Medical Innovation Bill [HL]

Lord Kakkar Excerpts

Friday 24th October 2014 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I have added my name to Amendment 15 and I hope that the Minister will give it due consideration. It is really important that the process laid out in the Bill is recorded in the patient’s clinical record. That is the one way that you can verify that things have been done properly. It is also important that there is notification to the central register, as referred to by the noble Lord, Lord Saatchi.

I also hope that the Minister will be able to give due consideration to the situations already mentioned by the noble Lord, Lord Winston, and others. It is very important that we do not make it more complicated than it is already for clinicians to be able to treat patients as they feel appropriate. It is also important that patients have the appropriate safeguards in place. While quite a lot will go into guidance, there is merit in having emergency treatment actually in the Bill as a situation where the Bill would not apply and that treatment in the best interests of the patient in an emergency can proceed by whichever means appear to be best at the time.

[Lord Kakkar (CB)]

My Lords, I declare an interest as Professor of Surgery at University College in London and as a member of the General Medical Council. I welcome the interventions of my senior clinical colleagues, the noble Lords, Lord Turnberg and Lord Winston. They have helped us to understand that, although it is hard, this is a vitally important Bill to drive forward the practicalities of innovation in clinical practice. I hope that it will also drive forward a positive culture of putting innovation at the heart of all clinical thinking. However, there must be safeguards to ensure the protection of vulnerable patients. A number of amendments in this grouping try to address that issue. When this Bill was first made available for public comment some years ago, I was initially anxious about the fact that there were insufficient safeguards. The approach that I wished to adopt was one that I know has been considered but has been also dismissed. I have, however, become reassured by the process under the supervision of the Medical Director of the NHS, Sir Bruce Keogh. He has consulted widely among the profession and I believe that the amendments in the name of the noble Lord, Lord Saatchi, particularly Amendments 12 and 16, bring us to a place where appropriate safeguards have now been introduced. I hope that they will be judged sufficient to provide the protection that all responsible and reasonable clinical practitioners would want in a Bill of this nature.

There are two other amendments being considered in this group that I believe to be vital, Amendments 15 and 19, dealing with the registration and reporting of the results of innovation. There is no doubt that if this Bill is to achieve what it hopes to, the innovations that are provided as a result of having this provision available to us in clinical practice must be reported widely and be available for other clinical practitioners to consider. I know that, at this stage, the view is that other mechanisms are available that provide the opportunity for that reporting to be made, but I wonder whether the Minister might consider during the further passage of the Bill how very powerful a provision of the kind suggested in the two amendments would be in securing the greatest benefit for the largest number of patients.

Another question to have been raised on this group of amendments is that of being certain that the Bill does not apply to situations of emergency care and does not in any way interfere with the mechanisms available for ethical and appropriate clinical research. A strong research governance structure supported by strong legislation is available in our country, and this Bill should not be seen to impinge on that in any way. I am reassured by the noble Lord, Lord Saatchi, saying that the Bill does not relate to the conduct of research and should not be confused as doing so, nor does it in any way interfere with what are, as the noble Lord, Lord Winston, said, acute and deeply stressful decisions that have to be taken in the situation of providing emergency care. I hope that the Minister will be able to reassure us that other legislation, guidance and mechanisms exist to ensure that the Bill does not impinge on those two areas.

[Baroness Gardner of Parkes (Con)]

My Lords, I strongly support the Bill and hope that we will be able to reach agreement on important points today. It is essential that patients should feel safe, so all the safeguards being put forward are welcome, but patients also want to feel hope. When I think of Les Halpin, referred to by the noble Baroness, Lady Masham, I recall his rapid deterioration with motor neurone disease. When he first launched the idea of doing something, it was hard to detect that there was anything wrong with him. Within no time at all, it seemed—but probably it was about a year—he could not stand; he was in a wheelchair; and he had to have his head supported. It was unbelievable. What he wanted, not only for himself but for others, was hope.

