery in children

Dear David, Phil copied me into his email to you. I am pleased to make contact. It has always seemed strange to me that, with my having been on the Bristol Inquiry panel, and Paul Aylin, and our Imperial College unit, having done the calculations for the Bristol Inquiry, we have never been able to get the CCAD data and yet there is no risk adjusted overall model published for PCS units (I don’t mean for individual procedures, where the umber of cases and deaths is not likely to lead to significant results that the public could use for making decisions about the units).

As you will see on my website, I say that our data is risk adjusted but we still use the case mix of procedures that we used for Bristol and they will have changed now. Paul has tried over the years to have access to the CCAD but HQIP has rejected the application and Paul says that they keep coming back to him saying he needs ethical approval, or ECC clearance. As you probably know, we have full clearance to receive HES data from the National Information Governance Board (NIGB), previously its predecessor the Patient Information Advisory Group (PIAG).

I think it could add to the information available if we were allowed to do our normal risk adjustments, which I describe on my website, using the CCAD data with the up-to-date case-mix. We would like to work with you to achieve an optimal analysis. At the Bristol Inquiry the parents of the children who died asked us why they weren’t told that the Bristol PCS, under 1 year, open heart surgery mortality was 29% (over 3 years). They could have driven an hour or two up the motorway and got a third of that mortality. We didn’t have an answer tor them then and, as far as I know, we don’t have an answer now. We concluded then (Bristol report, 2001, Chapter 12, “Concerns” paragraph 6):- “In short, there was no effective national system for monitoring outcomes. This situation was compounded by the assumption by a number of the respective organisations that it was not their responsibility but that of some other body. This meant, in turn, that the absence of, and need for, a national system was not recognised nor acknowledged at the time.” Also: “It would be reassuring to believe that it could not happen again. We cannot give that reassurance. Unless lessons are learned, it certainly could happen again, if not in the area of paediatric cardiac surgery, then in some other area of care.”

Best wishes, Brian.

 

From: Cunningham, A [mailto:david.cunningham@ucl.ac.uk]

Sent: 31 October 2012 19:13

To: Jarman, Brian Cc: Phil Hammond Subject:

RE: Outcomes of heart surgery in children

Dear Brian, Paul’s application to use for data has been rumbling on for a while now (but not ‘years’, but that’s by the by). I think HQIP’s point was there seemed little in the application that demonstrated any value to patients. I have no comment about that. Our point was that the application suggested the use of RACHS-1 methodology, which is quite definitely outdated and just doesn’t work. I do not personally see why Paul can’t word his application to keep HQIP happy. I would lose the reference to RACHS-1 and instead suggest that you/he will use or generate your own casemix adjustment. The adjustments you used in your analysis of 2006-12 data were necessarily limited due to you not having access to enough information in HES.

I don’t personally think valve disease is the way to go for risk adjustment in this very young group of patients – but here’s the thing, YOU may not agree with that and you may find that you can build a risk model that does work, which would of course be of value to everyone. I do not know about the ECC’s position – simplest way would be to email Claire Edgeworth (Claire.Edgeworth@nhs.net) – she is the Deputy Approvals Manager and could advise. Certainly we always have to have specific ECC approval when we seek to receive new data even if we have similar approvals already in place. I would refute any suggestion that all-cause, all-procedure mortality is a valid comparator UNTIL we have a properly working casemix adjustment tool.

