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‘Protect the patient: nurture the innovator’ writes Norman Williams, President, Royal College of Surgeons

‘Protect the patient: nurture the innovator’ writes Norman Williams, President of the Royal College of Surgeons (RCS) in the March 2014 RCS bulletin.

→READ: the full article in the bulletin

The bulletin text is reproduced below:

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A few weeks ago I spent the weekend in Innsbruck, participating with several European colleagues in a surgical workshop that concentrated on a new minimally invasive technique of sphincter preservation in rectal cancer. This innovation has the potential not only to reduce the incidence of permanent stomas significantly but to do so with the minimum of trauma.

It occurred to me and my fellow participants that it might also, if developed appropriately, be possible to carry out the whole procedure via one orifice – no prizes for guessing which one! I also thought that if robotics develop at the estimated pace then the technique could be performed with even more precision, thus reducing the margin of error inherent in such an operation.

Now, I know many of you will be thinking that the President is in ‘cloud cuckoo- land’ but I would like you to reflect on the considerable progress we have made in surgery over the past 50 years. When I was a medical student there was no such thing as organ transplantation, cardiac surgery was in its infancy, joint replacement had just been introduced (but only for hips), and laparoscopic and microsurgery were both at a very rudimentary stage.

The pace of innovation has been truly remarkable and yet we in the UK could be criticised for dragging our heels when it comes to the dissemination of some developments.

Four years ago, when I was Chairman of the RCS Research Board, we published a report entitled From theory to theatre, in which we explored the barriers to translational research that threatened to stifle surgical innovation and identified a series of actions to deliver high-quality surgical research now and in the future.

I am pleased to say the College rose to the challenge and, in addition to raising funds and influencing research councils and charities, has managed to develop an infrastructure that should markedly change for the better the way in which we carry out clinical surgical research. All in the research and development departments should be congratulated on their achievements.

I should also compliment the many surgical trainees who have contributed their time and efforts to developing trainee research collaboratives. There are more than 20 of these across the country, each carrying out some large clinical trials and audits as they try to answer important questions. All these efforts are to be applauded and celebrated but the challenges do not stop there.

The fruits of research are of little value if they are poorly implemented. Discovery only matters if it reaches all those patients who might benefit. The diffusion of surgical innovation has at times been painfully slow. The reasons are many, ranging from lack of evidence to training and capacity issues. We hope we are beginning to address some of these barriers with the actions mentioned above but others will require different solutions.

If we are to tackle the slow diffusion of innovation then we must learn from experience and not keep making the same mistakes.

That is why we commissioned a piece of work to investigate how we might improve. The report of this investigation, entitled From innovation to adoption: Successfully spreading surgical innovation, will be published soon. It sets out for the first time what makes adoption of surgical innovation different and why we need a new approach.

It is based on a review of five mainstream surgical procedures, across a number of specialties, in which patterns of uptake are analysed and the factors that helped and hindered surgical adoption in England are explored. As a result, a pathway of surgical innovation has been developed, which is made up of six critical factors:

1. Early identification of the promise of an innovation

2. Leadership to champion and advocate its adoption

3. Establishing the infrastructure to enable its use

4. Defining what should be implemented and how its impact will be measured

5. Developing levers and incentives to encourage appropriate adoption

6. Providing information to support clinical adoption and patient choice

These are vital factors if we are to achieve a more streamlined adoption mechanism but in addition I must stress that there is a responsible and ethical approach.

This applies particularly at the earliest stages but of course must be applied throughout the whole process. There is no room for ‘cowboys’ or the ‘have-a-go’ merchant.

My memory goes back to the early 1990s when a news conference was held at the College about the death of a patient that occurred at the hands of a surgeon performing an early laparoscopic procedure without appropriate governance arrangements in place.

The patient’s husband was a QC and the subsequent fallout was disastrous for the profession and set back laparoscopic abdominal surgery in the UK for a decade. Although governance has improved, a clear path showing how to support the innovator, while at the same time protecting the patient, is still lacking.

We need a transparent and supportive mechanism to assist the innovator in honing a truly new concept without the constant fear of litigation (or worse). Yet at the same time safeguards need to be in place so that patients are fully informed and protected from the unscrupulous practitioner.

This will not be easy but it is an issue that can no longer be avoided, otherwise it is only a matter of time before one of us is incarcerated for trying to advance his or her specialty.

