Professor Baum: three simple principles of clinical practice

Professor Baum’s rapid response to Margaret McCartney’s BMJ column ‘Withdraw Saatchi’s quackery bill’ may be read in full here

I have also included it here in full, for in its skilled brevity it sums up everything that is wrong with the (still) proposed legislation.

Re: Withdraw Saatchi’s quackery bill
30 April 2014
Professor Michael Baum, Emeritus Professor of Surgery UCL, London NW11 6PT

There is one thing worse than controlled experimentation and that is uncontrolled experimentation.

There are many patients we can no longer help but there are none that we are incapable of hurting.

When patients are judged beyond cure they are never beyond compassionate care.

The supporters of the Bill seem to have overlooked these three simple principles of clinical practice.

In 45 years experience involved in clinical cancer research I have never once encountered the law as an impediment to innovation.

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

Expert opinion unequivocal against the Medical Innovation Bill

The Department of Health consultation on the 2014 stab at the Medical Innovation Bill received damning responses from legal experts, medical bodies, defence unions, research charities and patient groups alike.

Nevertheless, the Bill proceeded and was heralded as new and improved prior to its first and second readings in the House of Lords in June this year. Again, the expert consensus against the Bill was clear, strong and unequivocal.

Thereafter, the Bill morphed twice more into the version that went to committee stage in the House of Lords on 24 October 2014;  it’s now at version 5 of its latest of numerous attempts.

The PR approach however remains unchanged its earliest days, announcing that the Bill is well received and supported..

This is not true but as we have seen with the campaign – perception is what matters, not truth.

Indeed, expert consensus is resolutely against the Bill; so much so that any government contemplating allowing such proceedings to become law would be somewhat failing in their duty of care – for it is so unthinkably wrong, arrogant and dangerous to push against such eminent, widely held opinion.

  • APIL has placed it high on their political agenda under ‘Caring for Patients: addressing the misconceptions at the core of the Medical Innovation Bill’ and for the committee stage, published ‘Myth vs Reality’, concluding that there is no evidence that doctors are sued for trying innovative treatment or are deterred by the law, that the Bill would generate confusion, that there are other barriers, that the Bill does not contain what it is said to and that statements made by Lord Saatchi are highly misleading and damaging.
  • The BMA has continued to oppose the Bill – reiterating that it is unnecessary, fails to support doctors and that rigid statute is inappropriate. The BMA ‘suggest that the bill is withdrawn and consideration given to identifying other means of increasing medical innovation’. The October parliamentary briefing can be read here, stating clearly that the current law and professional guidance allows for innovation and the latest drafts of the Bill are so far removed from the original intention behind it that it clearly should not proceed further.
  • The Medical Defence Union also issued a new brief to parliament, setting out that the current law and ethical guidance is very clear and that the Bill introduces the potential for adverse consequences that do not currently exist.
  • The Association of Medical Research Charities issued a briefing on the committee stage of the Bill, approved by the Medical Research Council, Academy of Medical Sciences, Wellcome Trust, Arthritis Research UK, Parkinsons UK, Leukaemia & Lymphoma Research, British Heart Foundation and Motor Neuron Disease Association. The AMRC briefing lists fundamental concerns with the Bill and the marshalled list of amendments, stating ‘we are concerned that the Bill risks subverting the frameworks currently in place to preserve patient safety. There may be unintended consequences for patients who could be at risk when receiving treatments for which the evidence base is not fully established, including treatments which could prove ineffective or harmful’ ‘We believe there is a need for better evidence to establish the main barriers to the development and utilisation of innovative medical treatments, and to clarify the best way to address this issue. We are also concerned that the Bill could introduce a degree of ambiguity to the law governing clinical negligence, potentially placing doctors at risk of further litigation.’   ‘ We are also concerned that the Bill may discourage patients and their clinicians from participating in clinical trials by encouraging the provision of novel treatments on an ad hoc basis, leading to a failure to develop the robust evidence of efficacy necessary to support wider adoption of innovations in the NHS.’
  • Nigel Poole QC gave an interview that very clearly sets out what is so wrong with the Bill, available here.
  • Likewise, Suzanne White, partner representing injured patients and bereaved relatives at Leigh Day & Co appeared on Sky News in the week running up to the committee stage – emphasising that this Bill is not an answer, doctors are not sued for innovating, patients will not benefit and the Bill fails to address any real barriers that may exist.    Prof Colquhoun also appeared on TV voicing strong concerns against the Bill, its mistaken premise and reiterating that off-label prescribing is permitted under the current law.

Lord Turnberg: ‘I would hate to see the opening up of a bureaucratic and legal nightmare that Sir Robert Francis tells me he still has problems with…In my own field of gastroenterology I constantly tried novel treatments…I say as an aside that at that time I did not feel the need for a Bill of this sort to allow me to innovate when I already had ethics committees’ approval and the informed consent of my patients. I fear that I am not alone in wondering whether the Bill is necessary. When Action against Medical Accidents, for example, and a number of important medical bodies express doubts about the need for it, one begins to wonder.’    ‘I fear that the Bill’s wording leaves open to too great a degree the potential for harm by unorthodox, unregulated practitioners.’ ‘…it is for …vulnerable people, desperate to try anything, that we have to have in place processes and mechanisms to protect them from unethical practitioners who may take advantage of their vulnerability.’

Lord Pannick recognised the need to  ‘ensure the protection of vulnerable and often desperate patients and their families’ and expressed a number of significant concerns.

Lord Winston   said ‘I feel that the whole of this Bill will increase lack of clarity and promote uncertainty on the part of patients, which is something that really concerns me. I must also say that, as it stands, I believe that the Bill is quite dangerous’  ‘I have to say that never once have I looked over my shoulder and thought that there might be a risk of litigation as a consequence of my innovating’

‘I believe that the noble Lord is mistaken ….Had the noble Lord, Lord Saatchi, along with his noble friend the Minister of Health, decided to focus on certain other aspects, I would have argued that some of the permissions for research ethics would have been a very important issue to look at. They are increasingly inhibitory. I would also cite some of the problems that have arisen out of the Human Tissue Act 2004, which was introduced by a Labour Government. There is a number of other issues that could have been looked at, such as the fitness to practise regime of the GMC…’

‘I have to say to the noble Lord, Lord Saatchi, that, unlike him, I have tangled with innovation throughout my life. I have had sleepless nights; I have had trembling hands when facing patients who might die because I knew that I had to take a decision on the spur of the moment that might make the difference between life and death’

Baronness Masham of Ilton, acknowledging the duty to try to improve the Bill, emphasised serious concerns: ‘The Royal College of Surgeons of Edinburgh said it retained its belief that the Bill presents a notable threat to patient safety and so should not become law. It said it shared the view of Sir Robert Francis QC, who said that the Bill “is actually dangerous for patients because it proposes safeguards which are illusory” meaning things that seem to be true, but are actually false.’

Lord Giddens: ‘it is highly important that this Bill …covers the question of whether perverse consequences could arise and whether the Bill could therefore end up subverting some of its own intentions.’

Lord Cormack: ‘ It has been said that the real poor of the 21st century are those without hope, but there is a worse condition and that is to have false hopes..’ I believe that if we are to legislate on this front we need to get the best possible Bill to become an Act of Parliament and speed must not be the only criterion we take into account when we are legislating on such a complex issue.’

Baroness O’Neill of Bengarve: ‘We do not wish to put in so much process that we successfully stifle the very innovation that it is the purpose of the Bill to achieve’ ‘Finally…there is a bit of a difference between reasonableness and proportionality. They tend to come as twins. I am entirely in favour of reasonableness but proportionality suggests that you have at the back of your mind enough data to say what is proportionate and what is not.’

