Professor Baum: three simple principles of clinical practice

Professor Baum’s rapid response to Margaret McCartney’s BMJ column ‘Withdraw Saatchi’s quackery bill’ may be read in full here

I have also included it here in full, for in its skilled brevity it sums up everything that is wrong with the (still) proposed legislation.

Re: Withdraw Saatchi’s quackery bill
30 April 2014
Professor Michael Baum, Emeritus Professor of Surgery UCL, London NW11 6PT

There is one thing worse than controlled experimentation and that is uncontrolled experimentation.

There are many patients we can no longer help but there are none that we are incapable of hurting.

When patients are judged beyond cure they are never beyond compassionate care.

The supporters of the Bill seem to have overlooked these three simple principles of clinical practice.

In 45 years experience involved in clinical cancer research I have never once encountered the law as an impediment to innovation.

Why don’t we drive through red lights?

Move over H.L.A. Hart –  a new quasi jurisprudential vehicular analogy is about.   In a google hangout hosted by Dr Ranj, Maurice Saatchi states his case.


 “I think the reason why the bill has gained so much support is reflected in remarks made by Professor Stephen Kennedy at Oxford. He put it this way:

What patients and their lovers, mothers, daughters, sisters, want to know is ‘ has everything been done? Is there anything else that could be done? Is there anything that we can do?’    that’s what people want the answer to – usually in terms of mounting desperation.

Scientific progress at the moment comes to a dead halt at the bedside of the cancer patient. Because, let’s take the position of the doctor who is dealing with a cancer patient. He knows what the prognosis is, which is a poor life quality followed by death. Being a decent, humane person the doctor would like to attempt some kind of innovation.  At that point, standing between the doctor and the patient, appears a red light in front of the doctor. I use the phrase red light advisedly. I was advised to use it by one of the most senior judges in the country. A red light. This red light says to the doctor are you sure you want to go ahead along this path of innovation.. if you do, and anything goes wrong, you are likely to be found guilty of medical negligence. Your reputation, your livelihood, your entire life is going to be put on the line. Faced with that, a normal person would say perhaps it’s safer to stick to the well-worn path of the standard procedure. And you can see in that way that the scientific process… that scientific process of trial and error has come to what I’d called a dead halt. That’s the problem as defined by the Bill..”


He has, of course, repeatedly expressed the opinion of doctors as complacent, self-interested beings of pre-conventional morals only concerned with the consequences for their career and bank balance, and not with patients’ lives.

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He’s compared them to medieval, barbaric hangmen, torturers and mass murderers in the House of Lords and pitied their patients in the press.

He then emphatically defends his case  – because it’s like driving through a red light, right?


Dr R: ‘One thing I have to point out is that…a lot of legal professionals …have expressed concerns over this Bill. Now what would you say to them Lord Saatchi because I cannot reassure them as a medical professional, this is going to have to come from the people involved in the Bill itself ?’

Saatchi: ‘Well what is their concern?’

Dr R: ‘Their concern is that it does leave people open to abuse, to exploitation; and that law already exists and this doesn’t actually add any more to it. Case law already stipulates that the Bolam test shouldn’t be used to hinder the progress of science.’

Saatchi: ‘Yes it does.
But there must be a reason why all the hundreds and hundreds of doctors, and thousands and thousands of patients are so in support of this Bill. They can’t all be living on another planet.’

Dr R: ‘..You could argue that’s the result of a very, very good publicity campaign, and obviously your background is in advertising and publicity; but the MDU says they do not see a need for this Bill. They say that the evidence just isn’t there from their point of view obviously and they’re seeing it from their side.’

Saatchi: ‘Yes I’ve heard what the MDU say which is that there are no cases of doctors being sued for lack of innovation therefore they say well there’s no problem here.’

Dr R: ‘You could say that those cases don’t happen because they are afraid of innovating and therefore…that’s the argument from the other side isn’t it..’

Saatchi: ‘I mean, it’s a really, it’s a fantastic argument and we should try and deal with it.’

‘Let me make an analogy.. I was talking before about a clear path and the red light. There are very very few, er I’m just checking with the House of Lords library, but I believe there are very few, hardly any, prosecutions for motorists who go through a red light. The reason for that is that um if I ask you whether you’re afraid of red lights you wouldn’t say yes I’m afraid of red lights.

Every motorist knows what a red light means which is if I go through this red light and I’m caught, I’m going to lose my licence. If I hurt anyone on the other side of this red light I’m going to go to prison. So consequently people don’t go through red lights. Exactly the same applies in the red light analogy by the bedside. There people don’t have to say I’m terrified of litigation any more than they have to say I’m terrified of red lights. They both know.. doctors know and motorists know what this red light means, and therefore it’s very important for people to look at, um, the culture of litigation which now exists.’

