MP’s Friday “fun”

MP’s Friday “fun”

Philip Davies, MP for Shipley, spoke in confused, confabulatory, support for the Chris Heaton-Harris version of the Saatchi Bill – ‘Access to Medical Treatments (Innovation) Bill’. In doing so, he ensured that not only would the Bill – criticised by patient safety experts, Royal Colleges, doctors, medical research organisations and more- get through its second reading; but also bolstered his filibustering of the next item, the  Homes (Fitness for Human Habitation) BillAfter all, who needs safe medical treatment, or a safe home to live in? 

Earning the accolade of ‘friend to rogue landlords’ last year by blocking the Tenancies (Reform) Bill to prevent eviction for asking for basic repairs in rented property, he’d been ‘unrepentant’ in the Independent:

“When I first got elected to Parliament my mentor was Eric Forth [the former Tory MP] and he really was the past master of talking out bills on a Friday… He did it for fun and he was brilliant at it. After he died I vowed I would do the same kind of work.”     …you can’t pass legislation on the whim of a worthy sentiment because it affects people’s lives and livelihoods.”

Soon after blocking Homes (Fitness for Human Habitation) Bill and endorsing the thoroughly terrible Access to Medical Treatments (Innovation) Bill, he spent 90 minutes blocking the Hospital Parking Charges Bill, which would have allowed free parking for carers in hospitals.  It’s not just Davies MP, but he certainly is the most prolific of the boys crowd who seem to get their kicks from this, without thought or care to the people who will be affected by their behaviour. 

 “To see the government playing games with it and to think that’s clever and funny is obscene.” – Labour MP Julie Bailey

Not content with voting through the very real risk of maiming individuals without consideration of their safety; and then increasing the financial burden on their carers, while they live in a home unfit for human habitation (which is alright, he’s a landlord so can’t be distracted from parliamentary duties by such matters as ensuring safe housing of tenants..) he turned his attention to what happens when one of them requires emergency life support – such as after a cardiac arrest, possibly brought on by exposure to toxic contaminants leaking into their rented house. Well, of course, why would those people be a priority? 

Presumably doing it “for fun” Davies MP and others set about blocking a backbench bill that had the support of the British Heart Foundation, St John Ambulance and the British Red Cross, as well as Resuscitation Council UK, the British Cardiovascular Society, PTA UK, the Royal College of Nursing, Association of Ambulance Chief Executives, Heartsafe Leicestershire and more.  The Compulsory Emergency First Aid Education (State-funded Secondary Schools) Bill would have ensured that emergency first aid/life support skills were taught as part of the national curriculum in state secondary schools. 


The British Heart Foundation are clear in their call to create ‘A Nation of Lifesavers’: More than 30,000 people have a cardiac arrest each year outside of hospital. Fewer than one in ten survive (e.g. 8.6% survival in 2013). The BHF have produced ‘Call Push Rescue’ kits for schools to teach CPR, and kits for workplaces and community groups. They run ‘HeartStart’ training schemes, and provide equipment for emergency life saving training to be run in a scheme for schools and colleges backed by St John Ambulance, SJA LINKS, the London Ambulance Service and the London medical schools, Saving Londoners Lives’. The British Red Cross have excellent teaching resources

But not all children are taught CPR, let alone other emergency life support. These are voluntary schemes, requiring funding and well trained volunteers and their time. For something so vital, this patchwork, unsupported provision is not enough – it doesn’t reach everyone. The BHF estimate that, although many thousands of children receive training at secondary school through HeartStart, the reach is just not enough overall.  In 2013, 70,000 were trained: just 2% of the total number of secondary age children.  In countries and states where ELS is part of the curriculum, including France, Norway, Denmark, Sweden; survival rates for out of hospital cardiac arrests far outstrip those of the UK.   In the UK, people are more likely to look the other way in public, and be unable to help at home. It’s no exaggeration to say this is life or death, on a very far reaching scale. Every child deserves to know how to save the life of a friend, a sibling, a parent. 


Peter Aldous: When she was 14, Samantha saved her mother’s life.  She said: “It is horrible to think what could have happened if I had not known CPR.”  In those countries where CPR is taught in schools, survival rates are more than double those of the UK.  If we could match our survival rates with those of Norway we could save 5,000 lives each year.


