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Archive - Year: 2010

February 18, 2010

Private Eye Column, Issue 1256, February 17, 2010
Filed under: Private Eye — Tags: , , , — Dr. Phil @ 8:18 am

THE EDITOR ASKS M.D. TO PEER REVIEW PRIVATE EYE’S MMR COVERAGE

M.D. writes: Private Eye got it wrong in its coverage of MMR. It gave undue prominence to unproven theories based on a small number of uncontrolled observations, and paid far less attention to the weight of evidence from large comparative studies that failed to find any association between MMR and autism. While the Eye cited potential conflicts of interest in many of the key supporters of MMR, it failed to point out any unethical or prejudicial behaviour by Andrew Wakefield.

The 1998 Lancet paper that started the scare has now been removed from the medical literature on ethical grounds; and Wakefield, its leading author, may soon be removed from the medical register. Clearly what precious research money there is should now be used to test more credible hypotheses for the causes of autism.

The Eye has never claimed that the link between MMR and autism or bowel disease was proven; rather that better research was needed to answer the question conclusively. And it stressed the danger of infectious disease and the importance of vaccination. M.D. twice asserted that he had no safety concerns about MMR and that both his children had been vaccinated (Eyes 1045 and 1096); but overall the Eye sided with parents who were suing the vaccine manufacturers, and its coverage was consequently one-sided.

The parents were supported not just by Wakefield but by 27 expert witnesses who submitted files to support their case, and an equal number behind the scenes. The 1998 Wakefield paper and press conference caught the medical community on the hop, and there was little evidence to refute the proposed link because trials simply hadn’t been done. When the Eye joined the controversy in 2001, there were plenty of specialists willing to support the possibility that Wakefield might be right.

So when should the Eye have bailed out?

Small trials and observations can eventually lead to proof, but only if their findings can be replicated in larger trials. The best attempt to replicate Wakefield’s original observations and hypothesis – that the measles component of the MMR vaccine can lead to inflammation in the bowel and cause the release of chemicals that promote autistic disorders – was headed by Ian Lipkin MD, of the Mailman School of Public Health of Columbia University, published in 20081. This was a case-control study looking at the timing of the onset of autism and gastrointestinal (GI) disorders, in relation to the MMR vaccine.

The study also looked for the presence of measles in the bowel tissue of 25 children with both autism and severe gut disorders and matched them for age with 13 children with similar gut symptoms but not autism. The median age of the autistic children and the control group was 5.5 and 5.1 years, respectively, and they got the first dose of MMR vaccine at about the same age – 15.3 versus 16 months.

The children were selected because their gut symptoms were sufficiently grave that a biopsy was indicated for clinical reasons, which allowed the researchers to obtain tissue samples for the current study and try to replicate the Wakefield research, which found measles virus RNA in bowel tissue of 77 percent of children who had both autism and gut disorders, but not in children in a non-autistic control group.

However, the Lipkin research found no difference between the two groups, with evidence of measles viral RNA found in only one case and one control, despite using three labs and the best molecular detection methods available. Neither did the timing support a link between the vaccine and either autism or gut disorders. Only 13 of the 25 children with autism had the vaccine before the onset of autism, and in only 16 had the gut symptoms preceded the autism.

Such invasive research on children is extremely difficult to recruit volunteers for, and get ethical approval for. Given the GMC’s condemnation of Wakefield for taking unethical shortcuts, it may now be much harder to perform similar or larger studies to add to the evidence base.

However, by far the strongest evidence that has failed to find a link between MMR and autism is epidemiological. Because autism is common, any association between it and the MMR vaccine would show up clearly in large population studies compared to a control group that had not had the vaccine.

In 2002, a large retrospective cohort study of 450,000 children who’d had MMR, and 100,000 who hadn’t, found no difference in rates of autism2. So if a link did exist between MMR and autism, it was so weak as to be statistically undetectable.

The trial was not perfect (a Cochrane review – the most rigorous and independent analysis of medical trials in existence – adjudged it to be of moderate risk of bias and the follow-up of children should have been longer3); but it had far more statistical weight than any trials preceding it. All of Wakefield’s four papers were excluded from the Cochrane review as they lacked any scientific weight (one was a small case series, two had no comparative data and one had no data at all).

Another large trial published in the Lancet in 2004 also found no evidence of a difference in the rates of autism in the two groups4 and the Eye reported the Cochrane findings in 2002 and 2005 that, when all the best available trials were analysed together, there was no credible evidence of a link between MMR and autism (Eye 1066 and 1145).

The Eye was right to keep asking questions on behalf of parents. There have been plenty of medical scandals exposed by investigative journalism, and plenty more to expose. This could have been one, but it wasn’t. By the time of the second Cochrane review, the Eye should have conceded the argument.

