Tag Archives: Cancertreatement

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.”


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.


The present law is not clear

Opponents of the Bill say it is unnecessary because the existing law is clear and they need “more than anecdotes to justify changing the law”[1].

The 19,521  “anecdotal” responses to the Department for Health public consultation supporting the Bill are apparently not enough evidence for some that the Bill is necessary to make the law clearer.

But evidence is to be found in the decisions of the courts, if one looks for it. Take the very recent case of McGovern v Sharkey[2]. The Appendix to this Note contains extracts from the judgment in this case; the judge’s articulation of the special legal principles to be applied in cases of clinical negligence demonstrate that whatever the law on this area may be, it is neither clear, nor simple nor certain.

The case also illustrates how the present law assumes that every claim will involve the claimant and the defendant each hiring two or more doctors to oppose each other in the witness box. One reason why the law is so uncertain is that it depends on how impressive the two sets of witnesses are at trial.

Which is why at present claimants may be advised to sue whether they have a good case or not, because there is always a chance that they will have a “surprise win”; and key opponents of the Bill – notably Leigh Day & Co. – profit from running “no win no fee” cases relying on the uncertainty of the existing law[3].

The Bill will preserve the existing common law for cases where it is necessary and sufficient. But it will also add a new statutory procedure by which doctors and patients can achieve clarity and certainty at the point of treatment. By following the process set out in the Bill, doctors can be confident that a decision to depart from standard practice will be upheld as responsible by the courts, the regulatory bodies and others.

That will improve certainty for doctors and patients, who can concentrate on exploring sensible avenues towards innovative treatments for rare conditions, and bringing hope to patients where it is reasonable and responsible to do so.




 [42] Disputes about questions of fact depend on the usual burden and standard of proof. However in relation to clinical or professional judgment the position is different. Bolam v Friern Hospital Management Committee [1957] 2 All ER 118 established that, in determining whether a defendant has fallen below the required standard of care, regard must be shown to responsible medical opinion, and to the fact that reasonable doctors may differ. A practitioner who acts in conformity with an accepted current practice is not negligent “merely because there is a body of opinion which would take a contrary view.” In Hunter v Hanley 1955 SLT 231 at 217 it was stated that

“In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his conclusion differs from that of other professional men … The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care … ”

That test in Hunter v Hanley, was approved in Maynard v West Midlands Regional Health Authority [1985] 1 All ER 635 and Lord Scarman also stated “It is not enough to show that there is a body of competent professional opinion which considers that theirs was a wrong decision, if there also exists a body of professional opinion, equally competent, which supports the decision as reasonable in the circumstances. … Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other, but that is no basis for a conclusion of negligence.

… I have to say that a judge’s ‘preference’ for one body of distinguished professional opinion to another also professionally distinguished is not sufficient to establish negligence in a practitioner whose actions have received the seal of approval of those whose opinions, truthfully expressed, honestly held, were not preferred. If this was the real reason for the judge’s finding, he erred in law even though elsewhere in his judgment he stated the law correctly. For in the realm of diagnosis and treatment negligence is not established by preferring one respectable body of professional opinion to another. Failure to exercise the ordinary skill of a doctor (in the appropriate speciality, if he be a specialist) is necessary” (emphasis added).

[43] In Bolitho (Administratrix of the Estate of Patrick Nigel Bolitho (deceased)) v City and Hackney Health Authority [1997] 4 All ER 771 it was established that a doctor could be liable for negligence in respect of diagnosis and treatment despite a body of professional opinion sanctioning his conduct where it had not been demonstrated to the judge’s satisfaction that the body of opinion relied on was reasonable or responsible. In the vast majority of cases the fact that distinguished experts in the field were of a particular opinion would demonstrate the reasonableness of that opinion. However, in a rare case, if it could be demonstrated that the professional opinion was not capable of withstanding logical analysis, the judge would be entitled to hold that the body of opinion was not reasonable or responsible. Accordingly the final arbiter as to whether there has been professional negligence is the court and not the medical profession. It is for the court to decide whether the requisite logical basis for a defendant’s expert medical opinion is absent. The legal question is as to what features particularly characterise an expert medical opinion as one that is “illogical”, “irresponsible”, and “indefensible”. It is clear that merely being a minority view of accepted medical practice does not, of itself, render that view “illogical” or “irrational” in the Bolitho sense. However it is suggested that a court would be more ready to find that the body of opinion was not capable of withstanding logical analysis if there was a dubious expert whose professional views existed at the fringe of medical consciousness, see Khoo v. Gunapathy d/o Muniandy [2002] 2 S.L.R. 414, at [63]. Another example would be “a residual adherence to out-of-date ideas” which “on examination do not really stand up to analysis” see Hucks v. Cole [1993] 4 Med. L.R. 393.