My mentor Tony Rickards always said if he was going for an op he would look for the centre with the HIGHEST overall mortality and the lowest for his risk group – in other words they weren’t afraid to take on high risk patients. Not everyone would agree, naturally! It will be a condition of releasing data, should you/we convince HQIP that this is in everyone’s interest, that one of our Steering Group (probably me) works with you on the project and that publications and presentations are cleared with HQIP. I know the latter might be seen as restrictive, but no “veto” has ever been applied to any of the research projects we have collaborated with so far. I hope this is helpful, and perhaps signals the begining of a long overdue collaborative effort,

Rgds David Dr A D Cunningham Senior Strategist for National Cardiac Audits 07753 682686 . david.cunningham@ucl.ac.uk NICOR . Centre for Cardiovascular Prevention and Outcomes . University College London 3rd Floor . 170 Tottenham Court Road . London W1T 7NU

From:Jarman, Brian [mailto:b.jarman@imperial.ac.uk] Sent: 31 October 2012 To: Cunningham, A Cc: Phil Hammond

Subject: RE: Outcomes of heart surgery in children

Thanks David, I love their comment “there seemed little in the application that demonstrated any value to patients.” Tell that to the Bristol parents. Such a typical attitude, one that I find appalling, simply appalling.. If you don’t mind I’ll email your comments to Paul. I’d love to be able to work with you on this data with you – I think there’s a chance that we’d produce something that would be of “value to patients. Congratulations to Phil and Private Eye – there’s a chance that they will again have done something valuable for those parents. Best wishes, Brian.

From: James.Ford@grayling.com To: hamm82@msn.com

Subject: the Jarman data Date: Fri, 2 Nov 2012 10:49:29 +0000

Dear Phil

I suspect you may get a few letters about this week’s column. The Jarman data tells a partial picture (eg complexity of caseload) and is therefore seen as misleading. Can I suggest we set up a briefing (face to face or phone) for you to speak to one of the experts. I would suggest Prof Martin Elliott. If not: Leslie Hamilton, Shak Qureshi or Roger Boyle?

Best wishes, James 020 7025 7523 Managing Director – Public Sector Grayling 29-35 Lexington Street London W1F 9AH 020 7025 7523 www.grayling.com

From: hamm82@msn.com To: james.ford@grayling.com Subject: RE: the Jarman data

Date: Fri, 2 Nov 2012 11:48:16 +0000

Thanks James

Have already had a helpful reply from David Cunningham (attached) which I’ll be using in my next column. Let me know if there’s anything you’d like to add.

I will also point out that Brian Jarman has now sent his data to Bruce Keogh and the DH twice, without any response, and that Paul Aylin applied for the CCAD data to improve the risk adjustment of their analyses but was turned down by HQIP. I find it inexcusable that statistical experts aren’t sharing data to come up with the best combined analysis to guide patients and spot avoidable harm. As David Cunningham says, he’d like to work with Professor Jarman and DFI, and if the Eye column facilitates this collaboration and gets HQIP to approve the data share, I believe it will be a good thing. It seems churlish to complain that there isn’t a robust method of risk adjustment for PCS if you aren’t enabling your best statisticians to collaborate on it.

Phil

Protecting Whistleblowers?

Well done the British Medical Association.  Having taken some flak for negotiating compromise agreements with gag clauses for doctors leaving employment (see Shoot the Messenge, STM), it hosted a conference on  October 2 called ‘Protecting Whistleblowers’ with the campaign group Patients First (MD is a patron).  Dr Kim Holt spoke about whistleblowing at the clinic run by Great Ormond Street Hospital (GOSH) where Baby Peter was treated (see STM). She was proud to be a whistleblower, but lived in fear of the GMC. A common thread amongst many whistleblowers is that their NHS employers engage in vindictive counter-accusations and referrals to the GMC or NMC. Dr Raj Mattu, the former consultant and internationally respected cardiologist at University Hospitals Coventry and Warwickshire NHS Trust (UHCW) probably holds the record for this, with what he believes are over 200 allegations made against him by UHCW (who decline to clarify the number).

