Branded Health Service Medicines (Costs) Regulations 2018

Lord Turnberg Excerpts

Wednesday 20th June 2018 Lords Chamber

[Lord Borwick (Con)]

My Lords, I declare an interest in this debate, as I am a patron of both the British Thyroid Foundation and the Thyroid Trust. I have heard it said that, somewhere in the Lords, there is always an expert on any subject raised; all I can claim is personal experience. I have suffered from Graves’ disease, which results in an overactive thyroid gland. Once it has had one episode, the thyroid can have an increased incidence of repeated episodes, and I had three in increasing frequency. The cure used often in the UK is to surgically remove the thyroid completely. Suddenly, the patient moves from too much hormone to none at all.

The thyroid, which is a small butterfly-shaped gland in the front of the neck, produces two hormones—levothyroxine and liothyronine—known as T4 and T3. As the noble Lord says, it is much easier to use those words. As T4 is a base stage, T4 makes T3 and the vast majority of patients, perhaps 80% and including me, can convert T4, the inactive hormone, into T3, the active one. Some cannot do so or can only do so inefficiently. The level of research is so low that, alas, we do not know for sure why this is. It may well be a faulty gene.

The trouble with thyroid patients is that their experience of the disease is so varied and the effect on their bodies is sometimes so profound, that they can be “hard to treat”. This is a marvellous medical euphemism that carries a wide range of patients with it, from ones who feel well when they are actually quite close to death, like me, to those whose low thyroid level makes them apathetic, befuddled and exhausted. The latter are the most frequently occurring cases. The majority of them are female and they are often overweight, finding that diets tend not to work for them, however hard they try to lose weight. As the thyroid affects the speed of every single cell in the body, including the brain, a nasty aspect of the disease is known as “brain fog”. That is the inability to think anything through at all, let alone explain what is wrong with you. That aspect, coupled with hormone tests that can declare that everything is within normal limits when they are still wrong, makes some patients particularly “hard to treat”.

With a high level of thyroid activity, life may feel quite pleasant. Even Brexit seems to be simple. A high thyroid level has something in common with being mildly overserved, even tipsy, and yet I know someone who sadly died of this disease and, for a few, the symptoms can be dramatically unpleasant, even as severe as psychosis. With a low level of thyroid, everything can be too complex, too difficult, too depressing or gloriously clear but wrong. Endocrinologists are doctors with immense patience. Overall, any imbalance in thyroid hormones, which can occur rapidly or very slowly, from high to low or low to none, can trigger brain fog and a range of other debilitating and diverse symptoms.

This liothyronine problem affects a group of patients who may appear to have the right level of T4, but who cannot make sufficient quantities of T3 from it. T3 was made by a single supplier for a time, Concordia, a company that I have met and been impressed by. It deals with a wide variety of generic drugs to be supplied to the Department of Health. These drugs are subject to several layers of regulation, including on price and quality. Most important is consistency, as the thyroid patient is peculiarly sensitive to inconsistency. Consistency depends in part on modern methods of manufacture, and the problem that Concordia faced, it tells me, was a need to update the manufacturing equipment with a large capital investment for a small number of patients.

To put the problems into context, the Department of Health buys a vast number of generic drugs. Millions of different patients need thousands of different drugs, and it is amazing how few problems occur. This is because of the great work done by the unsung heroes of the department’s regulatory agencies. All this takes place without much political input, and probably is the better for that, but a price that goes up so much raises an eyebrow or two, particularly compared to a price that is so much lower abroad. Even if the price increases had been agreed with the department, as Concordia informs me they were, the solution is likely to involve negotiation between the manufacturer and the department. Competition is likely to play a part here, and I gather that there are now three manufacturers in the market to provide T3 for UK use and prices are falling.

The bottom line is that, where there is a portfolio of generic drugs, used by different patients for different syndromes, the marginal price of any one drug in any one quantity is somewhat arbitrary. Should it be a loss leader or priced as the star of the portfolio? It is clear to me that the pricing, like thyroid disease, only becomes noticeable when it varies quickly or goes out of control. What caused a problem was misinterpretation of health department advice into suddenly not prescribing T3 to patients who had been happily taking it for years. I am not sure that a referral to the Competition and Markets Authority did anything other than raise the stakes, when negotiation is surely the best way to deal with the problem.

