Nearly a decade-and-a-half has passed since the publication of a study that showed that Paxil was both safe and effective at treating depression in teens. According to a re-analysis of the same data, which was published recently in The BMJ, Paxil may actually lead to self-harm and suicide in teens.
According to the Washington Post, the original paper was published in the Journal of the American Academy of Child and Adolescent Psychiatry in 2001, and it was known as Study 329. The paper concluded that Paxil was both safe and effective at treating depression in adolescents.
Study 329 was controversial from the start, and the Washington Post reports that the lead author of the paper was linked financially with big pharma.
One year after the results of Study 329 were published, the FDA reviewed the trial. According to The BMJ, the FDA officer responsible for reviewing the trial skewered it, saying, “On balance, this trial should be considered as a failed trial, in that neither active treatment group showed superiority over placebo by a statistically significant margin.”
Despite assertions that Study 329 showed Paxil to be safe and effective for teens, the Washington Post reports that the FDA slapped the antidepressant with a “black box” warning requirement in 2004.
Fourteen years later, a team led by Jon Jureidini, a professor from the University of Adelaide, has taken a fresh look at the raw data from Study 329. His team dug into patient level data to examine the true effects of the drug, and they came to starkly different conclusions.
“It’s hard to think there wasn’t some mischief being done,” Jureidini said of the controversial Study 329. He went on to assert that there must have been “deliberate attempts to play down the adverse event profile.”
Dr. Erick Turner, an associate professor of psychiatry from the Oregon Health and Science University, expressed his initial skepticism to the New York Times.
“When I first heard about this new analysis, I suspected it might be biased. But I did my own analysis and found, as they did, no significant effect.”
When he says that he found no significant effect, Dr. Turner refers to the fact that the study group that took Paxil experienced no benefits not seen in the control group that received a placebo.
According to the new analysis published in The BMJ, it’s much worse than that, with the group that took Paxil having experienced increased suicidal thoughts and behavior.
The New York Times reports that an early critic of Study 329, Dr. David Healy, from Bangor University, suggested that the results of the study were spun by labeling certain serious side effects as “emotional lability.” In fact, five of the six events with that label involved either suicidal behavior or thinking.
According to Dr. Healy, some teens involved in the study attempted suicide by overdose, while others suffered from “severe suicidal and homicidal ideation.”
Following the publication of the new analysis of Study 329, the authors of the original paper issued a joint statement. The statement concluded, “In summary, to describe our trial as ‘misreported’ is pejorative and wrong.”
Whether or not Study 329 was misreported, evidence from the last 14 years seems to prove the assertion that Paxil is not safe for teens, adolescents, and children.
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