I understand that several consecutive patients died when Professor Sir Roy Calne carried out the first liver transplants; I wonder what would happen to him nowadays were there to be a similar outcome. Complications are inevitable with new procedures and only by facing up to them and understanding them can they be overcome.

This requires courage on behalf of the innovator (and, indeed, the patient) and support from colleagues. Research ethics committees have their place but they are invariably composed of non-surgeons who do not have an appreciation of the problems. I would like to see our profession taking on this responsibility.

One way to do this might be for each specialty association to set up an Innovation Oversight Panel composed of individuals with experience of the trials and tribulations involved in surgical innovation. Such a panel could receive proposals for innovative procedures to assess whether or not they were feasible, appropriate and designed to improve the status quo.

The panel could then give approval for a small pilot study but request regular reports, so that when complications occurred they could help the innovator to resolve the particular issue. The process would be iterative and hopefully the new procedure would evolve so the trial could be widened to involve other groups. Ideally this would take place within the infrastructure discussed above to ensure more rapid dissemination.

Such a structure would enable the realisation of this piece’s title and is in keeping with the new Medical Innovation Bill promoted by Lord Saatchi, which is designed to improve responsible innovation in medicine and remove the fear of litigation.

I would exhort the officers of the specialist societies to think seriously about setting up an appropriate mechanism. It does not need to be the model I have outlined; they may well feel they could do better and I would be the first to applaud them.

However, unless a mechanism of some form is set up I fear that the progress of surgical innovation may be impeded by the imposition of stringent external regulation. I also fear that patients will be damaged unnecessarily and surgeons will be impugned or, at worst, indicted. Unless potential developments like the one I learnt about in Innsbruck can be developed speedily yet ethically, then disseminated appropriately, we are all the losers.

Supporting innovation – exposing the maverick

The Saatchi Bill will make it much easier for doctors to innovate safely in the interests of their patients.

At the same time, it will expose the doctor who wishes to exploit their patient, preying on them and their vulnerability in order to attempt a reckless experiment.

Doctors will not be protected by the Saatchi Bill unless they go through a rigorous and specific process to ensure that the attempted innovation is the right course of action for the patient.

As the draft Bill states in paragraph 2 (3a) a doctor wishing to try a new treatment – for example in the case where standard treatments aren’t working – must consult a body of senior and relevant medical experts and get their consent.

The doctor must also record their opinion, including and dissenting voices.

The decision of the panel of experts must then be presented to the patient – including any contrary opinions if there are any – and the patient must of course also agree to go through with the innovative treatment.

Finally, the note of the opinions must then be attached to the patient’s consent form as a permanent record.

Only then will the doctor be legally covered by the Bill.

The Bill imposes a much higher standard of consent than other health legislation.

For example in order to section a patient, the Mental Health Act requires the signatures of only two doctors.

Currently, it is easier now for a doctor to indulge in reckless experimentation and maverick medicine, than it will be if the Bill becomes law.

As it now stands – without the Saatchi Bill – a doctor can attempt to persuade a vulnerable patient to embark on a dangerous treatment path.

This is so because the doctor technically doesn’t need to refer to a panel of experts before trying the non-standard procedure. He or she can act alone.

So, the Medical Innovation Bill supports and encourages reasoned innovation – and exposes the maverick.

Lord Woolf: Former Master of the Roles and Lord Chief Justice:

[The Bill] could give confidence to medical practitioners engaged in the field of treatment of cancer that in appropriate circumstances they could safely recommend and implement a course of treatment, or non-treatment , which some, or indeed the majority of their professional colleagues, might regard as unorthodox.

I have come to this conclusion because it is, in my view, undoubtedly the case that there is insufficient certainty as to the course which courts will adopt in this country at the present time when faced with an allegation that a medical practitioner’s treatment of a patient was inappropriate because of its innovative nature.

[There is] a risk that the present state of the law could inhibit the proper development of treatment of particular cancers.

Any way of avoiding this by legislation, in my opinion, should be welcomed. I would therefore hope that in the Lords, at any rate, your Bill will be well received.

About Lord Woolf

Consultation launches in the House of Lords


Last week cancer bloggers, tweeters and patients united to make medical history in the House of Lords – at a Google Hangout in support of Maurice Saatchi’s Medical Innovation Bill.

