Abstract
Let us start with the most emotive word in the English language – cancer. Why is there no cure for cancer? We need more innovation obviously. But why don't we have it? Is it the money? Is it that NHS commissioning bodies take the view that they will only pay for treatment if it is known to be effective – so that innovation is not attractive to funders, whose aim is to drive down the cost of care? In this way, are funding decisions anti-innovative and clinicians' desire to innovate frustrated?
Perhaps, but even if that is true, what can the world of medicine do to affect UK GDP the percentage of GDP devoted to health, or the percentage of health expenditure allocated to innovation? Not much. In any case, so many billions have been spent on cancer research, and meanwhile so much technological innovation has been driven by two men in a garage that it is hard to conclude that money is the route of all progress.
As T.S. Eliot said: That is not it.
That is not it at all.
And we kill people unnecessarily. If that is true, it is not through lack of trying to do the right thing. Scholars in cancer have long sought general rules about the world as robust as the laws of physics – to verify statements, propositions and putative facts by the results of empirical studies.
Unfortunately, it has not worked out quite like that. Instead, we find the stubborn fact that, after 2000 years of human progress, cancer is still outside Newton's universe where physical laws govern reality.
In the natural sciences, even though, as Karl Popper says, the closest approach to proof is just a succession of unsuccessful attempts at falsification, we can nevertheless make statements, perhaps without finality, but with a certain degree of probability.
If you drop this journal, it will fall to the ground. Tomorrow the sun will rise. But in cancer, the record seems to show that once we express opinions or beliefs, or attempt to offer explanations or descriptions or predictions – then error, doubt and uncertainty come to the fore.
In cancer you hear it said that ‘every case is different’ and ‘there is always hope’. Such well-meaning sentiments are not science. There is no hope that if you drop this journal it will not fall.
These statements are meant to bring cheer to the desperate. Instead, the effect is the opposite. To bring despair: the dread revelation that cancer is a realm in which science has yet to achieve sovereignty.
We all believe in evidence-based medicine. But cancer is apparently the least evidence-based disease of all. Either there is no evidence, or if there is, it is not clear what it means.
In the end, all attempts to place cancer medicine within the canons of scientific objectivity have failed. There remains an irremediable tentativeness about the logically perplexing question of what is the cause or cure for cancer.
Cancer science has not yet found its Newton. And yet, aren't we all in awe of the intellectual genius of the great medical scientists and what they have achieved? Isn't it hard to credit that the human mind is not up to the job? And even if it isn't, like the lack of money, it is hard to see what we can do about it. So if it is not the money, and not the brains, what else could it be?
There is a powerful deterrent to innovation at the heart of the current system. Economists would call it a systemic failure. Current law is a barrier to progress in curing cancer.
Under present law, any deviation by a doctor from standard procedure is likely to result in a verdict of guilt for medical negligence. Current law defines medical negligence as deviation from standard procedure. But as innovation is deviation, non-deviation is non-innovation.
In this way, the entire process of scientific discovery has been cut in half. The first half, the doctor with the patient, has been stopped completely – by law. The other half has been outsourced to the randomized controlled trial. You will ask how can an Act of Parliament cure cancer? I will answer.
The striving for knowledge and the search for truth are the strongest motives of scientific discovery; the boldness of our questions, and the integrity of our tests. That is what makes the people of science – subjecting our ever tentative answers to ever more rigorous tests.
An idea acquires scientific status only when it is presented in falsifiable form: that is to say only when it has become possible to decide empirically between it and some rival theory. Using all the weapons of our logical, mathematical and technical armoury, we try to prove that our anticipations were false.
That is The Logic of Scientific Discovery, as described by Karl Popper – refutation by application; severe tests to see if the theory can prove its mettle. This entire, magnificent scientific process comes to what we may perhaps call a ‘dead halt’ at the bedside of the cancer patient.
Put the case of the doctor in a hospital standing beside a patient. Put the case that the doctor is considering an innovation. At that moment, a sign appears between the doctor and the patient. It reads: ‘Stop. Road Ahead Closed’.
The sign is the law.
The doctor must now ask himself: Do I want to go ahead along this road of innovation? If I do, I will deviate from the standard procedure. If I do, and anything goes wrong, there will be a trial. Expert witnesses will testify. I am likely to be found guilty of medical negligence. Should I put my livelihood, my family and my reputation at risk? Or should I stick to the well-worn path on which no liability can arise?
The present pre-eminence in law of the standard procedure provides no inducement to progress. It outlaws initiative. The self-interest of medical practitioners, as defined, for example, in doctors' insurance policies means that innovation (i.e. deviation) is a form of self-harm.
Under the present law, after establishing a duty of care, which is usually easily done in the case of a doctor/hospital and a patient, a plaintiff who alleges medical negligence must then demonstrate a breach of that duty. Breach of duty is analyzed by examining whether the defendant has fallen below the standard of care deemed appropriate by the courts. Such carelessness has consistently been evaluated by the courts in medical malpractice actions as: that which departs from the standard practised and accepted by a responsible body of medical persons skilled in the particular area of medicine in question. (Nelson-Jones and Barton, Medical Negligence Case Law, 1990)
Breach of the current law means deviation from the standard procedure. In Clark v McLennan (1983), the significance of departing from an approved mode of practice was treated by the trial judge as having the effect of reversing the burden of proof so that once the plaintiff established a deviation, the defendant had to disprove an inference of negligence.
