The MHRA owes us all an answer on this old Seroxat question

“This from Matthew Holford, writing to Sarah Walk at the MHRA.

I’ve got to say that Matt makes a very, very good point here. The reply will be most illuminating, I feel.

Dear Sarah,

We have, then, satisfied ourselves that the EWG was correct in asserting that patients on Seroxat are not dependent on the drug, to the extent that the DSM IV and ICD 10 systems are used to assess the characteristics of dependence. We have also satisfied ourselves that withdrawal is unquestionably a characteristic of dependence, and that withdrawal is also unquestionably a characteristic of Seroxat use.

The question that occurs to me immediately concerns the volume of patients, who may anticipate experiencing withdrawal, when they use the drug. I understand that the current PIL states 30% (it used to be 25%, and before that 0.7%, and less than four years ago, the figure was 0.1%), although I have seen estimates as high as 80%. Is the MHRA aware of any trials, which have been undertaken specifically to assess the extent of this issue?

Now, given that these figures have been revised so radically over such a short space of time, the question that occurs to me is “why?” What was it that caused GSK and the MHRA to come to the conclusion that the information provided on the PIL needed re-wording? I understand that spontaneous patient reports are not viewed as sufficiently compelling, irrespective of the importance allegedly attached to the Yellow Card scheme.

And I understand that, in the absence of a perceived (ie, as perceived by it) problem, GSK initially declined to conduct trials to investigate the prevalence of withdrawal. So why the sudden change in perception?
Clearly, we should be grateful that the manufacturer and the regulator are so concerned with patient health that their continuous monitoring of SSRIs has permitted them to identify an issue, albeit that it is now acknowledged to be 300 times worse than originally perceived (or 30,000%, whichever you prefer).

Would the MHRA have licensed the drug, had it been aware of the proximity and magnitude of the risk, at the time?”

Perhaps a visit to Matthew’s own blog It’s Quite an Experience would be in order.

6 Responses to “The MHRA owes us all an answer on this old Seroxat question”

  1. BOB FIDDAMAN Says:

    I’ve been in correspondence with them and asked them if they still stand by this… they do!

    Amazing ain’t it. Despite evidence to the contary Kent Woods and his band of merry man still stubbornly refuse to acknowledge that Seroxat is addictive.

    Three guesses to what the outcome of their investigation in GSK will result in.

    Useless incompetent morons!

    Fid

  2. truthman30 Says:

    I don’t think it’s so much incompetence on the part of the MHRA, i reckon it’s more like indifference, which, in a way, is much much worse…

    But Mathew has hit the nail on the head…

    Would the MHRA have licensed the drug, had it been aware of the proximity and magnitude of the risk, at the time?”

    I doubt it…

    They should have pulled it when the first panorama documentary was aired… But they decided to side with GSK because GSK pays their wages… (through regulation fees etc) …

    So basically we have a regulator in the UK who more or less condones unethical behaviour on the part of big pharmaceutical companies …

    And we have a regulator in the UK who does not give a rats arse about the well being of patients who are prescribed defective and dangerous pharmaceutical products like the demon drug Seroxat…

    The MHRA …. safe guarding public health or safe guarding the interests of the pharmaceutical industry?…

    After 4 panorama documentaries i think the obvious has been firmly stated…

  3. Matthew Holford Says:

    Bob’s got a post about GSK’s recent installment as “Most Ethical Pharma,” by some interested organization, or other. I’d just like to quote my reaction to that:

    “1 Comment – Show Original Post

    Radagast said…
    World’s most ethical pharmas? Fuck me! Isn’t that the same thing as the Tallest Midget Competition?

    What criteria swung it for GSK? Not stabbing your blind grandmother in the back?”

    Anyway, I don’t recall the MHRA’s answer to my ‘mail, above. It may have been on a different occasion, but it was claimed that GSK had always noted withdrawal as a side effect on the PIL, even before PILs were mandatory. I don’t think that’s true, though. Truthman could probably clear this up, but I seem to remember that the first PIL didn’t include it.

    As to the question that Mr Admin highlighted, above, I’m pretty damn sure I never received an answer to that. How could it answer? To say “yes” would make it look utterly incompetent. To answer “no” would require that it withdraw the drug’s marketing authorization. Much better to let the awful side effects of the drug leak out, little by little, analogous to the frog in a saucepan, slowly being boiled alive.

    The MHRA is not fit to be flipping burgers, as far as I’m concerned. From the evidence that it’s been willing to let me see (fuck all), overseeing drug regulation is a task that far exceeds its modest capabilities.

    Matt

  4. truthman30 Says:

    Oh yes the first Seroxat Pil…
    What a lovely Little document that is..
    As far as i can recall, it was about 10 lines of ..well not much really…
    The MHRA claim that the first Seroxat PIL dates back to 1996… Strange because i distinctly remember seeing the 1991 one… I wonder why the MHRA would deny its existence…? Oh.. Hang on, maybe because it would mean that they have been conning us about Seroxat?…Well anyhow it does exist …And it doesnt mention withdrawal, or the literally hundreds of side effects which are in the current one.. nor does it mention defects in babies or suicide, aggression etc…
    I think the MHRA owe all the people who have been harmed by Seroxat a BIG apology…
    But i doubt if an organisation which has consitently shown its complete indifference to the suffering of tens of thusands of people will ever admit to its failings…

  5. Matthew Holford Says:

    Well, I sent a copy of the first PIL (vintage 1991) to the MHRA, and it confirmed it to be the genuine article. However, it was kind enough to explain how responsibility for the PIL works. The MHRA agrees the wording with the relevant company, but the company retains responsibility, at all times.

    Prior to 1996, I imagine that the provision of a PIL was voluntary. As such, the MHRA probably couldn’t give a shit about the 1991 PIL, because it had no obligation in Law, and, as such, no liability. Now, as an added little tantalizing tidbit, I seem to remember an exchange I had with the MHRA, where it said that SKB had identified withdrawal during its original trials (I think it was the exchange that more directly concerned how many trials had been carried out, and how many had failed), and then continued to monitor it. Now, if my recollection as to this exchange is correct, one might ask why GSK decided not to include this on the 1991 PIL, when it was a known risk? Because there was no requirement so to do? Looks like misrepresentation, to me.

    Matt

  6. truthman30 Says:

    “The MHRA agrees the wording with the relevant company, but the company retains responsibility, at all times”

    If the MHRA agrees on wording of the PIL with the pharmaceutical company then the MHRA must shoulder part of the responsability when the drug is defective or the wording is difficult or misleading…

    Is it not the MHRA’s job to regulate?…
    Is that not the point of its very existence?
    What a joke…
    I wouldn’t trust the MHRA to regulate the boiling of an egg…


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