‘…I cannot imagine that you could have a wall of litigation of that* kind, whether these…this is not to do with innovation, that doesn’t create a culture of risk aversion and a culture in which the only safe path is to stick to the status quo. That, that must be the result. That’s why so many people have said in support of this Bill that ‘we want to change the culture’. The Department of Health wants the NHS culture to be less risk averse, more innovative. It produces many documents and people give speeches to that effect. But I think the reason people support the Bill is that I think they’ve seen you can’t change the culture without changing the law because the law is there and it creates the culture that it has. Therefore this change is of tremendous significance in terms of altering the culture.‘  *(out of context post LASPO,  misleading figures quoted that do not represent litigation or settlement expenditure)


 

red lights

 

Now, if one were to  explain negligence in medicine in the simplest of ways to an individual with no understanding whatsoever, such as David Tredinnick, Chris Grayling, Jeremy Hunt, Lord Saatchi’s crew of advisers, any of them – well,  a really handy analogy is the standard and duty of care expected generally in the most basic terms when driving a car on the road – sure you can go faster in some places, you can buy a convertible, you can have pink seats and blast 80s hits at full volume, your car can be spraypainted like a batmobile,  you can be the Stig (well, maybe – is the role still a zero hours contract?)

But what might kill someone would be, oh, I dunno, something obviously bad, like driving straight through a red light. Blindfolded. At speed. Outside a village primary school.  Even if there’s a colleague in the back of your car screaming no.  Onwards, you tragically mow down lots of grannies, children, pushchairs and a young boy excited about his new bicycle.

At a busy junction, are people to only fear being caught if they jump a red light? Are they to have no regard for the safety of other road users and consider not only their licence  but the high chance of being involved in a nasty crash? or of causing an accident that may easily leave families, lives, devastated?

The Bill doesn’t investigate new routes. It doesn’t pave new roads. It adds nothing, no new rights or reassurances – it makes the journey no better for doctor or patient.  While unnecessary, and unhelpful to the vast majority of doctors,  it unfortunately does have the effect of promoting very dangerous, unsafe practice on potentially all patients, all over the country. This inconceivably terrible idea is still charging ahead when it should have come to a halt on this road long ago. It must now be stopped.

 

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HealthWatch debate – Medical Innovation Bill – KCL 4 March 2015

A discussion that should have been had long ago; the Medical Innovation Bill (Saatchi Bill) debate is finally here – free to attend, King’s College London Waterloo Campus 4th March.

A fiery line-up: Nigel Poole QC, Nick Ross, Prof Sir Mike Rawlins and Daniel Greenburg, parliamentary lawyer (and the bill’s draftsman) will be there.

Register in advance for a space. Event arranged by HealthWatch. (join them!)

 

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No time is a good time for SARAH

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The ludicrous SARAH Bill received Royal Assent last week.

I’m struggling to imagine a better social action than firing Chris Grayling strapped to a rocket, into the North Sea. Perhaps Section 2 of the Act would consider any actions favourably.

2. Social action


‘The court must have regard to whether the alleged negligence or breach of statutory duty occurred when the person was acting for the benefit of society or any of its members.’


I didn’t ignore the ‘SARAH Bill’. It seemed more inert than certain other Bills of irritation – Indeed it seemed utterly pointless.  It seems, too, that I wasn’t alone in dismissing SARAH.

“so anodyne and pointless that the only appropriate response is a shrug of the shoulders or the raising of an eyebrow” - David Pannick QC

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What I did sideline was the possibility of this pointless political priapism either being passed in the first place or widening its reach and malingering into something more sinister, more damaging.

Why would it?  Why pass it?  Key concerns have included the scope of its effect and potential interpretation.  Would it be relied upon by the MoD? who would be targeted by this potential creeping mini-assault on access to justice? is it to minimise costs of incompetence in charge of public bodies and organisations failing in health and safety matters? would it be used in all cases where an injury is sustained as a result of negligence but judicially or socially acceptable negligence? what of the inequalities in acceptability? are there any? is this a legislative means to nudge the public, control the populus? what limits it? why does it exist?

What kind of a message does it seek to send?  go forth lad, tracheotomise thy inebriated friend?

Having spent countless hours securing C-spines with pre-hospital care, St John Ambulance and teaching first aid in schools and colleges … the very best potential intention jars somewhat with the need to control the scene. A, B, C, Danger.

Ketamine for Grayling.

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Any the wiser?

Why does it exist? Why should we allow legislation that was never necessary in the first place?   A legislative fix for a problem that doesn’t exist seems awfully bureaucracy-heavy and plain silly.

Lord Lloyd ‘s move to stop a second reading fell on deaf earssarahpng

as did his comments in the Lords.

“In truth the Bill is unamendable. That was the view taken by the Law Society, and it was right. The Bill is so defective in all three operative clauses that the only feasible amendment is to take each of the three clauses in turn and remove it from the Bill, one by one.”

“The Lord Chancellor has said over and over again that the purpose of the Bill is to send out signals – signals to the judges and signals to the public. I will say no more about sending out signals to the judges. What about signals to the public? If, as we are told, the intention is, for example, to increase the number of volunteers, or to reduce the number of spurious claims, surely the way to do that is for Ministers to appear on television and write to the papers.