Baroness Wheeler: ‘After Second Reading, the Minister for Health…acknowledged the Government’s support for the principles of the Bill but emphasised that the amendments were necessary “to ensure it does not: put patients at risk; deter good and responsible innovation; place an undue bureaucratic burden on the National Health Service; or expose doctors to a risk of additional liabilities”…’There is an extremely worrying potential for conflict of interest here…Sir Robert Francis QC points to the problem that arises from the choice of the appropriate qualified doctor to consult resting entirely with the doctor wanting to offer a new treatment… There is also concern among a number of stakeholder groups that pharmaceutical companies could put undue pressure on doctors to try out potentially dangerous treatments, and this concern will also need to be addressed. Concerns remain that the involvement and consent of patients to untested innovative treatments are not more explicitly in the Bill…’

Additional remarks included: Lords Winston and Turnberg on cancer surgery  ‘There is a problem there with the structure of the Bill as it presently stands.’ ‘The surgical aspects of the Bill are quite tricky.’

Lord Kirkwood of Kirkhope: ‘This changes how the regulator approaches a complaint, as far as I can see. As I know from previous experience, the General Medical Council has very clear, long-established systems for determining how complaints are lodged and how fitness-to-practise procedures are put in hand. It is very carefully controlled. Do I understand that the proposed new clause in Amendment 29 would merely—if I can put it that way—give the doctor against whom the complaint was alleged the choice of one of these channels of defence in relation to any complaint made against him by the regulator? I am still not clear as to whether I understand this properly’

Lord Turnberg: ‘I am sorry to interrupt the Minister’s flow. Does he not think that that is confusing for doctors in an emergency situation, wondering which route to take and about the options at that stage, rather than just getting on with the job?     Earl Howe: Personally, no, I do not—although my noble friend may choose to address that point. I believe that what initially motivated my noble friend to introduce the Bill was a perception on his part that there are doctors out there who are afraid to innovate, and perhaps afraid to innovate even on the spur of the moment, for fear of being litigated against.’

In addition to the agreement from experts in medical research, medicine, surgery, patient care, doctors’ representatives and defence unions that the Bill is unnecessary and dangerous, the expert opinion against the Bill is overwhelming.

Medical Innovation Bill – key points

The latest expert news and views on the Medical Innovation Bill have been posted here at stopthesaatchibill.co.uk 

The Medical Innovation Bill is a private members bill introduced by Lord Maurice Saatchi. It has followed a tortuous route through parliament so far. Unusually, a No.2 bill procedure was used to introduce it into the Lords and the Commons simultaneously in 2012. This is rarely used and typically reserved for legislation that must be passed very quickly. Following much criticism, it was withdrawn from the Commons and a second draft was produced of the Medical Innovation (No.2) Bill to progress through the Lords.

Despite the unequivocal opposition voiced by leading organisations to the Department of Health consultation on the Bill, which closed in April 2014,  it has not been withdrawn. There has been no arrangement to consult upon what barriers to innovation actually are. Instead, the bill was ‘redrafted’ rapidly before publication of the (very negative) consultation responses.   Its second reading in the House of Lords occurred on 27 June  2014, following which it was redrafted again,  and again.  The Medical Innovation (No.2) Bill (fourth draft) – (HL Bill 4) went to Committee Stage in the House of Lords on 24 October 2014. Thirty nine amendments were tabled. A revised version has been produced with amendments, due to be discussed further and intended for Report Stage.

Lord Saatchi’s assertion is that the current law of negligence inhibits innovative practice and hinders progress in research and patient care. He defines negligence as deviation from standard procedure, and innovation as deviation.  He believes that by removing any threat of an action in negligence the Bill will encourage innovation and will empower patients to demand access to experimental treatments.

Expert organisations, individuals and representatives have strongly opposed the Bill in force, and maintain their opposition to its current draft. Those opposing include leading medical charities and research organisations, the BMA, the RCP, MDU, MPS, and Sir Robert Francis QC, legal expert and Chair of Mid Staffordshire NHS Trust Public Inquiries.

Key Points

  • The current law of negligence does not inhibit medical innovation.

The law of medical negligence is settled and well understood by judges, lawyers and doctors. The test of whether a doctor has been negligent was set down in the case of Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 and adapted in the case of Bolitho v City and Hackney HA [1998] AC 232.

The law is very flexible and allows for innovative treatment if a responsible body of medical opinion would support it, however small that body may be. A doctor is only negligent if no responsible body of medical opinion would support their treatment or if the support for the treatment has no logical or rational justification.

The current law therefore does not mandate adherence to a standard treatment. Innovative therapy, including off-label prescribing of medication, is used daily by responsible doctors, and this is expressly supported by considerable weight of case law, alongside professional and ethical guidance, such as that from the GMC.   The law does not impede innovation, and no organisation has any evidence that a false perception of the law manifesting a fear of litigation, impedes innovation. If anything does, the law is not it.

  • The Bill would remove the most fundamental patient protections.

The Bill would act to change the law to offer absolute protection for conduct falling so far below an acceptable level that it would be negligent.   Lord Saatchi proposes that doctors should have an immunity from being sued by patients who have been harmed by such treatment, establishing that such a doctor would not be negligent even if no other doctor at all would have supported the treatment or the reasoning behind it. Those patients harmed by what would now be regarded as treatment so unacceptable, illogical, irresponsible or unjustifiable that it is negligent would have no access to any form of redress, no matter how serious their injury or suffering.   The latest versions of the Bill have been written in terms that apparently apply to the conduct of treatment itself, not only the decision to treat, and to apply to all medical treatment for all conditions.

The Bill does not empower a patient. It does nothing to help access to treatment: barriers to which are entirely unrelated to the law of negligence. In doing nothing to increase or enable access to a treatment (albeit one that may harm) it operates in theoretical terms only, and focuses on something that will only remove rights and remove safeguards from patients.

  • The Bill would not help or benefit doctors.

The Bill would not be helpful for doctors. Doctors’ representatives, including the RCP, other Royal Colleges, the BMA, Medical Protection Society and Medical Defence Union, have voiced strong opposition.

The current law is very deferential to medical opinion and expertise. It allows consideration on an individual case basis, allowing for developments, rapid scientific progress new ideas and individual features, supporting the exercise of clinical autonomy. If clinical autonomy faces a challenge, it is not justifiably a legal one.  The law does allow for the oversight of peer support to maintain a good standard, prevent serious bias, guard against exploitative or simply terrible practice and thus maintain public trust in the profession, with a consequential benefit to each clinical encounter. This is rarely used, however this ability serves to protect and uphold the deferential position that the law follows, respecting medical opinion and progress.

The illusions promoted by the introduction of such legislation would not help doctors. The perceived, illusory, shift of power further to the patient is set in a landscape of media hype, misinformation, increased expectation and demand, and with no resources, funding or infrastructure in place the likeliest outcome is patient dissatisfaction or harm. The increased pressure from patients and pharmaceutical companies would leave a doctor, in an office with bureaucracy propping up the ceiling, hands tied by purse strings and tape, in an untenably fraught position.

The Bill does nothing to support doctors in responsibly innovating, obtaining funding, access or time to effectively conduct appropriate activities; it merely promotes an unrealistic expectation from patients while adding to a bureaucratic nightmare for the doctor. There would be a significant increase in legal action, and doctors would be drawn into it. In treating a patient, the doctor may breach a number of professional regulations, while facing increased scrutiny for adverse events by virtue of decreased liability across the board, even for pharmaceutical products.

