Tag Archives: Medical Innovation Bill

Andy Burnham says LibDems’ decision to axe Saatchi Bill is ‘odd and wrong’

Andy Burnham MP - Medical Innovation Bill
Andy Burnham MP – Medical Innovation Bill

By Christopher Hope

Published in the Telegraph 2nd March 2015

→READ: Telegraph: Andy Burnham says LibDems’ decision to axe Saatchi Bill is ‘odd and wrong’

The Liberal Democrats’ decision to stop MPs voting on a new law to allow doctors to test treatments on dying patients is “odd and wrong”, Labour has said.

The comments from Andy Burnham, the shadow health secretary, leave Nick Clegg’s party politically isolated over its controversial decision to withdraw support for the Medical Innovation Bill.

The Bill – which was passed by the House of Lords – would have allowed doctors to test cutting edge new treatments on patients to help find cures for cancer and other serious illnesses.

It was being promoted by Lord Saatchi, the advertising magnate after his wife Josephine Hart died from ovarian cancer.

However last week the LibDems’ health minister Norman Lamb said the party would not allow the Commons to debate it – effectively killing the legislation.

Mr Burnham criticised the decision as “strange” and said the LibDems should have entered talks with Labour and the Tories to iron out any concerns.

He told The Daily Telegraph: “I am disappointed that the Liberals have done this – there should at least have been some cross-party talks about this, at the very least.

“The Bill was heavily amended and extra safeguards put in, and I worry a little bit that those who are opposed to it don’t realise that it is actually quite a different Bill now.”

Mr Burnham said that the Bill had offered hope to desperate parents of seriously ill or dying children.

He said: “For parents like them nothing is available and they have no hope, it [the Bill] is about opening up hope.

“It is often parents who struggle to get their voice heard – they often don’t get much parliamentary time or much focus.

“Norman’s move is odd and wrong, because just to give it an airing would help get some focus on the awful position many of these parents find themselves in.”

Margaret Hodge, a senior Labour MP, said the Bill provided “clarity and certainty for patients and doctors at the point of treatment, and enable doctors to innovate confidently”.

Peers also expressed their anger on the floor of the House of Lords on Monday that the legislation had been effectively axed without a vote by MPs.

David Cameron, the Prime Minister who had supported the Bill, said Mr Clegg and the LibDems would have to defend their decision.

The Prime Minister’s official spokesman said: “The Prime Minister has expressed his support for this – there were changes that were made during its passage through the Lords, with regard to safeguards.

“He has argued for it to go ahead and those who have come to it differently will have to explain their position.”

→READ: How exactly did the Lib Dems kill the debate

Lord Saatchi described the LibDems’ decision was “a death sentence” for “cancer patients. It is an extraordinary turn of events.

“This is a grotesque insult to the House of Lords. The Liberal Democrats are saying that the House of Commons will never debate this Bill which has been sent to it and passed by the House of Lords.”

But defending the decision, Mr Lamb said: “The Liberal Democrats have listened to the concerns of patient organisations, research charities, legal bodies, royal colleges and medical unions who have told us the Bill in its current form could actually put patient safety at risk.

“I am not interested in pushing this into the long grass. It should be given priority but we must get it right. Such an examination of the issue should involve patient organisations, legal bodies, royal colleges and medical unions.”


What Next for the Medical Innovation Bill?

The Liberal Democrats have prevented the House of Commons from debating the Medical Innovation Bill.

→TELEGRAPH: Fury as Lib Dems block Medical Innovation Bill

→SIGN: Petition demanding Nick Clegg debate the Bill

The Bill is on the order paper for Second Reading on 6th March 2015 – but with so many Bills on the list there will never be time for MPs to have a debate.

The Government had found time for a full debate. The debate would not have been whipped – meaning MPs could vote according to their own preference. It would have been truly democratic.

However, the Liberal Democrat leadership had the right to veto debate, under the terms of the coalition agreement set up when the Tories and Lib Dems joined forces in 2010 to form a government.

And veto it he did – meaning the there will now be no debate on the Medical Innovation Bill in the House of Commons.

This veto is of concern on two levels.

The Bill sought to provide clarity and certainty for patients and doctors at the point of treatment,  by setting clear statutory criteria for responsible and irresponsible innovation.

It would have ended the present litigation lottery, according to which you only find out whether treatment was responsible by setting up opposing teams of medical witnesses in expensive and protracted litigation after the fact.

And it would have paved the way for the establishment of a ground-breaking register of innovation results, allowing positive and negative results of new treatments to be shared, pointing the way to new full clinical trials, and reducing the appalling number of wasted lives.

The blocking of the Bill is therefore a medical calamity; but there is also a constitutional issue.

