Patient Safety and Medical Innovation

Julian Huppert 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.

--- Later in debate ---

[Dr Julian Huppert (Cambridge) (LD)]

It is a great pleasure to follow my hon. Friend the Member for Totnes (Dr Wollaston) and the excellent comments she made, although she should keep an eye on her Committee—I am sure she will—which I believe is currently questioning on the subjects of complementary medicine and homeopathic doctors in her absence. It is also good to have the Minister here. Between the three of us, we have a commitment to the idea of evidence-based medicine, which sadly not all Members of the House appear to share. I hope we are all singing from the same hymn sheet in that regard, as my hon. Friend has already set out so eloquently.

Suffering from terminal cancer, or any other serious condition, is clearly awful for anyone, so I understand why people would want to try something in the desperate hope that it might alleviate the problem and help them to survive. I absolutely understand that rationale. However, it does have real risks, and that is part of the problem with the Bill.

Of course we should innovate. We come up with new techniques all the time. As my hon. Friend said, we are far better at treating things now than we have been over time. However, we must avoid using the politician’s syllogism: we must do something; this is something; therefore, we must do this. That is not how it works, but unfortunately it seems to be the approach taken in the Bill.

As we have heard, there does not seem to be a serious problem of stultification and lack of innovation. Oncologist after oncologist will say how they are able to innovate. However, there is a system of research ethics regarding how we decide what is acceptable and what is not. There are ways of making sure that we do not just look at things with a selective bias. The paper that my hon. Friend mentioned described two patients who had had some reductions in tumour sizes, but it said nothing about how many patients had been looked at, or about the outcomes for those who had not been treated. If we pick people out from a large enough pool, we will always find strange things that we can write about or make a lot of money from by setting up a company, if we are allowed to go ahead.

We have to avoid dealing merely with anecdote, because that will lead to people getting substantially sub-optimal treatments. The safeguards in the Bill—I have been through all the proposed amendments as well—are very thin. As my hon. Friend said, asking another doctor makes little difference when that doctor could be somebody else who believes in the same slightly bizarre theory. Moreover, the doctor could be asking another doctor who works for them, because there is quite a hierarchy in medicine. A junior doctor would not feel able to challenge a more senior doctor on something like this.

This Bill tries to solve a problem that does not seem to exist, according to the doctors and lawyers involved. It puts patients at risk, especially if these innovative treatments replace standard treatments that are known to be effective. It opens the door to quacks of all persuasion who want to try out their pet theories but have no proper background and no evidence.

I hope that on Friday, their lordships will see the problems with the Bill and that they will not proceed with it and bring it to this place. I sincerely hope that the Minister, whom I respect for his efforts to improve innovation and his understanding of the role of an evidence base, will make sure that we do not have Government backing for such a Bill. If it does make it here as a private Member’s Bill, I am confident that this House will make the right choice to protect patient safety.

--- Later in debate ---

[George Freeman]

I will happily come on to the existing law and the protections within it.

Three weeks ago, I announced a major review of the landscape of innovative medicines development, which will involve a review of NICE and the Medicines and Healthcare Products Regulatory Agency. It will look closely at how we can develop a new landscape for the quicker development of innovation with patients in the NHS.

I reassure the House that the Government are committed in all this work to putting patient safety first and developing a landscape of evidence-based medicine. I have listened carefully to the concerns of my hon. Friends the Members for Totnes and for Cambridge. I reassure them that I and the Government take their concerns very seriously.

Lord Saatchi has identified the threat of litigation as a potential barrier to innovation. The purpose of his Bill is to set out a series of steps and a clearer legal framework that will make it less likely for doctors to be put off reasonable innovation because of the rather circular defence that the best treatment is one that is already well established. The intention of the Bill is to tackle the risk that the fear of clinical negligence could undermine the commitment of doctors to embracing innovation in the system. It does not claim to be a panacea or silver bullet to solve all our innovation challenges, but to be one measure in the broader landscape.

In Committee in the House of Lords, the Government supported Lord Saatchi’s amendments to the Bill, which added an objective test of responsibility to the doctor’s decision to innovate. The amendments exclude any doctors who act irresponsibly from enjoying the protections of the Bill.

The amended Bill provides a number of other safeguards for patients, including the requirement for doctors to take full account, in a responsible way, of the views of other appropriately qualified clinicians. My hon. Friend the Member for Totnes argues that that does not go far enough. I would be interested to hear the views of Members of the upper House who are more qualified than I am when they debate Third reading at the end of the week. The package of amendments is intended to ensure that there is expert peer review of any doctor’s proposal. Furthermore, it ensures that the doctor must act responsibly in taking account of that review, thereby applying an objective standard to their conduct. In addition, the Bill requires any doctor to consider the risks and benefits associated with the proposed treatment, alternative treatments and doing nothing. That provides a further safeguard.