[44] It is however important to consider some limitations to the Bolitho test. A practice is illogical if there was a “clear precaution” which ought to have been, but was not taken. In this case the precaution that is suggested is that there ought to have been a diagnostic vitrectomy after one month given the risks of an unidentified tear of the retina and what is suggested was the lack of response to steroid treatment. However if there are risks attached to the precaution, in this case the risks associated with operating on an inflamed eye and the risk that the operation will not resolve the underlying problem, and one body of medical opinion considers that the risks ought to have been taken and the other does not then there is no “clear precaution” but rather a balancing of risks. In such circumstances both sets of expert opinion withstand logical analysis. For the plaintiff the expert opinion being that the risk of an adverse outcome, in that a tear was present in the retina, should have been prevented by taking the precaution of performing the vitrectomy. For the other body of expert opinion on behalf of the defendant, the precaution of performing a vitrectomy would have posed an unacceptable risk of operating upon an inflamed eye where given the diagnosis of ERD the operation would not have achieved a satisfactory outcome. This is merely a different weighing of risk rather than a determination that the defendant’s expert opinion is illogical. The precaution that is being suggested is not a “clear precaution” but rather a precaution which involves a balancing of risks and that is a matter of clinical judgment with a logical basis.

[45] Another feature of applying the Bolitho test is that it introduces a lack of symmetry as between the plaintiff and the defendant’s expert evidence. The defendant’s expert has only to persuade the court that his views are capable of withstanding logical analysis, but he does not have to satisfy the court that the views of the plaintiff’s expert are not capable of withstanding logical analysis. However, the plaintiff’s expert has to do both.

[46] If the case is one that involves clinical judgment to which the Bolam test applies, and if the medical practitioner does produce evidence that his practice was supported by a responsible body of medical opinion, then, in the words of Sedley L.J. in Adams v. Rhymney Valley DC [2000] Lloyd’s Rep. P.N. 777, at [41], “the judge or jury have to accept the opinion of a body of responsible practitioners, unless it is unreasonable [in the Bolitho sense]” (emphasis added).

Accordingly in an action involving clinical judgment there is a two-step procedure to determine the question of alleged medical negligence:

(a) whether the medical practitioner acted in accordance with a practice accepted as proper for an ordinarily competent medical practitioner by a responsible body of medical opinion; and

(b) if “yes”, whether the practice survives Bolitho judicial scrutiny as being “responsible” or “logical”.

[47] Questions of fact and the question as to whether there was negligence are not to be conflated. Questions such as whether in the event there was a right retinal tear or hole in December 2006 or whether there was inflammation in the right eye in 2007 or whether there was scleral thickening in the right eye are questions of fact to be determined on the balance of probabilities with the onus of proof being on the plaintiff. The question of clinical and professional judgment as to whether a responsible body of medical opinion would form the view, in say January 2007, that there was a right retinal tear or hole or that there was inflammation in the right eye or that there was scleral thickening in the right eye are all subject to the Bolam test as qualified in Bolitho. In some cases the determination of a question of fact may lead inexorably to a finding that the medical practitioner did not act in conformity with an accepted current practice. In others it may have no such impact. So for instance in this case if there was a factual finding, on the balance of probabilities, that on 26 December 2006 the first defendant was informed that the plaintiff had suffered a sudden and profound loss of vision in his right eye and that the plaintiff’s right eye was not assessed or if the plaintiff was not advised to have his right eye assessed that day then inexorably that would lead to a finding that the first defendant had not acted in conformity with an accepted practice. Inexorably because no logical accepted current practice would do or advise anything other than immediate action. However if the factual finding was that the first defendant was informed that the plaintiff had some extremely modest effect on his vision in conjunction with a history that drops had not been taken then (though there was a dispute about this) it might be that to delay an examination until 4 January 2007 and to recommend that the plaintiff use his drops was in conformity with a logical accepted current practice.