The Bill was the subject of a Written Ministerial Statement approving the fundamental policy, a Government public consultation, and four full debating stages in the House of Lords.

The patient safeguard provisions were amended by the Medical Director of the NHS at the request of the Secretary of State for Health.

Other medical and legal peers tabled amendments which were accepted into the Bill.

→SIGN: Petition demanding Nick Clegg debate the Bill

The degree of cross-party scrutiny and consensus was unparalleled for a private peer’s Bill, reflecting the extreme importance of its subject matter.

The Conservative front-bench, with Labour co-operation, found a way to allow the Bill to be debated in the House of Commons; by vetoing that, and refusing to allow the issue even to be debated, the Liberal Democrats have shown utter contempt for the House of Lords, and a total disregard for the right of Members of Parliament to debate matters of crucial importance to their constituents.

The passing of the Medical Innovation Bill, with any additional safeguards or qualifications that the House of Commons had wanted to add to those proposed by the House of Lords, would have been a magnificent achievement in the final stages of this Parliament.

It would have reminded citizens that Parliamentarians on all sides are committed to doing everything possible to improve the health services, to encourage responsible innovation, to use shared anonymised health data to accelerate medical progress, and to protect patients and doctors.

That opportunity has been missed so that the Liberal Democrats could demonstrate their political power within Government: voters will not forget or forgive that lightly.

Where are we now?

Tthe Labour Party’s shadow Health Minister, Andy Burnham MP and Margaret Hodge MP (Labour) came out in favour of the Bill, further isolating the Lib Dems.

David Cameron, the Prime Minister who had supported the Bill,told the Telegraph that Mr Clegg and the LibDems would have to defend their decision

The Prime Minister’s official spokesman said: “The Prime Minister has expressed his support for this – there were changes that were made during its passage through the Lords with regard to safeguards.

“He would have wanted the Bill to go ahead clearly because he was supportive. He has argued for it to go ahead and those who have come to it differently will have to as they have explain their position.”

So it has government and opposition support in the Commons.  And supporters angered by the Lib Dems – and even some open-minded opponents who support and trust the democratic process – have spoken in number in favour of a debate on the Bill.

At best we are right back at the beginning.

It has taken more than two years to get to this stage – after a long public consultation, four debates in the House of Lords and a review undertaken by NHS chief Sir Bruce Keogh.

As you would expect we are doing our best to see if there is anything else we can do but unfortunately it does not look at all hopeful.

As things stand, it is a matter for supporters to tell us what they want and to tell their MPs too.

→SIGN: Petition demanding Nick Clegg debate the Bill

Fury as Lib Dems kill off Saatchi Bill

Fury as lib dems kill off bill copy
Fury as lib dems kill off bill copy

By Christopher Hope

Published 28th February 2015

→READ: Telegraph: Fury as Lib Dems kill off Saatchi Bill

→READ: How exactly did the Lib Dems kill the debate

→SIGN: Petition demanding Nick Clegg debate the Bill

A new law to allow doctors to test new drugs on seriously ill patients without the fear of being sued has been killed off the Liberal Democrats, The Telegraph can disclose.

The Medical Innovation Bill would have allowed doctors to test cutting edge new treatments on patients to help find cures for cancer and other serious illnesses.

It was being promoted by Lord Saatchi, the advertising magnate after his wife Josephine Hart died from ovarian cancer.

However Norman Lamb, a Lib Dem health minister, has told Jeremy Hunt, the Tory health secretary, that his party will not support it despite it passing through the House of Lords.

The veto – which was made because of concerns from patients’ groups and experts – has killed off the legislation in this Parliament.

The campaigners behind the Bill savagely attacked Mr Lamb and said the decision would “haunt” the LibDem leader Nick Clegg who had “handed down a death sentence to cancer patients”.

Lord Saatchi told The Telegraph he was “in a state of shock” that the LibDems could veto a policy which was so strongly backed by the Conservatives in this way.

He said: “They have killed the Medical Innovation Bill. It is dead. By killing the Bill they have killed the hopes of thousands of cancer patients.

“It is as simple as that. Nick Clegg has handed down a death sentence to cancer patients. It is an extraordinary turn of events.

“This is a grotesque insult to the House of Lords. The Liberal Democrats are saying that the House of Commons will never debate this Bill which has been sent to it and passed by the House of Lords.

“I have no difficulty putting this at Nick Clegg’s door. I am very happy to stand that on him. There is no doubt that he has authorised the letter.

“One day he will feel very guilty about this I imagine. To do what he has done, to kill all these people’s hopes, is something that will haunt him.”

The Bill started life as a Private Members’ Bill in the House of Lords before it won government support after new safeguards were introduced last year.

