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London, September 29: Holding the promise of halving strokes and heart attack related deaths, the new polypill, a combination of four effective medicines, is about to undergo human trials this week in London.
The long awaited pill is being backed by the Wellcome Trust and the British Heart Foundation, who have been providing all necessary aid to the international research teams, in order to make this pill a possibility in the near future.
The initial difficulties faced by the researchers in combining the four drugs together in a single tablet have been overcome now and the medicine is being manufactured currently by the Indian generic drug company - Dr Reddy's.
The human trial would last for twelve weeks and involve 700 people from six countries. This would be a pilot run for the drug and if successful, would be followed by a much larger main trial involving 5000-7000 people next year end.
If it clears all human trials it still might take the pill a year or two, to actually be launched in the market. The reason being many difficulties the researchers are facing to find pharmaceutical companies to get involved with the pill.
Christened as the Red Heart pill, the four ingredients of this ‘once a day’ tablet are not very expensive and are, in fact, low cost drugs, including aspirin. The other drugs which combine together to make this promising medicine are statin to lower cholesterol, an ACE inhibitor and a thiazide to counter high blood pressure.
However, pharmaceutical giants see it as a ‘no incentive’ medicine and are refraining from investing in it in the future.
With their focus mainly on better profit generating medicines, the drug makers find the Red Heart pill, which not only would cut the risk of heart strokes in half, but would also halve the money spent on similar drugs, a major threat in the industry.
Thus, a highly effective pill which, at most, would be available for £20 a year has no takers.
According to Anthony Rodgers, co-director of the clinical trials unit at the University of Auckland, leader of the project, “The chances of mainstream pharmaceutical industry taking this on are slim.” He also revealed that it was quite difficult to arrange funding for the research also, leave aside any future marketing plans.
The researchers firmly believe the utility of the drug lies more in the developing and the under developed countries where the low cost pill would prove to be a hit.
With cardiovascular diseases on a high in countries like India and Brazil the pill would find perfect candidates, especially those who are over-weight, smoke and are above 55 years of age, as these are the people high on risk for a heart stroke.
It is surprising, that in a world where 17 million people die of heart strokes every year, 80% of them from developing countries, a pill of such great significance is taking this long to get a trial with no buyers at all.