Lord Saatchi: "To prevent more needless cancer deaths, doctors must be free to innovate"
A new Bill before the House of Lords will allow doctors more freedom in the kinds of treatments they can prescribe to cancer patients.
In this guest post, author of the Bill Lord Maurice Saatchi, whose wife Josephine Hart died of cancer in 2011, explains why he's determined that the bill should become law.
Author, The Medical Innovation Bill
Posted on: Mon 20-Jan-14 14:20:53
(107 comments )
All cancer deaths are wasted deaths.
For many forms of the disease no new treatments have been developed for decades. Treatments remain brutal, painful and often ineffective.
But doctors are forced, by law, to offer only the standard treatments for cancer – or indeed any disease – even when the doctor knows that the patient is dying, and the standard treatment will not help.
We need innovation; we need to try new treatments where the old ones are known to lead only to death. But doctors are hampered by the courts: if doctors don’t follow the standard procedure they could be sued – a risk most are not willing to take. The NHS predicts it will face a bill of up to £24 billion for legal cases in the coming years, and the figure is rising.
And of course, when a doctor is sued - even if they win their case - the stress, isolation and fear they go through can wreck their careers and their lives. This is why most doctors will not offer you anything other than the standard treatment - even if they know it won’t be efficacious. It’s the only safe course for them, legally, and so they are doomed to repeat an endless cycle of failure.
And by this maddening repetition, nothing is gained, nothing new is learned, no lives can be saved the next time round.
This is why I say cancer deaths are wasted deaths: when a patient dies of cancer, medical science is not advanced one inch. No other cancer patient, now or in the future, will benefit, and no lessons will be learned that will improve treatments for others.
When a patient dies of cancer, medical science is not advanced one inch. No other cancer patient, now or in the future, will benefit, and no lessons will be learned that will improve treatments for others. But we can change this: we are on the brink of a great medical moment.
But we can change this: we are on the brink of a great medical moment.
I have introduced a Bill into the House of Lords that will, if it becomes law, protect doctors who want to try something new, who do not want to watch their patients dies needlessly. The Saatchi Bill is about creating a movement of patients, like you, to change the law which stops doctors trying new treatments.
First, it means doctors will be protected if they innovate reasonably and carefully. To do so they must of course have patient consent and the agreement of other senior medical experts and practitioners. They cannot go it alone.
But if they get this consent, reasonably and carefully, they can then innovate - safe in the knowledge their lives and livelihoods will not be in jeopardy if the treatment fails.
Second, it will stop maverick doctors from experimenting recklessly on patients. It will, in fact, tighten the law making it much harder for doctors to carry out untested treatments unreasonably.
This Bill is a patients' bill – it's for you and me. With it we can go to our doctors and say: "Have you tried everything? I understand there is a treatment out there that might help – can you try it on me? I have nothing to lose." And the doctor, for the first time ever, will be able to say yes.
But we're not there yet. The Secretary of State for Health, Jeremy Hunt, says he will support the Bill and ensure it becomes law in the next session of Parliament – but only if the public want it and show that they want it, clearly and loudly. In February the Department of Health is launching a public consultation asking if doctors, lawyers and if you – patients and public – support the bill.
We have one shot at it, and one shot only. If we fail, there is no second chance. I ask you to support the Bill, to respond to the consultation - and to ask your doctor, your MP and your friends and families to support it too.
Sign-up here to be the first to hear when the consultation launches. Follow us on Twitter @SaatchiBill and Facebook - and do tell us what you think. Have you wanted different treatment but couldn’t get it? And would you like to see the Bill become law? We’d love to hear from you.
By Lord Maurice Saatchi
Interesting, Nooka! I've never worked in healthcare at all myself. I can see some of the issues, though, even just as a lay person.
The other thing that seems very strange to me is the reference to the widespread use of off-label drugs in the States which is far more litigious than the UK (my several degrees of magnitude) but where new treatments are often offered to patients with far fewer safeguards than in the UK.
A while ago I used to work for a PCT and was on a group that heard requests to fund extra-ordinary treatment (I have public health training but was really there for process related reasons so not a contributor to the debate). All sorts of requests came through, most outside of standard treatments. Some for treatment abroad, some for treatment generally deemed ineffective or cosmetic. The reason they came to us was because they all involved additional costs. Most were denied on the grounds of lack of evidence of effectiveness or because there were alternative treatments available already, some were agreed on individual grounds. I imagine such a process continues today in the new commissioning groups because it was legally required (blanket bans having been held as illegal in a court case some time before).
I do not personally believe that there would be a cost saving from introducing a resource intensive vetting process (because there would need to be research into what the current literature said about any proposed treatment, and input from a number of specialists) that then provided greater access to new treatment options, many of which would involve additional cost. This might be offset against a small part of the litigation budget , but it would be a small part. I've been out of the NHS for over 5 years but when I was involved I did see claims data, and can confirm that the vast majority of the costs were related to birth injuries, which makes sense as they cover lifetime costs.
