Patient Safety and Medical Innovation

Sarah Wollaston Excerpts

Tuesday 9th December 2014 Commons Chamber

[Dr Sarah Wollaston (Totnes) (Con)]

Like books, one should never judge a Bill by its cover. Later this week, the Medical Innovation Bill reaches Report stage in the House of Lords, but I would like to demonstrate that it is fundamentally flawed in its premise, it is unnecessary, it removes essential protections for patients, and it increases the risks of their exposure to maverick doctors. I believe it will undermine not only patient safety but medical innovation and so will have precisely the opposite effect to that intended.

Under current law, a doctor is negligent if he or she acts in a way which no responsible body of medical opinion would support, or which is irrational or illogical—the so-called Bolam test, as refined in the case of Bolitho. The Bill would rewrite the law on clinical negligence and a doctor whose decision to treat would not be supported by any responsible body of medical opinion, or was illogical or irrational, would be able to call on a new Saatchi defence if they fulfilled the procedural requirements of the Bill. That is important: the Bill’s protection of doctors applies if the procedural requirements are met. The Bill states:

“For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, the doctor must…obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment”.

There is no requirement for the second doctor to have seen the patient or even read their notes, and no requirement for them to be independent. They could be working at the same private clinic. It is of little reassurance that the treating doctor must

“take full account of the views”

of the second doctor if the second doctor is in collusion with the first in that treatment, which may be unreasonable.

If the Bill is passed, we will put patient safety at risk and we will no doubt have to return to amend the legislation subsequently. Let me quote from a letter forwarded to me by a constituent who had met a visitor to my constituency who managed to convince him utterly that this individual’s company had found a cure—a miraculous treatment—for cancer, but was being obstructed by a vast conspiracy in the medical community. In the letter, David Noakes, who describes himself as the chief executive of a biotechnology company, refers to a compound he calls GcMAF, which he describes as

“a human protein, present in 5 billion healthy people, that removes a number of diseases, including terminal stage 4 cancer. It has no side effects.”

He attaches a couple of scientific-y looking papers, which have no bearing on proving its clinical effectiveness. Mr Noakes continues:

“It’s always difficult to get feedback, but we have hundreds of superb results. In Guernsey, we treat over 100 people and…have 50 successes including 10 excellent cancer results. We have perfect feedback in our German and Swiss clinics, where our 7 doctors reduce tumours at the rate of 25% a week”.

He says that he cannot do it in the UK

“because the law is so destructive.”

Here is the bit that really worries me. Mr Noakes states:

“But we state that if you have terminal stage 4…cancer, have not had chemotherapy, and you do the”

so-called

“GcMAF protocol, you have an 80% chance of being cancer free in a year.”

In other words, what the company is specifically saying to people is that they can look forward to that result if they do not have chemotherapy—it is actively encouraging people not to have evidence-based treatment and promising that it has a cure for cancer.

Mr Noakes says that

“The pharmaceutical industry is not interested in”

this treatment, because there is no profit in it—

“it is too cheap, and can’t be patented”.

He says:

“The chemo lobby is so powerful it has changed British law so that doctors are only allowed to prescribe the poison of chemo for cancer when there are…better treatments.”

He adds, specifically:

“Lord Maurice Saatchi is trying to get that law changed with his Medical Innovation bill, but against so powerful a lobby”—

and so on. In other words, for this individual and the seven doctors to whom he refers, the Bill would be carte blanche. They see it as a Bill that would provide them with protections. The Bill specifically refers to medical practitioners and doctors as the people who can take this forward—not homeopaths or unregistered doctors. He says that he has seven doctors in his company. If one of those seven consulted another doctor in the clinic, it is highly likely that they would agree that this was an eminently sensible treatment.

