Stop the Saatchi Bill stopthesaatchibill.co.uk launched this week as the bill pressed on to its reading in the HL without consultation on the new draft, and without publication of the recent consultation responses. The bill team declare that it is on track to be passed upon reaching the Commons and will receive the Royal assent prior to the May 2015 elections.
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
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.
Samaritans: 08457 90 90 90 email@example.com
The tragic loss of Robin Williams – absolutely devastating to his family – has also been felt this week around the world, for he touched so many lives with such unstoppable intellect, wit, passion and wisdom, warmth, kindness and generosity. He made the world a better place for so many and was truly one of a kind.
Most famous for his comedy roles and absolutely genius stand-up, he spread such happiness.
And here we have the tipping point.
I have written this because today I have seen just how many medic friends have no idea – the messages of ‘I can’t believe he could have been depressed’ among others .These friends are in charge of patients. More people need to know that these things don’t only affect a small group of easily identifiable people, the sufferers don’t wear a badge on their heads, or walk about weeping.
Look around you, be a good friend, for nothing in return. Have no preconceptions, for depression can affect anyone.
The class clown. The funny one. Hilarious. I can’t stop laughing! – are these comedy reviews? No.
They are things people have said about me. I’m not a clown. I’m not being funny now. I can be a little dry and different, I guess, but humour has been my shield of armour and my grounding point at once, so without even intending to, people fall about laughing. I’m no master, and I doubt anyone ever could be compared to Robin Williams. For me, it’s just how I am, how I have been for many years. It’s how I’ve survived my darkest days. These people in bars, these friends in the corridors, these colleagues sat on the grass with their M&S sandwiches.. they think of me as the funny one, the entertaining one in a drudge filled day. They know I’ll always be fine. ‘You’re always smiling!’ or ‘you’re hilarious’. Sure, I enjoy making them smile, it’s a default position now – and if something can be funny, well, we know that life is short – we know that sometimes the greatest humour can come from the darkest moments. The ‘laugh or cry’. More practically though humour is great for teaching, it’s a powerful tool in presentations where you’re losing the will to go just through being there. It is disarming. It’s genuine, it’s probably called a ‘personality’ in some fields.
Except the sunny side up personality – is so often concealing the darkness underneath. Sunshine casts the shadows. I’ve been in two comas. I have been in a number of serious accidents, but my recovery has been complicated by profound depression. I have deep scars that have very nearly faded up my arms, only visible in a turn of the sunlight. I spent a year of my life in the Priory. I was anorexic by the age of 8, and relapsed intermittently until 18, when I had a BMI of less than 9. At 13, I took a massive overdose, as a 9 year old I ‘fell’ from a roof top and swore to myself, at 9, Golden Gate or Brooklyn might be a better bet. I was just a child. I was the class clown then. I was the maths whizz funny one with all the jokes. I transcended popularity groups – the teacher gave me the best nickname, the cool kids loved me and so did the ‘unpopular’ ones. Nobody would have ever imagined me, of anyone in the class, could have come so close to ending my life. I have called the Samaritans, once. I have, even in recent years of sensible apparently fine life, meticulously planned how I would end it, right down to the day, the time, the location. I hate waiting for a train because I’m never entirely sure the inner urge to jump out won’t actually overpower ‘okay’ me that day. And normally I’m ‘fine’. I crack a ton of jokes. I am ‘the life and soul’ of places and groups, but scratch the surface just the smallest bit and it takes every last aching force to try and stop those terrifying waves of depression crashing out and catching me. I was diagnosed as a child as suffering from severe depression and anxiety, with anorexia as a side issue somewhat. Now I’ve had all the therapy, I’ve trained as a counsellor myself and I do manage to help others who call me. But ‘heal thyself’ doesn’t work here. No amount of intellectualising it, self awareness or rationalising the problem will make it just all be better. No amount of personal choice and willpower will level the rocky terrain I tread.
But do my colleagues and friends have the faintest idea? No. I feel some days so dark and low, I can barely walk down the street. A single jostle and I want to burst into tears. When it comes, it engulfs me. I’d rather hide in a dark dark room, and not come out for a month. Which I think I have done in the past. Sure, I’ve had the drugs, I’ve had the feelings diaries, I’m off the drugs, I’m ‘recovered’ -which is great – but that girl from then isn’t just my case report. She’s still me, and that’s still frightening. Were it not for ‘having responsibilities’ it’s quite possible I would not be here now. What those responsibilities entail varies person to person – but many of us have a sense of some obligation on this planet. I feel my uselessness could be outweighed by usefulness in contribution. I wonder if my child would ever question himself because I wasn’t there anymore. I wonder if he would be okay. Despite this, it’s hard not to think everyone would be better if I weren’t here now. But I carry on, reminding myself of these responsibilities, CBT myself on that in my mind and try to schtum the notion. Do I believe my CBT-ed spin? No. never. But I get on with it. I list the positives, I tell myself ‘it could be worse!’ or ‘it has been worse!!’ of course when I figure out time doesn’t come in discrete little parcels, and note the cumulative worse-ness, things plummet into unbearable. But we skip that part. A lifetime can be spent battling against the unforgiving crash of those waves – a split second falter in that can change someone’s story.
Addiction “It’s not caused by anything, it’s just there, it waits. It lays in wait for the time when you think, ‘It’s fine now, I’m OK.’ Then, the next thing you know, it’s not OK. Then you realize, ‘Where am I? I didn’t realize I was in Cleveland.”