While liothyronine is available at a lower cost from European suppliers, there have been calls for the NHS to source directly from overseas. This initially may seem appropriate, given that patients are currently being told to purchase directly from these overseas suppliers themselves, with a private prescription from their NHS GPs, who tell them that their practice or CCG will not pay.

The Thyroid Trust has given permission to me to share the alarming case of Maureen Elliott in South Thanet. Maureen was well for 10 years on liothyronine and agreed to stop taking it when her doctor flagged up the high cost to the NHS. Subsequently becoming very unwell without it, she was referred to an NHS endocrinologist, who confirmed that she should have it, yet the instruction she was given was to buy it herself from abroad. With prices from different suppliers varying wildly, from more than £600 to £50 a packet, and inconsistent quality, she has found the whole experience extremely stressful as well as expensive. Why should she and others have to do this as individuals, when the Department of Health could be doing it, presumably with the capacity to drive a better bargain?

However, if the quality control requirements of the UK’s Medicines and Healthcare products Regulatory Agency have triggered prices here to be higher than elsewhere, is the liothyronine from manufacturers that do not hold a UK marketing authorisation of questionable quality? Given the negative effect on patients such as Maureen, perhaps the Minister can help to stress to doctors that T3 has not been banned, that he agrees that some patients need it, that although it is expensive it is valuable to certain patients and that doctors should not restrict access for existing patients prior to clinical assessment by a specialist.

[Lord Turnberg (Lab)]

I want to restrict my observations to the case of the treatment of hypothyroidism, and elaborate just a little on the wise words of my noble friend Lord Hunt of Kings Heath.

We have here an unhappy coincidence of bureaucratic errors on the one hand and what can be described only as corporate greed on the other. The end result is that patients with hypothyroidism are suffering. I suppose that I should just say a little about this condition, in which these patients fail to produce enough of their own thyroid hormone, for one reason or another. Although I am no longer on the medical register, I do not feel too constrained: it causes a range of unpleasant symptoms and can be life threatening. It causes symptoms, some of which may sound familiar to your Lordships, including extreme tiredness and a general slowing down, which makes you gain weight, thickens your skin and makes you lose hair. It comes on insidiously, so that it can sometimes be difficult to diagnose. It is worth noting, as I think my noble friend said, that up to 5% of the population, or one in 20, are said to suffer from hypothyroidism—and, worst of all, it can cause heart attacks, if not treated.

Yet treatment is very easy indeed—just one tablet a day of the hormone thyroxine gets rid of all the symptoms and can make people normal again, which works for the vast majority. But here is the rub: a few patients do not feel better, and they need to take the more active metabolite of thyroxine, liothyronine, or T3, to make them well. There is some controversy over why some patients need that more expensive treatment. Do they have a problem with converting thyroxine to the active principle or not? That has not been resolved scientifically, but there is little doubt that, clinically, some patients get better only on the active metabolite, T3. That being so, clinicians should be able to prescribe it. Certainly, that is the case in many countries around the world.

Prescribing T3 here in the UK was never a problem until 2007, when the Canadian manufacturer, Concordia, got hold of it and was given the sole contract by the NHS to produce it. It was then that, as a monopoly supplier, it put the price up several-thousandfold, as we have heard, so that now the price has risen to over £900 for 100 tablets. Then, of course, NHS England found it increasingly unaffordable. So instead of trying to find cheaper suppliers, it put in draconian conditions on doctors under which it may be prescribed. On top of that, those conditions are so ambiguous that CCGs, GPs and consultants are fearful of prescribing it, so they have stopped. As we have heard, patients who have been on it for years now cannot get it and suffer the consequences. So what do the patients do? They go online and buy it privately in Europe for around €30, instead of £900 for 100 pills.

I have three questions for the Minister. Will the Government try to move the Competition and Markets Authority along after its preliminary hearing that the manufacturers should repay the several million pounds that they owe to the NHS? Will they consider purchasing the medicine from an alternative supplier, possibly elsewhere in Europe, for a fraction of the cost? Will he press NHS England to produce some straightforward, unambiguous guidance for patients and doctors about how it can and should be prescribed? I would be happy to help, if he would like that.

[Lord Lucas (Con)]

My Lords, I ask my noble friend to turn his intelligence and attention to how the NHS can get best value in the purchase of out-of-patent medicines, branded and generic. I have had the pleasure of reading the 2014 pharmaceutical price regulation scheme. If any noble Lord is in need of tickling his belly button with his jaw, I suggest that he does the same. It is the most astonishing system, guaranteed to produce lush profits for manufacturers, giving the NHS almost no purchase whatever on the price being charged. It is done in the name of promoting innovation and promoting the UK industry, but there does not seem to be the level of intelligence—meaning not mental intelligence but investigation and the understanding— that would be necessary to make sure that that was the case.