[Dr Julian Huppert (Cambridge) (LD)]

I thank my hon. Friend for giving way and for securing this debate on an important subject. It is a shame that more people are not in the Chamber to discuss it. There are some very real concerns. Does she agree that people who are terminally ill may be desperate for treatment, and that simply makes them prey to people who may be unethical, who may be trying to push the envelope, and who may be doing things that would harm them but that sound quite good?

[Dr Wollaston]

I agree with my hon. Friend. In my constituency a medically qualified individual attempted to set up a cancer conference. It had to be pointed out that under the Cancer Act 1939 it is not legal to advertise cures for cancer. The Bill would allow people to circumvent the Cancer Act. How easy is it to get a reference to a miracle treatment planted into a magazine article, for example? This is the real danger here. While the Cancer Act protects people against blatant advertising, it does not provide protection against the back-door advertising that we already see. What is to stop individuals who are absolutely desperate—as my hon. Friend has said—going to doctors with articles saying, “This is a cure. I want you to refer me to this clinic.”

[Dr Huppert]

I will try to resist the temptation to intervene too often. Does my hon. Friend agree that this is not just about cancer? We have already had homeopathic doctors, who may practise medicine as well as homeopathy, claiming that they have powerful treatments for Ebola that the World Health Organisation will not let them work on. The Bill would open the door for all sorts of quacks who will do serious harm in the name of medical innovation.

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[Dr Wollaston]

I agree. I thank my hon. Friend for making the point that this is not just about cancer treatment but about a wide range of surgical treatments and therapies for any number of conditions.

If the Bill is about reducing medical litigation so that doctors are free to undertake innovative treatments, why do those who are involved in medical litigation say that there is no need for it? The Medical Defence Union, the Medical Protection Society, even the NHS Litigation Authority, are clear that the law, with the Bolam and Bolitho tests, is well established. They feel that the Bill could increase uncertainty. The MPS briefing says:

“Fundamentally, current law allows doctors acting responsibly to innovate, and this Bill is unnecessary. The time has come for the debate to shift towards improving education about the present law, rather than confusing the law through a new piece of legislation.”

That is another point that is worth bearing in mind.

Far from promoting medical innovation, the Bill could undermine recruitment to genuine clinical trials. If someone had been persuaded by the likes of the doctors in the letter that I read out that there was a miraculous treatment for their terminal cancer, why would they wish to be enrolled in a clinical trial and be part of a randomised trial? If they could circumvent that and go along to a private clinic, why would they do that? Medical research does not just answer the question about whether a treatment works; it also helps answer the question whether a therapy or procedure has serious side effects. The history of medicine is littered with good intentions and innovations that seemed like a good idea but turned out to have disastrous side effects. I think, for example, of the use of 100% oxygen for premature babies, which led to blindness, or the use of steroids after head injury, which might have seemed like a good idea at the time but led to many, many deaths until it was realised that it was a dangerous innovation. There is an assumption that all innovation must be good innovation, but much innovation can be dangerous.

The randomised double-blind trial has been one of the greatest advances in medical science and has provided enormous protection for people. I look back at my time in medicine. Fairly soon after I qualified in 1986, I was a junior doctor on the Hedley Atkins breast unit. The newly appointed consultant is now Professor Sir Mike Richards, who is one of the country’s foremost and respected experts in cancer, formerly the cancer czar. He does not think the Bill will protect patients. We need to listen to the opinion of those who have serious concerns about such Bills. When I was working on that cancer unit in the 1980s, very many of the patients who did not survive at the time would survive today going to the same unit with similar conditions. That is because we now know what the best treatments are. We know that not from a series of unlinked anecdotal treatments, but because of former patients who were enrolled in clinical trials.

The accusation sometimes made is, “Aren’t clinical trials just experimenting on people?” Far from it. There seems to be a benefit for everyone taking part in a clinical trial, even those who are not receiving a treatment that turns out to be more effective. If the Bill is passed and undermines enrolment in clinical trials, we will be doing a grave disservice to medical innovation, and it will be to our great shame to have done so. I would like the Minister to address that point when he responds.

