The endless repetition of a failed experiment

Lord Saatchi’s Medical Innovation Bill and the new ‘Access to Medical Treatments (Innovation) Bill’, due for its second reading in the House of Commons on Friday 16th October, are cut from the same cloth – and it’s no Ede & Ravenscroft. Indeed, the Access to Medical Treatments (Innovation) Bill shares a similarly alluring [and similarly misleading] title –  and contains the same wording, the same premise and the same risks and problems as Saatchi’s originals.

Saatchi’s Medical Innovation Bill, version 7 or so, was not given extra special preferential deal time in the last parliament – if you’ll believe the Telegraph, it was “killed off” and Nick Clegg has “the blood of cancer patients on his hands” (having inspected I can confirm his hands are warm, well perfused, no Osler nodes, splinter haemorrhaging or blood of millions) – but, the Bill declared dead, deader than dead and gone, made a rather sprightly reappearance as soon as possible under the new parliament.   Now back in the House of Lords, Lord Saatchi put forward a motion to suspend SO46 which, if agreed, would permit his creation to pass through any number of stages on the same day.

Meanwhile, Saatchi endorsed a then-unannounced, entirely unwritten, conservative MP’s Private Members Bill as a new incarnation of his Medical Innovation Bill, carrying forward the Saatchi Bill to the Commons.  I get the impression that Chris Heaton-Harris is probably a nice guy who has some good ideas and probably has reasonable hands- indeed he wasn’t wholly sold on Saatchi’s plan himself – but whatever has pressed him into using his PMB ballot win on his/Saatchi’s new  ‘Access to Medical Treatments (Innovation) Bill’ – recently published – must be worth his while.

Now the really perplexing part. I mean, sure, it was perplexing to begin with – Lord Saatchi’s assertions in the House of Lords, articles in the Bill’s ‘media partner’ the Telegraph, google hangouts and briefing documents, included the following:

‘Current law requires that patients receive only standard procedure – the endless repetition of a failed experiment.’

‘In this way, the current law is a barrier to progress in curing cancer. It defines medical negligence as deviation from standard procedure. In other words, any deviation from standard procedure by a doctor could currently result in a verdict of guilt for medical negligence. However, as innovation is deviation, non-deviation is non-innovation.’

and

“The sentence of this Court is that you be taken from hence to the place of execution and that each of you there will be hanged by the neck until you be dead. And may Almighty God have mercy on your souls”

‘….much the same can be heard in every cancer ward in every NHS hospital every hour of every day

… those condemned by cancer suffer a worse fate than the worst mass murderer.

…While they await execution, they are tortured. For them, hair loss is the good news. Less good news is that their treatment regime—the drugs and the cycles of their administration, and the surgical procedures—are often 40 years old. They create the same symptoms as the disease: nausea, diarrhoea, vomiting and fatigue. A beautiful woman’s legs turn into elephant’s legs; her arms begin to make a heroin addict’s arms look attractive; and her bosoms turn into raisins’

‘The self-interest of medical practitioners…means that innovation (i.e. deviation) is a form of self-harm’

and so on, and on and on.

Er – right. Well, no; wrong. It is simply wrong. So wrong, that it’s hard to believe this can be serious.

Saatchi’s Medical Innovation Bill was met with widespread criticism from expert academics in law, medicine, medical defence and doctors’ representative organisations,  the regulator, the Royal Colleges, patient safety charities, medical research charities, clinicians, the National Assembly for Wales, and the likes of Sir Robert Francis QC and Sir Ian Kennedy QC, all of whom restated the correct law and emphasised the serious dangers and problems, and entirely flawed premise. The Department of Health consultation responses, withheld for some time, also revealed that just 10% would support it as it was.

 

‘The number of attempts at this Bill suggest it is not the right answer 

Each time objection has been raised to the Bill and its contents a different version is forthcoming.’

‘The difficulties that have caused so many drafts to be produced suggest that if there is to be legislation a more considered and less rushed approach is called for if we are to be satisfied that the patients who are intended to be benefit from this Bill, and patients generally, are not exposed to increased danger and risk.’

