Are Industry-Sponsored Clinical Trials Misleading Or Just As Sloppy As Those Done By Academics?

If you've read "Published clinical trials shown to be misleading", a story about a newly published article detailing discrepancies between a drug company's documents and the papers it published based on data drawn from those documents, and if you pondered this quote from one of the study's authors about their review of those internal company documents

[w]e could see all of the biases right in front of us all at once

then you probably think something really damning has been found. If you clicked through to the editorial published along with the article, "Getting More Generous with the Truth: Clinical Trial Reporting in 2013 and Beyond", you probably also agree that "[f]or many working in medical journal publishing, these results will sadly not be surprising" and would readily join the call to require greater transparency among drug companies conducting clinical trials of their products for safety and efficiency. Certainly that's been the common reaction seen across the various reports, blogposts and tweets about the article.

But if you actually read the article, "Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin", you might reconsider. Take all of those biases right in front of the investigators. Presumably the nefarious drug company was at least clever enough to bias the results in the drug's favor, right? Consider this from the Results section:

...we did not assess whether disagreements in descriptions of types of analyses resulted in different participants being analyzed for efficacy and safety. We also did not examine the impact of the observed disagreements on the effectiveness of gabapentin for the indications specified in our study

Yet surely the discrepancies must be the unmistakable sign of the profit motive at work, distorting the truth, right? Well, there's also this

The discrepancies in description of types of analyses we observed in our study are not unique to trials sponsored by for-profit entities such as pharmaceutical companies. Using trial protocols obtained from institutional review boards and corresponding publications, previous research has shown that disagreements such as those we described in our study can be observed in trials with funding from both for-profit and not-for-profit entities.

So while many who read only the tweets and posts about the paper concluded that it's a familiar story of books being cooked to show a drug to be safe and effective when it's not, there was no such conclusion. It's sort of like a murder case with no body and no motive; and nobody missing. All that having been said, drug companies are held to a higher standard and when it comes to transparency they ought to assume that every mistake their employees make will eventually wind up on the front page of the NYTimes, or at least PLOS One.

 

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