…does it not follow that the Bill is a misuse by the Government of the legislative process? I say it again – I and many others have said it many times – that the purpose of legislation is to make law that can be enforced in the courts.  It is not to send out Government messages, however well intentioned.”

“This Bill is indeed exceptional. Not because it is of any importance but because it is of no importance at all. It is useless.”Lord Lloyd of Berwick

Now, while it’s both irritating and alarming that inert piffle can pass as law without much ado in this country, perhaps I can live with that.  But why is the government legislating unnecessarily, with no mandate at all, no legitimate purpose? an infringement on the rule of law, on separation of powers if intended to coerce judicial decisions and interpretation of existing statute in a particular way?   Worse still, how do we know this is as suspected, a culture-speak, a foolproof non-entity? a meritless, vote-aiming ploy? creating a nation of heroes sure sounds like a voter-aimed ploy – but what in the above text really ensures its impotence?    all of it, you say?

Section 1 of the Compensation Act 2006 adequately covers what this intends to, if that was even required.

1. Deterrent effect of potential liability
A court considering a claim in negligence or breach of statutory duty may, in determining whether the defendant should have taken particular steps to meet a standard of care (whether by taking precautions against a risk or otherwise), have regard to whether a requirement to take those steps might—

  1. prevent a desirable activity from being undertaken at all, to a particular extent or in a particular way, or

  2. discourage persons from undertaking functions in connection with a desirable activity.

What effects will SARAH have on workplace injuries, for example? Grayling earlier vowed ‘to slay health and safety culture’ and  last week hailed  ‘a balance to counter the health and safety culture’ to provide reassurance to employers. He elaborated on businesses being ‘stifled by unnecessary insurance costs and the fear of being sued’.  Generally insurance is a good thing surely?  Is ‘the health and safety culture’ so terrible it requires a legislative snip? is this purposeful propagation of mythology?

Was SARAH constructed to move beyond personal injury?  what does  a ‘predominantly responsible way’ even mean?

Nigel Poole QC discusses concerns on his blog  in relation to SARAH being dragged into clinical negligence litigation: The SARAH Act 2015 – Similar Fact Evidence and Disclosure.    Clearly the text of the Act does not delineate when it will apply. Clearly if it can be used to the advantage of one party in litigation then lawyers would be somewhat bound to engaging with it.  Using the case of Laughton v Shalaby as an example Nigel Poole discusses the problems that may arise in future cases in relation to the evidential burdens and scope of disclosure required under SARAH.

Would a Court have to have regard to predominantly responsible approaches in all cases? The unlimited, ill-considered effects of the Act in practice would surely make litigation more lengthy, cumbersome and expensive and clog up the Courts unnecessarily. What of those harmed by true negligence? Would they be scuppered by the general vague gist of previous actions or vague idea of a vague aim of vaguely something good? Indeed, in the 2006 Act the judges ‘may’ take certain things into account. Under SARAH the word used is ‘must‘.

 

“Are they to say, in every negligence case, “I have had regard to this Bill”, so that people realise they are complying?” -Lord Lloyd

 

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The government should not legislate to send a message to the public through legislation; they should not legislate to correct false perceptions or misunderstandings- for education, infomercials, leafleting GP surgeries or their nearest Sainsbury’s would all prove more effective.  Why and how did the Commons and Lords allow this Frankenstein to get so far as it did?  Something’s very wrong in Parliament.  There is no doubt that this seems an anodyne, bafflingly pointless creature; but doubt remains over whether its effects will indeed creep in more than I’d dismissively believed.   Like spilt yoghurt on silk gowns.   Well, SARAH was Grayling’s creation.

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‘Miraculous Science’ – innovative advances in cancer medicine

We are told that 1 in 2 of us will be affected by cancer; a ‘disease that touches every family’.   In the UK cancer survival has doubled over the past 40 years, and ‘half of those diagnosed can now expect to live at least 10 years’. This is a staggering testament to the dedication of all involved in the study, development and understanding of treatments.

We have now reached an increasingly extraordinary technological era where treatment can ultimately be tailored to the genetic profile of a tumour.

this is an unprecedented time of progress in the history of cancer medicine and cancer research”

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BBC Panorama’s ‘Can You Cure My Cancer?’  shines a light on the work taking place at the Institute of Cancer Research and London’s The Royal Marsden Hospital which, at its inception in 1851 was the first specialist cancer treatment unit in the world and continues as a centre of excellence.  Filmed over 18 months, it allows a window into the fascinating research and direction of innovative cancer therapy, those who commit their professional lives to advancing this field and the many incredible patients who make such progress possible.

One such patient, Tami, at age 30  became one of the over 7000 women diagnosed with ovarian cancer each year.  Her prognosis was very poor. She underwent chemotherapy and surgery, but later became aware that her cancer had returned and spread.  Tami had 18 sessions of chemotherapy before swapping to the experimental oral medications MEK162 and BYL719 as part of a clinical trial, her parameters closely monitored by her medical team. These innovative drugs are personalised; targeted to the specific oncogenic mutations identified in the patient’s cancer.

