MHRA Wishing To Call The Shots

MHRA: "Unless you have enquiries on an entirely different subject, we will not be able to respond to further comments from you."

I've received a reply from someone at the MHRA, once again they failed to add their name to it, preferring to write anonymously or as a ghost spokesperson [how brave]

For those that don't know I wrote to the MHRA regarding their recent recommendations to healthcare professionals in the UK. Their [ahem] innovative SSRi Learning Module tackles, amongst other things, severe SSRi withdrawal and the MHRA recommend to doctor's to seek the advice of "specialists".

In previous correspondence with them I asked just who these "specialists" were. They couldn't answer.

Well, they've made it abundantly clear to me now with their final say on the matter. Make note of the final line of their response.

Dear Mr Fiddaman,

We are responding to your email of 15 December.

Below, we provide responses to your further questions. They should be read alongside our replies of 7 December and 15 December to your enquiries.

1. For the record, just so we are clear, are the MHRA suggesting that severe SSRi withdrawal can now be defined as an illness?

Our introductory remarks make no reference to ‘SSRi withdrawal’. We are simply saying that, when necessary, non-specialist health professionals are able to access appropriate specialist services for diverse range of clinical circumstances.

Summaries of product characteristics list effects that may follow SSRI discontinuation under ‘Undesirable effects’.

2. Do you have instances where a health care professional has sought the advice or requested for an SSRi withdrawal specialist?

It is not in the MHRA’s remit to monitor the practice of health professionals. Details about an individual’s care are confidential between the individual and the health professional.

3. Have the MHRA liaised with health professional regulators to determine whether or not 'specialists' have the required qualifications in treating patients with severe SSRi withdrawal?

The MHRA regulates medicines and healthcare products and provides information on these. It is not for the MHRA to set standards for health professionals’ knowledge and expertise or to monitor them.

4. If I were to randomly select 10 healthcare practitioners and ask them if they could refer an SSRi withdrawal specialist to me and, for one reason or another, they could not provide me with any such specialist, would the MHRA then concede that there are, in fact, no SSRi withdrawal specialists with adequate training that can provide help for patients suffering severe SSRi withdrawal?

This point has been dealt with in our response of 15 December. The organisation of health care delivery does not fall under the MHRA’s responsibilities. Details about how health care services (including some specialist services) are organised and how individuals can access them are described by NHS Choices at http://www.nhs.uk/NHSEngland/AboutNHSservices/Pages/NHSServices.aspx

5. [No specific question asked]

We have responded elsewhere to these comments.

6. Professor David Healy has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Do the MHRA agree with professor Healy's findings?

We do acknowledge that there are some individuals who find it extremely difficult to discontinue treatment with SSRIs and for some it may take many years to stop treatment. We also know that it is not possible to predict those who may be at particular risk of experiencing withdrawal reactions on stopping treatment. However, we have not seen evidence to suggest that a significant number of people will never be able to stop taking SSRIs.

7. You state that the SSRi Learning module was “constructed by MHRA staff and drew on information and evidence in the public domain.”. Please list all references/evidences used.

The introduction to the learning module states:

This learning module is derived largely from summaries of product characteristics (which, in turn, are based on rigorous evaluation of submitted evidence). Supplementary sources such as guidelines from NICE are used to expand on advice on managing specific risks of SSRIs; however, general advice on the management of depression and other disorders is not covered.

The learning module lists key resources under ‘Further information’; these, together with references cited by them, were among the sources we used.

We have responded to your recent emails by providing all the information that falls within the scope of our work. A great deal of information is also available on our website. The answers to some of your questions clearly fall outside this Agency’s role and are not appropriate for us to tackle.

Unless you have enquiries on an entirely different subject, we will not be able to respond to further comments from you.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

My response to this:

How novel. Not content with the word 'vexatious' any more?

So, to recap, the MHRA will not answer any more questions relating to this query because my line of questioning is 'not appropriate for them to answer'. Do you only answer questions that you feel comfortable with?

Let's look at the facts.

The MHRA have conjured up SSRi withdrawal specialists. They remain confident that healthcare professionals can call upon the services of these specialists when faced with a patient who is suffering severe SSRi withdrawal.

When the MHRA have been asked to provide a list of specialists [that they have recommended] they cannot provide any such list.

The MHRA have, at least, acknowledged that there are some patients who may 'take many years to stop treatment'. They do not tell us why or offer any solutions other than recommendations to 'specialists' whom don't exist.

To cap it all, the MHRA are now refusing to answer any more questions on this matter. In truth, they cannot answer the questions because they don't have any answers. Any effort to answer would be an admittance of a failure to protect the public.

I put it to the MHRA that your SSRi Learning Module is deeply flawed and that you have made a huge error in recommending specialists that both you and I know do not exist. You are either buck-passing or lying.

If the MHRA lay claim to SSRi withdrawal specialists being available on the NHS then any queries regarding this claim should be answered with proof. At no time have the MHRA provided me with any proof that any such specialist exists.

My recommendation to the MHRA would be for a recall of the SSRi Learning Module and for them to list specialists for doctors to use. Also to explain to doctors that there are some patients who may take many years to stop taking their medication and to explain the reasons behind this.

It's absurd that an alternative is mentioned...yet not mentioned.

If I were to have a conversation with a food critique who was displeased at food offered to him at 'Restaurant A' and I told this critique that there was much better food elsewhere, he would naturally ask where.

If I stood there with a blank expression on my face and told him, "Um, I don't actually know", he would probably laugh in my face or serve my testicles on a platter with a rich red wine and a nice camembert. He certainly wouldn't see me as an expert on the matter of food.

The MHRA should not be making any recommendations to healthcare practitioners regarding SSRi withdrawal, it takes an expert to do that. Maybe the MHRA should have liaised with the ghost specialists they have recommended for healthcare practitioners to use - in truth, they did not because these specialists simply don't exist. To suggest that they do is akin to burying one's head in the sand and hoping the SSRi withdrawal problem will go away. It won't.

To put it mildly, when the MHRA are criticised they either call their critique 'vexatious' or just refuse to answer any more questions. They are the past masters of deflection and will sit around waiting for a solution to fall onto their laps. If they acknowledge that there are some patients who may take many years to stop taking an SSRi then they should, at the very least, contact the pharmaceutical industry who manufacture these drugs and ask them; a; why it takes so long for this group of people and b; how this group of people can be helped. They don't, they just sit around thumb twiddling and deflecting questions put to them by people who actually know the truth about SSRi withdrawal.

I've gone on record before stating that the MHRA are limp-wristed, that was a few years ago. My recent correspondence with you suggests to me that you continue to be limp-wristed and you continue to ignore the banner you fly under, "MHRA - safeguarding public health."

You are solely responsible for the advice you have handed out to healthcare practitioners re SSRi withdrawal. Your invention of SSRi withdrawal specialists is a matter of great concern to me and one that needs further investigation. I, for one, will seek further advice on how to extract the information I need, be it through government officials [highly unlikely] or the court of human rights.

Your arrogance is staggering and your knowledge on SSRi withdrawal is woefully inept.

Bob Fiddaman


Related articles:

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA In Buck-Passing Specialist Cahoots

MHRA - More on the Mysterious "Ghost Specialists"

Fid


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