More doctors would face legal scrutiny and a potential litigation process, alongside an increased likelihood of regulator investigation or sanction for individuals. It would be a legal disaster with attempts in res ipsa, or a failure to treat,  loss of a chance, judicial reviews and considerable other legal challenge, including criminal liability. The scope for satellite litigation around the bill’s operation is significant and has the potential to continue for years, increasing confusion, adding barriers, damaging doctor-patient interaction and obstructing best practice.

  • The Bill would not advance scientific progress.

Many examples from recent history have shown that permitting access to a ‘treatment’ that may have no beneficial effect at all delays the acquisition of evidence required to determine its effects. It is an archaic and inappropriate model to promote in today’s era. Scientific progress is rarely linear and newer treatments are not always better, and rapid use with decreased critical evaluation is both inappropriate and reckless. Genome sequencing, and fields such as pharmacogenomics and concurrent rapid advances allow for precision in rationalising a treatment strategy for an individual.

Responsible decisions and compassionate access to treatments or potential treatments are supported by the current law, and if this is the Bill’s aim, it is unnecessary. It serves to obstruct the trials process and diminish available evidence, putting people at serious risk of harm, without progressing their care or advancing medical knowledge. No data generated would be of benefit to anyone, and the concept fails to address real areas that may assist in advancing progress, such as removing rather than adding bureaucracy; providing funding and support. Research and trials access and networks could be widened, not shut down. This would increase access to accurate data and meaningful, reliable information and encourage rapid advancement and adoption of effective treatment strategies without unacceptable risks of harm, suffering or hastened death.  It would promote a form of very high risk, reckless experimentation on patients, or dishonest exploitation at its worst, without the need for any evidence of benefit or any logical rationale with protection from a claim in negligence.

  • All key expert organisations oppose the Bill.

There is no evidence of claims in clinical negligence occurring following innovative treatment, and no evidence in support of the assertion that doctors do not innovate for fear of litigation. Instead there is a wealth of opposition; from doctors’ representatives, legal and defence bodies, patient organisations and medical research groups and charities, alongside notable experts including Lord Winston and Sir Robert Francis QC.

Key concerns are that it is founded on a clear misunderstanding of the law, it is a severe threat to patient safety, it is put forward by non-experts who fail to understand the clinical position and complexities and fail to recognise serious risk to patient groups, it applies to all patients, conditions and treatments and it fails to address anything that may in fact support doctors and enable access to more treatment or innovation appropriately.  It further fails to consider extremely important issues of quality of life, wellbeing, patient trust and the subtlety and complexity of illness experience and decision making.   Instead it expressly permits the use of drugs or therapeutic techniques where there is no known efficacy and no evidence base at all. It would also permit treatment where it is not logically or rationally justifiable. This would benefit pharmaceutical companies financially through the use of unused drugs and patent extensions, but may cause significant harm to the patients being ‘treated’.

Furthermore, any amendments to the Bill do not address the fundamental aspects that this legislation is  unacceptably dangerous, poorly targeted and is unnecessary when both current law and professional guidance support innovative treatment.

HL Committee Stage 24 October 2014

Summary of the Bill at 24 October 2014

We support responsible innovation but oppose the Medical Innovation Bill. It is unnecessary. It will not promote responsible innovation but will encourage irresponsible experimentation. It is liable to expose patients to disproportionate and avoidable harm.’

The Bill is unnecessary: innovative treatments happen daily, supported by the current law.The Bill acts to remove patient rights, not give new ones.

It permits treatment that would otherwise be regarded as negligent.

Its scope extends to any treatment for any condition and in any patient.

It will obstruct, inhibit and delay research.

It will not advance a cure for cancer or other disease, nor promote widened access to existing beneficial   therapies.

It will lead to increased legal uncertainty and bureaucracy for doctors.

It will increase the risk of legal action and result in protracted litigation.

It is a serious threat to patient safety.

It is opposed by all key medical, patient and defence organisations.

Premise for the Bill

Lord Saatchi has claimed that the current law of negligence inhibits innovative practice and hinders progress in research and patient care. He defines negligence as deviation from standard procedure, and innovation as deviation. The belief is that in removing the threat of an action in negligence, the Bill will encourage ‘innovation’ and will empower patients to access untested, experimental treatments.

The Law

The law of medical negligence is settled and well understood by judges, lawyers and doctors. The test of whether a doctor has been negligent was set down in the case of Bolam-v-Friern Hospital Management Committee [1957] 1 WLR 582 and adapted in the case of Bolitho-v-City and Hackney HA [1998] AC 232.

A doctor is not negligent if he provides treatment to a patient which is supported by a responsible body of medical opinion, even if there are other bodies of medical opinion who would not support it. A doctor is only negligent if no responsible body of medical opinion would support their treatment or if the treatment has no logical or rational justification. If that negligent treatment harms or kills the patient then the patient or their family will be entitled to compensation.

The current law does not mandate adherence to a standard treatment. The Bolam test is flexible and allows for innovative treatment if a responsible body of medical opinion would support it, however small that body may be.

Primary effect of the Bill

Innovative therapy occurs daily in medicine. The great majority of doctors providing innovative treatment act in accordance with a responsible body of medical opinion and give treatment which has a rational basis. The Medical Innovation Bill will not affect them or their patients. In contrast, the Bill does seek to change the law in respect of the small minority of doctors who do not act in accordance with a responsible body of medical opinion or who provide treatment which has no rational basis. Lord Saatchi proposes that those doctors should have an immunity from being sued by patients who have been harmed by such treatment.

Under Clause 1(2) of the Bill a doctor providing treatment would no longer be negligent even if his treatment had no support from any responsible body of medical opinion, indeed even if no other doctor at all supported the treatment. The patients of those doctors will not be entitled to compensation however seriously they are harmed.

The Bill does require such doctors to consult with another doctor who has experience of the patient’s condition and to take into account that doctor’s views as well as matters such as the known risks of the treatment. But these are procedural requirements which do not safeguard a patient against being given experimental treatment which no other doctor supports or which has no rational basis. There is no requirement for agreement from another professional.

The latest version of the Bill is written to apply to the conduct of treatment itself, not only the decision to treat. The Bill does not apply to a narrowed class of patient, such as terminally ill patients, adults, cancer patients. It applies to every patient including non-terminal conditions, children and those treated in emergencies.

Support for the Bill

Supporters believe it will allow access to treatments that are currently unavailable. They believe it empowers them and will ensure doctors provide specific therapies to them or their family.

They believe that it champions autonomy and that patients should have the right to accept the risk of untested treatment.

They believe information gained from the process will benefit others.

Some supporters believe that the Bill applies only to terminally ill patients or cancer patients further to this representation in media coverage.

Criticism of the Bill

Strong criticism has come from leading medical, regulatory, research, patient and legal organisations. These include the BMA, whose membership exceeds 153,000, defence organisations representing doctors, the Royal College of Physicians, whose membership exceeds 29,000 doctors, patient groups and Sir Robert Francis QC, Chair of the Mid Staffordshire NHS Trust Inquiry.

Criticism includes:

- The proposed legislation is not needed.

- No organisation has evidence that a fear of litigation impedes innovation.

- Innovative treatment is expressly permitted under current law and professional guidance.

- The Bill poses a serious threat to patient safety and threatens the welfare of vulnerable groups of people.

- It is based on a false premise, which fails to address access or other barriers to innovation that may exist.

- The erosion of professional responsibility, the illusion of choice and the likelihood of harm would damage a patient doctor relationship and overall trust in the profession.

