The unpublished studies were part of so-called Phase III trials, the final step that a company takes before asking the Food and Drug Administration to approve its product. Each inhaler constituted one dose, and the research showed that study participants weren't using enough inhalers every day, an error corrected in three later studies. And that's fine with some researchers. Because it is unpublished, you can't critically evaluate the methods, the soundness of the results. But others say that is just the point, and they warn that the file drawer shouldn't be the last stop for disappointing studies.
Great science needs negative results, too.
Instead of publishing the planned 340-person study, however, a smaller analysis of 100 people appeared in the journal Addiction . DuPont Merck only allowed publication of data on the smaller patient group because of a contractual obligation with the Mayo researchers and filed away the rest. In 1997, the Sano Corp. started three studies, reportedly designed for more than 1,000 patients, to gauge the benefits of adding the drug mecamylamine to the nicotine patch. No publication is planned, according to Dublin-based Elan Pharmaceuticals, which now owns Sano. In a Ciba-Geigy study of the Habitrol patch, researchers found some advantages to the nicotine device.