If this innovation is limited to end of life cancer patients I really can't see how multiple large payouts would be avoided because they are unlikely in the first place. For example my father recently died from brain cancer. He was terminally ill by the time it was detected and it was agreed that aggressive treatment wasn't an option. If his oncologist had suggested something new and novel, tried it and it failed and we had sued then what damages could have been awarded? He was dying anyway, surely the point is that there was effectively nothing to lose (except his quality of life in the last few months).
If the issue is purely one of risk aversion then I would have thought it was a matter that could be addressed with clinical protocols, guidance etc.
Just bumping this debate as the government has now stated the current draft of the bill must be amended.
Interestingly, the Medical Defence Union which apparently provides indemnity insurance to about 50% of drs in the uk is now quoted as saying that it has never seen a single litigation claim for negligence related to innovative treatments.
It is the link to cancer that makes this statement absolutely insulting. As if we are not already pouring money into scientific research to understand the causes of cancer, as if any random Gp not already working in a research group is going to say 'Ah well, I think if you rub a bit of lineament into it three times widdershins we may just discover the cure!'
I'm concerned that trials may be carried out without being subject to ethics committee approval which is a process designed to weigh up the interests of the subjects of the trial as well as the interests of the advancement of scientific knowledge.
Snog, what do you fear could happen if this was passed? Human trials on very vulnerable patients?
Not that many voices in favour here and not a lot of hard facts up back up the claims.
I would vote no if I had a vote.
This is dangerous rubbish. Cinical research is highly regulated for a reason and cancer patients are already free to enroll on research studies if they choose to. we are making huge advances in clinical research every day. Trisls exist to see whether new treatments are more effective than standard treatment. if they are then they become the new standard treatment.
Upthread, there was a statement made that 'for many cancers there is no progress'
In the Kings Fund 2011 document on 'Improving Cancer Survival' they showed the improvement in cancer survival across a range of tumour types.
Where cancer can be diagnosed early, huge improvements have been made - early prostate cancer is now a 99% no progression over 5 years disease with treatments such as brachytherapy having few side effects, and for men with locally advanced tumours, using exisiting techniques in better ways and combinations (and assessing those in clinical trials) is curing many more men then before.
Talk of 'off label' drugs and devices is not a good indicator of anything. Mostly the labelling only ever restricts the manufacturer of the drug or device from promoting/advising of its use, not the clinician.
The word 'innovation' seems to be have chosen as it can have an entirely new meaning, which can be credited to this Bill. It's not a word that can easily be found in records.
Painty, thanks for the link. It shows claims by medical specialty, but not claims by "type" (neglect, lack of consent, off-label prescribing, etc). Most oncology will be in medicine, but there's a chunk in surgery and a chunk in radiology and pathology, and probably some in A&E. But the figures don't enable us to make any guess as to what costs have been incurred due to innovation.
This "innovation legal costs are a problem" thing has all the feel of a convenient meme or possibly even an urban myth to me.
Link still doesn't work, so to look at the figures you would have to paste my wording from the link into google.
Trying again - not sure my links are working!
LA Factsheet 3 - claims information 2012-13.pdf
I can't add it up as off to a group with toddler, but I think from that we would be looking at the 'medicine' category?? And the whole of that category amounted to around 1/4 of which I suspect far less would be innovation/off label??
Interestingly, innovation/off label is not split out by the nhs la, suggesting it's not hugely significant in the figures?
Hopefully someone who understands the terminology will have a look.
LA Factsheet 3 - claims information 2012-13.pdf
Home, I would think it was 5% or less but I'm just guessing! Will try to google some figures!
Exactly, Painty. I would not be surprised to learn that no more than 10% of nhs litigation costs went on cases of innovation and off-label prescribing. But I don't know and id like some actual facts from the Bill's supporters.
I don't think it's about the external opinion or 'respect' that other people feel for a doctor, it's about whether a doctor themselves as a reflective practitioner feels that they have clinical competence to innovate. That's different. If a doctor does not have clinical confidence to prescribe off-label, I don't think the Bill can or should give them that confidence in itself.
I should probably stop nit-picking. I am not an expert in this field and my opinion one way or the other shouldn't sway others. I am not convinced, reading this, that this Bill is necessary or positive. There are things in the quotes you provide and in the way that this is being rolled out that smell wrong. It seems a shame, because there probably is something here that needs sorting, and the thread has at least made me think about that. Over and out.
I see what you are saying Hopes, I think. Basically the litigation figures quoted will be dominated by maternity?
