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.

Why there is no legal or medical justification for the Saatchi bill – BMJ

Time and again it has been stated that there is no legal or medical basis for the Bill. I like others have been frustrated by the refusal to listen to clear fact and some not-overly-complex law. I therefore warmly welcome today’s BMJ Editorial entitled ‘Why there is no legal or medical justification for the Saatchi bill’  Some included herewith – full text at bmj.com

‘Commentary supporting the bill states: “Under present law, any deviation by a doctor from standard procedure is likely to result in a verdict of guilt for medical negligence.” It continues, this is why “there is no cure for cancer.”

These are major overstatements. Common law rests on the Bolam principle, which states that a doctor is not negligent in prescribing an unproven experimental treatment if it is supported by a responsible body of medical opinion.

This “professional consensus” defence already accommodates innovation by minority opinions. For example, professional consensus approved a 1% minority opinion in favour of spinal surgery (by spinal surgeons) despite a large majority of neurosurgeons disapproving of the surgery (De Freitas v O’Brien [1995] Med LR 108). Doctors can prescribe unlicensed drugs and, in extreme cases, untested drugs awaiting approval, as they did for patients with variant Creutzfeldt-Jakob disease (Simms v Simms [2002] Fam 83). The Department of Health has not suggested that law is an obstacle to medical innovation…

The most thorough discussion of the legal aspects of the bill is by the Saatchi campaign’s barrister. Notably, he found “little to demonstrate that innovation is stifled by the risk of being sued.” He concludes that the bill did not “effect a substantive change in the law” but it may influence how doctors perceive the law. This is a major concession to those who dispute the need to change the law. If doctors’ perceptions are the problem, besides changing the law, softer solutions are available, including clarification and codification by professional bodies…

The health secretary has committed “that the government will seek to legislate at the earliest opportunity, subject to the results of the consultation.” In this he should be guided by the analysis of cases identified in the consultation. The consultation responses of 22 organisations did not identify a single instance of existing law deterring a doctor from innovation.  These responses also identify the risk of making the doctor’s decision more subjective, the weakness of reliance on the “responsible officer,” the shift of risk to patients from any sponsoring organisation and diversion of attention from relevant clinical trials…

That this bill has got so far is testament to Saatchi’s campaigning skills and, perhaps, the extent of his grief. But the lack of support for his two key arguments for change is striking. Even his own legal advice states that the bill leaves existing law unchanged. Numbers of medical negligence cases are likely to fall. The legal case for reform is weak. If the bill becomes law, it may be more as a memorial to a deeply missed partner than as a contribution to improving cancer care.’

 

There was never a legal justification for the Bill, and the only action the team should take is to withdraw this dangerous ill-thought through concept and take stock of the consultation responses, their comments and their recommendations for something to ‘back’ that would be of real benefit to patients, clinicians and progress.

BMJ – Letters to the Editor

There has been belated coverage of the Bill in the BMJ in recent weeks, notably Prof Sir Michael Rawlins writing in support on the entirely misunderstood and misrepresented basis of Butler-Sloss’s remarks in Simms v Simms –  a case which rather proves that there is no need for this legislation at all.  The article and its responses are here.

This was followed by the reasoned article from Dr Margaret McCartney – ‘Withdraw Saatchi’s quackery bill’ and its accompanying rapid responses.

Those posting rapid responses included Professor Michael Baum and Professor Susan Bewley.

The latest letters include responses from solicitor Dr Darren Conway, stating  ‘the bill will cause serious problems for the medical profession. It should be rejected’; the response from clinical research consultant Les Rose listing many current consultation responses from organisations against the Bill;  Consultant Oncologist Santhanam Sundar’s response ‘legal hurdles and clinical irrelevance’;  Professor Bewley’s response as above and a letter from Nigel Poole QC: The “Saatchi bill” is mistargeted and will put vulnerable patients at risk.