“Why on earth would I allow a bill that principle of which I don’t like a second reading?”

Speaking for 50 minutes to crash it into the rocks, his reasoning included that he simply did not agree with the principle of it. Other things I gather Davies MP doesn’t like in principle include gay marriage, international aid, international women’s day.  He’d been taught first aid and had forgotten what he was taught, he said. 

“I remember doing a first aid course at school, but I have to admit that if I were faced with a medical emergency, I would struggle to remember all the training I received. In that sense it would be rendered completely useless. That would apply to many of those who would go through first aid training at school, particularly if they were not paying attention because they did not want to be there in the first place.”

His failure to keep his first aid skills up to date, or indeed to pay attention in the first place, perhaps reinforced his conviction that it’s a waste of time. 

“If this Bill is so easy for schools to implement—it is said that it will save time, save money and save lives—then there is absolutely nothing to stop them from introducing first aid courses now as part of the existing curriculum….My point, which is very relevant to the Bill, is that all these things, very worthy in themselves, are like a salami slicer.   A serious effect of the Bill is that it will take up time in the curriculum… it is perfectly clear that spending extra time on English would be far more beneficial than a two-hour course in first aid, regardless of whether that is worth while.”


“I do not think first aid is worth teaching in schools”      The apparently more pressing concern was that people wouldn’t join the scouts.


Sir Roger Gale: I understand what my hon. Friend is saying… but the bottom line, as my hon. Friend knows and as I know, is that the overwhelming majority of children, for whatever reason, do not take advantage of any of those schemes. We are talking about life and death, and he ought to consider that very seriously indeed.

Philip Davies: I take my hon. Friend’s point, but I will explain why I do not think first aid is worth teaching in schools. My fear is if we start doing in school all the things that happen at the scouts, the guides and the Duke of Edinburgh’s award, there will be no point in people joining them, and these very worthy organisations—

Mr Deputy Speaker: Order. We are not debating what is provided by the scouts, the guides or anyone else. This is about the provision of first aid training. We do not want to get into all the activities those organisations do or try to compare the two. You understand that, Mr Davies. You are very good.

Philip Davies: The point I am trying to make, Mr Deputy Speaker—I apologise if I am making it in a ham-fisted way—is why the Bill is unnecessary. We are discussing whether the Bill should be enacted, and I am making the point—I apologise if I appear to be doing it in a deviant manner, but I assure you, Mr Deputy Speaker, I am not doing so intentionally—that the Bill is unnecessary, for the reasons I am giving. I hope that is well within the scope of the debate.

Teresa Pearce: Surely the Bill would be unnecessary only if everybody was trained in first aid? We know clearly that only a very small proportion of people in this country are.

Philip Davies: It would be very worth while if everybody joined the scouts.

In dismissing its inclusion, Davies entirely missed what’s in the National Curriculum – which is firmly supported by first aid training – (and was also wrong when he claimed it does not include sex education)

firstaidAnd despite the evident lack of expertise, he was happy to assert how teachers would feel  and leapt in to refute some of the arguments used  to support Chris Heaton-Harris MP’s widely condemned Access to Medical Treatments (Innovation) Bill. 

Philip Davies: I am very sorry that people seem to think they can come here with a worthy sentiment and expect it just to be nodded through because it is a worthy sentiment. That is not the purpose of this House; the purpose is to try to scrutinise legislation, and some of us take that seriously. 

Sir Roger Gale: I have been in this House for 32 years, and I think I know my way around the Bill procedures. I think I am right in saying that if a Bill has a Second Reading, it usually then goes into Committee, where it can be studied line by line and, if necessary, amended line by line. I would like to think that given that this is a matter of life and death, my hon. Friend might allow this Bill to have a Second Reading and then allow it to be dissected, if necessary, in Committee.

Philip Davies: It is not often that my hon. Friend makes a ludicrous argument, but I am afraid he has just done so. That would be like saying that any Bill should automatically be nodded through on its Second Reading because then we can amend it to how we would like it in Committee. That is not how this place works… I do not agree with the principle of compulsory emergency first aid education in schools, so why on earth would I want to allow such a Bill a Second Reading, any more than he would vote for the Second Reading of a Bill whose principle he disagrees with? That is how this place works.

