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.

A welcome decision

Stop the Saatchi Bill Alliance statement

The Stop the Saatchi Bill Alliance welcomes the decision not to move the Medical Innovation Bill at its second reading.

While we firmly support innovation, we were joined by countless charities, experts, professional and patients’ organisations in our concerns that the Bill, which was set to apply to all patients, all doctors, all conditions and all treatments, was both unnecessary and unacceptably dangerous.

The law of negligence does not impede responsible innovation and the Bill was poorly targeted on this baseless premise.

Some further concerns included that the Bill would undermine clinical trials and introduce contradictory and dangerous amendments to the law, removing a patient’s ability to access redress without providing any additional rights of access to treatment, helping neither doctors nor patients.

Importantly, it was widely agreed to be a serious threat to patient safety.

However well-meaning the originator and motivations of this private member’s Bill, it is a disgrace that the Government and Department of Health supported and encouraged dangerous primary legislation based on such lack of evidence and with such ill-conceived expectations.

The Stop the Saatchi Bill Alliance will firmly reject and repudiate any future moves to bring such legislation back. There is no legal impediment to medical innovation to be solved.

Read: Media articles about the Bill

The Saatchi Bill public debate – HealthWatch & KCL

The HealthWatch debate at King’s College London

The debate took place 4 March at KCL with Professor Sir Michael Rawlins and Daniel Greenberg proposing the motion ‘this house supports The Medical Innovation Bill’  with Nick Ross and Nigel Poole QC against.

Here’s the full debate:   HealthWatch Debate – Medical Innovation Bill

and a rather spiffing live-blog account of it at nhsshakeup.co.uk

 

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Crash call and a close call

Crash call and a close call

Scientific progress is not
linear. Newer does not automatically equate to better.

Rapid uptake of treatments with decreased critical evaluation  is driven by a number of factors including patient demand, industry and ‘gizmo idolatry’– the new, shiny drug or other technology is considered by many to be a better bet than the alternatives.  These new gizmos are more enticing – and not just on a profit basis-  the latest, the greatest, they are laden with assumptions of advancement and laced with hope for the most desperate.  Imagine turning a drug down, a new drug, with the hype and the sparkle and the plausible science, where accepting it means the newest, the best, surely?  accepting it means hope?

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Gizmo – Gremlins (1984)

Drugs that sound like they make sense and work in animal models may have catastrophic effects in healthy people – TGN1412 is just one example.  Even in drugs which have completed Stage 1, 2 and 3 trials, true adverse effects and true outcomes may remain unknown – still relatively few people will have taken the drug overall.  The results are often unpublished, undisclosed even to regulators, advisory or commissioning authorities and outcomes are tampered with to spin a drug company’s data for patenting and marketing purposes. In the population however, of unwell people with comorbidities, polypharmacy and physiological and pharmacogenetic differences, a drug that appears to be a logical, new, shiny upgrade on the old one may be anything but.   Large scale accurate trials of a drug and the open publication of all results are essential to understand a drug’s real spectrum of effects in vivo. The sooner that the data is available and may be seen transparently the sooner a drug’s therapeutic and all other effects will be determined.

The consequences of not having this data are clear. The drug (or any medical technology/device/procedure) will be in use in the population for longer before the effects become apparent.  In a new drug likely to be used in a significant number of people this is, obviously, a problem – the sooner a drug is introduced and taken up on a larger or ad-hoc scale, the longer that drug is in use without adequate assessment and data, the more people there will be who take the drug and over a longer period of time and yes, these people may be quite happy (for a while). They might have campaigned vociferously for access to the newest drug to treat their condition.

It’s shiny. It’s new. It’s better than the others. Hope and hype are all powerful and entirely understandable. But that drug might harm. It might have many effects which were not apparent in the data presented to NICE or the EMA or MHRA that was likely funded and chosen by the pharmaceutical company manufacturing it, it won’t feature in ghost written and false-meta-meta analyses of a selected group or even the genuine articles, for it’s simply not available; and it certainly may harm those patients who are taking it.  If a drug has an effect, side effects are normal and idiosyncratic reactions always possible. A wider responsibility exists  to know what any risks are at least most likely to be before dishing the drugs out to great fanfare to big groups, and a responsibility to report adverse reactions appropriately thereafter through reporting schemes that are in place.  

