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.

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Professor Michael Baum: Some thoughts on the Saatchi Bill after 45 years of innovation in cancer research

28 April 2014 – As published on Nigel Poole QC’s blog and then ‘Quack’s Charter’, as submitted to the BMJ

Some thoughts on the Saatchi Bill after 45 years of innovation in cancer research.
Professor Michael Baum FRCS, ChM, MD (hc), FRCR (hc)
Professor emeritus of surgery at Kings College London, the Royal Marsden Hospital and University College London
Past President of the British Oncology Association

I started my career as a surgeon involved in cancer research in 1965 as a lowly CRC research fellow and ended my career in 2013 after stepping down from the directorship of the cancer clinical trials group at University College London. I therefore have a very long first hand experience as a surgeon and clinical researcher dealing predominantly with cancer of the breast.

In 1969 I established the first multicentre collaborative clinical trial that was a stepping-stone that ultimately lead to the break from the dogma of radical mastectomy towards a more conservative and humane treatment of the disease. [1,2] However I learnt the hard way about the ethical dilemmas of challenging clinical dogma and the complexity of organizing multi-centre and multinational trials. Building on that experience I studied the scientific rationale and ethics of clinical research and raised sufficient funds to build the first clinical trials centre in Europe that opened its doors in 1981. [3] With that infrastructure we launched a portfolio of clinical trials that continue to this day. Along the way I published extensively on the scientific and moral philosophy that guides clinical trials and human experimentation. [4,5,6,7,8]

Apart from pioneering breast-conserving surgery [9] we were also the first to demonstrate the survival advantage of adjuvant tamoxifen [10] and later went on to be the first to discover that an aromatase inhibitor (Anastrozole) provided even better outcomes than tamoxifen for post-menopausal women. [11] The use of these endocrine agents has lead to a fall of close on 50% in mortality from breast cancer in the UK. [12]

Although the swing to breast conservation has improved quality of life for women with early stage disease, such treatment conventionally involves up to 22 treatments with radiotherapy spread over 6 weeks and as a result is unrealistic for those women who live a long way from radiotherapy centers or those women in resource poor parts of the globe. With that in mind we invented a new technique for delivering radiotherapy at the time of surgery that can be completed in about 30 minutes. We then tested out this treatment by comparing it with conventional whole breast radiation in a trial with the acronym TARGIT. This trial recruited over 3,000 patients from 11 countries over a period of 12 years. The results recently published in the Lancet, [13,14] confirm that for carefully selected patients, the TARGIT approach is equivalent to 6 weeks of daily visits to a radiotherapy centre.

I believe therefore that I am well qualified to pass an opinion on the Saatchi Bill. I categorically state that in over 40 years first hand experience at the “coal face” on innovative research governed according to the highest ethical principles, I have never once experienced any obstacle that could even indirectly be linked to fear of litigation.
I do not question for one moment the sincerity and good faith of Lord Saatchi in proposing this Bill, but without any knowledge of the logic of scientific discovery or the practice of clinical research, good intentions and new legislation will not speed up the process.
I could write much about the real obstacles to progress but that is another subject altogether but as a taster, this feature that has just appeared in “Pro Publica”, identifies one of the culprits.
http://www.propublica.org/article/where-are-the-low-cost-cancer-treatments

References

1. Edwards MH, Baum M, Magarey CJ, Myson J. Treatment of early breast cancer: The organisation of a national trial. Br J Surg 1971; 58: 861

2. Cancer Research Campaign Working Party. (Baum M). Trials and tribulations: thoughts on the organisation of multicentre clinical trials. Br Med J 1980;280:918-920

3. The ethics of clinical trials and informed consent
In: Clinical Trials in Early Breast Cancer.
Eds: Baum M, Kay R, Scheurlan H
Pub: William Heinemann Medical Books, London 1981

4. CRC Working Party in Breast Conservation (Faulder C, Peckham MJ, Baum M, et al). Informed Consent: ethical, legal and medical implications for doctors and patients who participate in randomised clinical trials. Br Med J 1983; 286:1117-1121
5.Baum M Scientific and/or Empirical Approach to the Logic of Medical Research In: Medical Ethics and/or Ethical MedicinePub: Elsevier, Paris 1989, 146-152

6. Baum M Randomised Trials: The Case for Science in Medicine
In: Medical Ethics and/or Ethical Medicine
Pub: Elsevier, Paris 1989, 170-179

7. Baum M The epistemology of surgery
In: Doctors’ Decisions – Ethical Conflicts in Medical Practice
Ed: Dunstan GR, Shinebourne EA Pub: Oxford University Press, 1989,133-144

8. Baum M The Ethics of Clinical Research
In: Ethics and Law in Health Care and Research
Ed: Peter Bryne Pub: John Wiley & Sons, 1990, 1-7

9. Fallowfield LJ, Baum M, Maguire GP. Effects of breast conservation on psychological morbidity associated with diagnosis and treatment of early breast cancer. Br Med J 1986; 293:1331-1334
10. Controlled trial of tamoxifen as adjuvant agent in management of Early Breast Cancer. Interim analysis at four years by the Nolvadex Adjuvant Trial Orginisation. Baum M, Brinkley DM, Dossett JA, et al
The Lancet Feb. 5th, 1983; 257- 261
11. Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists’ Group, Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, Baum M Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol. 2008 Jan; 9(1):45-53.

