Tag Archives: nhs

Guest blog: Saatchi Bill and Medical Anecdotes

By scientist Pan Pantziarka, a scientist in the UK employed by the Anticancer Fund of Belgium. Pan works on drug research as part of the Repurposing Drugs in Oncology project

Re-blogged with permission from  anticancer.org.uk

 

Opponents of the Medical Innovation Bill (aka as the Saatchi Bill), such as Sarah Wollaston MP, have been very vocal in attacking the Bill by making a number of false claims about what the Bill will do.

One such argument is that the Bill will undermine medical progress by doing away with clinical trials, and that instead we will just have to rely on individual anecdotes that arise from doctors using innovative off-label treatments on patients. In fact Sarah Wollaston even referred to the Bill as the ‘Medical Anecdotes Bill’ in her recent speech in the House of Commons.

There are a number of points that to raise in response to this false assertion.

First, there is no intention to replace clinical trials. The Bill is about treating patients with no place left to turn – these are people who have exhausted standard therapies and for whom there are few options left to explore. If a clinical trial is open and the patient is eligible then that is the place to go if it is in the patient’s best interest. There may be cases where it is the right thing to do, just as there are cases when it will not benefit the patient who is offered the additional choice of an non-standard treatment (for example an off-label drug with evidence of clinical activity in the patient’s illness). This will be decided on a case by case basis, what it will not do is force doctors to ignore clinical trials or undermine the trials process.

We also have to keep in mind that for many rarer cancers, genetic conditions and chronic illnesses there are few clinical trials available. Just as important, even when there are clinical trials open, many patients may not be eligible because of prior treatments, confounding conditions, age or physical status restrictions and so on. What are patients supposed to do when they cannot gain access to clinical trials?

Many of the opponents of the Bill act as if there are no unmet patient needs, as if every patient has access to trials and that there is no need to consider alternatives.

Secondly, rather than leaving us with a collection of anecdotes, the Bill offers the prospect of making a huge step forward in medicine through the creation of a central database to record patient data.

This database will be hosted at Oxford University, and work is progressing with the Department of Health to work out the details. A central database which will record each patient’s details, the treatment they receive and their outcomes is actually a hugely advance in medicine.

With all of the patient data recorded we do not have a collection of anecdotes but a database that we can mine and explore and use to design clinical trials based on the signals we can glean from real patient data. It also means that non-standard treatments that work can be identified more quickly, and just as importantly those that do not work can also be identified and discouraged.

This isn’t a replacement for the clinical trial, it’s an advance on the system we now have.

The central database is really the essential piece that makes the Bill so compelling. It offers doctors looking for innovative treatments a chance to explore and learn from the experience of their colleagues.

Many of the opponents of the Bill suggest that it is not needed – they claim that doctors are already free to innovate and explore non-standard therapies. But what is not in place now is a standard process for this to occur, nor a method by which doctors can learn from each other and help to evolve the breakthroughs we so badly need.

And, finally, a central database means that patient safety will be increased. As all data has to be recorded, those unscrupulous individuals prescribing crank treatments will have to reveal their data, they will no longer be able to keep their results away from scrutiny as they now can.

About the author:

Pan Pantziarka is a scientist in the UK employed by the Anticancer Fund of Belgium. He works on drug research as part of the Repurposing Drugs in Oncology project. He is also the co-founder and chairman of the George Pantziarka TP53 Trust, the only charity in the UK dedicated to supporting families with an inherited cancer predisposition condition called Li Fraumeni Syndrome. He lost his first wife to ovarian cancer when she was 29, and his son George died in 2011 at the age of 17 from osetosarcoma.

Further reading:

→READ: Oxford University offer to host the database

→READ:Prof Walker writes – there will never be enough clinical trials

 

 

House of Lords report stage

On Friday 12th December 2014 the House of Lords report stage for the Medical Innovation Bill took place.

The Bill has now moved through to a third reading stage.

