Reaction time is a factor, so please pay attention...

I was just wondering what the MHRA assessment process looked like. It wouldn't tell me, you see, so I had to do something to fill the gap in my knowledge. I came up with this:

MHRA: Are your drugs the best in the world, ever?

Worshipful Company: Oh, yes!

MHRA: Are they really safe, and efficacious, such that none may doubt your great wisdom and excellence?

Worshipful Company: Oh, yes!

MHRA: Well, I think that's all I need to know: the Marketing Authorization will be in the post, tonight.

Anyway, yesterday's "Here's an interesting little snippet" reminded me that I wrote to the Head of the MHRA's ill-named Intelligence and Enforcement Unit back in September (see Sept, 2007 archives). I re-sent the query, copied to Brown, Johnson, Vara and blind copied to a whole bunch of people:

Dear Mr Deats,

You may remember that I contacted you, back in September, of last year. I don't appear to have had a response from you, on this point:

"I am currently engaged in a discussion with Professors Woods and Breckenridge and the CPS (please see below) on a question over the application of Regulation 50 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended).

Would it be your position, as Head of the Intelligence and Enforcement Unit at the MHRA, that where trials have been carried out on a drug, and those trials have produced negative results, and that there are also trials of that same drug that have yielded results that are interpreted as positive, and it is subsequently only the positive results that are submitted in support of a marketing authorization application, that the presentation of only the positive data (owing to the suppression of the negative data) amounts to the provision of "false or misleading" information, under Regulation 50?"

Far be it from me to question the quality of the MHRA's response time to any but the most trivial of queries, but I think five months is probably enough thinking time. Would the scenario that I've drawn up for you qualify as a breach of Regulation 50? This is an example of one of those embarassing little questions that the MHRA is so piss poor at answering. However, the cumulative effect of all these unanswered questions is quite telling - they give me some idea of the areas where the MHRA does not wish to commit itself, and one may only speculate on why that would be...

Best regards


Matthew Holford