FOI COSTS AND THE MHRA

HOW MUCH DOES THE MHRA CONTRIBUTE TO THE COSTS OF FOI?

The government is considering increasing the charges made for Freedom of Information requests.¹ This very unwelcome proposal gives all the more cause for concern because of the mountains of evidence on this website, as elsewhere, that the MHRA’s own policies and practices would account for a large part of the total cost of responding to FOI requests.

The Table below gives examples from our (so-far) 10-month correspondence with the MHRA, about the paroxetine/Seroxat placebo suicides. The costs of handling these FOI requests seem overwhelmingly attributable to Agency shortcomings. The MHRA’s tendencies to delay, obfuscation, deviousness and error account for a greedy lion’s share of the total costs.

And now we have seem to have another example of vexatious refusal in the making. So long as the MHRA grudgingly provides misleading and/or incomplete replies, it seems bound to attract more questions and run up higher costs in the long run.

The MHRA could surely save a packet on its FOI budget, and do much for its credibility and reputation, if it made up its mind to communicate honestly. Hence these further FOI requests [now complete with the answers because the MHRA responded at speed]:

1. Have the MHRA's views been canvassed in relation to current government (DCA) proposals to increase the charges made for responding to requests under the Freedom of Information Act? If so, please provide any one piece of documentary evidence to show what questions the Agency was asked to address and what evidence it might usefully provide.

The Agency's views have not been canvassed on this matter.

2. Has the MHRA formally communicated in response to these proposals to increase the fees chargeable to FOI requesters? If so, please provide any one piece of documentary evidence to show [a] whether or not the Agency indicated support for an increase in such fees? [b] what evidence the MHRA offered in support of its position, on the basis of its own cost estimation(s) and experience in handling FOI requests.

See question 1. The information you seek does not exist as the Agency has made no such communication(s).

3. How much in total did the MHRA charge by way of fees to FOI requesters, for responding to requests in 2005 (or any other convenient and recent time period)? What did this total represent as a percentage of ‘total costs’ (i.e. of responding to FOI requests)?

Nil. From the full implementation of the Act on 1st January 2005 the Agency has to date never charged a fee for an FOIA request. In only two instances have we have asked for a fee from a requestor. In both cases the requestor declined to pay the charge.

4. Has the MHRA produced a breakdown showing the proportion of ‘total costs’ attributable to [a] more and less financially burdensome requests? [b] the number and proportion of requesters by category (e.g. "license holder’, "patient group", "trade association" "journalist") and/or type (e.g. ‘vexatious’ or not) ? If so, please provide any one document, in each case, detailing the results of the analyses made.

The Agency has produced no such breakdown, or any similar attribution of 'costs' arising from discharging its statutory responsibilities under the FOIA.

5. Has the MHRA ever given formal consideration to [a] the need to reduce the total costs of responding to FOI requests? [b] the measures that the Agency might itself introduce to try to do so? If so, please give (quantitatively modest) evidence of this, and of any actions taken and/or decisions made and/or conclusions reached.

No.

6. Has the MHRA made any formal assessment of its own contribution to the cost of responding to FOI requests? If so, please provide any (quantitatively modest) documentary evidence, to suggest that the Agency is cognisant of [a] its own contribution to the total costs of responding to FOI requests; and [b] the opportunities the Agency has to reduce them.

No such assessment has been made by the Agency.

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1. GOVERNMENT RESPONSE TO THE CONSTITUTIONAL AFFAIRS SELECT COMMITTEE REPORT: Freedom of Information-one year on. Presented to Parliament By the Secretary of State for Constitutional Affairs and Lord Chancellor, By Command of Her Majesty, October 2006, Cmnd 6937 BACK

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EXAMPLES OF FOI COSTS ATTRIBUTABLE TO MHRA SHORTCOMINGS

REQUEST MADE (date hyperlinked to reference)

MHRA RESPONSE

PROBLEM

"Can the MHRA confirm that none of the three people on placebo who committed suicide during the post-treatment phase had been taking an antidepressant drug at or around the time they died?" 060116 "From the case narratives reviewed it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died. In one of the cases the individual had received a course of ECT 3 days prior to the date that they committed suicide." 060213 Misleading

You wrote that the second placebo suicide had received ECT treatment three days before he/she committed suicide? Do you not agree that it would be very unusual to subject a patient to ECT before some drug treatment had been tried – especially when the patient was under supervision in a controlled clinical drug trial? 060217 "I am not in a position to comment on what would or would not be usual care in this situation." 060407 Evasive

"I was not inviting personal comment from you; I was requesting a response an Agency that persists in claiming that it deserves public trust. I have yet to receive a meaningful response and therefore make this more specific information request: was the MHRA aware on 7 April 2006, the date of your reply to my letter of 17 February: [a] that this patient had been withdrawn from the study on 1^st March 1999; [b] that the patient was treated for acute depression with clotiapine, oxazepam and fluoxetine prior to electro-convulsive therapy on 15 March 1999; before taking his own life on 18 March? 060426 "I can confirm that the case narratives for the three placebo suicides, which include the above information, were provided by the MAH to the CHMP and also to the Agency in January 2004." 060609 Misleading

You now tell me that the MHRA became aware in January 2004 that Patient 627.605.01012 was treated, shortly before his death by suicide, with clotiapine, oxazepam and fluoxetine. Yet on 13 February 2006, Dr Julie Williams wrote: "From the case narratives reviewed it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died."
You offered no explanation for this in your letter of 9 June, and I’m afraid I can only infer that the MHRA knowingly lied. However, I may have missed some nuance of this apparent deceipt. If so, I am sure you would want to put me right, as a matter of urgency." 060613
Thank you for your e-mail. I can assure you that there was no attempt to deceive.
The case narrative is not specific about the timelines of treatment relative to the death. Our reading of the narrative is that the patient was treated with clotiapine, oxazepam and fluoxetine for an event which occurred one month before the death. There is no indication in the narrative that these medicines were continued to around the time of death; and similarly no indication that they were stopped prior to the death. Our response of 13 February could have highlighted this uncertainty and I apologise for any confusion caused." 060613

