Tag Archives: Medical Innovation Bill

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 

 

 

Amendments to be moved on report – 12th December 2014

Following the Committee Stage in the House of Lords on 24th October Lord Saatchi has tabled a set of amendments to be considered on Report on 12th December.

The amendments were prepared by the Department of Health  to respond to concerns raised by peers and others at and around the Committee Stage.

We are very grateful for all the input we have received.

The Bill is going through the usual Parliamentary process and amendments are part of that process.

→READ: The Bill has been amended many times. Why?

→READ: Download the amendments on the Parliament website.

The following explanatory notes have been prepared by parliamentary draftsman Daniel Greenberg.

MEDICAL INNOVATION BILL [HL] EXPLANATORY NOTES TO AMENDMENTS FOR REPORT TABLED BY LORD SAATCHI
ON WEDNESDAY 3
rd DECEMBER 2014

Introduction

  1. On 3rd December 2014 Lord Saatchi tabled a set of amendments to his Medical Innovation Bill to be considered on Report on 12th December.
  2. The amendments were prepared by the Department for Health to respond to concerns raised by peers and others at and around the Committee Stage.
  3. These Notes explain the manner in which the amendments meet the concerns expressed.

Transparency: patients’ notes; and recording outcome of consultation

  1. Some peers wanted details of decisions to innovate to be recorded in patients’ notes.
  2. Peers and others have also expressed a wish to see greater transparency about the nature of responses received by the doctor when undertaking the consultation with colleagues required by clause 1(3)(a) and (b).
  3. Amendment 1 requires the results of the consultation to be recorded in the patient’s notes, together with details of the doctor’s decision to innovate.
  4. There has also been pressure to turn the requirement to consult colleagues into a requirement to obtain colleagues’ written consent. These amendments do not give effect to that suggestion. Senior doctors consulted by Lord Saatchi expressed concern about giving formal written consent to another doctor’s proposed course of treatment, without knowing the full history and other circumstances, while they would be relaxed about expressing a view of the soundness of the doctor’s proposal as described to them. Lawyers consulted were also concerned about a possible new form of legal liability for consenting doctors. The requirement to record views in the patient’s notes should introduce the necessary formality, transparency and accountability, while avoiding both of these objections.

Preservation of existing law about clinical trials and other forms of research

  1. It has always been the intention of the Bill to make no change of the law relating to research (see clause 1(5)). But concerns were expressed that this needs to be made even clearer.
  2. Amendments 2 and 3 are designed to put the point beyond possible doubt.

Exclusion of cosmetic surgery

  1. At the Committee Stage and elsewhere suggestions have been made that the Bill should be confined expressly to the principal kinds of case at which it is aimed, namely relatively rare terminal cancers and other terminal conditions.
  2. Lord Saatchi has reconsidered attempting to define the intended scope of the Bill, but has found it impossible to do so in a way that answers more questions than it raises.
  3. Much of the concern has centred around the potential use of the Bill in relation to cosmetic surgery, and it was suggested that it could at least be made clear that it is not the purpose of the Bill to apply to that.

13. Amendment 4 accordingly excludes cosmetic surgery from the Bill. (Cosmetic surgery can of course in some cases be crucial to life or quality of life – as in the case of severe burns; doctors wishing to innovate in such cases will be able to rely on the existing common law Bolam test.)

Emergency treatment; and preservation of common law

14. Concern has been expressed whether in emergency situations doctors will realise that they are not expected to follow the procedures set out in the Bill.

15. Amendment 5 accordingly introduces a reference to emergencies, as an example of a situation in which the existing common law Bolam test would apply and a doctor might not engage the procedures in the Bill.

16. Amendment 6 recasts the principle that the Bill does not force doctors to rely on its procedures and that they can simply rely on the existing Bolam test in all cases. The new form is designed to meet concerns expressed as to whether the intention of existing clause 2(2)(a) was sufficiently clear.

17. Amendment 7 is a consequential amendment to reflect the numbering changes effected by Amendment 5.

Daniel Greenberg 3rd December 2014 

 

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.

Does the Bill falsely promising ‘miracle cures’ for all patients?

The Bill does not offer false hope.

It is for the doctor to manage the expectations of the patient.