Nigel Poole QC’s letter states:

The Medical Innovation Bill is unnecessary, mistargeted, and will put vulnerable patients at risk.1 In its response to the public consultation, the BMA said it “strongly believes that the draft bill should not become law.”2 I agree.

The bill’s laudable aim is to promote responsible medical innovation, but the draft on which the government has consulted seeks to do so by providing that doctors who give treatment that no responsible body of medical opinion would support shall not be negligent.

The bill is aimed at the wrong target. As the Medical Defence Union said,3 4 medical negligence law does not prevent responsible innovation. Doctors who act in accordance with a responsible body of medical opinion are not negligent, even if most other doctors would not support the treatment given (the Bolam test). Sir Michael misunderstands the judgment of Lady Butler-Sloss in Simms. Far from holding that the Bolam test obstructed innovative treatment, she deployed it to justify allowing untried treatment to be given to two patients with variant Creutzfeldt-Jakob disease. Whether that was a good decision or not, it cannot be used to argue that the current law impedes innovation.

The bill has nothing to say about matters that have a real bearing on innovation, such as funding or regulation.

“Innovative treatment” is not defined, so the bill applies to all negligent decisions to treat, whether innovative or not. It does require that certain procedural steps should be taken by the doctor before making the decision, but, by definition, the decision would still be one that no responsible body of medical opinion would support. Contrary to some reports, the bill does not require other professionals to endorse the doctor’s decision.

Surely there are better ways of promoting responsible innovation than by removing the right of redress to patients who are harmed as a result of treatment that no responsible body of doctors would support?

 

Surely there are better ways; as stated by Dr McCartney, ‘the intentions may be honourable—more honourable would be the bill’s withdrawal.’

Smokescreens and spin

Those who are ill or parents of an ill child, as well as those who have lost loved ones, will naturally seek hope, meaning and will move mountains to try and find a cure or make progress. Some will be, understandably, desperate. Some will be resolutely determined.  All are likely intelligent, indeed inspirational people, keen to make things happen – so how have so many of these great people been lured in to supporting this campaign?

Unrelenting smoke, mirrors and spin from an expert ensemble.

Repetition of set lines and phrases is a known political tool, put to great use by Saatchi & Saatchi in the 1979 Thatcher campaign ‘Labour isn’t Working’ and put to continued use by Lord Saatchi in articles, interviews and oration in broadcasted meetings. This is combined with an emotive, powerful support team, set up to tug on heartstrings with a pull of hope, guilt and despair.

Further still, the use of the media. Lord Saatchi has significant power and wealth and has used this, and many trusty contacts, to bulldoze the public into support through various media channels. His Director of Communications Dominic Nutt is a journalist who has written for the guardian, and who worked at Save the Children as did Liz Scarff.  Liz, an award-winning digital media consultant, has been a driving force of campaign policy. She has done some admirable work in the past, the Saatchi Bill being only her latest project. Her USP has become crowdsourcing mega campaigns through social media: she was behind the success of crowdfunding £2m for the icancer campaign (also featuring Dominic Nutt).

Great, wow, so what’s her secret?
She states here her approach to a very successful save the children campaign:

“to use digital and social media to engage with key target audiences.. (real mums)…telling the story.. is immensely powerful.. they could connect… on that very real level – as their journey progressed the…. community became more passionate and actually began to take ownership of the campaign themselves.. so we effectively started to crowd source”

“Blogs in support… media coverage… it was amazing to see how passionate the community were about the campaign very quickly…we had lots of media… it helped that … (bloggers) work in the PR industry’’

“I think that the essence.. is this idea of peer-to-peer communication and authenticity in the voice and how you communicate, and the sort of content that you produce”

Well super. But rolling out this exact model to go against evidence based medicine or legal safeguards is, I would suggest, thoroughly inappropriate. To use ‘immensely powerful’ stories (ooh, like dead children and cancer?) to drive passion in the community (of parents of children who are or could ever become ill, those who are terminally ill and the bereaved?) to reenact this model is not an appropriate application of her talent.