Together we launched the Saatchi Bill public consultation – backed by the Department of Health and Secretary of State @Jeremy_Hunt.

The Bill will allow patients to ask for – and doctors to deliver – new and innovative medical treatments for rare and hard-to-cure diseases without fear of being sued.

The Government backs our Bill – and promises to pass it into law, if the public consultation is successful.

It all hangs in the balance right now. Nothing is certain.

But if the response we got from those in the room who came to hear Maurice Saatchi, patients, families and professors speak up for the Bill is anything to go by, we have a fighting chance.

You joined us in a Google Hangout and heard the arguments of Debbie Binner who lost her daughter, Chloë to a rare bone cancer, to Chloë’s best friend Mike Thomas and to Mavis Nye who is dying of mesothelioma.

They all want the Bill. They want innovation – not the endless repetition of failed medical treatments.

After the Hangout, #SaatchiBill twitter and blog conversations went ballistic. We want more of that and we want hundreds of people to respond to the government’s public consultation so that no politician can say the Bill is not needed or wanted.

As Mavis Nye told the room: “I’m terminally ill. I shouldn’t have to chase treatment. My oncologist can only give me what’s laid down by the national health system. I back this innovation Bill. I want it and I want it today – because I might not be here tomorrow.”

 

In Memory of Chloë Drury

Chloe Drury by Mike Thomas

I gripped the wooden lectern tightly with both hands to try and prevent myself breaking down with emotion.

It was a year ago last Friday. The lectern was at the front of St Mark’s Church, Purley – and I was starting to speak at the Memorial Service of my best friend, Chloë.

In front of me were hundreds of faces, young and old alike. They were there to celebrate and remember an ultimately, short but extremely well-lived life.The life of Chloë Drury.

On Wednesday the 27th of February last year, I received a call from a friend, she sat me down, she looked me in the eye and told me that Chloë was going to die, that there was nothing anyone could do anymore and it was going to happen in the next few days.

I sat in shock, I tried to ask questions about when it would happen, and how did they know?

Chloe Drury - Medical Innovation Bill
Chloe Drury – Medical Innovation Bill

All I remember thinking is that I felt desperately helpless. That night I stayed surrounded by friends, trying to find comfort in each other, anything not to be alone.

All night I relived the time I spent with Chloe, the first time we met, the days spent in her company, the last time I ever saw her. I thought about her dreams and aspirations, the things that she’d been so excited about, and which now would never be fulfilled.

When the news finally came through early the next morning that Chloë had passed, there were no more tears, no more uncontrollable emotion just silence, I was completely numb.

Mike Thomas and Liam Ryan at the Houses of Parliament 24th Feb 2014 speaking alongside Lord Saatchi as he launched the public consultation LIVE via Google Hangout.

Over the next few hours I had to have conversations that I wish never had to happen, to be bearer of the worst news possible, to look people in the eye, friends and family alike, and tell them that Chloë had died.

Watching them breakdown in front of me was unbearable.

The following weeks, were the most difficult. As a friendship group we spent nearly every day together, making sure that no one was alone for too long.

Being alone let you think too much, it allowed you to dwell and let reality set in, it let you realise that you would never see Chloë again, that you never got to say goodbye.

These painful thoughts would stay with me for months.

Eventually, we had to return to school, we had to return to everyday life.

But no matter how normal you try to make it, it’s impossible to pretend that nothing has changed.

For me personally, my school attendance was almost non existent, the last place I wanted to be was at school, because at that point in my life, lessons and exams didn’t matter, grades and university places weren’t important, I’d lost a friend and it had stripped me of all motivation. I had no drive.

There were two factors that help me deal with Chloë’s passing. Firstly the unwavering and resolute support that we all received from friends, dealing with this alone would have been undoubtedly impossible.

Secondly, the sheer bravery and optimism of her mum, Debbie Binner.

Despite what she has had to endure, she is always looking for a positive. Debbie has turned loosing Chloë into her driving force.

It was Debbie who urged me to speak in St Mark’s Church, who gave me the opportunity to say goodbye properly. When I stood at that lectern and spoke, I felt like I had finally let Chloë know how much she meant to me.

I hope that I have given you an insight into the pain that losing a friend causes, for young people like me.

And if you remember just one aspect of my words, I urge for it to be this one.

Chloe’s death has brought about many questions about cancer treatments.