- Codifying best practice is flawed and inappropriate in this area.

- Doctors’ refusal to treat with what they regard as a potentially harmful therapy may result in new legal actions while inability to fund or access therapy may result in more legal action involving an individual doctor.

- The consequence will be increased legal action, liabilities and satellite litigation surrounding any Act.

- It may involve breaches of professional and ethical guidance and principles, and increase the likelihood of regulator sanction for individual doctors.

- The Bill expressly removes liability for treatment that would otherwise be regarded as negligent.

- It removes access to any redress for patients who are seriously injured by negligent decisions or conduct, leaving them without remedy.

- In the event of a legal action proceeding, it conceals and confuses liability for harm caused and may serve to increase scrutiny on individual doctors and bureaucratic process, while potential product liability concerns are protected and unchallenged.

- It makes it easier for a quack doctor to prey on vulnerable people, without any potential for legal or peer scrutiny after the event.

- It fundamentally confuses research and treatment activities and processes, and may remove REC approval oversight and insurance requirement for what would otherwise be research on this basis.

- Makes no provision for data protection and storage of information.

- It will add more bureaucracy and confusion to clinical practice, in time taken, managerial and legal barriers to innovation.

- Daily, responsible, innovation that happens now will be obstructed.

- It obstructs and inhibits progress in clinical research, and would delay appropriate research findings, perhaps by many years, with significant resultant harm.

- It fails to provide for medical and technological advances such as precision medicine techniques, and does not promote personalised medicine.

- It is an archaic model, long outdated, and patients deserve better.

- It fails to distinguish medical and surgical treatment which present very different challenges.

- It fails to address infrastructure, resources and funding.

- It arrives at a time when Academic Health Science Network ‘Innovation Funds’ not provided, reduced and removed by government for academic institutions, funding to cancer services has been reduced by £790m and other significant cuts have occurred across relevant sectors.

- The Bill would put doctors under pressure from pharmaceutical companies and the most understandably desperate patients to try out potentially dangerous treatments.

- The Bill applies to any form of medical treatment and any category of patient.

- It will benefit pharmaceutical companies, lawyers and ‘charlatans’ but confers no benefit to patients or doctors.

Criticism of the Bill Campaign

- Lord Saatchi has consistently misstated the law when speaking in public and in the Lords.

- There was a failure to conduct any consultation regarding the premise for the bill, that doctors do not innovate because they fear being sued. 4

- No evidence has been provided that doctors do not innovate because of a fear of litigation.

- There has been no effort to construct any appropriate or legitimate consultation in respect of what may obstruct innovation and therefore what could be addressed and supported.

- Media manipulation, misleading anecdotes, emotive human interest stories and spin have been used to great effect by the Saatchi team.

- Vulnerable and desperate groups of people have been manipulated by the campaign.

- Key speakers for the campaign, such as cancer representatives, bereaved parents and parents of sick children, have been targeted and misled to gain public backing and deflect criticism. Their genuine and laudable desire to improve treatment has been used to drive forward support for a change in the law that will not represent their needs or achieve their aims.

 

5 key points

  1. The current law does not impede innovation.

Lord Saatchi has used the message that the current law requires doctors to follow standard procedure to gain public and media support. His accompanying remarks about doctors’ livelihoods being at stake, or destroyed, and a rising litigation culture have attempted to gain medical support. This is not at all an accurate definition or representation of the current law. Doctors can and do ‘innovate’ daily; experimental therapies are frequently recommended and drugs frequently used off-label.

Case law supports the use of innovative treatment, and cases include those where a treatment has never been used in humans for that purpose before, and those where a minority of only 2 doctors in a speciality would have agreed with the conduct in question.

The GMC expressly supports innovative treatment, as do other sources of ethical and professional guidance.

Doctors are not unclear about the law, and in the event that they were, the correct response would be supportive education and training to encourage better understanding, not increasing legislation, confusion and bureaucracy. No evidence has been produced to substantiate the anecdote that doctors’ fear of litigation, caused by the current law, inhibits the use of innovative treatment options with patients. No expert body responding to the consultation or subsequently has agreed with this assertion, instead all have strongly disputed this.

There is not an increase in ‘defensive medicine’ as a result of the law in this country and there is no real evidence of a litigation crisis. It is extremely hard to win a clinical negligence case. The increase in new negligence actions notified to the NHSLA is due to:

- An increase in negligent treatment, often similar incidents repeating and not being addressed; lack of funding, resource cuts and staffing levels contribute.

- An increase in non-expert firms taking highly specialised clinical negligence claims, following earlier government changes to legal case funding.

- The LASPO changes to CFA funding arrangements ‘no win no fee’ and costs recoverability, and the near-total removal of legal aid which already serve to decrease access to redress; many new claims were notified or issued to precede the change in funding arrangements.

- Importantly there is no evidence of claims in clinical negligence occurring following innovative treatment.

The law in this area has evolved carefully and robustly considers cases on an individual basis, progressing with the rapid advancement of medical science and supporting doctors in treatment decisions. A change in this careful and nuanced field of law is extremely inappropriate and would serve to confuse and deter innovative practice and increase rather than decrease involvement in legal action and satellite litigation.

 

  1. The Bill acts to remove patient rights, not give new ones.

The Bill does not empower a patient to demand a treatment. It does not enable them to ask for a specified therapy and expect to receive it; it does nothing to address this most important issue of access to treatment. Many drugs have known efficacy yet are not commissioned or funded for patients. This Bill does not provide funding or access to these drugs. Instead it expressly permits the use of drugs or therapeutic techniques where there is no known efficacy and no evidence base at all. It would also permit treatment where it is not logically or rationally justifiable. This would benefit pharmaceutical companies financially through the use of unused drugs and patent extensions, but may cause significant harm to the patients being ‘treated’.

For the patient it provides no funding for treatment, no increased access to trial networks or other strategy for accessing potentially beneficial therapy, which would be permitted under the current law. Instead it removes safeguards for patients, removes a requirement for any peer to have agreed with a treatment decision and removes the ability of a Court to examine whether a decision was logically explicable or justifiable. It prevents legal action for treatment that would otherwise be so unacceptable as to be negligent. This leaves patients or relatives of those who have been seriously harmed, have suffered or died as a result of a decision or treatment that would today be negligent, without any legal remedy, and very vulnerable to exploitation or simply to misplaced hope.

 

  1. The Bill as it stands applies to all medical treatment, all conditions and all patients.

As the Bill stands it applies to any category of patient, not solely those who are terminally ill with cancer; and to any form of medical treatment. It does not limit the scope to cancer patients, to terminal illness or to those who have exhausted other treatment options. It is not limited to treatments with a known chance of success. It is not limited to adults, and would apply in paediatric cases, emergencies and other situations where both consent may be impossible and where the addition of a bureaucratic process may delay or prevent medical treatment that can be given according to the current law, and operate to the patient’s detriment.

This remains the case if Lord Saatchi’s amendments are accepted. Although additional amendments may serve to limit the operational remit of the Bill they fail to remedy the position for relevant persons who could be treated under the proposed Act. In narrowing a class of patients to limit the scope and potential harm caused by the Bill, it increases risk and carries significant implications to those within the relevant categories. In narrowing experimentation to a class of patients, an ethical shift occurs that fails to consider extremely important issues of quality of life, wellbeing, patient trust and the subtlety and complexity of illness experience and decision making. Furthermore, any amendments to the Bill do not address the fundamental aspects that this legislation is not well targeted and is unnecessary when both current law and professional guidance support innovative treatment.