A responsibility to not create unnecessarily or disproportionately heightened risks of harm – to treat the individual in their own best interests while maximising patient safety as much as possible. To first, do no (entirely avoidable, unjustifiable and reckless) harm.  Surely that’s what patients would be campaigning vociferously for, too?

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It is an unfortunate fact that many millions of people have taken drugs that were harmful and they did not find out until long after the harm was done. Others may have had an inkling before their last breath but it’s quite unlikely they realised they were being killed by their medicine.  We’ve all heard of thalidomide yet there are so many more examples of drugs that, when taken up too quickly, have had devastating effects. Many others still have prolonged unnecessary expense or increased relative deterioration by being no more or considerably less effective than existing options.

Take Stevie Wonder. He was given oxygen as a neonate. Makes sense right? Sure it made sense to give high-dose oxygen to premature neonates. Unfortunately, this was in place for over 12 years  before a causal link was made to ROP- Retinopathy of Prematurity (aka RLF).  Due to this delay and lack of a link, the therapy harmed many infants, causing permanent blindness in more than 10,000 – including Stevie.  

Women with breast cancer petitioned, in their tens of thousands, for bone marrow transplant to accompany high dose chemotherapy. It made sense – it would allow better toleration of a higher dose of treatment, right? The pressure was enormous from patient advocates, lawyers and even their doctors. Some launched legal actions to gain access to this new treatment.  Unfortunately despite the hype and intense demand, it was much more expensive yet conferred no benefit at all. Worse, it was far more toxic- leading to greatly impaired life quality and hastened deaths.  More than 42,000 women received the treatment before it was stopped – at a cost of $3.4bn to the US.

Baycol (cerivastatin) was a hugely profitable snazzy new statin taken by more than 6 million people. Unfortunately, although a new upgrade, it conferred no benefit compared to any existing treatment. Actually, it transpired that it had a serious adverse risk profile, including things like rhabdomyolisis. Including things like death. It was directly implicated in many  deaths – in reality thought accountable for hundreds, thousands of deaths and withdrawn by Bayer amidst legal disaster.  Other disasters include  Diethystilbestrol (DES), given in pregnancy to prevent miscarriage and widely used for other purposes, becoming routine. Unfortunately as there was no reliable data it took decades to link DES as the cause of cancer and other illness in the children of pregnant women, in which time thousands of women and children were harmed and/or died.  The anti-arrythmics Encainide and Flecainide caused excess mortality – with 50,000 deaths that were entirely unexpected and unexplained – 50,000 people who died when the drug companies had failed to undertake trials to observe any potential benefit, and surrogate markers and assumptions had been relied upon.  The ALLHAT trial finally revealed that, while a drug may confer little benefit over another for one variable, in this case BP, it can be very different in its effects on another- here, its effects on preventing MI.   Huge numbers of patients died unnecessarily through the delay in realising that they were being prescribed a drug that did not work as well as the other on the outcome they should have been interested in, rather than a surrogate.  While they were dying, the drug company were cashing in as the newer much snazzier drug was much more expensive.

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Something  else- something that really made sense- was giving corticosteroids to patients who had acute head injuries. People did this, but there hadn’t been a trial. It just made sense – let’s reduce that swelling- and it had been the case for more than 30 years.  A review came about in 1997 and suggested perhaps this treatment conferred a 1-2% reduction in the risk of death.   Many doctors deployed this treatment. Others were less convinced and did not, but nobody knew.  A trial was finally launched.  The CRASH1 trial recruited more than 10,000 patients. It was hard to get approval, randomising unconscious people (who would have been randomised anyway in real life).   The results showed an excess mortality in patients treated with IV methylprednisolone compared with placebo – what was  immediately clear was that the treatment conferred no survival benefit at all, no advantage for these patients. Indeed, the steroids given to so many had been positively harmful. While a quarter of patients died from their injuries no matter what treatment they received, there were 2.5 extra deaths per 100 for those treated with steroids. ‘The risk of death was higher in the corticosteroid group than in the placebo group (1248 [25.7%] vs 1075 [22.3%] deaths; relative risk 1.15, 95% CI 1.07-1.24; p=0.0001), as was the risk of death or severe disability (1828 [38.1%] vs 1728 [36.3%] dead or severely disabled; 1.05, 0.99-1.10; p=0.079).’  In real world numbers of patients, that’s a lot of extra death. So unequivocal was the result, the trial was stopped early.  ‘The lethal effects we have shown might have been found decades ago’ wrote the study’s authors, lamenting a failure to ‘provide robust evidence’ to prove that ‘ prescriptions are likely to do more good than harm’. 

