Drug Side Effects Under Reported

An astonishing 64 per cent of drug or medical device side effects are left out of the published reports that clinicians so frequently base decisions on. This is the finding of a recent paper published in the journal PLOS Medicine by a team of UK researchers. I would estimate that percentage is much higher for statins.

The paper looked at 28 studies dealing with the discrepancies present in hundreds of published trial results, versus their unpublished counterparts. Unpublished data was found in places such as pharmaceutical reports and clinical trial registries. This includes ClinicalTrials.gov in the US, one of the first of its kind set up to bring greater transparency to the industry.

The authors found that harmful side effects would have been missed between 43 per cent and 100 per cent of the time if only the published findings were consulted and 64 per cent on average.

“There is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study,” the authors wrote.

The main purpose of a paper is that there is good news and that something works. Most people consider side effects to be bad news so they present the minimum possible. The journals want to publish something that is exciting and interesting. I wouldn’t say it is anyone’s fault in particular. People like to think they have the new cure for cancer. I blame the culture.

The 28 studies the team looked at each approached the problem differently; so various specific issues were highlighted in each. One study, in particular, found that although there were fewer unpublished data sources than published among the trials studied, the total number of serious side effects was higher in the unpublished set. For example, instances of “suicide ideations, attempts, or injury, homicidal ideations, and psychiatric symptoms” all higher in the unpublished set. The side effects being dealt with in these broad studies are clearly not all trivial.

The researcher authors are now calling for full and transparent reporting of trial results so that medical professionals can base their decisions on the wider picture.

This is far from an unknown problem. Loke says we are so frequently getting only “a small, incomplete picture” of what actually happened in a trial. In many instances the authors behind the 28 studies had to submit Freedom of Information requests to get a fuller picture.

John Ioannidis, professor in disease prevention at Stanford Medicine and academic editor on the PLOS Medicine study, believes most editors and journals are in fact not actually aware of the extent of the problem. “Reporting of harms has always been suboptimal, even worse than reporting of effectiveness outcomes that has also had substantial deficiencies,” he told WIRED. “Many journals are starting to take more seriously the need for making detailed protocols and raw data routinely available. This will hopefully help remedy some of this bias or at a minimum it will help probe its depth. But there will still remain a lot of unpublished data and their non-availability may keep distorting the literature.”

Please read the full article here as I would have an extra long blog otherwise,