Controversies about the safety of medicines given to millions of people can’t be settled unless data is made more freely available

Putting your heart into it Simon Danaher

TENS of millions of people took Vioxx for their arthritis between 1999 and 2004. Tens of thousands probably had a heart attack as a result. It was a similar story with the anti-diabetes drug Avandia. In both cases, the drugs’ makers were accused of withholding trial data that would have revealed the risks to doctors and patients.

Access to data is at the centre of many controversies in modern medicine – not just to do with the usefulness of drugs, but also of treatments (such as exercise for chronic fatigue syndrome) and screening programmes (for breast cancer in younger women, say). Big trials are hard to organise, and so researchers often keep a tight grip on the data they create.

As preventative medicine has become more common, concerns have risen that we may be missing key evidence about the effects of drugs given to huge numbers of people. Recently, statins – given to manage cholesterol levels in those deemed at risk of heart attacks – have come under scrutiny.


The trials run to assess statins’ efficacy didn’t focus on possible adverse effects. Those most worried about these – debilitating muscle pain is often cited – have so far been unable to assess the data for themselves. Other critics say there isn’t strong enough evidence for mass prescription of statins (see “Cholesterol wars: Does a pill a day keep heart attacks away?“).

That has provoked a furious war of words with those who do have access to the data. They say complex ownership and usage conditions mean it can’t be released widely. That’s a familiar problem: similar issues dogged the release of raw data from the 2011 PACE trial of chronic fatigue syndrome treatments, which a tribunal finally ordered to be released last year.

So the controversy over statins, whether well founded or not, rages on with no resolution in sight, damaging confidence in medicine. This simply isn’t good enough. When it comes to treatments for millions, data should be gathered with a view to its eventual release. That won’t be easy. But evidence-based medicine requires no less.

This article appeared in print under the headline “Hearts on our sleeves”