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Lord Saatchi’s Bill as he proposed would not benefit patients who want access to a treatment – it provides no right or means of access, and would not benefit doctors who are able to innovate responsibly under the current law. Its selling of the register of uncontrolled experimentation (that didn’t exist)  and promises of trying something out would prolong the time taken for reliable evidence to become available, reducing the evidence quantity and quality, knowingly promoting an archaic method which lengthens time and heightens risks sustained from any technologies that are unsafe.

Treating innovatively in a patient’s best interests, even where a doctor doesn’t know which is the better method, or has no data, is really not going to be found negligent under the current law, unless it’s so totally and ridiculously illogical and unsupported by any strand of reality.  But any treatment currently so so bad that it would be considered negligent  would be defensible under the Saatchi Bill’s proposals  -and what of cases of product liability and serious adverse drug effects?   No redress. No ethics committee equals no REC insurance cover. No implications at all for a pharmaceutical company with a harmful product?  

Interventions should be widely introduced in a critical, carefully targeted manner and yes, reliable evidence is required to ensure there is no unnecessary, excessive risk of harm to a patient or a larger group of patients.  Without accurate and systematic monitoring and reporting there will be diminished evidence regarding a drug’s safety or efficacy, widening the gap in knowledge required also for properly informing and gaining consent from a patient.   Rapid adoption of treatment with decreased critical evaluation has led to countless adverse events in recent history.  While many advances offer real advantages, others can be aggressively marketed and championed yet offer little, if any benefit; cause alarming side effects, serious harm, suffering and even death. 

There are problems with aspects of research and regulatory frameworks, there are problems with data access and publications, there are problems with bureaucracy and huge problems with funding.  A broken system perhaps. But you cannot mend a broken plate by smashing up your entire kitchen, destroying an aga and removing the sink.  While it’s possible to advocate for a number of methods to assess an intervention, it is impossible to rationally, or innovatively, advocate that anecdote, uncontrolled and irresponsible experimentation is anything other than a timehop straight back to an era we’d rather not repeat.  This imprecise, outdated approach is markedly out of step with current practice, as well as out of step with increasing precision approaches, targeting a drug to genomic features which are increasingly in use and can be incorporated into trial methodologies worldwide for some patients.  The Bill would have been an inappropriate step backward that places current and future patients at considerable risk of harm, delaying beneficial data as well.   It’s the opposite of innovative, the opposite of an advancement and patients deserve better. Patients deserve their lives to be valued. There is no excuse for this today.

The Medical Innovation Bill,  full of hope and packaged with hype-  would have harmed, not helped.

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As a means to an end?

The Medical Innovation Bill (v… wait, which is it on now? do they even know what it says? ) having passed through the Lords despite vocal disagreements from some peers, was due for its second reading in the Commons on Friday 27 February. It was unlikely to be debated due to the length of the list, however it would have been voted on in order to proceed to committee stage and third reading. On Thursday, after a week of letters and articles highlighting the Bill’s unworkability and failings, as well as confirmation from a number of MPs that they would be present and intending to oppose, it was announced by the Bill team that it had been moved (by them) to the following Friday, 6 March.

On Saturday night (28 Feb) the Bill’s media partner-the Telegraph- published 2 articles covering the story that the Bill had been ‘killed’ as a result of Liberal Democrat opposition. The Lib Dems have not done a lot of legislative good in government. In fact they’ve let through some gross atrocities of law. Perhaps they are starting to see the light?

An article featuring Norman Lamb, the party’s health spokesman confirmed that the Liberal Democrats believe that the most appropriate approach to the issue is not to rush this far-reaching legislation, which operates to remove patients’ rights to legal redress, but ‘to examine what the barriers to innovation really are and how best to overcome them’. ‘It should be given priority but we must get it right’.