That is a fundamental flaw in the Bill. There is also a fundamental flaw in the premise that separate anecdotal treatments can progress medical research. Interestingly, clause 1(5) states:

“Nothing in this section permits a doctor to carry out treatment for the purposes of research”.

In other words, it specifically precludes the treatments being linked in any way, so we will learn nothing from these treatments. Lord Saatchi’s premise is that his Bill will advance medical knowledge, but there is no evidence that it will advance medical knowledge an inch because we will not be able to answer that fundamental question about whether there are unintended harms from the treatments or any long-term benefits.

Where will the evidence be of benefit from those “innovative treatments”? Will the Minister look carefully at that, and be clear in responding? The list of bodies opposed to the Medical Innovation Bill is very long—the Academy for Healthcare Science, the Academy of Medical Royal Colleges, the Academy of Medical Sciences, the Medical Research Council, the Wellcome Trust, Action Against Medical Accidents, the Association of Medical Research Charities, the Association of Personal Injury Lawyers, the British Medical Association, the British Pharmacological Society, Cancer Research UK, the Good Thinking Society, Healthwatch, the Medical Protection Society, the Medical Defence Union, the Motor Neurone Disease Association, the National Institute for Health and Care Excellence, the NHS Health Research Authority and the NHS Litigation Authority.

Richard Francis QC, one of our most respected national authorities on patient safety, opposes the legislation. I think that we ought to reflect carefully on his words:

“If there is misunderstanding then it should be corrected by guidance, not by legislation which exposes vulnerable patients to unjustified risk and deprives them of remedies when mistreated by those who have no acceptable justification for what they have done.”

Those are very serious words indeed. The legislation is also opposed by the Royal College of General Practitioners, the Royal College of Physicians, the Royal College of Psychiatrists and the Royal College of Radiologists. That is an important list.

There is a powerful lobby in favour of this legislation that purports that those who oppose it are somehow dinosaurs.

I urge the Minister to read the letter from 100 leading oncologists that was published in The Times on 13 November, which states:

“We devote our professional lives to treating patients with cancer and advancing research that contributes to finding more effective treatments for cancer. We neither want nor need Lord Saatchi’s bill. We do not believe that it will help our patients or future patients. We are dismayed that the bill is being promoted as offering hope to patients and their families when it will not make any meaningful difference to progress in treating cancer.

The law of medical negligence does not hinder our work or prevent innovation. There have been significant advances across all the modalities of cancer treatment over recent decades. There was no call for this change in the law from the medical profession. The current law already allows us to use off label drugs and to try new treatments when they are in patients’ best interests.

We are concerned that rather than promoting responsible scientific innovation in the treatment of cancer, the Medical Innovation Bill will actually encourage irresponsible experimentation producing nothing more than anecdotal ‘evidence’, at the potential expense of causing serious harm and suffering to patients, their families and carers. Innovation is best carried out within the discipline of controlled clinical trials, not by individual doctors acting on a whim.”

I think that sums it up well.

Were we to title the Bill correctly, it would be called the medical anecdote Bill. We should be saying that it makes provision in relation to anecdotal treatments in medical treatment. If we titled it correctly, there would be no question whatsoever of its having Government support. I urge the Minister in the strongest terms please not to give the Bill Government backing. To do so, I think, would be to our great shame. We would undoubtedly have to return to amend it. It would put patients at risk, and it would put recruitment to clinical trials and genuine innovation at risk.

I look forward to hearing the Minister’s response and about the many good things the Government have done to promote genuine innovation. I will not detain the House by offering that list now, because I know the Minister has done more than anyone I can think of in the House to promote true medical innovation. I therefore hope he will recognise that the Bill would do quite the opposite, and ensure that it does not progress.

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[The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)]

I thank my hon. Friend the Member for Totnes (Dr Wollaston) for securing this Adjournment debate and giving the House, albeit only a few of us, the chance to debate what is, I agree, a very important issue that is the subject of live discussion in another place. I also thank my hon. Friend the Member for Cambridge (Dr Huppert) for his comments.