1 Hornig M, et al “Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study” PLoS ONE 2008; 3(9): e3140. DOI: 10.1371/journal.pone.0003140

2 Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P et al. A population-based study of measles, mumps, and rubella vaccination and autism. N Eng J Med (2002); 347 (19): 1477–82

3 www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004407/pdf_fs.html

4 Smeeth L, Cook C, Fombonne E, Heavey L, Rodrigues LC, Smith PG et al. MMR vaccination and pervasive developmental disorders: a case-control study. Lancet (2004); 364 (9438): 963–9




February 16, 2010

Dr Phil’s Private Eye Column, Issue 1255, February 3, 2010
Filed under: Private Eye — Tags: , , , — Dr. Phil @ 10:05 pm

Very human errors

Last year, MD met an Australian surgeon who tells his junior staff: ‘Your job is to stop me killing anyone.’ Nurses, receptionists, patients and relatives are all encouraged to speak up if they think something isn’t right, and it’s looked into promptly without knee-jerk blame. As a result, his cock-ups and complaints are commendably sparse and he has no shortage of applicants for his training posts.

The NHS has been trying to develop a grown-up safety culture for over a decade, but there is still a huge reluctance for staff to comment on each other’s work. A senior nurse who helped developed the national guidelines for the safe and sterile insertion of central venous lines recently observed a junior doctor putting a central line with a clearly dirty technique. The drapes weren’t in place and there was a danger he would introduce infection directly into the patient’s blood stream. But because it wasn’t her patient and she didn’t know the doctor, she didn’t feel in a position to comment.

The reticence of some NHS staff to offer constructive criticism and the unwillingness of others to accept it is at the heart of many clinical errors. When serious errors are analysed in detail, staff have often spotted something wrong but not said anything, or tried to raise concerns and not been taken seriously. In the infamous ‘wrong kidney’ disaster, both the medical and nursing students tried to point out the surgeon was operating on the wrong side. And in the death of Elaine Bromiley (Eye 8.5.08 ), nurses recognised that she needed an emergency tracheotomy after a failed anaesthetic,  and even brought the kit into the operating theatre, but didn’t feel able to interrupt the consultants.

Elaine’s husband Martin, a pilot, founded the Clinical Human Factors Group (CHFG) to help the NHS learn that guidelines and checklists are pointless without behavioural and cultural change. Under pressure, even the most senior doctor can panic, develop tunnel vision and go badly off piste, and without a team ethos that allows someone more junior to point this out, a disaster inevitably happens. The CHFG has now joined forces with the Patient Safety First campaign for a series of webcasts on the importance of addressing human factors in preventing medical error. One relatively simple idea is to encourage anyone performing a procedure to say: ‘If you think I’m going to make a mistake, please tell me.’ This also applies to patients and relatives. A change of pill colour or site of infusion is always worth querying. And given that 1 in 10 patients are harmed by their treatment, even a modest reduction in medical error could pay huge dividends.

Picking up errors after the event is also important. Pathologists are particularly vulnerable because tissue patterns are complex and subtle, and samples reported under stress are then stored for others to analyse at leisure. Specialists are also in short supply and this makes it imperative that pathologists work in teams and networks across regions, double checking difficult samples and seeking expert opinions. In Bristol, where pathologists in one hospital have tried to raise concerns about errors at another, the culture appears to be stuck in ‘how dare you question my reporting?’, rather than ‘let’s work together to make sure this patient gets the correct diagnosis and best treatment.’ Whether the current inquiry sorts it remains to be seen (Eye last), but the pathology departments of both hospitals could do worse than sitting down together for the Truth and reconciliation following serious harm webcast (Thu 4 Feb, 10.30-11.30)1

1  www.patientsafetyfirst.nhs.uk/Content.aspx?path=/Campaign-support/humanfactorsweek/.




February 1, 2010

Dr Phil’s Private Eye Column, Issue 1254, January 24, 2010
Filed under: Private Eye — Tags: , , , — Dr. Phil @ 5:29 pm

