How pharma keeps a trove of drug trials out of public view

(WASHINGTON POST)  November 12, 2015 — Clinical trials showing how drugs worked aren’t always publicly available

A third of the clinical trial results that federal regulators reviewed to approve drugs made by large pharmaceutical companies in 2012 were never publicly reported, according to a new study that grades companies on their transparency.

To assemble the report, a handful of dogged researchers pored over thousands of pages of regulatory documents, counting up the number of trials Food and Drug Administration regulators reviewed, versus how many trials were published or publicly reported. The result is an inaugural transparency report card — essentially an index showing just how much of the evidence about how the 15 drugs actually work in people is publicly available.

“Right now, there’s a big push for evidence-based medicine. It’s impossible to have evidence-based medicine without the evidence,” said Jennifer Miller, an assistant professor in the division of medical ethics at New York University School of Medicine, who oversaw the report. “If the public evidence is partial or biased you risk having partial or biased [prescription] guidelines,” on how to give the drugs to patients.

The study, published Thursday in the journal BMJ Open, shows gaps in transparency, but has limitations. It analyzed only a subset of drugs approved in a single year, 2012. The researchers also only examined whether clinical trials were registered and reported, not what that data suggested about how the drugs worked.