Let me be clear that we do not want the Bill to prevent patients from taking doctors to court when there is a good reason to do so. Doctors who follow the steps set out in the Bill or the steps required in normal practice should be able to demonstrate more easily that they have acted responsibly, because they will have considered the necessary steps in advance of any innovation. However, by invoking the freedom to innovate that is set out in the Bill, one does not in any way avoid the scrutiny of the courts. Doctors will still have to justify their actions if any case is brought against them, just as they do now.

[Dr Huppert]

At the beginning of the Minister’s comments, he said that he and the Government were keen to ensure that this would not be a divisive issue, and that they would not progress with it if it became one. He now sounds like he is being very supportive of the Bill. Will he provide an assurance that if the Bill continues to have the vast weight of medical and legal expertise against it, whether that is expressed in the House of Lords or by the organisations that my hon. Friend the Member for Totnes mentioned, he will ensure that the Government do not back it?

[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.

[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.

[Dr Huppert]

The Minister is being very generous, although we do appear to have quite a lot of time. He talked about 170 responses. How many were supportive of the Bill and how many were not?

[George Freeman]

I do not have that information at my fingertips, but I will happily look into it and come back to my hon. Friend if I may.

Crucially, following the Committee stage, Lord Saatchi and the Government have continued to engage with peers and key stakeholders. Let me take this opportunity, on the question of the Government’s support, to reiterate that this is a private Member’s Bill. This is not a Government Bill. We are very supportive of the Bill’s aims and intent to promote a culture and regulatory framework that is supportive of innovation within the NHS, but it is equally important that we do not in any way damage or undermine public or patient confidence in research in this country and in the NHS. I stress that the Bill has not been given Government time. We are supportive of its principles, but it is very important that when it leaves the House of Lords, where it will have been subject to extensive scrutiny by very eminent medical and legal opinion, it comes to us in a format, even if not every single point is unanimously supported, that has the very strong support of our most senior lawyers and medics.

I want to close by highlighting the fact that the Bill has generated substantial interest, both in Parliament and outside. In many ways, if those concerns can be reflected in high-quality scrutiny and the tabling of amendments, we should be able to demonstrate that democracy works and end up with a Bill that both achieves the aims of Lord Saatchi and reassures those with concerns. I want to be clear that, as the Bill completes its passage in the House of Lords, I hope it returns to this House in a form that the vast majority of medical opinion and respectable bodies in the medical field feel able to support. It is not our intention to have a Bill that undermines public or patient trust in research medicine.

We cannot legislate for best practice; we can only legislate to support our front-line clinicians to do what they believe is best for their patients. At the heart of that is a sacrosanct duty of care that all clinicians share, and which the Bill does not in any way weaken or undermine. That duty is to do what is best for patients.

I want to close with some supportive quotes the Bill has received from a number of important people, lest the House should form the view that it is unanimously opposed, which is not the case. Dame Sally Davies, the chief medical officer, has said:

“I am confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation.”

Sir Bruce Keogh, at NHS England, said:

“Encouraging innovation in medicine and protecting patients are both of vital importance. That is why I am pleased that amendments have been devised to address concerns about patient safety.”

Sir Michael Rawlins, president of the Royal Society of Medicine, said that the Bill will allow responsible innovation and treatment:

“I believe the use of the provisions in the draft Medical Innovation Bill will benefit patients, especially those with rarer diseases, and the furtherance of medical science.”

A letter to The Telegraph from 40 leading medical professionals, including David Walker, professor of paediatric oncology at Nottingham university, and Riccardo Audisio, the president of the Association of Cancer Surgery, said the Bill

“legally protects doctors who try out innovative new techniques or drugs on patients when all else has failed. This Bill will protect the patient and nurture the innovator. It will encourage safe medical advancement, while at the same time deterring the maverick, thereby recalibrating the culture of defensive medicine. Finally, it will work with evidence-based medicine and provide new data that will inspire and support new research.”

I hope very much that that is the case and that when the Bill leaves the House of Lords, the vast majority of qualified senior opinion in this field is able to agree with it. It is absolutely our intention to support the Bill’s noble intent to promote medical innovation, but equally our intention is to not undermine in any way the Government’s commitment to patient safety or the duty of care that all clinicians share and owe to their patients.

Question put and agreed to.