Mattu first blew the whistle in 1999 because he believed a patient had died as a result of UHCW’s policy of putting 5 patients in a 4 bedded bay to meet waiting time targets. This made it impossible to resuscitate effectively in an emergency (see STM).  In 2001, a Commission for Health Improvement review found the comparative death rate for non emergency admissions including cardiology was 160 (compared to the English NHS average of 100). Mattu continued to raise concerns and was suspended on full pay for eight years from 2002, despite an independent inquiry recommending his reinstatement in 2005. He was sacked in 2010. He persistently refused to take a pay-off with a gagging clause and instead pursued an unsuccessful claim against UHCW in the High Court.  Next month, Mattu and UHCW meet at employment tribunal. He has no money and will represent himself. This case is already one of the most expensive in NHS history, costing the taxpayer over £5 million, and Mattu has had  his career, health and vital research slides destroyed. At the time, UHWC’s mortality rates were as bad as nearby Mid Staffs, and it may be that the brutal treatment of Mattu dissuaded other whistleblowers in the region.

Kim Holt did not take the gag money either and was suspended for over 4 years. As she put it: ‘Any employer can sack any employee in any sector. All you can get is compensation.’  She also warned of the dangers of signing a gag clause. ‘The clause will often oblige you to hand back all your documentation,  so you subsequently have no evidence even if you wanted to take it to the regulators. But if the scandal ‘blows’, you will be charged with complicity in the cover up.’

NHS whistleblowers won’t be protected until those who may have suppressed  or failed to act on their concerns are properly investigated, and their Trust boards held to account. On 30.9.2011, MD and Andrew Bousfield asked the GMC to investigate whether Dr David Elliman, a GOSH consultant with responsibility for child protection, had acted appropriately on the concerns raised by Dr Holt. A year later, the GMC is still taking legal advice. On 10.7.2012, we asked the GMC to investigate Dr Barbara Hakin, the NHS Director of Commissioning, in her former role as CEO of East Midlands SHA, to judge whether she had acted appropriately on the patient safety concerns raised by former United Lincolnshire Healthcare Trust Gary Walker, who was sacked and super-gagged by the NHS. On 6.8.12, the GMC  instructed Field Fisher Waterhouse LLP to ‘assist in the investigation’.

Walker also made a protected disclosure to NHS chief executive Sir David Nicholson, who must now specifically and publicly remove the gag from Gary Walker and allow him to present his evidence that patient safety was compromised by government targets that he was ordered to meet. The lifting of this single gag would signal a profound change of culture at the top of the NHS towards protecting whistleblowers. If Nicholson and Hakin have nothing to hide, they have nothing to lose.

Note: The BMA has just produced  Guidance on Whistleblowing

It says, as a key point, ‘You are protected in law from harassment and bullying when you raise a concern.’

 

In fact, all the law currently does is to compensate a few lucky whistleblowers after they have been victimised. It does very little to protect them

 

The BMC and Public Concern at Work are at least raising concerns about the potential amendments to Clause 14 of the Enterprise and Regulatory Reform Bill which would make whistleblowers more vulnerable than they already are. At present, it’s all too easy just to suspend or sack them, even if they are members of the BMA.

 

How to choose a hip surgeon

If you’re having a new hip put in, would you go for one with an established track record, or a brand new one with slick marketing but no safety data in humans? And which of the 107 cups to put with which of the 139 stems? A big or small head? Metal on metal, metal on plastic or ceramic on ceramic? A total hip replacement or just a resurfacing?  Unsurprisingly, most patients let their surgeon decide for them. Get it right and a hip replacement removes crippling pain and restores mobility for 15 years or more. When it fails – as 8,641did in 2011 – it can be a disaster, requiring extensive, expensive and unpleasant revision surgery that isn’t always successful. But if you ask ten different surgeons, you might get ten different opinions. So who can you trust?

