The Independent View: Commons must debate key Medical Innovation Bill before election

Maurice Saatchi’s Medical innovation Bill has caused controversy and inspired a passionate debate on how doctors and scientists can and should speed up medical advance for currently incurable diseases.

The Bill is designed to do two things. First, it will offer clarity and confidence to doctors who want to innovate and move away from standard procedures.

When might that be relevant? In most cases standard procedures work and innovation is unnecessary. There is a vast quantity of scientifically validated data which supports standard medical procedures.

But in some cases – specially for rare and incurable diseases –  there is little scientific data and no effective treatments. In such cases, a doctor and the patient may face a choice, between applying the standard treatments, even though they are known not to work and will lead only to death, or to try something new.

A good example is around ebola. WHO issued guidelines to doctors saying they could offer untested treatments to patients who would otherwise die. It is worth noting that one of the doctors o the WHO panel, Prof Peter Smith from the London School of Hygiene and Tropical Medicine, states there are obvious parallels between the WHO guidance and the Medical Innovation Bill.

Doctors, with their patients’ consent, who do want to innovate will of course need some evidence that the innovative treatment may make a difference. And there is a risk. If the treatment fails – as it may well do – doctors may face a negligence claim and disciplinary action. Such an action is, of course, defensible in law. A doctor will need to get the support of other relevantly qualified practitioners to say they would have tried the same procedure.

But this means having the threat of legal action hanging over the doctor who seeks to innovate. For many this fear is a break on innovation.

The Medical Innovation Bill, then, allows the doctor to get support from doctors in advance of the innovative treatment, so that the doctor and patient has legal clarity and confidence before the treatment starts.

The Bill also makes it a requirement to register innovative treatments – including their results – so that other doctors and researchers can learn from and build on this new data.

Even when doctors do innovate today, data is not collected and shared in a central database. That has to be wrong.

Doctors don’t  to have to use the Bill – the Bill leaves the current common law in place. It gives doctors a choice.

What else will it do? It will help change the culture around innovation. In a world of increasing medical litigation, medical students are told they will be sued at least once during their careers. This increases the culture of defensive medicine.

When a patient is dying, some will want to be assured that their doctor can, and has, tried everything. And if the treatment fails, rather like the organ donor who in death leaves a legacy to others, they will know their treatment has added to the sum of scientific knowledge. Over and over terminal patients have told us they want to know their deaths meant something and helped others.

I, too have an axe to grind and I should be clear to you about that. As well as working for Lord Saatchi advocating for the Bill, I also have a rare cancer. It affects so few people that there is little data on new treatments and currently, it is incurable.

The Bill has been debated four times in the Lords and now has unanimous support from all parties and cross benchers. It is now due to come to the Commons. But is needs Coalition agreement for time to be found before the election.

I urge you to encourage Lib Dem Whips to agree to time being found – even if you don’t support the Bill.

It is the Liberal way. There must be debate. It is wrong that a Bill that has so much public support, faces termination not on the floor of the Commons, but by administrative fiat.

UPDATE 16:36: This post was updated to include a paragraph about Dominic’s interest in the Bill.

The Independent View‘ is a slot on Lib Dem Voice which allows those from beyond the party to contribute to debates we believe are of interest to LDV’s readers. Please email [email protected] if you are interested in contributing.

* Dominic Nutt was a former local and national print journalist. In 1999 he became a communications specialist and worked for aid agencies including Save the Children and Christian Aid. He covered humanitarian and man-made disasters, including famines, floods and earthquakes and the wars in Iraq, Afghanistan, Somalia and Lebanon. He has contributed pieces to The Guardian, Express, Telegraph and BBC Radio 4 – many from overseas. He is a campaigner for the marginalised, fighting for human rights and justice.

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64 Comments

  • The Bill is opposed by pretty much all of the major medical bodies (GMC, BMA, Royal Colleges), both of the main medical protection bodies (MDU, MPS), and some of the most important research organisations (Medical Research Council, Wellcome Trust, Cancer Research UK) – precisely the groups that should most benefit from this proposed legislation. This should tell you just how flawed it is.

    The author is actually a key member of the Bill’s team (see here: http://medicalinnovationbill.co.uk/who-are-the-medical-innovation-bill-team/).

    For a counter view, including links to the views of the bodies listed above and many more, see http://www.stopthesaatchibill.co.uk. You ,might also want to seek the views of Lib Dem MP Julian Huppert.