My hon. Friend the Member for Totnes is a tireless campaigner for good health care and good medicine, as Member of Parliament for Totnes, as a member of the medical profession, and as Chair of the Health Committee. I very much welcome her contribution. I will first deal with the points that she made, then set the scene and provide a little context about the Government’s view of this Bill, and then close with what I hope may be some reassurance about our commitment to patient safety.

My hon. Friend made a number of important points, which I repeat merely to signal that I have heard them loud and clear. She said that the Bill might risk creating a carte blanche, or open door, situation as an inadvertent side effect of unjustified and unsubstantiated claims. My hon. Friend the Member for Cambridge mentioned homeopathy and other non-evidence-based forms of medicine. My hon. Friend the Member for Totnes highlighted the danger of relying too heavily on the protection of a clinician merely seeking the endorsement of a fellow clinician. Implicit in her concern is the fact that most of us could probably find one person in life to support our own prejudices, however well intentioned.

My hon. Friend highlighted the risk of unethical approaches and the danger of back-door promotions, which none of us wants to see. On the danger of undermining public and patient trust in clinical trials, she knows that I am passionate about achieving precisely the opposite. We are very proud in this country that more and more of our patients are enrolling in clinical trials. The NHS is running a fabulously successful programme of promoting research medicine, and this year the numbers are up by 24% or 25%. That is good for patients, good for NHS research, and good for our life sciences sector.

My hon. Friend has highlighted the danger of accidental errors across the system today. We live with that risk, but I hear her point that it would be a disaster if the Bill inadvertently made errors more likely, rather than less. She also raised concerns about the Bill not promoting evidence-based medicine or requiring claims to be based on clear patient benefit. She made a specific point about the Cancer Act 1939, which I will follow up and deal with by letter, if I may.

Most concerning of all, my hon. Friend ran through a very long list of medical and health organisations that she described as being opposed to the Bill. I will look into that following the debate because—I will say more about this in a moment—we do not want the measure to be divisive or to alienate or undermine the consensus about the importance of good medical research in the UK and the NHS. I take that point seriously. My hon. Friend flagged up the letter from 100 oncologists that appeared in newspapers recently. Since that was published, there have been a number of discussions about—and, indeed, amendments tabled to—the Bill in the Lords. I want to have a look and make sure which, if any, of those concerns are extant as the Bill completes its passage through the Lords. I will say more about that in a moment.

My hon. Friend the Member for Cambridge endorsed those comments. I note in particular his comments about the importance of evidence-based medicine. As with so many issues that we deal with in this House, a good test is to ask: would I apply this to myself? Certainly, for myself and my family, I am a strong believer in evidence-based medicine. I am a believer in innovation as well, but my hon. Friend made an important point. I particularly enjoyed his mention of the politician’s syllogism: “We must do something; this is something; ergo, we should do it.” I assure him that that is not in any way the reason for the Government’s benign support for the Bill’s principles and the case it seeks to make to promote innovation. I align myself hugely with his comments about not wanting to open the door to quackery.

[Dr Wollaston]

Lord Saatchi has said that 20,000 people support his Bill, but if people are asked whether they are in favour of medical innovation, they are likely to answer yes, and if the same people are asked whether they are likely to support medical anecdotes, I think they are likely to say no. Sometimes the answer depends on the question being asked.

[George Freeman]

I am sure my hon. Friend is right. She makes an excellent point about the nature of the question having an impact on the answer one gets. I have repeated the concerns because they bear repetition and are important, and I want to signal that I am taking them seriously.

I want to set the scene in terms of the Government’s commitment to patient safety, the context in which innovative medicines are being developed, and the changes in the sector that are challenging some of the traditional methods of drug development. I will then address some of the specific points that my hon. Friends the Members for Totnes and for Cambridge have made and say something about the Government’s position on the Bill.

