Tag Archives: duchenne

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

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.

Join our Facebook Chat TONIGHT at 8pm


Health Secretary Jeremy Hunt has told patients in England and Wales that he will pass the Medical innovation Bill into law if the public tell him they want it.

Patients, doctors and lawyers have responded in their thousands telling him they want the Bill – and, crucially, why.

Officials at the Department of health tell us that it isn’t enough just to tick the ‘Yes’ box – they want to see reasons too. You have been telling him your stories, through the Change.Org response form which goes straight to the civil servants analysing the responses at the department.

Thank you for this.

Yet, we know that even though people want the Bill, there is a real danger that officials will remain unmoved. Don’t give them the option to ignore you. That’s why we’re holding this Facebook chat – to hear your stories, to inspire each other to respond, to tell civil servants who control the consultation that this is a democracy and that you want the Bill.

Join our Facebook Chat April 15th 8pm on our Facebook page: http://on.fb.me/1fOcOUG

But the Bill isn’t the only game in town – it is part of a bigger movement for medical innovation and the search or new treatments for so-far incurable diseases, like Duchene’s Muscular Dystrophy, for example. The Saatchi Bill Team has been working with Empower Access To Medicine, Harrison’s Fund, cancer charities, patient groups and many others to support each other as a community of patients and carers who want to see lives saved and changed for the better.

Empower Access to Medicine  wants to speed up access to new drugs therapies. At the moment drug trials and development take years. But patients who are dying don’t have time to spare. So Empower has persuaded the Department of Health to allow patients and doctors to use promising drug therapies before they have finished the full trials process.

It’s a great achievement.

James Hargrave, Empower says: “Both Empower: Access to Medicine and Lord Saatchi’s Medical Innovation Bill are working to put patients at the heart of medicine. Doctors must be allowed the space to innovate responsibly without fear or favour – but to be able to do this the drug development process needs to be fit for purpose so that there are innovative treatments for them to use.

“The time has come for medical regulation to match modern medicine.”

The Saatchi Bill will, if passed, support doctors who want to use such medicines early – by giving them confidence to prescribe them without the risk of being sued – as long as they get the consent of other senior doctors and the patient.

So, the Saatchi Bill is vital part of a bigger picture. The Bill alone will make a big difference. But in alliance with all the work and big campaigns by Empower and others, we will be unstoppable.

The consultation ends on 25 April. Don’t let officials say that you didn’t want the Bill. Please respond. 

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

Join our Facebook chat tonight, April 15th, at 8pm on the Saatchi Bill Facebook page: www.facebook.com/SaatchiBill

 Sign the petition for the Medical Innovation Bill: http://chn.ge/1pqY6lS


33 days to make medical history

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Help us ensure the Government keep their promise.

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

Read about Alex and Harrison here

Find out more about Harrison’s Fund

Supporting innovation – exposing the maverick

The Saatchi Bill will make it much easier for doctors to innovate safely in the interests of their patients.

At the same time, it will expose the doctor who wishes to exploit their patient, preying on them and their vulnerability in order to attempt a reckless experiment.

Doctors will not be protected by the Saatchi Bill unless they go through a rigorous and specific process to ensure that the attempted innovation is the right course of action for the patient.

As the draft Bill states in paragraph 2 (3a) a doctor wishing to try a new treatment – for example in the case where standard treatments aren’t working – must consult a body of senior and relevant medical experts and get their consent.

The doctor must also record their opinion, including and dissenting voices.

The decision of the panel of experts must then be presented to the patient – including any contrary opinions if there are any – and the patient must of course also agree to go through with the innovative treatment.

Finally, the note of the opinions must then be attached to the patient’s consent form as a permanent record.

Only then will the doctor be legally covered by the Bill.

The Bill imposes a much higher standard of consent than other health legislation.

For example in order to section a patient, the Mental Health Act requires the signatures of only two doctors.

Currently, it is easier now for a doctor to indulge in reckless experimentation and maverick medicine, than it will be if the Bill becomes law.