Medical Innovation Bill – Comments of Sir Robert Francis QC 23 June 2014

 

So, despite its intense polishing and spin, no-one with insight can possibly support it. There is no evidence to support its existence.  It does not stand up to scrutiny. 

Yet the situation today is this:

Chris Heaton-Harris MP has taken the Bill forward in the House of Commons – replicating the harmful bits, and adding some more.  

 

First published in September, the draft being taken forward on Friday has been finalised and published this week, along with ‘explanatory’ notes.

MPs are being presented with a whole brochure of masterful spin.

Sensing opposition rumbling, and the fact there’s no evidence in its favour, the medical innovation bill team have emailed asking for ‘stories’.. (‘cos that’s what sells stuff)

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This would all have a bit of comedic value for a 10 minute exaggerated sketch.  But the mild bemusement at the return of this spectacle makes way for a grim disquiet.  The serious threat to patient safety, the woeful misapplication of the law, the distortion, confusion and hurdles for doctors, and the absolute refusal to acknowledge any real barriers to innovation – aren’t funny at all. 

Stop the Saatchi Bill Alliance would like as many people as possible to contact their MP before Friday, to stand up to this obvious abuse of process and prevent its disastrous consequences.

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Stop the Bill now! was the plea from the Royal College of Paediatrics and Child Health, who note the ‘sinister’  and ‘disastrous’ Access to Medical Treatments (Innovation) Bill would place patients at grave risk; the Royal College of Surgeons has said it risks harming vulnerable patients and unequivocally opposes the Bill; RCSEd have told MPs it is unnecessary, dangerous and offers no practical assistance for responsible doctors -and  the Medical Royal Colleges have made their opposition clear. Again, the BMA have warned it is an unnecessary and nevertheless crude tool, that is counterproductive and would have implications for patient safety, and AvMA, charity for patient safety and justice, have expressed deep concern at the proposed, unnecessary, legislation- fraught with unintended and dangerous consequences.

See:  Stop the Saatchi Bill Alliance – Call to action!

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Honestly? patients deserve better

Lord Saatchi, between referencing his bereavement as the motivator for his bill, writes in the Telegraph that honest opposition to his bill has dispersed contentedly. Not so.

I experienced a very bad bereavement, indeed more than 5 significant ones within around 18 months, and it certainly did influence my decisions post-hoc. I had intrusive flashbacks of drawn out and agonising deaths, I was plagued by second guessing what I could have done or said differently, what I could have done to have altered the outcome, did I let them down by allowing them to do that, did I let them down by not insisting on more?  I crumbled entirely, indeed so much that I can never apologise adequately for the extent to which I fell apart. The experiences I went through and the profound and haunting loss had such a detonating influence on me that I tore my previous life to shreds, annihilated my job in a place with good colleagues, polite receptionists, comfy chairs and sensible pension schemes which gave out free cake and drinks and went back to the beginning, to medical school, to become a doctor. I also teach students and health care professionals, help others who have experienced traumatic bereavements and give time I don’t have in my committed work for a national charity.

So, I give a nod of respect to Lord Saatchi’s stated vision and aim and feel protective of his tenacity and drive to make a difference, make it matter and continue his strongest bonds and meaning through these activities, effecting positive, meaningful change.  I am however a firmly opposed critic, which doesn’t sit easily with me.

Why am I critical?   I do not admire how he appears to choose to abuse his power, wealth and political influence to exert control over a legislative catastrophe in his name. I do not admire deliberately falsifying the law, misrepresenting medical practice and nasty spin on his opponents. I couldn’t bear his misuse of grieving and aggrieved relatives as a PR victory.  I find his total lack of mandate from those whose opinions should matter and the lack of legitimacy in the process simply unconstitutional, arrogant, hubristic, chilling, recklessly harmful and misleading.