Such targeted treatments “are producing spectacular results” in a range of applications.   John shares his story. John was diagnosed with prostate cancer which spread to his spine. Enrolled on an international drug trial led by the Marsden and involving more than 1000 patients, he  has had good results.

“I’m so happy to be alive and may many more years of it come”

Professor Johann de Bono is a clinician scientist overseeing almost 40 such early drug trials in a partnership with the Royal Marsden and ICR where he heads the Drug Development Unit.

“I am very confident that with some of these drugs we will be giving patients many, many years of life. In prostate cancer, I’m seeing patients living 5, 10 years regularly. So you’re really now coming to making cancer a chronic illness that you can live with like blood pressure and diabetes for many years.

I do think increasingly we will cure a larger number of cancers, particularly if we can catch them early.” 

Tami’s therapy delivered excellent results for a year before signs of resistance were detected. She was then selected to start on a new drug that had good early trial results. Resistance is a significant challenge. Adapting the treatment regime to the genetics and molecular biology of the individual and their cancer strategically over the course of the disease can tackle resistance – allowing such previously terminal cancers to become manageable as long term conditions.

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  “It’s a very, very exciting time”  – Dr Amanda Swain 

 

Some cancers however are particularly difficult. Mum-of-three Anne’s cancer was very hard to treat, having originated in her trachea before spreading and showing no response to conventional treatments. Her tumour was biopsied for genetic analysis at the ICR tumour profiling unit. Advances in rapid lower cost sequencing and knowledge through this step allow precision drugs to be targeted directly at the cancer.

Mice can be used in the lab to act as ‘cancer avatars’ to replicate the cancer’s genetic profile for drugs to be tested on both primary and secondary tumours.  While not all treatments will be effective in halting progression of the disease, this approach promotes fast uptake of targeted therapies that are thought to have a likely acceptable safety profile and a chance of success.

“the idea around this approach is to try to avoid using people, patients, as the field of battle in which we test these drugs. When we try treatments, we want to be as certain as we possibly can be that there is a very good chance that it’s a good selection of therapy and that there’s a good chance that you’re going to respond to this treatment.”  – Professor Kevin Harrington

Using precision approaches, targeting treatments to cancer genotype and morphology, switching and combining targeted treatments are extraordinary ways that cancer treatment and care has been advanced, tackling evolving mutations and resistance to therapy.  Metastatic spread can now be monitored and detected earlier by blood tests. Another cutting-edge approach is immunotherapy, modulating the patient’s own immune response to the cancerous cells.

“With immunotherapy, you’ve reprogrammed the system so inside the patient you have an immune system that can recognise tumour cells. If a bit of the tumour does become resistant, the experience to date certainly seems to be that the immune system can still deal with that.”

Vicky’s melanoma was advanced at the time of detection, already having spread to her breast and lung tissue. Vicky took part in a clinical trial of monoclonal antibody therapies in combination. She was forced to stop the treatment early as she developed serious reactions to the immunomodulation. However, the time that she spent taking them was very effective and she is still cancer free.

“Life-affirming” – Dr Louis Chesler

An extraordinary response is seen in Sophie, 11, one of the 170 paediatric patients treated a year at the Marsden.  Sophie was diagnosed with an especially unusual and aggressive inflammatory myofibroblastic tumour a few years ago;  her condition without effective treatment would have been ‘incompatible with life’.  Her cancer was caused by an ALK gene mutation promoting oncogenesis.  Research undertaken at the ICR established targets for this specific mutation, testing the drugs in mice before trying them on children.

Sophie was accepted onto a clinical trial of a drug, LDK378 and, incredibly, at her first scan since starting the drug her tumour had shrunk by 60%.   The bench-to-bedside approach used for Sophie sped the delivery of drugs to her targeted to the specific genetic mutation exhibited. Sophie has been able to take oral medication avoiding the side effects of chemotherapy,  and her continued remission has ensured she has an excellent prognosis with a normal, full life ahead of her.

“It’s the goal of every paediatric oncologist to see that kind of response. It’s truly astonishing and miraculous to see”

 

 

“But of course, it’s not a miracle, it’s science?”

“It’s miraculous science”, replied young Sophie’s father.

The Institute of Cancer Research is calling for funding for trials and a change in the law to remove a loophole allowing ‘class waivers’ to pharmaceutical companies exempting them from testing drugs in children – so that important drugs can be tested and brought into use in children like Sophie. Read more here.

BBC Panorama ‘Can You Cure My Cancer?’ is available to view on the show’s website and on BBC iPlayer.

Bil Arloesi Meddygol? Wales votes No

The Welsh Assembly votes unanimously against Saatchi Bill

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Vote in the Senedd clear: National Assembly for Wales united against Saatchi Bill

“a solution in search of a problem and not a very sound solution at that”

Previous post on LCM here.

The National Assembly for Wales debated the Medical Innovation Bill in Plenary yesterday, February 3 2015.

The debate, informed by the report of the Committee released last week, revealed a cross-party clarity and cutting precision from the Senedd, despite Lord Saatchi’s best attempt and Lord Howe’s assertions in the Lords.