The debate was adjourned to Friday 29 January 2016, while Sam Gyimah MP continued reading lists. 

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World first innovation in cancer therapy at Great Ormond Street

The twinkling eyes and smile of Layla Richards shine out from many newspaper front pages today – and for a newsworthy reason. A world first treatment for her Acute Lymphoblastic Leukaemia was tried out by doctors at London’s Great Ormond Street Hospital. 

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All of this went on without the Medical Innovation Bill or Access to Medical Treatments (Innovation) Bill.

Photo: Great Ormond Street Hospital

Lord Saatchi has consistently framed the need for his legislation with tales of denials of a potential cure, ‘wasted lives’, ‘cut and drilled’ on traumatic trajectories to death, as an uncaring and purely self-interested medical profession looks on.    

‘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 = non- innovation.

The result is that all cancer deaths are wasted lives. The deaths, and their attendant tragedies, have not advanced scientific knowledge by one centimetre.

Why?

Because all the deceased have received is the standard procedure – the endless repetition of a failed experiment.’
–  Lord Maurice Saatchi

The rationale for the legislation was, apparently, and as has been written about extensively, to change the law and in turn encourage more doctors to innovate. 

The ‘current law obliges the doctor to follow the status quo, even though he/she knows it leads only to poor life quality followed by death.’

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His claims have been repeated in briefing documents, in the press, at meetings, in the House of Lords and the House of Commons.

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There is no need to change the law of negligence – as this already permits innovative practice. Nor is there any evidence to suggest any case in negligence has arisen due to responsible innovation in treatment, regardless of the outcome. Indeed there are many examples where the legal position is used expressly to favour an innovative approach. 

Those responding to the consultation and responding in an unwaveringly loud chorus against the proposals of any variation of the Bill have made it clear that if there are barriers to innovative treatment, the law of negligence is not the issue. Changing it will not help doctors, and will not help patients. Nor will it be inert. It is a deeply misguided attempt that is not based on evidence – ‘a solution in search of a problem and not  very sound solution at that’, surmised the National Assembly for Wales. The interim report of the Accelerated Access Review led by Sir Hugh Taylor makes no mention of the law of negligence or the fear of it as an obstruction to accessing innovative treatments. No legal, medical or research organisation supports this assertion either. The proposals would destroy the law that operates responsively and permissively to allow responsible innovation to happen today. 

It is time for Chris Heaton-Harris, Lord Saatchi and the Department of Health to recognise when it’s time to stop and- if truly concerned about patients and access to treatments-  assess any of the genuine barriers to access and support a change that would help, rather than harm doctors and patients – children like Layla in future. 

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Photo: Great Ormond Street Hospital

Layla’s case

Read: Full account of Layla’s experience at GOSH

Baby Layla was diagnosed with ALL at 14 weeks. She received a bone marrow transplant and chemotherapy but they were not successful.  Shortly before her first birthday all normal treatments were exhausted, and her cancer was incurable. Her parents asked if anything else could be done.

A highly experimental therapy – tried only in mice- used TALEN gene editing technology to enzymatically deactivate genes in healthy donor T cells and precisely edit DNA to create ‘designer ‘cells targeted to the cancer that would withstand the necessary medication. After a 1ml infusion of 50m engineered cells over 10 minutes, a second bone marrow transplant 2 months later and now just 3 months down the line, baby Layla has a restored immune response and has been declared ‘cancer free’.   This is the first time- ever- that human cells engineered using this technology have been given back to a patient. The first trial of gene editing therapy was published last year, where an approach using a different DNA editing enzyme was used for HIV. 

Layla’s case will require very close follow-up and monitoring to ensure that the therapy is as effective as it appears to be, and a trial is planned for the approach next year. 

As Professor Waseem Qasim said: “We have only used this treatment on one very strong little girl and we have to be cautious about claiming this will be suitable for all children. But this is a landmark in the use of new gene engineering technology and the effects on this child have been staggering. If replicated, it could represent a huge step forward in treating leukaemia and other cancers.”