Devious

"Were the ‘Narratives for Cases of Suicides in Clinical Trials’ (supplied to the MHRA by GSK in January 2004, as Appendix 6, in response to the Seroxat Article 31 submission) made available to [a] Professor D Ashby; [b] Professor D. Gunnell and/or [c] to any other member of the CSM Expert Working Group (EWG) on the Safety of SSRIs? If so, please explain why did the Gunnell/Ashby review in the BMJ (19 February 2005) state: " … we did not have access to individual patients' data …" and if they were not supplied, please explain why not." 060710 "The text of the narratives of the cases in question were supplied as annexes to assessment reports provided to the members of the Expert Working Group on SSRIs. I would ask that you direct any questions about the BMJ review (19 February 2005) to the authors." 060904 Misleading and evasive

"Please will you let me know [a] on what date (at which meeting) members of the CSM Expert Working Group on SSRIs were supplied with copies of summaries of individual case reports of the three placebo suicides reported in paroxetine trials, and [b] to which of the "assessment reports" she refers were these case summaries attached." 061001 "I would like to correct one of the points made in Miss Wark's letter of 4 September 2006. The case narratives themselves were not supplied to the SSRI Expert Working Group" 061016 Eventually, an admission … but presented as if a tiny glitch ...

Getting at the facts in this case has meant sifting through contorted meanings and making repeated FOI requests, over many months. Net result? Higher administrative costs; reduced Agency reputation; frustrated and discredited staff; and a highly aggrieved customer.

Charles Medawar
27 November 2006

UK citizens and residents may wish to sign the related petition on the 10 Downing Street website, and encourage others to do so.

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REQUEST MADE (date hyperlinked to reference)	MHRA RESPONSE	PROBLEM
"Can the MHRA confirm that none of the three people on placebo who committed suicide during the post-treatment phase had been taking an antidepressant drug at or around the time they died?" 060116	"From the case narratives reviewed it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died. In one of the cases the individual had received a course of ECT 3 days prior to the date that they committed suicide." 060213	Misleading
You wrote that the second placebo suicide had received ECT treatment three days before he/she committed suicide? Do you not agree that it would be very unusual to subject a patient to ECT before some drug treatment had been tried – especially when the patient was under supervision in a controlled clinical drug trial? 060217	"I am not in a position to comment on what would or would not be usual care in this situation." 060407	Evasive
"I was not inviting personal comment from you; I was requesting a response an Agency that persists in claiming that it deserves public trust. I have yet to receive a meaningful response and therefore make this more specific information request: was the MHRA aware on 7 April 2006, the date of your reply to my letter of 17 February: [a] that this patient had been withdrawn from the study on 1^st March 1999; [b] that the patient was treated for acute depression with clotiapine, oxazepam and fluoxetine prior to electro-convulsive therapy on 15 March 1999; before taking his own life on 18 March? 060426	"I can confirm that the case narratives for the three placebo suicides, which include the above information, were provided by the MAH to the CHMP and also to the Agency in January 2004." 060609	Misleading
You now tell me that the MHRA became aware in January 2004 that Patient 627.605.01012 was treated, shortly before his death by suicide, with clotiapine, oxazepam and fluoxetine. Yet on 13 February 2006, Dr Julie Williams wrote: "From the case narratives reviewed it does not appear that any of the individuals in these three placebo suicides were receiving an antidepressant drug around the time they died." You offered no explanation for this in your letter of 9 June, and I’m afraid I can only infer that the MHRA knowingly lied. However, I may have missed some nuance of this apparent deceipt. If so, I am sure you would want to put me right, as a matter of urgency." 060613	Thank you for your e-mail. I can assure you that there was no attempt to deceive. The case narrative is not specific about the timelines of treatment relative to the death. Our reading of the narrative is that the patient was treated with clotiapine, oxazepam and fluoxetine for an event which occurred one month before the death. There is no indication in the narrative that these medicines were continued to around the time of death; and similarly no indication that they were stopped prior to the death. Our response of 13 February could have highlighted this uncertainty and I apologise for any confusion caused." 060613	Devious
"Were the ‘Narratives for Cases of Suicides in Clinical Trials’ (supplied to the MHRA by GSK in January 2004, as Appendix 6, in response to the Seroxat Article 31 submission) made available to [a] Professor D Ashby; [b] Professor D. Gunnell and/or [c] to any other member of the CSM Expert Working Group (EWG) on the Safety of SSRIs? If so, please explain why did the Gunnell/Ashby review in the BMJ (19 February 2005) state: " … we did not have access to individual patients' data …" and if they were not supplied, please explain why not." 060710	"The text of the narratives of the cases in question were supplied as annexes to assessment reports provided to the members of the Expert Working Group on SSRIs. I would ask that you direct any questions about the BMJ review (19 February 2005) to the authors." 060904	Misleading and evasive
"Please will you let me know [a] on what date (at which meeting) members of the CSM Expert Working Group on SSRIs were supplied with copies of summaries of individual case reports of the three placebo suicides reported in paroxetine trials, and [b] to which of the "assessment reports" she refers were these case summaries attached." 061001	"I would like to correct one of the points made in Miss Wark's letter of 4 September 2006. The case narratives themselves were not supplied to the SSRI Expert Working Group" 061016	Eventually, an admission … but presented as if a tiny glitch ...