RxISK Stories: Facts About FACS

September, 7, 2012 | 5 Comments


  1. There seem to be two inevitable outcomes to the long string of pharmaceutical scandals. Problems with individual drugs will eventually come to light and the manufacturers will continue to avoid culpability in all but the most trivial ways. It’s telling that a $3 billion fine is still considered trivial to both regulators and Glaxo. The pharmaceutical companies have nearly reached the point where they are beyond reach of the government agencies that are tasked with regulating them.

  2. Reading through some of the documents on the USC drug industry document archive, I ran across a CME audio-conference from 1998 given by Dr. Nemeroff [http://dida.library.ucsf.edu/pdf/omu38h10#page=13]. In answer to a question about Prozac vs. Paxil during pregnancy, he said “…there’s no evidence that one or another of the SSRIs is associated with a better or worse outcome. Taken together, the data would suggest that in terms of safety, they are all probably equal and relatively benign in terms of effects on the fetus.” on the last page [http://dida.library.ucsf.edu/pdf/omu38h10#page 21], it says “Supported through an unrestricted educational grant from SmithKline Beecham Pharmaceuticals.” One wonders if either Dr. Nemeroff or ACPE [the CME provider] acrue liability for such presentations?

  3. Just read ‘Thalidomide and its sequelae’ by Breckenridge et al.

    MHRA like to think of themselves as the best in the world, in truth they are probably the best of a piss-poor bunch of global regulators.

    As for Breckenridge, exactly what are his duties as Chairman of the MHRA?

    What role does he play there, Is he involved in any of the decision-making, assuming the MHRA arrive at decisions that is?

    His performance on Panorama defending Seroxat was cringe worthy, something that surely must have embarrassed the MHRA.

    He’s been Chairman there for years… nobody actually knows what he does.

    I think it was Charles Medawar that called for Breckenridge to resign many years ago.

    Medawar was right.

    I’d go further and call for the MHRA to be disbanded or at the very least get some new blood running the show. Former patients affected by drugs that the MHRA were supposed to protect them from would make great advocates for protecting patients.

    The current mob couldn’t run a bath.

  4. What the MHRA have done regarding Seroxat is to allow and promote the use of Seroxat; there could not be more compelling evidence, but I doubt the MHRA even know about my desire to attempt some sort of legal redress. I told them about Seroxat and me, and the reply I got was so naive and so ridiculous, would I please send in a yellow card. This was last year, I have the emails from them.

    Let’s not forget an important person in all this – Richard Brook, Chief Executive, Mind – The Mental Health Charity.

    I wrote to Mr. Brook on 28 May, 2003, after seeing him on the Panorama Programme. My opening statement in my letter said ‘ I am delighted that the MHRA are to hold an enquiry into the side-effects/withdrawal effects of Seroxat.’
    I then described what had happened to me.

    Mr. Brook replied on 29 May 2003, saying:
    ‘Thank you for your email outlining your experiences on Seroxat. Unfortunately, your story is one that is all too familiar to Mind.
    You may also be pleased to know that I have been approached since the Panorama programme and Mind’s campaigning efforts to be a member of the review group looking into SSRIs so I am unable to comment directly on the details of your email as this is a condition of membership.
    I can assure you that I will ensure that the aspects you raise in your email and are raised by many others are robustly taken up.
    It is essential to us to have feedback from those who have been affected and I thank you for taking the time to email me. Your details will be kept on file.’

    Mr. Brook resigned from Mind not long after this because his desire to assist, was met with a brick-wall from the MHRA, and I am not sure if he was threatened, but I do know that he was pretty upset that the MHRA would not back him up in any way, shape or form. Mr. Brook was a thoroughly decent and supportive individual who seemingly lost his chance to defend us. Why?

  5. We cannot have a UK regulatory agency funded by pharmaceutical companies.
    It is clinically insane, and the MHRA are in their pockets and are their puppets.
    It would be ok, if pharma were honest, correct, upstanding, and wholly on the side of the patient, but, in fact, they are not.

    Why is methadone, willingly and forgivingly handed out to Heroin addicts.

    Why as an SSRI loser, was I was not offered Methadone or an equivalent, to get me off a particularly nasty ssri.

    Some ssris are worse than heroin to get off, and I would have taken a methadone equivalent with enthusiasm and joy, but no offer of that came my way.

    Prescription meds, street meds, extremely similar, and I am looking forward to reading Peter Hitchen’s new book on Drugs. This man knows what he is talking aout. We are dealing with similar territory here.

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