Tag Archives: Department of Health

What difference will it make for patients?

It will free your doctor to consider new treatments and ideas, safely and responsibly, with your consent.

So when standard treatments are exhausted, you and your doctor can then consider what other options may be available, if any.

 


“The Bill seeks to support doctors who endeavour to act in the best interest of their patients without the fear from litigation.

“It deters from irresponsible experimentation but encourages a much needed attitude change of innovation in the provision of care to cancer patients.”

Professor Ahmed Ashour Ahmed
Professor Ahmed Ashour Ahmed

Professor Ahmed Ashour Ahmed, Professor of Gynaecological Oncology,  Consultant Gynaecological Oncology Surgeon and Scientist, University of Oxford

 

 

 


 →WATCH: Debbie Binner, mother and campaigner who lost her 18 year old daughter to Ewings Sarcoma.

“Once Chloe only had 6 months left to live, how could any radical potential new treatment, actually I’d prefer innovative rather than radical, have been defined as too risky or too dangerous. These words risky, dangerous, are utterly meaningless in this context.

“What if doctors tried something different, something new, something promising. Chloe might well have died anyway, and I accept that, but surely what she would have left behind would have been more clinically valuable for other children, for other teenagers.”

Debbie is speaking at the House of Lords.

 

Telegraph: The fear of being sued is ruining modern medicine by Dr Max Pemberton

Dr Max Pemberton writes about why he supports Maurice Saatchi’s Medical Innovation Bill in the Telegraph.

Telegraph

By doctor and Telegraph journalist Max Pemberton

Published 9th December 2012

Read in the Telegraph.

Doctors are too scared to deviate from evidence-based medicine and innovation is being stifled.

In recent years there has been a seismic shift in the way that doctors practise. The mantra that young, fledgling doctors repeat to themselves endlessly is “evidence-based practice”. On the face of it, this seems sensible. Of course doctors should only prescribe or recommend treatments for which there is a clear, empirical evidence base. Modern medicine is founded on the principles of scientific inquiry; a hypothesis is put forward, tested and proved or disproved. But, as any doctor will tell you, in real life things are a lot messier than that, and nowhere more so than in cancer management.

Here, evidence is not always as clear and decisive as we would wish it to be. When I worked on a paediatric cancer ward a few years ago, I remember being struck by how little evidence was available to support many of the treatments that were at the clinicians’ disposal. While evidence-based practice is noble in theory, in reality, it’s simply not always realistic, given the complex nature of cancer when its multiple variables, contributing factors and idiosyncrasies are taken into account. This is what makes medicine as much an art as a science.

But worryingly, while doctors know that evidence-based medicine is not always the best choice for treating their patients, they have, in recent years, become increasingly scared of deviating from the standard treatments available to them, even if these don’t appear to be working. One man is trying to change this. Maurice Saatchi, the advertising guru who sits in the House of Lords, last week launched his Medical Innovation Bill, with the specific aim of changing the current culture within medicine that makes doctors fearful of the new and untested. I give it my wholehearted support because I despair at the way medicine is heading.

It’s a tragic indictment of modern medicine that too often innovation is jettisoned in favour of the status quo – not because it’s in the patient’s best interest, but because of the fear of being sued. This defensive medicine is at the heart of so much clinical practice now. Several factors have coalesced to create an environment whereby evidence-based medicine is something to hide behind, rather than simply a gold standard to inform decision-making.

The seeds of this defensiveness were sown in the medical profession’s consciousness following the fall-out from the Harold Shipman case. One of the unintended consequences of the regulation that came in as a result was that, suddenly, doctors and what they did for their patients was under incredible scrutiny. It was no longer assumed that the doctor would, de facto, have the patient’s best interests at heart. The authorities became increasingly suspicious of doctors and what they got up to behind the closed doors of their surgeries. A culture of fear crept into the medical profession. This was against the backdrop of the insidious creep of the compensation culture and the rise of the no-win no-fee lawyer.

Also, as hospitals have become run increasingly like businesses, so a new ruling class has emerged from within health care – the managers. They tend to be wary of any innovation or deviation from protocol that might expose the hospital to litigation risk. With often little or no experience of health care at the coalface, they struggle to grasp the speed, daring and courage needed for medical innovation. So they hide behind protocols and policies and mete out punitive consequences for any clinician who deviates from them. Protocols have solidified into monolithic rules – not to help patients but so they could be waved across a courtroom to defend the hospital against complaints.