It was due to be debated by MPs on Friday in a race to ensure it was put onto the statute books by the end of next month, when MPs break for the election campaign. However it was pulled at the 11th hour.

Mr Lamb has now offered a review of the plans, chaired by a senior medical expert like the Labour peer Lord Winston, which would report after May’s general election.

Dominic Nutt, a spokesman for Lord Saatchi’s campaign, added that the decision was “a shameful way to do business” and “disingenuous, dissembling cowardice”.

He said: “It is the most illiberal undemocratic move by the so-called Liberal party, to deny elected MPs the right to debate and vote on a bill supported by thousands of patients and voters.”

He accused Mr Lamb of “monumental and feudal arrogance”, adding: “Norman Lamb knows that he is finding a way to kick this into the long grass and that he has personally destroyed the bill without the option for a vote.

“Norman Lamb claims he supports it, yet he has personally and singlehandedly destroyed it with a stroke of his pen.”

Mr Nutt said the Bill – technically a Private Members Bill with Government support – had “undergone a full public consultation, two years of media scrutiny, four full debates in the House of Lords” and been amended by all parties and medical and legal experts.

However Mr Lamb hit back, claiming that there were real doubts about the legislation as it has been drafted, saying that the decision to axe it was “a collective decision”.

The Bill had come under sustained attack from personal injury lawyers who said it would leave patients at the mercy of “maverick doctors”.

Writing for The Telegraph’s website, Mr Lamb said: “The Liberal Democrats have listened to the concerns of patient organisations, research charities, legal bodies, royal colleges and medical unions who have told us the Bill in its current form could actually put patient safety at risk.

“Surely we shouldn’t rush this through the House of Commons under pressure of time before the general election when organisations like the Patients’ Association, Action Against Medical Accidents, the Wellcome Trust, the British Medical Association and the Royal College of Physicians raise serious concerns?”

→READ: How exactly did the Lib Dems kill the debate

→READ: Support for the Bill

Some “highly vulnerable people, desperate for a chance of recovery or remission, could be easy prey for exploitation by the few unscrupulous practitioners who peddle false hope”, he said.

“So, faced with this level of concern, but recognising the profound importance of innovation and of saving lives, the best way to proceed is surely to appoint an eminent person examine what the barriers to innovation really are and how best to overcome them.

“I am not interested in pushing this into the long grass. It should be given priority but we must get it right. Such an examination of the issue should involve patient organisations, legal bodies, royal colleges and medical unions.”

Sarah Wollaston, the chairman of the House of Commons’ Health select committee, supported Mr Lamb. She said: “It was unnecessary, there would be a huge number of unintended consequences.

“This was the wrong answer to medical innovation. It would hamper recruitment for medical trials. It was a ‘charlatan’s charter’ and will lesson protections for patients.”

Another opponent Sir Robert Francis QC, who carried out the review into scandal at Mid-Staffordshire Hospital and president of the Patients’ Association, added: “I have every sympathy with Lord Saatchi and all those who have been through the terrible experience of finding that they are not offered treatment which they believe might offer the chance of saving their lives or improving their condition.

“However I do not agree that the cause of any reluctance on the part of the medical profession to offer treatments of this kind is anything to do with the fear of being sued for negligence. I am afraid that because it starts from the wrong place.”

Mr Francis said that the Bill would “cause confusion, lead to a greater threat of legal consequences because of the additional uncertainties it creates [and] make it more likely that those few doctors who have ulterior motives for offering or trying to sell dubious treatments could exploit a very vulnerable group of patients”.

→SIGN: Petition demanding Nick Clegg debate the Bill

Nick Clegg and Lib Dems Refuse to Debate the Bill – and Kill It

Nick Clegg and the Liberal Democrats have refused to debate the Medical Innovation Bill in the House of Commons in doing so they have killed the Bill.

The Bill has been extensively debated four times in the House of Lords.

It has been the subject of a Department of Health consultation, and the team have consulted and debated widely across the medical and legal professions for two years.

The BIll has received numerous amendments refining the process and improving patient safety.

And yet the Lib Dems refuse to even allow it to be debated in the House of Commons.



Tweet Nick Clegg and give him your views – @Nick_Clegg

Email him: cleggn@parliament.uk

Or email him using the form on his website

Post-hoc scrutiny of medical innovation is inadequate

Professor Jo Samanta - Medical Innovation Bill / Saatchi Bill
Professor Jo Samanta – Medical Innovation Bill / Saatchi Bill

By Professor Jo Samanta - Reader in Medical Law at Leicester De Montfort Law School writes about the Medical Innovation Bill (Saatchi Bill) and the law.

Post-hoc scrutiny of medical innovation is inadequate

The publicity around Lord Saatchi’s Medical Innovation Bill has put innovative therapy high on the political and public agenda.

