As if by magic…

Just when I’d finished a recent post – The caring face of GlaxoSmithKline – I got alerted to a new post over at Seroxat Sufferers – Objection your Honour – which you really should have a look at it. It’s part of an old trial transcript and it kind of underlines what I was saying in The caring face…. why don’t Glaxo admit there’s a problem?

Here are some details:

Q: How many complaints on Paxil withdrawal have you received since January 1, 1993?
A (Glaxo): We object to the question. We don’t know what you mean by “complaint” and “withdrawal”…

Q: What efforts have you made since 1993 to find out about the Paxil withdrawal problem?
A (Glaxo): We object to the question…

Q: What were the symptoms of the 18 Yugoslav patients you claim were suffering “relapse” (and we claim may have been suffering withdrawal)?
A (Glaxo): We object to the question…

Q: In Paxil’s labeling, why did you warn patients that those with a “history of drug abuse” should worry about tolerance for the drug when other patients were not so warned?
A (Glaxo): We object to the definition of “history of drug abuse”…

And so on…

10 Responses to “As if by magic…”

  1. Matthew Holford Says:

    I don’t suppose anybody has a copy of the PIL, dating from when Seroxat was first licensed, does it? Alternatively, does anybody know what changes have been made, with respect to side effects, withdrawal symptoms, and so on?

    On the current PIL (http://us.gsk.com/products/assets/us_paxil.pdf, which is presumably the current one), we have:
    Headache
    Asthenia
    Palpitation
    Vasodilation
    Sweating
    Rash
    Nausea
    Dry mouth
    Constipation
    Decreasted appetite
    Diarrhea
    Flatulence
    Dyspepsia
    Oropharynx disorder
    Myopathy
    Myalgia
    Myasthenia
    Somnolence
    Dizziness
    Insomnia
    Tremor
    Nervousness
    Anxiety
    Paresthesia
    Decreased libido
    Drugged feeling [no shit!]
    Confusion
    Yawn
    Blurred vision
    Taste perversion
    Ejaculatory disturbance
    Other male genial disorders
    Urinary frequency
    Urination disorder
    Female genital disorders

    These are listed on page 27 of the 43 page document, and apply specifically to major depression (there are different lists for OCD, and so on). Suicide is discussed separately.

    I’d be quite interested to compare this list to the original list, just to establish what side effects have been added to the PIL, since it was first licensed. Depending upon how impressive the sub-list is, I think I’ll ask the MHRA if it would have licensed the drug, had it been aware of these side effects, at the outset.

    Matt

  2. BOB FIDDAMAN Says:

    I object to this post🙂

    Matt – I’ll send you the PIL from 1998 later

    Bob

  3. Matthew Holford Says:

    I find this all very interesting. I think it could be argued that the PIL essentially amounts to an attempt at exclusion of liability for personal injury, but given that the patient doesn’t have access to the PIL until after the contract is made with the pharmacist, it should be excluded from the terms of the contract.

    If this is a good argument, then I think most of these side effects are so serious that they require special treatment, under the Red Hand Rule in Shoe Lane Parking, which provides that where a term is so onerous it should be brought to the attention of the consumer with a big, red hand pointing to it. Of course, the Unfair Contract Terms Act deals with such things, these days.

    Matt

  4. Matthew Holford Says:

    Viz that last post, I note that responsibility for keeping children under observation (and, more recently, 18-30s) falls squarely on the shoulders of the parents and medical practitioners. Again, I can’t see that GSK may avoid responsibility for the side effects of its drug, and shift responsibility for avoiding those side effects onto carers and clinicians.

    Matt

  5. squirrel Says:

    If anyone does have the old pil can it be posted on here so we can compare them?

  6. truthman30 Says:

    They have been shifting blame from one thing to another since they released this toxic crap back in 1991, they originally tried to blame the patient for experiencing withdrawal and side effects (as part of their “original condition” returning), then when the GP’s found out what was going on , they claimed that it was Glaxo’s fault for “faling to warn” and now they are trying to shift the responsability of young adult seroxat induced suicides back on to the heads of the GP’s and prescribers…
    Why don’t they just do the right thing and admit that they have released one of the most toxic and dangerous drugs known to man ?…
    Seroxat has been like a chemical grenade, no one wants to take responsability for it , no one wants to touch it, they all just keep throwing it back and forth … Excuses are wearing thin at this stage…It’s a joke…Get rid of it…
    They need to ban this defective, horrible drug for new prescriptions, and wean all the existing Seroxat addicts off it NOW before any more lives are destroyed…
    This is a Public Health Catastrophe..
    The Devastation already caused ,and still being caused by Seroxat is…immeasurable..

  7. Matthew Holford Says:

    “If anyone does have the old pil can it be posted on here so we can compare them?”

    I’ve requested the original, from the MHRA. I’ll see you back here in 20 working days, if we’re lucky!

    Matt

  8. bux Says:

    they need to be adding that these drug side effects can last a long time after discontinuation too,in the way of discontinuation syndrome,you know the hell they deny and call”relapse”,all those symptoms listed above i still suffer 30 months after my final dose of the poison,can they explain this?,oh and if they call it “relapse”,can they explain why these symptoms were non existant prior to seroxat use? but hey the hell i still have them now?

  9. Matthew Holford Says:

    Hey bux,

    Those are examples of the really embarassing questions, which you might want to put to the regulator, assuming that you’ve not been able to discuss this direct with GSK, that is. And if you’re in the UK, I recommend you complete a Yellow Card, which the MHRA is always keen to scrutinize, and give feedback on.

    Matt


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