[1] “The law currently works and is fair and clear. I am afraid that I require more than a few anecdotes to justify changing the law.” – Suzanne White, Partner, Leigh Day & Co; http://www.clinicalnegligencelaw.co.uk/2014/07/20/innovate-innovate-saatchi-bill/ – accessed 4.1.15.

[2] [2014] NIQB 117 – http://www.bailii.org/nie/cases/NIHC/QB/2014/117.html

[3] “Do you take cases on a “no win, no fee” basis? Does that mean I won’t have to pay anything at all? Yes we do.” – http://www.leighday.co.uk/Illness-and-injury/Clinical-negligence/FAQs/Costs – Accessed 4.1.15.

Telegraph: We now have hope of finding new ways to treat incurable diseases


Published in the Telegraph 24th January 2015

I left the Palace of Westminster yesterday with the word “content” ringing in my ears – the Medical Innovation Bill has passed the House of Lords.

A gentle utterance by fellow peers has ended a three‑year roller-coaster ride that has left me at times elated and at times in despair. But for the moment at least, I too am content. The day when patients with terminal diseases, and their doctors, will together be better able to try novel treatments, legally, safely and confidently, has all but arrived.

There is one more river to cross before we reach the Promised Land. The Bill will now be carried to the House of Commons by Michael Ellis MP, where it will again be debated. Time is the enemy now. Parliament is dissolved in a matter of weeks, ahead of the General Election. But I am confident, because the Lords have sent this Bill to the Commons in good order.

It has been roundly debated, challenged, amended, honed, tightened, clarified and improved by my colleagues on all sides of the House. Honest opposition to elements of it – no one has objected to the principle of the legislation – have now had their concerns met.

I’m particularly grateful to the Labour front bench and Lords Winston and Turnberg – both eminent doctors; Lord Pannick QC, a renowned legal mind; and Lord Hunt, who comes from a stellar medical background. They have debated the Bill and laid helpful amendments that have strengthened it. I also owe a debt to Baronesses Wheeler and Masham.

We have all worked together to lay a joint amendment making it a requirement that doctors who innovate under the Bill must record and share the results – good and bad – of their innovations on an open register. This is crucial if medical science is to be advanced. Doctors and scientists must know what works and what doesn’t. It is a leap forward for all doctors because today those innovations that do take place are not formally and universally recorded. It is also an amendment many medical and research bodies have called for, and I am delighted that today it is on the face of my Bill.

I must also thank the Telegraph and its readers who have followed this Bill and cheered for it. We would not be where we are today without you. Are we home? We are certainly close. I am confident we will find time in the Commons.

I say this because more than 18,000 patients contributed to the Department of Health’s consultation on the Bill last year. Another word for patients is voters. I believe that MPs will also recognise that their constituents want to see change. And they will see that the Bill has been tested no fewer than four times in the House of Lords, taken apart and reassembled line by line. Opposition has evolved into support. During the first committee stage there were 39 amendments made. Yesterday, there were just two – both of which I supported.

But what a journey it has been. The Bill was born in the mire of my personal grief, and inspired by some of Britain’s most brilliant doctors. In recent weeks I have seen supporters such as Charlie Kitley, Ismena Clout, Rachel Stevens – daughter of the Bishop of Leicester – all succumb to cancer. Their memory is dyed in the fabric of this Bill.

And opponents have fought the Bill. Most in good faith. Others less so – and it has been a struggle at times to hold back as my team and I have been accused of being liars, of being in bed with Big Pharma, of having some perverse agenda other than the acceleration of medical science. All I wish is that others may not have to experience what I and the families of those I have just mentioned are experiencing today.

