When I first read of the Saatchi bill it was reminiscent of a glinting, brazen piece of ironic abstract art, standing in such stark contrast to commissioning cuts, reduction in research funding and recent legislation, easily dismissed as nonsense that would go nowhere. The rapidly impending closure of consultation on this matter though is less ironic, a touch more unsettling. I am left struggling to comprehend how, in such technologically advanced years, with so many educated experts, clinicians and patients, anyone could possibly buy into this. A perfect PR campaign, perhaps, Saatchi?
The Bill has been described as well-intentioned. Is it really? I agree with those stating it is misguided. Is it poorly thought through? Almost certainly; unrealistic to implement? Well yes; unethical, even? I’d say so and think others would agree.
Lord Saatchi lost his wife to cancer not long ago. Josephine Hart, the esteemed novelist, producer, presenter and poet, died from primary peritoneal cancer in 2011. Saatchi’s loss has been the subject of many press interviews, supportive statements and acknowledged as instrumental in developing the Bill. PPC, closely overlapping and linked to ovarian cancers, has a poor prognosis. Anyone who themselves has had the experience of witnessing a death or deterioration of a loved one, particularly perhaps while in the course of medical treatment, will be very familiar with the feelings of frustration and anguish it can evoke. This will also be familiar in concept, though not in such raw intensity, to those with clients, acquaintances, or in dealing with relatives of patients. Indeed powerlessness, anger, guilt, horror and confusion were all feelings I myself experienced watching a deterioration.
These were heightened by interest in and existing knowledge of applications of medical technologies and drugs. I didn’t need to navigate the hospital’s prohibitively complex WiFi logons to know that so much could theoretically be done. So why weren’t they doing this? Why didn’t they give her that drug, the one that made such logical sense? Why did they approach it like that? Why didn’t they provide that infusion? Why on earth was that treatment not an option? Why was that approach I had read about a number of years before not offered? Looking back on the experience of being next of kin in such a setting, I picture Munch’s The Scream – I stood, frozen in horror, for at times I could not quite believe what they weren’t doing. Attempts to advocate were ignored. I felt unheard, and as if I had failed. I reasoned there must be an evidence base for my thoughts somewhere in the world (there was, it turned out) and if their colleagues were successfully saving lives with these methods or drugs, why was this London teaching hospital seemingly so far behind? What was behind the reluctance to try and save people? Was a bed space worth more than a life? Was she just a number to them? Not only was the end of her life gruelling and traumatic for her, it was gruelling and traumatic for me, the impotent observer. Staggered disbelief and horror at the loss of the centre of my world oscillated with self-persecution. Could I have done it differently? Was it my fault, for not advocating better? A life had hung in the balance before me, and I never wanted to feel so powerless, so complicit again.
I therefore fully understand Saatchi’s comments in the press. With long continuous thoughts of suicide, he expressed his grief as an ‘incomparable nightmare’. I continued to work full time, appearing quite fine, initially, but I experienced flashbacks at night that left it hard for me to sleep at all, and I awoke each morning for over a year having completely ‘forgotten’ my daughter’s death, forcibly reliving the shock afresh. As I went shopping and still bought the occasional toy she would have liked or her favourite foods so that my fridge looked right, Saatchi still set the table for his wife each day, still laid out the papers as she had liked them for so long. He said in 2012 “this is close to madness”. I’d like to think he was a smidge closer on the continuum than me, but I, like many others, certainly do understand this type of grief.
Thousands have expressed support for his Medical Innovation Bill- but why? In the most basic of ways it could represent a meaning from loss and a beacon of hope. Many bereaved relatives are comforted by campaigning to raise awareness of symptoms or fundraising, but here is where Saatchi diverges into something altogether more concerning, altogether more inappropriate. For what do his supporters think they are supporting? Do they believe each word from the slick propaganda machine? So Jeremy Hunt himself ‘and Number 10’ are openly backing the bill, and discussion has taken on a disturbing air of inevitability. Lord Woolf’s article in the Daily Telegraph is half taken up with discussing the death of Lord Saatchi’s wife. Relating legislation to emotion is surely removing impartiality in appraisal. Emotive petitioning and brazen use of bereaved parents or parents of seriously unwell children, in all videos and ‘hangouts’ on the matter is arguably unethical as their situations are so serious, and as it is designed to have its impact- playing on the public conscience and that of those in similar positions, influencing the most vulnerable and desperate.
