The antidepressant paroxetine was reported in 2001 to be effective and safe for adolescents. Now, this trial was re-evaluated following an open call in the Britsh Medicinal Journal (BMJ), as IFLScience reports. The new study was made possible with the help of GlaxoSmithKline, who initiated the original work and made the data accessible for re-evaluation. Paroxetine has been disputed over the last years, which was scaringly justified by the new results.
It came out that not only paroxetine is not beneficial to adolescents, but also that 11 persons from the 2001 study taking paroxetine attempted suicide or showed self-harming behavior, in comparison to only one person in the control group. This had been ignored by the researchers. It also had been ignored that parent- or self-rating by the patients of paroxetine did not show a significant difference from placebos. Here, we have a point that is valid in whole science.
“The investigator assessments always end up looking more favorable to the drug than those from the patients,” Jureidini told IFLScience.
Scientists are considered to be neutral and unbiased while they develop theories and prove or disprove them. But of course, this cannot be true, as scientists – along with all other human beings – have expectactions and are influenced by their opinions. That a researcher will judge results tendentially in favor for his new theory is not the problem, because it is just human. But it is apparently not responsible to legalize a medicine based on a trial wich was not double-checked.
Even though the danger of paroxetine is now revealed, not earlier than 14 years after the initial study, the BMJ call shows how important double-checking of clinical trials is. It should be not too difficult to legalize a drug only if its effectiveness and danger potential has been confirmed by two independent studies. Or, like in this case, the data set being analyzed separately.