I broadly support the Bill, and think there needs to be a clear balance between the risks of innovation and patient safety.

It is my view that the Bill can be fine-tuned to meet this challenge. In a paper recently published in the Journal of Medical Ethics – Quackery or quality: the ethicolegal basis for a legislative framework for medical innovation – I, along with my co-author, argue that a regulatory framework is needed to allow a full consideration of the applicability of innovation, prior to the proposed treatment taking place.

In this blog I focus on the issue of pre-treatment scrutiny of proposed innovative treatment, rather than post-hoc scrutiny and of the issue of valid patient consent to innovation.

The vociferous debate over the recent Medical Innovation Bill introduced in the UK by Lord Saatchi is testament to the continuing relevance of innovation for contemporary healthcare provision.

The Bill has been criticised by some, with suggestions that the proposed legislation is unnecessary and might even promote quackery.

However, this criticism is perhaps too harsh, since innovation has often been the impetus for a range of diagnostic and therapeutic developments in medical science.

Legislation would permit doctors to deploy medical innovation optimally for the benefit of patients and within a legitimate assurance framework.


As yet there is no formally established quality assurance framework for proactive evaluation of innovative therapy in respect of its applicability, or suitability, prior to delivery.

The existing pathways tend to be post hoc review through litigation, regulatory or disciplinary processes, or local procedures such as root cause analysis, serious incident review, or clinical audit.

These ‘after the event’ mechanisms are unsatisfactory, since they are usually predicated on some form of adverse outcome.

The Bill seeks to encourage ‘responsible innovation’ on the basis that doctors will not be prima facie negligent for deciding to depart from the existing range of accepted treatment if their decisions are transparent and accountable and all relevant matters have been considered fully.

For an action in negligence, the question for the court will be whether the doctor has breached the standard of care expected in law.This is based on the Bolam test with the Bolitho proviso that the decision withstands ‘logical analysis’.

Both these tests could be problematic in the context of innovative practice. A standard for responsible innovation that is defined by legislation would carry the force of law, provide clarity for the de jure limits of innovative practice, and offer protection against improper experimentation on patients.

Innovative therapy falls between two highly regulated areas: standard medical treatment and clinical research.

The regulatory mechanism of post hoc review is largely unsatisfactory. In the presence of terminal or incurable illness, patients may be vulnerable to a greater or lesser degree and might not be best placed to assess the risks and benefits of potential innovations adequately, particularly if they believe they have nothing left to lose.

It has been argued that since the decision-making process is based typically on an individual doctor–patient axis, a clear framework is needed for appropriate regulation.

Innovative therapy includes departures from standard medical therapy, which may lack an evidence base or a demonstrable safety profile. The primary purpose of innovation must be to benefit the individual patient.

I hold that legislation of medical innovation would be beneficial. Legislation would provide a legal standard for responsible innovation, define the boundaries of acceptable medical conduct in this area, and provide the basis for legal protection of patients (many of whom could be highly vulnerable) against wrongful exposure to inappropriate therapies (at best) or unwarranted experimentation (at worst).

I propose that the Bill could be further refined through a two-stage test for embarking on responsible innovation, by creating mandatory requirements for ongoing oversight accountability, and by placing patient-centred care at the heart of the statute with an emphasis on consent and compassion. There is need for fine-tuning between empathetic care, innovation and regulation in order to get the balance right.

→READ: For a wider exploration of this issue see Quackery or quality: the ethicolegal basis for a legislative framework for medical innovation

Another argument against the Bill has been around the concern that vulnerable patients are not able to consent validly to innovative treatments.

Valid consent is a necessary precursor for therapeutic treatment of competent patients and raises particular challenges in the context of innovation.

The human instinct to cling to hope together with a dearth of alternative options might mean that duress of circumstances can interfere with the validity of apparent consent.

The potential vulnerability of those who seemingly have ‘nothing to lose’ is recognised in international guidance for research participants with incurable and life-limiting conditions.

Nevertheless, while circumstances such as these may well affect freedom of choice, it is wrong to conclude that this inevitably compromises autonomous choice.

The possibility of well- intentioned beneficent medical paternalism needs to be guarded against and further strengthens the argument for legislation.

Professor Jo Samanta is Reader in Medical Law at Leicester De Montfort Law School. Her primary research focus is on end-of-life decision making. She is the lead author of Medical Law – Palgrave Law Masters and is Chair of the Business and Law Faculty Human Research Ethics Committee. ENDS

Prof Chas Bountra talks about crowdsourcing science & medical innovation

Chas Bountra is a visionary. A human dynamo who seems to generate his own energy, who doesn’t know the meaning of ‘impossible’.

