Professor Baum: three simple principles of clinical practice

Professor Baum’s rapid response to Margaret McCartney’s BMJ column ‘Withdraw Saatchi’s quackery bill’:

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.

Double, Double Toil and Trouble

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

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

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

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

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

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

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

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

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

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

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

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

For excellent analysis please see:

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

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


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


More Trick than Treat

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

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

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


Blink and it’s back, again, twice

In a fascinating display of parliamentary quick change tango, Lord Saatchi’s creation has hotfooted not only back to the Lords to be read a second time in July (with the hopes of subverting usual procedure and fast-tracking straight to the lower house for its completion- with a time limit of one year from its reappearance) but, according to the Bill’s website, it is now replicated in the PMB proposed by MP Chris Heaton-Harris in the Commons.

Of course, if this is the case then it’s gone from a, relatively, restrained misrepresenting of benefit by using the word ‘innovation’ rather than ‘experimentation’; to a wholesale misrepresentation of content. The original never contained anything that would have enabled access to treatment,at all, despite the heavy lines spun to encourage loud, urgent, understandable, support.  One suspects Lord Saatchi’s new bill will be the same when it suits him to dupe supporters into believing it’s had the ok-go from the Lords; and will be an entirely new and fresh venture when the hideous problems and wall of opposition, from doctors’ representatives, patient charities, research groups and patient safety experts, to the original attempts are pointed out.    Nobody’s quite sure whether the Bill site has told the truth or not because the Bill probably hasn’t been written yet, despite having its first reading yesterday. Nor can anyone know how many willing helpers put their names in for the PMB ballot to run it for Saatchi; brownie points all round, right?
And what dazzling speed – Britain’s got talent for something, anyway, just apparently not appropriate, considered, transparent health policy or legislative drafting.
From the website:
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With a typically overt disregard for quality of life or respect for human worth, the mass guinea pig market was announced in the Telegraph as well, will they be this Bill’s media partner too?
On the plus side, Tredinnick’s cleared off temporarily for his gig at Glastonbury.

Anticoagulation, powdered owl & an outlier on the spectrum of reason

A GP with decades of experience in practice and medical education, Dr Wollaston became an MP in 2010 after an open primary in Totnes. Her invaluable experience and insight on national and local issues of importance as well as her specialist expertise made her the ideal choice to inform the Westminster vacuum.

She was soon appointed to the Health Select Committee, a cross-party committee to hold the government and health bodies to account and make policy recommendations. In 2014 she was elected Chair. She did a fantastic job in the role and it would be a terrible disservice to health policy, the committee and the government’s credibility if she were not Chair again. Very few are as qualified and appropriate for the role and,  felt keenly with the absence of such MPs as Julian Huppert on this occasion, we need to maximise the insightful few that we have. She’s also a rather great role model.

Her challenger for the role is David Tredinnick.

Why is that news? Well it’s perhaps not that newsworthy I guess, and that’s what’s scary. 

David Tredinnick’s appointment to the Health Select Committee itself was really quite shocking, but that was way back in 2010. Though inapposite, add in the company of other desperately unqualified persons such as Nadine Dorries and it’s no longer a surprise.   

Tredinnick, MP is so out there he’s ‘a hallucinogenic substance in his own right’.  He is a big supporter of his own variant of astrology, not only claiming for personal development courses, but once claiming expenses from taxpayers for £755.33 of ‘computer software and consultancy to investigate whether astrology can be linked to alternative medicine.’

In the House of Commons he has stated emphatically that blood does not clot on a full moon, and surgeons won’t operate on full moons. Indeed his fear of the moon has been raised on a number of occasions.   He launched a tirade of EDMs at the indignance of people who knew what they were talking about to talk about stuff, like homeopathy; and relied upon so-completely-unambiguously-discredited studies to support his claims, even those which claimed to cure cancer and where authors asked to be removed from papers. 

Like Australia have concluded, our Science and Technology Committee found homeopathy useless. David Tredinnick then joined the Committee.  

He still believes astrology should be used more often in healthcare in the UK.  Recently in 2015 he reiterated the virtues of astrology as “a useful diagnostic tool enabling us to see strengths and weaknesses via the birth chart” and proclaimed that astrology and complementary medicine “would help take the huge pressure off doctors”. So much for Francis and safe staffing. Perhaps NICE have already a-okayed this as it’s clearly cheaper to replace legitimate health policy with the nuttier side of woomongery’. 

‘How to handle the ongoing issue of having this bizarre, deeply wrongheaded man in a position of influence over matters that demand evidence-based decision making?’ asked Adam Rutherford, 5 years ago.   The indulgence of his personal interest in astrology to the detriment and exclusion of real matters for his constituents and for the health of the nation has not gone unnoticed in parliament either. 

But now this man, who Professor Brian Cox politely termed ‘an outlier on the spectrum of reason’  not only wants to be on it, he has been nominated to chair the Health Select Committee. 

Beating cancer with astrology

Beating cancer with astrology

Almost impossible to parody it’s not actually funny.

These are not the affable, eccentricities of your distant uncle or your old headmaster. This is not harmless.

Championing discredited studies as evidence in parliament, including for cancer treatment, is deeply contemptible. Steering health policy in this way is like crashing it into the dover cliffs. It’s not “the awesome power of the moon” flinging it there – it’s Westminster sinking itself, and the rest of us in the process. 

More from Professor Cox here. 


Novel use of procedures to avoid scrutiny

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

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

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

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

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

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

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

More info: Stop the Saatchi Bill and openDemocracy

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