Health: Polypill

Lord Willis of Knaresborough Excerpts

Monday 7th July 2014 Lords Chamber

[Lord Turnberg (Lab)]

My Lords, I too am grateful to my noble friend Lord Hunt for introducing this debate. It is pretty obvious that he, like me, has been briefed by Sir Nick Wald—and I suspect that the noble Earl may have heard a little from him too—so if what I say sounds a little familiar, I hope he will forgive me. Heart attacks and strokes remain among the biggest killers, despite the improvements in mortality rates in recent years. We know many of the risk factors—smoking, alcohol, obesity, salt and lack of exercise—and we must not be distracted, as the noble Baroness, Lady Brinton, says, from dealing with these public health issues. They are not mutually exclusive, of course.

We know that we should do more to detect and treat high blood pressure and raised blood cholesterol levels, but there is one important risk factor that we can do little about. That is age. There is a straight-line relationship between age and the incidence of heart attacks and stroke. The older you are, the higher the risk. The most striking thing about this is that about half of those getting one of these killers do not have one or other of the conventional risk factors—they have normal cholesterol and normal blood pressure. They come as a surprise in people thought to be fit, and it is in these unsuspected and unsuspecting individuals where the polypill may play a role.

The rationale for the polypill relies on a number of basic principles and here I rely specifically on Sir Nick Wald’s briefing, so what I say, as I pointed out, may not be entirely novel. First, we know that using drugs to lower a raised serum LDL cholesterol reduces the rate of heart attacks, and lowering the raised blood pressure reduces the incidence of strokes, but the intriguing observation is that the same drugs reduce even normal levels of cholesterol or blood pressure to a similar proportion as in those with raised values.

Furthermore—and here is the nub of the argument—lowering even normal levels reduces the risk of heart attacks and stroke. For example, Nick Wald calculates that a fall in blood pressure of 10 millimetres of mercury reduces the risk of stroke by about 60% and reducing serum LDL by 1 millimole per litre lowers the risk of coronary artery disease by 40%. The fact is that there does not appear to be a lower limit below which reducing blood pressure or cholesterol is not effective in reducing risk.

The second principle is that you can achieve as good or better effect in reducing blood pressure from a combination of two or more hypotensive drugs given in half or lower doses than a single drug given in a normal dose, and in this way markedly reduce the incidence of side effects. You get the same impact on blood pressure with many fewer side effects from a combination of half doses.

Therefore, combining these pieces of evidence—risk increasing with age, lowering risk factors even when they are seemingly in the normal range, and combining low doses of drugs to reduce side effects—leads to a conclusion that points to a need to give polypills as a preventive measure to those at risk, namely all the population over the age of 55, say, regardless of their conventional risk profile. Indeed, if they have other more obvious risk factors they are likely to be treated for them by one means or another already. It is the unsuspecting population where a polypill is most likely to be effective. In these, it lowers cholesterol and blood pressure as well as risk.

Nick Wald has suggested that one in three individuals taking a polypill containing small doses of simvastatin, losartan, amlodipine and hydrochlorothiazide would live an extra eight years than they would have done without the pill. It could reasonably be concluded that we should be giving everyone over 55 a polypill of this type, and it would help those harbouring unsuspected coronary artery disease or strokes. If this were a preventive programme like vaccination, as my noble friend suggested, we probably would not hesitate, but of course it is not a one-off, single shot like a vaccine. It is to be taken life long, every day, as a prophylactic treatment, more like the contraceptive pill to prevent pregnancy, although of course for rather longer.

So many issues would have to be overcome, and a number of critics of the mass medication that such a programme would entail have to be answered. There is the question of regulation. Although all the constituents of the pill have been through all the regulators and are in fact well out of patent, the MHRA and MEA may well need convincing that the combinations do not need further appraisal and approval. There is the question of side-effects. Although doses are low, there are undoubted side-effects with all the constituents of the pill, even in the low doses used here. They may well become significant when trying to reach whole populations.

Some say that we are already an overmedicalised society and we do not need yet more pills for everyone. I am not sure that that is a terribly good argument, because we rely quite heavily for our longevity on many of the medicines we take. I am one of the few, it seems, who is on simvastatin without side-effects, out of a huge population who are similar to me. In any case, no one is forced to take drugs if they do not want to. Nevertheless, those are views that we cannot easily dismiss and are to be taken seriously.

We come to the question of whether the polypill should be available for prescription on the NHS or simply over the counter at pharmacists. It is probably very cheap, and the economic value of preventing those diseases is a strong argument for prescription. It would at least allow us to get a clear angle on the number and incidence of side-effects, which free availability would not. It would allow doctors the opportunity to assess their patients for other preventable risk factors at the same time, which we have to do something about. On the other hand, an approach in which people simply decide whether to buy the pill over the counter is certainly more libertarian, but would probably not make a great impact on the epidemiology of those diseases, nor on the health of the nation.

There are certainly interesting debates to be had, and I am very grateful to the noble Lord, Lord Hunt, for starting us off on this topic.

[Lord Willis of Knaresborough (LD)]

I am grateful to the noble Lord for giving way. One issue raised earlier was about the dosage and combining those dosages in relation to particular side-effects. It was only 12 months ago, I think, that NICE advised against giving particular doses of simvastatin together with a modifier. When doses are given separately, you can take the evidence and change them. When they are combined in a polypill, that goes out of the window and you are left with all the elements at the dosages that have been agreed. Is that not an argument for retaining the current position of giving separate dosages rather than combining them all?

[Lord Turnberg]

Those are very good points. The doses used in polypills are very low, in fact—20 milligrams of simvastatin, when the normal dose is 40 to 80 milligrams. The other drugs in the polypill are half doses. The point is that, if you have raised LDL cholesterol or raised blood pressure, you should certainly be on the treatments; they have been shown to be effective. It is people who do not have raised cholesterol or raised blood pressure who we are aiming to treat—or to prevent their diseases—so it is a different situation. The point about safety is important. It is clear that we need and should have proper clinical trials of those doses, but the impact of such doses, from what we know about them in this combination, is that they are likely to be safe in the vast majority of cases. What we do not know is the number who will get side-effects.

--- Later in debate ---

[Lord Willis of Knaresborough]

My Lords, perhaps in the time we have I might make a very short intervention because I agree with my noble friend in her analysis. I feel that there is a real issue not simply with the polypill but with the research, which needs to take place where there are combinations of drugs being given anyhow. You can give a combination of drugs without having serious clinical research and that is okay, but if you combine them into a single dose, you need a complete clinical trial. That issue has to be addressed.