Watch the full debate here

→READ: The debate in Hansard

→READ: The Bill as amended in report stage

→READ: All the documents relating to the Bill and the report stage debate

A few highlighted extracts :

Lord Saatchi (Con): Before I start, I will take a moment to echo what the noble and learned Lord, Lord Woolf, said. He described the discussions about the Bill at all its stages as being your Lordships’ House at its best. I so agree.

I said in the debate in the Moses Room last week in the name of the noble Lord, Lord Kakkar, that the experience of watching your Lordships’ House debate and discuss the Bill is, as far as I am concerned, a tremendous privilege to be able to hear the greatest legal and medical minds in the country at work.

I thank the noble Lord, Lord Turnberg, for saying that there had been a constructive process of listening to Peers’ views as expressed in Committee. I am also grateful for the view expressed by the noble Baroness, Lady Wheeler, that the Bill team and the Department of Health have behaved constructively since Committee.

I have really been only a witness to the toing and froing between Peers whose views were expressed in Committee and the Department of Health through our own Bill team.

It will not come as any surprise to your Lordships that this has been a really admirable process of the officials and the legislation department in the Department of Health listening carefully and trying to respond, and I certainly have appreciated that hugely. I know your Lordships will agree.

I also thank my noble friend the Minister for her clarification of the Government’s position on many of these amendments.

 

Baroness Wheeler (Lab): My Lords, as this is the first contribution from the Front Bench to the discussion of today’s amendments, perhaps I may again place on the record our support for the key principles and intent of the Bill.

As we stress, Labour has always strongly supported efforts to bring innovative treatments to patients faster, and we underline the need for a major effort by government to address the barriers and bureaucracy that prevent progress being made and ensure that innovations are rapidly transcribed into practice.

The noble Lord, Lord Kakkar, recently held a short debate in the Moses Room on the impact of innovation and research strategies on health improvement. It provided an excellent overview of the key issues, the progress being made, and the problems still to be addressed.

We are keen to ensure that the Bill of the noble Lord, Lord Saatchi, is seen in the context of this wider, bigger picture.

I know that the noble Lord accepts that his Bill will be one measure in the broader landscape of what needs to be done.

Along with my noble friend Lord Turnberg, I am also grateful to the noble Lord for the efforts he has made to address the issues and concerns raised by noble Lords across the House.

In Committee we underlined our broad support for the changes—the “Sir Bruce Keogh amendments”, as they are now known—which have been made to ensure patient safety and safeguarding.

We also found the round-table discussions for Peers that were organised by the noble Lord following our suggestions in Committee very valuable and useful.

Again, we are broadly supportive of the new amendments he has brought forward today, which are the result of the discussions, on emergency care, on the recording of key information in the notes of the patient receiving the treatment, on excluding cosmetic surgery from the scope of the Bill, and on ensuring the preservation of the existing law about clinical trials and other forms of research.

Lord Woolf (CB): The progress of the Bill has been a remarkable example of this House at its very best.

The Bill has been very carefully scrutinised by people who have immense knowledge of the areas covered in the Bill.

That does not mean that anything said by a particular Member of the House with undoubted expertise in this area is necessarily right in this matter.

As is the case with many Bills, sometimes more than one profession can be involved.

I suggest that this is an example where two professions, which in the past have been guilty at times of excessive conservatism, are involved and have been loud in some of the things that they have had to say.

The other profession of which I am thinking is my own; lawyers are not always celebrated for their innovative approach.

They have improved from the situation of not so long ago. They are more ready to accept change—indeed, they have been forced to accept it—than they willingly would have done in the early days when I was practising.

I have been criticised in letters I have received in a way in which I perhaps am not accustomed for my involvement in the Bill sponsored by the noble Lord, Lord Saatchi.

Those who have asked me to identify cases by name and reference so that they can analyse the cases and show how they do not help any particular argument might be relieved to hear me say that if they want to know where I come from, I wrote a little book called The Pursuit of Justice.

I focused on the medical profession at that time because I found that its conservatism was interfering with the pursuit of justice.

As far as victims were concerned, one of the most difficult areas of litigation in this country was clinical negligence cases.

