Zantac Lawsuit

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

Tuesday, October 20, 2015

MHRA: "We Now Consider This Request Closed"

It took me a while to get to the bottom of this. The MHRA are, and have always been quite vague when it comes to answering the simplest of questions put to them. None more so then when I asked a series of questions regarding their Yellow Card Reporting System. (YCRS)

For those that don't know, the YCRS is a way of reporting adverse events from the drugs you take to the British drug regulator, the MHRA. What they do with these reports has, to me at least, always remained a mystery.

A recent series of emails between myself and the MHRA leaves me somewhat perplexed, particularly as their last one to me finished with, "we now consider this case closed".

Hmm, I don't. So, where does that leave us?

My issue with the YCRS is that, I believe, it is a system designed to fail, moreover, it does not do as it suggests, ie; "Helping to make medicines safer."

After much hulabaloo of answering questions I put to them, I finally got the answer I needed. My question being, Do the MHRA actually follow up any Yellow card report sent in by the original reporter, i.e.; do they,or have they, ever contacted the patient who sent in the original yellow card?

Their reply...

"The MHRA regularly follows up Yellow Card reports with the original reporter. If permission has been given on the Yellow Card, we will contact the reporter to request any further information that we think would be helpful to enable assessment of the case."


I followed up their reply with, what I thought, a simple question...

We seem to be getting somewhere.
The answer, however, is quite vague. Please define 'regularly' - give me some figures.
You may think I am publicly bashing the MHRA via my blog, in truth, I do when you respond with vagueness.
Can you give me actual figures, ie; how many yellow card reports have been followed up with the original reporter, you must keep a record of this, right?

Their answer left me bemused. Years ago it would have left me frustrated but I've come accustomed to such contradictory answers from the MHRA.

We do not record the number of follow-up requests that are sent out by the Agency as knowing this information does not help monitor the safety of medicines in the UK. Rather, it is the follow-up information received that is useful for assessment of a suspected Adverse Drug Reaction (ADR). This can either be in response to a request sent out by the MHRA, or follow-up information that has been spontaneously provided by the reporter.

They added the standard disclaimers and also, bizarrely, a request for money (minimum £600) if I wanted them to perform searches for "an actual figure for the total number of all Yellow Card follow-up requests that have been sent out."

Here's their full suggestion..

Therefore to provide you with an actual figure for the total number of all Yellow Card follow-up requests that have been sent out, we would be required to manually review the case folder for each individual Yellow Card report submitted to the agency.  Under the Freedom of Information (FOI) Act, a public body is only required to collate information that is already in a recorded form, rather than creating new information beyond basic collation. Furthermore, the agency has received over 600, 000 Yellow Card reports directly from healthcare professionals and members of the public to date, with approximately 16,500 Yellow Cards reported a year. The staff time and cost of extracting the requested information from this would far exceed the £600 limit for central government set by Section 12 of the FOI Act.

You can see my confusion. If they don't keep records of follow-up requests that are sent out then why are they asking for a minimum fee of £600 to search for records that, they have already said, don't actually exist?

Furthermore, how can they make the claim that "The MHRA regularly follows up Yellow Card reports with the original reporter", when they don't actually "record the number of follow-up requests that are sent out."

I'd like to ask them but at the foot of their final email to me they told me, "We now consider this request closed."

Ho hum.

To date, the Drug Analysis Prints on the MHRA website list the number of yellow cards submitted to them and also the nature of the events, they range from completed suicide to skin rashes. There has not, to my knowledge, been any statement from the MHRA that any prescription drug currently on the market in the UK has caused a patient to complete suicide.

This attitude, I believe, keeps poor, unsafe drugs in pharmacies and keeps the MHRA from coming under fire - remember, it is the MHRA who grant licenses to the medicines you and I take.

The MHRA recently went all 21st century on us by creating a phone app for the yellow card. I have to ask what is the point in sending in adverse reactions when they don't, and I assume, never will, blame the drug for the more severe adverse reactions, such as completed suicide, suicidal thoughts and/or self harm.

I have further requests pending that are not related to the above. I suspect, due to my asking questions to seek the truth, the MHRA will probably, sooner or later, consider those requests closed too.

Bob Fiddaman.

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