Legislative Consent

The Government of Wales Act 2006 permitted a referendum on devolving legislative competence to the Welsh Government. This occurred in 2011 since which Wales has had full legislative competence in the 20 areas set out in Schedule 7 of the 2006 Act, subject to any exceptions listed therein.  One of these areas, under Para 9, Pt 1 Schedule 7 is health and health service provision.  A Legislative Consent Motion must be passed by the Assembly to provide agreement for Westminster to legislate for Wales in an area of Welsh legislative competence. The Welsh government identified that the Bill clearly applied to an area that has been fully devolved, and so the Minister for Health and Social Services Mark Drakeford issued a legislative consent memorandum in December 2014.

Ignorance or arrogance?

Already clear, the 2014 SC judgment on Agricultural Sector (Wales) Bill  irrefutably delineated the matter of legislative competence as being a test of whether the provisions of a Bill relate to a devolved subject.  Indeed, the Bill “sits firmly” within the legislative competence of the National Assembly: the Westminster Parliament’s assertions that it does not apply are “plainly not the case”.

What were the UK govt, Bill team, DH thinking? To attempt to pass legislation in an area so clearly devolved to Wales is a fundamental breach of convention, but to add to that the Bill is widely considered unnecessary and harmful. Surely they knew this would be picked up? and if they aren’t aware, then what are they doing in their jobs?  Earl Howe was wrong in his assertions to Baroness Finlay which is somewhat remarkable for a Parliamentary Under-Secretary of State for Quality at the Department of Health, speaking for the UK government in the House of Lords.

“It is extremely concerning that there is still advice being given that clearly contradicts the position that’s been outlined very clearly by the Supreme Court, and the amount of time that appears to be wasted in Westminster now as a consequence of that lack of understanding and lack of attention to decisions relating to Welsh devolution should concern us all. It’s certainly my view that approaches should be made, either via the First Minister or via the Counsel General, to try and resolve that situation.” – Mick Antoniw

“is this Bill the appropriate vehicle, and does this lie within the competence of the National Assembly for Wales?”
“I have to say that I fully concur with the Welsh Government in terms of its view and the view of the Health and Social Care Committee in terms of the scope of this Bill falling absolutely within the competence of the Assembly. It is very clear that this is touching on issues that relate to the field of health in the Government of Wales Act 2006, and therefore it is entirely appropriate that we’re having this debate in the Senedd today.”
“We will be voting against the LCM on the basis that we do not feel that there is a need, frankly, for the provisions in this Bill in order to allow for appropriate medical innovation here in Wales. As the Minister has already said, and, as we received evidence to the health committee from a range of sources, there is innovation already taking place. Frankly, Wales and the rest of the United Kingdom are at the cutting edge, in many respects, of medical innovation, with new treatments coming online and upstream all of the time.     We ought not to undermine that by tinkering with our legislative arrangements in a way that would undermine the accountability that’s currently in the system, which allows for that innovation to take place. So, we do feel that the provisions in this Bill are unnecessary, that the current law, and the ethical guidance that sits alongside that law, are sufficient and adequate to be able to allow for responsible medical innovation where there is a patient interest that clearly is going to be pursued. For that reason, we’ll be supporting the Government’s position today and encouraging Members in this Chamber to vote against this LCM.”
 

An appropriate vehicle?

The Assembly debate had to consider whether to pass the LCM to agree to the Bill applying in Wales. In considering the Bill Wales took into account its consultation, which though brief received “clear and robust responses”, as did that run by the DH and Bill team . They concluded:

  • “against Lord Saatchi’s own test, the Bill is unnecessary as there is no evidence that innovative care is prevented by doctors’ fears of the current system of clinical negligence”  “there are many organisations and individuals who go beyond the belief that the Bill is unnecessary to argue that it is positively harmful“(Mark Drakeford)
  • “The Bill is ill thought out. It also offers fewer guarantees and protections than currently exist in common law and therefore the legislation is unnecessary and also undesirable.” (Mick Antoniw, Welsh Labour)
  • “there is a lack of research accountability inherent in the Bill ” (Elin Jones, Plaid Cymru)
  • “we do not feel that there is a need, frankly, for the provisions in this bill in order to allow for appropriate medical innovation” (Darren Millar)
  • “as outlined by many of the responses that the health committee received, or, indeed, responses to Lord Saatchi’s own consultation, there is a very genuine fear that patients could be harmed as a result of this legislation, and innovation stifled.” (Kirsty Williams, Welsh Liberal Democrats)
  • “Not only would the Bill risk real detriment to individual patients, but as the Academy of Medical Royal Colleges concludes, one of its unintended but adverse consequences could be to undermine the essential role of proper, scientifically rigorous clinical trials on which innovative treatments for the whole of our patient body are legitimately based.”    “Above all, it will leave patients without a remedy when injured by treatments that many doctors would consider unacceptable, and at the mercy of the judgments made by individual practitioners who have no professional support or oversight.”    “The Bill is unnecessary and should not proceed” (Mark Drakeford)

“There’s clearly an emerging consensus across the Chamber around three key issues. Firstly, it’s common ground in this Chamber that this is a Bill that trespasses into areas of devolved competence…. Secondly, we are all agreed here that responsible medical innovation is something we want to see and we strongly support, but, in the third point of consensus, our fear is that the Bill, far from adding to the capacity to do that, runs the risk of frustrating responsible innovation. I therefore ask Members to vote against the motion, confirming our view that the provisions within this Bill should not apply to Wales.” – Mark Drakeford

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Never judge a Bill by its cover

The opposition to the Medical Innovation Bill has been overwhelming in its volume, consistency and expert authorship, notably receiving negative feedback from patients’ groups and charities too.  It passed its third reading in the Lords recently despite this widespread opposition and is scheduled for a second reading in the House of Commons later this month.