I’m critical because, with such power and influence, such drive to make a change, I am left wondering just why Lord Saatchi ignores the views of the medical profession who tell him this is unnecessary and undesirable, repeatedly ignores esteemed medical law experts who unanimously tell him he’s wrong on the law, ignores the views of patient groups and charities who are fearful of the consequences and ignores defence unions- whose role is to defend doctors on the front line and provide guidance on best practice.  Overlooking the failure to consult before his bill was ever launched, I can’t get past the failure to listen to an overwhelming body of opinion saying his idea was not based on the right law, was not required and would not help doctors or patients.        For, under his proposal, nobody wins. Doctors aren’t entirely able to be protected from being sued, for such is the likelihood of satellite litigation that many more doctors and their colleagues may be dragged into the churning mill of the legal process. They will also be swamped by his procedural red tape and lose the remaining crumbs of clinical autonomy trying to follow a procedural hoop-athon. It’s written to provide a benefit for only those who are truly negligent or even exploitative of desperation and hope-in-hype, which is precisely why some have termed this a ‘quack’s charter’. This is not however inert for non-quacks. It will have procedural and practical consequences for the vast majority who are committed and excellent doctors,  rendering them handicapped, bureaucratised, pressured yet uncertain of potential liabilities in an array of legally creative and expensive ways; and possibly, if Friday’s musings are to be followed up, it may leave them wide open to GMC fitness to practice investigations, and all in the name of Maurice Saatchi, the PR and advertising legend with no legal or medical background at all.

Patients do not gain any rights of access to a drug under this bill.  All they stand to gain is the knowledge they will have immeasurable difficulty in ever obtaining any form of redress for serious harm and suffering, serious care needs unmet by the health service, caused by defective drugs; for who is liable for these under the bill?; or an entirely negligent decision or unreasonable basis to treat. Their relatives gain the comforting knowledge that they ‘tried everything’, against the best possible knowledge of science, that could easily end in death, suffering and the removal of any quality of life for the patient.  They gain the knowledge that the ‘results’ of such experimentation are meaningless, and will help no future patient. A dehumanising, agonising and barbaric accolade.

Indeed, the bill doesn’t even solely apply to those with cancer, or nearing the end of their lives. This allows full-on experimentation, expressly and entirely unscientifically, and attempts to act as a defence, while simultaneously adding bureaucratic mayhem and managerial mandates for the good doctor, that still don’t combine for any logical purpose.  It does not make sense.  If it made sense, I’d be supportive and the medical defence organisations would be supportive.

It trashes the law and trashes the importance and respect for any scientific integrity and for a patient’s quality of life.  Patients deserve better than this. It’s frustrating, as in his esteemed, powerful position I would listen and put my name to something that might genuinely help others.  I’m still not honestly sure why he won’t.

More than 100 leading cancer specialists sign letter in The Times opposing Bill

Letter published in The Times

13 November 2014

Dear Editor,

Lord Saatchi says he wants to make parliament find a cure for cancer. He condemns current cancer treatment as “the endless repetition of a failed experiment”. The reason for such “abject failure” is, he believes, the law of medical negligence. His Medical Innovation Bill seeks to protect doctors who offer treatment that no responsible body of medical opinion supports and would therefore be considered negligent under the current law.

We devote our professional lives to treating patients with cancer and advancing research that contributes to finding more effective treatments for cancer. We neither want nor need Lord Saatchi’s bill. We do not believe that it will help our patients or future patients. We are dismayed that the bill is being promoted as offering hope to patients and their families when it will not make any meaningful difference to progress in treating cancer.

The law of medical negligence does not hinder our work or prevent innovation. There have been significant advances across all the modalities of cancer treatment over recent decades. There was no call for this change in the law from the medical profession. The current law already allows us to use off label drugs and to try new treatments when they are in patients’ best interests.

We are concerned that rather than promoting responsible scientific innovation in the treatment of cancer, the Medical Innovation Bill will actually encourage irresponsible experimentation producing nothing more than anecdotal “evidence”, at the potential expense of causing serious harm and suffering to patients, their families and carers. Innovation is best carried out within the discipline of controlled clinical trials, not by individual doctors acting on a whim.

