Guest blog by Dominic Nutt, Director of Communications, The Saatchi Cancer Initiative. Dominic spoke at 2020health’s Party Conference fringe event Commercialising Innovation in the NHS.
Last year, thousands of women died of cancer. This year thousands more will die. Next year, more thousands. All these cancer deaths are wasted lives. Scientific knowledge will not advance by one centimetre as a result of these thousands of deaths.
Why? Because the deceased only receive the standard procedure − the endless repetition of a failed experiment. The entire process of scientific discovery is blocked − by law. Under current law, any deviation by a doctor from standard procedure is likely to result in a verdict of guilt for medical negligence.
The law defines medical negligence as deviation from standard procedure. But as innovation is deviation, non-deviation is non-innovation. Current law obliges the doctor to stick to the well worn path, even though they know it leads in many cases only to poor life quality followed by death. Ovarian cancer is a case in point.
Unfortunately, here is the status quo:
A woman is told her tests are “normal” and to come back in 12 months. A year later she is removed from her home. The woman is cut and drilled until she loses half her body weight; wires and tubes are attached to her body. Drugs are given to her that cause nausea, vomiting, diarrhoea and fatigue. These procedures open the path for deadly infections to enter the woman’s body. Then, finally, they reduce her body’s defences against infection. The woman turns into a sparrow. She is left for dead. Soon after, the woman dies.
The treatment regimes, when belatedly provided − the drugs, the cycles of their administration and the surgical procedures − are 40 years old. They are also ineffective − cancer quickly develops “resistance”.
“The process”, as it is called, involves scenes that would not be permitted in a Hollywood horror movie. Not surprisingly, the survival rate for such cancers is the same as it was 40 years ago: nought. The mortality rate is also the same as it was 40 years ago: 100 per cent.
Yet, breach of the current law means deviation from the standard procedure.
In Clark v MacLennan (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 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.
The present emphasis of the law on medical negligence is for the parties to line up sets of opposing expert opinions and require the courts to choose between them. The ambiguity and uncertainty of a trial 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.
Where there is only one established practice, even if it is the same course of treatment that has been applied unchanged for 40 years without any particular history of success, it will be impossible for a doctor to depart from it with confidence that he or she will not be exposed to litigation.
The Medical Innovation Bill, now before Parliament, sets out in law for the first time the difference between reckless experimentation and responsible, scientific innovation. The good doctor will feel safer and the bad doctor will be revealed as negligent.
The law may not have changed much in 250 years but society has. We are more informed, less deferential and more litigious. The cost of successful lawsuits filed against the NHS has doubled in four years reaching £1.2 billion in 2012.
And the NHS, by its own reckoning, estimates that current cases in the pipeline that it assumes it will lose will cost £19 billion – that’s half the UK defence budget.
Growing fear of litigation creates a growing bias against innovation.
The bill strengthens the ability of the medical profession to prevent irresponsible innovation and to control the manner in which responsible decisions to innovate are taken.
The requirement in the bill for the approval of any proposed innovation by the hospital’s multidisciplinary team is a severe test − more severe than the “two doctors” authorisation currently required by law in order to carry out an abortion under the Abortion Act, or sectioning under the Mental Health Act.
However severe, it is better than the current position, in which the law closes the road ahead to any innovation in cancer.
The bill will strike a better balance between therapeutic conservatism and therapeutic innovation. It will help the government safely move the culture towards innovation.
This bill will not cure cancer − but it will encourage the people who will.