12. Early Breast Cancer Trialists’ Collaborative Group (Baum M) [a member of the working group]) A systematic overview of all available randomized trials of adjuvant endocrine and cytotoxic therapy.
In: Treatment of early breast cancer: Worldwide Evidence 1985-1990
Eds: Early Breast Cancer Trialists’ Collaborative Group (EBCTCG)
Pubs: Oxford University Press

13. Vaidya JS, Joseph DJ, Tobias JS, Baum M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet 2010;376(9735):91-102.

14. Vaidya JS, Wenz F, Tobias JS, Baum M (on behalf of the TARGIT collaborative group) Risk-adapted targeted intra-operative radiotherapy versus whole-breast radiotherapy for breast cancer:5 year results for local control and overall survival from the TARGIT A randomized trial.
Lancet November 11th 2013
http://doi.org/10.1016/S0140-6736(13)61950-9

The BMJ – and Professor Susan Bewley’s excellent response

The BMJ recently published an article by Sir Michael Rawlins: here, entitled ‘The “Saatchi bill” will allow responsible innovation in treatment’.

I think I was a little too cross to respond at the time as it felt like another wonderful PR spin from the reaches of the Saatchi campaign, and all in all came across as self-contradictory, unquestioning of fact, and largely offensive to the intellect of most doctors, or so I would hope.

I was pleased to see rapid responses correcting the quote from the brilliant Butler-Sloss in Simms and stating the law accurately, including some points I have raised myself regarding compliance with a number of Directives and regulatory EU law. My faith has been restored if this was the extent of her so-called support for the Bill.

I was very pleased to read the insightful response by Professor Susan Bewley, cutting in its common-sense which can be read in full here

She raises the point very clearly that this legislation may not drive innovation at all – quite the contrary, and neatly sums up some most valid points.

‘It is both an insult, and dangerous, for one rich persuasive individual with deep pockets, access and influence to tell the medical profession that it has not been innovative (enough) and that we need a Bill to help us do what we already do safely and legally. This is not a simple cultural debate – it is a category error’

‘Hype about ‘innovation’ is all, drives and is driven by commercial pressures and desperate clients, and it seems bizarre to accelerate this’.

‘As medicine already has lots of laws, good practice, governance and the normal academic and clinical safeguards, there is no need to add more polish to the Bill of the sorts of ‘good’ things that happen anyway.’

She points out that it would be inflexible, and anti-innovation if codified in the law, written in the past ‘that largely operates after the event.’

What happened to “First of all, do no harm”? This Bill is not needed, it is not the right prescription for the wrongly thought through diagnosis. Bad doctors come up with treatments and then justify them. That is what Lord Saatchi is doing. The solution was found and now comes the justification. Starting a PR campaign and then finding lots of people agreeing might feel familiar and comfortable to him, but it really should carry no weight with us. It’s misleading to think ‘votes’ or even the ‘opinions’ of the great and good change scientific or medical facts. He really oughtn’t be influenced by the agreement he and his Bill Team set out to find. Good scientists, innovators and lawyers pay a lot more attention to areas of weakness and disagreement.

The Bill just doesn’t make sense. The only people who can assuredly benefit from devising new law are barristers specialising in legislation or members of the ‘Bill Team’ driving this project.

Sir Rawlins, “I rest my case”

The Royal College of Radiologists

Here is the RCR response in full to the DoH Consultation

RCR Final Response Apr 2014

The RCR state ‘we have no evidence that doctors are deterred from innovation by fear of litigation.’ They further point out (emphasis added) ‘If the doctor considers that the proposed treatment would not …satisfy the Bolam test if challenged in court, then the overwhelming likelihood is that the treatment will not be of value and there is a significant risk that it may be harmful.’

‘If the decision to offer an innovative treatment has been made within a multi-disciplinary team, as in 1(7)(c), then it is highly likely that it would satisfy the Bolam test if challenged in court, therefore making this Bill unnecessary.’

‘There is concern .. that the intent of the Bill is that those in independent practice would have greater flexibility and opportunity for innovation. This could have perverse effects as there might be fewer checks and balances to ensure that innovation is appropriate, safe and potentially effective.’