Yours sincerely,

Dr Clive Peedell, Consultant Clinical Oncologist, Co-chair NHS Consultants’ Association

Professor Ruth Plummer, Professor of Experimental Cancer Medicine, Director of Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care, Freeman Hospital, Newcastle

Professor Charles Swanton, Group Leader, Cancer Research UK London, Chair in Personalised Cancer Medicine at the University College London Cancer Institute

Prof Jonathan A Ledermann, Professor of Medical Oncology, Clinical Director, UCL Cancer Institute & Director, CR-UK & UCL Cancer Trials Centre

Professor Michael Baum, Professor Emeritus of Surgery and visiting Professor of Medical Humanities, University College London

Professor Iain McNeish, Professor of Gynaecological Oncology, Institute of Cancer Sciences, University of Glasgow

Professor John Radford, Professor of Medical Oncology, Institute of Cancer Sciences, The University of Manchester and the Christie NHS

Professor Tim Maughan, Professor of Clinical Oncology, CRUK/MRC Oxford Institute for Radiation Oncology, Gray Laboratories, University of Oxford

Professor Jeff Evans, Professor of Translational Cancer Research (Experimental Therapeutics) and Director of the Institute of Cancer Sciences, CR-UK Beatson Institute

Professor Anthony Chalmers, Professor of Clinical Oncology, University of Glasgow, Beatson West of Scotland Cancer Centre

Professor David Cameron, Professor of Oncology at Edinburgh University and Director of Cancer Services in NHS Lothian, Edinburgh, ECMC lead, lead for Scottish Cancer Research network

Professor Tim Meyer, Department of Oncology, UCL Cancer Institute

Professor Robert Coleman, Professor of Medical Oncology, Academic Unit of Clinical Oncology, Weston Park Hospital, Sheffield

Professor Daniel Hochhauser, UCL Cancer Institute, University College London

Professor Christian Ottensmeier, Consultant Medical Oncology, Professor in Experimental Cancer Medicine, Southampton University Hospitals and University of Southampton

Professor Matt Seymour, Professor of Gastrointestinal Cancer Medicine and Consultant Medical Oncologist, Leeds

Professor Richard Kaplan, MRC Trials Unit, University College London

Professor Richard Kennedy, Centre for Cancer Research and Cell Biology, Queen’s University Belfast

Professor William Steward, Professor of Oncology and Co-Director of Cancer Biomarkers and Prevention Group, Department of Oncology, University of Leicester

Professor Mark Middleton, Dept of Oncology, University of Oxford

Professor Chris Twelves, Deputy Director of Cancer Research UK’s Clinical Centre, St James’s Hospital, Leeds

Professor Gary Middleton, Professor of Medical Oncology, School of Cancer Sciences, University of Birmingham

Professor Tessa Holyoake, Professor of Experimental Haematology, University of Glasgow

Professor Anne L Thomas, Professor of Cancer Therapeutics, University of Leicester

Dr Robert J Jones, Consultant Medical Oncologist, Director, Cancer Clinical Trials Unit for Scotland (CaCTUS)

Dr Corinne Fairve-Finn, Honorary Consultant Clinical Oncologist, and Reader at the University of Manchester

Dr Richard Adams , Clinical Senior Lecturer, Institute of Cancer & Genetics, Cardiff

Dr Martin Forster, Clinical Senior Lecturer in Experimental Cancer Medicine and Consultant Medical Oncologist, UCL

Dr. Richard Baird, Academic Consultant in Experimental Cancer Therapeutics, University of Cambridge, Honorary Consultant in Medical Oncology, Addenbrooke’s Hospital

Dr Alan Anthony, Senior Lecturer and Oncology Research and Innovation Lead, St James’ Hospital, Leeds

Dr Richard Wilson, Reader in Cancer Medicine, Centre for Cancer Research and Cell Biology, Queen’s University Belfast, Clinical Director, N. Ireland Cancer Trials Centre and Network, Consultant Oncologist

Dr Rebecca Kristeleit, clinical senior lecturer and consultant medical oncologist UCL/UCLH

Dr Pippa G Corrie, Deputy Director, Cambridge Cancer Trials Centre, Consultant and Associate Lecturer in Medical Oncology, Cambridge University Hospitals NHS Foundation Trust

