Health: Polypill

Lord Hunt of Kings Heath Excerpts

Monday 7th July 2014 Lords Chamber

Asked by

[Lord Hunt of Kings Heath]

To ask Her Majesty’s Government what action they will take to encourage the use of the polypill by the National Health Service.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am very grateful for this opportunity to put some probing questions to the noble Earl, Lord Howe, and perhaps ask for his help with something that I am rather puzzled about. I detect a less than enthusiastic response from the medical and health establishment to the development and potential of what is being called the polypill. Perhaps the noble Earl will share the reasons for it and helpfully suggest a way forward for some more constructive engagement on the issue, if that is at all possible.

As we know, strokes and heart disease remain a major public health problem. Across the population as a whole, the chance of having a heart attack or cerebrovascular accident rises as people get older, and age is the single most important predictor of future cardiovascular disease. But we know now—there is robust evidence—that the consumption of fixed-dose polypills containing effective combinations of low-cost off-patent statins and blood pressure medicines can safely cut the rate of unwanted vascular events by 70% or more in otherwise untreated subjects, whatever the initial combined level of their blood cholesterol and other disease risk factors. The use of such a preventive technology across the general population, with access determined by age alone, would prevent the need for much more costly and inefficient risk-testing, and maximise the health gains. Clearly, it is aimed at people in their 50s and 60s who would not at the moment meet any treatment threshold.

The use of the polypill focuses on primary prevention, whereas the majority of current medical activity is focused on secondary prevention. Of course, if a first heart attack or stroke is prevented, there is no second one to prevent. My understanding is that if people take this daily from the age of 50, one in three people would benefit and would gain an extra eight years of life without heart attack or stroke—similar to the benefit achieved by stopping smoking in middle age.

I suppose that the polypill can be thought of as a form of drug-based vaccination that reduces vascular disease rates. However, unlike the situation with vaccines, there is no threshold level of use needed to ensure herd immunity—the higher proportion of healthy people taking the polypill, the greater the benefits—but no one needs to be encouraged against their personal judgment to take it if they do not wish to do so.

An article in the BMJ in April, which contained research news, said:

“Inconsistencies in the design of studies investigating the potential of polypills to prevent cardiovascular disease make the impact of these pills difficult to prove, a systematic review by the Cochrane Collaboration has found. However, the reviewers are confident that polypills do have a role in protecting large populations against cardiovascular disease”.

One would have thought that there would then be a great rush of enthusiasm by the NHS and indeed the medical and health sector generally to use the polypill. But as far as I can see, we have had mostly silence and in some cases downright hostility. There has clearly been difficulty making a polypill with a licence for the primary presentation of cardiovascular disease, and pharmaceutical companies see little commercial advantage because the components of the polypill are all generic. I understand that they are also put off by the uncertainty and cost of obtaining regulatory approval.

I wonder whether we are seeing here a parallel to the statin debate, which, as a lay person, I have found utterly confusing. I pick up the sense among some sections of the medical profession, particularly the public health profession—and I stand here as president of the Royal Society for Public Health—that pills are not really virtuous. It feels as though there is a puritanical approach which suggests that healthy living is the only appropriate policy to adopt in the prevention of stroke and heart disease. I also suspect that doctors fear the workload implication of this kind of medication when it comes out. Perhaps they also fear losing control. In a sense, the use of polypills could be seen as the public very much taking ownership of their own health.

There is no evidence that the use of polypills would lead to increased vascular disease risk-taking. I understand that the available studies imply that health-promoting behaviours tend to be positively correlated with one another, as might be the case with health-damaging behaviours. As with vaccines, the introduction of a general polypill prevention programme within the NHS would probably require a positive, proactive approach, possibly in the form of some government/private partnership.

I was interested in the Government’s approach to antibiotics last week. Clearly, the current mechanisms—the factors that lead pharmaceutical companies to make major investments—were simply not going to produce the goods and the Government felt that they had to step in. Will the Minister consider whether his department might at least play a somewhat more active role in this debate than it has done hitherto? Would he, at the very least, be prepared either to convene a study or an objective, independent review of the potential of the polypill? Would he, at the very least, be prepared to meet me and colleagues to discuss whether there is a way to take this forward?

I am puzzled that, on the face of it, the polypill could lead to a major reduction in the number of heart attacks and strokes that occur in this country, yet the combined efforts of the medical, health and pharmaceutical establishments seem to want to look the other way. Why?

--- Later in debate ---

[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.

[Lord Hunt of Kings Heath (Lab)]

My noble friend, and other noble Lords, mentioned the importance of clinical trials, which I am sure is absolutely right. Is not the problem here that in fact no pharmaceutical company will conduct a clinical trial because all the drugs used in combination in the polypill are off-patent, so there can be no protection of that research by any company taking it forward? So there is, if you like, a block here, although people can see the potential benefits. Rightly, noble Lords are asking for clinical research, but there is no possibility of that happening unless the Government take a hand themselves, which is why the debate on antibiotics is interesting. They are completely separate subjects, but the Government had to step in there because, at the moment, the market simply cannot respond to the issue.

[Lord Turnberg]

I agree entirely. I think that it will be difficult for the drug firms themselves to conduct trials because these are generics and they are manufactured by a number of companies. The only way forward, I suspect, if we are to have a clinical trial, is through NHS funding—that sort of trial. My final remark is that I very much look forward to the noble Earl’s response.