Drugmakers Rebut Claim They Are Withholding Trial Data

June 7, 2005

Recent criticism from the medical journal community, which accused drugmakers of withholding information from online public trial registries, is unfounded and unfair, according to a pair of large pharmaceutical firms that said they are doing everything in their power to improve transparency and accessibility.

Pfizer and Merck contend they are leaders in the drug industry when it comes to working with academic and consumer groups to promote the publication of clinical trial data. The companies' comments came in response to a recent editorial authored by a prominent medical journal group calling for drug companies to provide more useful and complete information when registering trials in public databases.

Jeffrey Drazen, editor-in-chief of The New England Journal of Medicine and one of the authors of the editorial, accused certain drugmakers -- including Pfizer and Merck -- of abusing the registry system by deliberately providing incomplete information in certain registry fields. Specifically, the companies failed to list adequate drug names in their registrations at ClinicalTrials.gov, the online trial registry maintained by the NIH.

A recent NIH review of ClinicalTrials.gov revealed that, in many cases, the phrase "investigational new drug" was entered into the drug-name field, instead of the drug's specific intervention name, which is what drug companies are required to enter. Without the intervention name, it is impossible to find data on a specific drug, Drazen said.