The mass medication of middle-aged Britain is proposed by doctors today in a bold move that they say could virtually eliminate deaths from heart disease, the biggest killer in the Western world.
Specialists from the Wolfson Institute of Preventive Medicine in London suggest that every person over 55 should be offered a "polypill" - a magic bullet containing six different medicines in a single tablet taken once a day - which would prevent 80 per cent of heart attacks and strokes.
The pill could cost as little as 60p to 80p a day and be on the market in two years. It would require a prescription, at least at first, but there would be no need for a medical examination.
The British Medical Journal, which publishes three papers on the subject today, describes them as "perhaps the most important [it has published] for 50 years". Richard Smith, the BMJ's editor, said yesterday that it was a "step of genius" to come up with the idea of a polypill.
The man who did so, Professor Nicholas Wald, professor of environmental and preventive medicine at the University of London, has an international reputation for his work in epidemiology. With four colleagues, he devised the six constituents of the pill based on tried and tested medicines that provide the greatest benefit with the least side-effects.
The polypill would contain aspirin to prevent blood clots, a statin to lower cholesterol, three blood-pressure lowering agents at half the standard dose and folic acid to lower homocysteine, which causes furring of the arteries. If given to everyone aged over 55, one in three people would gain from the treatment, surviving for an extra 12 years on average without a heart attack or stroke.
"It would be acceptably safe and with widespread use would have a greater impact on the prevention of disease in the Western world than any other single intervention," the authors say in the BMJ.
As well as delivering extraordinary benefits, the strategy turns on its head the principle that medical treatment should be geared to specific risks. The problem with heart disease is that identifying those at particular risk has proved extremely difficult. As 96 per cent of deaths from heart attacks and strokes occur in people over 55, treating everyone over this age would "prevent nearly all such deaths", the authors say. "It is time to discard the view that risk factors need to be measured and treated individually if found to be 'abnormal'. Instead it should be recognised that in Western society the risk factors are high in us all, so everyone is at risk." People with known heart disease but who are under 55 should also be treated, they say.
Heart attacks and strokes kill or seriously affect half the British population and cause a third of all deaths. Some 275,000 people have a heart attack each year and 120,000 die. A further 130,000 have strokes, which cause 60,000 deaths. An estimated 2.65 million people suffer from coronary heart disease in the UK, which costs the economy £7bn a year, according to the British Heart Foundation.
Professor Wald said what he was proposing was analogous to vaccination against infection. Smoking, high-fat diets and a lack of exercise are the chief causes of heart disease, but trying to get people to change their behaviour was very hard to do. "The practical effects of lifestyle changes are small," he said.
But whereas a vaccine might benefit one in 1,000 or fewer of those it was given to, the polypill would benefit one in three. "This is a disease that is all over the place," Professor Wald said.
People taking the pill would gain half the benefit straight away, from the aspirin and the blood-pressure lowering agents, but it would be three or four years before they felt the full benefit from the lowered cholesterol level brought about by the statin.
All the six drugs involved in the polypill have been in use for decades and have few side-effects. The researchers based their conclusions on an analysis of 750 trials of the constituent medicines, involving 400,000 patients.
The idea was enthusiastically backed yesterday by Anthony Rodgers, of the Clinical Trials Research Unit at the University of Auckland, New Zealand, who described it in a BMJ editorial as "one of the boldest claims for a new intervention" that could "quite possibly" be justified. "Realising this enormous potential should be a major goal," he said.
There was a need for a wide debate on the use of preventive medication in "healthy" people without symptoms of disease, Dr Rodgers said. Acceptance of the idea would depend on overcoming perceptions that heart disease is a "natural" cause of death. A third or more of adults in many countries are already self-medicated with pills, mostly multivitamins with uncertain benefits. He suggested that the polypill could be especially useful in developing countries, which have rising rates of heart disease but little preventive or curative care.
But the British Heart Foundation declined to join the party. Professor Sir Charles George, its medical director warned: "There is no doubt the idea of a 'pill for all ills' is enticing but whether we like it or not the rising tide of obesity, inactivity, diabetes and continued smoking rates cannot be ignored.
"A polypill should never be a licence for people to lead unhealthy lifestyles. Known risk factors will always compete with progress in medicine and can lead to other debilitating conditions such as cancer, arthritis and bronchitis."
But Professor Wald said the polypill should be used in combination with other strategies, not in place of them, and efforts to reduce smoking and obesity should continue. "I don't think they need to be mutually exclusive strategies. They should be complementary. We need a multifaceted approach," he said.
The authors have filed a patent application for their invention and Professor Wald said its price could be low because the patents on all six ingredients had expired or were about to. But this had reduced its appeal to the big pharmaceutical companies, which were anxious about its potential impact on their other expensive patented heart drugs. "Something as new as this is a threat to everyone. We have got to sort out a mechanism for funding it and getting it to trial," he said.
Three trials would be needed to satisfy medicine regulators that the polypill was safe and effective, which might take four to five years. But given the existing information about its constituents, it could acquire a licence in two years, provided a backer for the pill could be found. Once on the market it could herald a revolution in the treatment of heart disease.
"It might put some people out of business, but it is the kind of business I would be pleased to put them out of," Professor Wald said.
In use for more than a century, it is widely prescribed to patients with heart disease to reduce the risk of blood clots, which can block the coronary arteries (supplying blood to the heart muscle) triggering a heart attack. However, aspirin also has the most serious side-effects of the six constituents, causing haemorrhage in some people.
Drugs to lower cholesterol, which are widely prescribed and effective but take three to four years of continuous use to reduce the risk of a heart attack. Only rarely will they cause damage to the muscles (rhabdomolysis) or liver (hepatitis) but the early signs, such as muscle aches, can be spotted and the drug withdrawn.
Normally given to pregnant women to prevent neural tube defects (spina bifida) in their offspring, it is also known to reduce homocysteine in the blood, an agent involved in clotting. High levels of homocysteine lead to the build up of fatty deposits, which narrow the arteries, making blockages more likely.
Three Blood Pressure Lowering Agents
The polypill would contain half doses of three blood pressure drugs, more than halving the side-effects while only slightly reducing the benefit. In all, 8-15 per cent of people might experience side-effects from one of six constituents but alternatives could be prescribed to avoid this.Reuse content