Both sides in those cases were put into great difficulty because of that conservatism. On one side were the patients who often wanted the doctors to say sorry. On the other side were the doctors who felt that they could not say sorry because if they did they would be admitting liability for negligence. So the two never met—and that, I am afraid, can happen.

I listened very carefully to the graphic examples given by the noble Lord, Lord Winston, of where he thought that the Bill could be a problem.

In his first example, he said that there was a difference of opinion between his anaesthetist, who did not think that an unusual and innovative form of intervention was appropriate, and the noble Lord, who thought that it was appropriate in the circumstances.

Happily, he took the initiative and acted in an innovative way. But if one pauses and thinks about what would have been the position under the Bill as it is at present, would it have made the situation more difficult or would it have alleviated the situation?

I suggest it is quite clear that it would have done neither.

 

Medical Innovation Bill – adjournment debate

George Freeman during Bill Adjournment debate
George Freeman, MInister for Life Sciences, speaking during the adjournment debate

Yesterday December 10, 2014 Sarah Wollaston MP was granted leave to hold an adjournment debate on the Medical Innovation Bill.

The Bill team were also invited to meet Dr Wollaston earlier in the week to discuss the Bill. We thank her for that meeting and for requesting the debate.

During the debate Dr Wollaston raised several important points about the Bill, which could formally come to the Commons in early January.

The points revolve around patient safety and scientific rigour – issues which have been raised by senior doctors and lawyers in the House of Lords and which have been discussed with peers in committee and in bilateral meetings with Lord Saatchi, health ministers Earl Howe, George Freeman and Department of Health lawyers and officials.

On the back of these meetings, amendments have been laid which address the issues raised, and they will be further debated on Friday (December 12) in the Lords.

Edit: This debate has now taken place. Read here.

Chief Medical Officer Dame Sally Davies and NHS chief Sir Bruce Keogh, who has inputted into the Bill himself, remain satisfied that the Bill is robust, safe and will enhance, not hinder scientific research.

Summing up in favour of the Bill, Minister George Freeman said:

‘I want to close with some supportive quotes the Bill has received from a number of important people, lest the House should form the view that it is unanimously opposed, which is not the case.

 

Dame Sally Davies, the chief medical officer, has said:

“I am confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation.”

 

Sir Bruce Keogh, Medical Director of the NHS, said:

“Encouraging innovation in medicine and protecting patients are both of vital importance. That is why I am pleased that amendments have been devised to address concerns about patient safety.”

 

Sir Michael Rawlins, president of the Royal Society of Medicine, said that the Bill will allow responsible innovation and treatment:

“I believe the use of the provisions in the draft Medical Innovation Bill will benefit patients, especially those with rarer diseases, and the furtherance of medical science.”

 

A letter to The Telegraph from 40 leading medical professionals, including David Walker, professor of paediatric oncology at Nottingham university and Riccardo Audisio, the president of the Association of Cancer Surgery, said the Bill

“legally protects doctors who try out innovative new techniques or drugs on patients when all else has failed. This Bill will protect the patient and nurture the innovator. It will encourage safe medical advancement, while at the same time deterring the maverick, thereby recalibrating the culture of defensive medicine. Finally, it will work with evidence-based medicine and provide new data that will inspire and support new research.”

I hope very much that that is the case and that when the Bill leaves the House of Lords, the vast majority of qualified senior opinion in this field is able to agree with it. It is absolutely our intention to support the Bill’s noble intent to promote medical innovation, but equally our intention is to not undermine in any way the Government’s commitment to patient safety or the duty of care that all clinicians share and owe to their patients.’

→Read: The full text in Hansard 

 

 

Why the Medical Innovation bill will be safer for patients

Surgery medical innovation from Flickr by Phalinn

Critics of the Medical Innovation Bill like to say that patients will be at risk from doctors trying out new treatments because they will somehow be protected from negligence claims.

This is wrong for two reasons. A patient will be safer under this bill than under current common law.

First, a doctor wishing to rely on the bill must obtain the views of at least one other qualified doctor experienced in the patient’s condition.