The leading article featuring Lord Saatchi, entitled ‘Fury as Lib Dems kill off Saatchi Bill’ was rather less moderate. Penned by the Telegraph’s Chief Political Correspondent  Christopher Hope  [promoted following the principled departure of Peter Oborne] it includes aggrieved snippets from Lord Saatchi and Mr Nutt, and makes and frames a number of factually inaccurate statements about the Bill.

It erroneously refers to the Bill as a ‘law to allow doctors to test new drugs on seriously ill patients without the fear of being sued’ which would have ‘allowed doctors to test cutting edge new treatments on patients to help find cures for cancer and other serious illnesses’ and in which ‘new safeguards were introduced last year.’

It states that the Bill has been pulled.  ‘It was due to be debated by MPs on Friday in a race to ensure it was put onto the statute books by the end of next month, when MPs break for the election campaign. However it was pulled at the 11th hour.’    Lord Saatchi is then quoted, saying that Nick Clegg has handed down a death sentence to cancer patients.

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Meanwhile in the realm of Twitter the Saatchi team were in full swing, declaring that yes the Bill is dead, and yes it is the Lib Dems’ fault.  Their supporters, who in good faith believe the Bill would help them access treatment or cure disease, were shocked and understandably very upset.

The emotive pleas, the anguish and the anger were deafening. The deep visceral pain from the hit palpable through less than 140 characters on a screen. All the while team Saatchi (having blocked all those known to disagree with the Bill, including those who have never engaged with them, never followed them), were stoking the flames.  The following day saw more carefully planned articles such as ‘Nick Clegg is spineless says father whose son is dying of terminal illness’ There were tweets of fury and increasingly offensive content, including declarations that people would like to know what will happen when Nick Clegg’s children had cancer.  The media front went into full swing with interviews demanding time for a debate, tweets and articles about the Lib Dems and the blood on their hands.

Andy Burnham then waded in and spoke to the Telegraph to say the Liberal Democrat decision was ‘odd and wrong’ as the Bill ‘was heavily amended and extra safeguards put in’  and offered hope to desperate parents of seriously ill or dying children “For parents like them nothing is available and they have no hope, it [the Bill] is about opening up hope.”     (incidentally, searching ‘Andy Burnham odd wrong’ on google yields 134,000 results)

Labour MP Margaret Hodge also said things and David Cameron’s spokesman spoke a bit too.

“The Prime Minister has expressed his support for this – there were changes that were made during its passage through the Lords, with regard to safeguards.
He has argued for it to go ahead and those who have come to it differently will have to explain their position.”

Labour supporters opportunistically piled in in various ways,  including an encounter with a Labour chap who appeared to compare the false premise i.e. lack of existence of the reasons for the Bill with the existence of Stephen Lawrence as his argument, before then championing it on the basis that Lord Saatchi has an ’emotional connection with his wife who died a painful death because of restrictions on drugs’. Right.

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Meanwhile team Saatchi were clear.

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They never withdrew the Bill and had carefully timed the media coverage around the announcement.  As the Bill was still alive it was wrong to say it was dead, ergo Clegg was responsible for the deaths of patients.   They chose targeted language to create mass outpouring of genuine distress from their supporters. They knew this would mobilise political forces.

This has been pointed out by a patient safety and justice charity among others.

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Burnham has obviously failed to read the Bill or the remarks of anyone in opposition to it. ‘#Politicsbeforelives’ Mr Burnham?  Cheap’n’easy votes for curing cancer?  Either Andy’s strings have been pulled by Saatchi as well, he couldn’t even be bothered to read it, or he’s doubly incompetent to fail to understand science, medicine, false hope, anecdotal propagation of nothingness, the fact ill children should have quality of life prioritised over irresponsible experimentation,  the real dilemmas parents feel who simply will and often must try everything,  and the issues that could have been addressed in the past few years to see how they could actually be helped, not harmed.  The Liberal Democrats certainly seem to have understood what Burnham has not.

