Wednesday, 19 March 2008

Fluoxetine - Part II

God, I'm bored. The MHRA's mail is in bold, as usual:

Dear Sir or Madam,

I have had the opportunity to scan the excellent and informative documents that you linked. I am particularly interested in the second of these:

Making Regulatory Decisions about Medicines and Medical Devices

and most particularly Section C., paras 1/2:

1 Does the product work and offer useful clinical benefit if used in its specified way? [my emphasis - was this rider included by a scientist, or a lawyer?]

Is there robust evidence that the product will do what the company says it will do?

2 What impact will the product have, or is it having, on both the quality and length of life in those patients who are treated with it or on whose behalf it is used?

Are you able to expand, at all? I think that these questions, in combination, essentially ask the same question that I put to you, initially - ie, "what is the benefit of fluoxetine?". So, perhaps you could detail what "robust" evidence amounts to, and what evidence would be sufficiently robust, such that it demonstrates that which is claimed of a drug? I am particularly interested, in this context, on the question of "quality of life," alluded to in para 2 - presumably the "impact" spoken of is intended to refer to a positive/beneficial impact? In which case, what "robust" evidence would demonstrate the same beneficial impact claimed of a given drug by the manufacturer?

Please feel free to use fluoxetine as a case study, when answering these questions - I imagine that this would assist my understanding.

Best regards

Matthew Hoford

Subject: FW: FOI 08/064 - FW: Fluoxetine
Date: Wed, 19 Mar 2008 12:06:56 +0000
To: [redacted]

Dear Mr Holford,

Thank you for your recent enquiry to the MHRA.

Please find attached a response to your enquiry.

Please contact us again if you need further assistance with this, or any other queries.

Kind Regards,

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

Thank you for your e-mail dated 18 February, 2008, concerning fluoxetine. In particular, you wish to conduct you own risk:benefit analysis using the MHRA’s methodology. You will not be surprised to know that the risk:benefit analysis does not consist of a magic formula. We do however outline our approach to weighing up risks and benefits for medicines in a document on our website called "Medicines and Medical Devices Regulation: What you need to know, particularly in the box entitled "When is a product acceptably safe?" on page 2). There is further detail in another document on our website titled "Making Regulatory Decisions about Medicines and Medical Devices"

These documents should give you some insight into the way we make decisions and the factors and considerations that go into the risk:benefit analysis.

You have also asked us to explain the benefit of fluoxetine, this information can be obtained from the Summary of the Product Characteristics for fluoxetine which you can access through the Electronic Medicines Compendium (

I hope the above information is helpful and answers your query.


Stephany said...

"You will not be surprised to know that the risk:benefit analysis does not consist of a magic formula."

Well hell, really?!

The magic formula appears to be all in their minds for robust and benefit outweighs the risk crap.

Radagast said...

LOL. You know, every time I have a conversation with these guys, I feel I need to define each and every word, beforehand. I'm willing to bet that "robust" doesn't mean to me what it means to the MHRA!