I have, on occasion, let my feelings show. It has been particularly irksome to be criticised by legal firms who profit by suing doctors. In particular, I think of Leigh Day – under investigation themselves for destroying evidence crucial to the defence of British soldiers in Iraq wrongly accused of deliberately abusing detainees.

What is my motivation? Do I have an axe to grind? What is my interest? I will be clear. I am doing this because I believe it is the right thing for patients, for medical science, for finding new ways to treat incurable diseases. And in memory of my wife and all those who have died of cancer.

Published in the Telegraph 24th January 2015


Telegraph: Lord Saatchi, ‘Cuts to cancer drug funding will cause ‘great anxiety’ for thousands’


Published in the Telegraph By Ben Riley-Smith, Political 
12 Jan 2015

Thousands of Britons with cancer will be plunged into “great anxiety” because of cuts to crucial drug treatments announced on Monday, Lord (Maurice) Saatchi has warned.

The Conservative peer and advertising mogul told The Telegraph his life has been “immersed” with cancer recently with loved ones battling the same disease that took his wife as he criticised the scaling back of NHS funding.

It comes as charities and industry experts warned that NHS England’s expected decision to stop funding a series of cancer drugs was “short-sighted” and would endanger lives.

A review by the Cancer Drugs Fund, introduced in 2011 after the Conservatives pledged cancer patients would no longer be denied drugs on grounds of cost, is published today.

As many as half of the 25 drugs under review – which are used in 42 treatments – could have funding pulled according to industry sources.

The move comes amid spiralling costs, with the initial £200 million budget set aside by the Coalition already having increased to £280 given demand.

However the expected ‘delisting’ of potentially life-changing drugs has triggered uproar from cancer charities who fear the impact of pulling the funding on future patients.

Lord Saatchi, whose Medical Innovation Bill is being debated in Parliament and would increase the ability of doctors to try out new medicines on willing patients, said the funding cuts were of “great concern”.

“There is a sense of possibility with the Cancer Drugs Fund. Withdrawing funding is going to cause people who would potentially benefit from the treatments great anxiety,” Lord Saatchi told this newspaper.

However he noted that the fund could never alone answer why there has not been more innovation in cancer treatments and called for “big, cultural, systematic change”.

“I am immersed with cancer as friends and loved ones around me suffer from the same disease which also took my wife [the novelist Josephine Hart],” said Lord Saatchi.

“What I faced – as thousands do across the country – is the problem that doctors are only able to use those tools that are in front of them.

“I don’t want cancer patients to be told drugs can only stem their dying – that is a guarantee of failure. I want us to give people the opportunity to try to survive.”

It is understood pharmaceutical companies were given until the end of Friday by NHS England to justify why cancer drugs they produce should still receive funding.

At least eight life-extending treatments will be denied funding, with drugs that offer a last chance to patients with breast, prostate and bowel disease among those affected.

Prof Karol Sikora, chief medical officer at Cancer Partners UK and one of the country’s leading cancer experts, told The Telegraph the situation was “very sad”.

“Why cant the NHS negotiate better with the pharma industry so that our patients can have equivalence with the rest of Europe? Sure these are all expensive but lives have been prolonged significantly,” he said.

“To know that there is a drug out there that might give you a chance and to be turned down is not what our patients need.”

In a letter to this newspaper, Jonathan Emms, president of the Association of the British Pharmaceutical Industry, warned against the NHS cutting funding for medicines.

“The NHS already spends less than £1 in every £10 on medicine. Further cuts would be short-sighted and compromise patient care,” he said.

“Innovation in medicines is moving faster than the health system can deliver to patients. The NHS needs to catch up.”

Danni Manzi, head of policy at Breast Cancer Care, said: “This re-evaluation shows yet again that the Cancer Drugs Fund is not fit for purpose. We hope that none of the breast cancer drugs are removed due to cost.

“Having secondary, incurable breast cancer is devastating – and these patients should be entitled to improved quality of life and extra time with their loved-ones.”

“Until this is resolved cancer patients could miss out on vital treatment. We must urgently find a long-term, sustainable system that works.”

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.


