Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Tuesday, September 29, 2015

MHRA: Follow-Up Rate at a Price

I've been at loggerheads with the British drug regulator, the MHRA, for many years. I saw a window of opportunity a few years ago when I was (finally) given the chance to sit with their (then) CEO, Kent Woods, to discuss the struggles patients were having when trying to withdraw from SSRi- type medications. (Notes on that meeting can be viewed here) Any such meetings with them these days would be kinda frowned upon by me - their current CEO being the former World Safety Officer for GlaxoSmithKline - Safety and GlaxoSmithKline, two words, combined, that just don't sit right with me. I don't wish to sit at the same table as him or anyone connected with GSK for that matter, well, not unless they have some sort of apology to offer me. (See here)

Some months after my meeting with Kent Woods I finally gave up communicating with the MHRA. The final correspondence between myself and Kent Woods is detailed in my book, The evidence, however, is clear: the Seroxat scandal. (US - UK) - In a nutshell, the MHRA did not agree with a US Court's findings that Seroxat, known as Paxil in the US, is a tearatogen (an agent or factor that causes malformation of an embryo.)

From time to time I still send in Freedom of Information requests to the MHRA, it's all very formal, no name-calling or accusations that they are limp-wristed and incompetent.

A recent request sent in to them has been going back-and-forth - apparently my wording confused them in an original request of mine so I had to wait almost two months for their reply.

My question was, I thought, pretty straight forward but I amended it for their ease.

Please provide total number of yellow cards and total number of full investigations into the alleged adverse reaction for the following years... 2011 to date (where full investigation = how many of the affected persons, or the affected persons health care professionals, did the MHRA contact to see what happened to them or to discuss with them the adverse drug reaction)

Basically, I want to see if the MHRA ever contact any person who sends in a report of an adverse reaction, after all, the patient is the one suffering here.

It's worthy to note also that the MHRA list the number of reports sent in by patients, healthcare professionals on their website. They will list, for example, the number of reported fatalities sent in via their yellow card reporting system but, and here's the crunch, they don't provide information as to whether their team of investigators have actually discussed the adverse reaction with the patient or doctor. They also claim that just because xxx fatalities have been reported with drugs x,y and z, it does not necessarily mean that drugs x,y and z caused the deaths. How, then, can they know for sure that, for example, a suicide has been caused by a drug? Leaving the public, and doctors, second guessing just adds to the woeful way the Yellow Card Reporting System is run.

Anyway, here is their reply - looks like I need to pay money up front - £600 (minimum)

So, let's just get this straight. Me (a patient) is asking for information that, I feel, is important - in as much that I wish to try and find out if the MHRA investigative team actually respond to patients or doctors on a personal level. An example here would be a yellow-card report sent in by the family of a suicide victim, or indeed the victim's doctor - I just want to know if the MHRA would, during their investigation, contact the family to ask questions about their loved one taking his/her life and if this victim displayed suicidal thinking before he/she had taken the drug.

It seems the MHRA are avoiding the question and putting other excuses in place. (Just an opinion of mine so no need to label me vexatious)

  • It is important to note that each report is different and not every report requires follow up. 
  • Some reporters request they do not wish to be contacted again by the MHRA 
  • The MHRA determine which cases should be followed up, on a case by case basis. 

I understand that my request would take up many man hours so I sent back the following to them. It's short and sweet and yet, my lack of confidence in the MHRA tells me that they may further stonewall me with their next reply.

Dear MHRA,
I'm somewhat bemused by your answer but, I guess, I will have to take it on trust that you are not trying to pull the wool over my eyes.
Simple question as a follow-up to your reply...
Do the MHRA actually follow up any Yellow Card Report sent in by the original reporter, ie; do they,or have they, ever contacted the patient who sent in the original yellow card?

This simple question, one would think, could be answered in the blink of an eye. However, it appears that I may now have to wait a further 21 working days for a reply that I suspect will be decorated with bricks and mortar.

I hope they prove me wrong.

That will be a first!

It's simple. How many reports have the MHRA followed up by speaking with the original reporter?

I'd draw a picture for them but art was never really my thing, I draw horses that resemble hedgehogs and even my stick-men have deformities.

If the answer to the question embarrasses the MHRA, ie they don't ever follow-up with the original reporter, then why don't they just say so instead of, seemingly, putting up these stonewalls?

Bob Fiddaman

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