Here’s to Layla and her family – fantastic and all the very best!

I’ve been somewhat confused, says MP

Friday morning saw the second reading of the Access to Medical Treatments (Innovation) Bill – the latest incarnation of the Saatchi Bill – take place in the House of Commons.

Now, the list of those opposing the latest rehash of the Saatchi theme includes the Medical Royal Colleges, the BMA, the Association of Medical Research Charities and its constituent members such as Cancer Research UK, and many more. This was pointed out clearly and indefatigably. 

Dr Sarah Wollaston (Totnes) (Con): As with any book, we should not judge a Bill by its cover. All Members want to improve access to innovative medical treatments, but I sincerely believe that the Bill is not the right way forward. My hon. Friend the Member for Daventry (Chris Heaton-Harris) referred to a number of organisations, implying that they are in favour of the Bill, but he knows that the overwhelming majority of research and charitable organisations are ranged against it. It is opposed by the Association of Medical Research Charities, whose membership reads like an “A to Z” of expertise, including bodies such as Cancer Research UK, the Wellcome Trust—the list is very long, so I will not detain the House by reading it out. The Academy of Medical Sciences opposes the Bill, as does the Academy of Medical Royal Colleges, including all those he quoted in his speech.

The General Medical Council, the British Medical Association and the Patients Association oppose the Bill, and I direct my hon. Friend to their article in The Guardian. Action against Medical Accidents, and even the Association of the British Pharmaceutical Industry, oppose the Bill because of its unintended consequences. Legal experts, including Sir Robert Francis, firmly oppose the Bill. All those organisations oppose the Bill because it is unnecessary, it is unworkable, it would unravel important patient protections and, most importantly, it would have unintended and dangerous consequences for research.

I pay tribute to all the Bill’s sponsors and absolutely understand that they are motivated by very good intentions. I would love to sit down and work with them on how we genuinely improve access to innovative treatments. I hope they understand that I oppose the Bill because I sincerely believe that it is the wrong way forward.

Both Dr Wollaston and Labour Shadow Secretary of State for Health Heidi Alexander spoke with real and carefully applied insight to explain why there’s such concern about the baseless and ‘irresponsible’ proposals. 

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Unfortunately, with only 51 MPs voting – despite the unwavering censure toward the latest version from expert medical organisations, research and patient safety charities –  it passed its second reading at 32 votes to 19. 

Mr Heaton-Harris  set about spinning support for the premise behind the Bill – despite his quoted organisations having reiterated their “unequivocal opposition” in new briefing notes. 

Dr Wollaston: My hon. Friend has quoted a number of organisations. Does he accept that all those organisations oppose the Bill? He needs to make that explicit to the House. It is not fair to quote the Royal College of Surgeons, for example, without making it clear that it has explicitly opposed this Bill.

This was nothing compared to the great lashings of nonsense brought forth by Philip Davies MP,  who selectively quoted snippets of consultation responses predating April 2014, out of context, defended by announcing “I am perfectly happy for people to put their own gloss on what others are saying” – when it was pointed out that others aren’t even saying anything like that, Davies continued to derail proceedings, talk in circles, and throw in half sentences, historic quotations, and confabulatory haze for over an hour.

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Seems he was at his filibustering best – most likely because of the next slot.

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The Homes (Fitness for Human Habitation) Bill was an inconvenience to him that he succeeded in talking out.

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Next up David Nuttall MP who managed to speak for many minutes without pausing to let in fact, and George Freeman MP- setting out the government’s position- conflating, again,the Early Access to Medicines Scheme with the Saatchi monster, and fudging plentifully.  Both denied that it would affect the law of negligence; so too did Chris Heaton-Harris MP. This was very interesting, seeing as its operative effect is to change the law of negligence.

Nuttall demonstrated how the Saatchi defence to negligent decisions operates:

‘I have to admit at the outset that an impressive array of bodies have lined up either in outright opposition to the Bill or with at least some reservations about it. When I was considering the evidence, I had to take that into account. I had to decide whether in the light of that evidence I should simply go with the flow and decide that if all those people said that it is a bad thing, it must be a bad thing, or whether I should think about the other side of the coin. I did that, and on balance, I came down on the side of what I like to think of as my constituents’ view. I believe that the Bill has the potential to improve the lives of my constituents if they are struck down by a rare disease that means that they require innovative medical treatment.’