This must be done in advance of treatment. Under current law, a doctor does not need to consult with colleagues; there is no legal requirement to take account of, or even obtain, the views of other doctors.

Therefore, the Medical innovation Bill is a step forward for patient safety.

It has been argued by some that the necessity to obtain the views – while not requiring their full agreement – is also a danger. This is not so.

A doctor wishing to innovate under the bill could not ignore advice because no judge would find in favour of a doctor who proceeded with an innovation against the advice of colleagues.

The Bill obliges the innovating doctor not only to seek the views of others before treating the patient, it also obliges the doctor to obtain all the standard consents necessary under current law.

Hence, a doctor must do what he or she does now AND build consensus for his or her innovation as well.

Therefore, those who like the current innovation process will welcome the Medical Innovation Bill for adding an extra level of patient protection.

Ovarian cancer kills too many women – pass the Medical Innovation Bill

Athena Lamnisos, CEO, The Eve Appeal, writes a letter to the Telegraph.

Ovarian Cancer kills too many women - pass the medical innovation bill
Ovarian Cancer kills too many women – pass the medical innovation bill

SIR – The Medical Innovation Bill reaches a crucial committee stage in the House of Lords today. Spearheaded by Lord Saatchi, whose wife died of ovarian cancer – a disease he quite rightly describes as “relentless, remorseless, merciless” – the Bill will make it easier for dying patients to access untested drugs and treatments.

The statistics for ovarian cancer are woeful: the number of deaths has barely changed in 30 years. So, unquestionably, something needs to change dramatically.

Innovation in treatment is important, but with gynaecological cancers it is innovative research into risk prediction, prevention and earlier detection that is going to make the most difference and save more women’s lives.

The statistics for cervical cancer are astounding by comparison: there has been a 70 per cent decrease in deaths over the same 30-year period thanks to advances in screening.

Investing in finding a cure for cancer is important, but we shouldn’t ignore investing in earlier detection.

Athena Lamnisos
CEO, The Eve Appeal
London W14

→READ: in the Telegraph

→VISIT: the Eve Appeal

Telegraph: If it works for Ebola, it can work for cancer

Read the article in the Telegraph
Read the article in the Telegraph

In the Telegraph today Lord Saatchi writes: ‘If it works for Ebola, it can work for cancer’

How do the conditions imposed by the WHO on ZMapp compare with the conditions set in the Medical Innovation Bill?

Read the article in the Telegraph 

It is hard, when confronted with pictures and reports detailing the Ebola outbreak in Africa, not to shake one’s head in pity. What medical facilities there are, we hear, are overwhelmed by the scale of it. So it is extraordinary to learn that Liberians dying of Ebola have better access to groundbreaking, potentially life-saving new treatments than do people dying of cancer here in Britain.

The Ebola treatment in question is ZMapp, an experimental serum which has not been tested on humans in medical trials, but was none the less given to two American doctors – Kent Brantly and Nancy Writebol – who were infected while working in Liberia. Both have now made a full recovery. Three infected African medics who have received ZMapp in Liberia are also reportedly doing well. Now a British doctor, infected with Ebola while working in Sierra Leone, is to be returned to this country for treatment at the Royal Free Hospital in north London.

The reason that such patients are able to receive ZMapp is because an ethics panel at the World Health Organisation has decided that, given the magnitude of the Ebola outbreak, a departure from standard evidence-based treatments is justified. Potential treatments that have shown promising results in the laboratory but have not been evaluated for safety and efficacy in humans are, in certain conditions, now acceptable on both ethical and evidential grounds, the WHO says.

Few doubt that the gravity of this outbreak of Ebola, which has killed about 1,500 so far, requires a response by all means necessary. Yet in Britain today the toll of another disease – cancer – is 100 times higher, and access to such experimental treatments is not available, even for those desperate patients beyond the help of current medicine.

Some 150,000 British citizens will die from cancer this year, making it the number one cause of untimely death. And while the disease may have a different name, our response should be the same as with Ebola – doctors should be encouraged to try new treatments, and be protected when they do so. Importantly, the Medical Innovation Bill, now before Parliament, will allow doctors and their patients in Britain to try treatments that have not been tested or fully trialled.