There will never be enough trials – additional innovation is needed


By Professor David Walker

Professor of Paediatric Oncology Faculty of Medicine Health Sciences, University of Nottingham

There will never be enough trials – additional innovation is needed I was at a meeting recently with clinical academics, charity chief execs, health regulators, representatives of the pharmaceutical industry – and one lone voice that cut to the heart of the matter.

That voice was Debbie Binner, whose teenage daughter had died of a rare bone cancer, Ewing’s Sarcoma. Debbie was the reason we were there. When her daughter, Chloe, died she had just turned 18. A few months short of her 18th birthday, the chance of a drug trial was offered.

But Chloe needed to be 18 to be eligible and was refused entry. Our meeting, held in the House of Commons with Paul Burstow MP in the Chair, was to discuss how we, the experts, could ensure that younger people had access to more trials of new therapies for their life-threatening conditions.

Many speakers spoke about new ways to reform the regulatory system so that it could work better for young patients. We heard about changes in the EU Clinical Trials Directive that is being enacted in Brussels, that may help.

Listening to my colleagues, I was struck by one thought: that if you put people in a room who are expert on a regulatory process they want to make better, but inevitably more rules.

What is needed is a feeling that we can work for the patients’ benefit using our established professional values and standards rather than a raft of ever more complex rules. Research does require regulation to introduce new drugs and treatments safely. That is true. But trials cannot be the only answer.

There will never be enough trials, they take time and money, there are rarely trials for the less common diseases. So when patients are in a situation with “nowhere else to go” and if there is no trial for which they are eligible, they need to be able to try treatments that might work, based upon the best judgment of their medical advisors. We need to allow them to try such new drugs that may be applicable and collect that experience to inform the next generation of trials.

The Saatchi Bill would do this, by protecting individual doctors who try new, licensed but untrialled treatments, on patients who have consented to such treatment outside of a formal trial. This cannot be – and isn’t – a license for the maverick doctor acting alone.

The doctor would also need to share the decision with peers as part of the multi-disciplinary teams that already exist in modern health systems. The Saatchi Bill would meet the needs of pharma and academia – but most importantly the patients and their families who need to be given additional choice – and experience the associated hope.

If organised with light touch this could offer valuable information to researchers whilst sustaining hope for families that “no stone is being left unturned”.

The Saatchi Bill offers a framework where practitioners would be supported in exploring innovative therapies, whilst building evidence of their applicability and effectiveness as part of the process of acquiring the evidence necessary to launch the next generation of trials. This is why I commend the Saatchi initiative.

→READ Professor Walker’s biog

→READ the full story in the Telegraph

→WATCH Lord Saatchi explain the Bill

My brain tumour and me…


By Claire Bullimore

I will always remember the day the doctor said: “I’m very, very sorry but we can’t help you, you have a very small percentage chance of recovery.”

I just sat there looking around the room trying to get my head around it.

“A tumour,” I said.

He said he was surprised I had not been showing symptoms a long time ago as it was one of the biggest he had seen. Must have been growing for around 10 years he said.

I said I had been telling my GP I had problems for years but they wouldn’t help me. He said he was going to get me a bed ASAP and get me into surgery. I felt sick. I just said “Wow, OK.” What else can you say to that?”

My train pulled into London Bridge Station that early morning in May 2008. I grabbed my usual coffee and walked to my building.

I had a beautiful view over the river and always loved the location I was in. I was 25 and enjoying my life, London is such a beautiful city and I loved being a part of the hustle and bustle of the city.

Overnight my life went from independent woman to where am I now. Anxious waiting for results, depending on a number of tablets including seizure medication.

I suddenly became a child again and was very dependent on my mum. I decided from the day I heard the words “You have a brain tumour”, this will not beat me and my faith would pull me through and win.


Claire’s brain tumour x-ray

I knew things were going to change drastically, I had lost my speech, wordfinding, partially blind, weak on one side, heavily reliant on seizure medication, fatigue are just a few to mention. I wanted to be given a chance to get well. I wanted a chance to try something else rather than straight to surgery.

People would say they thought I was very strong and my positivity was inspiring, but the fear I was left with was life destroying. I would never be able to do the job I had before, I would never drive again, I would deal with fatigue for the rest of my life.. however determined you are; medication and brain surgery wears you down.