Both Nuttall and Freeman mentioned litigation costs – but omitted that the known figure for litigation relating to innovation is … £0.

Dr Wollaston: How much of the litigation cost is related to complaints about innovative treatments?

George Freeman: Most of the cases are a result of other contexts – as my hon. Friend will know, obstetrics is a big part of that – rather than innovation. I am happy to write to her with the actual figure as I do not have it to hand…

All other pertinent questions were similarly obfuscated around.

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HA4

Staggeringly the Access to Medical Treatments (Innovation) Bill edition of the Saatchi Bill was voted through to committee stage in the House of Commons, and while claiming it’s been ‘handed over’ to Heaton-Harris, Lord Saatchi’s Medical Innovation Bill remains in the House of Lords- alongside his motion to suspend SO46. 

HA.

Professor José Miola on the nonsense: ‘It’s like déjà vu all over again…’

What can be done?  Despair, despair some more – then contact your MP  ‘Call to action!’

Short shrift for Saatchi spin-off

We’ve been here beforeand, remarkably, here we are again. The weight of opposition to the Access to Medical Treatments (Innovation) Bill leaves no room for misunderstanding ahead of the second reading in the Commons.  

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The British Medical Association, Patients Association, AvMA, Royal College of Surgeons, Royal College of Surgeons Edinburgh, Royal College of Paediatrics and Child Health, the Academy of Medical Royal Colleges and now the Association of Medical Research Charities and Medical Research Council are the latest to make their positions absolutely clear on the Bill, due its second reading in the House of Commons 16th October.

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  • The Royal College of Surgeons  ‘unequivocally oppose’ the Bill. It is unnecessary with no evidence that any part of it is required. It misunderstands the doctor-patient relationship and could provide justification for unethical treatment. 

  • The RCPCH could not present a clearer warning of the ‘sinister piece of draft legislation’ lurking ‘which, if passed, will have detrimental effects on the wellbeing of children’.       ‘The Bill places patients – in particular infants, children and young people – at grave risk’, writes President Professor Modi.     The Bill will encourage irresponsible experimentation.  Families, already at heightened susceptibility…will be prey to at worst quackery and at best to the possibly strongly held but inadequately justified convictions of medical practitioners who do not know how, or do not wish, to test treatments objectively.’          ‘What’s more, the Bill’s stated purpose of enabling practitioners to employ innovative treatments without fear of litigation is completely unfounded.’    The Bill ‘will set back’ progress in bringing innovation into the care of sick children through clinical research, ‘legal and public confusion’ will ensue, efforts to improve understanding will suffer and support for research to improve the care of children will be at risk.’
  • The AMRC, representing 137 charities, and its members engaged in talks with Mr Heaton-Harris MP and communicated their concerns about the proposed draft. The organisation has now issued a formal briefing against the Access to Medical Treatments (Innovation) Bill, urging MPs to oppose the Bill as it is unnecessary and may adversely impact on patients and medical research.  Key members united as signatories to this briefing include Cancer Research UK, British Heart Foundation, MND Association, cancer charity Bloodies, the Academy of Medical Sciences, Alzheimer’s Research UK, Anthony Nolan, Arthritis Research UK, Ataxia UK, GI and liver disease charity CORE, The Encephalitis Society, The Brain Tumour Charity, Parkinson’s UK, Prostate Cancer UK, the Wellcome Trust, the British Pain Society, the Society for Endocrinology, British Orthopaedic Association, Autistica, Fight for Sight, Tuberous Sclerosis Association, Pelican Cancer Foundation, Pharmacy Research UK, and Genetic Alliance UK. 
  • The AoMRC , the representative body for the 16 Medical Royal Colleges, express ‘real concerns that the Bill will have unintended adverse consequences’, that it is ‘based on a false assumption’ with a ‘ false and potentially dangerous’ distinction between innovation and research.
  • The BMA firmly restate their position that the Bill is ‘unnecessary’, ‘counterproductive and…not based on any felt need from the medical profession.’  Screen Shot 2015-10-15 at 10.45.02They are clear that such ‘legislative proposals add nothing of value to the current law – rather, they increase bureaucracy and could create confusion, which may have implications for patient safety’.  Strong concerns are also expressed regarding a database.  ‘There are no plans for the information and innovative treatments to be quality assessed or peer reviewed. The inclusion of events on a database may give the impression that they are approved or have been given some form of endorsement for use again. This may lead to the inappropriate use of a treatment. Further it is not clear what safeguards will be in place ensure that all patient data is anonymised.’
  • The Medical Research Council ‘believe this Bill does not tackle the real barriers to adoption of medical innovation that need to be addressed, and may lead to unintended consequences’.
  • Patient safety and justice charity AvMA state that the Bill is ‘fraught with unintended and dangerous consequences’. It ‘would threaten patient safety’, fails to address anything that would benefit doctors or patients, and ‘as well as being based on a false premise, the Bill would actually make it harder to provide innovative treatment by creating a confusing, bureaucratic set of rules set in law’.
  • Conservative MP, GP and Health Select Committee Chair Dr Sarah Wollaston has spoken out to say that the rehash of what she previously termed the ‘Medical Anecdote Bill’ is still half-baked and dangerously rewarmed – ‘hopefully MPs will listen to all the serious concerns’. 
  • While academics note that it ‘does not help patients at all’.

