Criticism of Industry-paid studies? Get real!

Reuters and the Los Angeles Times have opined on a recent study published in the Annals of Internal Medicine that raises questions about possible bias in clinical trials that are funded by the pharmaceutical industry.  There are 2 points that need to be emphasized, so listen up.  First, the pharmaceutical industry is spending its own money on clinical trials, not government grants, not money from charitable organizations.  They are accountable to share holders for wisely spending these monies.  Therefore, they design studies that are generally simple – simple questions that are either yes or no.  Second, they are goal oriented, seeking information that is useful in determining the safety and efficacy/effectiveness of a particular drug, unlike government and academic research that tends to design studies which raise unanswered questions which must be answered in yet another government-grant sponsored study. 

The article also challenges the delay in publishing industry-paid studies.  Leaving the proprietary nature of the information aside, it costs money to publish a study – physicians must prepare the data for publishing, biometricians must analyze the data for the writing team, medical writers must prepare the documents, and all of this must be subjected to a quality review.  All of these are resources that are also needed to prepare documents for regulatory submission.  Now, I ask you – does it make sense for a company to prepare Phase I and Phase II studies for publication before there is an indication that the drug is acceptable for submission to a regulatory authority in support of a marketing application?  Of course not.

The academics that raise the concern should look within their own ranks.  They should ask themselves why their colleagues are not doing Phase I studies.  They know the answer.  Phase I studies are cookie cutter design studies with no opportunity for the opinion leaders to introduce new concepts or analysis.  In other words, Phase I studies do not enhance their bibliography.