Lord Saatchi: "To prevent more needless cancer deaths, doctors must be free to innovate"

[MumsnetGuestPosts]

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.

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.

[LizScarff]

@winterwobbles

The Bill provides a process to be followed in deciding whether to innovate; if the doctor follows the process and concludes that innovation is not the responsible decision, he or she will be just as much protected as if they decide to innovate. In your case, part of the problem was that the doctor did not have a statutory process to point to in explaining why he had decided against innovating - so the Bill could have helped bring certainty and confidence to him. In particular, we hope and expect (and judges have confirmed) that lawyers will be less quick to encourage people to sue where the doctor has clearly followed the new statutory process.

[LizScarff]

@Paintyfingers:

Appearance is part of it, yes; but it is the authority that an Act of Parliament will give to what is already best practice that will help - insurers, courts, lawyers and everybody involved will have more certainty and clarity. GMC guidance will still be as important as it already is, and will feed into the statutory process as one of things the doctor will show that he or she has considered.

[LizScarff]

@WhiskeyTangoFoxtrot

Whether a medicine is licensed does not determine whether its use is correct for an individual patient. And our reading of the 2012 Regulations is less extreme than that given above.

[LizScarff]

@Joanofarchitrave

I have pasted above some quotes from a small selection of those who support the Bill. As to whether the Bill will cost any money, it won’t. The Bill is cost neutral. It will not affect funding of research in any way.

[LizScarff]

Thank you once again to everybody who has asked questions.

We would be very pleased to host a special briefing for all Mumsnetters - please do let me know if you would like to attend. liz at fieldcraftstudios.com

Have a great evening,

Liz

[HomeHelpMeGawd]

Liz, I note that you have not addressed the points I raised about the fact base to support your assertions

[joanofarchitrave]

Thank you Liz, those are very helpful.

Professor Dalgliesh was able to innovate without the bill. I wonder why he feels that he is able to prescribe off-label while 'local doctors' are not willing to do so? Is it about his awareness of his own clinical competence, which must be enormous? Here is a statement of the responsibilities of those prescribing off-label. If a doctor does not feel it is within their clinical competence to prescribe off-label, they should not do so, and I can understand why 'local doctors' who may well not be cancer experts at the high level that Prof Dalgliesh has achieved, may not feel able to do so, with or without the Bill. However, provided they follow these guidelines and document clearly what they are doing, I still don't see the need for additional legislation. I hope that Professor Dalgliesh has published the results of his innovation as described and that this too will become standard practice.

I wonder if the feeling is that life in the NHS for doctors is too time-pressured to risk innovation in this way, given the time needed to review evidence and brood over possibilities? A good point. Again, unlikely to be solved by this legislation. If doctors don't have time to innovate safely, then that is a separate issue and should not be dealt with by giving them immunity from legal procedures.

Liz, I'll pass over your comment that the Bill is cost-neutral - it certainly shouldn't be - is the suggestion that the times when doctors treat by trying something new, and the times when doctors withhold treatment, will balance each other out? Sounds unlikely. Is there any costing of which of the standard procedures described in the original blog post is considered to be ineffective? Are they due for review by NICE?

[ShreddedHoops]

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.

[LizScarff]

Hello @HomeHelpMeGawd

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.

[Winterwobbles]

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.

[LizScarff]

Hello @joanofarchitrave

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.

[LizScarff]

Hi @ShreddedHoops

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.

[HomeHelpMeGawd]

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

[joanofarchitrave]

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.

[HomeHelpMeGawd]

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.

[HomeHelpMeGawd]

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.

[ShreddedHoops]

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.

[CMOTDibbler]

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.

[Snog]

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.