Long-term Plan for the NHS

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Tuesday 19th June 2018 Lords Chamber

[Lord O’Shaughnessy]

My noble and learned friend is quite right: these commissions do not always produce action. I realise that there is some frustration in the House over the delay to the social care Green Paper. I hope noble Lords will respect the fact that it is sometimes difficult to fight battles on many fronts. We have made some progress on the NHS and the army moves on to win the war on social care as well.

[Lord Turnberg (Lab)]

My Lords, I for one from these Benches welcome the influx of funds. We have been waiting quite a while for it so it is well received. Everyone knows, however—we have heard today—that without changes and improvement in social care, this 3.5% will go down the drain as well. It is not just that we need to do both together; we need provision for social care at the same time as, if not in front of, the influx of funds for the NHS.

[Lord O’Shaughnessy]

I agree with the noble Lord and thank him for his welcome. We all agree; indeed, the Statement sets out clearly that the two must go hand in glove. I should point out that additional money for social care in the short term was put in a previous Budget by the Chancellor—£2 billion extra over three years, a budget that is now growing. Clearly that was a short-term measure. Now we need to find that long-term settlement that goes hand in hand with the NHS and ensure that we have true service integration as well.

Children: Obesity

Lord Turnberg Excerpts

Thursday 10th May 2018 Lords Chamber

[Lord O'Shaughnessy]

I am turning into the commissioner of children’s programming. I am trying to remember—I think that there is actually a CBBC programme that encourages children to cook. Its name has gone completely out of my mind but it was popular with my children. The noble Baroness raises an important point. Children learn to cook in primary schools, most of which have some sort of kit that allows them to do that. It is critical for them to understand that food does not just come from packets or shops but can be created by hand—and enjoyably, too.

[Lord Turnberg (Lab)]

My Lords, is the noble Lord aware that it has been shown that having a good breakfast, such as an egg or two in the morning, reduces one’s appetite for the rest of the day, and one’s weight? One of the problems for children is that many do not get a good breakfast. Can the Government do anything to encourage breakfast as a proper meal?

[Lord O'Shaughnessy]

It goes to show that public health campaigns can be effective. I remember the “Go to work on an egg” campaign—although I had a banana myself. The serious point is that too many children do not go to school after a proper breakfast, and one of the great advances with the sugar levy has been a commitment of around £26 million to support breakfast clubs in about 1,500 schools in areas that unfortunately have the worst outcomes for healthy children and obesity. That support will help those children go to school on a good breakfast and function properly.

Children: Obesity

Lord Turnberg Excerpts

Thursday 19th April 2018 Lords Chamber

[Lord O'Shaughnessy]

All I can say is that both my noble friends are excellent examples of slim and fit young men.

[Lord Turnberg (Lab)]

I am sure that the Minister is aware that while exercise is very good for children and adults—it improves mental and physical health—it does not do much for obesity. It is food that does the worst. It is not just sugar, it is fat, and ice cream, crisps and chocolates are so appealing to children. Ice cream has twice the calories of sugar. Will he consider how to get that message across?

[Lord O'Shaughnessy]

One thing I noticed at Easter was that Easter eggs seem to have got bigger. I was counting the calories on the Easter egg that my children had. There is a serious point there. It is about reformulation, it is not just about reduced sugar, salt and so on; it is also about smaller portion sizes, and that is a measure that we are tracking as well.

General Practitioners: Workforce

Lord Turnberg Excerpts

Monday 5th March 2018 Lords Chamber

[Lord O’Shaughnessy]

My noble friend is absolutely right. As well as our commitment to increase the number of GPs by 5,000, we also have a commitment to increase the number of GP practice staff by 5,000, including 1,500 pharmacists, who provide exactly the kind of support she outlined.

[Lord Turnberg (Lab)]

My Lords, one of the reasons why general practice is less attractive than it used to be is because of the enormous bureaucratic load that is placed on GPs nowadays. They have to sit on committees and on CCGs, and they rush around doing non-clinical work. Is there any way to reduce this non-clinical workload?