And I urge you to ask yourself this question: Have you done everything you could have, were you bold enough, brave enough to demand more, more innovation and more accessibility to cancer treatments, so that more lives are saved where possible?

For Chloë and the hundreds of others who find themselves in her situation, Make sure the answer is yes.

This blog is based on a speech by Mike Thomas, who spoke at the House of Lords on Monday 24 Februrary about the death of his friend Chloë Drury and in support of the Medical Innovation Bill. Chloë died on 28 February 2013, of Ewings sarcoma aged 18. 

Telegraph: Lord Saatchi launches the consultation on his medical innovation bill – live from the House of Lords

Today Lord Saatchi launched his Medical Innovation Bill LIVE via Google Hangout from the House of Lords.

The politician was joined by a panel of experts including Telegraph doctor Max Pemberton in a live video stream from the House of Lords today where they will call on the public to support his Medical Innovation Bill.

Introduced by Lord Saatchi last year following the death of his novelist wife Josephine Hart to ovarian cancer in 2011, the Bill seeks to give medics greater freedom to test out cutting edge treatments on dying patients.

Currently doctors are forced by the threat of legal action to stick to standard procedures, even when they are proving ineffective.

Lord Saatchi’s bill has already received huge public support and health secretary Jeremy Hunt promised to support legislation on the issue after the public consultation which is launched today and ends in May.

Read in the Telegraph 

 

Guest blog: Fearful doctors ‘in a war against inertia’

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By Dr Lefever

The Medical Innovation Bill, to be introduced by Lord Saatchi, is intended to help patients by allowing their doctors to be less constrained by clinical orthodoxy.

Single issue fanatics, whose fervent beliefs have no scientific merit, will still be reined in. But doctors who can make a reasonable case for a non-standard approach will be able to do so. Clearly they have to have the support of the patient. Also they must convince a scrutinising panel

The Medical Innovation Bill intends to make it easier to define what is sensible and permissible innovation and, by contrast, what is reckless experimentation.

It would do this by setting out a clear protocol to follow before offering the patient an innovative or experimental procedure.

Under the bill, the lead clinician must consult with, and gain approval from, a multi-disciplinary team. Without approval, the innovation cannot be legally offered.

This approach is eminently sensible. Which of us would not want to brush aside ‘the way things have always been done’ if doing so might bring additional years of health and happiness to a loved one?

Doctors in the front line, right alongside their patients in the battle with disease and decay, want to do the best they can. So who is the enemy? Who has a vested interest in the status quo? Whose head would roll if something did not work out as hoped when something new is tried?

The answer at present is that we are witnessing a civil war. The doctor’s own career would be sacrificed if he or she steps out of line.

The National Institute for Health and Clinical Excellence (NICE) was intended to weed out mavericks. It has become the keeper of the purse for the NHS.

The General Medical Council has responsibility for putting doctors names onto the medical register, through monitoring medical education, as well as for striking off miscreants. Yet how much attention do they pay to considering whether doctors are properly trained for the job they actually do? For example, are GPs trained to counsel? Hardly at all. Yet that is half the work. Are specialists trained to take risks? No. But they have to.

Lawyers and Coroners judge the actions of doctors on what their colleagues would customarily do.

A profound inertia results from the limited vision of these guardians of public safety – with the consequence, as Lord Saatchi understands only too well, that doctors now fear more for themselves and their families than they do for their patients.

About the author

Dr Robert Lefever is regarded as the pioneer of addiction treatment methods and rehab centres in the UK. He established the very first rehabilitation centre that treated patients with eating disorders alongside those with drug and alcohol problems. He was also the first to treat compulsive gambling, and workaholism.

READ: Dr Lefever blogs for the Daily Mail

READ: Dr Lefever’s own blog

READ: http://www.doctor-robert.com/

‘Why I back the pioneer Lord Saatchi,’ by Max Pemberton, doctor and Telegraph columnist

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By Max Pemberton, doctor and Telegraph columnist

Doctors experience a strange conflict throughout their working lives. On the one hand, we are trained to save lives and alleviate suffering. On the other, medicine is incredibly conservative – slow to change and wary of ideas that challenge the status quo.

Indeed, there is an estimated average time lag of 17 years for a new treatment or research evidence to reach clinical practice. The reasons for this are long and complex: to do with processes and policy but also, in no small part, a reluctance by doctors to change their current practice.

