Clinical Trial Transparency

The latest impetus for the movement apparently came from public outrage over undisclosed unfavorable results in tests of Paxil', the antidepressant manufactured by GlaxoSmithKline. The pharmaceutical manufacturer had published test results that showed Paxil's advantages in treating depression, but did not disclose certain problems that could develop when taking the drug. Some of those unfavorable test results came to light when a researcher who had worked on the development of Paxil disclosed them at a conference. Members of the public began to ask the question: “What else are the drug companies keeping from us?” When British regulators last year asked for and received unpublished test findings for several antidepressants, they got the full story. The British conclusion: Drug manufacturers had evidence that antidepressants could engender suicidal ideation in children and adolescents, but they had failed to clue the public in to these findings. Disclosure of this information, of course, caused a good deal of consternation in the medical world, with parents and medical practitioners questioning the wisdom of giving youngsters such medications at all.