Concerns I would like nothing more than for this to be workable, logical and worthy of full support. I don’t want to get sued, I want to innovate and my secret god complex wants to save everyone. I’ve tried hard to like this, but it is inescapably unnecessary, partisan, coercive, misconstrued, misrepresented, dangerous for patients and damaging to the medical profession. Indeed it has riled me enough to make me want to speak up – I am staggered and extremely concerned. It is of concern that a large dose of misinformation has been systematically infused by regular press releases in the Daily Telegraph among other cuprits “this will cure cancer”. Will it, really? I am unimpressed by the apparent ignorance of the law shown by law makers, and that professional and ethical standards of lawyers and doctors are being brought into disrepute, both implicitly and explicitly tarnished. Doctors are not ‘quacks’ yet Lord Saatchi repeatedly adopts this phrase himself. Lawyers are not ambulance chasing destroyers of the NHS and innovation. With around 6,000 claims brought to the NHSLA p.a. before the cuts in legal aid/funding reforms, out of a known total of adverse incidents exceeding 1 million, on the backdrop of extraordinary difficulty in succeeding in a case, clinical negligence law is very modest indeed.
Not exactly Kantian
Professor David Walker in support of the Bill has stated ‘Research does require regulation to introduce new drugs and treatment safely’ – right, we agree there. But we can ‘do it in such a way as we could all learn from it’ “When people are dying” he says, “they all would like their passage through their illness to have some meaning and to learn from the loss of their life”. Saatchi states “every cancer death is a wasted death“. So, hang on a minute – are we talking about innovative treatment; or are we talking about trying things out to help others? Which is it? If it’s ‘to learn’ then this is research, this is not treatment.
Medical treatment should strictly be weighed by a risk: benefit ratio. This is putting people at risk. Is Prof Walker suggesting that the terminally ill are in some way expendable? is this not a frightening plunge, attributing more or less intrinsic worth to one life than another? are the disabled ripe pickings for experimentation too? To suggest one life has more intrinsic value than another is surely an abhorrent concept, done away with at Nuremberg. Indeed using particularly vulnerable groups of society for research is exactly how this is sounding, and is quite clearly using people ‘as a means to an end’.
Not exactly strong on any other basis either
We can all, I think, agree, that there are problems in the provision of treatment for cancer as a very strong example; but these are predominantly funding issues. How can it possibly be right for unproven treatments to be used on individuals and law to be changed at no doubt great cost, when treatments already exist that are known to improve both quality and quantity of life? What about funding those treatments with PROVEN success, still denied to so many? What about funding faster development-to-market? Independent clinical research? We’ve surely all heard of Avastin, Herceptin, and Top Up fees – NICE were in the press only this week over refusing to approve funding for Kadcyla.
With so many suffering from cancer – how is it at all appropriate to not fund drugs we think will work, yet fund experimental drugs with no such evidence base?
Is it even right to fund individual treatments with minimal chances of success without a full appraisal of existing clinical need elsewhere? and who will be accessing this treatment? will it be, as suggested, open to those who ‘consent’ or request? Does this not imply a tiered access to treatment based upon a distinction between the prudent patient who is informed and the one who is not but who is trusting medics to act in their best interests? Is it right to divert funds from the NHS with one hand, and sprinkle out a few bits with the other in such a haphazard way, or is it a good bit of defensive electioneering by the Conservatives? What about the genetics research, the technological advances and the forefront of regenerative and translational medicine? Did anyone notice the 23% funding cut to Academic Health Science Networks (aka innovation networks)?
What about the woeful inadequacy in funding appropriate care? Only this week, three children with care needs died and their mother, who left (aka had to leave) her job to care for them, has been arrested. Having been faced with the reality of a disabled child myself to be sent home with absolutely no respite support despite 24/7 care needs and being told I had to leave my job in the city to be a full-time carer, and no I wouldn’t be able to sit any exams either or have an afternoon a week off- I can understand the immense pressures on carers. The country is propped up by a huge, voiceless number of informal carers without even so much as respite provision due to ‘no funding’. Additionally ONS data from 2013 shows a 25% reduction in numbers of people receiving social care services, reasons including CCG/LA funding cuts and eligibility restrictions. In 2011, >5.8m people were providing entirely unpaid care. That’s ~10% of the population. I am incredulous that a personal whim, a self confessed ‘(litmus) test’ of cancer – cleverly pitched, as do we not all at least know someone who has had cancer?- can be prioritised for a political agenda.
In 2012 there were 3.45m new diagnoses and 1.75m deaths attributable to cancer in the EU. In 2020 it is estimated that half of the population will be affected by cancer. But this is no reason whatsoever to support this Bill. It is a reason to fund research, ensuring better and faster access to useful drugs, affordable for the NHS.