In 1997, following the failure of the Capital Hip, MD advised patients to choose a hip surgeon who used a tried and tested prosthesis and had long term audit to show he or she was good at putting it in. I also campaigned for a compulsory National Joint Registry (NJR) that published comparative data for all surgeons and the joint replacements they used, so that patients could see the evidence and surgeons and regulators could spot a failing hip quickly and avoid unnecessary harm. The registry was finally up and running in 2003, but only this year has it identified hospitals with the highest joint replacement failure rates. Any hospital could have a brilliant and a woeful surgeon whose amalgamated results are ‘average,’ and patients still don’t have access to surgeon specific data. More worrying, regulators didn’t act to stop ASR hip replacements until 2010, even though the Australian joint registry had been flagging problems since 2005. 93,000 were put in worldwide, 10,000 in the UK, with failure rates up to 50%.

Part of the problem is that the UK NJR only became mandatory in 2011. Professor Paul Gregg, who helped set up the registry, strongly lobbied for a mandatory register but the DH under Labour resisted. Voluntary and incomplete reporting has allowed surgeons to hide bad results and almost certainly delayed the NJR identifying failing ASR joints and those surgeons who should have stopped using them. At the very least, the NJR should name and shame the surgeons who have not submitted all their data for independent scrutiny.

A further problem is the freedom given to orthopaedic surgeons to choose any prosthesis. New is often not better, despite what the manufacturers claim, and even small modifications can have untoward effects. And because medical devices aren’t tested in humans prior to use, problems can only be spotted in a timely way by if the registry is complete.  Surgeons in North Tees lead by Tony Nargol were convinced ASR hips would be best for over 400 of their patients, but at least were very diligent in submitting data to the NJR. In the latest NJR report, three out of the eight statistical outliers for hip revision surgery are the University Hospital of North Tees, the University Hospital of Hartlepool and Nuffield Health Tees hospital. North Tees and Hartlepool NHS Foundation Trust has also been issued with an alert because its Patient Reported Outcome Measures after hip replacement show ‘significantly lower EQ-5D Health Gain than the average across England.’

Nargol deserves credit for blowing the whistle to manufacturers DePuy and the MHRA about problems with the ASR, and is reaping rewards now by specialising in researching and revising the failed hips he and his colleagues put in, and as a medicolegal adviser against DePuy. However, the ASR patients of North Tees are not so fortunate. In 2000, NICE advised that ‘wherever possible’, the NHS should use artificial hip joints that can show they last for 10 years or more’ (i.e. with a maximum failure rate of 1% a year). Three years of data was considered and absolute minimum,  and newer prostheses such as the ASR should only be introduced in a proper clinical trial with ethical approval and full consent from patients to show they accepted the longer term risks were unknown.

The Care Quality Commission is now considering an investigation in North Tees. It needs to discover whether a proper controlled trial of ASR hips took place, whether patients consented to the potential risks and complications as they arose, whether patients were selected appropriately, whether surgeons stopped using the ASR brands quickly enough when they identified problems and whether the Trust management tried to stop them. At present, only surgeons and their chief executive have access to an individual’s NJR data and a ‘funnel plot’ of how it compares with the rest of the UK. It’s entirely up to them whether they act on it or bury it. If you’re having any joint replacement, you should demand to see your surgeon’s funnel plot. Outliers are easy to spot outside the funnel. If he or she won’t show you, run a mile. Or hobble out.

MD

Medicine Balls Special: Metal Hips, Cancer Scares and the British Medical Journal  

To commercially damage any product, however inadvertently, all you have to do is link it with cancer in the public mind. The ensuing panic benefits lawyers and journalists, but it only helps the public if the risks are substantial and somewhere near proven. In March, a group of angry orthopaedic surgeons contacted the Eye to complain about the link of Metal on Metal (MoM) hips to cancer in the March 3^rd edition of the British Medical Journal^{1 2}, and a BMJ-Newsnight ‘special report’ on February 28^{th 3}. The cancer link was picked up in the Sunday Times ⁴ on March 4^th and fuelled an ongoing cancer scare in patients with MoM hips, and patients who weren’t sure what hip they had.