In Maynard v West Midlands Regional Health Authority (1984), the House of Lords affirmed the Bolam medical standard of care in cases of misdiagnosis. Lord Scarman quoted with approval the Lord President in Hunter v Hanley (1955) to the effect that to establish medical negligence in misdiagnosis a plaintiff had to prove a failure such that no doctor acting with ordinary skill and care would commit. The decision in Maynard to use a particular diagnostic procedure could not amount to negligence, when a competent body of professional opinion would have used the same technique.
The present emphasis of the law on medical negligence is for the parties to line up sets of opposing expert opinion and require the courts to choose between them. That inevitably makes it the safest course to adhere to existing established practices, irrespective of how long and how unsuccessfully they have been applied.
The result of this is that a doctor deciding how to treat a particular case starts with the knowledge that as soon as he or she moves away from existing and established standards within the profession, there is an automatic and serious risk that he or she will be found guilty of negligence if the treatment is less successful than hoped.
In other words: The practitioner who treads the well-worn path will usually be safer, as far as concerns legal liability, than the one who adopts a newly discovered method of treatment. (Crawford v Board of Governors of Charing Cross Hospital, 1953, p. 293)
The point was made by Lady Butler–Sloss in her capacity as President of the Family Division of the High Court in the case of Simms v Simms (2002) FAM.83 where she said at paragraph 48: The Bolam test ought not be allowed to inhibit medical progress. And it is clear that if one waited for the Bolam test to be complied with to its fullest extent, no innovative work such as the use of penicillin or performing heart transplant surgery would ever be attempted.
It is equally true, however, that both the doctor, and perhaps more importantly his or her professional indemnity insurers, will be aware from the start that by departing from established practice – including where that amounts to the absence of effective treatment, they are exposing themselves to risks that the courts may, but equally may not in their particular case, protect them from.
Is the Bolam test still applied rigidly? Despite occasional remarks from judges that the Bolam test should not be applied rigidly and should not be allowed to deter innovation, the reality remains that it is used not just as the starting point, but as the end point, for most practical purposes in relation to medical negligence litigation.
To give a recent example, in the case of Murray v NHS Lanarkshire Health Board (2012) CSOH 123 Outer House, Court of Session, Lady Dorrian says at paragraph 7: There was some issue about the nature of the original discussion which led to conservative treatment being embarked upon, but since it is admitted that such treatment is standard practice I need not address the matter in detail.
The fear of litigation creates an inherent bias against innovation. This is why, unfortunately, the Government's well-intentioned efforts to weaken the dominance of the ‘accepted mode of practice’ by encouraging a culture change towards innovation (as in NHS Chief Executive Sir David Nicholson's letter to NHS managers) are unlikely to succeed in the current judicial climate. Such a risk–benefit culture, under present law, can only be met by persuading the courts that the opinion of the defence experts is not, as a matter of fact, one held by a responsible body of opinion or alternatively that it is not a proper and responsible one to hold.
The present law leaves much uncertainty about what is best practice in innovation. Present law makes the status quo the only safe option and gives clinicians no confidence about how to pursue responsible innovation.
Could we agree with Lord Diplock, that a better balance has to be struck between therapeutic innovation and therapeutic conservatism. In Sidaway v Bethlem Royal Hospital Governors (1985 1 ALL ER 643 at p. 657), Lord Diplock warned of the dangers of so-called defensive medicine: Those members of the public who seek medical or surgical aid would be badly served by the adoption of any legal principle that would confine the doctor to some long-established, well-tried method of treatment only, although its past record of success might be small, if he wanted to be confident that he would not run the risk of being held liable in negligence simply because he tried some more modern treatment, and by some unavoidable mischance it failed to heal but did some harm to the patient. This would encourage “defensive medicine” with a vengeance.
The Bill will codify into law what constitutes best practice in relation to responsible medical innovation; contrast that with reckless experimentation which puts patients' lives at risk; and provide certainty to the courts, doctors, insurers and commissioning bodies about the difference between the two.
For the first time, the Bill will give statutory expression to what the range of medical consultees have described as proper practice and process for taking decisions to innovate.
The results are that:
a doctor who innovates irresponsibly without having gone through careful and structured consideration of all relevant criteria will be more easily exposed as negligent; and a doctor who takes care to innovate responsibly and in accordance with best professional practice will have statutory support on which to rely in justifying his or her decision to insurers, to the GMC and other regulatory bodies and, if necessary, to the courts.
The present state of the law exposes patients to harmful inaction as a result of the uncertainties of litigation, as well as to irresponsible innovation, in the absence of clear statutory criteria to determine how decisions to innovate should be taken.
The advance of science depends upon the free competition of thought, and thus upon freedom, and that must come to an end if freedom is destroyed. Are the intellectual problems of cancer insoluble? I do not think so. What is more inspiring than the quest by scientists to explain the world; to find satisfactory explanatory theories – simple theories – and to test them? One of them will cure cancer.
We should rise to our feet to applaud the great cancer doctors and scientists who are striving by their own best lights to serve the community. Let us erect statues in their honour. Or build bridges in their name, or parks, or avenues, or airports. Let us encourage them, not frighten them. Doctors should not be governed by fear.
Only a change in the law can solve this problem, because the law is the problem.
The Medical Innovation Bill and Explanatory Notes are available at: http://www.publications.parliament.uk/pa/bills/lbill/2012-2013/0061/20130061.pdf
http://www.publications.parliament.uk/pa/bills/lbill/2012-2013/0061/en/20130061en.pdf