The current climate has resulted in a loss of professional autonomy and transmogrified doctors into tick-box automatons, no longer guided by guidelines but strangled and suffocated by them. Mavericks used to flourish in medicine, but they have now been stamped out – branded unacceptable variables of unpredictable risk.

All of this has coalesced to mean that the fear of being sued has ruined modern medicine. It’s not good for the doctors, who are constantly questioning what they do and don’t do – not on behalf of the patient, but because they fear having to justify what they are doing in front of cross-examination. And it’s not good for patients, who are denied the chance of cutting edge, untested and unlicensed treatments when they have little or nothing to lose. Things that might be in the patients’ best interests are not pursued, meaning that nothing moves forward for them, or indeed future generations.

It’s this that the Saatchi Bill is designed to address. Its origins lie in Lord Saatchi’s devastation as he watched his wife, the novelist Josephine Hart, die of ovarian cancer last year. He has managed to turn his grief and sense of loss into something that has the potential to bring untold benefit to future sufferers.

The drafting of the Bill, Lord Saatchi explains, is designed to safely advance the freedom of doctors to innovate and strive for advancement, rather than simply accept the status quo because it means that no one can sue them. This doesn’t mean that doctors will have free rein to experiment on a patient. They are still bound by professional guidance and their duty of care still remains to their patient. But what it does mean is that, in cases where the evidence is shaky or wanting, or is not yet clear, the Bill sets out a code by which doctors can try alternatives. In this way, it actually offers the patient more security than they have at present because it provides, for the first time, a robust legal framework to encourage responsible innovation in diagnosis and treatment.

One in three of us will get cancer. If the survival rates are going to improve, doctors must be free to innovate, and this is what Lord Saatchi’s Bill does. I hope our politicians can see this, too.

→READ in the Telegraph: Dr Max Pemberton writes about why he supports Maurice Saatchi’s Medical Innovation Bill in the Telegraph.

What is the Medical Innovation Bill ?

The Medical Innovation Bill is designed to help medical doctors innovate new treatments and cures safely and responsibly for cancer and other diseases.


Lord Woolf
Lord Woolf

“At the moment, the doctor’s hands are tied – by concerns about professional reputation and potential negligence claims,” says Lord Woolf.

“That needs to change.”

Lord Woolf, Former Lord Chief Justice, former Master of the Rolls.

He was the first Lord Chief Justice to be President of the Courts of England and Wales.


Sir Michael Rawlins
Sir Michael Rawlins

“The Saatchi Bill will allow responsible innovation.” says Sir Michael Rawlins.

“From trying out things in individual patients, that can lead onto research and benefit thousands of other patients.”

Sir Michael Rawlins is Chair of Medicines and Healthcare Products Regulatory Agency, former chairman for National Institute for Health and Clinical Excellence (NICE) and President of the Royal Society of Medicine


The Saatchi Bill Consultation is over – what happens now?

Department of Health - Medical Innovation Bill
Department of Health – Medical Innovation Bill

The Department of Health’s consultation into the Medical Innovation Bill has closed and we now know that the evidence demonstrating a need for the Bill is compelling.

So far, more than 18,000 people ¬– including patients, doctors, researchers, scientists and charities – have responded to the consultation supporting the Bill, many confirming that they have experienced the deterrent effect that an increasingly risk-averse culture is having on responsible medical innovation.

The Saatchi Bill team is grateful for all the comments and input we have received throughout the consultation period. Thank you for your help and support.

All the concerns expressed about the Bill have been heard and a new draft Bill is already in play – it remains true to the core principles of nurturing the innovator and protecting the patient, but is clearer on the process that doctors must go through if they are to innovate safely.

The Bill team will publish a guide showing how the new draft Bill meets concerns expressed by legal and medical professionals. (For those lawyers reading this, it will make it clear that Bolam-Bolitho still stands and that the Bill will not support reckless experimentation).

At the same time, the new Bill will hold fast to our guiding principles. Doctors must be given the freedom to innovate responsibly, with the confidence that the law will protect them if their decision is made with the support of a responsible body of medical opinion and consultation.

They must not be forced to wait until their decision is tested in expensive and traumatic litigation or disciplinary proceedings. Nobody wants that, except perhaps a small group of lawyers who make their living from the existing litigation-focused system.

The Bill will be an opportunity for all those who are concerned that the legal system is not properly serving patients with rare diseases, whose hope rests entirely on innovation.

Patients want to know that every responsible avenue is being explored in order to help them, and that doing nothing is no longer the easy and safe answer.

