Send in the Data!

The New England Journal has issued a statement expressing concern that data reflecting adverse events associated with Vioxx was not included in a key paper that the Journal published concerning the efficacy of the drug. If there was ever a case for insisting that all sponsors send their protocols to journals when papers are submitted and that raw data be avaible to those same editors for every paper this is it. Kudos to the editors at the New England Journal and the many other journal editors who have been arguing for some time now that all data, negative and positive, must appear in standardized registries within a reasonable period of time after every study is completed. Not to do so is to breach the promise made to researh subjects when they are recruited into clinical trials that knowledge will result from their participation. In the case of the Vioxx trial apparently the sponsor and the investigator felt that a little more knowledge might have been a dangerous thing.
- Art Caplan