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So Nick Clegg hasn’t killed anyone, that we know of.  He hasn’t even killed the Bill off yet. Indeed rather than it being ‘pulled’ at all as in the Telegraph’s leader it remained and remains listed for its second reading.   The deal was struck with Lord Saatchi, whose M&C Saatchi firm has just produced the Conservative election campaign ads.  That deal was – for the Bill to be given additional time in the Commons in the race to wrap it up before the end of the month: the reason that they switched it from the 27th when they knew MPs could and would be there to object summarily. Of course, a Private Members Bill completing its tumble through the Lords and entering the Commons has no priority whatsoever over any other Bill, private, public, any.  It’s also clear that Lord Saatchi’s advisors failed to remind him it was a Coalition government.

What followed when he was denied his special velvet gloves VIP treatment was no more than an almighty, vindictive and increasingly disturbing temper tantrum.

He announced the  Bill’s demise inaccurately along with the press and in doing so maximised the column inches, the interest but also the devastation expressed among his supporters. Who cannot support hope, after all? Telling them that it was dead, killed;  they knew the outpourings of genuine distress would put pressure on decisions in parliament and try to force time to be allocated.

While it is highly improbable it would get through –  and deeply wrong that legislation of this nature would be rushed through in the face of unending opposition from doctors’ organisations, academics, patients and charities,  it’s still listed for tomorrow just as it always was, without the secret special deals, and an MP therefore still needs to shout “object”.  Meanwhile  a petition has been launched and the Bill’s website is backing it.

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Lord Saatchi sure is talented;  he can sell anything.

When Harry met Saatchi

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Lord Saatchi’s Medical Innovation Bill is bizarre and surreal  but it’s no cartoon. It’s dangerous. The only thing light about it is the complete absence of scientific or legal understanding. Throughout the lengthy campaign Lord Saatchi has sought to suggest that his Bill will indeed cure or enable others to cure cancer. He has stated outright that the current law is the reason there is no cure for cancer. He published the startling ‘How Can an Act of Parliament Cure Cancer?’ as a guide to his plan and ensured it was disseminated on cancer treatment forums. More surreal than Jon Snow on skunk

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Despite the propaganda Saatchi’s proposals would not cure cancer, nor offer any other benefit to doctors or their patients.

He has criticised doctors repeatedly for their “complacency” about it all. He has criticised oncologists writing in The Lancet, The Times and any other place they have disagreed with him. Such as the formal consultation. To which an overwhelming number of medical bodies, representative organisations and experts responded with a clear and resounding NO. These include the BMA, RCP, AoMRC, the MDU, MPS, GMC, RCSEd, RCS, RCPath, RCPsych, RCR, RCGP – the list goes on, and accounts for hundreds of thousands of doctors represented. It includes experts such as Sir Robert Francis QC, Chair of the Mid Staffordshire Inquiries – speaking for patient safety.

Lord Saatchi reminded us that perception is reality – if the people perceive a problem there is one. Well, the perception of doctors and their representative organisations is that doctors and patients have no need for his Bill.    The perception of Wales – which convened a committee that concluded the Bill was unnecessary and dangerous, and which then voted unanimously in the National Assembly on a cross-party basis against the matter is that doctors, and patients, have no need for his Bill.

But this has not been listened to. Indeed it has been met with complacency. Complacent disregard to the concerns raised and to what actually would help improve patient care or facilitate good innovation. Which seems a terrible shame for patients – particularly a few of ardent supporters who have spent probably 2 years of precious, currently limited, time on this project. They have thrown every ounce of passion and effort into fighting for this, for their child’s life. They have done this because they have been assured the Bill will help them.  The evidence for this assurance is and always was entirely absent. The evidence against is overwhelming. This is more than a bit troubling.    Saatchi’s view on doctors, the people who devote their lives to treating patients and those researching diseases such as cancer, and how they’re getting on,  is also more than a bit troubling. 


“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”

‘It sounds medieval—barbaric even—does it not? Death by hanging, by firing squad, by electric chair—no human being has ever devised a more brutal execution than death by cancer… those condemned…suffer a worse fate than the mass murderer. While they await execution, they are tortured.’

– House of Lords 27 June 2014


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complacAs Panorama showcased recently  technologies in cancer care are improving all the time, as are results.  While quackery and poor practice do exist, the Bill actually only benefits this concerning crew, and by happenstance maybe some other interests. The vast, vast majority of doctors are dedicated, extraordinary professionals who really do devote their lives to their profession, to their patients. To suggest otherwise is deeply insulting.    Worse, it’s deeply misleading – arguably hinting to a very real lack of ability to understand what would possibly drive anyone other than self interest.