And patients will still be protected from negligent treatment. A doctor who harms a patient through bad practice or negligent treatment or who makes a mistake can still be sued. Bad doctoring is still bad doctoring and a mistake that causes damage, remains a mistake.

Good doctors must be given the protection and encouragement of the law to innovate safely and responsibly.

And bad doctors must be deterred from innovating without support of their colleagues.

The Bill achieves both aims.

So, what happens next?

Jeremy Hunt promised to pass the Bill into law if the public wanted it. You have spoken and you have said, clearly and in numbers, that you support the Bill.

Civil servants in the Department of Health will analyse the results and then make a recommendation to Jeremy Hunt whether to support the Bill or not.

We are confident that he will.

It will then be up to the Government to find time to bring the Bill before Parliament for debate and to be passed in to law. This should happen before the next election.

The new Bill and the guide will be published shortly.

33 days to make medical history

Right now, the government is deciding whether to pass a new law, the Medical Innovation Bill, that will help doctors to find new treatments safely and responsibly for cancer and other diseases.

In order to spread the word further and faster we have launched a change.org petition. Please SIGN and share with your friends.

Alex Smith, CEO Harrison’s Fund, explains how the Bill could help his son Harrison, 8, who has Duchenne – a 100% fatal condition – and those with cancer and other diseases it is a matter of life and death.

Standard treatments for rare cancers and other less common diseases often don’t work. And in many cases they haven’t changed or been improved for years.

This leaves the patient with a terminal illness no hope, no choice and no chance.

The law makes it hard for doctors to try new treatments – even when they know that standard procedures are not going to cure the patient.

Offering only the standard procedure guarantees the doctor will not be sued.

Safely trying something new leaves the doctor open to litigation and the loss of his or her job.

This is why current law is a barrier to innovation – it creates a culture of defensive medicine in the NHS.

The Medical Innovation Bill will remove this barrier and help doctors innovate safely on behalf of their patients.image

Harrison, 8, has Duchenne Muscular Dystrophy, the Bill could help him access treatments.

Jeremy Hunt, Health Secretary, said he would pass the Bill into law but only if the public say they want it.

Hunt said: “The government should do whatever is needed to remove barriers that prevent innovation which can save and improve lives. The Medical Innovation Bill…correctly identifies the threat of litigation as one such barrier.

There are 33 days left of the Department of Health public consultation and we need your voice.

Help us ensure the Government keep their promise.

Sign the petition: http://chn.ge/1pqY6lS

Read about Alex and Harrison here

Find out more about Harrison’s Fund

Cardiff consultation: Answers to questions that came via Twitter

During the recent Department of Health public consultation meeting in Cardiff (18 March 2014) attended by doctors, academics and patients, we got some questions on Twitter we discussed.

Sean Kielthy – @LMKPartnership – in particular asked three questions which sum up what many others are asking.

Sean asked:

1. ‘Defining experts [in the Bill]. A homeopath may be an expert in their field. How do we stop them getting in?’

Answer: The Bill can only be used by qualified and registered doctors. The term ‘doctor’ is a legal one and homeopaths (for example) would not be protected by the Bill, if it became law.

Basically, you have to be a legally-recognised doctor. If not, the Bill doesn’t cover you.

2. ‘How do we keep the quacks out? [I want] science-based medicine only’.

Answer: Apart from the answer above – that you must be a doctor to be covered by the Medical Innovation Bill – you must also get the agreement of a panel of medical experts and other doctors before you offer a new treatment to the patient.

It is inconceivable that a quack doctor, treating a terminally ill patient, who comes up with a crazy ‘snake-oil’ treatment would get the support of a panel of other senior doctors.

To get agreement, the doctor will have to produce evidence or coherent reasons and a theory as to why the new treatment is worth considering.

The supporting doctors will be named as part of the sign-off process. At the moment, it is possible for a doctor to act alone without the agreement of senior and qualified peers.

So the Bill makes it harder for a quack to prey on a patient. After the Bill is passed, they will not be able to act alone.

3. ‘People in these situations [patients who are very ill] can be desperate. [I] don’t want to see quackery used and funding taken from science.’

Answer: Quacks will not be able to hide behind the Bill. In fact the Bill will expose quacks.

There is another question here, though – the cost of innovation. Will the Bill cost money? There is no logical reason to say that it will. An innovation may cost, it may cost less or it may cost nothing.

