Who is running pharmacovigilance?

Ebeneezer could add up.

In our last Dickensian post, we remarked that the MHRA was failing to respond to detailed questions about the possible important harms of Covid-19 vaccines. MHRA was pleading poverty of resources just like Dickens’s Ebenezer Scrooge. Remember, the focus is the worst possible outcome - deaths.

MHRA does not have a sterling record of responding to FOIs. Between 2008 and 2017, a low proportion of requests (41%) were successful. In comparison, the then most recently available data from the USA Food and Drug Administration in 2015 showed that of 10,611 FOI requests processed, 8130 (77%) were fully disclosed.

Here is a synopsis of the MHRA reasons for the refusal; it seems that Bob was on his own even then. Being Ebenezer Scrooge’s one and only employee, Bob Crutchit, sits in a cold and dirty room bent over his ledgers, overworked and underpaid in A Christmas Carol.

We wrote, “Given the plot theories swirling around possible Covid vaccine harms can anyone think of a higher priority? We are the combined holders of four doses, and we would like to know that Bob is joined by other employees, and his ledger is, in fact, a database”. 

Have some understanding, please. MHRA is 20 per cent down on its workforce; you can not create skills in pharmacovigilance overnight. Apparently, they have been swamped with 470,000 notifications of possible harm from Covid-19 vaccines. The MHRA responded as follows to a question by a member of the public:

 They also have to contend with the nuisance of responding to Freedom of Information requests. They have to manually inspect and pull out each report of - let’s take the hard stuff: deaths - from Bob Cructhit’s ledger, fiddle with it, integrate it with other knowledge from different sources and then discuss it in committee. Perhaps they might even get their hands on the odd post-mortem report. Who knows? So let’s cut them some slack, shall we?

However, to keep us safe, which is their remit, the MHRA should prioritise the outcome that proffers the most harm - death. The only outcome you can not argue about.   

The MHRA answered it would take 5,875 hours to open each Yellow Card. This gets them an immediate opt-out because section 12 of the FOI states costs cannot exceed £600, and if they do, then it's refusal time. 

While this may have been acceptable in the days of paper and the post, it is unacceptable given the system requires an electronic entry. The days of paper, post and Charles Dickens are over. With over 10,000 data analysts in the NHS, you'd think one of them could help build an electronically searchable database with a few drop-downs to overcome the need for manual checks.

“Bah,” said Scrooge, “Humbug.” Humbug it is, indeed.