[Lord O’Shaughnessy]

That is an important issue. We know that workload is a problem. I point the noble Lord and other noble Lords to NHS England’s 10 high-impact actions. These are actions which all GP surgeries can take; for instance, using technology such as e-booking and e-prescribing to reduce the kind of workload he is talking about.

NHS: Cancer Treatments

Lord Turnberg Excerpts

Thursday 25th January 2018 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, it has been a real privilege to hear the noble Baroness, Lady Jowell, give such a brave and inspiring speech. I do not know how anyone cannot be very touched by her words. I have long admired her and now more than ever see her as an inspiration. The spirit that she demonstrated so clearly is absolutely characteristic of her. If I may be permitted a personal note, I love the hat.

The noble Baroness makes an impassioned case for the availability of new experimental forms of treatment, and who is there to gainsay her? Cancer Research UK says we need much more research to understand the nature of glioblastomas—and of course it is right too—but meanwhile what are patients to do? It is true that doctors are able to prescribe novel treatments for individuals on what is known as the named patient basis, and the Bill of the noble Lord, Lord Saatchi, a couple of years ago encourages that approach. However, the problem is that many such new treatments are specific for very small numbers of cancer patients and the costs are enormous.

That immediately brings us to the question of funding—we cannot get away from that. The late lamented cancer drugs fund was soon overwhelmed by the high costs of new diagnostics and drugs. The remarkable advances in so-called liquid biopsies, in scanning, in proton beams and in specifically tailored molecular therapies and immunotherapy are all extremely costly, and no amount of juggling with flexible pricing mechanisms and outcomes-based pricing will find the money needed. So I ask the Minister whether the Government will take note of the recommendation in the Select Committee’s report on the future sustainability of the NHS for a new method of funding involving a hypothecated tax system based on national insurance payments. I am sorry to be so controversial.

The average age of your Lordships’ House is 69. That means that almost half of us have or will have had one cancer or another. I have had two and I suppose, statistically speaking, that saves one other from having one. That makes cancer take on an intensely personal meaning for all of us and we are fortunate to live at times when so much more can be done for us than ever before. Unfortunately, it all comes at a cost and we could be doing so much better. As we lag behind in so many ways, in some cases we are complicit in failures that should just not happen.

I finish on a point about prevention, where we might be able to save someone. We have an extremely effective way of detecting women who are susceptible to ovarian and breast cancer. Here I express my interest as a recently retired trustee of the charity Ovarian Cancer Action. Testing for the BRCA gene, the gene responsible for passing on susceptibility, is now offered to close relatives of ovarian cancer patients, but a relative who is not quite so close, with a smaller chance—say 5%—of being a carrier, cannot have the test. If you have a one in 20 chance of carrying a gene such as that, would you not go for a test costing just £175? It is a bargain for the NHS. I ask the Minister: will the offer of such a test now be made to all such at-risk relatives?

Finally, the briefing I have had from Cancer Research UK suggests that our ability to conduct vital cancer research will be compromised after we Brexit from the EU if we cannot ensure the future of cross-border clinical trials, as has been spoken of. Will the Government ensure that we will be able to continue to collaborate seamlessly with centres in the rest of Europe after Brexit?

Children: Oral Health

Lord Turnberg Excerpts

Monday 4th December 2017 Lords Chamber

[Lord O'Shaughnessy]

Yes, I agree with my noble friend. Preventive care is important. Pilot schemes have been going on in 75 practices to look at incentivising preventive care and population care. I understand that an evaluation report of that first full year of prototyping is due to be published in the new year.

[Lord Turnberg (Lab)]

My Lords, regarding fluoride and dental decay in children, can the Minister provide figures for the incidence of dental decay in areas that fluoridate their water compared with those that do not?

[Lord O'Shaughnessy]

I do not have that exact comparison in front of me. I understand that areas that fluoridate have much better oral health than others, which is why, as I said to my noble friend, we encourage all local areas to look at the evidence and make decisions accordingly.

Nurses and Midwives: Numbers

Lord Turnberg Excerpts

Monday 4th December 2017 Lords Chamber

[Lord O'Shaughnessy]

The noble Lord’s mental maths are far better than mine. I agree that it will provide for the possibility of yet more funding for the NHS, which is something that this Government have delivered in the past seven years.

[Lord Turnberg (Lab)]

My Lords, I wonder whether the Minister can help clear up my confusion. He is telling us that the number of training places is increasing while my noble friend Lady Thornton suggested that the number of people coming into those places is decreasing. What is the correct interpretation? Have we got more, fewer, or what?

