Medical breakthrough? No, just a marketing wheeze

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The Independent Online

Miracle cures and deadly scares are the sort of health stories editors crave. It has been a vintage week for both.

As gossip round the water cooler focused on the drug trial at Northwick Park Hospital that went so catastrophically wrong, luminaries of the medical establishment popped up to remind us of the importance of medical research and the central role trials play in the development of life-saving medicines. It would be a disaster even greater than the one that has occurred if such research were threatened, they said. Hence the urgency of discovering how it happened.

They might have cited, as a successful trial, the one-pill-beats-heart-disease "wonder drug" that stole the front pages on Tuesday, as the drama at Northwick Park unfolded. The researchers made an astonishing claim, that the cholesterol lowering drug they were testing, one of the drugs known as statins, could reverse heart disease by reducing fatty deposits in the arteries.

But did the trial deserve its front-page status? This was a victory for marketing, rather than for the research department. AstraZeneca, the manufacturer, had pulled off a coup. A drug that cleaned your arteries and gave you a new heart would be a breakthrough, and a billion dollar earner for its maker.

That is the upside. Now consider the downside. The drug in question is Crestor, launched in 2003, which AstraZeneca hoped would win a big share of the multi-billion dollar heart drug market. Its hopes were dashed when doubts were raised over the drug's safety after evidence emerged that it could cause a muscle-wasting disease, rhabdomyolysis. Warning labels were strengthened by the US Food and Drug Administration last year and the drug has languished close to the bottom of the statins league.

So AstraZeneca was desperate for some good news to promote the drug. It got it by designing a "marketing trial" - a trial designed to give the drug a selling point but without necessarily advancing scientific understanding. The trial was small (349 patients, against the thousands needed to establish a real effect) and the drug wasgiven at maximum dose. Yet the effect on the arteries was tiny: a 0.9 per cent reduction in fatty deposits by one measure and 6.8 per cent by another.

Crucially, the trial ran for two years - just long enough to see an effect on the arteries, but not long enough to see if this made any difference to the patients. The key evidence - whether it reduces heart attacks and saves lives - was missing. The British Heart Foundation cautiously said the results were encouraging, but warned that the pill was not a magic cure. But the appetite for miracles was too strong - and the story hit the headlines. Another study will be along shortly with the opposite finding. Will it get the same publicity? Unlikely.

Research is also risky, as we have seen at Northwick Park. It matters, not least to the families of those still fighting for their lives, whether it is conducted in the interests of scientific advance - or just to defend a market.

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