 

  1. It would not advance a cure for cancer or other disease.

The Bill is restricted solely to changing the law of clinical negligence, removing the ability of patients to have access to legal redress. This very narrow approach and the failure to undertake prior consultation does not address existing barriers to innovation. It does nothing to support doctors in responsibly innovating or effectively conducting clinical research; while promoting an unrealistic expectation from patients.

Areas of focus that may assist include:

-Funding provision for all related activities

-Increased funding for research

-Increased access to trials

-Rigorous design, speeding up and promoting individual patient access to trial networks

-Investment in infrastructure locally and globally in equipment, capabilities and trial networks

-Removing bureaucratic barriers

-Regulation of drug marketing and media misrepresentation 6

-Disclosure of business relationships

-Publication of all results in trials

-Information sharing and availability

-Supporting clinicians practically

-Supporting education and awareness of existing legal position if required

-Supporting shared decision making

-Encouraging innovation culture and research skills

-Widening and improving ethical support mechanisms

-Widening of existing schemes

The Bill has been promoted as allowing a cure for cancer to be found It promotes public demand for inclusion in clinical research and access to therapies, however it expressly excludes research. The use of the Bill would therefore not yield valuable data, and patients who support the Bill are unlikely to be aware of this. Responsible decisions and compassionate access to treatments or potential treatments are supported by the current law, and if this is the Bill’s aim, it is again unnecessary. It will promote a form of experimentation with protection from a claim in negligence. It may pressure, encourage or mislead doctors so that they breach existing and continuing regulations, while still failing to yield relevant data or progress scientific knowledge.

In times long past, astute observation of health effects was the only scientific method available, but one that led to false inferences and many tragedies in recent medical history, and which frequently delayed the acquisition of evidence. It is an archaic and inappropriate model to promote in today’s era. Scientific progress is rarely linear and newer treatments are not always better. Rapid adoption of a treatment with decreased critical evaluation is both inappropriate and reckless. A pro-innovation bias in the media, in research and with accompanying social demand risks causing harm, plays to profit motives and does not progress individual patient care or wider medical knowledge.

Innovative, novel treatments are permitted expressly by law and professional guidance. Therapy should be supported where it is carefully targeted and critically evaluated, and infrastructure and funding should allow for rapid dissemination of advancements and wide access to properly conducted clinical trials.

New technological advancements have permitted a personalised and precision based approach through genomic applications, including pharmacogenomics, particularly in cancer care. This approach requires a significant investment in the UK. The Bill promotes a very imprecise and outdated model that would yield no results at all for any scientific community, would not be reliable or reproducible and any data capture as part of the Bill if added at a later stage would fail to allay these concerns or wider issues of increased bureaucratic process and protection of patient data.

Many examples exist where the introduction of an experimental treatment has delayed the acquisition of evidence and reduced trial participation. This delays and impedes scientific progress, and has led to many cases of harm in the interim. A study of the FDA in the US revealed more than 10% of drugs licensed are later withdrawn or subject to black box warnings, and adverse drug reactions are a leading cause of death.

Patients deserve increased access to clinical trials, accurate data and rapid advancement and adoption of the most effective treatment, without an unacceptable risk of harm, suffering or hastened death. They deserve to make informed decisions based on reliable, meaningful information. They deserve this without reckless experimentation at best, and dishonest exploitation at worst, which is what the Bill serves to protect.

 

  1. Opposition from key medical bodies, experts, patient groups, charities, research and defence organisations.

The Department of Health consultation responses from all expert organisations revealed that none had evidence that the law prevented innovation. All felt that the Bill was unnecessary, would remove vital patient protections, impede doctors and obstruct responsible research. New drafting or proposed amendments do not address fundamental concerns about the Bill and key organisations maintain their opposition.

Those opposing the Bill include:

Sir Robert Francis QC, Chair of the Mid Staffordshire NHS Trust Public Inquiries

Sir Ian Kennedy QC

The BMA (British Medical Association)

The RCP (Royal College of Physicians)

The RCGP (Royal College of General Practitioners)

The RCR (Royal College of Radiologists)

The RCPsych (Royal College of Psychiatrists)

RCP Edinburgh

The Academy of Medical Royal Colleges

The Association of Medical Research Charities

The Wellcome Trust, Medical Research Council, Academy of Medical Sciences

NICE

MDU (Medical Defence Union)

MPS (Medical Protection Society)

The NHS Litigation Authority

The Health Research Authority

Academy for Healthcare Sciences

The British Pharmacological Society

Sense About Science

The Good Thinking Society

The Nightingale Collaboration

AvMA (Action against Medical Accidents)

MND Association

The Patients Association

Healthwatch

APIL

Leigh Day & Co

Kingsley Napley LLP

Notable academics, consultants and experts, including: Professor Michael Baum, Professor José Miola, Professor Richard Ashcroft, Professor Susan Bewley, Nigel Poole QC, Professor David Colquhoun, Dr Margaret McCartney.

 

Experts say:

 ‘The BMA strongly believes that this Bill should not become law and.. does not believe that primary legislation which focuses on redefining clinical negligence is the best mechanism to promote or encourage responsible innovation’ …‘is unnecessary, risks removing important protections for patients and could encourage reckless practice, with attendant risks for patient safety.’ BMA

 

 ‘Legislation is both unnecessary and undesirable.’ ‘Legislation which aims to clarify and encourage good practice in terms of when medical innovation is responsible could have the opposite effect as well as unintentionally weaken the principles which we regard as fundamental to safe, effective patient care.’ GMC

 

 ‘The proposal of this Bill proceeds from a fundamental misunderstanding of the effect of the current law’ ‘no evidence has been produced which shows that innovative treatment has been significantly deterred by a fear of litigation related to the Bolam test.’ ‘It explicitly frees the doctor to offer treatment which has no support from responsible medical opinion’

‘the vulnerability of those who desperately seek new treatments should not be forgotten: those in the greatest medical need deserve protection from injury caused by unjustifiable practice, exploitation, the raising of false hopes, and outright deception.’ ‘Therefore to legalise the taking of a step which may result not only in disappointment but in some cases actual injury, while at the same time removing the right to compensation, is to do a disservice to patients’ Sir Robert Francis QC

 ‘This Bill is, like its two or three predecessors, based on the fundamental misapprehension that the law of negligence inhibits genuine and responsible innovative treatment.

Not only that, but for all its good intentions, it is actually dangerous for patients because it proposes “safeguards” which are illusory and which may give free rein to mavericks peddling dangerous remedies to vulnerable and desperate people.’

‘the law of negligence does not prevent responsible innovation and never has’

‘The Bill would apparently free a doctor from any constraint to act in a logical, responsible or reasonable manner, so long as he/she follows a process the outcome of which he/she is free to reject’

‘This Bill introduces a level of complexity and process driven rigidity to an area calling out for responsible flexibility to meet new circumstances as they arise, as well as an increased risk of provoking litigation over the meaning of the legislation’ Sir Robert Francis QC

 ‘In summary the new version of this Bill suffers from the same deficiencies as its predecessors:

  1. It purports to address a problem of law which in reality does not exist.
  2. It proposes requirements which are bureaucratic and ineffective.
  3. It does not succeed in limiting its scope to treatment that would be generally accepted as innovative.
  4. It frees a doctor from any duty to be reasonable or rational in a decision to offer a treatment so long as he goes through the motions of a process. It is therefore a threat to patient safety in relation to a particularly vulnerable group. In reality the claimed safeguards are no safeguards at all.’ Sir Robert Francis QC

 

‘We have not seen any evidence that suggests litigation or the possibility of litigation is deterring clinicians from innovative practice’ ‘Bill will not actually deter innovation which is irresponsible and may indeed have the opposite effect’ AoMRC

 

 We ‘have no evidence that doctors are deterred from innovation by fear of litigation.’ ‘we are very concerned that there could be serious unintended consequences of the proposed legislation.’ ‘If the doctor considers that the proposed treatment would not …satisfy the Bolam test if challenged in court, then the overwhelming likelihood is that the treatment will not be of value and there is a significant risk that it may be harmful.’