The Government’s response to the Mid Staffordshire NHS Foundation Trust public inquiry, led by Sir Robert Francis, “Hard Truths: The Journey to Putting Patients First”, demonstrated beyond any doubt, I hope, the Government’s absolute commitment to creating a new culture of openness, compassion and accountability and a renewed focus on patient safety right at the heart of the NHS.

The truth is that the NHS is one of the safest health care systems in the world. I am delighted to report that, in the recent Commonwealth Fund report comparing the US health care system with those of 11 other nations, the UK came top. However, there is always scope to improve health care standards universally and to reduce avoidable harm further. That is why the Secretary of State set the ambition this June, at the launch of the Sign up to Safety campaign, to reduce avoidable harm by half and save 6,000 lives over the next three years.

We have put patient safety right at the heart of the Government’s agenda for health. For that reason, I am delighted that the Government are actively supporting the Bill on patient safety sponsored by my hon. Friend the Member for Stafford (Jeremy Lefroy). The Bill has several important provisions on the use of data to drive safety across the system and to ensure transparency and accountability in health outcomes.

Why do we need to look at mechanisms for promoting innovation? My hon. Friend the Member for Totnes was kind enough to signal her awareness that the Government—particularly me, as the first Minister for life sciences—have taken an active role in trying to promote it. The reason is that we face a challenge in the field of drug discovery and development, as well as in medical technology generally. There is a challenge and an opportunity.

The challenge is that the more we know about disease, genetics and data—the datasets at our disposal in the NHS, and the history of drug reactions and the way in which patients respond to diseases differently—the more we realise that patients respond to the same disease or the same drug in different ways, and that those ways can often be predicted. These insights are beginning to change the way in which drugs are developed.

Increasingly, we do not need the one-size-fits-all, blockbuster drugs that we have traditionally expected the industry to bring us after long, slow, protracted and increasingly expensive clinical trials and randomised, double-blind trials. Of course, those trials have a strong part to play in our system, but the more we know about the nature of disease and the extraordinary breakthroughs that our biomedical and life sciences sector is making, the more the agenda shifts to designing around patients, as well as around tissues, data and genomics. That is why the Government are so committed to shifting our policy landscape to support the extraordinary role that our NHS can play globally. It is a uniquely well positioned, integrated national health care system, with extraordinary leadership in genomics and informatics, which the Government are actively supporting.

My hon. Friend made the point that the randomised, double-blind trial has given medicine great service in the 20th century, and I agree. As we move further into the 21st century and see the transformational power of new technologies, it is equally true that the system of expecting the industry to go away and spend 10 to 15 years, and an average of £1.5 billion, to develop a new drug—many of them fail in late-stage clinical trials, because of some toxic side effect in one patient or a few small number of patients—is leading to a crisis in the industry and in the pipeline for new drugs and new treatments, and to patients increasingly suffering because we cannot give them innovative medicines.

Part of the agenda for this Government and all western Governments is to look at how to accelerate the way in which our health systems support research and to bring innovative medicines, as well as devices, diagnostics and other innovations, to benefit patients more quickly.

[George Freeman]

The hon. Gentleman makes an important point. I want to take this opportunity to pay tribute to the work being done in that cluster at Queen’s. I am delighted to say that I will be coming in the new year to support it and to show, as the UK Minister, that there are great clusters in Scotland, Northern Ireland and Wales. I very much look forward to that visit.

The truth is that the landscape is changing. Part of the challenge that we all face is to find ways to accelerate earlier access to innovative treatments for patients, and earlier access for those developing innovative drugs, devices and diagnostics to our health system, so that we can more quickly design innovations that are more targeted and personalised. We are seeing the first genuinely personalised cancer therapies and drugs that, in the unfortunate event that one is diagnosed with cancer, can be designed around one’s genetic profile. I was at a seminar on that development this morning. It is changing the landscape of drug development. We are keen to ensure that we benefit from it in the UK and that we use every mechanism in the NHS to support it.