Why should this be the case? If a treatment or procedure has been suggested to be of benefit, why not try it, especially as it might offer new hope to patients? The argument for this is particularly strong in the case of cancer treatment.

The reality is that doctors’ reluctance to go “off piste” when conventional treatment has failed is often due to their concern over being sued. Once doctors deviate from standard practice, they open themselves up to litigation. Indeed, the Bolam test – currently used to assess medical negligence – involves assessing what the average doctor would accept as standard procedure.

This inhibits innovation, it is argued, and Maurice Saatchi, the former advertising guru, is seeking to change this with his Medical Innovation Bill. Its origins lie in Lord Saatchi’s devastation as he watched his wife, the novelist Josephine Hart, die of ovarian cancer in 2011. He has managed to turn his loss into something that has the potential to bring untold benefit to future sufferers.

It is a tragic indictment of modern medicine that innovation is too often jettisoned in favour of the status quo for fear of legal action. Defensive medicine is at the heart of so much clinical practice today, but the Bill – if accepted into law – would deftly excise this, leading the way for doctors to feel free to strive for medical advancement.

This doesn’t mean that doctors would have free rein to experiment on a patient – they would still be bound by professional guidance and their duty of care would remain to their patient. Nor would it mean that the Bill would become a substitute for proper clinical trials.

But what it does mean is that, in cases where the evidence is shaky, wanting or not yet clear, the Bill would set out a code by which doctors could try alternatives. It would provide a legal framework by which doctors, in discussion with their patients, could try off-label drugs or a device, treatment or intervention that might have some clinical data supporting it, but has yet to be fully proven.

Initially, the Department of Health was sceptical, but since the Bill was launched it has gained considerable public, medical and legal support. Then, in November last year, Jeremy Hunt, the Health Secretary, gave it his backing, saying that “we must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment”, and commending Lord Saatchi as “a great example of a parliamentarian motivated by conscience”.

A public consultation is now planned, beginning later this month. This is tremendously exciting: the history of medicine is littered with innovators who flew in the face of received wisdom and dared to challenge orthodoxy.

If the Bill passes, it may well be that in years to come Maurice Saatchi will join their ranks, and will no longer be known as an advertising guru, but the man who helped doctors find a cure for cancer – and saved an untold number of lives.

→READ: Max Pemberton’s column

Telegraph: Lord Saatchi Bill: We must liberate doctors to innovate

Lord Saatchi urges the public to seize a ‘once in a lifetime’ opportunity to change how medicine is practised in British hospitals.

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I don’t remember feeling anger when my wife, the novelist Josephine Hart, died in 2011 of ovarian cancer. I certainly didn’t want to thump anyone. It was a calamity, but grief is not a disqualification for rational thought.

I knew that no one had done anything wrong, or behaved badly, that the doctors who had treated Josephine were neither incompetent nor inefficient, that they did what they were supposed to do with drugs and chemotherapy. They followed “standard procedure”, even if the treatment was degrading, medieval and ineffective, and they knew it would lead to her death.

What puzzled me was how there could be such a ready acceptance in the medical profession of “standard procedure” in the light of the hundreds of thousands who die of cancer. In the case of advanced gynaecological cancers, such as my wife’s, “standard procedure” is 40 years old, offers poor quality of life, and the mortality rate is 100 per cent, with the survival rate correspondingly zero.

They did it, I came to understand, because “standard procedure” is the only safe route they can take legally. The patient, their family, their partners and their lovers may all be desperate for something else to be tried, something new, something innovatory, but the law prevents any innovation, however reasonably chosen and carefully managed. Why? Because it defines innovation as deviation from “standard procedure”, and deviation makes it medical negligence.

In 2012, the NHS paid out £1.2 billion as a result of medical negligence claims, that figure had doubled in four years. And Treasury figures show that we have a pot of £24 billion set aside to cover future liabilities. That is a staggering sum, roughly half of the defence budget. The result is that, if you are a doctor in a hospital, you are all too conscious of the tide of litigation, and you become risk averse. And innovation averse.

There may not have been anything to stop Josephine dying, but the terrible thought that haunts me is that her death was a wasted death. Indeed, all 165,000 cancer deaths in this country every year are wasted deaths because science advances not one centimetre as a result of them. Nothing new is tried and so nothing can be learnt that might spare others. Scientific progress is being halted by the law and fear of negligence bills.