However, hope is not a bad thing. consider trying novel treatments and encourages a patient to read and research and if, between the doctor and patient it is decided that it is worth innovating, then that is a good thing – and arguably better than the false hope a doctor gives when offering standard treatments that are known to fail.

Why is research specifically excluded from the Bill?

It is vital that the Bill does not facilitate reckless experimentation nor allow patients to be used as laboratory mice.

The bill excludes the use of treatment specifically as just research. It allows only for treatment that is in the best interests of the patient.

However, this does not stand as an obstacle to the furtherance of medical knowledge.

In trying novel treatments in the best interests of the patient it is likely that new and successful ways of treating diseases will emerge.

Guardian: Lord Saatchi responds to the Times letter

Lord Saatchi Guardian

Published in the Guardian 14th November 2014

The 100 doctors who wrote to the Times rubbishing my medical innovation bill are the authentic voice of complacency. Let us help them to move on

Writes Lord Saatchi

How many of the 300,000 British citizens diagnosed with cancer this year will receive an innovative treatment?

The answer, according to the awesome House of Lords Library, is 5.6%. In other words, 94.4% of Britain’s cancer patients will receive only the standard procedure. In the endless repetition of a failed experiment, 165,000 of them will die. You would need a fleet of JCB’s biggest excavators to dig the mass grave for this year’s cancer dead.

This is why I proposed the medical innovation bill, which is now before parliament. If passed, it will allow doctors to try reasonable innovative treatments, so long as they have the agreement of the patient (or patient’s representative) and of a panel of medical specialists.

The bill has the support of No 10, the secretary of state for health, the UK chief medical officer, the government’s chief scientific adviser, the medical director of the NHS, Britain’s top judges and 20,000 respondents to the government’s public consultation on the bill. But it is opposed by 100 doctors, who wrote a letter to the Times this week [paywalled link] saying the bill is rubbish.

How I pity their patients.

Theirs is the authentic voice of complacency and self-satisfaction, as in one of their quotes: “It is time that people listened to the experts.” These doctors sound like Lady Ludlow in Elizabeth Gaskell’s novel Cranford. She objected to the education of poor people on the grounds that “it is becoming common for the lowest class to have some education … the proper order of the world will be undone.” The doctors may not have realised that the age of deference is over – not just in medicine but in politics and all walks of life.

The “Times 100” insist that the only method of scientific advance is the clinical trial. Perhaps they overlooked the view of the forefather of the randomised controlled trial, Sir Austin Bradford Hill, who said: “Any belief that the controlled trial is the only way [to study therapeutic efficacy] would mean not that the pendulum had swung too far, but that it had come right off its hook”. Or maybe they missed the view of Professor Sir John Bell, regius professor of medicine at Oxford, who says there will be no cure for cancer “until real doctors with real patients in real hospitals can attempt an innovation”.

What sort of people do these 100 people think we are? Are we downstairs in Downton? Are we supposed to doff our cloth caps as these doctors go past us in Harley Street in their horse-drawn carriages?

They are living in another era. Our iPads can follow the proceedings of the American Society of Clinical Oncology conference in Melbourne at the same time as they do.

Let us help them to move on. In the modern era, any half-decent protest movement such as theirs needs a logo. They say a picture tells a thousand words, so here is their picture – a shrug of the shoulders.

They need a good simple “narrative” that gets to the essence of what they are saying. Here it is: “Save the status quo!”

That slogan will look good on a poster. Let them put it up in Britain’s hospices, where 80% of the patients – with a life expectancy of two weeks – are dying of cancer.

Why the research community needs to rethink

Professor Andy Hall
Professor Andy Hall

By Prof Andy Hall ­–   Professor of Experimental Haematology, Newcastle University

There is a deep-rooted and complacent culture across substantial sections of the medical research community that all is rosy in the garden, that we scientists know what we’re doing and we don’t need any help from outsiders.

Men and women of science should, of course, welcome challenge. It is the grist to the scientific mill – to propose a thesis, and test it, to see if it stands up or falls down. This is what science is about.

But when it comes to medical research and cancer research in particular, there is a sensitivity to challenge that tends towards destructive defensiveness and at times a pig-headed aggression.