  • Susan Bewley 19th Feb '15 - 9:55am

    This is flannel. The bill does not have such support. See http://www.stopthesaatchibill.co.uk/. It has almost unanimous opposition from informed commentators. There are no legal barriers to innovation that this Bill will address. It will not lead to creativity. Such controversial legislation changing the very boundaries of the doctor-patient relationship should not be passed ‘on the nod’ without the full scrutiny of the Commons. It is bad to remove protections from patients, confusing to doctors and will lead to more work for lawyers.

  • Rob Hinkley 19th Feb '15 - 9:59am

    Regrettable that Dominic Nutt’s bio at the foot of the article doesn’t mention that he’s also paid by Maurice Saatchi to be PR director for the Medical Innovation Bill, a Bill opposed by (among others) the General Medical Council, Cancer Research UK, Academy Of Medical Royal colleges, British Medical Association, Wellcome Trust, and Motor Neurone Disease Association on the grounds that (among others) it is unnecessary and removes patient protections and patients’ right of redress if they are harmed.

  • Caron Lindsay Caron Lindsay 19th Feb '15 - 10:01am

    Can I just point out what “The Independent View” slot is about? From the bottom of the article:

    “‘The Independent View‘ is a slot on Lib Dem Voice which allows those from beyond the party to contribute to debates we believe are of interest to LDV’s readers. ”

    Clearly whoever writes will have a particular view on any issue. If the Stop the Saatchi Bill supporters wanted to write a piece, then they could to. I just thought it would be an interesting debate for our readers – and it’s not as if the article isn’t open to criticism.

  • Drew Burdett 19th Feb '15 - 10:15am

    Caron,

    While what you say is true it still leaves 2 issues:

    1) the author has a massive undeclared conflict of interest.
    2) since highly partisan contributors can write for this column you must admit it’s a misleading title.

    Next up “The Independent View – why sweets must be eaten by everybody” by Bertie Bassett.

  • As others have said Dominic Nutt has not declared his interest as being paid as head of the Bills PR team to promote this Bill. If he really wanted the Bill to be debated and properly considered then why try and try and rush this through on the Second Reading in the House of Commons. Most of what Dominic says in this piece is competely inaccurate , he does not understand the law he is trying to change, and he does not appear to understand the dangerous implications of this Bill.

    Julian Huppert is right the extent of opposition by doctors, patients and charities is staggering yet their voices are being totally ignored. Time and time we hear from Dominic Nutt that Bill will help doctors innovate new cures for cancer and other illnesses. Yet doctors have told him loud and clear ; they don’t want the bill, they don’t need the bill; the bill may cause harm to patients; the bill will impede Innvation. Why won’t he listen and why won’t his boss Lord Saatchi listen to them ?

  • Simon McGrath 19th Feb '15 - 11:05am

    @Andy Lewis your comment : “Your strap line is “Not paid for by trade unions or millionaires.” This article is and it is not declared.”
    is simply not true. Saatchi hasn’t paid for it to appear.
    I agree that Dominic Nutt should have declared his interest though.

  • This Bill is needed for terminal Ill patients that have no hope for standard treatment,to survive. This bill will allow these patients a last ditch hope for a cure. If your Wife husband parent or a Child was given weeks to live and they were offered this service they would grab it. And if it was your decision to live or die then YOU would grab it also. So you must support this Bill because Next week you may need it. Think on.

  • Ray, you make it sound as if the NHS has dozens of legitimate potential cures for Stage 4 cancer just waiting to be tried on patients, except for some fear that their relatives will sue if the cure doesn’t work. Well, it doesn’t. But a whole host of quacks and charlatans are willing to take the money of distressed people on the “one in a million” chance that their brand of magic water might save your loved ones. This bill will enable them to get away with the most appalling abuses of vulnerable people (suffering from any medical condition whatsoever), and it will save precisely zero lives.

  • You in the above comments really dont understand what we patients that are terminal have to go through. having been told I was terminal and 3 monthst to live only make me comfortable. So 4 lines of chemo 4×6 I was proving them wrong. all that sickness and my body breaking down. Unable to have the latest trials as I was to Toxic. I had to bang on so many doors for treatment and the NHS had to stick to what was licensed. I had a glimmer of hope and 3 of us got on a Phase 1 trial at the Innovation Hospital The Royal Marsden. Im classed as Private now and the trial has only worked for me for mesothelioma. Everyone should have a chance for my trial. Its so unfair when others need the chance I have been lucky to have, We need the Bill to make the latest drugs available. We sign to say we wont sue.
    Dominic Nutt Speaks for all the Patients in this country he doesnt deserve to be ridiculed he deserves Praise. and Boy do I Praise him and Lord Saatchie .