More formally, he is professor of translational medicine and head of the Structural Genomics Consortium at Oxford University.

Like many scientists working to develop new molecular entities – drugs to you and me – he realises the system is broken littered with barriers and blocks. It takes too long and is too expensive to develop new drugs for killer diseases.

He has said: “The cost of developing new drugs is spiralling. Analysis by Forbes [in 2012] showed that it cost as much as $12 billion to produce one new successful drug. “Most of the cost pays for failed projects that never see the light of day. From 1996 to 2009, research costs have almost tripled, while the number of drugs approved for use has more than halved. “Drug companies do similar research in parallel and in secret, and usually do not share their failures – and 90 per cent of potential therapeutic compounds fail.

It’s madness. “If companies shared their failures they would prevent each other going down blind alleys – and it would mean patients wouldn’t be used as guinea pigs for drugs that another company already knows won’t work.”

And like Lord Saatchi, he knows there is not one single answer to the problem.

His focus is on encouraging big pharma to share the results of their research so that both development time and costs decrease.

Like Lord Saatchi, he is pushing for greater innovation and recognises that the Medical Innovation Bill can play a part in speeding up the drugs discovery pipeline.

No one on the Bill team says innovation doesn’t happen now. It does. But, that is not an argument against more innovation.

As long as there are incurable diseases we must dedicate ourselves to greater, effective, innovation.

Prof Chas Bountra has been in the news this week (16th Feb 2015)  as part of a group scientists pooling their resources to work together on a treatment for dementia.

We visited him at Oxford University last year. In this video he talks about his support for the Medical Innovation Bill, highlights a few of the challenges within the industry and talks about the innovative work of the Structural Genomics Consortium at Oxford University.


My son Daniel

By David Thomas

The Medical Innovation Bill encourages doctors to take responsible risks, if this is what a fully-informed patient wants. Ensuring appropriate safeguards is, of course, vital.

The Bill should be seen as part of a wider picture. Palliation apart, the aim of medicine is to give those suffering from serious conditions the best chance of getting better. A statement of the obvious, perhaps, but in my experience it does not always happen.

My son Daniel, then aged 17, was diagnosed with a life-decimating bone cancer, Ewing’s sarcoma, in 2006. He had the standard treatment and was well looked after. He got into remission and on with his life. But prognosis was dismal.

So, naturally, we scoured the world for possible solutions. I found out about insulin growth factor inhibitors. There was a good deal of excitement about them in the Ewing’s world at the time. Unusually for cancer treatment, there seemed to be few side-effects. There were a number of clinical trials. A principal criterion for Roche’s was that a patient must have disease measurable by scan, standard in oncology so that efficacy can be measured. At that time, Daniel, in remission, had no measurable disease.

But a special diagnostic test, RT-PCR, indicated that he still had microscopic cancerous cells, as was expected. Now was the time to hit those cells, when they were at their weakest and had not mutated. We needed Roche to accept Daniel onto their trial, either by interpreting the criteria flexibly (I’m a lawyer and provided the interpretive ammunition) or by extending them to include RT-PCR–positive patients. If the inhibitor killed Daniel’s microscopic cells, Roche could chalk up a response. The company blanked me. Daniel’s doctor, involved with the UK trial, appeared unwilling to advocate for his patient and felt constrained by confidentiality not to release important information, an intolerable situation.

I turned to the MHRA, the UK clinical trials regulator. My argument was that, with rare conditions (especially involving children), the MHRA had a duty to ensure not only that trials are safe but that they produce as much useful data as possible. Allowing RT-PCR-positive patients onto the trial would increase the data pool. However, the MHRA responded that, safety apart, trial criteria were for the drug company.

I was willing to take the regulator to court. But Daniel then tested negatively in another RT-PCR, in Barcelona. This was great news but it effectively destroyed my legal arguments. We put the inhibitor on the back-burner.

Daniel eventually relapsed. After much failed treatment, he had a different IGF inhibitor but, although he showed some response, his cancer was by now far too powerful. He died in October 2011, just short of his 23rd birthday, a classics student at Oxford, full of dreams and promise and surrounded by love.

Would earlier access to an inhibitor have helped? It is fair to record that overall they have been a disappointment. But there have been some remarkable results. Sadly, the system was not flexible enough to allow Daniel access at the most opportune time. That might just have cost him his life and much suffering (and the NHS tens of thousands of pounds on wasted treatment).

Medical treatment should seek to squeeze every last drop out of current knowledge. There are many aspects to that, not least ensuring that clinical trials are regulated for the benefit of patients, not the convenience of pharmaceutical companies.

Lord Saatchi’s Bill has the laudable aim of putting the interests of seriously ill patients at the heart of decision-making.  Everyone, surely, must support that objective.