‘We do not believe this legislation is needed. We do not feel that doctors are constrained as regards innovation and we believe that the current structures provide the appropriate checks and balances. This could have perverse effects as there might be fewer checks and balances to ensure that innovation is appropriate, safe and potentially effective.’ RCR

 

 ‘ The existing legal framework allows for innovation in the NHS’ NHS Health Research Authority

 

 ‘..we know of cases where drugs are used by NHS clinicians off-licence when doctors consider that their prescription will be beneficial for individual patients.’ ‘Our broad view is that existing case law caters appropriately for cases of innovative treatment’ NHSLA

 

 ‘The RCP does not have significant evidence (anecdotal or through case examples) from our members and fellows, nor we understand do two medical protection organisations, that litigation or potential litigation is a substantial or primary deterrent to clinicians’ use of innovative treatment’ ‘departure from standard practice is not prevented in law’ ‘clinician involvement in and patient referral into larger NHS clinical trials.. could be put at risk’       ‘proper consent from patients is crucial. Beyond this, it is also necessary to protect vulnerable patients who may have received a devastating diagnosis or have exhausted standard treatment options’ RCP

 

‘We have been unable to find evidence that fear of medical litigation is currently a barrier to innovation in cancer.’

‘We have been unable to find evidence that cases have been brought, or led to compensation, based on a competent doctor attempting to use an innovative treatment with the consent of a patient.’ CRUK

 ‘We believe that some of the biggest barriers to innovation are at the structural and organisational level, rather than at the level of the individual.’ Wellcome Trust/MRC/AMS

 

 ‘The MDU does not have any experience or evidence to suggest that doctors are deterred from innovating by the fear of litigation. We have no experience or evidence to suggest there is or that our members believe there is a lack of clarity or certainty about the circumstances in which they can innovate without fear of litigation’

‘The law currently considers innovation is responsible if it is in the patient’s best interests and can be supported by a responsible body of medical opinion and the patient has been fully informed and given consent. We do not think anything else needs to happen to encourage responsible innovation.’

‘If the standard applied to determining whether the doctor acted responsibly in making the decision would be the Bolam standard, this suggests that the current test that applies provides all the protection a doctor needs when considering innovation and that there is no need for a new law.’ MDU

 

 ‘Despite many years of experience in the clinical negligence claims environment we have no evidence that the fear of litigation is holding back innovation in medicine.’ ‘There is a risk that patients will misunderstand and overestimate what this Bill would do’ ‘We believe that it increases risk… The consultation admits that ‘it has not been possible to identify the likelihood and scale of these risks’. ‘It is important that thorough analysis is undertaken before there is any change in law.’ MPS

 

 ‘We have no evidence to suggest that that the possibility of litigation, or a lack of clarity and certainty about the circumstances in which a doctor may innovate without fear of litigation, has ever deterred a doctor from deploying an innovative treatment in respect of MND.’ ‘These clauses ..appear to give a signal to doctors that ‘anything goes’ when faced with a terminal and profoundly disabling illness’ ‘a charter for irresponsible treatment and experimentation, and the exploitation of potentially vulnerable patients faced with a devastating diagnosis and feeling – rationally or not – that they have nothing to lose’

‘the quality of life that a person ..can achieve with appropriate care and support should not be gambled with lightly’

‘We believe that the current legal position offers an appropriate balance between latitude for doctors and safeguards for patients’ ‘Bill offers no prospect of benefit but poses a genuine risk of causing harm, and we advise the Government not to proceed with it.’ MND Association

 

 ‘We agree with the many doctors and doctors’ organisations who say that as well as being based on a false premise, the Bill would actually make it harder to provide innovative treatment by creating a confusing, bureaucratic set of rules set in law’ ‘Medical Innovation is too important to be dealt with by a hastily prepared and ill evidenced Bill which only seeks to help innovation by depriving the injured patient of the legal remedy to which they have up to now had a right.’ AvMA

 

 

 

The expert responses to the Saatchi Bill must not be ignored

Consultation responses & recommendations

It’s rather hard to know where to begin with the latest from the Saatchi PR onslaught – bulldozing ahead with version #3 deliberately without a public consultation – this Bill is like a runaway train about to wreak havoc on those least expecting it further down the track- The recent consultation on the subject received overwhelmingly negative responses from an exceptionally long list of expert bodies – from charities, from patient groups, health groups, Royal Colleges, lawyers, doctors and including the GMC, BMA, RCP, MDU, MPS, Nightingale Collaboration, Wellcome Trust, NHS Health Research Authority, HealthWatch – the feedback from those who could refer to experience, facts and knowledge rather than swallowing spin from the Telegraph was a loud, unequivocal NO.

For if this were a good idea – I would be jumping for joy! Less chance of being sued, you say? Oh of course I’ll take that thanks. But after the very first glance what becomes abundantly clear to anyone who takes the time to think it over, including doctors, rather than listen to Saatchi’s lines that your entire livelihood, career will be destroyed is that this is as far removed from a good idea as it can possibly get. What then becomes apparent is that this Bill should never have had the time of day, let alone the media backing that it has, and nor would it have in different circumstances with, I suspect,  less powerful financial and political lobbying in the background.

If nothing is done the Bill clearly will be passed if it reaches the Commons, as Hunt has already guaranteed. It suits the government to try to triplewhip the House as there is surely no better retort to criticism over privatisation and destruction of the NHS (over 70% of its contracts since April 2013 are private) when it comes to the 2015 elections, than ‘ah, but we cured cancer!’ ‘we did what the people wanted!’

This Bill is NOT what the people want – they have been systematically, unrelentingly deceived – they want what is promised to them, not the reality of what it would deliver. If my child had cancer of course I would want to do everything in my power to give her every chance of survival – pull out all the stops. This bill is terrifying for that very reason alone – it removes real informed consent, plays on desperation , a need for some hope – and will result in painful, terrible deaths and removal of quality of life for many and overall respect for life’s worth in terminal conditions. Who next?

Nor will it add to the evidence base, further research or science. Furthermore it removes what little access to justice or redress there may be available left for those harmed by negligent treatment.

What about for doctors? Well it won’t actually protect them either – quite the opposite. To introduce a consumer demand will hugely increase litigation around such concepts as right to the treatment, negligence in not treating, failures to warn, res ipsa cases. It will dramatically increase litigation around the meaning and scope of the Bill. It will potentially force the hands of many doctors. It may create situations where patients are more inclined to sue, for not providing a treatment – or may create new confusion that makes innovation much less likely.
It will completely destroy the remit of the RO as stands, with dangerous and unrealistic implications. It will demand decisions beyond the scope are decided by MDTs who may lack specialised knowledge, or have an abundance of competence but not approve the treatment for uncertainty as to the new legislation. MDTs have no time as it is already to get through what needs to be done. It will create a situation where doctors are acting in direct contravention of GMC guidance and will NOT provide a defence to the GMC fitness to practise panels. The current law is protective of doctors responsibly innovating, and is supportive of such innovations. This codifies and seals an uncertain fate for the good innovator, and enables ‘the perfect storm’ to occur for both doctor and patient.