    ““At the moment, the doctor’s hands are tied – by concerns about professional reputation and potential negligence claims. That needs to change.”” Lord Woolf, Former Lord Chief Justice Source – Telegraph

  • Malcolm Todd 19th Feb '15 - 12:19pm

    This is a fascinating argument. Could anyone from the very articulate and persuasive “anti” side explain what they think the Saatchi lobby are actually trying to achieve, if their declared aim makes no sense? Surely, somebody must believe they have something to gain from this bill?

  • Andy Lewis the patient will also gain. If your family were terminal ill you would move heaven and earth for them so please let the patient decide what we would or would not like to do.

  • Drugs will not go untested thats not what the bill is about. We just need the red tape to be cut. Why do we have to retest drugs that have been passed in another country . Why do we have to go through Placebos when they are proven to work in other countries. This Bill will cause a much needed shake up. It is being approached very sensible in my opinion. Quote ——–However under the new bill, a body of medical experts would decide before the treatment so that the doctor was not left wondering if he or she might appear in court.

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

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

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

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

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

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

    “If the Bill receives Royal Assent after scrutiny in both Houses of Parliament, good doctors will be protected and encouraged by the law.

  • David Allen 19th Feb '15 - 1:50pm

    I fear that this is one more example of the pervasive influence of lobbyists in our political system. There are literally hundreds of paid political lobbyists in Britain for each and every one of our MPs. Similarly, the total earnings of all ou MPs are dwarfed by the total earnings of lobbyists, who are paid to persuade those MPs to act in ways which help their business interests.

    http://www.theprostitutestate.co.uk/page2.html

    One of the keys to successful lobbying is to find a sympathetic front for the activity, and make that the basis for publicity. In this case, everybody can relate to and sympathise with the grief of a man whose wife has died. Whether his fellow travellers have equally sympathetic motives, and whether they have all reached valid conclusions about medical innovation, is a different question entirely.

  • Dinah Liversidge 19th Feb '15 - 2:09pm

    This bill has enormous support from those of us living with terminal or un-treatable conditions. We’re simply asking now that the House of Commons has a chance to debate it, properly, in open discussion. We’ve all heard both sides of the rather hot-potato this has become, but what patients are really interested in is HOPE. Hope that our doctors can make decisions that might extend our lives, or the lives of those we love. Please, let’s have a proper debate and then move forward.

  • Laurie Willberg 19th Feb '15 - 3:16pm

    Only the status quo with a vested interest in continuing its present monopoly in its present form is opposing this Bill. It’s beyond obvious that the status quo is attempting to prevent or stall meaningful debate and trots out the same arguments that have already been dismissed by the majority of people it will most significantly impact: patients.

  • Malcolm Todd 19th Feb '15 - 3:28pm

    Thank you, Andy Lewis and Graham Lowell, for most informative replies, and all-too-credible analysis of motives. Worrying that people continue to post on here as if the Bill were about allowing access to otherwise unavailable treatment for the terminally or critically ill despite the clear explanations that that’s not what it does at all.

    What a shame Dominic Nutt hasn’t been back to argue his corner.

  • http://medicalinnovationbill.co.uk/about-the-medical-innovation-bill/supporters-medical-innovation-bill/
    This link shows the support for the Bill.
    Dinah Liversidge has hit the nail on the head -We’re simply asking now that the House of Commons has a chance to debate it, properly, in open discussion. It has been discussed and all amendments were passed so we now have a great Bill. Please lets let our MP’s debate it.

  • Charlie Chan 19th Feb '15 - 5:40pm

    The detractors of this Bill somehow think that this Bill will be dangerous, encourage charlatan practice and hinder clinical research. These are all very important issues to be debated publicly and in Parliament. The House of Lords has debated this widely on four occasions – with far more time and scrutiny than even the most ardent of the detractors. This has cross-party support from the Lords, including support from many medical Lords, who had initial concerns.

    If the Bill is flawed and dangerous, then let it be aired on the debating floor in the House of Commons. Surely that is the right and proper place for this to be discussed. The Bill has been studied in depth in the Lords and been amended astutely. The Medical Director of the NHS, Sir Bruce Keogh, has personally scrutinised the Bill and tabled amendments, which have gone through. If the Bill is truly unsafe, then let the Honourable Elected Members of Parliament decide whether to pass it or throw it out.

    Returning to the beginning of my post, is this Bill dangerous, encouraging of charlatans and bad for clinical trials or research? I do not believe it is, and neither do many others. The Bill is designed to help only those with serious illness, for whom all standard and trial treatments have failed. Some patients, such as those with motor neurone disease or muscular dystrophy have no effective treatments available at all.