David Thomas is a consultant to Bindmans LLP and for several years was legal officer to Child Poverty Action Group. He is a former chair of the RSPCA, trustee of Compassion in World Farming and member of the advisory panel for Burma Campaign UK and is currently a trustee of a Casa Alianza UK, a street children charity.

He has written extensively about legal and related issues, especially in the campaigning context, and used to teach judicial review and human rights law, primarily in the context of welfare benefits.

He is a former member of the Law Society’s mental health and disability committee and of the Legal Services Commission panel advising on the grant of legal aid in public interest cases. He is also a part-time judge. 

Powerful plea from patients in support of Medical Innovation Bill

The Sunday Times have today published a letter in support of the Medical Innovation Bill from 100 patients and family who have lost loved ones.

The group, which includes Andrew Lloyd Webber, Melvyn Bragg and the publisher Gail Rebuck, widow of the Labour grandee Philip Gould, today issue a powerful plea for dying patients to be given access to experimental drugs and other treatments.

The Bill has moved recently into the House of Commons, having been passed unanimously by the House of Lords.

Last week senior oncologists wrote to Telegraph this week 100 patients & family write to Times.

The letter this week to the Sunday Times follows a supportive letter last week to the Telegraph from senior oncologists, researchers and patient groups.

→READ: Letter to the Telegraph from senior oncologists, researchers and patient groups.

READ: Letter to the Sunday Times – a powerful plea

We are a group united by grief.

We are the bereaved – widows, widowers, brothers, sisters and parents who have lost loved ones to incurable diseases.

We are the parents fighting for the lives of our children who have cancers and degenerative diseases.

We are the patients dying for an answer to our own illnesses.

We have never met each other. But we share a bond of pain and fear.

And we are united in our support for The Medical Innovation Bill.

Not because we believe that it is the silver bullet.

Not because we think if it is passed that tomorrow there will suddenly be new cures for cancers, for Duchenne Muscular Dystrophy and other killer diseases.

We support the Medical Innovation Bill because it gives us hope – hope that doctors will feel more confident to try novel approaches to killer diseases for which current treatments are known not to work.

We support the Medical Innovation Bill because it offers hope to people yet to face what we have faced.

We support the Medical Innovation Bill because it will inspire doctors to innovate and to collect and share the results of their innovations so that medical science is advanced.

We know it will give doctors confidence and legal clarity to try more and to do more.

The patient’s voice has been drowned out. We have been patronised and told we must leave it to the experts.

But we have watched – and are watching – our families die. Some of us are watching our own bodies die.

Doctors have the medical experience.  But we have the human experience.  Nobody knows more about these fatal diseases than we do.

As the Bill proceeds to The Commons, our voice will be heard.

 Gail Rebuck

Sir Michael and Lady Pakenham

Lord and Lady Lloyd-Webber

Victoria Gray

Antonia Wellington

Lord Bragg

Sir Christopher Bland

Frieda Hughes

Vita Paladino

Lord Foster

Debbie Binner

Tom Parker-Bowles

Sara Parker Bowles

Richard Kitley

Mavis Nye

Ray Nye

Omaira Gill

Alex Smith

Rose Fletcher

Claire Cowley

Paul Cowley

Annette Gration

Philip Gration

Pat Hay

Julia Samuel

Sir Henry Keswick

Vivian Duffield

Neil Hay

Mary Toms

Nathan Toms

Barbara Whitehead

Julie Cooper

Christine Winters

Esther Driscol

James Driscol

Maurice Chambers

Beverley Chambers

Gemma Chambers

Clare Smith Daughter

Stauroulla Parker

Michele Parker

Dorothy Vaux

Diane Salisbury

Betty Salisbury

Pauline Debra

Debra Stuart

Stuart Faulser

Jan Weston

Cathy Dear

Elaine Bounds

Karyanne Todd

Amanda Reynolds

Steve Wride

Linda Wride

Richard Elson

Jackie Elson

Dr Irene Kappes

David Wilshire

Faye Wiltshire

Patricia Wiltshire

Dawn Fiddler

Barbara Scott

Robert Scott

Barbara Hampel

Billy Jenkins

Hannah Richards

Angela Davies

Michael Lasseter

Pan Pantziarka

Gail Mathe

Elaine Mitchell

Louis Brooks

Julia Travers-Wakeford

Lawrence Tansley

Sue North

William Pope

Diana Boyle

Robert Johnson

Karen Waldron

Ian White

Gayle McElhinney

Patricia Stubbs

David Williams

Jonathan Stubbs,

Julie Williams

Jane Weitzmann

Jen Selig

Sally Greene

Emily Crossley

Nick Crossley

Tony Levene

Paul Fitzpatrick

Lord Smith of Clifton

Alex Johnson

Andy Johnson

Lara Veitch

Natasha Bramble

Kerry Rosenfield

Doron Rosenfield

Emma Hallam

Andy Hallam

Steven Ho

Why Ebola treatment has parallels with the Medical Innovation Bill

Ebola Virus ©NIAID
Ebola Virus ©NIAID

A leading epidemiologist and governor of the Wellcome Trust has said there were “obviously parallels” between the Medical Innovation Bill and the sanctioning of untested therapies for Ebola patients.