For those who want to find new treatments for cancers, this is a problem. Progress in many areas of cancer research has been painfully slow. This is not for want of trying, or of bad intentions, there really are “no villains in this story”. It is because cancers are incredibly hard to tackle.

Many researchers have focused on developing therapies that target individual gene mutations within a tumour. But tumours are often heterogeneous with multiple mutations that will never respond to just one drug.

This focus on the individual gene mutation is in part a legacy of the phenomenal – but one-off – success scientists and doctors had in finding a cure for Chronic Myeloid Leukaemia a form of cancer which is almost unique in having one driver mutation.

Many of us have become fixated on this  success and we have become accustomed to a method of research designed to repeat it.

But sadly it will probably never happen. Unfortunately this means the science community is stuck in a rut. A culture of group-think has taken over and it is reinforced by an endless round of conferences where we clever laboratory kings and queens speak only to each other swapping high-minded clever research papers – all based on the same research methodology.

We need to break out, we need to be challenged and we need to accept that too little progress has been made in finding new cures for cancers.

But the problem is fundamental. My generation, who are now leaders in our research labs, hold our beliefs so dear that any challenge feels like an assault on us as people. Our work and our beliefs are bound up with our identity.

When pushed, doctors and researchers can be genuinely unpleasant to those who challenge them  – I’ve seen this at first hand. But to repel contrary thinking is a derogation of the scientific principle.

One area that must be challenged is the singular and exclusive reliance on old-school and large randomized clinical trials.

Of course, they have their place. But they are slow, cumbersome, expensive and at times wholly inappropriate to the needs of science and, more importantly, patients.

We also need smaller, faster, lighter trials with fewer participants. Trials that are easier to set up, when – as in the case of rare diseases and diseases affecting children – which can be set up quickly, and, crucially, can be adapted quickly during the trial.

We must no longer only rely on trials designed to detect small changes, which need large numbers of patients to find only marginal.benefits.

We need more, smaller, cheaper trials where we look for big effects. And we must record and share the data of success and, very importantly, of the inevitable failures.

Patients deserve this. Particularly, patients with rare diseases where there are never enough patients to fill a large and traditional randomized controlled trial

We need to challenge ourselves and we need to change.

Fortunately new ideas are emerging which are provoking debate and new ways of thinking.

One is the  Medical Innovation Bill. It will encourage doctors to try novel treatments in a clinical environment.

It is not the only answer, though it will certainly help encourage innovation. It is just one solution to a raft of problems that must be resolved. But my interest and support for the Bill is based on this – it is a start.

It is new thinking. It is challenging, it has  inspired debate – as well as anger among some conservative colleagues – that is driving scientists to question themselves and their ways of working.

This has to be good for patients.

About Prof Andy Hall
→READ:  Read his biog

The views in this blog post are Prof Andy Hall’s personal views and do not represent those of Newcastle University.

Does the Bill apply to mental health?

The Medical Innovation Bill applies to all areas of medicine.

However as defined in the Bill a doctor cannot give any treatment without patient consent and the Bill does not change the law on what treatments may and may not be given to patients without consent.

So if a patient were detained under section 2 or 3 of the Mental Health Act, and thus being detained and treated without consent a doctor would not be able to give innovative treatment without consent.

The Bill does not change the law about what treatment can or should be given to persons suffering from mental illness (in particular, the issue of “appropriate” medical treatment under section 3(4) of the MHA 1983).

So the Bill could apply to determine whether a decision to exercise a discretion to depart from standard practice in the treatment of mental illness was negligent: but it does not determine whether the doctor has a discretion in the first place, in terms of the law applying to mental illness.

The Bill also expressly does not change the law as to the need for consents, as to which there are of course particular considerations in relation to mental illness.

The Bill expressly limits itself to treatment that in the opinion of the doctor, having consulted appropriately qualified colleagues, is in the best interests of the patient himself or herself: so there is no question of the Bill being relied upon to use patients suffering from mental illness as opportunities to experiment for the purpose of scientific research.

 The provision of treatment will have to be justified, exactly as in the case of non-innovative treatment, both in terms of the risk-benefit analysis for the patient and in terms of the laws addressing the provision of treatment to those suffering from mental illness.