This study's conclusion is dangerously wrong, yet it is still up on PubMed. Why this matters.
The conclusion on this study does not align with the results.
Why Am I Talking About a Study From Over 20 Years Ago?
The Keller et al. (2001) study on Paxil is essential because the authors were never required to alter the study's conclusion. The study has not been retracted.
If you research Paxil, thankfully, the FDA no longer approves it for children, but doctors continue to use it off-label on children 7 years old and older.
This study by Keller et al. (2001)
Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial
concluded that
Paroxetine is a generally well-tolerated and effective drug for major depression in adolescents.
Paroxetine is also known as Paxil and is an SSRI medication used to treat depression. This drug was approved in 1992, and by 2007, it was the fifth-most prescribed antidepressant in the US, with over 18 million prescriptions.
The Keller et al. (2001) study is over 20 years old, but it was mentioned in the Epoch Times movie In the Shadow of Flexner, in which they discussed that the study results indicated:
Paroxetine was found to be no better than the placebo
AND
The drug, Paroxetine, caused 11 times more suicides than the placebo.
They also misreported the drug’s effects.
This study’s authors reached the wrong conclusion, yet it was never retracted; they were never reprimanded, nor did they apologize for any harm they may have caused by their incorrect conclusion.
I was curious, so I read the entire study last night. I will highlight some shocking points.
After I read the study, here is what I would conclude:
Paroxetine showed slight mood improvements for depressed adolescents over the placebo based on test scores but saw higher rates of hostility and suicidal ideation, whereas this was not indicated in the placebo group. Paroxetine requires more research and, at this time, is unsafe to use to treat adolescent depression.
I could locate the entire published study and read it last night.
It is an old study (2001) conducted when there was limited published data on SSRIs since they were relatively new.
About the Study
It was an 8-week study that included 190 adolescent participants who met the inclusion criteria for depression. The participants were divided into groups that received either paroxetine, imipramine, or a placebo.
Participants were drawn from centers in the US and Canada. The majority of the participants were dealing with feelings of depression for one year at the starting point of the study.
The study was funded by GlaxoSmithKline, which is probably all you need to know about why it was published.
The design, methods, and results were written and represented in easy-to-understand charts. The issue is that most people, especially busy medical doctors, are only going to read abstracts and conclusions or get the abridged version from the pharma rep.
I encourage you to read the study to understand how the drug was misrepresented.
They used three scales to measure baseline and endpoint depression scores: the Hamilton Depression Rating Scale (HAM-D), the Children’s Global Assessment Scale, and the K-SADS-L. The K-SADS-L is stated in the article as a tool used
so that symptoms were specifically rated for clinical relevance and by adding items to generate DSM-IV diagnosis.
They excluded adolescents who were suicidal or who were using other drugs to manage mental health issues.
Note again that they excluded people with depression who were suicidal.
The researchers incorporated a great deal of helpful information into the study, such as examining cardiovascular parameters since Immiprine was known at the time to raise blood pressure and heart rate. They also included checklists to assess self-esteem and quality of life perception.
What the Results Indicated After 8 Weeks
Depression Scores
Most people are more familiar with the HAM-D so that I will focus on that. However, please look at Table 2 from the study to view the results from the other assessments.
The HAM-D total baseline score for the people in the Paroxetine group was 18.98, and at the end of the study, it decreased to 8.24.
The HAM-D total baseline score for the placebo group was 18.97 and decreased to 9.88 after 8 weeks. Therefore, the SSRI did perform slightly better than the placebo, but not by much.
A HAM-D score of 10-13 is considered mild depression, and a score of over 17 is severe. So that means that the participants in the drug and placebo group all had severe depression, and all at the 8-week point did not have depression.
Adverse Events
Here is where the study takes a turn, in my opinion.
Serious adverse events occurred in 11 participants in the paroxetine group, 5 in the imipramine, and 2 in the placebo (one of the headaches and one in the emotional liability category).
The event was considered serious if it required hospitalization, was associated with suicidal gestures, or was determined serious via the MD.
The serious events in the paroxetine group consisted of the following:
psychiatric events in 10 people
worsening depression in 2
1 headache
5 with suicidal ideation and
2 issues of hostility, aggressive behavior, and disruption in school
1 Europhoria mood
Note that multiple events could have occurred in one person.
Seven of the 11 had to be hospitalized.
But here is what they concluded about the serious adverse events in the paroxetine group:
Of the 11 patients, only headache (1 patient) was considered by the treating investigator to be related to the treatment.
So, let me get this straight.
There were 6 serious events related to suicidal ideation (what they called emotional liability) in the paroxetine group, 1 in the placebo group, 7 serious AE of hostility in the paroxetine group, and ZERO in the placebo. Yet, they somehow concluded that none of the episodes EXCEPT for a HEADACHE was related to the drug.
Six participants on Paxil had suicidal ideation, but that was not considered a drug effect, even though the study excluded participants with suicidal ideation.
Here is the keywording
“Judged by the investigator”
Who was the investigator, and how much money was the person getting from GSK?
Clinical Implications
This section is where the authors include how the findings of this study can impact adolescents with depression.
They determined
Treatment with paroxetine results in a clinically relevant improvement in depression scores.
The SSRIs are the medications of choice for the treatment of major depression in adolescents because they are the only agents that have been shown to be efficacious in this population
They (SSRIs) have a safer side-effect profit than other antidepressants.
Think of all the parents who still trust their doctor and put faith in the medication recommendation yet may instead increase suicide and suicidal and homicidal ideation.
Think of all the homicidal and suicidal instances in our youth in the past 20 or so years.
Could it be related to the hostility and suicidal (and homicidal) ideation that may be attributed to mood/mind-altering drugs given to children whose brains are still developing?
I focused on this one study, but since it is still available to read, it makes me wonder how many similar studies on SSRI drugs exist.
And why can a doctor prescribe a dangerous SSRI drug for children off-label, yet a doctor could not prescribe a very safe medication, Ivermectin, for someone with C19?
Here is the full article for anyone who wants to read it
https://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/complaint-ex2.pdf
Watch Manufacturing Madness
This documentary takes you through the history of mental illness and how much of it was caused by syphilis.
https://rumble.com/v42drbt-manufacturing-madness-a-gary-null-production.html
Bottom Line
Whether you agree with a study’s conclusion or not, read it!
Read the entire study, stop reading before you get to the conclusion, draw your conclusion based on what you read, and see if it aligns with the study’s conclusion.
All studies have limitations and gaps, but there were biases, at minimum, in the investigator's adverse side effects determinations conducted as part of this research.
For people who still believe in the chemical imbalance theory of depression and that drugs can correct it, they need to read this post and do a deep dive into the beliefs created by big pharma that, in reality, are myths.
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