In that campaign, against “9 million children dying needlessly every year” evidence based practical health solutions existed to drive change – the absolute opposite premise of the Saatchi Bill; but despite this paradox the tactic has been to drive the Bill forwards with the same winning approach, using emotive stories from relatives to disband concerns as to whether or not the campaign is telling the truth.

Back to Dominic. Dominic has not only, in the true spirit of the campaign, written articles absolutely failing to declare his clear conflict of interest, but is notably married to Glenda Cooper; a journalist with an impressive career including a role at the Daily Telegraph who was also previous Consulting Editor at the Telegraph, and former Guardian Research Fellow. The Telegraph is one of the media outposts that the Saatchi campaign has broadcast from, dedicating a whole webpage to the campaign, running frequent press releases in print, disguised as articles. Any reader of the Telegraph would likely assume the editorial standards would ensure the content that they are reading is factually accurate, and would be inclined to believe every word.

I do not doubt the character and integrity of the individuals involved, all clearly very talented in their respective industry – but when patient safety and lives are at stake, this powerful smokescreen team begs the question – Why? Why would they need this spin if any of it was a genuinely good idea in the first place? With historical electoral campaigns, Lord Saatchi as former chairman of the party turned Tory life peer, and numerous donations from Saatchi & Saatchi- £322,605.41 in advertising alone in 2010; Conservative backing including support from the one and only Jeremy Hunt is not surprising, and nor is it too much of a stretch to wonder, really, what else here is being concealed or lobbied in the background.

It’s all a bit unsettling – who on earth is running the show for this to have gone so far when so clearly inappropriate from the beginning? But oh, what a show it is.

GMC response to Medical Innovation Bill – unnecessary and undesirable

The GMC has issued their response to the Consultation.  It may also be read in full here: GMC Response

They reiterate the remarks of many doctors responding, both that innovative practice is inherent in medicine, and that innovation is not impeded by guidance or litigation.

‘Medicine is a risky business. There are many people alive today due to the willingness of doctors to innovate, deal with uncertainty and take reasonable risks which are understood by, shared with, and consented to by, the patient.’

Importantly they state the following: ‘legislation may unintentionally weaken the principles ..fundamental to safe, effective patient care; legislation is both unnecessary and undesirable.’

‘We are however concerned that 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. We take the view, therefore, that legislation is both unnecessary and undesirable.’

They note that legislation as proposed would breach core GMC guidance. Good Medical Practice states that doctors

‘must be satisfied that the drugs or treatment serve the patient’s needs’ and must ‘provide effective treatments based on the best available evidence’.

Noting the particular difficulties of innovative treatments, varying capacity and gaps in evidence the GMC reiterate that their guidance on Consent ‘already recognises and allows for innovation’, with important steps for optimally informing the patient in the difficult setting of additional risk or less evidence the GMC emphasise that ‘our guidance certainly does not discourage innovation.’ ‘Doctors who make decisions based on the principles in our guidance will be able to justify their decisions and actions if we receive a complaint about their practice.’

Noting a number of fundamental examples, the GMC state that ‘a lack of clarity in legislation of this kind can only serve to undermine any safeguards aimed at deterring dangerous practice or reducing the risk of exploitation.’

They also believe that this may hinder responsible innovation, using RO notification as an example as to how it may delay and inhibit doctors from ‘taking some of the responsible risks they are able to make under current arrangements’, and RO ‘assurance’ would involve ‘substantially changing the role and remit of ROs’ which
‘would have resource and other implications for NHS and independent sector services, add unwelcome layers of bureaucracy, and require changes to the Medical Act which would be virtually impossible to draft in a meaningful way.’
Further noting ‘it is difficult to see how (the role of the MDT) would be interpreted in law, which would introduce further uncertainty for doctors and members of any multi-disciplinary team.’