As it now stands – without the Saatchi Bill – a doctor can attempt to persuade a vulnerable patient to embark on a dangerous treatment path.

This is so because the doctor technically doesn’t need to refer to a panel of experts before trying the non-standard procedure. He or she can act alone.

So, the Medical Innovation Bill supports and encourages reasoned innovation – and exposes the maverick.

Lord Woolf: Former Master of the Roles and Lord Chief Justice:

[The Bill] could give confidence to medical practitioners engaged in the field of treatment of cancer that in appropriate circumstances they could safely recommend and implement a course of treatment, or non-treatment , which some, or indeed the majority of their professional colleagues, might regard as unorthodox.

I have come to this conclusion because it is, in my view, undoubtedly the case that there is insufficient certainty as to the course which courts will adopt in this country at the present time when faced with an allegation that a medical practitioner’s treatment of a patient was inappropriate because of its innovative nature.

[There is] a risk that the present state of the law could inhibit the proper development of treatment of particular cancers.

Any way of avoiding this by legislation, in my opinion, should be welcomed. I would therefore hope that in the Lords, at any rate, your Bill will be well received.

About Lord Woolf

Telegraph: Lord Saatchi launches the consultation on his medical innovation bill – live from the House of Lords

Today Lord Saatchi launched his Medical Innovation Bill LIVE via Google Hangout from the House of Lords.

The politician was joined by a panel of experts including Telegraph doctor Max Pemberton in a live video stream from the House of Lords today where they will call on the public to support his Medical Innovation Bill.

Introduced by Lord Saatchi last year following the death of his novelist wife Josephine Hart to ovarian cancer in 2011, the Bill seeks to give medics greater freedom to test out cutting edge treatments on dying patients.

Currently doctors are forced by the threat of legal action to stick to standard procedures, even when they are proving ineffective.

Lord Saatchi’s bill has already received huge public support and health secretary Jeremy Hunt promised to support legislation on the issue after the public consultation which is launched today and ends in May.

Read in the Telegraph 


Harrison, Duchenne and I

Harrison and Alex Smith

When Harrison was just 4 years old, I took him to his pediatrician thinking he might have a mild physical delay and may need physical therapy.  Within 2 weeks, a blood test and a visit with a neurologist provided us with the most devastating diagnosis imaginable.  Duchenne muscular dystrophy.  The neurologist explained to us that Harrison’s muscles would rapidly deteriorate, he would lose the ability to walk, to use his arms, to bathe himself, to go to the bathroom on his own. Eventually Duchenne would attack his heart and lungs and the disease would take his life.  We have nothing to stop it he told us.  It’s 100 % fatal, I wish I could tell you it was cancer.

I swung in to action, I challenge myself daily…mentally and physically to do the best I can.  I’ve started a charity, Harrison’s Fund, to generate as much cash as I can to put into breakthrough Duchenne research to find a treatment for this generation of children and young adults. We have already invested hundreds of thousands of pounds. I’ve become a networker, at all times, this never really switches off, I’ve started a not for profit race team, Harrison’s Racing,  I’ve literally gone from  Average Man to Ironman, completing my first Ironman triathlon in October last year. But, becoming just an Ironman doesn’t seem quite enough for me now… next in the challenge list is to take Harrison on an Ironman with me. Drag him in a boat behind me for 3.8km, take him on the 180km bike leg and then push him the no small matter of a 42.2km marathon, all back to back in under 13hrs and 47mins, a world record time. Harrison will also be an Ironman… that’s just cool! I am in the process of assembling the team to get this done, from building a bespoke catamaran to drag, to building the bike and Harrison machine and the running chair needed to take a child that no longer really fits in any of the running chairs out there anymore.

Harrison is now nearly 8, and we live each day with the knowledge that because he’s got a duplication of exon 51 of his dystrophin gene, his symptoms continue to progress and he continues on a steady and rapid physical decline.

Harrison’s doing incredibly well considering but he has reached a plateau all children with Duchenne  do around there seventh and eighth birthdays.