It is likely to reduce public trust in doctors – for it creates the real chance not for the good doctor to innovate, but for the bad doctor to exploit and defend himself. This Bill has ridden on the back of the image of the doctor as a self interested financially driven individual who deliberately causes harm to their patients – repeated over and over by Lord Saatchi. This is not only offensive, it is highly inaccurate, inappropriate and already damaging for patients and doctors. Furthermore the arguments that it does nothing to protect patients against ‘quacks’ are true – and this will have a knock on effect not only on patient safety and exploitation but also on trust in the good doctor. It will create the situation of desperate patients shopping around for someone willing to give something (harmful) a try. It will protect the reckless and shackle the true innovators–vastly impeding progress. It will leave the door open for financially linked motives with pharmaceutical companies. In an era of transparency, one-off attempts at innovation with obscured motives will achieve the very opposite, while substantially risking patient safety. It will be a wrecking ball to the integrity of the medical profession, and I do not want to work under such a misguided, confining and duplicitous statute, and nor would I wish to be a patient degraded in terms of human worth on the basis of my disease and put at real risk of harm in such a way.

Nigel Poole QC illustrates very well in this blog post what the Bill  v3 will enable.

The present law encourages and protects doctors to innovate responsibly, while maintaining a standard and safeguard for patients and respect for the patient’s worth as an individual. ‘The protection of patients is ensured by a requirement that treatment should be capable of reasoned justification, as explained in Bolitho. A requirement that proposed treatment should be supported by some responsible professional opinion provides a degree of assurance that the risks and benefits have been appropriately balanced. This does not require a treatment to have been adopted already by others, merely that there is a level of professional support for it which has a logical basis.’ – Robert Francis QC

It is a great shame that Lord Saatchi has not bothered to take into account the many expert responses received to the DoH consultation – for they provide much information, well considered insight and advice on what would help patients both now and in the future, and what would actually help doctors to innovate. The same potential barriers are raised many times: funding, research approval, bureaucracy and so on. Solutions are proposed: Innovation Oversight Panels, an open-access database, better data usage, using the Systematic Anti-Cancer Therapy (SACT) data set model for databases, clarifying EU Clinical Trials Directives and UK Medicines for Humans Use (Clinical Trials) Regulations and existing ways to improve innovation that could be enhanced – the MHRA Early Access Scheme, the EMA’s Adaptive Licensing, the Cancer Drugs Fund. Extensive access to CECs, improved commissioning, funding availability and streamlining to reduce delays. Better access to trials, recording and access to information worldwide and reduced bureaucracy would all help. This will add bureaucracy, reduce access to trials and keep some information at a local level. It is thoroughly inappropriate. There is real potential for Lord Saatchi to make a positive difference here – but it is certainly not with the Medical Innovation Bill v.3.

Here are, in table format,  a number of responses from some key organisations and their findings/recommendations: Consultation responses & recommendations

Stop the Saatchi Bill

Saatchi Soundbites

Misleading the nation

Many people believe what they see broadcast on TV, what they read in newspapers. A much greater number of people than this will without doubt trust that what they are told by a Lord and his expert team is the truth.  Unfortunately the statements from the Saatchi Bill campaign team are so thoroughly removed from this, their spin so heavily spun, that in many instances there is a complete reversal of truth, and in all an exaggeration and misrepresentation. Support is not for the Bill, it is for the exaggerated, illogical claims put forward on a false basis.

This can be seen in the public, campaigners and parents. Moreover the power of Saatchi Spin even led to convincing eminent Professor Sir Michael Rawlins, formerly Chair of NICE, to write in the BMJ that he had previously been against the Bill, however what the team had told him, citing Simms and Butler-Sloss, had convinced him there was a need.    ‘Several legal authorities have pointed out that …’ ‘I was originally sceptical about the need for the bill but have been persuaded otherwise, for three reasons. Firstly, it is clear from the comments of Butler-Schloss and other legal authorities consulted by Saatchi..’

Playing on eminent names and pinning most hope on doctors not being lawyers, the team ploughed on. Rawlins followed criticism not with reason but with, to paraphrase but Woolf says so in The Telegraph so it must be so.. ‘I rest my case’.   Professor Sir Rawlins has now obviously taken stock of the overwhelming opinion to the contrary. Who knows – perhaps he remembered the contents of his own book, and issued a Letter in the BMJ stating defensively         ‘the current law is clearly confusing even to lawyers’         ‘I believe any doctor …. Should ensure the results are placed in the public domain’ [not in the Bill] … ‘I am uncertain how this might be enshrined in law’ .   This altogether reads like an about turn defending and explaining his reliance on apparent experts, and is certainly a qualification of and comes perilously close to a complete retraction of his original article.

There is distortion of fact, misrepresentation of the law and exploitation of people who are not experts in the field.  The law is not confusing but has been so misrepresented by the campaign that the distortions result in confusion.  Over and above this, there is crass use of emotive campaigning to pull in the hopes of the desperate the fears of the many and the consciences of the compassionate. Ultracrepidarianism in this campaign is not a political matter; misleading by misrepresenting to gain support will put real patients at real risk of harm.

Here is only a brief selection of examples showing why people have, inevitably, declared the Saatchi Bill a good idea.

The Medical Innovation Bill launch, in the House of Lords

Chair, Dr Max Pemberton, author and writer for The Telegraph: ‘you and your followers have a genuine opportunity to change the course of medical history: to help patients and doctors innovate and find new cures and treatments. The Health Secretary Jeremy Hunt has promised that if you tell him you want the Medical Innovation Bill by responding positively to the DoH consultation then he will pass this Bill into law.’

Lord Saatchi:

‘The basic premise of this bill is that all cancer deaths are wasted lives. Science does not advance by 1cm as a result of all these deaths.. because the deceased receive only the standard procedure. The endless repetition of a failed experiment.
Why is that? Because under current law any deviation by a doctor from standard procedure, if anything goes wrong, is likely to lead to a verdict of guilt for medical negligence. Why’s that? Because current law defines medical negligence as ‘deviation from standard procedure’, but as innovation is deviation, so non deviation is non innovation. Under the current law, just to be clear, the doctor is obliged to stick to the well-worn path, even though he or she knows it leads only to poor life quality followed by death. This is how current law inhibits medical progress.
The pre-eminence of standard procedure is a flat contradiction of the logic of scientific discovery and the whole majestic scientific process comes to what we might call a dead halt at the bedside of the cancer victim.
That’s why the prime minister and the secretary of state have supported this bill and are taking it forward.
‘There will be no cure for cancer until real doctors with real patients in real hospitals can attempt some kind of innovation.’
It codifies what is best practice… the judges are saying is that.. there needs to be a better balance between defensive medicine.. and innovation. Under the current law that’s impossible to achieve.’

[Erm. Hang about. You see what he did there? He sat, brazenly, in the House of Lords, and spoke to ‘the people’ with authority as if he knew what he was talking about. He told them THE CURRENT LAW SAYS THIS. He told them doctors know they are causing poor life quality and death. He guilt-tripped them into wanting it for themselves and others; wasted lives.. no cure for cancer until. In this he shows a staggering abuse of power and trust.]

Jeremy Hunt:
Hunt said: ‘The government should do whatever is needed to remove barriers that prevent innovation which can save and improve lives. The Medical Innovation Bill (s)….. introduced by my noble friend Lord Saatchi…. correctly identify the threat of litigation as one such barrier.’
‘it could lead to major breakthroughs, such as a cure for cancer’.