Prof Peter Smith was on the World Health Organisation’s panel which permitted the use of untested therapies for the fatal Ebola virus.

Prof Smith said the WHO panel’s guidance “gave the go-ahead to use products for treatment that were not licensed for treating Ebola.”

Prof Smith said there were similarities between the Medical Innovation Bill and WHO Ebola Guidance.

“There are obviously parallels,” he said. If I had a cancer that say had a 70% mortality in six months and there was an experimental therapy and there’s no data on it, but which might actually improve that survival – and it looked at if it wasn’t going to kill me tomorrow – then I might well want the opportunity of taking that drug or whatever it was. And that’s the situation the Ebola patients are in.

“I think the situation here [with Ebola] was sufficiently dire that there was encouragement to actually shortcut the normal processes. I mean, to use therapies for which there may not be as strong an evidence base with respect to safety as you would normally require – but these were special circumstances.”

Another parallel with novel Ebola treatments and the medical Innovation Bill is the idea that in cases where a full trial is impossible – for lack of patient numbers, or because of an imminent likelihood of the death of the patient, innovative treatments could form the foundation of a full trial at a later date.

He said while it was impossible to draw sound data from a small number of cases, such innovations would “at least produce the evidence needed to justify doing a proper trial.”

“Treating a small number of patients with a new therapy, can’t make that judgment with any confidence in a small number of patients but at least it will produce the evidence needed to justify doing a proper trial. One of the strategies that’s being used for the new Ebola treatment is to really just do that.”

Acknowledging there was a risk in prescribing treatments that had not been through full clinical trials, he added: “You don’t want to give [patients] treatments that would hasten their mortality but you’re more inclined to take that chance because they’ve got this severely life threatening condition anyway.

“The mortality rate is still very high and there’s really nothing on the shelf that is licensed to treat these conditions and that, I think, is the incentive to use things which have been either been slow to being developed or really are experimental.

“These [treatments] might have worked against other viruses but one doesn’t know if they’re going to work against this virus. Obviously you’re prepared to take more risks with respect to something that is going to be given to someone who has quite a high chance of dying anyway than you would in someone who is perfectly healthy.”

However, Prof Smith said novel treatments should only be used in the best interests of the patient – and not as mini-experiments.

“If you are giving a certain therapy to a patient then you have to believe it’s going to do them some good. But you may do that with considerable doubt as to whether it will actually will do them good – but you have to believe it will do them more good than harm.”

As with the Medical Innovation Bill, which will require a mandatory reporting of the results of medical innovations – something that does not happen at the moment – Prof Smith said doctors using novel Ebola therapies should also collect data. “You should maximise the information you get out of that and measure as much as you can even though it’s not a formal trial.

Letter to the Telegraph – Pass the Medical Innovation Bill say senior oncologists, researchers and patient groups

Letter to the editor of the Telegraph from senior oncologists, researchers and patient groups.
Letter to the editor of the Telegraph from senior oncologists, researchers and patient groups.


Letter to the Telegraph published today in support of the Medical Innovation Bill (Saatchi Bill) from senior oncologists, professors across numerous disciplines, cancer and rare disease CEOs, research groups, early access to medicine campaigners and patient advocates.

They ask, “Ultimately the question that must be addressed is: what can we responsibly offer to those patients for whom there are no suitable clinical trials?”

Letter to the Telegraph on Medical Innovation Bill (Saatchi Bill)

SIR – We note the successful third reading of the proposed Medical Innovation Bill (the Saatchi Bill).

While there have been significant advances in cancer treatments in recent decades, there remain areas where there has been no meaningful advance. Diseases such as glioblastoma, sarcoma or pancreatic cancer have seen no clinically relevant improvements over those decades.

While clinicians have leeway to prescribe drugs “off-label”, we know from our direct experience with patients that viable clinical options are not being used in the vast majority of “terminal” cases. When all standard therapies have failed, and there are no clinical trials available, the response is almost uniformly to move that patient into palliative care.