Interesting point about it maybe being down to level of seniority/expertise and confidence in that. The surgeon who agreed to operate on me without the usual scans being done first is one of the top two surgeons in the uk for his discipline afaik.
I agree with the sticking plaster solution comment. I don't see this bill changing anything if passed, sadly.
I would be amazed if there has been any significant degree litigation where innovation of the sorts proposed has been attempted. This is much more about fear of litigation and that is a cultural/education issue.
Hello Liz. Quotes won't cut it, really. The plural of anecdote is not data.
I don't think you've got what I'm saying about litigation. I know your figures are accurate. They're just irrelevant. The figure that matters if you want to prove that the risk of litigation is real is the annual cost of litigation related directly to innovation / off-label prescribing. Quoting the total future liabilities is disingenuous. It's like talking about cycling deaths while quoting figures about all deaths and injuries across all forms of transportation across multiple years.
As I say, you need to show that there is an actual problem, not quote people who claim there is. That requires some testable facts and hypotheses
Thanks for your comment – we whole-heartedly agree. And fantastic that you found a role where you were able to shine. Your culture point is spot on – we hope that, rather than being a sticking plaster, the Bill will help to slowly drive a culture change.
Whether Professor Dalgliesh has published his innovation or not is a good question - we shall have to ask him. We know about it from a private conversation. On local versus someone of Prf Dalgliesh's very well respected position: the Bill would help doctors to feel more confident in their actions and, if they follow the correct procedure, that the law supports them.
Time pressure is a really good point too. Who doesn't feel as if there is too much to do and not enough hours to do it all in. But we hope that the Bill is a step towards a culture change.
We will be organising some online chats with various independent experts over the coming weeks - if you are interested in joining us we'd be thrilled. I'd be very pleased to post the details, as we set the dates, on this post. And of course if there is enough interest we could always put the idea of a Mumsnet chat to HQ.
Well that is rather what I had feared.
In other words, if any patient suggests something like homeopathy to me then to protect myself I'll now have to take it through an MDT and 'statutory process' in order to say its not worth trying?
In fact, presumably, this would be the case for any patient even if they didn't have a specific treatment in mind?
As such it wouldn't have helped in my colleagues case either. The patient had a common condition with limited but evidence based standard treatments and sadly an unpredictable small mortality. The doctor was aware of several unproven treatments and interventions and the lack of evidence for these as well as the known risks for these treatments. He didnt mention them to the patient or document them in the notes, nor discuss it with the MDT in the same way as he didn't mention a course of leeches as a possible treatment that had been tried in the past but was unlikely to help. Sadly the patient died on the evidence based treatment at which point the family then find their expert who suggests more could have been done - ie one of the unproven treatments. My colleague might have treated 100 patients in the way he did with better outcomes than he would have had he treated the same 100 patients by adding in the extra treatment. According to the available evidence he would have ended up harming more patients taking this route.
It is possible to find many 'treatments' or interventions that are in very early stages of study or for which there might be one case study or small preclinical study. The vast majority never come to anything. Not to mention hundreds of alternative therapies. This is the case for virtually every medical diagnosis.
It sounds as if this bill would mean I would need to justify why I was using standard treatment for every single patient I see, including following a statutory process in order to protect myself. Presumably it would be equally logical that I would also need to mention every theoretical treatment specifically and justify why not? That does not make it cost neutral, nor does it aid the search for good treatments. It seems to misunderstand the basics of evidenced based medicine which already allow for treatments based only on expert opinion if that is the only option.
Hopefully the quotes I posted above will address that part of your question. We have many more but we need to seek permission from them to publish.
As for the litigation figures. Our figures come from published reports, but also, and perhaps most relevant, from a meeting with the CEO of NHS Litigation Authority.
Thanks Liz - and sorry for calling you politicians
As a teacher with friends who work for the NHS, we often find parallels in the way politics and poor management negatively impact what we do. In my experience of working in an academy, big, full of managers, teachers terrified of putting a foot wrong for Ofsted, a real bullying culture - I would not have innovated in my teaching. But in another role working in a small but Outstanding school, I was trusted to get on with my professional role without being micro managed. In this role I blossomed, I was full of innovation and my pupils reaped the benefits.
Just a thought. But don't you think that it's a culture-led thing that prevents doctors feeling confident in their own professional standing, their ability and right to choose the best treatment? Because it seems to me that there is no real legal barrier, but that it is hoped that this Bill will encourage currently scared medics to feel safe. But it feels wrong somehow. Like a sticking plaster. If this were education and school management we were discussing, I'd be lecturing you til the cows come home. But I'm not sure your team have got to the bottom of why doctors are going for the 'easy option' - when my guess is that it's down to poor motivation and lack of confidence caused by increasing workload, more paperwork for every decision (which this Bill wouldn't help), longer hours and so on.
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