They assert that it ‘does not provide a clear enough definition of medical innovation so as to define where the boundary lies between innovation and medical research. Our understanding is that this bill is aimed at doctors innovating to meet the needs of a particular patient. Whereas our understanding would be that innovation for a whole population of patients constitutes medical research.’

Clear that the Bill would ‘add new areas of uncertainty for doctors and others…adding unhelpful addition to the current practice.. removing an important safeguard for patients by removing a key requirement of responsible practice’ ; the GMC state ‘we do not consider that further developments in medical innovation can be best achieved by legislation drafted in these terms. We believe that much more can be done to promote responsible innovation in a way that may be more effective in achieving the stated aims of the draft Bill.’

BMA response to Medical Innovation Bill ‘Saatchi Bill’

220px-BMAlogo
The BMA have over 153,000 members. They ‘maintain the honour and interests of the medical profession and promote the achievement of high quality healthcare.’ They aim to represent members’ best interests, and in turn aim to achieve the highest standards for patients.

The BMA’s response to the consultation on the Saatchi Bill / Medical Innovation Bill can be read in full here:

BMA Response

The BMA ‘strongly believes that this Bill should not become law’ and is
‘unnecessary, risks removing important protections for patients and could encourage reckless practice, with attendant risks for patient safety.’

The BMA believes that the best mechanism through which medical science can advance is through well-regulated research and clinical trials. However, If there is sufficient justification to believe an untested or unlicensed treatment could be beneficial, doctors should be confident in pursuing these with patients where clinically indicated and in their best interests.

We have no evidence to suggest that the threat of litigation is a barrier to the provision of innovative treatment of this kind and we strongly question the necessity and desirability of introducing statute to clarify or change the law in this area.

Where it is necessary to pursue innovative treatments and it is not practical to follow a research pathway, doctors are required to act in the best interests of their patient;

It is clear that treatment which is outside of standard practice can be provided in these circumstances and doctors are prepared to explore these options with their patients under the law as it stands. The Simms v Simms judgment itself showed that even risky, innovative treatment, for which there was minimal evidence of effectiveness and which had not been tested on human beings, can be allowed provided it is in the best interests of patients.

The BMA has received..reports..that funding requests for innovative treatment are submitted and approved, often on condition that the results will then be distributed, adding to the wider body of medical knowledge.

If the Government’s aim is to encourage medical innovation, the BMA believes the focus on negligence is misguided and may send the wrong message to patients
It focuses on the process of decision making rather than the outcome for patients and, in contrast to the current test of medical negligence, places considerable emphasis on individual opinion and subjective analysis, rather than on the validation of a decision..

Focusing on negligence also fails to acknowledge other barriers to doctors developing and exploring innovative treatments and offering them to their patients, including funding, being allowed the time to undertake the necessary studies, and the various approvals processes.

An overwhelming expert consensus against Saatchi Bill

Update: further responses have been released and are included herewith. They are included in list format here and here.

Medical Opinion

NICE has issued their response to the consultation:  NICE Response  

RCP’s consultation response:   RCP Response

The Royal College of Physicians  already encourages innovation and finds, together with medical protection bodies, no real evidence, anecdotal or otherwise, that fear of litigation deters doctors from responsible innovation. It does however set out some recommendations for improvement in this area and notes the key factors which may arise as barriers to innovation and would thus be more suitably addressed as areas of focus for any future, careful improvements.  The RCP also note in their response that there is no legal barrier to responsible innovation in the present law or guidelines.

The GMC has  responded to the consultationGMC Response

The GMC state ‘we are concerned that 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. We take the view, therefore, that legislation is both unnecessary and undesirable.’