Dr Gerry Hanna, Senior Lecturer and Consultant in Clinical Oncology, Centre for Cancer Research and Cell Biology, Queen’s University, Belfast

Dr Emma Dean, Honorary Consultant in Experimental Medicine and Clinical Senior Lecturer University of Manchester, Christie Hospital, Manchester

Dr Ellen Copson, Associate Professor in Medical Oncology/Honorary Consultant Southampton Oncology Centre

Dr Alastair Greystoke, Senior Lecturer and Honorary Consultant in Medical Oncology,Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care, Freeman Hospital, Newcastle

Dr Paul Hatfield, Consultant Clinical Oncologist and Honorary Senior Lecturer, Leeds Cancer Centre, St James’s Institute of Oncology

Dr Mike Bayne, Clinical Director and Consultant Clinical Oncologist, Poole Hospital Cancer Centre, Dorset

Dr Chris Baughan, Consultant in Clinical Oncology and Care Group Lead, University Hospitals Southampton NHS trust

Dr Matthew Krebs, Clinical Senior Lecturer and Honorary Consultant in Experimental Cancer Medicine, Christie Hospital, Manchester

Dr Kevin Franks, Consultant Clinical Oncologist, St James’s Institute of Oncology, Leeds Cancer Centre, St James’s University Hospital, Leeds Teaching Hospitals NHS Trust

Dr Matthew Hatton, Consultant Clinical Oncologist Weston Park Hospital, and Honorary Senior Lecturer at the University of Sheffield.

Dr David Wilson, Consultant Clinical Oncologist, James Cook University Hospital, Middlesbrough

Dr Eleanor Aynsley, Consultant Clinical Oncologist, James Cook University Hospital, Middlesbrough

Dr Peter Dunlop, Consultant Clinical Oncologist, James Cook University Hospital, Middlesbrough

Dr David Landau, Consultant Clinical Oncologist, Guy’s and St Thomas’ NHS Foundation Trust, London

Dr John Frew, Consultant Clinical Oncologist, Northern Centre for Cancer Care, Freeman Hospital, Newcastle

Dr Toby Talbot, Consultant Clinical Oncologist, Royal Cornwall Hospitals

Dr Alison Humphreys, Consultant medical oncologist, James Cook University Hospital, Middlesbrough

Dr. Noelle O’Rourke, Consultant and Hon Senior Lecturer in Clinical Oncology, Beatson West of Scotland Cancer Centre

Dr Andrew Bates, Consultant Clinical Oncologist, Southampton

Dr Janine Graham, Consultant medical oncologist, James Cook University Hospital, Middlesbrough

Dr Jonathan McAleese, Consultant Clinical Oncologist, Belfast City Hospital

Dr Sophie Haney, Consultant Medical Oncologist, James Cook University Hospital, Middlesbrough

Dr Anna Gajewska, Associate Specialist, Palliative Medicine, Oncology Directorate Poole Hospitals FT

Dr Judith Cave, Consultant Medical Oncologist, Southampton General Hospital

Dr Luke Nolan, consultant medical oncologist, University Hospital, Southampton

Dr Yvette Drew, Senior Lecturer and Honorary Consultant Medical Oncologist, Newcastle University and Northern Centre for Cancer Care

Dr Syed Zubair, Consultant Medical Oncologist, James Cook University Hospital, Middlesbrough

Dr Maxine Flubacher, Consultant Clinical Oncologist, Poole Hospital

Dr Joe Davies, Consultant Oncologist, Dorset Cancer Centre, Poole Hospital NHS Foundation Trust

Dr Shahid Iqbal, Clinical Oncologist, Newcastle

Dr Nick Wadd, Consultant Clinical Oncologist, James Cook University Hospital, Middlesbrough

Dr Sheela Rao, Consultant Medical Oncologist, GI Unit, The Royal Marsden Foundation Trust, London

Dr Martin Eatock, Medical Director, Northern Ireland Cancer Network

Dr DebashisSarker, Senior Lecturer and Consultant in Medical Oncology

Dr Joanne Hornbuckle, Consultant and Honorary Senior Lecturer in Medical Oncology, Sheffield