As an issue of high public importance affecting all patients, MPs in the Commons would be wise to listen to the concerns and take a read of the consultation responses and subsequent statements of alarm by leading experts. If that’s too much hard work, it is at the very least wise to listen to the words of other Members of the House; those who have taken the time to consider this matter deeply, appraise the evidence and speak on the Bill with an opinion informed by a life’s career in medicine and scientific research.

 ‘Like books, one should never judge a Bill by its cover’ opened Dr Sarah Wollaston, GP, Conservative MP for Totnes and Chair of the Health Select Committee in the adjournment debate that she scheduled in the Commons on the Medical Innovation Bill.    

‘it is fundamentally flawed in its premise, it is unnecessary, it removes essential protections for patients, and it increases the risks of their exposure to maverick doctors. I believe it will undermine not only patients’ safety but medical innovation and so will have precisely the opposite effect to that intended.’

‘Under current law, a doctor is negligent if he or she acts in a way which no responsible body of medical opinion would support, or which is irrational or illogical—the so-called Bolam test, as refined in the case of Bolitho. The Bill would rewrite the law on clinical negligence and a doctor whose decision to treat would not be supported by any responsible body of medical opinion, or was illogical or irrational, would be able to call on a new Saatchi defence if they fulfilled the procedural requirements of the Bill. That is important: the Bill’s protection of doctors applies if the procedural requirements are met.’…

‘There is no requirement for the second doctor to have seen the patient or even read their notes, and no requirement for them to be independent. They could be working at the same private clinic. It is of little reassurance that the treating doctor must   “take full account of the views” of the second doctor if the second doctor is in collusion with the first in that treatment, which may be unreasonable.

If the Bill is passed, we will put patient safety at risk and we will no doubt have to return to amend the legislation subsequently.’

Dr Wollaston continued, providing a compelling example of the terrifying and misguided Saatchi-future from a letter she had received, one of countless, indeed limitless, that would be given ‘carte blanche’ if the Bill is passed into law.  She touched upon further problems including media portrayals of treatment, and the Bill working as a legal circumvention of the Cancer Act 1939.

These ‘very real concerns’ were echoed by Dr Julian Huppert, who put his PhD to good use in his career as a research scientist and fellow at Cambridge. He expressed concern for ‘people who…may be desperate for treatment’ and at risk of unethical practice, or  unknown iatrogenic harms, noting

‘This is not just about cancer treatment but about a wide range of surgical treatments and therapies for any number of conditions.’

‘If the Bill is about reducing medical litigation so that doctors are free to undertake innovative treatments, why do those who are involved in medical litigation say that there is no need for it? The Medical Defence Union, the Medical Protection Society, even the NHS Litigation Authority, are clear that the law, with the Bolam and Bolitho tests, is well established. They feel that the Bill could increase uncertainty.’

If the Bill is passed and undermines enrolment in clinical trials, we will be  doing a grave disservice to medical innovation, and it will be to our great shame to have done so.That is a fundamental flaw in the Bill. There is also a fundamental flaw in the premise that separate anecdotal treatments can progress medical research. Interestingly, clause 1(5) states: “Nothing in this section permits a doctor to carry out treatment for the purposes of research”.   In other words, it specifically precludes the treatments being linked in any way, so we will learn nothing from these treatments.Lord Saatchi’s premise is that his Bill will advance medical knowledge, but there is no evidence that it will advance medical knowledge an inch because we will not be able to answer that fundamental question about whether there are unintended harms from the treatments or any long-term benefits.  The history of medicine is littered with good intentions and innovations that seemed like a good idea but turned out to have disastrous side effects. There is an assumption that all innovation must be good innovation, but much innovation can be dangerous.’

Dr Huppert continued ‘Professor Sir Mike Richards, who is one of the country’s foremost and respected experts in cancer… does not think the Bill will protect patients. We need to listen to the opinion of those who have serious concerns about such Bills.’

 ‘The list of bodies opposed to the Medical Innovation Bill is very long—the Academy for Healthcare Science, the Academy of Medical Royal Colleges, the Academy of Medical Sciences, the Medical Research Council, the Wellcome Trust, Action Against Medical Accidents, the Association of Medical Research Charities, the Association of Personal Injury Lawyers, the British Medical Association, the British Pharmacological Society, Cancer Research UK, the Good Thinking Society, Healthwatch, the Medical Protection Society, the Medical Defence Union, the Motor Neurone Disease Association, the National Institute for Health and Care Excellence, the NHS Health Research Authority and the NHS Litigation Authority.’