[though we may know differently, of course, to generalise the public *will* believe everything spoken by someone risen to the highest echelons of government – how can they not tell the truth?]

The Telegraph coverage:
Incessantly biased, in a paper many people will use as their only source of news information, and trust for its editorial competence. It’s hard to know where to begin – all of it, and ‘without innovation we’ll never cure cancer’

The Saatchi Bill tumblr:
The law is one barrier to change, and it is a barrier that engenders and encourages a wider culture of inertia. Changing the law, will encourage more doctors to innovate, and to pass on the sense of enterprise to others around them. They in turn will pass on that enthusiasm and sense of hope that incurable diseases can be treated. The Bill will be a fire starter.

‘For..Duchenne – a 100% fatal condition – and those with cancer and other diseases it is a matter of life and death. This leaves the patient with a terminal illness no hope, no choice and no chance.
The law makes it hard for doctors to try new treatments – even when they know that standard procedures are not going to cure the patient. Something new leaves the doctor open to litigation and the loss of his or her job. This is why current law is a barrier to innovation – it creates a culture of defensive medicine in the NHS.’

‘Currently the law dictates that patients are only offered standard treatments. Innovation requires deviation from standard procedure. So under current law innovation is deviation.’

Patients and families can confidently ask, “Are you trying everything? Is there anything else you can do?’’

‘The Bill was written with input and guidance from eminent clinicians, lawyers and judges including Lord Woolf, Former Master of the Roles [sic] and Lord Chief Justice, Baroness Butler-Sloss, former Lord Justice of Appeal and leading Professors from the Oxford School of Medicine among others.’

‘Jeremy Hunt promised to pass the Bill into law if the public wanted it. You have spoken and you have said, clearly and in numbers, that you support the Bill. Civil servants in the Department of Health will analyse the results and then make a recommendation to Jeremy Hunt whether to support the Bill or not. We are confident that he will. It will then be up to the Government to find time to bring the Bill before Parliament for debate and to be passed in to law. This should happen before the next election.’

etc

Posting on cancer forums:   Dominic Nutt, Liz Scarff posted on various cancer forums thorughout the campaign to gain support and ask for increased community support, sharing of PR, and to find speakers for the Bill’s broadcast events.  The help given to the forum users included a guide to the Medical Innovation Bill ‘easier than reading the Bill’ entitled ‘HOW CAN AN ACT OF PARLIAMENT CURE CANCER?’ which has predictably misleading, biased content.  A further dropbox shared file was even less restrained.

‘Do you want to be in the Telegraph?’ states ‘in many cases standard procedures lead only to a repeated cycle of painful treatments and death with no opportunity for cure furthering medical science’ 

Strangely, many links to documents sent to cancer patients have now been removed, for they may well bring into question the tactics used and the basis upon which people clicked in favour – after all, what kind of monster wouldn’t want to cure cancer? Especially those with a dying relative?

From  ‘HOW CAN AN ACT OF PARLIAMENT CURE CANCER?’

‘SUMMARY

WHY DO WE NEED THIS BILL?

1. All cancer deaths are wasted lives.

2. Science learns nothing from these deaths. Scientific knowledge does not advance by one centimetre.

3. Scientific discovery comes to a ‘dead halt’ at the bedside of the cancer victim.

4. Because current law requires that the deceased receive only the standard procedure – the endless repetition of a failed experiment.

5. Current law is a barrier to progress in curing

6. Under present law, any deviation by a doctor from standard procedure is likely to result in a verdict of guilt for medical negligence.

7. Current law defines medical negligence as deviation from standard procedure.

8. But as innovation is deviation, non-deviation is non-innovation.

9. This is why there is no cure for cancer.

WHY DO WE NEED THIS BILL NOW?

The law of medical negligence hasn’t changed for decades and medical innovations have still been made.

So why is the Bill suddenly so urgent?

1. 1. The law may not have changed much, but society has. We are more informed, less deferential and more litigious.

2. The number of lawsuits filed against the NHS has doubled in four years. Last year’s pay-out was £1.2bn. The Treasury provision for claims against the NHS has now reached £19bn.

3. So doctors are increasingly frightened of being sued, and even less likely to feel able to innovate.

4. “Risk-management” processes within the NHS and insurers’ policies designed to stem the rise of litigation can only increase this anti-innovative pressure.

5. Growing fear of litigation leads to growing bias against innovation.

6. This is why there is no cure for cancer.

LEGAL MEMORANDUM

…In legislative terms, the key operative provision is clause 1(2), which declares that it is not negligent to innovate if the decision is taken responsibly. Even this provision is arguably merely declaratory of the existing law – but sufficient doubt appears to exist as to a perceived legal presumption against innovation to make this provision necessary.

THE STATUS QUO

Unfortunately, here is the status quo:

A woman is told her tests are ‘normal’, to come back in twelve months. Twelve months later, she is removed from her home.

The woman is cut and drilled until she loses half her body weight. Wires and tubes are attached to her throat, nose, stomach, vagina. Drugs are given to her which cause nausea, vomiting, diarrhoea and fatigue. These procedures open the path for deadly infections

to enter the woman’s body. Then, finally, they reduce her body’s defences against infection.

The woman turns into a sparrow.

The woman is left for dead.

Soon after, the woman dies.

REASON FOR CHANGE IN LAW

The aim of the Bill is to improve the detection, diagnosis and treatment of cancer, in particular, ‘hard-to-treat’ women’s gynaecological cancer.

….  “The process”, as it is called, involves scenes which would not permitted in a Hollywood horror movie.

Not surprisingly, the survival rate for such cancers is the same as it was forty years ago; i.e. nought; and the mortality rate is the same as it was forty years ago; i.e. 100%.

Current law in relation to medical negligence contributes to this failure. It defines medical negligence as deviation from standard procedure. But as innovation = deviation, then non-deviation = noninnovation.

DEFECT OF CURRENT LAW

The present pre-eminence in law of the standard procedure provides no inducement to progress. It outlaws initiative. The self-interest of medical practitioners, as defined, for example, in doctors’insurance policies, means that innovation (i.e. deviation) is a form of self-harm.’

And on this official document goes, for all its 104 pages, using sensationalist language, emotive petitioning and unrelenting misrepresentation of the law of medical professionals and science.

These are taken from a cursory glance through, and are repeated  additively time and time again by Lord Saatchi and the team. They intentionally misrepresent medical practice in the UK, cancer care, scientific facts, research progress, and importantly the law. Prof Rawlins went from against the Bill to being swayed by eminence and the portrayal of Simms.  Simms is a perfect example of the Bill’s spin in action – Butler Sloss’s comments depict the reality:  Bolam is no barrier to innovation. Simms was the case where PPS was explicitly approved for use intracerebrally for the first time in 2 young patients with vCJD. If squirting PPS into someone’s brain doesn’t count as innovation, I’m not sure what does.
Yet they take her remark out of context, so out of context that they reverse its meaning, then broadcast on twitter ‘Butler-Sloss has supported’ and tell leading clinicians and experts that a leading, respectable and great legal authority has supported the Bill.

Lord Saatchi stated ”The survival rate for gynaecological cancer is zero and the mortality rate is 100 per cent. “These figures are the same as they were 40 years ago.’ – this is not at all true and is either based on misunderstanding or intentional misrepresentation.

There is no place for this style of campaigning when real lives, real medical progress, real research and real people and their families are squarely put at risk. Open, honest and transparent is what we are all striving for in healthcare improvement and patient involvement. This campaign has been a serious affront to those principles.