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Independents' Day

Kendrick asks...are drug trial results being hyped to the skies?

Our clinical columnist, Dr Malcolm Kendrick, argues that hyping of positive research results is a growing problem

Our clinical columnist, Dr Malcolm Kendrick, argues that hyping of positive research results is a growing problem

Most GPs have little time to read the results of clinical trials. We tend to learn about them from reading magazines such as Pulse or newspapers or catching something on the television news.

Some of us with a specific interest may go as far as reading the BMJ or The Lancet, where many papers are published. But very few will get past the abstract or the discussion.

We rely, I suppose, on the fact that someone, somewhere, is taking the time and effort to ensure that the research is robust, and that the messages given out about the study are accurate.

We also assume that guidelines on clinical practice are based on the actual results, rather than the interpretation of those results.

However, if we look at a very recently published trial – Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) – it seems clear that the various results of the trial are not being given equal billing.

All in the detail

Here, for example, is how the SPARCL trial was reported on Medscape. '"These results support the initiation of atorvastatin 80mg/day in patients with stroke or TIA soon after the event," Dr Welch declared, referring to SPARCL as a "unique, landmark trial".

'As well as bringing about a 16 per cent reduction in the risk of stroke, the atorvastatin regimen also reduced the risk of major coronary events by 35 per cent, coronary heart disease events by 42 per cent and revascularisation procedures by 45 per cent in the SPARCL patients. A small increase in the incidence of haemorrhagic stroke was seen with atorvastatin, but the regimen of 80mg/day of atorvastatin was well tolerated and the incidence of musculoskeletal adverse events was low, Dr. Welch reported.'

1. In this case, the reductions in stroke, coronary events and revascularisation are given exact percentages. On the other hand, the increase in haemorrhagic stroke was described as 'small'. Was this an oversight and does it really matter?

Perhaps it is not hugely significant, but why not give the figure? I have worked for a time in the world of medical education and its overlap into PR.

I can assure you that every comma is debated, so the use of the world 'small' was unlikely to be an oversight.

The Daily Telegraph reported the trial as follows: 'Lipitor reduced the risk of ischaemic strokes, those that cut off the blood supply to the brain, by 22 per cent.

Dr Larry Goldstein, the director of the Duke Stroke Centre in Durham, North Carolina, US, said: "These results will have a major effect on how people are treated following a stroke."'

2. Moving on to the paper itself (yes, I did read it), the authors concluded: 'In patients with recent stroke or TIA and without known coronary heart disease, 80 mg of atorvastatin per day reduced the overall incidence of strokes and of cardiovascular events, despite a small increase in the incidence of haemorrhagic stroke.'

3. Whatever you read about the SPARCL trial, and wherever you read it, the message is very much the same. We should be prescribing high-dose atorvastatin to everyone who has had a stroke or TIA.

How long will it be before NICE decides that this treatment is cost-effective and should be recommended? Will it be in next year's QOF targets? I suspect it will.

At this point I think it is relevant to quote directly from the actual SPARCL trial again. 'The overall mortality rate was similar, with 216 deaths in the atorvastatin group and 211 deaths in the placebo group (p = 0.98), as were the rates of serious adverse events. Elevated liver enzyme values were more common in patients taking atorvastatin.'

High-pressure hyping

So here you have it. High-dose atorvastatin did not prevent a single death, nor a single serious adverse event. All it did, it seems, was to alter what was written on the death certificate – but not the date.

I recognise that there is huge pressure on all involved to generate positive results from their studies. I have chosen only one paper to look at in any detail, but the same things can be seen in paper after paper – and in how those papers are then reported by news agencies around the world.

This hyping of positive results is becoming a major problem. It has now reached the point, I believe, where clinical practice has become distorted towards treatments which are providing little true clinical benefit.

As a wise man once said: 'Jumping out of a plane without a parachute reduces the risk of dying from cancer to zero. But the incidence of other serious adverse events may rule it out as an effective preventive measure.'

Dr Malcolm Kendrick is a salaried GP in south Manchester

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