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
I'd disagree strongly with this. Theres a huge amount of research into things that may improve cancer patients outcomes, but this has to be done in a controlled, planned manner in order to make any progress. 'N of 1' trials (as Lord Saatchi proposes) have no power as theres nothing to compare them to, and you might think something had a positive effect for a particular patient, but it actually didn't, or worse had a negative effect.
I'm also going to have to disagree. My biggest concern is that it seems to propose or accept using patients that are scared, vulnerable, and desperate to test treatments that may or may not be of help, and may even be detrimental to them. While I understand the need for more treatments, this smacks just a bit of human guinea pigs, and I would be worried that patients would be pressured into alternative treatments.
The Saatchi Bill won't put vulnerable patients as guinea pigs. Quite the opposite.
They will always be able to have the standard treatments. That won't change.
If a doctor wants to offer them something new, the doctor 1/will have to get validation and agreement from a panel of other medical experts (at the moment doctors do not have to do that - they can gout alone) and 2/ they need patient consent. The law at the moment needs neither.
The Bill places a higher test and barrier on doctors wishing to try novel treatments.
The #SaatchiBill puts innovation back into the hands of the patients. It will allow them to ask their doctor if they are trying everything - if there are any other treatments available.
Using patients as guinea pigs simply will not happen. And any treatment cannot be given without agreement from both the patient and a panel of medical experts. At the moment Doctors do not have to seek this agreement from an expert panel.
The Bill will protect the good doctor and expose the bad.
A full FAQ on the Bill can be found here: saatchibill.tumblr.com/Getthefacts#.Ut1dRGTFI18
I think this bit is important:
'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.'
It seems to me that this Bill is long overdue - a Bill which removes fear of litigation from doctors and encourages them to innovate while protecting patients can only be a good thing. Surely patients shouldn't be faced with the same old, same old if it isn't working - surely if it was you or yours you would want your consultant to be able to try new treatments without having his/her hands tied?
There has never been any notion of human guinea pigs - and to suggest so is insulting to the months of work that have gone into the proposal. There are many occasions when the standard treatment does not and will never work - and the doctors know this, yet fear of litigation and the system we have at the moment forces them to administer often painful and pointless treatment, when at the time the kindest thing to do is nothing at all and all the patient to pass with dignity. Innovation is the cornerstone of medical advancement and this bill seeks to assist and support that innovation and ultimately support and improve the lives of the people who need it most.
I think, though, it depends on what safeguards are going to be in place. It's been posted here presumably to get opinions, and I'm allowed one. I hardly think it's necessary to suggest it's "insulting" in any way. If you don't agree with me, that's certainly fine, but kindly don't act like I'm being unreasonable simply because I don't agree with you.
Patients already need to consent to any/all forms of treatment. And serious researchers will already do bring 'novel' treatments to patients. This 'hands are tied' business is far from the truth.
Unproven treatments beyond that do indeed make the patients 'test cases' (aka guinea pigs).
There are many complementary therapies already available, though probably not on NHS.
Reducing treatment to palliative care to enable dignified death already occurs perfectl legally.
I do not know what this proposal would achieve that is not already provided for or 'innovative' in the sense of being a charlatan's charter.
My opinion is that you are insinuating the bill is is advocating human experimentation - and that I think is insulting. The bill is designed to improve the care of patients while encouraging doctors to innovate. It will be well regulated and administered and no one will be experimented on.
However, I'm sorry if you find my view unreasonable - it is something I feel passionately about - from a personal and professional viewpoint!
I don't find your view unreasonable. I respect the opinions people have on here. It's a shame that you can't do the same.
Well opinions differ I guess! Things need to change to improve the situation and this bill seeks to do just that!
It worth reading it to better understand its aims
Seems extremely odd to me. 1 in 6 patients diagnosed with cancer will end up in a research trial for innovative treatments. Thats higher than any otger Eurpean country or the USA. Research trials have to pass far more stringent ethically approval than whats being proposed here for very good reason - they might cause harm. I agree with Whiskey - what exactly is this going to add except a licence for very dubious 'treatments'.
Things don't "need to change to improve the situation"
Yes, everyone wants better treatment and improved outcomes. But that does not mean that 'change' is needed. The evidence base is important in medicine and this represents a major departure from that without any firm benefit (especially as innovative treatments where there is at least some evidence of utility can be used without risk of litigation, and in UK there is also a thriving complements sector readily available to those who want to use it in parallel)
I don't understand the purpose of this.
Negligent doctors get rightly sued, sad though this is for everyone involved. This wouldn't change.
You always have to ask for consent to administer any medical treatment / op afaik.
Innovation is going on already.
I really can't see how this helps.
Exactly Winterwobbles - we have ethics committees, and stringent trial management (including requirements to publish) for a good reason. And I've never met a consultant oncologist (and I meet a lot) who was afraid to recommend that further treatment would not be right for a patient, or indeed to advocate for them to access a treatment that wasn't standard but might help based on evidence.
Evidence based medicine is crucial to move forward, and funding to help build that evidence base or help in the translation of science from lab bench to ready to enter trials is what is needed.
