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Author of The evidence, however, is clear, the Seroxat scandal
Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Thursday, October 20, 2016

British Drug Regulator (MHRA) Dodging the Curve Ball






throw (sb) a curve (ball)

to surprise someone with something that is difficult or unpleasant to deal with.

Many of you will know by now that the MHRA and I have this love/hate relationship.

The MHRA, for those of you who don't know, are the equivalent of the FDA in the US, Health Canada in, um, Canada, and the TGA in Australia. Their duty is protect the public from unsafe prescription drugs, both licenced ones and ones that are illegally sold, they seem to focus heavily on fake pharmaceutical drugs more than regulate the drugs they have already granted a license to.

So, I've been at loggerheads with the MHRA regarding the whole 'benefit vs risk' ratio that they lay claim to when granting a drug a licence here in the UK.

Many people focus on the risks of these drugs, in fact my own focus used to be on the risks but after stepping out of the bubble and looking in from the outside I saw something that has been staring many of us in the face, yet we've been blind-sided and focused on the risks. We all know what the risks are because these days we are told via the patient information leaflets, albeit in watered down versions.

An old advocate friend of mine, Matthew Holford, was, to my knowledge, the first person to raise the issue regarding the "benefits" of these drugs, namely; SSRI's.

I miss Matt's rantings - he was colorful in the language he used and yet had intelligence that he could use tactically. We still correspond - the guy is a legend.

Anyway, back to the MHRA.

I have asked them a simple question that they have, on numerous occasion, failed to answer. Their latest 'answer' is no different. In fact, it would appear that they are now questioning the English Oxford Dictionary. (I've highlighted in yellow). It would also appear that whoever is answering my emails (they never leave a name) has some form of Avoidant Personality Disorder.

First off, here's the question that they seem to be struggling with...

Please provide me with a "detailed list" that shows the benefits of taking Prozac.
Their previous response to this can be seen here. I questioned that response and they have now replied. Once again, no detailed list of any benefits of Prozac has been sent to me. Once again, they have put "Final response" in the subject line.

Dear Mr Fiddaman

Many thanks for your email concerning our response to your FOI request.

Concerning Question 2, a detailed list of the benefits of taking fluoxetine are presented in the Patient Information Leaflet and the Summary of Product Characteristics for products that contain this active. As we stated in our response, the beneficial effects of the product you specifically mentioned in Question 2 (Fluoxetine 20mg Capsules – PL 17907/0374) have been shown through the clinical data submitted for the grant of the marketing authorisation for Prozac 20mg Capsules (PL 00006/0195). The current list of indications or “benefits” of taking Fluoxetine 20mg Capsules are listed in Section 4.1 of the SmPC, a link to which has been provided below:

http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1474003257568.pdf

Best regards

The FOI Licensing Team.
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So, once again, I have had to reply to them. Here's my response.

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Dear MHRA,
I'm somewhat confused?
Are you now suggesting that 'indications' and 'benefits' have the same meaning?  I don't really want to enter into a game of semantics, but when I use the word "benefit," in this context, I want to understand how Prozac is going to help me, as the patient, overcome my depression. In other words, what positive thing is going to happen to me, which causes my depression to be alleviated, or else go away altogether?  It is not a clinical benefit to me to know that Prozac may be prescribed for depression - in fact, that information is not a benefit to anybody apart from doctors and drug companies, as far as I can establish.  Do you understand the distinction, between my definition of "benefit," and yours?
I'll cut to the chase, if I may?
I have asked you, the British drug regulator, to provide me a list of benefits, not indications.
Thus far you have sent me links that have not answered my question. In any event, I am asking specifically for a list of benefits from the MHRA and not anyone else.
You licenced a drug and cited that the benefits outweighed the risks. The risks are, as you say, clearly marked in the patient information leaflet that the drug companies provide. I have no interest in what the drug companies say, nor of the risks associated with Prozac. My question was, and still is, to you, the MHRA.
You made the decision to grant Prozac a licence after weighing up the 'benefits and risks', ergo you should be able to provide me with a detailed list of the benefits based upon which you granted Prozac a licence.
Is this going to be a series of emails between us whereby you continue to avoid the question at hand, is this how you treat all stakeholders?
PS - Once again, the subject line from you indicates that this is your 'final response'. Once again, I will decide when my question has been answered adequately, not the other way around.

Bob Fiddaman
Author/Blogger/Researcher

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I'll let you know when they next send me a reply avoiding the question.


Bob Fiddaman.




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