It is a reason to atone to the principles within the European Cancer Patient’s Bill of Rights:
Article 1 – the right of every European citizen to receive the most accurate information and to be proactively involved in his/her care.
Article 2 – every European citizen should have the right to ‘optimal and timely access to appropriate specialised care, underpinned by research and innovation’
Article 3 – a patient’s right to be given care within a system ensuring ‘improved outcomes, patient rehabilitation, best quality of life and affordable healthcare’
Doctors, not demons
Lord Woolf remarks ‘At the moment, the doctor’s hands are tied – by concerns about professional reputation and potential negligence claims’ I regard this as offensive to doctors. No longer working in clinical negligence, I am going through the rigours of medical training myself – it requires absolute devotion to medicine, hours of on-calls, night shifts, years upon years of relentless examinations, jumping higher and higher bars, attending crashes, valiantly throwing every ounce of effort and skill at saving each and every life in trauma, and excruciatingly long days in theatre elbow deep in pelvic exenterations and colon. Doctors are dedicated to the profession. Doctors put up with poor conditions, uncertain employment, ridiculous hours and are routinely, systematically vilified by the press. Doctors are not well paid in the NHS- this is a pure media myth. A cursory glance at nhsjobs will yield adverts for Trust doctors paying £22k, vascular surgeons on £28k. I earned more than that as a 20 year old undergraduate in a law firm. Doctors are strictly bound by professional Codes of Conduct – the GMC clearly sets out Duties of a Doctor. Medicine is not about money or status – it is strictly entwined with ethics and always has been, with beneficence, non-maleficence at the fore of clinicians’ minds and professional codes.
The realities of commissioning in the NHS are harsh. Despite my lowly status I am already well accustomed to plotting how best to word scan requests for a patient so they are not thrown straight back at me; indeed there are clandestine lunch meetings in hospital darkrooms and basements about how precisely such tests should be ordered to ensure they go through. I know how to work up an acute surgical patient by sneaking in buzzwords to ensure a CT is urgent, or the exploratory laparascope really is done that day, and they really are kept in overnight. It’s a bit like a sport, or sudoku. Radiology is equally frustrated with unnecessary or ill thought through requests that are inappropriate, potentially harmful and use precious resources unnecessarily.
Doctors want to help their patients. Doctors live to help their patients. Doctors stay awake for days on end helping patients, destroy their own lives and relationships for careers, may uproot their homes frequently, throw themselves into medicine in its truest grassroots approach, wholeheartedly, sincerely, with the desire to do the very best for their patients. What most live in fear of is not litigation. I am not afraid of litigation, that small minority percentage of clinical negligence cases brought annually. Doctor friends are not afraid either. Litigation can be extremely stressful for those involved, but it is extraordinarily rare to find and hard to prove the components of a clinical negligence case in court. Of course there are examples of inadequate care (and this Bill would remove redress in those cases) but more often than not there is a systems-based problem, a top-down issue. Doctors who treated my child remember her case in detail to this day, and sincerely regret that she died. They are hampered by red tape and excessive regulation in areas that impede innovation, top-down shouts to get their figures in order, evidence holes and commissioning. Doctors are plagued by the stopping of attempts to provide care that costs money that they are not allowed to spend to better the patient’s diagnosis, management or outcome. There is then for some fear of speaking up to management about standards; for HCP bullying by management is rife and whistleblowers are routinely and enduringly crucified by the State – such as Dr Raj Mattu, again in the press this week (see also websites by Dr Kim Holt, Sharmila Chowdhury, Patients First and the excellent insights from Dr Phil Hammond).
This is a top-down, management/bureaucracy heavy, cost-driven bonanza of bonkers; systematically hounding, silencing and destroying the very people with the integrity so defining of the professional duties required.
Doctors are also, it is important to state, already using innovative treatment: innovative treatment and off-label use or unique modifications for patients are a standard feature of care and always have been. Doctors want the best outcome for the individual patient when the standard treatment options have no, or limited, success; clinical acumen, experience and evidence enables such decisions. This is approved by the BMA and GMC with guidance issued on consent, explaining to the patient how it differs; the risks and degree of digression from the norm. It is also well accepted that RCTs are not appropriate for all patients and doctors can innovate even here where the RCT format of research is inappropriate for the individual, as the overriding duty is to consider the patient’s wellbeing.
The BMA however recommends conclusions reached from such implementation should be shared with others as a step towards improving care for subsequent patients, and states that it is ‘nowadays… unacceptable’ to provide unproven remedies or new techniques without ethical overview or independent assessment. New drugs, products or techniques require research ethics approval, critical review and appraisal.