And that’s the thing. My doctor wrote to me when I started law school and said ‘it will always be with you, you have to do your best to learn to live with it, but manage it’ which surprised me. She was right, though. Only a few years later, my best friend from there (a very close friend, the only person in the world I was absolutely honest with) was found dead at home. Her last email to me was begging me to help her, asking me to tell her how I did it – how I was ‘fine now’.
Well, I never replied to that email. Maybe I didn’t have an answer. I’m fine is meaningless and a detraction from the tumultuous torrent of agony, so often. But I am fine , because I have to be. Because I’m so unrelentingly busy and overcommitted that I must be. I don’t have days off, or stop to allow in any crack of the harsh light of the world. If I did, I’d have time to remember any of the closest people who have died and gone forever, I’d have time to really experience the hopelessness, the broken shattered endings of what I fear to be my own making. I’d have to confront the surety within me that everyone would be better without me, that I am but a finger pulled from a glass of water, that no ripple would exist and I do not deserve happiness or life, that there is no reason to be around now and that ending it, would mean I’d end the pain. I’d have an ear splitting silence. So instead I carry on and I’m fine.
And I’m fine. But at the back of my mind I always leave my apartment tidy, just in case I die. Too many people I know have. I also see too many accidents – and as a London cyclist, I’ve BEEN IN too many accidents, to not realise this. Medicine confronts you with this daily. When I last went away – I teetered over a cliff, staring at the rocks below over the coast in an absolutely stunning bay. I was in good company, and had a wonderful time. But. Sometimes the happiest I have felt is when I know it’s within reach. I finally feel freed, and living becomes the active choice and not the default. Indeed, too, the process of planning, of knowing it can be over – can bring a tremendous sense of calm. But it also has an effect of placing you somewhere out of kilter, you’re not really fully into the swing of living like the rest of the world if you have this back up. Or it can make some more able to live life to the full, for as long as they choose to. This loss of fear, that can come with either close bereavements, trauma, or professionally when confronted with death unavoidably and unrelentingly, as in medicine, can make death seem less of a terrifying, or certainly less unimaginable way to go. This close awareness of mortality can bring out the best in us, but the precipice when vulnerable and the fact it’s never far away from anyone, makes the active choice of staying an even harder one to bear at times.
Tomorrow if I walk through the corridor, and see my colleagues – and they come up to me and pat me on the back and expect a coffee break full of witty retorts and great fun; I’ll step into role just fine, but I hope that more of them one day may be less shocked and less entirely blind, or even indifferent, to who depression may affect.
I believe that talking openly about mental health will help, and it’s a long road still, to destigmatise it. I believe that the GMC and equally medical schools are not conducive to supporting those with depression, addiction, anxiety or any MH disorder. Instead it is permanently imprinted upon your file, forever more, and becomes something of a noose to be used in future. We all know the brightest perhaps are more affected in some ways than others. This is in no way a reflection on their aptitude if they maintain self-awareness, and a key to this is accessing support or being open if they need additional support in keeping on track, avoiding substance abuse or asking for help, remaining in control. I have been fortunate in meeting some great people and without them at the hardest times things would have been very different. Medicine of all professions has a stoical oddness that mandates illness to be for other people, while having a very high rate of addiction and depression. It has a high rate of suicide, and at least 96 doctors have committed suicide after referral to the GMC in recent years, awaiting FTP proceedings. That’s a staggering number of lives, people, professionals who felt they had no way out, or were unable to access the support they needed to stop them from taking their own lives. I believe addiction or depression, as examples, do not make someone a bad doctor. They make someone insightful, human, empathic, wised up to people, their patients and their safety. Opening up and feeling allowed to open up without consequence is the first step in accessing appropriate treatment and managing the problem.
This is hugely important in medicine: that doctors are able to access help without fear of consequence. Professionally, and in terms of patient safety. There should be no professional repercussions to accessing help or treatment. What is the purpose of a professional regulatory body that actually encourages people to conceal their illness when they need help? How utterly senseless, how dangerous a system that encourages people to never seek help that they need for fear of professional sanction.
As we know, life is precious, precarious, can be fleeting and must be lived fully. I regret not telling someone how thankful I was for their help. They died, before I ever had the chance. Except, I did have that chance. Memento mori.
I hope to see the end of stigma attached to any illness. Asking for help? Only any good if there is help for everyone, no matter what their profession or status may be. I also hope that media coverage sharply corrects itself – journalists and editors are coming across as teenaged buffoons, lucky to have no clue about any serious topic, but seriously risking harm to others in their disgraceful coverage of sad events.
What can you do as a friend? How can you help?
Just be there. Expect nothing in return. Do not take offence when your calls are unanswered, your messages unread. It may take weeks, months. My real friends are the ones who I know, even though I haven’t seen them for perhaps even 8 years – are there, and don’t want anything back. Just being there, silently, is so much more helpful than placing limits on your patience, or demands on someone who may have just nothing within them to answer right away. It takes time, and knowing they have a friend, irrespective of what they’ve been able to put back into the friendship recently, can be very helpful.
Addiction, depression, mental health problems affect all layers of society, rich, poor, beautiful, clever. Nobody is immune and no preconceptions should be held against anyone. You don’t get depression because of something. Depression IS. It just IS. It may make all the bad things harder, but it makes the colour drain from the good things, it removes everything and anything and is an oppressive and unforgiving illness.
Samaritans: 08457 90 90 90 firstname.lastname@example.org
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.’
‘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.]
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.’
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?’
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.
…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.
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  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  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.
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.
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.’
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.