Contrary to what a 2001 study found, the antidepressant drug Paxil is not safe and effective for teens. In fact, the very opposite is true.

According to a new study published Wednesday in the journal BMJ, a team of researchers found that after taking Paxil, also known by its generic name paroxetine, many of the adolescents surveyed became even more distressed, and an alarming number attempted suicide. [1]

Experts say the article reflects massive changes in scientific publishing. The departure from scientific custom clears the way for medical journals to post multiple interpretations of the same experiment. These journals are publishing retractions at an ever-increasing rate in the wake of revelations that several studies were fraudulent. It came to light earlier this year that less than half of a sample of psychology papers actually contained legitimate data. Though it’s hard to say which studies are, in reality, legitimate, and which are taken down for illegitimate reasons.

The first study of Paxil began in the late 1990’s, when drug makers began testing antidepressants on teens. Dr. Martin Keller, of Brown University, and colleagues tracked depression scores over 8 weeks in 3 groups of approximately 90 teens each. One group took Paxil, another took placebo pills, and a third group took an older generic antidepressant known as imipramine.

The students taking Paxil showed no improvement in their symptoms when compared with the other 2 groups on a main depression questionnaire, though they did rate higher on other, “secondary” measures, such as another scale of mood problems.

Secondary measures are considered circumstantial evidence to scientists; they’re important, but not as valuable as the primary measures.

Shortly after GlaxoSmithKline (GSK) – then SmithKline Beecham (SKB) – submitted the study’s results to the Food and Drug Administration, health regulators said the drug was on track for approval for use in teens. That began an onslaught of criticism from other scientists, who said the research was weak, and that the study’s authors had downplayed the medication’s side effects.

More than 2 million prescriptions for Paxil were written for children and teens for off-label use in the United States in 2002 thanks to an aggressive marketing campaign by SKB claiming the trial had shown “remarkable efficacy and safety.” Sales of the antidepressant exploded, even after the FDA said that same year that the study should be considered a failed drug trial because the depressed adolescents taking Paxil showed no improvement over those taking placebo or imipramine.

In 2003, the United Kingdom banned the drug, known as Seroxat in the U.K., for use in teens under 18.

In 2004, the New York State Attorney General’s Office sued GSK, alleging that the drug manufacturer had misrepresented data on the medication.

Then, in 2012, GSK was fined $3 billion for fraudulently promoting Paxil. [2]

Despite all of this, GSK continued to stand by its original findings. [3]

But the new study – a reanalysis of the 2001 trial – produced even more worrisome results than the original. Out of 275 children and teens in the trial, 11 of the youngsters taking Paxil and one adolescent given a placebo drug became suicidal or started engaging in self-injurious behaviors. The 2001 study noted 5 adolescents on Paxil and one on placebo demonstrated suicidal ideation, or self-harm. None of the teens on imipramine engaged in self-harm or reported feeling suicidal.

“This is a very high rate of kids going on to become suicidal. It doesn’t take expertise to find this. It takes extraordinary expertise to avoid finding it,” says David Healy, professor of psychiatry at Bangor University in Wales.

The re-analyzation “sets the record straight” and “shows the extent to which drug regulation is failing us,” says Dr. Fiona Godlee, BMJ’s editor-in-chief. She added that it shows that the public and physicians lacked the unbiased information necessary for making informed decisions.

Godlee says that trials funded and managed by the industry need to be replaced with independent clinical trials, as well as legislation “to ensure that the results of all clinical trials are made fully available and the individual patient data are available for legitimate independent third-party scrutiny.”

GSK responded by saying:

“Importantly, the findings from this team’s analysis appear to be in line with the longstanding view that there is an increased risk of suicidality in paediatric and adolescent patients given antidepressants like paroxetine,” it said.

“This is widely known and clear warnings have been in place on the product label for more than a decade. As such we don’t believe this reanalysis affects patient safety.”

This article originally appeared at Natural Society.


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