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The government has recently consulted on the medical innovation bill – the so-called “Saatchi Bill”, which – if passed – would fundamentally change the way in which doctors can provide treatment. This bill is intended, in its own words, “to encourage responsible innovation in medical treatment (and accordingly to deter innovation which is not responsible).” According to the bill’s promoters, the thing that is currently stifling innovation is that doctors are reluctant to deviate from standard treatment for fear of litigation.
In a recent article for the Guardian blog Occam’s Corner, Richard P Grant imagines a conversation between a helpless GP and a desperate patient with an untreatable illness. Mr Grant’s characters rail against a system that won’t let them try promising new treatments because of the fear of being sued. Grant is honest in admitting he has no idea whether this story is true. We will shortly see that it isn’t.
The Saatchi bill, driven by a slick social media campaign and its own Twitter account, has been touted as the means by which we will find a cure for cancer, as well other currently incurable diseases. It is claimed to have wide support across the medical profession and patient groups. Unfortunately, evidence shows otherwise, and the pro-Saatchi campaign has been marred by frequent and repeated accusations regarding lack of openness or honesty, either about the campaign and its support, or the real effect this bill would have if passed into law.
The campaign has been conducted in PR terms rather than on actual evidence, and there is a huge gulf between what the supporters claim the bill says, and what it actually says, which results in a similar gulf between the claimed effect and what would likely happen in reality.
The bill seems specifically written to protect a doctor who makes a decision that none of their professional colleagues would support. So, if a doctor decides to do something their colleagues say is stupid, wrong or even dangerous, he or she can still do it, and be protected by this bill. As Robert Francis QC, author of the two enquiries into Mid-Staffordshire NHS Foundation Trust, says, “It explicitly frees the doctor to offer treatment which has no support from responsible medical opinion.”
Campaigners claim that the patient is protected because, “The patient’s medical doctor will be obliged to discuss the patient’s case with specialists and experts, normally within their own hospital or clinic, seeking consensus from them about the best course of action for the patient.” They must also discuss it with the patient.
But this is not stated in the actual bill. It does suggest that one of the factors the doctor may take into account is consultation with a multidisciplinary team of colleagues, but it doesn’t oblige them to do so. There’s also no restriction on whom those colleagues may be, or on the qualifications or expertise of said colleagues, no requirement they should be independent and therefore free to disagree, and if the multidisciplinary team all disagree over the treatment, the doctor can still go ahead anyway.
This is no protection against irresponsible treatment. According to the GP, writer and broadcaster Dr Margaret McCartney, “to pretend that this gives patients any protection from naked quackery would be misguided.”
Also, while it might be intended for use only in extreme cases where there is no current treatment, there is nothing in the bill to limit it to such cases. It could be used for any treatment, minor or major, regardless of whether there is an effective treatment already available.
Discussions with patients may seem like a means to prevent abuse of the law, but surely patients themselves can’t be expected to act as the barrier to abuse of patients. In the case of serious illnesses with no cure, the patient is likely to be desperate, ready to try anything. It is not the time to expect them to think dispassionately about their own protection. This is not parochialism; the patient shouldn’t be expected to understand fully the complex details of an innovative treatment when even the doctor’s colleagues may not understand it.
The Saatchi bill campaigners claim that enacting it will help find a cure for cancer. I have blogged about this, but in essence the bill cannot achieve this aim. In fact, research use is specifically banned in the bill, as is stated by the following passage:
8) Nothing in this section permits a doctor—
(a)to provide treatment without consent that is otherwise required by law,
or
(b)to carry out treatment for the purposes of research or for any purpose other than the patient’s best interests.
So we can’t use it to get feedback on whether an experimental treatment works. Worse, we also won’t get feedback to tell us if it is harmful.
The story that doctors are prevented from innovating because of fear of litigation is just that, a story. Doctors actually innovate all the time, and there is a strong framework to protect them. The Royal College of Radiologists said “we have no evidence that doctors are deterred from innovation by fear of litigation.” Cancer Research UK, The Royal College of Physicians, the Academy of Royal Medical Colleges, the Academy of Medical Sciences, Medical Research Council and Wellcome Trust, the British Medical Association, the Association of Medical Research Charities, the British Pharmacological Society, the Medical Defence Union, and the Motor Neurone Disease Association all struggle to find a problem with fear of litigation stifling innovation. Many of these bodies question whether, even if there were a problem with innovation, legislation would be the way to solve it. The General Medical Council takes the view that “legislation is both unnecessary and undesirable.”
The medical innovation bill campaign seems heavily dependent on wishful thinking. Firstly, the idea that brilliant new treatments are there for the taking if only we’d be allowed to try them. Those treatments, if they exist at all, are vastly outnumbered by indifferent, ineffective and downright dangerous ones. We have no way of telling the difference. Then there’s the belief that the bill would only be used as intended. There’s no reason to suppose this will be the case, and that quack or incompetent doctors won’t exploit it, endangering patients.
The Royal College of Radiologists says the bill “risks exposing vulnerable and desperate patients to false hope, futile and potentially harmful (and expensive) treatments.” The British Medical Association “strongly believes that this bill should not become law.” The Motor Neurone Disease Association says “The bill would be bad law.” They are not alone.
While the Saatchi campaign has ground on, with a glowing puff piece in the Telegraph written by Dominic Nutt (in which he failed to point out that he is communications director for the bill) with repeated claims that only lawyers oppose the bill (not true, as we have seen), it would be easy for onlookers to gain a false impression of the bill and then support it.
There are significant genuine problems in the development of new treatments, in how we encourage and fund research, how we operate our clinical trials and the ethics committees that support them. None of these problems will be solved by this bill, and research may in fact be harmed.
According to Robert Francis QC, the bill is likely to increase the amount of litigation, rather than reducing it. Fixing the manifold problems in the bill would effectively leave us with no bill at all.
I think it would be true to say that everybody supports responsible medical innovation. I’d certainly like some of that, please. We’ve all lost a relative to cancer, we’re all likely to face, at some point in our lives, the insurmountable barrier of a condition that medical science can’t treat. But the reality is that the medical innovation bill will not lead us towards a cure for anything.
We need to stop thinking about the intended consequences of this bill in an ideal world and start thinking about the actual consequences in the real one.
David Hills blogs about the Saatchi Bill at The Wandering Teacake, and tweets via @WanderinTeacake
• This article was amended on 22nd May. It originally stated that the Saatchi campaign ran their own consultation on the bill. That was not correct. Responses delivered via a form on the campaign's webpage were directed to the official Department of Health consultation on the bill. This paragraph has been removed.
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