Research ethics

Saatchi Bill – a brush with autonomy

This debate pulls me in two directions. I know that the Medical Innovation Bill, which proposes that,

 

It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition […] if the decision to do so is taken responsibly.

 

makes little sense in terms of encouraging medical innovation. It seems unlikely that useful discoveries will arise from individual patient experiences with new treatments outside properly conducted clinical trials. This is not to say that individual lives will not be improved or extended by treatments that doctors liberated by the bill are able to propose. An untested but logically promising approach to treatment might work, and without access to that treatment a patient’s chance of longer life* falls from x% (however small) to zero. But, should they benefit, their experience and ‘outcome’ will count for nothing in the larger world of evidence based medicine.

 

Allowing patients who might be entered into clinical trials to be beguiled by alternative and generally unsupported treatments will reduce the evidence base, and delay access to proven treatment for future generations. But what if the patient’s condition is not the subject of a clinical trial? Should the patient be denied an unconventional treatment just because his or her doctor finds themselves in an indefensible position? A common retort is, ‘How can you give a dying person a treatment that is not proven to work, but which may harm them?’ As quoted on the Stop the Saatchi Bill website, “There are many patients that we can’t cure, but no patients we can’t hurt.”

Lord Saatchi’s introductory speech in the Lords was emotional, describing the common indignity of the dying and the powerlessness that is brings.

 

‘…those condemned by cancer suffer a worse fate than the worst mass murderer. While they await execution, they are tortured. For them, hair loss is the good news. Less good news is that their treatment regime—the drugs and the cycles of their administration, and the surgical procedures—are often 40 years old. They create the same symptoms as the disease: nausea, diarrhoea, vomiting and fatigue. A beautiful woman’s legs turn into elephant’s legs; her arms begin to make a heroin addict’s arms look attractive…’’

 

How could a person in this situation not be offered an alternative? The emotional heart of the speech draws us into a perhaps under-regarded side of the argument – patient autonomy. To put it starkly, ‘Why shouldn’t a dying patient try treatment X?’ If the patient wants it, why deny them the access? If there is a risk of harm them – so what, as long as they give informed consent. It’s up to them. It’s their body.

The counter to this argument is that dying patients do not give fully informed consent. They are vulnerable. Their proximity to death has made them victims to false promises and unjustified hope. Stop the Saatchi Bill dwells on this –

Patients and those making decisions on their behalf will almost always want to try anything at all. This bill expressly permits harm and exploitation of this vulnerability and does nothing to promote shared decision making or patient empowerment.

And,

Sir Robert Francis QC says “It increases the risk to vulnerable patients of mavericks with irrational or unjustifiable grounds for proposing a treatment and those with commercial interests in promoting dubious treatments.”

And,

The Motor Neurone Disease Association says “There is a clear danger that the Bill could lead to the exploitation of vulnerable people.”

Are these arguments overly paternalistic? Most terminally ill patients have retained their critical faculties, and are not likely to be hoodwinked. Although dying, they are not bedbound or semi-alert, nodding weakly to whispered suggestions from the ‘quack’.

I wonder what I would want. It is a difficult and potentially insensitive exercise, imagining what it would be like to be terminally ill. I see myself sitting in the oncology clinic, hearing that my recent scan shows that I have progressed on chemotherapy and that there is no more to be done. I pull a newspaper cutting from my pocket, and ask about a new, unproven, scientifically dubious therapy. My doctor shakes her head and says,

“Ah yes, I’ve have heard of that. There’s very little evidence to support it. And the experts disagree that even the theory is right.”

“But do you do it here?”

“No. It’s not licensed, it hasn’t been funded…”

“But I’d really like to try it.”

“I’m sorry, the NHS just doesn’t do it.”

“Can you refer me to a clinic that does though?”

“I’m really sorry, I can’t. If there were side effects…”

And she is worried now, worried about her reputation, the accusations of being a maverick. I don’t understand why she can’t refer me – it’s my choice, and if it kills me faster then so be it. I’ll sign anything. I want to try it. Hope is what I need, and in this treatment I see hope, even if others more knowledgeable than me, see ‘snake oil’.

Stop the Saatchi Bill says the bill has been promoted as a way to,

“empower patients to demand that every possible route should be tried to prolong their life and improve its quality.” However, the power to choose or reject new treatments remains with the doctor. While the patient can suggest a treatment, the doctor can still reject it. The bill does not give patients the power to make the doctor consider any new treatment at all.”

This is true. Just because a patient wants something doesn’t mean the patient gets it. This applies to cardiopulmonary resuscitation, for instance. It’s the doctor’s choice at the end of the day. For all my instinctive warmth towards a Bill that appears to enhance patient autonomy, the truth is that towards the end of life, or in circumstances of grave illness, we operate in a fairly paternalistic system.

So am I for or against? The part of me that regrets a terminally ill patient’s inexorable loss of autonomy  would reject the arguments listed in Stop the Saatchi Bill… but I would not seek to change the current status quo. Lord Saatchi was I think wrong to say,

‘All cancer deaths are wasted lives. Scientific knowledge does not advance by one centimetre as a result of all these deaths, because the current law requires that the deceased receive only a standard procedure—the endless repetition of a failed experiment.’

