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.  

Screen Shot 2015-10-15 at 00.11.51

Screen Shot 2015-10-15 at 21.54.34

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.

Screen Shot 2015-10-15 at 10.25.57

Screen Shot 2015-10-14 at 10.26.50

  • 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)

Screen Shot 2015-10-14 at 19.47.45

 

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.

Screen Shot 2015-10-14 at 20.53.41

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.

Screen Shot 2015-09-16 at 13.23.38

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.

234422538alt1

Novel use of procedures to avoid scrutiny

Saatchi’s Medical Innovation Bill (more properly titled the unfounded novel use, irresponsible human experimentation and removal of redress Bill) was not, in the end, rushed through in the last parliament, despite the best attempts of Lord Saatchi to use his weight and talents to create extra time and special rules. In his shock that this, sanctioned by the conservatives, was not going to work out, he proclaimed that Nick Clegg was a nasty murderous sort with blood on his hands, and had handed down a death sentence to patients.

All Nick et al had done was say, hang on a minute – medical organisations, patient charities and medical defence orgs don’t want the Bill, patient safety experts and legal experts are up in arms abut the Bill, and Wales unanimously condemned it, and were quite horrified by it. Perhaps we shouldn’t rush this dangerous and widely condemned draft legislation in these circumstances and instead it warrants detailed scrutiny, at best, and certainly not to be pushed through in this cavalier fashion because of who Saatchi is how much power he wields or how much he donates.

Who he is does not make it right to risk (limitless) patients’ lives, safety, dignity and their quality of life.

Saatchi’s crew then went flat out trying to pressure the Lib Dems to cave in to the Conservative deal to allow this monster of a danger to be passed without any scrutiny by deploying the tried and tested setting up of petitions and shouting in the press at a crucial pinch point before the election. Thankfully the Lib Dems had more integrity, and some very sensible MPs who understood science. (Though Sarah Wollaston is a stalwart of sense, she has not been listened to by her own party – and has found herself surrounded by some extraordinarily inept characters.)

At the HealthWatch public debate on the Bill held at King’s College London in March, Nigel Poole QC and Nick Ross spelled out the problems with irrefutable clarity and sense.

Alas clarity, sense, science and integrity are being challenged once more by the undead Bill, raised from the ground and re-entering the House of Lords on the 8th June.

Worse still, the attempt to limit scrutiny and avert the gaze of noble Lords who may know what they are talking about has gone to new lengths. Lord Saatchi has given notice to the House to agree a motion that Standing Order 46 (no two stages of a Bill to be taken on one day) be dispensed with, allowing the Bill, which would need to be identical to that which left the Lords, to career straight through to the Commons without any stages of examination by learned peers, and be pushed through on the nod. If there’s one thing we need, it is proper scrutiny, particularly in light of the overwhelming opposition to the Bill from those who know what they are talking about, including those in parliament and experts in patient safety such as Sir Francis QC and Sir Ian Kennedy QC.

More info: Stop the Saatchi Bill

politics.co.uk and openDemocracy