A report on the drug trial results for the antidepressant drug Paxil (Seroxat in the UK) was published in The Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001 under the title “Study 329”. The authors of the study stated paroxetine is generally well tolerated and effective for major depression in adolescents.
The report claimed the drug was safe for children and claimed the trial had shown Paxil demonstrates “REMARKABLE Efficacy and Safety” in the treatment of adolescent depression. GlaxoSmithKline marketed the drug heavily and by 2002, more than two million prescriptions for Paxil were written for adolescents and children in the United States, yielding about $55 million in earnings.
But also in 2002, a U.S. Food and Drug Administration reviewer concluded:
“This trial should be considered as a failed trial, in that neither active treatment group showed superiority over placebo by a statistically significant margin.”
In 2004, the FDA added a black-box warning on the drug’s label about the increased risk of suicidal thoughts in teens who take it. Yet nothing was done to halt the growing Paxil sales.
It was later discovered that although Study 329 listed Martin Keller, Professor of Psychiatry at Brown University, and 21 other physicians and researchers as the authors, it had actually been ghost written by a PR firm called Scientific Therapeutics Information (STI) that had been hired by the drug manufacturer. So much for the ethics of these psychiatrists when there was money to be made! The author of Study 329 sold GSK 500 reprints of this article, 300 for Dr. Keller and 200 for GSK’s Paxil Product Management team, that were given out by the company’s neuroscience sales force.
Stories of suicides induced by Paxil began to appear followed by lawsuits and by 2012 GlaxoSmithKline was shown to have fraudulently promoted the drug and paid $3 billion in fines – “costs of business” for a company who made many billions on Paxil during the prior decade.
With the patent run out, the drug continues to be sold today in generic form by companies contracted to GSK who makes and delivers the product to them. In September of 2015, The British Medical Journal came forth with an article re-analyzing the 2001 Study 329 report and including a scathing editorial about the false reports that had launched Paxil into the world.
As it turns out there were 12 children and adolescents in the trial taking the drug who developed suicidal or self-harming behavior – not 5 as stated in Study 329. David Healy, Professor of Psychiatry at Bangor University in Wales, was surprised so many suicidal kids were not noticed. He commented,
“We think if you were to go in and look at this data, anyone without training will find there are at least of the order of 12 children becoming suicidal on this drug out of about 93 [who were given it].”
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. It’s interesting how the BMJ totally focused on correcting the errors in scientific literature, correcting the record and perhaps disciplining the authors – nothing about the horrific effects Paxil has created in the lives of families in the US and the UK.
Why Paxil Itself should be Retracted
Paxil’s side effects include hallucinations, seizures, confusion, suicidal thoughts and suicide. Women who took Paxil during pregnancy have had children with serious birth defects. And the withdrawal symptoms of Paxil form a very long list – here are a few of them:
- Anger – Want to see someone get mad? Have them withdraw from Paxil. Coming off of this medication can make even the most docile human being turn into a raging evil monster.
- Anxiety – The anxiety coming off of Paxil is among the worst many people ever experience in their lives.
- Confusion – You may experience difficulties with thinking and may become easily confused throughout the day.
- Crying spells – It is common for people coming off of Paxil to breakdown and start crying – often uncontrollably. Feelings of deep depression and desperation may accompany this crying.
- Dizziness – You may experience an extreme case of vertigo for the first couple weeks coming off of this medication.
- Electric shocks – You may feel as though you are being electrically shocked or experience what many refer to as brain zaps.
- Fatigue – It is very common to experience lethargy or fatigue. You may feel like sleeping all day and not wanting to do anything.
- Headaches – It is common to get severe headaches and/or feel pressure in the head during withdrawal.
- Hypochondria – It is pretty common to fear that you are going crazy while withdrawing.
- Mood swings – You may go from extreme anger, to extreme sadness, feel aggressive one minute, and be sympathetic the next.
- Panic attacks – You may find yourself panicking in almost every major situation.
- Poor concentration
- Slowed thinking
- Severe depression
- Suicidal thoughts – Feel suicidal before you take Paxil? Coming off of it the suicidal thoughts may be 100x worse.
GlaxoSmithKline, knowing they are producing a harmful product, doesn’t even bother to maintain quality controls in its manufacture. In 2005 there were manufacturing problems at GSK facilities in Knoxville, Tennessee, and Cidra, Puerto Rico. The FDA seized suspect lots after discovering that the tablets could split apart causing some patients to receive a portion that lacks any active ingredient, or alternatively a portion that contains the active ingredient but does not have the intended controlled-release effect. Several months after this recall, GSK began producing Paxil again in these same facilities.
Then in 2014 GSK had to recall batches of Paxil and Seroxat because the active ingredient used to make them might have been tainted. But only after the FDA investigated the GSK plant in Cork, Ireland and sent a strong warning letter.
It criticized the drug maker for releasing some products made with solvents contaminated from a “waste tank.” It also was very critical of drug maker for deciding that the issue was not important enough to tell its customers and for deciding there was no reason to believe the products were affected.
“We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact,” the FDA told GSK.
How did GlaxoSmithKline respond to the FDA?
“A medical assessment concluded that there is no risk of harm to patients by taking Paxil/Seroxat manufactured from the implicated batches of Paroxetine.”
It’s very evident that the psychiatrists who push Paxil sales and GSK who manufactures it could care less what the drug does as long as the money rolls in.