PLACEBO (PAROXETINE) SUICIDES

E-mail correspondence between Social Audit and the MHRA

13 June 2006 – By email

Dear Ms Wark, 

Thank you for your letter of 9 June, re FOI 06-181, your belated reply to my letter to you of 26 April.

You now tell me that the MHRA became aware in January 2004 that Patient 627.605.01012 was treated, shortly before his death by suicide, with clotiapine, oxazepam and fluoxetine. Yet on 13 February 2006, Dr Julie Williams wrote: "From the case narratives reviewed it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died."

You offered no explanation for this in your letter of 9 June, and I’m afraid I can only infer that the MHRA knowingly lied. However, I may have missed some nuance of this apparent deceipt. If so, I am sure you would want to put me right, as a matter of urgency.

If I don’t hear from you in the next day or two, I shall conclude the worst. I am that sick of the MHRA’s modus operandi that I’m copying this note also to Mr Goldfinch and to Professors Woods, Ashby and Gunnell.

Sincerely,
Charles Medawar

 

13 June 2006 – By email

Dear Mr Medawar

Thank you for your e-mail. I can assure you that there was no attempt to deceive.

The case narrative is not specific about the timelines of treatment relative to the death. Our reading of the narrative is that the patient was treated with clotiapine, oxazepam and fluoxetine for an event which occurred one month before the death. There is no indication in the narrative that these medicines were continued to around the time of death; and similarly no indication that they were stopped prior to the death. Our response of 13 February could have highlighted this uncertainty and I apologise for any confusion caused.

Yours sincerely
Sarah Wark
Group Manager, Pharmacovigilance Risk Management
Vigilance Risk Management of Medicines
Medicines and Healthcare products Regulatory Agency
Tel: 02070842763

 

13 June 2006 – By email

Dear Ms Wark,

Thank you for replying so promptly to my mail but I am in no way reassured that "there was no attempt to deceive". If I wasn’t actually lied to, I might just as well have been: no matter that it was done by omission and leaves everyone feeling they are in the clear.

The Agency clearly bent over backwards to avoid the admission that that Patient 627.605.01012 was treated, shortly before his death by suicide, with antidepressant and other drugs. In my 17 February FOI request to Dr Julie Williams, I specifically asked: "does the MHRA stand by its affirmation that the patient was prescribed [a] no antidepressant drug (notwithstanding an impending ECT)? [b] no benzodiazepine? and [c] no antipsychotic medication? You failed to answer that question when its significance would or should have been perfectly clear to you, and now have the gall to offer some winsome apology. Moreover, the Agency’s reading of the case narrative appears thoroughly sloppy: because there was no indication otherwise, you simply take for granted that this patient was not taking those drugs shortly before his death – and, without further checking the facts, decide that this should be counted as a placebo suicide.

This whole episode leaves me feeling that the MHRA is absolutely not to be trusted and that something of a culture of mendacity seems to prevail. Please add this to the complaint this correspondence has already generated.

Sincerely,
Charles Medawar

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