    Creating a new culture where doctors can discuss novel treatments in an open manner should be a good thing. No-one expects miracle cures. But using established drugs in different situations or new drugs, which are on clinical trials in other fields, may be reasonable. After all, the WHO sanctioned the use of ZMAPP and other untested drugs in the current Ebola crisis, for an illness, which has a 70-90% mortality rate; they felt that this was ethical and the right thing to do. Some diseases carry a 100% early mortality rate. So why should Ebola be different to cancer, muscular dystrophy, motor neurone disease and other fatal diseases?

    The creation of a new Medical Innovation Register is a key part of the Bill. This will oblige all doctors seeking to use the Bill to register each patient, who has a novel treatment. The follow up and outcomes must be recorded too. This database will be set up at Oxford University in a department with impeccable medical statistical and trial credentials. No charlatan or quack would wish to have his/her witchcraft potion registered and the failures recorded on an open access database for all to see across the world. The database will be open and transparent, so that every doctors using it can be publicly scrutinised.

    Finally, Oxford University will also undertake to review novel treatments in the same way as clinical trials, producing reports on which new therapies show promise and which don’t. These reports can then be used by doctors and scientists to initiate substantive clinical trials to confirm or refute new treatments, which show promise. Thus medical knowledge advances and the experience of individual patients can be learned from.

    Five days ago, I helped to carry the coffin of my 50 year old brother in law, who died from oesophageal cancer. He was an archetypal technocrat, who crashed the nascent world wide web in the early 90s by uploading too many cookery recipes. We spoke many times about the Bill. He supported it, as he understood that it aims to improve mankind. Please allow this to be debated freely in the House of Commons – that is all he would ask of you.

    Charlie Chan DPhil FRCS
    Consultant Surgeon

  • This is what Im so pleased to see happen It doesnt hapen now as I would have used such a data base and saved myself so much money in phonecalls and traveling to find a treatment ——–Oxford University has also agreed to set up and run a database containing anonymised information about those who agree to the treatments.

    Stephen Kennedy, a professor of reproductive medicine at Oxford University, told The Telegraph the database will be “publicly accessible to patients and healthcare professionals alike”.

    Patients would be able to go onto the website, find an innovative treatment that had been tested on other people and then ask for it to be tested on them.

    Prof Kennedy said: “There would be a facility within the database to enable people to search on the basis of conditions and treatments.” Patients’ details on the site “would be completely anonymous,” he added

  • Rachel Lewis-Mayhew 19th Feb '15 - 7:47pm

    I find it frustrating but not surprising that opposition to the Bill does not come from those who directly experience the problems that the Saatchi Bill is trying to put right. These problems are real to patients and carers like myself. Evidence absolutely exist and can prove that even though there may be a treatment that could help but is not licenced for that particular rare cancer or condition, your oncologist most likely will not suggest it. Medical professionals entered their profession to help patients, however current law is such that they are forced to put their career before the very people they want to help. It is only those, and there are thousands and counting, who actually understand what it is to be diagnosed incurable or terminal that understand that the Saatchi Bill will allow medical innovation for the ever increasing rare conditions that can’t be ignore or considered insignificant. Under current law it is extremely unlikely that a clinical trial will ever be conducted on a rare condition, but under the Satchi Bill a clinical trial for rare conditions would be possible. I really do hope that those who oppose the Bill are never in a position of needing innovation for themselves or a loved one, although only then would they really understand that we need the changes that the Saatchi Bill will help to make a reality for thousands who have the right to choose to fight for their life.

  • Susan Bewley 19th Feb '15 - 9:24pm

    Rachel

    1. How do you know opponents of the MIB don’t experience the problems Saatchi is trying to put right? Where do you think opponents of the Bill live? In a world where they do not have heartbreaking, chronic medical disorders, and dying friends and relatives? Just because someone doesn’t put their personal story into the public domain doesn’t mean they have no personal experience. A personal experience of suffering doesn’t make me an expert in law or science or medicine or anything else for that matter. My hope for a better future (short or long) cannot make the world better just by willing it desperately. I’ve been amazed by the dramatic innovations in my lifetime, and long may they continue.

    2. And which law exactly is it that forces doctors to put their career before the very people they want to help?

  • Laurie Willberg 19th Feb '15 - 11:14pm

    It appears this Bill is only opposed by those who have the most to lose (the status quo) and embraced by those who have the most to gain — the public. It’s glaringly obvious that medical innovation has been resisted and suppressed, but that’s quite typical of mainstream medicine. Current oncology chemotherapy treatments net about $300,000 per patient with a 5 yr survival rate of around 2%. There have been no significant innovations or improvements in cancer treatment for years while promising new treatments are not thoroughly investigated through patient outcome studies, of course, with full patient consent.