Dr Jon Wadsley, Consultant Clinical Oncologist, Clinical Lead for Division 1 (Cancer) Yorkshire and Humber Clinical Research Network, Weston Park Hospital, Sheffield

Dr Julia McBride, Specialty Doctor Oncology, James Cook University Hospital, Middlesbrough

Dr Simon Pledge, Consultant Clinical Oncologist, Weston Park Hospital, Sheffield

Dr Joanne Lewis, Consultant Oncologist, Lead Neuro-science MDT and Lead Network Research CNS Tumours, Northern Centre for Cancer Care, Newcastle

Dr Rhona McMenemin, Consultant Clinical Oncologist, Northern Centre for Cancer Care, Newcastle

Dr Joanne Parkinson, Associate Specialist Oncology, Poole Hospital Foundation Trust

Dr Mary Comisky, Consultant in Palliative Medicine, Northern Centre for Cancer Care, Newcastle

Dr Olly Donelly, Clinical Lecturer in Clinical Oncology, St James’s Institute of Oncology & Leeds Institute of Cancer and Pathology

Dr Rachel Cooper, Consultant Clinical Oncologist, St James’s University Hospital, Leeds

Dr David Bottomley, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Fiona Roberts, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Ganesh Radhakrishna, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Joji Joseph, Consultant Clinical Oncologist, Lead Clinician, York Teaching Hospital NHS Foundation Trust

Dr Katy Clarke, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Chris Fosker, Consultant Clinical Oncologist and Honorary Senior Lecturer, St James’ University Hospital, Leeds

Dr Peter Dickinson, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Bojidar Goranov, Oncologist, Northern Centre for Cancer Care, Newcastle

Dr Kate Sumpter, Consultant Medical Oncologist, Northern Centre for Cancer Care, Newcastle

Dr Christopher Jones, Consultant Medical Oncologist & Carcinoma of Unknown Primary Lead, Northern Centre for Cancer Care, Newcastle

Dr Caroline Lee, Consultant Clinical Oncologist, Sheffield Teaching Hospitals NHS Foundation Trust

Dr Mark Teo, National Institute Health Research, Academic Clinical Lecturer in Clinical Oncology, Leeds Institute of Cancer and Pathology, St James’ University Hospital, Leeds

Dr Pooja Jain, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Martin Robinson, Reader and Honorary Consultant Clinical Oncologist, Academic Unit of Clinical Oncology (Cancer Clinical Trials Centre) , Weston Park Hospital, Sheffield

Dr Niladri Ghosal, Consultant Clinical Oncologist, Glan Clwyd Hospital, Rhyl

Dr Emma Dugdale, Locum Consultant Clinical Oncologist, Sir Robert Ogden Centre, Harrogate District Hospital

Dr Nicola Cresti, Consultant Medical Oncologist, Northern Centre for Cancer Care, The Newcastle upon Tyne Hospitals NHS Foundation Trust

Dr Nazia Mohammed, Consultant Clinical Oncologist, Honorary Clinical Senior Lecturer, Beatson West of Scotland Cancer Centre, Glasgow

Dr Paula Mulvenna, Consultant Clinical Oncologist, Chief Investigator QUARTZ Trial, Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS FT

Dr Kate Cardale, Consultant Clinical Oncologist, Leeds Teaching Hospitals NHS Trust

Dr Katie Spencer, Specialist Registrar in Clinical Oncology, Leeds Teaching Hospitals NHS Trust

Dr Maria Marples, Consultant/Honorary Senior Lecturer in Medical Oncology, St James’s University Hospital, Leeds

Dr Vanessa Gill, Consultant Clinical Oncologist, Clinical Oncology, St James’s Institute of Oncology, Leeds

Dr Michelle Kwok-Williams, Consultant Clinical Oncologist, St James’s Institute of Oncology, Leeds

Dr Emma Thomas, Consultant Clinical Oncologist, St James’s Institute of Oncology, Leeds

Dr Kathleen S. Dunn, Consultant Clinical Oncologist, Weston Park Hospital, Sheffield