Inevitably, there are objections that the Bill’s restrictions and conditions placed on doctors are too lax – that they can play fast and loose with vulnerable, dying patients. So it’s worth looking at the conditions imposed by the WHO on ZMapp to see how they compare with the conditions set in the Medical Innovation Bill.

First: lethality. On Ebola, the WHO panel agreed that the threat posed by Ebola, with its “high case-fatality rate” was sufficient to warrant the use of experimental therapies. The Medical Innovation Bill is explicitly designed to achieve the very same result. This is why the Health Secretary, Jeremy Hunt, said about the Bill that “the Government should do 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.” The Secretary of State wisely asked Sir Bruce Keogh, the medical director of the NHS, to devise the legislative safeguards to be included in the Bill.

Secondly, ethics: the WHO rightly sets a high ethical standard for use of ZMapp, including “transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community”. The Bill echoes this ethical standard, requiring informed consent of the patient, or the patient’s representative, and full transparency. Indeed, the Bill goes further than the WHO guidelines, stating that in order to depart from the existing range of accepted medical treatments, a doctor must also obtain the views of at least one other relevantly qualified doctor, carry out a full risk assessment, and obtain any other consents required by law.

And, of course, while the WHO offers guidelines, the Medical Innovation Bill is backed by the full force of the law.

Finally, WHO guidance requires that all data generated by the use of ZMapp should be collected and shared. If scientific progress is to be made through such experimental use of untested treatments, results must be available to the scientific community. The Bill will secure this. The University of Oxford has offered to create a database to register innovative medical interventions under the Bill and to collect and share the data from them, so that they may inform and inspire clinical trials. As Sir John Bell, Regis Professor of Medicine at Oxford, said: “There will be no cure for cancer until real doctors with real patients in real hospitals are allowed to innovate.”

So those of us who have cheered the use of an untested drug to help apparently hopeless cases in Liberia should cheer the Medical Innovation Bill. It will help medical science progress, aid researchers in their hunt for cures for fatal diseases – and offer hope to the 300,000 Britons who will be diagnosed with cancer this year.

Read the article in the Telegraph 

The Times: Saatchi pushes for cancer drug freedom

Saatchi pushes for cancer drug freedom - Medical Innovation Bill
Saatchi pushes for cancer drug freedom – Medical Innovation Bill

By Laura Pitel Political Correspondent

→Read in The Times

People who receive a cancer diagnosis suffer a fate worse than death by firing squad, a Conservative peer said yesterday, as he called for doctors to be granted the freedom to try out new treatments on patients.

→Watch: Medical Innovation Bill House of Lords debate 27th June 2014

Lord Saatchi, the advertising guru, said that execution methods such as hanging and the electric chair were less harrowing than wasting away with cancer. “Death by hanging, by firing squad, by electric chair: no human being has devised a more brutal execution than death by cancer,” he said.

“These cancer-condemned suffer a worse fate than the worst mass murderer. While they await execution they are tortured. For them, hair loss is the good news. Less good news is their treatment regime. The drugs, the cycles of their administration, the surgical procedures are often 40 years old.”

Lord Saatchi argued that the law acts as an impediment to finding a cure for the disease. He has introduced a bill that aims to give legal protection to doctors who experiment with different procedures or treatments when all other options have been exhausted.

Under present legislation, he said, doctors worried that they could be found guilty of medical negligence if they deviated from “standard procedure”.

Introducing the second reading of his Medical Innovation Bill in the House of Lords, he said that the proposals would lift the fears from doctors’ shoulders by defining “responsible innovation” and setting out a framework for them to find new cures. They would have to consult colleagues and discuss the options with patients, he said.

The peer has been campaigning for changes to the law since the death of his wife, Josephine Hart, the novelist, from ovarian cancer in 2011. More than 40 medical professionals have backed his idea.

Earl Howe, the health minister, said that there was a delicate balance between encouraging innovation and ensuring patient safety, but said the latter should not stifle the former.