This culture has to change. Last year I introduced a Private Member’s Bill into the House of Lords that set out a legal framework “to encourage responsible innovation in medical treatment and to deter reckless departure from standard practice”.

It was drawn up with the help of the best legal and medical minds, and stipulated that, to innovate, doctors must have patient consent and the agreement of other senior medical experts and practitioners. They cannot go it alone, but they can go beyond standard procedure without fear of ending up in court.

Such Bills usually stand little chance of success, but two things were in my favour. The first was the overwhelming tide of support I received from doctors, lawyers and, most of all, from those who wives, husbands, sons, daughters, brothers and sisters have died wasted deaths from cancer.

“I truly hope with all my heart,” one correspondent told me, “that your Bill is a success and it changes for the better the treatment offered to cancer sufferers in the UK. It drastically needs to change. My husband was belatedly diagnosed with pancreatic cancer in February 2007. We were told (mistakenly) it was inoperable and that chemo was the only option, not as a cure, just to buy him more time, before finally a different surgeon at a different hospital agreed to operate to remove the tumour, saying he could’ve done so at time of diagnosis. The op was too late and the cancer had spread to his lungs. My husband died.”

Or another, who wrote that “when discussing the benefits/disbenefits of certain treatments with my GP, he pointed out that if he did not follow the “guidelines” and something went wrong, he could be open to a legal suit”.

And the second was that, last November, Jeremy Hunt, the Health Secretary, with the backing of the Prime Minister, announced his “wholehearted support” for my proposals, and promised government support to legislate to make them happen, after a public consultation.

But this had to be, he stipulated, “a full and open consultation, a consultation that gets the views of patients on the right balance between innovation and safeguards, a consultation that hears from clinicians on the problems they face in innovating and how to overcome them”. He has even agreed that responses to the consultation – which must be received by May – can be sent to the Department of Health via social media.

Mr Hunt has laid down the challenge. I’m appealing to Daily Telegraph readers to join with me, and the tens of thousands who have already given me their support, to make this the biggest government consultation response ever. We need to say loudly and clearly we want to try new treatments for cancer where the old ones are known to lead only to death. We want to escape being doomed to repeat an endless cycle of failure.

What’s wrong, you may ask, with the way we explore new treatments for cancer now? Clinical trials, random clinical trials, take a long, long time to produce results. It can take 15 years and £1 billion to come up with just one drug. I believe passionately that we will get no closer to a cure for cancer until doctors can test new treatments, in a controlled way, not on laboratory animals but on real patients, with real illnesses in real hospitals.

I believe that we are on the brink of a great medical moment, a once-in-a-lifetime opportunity for a change of culture, away from being risk averse, and back to the spirit of medical innovation that once led Alexander Fleming to the discovery of penicillin or Sir Peter Mansfield to enable magnetic resonance imaging.

In this new culture, we will be able 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, will be able to say yes.

I can’t promise you that, by itself, this change will cure cancer, but it could encourage the person who is out there right now, who may still be a child, and who one day may free us from this blight on my life, and yours.

Curing leukaemia

IN THE 1940s, the survival rate for childhood blood cancers was pretty much zero. At the time, the scientific literature argued that anyone trying to cure childhood leukaemia was cruel, because the result was always the same: death.

Prolonging the agony with needless, unproven medical interventions was wrong, it was argued; the condemned child should be made as comfortable as possible and allowed to waste away.

A few determined doctors in the United States and Europe challenged this defeatist sentiment. They tried treating the disease with folate, a B vitamin, and discovered that it got worse.

As a result, they tried drugs which reduced folate levels instead. This worked and led to the introduction of the still-used drug methotrexate.

Andy Hall, Professor of Experimental Haematology at the University of Newcastle upon Tyne, says: “What those doctors did then couldn’t be done so quickly now.

“Those doctors were close to the patients dying on the ward and not prepared to accept the status quo. Survival rates for children with leukaemia today are around 90 per cent.”

‘Off-label’ drugs

DEVIATING from the standard medical procedure can offer hope to those with the most dire prognoses — which is why Prof Angus Dalgleish, Professor of Oncology at the University of London and the Principal of the Cancer Vaccine Institute, is a supporter of the Saatchi Bill. He feels doctors are too often afraid to try new ideas, by prescribing drugs “off label” — for diseases for which they have not been licensed. “I have recommended logical, non-standard treatments to cancer patients who have run out of standard options,” he says. “I have seen on many occasions patients who have benefited dramatically.”