[Dr Wollaston]

Does the Minister accept that a doctor who uses such innovative treatments within the NHS is protected under existing law and that we do not need new legislation to make them available to patients?

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[George Freeman]

I am merely trying to set out a balanced review of the arguments. In closing my speech, I will give an assurance that I hope will satisfy my hon. Friend on that point.

On protection, under existing common law and in the Bill doctors must show that they have acted responsibly. They cannot simply go through the motions and seek advice from an inappropriate source as that would not be “responsible”, which is the key test in the Bill and common law. Even if doctors follow the steps in the Bill when deciding to adopt an innovative treatment, they might still carry it out negligently and be subject to a negligence claim in the same way. When something goes wrong it is right that patients are free to seek compensation, and that will continue to be the case. The Government do not want any undermining of protection for patients against clinical negligence.

My hon. Friend the Member for Totnes made a point about the Bill not requiring doctors to seek the prior agreement of an appropriately qualified doctor, and instead being required only to take account of their views. I would not want the Bill to give a carte blanche to quackery or non-evidence based medicine. The Bill requires a doctor to take full account of the views of at least one appropriately qualified doctor, just as any responsible doctor would be expected to do, and they would not be able to ignore certain views or give them minimal weight by just “noting” them unless there were reasonable grounds for doing so. All doctors will be bound by the core and primary duty of responsibility and care to their patients. If the Bill were to require the explicit agreement of another doctor to innovate—that is one suggestion made in the other place—we are worried that that would open the possibility of a new negligence action against the countersigning doctor and lead to more confusion. We would not be able to give the countersigning doctor any certainty about their legal position, and they would not be able to rely on provisions in the Bill.

My hon. Friend made a point about undermining confidence in clinical trials. Although the Bill has raised awareness of innovation in medical treatment, it does not confer additional rights on patients to demand innovative treatment. It will still be for the doctor to decide the most appropriate course of treatment in discussion with their patient and using their best professional clinical judgment. Nothing in the Bill allows doctors to bypass any processes or requirements set by their trust when undertaking innovative treatments in the NHS, which includes ensuring that the commissioner would fund the treatment if it is to be provided within the service.

Individual innovation is important but no substitute for medical research and testing the efficacy of new treatments in a systematic way. A large part of my work is about ensuring that we use all of our £1 billion a year for the National Institute for Health Research infrastructure in the NHS, to ensure—as the Prime Minister set out in his speech when launching our life science strategy—that every willing patient is a research patient and every hospital a research hospital, and that we learn from evidence that we develop daily in our interaction with patients. Lord Saatchi and Ministers are determined that doctors should learn from innovative medicine as we go along, and a large part of the NIHR and our data programme is about ensuring that we pick up and track innovations and outcomes more accurately across the system.

[Dr Wollaston]

Does the Minister accept that that cannot happen under the Bill, and that those things will remain a series of unlinking anecdotes? In medical science and for the safety of patients no one will be able to track whether there were unintended consequences or benefits, and it will not advance the cause of medical innovation whatsoever.

[George Freeman]

I would be interested to see the Bill once it has completed its passage through another place and ensure that it contains adequate provision for evidence-based medicine, and that, by encouraging innovation, we are not in any way encouraging medicine that is not supported by the best evidence available.

My hon. Friend spoke about consultation. The Department of Health carried out a full consultation on the issues raised in the Bill, which ran from February to April this year. It was delighted to receive 170 responses to that consultation, making clear a range of opinions. Responses came from a range of audiences, professional bodies, patients and clinicians. Four regional public consultation events were also held. Lord Saatchi attended those events and it was in no small part thanks to his involvement that a number of changes were made to strengthen the oversight mechanisms in the Bill. At every stage, the Department of Health has engaged with Lord Saatchi to develop amendments to align the policy of the Bill with the legal and expert clinical advice we have taken, including from Sir Bruce Keogh.