The government has suggested some amendments to the bill to strengthen oversight. Lord Saatchi said that he would adopt these suggestions.

→Read in The Times

Telegraph: Sir Bruce Keogh, medical director NHS, proposes new safeguards for Medical Innovation Bill

In the Telegraph today : Doctors will have to obtain agreement from specialists in other hospitals before trying untested medical treatments on patients, under new amendments to the Medical Innovation Bill.

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

The amendment, proposed by the Department of Health, comes after a meeting last month with the Medical Innovation Bill team, Jeremy Hunt, Health Secretary, and officials and representatives from the professional bodies.

 

The Telegraph reported on 1st June 2014 that Sir Bruce Keogh, the medical director of the NHS, had been asked by the health secretary to decide how safeguards would work in practice.

Sir Bruce Keogh Medical Innovation Bill safeguard
Sir Bruce Keogh Medical Innovation Bill safeguards

READ: in the Telegraph today

By Christopher Hope and Laura Donnelly

A new Bill to allow dying patients to try untested medicines could be eased through Parliament by new safeguards proposed by ministers requiring doctors to seek an independent opinion.

Lord Saatchi, the advertising magnate, has been campaigning for changes in the law following the death of his wife Josephine Hart from ovarian cancer.

The Medical Innovation Bill would allow doctors to try out innovative new techniques or experimental drugs on patients, without the fear of prosecution, when all else has failed and patients are nearing the end of their life.

A public consultation showed overwhelming backing for the idea, but some medics have raised concerns that the bill could promote “reckless practice” and quackery.

The new amendment, proposed by the Department of Health, means doctors would have to secure the agreement of specialists in other hospitals before trying out untested medical treatments.

The change is being proposed ahead of the Bill’s second reading in the House of Lords on Friday.

Jeremy Hunt, the Health Secretary, is hoping that the extra safeguard for patients will be enough to see off claims from opponents that the Bill is a “quacks’ charter”.

Currently doctors only have to satisfy themselves that the treatment they decide to give patients would pass the “Bolam test – based on a 1957 medical negligence ruling – that an average doctor might have taken the same view.

To do so, doctors often seek the opinion of peers in their own hospital.

The amendment to the Medical Innovation Bill would require them to go outside the hospital to seek specific consent from other specialists in the field to pass this test.

Whitehall sources said that this was to stop “dominant personalities” in a hospital – perhaps a senior consultant – getting their own way.

Mr Hunt committed to bringing in safeguards at a meeting of officials and representatives from the professional bodies last month.

The compromise has been put together by Professor Sir Bruce Keogh, the NHS’s medical director, over the past six weeks.

The source said: “The feeling is that because membership of those teams varies you can have one very strong minded and bossy consultant who says ‘look I am the expert in this area and I think it is a good idea’.

“The Government feeling is that oversight should come from other doctors with experience and expertise in dealing with that condition.”

Lord Saatchi said he was pleased with the amendments. He said: “I greatly welcome the Secretary of State’s invitation to Sir Bruce Keogh to consider the oversight mechanism in the Bill. We will gratefully take forward the safeguards he recommends.”

A Department of Health spokesman said: “NHS England’s Medical Director Professor Sir Bruce Keogh recognises the critical importance of the innovation agenda, and is working with the medical profession to further consider ways of guaranteeing patient safety if the Bill is enacted.”

Telegraph: Huge response to Lord Saatchi’s Medical Innovation Bill

Medical Innovation Bill update published in The Telegraph 1st June

Medical Innovation Bill - Saatchi Bill - huge response to the consultation
Medical Innovation Bill – Saatchi Bill – huge response to the consultation

A public consultation on whether doctors should be allowed to experiment on dying patients with novel techniques has won huge support from the public.

Doctors could be allowed to experiment on dying patients with novel treatments under a new bill brought by Lord Saatchi which looks set to become law.

Jeremy Hunt, the Health Secretary, promised to back the Medical Innovation Bill if it was supported by the public.

It allows doctors to try out innovative new techniques or drugs on patients, without the fear of prosecution, when all else has failed and they are nearing the end of their life.