As for patients considering a new hip, who would now choose an MoM when a source as credible as the BMJ states there are ‘substantial concerns about the increased risk of cancer’? But there is no good evidence showing MoM hips cause cancer. Bristol University, one of the leading research centres looking at this told the Eye: ‘It is far too early to make any conclusions’ about any link with MoM hips and cancer. And although cancer scares are regular occurrences in the media, you’d expect better from the BMJ (motto ‘helping doctors make better decisions.’)

This was the second cancer scare orthopaedic clinics had to deal with in only a month. On February 5^th, the Telegraph ran a story linking MoM hips to bladder cancer ⁵, based on unpublished research from Dr Patrick Case and colleagues in Bristol. Because the research was unpublished, NHS staff dealing with anxious callers had no access to any reliable information to give to patients. When the Sunday Times later became interested, Dr Case – a Consultant Senior Lecturer at the University of Bristol – wrote a desperate e mail to colleagues: ‘I have told this journalist that our study does NOT provide the first clinical evidence linking metal-on-metal hip implants to an increased risk of cancer. Our paper is not yet written and it will not conclude this. The journalist has told me that he will change his story. I have warned him of a public scare and have reminded him of the MMR panic.’ The Sunday Times (March 4^th) duly lead with the front page headline: ‘Research links hip implants to cancer’.

The research has still not been published and may never be. Of 80 patients studied, one had bladder cancer, he’d only had an MoM hip in for a short time but he was a heavy smoker (a far more likely cause). To make matters worse, a BMJ-Newsnight investigation on February 28^th gave another plug to the Bristol scare. ‘We understand that on Thursday, research will be presented looking at the risks of bladder cancer in these (MoM hip) patients.’ The BMJ and Newsnight should have been aware of the widespread panic this ‘non story’ had already caused. The University of Bristol states that no one from the BMJ or Newsnight contacted them prior to broadcast, and that there is, as yet, no clinical evidence linking bladder cancer and MoM hips. And the BMJ had far more substantial research due for publication from the National Joint Registry that was much less alarmist.

On April 3^rd, the BMJ published the paper ⁶ which concluded: ‘In a large representative sample there was no association between metal-on-metal hip replacements and increased incidence of cancer in the first seven years after hip replacement.’ And ‘the one year incidence of cancer after total hip replacement is lower than that observed in the general population.’ But by that stage, the damage in the public mind had been done. As a lawyer from the London firm Leigh Day – which specialises in MoM hip litigation – told the Sunday Times: “The fact that you’ve now got a study which demonstrates that there may be cell changes is very significant.” And doubtless many more clients were flushed out by the scare.

There are failure problems with some types of MoM hip. The DePuy ASR range was removed from the market in 2010 and stemmed MOM implants are failing at much higher rates than other types, particularly those with larger head sizes and those implanted in women, in whom failure rates are up to four-times higher. But other types, such as the Birmingham Hip Resurfacing (which MD would choose for himself), have an excellent track record over 15 years, particularly in large, active men, and the last thing they need is an unsubstantiated cancer scare.

The theory linking MoM hips with cancer is that the metal surfaces of the cup and ball joint wear, producing particles of chromium and cobalt that enter the tissues and blood stream and could one day lead to cancer. Some of the newer MoM hips release more chromium and cobalt than previous models. Whether this is just a marker of wear and tear in the hip, or whether it could lead to distant disease or widespread poisoning has yet to be established. After 7 years of follow up on these models, no proof has been found.

The BMJ is part of a worthy campaign to improve the regulation of medical devices. New rules are currently being drawn up by the European Commission to give the public access to details of the clinical research about all devices and implants, and their safety record. But the BMJ’s high profile campaigning has to tempered with scientific balance. The March 3^rd issue seemed to damn all types of MoM implant. ‘The risks of metal on metal hip implants’ had a bold green headline on the cover and the story – and link with Newsnight– was heavily trailed by the BMJ publicity department. The editor’s choice was headlined ‘Serious risks of metal on metal hip implants’ and the only two features in the journal were an investigation titled ‘Hip implants: how safe is metal on metal?’ and an adjacent commentary taking a very similar line: ‘Ongoing problems with metal-on-metal hip implants.’ The coverage was overwhelming negative with no balancing article on, say, the success of the Birmingham hip.

