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

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.

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 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?

‘HOW CAN AN ACT OF PARLIAMENT CURE CANCER?’

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.’