Seroxat withdrawal warnings ignored by Glaxo…

…and do you know the worst thing about this… the clinical trial talked about here is from the end of the 1980s

This exchange is from Taken on Trust – a Panorama programme from 2004 (thanks to Truthman30).

JOFRE: One psychiatrist above all others has insured that we’ve heard information about Seroxat that its
manufacturer would rather we hadn’t. On Panorama’s previous programme Doctor David Healy explained
what he’d found in the secret archives of GlaxoSmithKline during an American legal action, evidence he
says proves the company has known all along that Seroxat can make all age groups suicidal.
In your view does Seroxat make some adults self harm and become suicidal?

Prof PETER TYRER
Head of Psychological Medicine
Imperial College
Yes, I’ve had a patient that I treated myself who found this effect. He found it only on a certain dose and
when the dose was changed it disappeared, but the fact is, it was clearly related and she actually
experimented with the dosage and found that she could almost predict the suicidal effects.

Prof PETER TYRER
Head of Psychological Medicine
Imperial College
For a time, even only in a matter of a few years, almost critical scepticism, the objectivity were suspended
in favour of the all out rush to develop these new drugs and develop new markets.

JOFRE: Because there was such an excitement created about them.

TYRER: Yes, as the head of GlaxoSmithKline once said: “There’s a lot of runway space out there for
Seroxat you know, let’s get the planes down.”

JOFRE: Getting the planes down, would the company hoped, lead to their second billion. It applied to
extend Seroxat’s licence for the treatment of five more illnesses, some familiar like obsessive compulsive
disorder, some not so familiar like social phobia. Each of Glaxo’s planes landed safely with the regulator’s
full approval. As more and more people are being prescribed Seroxat for a bewildering array of illnesses,
another massive problem has emerged, a problem not as devastating as suicide, but one that affects a much
larger number of patients, many people on the drug say they’ve become hooked. Again, the regulator has
failed to issue proper warnings, even though the evidence has been staring them in the face for years. When
Seroxat was first licensed it was marketed with the regulator’s approval as a safe non addictive drug, back
then even Dr Healy believed the hype.

JOFRE: In the late 1980s, before Seroxat was licensed, GlaxoSmithKline funded a clinical trial into the
drugs affects on depressed patients. The man they asked to conduct it was Professor Peter Tyrer a world
expert on drug dependence. He came across a problem that would go on to affect millions of patients
around the world. After six weeks on Seroxat some of his patients were feeling better, but some of them
were also hooked.

Prof PETER TYRER
Head of Psychological Medicine
Imperial College
After the trial ended they said: “Can we continue on these tablets because we feel we’ve got to have them
because they seem to be so effective”, but more concerning.. was more concerning to us was the fact that
they were saying: “I cannot tolerate the symptoms when I stop it”.

JOFRE: As far as you were concerned then were these people dependant on Seroxat?

TYRER: They were showing yes signs of dependence…

JOFRE: And this was after..

TYRER: ..after only six weeks.

JOFRE: …just six weeks on the drug.

TYRER: Yes.

JOFRE: Some of the withdrawal effects were very disturbing.

TYRER: They also felt more anxious, they felt this feeling of dysphoria, the feeling of being depressed and
in some cases entertaining suicidal thoughts.

JOFRE: That sounds pretty serious then if people were thinking of suicide when they stopped.

TYRER: Yes it is serious and in particular we were led to believe that these drugs were particularly
effective against suicidal thoughts and therefore, having them at any stage during the course of treatment..
and on withdrawal was a matter of great concern.

JOFRE: Professor Tyrer didn’t investigate these problems any further at the time, but he did tell
GlaxoSmithKline what he found, he says they weren’t very interested.

TYRER: It was very important to concentrate on the positive, so we didn’t expect that they would rush in
and investigate this problem as a matter of priority.

JOFRE: And as far as you’re aware they didn’t investigate the problem.

TYRER: No.

JOFRE: We asked GlaxoSmithKline if further studies were commissioned as a result of Professor Tyrer’s
findings on withdrawal. They didn’t say. What they did tell us was ‘The company reviewed reports of such
symptoms in all its clinical trials as a matter of course’. If the drug company didn’t investigate it, what
about the regulator? Since the early 90s its Yellow Card scheme has been throwing out signals that many
patients are hooked on Seroxat, the drug has attracted more Yellow Card complaints about withdrawal
problems than any other prescription medicine. The MHRA says: “Patients should have been well aware of
the risks before they started taking it.”
JOFRE: Really, up until last year the patient leaflet said that withdrawal symptoms were “not common”
and “you cannot become addicted to Seroxat”. The leaflets wording was approved by the regulator.

So was it helpful to tell patients that they couldn’t become addicted to Seroxat?

TYRER: No it wasn’t.

JOFRE: What do you think patients would have understood by that?

TYRER: Well they would have understood that it wasn’t habit forming and that really when the time came
for them to stop their drugs they would have no problem in stopping them, and clearly, the evidence didn’t
support that.

JOFRE: Do you think the regulator should have insisted on something clearer in the patient information
leaflet?

TYRER: Yes.

One Response to “Seroxat withdrawal warnings ignored by Glaxo…”

  1. truthman30 Says:

    I wanted to highlight this because I think it is yet another example of the complete disregard and abortion of ethics by GSK in regards to the discovery of Paroxetine withdrawal early on in clinical trials. In this case it was the late 80’s, shortly before Seroxat was first licensed in 1991.

    Peter Tyrer is a world renowned psychiatrist and one of the UK’s most esteemed professors in the field of pharmacology and “drug dependence”. He conducted one of Glaxo’s early Seroxat trials, he informed GSK of the addictive and withdrawal effects of the drug, but they ignored it because they wanted to rush it to market. Decisions like this based on profit before people are incredibly inhuman and incomprehensible to any individual with any degree of a moral compass. Those whom made the decisions to push Seroxat on people with depression and suppress the side effects profile for years have blood and tears of countless lives on their hands.

    It is absolutely astonishing how GSK have conducted themselves throughout this whole sordid Seroxat saga..
    And each an every time I discover new information or see the facts in a different light I am again disgusted and appalled at how they have gotten away with all this.

    I am also saddened and disappointed that the MHRA have proven themselves to be such a cowardly watchdog of the pharmaceutical industry. A monkey would do a better job at protecting the public from dangerous drugs like Seroxat than they have.

    I would like to know what conflicts of interest exist between the MHRA and GlaxoSmithKline. Because it seems to me that this whole affair is beginning to look more and more sinister every day. Would Pfizer , Eli Lilly or any other foreign (non-uk) pharmaceutical company have gotten away with this type of corporate crime in the UK?

    Are GSK permitted to operate above common law in the UK because of their financial muscle and the benefits they bring to the UK economy?

    These are questions whose answers are obvious to anyone with an iota of sense in their heads and the Seroxat scandal in many ways speaks for itself. It is the mental health thalidomide.


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