The large print summary in the first BMJ article claimed that ‘hundreds of thousands of patients may have been exposed to toxic substances after being implanted with potentially dangerous hip implants’ and the second opened with ‘substantial concerns currently exist’ about ‘newer (MoM) hip implants and increased risk of cancer.’ MD asked some of the authors to provide details of any patient known to have cancer or poisoning from an MoM implant. There were no cancer patients to be found, and a few possible metal ion poisonings in Alaska. The best we can currently say is more research is needed (see University of Bristol statement below). Far from sounding like the balanced voice of British medicine, parts of March 3^rd issue read like a lawyers’ press release. An internet search of ‘hip lawyer bmj’ reveals pages of citations on legal websites in the US and UK, many feeding on the credibility of the BMJ.

The BMJ did at least disclose that one of its expert authors, David Langton, is also an expert witness in a class action lawsuit in the United States in relation to the DePuy ASR MoM implant. But it chose not to declare that he is in a relationship with the BMJ’s investigations’ editor, Deborah Cohen, who wrote the other article and presented the Newsnight film, and who had declared the relationship to the BMJ. Dr Cohen introduced Mr Langton to the other authors, but the BMJ says there is no financial relationship between them, so it did not need to be declared to its readers. Many orthopaedic surgeons and hip manufacturers who were aware of the relationship have other views and in MD’s opinion, the BMJ should either have declared it or simply removed one of these authors from the investigation.

 

What is certain is that the hip-cancer scare caused considerable short-term distress for patients and a large increase in workload for NHS staff dealing with calls and inquiries. The long term fear is that patients will shun a proven prosthesis such as the Birmingham hip for a less tested variety, and that those with existing MoM hips will ask them to be removed because of the cancer scare when the known risks of revision are far greater than the unproven risk of cancer. In June the BMJ quietly published a paper on line (with no press release or Newsnight film) that concluded ⁷‘Compared with uncemented and cemented total hip replacements, (the) Birmingham hip has a significantly lower risk of death in men of all ages.’

 

The BMJ has admitted to the Eye that the evidence linking hip replacements and cancer is ‘sparse’, and for those who read the offending articles in their entirety, this point is made. However, the alarmist headlines, press release and accompanying film had a predictable effect in whipping up anxiety and legal interest. And once a health scare is out of the bottle, as the Eye well knows following its involvement with MMR, er…. it’s extremely hard to put back in.

MD

1  BMJ2012;344:e1410

2  BMJ2012;344:e1349

3  http://news.bbc.co.uk/1/hi/programmes/newsnight/9700909.stm

4 http://www.thesundaytimes.co.uk/sto/news/uk_news/Health/article986358.ece

5http://www.telegraph.co.uk/health/9061781/Hip-replacement-patients-could-face-increased-risk-of-cancer.html

6 BMJ2012;344:e2383

7 BMJ 2012;344:e3319

 

Statement from University of Bristol re: Sunday Times article –
Research links hip implants to cancer

Researchers at the University of Bristol presented a paper to the Hip Society last week [Thursday 1 March] about an unpublished study on metal-on-metal hip implants.

Contrary to media reports, the study will NOT provide the first clinical evidence linking metal-on-metal hip implants to an increased risk of cancer.

The paper, which has not yet been peer-reviewed when published, is expected to conclude that metal-on-metal hip implants is an important subject and a larger study involving several centres will need to be conducted to show whether or not there is a risk of cancer from metal-on-metal hip implants.

Patients who are concerned about their metal-on-metal hip implants should contact the hospital that carried out the procedure for advice.