Previous experience has shown that we require proper means of assessment of risks and efficacy in the implementation of new treatments- as with TGN1412 which spurred the 2006 report recommending strongly a means of global sharing of information, the establishment of an open access database with preclinical reports of results. Adequate risk assessment is essential both to ensure the risk taken is proportionate to the expected benefit, and to ensure the risk is adequately explained. This is particularly relevant in children. Doctors are forced to prescribe off-label or new treatments in children and this is routine practice already. Pharmaceutical products specifically for children are certainly required – so many pharmacokinetic, pharmacodynamic and other considerations are relevant to children’s response to medication. It is high risk, and research is required to be recorded systematically on EudraCT. The BNFC is still a relatively recent development. ‘Innovative therapy’ is thus already approved for children despite the added risks – the BMA states that it is unethical not to research and leads to stagnation and continuation of unproven remedies. This is both an example of an obvious aspect which requires careful study and better funding, for what’s used with great success at John Hopkins in adults may cause deleterious side effects in paediatric RCTs; and an example of innovative treatment already being used in practice, every day. Incidentally, in my child’s case I berated a decision I made when I refused to join an RCT where instead of antibiotics another treatment would be infused, or a placebo. At the time I was in shock, the basis for the trial was not explained at all and I remained firmly in lawyer mode thinking it may do more harm. I really, later on, struggled, knowing the metabolism and pharmacology behind the proposed intervention. It made absolute sense. In only 2013 the results were published from the RCT: those who had the treatment had fared worse than those who had not. There was no logic behind this as the evidence in adults had pointed to an effective treatment; and there was no way of collating this information without such a large multicentre RCT.
Further, the importance of external review cannot be overstated, vis. Bristol Heart; the 2001 report confirming that new untried invasive clinical procedures should be subject to critical review. NICE was the response with RECs for scrutiny (with 3 independent members – not a feature of the bill at all, which prefers an MDT panel? if the doctor thinks it’s appropriate?) and NRES.
Following the ‘wasted death’ logic, this is thus a poorly drafted attempt to use patients as a means to an end and lacks all foresight. Doctors are happy and keen to innovate but are hindered by the refusal of funding, existing legislative barriers to technologies, and by realistic challenges to practical implementation. McMaster evidence updates are an example of research bulletins pinging into the inboxes of doctors frequently. Audit is essential. Significant progress has been made worldwide in neural networking, fields such as biomarkers, metabolomics, genetics, and programs run that collect data on specialist areas on a multicentre basis, or collaboratively perform clinical trials -essential in rare diseases. Clinicians should ensure a systematic review of evidence base for procedures so information accurately reflects current knowledge. The potential benefits of an intervention must outweigh inherent risks of harm: safety is of primary importance. Harm can also come in many, less tangible, forms to the patient. A failure to report or publish results , as seen here in this bill, prevents future accuracy in treatment decisions and is considered a form of misconduct. Regulatory bodies worldwide should facilitate sharing and reporting models such as EU SUSARs.
Lord Woolf states, crucial to the proposals, is ‘the principle of true consent’. I spluttered upon reading such a sentence. Without going into the finer aspects of ‘consent’ and the extent of information dissemination and understanding required for an ‘informed consent’ (is true the new informed, then?), anyone who sits for a moment and thinks can see this is a fiction.
The EMA notes for guidance (2002) states ‘consent is dubious when person’s willingness to volunteer in a clinical trial may be unduly influenced by the expectation, justified or not, of benefits associated with participation.. or a net response.’
The BMA agrees: ‘patients often find it hard to resist agreeing to a therapy when they have few other treatment options’. To use the intuitive wish ‘to try anything’ with treatments lacking much evidential support or with unknown risks is surely highly unethical. The decision to proceed with treatment will be based upon a trust in the medical profession, a trust that they know what they are doing, that the risk will not be too high. For there is surely no quality of life in a hastened death, or significant medical experimentation. This creates inducement, too, in a wish to please based on trust and expectations. To suggest it would benefit others is a falsehood – there is no such requirement for reporting in the Medical Innovations Bill. This would then be admitting that it is research (which is what innovative treatment actually is: previously known as therapeutic or clinical research). At present innovative individualised treatment requires an assiduous monitoring of outcomes, collection of results, and should usually ultimately lead to formal research protocols for appraisal by RECs if found to be successful. In suggesting it may be of some greater good, this misleads those ‘consenting’, In proclaiming it to be curative, a saviour of lives, I have no real words to describe my abhorrence.
