Medical Innovation Bill [HL]

Debate between Lord Kakkar and Lord Blencathra

Friday 24th October 2014 Lords Chamber

[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?