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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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!’

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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!