The NHS Health Research Authority has strongly opposed the proposed legislation. HRA Response

The members of the British Pharmacological Society oppose the Bill and its rationale.  BPS Response

The Academy of Medical Royal Colleges has issued their opposition in a statement following the consultation closure, enclosing their consultation response- see below

Academy Response to the Medical Innovation Bill Consultation

This is an enormous body of medical, expert opinion collaboratively responding to the Bill, clearly aghast at the suggestions therein:
‘We have not seen any evidence that suggests litigation or the possibility of litigation is deterring clinicians from innovative practice’    ‘We are therefore concerned that the Bill will not actually deter innovation which is irresponsible and may indeed have the opposite effect’. ..’the Bill could inadvertently undermine the undertaking of  proper clinical trials.’  Noting that  ‘informed consent, which can be difficult enough when a body of evidence has accumulated following clinical trials, becomes much more difficult when there is little evidence to support innovation.’

The BMA Response may be read here:

BMA Response

The BMA summary states: ‘this Bill should not become law.. is .. unnecessary, risks removing important protections for patients and could encourage reckless practice, with attendant risks for patient safety.’

The Wellcome Trust, Medical Research Council and Academy of Medical Sciences oppose the Bill.

They have ‘significant concerns’ feeling ‘there is a degree of disconnect’ and stating ‘patients could be at risk of receiving treatments for which the evidence base is not well established, including treatments which could prove ineffective or even harmful.’ They identify many concerning aspects of the Bill.

AMS, MRC, Wellcome Trust Response here

The British Dietetic Association has opposed the Bill. The Academy for Healthcare Science, the overarching body for the 50,000 Healthcare Scientists working across the NHS, opposes.  AHCS Response here

The RCR opposed strongly, alongside  the MDU,  representing half of all UK doctors.

The RCS does not believe the Bill would achieve its proposed aims.   The Royal College of Psychiatrists  would support – subject to total modification.

Professor of Complex Obstetrics Susan Bewley, Professor of Surgery Michael Baum, Professor of Bioethics Richard Ashcroft and GP and Author Dr Margaret McCartney in her response and writing in the BMJ, haveall joined an expert opposition to the Bill.

 

Expert Legal Opinion

Sir Robert Francis QC responded to the consultation, acknowledging the flawed legal basis and significant risks. His response can be read in full here:

Sir Francis QC Response

Many QCs, Solicitors, APIL, Leigh Day & Co, Irwin Mitchell,  Kingsley Napley and other legal organisations are resounding in their opposition of the Bill. The defence organisations the MDU and MPS  strongly oppose the Bill.  MPS Response.

It is clearly not just lawyers opposing this Bill. The Good Thinking Society strongly opposes. The Nightingale Collaboration strongly opposes the Bill.  Junior doctors and medical students disapprove – they don’t want to practice in the broken environment that would be created by the Bill, one dubbing the campaigning Orwellian.

It is opposed by many, many doctors, research experts and medical professionals: and, importantly, by the public, patients and charities.

 

Charities and Patient Associations

Cancer Research UK Response

CRUK, supporting clinical studies on which over 35,000 patients are enrolled, having ‘consulted with both patients and clinicians, including the Chairs of the National Cancer Research Institute Clinical Studies Groups’ is against the Bill.

AvMA – a charity ‘Action against Medical Accidents’  are against the Bill  – AvMA press release

The AMRC Response from the Association of Medical Research Charities does not support the Bill.

HealthWatch  who  promote fair tests of health treatments and quality information for the public and health care professionals, are against the Bill.

The Patients Association responded in opposition of the Bill.

The Motor Neuron Disease Association Response to the Bill.

The MND Association state the following:

‘It is only after very serious consideration that we have decided that we cannot support the Bill, and must recommend to the Government that it does not legislate as proposed.’