The noble Baroness, Lady Masham, referred to Ebola, where they are trying things, irrespective of whether they know they are right, and in many cases they are probably working. It is hard to know. When I was chair of the hospital that has the Ebola clinic here in the UK, we had a case and the man recovered. In those days, there was no treatment other than just isolation and patients relying on their own strength to pull through. The noble Lord, Lord Winston, related a story about an ectopic pregnancy. It was interesting to see there how there was a conflict between two highly qualified medical practitioners. If he had not bravely taken that action, irrespective of any action that might be taken against him, that woman would not have survived. We do not want to make the procedure so enormously complicated that, by the time you have the result, it is too late for the person that you are aiming to help. On the other hand, I think that everyone agrees that the recording of the information, referred to by the noble Lord, Lord Turnberg, in speaking to his amendments, is essential. Unless it is recorded and open for use by everyone, it might help one individual, but no one will know what happens and how to help any others afterwards on a wide scale.

I think that everything that can be said on this Bill today will be said. I remember at Second Reading that the noble Lord, Lord Winston, was worried about people being sued for failure to innovate. I feel that that is only a remote prospect and should not be worried about too much. If all the safeguards are put in place, I believe that that will not happen. I strongly support the Bill and hope that the Minister will assure us that we will be able to proceed with it.

--- Later in debate ---

[Lord Blencathra (Con)]

My Lords, I say, for the record, that I have been here throughout but below the Bar of the House, so I am not suddenly intervening in the debate.

Inevitably, the Bill of my noble friend Lord Saatchi has been driven by terminal cancer care, and we understand the motivation. As regards the discussions on the first group of amendments, I agree with the noble Baroness, Lady O’Neill, that we have heard from some of Britain’s most distinguished “scalpel” experts but we need to hear a bit more from physicians who have responsibility for long-term and chronic care. That is why I totally support my noble friend’s Bill and the amendments he has proposed but I also support Amendment 6 proposed by the noble Lord, Lord Winston. I support it but I hope that it may not be necessary and that my noble friend Lord Saatchi will see that it is already taken care of in the Bill. However, I would like to flag up in this debate that it is important that the Bill covers innovative drug treatments, including drugs which are not necessarily authorised or approved in this country.

One does not want to get into describing personal medical things—it is a bit grubby. However, as an enthusiast for the Bill, who has experience of innovation approved by medical authorities in this country and has participated in some innovative treatments not approved in this country, I think that the House should hear from the users at the sharp end, so to speak.

I was diagnosed with MS in 1996. It is slow, progressive and each year it slightly tightens its grip. I would say to our distinguished lawyers, as I said at Second Reading, that when one goes to see one’s consultant, one does not go with a lawyer in hand to see whether the consultant makes mistakes and one can sue him. I suspect that, like me, a hundred thousand other MS sufferers and those with Parkinson’s and motor neurone disease all go along to ask, “What is new? Have you seen the latest research? What have you got? Is there anything that will work?”. We know that at the moment there is no cure for MS, although I think that researchers are getting pretty close to finding one, but we want to get palliative care.

As I say, I do not want to go into details but some of the side-effects of increasing MS are pretty nasty and, frankly, life is not worth living unless those side-effects are dealt with. For many MS sufferers, as the nerve endings die, particularly in the legs and feet, the feet drag. No problem there, as one loses some strength in the legs, one can have a wheelchair. But many people suffer a complete loss of bladder control. If one has to go to the loo every 10 minutes, life is just not worth living. An innovative treatment was developed by the Swiss, which was then experimented by the National Hospital in London. Those Botox injections directly into the bladder were not a life-saver but they made life worth living again. Without going into details, I fought my way through to become patient No. 51 in the clinical trials. That treatment has now been approved by NICE after all these years.

I am not saying that I am typical of patients with this sort of slow, progressive disease but I suspect that I am typical of many who will try any innovative treatment. I am 16 days into a treatment with a new drug, Fampridine, which is approved for use in this country but only, I think, in the national neurological hospital in the wonderful Queen Square. I believe that in clinical trials of the drug, 40% of people experienced a 40% improvement in their ability to lift their feet a tiny bit. However, lifting one’s feet a quarter of an inch when one is walking is very beneficial as it stops one tripping over every dead fly on the carpet.