The Royal College continues ‘We are very concerned that there could be serious unintended consequences of the proposed legislation.’

‘Existing governance mechanisms protect patients from inappropriate experimentation and protect doctors from pressure to innovate in ways which are potentially detrimental to their patients. Patients who are not satisfied with the response of a particular doctor to a proposed innovative treatment may seek a second opinion. Relaxation of these governance mechanisms, which this Bill proposes, risks exposing vulnerable and desperate patients to false hope, futile and potentially harmful (and expensive) treatments.’

‘Fundamentally, we do not believe this legislation is needed. We do not feel that doctors are constrained as regards innovation and we believe that the current structures provide the appropriate checks and balances.’

The MDU

The MDU’s position on the Saatchi Bill can be found here . Representing a large percentage of UK doctors, the MDU would presumably welcome something that would minimise litigation. They assert the position however, as do many doctors, that this bill is neither necessary nor beneficial.

“We see no need for new legislation and are happy to reassure doctors that medical innovation should not leave them open to an increased threat of litigation, so long as they can show they acted in accordance with current legal and ethical principles governing clinical practice.” says Dr Devlin.

The MDU believes the current legal position is clear in that doctors need not fear litigation if they apply some very basic principles to innovative treatment: safeguarding, good reasons for departure, patient understanding of reasoning of belief it is in best interests, patient consent. This is long echoed by the BMA, GMC, and in case law.

The current legal position is clear, and has evolved carefully and robustly over many years. Would any reasonable or responsible practitioner have done the same, can logical reasoning be applied, can the decision be explained or defended? This is firmly pro-innovation. There is no need for any change or statutory legislation in this regard.

The risks of a bill would include, as the MDU state, the potential to cause considerable confusion among doctors and thus acually impede medical innovation. “This is because doctors thinking of using a new approach or procedure would have to consider the effect of the Bill, which would be an additional process.”

Indeed in the process of reducing access to justice for claimants it may paradoxically create a significant number of new liabilities, hurdles and uncertainties for doctors and put the law back by decades.

‘Experimenting’ – The Telegraph’s latest

So, the day after the consultation closed there was another piece of skewed journalism by The Telegraph. Here in unapologetically crass terminology from Martha Gill (they pay her for her blogging? seriously?) we were presented with “Why experimenting on the dying is a brilliant idea” throughout which assertions were that ‘at least’ patients would be making use of themselves; ‘at least…you haven’t fought against the dying of the light’.  I wonder if Ms Gill has spent any time with dying patients? I wonder if she has cared for palliative cancer patients, spent time with them at home, in hospital, in hospice? I have and I find her remarks demeaning.  Kate Granger has written articles on living with cancer for the guardian that should be read – her most recent here and here.

Semantically however this blog is revealing – experimenting, finding cures – we see the true stripped back meaning behind Saatchi’s bill: to experiment, to regard these people as expendable. This is in direct contravention of the principles of innovative treatment which are surely to be weighed on that individual’s best interests.   So – innovative treatment? or ‘therapeutic research’? The latter was ruled out by the World Medical Association back in 2000 (you know them, the Helsinki Declaration?)

Some other fundamental inaccuracies exist within the piece regarding the suing culture in the UK. As someone who was both affected by and worked in clinical negligence, I can state emphatically that there is no such culture when it comes to these claims. This is not and never has been the pile ’em high sell ’em cheap of the rear-end-shunt. These cases are intricate, take years of careful, clever preparation and fight against a systemic problem, a system that is top-mid-down complicit in concealment. The chances of success in a claim for clinical negligence are always precariously swinging about 50% in even some of the best cases. To prove a case it must be shown there was a duty of care, a breach of the standard of care and that this itself was causative of the damage. New client enquiries are frequently turned away; of those that are accepted the cases must have real merit.

There is little avaricious mentality in claimants – frequently a claim is driven by a real, practical need for future care provision: care needs that are not being met by the NHS. Whether it’s right that a baby born with cerebral palsy through negligence is awarded millions in compensation, to adapt a property, pay carers, meet physical and educational needs; and one who has cerebral palsy without negligence is awarded nothing at all; is only worth discussion in the setting of a fully functioning redress system, NZ-like and statute based. Whether anyone would access justice then, whether any amount paid would be high enough to account for the huge costs of living with the consequences of clinical negligence, whether any unsafe practices or systems would be investigated, who knows. Until then claimants require justice and adequate care provision for their needs.

