MHRA - Cash for Questions

Latest correspondence with Stephen Fawbert of the MHRA

Dear Mr Fiddaman

Thank you for your Freedom of Information request of 8 April. As this is for my division it has been passed to me for reply.

Thank you for your interest in patient reporting of the Yellow Card Scheme. As of 12/04/2007 we had received 5,490 Patient Yellow Cards, and 340 of these stated Paroxetine as the suspect drug.

As you may be aware, the 2004 Independent Review of Access to the Yellow Card Scheme concluded that Yellow Card data should be made more widely available. Based on the advice of Dr Jeremy Metters, the MHRA divided Yellow Card data into different categories which were endorsed by the Information Commissioner's Office. Category 1(a) data are the drug analysis prints placed on the MHRA website. Category I(b) data case details listed below are releasable under the Freedom of Information Act (FOIA) without consideration by the Independent Scientific Advisory Committee for MHRA database research (ISAC). Provision of these data will depend on the number of cases held by the Agency. The MHRA will not release any data subset in which there are five or fewer cases per cell. This is necessary to prevent identification of patients and/or reporters. Where there are less than five cases per cell the data will be aggregated with adjacent cells. Any aggregation will be clearly marked on the dataset.

Patient age categories (<18,>85 years)
Patient gender (number of female and male patients)
Suspect drug(s)
Dose of suspect drug
Route of administration
Duration of treatment
Suspected adverse drug reaction(s)

If you would like to proceed with a request for category 1(b) data please let me know and I can put you in touch with one of the Pharmacovigilance team who will be able to discuss with you exactly what data we can supply to meet your needs. As you are aware, there is a limit of £600 to the amount of data that we can provide under the FOIA.

If you require data beyond 1(b) data, then your request will be exempt under the FOIA and classed as a category II data request, available subject to scientific approval from the ISAC. Ethical approval may also be required. More information on Accessing Yellow Card data, the ISAC and a link to the Yellow Card ISAC application form is available on the internet at:


http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=744

The 20 day deadline for answering your request under the FOIA is 8 May 2007. If I do not hear from you by this date I will assume you do not wish to pursue this request further.

Yours sincerely
Stephen Fawbert
Freedom of Information CoordinatorInformation for Public Health Group,
VRMM Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers 14-1101,
Nine Elms LaneLondon SW8 5NQ
Tel: 020 7084 2788
www.yellowcard.gov.uk


They don't like handing out the data do they?

Wonder why?

Remember the bumbling bafoon Breckenridge during Panorama's 'Taken On Trust'?

Prof Sir ALASDAIR BRECKENRIDGE Chair, Medicines Healthcare andproducts Regulatory Agency:

When information like this comes in this is investigated. The way that we.. we firstly we investigate individual reports and then we take..

JOFRE: And how do you do that, you go back to the doctor and follow it up?

BRECKENRIDGE: Yes.. yes.

JOFRE: And that happened in all of these cases?

BRECKENRIDGE: Not in all of them at.. in the appropriate.. in the appropriate cases, this is.. these patients are followed up. The follow up rate for Yellow Card reports is some 48% - 49%.

The follow up rate for Yellow Card reports is some 48% - 49%?

Kinda makes a mockery of the term 'regulator' dosen't it?

Regulate - to govern or direct according to rule

Thing is...... and this is the important bit.... The MHRA regulate by adhering the the very same directions they gave themselves!

What a travesty!

What an utter shambles!

What a bunch of con artists!


Bob