After my own battle to get as much as possible out of my life regardless of my health and disabilities. I knew I wanted to help others. While I sat at home recovering, I set up a support group through Facebook. I was about to meet others who understood. I knew very quickly that I could sympathise with others affected by a brain tumour. I set up www.auntymbraintumours.co.uk as a place for people to meet others.


I have over 15,000 people viewing my social media pages and I can see what people want, don’t want, what their fears are. It is not just for patients with tumours but also for anyone who has been affected by a brain tumour.

I believe the support people need is not just during the initial diagnoses but long after the treatment. Aunty M Brain Tumours is a life-long support network”

Join our community and meet people who understand. Join us on Facebook and Twitter I am a presenter on Croydon Radio (online) and host a weekly show dedicated to people affected by a brain tumour. It is there to encourage everyone, it is somewhere they can learn about the issues that can affect them.

So that is why I support the Saatchi Bill.

I want my friends and others who are suffering from cancer or other long term illnesses, to be able to say to their doctor “can you do anything, what are the treatments available, is there anything new that I can try?’ and they will say ‘yes’

(read more about Claire’s story in her book: A Brain tumour’s travel tale)


How Medical Innovation Saved My Life


By @DominicNutt diabetic and cancer patient

Two years ago I was diagnosed with a rare, incurable cancer. Had it not been for my surgeon, who pushed the boundaries of accepted treatment, the chances are that I would now be living on death row. But unless a new Bill is made law, other doctors may be too scared to do the same.

In December 2011, I developed a nagging pain in the lower right side of my stomach and was admitted to hospital for an emergency appendectomy. However, tests showed there was nothing wrong with my appendix. But my consultant, told me that “by luck” they had found on it a rare, 12mm neuroendocrine tumour (known as a Net).

It had not been responsible for the pain, the cause of which to this day remains a mystery.

I had my appendix removed, which is standard treatment for Nets – otherwise, the tumour would have spread and killed me, because Nets do not respond to chemotherapy or radiotherapy.

The next bit was tricky. Nets are so rare that there is little knowledge as to how they behave. All doctors do is make estimates based on limited case studies.

My consultant, a colorectal surgeon, said that standard procedure for a Net of 10mm or smaller is to remove it, but not to take any other action, since the best guess is that the chance of spread is low.

Anything over 20mm, however, and doctors will remove nearby lymph nodes, the first organs that cancers normally spread to before invading the rest of the body.

Anything between those sizes, like my tumour, leaves doctors scratching their heads. They would be entitled to take no action. Also, surgery to remove my lymph nodes would mean slicing out a large part of my colon, with all the inherent risks. I am an insulin-dependent diabetic, so the hazards of surgery were even greater for me.

Fortunately, my consultant reviewed my case with other experts and they recommended surgery.

When the results came back, they found a cancerous cell in one of the 17 lymph nodes they had removed. The cancer had spread, despite very low odds.

This is a tale of a doctor who was prepared to take a risk – one that has probably saved my life. But had there been complications, and had he not found a cancerous cell, I, or my widow, could have sued.

Last year, spending on negligence claims by the NHS Litigation Authority, which provides indemnity cover for such claims, was, for the first time, more than £1  billion.

And legal cases against the NHS pending in the litigation pipeline could amount to a bill of £24 billion – around half the UK defence budget.

Frightened of litigation, many doctors do not push the boundaries of medical knowledge, and opt instead for “safe” standard procedures.

I tell this tale in support of Maurice Saatchi, who has drafted the Medical Innovation Bill which, if passed, will allow doctors, with the patient’s consent and in cases where the evidence on standard procedures is unclear, to innovate.

It would enable them to review such cases with other experts – as my consultant did – and come to a collective decision. Following this process would give them a legal defence if things were to go wrong.

The Secretary of State for Health, @Jeremy_Hunt, supports the Bill and has opened it out to a public consultation.  He has told Parliament that if the public responds positively to the consultation, then the Bill will become law.

It’s now in our hands.

Dominic Nutt is part of the Saatchi Bill team.