REVIEW OF FOI REQUEST 06/038
INTRODUCTION
1. In a letter dated 26 April 2006, Mr Charles Medawar requested a review of the Medicines and Healthcare products Regulatory Agency's (MHRA) failure to adequately answer a question raised in relation to the inclusion of information from a "placebo suicide", and its decision to withhold the requested patient numbers. This was in response to his request under the Freedom of Information Act (FOIA) in relation to Seroxat/Placebo suicides. The Agency justified its decision not to release the patient numbers as they were exempt under Section 40 of the FOIA.
2. Mr Medawar has asked for this decision to be reviewed on the following grounds:
2.1 The MHRA's response did not adequately answer his question as to whether the Agency stands by the inclusion of the "placebo suicide" which occurred after the trial cut-off point of 30 days. Mr. Medawar has asked what the justification was for including this case as a "placebo suicide" when death occurred after the 30-day cut-off point, and when the investigator "considered his death to be unrelated to trial therapy"?
2.2 The MHRA withheld the patient numbers requested invoking Section 40 (Personal Information) of the FOIA as it considered their release could potentially lead to the identification of individual patients.
3. In addition, Mr Medawar has made further new requests for information, clarifying exactly what he would like. This review does not cover these new requests. They will be dealt with separately as a new FOI request by the appropriate Division.
PURPOSE OF INTERNAL REVIEW
4. The purpose of this internal review is to determine whether the MHRA dealt properly with Mr Medawar's request under the FOIA. The terms of reference of this review are:
4.1. To read all correspondence between Mr Medawar and the Agency, and other relevant correspondence and enclosures;
4.2 To form an opinion on the handling of the correspondence by the Agency;
4.3 To advise whether the actions taken by the Agency in reaching its decisions is justified under the FOIA;
4.4 To make recommendations for further action by the Agency if appropriate; and
4.5 To prepare a report of the review for the Agency and Mr Medawar.
BACKGROUND
5. Following an earlier FOI request in January 2006 (FOI 06/007), on 17 February 2006 Mr Medawar raised a number of further questions. For the purpose of this report I will deal only with the questions which are the subject of review. The following questions were asked:
(i) Whether the MHRA stood by its analysis - that one patient on paroxetine committed suicide, compared with three on placebo - when the first of the "placebo suicides" occurred beyond the cut-off point at 30 days;
(ii) The Protocol Title and Patient Number of each of the three placebo suicides plus the one paroxetine suicide.
6. The MHRA replied to Mr Medawar's letter of 17 February 2006 on 7 April 2006. In relation to question (i), the following response was provided:
"All the assessments considered by the CSM's Expert Working Group on the safety of SSRIs and the European Scientific Advisory Committee have clearly stated that in the paroxetine placebo-controlled trials there were 4 completed suicides - one in the paroxetine group (on therapy) and three in the placebo group (all in the post treatment period). The analyses considered by the Expert Group during its review include one which examined the incidence of suicidal behaviour during the ontherapy period (including taper phase) and another analysis which examined the incidence of suicidal behaviour during the on therapy period (including taper phase) plus 30 days post-therapy. "
In relation to question (ii), the MHRA provided Mr Medawar with the protocol numbers of the trials. The patient numbers, however, we withheld under Section 40 of the FOIA (Personal Information) on the ground that their release could potentially lead to the identification of individual patients.
CONSIDERATION OF THE ISSUES
7. I have read the correspondence and other relevant documents related to this enquiry, I have considered the remarks of Mr Medawar and the Agency, and the actions taken by the Agency prior to the reply of 7 April 2006.
8. In responding to Mr Medawar's question in relation to whether the MHRA stands by the inclusion of the "placebo suicide" which occurred beyond the 30 day cut-off point, the Agency merely refers to the assessments considered by the CSM's Expert Working Group on the safety of SSRIs and the European Scientific Advisory Group. The response does not state whether the MHRA stands by the inclusion of this "placebo suicide", therefore Mr Medawar's question has not been adequately answered.
9. In respect of Mr Medawar's request for the patient numbers of each of the three placebo suicides and the paroxetine suicide, the Agency has invoked Section 40 of the FOIA on the ground that the release of the numbers could potentially lead to the identification of the individual patients.
The application of Section 40 is justified in these circumstances for the following reasons:
(i) given that there were only four patients involved, the risk of establishing their identity through the patient numbers is far greater than if there was a larger number of patients;
(ii) given the sensitive nature of suicide, one has to look beyond merely protecting the deceased, but also their families. The release of the patient numbers could potentially prejudice the respect that the families are due in their own private lives;
(iii) the risks and potential consequences if the patients' identifications were to be established far outweigh any benefit to the public by releasing the patient numbers.
Conclusions and Recommendations
10. The Agency's decision not to release the patient numbers on the ground of the Section 40 exemption (Personal information) is justified.
11. The Agency failed to adequately answer Mr Medawar's question in relation to the inclusion of the placebo suicide which occurred beyond the 30 day cut-off point.
This question should be reconsidered and an adequate response provided to Mr Medawar.
Sean Fletcher MHRA Policy
8 June 2006