We do not dispute that the clinical trial is necessary in order to identify those advances that work and those that do not. However, the evidence base for medicine can come from many different sources. Data collection is a necessary corollary of increased off-label usage and the new registry included in the Bill will record information (including side-effects and outcome data) in every instance of an innovative treatment. This ground-breaking registry will enable us to analyse real-world data, thereby providing greater patient protection than exists at present.

Ultimately the question that must be addressed is: what can we responsibly offer to those patients for whom there are no suitable clinical trials?

Pan Pantziarka
The George Pantziarka TP53 Trust
Dominic Hill
Film maker & patient advocate
Professor Marc-Eric Halatsch
Professor of Neurosurgery, University of Ulm
Lydie Meheus
Managing Director, Anticancer Fund, Brussels
Dr Gauthier Bouche
Medical Director, Anticancer Fund, Brussels
Richard Gerber
Glioblastoma survivor and patient advocate
Professor Angus Dalgleish
St George’s Hospital, University of London
Professor Ahmed Ashour Ahmed
Professor of Gynaecological Oncology, University of Oxford
James Hargrave
Empower Access to Medicine
Dr John Symons
Director, Cancer of Unknown Primary Foundation
Flóra Raffai
Professor Stephen Kennedy
Professor of Reproductive Medicine, University of Oxford
Dr Ian N Hampson
Reader in Viral Oncology, University of Manchester
Professor Andy Hall
Associate Dean of Translational Research, Newcastle University
Professor Emeritus Ben A Williams
Psychology, long-term glioblastoma survivor, patient advocate, Moore’s Cancer Center, University of California, San Diego
Dr Al Musella
President, Musella Foundation, founder The Grey Ribbon crusade: umbrella organisation for over 100 brain cancer charities
Professor John Boockvar
Director, Brain Tumor Center Lenox Hill Hospital NYC
Professor Emil J Freireich
Ruth Harriet Ainsworth Chair, Developmental Therapeutics, The University of Texas, MD Anderson Cancer Center, Houston, Texas
Brett Shockley
Patient advocate
Professor David Walker
Professor Pediatric Oncology, University of Nottingham
Laura Mancini
Clinical Scientist, National Hospital for Neurology and Neurosurgery, UCLH NHS Foundation Trust, London
John Morrissey
Adviser to the Children’s Cancer Research Fund
Stephen Western
Patient advocate, Astrocytomaoptions.com
Richard E Kast
MD, IIAIGC Study Center
Charlie Chan FRCS
Consultant Breast Surgeon
Professor Chas Bountra
Professor of Translational Medicine, University of Oxford
Dr Henrietta Morton-King
North Cumbria University Hospitals Trust
Dr Andrew Brunskill
Clinical Assistant Professor of Epidemiology and Health Services, University of Washington Seattle)
Vincent Galbiati
President & CEO of Tomorrow’s Cures Today, Washington DC
Neil Hutchison
Founder, Magic Water Pediatric Cancer Foundation, San Diego
Fiona Court
Consultant Oncoplastic Breast Surgeon, Cheltenham
Professor Alastair Buchan
Head of the Medical Science Division and the Dean of the Medical School at the University of Oxford
Dr Georgios Evangelopoulos
Patient advocate, lawyer & political scientist
Professor John Yarnold
Professor of Clinical Oncology at The Royal Marsden and Institute of Cancer Research
Professor Jerome H Pereira
Consultant General & Oncoplastic Breast Surgeon, Norwich Medical School University of East Anglia
Dr Lynne Hampson
Non Clinical Lecturer in Oncology, Institute of Cancer Sciences, Manchester
Dr Robert Kirby
Senior Lecturer, Hospital Dean, University Hospitals of North Midlands
Professor Gareth Evans
Professor of Medical Genetics and Cancer Epidemiology, University of Manchester
Dr Rupert McShane
Coordinating Editor Cochrane Dementia and Cognitive Improvement Group, Oxford University
Michael Shackcloth
Consultant Thoracic Surgeon, Liverpool Heart and Chest Hospital
Professor Vikas P Sukhatme
Professor of Medicine, Harvard Medical School, Co-founder Global Cures
Vidula Sukhatme
Co-founder Global Cures
Sarah Lindsell
CEO, The Brain Tumour Charity
Neil Dickson
Chairman, The Brain Tumour Charity
Alex Smith
Founder, Harrison’s Fund
Giles Cunnick
Consultant General & Breast Surgeon, Bucks Healthcare NHS Trust
Dr Piers Mahon
Biotech Consultant
Paul Fitzpatrick
Chairman, Duchenne Now
Dr David Faurrugia
Consultant Oncologist, Cheltenham General Hospital
Dr Chris Govender
Medical Officer in Addictions
Sue Farrington Smith
Chief Executive, Brain Tumour Research
Professor Steven Gill
Professor in Neurosurgery, University of Bristol