A particularly unsettling aspect is using parents as chief speakers in PR for the bill. I have only the utmost empathy for passionate speakers who are bereaved parents. Having ‘lost’ a child myself I am very involved in work with supporting bereaved parents. I also respect publicly stating support for new treatments and funding – trying to change something that could save your sick child’s life and improve its quality, for there is no greater toll than watching your own child deteriorate. But ‘consent’ and parents/proxies are a particular bugbear of mine in how far this is ever, ever, a reality. To dress it up as ‘consenting’ is entirely missing it being informed, and the practical, emotional and legal difficulties in adolescents/children.
It misses the overriding need above all else to try everything possible for that child, and exploits that for no constructive purpose. It is also a carefully constructed spin shield. Surely, they are untouchable – who can critique the opinions of those parents in those unimaginably difficult situations? Well, I am sorry – but being one of the club, I have no hesitation in my criticism of this. Not of the parents – of course, no – they are rationally acting in what they are believing to be the best interests of their child, or in a way to create a meaningful improvement in care from their child’s death. I will vehemently stand by my criticism of the campaign for their exploitation of these people, however, and fear it is only a small nod to what significant droves of patients/relatives/bereaved would apply rational, logical support to this Bill; the same numbers who would practically be at serious risk of harm by their blind unquestioning faith and hope if it were implemented.
Doctors are already told they should inform patients about other available treatments – both the GMC and BMA agree – but the reality is that not every treatment can or should be funded. What we do know is that currently effective treatments are going unfunded – based on assessments of clinical and cost effectiveness. As we are taking this justice-based stance, surely a necessity to provide optimal standards across the board, how can it be plausible to fund experiments with no data collection or ethical approval? Who is meant to pay? Further, who is meant to pay if (when) something goes wrong? This removes the requirement for indemnity in current arrangements. It’s also unethical to fail to monitor your own professional ability or mastery and doctors are under this duty to know their limitations, not exceed their competence or knowledge – so surely what we require is more unbiased research funding, systematic data collection and sharing of the results, better focused development and funding of paediatric drugs, faster access to treatment of a more reasonable cost. Having been involved in research into therapeutic targets in virology I am aware of the fetters and delays, and potential for changes. Decision aids could better serve relatives and patients about risk in procedures (see Cochrane Review 2014), and up to date use of technology, neural coding and networking, predictive calibrations of outcomes and best treatment options with a background multicentre access to EBM data in real-time is an obvious investment we should be making for both clinical knowledge and improvement in quality and safety, as is better access to clinical trials.
Legally it is not required at all – a point which few acknowledged initially. The law has been deliberately misstated, or erroneously represented, by Lord Saatchi and his team. Dominic Nutt, Lord Saatchi’s Director of Communications sent me ‘tweets’ to suggest that Baroness Butler-Sloss had herself approved of the legal basis behind the bill. As rather a fan of Baroness Butler-Sloss I cannot imagine she would have approved of Saatchi’s definitions ‘word for word’ he said, of negligence. If I were marking an essay I would feel that the student had not properly understood, or bothered to read, a basic introductory tort text. Lord Saatchi also clearly semantically confuses ‘standard’ with ‘standards’. Furthermore, adding legislation adds red tape to attempts at innovation which is already approved expressly by the GMC, while removing access to justice yet again for claimants, already stripped of legal aid and forced to pay additional legal fees and costs. It will add to confusion and a feeling of treading on legal eggshells by doctors and clearly impede innovation. The legal aspects are worthy of a more complete analysis and are therefore included in a separate entry. Suffice to say it is not legally required- negligence will not be found in innovation if it is responsible/logical. Instead this adds legislation that contravenes, I would suggest, a number of UK Acts and the European Clinical Trials Directive.
I strongly feel despite clearly attempting to reduce clinical negligence claims it could lead to a significant increase in liability for doctors, for how will the panel make decisions, what evidence are they to base it upon, and with increasing segregation and privatisation of services, who is liable for errors? Statutory breaches, contractual breaches and a new reach for res ipsa are all on the horizon with such a statute.
Although I am willing to accede it is borne of good intentions by Lord Saatchi, I find it to be utterly lacking in insight and woefully amateurish. I am angered that the government would back this for it seems to me, not so much that Lord Saatchi has intended anything but the best by it (despite cynicism induced by his politics and comments published in 2005 about the best ways to win an election), but that it has been seized upon and exploited by Jeremy Hunt and No.10 for electioneering purposes in 2015. What better defence to the destruction of the NHS? the outsourcing, the dismantling beneath our noses, the removal of significant amounts of funding for research? the hounding of whistleblowers?
What better vote winner than, in the words of Lord Saatchi, “this will cure cancer”?