My perception, sitting regularly in liver and pancreas cancer multi-disciplinary team meetings as I do, is that many die within clinical trials which are by definition attempts to break the ‘endless repetition’ of treatment. Innovation is alive and well, albeit progressing at a slower pace than those who have contracted serious disease would like. The pace is slow because the method is deliberate. And the method is deliberate because safety in paramount. Frustratingly, it is future generations who will benefit from the suffering of the present.

 

* The Bill is directed at doctors who look after the terminally ill, but does not mention terminal illness in its text.

 

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Meta-patient: balancing the value of people and their data

meta – definition

A prefix meaning one level of description higher. If X is some concept then meta-X is data about X.

 

– Is your doctor interested in you, or in something about you? –

 

As a 3rd year medical student in Bristol I overheard a conversation between the senior registrar and his consultant. The senior registrar had just been appointed to a consultant post in the same hospital, and he was overjoyed. His soon-to-be colleague said to him

            ‘It’s great, but you need to find something else to do.’

I kept listening.

            ‘Seeing patients just isn’t enough to keep you going for twenty-five years.’

What on earth was he on about?

 

His point was that seeing patients day in – day out does not provide sufficient intellectual reward. Although treating thousands of individuals over a career would seem more than enough (and a privilege at that), many doctors feel the need to step back and understand where they, and their patients, belong in the scheme of things. In addition, they feel the need to ‘make a difference’ on a larger scale. To achieve this it is necessary not only to manage patients as they arrive in the surgery or the ward, but to gather data, recognise patterns and communicate those findings to the wider world.

To a greater or lesser extent therefore, doctors come to see each patient not only as a person with specific needs and expectations, but as a part of a cohort, bringing with them information that may not directly inform their care, but which may be useful to the population in the longer term. It is these measurements (blood results, physiological variables), when added to the whole, that go to make up the ‘meta-patient’*. So what’s the problem? Does the fact that a ‘body of data’ sits alongside the ailing individual detract from the purity of the doctor-patient relationship?

At first glance there should be no connection between the ability to provide compassionate care and the need for ongoing intellectual stimulation. However, I believe that there is a balance to be struck between our primary role, as carers, and our academic or intellectual pursuits. Different doctors respond to different forms of mental stimulation, and I think it is important that each one reflects on what it is that really makes them tick. There is a risk, in my view, that if the data a patient provides becomes more important to the doctor than their problem and its treatment, they may begin to value the meta-patient more than the real patient.

 On a day-to-day basis, for the majority of doctors, it is undoubtedly the process of meeting patients, making diagnoses and observing how they and the disease respond to treatment which provides most satisfaction. Empathy, trust and gratitude enrich this experience. But we must be honest about the benefits of data collection in order to comprehend the full spectrum of medical motivation.

 Data collection allows us to develop databases, be they local, national or global. Sitting back in the office, looking at the numbers in a spreadsheet, the doctor reflects on his or her cumulative experience. The accumulation of small interactions begins to take shape, like a pointillist painting. By developing hypotheses and processing the data we are able to publish abstracts or papers. If we are lucky and so inclined, we may take the results to national or international meetings. Egos are augmented, and the most assiduous or gifted will develop great reputations. Knowledge grows, breakthroughs in our understanding occur, healthcare improves, humanity benefits. I am not cynical about this…just fascinated by the fact these developments remain largely invisible to the patients who contributed to them.  

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Through anonymisation, data becomes separated from the person. The meta-patient takes on a life of its own, melds with the cloud of information that has been collected elsewhere, and is subjected to statistical analysis. Now, from the point of view of the study in question, it does not matter if the patient improves, deteriorates or dies. It is the data that matters. For the doctor who saw the patient it is necessary to remain focussed on the individual’s wellbeing. For the good of the study it is important that whatever happens, the outcome is known and reported.

 The question then comes – when you meet a patient for the first time, one whose disease falls within your area of research expertise, do you think first about the needs of the individual, or the value of their data?

 My own experience of this is limited to a two year research project that I undertook into liver disease. I roamed the wards looking for patients who fulfilled the criteria for my study, and was excited when I found one. Each successful recruitment took me closer to my target of 100 patients. Having obtained their consent I diligently recorded the relevant data, took the special blood test and ran off to examine the white cells. From that point on, my interest in the fate of the patient was, in the truest sense of the word, ‘academic’. The crucial point to make here though, is that I was not on the medical team looking after these patients. As a research fellow I functioned separately, so there was no overlap between my usual role, that of providing medical care, and my research role. I often wonder (not being a particularly ‘academic’ physician) how doctors who are perpetually involved in clinical trials manage this dichotomy.

 Observational studies, like the one I conducted, do not involve treatment decisions, so the psychological (if not ethical) dilemma is less challenging. Studies that focus on treatment are far more important and delicate. However, these are highly regulated, and in my experience the clinicians involved have no problem separating their duties as a physician from their academic interest. In fact, I believe that involvement in therapeutic trials often brings with it the benefit of close observation and even more careful management.

 Is it worth highlighting the dual roles of doctors, and the invisible simulacrum that accompanies their patients? I think so. Doctors, especially those in training, need to recognise where they derive their energy from (one-to-one interactions, patterns, both?); and patients should be aware that when they come to hospital, their meta-self may elicit as much interest as their true self.

 

* This term came to me over my cornflakes recently, and it sounded so cool I had to use it. I have not seen in used elsewhere.