Saturday, 27 October 2007

Re: Eli Lilley, Janssen Pharmaceutica and AstraZeneca

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.

Best regards

Matthew Holford

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.

Yours sincerely

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000

From: Matthew Holford []
Sent: 02 October 2007 01:56
To: MHRA Information Centre
Cc:; 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?

Best regards

Matthew Holford


Brad Abbey said...

As a person involved in drug safety, I can tell you that the MHRA is unbelievably vigilant and concerned about the health of the public. They have the right to enter any marketing authorisation holders office (which they do in the form of inspections) and turn the place over. They are very effective, and I believe it would be very difficult in the UK to try to hide safety information

Radagast said...

Dear brad abbey,

You're right, of course: I don't believe it. I agree that it has many powers at its disposal. That is not at issue, as you may have realized.

There are gaping holes in its procedures, which it was kind enough to tell me about. The MHRA doesn't have to use inspections; it has a system of assessment, which ought to be capable of being near watertight. But it isn't.

In any event, it would be interesting to hear how you are involved in drug safety, and in what capacity? With the MHRA? Perhaps you could fill me in on some of the details that it declined to provide?