One example was a 63-year-old man with metastatic prostate cancer for whom the usual treatments were not working. “We agreed that he try a drug licensed at a high dose for another condition. Even though his other doctors thought his case was terminal, he had a marked clinical response and survived for another three years, dying not from his disease but due to the indirect chronic effects of his previous therapies.”

How war promoted modern surgery

War is a crucible for medical innovation. Medics are faced with men and women who are dying, often in large numbers and are driven to try new techniques, sometimes developed in the heat of battle. They have little to lose and all to gain – saving otherwise doomed soldiers from death.

In the Falklands war of 1982, Surgeon-Captain Rick Jolly OBE – a man decorated both by the British and the Argentinians for saving lives on both sides – operated in a field hospital with an undetonated bomb lodged near his operating table. He discovered that casualties left out in the cold because it was impossible to collect them from the battlefield fared well, in many cases, leading to the development of theory of therapeutic hypothermia, whereby patients can benefit from deliberate cooling.

Penicillin was first used in earnest in the Second World War. Doctors were aware of its benefits, but not necessarily how to use it and in what doses. However, knowing that personnel would likely die without it, doctors administered it, learning as they went. Military doctors facing injury and suffering on a massive scale during the Second World War also pioneered advances in antibiotics, anaesthesia and blood transfusions – advances that would usher in the age of modern surgery.

The innovating breast cancer surgeon

GEOFFREY Keynes could arguably be considered the patron saint of innovation. In 1922, the surgeon, based at Barts Hospital in London, developed the lumpectomy for breast cancer, flying in the face of orthodoxy. Back then, the accepted practice for dealing with breast cancer, developed by the all-powerful American surgeon William Halsted was the radical mastectomy. The “Halsted Procedure” was a physically deforming operation involving removal of the breast tissue, skin, nipple, axillary lymph nodes and the underlying chest wall muscles.

Keynes, the brother of economist John Maynard, began using removal of the tumour and radiation therapy to treat breast cancer. More than 70 per cent of his patients survived five years, a rate that was similar to that in patients who underwent the Halsted operation, yet without the massive, debilitating surgery.

For his pains, Keynes was ridiculed — yet lumpectomy was gradually accepted as a standard treatment, with the Halsted operation rarely performed today.

The future?

How might the Saatchi Bill work in practice: a hypothetical case study.

Doctor Glenda Smith is treating a patient, Alison Jones, for a rare and life-threatening condition. She asks Dr Smith about a new kind of non-surgical treatment she has read about. Dr Smith discovers the new treatment has not been tested for Alison’s condition, although it has been used for other illnesses.

Under the present legal conditions, Dr Smith will feel safest to say that in the absence of published research, she cannot advise anything departing from the standard surgical procedure. If she innovates and Alison dies earlier than would be expected statistically with standard treatment, she will be vulnerable to disciplinary or legal proceedings.

Under the Bill, if Dr Smith was impressed by the arguments in favour of the new treatment, she could follow the process outlined in the Bill, which includes talking to other experts and to Alison and her relatives about the innovative treatment, and obtaining a consensus as to its use.

If the case came to court, Dr Smith could be confident she had followed the Bill’s processes and any court decision would be made in that light. There would be no opposing ranks of “experts” commissioned by the two opposing legal sides, after the event.

→Watch Lord Saatchi explain his Bill visit telegraph.co.uk/video

→Read: Telegraph stories and updates on the Bill:telegraph.co.uk/health/saatchi-bill/

 

 

What innovation will mean to me as a bowel cancer patient

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By Charley Kitely

The definition of innovation according to the Collins English dictionary is ‘something newly introduced, such as a new method or device’. But, to a cancer patient, innovation means something much more.  It means opportunity, a chance and hope.

The Saatchi Medical Innovation Bill hopes to support doctors and scientists, providing them with the opportunity to question if there is a new way of managing cancer and the chance to develop treatment, perhaps even a cure. And then there is the hope doctors and scientists will refuse to accept that the standard procedure is good enough and consider a new way to treat cancer, providing people in my situation with the opportunity to test out their theory without the fear of legal recourse.

