In a study published yesterday in PLOS Medicine, researchers at the Johns Hopkins Bloomberg School of Public Health compared internal Pfizer documents to published studies on the drug Neurontin and found that "trial publication was not a transparent, or accurate...record for the numbers of participants randomized and analyzed for efficacy." In one case, "the description in the publication did not include data from 40% of participants actually randomized in the trial."
It's not the first time we've heard that drug-company sponsored studies might be suspect, but this study advances the story. And it was made possible only because of the unusual circumstance that the internal Pfizer documents became available through litigation.
The study was promoted in an embargoed press release available to reporters on Eurekalert.org. The researchers were careful not to indict Pfizer, but instead to let the facts speak for themselves. The press release was even more careful not to indict Pfizer, saying only that mere "discrepancies" led to "further calls for transparency."
Did the inaccuracies in the Pfizer publications point in the direction of boosting sales of Neurontin? Were they, in other words, possibly calculated to boost profits? These are the questions I would have asked the researchers and Pfizer. Indeed, the Hopkins study seems ripe for a serious journalistic investigation, in which a skilled reporter could try to assess motives and consequences, which the cautious researchers did not do.
So what do we find in the coverage?
Or not quite nothing. I found one story in a Google news search. A blog search turned up one site that republished the press release, and one site that reprinted the single Google story.
That story was written by Rachel Ehrenberg of Science News under the headline "Published clinical trials shown to be misleading."
The evident importance of this story is underscored by Pfizer's history of troubles with Neurontin. In 2007, the AP reported that "Pfizer Inc. has agreed to plead guilty and pay $430 million in fines to settle charges that its Warner-Lambert unit flouted federal law by promoting non-approved uses for one of its drugs." The drug was Neurontin. And I could go on; the voluminous clips on this story are only a click or two away.
Kudos to Ehrenberg for picking it up. Where was everybody else?