For example, it may conceivably be an innovation to do nothing. There are examples where it is felt that adjuvant chemotherapy for certain cancers may be at best only marginally beneficial, and that the associated potential side-affects of the treatment may outweigh the standard chemo treatment.

In this case, doing nothing would be an innovation. (This is not to advocate in any way that not having chemo is a good thing – it is simply a generic example).

However, if people argue that innovation costs money and that the Bill will inspire innovation and new and better treatments, then that is not an argument against the Bill – it’s an argument against all medical innovation and medical progress.

The Bill won’t divert resources from science. The Bill will help individual doctors help individual patients on a one-off basis.

By trying new ideas and techniques in this way, doctors will learn and the data they collect can be used by other doctors and scientists to inspire full medical trials and scientific discovery.

The Medical Innovation Bill works hand-in-hand with science to deliver new treatments for hard-to-cure diseases.

 

Department of Health Medical Innovation Bill events

The Department of Health are hosting public consultation events in Leeds, Cardiff and London.

The Department of Health say:

The Department of Health on behalf of HM Government is proposing to clarify the law in certain circumstances in order to encourage responsible medical innovation.

Medical innovation has been vital to the dramatic rise in life expectancy of the last century. This country has a proud heritage of medical innovation from Alexander Fleming and the discovery of penicillin to Sir Peter Mansfield’s enabling of magnetic resonance imaging.

However, where doctors are innovating outside of a research study, one of the barriers to improved treatment is the possibility of medical negligence claims and the pressure this can place on doctors to practice defensive medicine.

Consequently, instead of becoming the latest medical pioneers, doctors may feel obliged to follow standard treatments, even where those standard treatments have poor outcomes.

The Government is committed to doing whatever is needed to remove barriers that prevent innovation which can save and improve lives.

We must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment.

It is important to be clear that we are not suggesting that doctors are concerned about the possibility of a negligence claim in relation to all the treatment decisions they take.

However, where there is insufficient or no evidence about the effects of a treatment, a doctor may hesitate to offer it.

We are keen to hear views, especially from doctors, on whether medical innovation is being unduly constrained by the possibility of litigation where there is insufficient or no evidence about the effects of a treatment that might otherwise be offered.

We also want to hear from patients whose experience suggests that the possibility of litigation has been a factor in their doctor’s attitude to possible innovation.

This event is an opportunity for those with an interest to join us to discuss the issues in order to inform the formal consultation process. Click here to view the online consultation.

If you are unable to attend this event, you may prefer to attend the following alternative events around the country:

The dates are as follows:

Cardiff
18th March 2014
13.30-17:00

Leeds
2nd April 2014
13.30 – 17:00

London
10th April 2014
13:30-17:00

Please note these events are organised by the Department of Health.

Daily Mail: ‘It could lead to a cure': Jeremy Hunt praises Saatchi’s bid to overhaul ‘medieval’ cancer care

Lord Saatchi and Josephine Hart

→READ: article in the Daily Mail

By Stephen Adams for The Mail on Sunday

Advertising guru Maurice Saatchi, whose wife died of ovarian cancer, has won Government backing for his private member’s Bill calling for more innovation in treatment of the disease.

When novelist Josephine Hart died two years ago, the Tory peer described her treatment  as ‘medieval’.

Lord Saatchi has since fought to enable doctors to use procedures other than surgery, radiotherapy and chemotherapy.

He argued they are too often hamstrung by legal rules which mean they can be sued if they ‘deviate’ from standard treatments, even if they know it will do little good.

 The peer, founder of advertising giants Saatchi  & Saatchi, sponsored the Medical Innovations Bill to reduce the threat of litigation and ‘encourage responsible innovation’.

And on Friday, Health Secretary Jeremy Hunt praised the Bill, saying it ‘could lead to major breakthroughs, such as a cure for cancer’

Mr Hunt announced a ‘full and open consultation’ in the New Year to understand ‘the problems [doctors] face in innovating’ and strike ‘the right balance between innovation and safeguards’.

Last night, Lord Saatchi said: ‘I think the  Prime Minister and the Secretary of State want Britain to regain its place as the world leader  in medical innovation.’

He stressed patient safety was at the heart of his proposals. ‘We do not want reckless experimentation that puts patients at risk, and we don’t want patients to be treated like mice,’ he said.

Obtaining informed consent to take part in experimental treatments would remain essential, the peer stressed,  and doctors would retain full legal responsibility for  their decisions.

→READ: article in the Daily Mail