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He has spoken with the same moral viewpoint on lawyers, too, using some pretty nasty tactics against one particular firm (a firm which specialises in human rights, assisting victims of abuse, victims of torture, those harmed in serious accidents and devastated by truly negligent clinical practice and events – as well as helping advocate for those who have been seriously harmed by drugs or other technologies, improving safety for others, helping challenge treatment decisions and gain access to treatment for patients). His remarks about them are disgraceful and revealing of a deep-seated inability to understand why people work for good, not only for self interest.  Lord Blencathra, supporting Lord Saatchi’s Medical Innovation Bill on Radio 4 – 21 October 2014- went so far as to state that the country would be a much better place if lawyers were euthanised.

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Where does he get these views from?  About doctors and lawyers and scientists dedicated to finding new treatments and making them a reality for patients? Where does he draw the view that doctors fail to treat patients with the most appropriate treatments because they like the easy life for themselves? Because they fear for their livelihoods? the livelihood, the drive for most doctors is patient care.  His view is that doctors care not one jot about their patients, do not act in their best interests and deliberately cause harm, then ‘torture’ them to death.
Where has he got his perversely wrong interpretation of the law? From where has he drawn the opinion that doctors don’t provide treatment in the best interests of the patient due to their fear of litigation?

It’s outrageous and wrong. He hasn’t got these ideas from any organisation that would know- the Medical Defence Union, Medical Protection Society, NHSLA,  British Medical Association, APIL and others have all drawn blanks on even one case and have all been clearly and firmly opposed.  He certainly hasn’t had any of his ideas confirmed in the consultation responses either.

He has ignored and insulted the medical profession and continues to do so.  He has ignored the responses to his own consultation. He has ignored patient safety experts, patients, charities, academics and more. Lord Saatchi, as a peer in the House of Lords, albeit unelected, has a public responsibility. He holds a position of trust to both the public and to Parliament. He has stood in the House of Lords and erroneously stated the law. He has stood and compared doctors to medieval torturers, driven by unrelenting self-interest.  He has stood up in the Lords and gained the trust of some members of the public; who he has used, unrelentingly, as media spokespeople – their tragic circumstance as his emotive hook to further his own interests.  It’s just appalling.

 

But, perhaps I’ve been too hard on Lord Saatchi. Perhaps he was advised badly by someone he trusted. Like the public believing his position of authority and access to accurate law, perhaps he has fallen for a similar fate, dressed as a reliable trustworthy authority.

Lord Harry Woolf is perhaps most famous for his extensive civil reforms that were designed to drive down incidence and costs of litigation. While access to justice is very much down, costs of litigation overall have risen.  Woolf, a crossbench life peer, once a member of the Conservatives,  Master of the Rolls from 1996 to 2000 and Lord Chief Justice from then until 2005 – although not a medical lawyer, is an impressive fellow with legal experience and such eminence whose views must have been unquestionably reassuring for Lord Saatchi.  He trusted him.

So too have other non-legally-qualified individuals trusted him.

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Professor Sir Michael Rawlins, writing in the BMJ in support of Lord Saatchi’s Bill, stated, citing Bolam as his anti-innovation example, that

‘Several legal authorities have pointed out that departing from what is regarded as “established practice” or “the standard of care” leaves a doctor open to legal action for negligence’. 

In the comments section, he backs up his case, citing what he deems an irrefutable authority.

…Lord Woolf – the former Master of the Rolls and Lord Chief Justice – has an article published in today’s (24th April) Daily Telegraph explaining his reasons for supporting the Saatchi Bill. As my learned friends would say, “I rest my case”.

Michael Rawlins

He then responds to the comments in a Letter – BMJ 2014;348:g3152 –  citing his firm belief that he has got it right, as Lord Woolf said so.

‘The current law is clearly confusing even to lawyers. Poole QC and Conway, as well as Bewley, claim that the bill is unnecessary, and that the existing state of affairs allows for “responsible innovation” along the lines of the Saatchi bill.  Lord Woolf—a former master of the rolls and a former lord chief justice—disagrees. In an article published on 24 April 2014, he stated: “what I do know about, from sitting as a judge, are the cases where doctors are sued for negligence because they have innovated in the treatment they offer, rather than following generally-accepted medical standards.” The Saatchi bill will bring much needed clarity to an area of law that even the most eminent lawyers disagree about.’