Remarking that Sir Robert Francis QC, ‘one of our most respected national authorities on patient safety’ opposes the legislation, Dr Wollaston urged careful reflection on ‘very serious words indeed’.

‘If there is misunderstanding then it should be corrected by guidance, not by legislation which exposes vulnerable patients to unjustified risk and deprives them of remedies when mistreated by those who have no acceptable justification for what they have done. The legislation is also opposed by the Royal College of General Practitioners, the Royal College of Physicians, the Royal College of Psychiatrists and the Royal College of Radiologists. That is an important list.  Were we to title the Bill correctly, it would be called the medical anecdote Bill. We should be saying that it makes provision in relation to anecdotal treatments in medical treatment. If we titled it correctly, there would be no question whatsoever of its having Government support. I urge the Minister in the strongest terms please not to give the Bill Government backing. To do so, I think, would be to our great shame. We would undoubtedly have to return to amend it. It would put patients at risk, and it would put recruitment to clinical trials and genuine innovation at risk.’

Dr Wollaston restated that ‘a doctor who uses such innovative treatments within the NHS is protected under existing law …we do not need new legislation to make them available to patients’ and later, responding to George Freeman MP’s advocacy for the Bill on the basis of learning along the way, she asked:

‘Does the Minister accept that that cannot happen under the Bill, and that those things will remain a series of unlinking anecdotes? In medical science and for the safety of patients no one will be able to track whether there were unintended consequences or benefits, and it will not advance the cause of medical innovation whatsoever.’

Michael Ellis MP should consider these learned words carefully in his attempt to popularise the Bill and ensure a rapid passage through the Commons.  While he’s considering them, he may wish to revise his explanatory notes and ensure press coverage accurately represents the Bill’s contents.

leo-cullum-if-it-s-a-choice-between-ethical-behavior-and-increased-profits-we-must-cartoon

While ‘curing cancer’ may be thought of as a vote-winner for the election, MPs should be aware that rushing ill considered legislation to gain popularity points does not make them a good representative of their constituency’s interests.  Legislation that entirely transforms the law of negligence, that alters clinical practice, doctors’ regulation and removes or diminishes and obstructs access to justice for vulnerable people, doesn’t serve the electorate, but does serve the short-term self interest of some MPs.

They must listen to Dr Wollaston, Dr Huppert, Sir Robert Francis QC, Cancer Research UK and many more. This Bill is not necessary, will not achieve its stated aims and on the contrary may be extremely harmful and damaging. It is not appropriate for the Bill to advance, and anything playing with lives, quality of life and diminishing legal and personal rights requires consultation and careful consideration as patients, doctors and all the public should be able to expect from a rational, responsible Parliament.

 

The GMC: There is still no convincing argument

The GMC tweeted a link yesterday highlighting its current position on the Medical Innovation Bill. This was a link to this month’s accountability hearing where the GMC provided oral evidence to the Health Committee in the House of Commons.  At this hearing questions were asked about the Medical Innovation Bill and the responses given represent the official and continuing views of the GMC.

The full transcript of this hearing is available here, with the relevant paras at Q66 and 67 provided here in full.


Q66 Chair: Thank you for clarifying that. Another area of interest at the moment is Lord Saatchi’s proposed Medical Innovation Bill. A number of concerns have been expressed from various  quarters about whether the Bill is necessary and whether it would have unintended consequences resulting in potential harm to patients. Some people have argued that we need the GMC to issue clearer guidance to doctors around the limits on when they can innovate and use unlicensed medicines. Is it your view that this should be a matter for the GMC and regulators, or do you feel that stand-alone legislation is necessary?

Professor Stephenson: One of the things the profession is struggling with on this Bill is the problem that it purports to solve. We have just had published in December the research excellence framework that looks at all the research done by UK universities over the last five years. In that report, UK biomedicine and UK medicine did extraordinarily well and probably punch above their weight; the quality and output of research per pound or per dollar probably even eclipses the United States’.

This is a country that has pioneered gene research, monoclonal antibodies, many new drugs and many new cancer treatments. I am a researcher, an academic; I have been researching throughout my career. Many of us are struggling to see that we would be inhibited in our research by fear of litigation. That is also what the Medical Protection Society and the Medical Defence Union say; they do not have records of cases of doctors being sued because of being inhibited from doing research or doing new things. The UK leads the way in high-quality biomedical research. It has a record that it should be justly proud of, so we are struggling a bit to see why the Bill is necessary.

Q67 Chair: So the GMC is opposed to the Bill.

Professor Stephenson: The GMC is waiting to see. There are a number of organisations in the public domain who are quite clearly opposed to the Bill—I was chair of the Academy of Medical Royal Colleges and this is in the public domain, so I am not saying anything new—the Academy of Medical Sciences, the Wellcome Trust and the Medical Research Council. The GMC’s position, up to now, has been that it needs to see the final draft of the Bill. It has undergone a huge number of amendments and the devil is in the detail. The GMC reserves judgment until it sees the final version.

