Glaxo refuse to co-operate with the MHRA once again – read the letter

At the end of the recent 4 year long investigation into Glaxo by the MHRA (the probe began after disclosure that Glaxo withheld 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 read:

“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.”

This was the MHRA beating its breast in a very public manner.

Unfortunately it seems that Glaxo’s reply has not been treated in the same way. The MHRA actually had a reply dated 18 March and a pdf file is hidden away on the MHRA website. Perhaps the MHRA’s embarrassed silence over Glaxo’s reply can be explained by the very final paragraph of the two page letter:

“Finally, it is our strong wish to be as transparent as possible in disclosing information around this investigation. However, from GSK’s standpoint there are legitimate concerns which would need to be addressed prior to any disclosure. These include, for example, the identification of individual employees, independent clinicians and patients, as well as the need to preserve commercial confidentiality of certain information. On this basis, we would be happy to consider requests for information, under the Freedom of Information Act, on a case by case basis in relation to specific documents or categories of documents.”

There you have it. GSK will consider FOI requests (which will have to sent to the MHRA as the FOI Act does not cover GSK) to release “specific documents or categories of documents”.

The only problem is that I can’t ask for“specific documents or categories of documents” as the MHRA can’t release any information into the public domain without GSK’s consent. Oh and another thing – approximately 1,000,000 pages of documentation were reviewed by the MHRA in its investigation.

So – I’m looking for a needle in a haystack, but I’m not allowed to know which haystack it’s in or even if it’s in a haystack – or even if it’s a needle I’m looking for.

GSK is in no way being “as transparent as possible” in this matter – their reply to the MHRA is a de facto refusal to release any of the information the MHRA has reviewed.

For more on this subject please look here and here.

To read the full MHRA report on the investigation read here.


3 Responses to “Glaxo refuse to co-operate with the MHRA once again – read the letter”

  1. truthman30 Says:

    This is ridiculous..

    The MHRA must be terribly embarassed by the Glaxo response as what this letter clearly shows is the subordinate role the MHRA have as regulator to the Big pharmaceutical companies such as GSK. Would a smaller pharma company like Shire get away with insulting the regulator in such a way? Would a pharmaceutical company with less power, less sphere of influence and less financial muscle get away with such condecending tone and behaviour?

    I doubt it.

    I have said all along that the MHRA is big pharmas lapdog and nothing but a smokescreen between pharma and the consumer and these letters from woods to Garnier, and Krall to Woods prove just that. Clearly the MHRA has no power to prosceute or even call witnesses in an investigation which stems from Glaxo witholding negative data. The result of which meant children were harmed(some killed) by the defective, dangerous and highly toxic Seroxat. Seroxat affects Adults in the same way, and it should hav been banned across all age groups years ago. Yet, the reugulator can’t even pull the drug because they haven’t got the powers. The power is completely in the hands of the pharmaceutical companies, who can sometimes literally “get away with murder”.

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