In cases of bereavement a paltry sum cannot replace the lost loved one. It cannot atone for the harms and sequelae extending long into the claimant’s life. In most cases we know that claimants are motivated not by money but by a need to have an explanation, at times an apology; or by a real desire to change a policy which caused harm to prevent future harms occurring.   The claims process is tough and often traumatic itself. The cases can take years. The process does not leave claimants satisfied. I will state again, that the numbers speak for themselves – before the government interference and stripping away of legal aid/ meddling with CFAs, only around 6,000 cases were brought out of a total of > 1million known adverse incidents. Very modest.  In 2009/10 just 6,652 clinical negligence cases were notified to the NHSLA. The 2010/11 figures are of 8,655 being notified, many of which being repeat incidents,  increased categories of never events that still happen;  systems and safety going awry here. In that year the clinical negligence damages still accounted for only 0.7% of the NHS budget.    Lord Woolf’s support for the bill, I suggest, is not in isolation to his involvement before in reforms designed to cut legal expenditure. The LASPO evisceration of legal aid has already removed access to justice for many. 
Penningtons  state ‘the question could be asked whether the Government’s real aim is to reduce the cost of clinical negligence claims overall – by making them more difficult to bring – rather than reducing the cost of legal aid’. This bill would remove any remaining recourse to justice, destroying almost all chances of success for people affected by clinical negligence.

The assertion by the bill’s PR team that doctors fear litigation appears to be based perhaps solely on the opinion of those not in clinical practice or medically qualified themselves. The repetition of the sound bite from an F2 doctor, who rather informally says ‘will my ass get sued’, by a process of elimination leaves me personally in doubt as to whether they had anyone else in the medical profession to support this view.  Doctors have expressed that they do not fear innovation, despite the best efforts of the Saatchi campaign to scaremonger support ‘your entire livelihood ….’ and misrepresent the law.  I do not know anyone who fears innovating appropriately.  Doctors have spoken out to state that this is wrong.  Margaret McCartney is clear on the fact ‘it is currently not negligent for a doctor to depart from the existing range of medical guidelines for a condition’. We all know we can depart from guidelines where it is appropriate to do so.  Esteemed Professor Michael Baum has emphatically stated that never once has fear of litigation impeded him in innovating: ‘NEVER ONCE HAVE I ENCOUNTERED INTERFERENCE OR OBSTRUCTION ON LEGAL GROUNDS’, emphasising this later when he writes:  ‘I have never once experienced any obstacle that could even indirectly be linked to fear of litigation.’ 

The MDU, representing half of UK doctors,  would surely want a bill that can be used to defend against malpractice litigation.  They, however, have stated it is unnecessary and likely to cause harm, and will act to impede innovation.

The legal basis for justifying this bill has been poorly understood and blindly regurgitated by one-sided PR articles and the bill team. This is because there is no legal basis.  Negligence has never been defined as not following the standard procedure and to believe it has is to fundamentally confuse standard with standards.  Negligence is falling below the minimum of standards; it is not ascribing to one standard course.  Treatment is generally required to be supported by ‘a’ responsible body of medical opinion, even if it is a very small minority one. In Bolam this was the case itself: ‘a’ was used in the directions, not ‘the‘.  Simms v Simms is the case where Baroness Butler-Sloss states ‘…The Bolam test ought not to be allowed to inhibit medical progress’ – the law so clearly recognises the need for innovation and is protective of those who innovate responsibly.  Departure should have some logic and reason to it  but not necessarily be backed by any substantial body – just for the rationale to be in some way logical or explicable:  surely this is the very lowest we can all expect from our doctors? how is this anti-innovation, then?

Perhaps Martha Gill is attempting to be the self-styled Katie Hopkins of blogging, knowing her comments to be laughable.  For ‘there are of course some caveats’, The Telegraph piece adds tentatively at the very end; ‘just because a new treatment helps one patient, it doesn’t mean it will help others’.  No, it doesn’t.  It puts the individual at significant risk, and n=1 is not going to help patients in the future. To coercively gain support in this way is suggesting this will lead to empirical research studies, though this is not a part of the bill (yet is a part of current practice).  By making claims it can help another again shows the true intention to be one of research, the true worth of the person with cancer as an example to be expendable. To better care, many drugs that we know do work could be funded, pharmaceutical development could progress to provide drugs for more patient groups at lower costs, and better, faster access to trials and research funding for small projects and technology advances could be available. We need more evidence funded for there to be more drugs available faster, and for more people to make optimal clinical decisions. Not less evidence.    Current research and legal guidance allows innovative individualised treatments but also safeguards patients responsibly.

This bill would achieve no reasonable aim:  it would however remove all access to justice, trample over any true informed consent or autonomous process,  increase red tape and legal interference and contravene existing laws and regulations. It would instantly dehumanise ‘the dying’ to no more worth than a lab rat.  A ‘wasted death’ indeed.