Niall Dickson: Just to expand on that, we absolutely, first of all, come at this from, “Why is this Bill necessary?” We still have not heard a convincing argument about why. We had very serious concerns about some of the clauses inserted as so-called safeguards. For example, having to go to a responsible officer beforehand would seem to us absolutely counterproductive, in terms of both putting responsible officers in an impossible position and also being an inhibitor for innovation rather than something that would enhance it. So we were pleased when it seemed to indicate from Lord Saatchi’s amendments that they were going to drop those clauses. We still have concerns that the Bill, as currently drafted, talks about a doctor having another qualified doctor being enough for them to innovate. Our guidance is clear around people looking at expert opinion, people who are expert in that area and using that, of course, as one of the means by which you decide whether a particular treatment is to be taken forward. As Terence said, our position at the moment is, “Let’s see the next iteration of the Bill.” We still have concerns and there is still a question mark over the big picture, as it were: what is it trying to do? I suppose, in response to the final comment in your introduction, that if there is anything the GMC could do that would be helpful in terms of guidance, clarifying guidance or whatever, we would be absolutely happy to consider it.


The position put forward by the GMC is certainly not one of support at this stage. With countless revisions, amendments, references to the GMC by the Dept of Health and bill team, discussion of their involvement in ways that vary from ROs being responsible for innovative decision-making, to GMC policing non-Saatchi confirming doctors on the acute take and his mythical register; they are probably somewhat concerned, bemused and struggling to ascertain what their role is in all of this, and what all of this is anyway, let alone why.  It’s absolutely fair and appropriate for the GMC to be supportive of the principles of encouraging innovation and best practice, yet reserve final comment until they have considered a final version.

When they had a finalised proposal in 2014 they duly responded to the Department of Health’s consultation.

The GMC response  was thorough, carefully considered and clear.

‘We are…concerned that legislation which aims to clarify and encourage good practice in terms of when medical innovation is responsible could have the opposite effect as well as unintentionally weaken the principles which we regard as fundamental to safe, effective patient care. We take the view, therefore, that legislation is both unnecessary and undesirable.’

The GMC raised a number of concerns and points – as discussed here in more detail. These include a lack of clarity in proposals, hindering responsible innovation, substantially changing roles and remits with ‘unwelcome layers of bureaucracy’.  They noted that legislation as proposed would breach core GMC guidance and would be  an unhelpful addition to current practice, adding new areas of uncertainty for doctors and others while removing important safeguards for patients.

Such ‘a lack of clarity in legislation of this kind can only serve to undermine any safeguards aimed at deterring dangerous practice or reducing the risk of exploitation.‘  And while the Lords were still stuck on what the difference is between innovation and research this month, the GMC raised this at the outset;  concerned that the Bill fails to ‘provide a clear enough definition of medical innovation so as to define where the boundary lies between innovation and medical research. Our understanding is that this bill is aimed at doctors innovating to meet the needs of a particular patient. Whereas our understanding would be that innovation for a whole population of patients constitutes medical research.’

Now, following a fanciful passing-the-buck in the Lords at third reading the GMC are left in the frame over the latest amendment for a mandatory ‘register’.  The Lords considered the options for this invisible database, including the GMC’s role on patrol as Saatchi’s FTP henchmen, and passed the Bill despite none of this having been agreed or scrutinised at all (but it sounds good, and capitalises through association on valid concerns about evidence – entirely unrelated to the Bill – and which it would serve to worsen -so scrutiny is the last thing Lord Saatchi would want).    Of course, the workings of such a register, its parameters, applications, data laws and safeguards, operational capacity, everything, apparently haven’t appeared on the Bill team’s agenda, but the GMC have been squarely, potentially saddled with creating a new professional requirement, guidance, an invisible register and the witch from the wardrobe to Narnia.

Prior to the third reading however, the GMC and Dept of Health had been in communication as Nigel Poole QC has established, and the GMC communicated the view to the Dept of Health that fitness to practise proceedings being brought against a doctor for failing in an online  recording requirement under Saatchi’s Bill ‘does not seem to be a proportionate response.’

Nigel Poole QC, cutting through the gaping voids of legal illiteracy, clinical implausibility and grim potential realities of the Bill, neatly illustrates that ‘perception is reality’ has struck once more.    There has been no agreement from the GMC on any of these proposals, and as without making registration of treatment a professional requirement  a mandatory register as per the latest amendment cannot exist:   ‘A vote for the bill on the basis that it will create a mandatory register would be a vote for a chimera’.

The GMC are left questioning not only an unworkable amendment, but the entire premise behind the Bill.

‘What is the problem that it purports to solve?’ ‘What is it trying to do?’

“We had very serious concerns about some of the clauses inserted as so-called safeguards.”   “We still have concerns and there is still a question mark over the big picture”

“Why is this Bill necessary?”   “We still have not heard a convincing argument about why” (Niall Dickson, January 2015).