The endless repetition of a failed experiment

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

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

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

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

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

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

and

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

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

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

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

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

and so on, and on and on.

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

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

 

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

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

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

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

 

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

Yet the situation today is this:

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

 

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

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

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

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

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

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

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

Double, Double Toil and Trouble

The leaves are turning rusty brown, the weather turning crisper.  John Lewis are selling ghostly tinsel for Halloween. But something rather more scary is on the horizon.

Lord Saatchi’s Medical Innovation Bill reappeared after its demise in the last parliament. The legislative zombie crept back to the Lords and a motion was scheduled for it to be fast-tracked.  In the meantime, Lord Saatchi heralded Chris Heaton-Harris MP’s private members ballot win as the next carrier of the Bill’s baton before Mr Heaton-Harris admitted this himself.   It is now very clear that Saatchi was correct.

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This next Saatchi Bill, be it Saatchi (No.9 3/4), Mambo (No.5), was ‘won’ by Chris Heaton Harris MP when his name came up in the draw and the Saatchi lobby were in. It has just been published in draft form and it would appear that Mr Heaton-Harris sat back and thought of England while it was being drafted. Nurtured through the medium of cut and paste by the Department of Health, it is an almost identical replica of the much-criticised Saatchi horror, with some clangers thrown in to spin it in a better light without any substantive change to the concerning aspects of the original(s). 

As Sir Robert Francis QC observed in his comments over a year ago on Saatchi’s Bill; 

‘The evidence relied on by Lord Saatchi…does not provide the convincing support claimed. The difficulties that have caused so many drafts to be produced suggest that if there is to be legislation a more considered and less rushed approach is called for if we are to be satisfied that the patients who are intended to be benefit from this Bill, and patients generally, are not exposed to increased danger and risk.’

‘The number of attempts at this Bill suggest it is not the right answer… the deficiencies all versions show indicate that it would be quite wrong to rush legislation through… Considered scrutiny is required … calm assessment of the evidence of what are the real problems in practice.’

Despite evidence, reports, and meetings with concerned parties and expert organisations at the Heaton-Harris fingertips it seems that none of what made Saatchi’s originals awful has been removed. Indeed it is a reproduction of the original, with a database.  Everything that made the originals terrible still stands. And despite the alluring title of Access to Medical Treatments (Innovation) Bill, it contains nothing at all about access to medical treatments or innovation for patients, and nothing at all to address such access issues for their doctors.  

Indeed what it does is: preserve a complete defence to negligence for doctors who are actually so bad, so irresponsible, so irrational, so illogical in their treatment decisions, that they would be classed as negligent.  These are the only doctors it helps.  Not the majority of doctors, but the very minority that should not be protected by the law.