Since the death of his wife, Josephine Hart, to ovarian cancer, Lord Saatchi has campaigned to change the law.

A public consultation which has just closed showed overwhelming support for the proposal. It will be presented to the House of Lords on Thursday.

So far, more than 18,000 people, including patients, doctors, researchers, scientists and charities – have responded to the supporting the proposals.

Dominic Nutt, the director of communications for the Medical Innovation Bill said: “On Thursday, the new, leaner, cleaner Bill, steeled in the furnace of vociferous public debate, will be presented in the House of Lords.

“It remains true to its original two principles: to give doctors legal clarity and confidence when they wish to innovate, and to stop the quack experimenting recklessly on vulnerable patients.

“At the moment, a doctor who uses standard treatments, according to the proscribed guidelines, cannot be sued even if the patient dies. A doctor who deviates, who tries something new, risks ending up in court. “

Presently, a doctor who has tried out a new approach can be taken to court and must pass the ‘Bolam Test’ in which other specialists must defend the procedure.

However under the new bill, a body of medical experts would decide before the treatment so that the doctor was not left wondering if he or she might appear in court.

Sir Bruce Keogh, the medical director of the NHS, has been asked by the health secretary to decide how this would work in practice. He is due to report back this week.

“The Bill simply brings the Bolam defence forward – to the clinic – and cuts out the fear of the long, stressful court case, said Mr Nutt.

The new Bill has been slightly amended so that doctors cannot carry out untested treatment for research purposes, but only in the best interest of the patient.

Lord Saatchi, who introduced the bill in December 2012, said: “Over the past few months, in one of the largest public consultations ever undertaken in this country, the people have agreed that there is a problem with how we are treating some of the sickest in our society.

“We have a culture of defensive medicine in the NHS, a culture created by the fear of litigation that hangs over doctors. Last year, the health service paid £1.2 billion in lawsuits.

“The Bill has obviously touched a nerve. Why? Because people know that all cancer deaths are wasted lives

“If the Bill receives Royal Assent after scrutiny in both Houses of Parliament, good doctors will be protected and encouraged by the law. I hope Her Majesty’s pen is full of ink.”

Read in the Telegraph

 

BMJ: The “Saatchi bill” will allow responsible innovation in treatment says Sir Michael D Rawlins President, Royal Society of Medicine

image

By Michael D Rawlins President, Royal Society of Medicine

Published in the BMJ (British Medical Journal) 15th April 2014

You need to either be a member of the BMJ or to sign up for their 14 day trial.

Many doctors, myself included, will have occasionally tried to treat individual patients – where all else has failed – with novel interventions. This may be where there is no recognised form of effective treatment; or when existing one(s) have not produced the desired effect. The legal basis for doing so, at least for pharmaceuticals, has been the so-called “named patient” provisions of Section 9 of the Medicines Act 19682 which permits any doctor to be able “to sell, procure or supply a medicinal product to a patient under his or her care”.

Although my own experience has been disappointing there have been occasions, when intervening in such a manner, have subsequently led to significant advances. Indeed, such observations are arguably a form of n-of-1 trial.

Confidence in using the “named patient” provisions of the Medicines Act has though become eroded. A number of legal authorities have pointed out that departing from what is regarded as “established practice” or “the standard of care” leaves a doctor open to an action for negligence. The definition of “the standard of care” traditionally follows the Bolam principle2 as amended by the Bolitho decision3 but was forcefully criticised by Lady Butler-Schloss4 in her capacity as President of the Family Division of the High Court:

“The Bolam test ought not to be allowed to inhibit medical

progress. And it is clear that if one waited for the Bolam

test to be complied with to its fullest extent, no innovative

work such as the use of penicillin or performing heart

transplant surgery would ever be attempted”.

