Tag Archives: publication bias

Ghost protocols: Scientists propose a way to plug major holes in the medical literature

Reporters who cover medical studies often take great care not to be fooled by the spin put on research by drug companies, universities and even government agencies.

But sometimes the spin is the study itself, and that’s a serious problem. It’s a big story that’s hiding in plain sight, to borrow a phrase Steven Brill likes to use.

By some estimates, half of clinical trials are unpublished. Half. And because positive studies are far more likely to be published than negative studies – a phenomenon called publication bias – the studies that don’t get published often throw some seriously cold water on how good a treatment looks.

If this research hasn’t been published, how do we know it exists? Some of these trials have been released because of lawsuits; others can be found in standardized documents called clinical study reports that drug companies file with the FDA and its counterpart, the European Medicines Agency. Regulatory agencies use them for their reviews, but because they’re never published in medical journals, they remain hidden to the medical community and general public.

For a case in point, consider the antidepressant reboxetine. Unpublished studies that were brought to light in a stunning 2010 meta-analysis in the British Medical Journal showed that Pfizer had failed to publish data – all of it negative – on 74 percent of patients who had participated in the clinical trials of the medication.

“Not only does the drug not work, it really doesn’t work,” wrote the blogger SciCurious in a guest post for Scientific American on the reboxetine revelations. Continue reading