Harrison Smith

This is a stage of progression that is marked by an accelerated decline…  It is marked by …

Shock – the shock of his legs buckling without warning, sending him tumbling to the ground. It is marked by the shock of not being able to open the jar he used to be able to

Fatigue – he is plagued by the fatigue of exerting great effort just to do “normal” things – like keeping his balance and getting up from the floor.

Strategizing – thinking about how we organise and prioritize a day for the family that will not wear him out yet still let him experience all the world has to offer.

Disappointment – the searing realization that he can’t play organized sports, my lack of words or adequate comfort when he walks into the house fighting back tears because his brother or friends just rode off on their bikes and he can’t be with them.

Routine –  daily stretching sessions, and regularly physical therapy appointments and doctor appointments.

Hanging on – to what may be the last time he’ll complete a task or have the energy to help me coach his brother Williams under 6 rugby team.

This is the time when kids are moving faster and pushing limits and growing and looking forward to the future.  And I’m terrified that Harrison may not have one.  Annual events like birthdays and the end of a school year are marked by conflicting emotions – they’re marked by relief that we were given the gift of another year.  And by grieving one less year we have together.

While these symptoms are heartbreaking, I am also filled with the sobering reality that this is MILD compared to what we will face in the very near future.  There is a train racing toward my little boy and I’m running as fast as I can to scoop him up and save him, but I’m acutely aware that I may not make it in time.  We need to affect massive change to help stop the train.

Children at any age – whether they’re 3 or 5 or 7, like Harrison, should be afraid of the dark.  Of the bully on the playground.  Of the monsters under their bed.  But they should NOT be afraid of needles and biopsies and surgeries and falling and breaking bones.  They should NOT be afraid of no longer walking or of being unable to feed themselves or of losing so much strength in their arms that they can no longer hug their mum’s and dad’s.  Most importantly, they should NOT be afraid of dying.

I’m writing this blog today because this medical innovation bill has the very real potential to help doctors and clinicians slow down the train. In our case the risk of doing nothing is not nothing, the risk of doing nothing is fatal. Fatal every single time. You never survive this.

In any innovation in medicine there is an element of risk, and between clinicians and patients there has to be a level of permissible risk particularly when the population is small and the need is great. In terms of acceptance of risk – our community has already demonstrated our philosophy on this – we have one option right now – it causes cataracts and growth stoppage and osteoporosis, and weight gain and immune system suppression – and this drug is still being studied in the Duchenne population. There are debates over dosing and efficacy and this drug doesn’t even change the final outcome for Duchenne patients.  Yet, our children’s doctors prescribe it, and in fact encourage its use.  It’s part of the standard of care for Duchenne.   Through this use of steroids, we’ve already shown that we’re willing to assume risk.  We understand that the long-term risks of steroid therapy are known, and the long-term risks of a new therapy would be unknown.  But it’s also quite straightforward and simple logic that helps us understand that long-term risks can only become clear when something has been used for the long term – and the only way to get to the long term is to begin.  We have to begin somewhere. Sometime.  And the time has to be now.

What we are not willing to do is assume the risk of doing nothing. If a potential therapy shows promise of stabilization or improvement over what would be expected without any treatment, and it shows safety, then patients and parents should be given a choice to try it with long-term studies taking place concurrently.  Because, at the end of every discussion and assessment of a therapy, we must never lose sight of the reality that the risk of having Duchenne far outweighs the risk of most potential treatments.  And our children must be the beneficiaries of our best effort, of our most noble intentions, and of our greatest commitment to safety AND speed. Because at the end of the day, these children are not a statistic.  They are not a commodity. They are not someone’s science experiment.

They could be YOUR boys or grandchildren…..and they may not be, but the responsibility for saving them belongs to all of us.  I believe we are close to a treatment. We are so close that my son Harrison is part of a generation that will either be the last to die from Duchenne or the first to survive.  We must have a great sense of urgency and we must always remember that the children should NOT serve the science, but the science must always serve the children.

With this bill and the innovation it would encourage we have the potential to move forward and reduce Duchenne from a 100% fatal condition to that of a chronic condition. The time is now, we don’t have time to waste, #maketime.