Incorrect conclusions about unpublished pharmaceutical research

In a CMAJ news article,1 David Juurlink states that “there is no obligation on a manufacturer to publish the results of a study,” and that he “only sees the evidence that the companies let come to light.”

Pharmaceutical companies should not be blamed automatically for the failure to publish an article once a study is complete. Often, these papers are submitted for publication and are rejected by peer-reviewed journals. There are a number of potential reasons why a journal may reject a paper. Peer reviewers may have a bias against a particular drug, company or the entire pharmaceutical industry. Reviewers may think that the quality of the research is inadequate or that there are problems with how the paper is written. In such situations, the paper is usually revised and resubmitted, either to the same journal or to a different one.

Many journals are motivated by impact factor which, from a business standpoint, is completely understandable. Impact factor is a measure of how many times a journal’s published articles are cited.2 This measure can dictate how good a journal is perceived to be and can lead to increased readership and revenue. This concern over impact factor may lead journal editors to reject a study if they believe that study will not increase their journal’s impact factor. I suggest that negative or failed studies are most likely to fall into this category. Thus, a negative study may go unpublished because of a journal’s business priorities and not because a pharmaceutical company is withholding data. Unfortunately, this gives the appearance that there is an overrepresentation of positive studies and an underrepresentation of negative studies when the literature is subsequently reviewed.

Any study done in the United States, including most clinical trials with Canadian sites, must be registered with www.clinicaltrials.gov. All pharmaceutical companies must post study results within a reasonable period of time following study completion. Also, some companies require researchers to post study results on public websites. Not adhering to these rules can result in huge financial penalties. Companies risk a decline in stock price if they are accused of not publishing results, and therefore they have much to lose from not publishing even negative studies.

Readers should not assume that non-publication in a journal automatically equates to the purposeful withholding of data.