Matthew Holford has been at it again (does the man ever stop?)… see below for his latest note to those MHRA stalwarts Stephen Fawbert, Jan MacDonald and Sarah Walk:
Dear Stephen, Jan and Sarah,
Further to my recent enquiries, concerning PILs and the EWG Report, are you able to add in one further item, please? That is, are you able to confirm the date upon which the risk of suicide was first acknowledged/approved by GSK/MHRA on the Seroxat PIL?
I am interested in this point, because I note from Stephen’s previous replies that a UK exercise in 2000 identified the issue, and that GPs were advised accordingly, shortly thereafter. However, GSK, in the person of Dr Alistair Benbow, an officer of the Company, was publicly arguing the absence of any risk, at least as recently as 2003. If my anticipation is correct, I would be interested to hear of the MHRA’s position on this peddling of misinformation, whether it be innocent, or not.
As a general point, what would be the MHRA’s position on the status of an officer of a company, who deliberately misled the public, as to the nature of a serious adverse event of one of its drugs? Does it, for example, possess any sanctions, which might be applied, or would this be left as a matter for the company concerned? To what extent does the MHRA imagine that the solutions it has at its disposal are adequate to deal with such a scenario (ie, would it be able to prevent such a thing happening again, if only with respect to the company/officer concerned)?
Yet more questions that we need answers to. Watch this space.