A team of researchers has discovered that claims made by an industry-funded study are false. The antidepressant Paxil, or paroxetine, is not safe for teens and young children.
The reanalysis of the 2001 study, which was published in the “British Medical Journal”, found that “neither paroxetine nor high dose imipramine (a generic antidepressant) showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs.”
This is completely opposite from what the original study said. The original study was published in 2001 in “The Journal of the American Academy of Child and Adolescent Psychiatry”. That study stated, “paroxetine is generally well tolerated and effective for major depression in adolescents.”
Paxil Markets False Report For Gain, But Loses
That research was then used in the companies 2002 marketing to claim that Paxil was effective and safe for adolescents to use. That year, more than 2 million prescriptions for Paxil were written for teens and adolescents.
A decade later, GlaxoSmithKline, the company that manufactured Paxil, settled for $3 billion with the U.S. Department of Justice for false marketing claims based on the study. Many have called on Martin Keller, the original study’s lead author, and others as to why they remained silent on the false results.
The reanalysis was part of the Restoring Invisible and Abandoned Trials (RIAT) Initiative that was launched by the BMJ and Public Library of Science in 2013.
Researchers for the BMJ stated, “The RIAT initiative offered us a chance to report Study 329 ourselves, so as to correct the record, and perhaps finally embarrass the authors, institutions and the journal into taking the actions they have so far resisted.”
Paxil No Better Than Placebo, Could Cause Suicide
The new study also found that Paxil was no better than a placebo in it’s effects for treating depression in teens and adolescents.
The 2001 study compared the children taking Paxil, placebo and the generic imipramine. They admitted that those taking Paxil didn’t score better than others on the depression questionnaire, but argued they did better with other depression assessing measures.
While the team doing the reanalysis agreed that those on Paxil didn’t score any better than others, they argued that they downplayed some of the serious side effects. One of those includes multiple suicide attempts. The data also suggests that Paxil was no better than a placebo.
After Paxil was introduced, thousands suffered from side effects such as hallucinations, withdrawals, seizures, suicidal thoughts and confusion. Women who were pregnant that took Paxil also had their children suffer serious birth defects.
Paxil Just Another Pill That’s Hard To Swallow
This recent scandal is just another nail in the coffin of controversies that has to deal with SSRIs, or serotonin reuptake inhibitors, like Paxil. It also shows the corruption of pharmaceutical companies when it comes to their clinical trials, weakening any trust that may exist with the public.
After many red flags were raised, and concluding with the multi-billion dollar trial, the company decided to make their study available to the public. This is what allowed for the reanalysis to take place. The company said it provided “an unprecedented level of data sharing that speaks to our absolute commitment to transparency,” to make the reanalysis of Paxil possible.
This attempt at a newfound trust though is coming long and billions of dollars later after many lives have been damaged. The researchers at RIAT are the ones who deserve the credit for bringing this complete level of information to the public