‘Some people who promote such treatments are misguided, mistaken about their efficacy, or motivated by the prospect of monetary gain without any regard for the safety or wellbeing of people with MND. While there are some potential new treatments for MND in development, there are also numerous unproven treatments that have been developed and marketed, outside orthodox research and clinical channels…all of these unproven treatments could be made available via the provisions of the Bill’

‘It is the bedrock of medical ethics that treatments must be both safe and efficacious, and these principles serve well to strike a balance that allows scientifically proven new treatments to be promoted without making it easy to exploit vulnerable people with a serious illness. We fear that the provisions of this Bill could undermine this position, and unintentionally open the door to the exploitation of people’

‘Furthermore, the evidence presented for change in the consultation paper is unconvincing’

‘The Bill would not remedy the problem it is aimed at, for such a problem does not exist: uncertainty around the law or fear of litigation do not.. dissuade doctors from trying new treatmentsIt  is certainly the case that such factors are not at all the reason for the lack of curative treatments..’

‘Indeed, we believe that the current legal position offers an appropriate balance between latitude for doctors and safeguards for patients

‘(The Bill does) not appear to offer any safeguard against the inappropriate or exploitative use of unproven treatments’

‘In the face of legislation which could open the way for, and .. encourage, people with terminal illnesses to take significant risks with their health, it should be remembered that people who live with such illnesses can achieve a quality of life sufficient to make life worth living.’

‘We are very concerned’

 

To apply Bolitho, there is no responsible body and no logical way that this can be supported.  The Bill was misconstrued, dangerous and indefensible from the outset.  No responsible body of medical or ethical opinion would support the Bill.  It should have ‘a survival rate of zero’ and be withdrawn with immediate effect.

Additionally  here are those listed  on Nigel Poole QC’s blog  at 26 April, plus many others expressing objection via twitter:

As at 26 April 2014 the following have agreed this statement: Suzanne White, Partner on behalf of Leigh Day Solicitors, Professor Michael Baum, Emeritus Professor of Surgery, UCL and past President of the British Oncology Association, Peter Walsh, CEO Action against Medical Accidents, Matthew Stockwell, President, Association of Personal Injury Lawyers, Stephen Webber, Chairman of the Society of Clinical Injury Lawyers, Catherine Collins, Chair of England Board, The British Dietetic Association  Keith Isaacson, Chairman, HealthWatch, Alan Henness, Director, The Nightingale Collaboration;  Laura Thomason, Good Thinking Society, Margaret McCartney, GP, author and broadcaster;  Professor John McLachlan, Professor of Medical Education, Durham University, Professor Richard Ashcroft, Professor of Bioethics, QMUL, Professor David Curtis, Honorary Professor of Psychiatry;  Kate Rohde, Partner, Kingsley Napley LLP, Edwina Rawson, Partner, Field Fisher Waterhouse LLP ; Dr Simon Taylor QC, Amanda Yip QC, William Waldron QC, Henry Whitcombe, Barrister, Dr David Nicholl, Consultant Neurologist, Les Rose, Clinical Research Consultant, Dr Darren Conway, Solicitor;  Benjamin Dean, Orthopaedic Registrar, Nuffield Orthopaedic Centre, Oxford, Richard Borrett, Barrister;  Lindy Williams, Paula Ashton, Azalea Read, Diane Lyall, Solicitor, Jack Skellington, Roger Fisken, Consultant Physician, Steve Cornforth, lawyer, author and blogger, David Hills, Michelle Beckett, Killian Garvey, Peter Novakovich, Lucy Barker, James T Randall, Jo Brodie, Nicola Jenkins, Caroline Aspinwall;  Adam Gyulani-Lancaster, Mark Slater, Partner PSG Solicitors, Tabatha James, David Ratcliffe, S Hart, Ben Harris, Kiri Shala, Roy Omond, David Brims, Andrew Buckley, Robert Kane, Jonathan Hartley, Robert Kane, Darryl Allen QC, Alan Lodge, John Bates, Geoff Silva, David Marshall, Sandra Patton, Muiris Lyons on behalf of Stewarts LLP, Dr Fiona Hamilton, Hamish Morrin, Angelina Curtis, Dr Peter English