 

So how can you tell when it’s .. ?

Unfortunately, Lord Woolf has not been able to substantiate his suggestion that doctors have been sued and are sued for innovative treatment  and are therefore so afraid of being sued for providing treatment in the patient’s best interests that, to paraphrase Lord Saatchi, they torture their patients to death, and this is why there is no cure for cancer, and this is why the current law requires a radical wrecking ball.

In fact, his authority for this does not exist. It does not exist even in the haziest recesses of recall.  It does not exist in his book. It does not exist in case reports. It does not exist in the records of the Medical Defence Union, or the Medical Protection Society, or the Royal Colleges or the BMA or the NHS Litigation Authority.

He wrote up his support for the Bill in an opus for the Telegraph, ‘Saatchi Bill: your last chance to help’, imploring readers to respond positively to the consultation.

‘My own reasons for giving my support to his plans – currently the subject of a Department of Health consultation that ends tomorrow – arise from my work as a lawyer. I have not, thankfully, had to face a similar domestic tragedy to his, but what I do know about, from sitting as a judge, are the cases where doctors are sued for negligence because they have innovated in the treatment they offer, rather than following generally-accepted medical standards.

In my experience, professional people are, on the whole, very conservative, and it is cases such as the ones I mention that make doctors frightened to try something different, something not yet fully tested, even when their patients give their consent, and when, as was the case with Josephine Hart and many others, they face certain death if standard procedure is all that is on offer.

Doctors don’t by nature want to step out of line, risk their professional reputation, or being labelled a quack by colleagues. That is, most of the time, a good thing. There should not be a culture in our hospitals of risk-taking with patients’ lives. But what is covered in these plans is a very specific set of exceptional circumstances, where there are potential benefits to allowing doctors to put their heads above the parapet.

…It shouldn’t require too much imagination to envisage those that these proposals might help. If you are a patient suffering with a terrible cancer, where conventional treatment has proved ineffective, your doctor may be aware of something else that could be of benefit, but which has not yet gone through the currently very long process of being fully tried and tested. It can take 15 years and £1 billion to approve just one drug. By the time that has been done, the patient will be dead.

At the moment, the doctor’s hands are tied – by concerns about professional reputation and potential negligence claims. That needs to change.

..Maurice Saatchi’s proposal is about is extending and saving life.’

 

When asked his authorities in a letter sent to parliament he replied in email correspondence:

 ‘In the time available, I cannot find references to the cases I had in mind when I wrote the article for “The Telegraph”.  I am afraid that it is most unlikely that I will be able to do so even if I had more time but I apologise and have to ask you to accept my recollection, which is of cases I was involved in very many years ago.

 My general position remains, however, what is needed is protection available before the event and not a defence, the existence of which can only be determined after a doctor is accused of departing from proper standards of practice.

 Yours ever,

 Harry Woolf’

Upon reading a piece about this very lack of an authority in Solicitors Journal he sent another email.

‘A person I assume who is known to you followed up what I wrote to you with what regarded as an unpleasant threatening  request and I am not prepared to be cross examined further I can only say that I am disappointed that your interest in forensic matters does not make you willing to accept that having been appointed a judge in 1979 and having tried many cases depending on medical evidence that I doubt were ever reported it is now impossible for me to give you the information you seek and so if you do not accept my word that is your problem not mine. 

 Sent from my iPad  

Harry Woolf ‘

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He has dismissed all calls for evidence so incredulously that you know you wouldn’t want to be sat next to him dictating his response.  But while everyone everywhere has drawn a blank, and requests for his authorities have been met with this ‘unrepentant’ wall,  his words have been used with flourish by team Saatchi and the patients, families and other supporters drawn in by his authority on the issue. Including medical experts such as Professor Sir Rawlins.   rawl It’s concerning indeed if a meeting of Harry Woolf and Saatchi resulted in the unfortunate creation of the Medical Innovation Bill, and in drawing in supporters who had absolutely no way of telling that the premise wasn’t the real thing.

1LUD100Z

 

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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