Change IS needed. For anybody out there who has been diagnosed with advanced cancer choices are minimal. Actually non existent. My 32 year old husband died quite tragically and horribly only a few months ago. We were given palliative care and nothing else. Although there were treatments out there that had been tried and tested, our oncologist would not go near them for this reason. Also, we searched and met up with top surgeons hoping to have his cancer removed purely to hope for a kinder death but it was too risky and nobody would touch him even though he was given a life sentence. As a result he died in the worst way imaginable. I would never have anticipated that kind of suffering.
Imagine that, fighting an illness that is desperate to win and knowing you are losing, imagine being told you won't be able to see your kids grow up, your grandchildren born, imagine a doctor who approaches your bedside and tells you he may offer a tiny speck of light, a safe innovation that maybe, just maybe may help the fight the battle. Imagine if that new treatment goes on to be developed into a treatment that one day helps your daughter if she faces the same battle.
I would want the chance to choose, a chance when all hope is lost to be able to ask my doctor if he has tried everything and be prepared for anything that could extend my time in this world.
This bill is about choice, the patients choice, you don't have to say yes, god knows none of us want to ever be in this position, but I for one welcome this change because should it ever happen to me I don't want a doctor wishing he could have tried something but didn't for fear of repercussions.
I've just read Josephine Hart's obituary. She sounds wonderful.
My reaction to this proposal is not immediately positive, but I'm aware I don't know much about it. I would like to hear more from oncologists supporting the bill about what treatments they have felt unable to offer patients due to the risk of litigation involved.
In my own work in a completely unrelated healthcare field, I really don't think that innovation is often prevented by fear of litigation. What can militate against innovation is lack of time and full scale multi-site research projects (the latter being particularly important in rare conditions such as the one Josephine Hart died of). I have perhaps 2 hours a month to pursue projects that aren't directly related to current patient care. It's not a whole lot. Who will fund the increased multidisciplinary team meeting time required to discuss innovative treatments for patients for whom nothing has worked? Will this restrict time and research on methods of screening for earlier identification?
When I was diagnosed with breast cancer in 2010, fortunately my story was different from Josephine Hart's: I was ‘lucky’ enough to have had one of the ‘Big Four’ cancers where survival rates are high and treatment is evolving rapidly with successful outcomes. I also had a caring, inspired team that wasn’t afraid to innovate, putting me on a drugs trial and taking a new post-chemo surgical approach that meant I avoided a full mastectomy. Most people with cancer – and it will touch all of us at some point in our lives, either directly or through someone we love – are not so fortunate.
There is a lot of talk about breakthroughs in treatment for cancer and other diseases. Breast cancer and leukemia, for instance, are no longer a death sentence. But in most cancers, too little progress has been made in recent decades, and the status quo simply isn’t working. For many cancers, there are simply no treatments other than surgery: no effective chemotherapy, no drugs, nothing. For others, there have been no advances for 30 or 40 years. Sadly, there is a commercial imperative at work here: if there’s no money to be made from a treatment, drugs companies won’t invest millions of pounds and many years in the research and development required to bring a new drug to market.
Under the new bill, although consensus from the patient’s multidisciplinary team will be an absolute requirement in advance of any innovative approach being taken, it’s true that often, innovation comes from the brilliant idea of one clinician.
The doctor at Barts, for example, Geoffrey Keynes, who refused to do what surgeons across the US and UK were doing with breast cancer – the Halsted method, whereby women automatically faced a double mastectomy and the removal of all tissue from the shoulder, to the chest wall and ribs – and instead removed only the tumour and followed it with radiotherapy. He was ridiculed, and his ‘lumpectomy’ was used as a term of derision. Today, it’s standard procedure. Penicillin is another example: it came straight from the lab to save soldiers fighting the desert campaign of WWII, with no clear evidence base of years of trials. It was a new treatment, and it saved thousands of men who would previously have died from their infections. That’s what Saatchi means by innovation. Today, they’d probably be sued.
Fear of litigation is what's wrong with so many things in our society today. Of course protection is necessary, but with such a wealth of expertise and intelligence in our medical services it's a crying shame that people sometimes don't get to make a choice about their health outcomes. I'm completely in favour of a bill which seeks to allow medical professionals to make better advances in patient outcomes.
Improvement is definitely needed.
But it does not follow that change (or any one particular change) is the best route to improvement.
New techniques are being brought in all the time - even the lumpectomy. This change isn't suddenly going to unleash lots of treatments held up by conspiracy. New is not a synonym for good, amd more than change is a synonym for improvment.
Good, effective treatments can already be introduced. New treatments which aren't good or effective don't get traction.
Pencillin would of course be approved today.
The effect on bacteria which led to penicillin, btw, was first noticed in 1928. Development followed, including animal then human testing, followed, and results pulished in a peer reviewed journal in 1941, after which it went into larger scale production and was indeed ready to be used before the end of the war.
It's essentially identical to drug approval system still in use, but approval can be achieved less than penicillin's 15 years these days.
Yes drs should innovate. But to do they they need drugs and treatments to innovate WITH. The lack of research in this area- particularly in paediatric cancers- is staggering, despite what national charities choose to promote. You can live without prostates and breasts, yet you can't survice without brains or blood. And the people who pay the price are little children. Research needs to be directed at cancers of the brains and blood, not whatever is easy to grab the headlines. I would much prefer saatchi takes that fight on.
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