When I was diagnosed with bowel cancer in February 2012, I was asked my family history.  A quick phone call to my parents revealed that unfortunately my odds weren’t great – my paternal Grandfather had died 35years previously and my maternal Grandmother some 15 years ago, both to bowel cancer.

But surely that was a long time ago and medical research has come a long way?  I was only 33 when diagnosed, a young, fit and healthy mum.  Surely my odds would be significantly better?

Yet 35 years after my grandfather was being treated for the same disease, we are still tackling cancer in the same way – cut, burn and poison.  And whilst there has been moderate improvements on the potential side effects (for example I haven’t lost my hair, it’s just thinned and my stomach convulsions are dramatically improved with an injection prior to chemo), unless detected early, the ‘cure rates’ of bowel cancer remain disappointing. 

I’m not by any means detracting from the ground-breaking work doctors and scientists are doing in the labs. There have been massive advancements in life pro-longing drugs such as Avastin and more recently Aflibercept, which have worked to keep me here, with my young family a year over my ‘expiry date’ and we are detecting cancer much earlier with better screening, though for bowel cancer patients, this is from the age of 65, not much help when you’re 33!

And this is why the Saatchi Medical Innovation Bill is so important.  This bill will give doctors the opportunity to consider new drugs or techniques that could go on to save the lives of people like me.  People who at the moment are written off as incurable, where the best I am offered is a comfortable quality of (shortened) life.

I am, in terms of bowel cancer patient, young and (if you forget the minor cancer detail) healthy.  I lead an active life, from swimming with dolphins to teaching my 3 and 5yr olds to ski (clearly against Drs orders!), I refuse to be defined by or compromise my ambitions just because I’m fitting fortnightly chemo sessions into my life.image

Given I have tried and exhausted the traditional routes, I am now looking at alternative treatment programmes to get me out of this pickle. Trials and innovation could be the answer for me surviving this disease.

We need to encourage innovation, allowing doctors a more exhaustive list of treatments to try out. I need to be able to look my doctor in the eye and ask him if he really has tried everything and if not, what else can we try.

Of course this is not to suggest my doctor will suddenly run into a laboratory, mix some random drugs together, give me an injection and hope all will be better.

R&D and drug development takes years to bring to market and for every successful drug, there are hundreds that don’t make it. And of course there are the research hospitals that already give patients the opportunity to be considered for trials.

But, this bill will make it possible for me to push for a new treatment, accepting the consequences are for me to bear.  It returns some control to the patient (which is something many with cancer feel is lost when they are diagnosed) and encourages better education.  Surely this can only be a good thing?

As patients, we should be open to new, exciting and alternative treatments.

There may not be the vast numbers of patients in new research, but if more of us consider new treatments rather than being scared by it, these figures will increase, prompting further confidence for other patients. We should be taking responsibility as much as the doctors in finding a cure, not only opting in to research programmes, but also taking an honest view of what we put in and around our bodies.

For me, that means avoiding things that could be considered to encourage cancer growth (sugar and dairy) and instead surround myself with things that prevent further tumours (lots of green veg and turmeric).

Doctors need to be encouraged to think beyond what they have always done.  As Einstein once said, ‘insanity is doing the same thing over and over and expecting different results’. If we continue to treat cancer as we have for the last 40 years, we can only expect the same results – more people needlessly dying to a disease that could be curable.

Innovation has to be at the heart of the next stage of cancer research and the Saatchi Medical Innovation Bill could be the bill that makes the difference for doctors to be able to innovate and think outside the box we seem so snugly determined to remain in.

 

 

Mumsnet: Campaign of the week

This week Mumsnet are getting behind the Saatchi Bill. Here is the blog post Lord Saatchi wrote for them. Read it here on Mumsnet.

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Sign-up here (http://eepurl.com/GcrZ9 ) to be the first to hear when the consultation launches.

And click here to follow us on Twitter @SaatchiBill and Facebook so we are ready to respond.

All cancer deaths are wasted deaths.

For many forms of the disease no new treatments have been developed for decades, and 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 innovating and 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 and if the patient wants them to, they can then innovate safe in the knowledge their lives and livelihoods will not be in jeopardy if the treatment fails.

Second, it will also 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 is 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 are 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 (http://eepurl.com/GcrZ9 ) to be the first to hear when the consultation launches.

And click here to follow us on Twitter @SaatchiBill and Facebook so we are ready to respond.

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.