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Buck-passing: - The shifting of responsibility or blame to another.
Vague - Not clearly expressed; inexplicit.
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I used to liaise with the MHRA. There was a time when they sought my advice on the Yellow Card reporting system. I'm not the only person or organisation they sought help from.
I called it quits with the MHRA when they would not admit that Seroxat [Paxil] was a teratogen. I severed ties with them, save for the odd Freedom of Information request.
Regular readers will know of the recent SSRi Learning Module that the MHRA have apparently devised for healthcare practitioners. I criticized this module in three separate posts on this blog [Links at foot of this article]
What was irksome for me was the buck-passing that was apparent throughout the module. On the subject of severe SSRi withdrawal the MHRA are telling healthcare practitioners to recommend "specialists" to patients.
With this in mind I sent the following to the MHRA:
Can the MHRA provide me with a list of specialists experienced in SSRi withdrawal that are a; in the UK and b; available on the NHS.
The MHRA, as transparent as ever, have replied:
Dear Mr Fiddaman,
You ask for a list of specialists with experience of managing SSRI withdrawal.
The MHRA regulates the quality, safety and efficacy of medicines and medical devices, but it does not regulate health professionals. We do not, therefore, hold lists of individual health professionals of the type you seek.
Health professionals are registered to practice by their statutory regulatory bodies (such as the General Medical Council and the Nursing and Midwifery Council). Those who specialise are further accredited by their professional institutions (such as the Royal College of General Practitioners and the Royal College of Psychiatrists).
Turning to SSRI withdrawal, health professionals have recourse to summaries of product characteristics, which give information on SSRI withdrawal. Further, in July, the MHRA published information on selective serotonin reuptake inhibitors and serotonin and noradrenaline reuptake inhibitors (link below), which has a section on ‘SSRIs/SNRIs and the risk of withdrawal reactions’. It links to several documents on advice emerging from detailed review of evidence on SSRI withdrawal undertaken by the MHRA and its Expert Working Groups.
More recently, the MHRA’s learning module on the SSRIs briefly outlines points for health professionals to bear in mind about SSRI treatment. The learning module, developed for healthcare professionals, should be read in conjunction with other information such as treatment guidelines.
Withdrawal effects vary from person to person and call for individual management guided by advice in summaries of product characteristics and the background information we have published. If necessary, health professionals can request advice from local specialist mental health services.
Because I feel this should be out in the open, I am adding my response to the above on my blog. I feel the MHRA are once again shirking their responsibilities here and simply playing the game of 'pass the buck'.
My response:
Dear Whoever,
Firstly, I apologise for not naming you in person, there was no sig at the foot of the email you sent me. There was also no reference number to quote.
I am well aware of your SSRi Learning module and also aware that you are recommending doctors to advise patients, who are struggling severe withdrawal, to seek 'specialist' advice.
Couple of points.
You, as a regulator, do not have a list of these so-called specialists yet, without any qualms or vetting them, you are advising doctor's to use their services. Why?
If I were to ask my GP to consult the RCP and RCGP will they be able to give him a list of specialists in SSRI dependence and withdrawal that he can consult?
Do you not feel, as a regulator, that you should, at the very least, see what training these specialists have had in the field of SSRi withdrawal?
To be brutally honest, your SSRi Learning Module is, quite frankly, poor advice. You will be no doubt aware of my criticism of it on my blog?
You have, in the past, met with stakeholders with regard to antidepressants [SSRi's] - it appears you have ignored those meetings in favour of what the manufacturers of these drugs have to offer.
You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong? I would like a straight answer on this please.
As I understand, you promised to liaise with Professor Healy should any more concerns arise re SSRi withdrawal. To my knowledge you have not liaised with him since your 2010 meeting with him. Why?
There is no withdrawal protocol for SSRi's, you can't offer it neither can the manufacturers, it's left, in the main, to former patients who have struggled at the hands of SSRi withdrawal.
In essence, your recommendations to healthcare professionals via your SSRi Learning Module regarding these 'specialists' has been recommended without first researching these specialists. That's poor management on your part and once again you, the regulator, are putting the onus on healthcare professionals to make a decision.
Obviously my next question will fall under the Freedom of Information Act.
1. What input did you receive from the pharmaceutical industry for your SSRi Learning Module?
2. Please list any grants/funding you, may or may not have, received for your SSRi Learning Module.
To recap:
Non FOI questions:
1. You, as a regulator, do not have a list of these so-called specialists yet, without any qualms or vetting them, you are advising doctor's to use their services. Why?
2. If I were to ask my GP to consult the RCP and RCGP will they be able to give him a list of specialists in SSRI dependence and withdrawal that he can consult?
3. Do you not feel, as a regulator, that you should, at the very least, see what training these specialists have had in the field of SSRi withdrawal?
4. You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong?
5. As I understand, you promised to liaise with Professor Healy should any more concerns arise re SSRi withdrawal. To my knowledge you have not liaised with him since your 2010 meeting with him. Why?
The following two questions fall within the remit of the Freedom of Information Act.
1. What input did you receive from the pharmaceutical industry for your SSRi Learning Module?
2. Please list any grants/funding you, may or may not have, received for your SSRi Learning Module.
Bob Fiddaman.
PS: I'd appreciate a reference number for this continued correspondence.
The reason I am adamant to get to the bottom of this matter stems from the three critiques I wrote concerning the MHRA's SSRi Learning Module which can be read at the following links:
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
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