In 2001, a leading drug maker published a study indicating that Paxil was a safe and effective antidepressant for teenagers, but on September 16, 2015, the British Medical Journal (BMJ) published another study that found the opposite to be true. The BMJ study concluded that the original data did not demonstrate efficacy in treating major depression among adolescents, and also concluded that use of the drug was associated with an increased risk of harm.
Same Data, Different Results
The BMJ study provided a new analysis of the same data behind the published findings of the controversial 2001 study, which was funded by Paxil’s manufacturer GlaxoSmithKline. This time, researchers spent a year examining company files and poring over detailed descriptions of what happened for each person who took part in the original clinical trial 14 years ago.
The new analysis showed Paxil to be no more effective at treating major depression in those aged 12-18 than the placebo pill used in the study. Researchers also found that the harmful side effects associated with Paxil, including an increased suicide risk, were underreported in the original study, where a suicide attempt was incorrectly coded as an “emotional liability.” Thus, the new study found a more significant risk of suicide associated with Paxil than was reported by the original authors.
This is not the first time the results of the original study have come into question. In the wake of the original study, known in the scientific community as Study 329, prescriptions of antidepressants for young people initially rose, increasing by as much as 36 percent between 2002 and 2003, but fell significantly when questions surrounding the 2001 study led to strong warnings on the drug’s label, citing the potential suicide risk for children, adolescents, and young adults. However, the drug continued to be considered beneficial and less risky for many depressed adults over the age of 25.
The research team has said that it hopes the new study sets a precedent for further reevaluations of other misreported studies, and determined that published conclusions about efficacy and safety should not be treated as authoritative. The BMJ study demonstrates the need for all data and protocols from clinical trials to be made available to independent, third party scrutiny. Anything less runs the risk of compromising consumer safety.