As I say, at the moment there is no cure for MS but these innovative treatments are making life better. After just 16 days of my experimental treatment, I certainly feel a marginal improvement—at least I am not declining further. That may be the only hope one can offer many people—not that we can fix them but we will make the quality of their lives better for the long term and we will try to hold the disease at bay. Therefore, the provisions of Amendment 6 are absolutely apposite.

In October or November of last year, an American research institute, the Scripps Institute, reviewed about 10,000 drugs currently approved in the United States for various conditions and treatments. The staff there discovered, partly by accident, that there was one drug prescribed for Parkinson’s which seemed to repair the myelin sheath, certainly in their laboratory animals suffering from MS. I understand from my research that American doctors have slightly more power to prescribe off-label treatments than do British doctors. If it is in the patient’s best interests, they are entitled to prescribe a medicine which is not authorised or approved for that condition. British doctors do not seem to have that same flexibility or freedom, except perhaps if a drug is prescribed for adults and a child has those same symptoms, they may off-label prescribe a quarter of a pill or half a pill, like half an aspirin given to children with an illness. As I say, British doctors do not seem to have that freedom or flexibility.

The vast majority of people do not have the benefits I have of contacting an American doctor and managing to get my hands on some of those pills. They are prescribed in this country for a certain condition but no doctor can prescribe them for MS patients at present. It will be another five or 10 years by the time all the trials are conducted. I appreciate that this Bill is not about laboratory experiments or turning us into lab rats, although I am happy to go much further than the terms of my noble friend’s Bill and be a lab rat for some of these things. However, unless physicians treating long-term chronic illnesses can prescribe off-label treatments, which they think are in the best interests of the patients, this Bill will have failed. I hope that we can include off-label treatments.

I am obviously not an expert but I am deeply interested—I declare that interest as a patient—in the cocktails of drugs that seem to be available. For many treatments—it is the same for HIV and many others— there is no magic pill about to come on the market that will fix them. However, doctors have discovered that a combination of drugs, cocktails of various things, may have palliative or curative effects. I am on various cocktails of drugs, involving daily injections, weekly pills and various tablets. I can say that most of these are approved in this country but some are not. I am not taking illegal drugs but tablets and pills that have not been approved by NICE but which I, unlike the vast majority of patients in this country, can acquire from abroad. So I hope that if the Bill goes through and if the treatments mentioned in Amendment 6 are automatically included I will, one day soon, able to try those drugs without having to acquire them from doctors in New York. I hope that that would apply to many other patients in this country.

I am supportive of all the contents of Amendment 6 but if my noble friend says that it is not necessary, I am happy to go along with that.

[Lord Kakkar]

My Lords, I have some concerns about the wording of Amendment 6. Is it intended, for instance, to restrict the use of an agent or intervention that has been tested in a completely different situation—there may be some peer-review publication or some clinical validation in a completely different situation—but where it is proposed to use the treatment for another condition? One will recall that Gleevec was an agent developed principally for the management of patients with chronic myeloid leukaemia; it was an interesting biological compound that targeted a specific mutation in a signalling pathway in cells in that form of leukaemia. Many years later, it was noticed that that signalling pathway mutation was also seen in a particularly rare form of tumour, a gastrointestinal stromal tumour. Those who were innovating decided to use the drug because the genetic mutation appeared to be the same for treating that particular type of tumour to great effect. Would the description of innovation in the amendment have prevented that happening?

Proposed new paragraph (d) of the amendment deals with the question of devices or instruments. What happens if they have been developed and regulated for a particular intervention, and then an innovator decides to use them for a completely different condition? They will have been made available for regulated use but not for the condition in question. Would this amendment therefore restrict that type of innovation?

[Lord Winston]

I do not think that it restricts anything at all but actually makes the Bill of the noble Lord, Lord Saatchi, workable. We need some kind of definition of what an innovation is. That is all the amendment tries to achieve. It is not in any way restrictive. Of course, if one decides to put a plastic tube that is normally used to infiltrate the trachea into another organ, this amendment will permit that to happen, when currently it would not be allowed.