Earlier this year Marquardsen and colleagues published a sobering study in the Journal of the Royal Society of Medicine entitled “Redactions in protocols for drug trials: what industry sponsors concealed,” in which the authors requested a number of clinical trial protocols (and any related documents) and surveyed the materials received for censorship. They note at the outset that commercial entities are well-known to be uncomfortable with releasing such materials, often claiming that “they contain commercially sensitive information, trade secrets or intellectual property.”

I won’t summarize the entire paper, but needless to say the results constitute a piercing indictment of the industry-sponsored medical research complex. Here are a few highlights:

  • It took three years for the authors to receive the full set of 78 trial protocols requested, and “several companies refused to provide their protocol and involved their lawyers.”
  • In some cases the redaction was hilariously sloppy, as the authors summarize: “In some protocols, we could reveal what was hidden by copying the blackened out text and pasting it into a Word document.”
  • Fully half (17) of the 34 protocols for commercially sponsored trials featured some redaction, as opposed to only two of 36 non-commercially sponsored trials, and three of the unredacted commercially sponsored trial protocols were missing related documents.
  • Across 22 assessment variables (ranging from primary outcome specification to randomization procedure) examined for the (17) redacted protocols, redaction pattern was highly variable and heterogeneous, with redaction identifiable in at least one case for almost every variable.

  • The study abstract provides disheartening summaries:

    “The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials…”

    The message to take from this study is related to that emphasized by Jefferson & Jørgensen,

    “In the last decade, evidence has accumulated, across a spectrum of different interventions, that journal publications cannot be trusted.”

    Apparently, neither can profit-driven funders be trusted to provide the means for investigators to evaluate the trustworthiness of the publications. It seems the claim to “trade secrets” provides an opaque “paper curtain” behind which corporations can conceal whatever they wish, and cutting through requires considerable investigatory effort to attempt to appraise the methodology underlying published research.

    In a letter commenting on this study, Will & Noble (2018) observe that,

    “Arguably, the incomplete records provided in the modern, economically practical, model of science publication cannot sustain trust of science in the community…”

    Indeed, and nor should they.