Bristol Update

 ‘Failure to reconfigure child heart surgery will be a stain on the soul of the specialty and will compromise the treatment of the most vulnerable members of the next generation.’ So says NHS Medical Director and cardiac surgeon Sir Bruce Keogh, just 18 years after the Bristol heart scandal was exposed in Private Eye. The Public Inquiry a decade ago found that as many as 35 babies had died unnecessarily, and a review in 2003 recommended the concentration of scarce expertise and equipment in fewer centres. Alas, Labour ignored it for fear of the political ramifications. Keogh admits there has ‘frankly been little progress’ since the inquiry and he can’t at present guarantee that ‘another Bristol’ won’t happen. The job of fixing it has now been handed to the National Specialised Commissioning Group (NSCG), which since 2007 has been responsible for making sure the treatment for all rare and complex conditions is ‘safe and sustainable.’ As Keogh puts it: ‘The NSCG has to flex its muscles. Politicians have to accept their recommendations and clinicians have to put aside personal conflict and institutional self interest.’ And patients and parents have to accept they may have to travel further to get the best treatment. We shall see. The battle to safely reconfigure specialist services is also at the heart of the current Bristol pathology inquiry, which MD is due to give evidence to next month. The Royal College of Pathologists (RCPath) describes pathology as ‘the hidden science at the heart of modern medicine’ but it’s high time it was flushed out into the open. As medicine becomes increasingly technical and individualised, there is an urgent demand for specialist pathologists with the experience to spot the complex nuances in tissue samples and advise on treatment. Alas, specialist pathologists are in short supply and the temptation, to save money and hold onto business, is to let those with insufficient expertise report on complex slides. This is the allegation made against pathologists at University Hospital Bristol, with evidence submitted of serious reporting errors for complex gynaecology, respiratory, dermatology, breast and paediatric tissue samples. There is also evidence that, as with the heart scandal, a lot of senior NHS managers, consultants and the royal college have known concerns about UHB’s pathology department for some time. So there are powerful vested interests in not having another scandal. UHB ordered the external inquiry, chaired by Jane Mishcon, but only after the Eye went public with the allegations. The Trust was initially overseeing the inquiry, but this clearly lacked independence and it has now transferred to London under the management of Verita. However, the inquiry panel has no control over the analysis of samples. The alleged errors reported to MD have occurred between 2000 and 2009, and all in specialist areas. Whereas the inquiry is looking at a random sample of 3,500 adult slides taken across a single year and including all the ‘bread and butter’ reporting, so complex mistakes can be buried and the overall error rate will look small. This is precisely the tactic used in defence of the heart surgeons. The inquiry needs to focus its attention on specialist areas and specific cases. Against this background, local cancer services are in the process of being reconfigured to make them ‘safe and sustainable’. All are highly dependent on co-operation between hospitals and developing specialist pathology services but whether Bristol’s clinicians and managers can work together and share expertise remains to be seen. Oh, and UHBs chief executive Graham Rich has just resigned.




January 10, 2010

Dr Phil’s Private Eye Column, Issue 1253, January 10, 2010
Filed under: Private Eye — Tags: , — Dr. Phil @ 9:33 am

Have anyone read the NHS Constitution? The draft document was launched a year ago, when Gordon Brown, former health secretary Alan Johnson and NHS chief executive David Nicholson staged a glitzy Downing St signing of this ‘historic document’ that would repackage targets as ‘patients’ rights enshrined in law.’  All of us were encouraged to feedback by February 5, 2010. But a DoH survey a month ago found that only 47% of NHS staff were even aware of the constitution, and just 22% of patients. And virtually no-one had an in depth knowledge of what it contained, leading the researchers to conclude there was a ‘vision gap’ and that more work was needed to keep it ‘vital and fresh.’ 

As a result, health secretary Andy ‘Little Boy’ Burnham added seven ‘vital and fresh’ patient rights to the twenty five we still haven’t read. These are that patients should have the right to 1) choose to die at home 2) access NHS dentistry 3) have a personal health budget 4) choose a GP practice offering extended access to evening and weekend appointments 5) have key diagnostic tests for suspected cancer patients within one week of seeing a GP 6)  Be treated in a private hospital if the NHS can’t do so within 18 weeks of referral (or 2 weeks in the case of cancer) 7) have a 5 yearly NHS check to assess the risk of heart disease, stroke, diabetes and kidney disease (aged 40-74 only, starting 2012).

The idea that patients should have a clear idea of what we can expect for our £105 billion a year is not a bad one, and there are also responsibilities for patients and rights for NHS staff. But the NHS has to make ‘efficiency savings’ of at least £20 billion over the next few years and, along with Brown’s populist promise of free social care for the elderly, none of the rights appear to have been costed.  Take Burnham’s first proposal. Half a million people die in England every year, two-thirds of them are over 75 and the vast majority of deaths follow a period of chronic illness such as cancer or heart disease. About 60% of these deaths currently occur in acute hospitals, there is no clinical need for patients to be there and most would rather die at home.  But palliative care is so poorly funded by the NHS that many people only manage a home-death thanks to the work of hospices and other charities.  So making this a legally enforceable right for such a large number of people without providing the resources to do it smacks of desperate electioneering.

Of the 25 original proposed rights, many are reworking of the original values of the NHS with appropriate cop outs (e.g. “You have the right to receive NHS services free of charge, apart from certain limited exceptions sanctioned by Parliament.” And “You will not be refused access to NHS treatment on unreasonable grounds.”) There’s a proposed a legal right to receive any appropriate treatment that has been approved by NICE and a right (under certain circumstances) to be treated in other European Economic Area countries or Switzerland. And above all, “you have the right to be treated with dignity and respect” and “a right to a professional standard of care, by appropriately qualified and experienced staff, in a properly approved or registered organisation that meets required levels of safety and quality.”

All those on the wrong end of NHS scandals last year will doubtless be interested in the last right, which also comes with a right to compensation in the case of proven negligence. The fact that you have to go through the tortuous process of proving negligence when you’ve been harmed by healthcare will  hardly make the NHS more humane. Indeed, the only winners in this scattergun of un-costed legal rights are likely to be lawyers. But you still have a month to air your views. Happy New Year.

FFI www.dh.gov.uk/en/Healthcare/NHSConstitution/index.htm




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