It does not preserve the common law tests of Bolam/Bolitho but jumbles concepts into nonsense.  It would prevent people who are injured from obtaining compensation to help them live or help them pay for the carers they need after sustaining injuries from negligent treatment decisions – all this despite there being no evidence that innovative treatment forms the basis of such claims.  It does nothing to ensure a patient is in the driving seat and improve communication and informed decision making, and nothing to address any barriers to accessing treatments that may actually help patients.

It applies squarely to those decisions which no other doctor would support or which are so indefensibly irrational that they are negligent.

It does not limit the scope of the Bill in the patients it can apply to or in what is classed as innovation, and thus does not limit the scope of this defence. Homeopathic remedies for childhood leukaemia would be a-okay under this defence if the process was followed when deciding to give a dying child a homeopathic tincture, rather than chemotherapy or another proven treatment and rather than include them in a global trial for a promising drug for their precise diagnosis. A wildly experimental drug from a pharmaceutical company the prescriber is a shareholder in, one that shortens lives and removes all quality of life for those who take it and inflicts a terminal suffering, sold as hope in a capsule- well, yeah that wouldn’t be a problem either. 

It adds a completely separate concept of a database – ignoring the fact that such results are meaningless without clear methodology in data collection, reporting and conduct and patient selection, ignoring swathes of data security concerns, confidentiality factors, EU regulatory and even insurance issues; all the while missing the entire point of such initiatives as the AllTrials campaign which are very worthy of support. Nevertheless any such database could operate without the firmly refuted Saatchi Bill proforma defence for negligence.  The ‘that sounds good let’s say that’ hooks added for selling points are completely meaningless, confused, soundbites that demonstrate a lack of understanding and substance. Patients deserve better care than that. 

For excellent analysis please see:

Chris Heaton-Harris Resurrects Lord Saatchi’s Zombie Quacks’ Charter

Learned Friend: Access to Medical Treatments (Innovation) Bill 2015

and

this paper: Bye Bye Bolitho? The Curious Case of the Medical Innovation Bill

 

More Trick than Treat

cauldronLord Saatchi’s PMB has tortuously rattled around despite loud criticism from all key experts, medical organisations, research and patient charities. Unusually, a No.2 bill procedure was used to introduce it into the Lords and the Commons simultaneously in 2012. Much criticism led to its withdrawal from the Commons and a second draft, the Medical Innovation (No.2) Bill, in the Lords. A Department of Health consultations as issued on the second version of this, and this consultation closed in April 2014. Before the responses were published, a new, third draft had been written and announced as improved and an answer to all criticism. Its first reading in the Lords, a formality, was on 5 June 2014 and its second took place on 27 June 2014. It was amended again following the second reading, and it entered committee stage as its fourth version, with 39 amendments tabled. It was amended again prior to Report stage, and again thereafter, and again (v7, mark 2).   Once to the Commons Saatchi thought he’d get extra time in the last parliament to push it through and into law before the general election – despite legislative consent being unanimously rejected by a country. Indeed, if no MP objected and no amendments were tabled it could have been rushed through to Royal Assent in a day. Sarah Wollaston and Julian Huppert arranged a rota so that one of them, at least, would be around to object. When debating time and special deals were hanging in the balance the coalition government parted ways when someone said hang on, all the stakeholders say this is dangerous – let’s not do this.  

Despite the ongoing opposition from across the board: medical organisations, patient charities and groups, research charities, academics, legal and patient safety experts, Lord Saatchi reintroduced his Bill in 2015/16 in the configuration it had left the Lords – and a motion to set aside SO46 (Standing Order 46 of the House of Lords, a rule that no two stages of a Bill shall be taken in one day) was scheduled which would allow a fast tracked passing back to the Commons and even passing its stages in one day, averting the proper scrutiny of the chambers.   The motion to set aside SO46 is still scheduled for November and would allow the original Medical Innovation (No.2) Bill to pass. But Lord Saatchi has now confirmed that Chris Heaton-Harris’s private members bill IS the Medical Innovation Bill handed over, and thus given more time to run. 

The second reading of the Access to Medical Treatments (Innovation) Bill is now scheduled for 16 October 2015 in the House of Commons.

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