JP Garnier – “Glaxo has nothing to hide” …prove it then JP

Here is the letter from the Kent Woods at the MHRA to JP Garnier:

Dear Dr Garnier

I am writing to advise you that the Medicines and Healthcare products Regulatory Agency is today announcing the conclusion and outcome of its investigation into a number of allegations regarding GSK, in particular that the company withheld from the MHRA important clinical trial data relating to the safety and efficacy of Seroxat in children and adolescents, and promoted that product for use in this age group despite safety and efficacy concerns.

In immediate practical terms, the outcome of the investigation is that, having considered our investigation report, government lawyers have decided not to pursue a prosecution of GSK. Their view is that the law at the time these events took place did not require a pharmaceutical company to inform the regulator of clinical trials date in groups for whom the medicine was not licensed, and that there is insufficient evidence of GSK promoting the product for “off-label” use in under 18s. We will today be issuing a press release to confirm that, and will be publishing on our website a short report setting out the conduct and conclusions of the investigation. I am attaching both the press release and the report for your records.

This is the immediate practical outcome but there are a number of other issues arising from the process. There is obviously a need to tighten the law to make it absolutely clear that pharmaceutical companies have a legal responsibility to inform the regulator of any information that changes the benefit risk profile of their products, regardless of whether the information relates to a licensed indication. We will be using the current European Commission consultation on pharmacovigilance regulations and other opportunities to press for changes to the law in this area.

Such a course of action should be unnecessary in an industry which relies so heavily on public trust and aspires to high ethical standards. I would have thought it self-evident that such information should be made available promptly to the regulator in order that action can be taken to protect public health. However, that moral responsibility now needs to be insisted up by the unambiguous force of law.

You will be aware that we have reviewed a large quantity of documents from GSK. Legal provisions prevent us from releasing publicly any information gained under our statutory powers in the course of a criminal investigation. However, there has been a significant level of quite legitimate public interest in this case, and I would there like to release that information into the public domain. This of course requires your consent. GSK has regularly asserted that it has nothing to hide in this matter and so I should be grateful if you could confirm in writing your consent to the release.

Finally, I have no doubt that the content of this letter will be the subject of numerous Freedom of Information requests to the Agency in the coming weeks. The MHRA takes the view that any considerations of confidentiality are outweighed by the public interest in disclosure, and we will therefore be publishing this letter today alongside our investigation report.

If you have any queries about the contents of this letter, please do not hesitate to contact me.

I think it’ll be interesting to see how much information is released “into the the public domain.” 

It’s completely up to you Garnier – give your consent and prove to the world you really have nothing to hide. 

9 Responses to “JP Garnier – “Glaxo has nothing to hide” …prove it then JP”

  1. BOB FIDDAMAN Says:

    I bet my left nut that this letter was drafted by Woods after a lengthy conversation with Garnier.

    JP me old mucka, I’m gonna have to write a letter to you and make it publically available – just to show the public that it has been done.

    It took the MHRA four years to investigate what has been in the public domain for over 10 years prior to their investigation.

    They knew there would be no criminal charges – they must have known the law when they started the investigation. In truth, they didn’t have the balls to tell the public because public outcry would have called for the investigation to be carried out by an impartial investigator – they didn’t want that. They let GSK off the hook because they wanted to… nothing more, nothing less!

  2. truthman30 Says:

    GSK pays their wages through drug licenses …
    They wouldn’t want to upset their biggest client now would they..?

  3. Matthew Holford Says:

    Woods wrote:
    “…Such a course of action should be unnecessary in an industry which relies so heavily on public trust…”

    I think this is quite funny, because there is absolutely no trust vested in the industry by the British public, as far as I can see, and the industry has done nothing to restore the trust that has been lost in the making of this decision. What the industry relies upon is ignorance: if one accepts that the EWG report demonstrates that the drugs are reasonably safe, etc, etc, then one is the kind of public that the MHRA wants. If one questions any of that guff, then one’s view will be ignored as irrelevant twaddle.

    Where is the need for trust, amidst that arrangement?

    Matt

  4. Lynn Says:

    Can people do a class-action lawsuit against the MHRA, gross negligence, something?

  5. truthman Says:

    I would say people could do that Lynn..
    And a prosecution of Glaxo would have brought more curious eyes on the conduct of the MHRA. Its code of secrecy would have been exposed..

  6. Lynn Says:

    Cool.

  7. 3 questions for JP Garnier… who, after all “has nothing to hide” « seroxat secrets… Says:

    […] JP Garnier – “Glaxo has nothing to hide” …prove it then JP […]

  8. Glaxo refuse to co-operate with the MHRA once again « seroxat secrets… Says:

    […] data from Seroxat clinical trials), Kent Woods (CEO of the UK’s medicines regulator the MHRA) wrote to JP Garnier at GlaxoS mithKline – a small section of the letter […]


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