  • John Broggio 19th Feb '15 - 11:52pm

    Laurie

    I’m afraid the assertions you make do not stand up to published statistics from the Office for National Statistics, cancer charities and academic papers. The third bullet point on CRUKs headline page on survival (http://www.cancerresearchuk.org/cancer-info/cancerstats/survival/) says “Cancer survival in the UK has doubled in the last 40 years.” Personally, I think that shows considerable improvement and innovation here in the UK.

    Treatments are thoroughly investigated through patient outcome studies; there was a Panorama programme last week on this very issue focussing on the incredible work being done at The Royal Marsden NHS Foundation Trust (http://www.bbc.co.uk/iplayer/episode/b052sjsg/panorama-can-you-cure-my-cancer). Similarly, there is at least one public database of clinical trials in progress (http://www.ukctg.nihr.ac.uk/default.aspx in general, http://www.cancerresearchuk.org/about-cancer/trials/ for cancer specifically).

  • Charlie Chan 20th Feb '15 - 12:11am

    In the Explanatory Notes accompanying the Bill, the Medical Innovation Register is described in principle here. Of course, there is no Register yet, as the Bill has not become Law. But the Register is agreed in principle and will be compulsory, if the Bill is passed.

    11. Subsection (3)(e) requires the doctor to comply with any professional requirements that may be in place to register the proposed innovative treatment with a data-capture scheme. The Bill does not establish a data-bank, but if one is established, and if the medical regulatory bodies require doctors to use it, then the Bill will make compliance with registration requirements compulsory for doctors relying on the provisions of the Bill in order to innovate. The provision includes reference to the registration of all data, including negative results and information about small-scale treatments and patients’ experiences.

  • Laurie Willberg 20th Feb '15 - 1:45am

    It should be noted that Andy Lewis belongs to the organized “skeptic” pharma lobby that only Astroturfs as consumer advocates. Nothing could be further from the truth.

  • Charlie

    Do you really not see the difference between these two statements of yours:

    “The creation of a new Medical Innovation Register is a key part of the Bill. This will oblige all doctors seeking to use the Bill to register each patient, who has a novel treatment.”

    and

    “but IF one is established, and IF the medical regulatory bodies require doctors to use it, THEN the Bill will make compliance with registration requirements compulsory for doctors relying on the provisions of the Bill” (my emphasis)

    There is no register, and while Oxford seems to have offered to host one, it is not actually the Bill or Lord Saatchi who will be setting it up. This relies on the GMC to do so. Leaving aside the very many issues that have yet to be determined (the register is said to be anonymous, but how can this be guaranteed with very rare diseases such as Ebola? Who will fund it? Who will have access to the information?), here’s the big one:

    The GMC is against the register and does not think that it can mandate and police compliance. See here:http://nigelpooleqc.blogspot.co.uk/2015/01/the-medical-innovation-register.html

    Indeed the GMC, like the BMA, Royal Colleges, MDU, MPS, Cancer Research UK, the Wellcome Trust, the MRC, the Patient’s Association and AvMA (you’ll note that those comprise pretty much all of the medical, medical protection, research and patient bodies) are AGAINST the Bill. For the GMC’s current position see here at paras 66-7:http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/health-committee/2015-accountability-hearing-with-the-general-medical-council/oral/17274.pdf

    To be frank, there’s either something fundamentally wrong with the Bill or all of the above major bodies have had a collective brain fade. I’d ask you which you think is more likely.

  • Drew Burdett 20th Feb '15 - 5:43pm

    @sandra

    An ad hominem would be “she’s not to be trusted because she’s a homeopath”.
    “Laurie Willberg is a homeopath” is a statement of fact.

    @laurie

    You saying Andy Lewis is part of the “organised ‘skeptic’ pharma lobby” reminded me of Kevin M. Folta’s response to being called a GMO lobbying shill:

    1. It immediately says that you are willing to make up information in the absence of evidence.
    2. It says that you are finished with the conversation, that nothing I communicate is valid in your opinion.
    3. It shows that you are willing to try to influence other like-minded people with disinformation.

    http://kfolta.blogspot.co.uk/2012/07/thoughts-from-shill-for-monsanto.html

  • Jayne Mansfield 20th Feb '15 - 8:46pm

    As someone who has worked in tribal areas abroad where the people do not have access to litigation if things go wrong, and where they are prey to all sorts of unproven interventions by people who sell potions etc., I would just like to say that I don’t find the idea of doctors practising ‘defensive’ medicine a problem at all. I would go further and say that, in my opinion, the law has caused the medical profession to raise their game when it comes to how they treat their patients and that patients have benefitted as a result.

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