The Medical Innovation Bill attempts to rectify this situation. It proposes legislation stating that it would not be negligent for a doctor to depart from the existing range of accepted medical treatments, for a condition, in carefully defined circumstances. These circumstances – allowing for responsible innovation – are laid out in later Sections of the Bill. They include a plausible basis for the use proposed treatment, and an assessment of the risks that could be reasonably expected to be associated with it. The Bill also proposes that, before embarking on such a treatment, the doctor should have discussed it with the patient, the multi-disciplinary team responsible for the patient’s care, and with the Institutions Responsible Officer. The Bill emphasises that its provisions are solely concerned with the patient’s best interests.

The Bill as originally introduced into the House of Lords in May 2013, as a Private Members Bill by Lord (Maurice) Saatchi, and has become known colloquially as “The Saatchi Bill”. The Department of Health is currently consulting on a draft version of it5. I was originally sceptical about the need for the Saatchi Bill but I have been persuaded otherwise. First, it is clear from the comments of Lady Butler-Schloss4, as well as other legal authorities Lord Saatchi has consulted, that there are serious legal impediments in civil law to using therapeutic interventions that do not represent the current standard of care. Second, although Lord Saatchi’s original Bill was confined to patients with malignant disease this restriction has, rightly in my view, been removed in the current draft. There are, after all, many other miserable conditions for which we have no, or very limited, remedies. Third, I did not believe that his suggestion for approval by a multi-disciplinary team, alone, provided sufficient safeguards: the inclusion, now, of agreement by a doctor’s Responsible Officer provides me with re-assurance.

Despite my strong support for the Medical Innovation Bill there are important consequences for the professions when (as I hope) it becomes law:

1) Just because a particular intervention appears to have been effective in an individual patient it cannot be assumed that the results are generalisable. Further research in the form of one or more randomised controlled trials, or case series, will be necessary to establish its effectiveness. To take a recent example, a case report6 describing the apparently successful treatment of generalised juvenile pustular psoriasis with etanercept, requires confirmation before it can be regarded as the current standard of care.

2) There may be occasions when Responsible Officers wish to seek other advice before approving the proposed use of an intervention in accordance with the provisions of the Medical Innovation Bill. This will often need to be provided very rapidly especially when a patient has a life-threatening illness. The Academy of Medical Sciences, or some of the specialist associations such as the British Pharmacological Society, could have an important role here in offering a speedy advice service.

3) If the intentions behind the Medical Innovation Bill are to be fulfilled, NHS hospital Trusts, and their Responsible Officers, will need to look on proposals sympathetically. Anecdotal evidence suggests that too many Trusts are fearful of departing from the prevailing standard of care because of the possibility of litigation. The Bill should provide them with adequate reassurance.

4) It is essential that the results of using the Bill’s provisions, in individual patients, are placed in the public domain whether or not they have been successful. This would allow others not only to learn from such experiences but – especially for interventions that appear to have been successful – to undertake formal research.

I believe that the use of the provisions in the draft Medical Innovation Bill offer benefits to patients – especially those with rarer diseases – as well as to the furtherance of medical science. Subject to the responses to consultation it is the government’s intention to have it on the statute book at the earliest opportunity5.

References

1. Medicines Act (1968). www.legislation.gov.uk/ukpga/1968/67 (accessed 12.04.14)

2. McNair J. Bolam v Friern Hospital Management Committee (1957) 1 WLR 582. www.e-lawresources.co.uk/Bolam-v—Friern-Hospital-Management-Committee.php (accessed 12.04.14)

3. House of Lords. Bolitho v City and Hackney Health Authority (1998) AC 232. www.bailii.org/uk/cases/UKHL/1997/46.html (accessed 12.04.14)

4. Butler-Schloss LJ. Simms v Simms (2002) FAM.83 para 48. www.bailii.org/ew/cases/EWHC/Fam/2002/2734.html (accessed 12.04.14)

5. Department of Health. Legislation to encourage medical innovation. www.gov.uk/government/uploads/system/uploads/attachment_data/file/285272/9959-TSO-2901828-Legislation_to_Encourage_Medical_Innovation.pdf (accessed 12.04.14)

6. Fialová J1, Vojáčková N, Vaňousová D, Hercogová J. Juvenile generalized pustular psoriasis treated with etanercept. 2014;2:105-8. doi:10.1111/dth.12065.

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