Aubrey Blumsohn is currently running a jolly little tale, which should comfort all those who are concerned that the UK is just as corrupt as everywhere else, but is better at hiding/ignoring it:
Why there is no scientific fraud in Britain
It's official: we don't do corruption. OK? And no amount of subtle (and not-so-subtle) inuendo on my part is going to change that. Do you understand?
Dear Sir or Madam,
Many thanks. Must just be in the US, then.
As it happens, I am aware of the legal requirement. I am also aware that there are allegations of suppressing this type of data. I am aware that companies have used euphemistic language to disguise severe side effects (witness "emotional liability" for "suicidality"), and that there are allegations that the same side effect has been reported under several different head, in order to disguise the incidence of that side effect. And I am aware that the MHRA does not routinely require companies to submit original data, with marketing authorization applications. Nor does it require companies to submit any kind of data, either original or statistical analysis, when a trial fails (at least, that's what the MHRA told me).
How would the MHRA know that a company was, or was not, suppressing side effect data, in the circumstances? In short, there is a problem here. That the MHRA chooses not to acknowledge it, for whatever reasons that it may have, is neither here, nor there.
Subject: FW: FOI 07/292 - FW: Eli Lilly; Janssen Pharmaceutica; and Astra Zeneca
Date: Fri, 26 Oct 2007 13:01:51 +0100
Dear Mr Holford
Re: Marketing Irregularities Our Ref: FOI 07/292
Thank you for your enquiry to the Medicines and Healthcare products Regulatory Agency (MHRA).
1. There are no current investigations at the MHRA as described in your email.
2. The legal requirement to report suspected side effects is in the following legislation:
European legislation: EC Directive 2001/83 Title IX Article 104 requirements for reporting suspected adverse reactions. Article 103 requires a marketing authorisation holder (MAH) to have the services of a qualified person responsible for pharmacovigilance
UK legislation: SI 1994 No.3144 Section 7 is the relevant one which requires a MAH to comply with the EU legislation and Schedule 3 to this SI provides the offences and penalties.
Central Enquiry Point
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
From: Matthew Holford [mailto:firstname.lastname@example.org]
Sent: 02 October 2007 01:56
To: MHRA Information Centre
Cc: email@example.com; Shailesh Vara
Subject: Eli Lilly; Janssen Pharmaceutica; and Astra Zeneca
Dear Sir or Madam,
Are the abovecaptioned companies being investigated in the UK for marketing irregularities, with respect to their drugs Zyprexa, Risperdal and Seroquel? That is to say, are they being investigated for intentially hiding side effects and downplaying the efficacy of alternatives? Does the MHRA regard such activities as unlawful?