How Drug Data Can Be Hidden and Spun: The Story of Paxil | Maryanne Demasi
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The drug Paxil or Peroxetine is a really interesting case.
Again, corruption at every level you could possibly think of.
In the late 90s, the manufacturer GlaxoSmithKline, or GSK, did a series of trials and found that the drug was no better than placebo.
And this one particular study?
I just want to emphasize this.
It means that it did nothing.
Yeah.
It literally did nothing.
Please continue.
This was just untenable for them.
And later through legal discovery, there was an email that was sent to staff where GSK said that this would be commercially unacceptable to disclose the poor efficacy data of this drug.
So instead of telling the truth, they hired a PR firm to write the medical journal for them, so to ghost write the article, and put a positive spin on it.
And then that was submitted to the journal and it was published in 2001.
It wasn't long before the regulators in the US and also in Europe, they discovered that the drug actually was increasing the risk of suicidal ideation.
It was doing the exact opposite of what the drug was meant to do.
So they put out a warning saying that this drug showed no efficacy in children and adolescents.
But the drug continued to be marketed off label.
And because the prominent journal had published this peer-review paper, GSK purchased thousands of preprints and sent them out to all their representatives.
And then they went to doctors giving free samples saying this drug is safe and effective for children.
And I think within a time span of three years, GSK made over a billion dollars in sales from a drug that had never proven to be safe or effective in children and adolescents.
And in 2015, there was a publication in the BMJ that was looking at a reanalysis.
It was called Restoring Study 329.
And researchers went and looked at what the regulatory data, what the documents actually showed.
And they found that the drug was no safer than placebo, but they also found that there were suicides that were hidden and buried in the data.
Or they reclassified them as things like emotional liability or worsening depression.
So they weren't categorized as suicidal ideation.
They were recategorised as another adverse event.
And so that kind of masks it and helps it disappear from the data.
So it was really terrible behaviour on behalf of the pharmaceutical industry to be doing this.
And the authors on the papers, I think about there was 21 odd authors on the paper and over half of them hadn't disclosed conflicts of interest or hadn't even seen the raw data.
They just accepted what the ghost written article had said, continued to market the drug, continued to profit, continued to go on conferences.
In the meantime, children were dying from this and the journal refused to retract the paper, despite the fact that I think it was 2012,
the Department of Justice managed to get GSK to admit to fraudulently promoting the use of Paxil in adolescents and they paid a $3 billion study 329 was part of that settlement and it was the biggest in medical history at the time that fine.
The journal still refused to retract the paper.
It turns out that recently a lawyer who had been litigating this case for some people who were harmed by antidepressants started digging out all the evidence and decided to sue not just the journal but also the publisher Elsevier.
And I suspect that a retraction might be on the horizon because the journal has acted since finding this out and they've put an expression of interest on the paper.
How many years from publication to again maybe a retraction?