[Lord O'Shaughnessy]

I will do my best to provide clarity. If you look at nurse training places in universities, in 2016 the number was 3% higher than this year. One reason for that has obviously been the change in the financing arrangements. However, this year still represents the second-highest number since it became a degree profession. If we look to the future, from 2018 onwards there will be 5,000 more funded clinical placements which will enable the number of nurse training places to increase by some 20% to 25%.

Health and Social Care: Falls Prevention

Lord Turnberg Excerpts

Thursday 30th November 2017 Lords Chamber

[Lord O’Shaughnessy]

I accept that there is a challenge that we have to meet in social care: it is the reason that the Government are committed to a social care Green Paper next summer to provide long-lasting reform. In the meantime, I hope that my noble friend will recognise that another £2 billion was announced in the previous Budget to go into social care over the next three years in order to move people out of inappropriate hospital stays and into their homes. That is backed up, as I pointed out, by a doubling of the disabled facilities grant year on year, precisely to provide the kind of interventions that have a huge pay-off for the public sector. Something like £1 spent on the disabled facilities grant saves £4 in the wider public sector, so this is very important work.

[Lord Turnberg (Lab)]

My Lords, one of the main causes of fracture of the hip in someone who falls is osteoporosis, which is both preventable and treatable. Will the Minister consider starting a screening programme for at-risk groups?

[Lord O'Shaughnessy]

That is a very interesting idea. I will write to the noble Lord. Of course, since this summer general practices are now obliged to carry out screening of over-65s specifically to look at frailty, looking at those with mild, moderate and severe frailty, and that may already include osteoporosis. But I will write to him with the specific details.

Greater Manchester Combined Authority (Public Health Functions) Order 2017

Lord Turnberg Excerpts

Tuesday 7th November 2017 Lords Chamber

[Baroness McIntosh of Pickering (Con)]

My Lords, perhaps I may take this opportunity to question my noble friend on the fluoridation programme. I must declare an interest. I cut my legal teeth as a devil and an apprentice with Simpson & Marwick, and my devil master was the junior advocate in the fluoridation case brought by a pensioner who had dentures—she had none of her own teeth. She objected to the fluoridation programme to be carried out by Strathclyde regional council in the early 1980s. She won her case and Strathclyde regional council did not fluoridate the water supply at the time on the grounds that compelling evidence was led by the petitioner, Mrs McColl, to prove, among other things, that fluoride could be a carcinogen.

Has the Minister taken the time to consider such evidence, and can he assure the House that the level of fluoridation in the public water supply will not be such that any such fears will be raised in the fluoridation programme to be carried out by Greater Manchester council?

[Lord Turnberg (Lab)]

My Lords, perhaps I may ask the Minister about infectious diseases and express my interest as a past chairman of what was the Public Health Laboratory Service and as a Mancunian. Infectious diseases know no boundaries, and it is important with any infectious disease outbreak, which may occur anywhere in the UK, that information is spread very easily to epidemiological centres and central laboratories, so that such outbreaks can be traced and checked. Is there anything in this agreement that will ensure that there is association, collaboration and co-operation with the central laboratory services?

[Lord O’Shaughnessy]

I thank noble Lords for their contributions and for their broad support for the order before the House today. As I outlined, it represents another significant milestone in the Government’s devolution agenda and I am glad that that has been welcomed across the House. I will try to respond to the various points that noble Lords have made.

Like the noble Lord, Lord Hunt, we support the idea of the population plan, which will clearly differ from place to place where there is this kind of devolution. I stress that an important and distinctive part of this plan is that it confers on the combined authority the same powers and responsibilities as a local authority. It is therefore about them acting concurrently, rather than in an overbearing way, or seeking to override.

I have been in your Lordships’ House long enough to know that fluoridation is an area of particular interest. I wonder only why it has taken so long for me to have to answer a question on it. This is a devolution deal, and it is therefore about those powers being taken locally and acting in concert. I do not think it is consistent with the idea of devolution for me to urge any combined authority to point in one direction or another, and it sounds like my noble friend Lady Gardner has been doing plenty of urging already. Any such move would have to be made in concert by all 10 of the local authorities and the combined authorities and be done through the usual processes of consultation and so on, with regard to all the responsibilities that attend on those public health powers. I hope that provides some reassurance to my noble friend Lady McIntosh.