|Social Audit Ltd
|P O Box 111 London NW1 8XG
|Telephone/Fax 44 (0)171 586 7771
|Mr Peter Clift, Executive Officer
|Prescription Medicines Code of Practice Authority
|London SW1A 2DY
|10 September 2002
Dear Mr Clift,
Case AUTH/1318/5/02 Safety of Seroxat (paroxetine)
Thank you for your letter of 5 September, enclosing GlaxoSmithKlines response to our appeal in the above case.
The Company has failed to address almost all of the issues raised in our Appeal dated 1st August and we are generally content to rely on the assertions and arguments raised therein. We submit that the Companys refusal to address these issues (See Appendix) gives further and substantial grounds for our complaint that GSK is bringing discredit on, and reducing confidence in the pharmaceutical industry, in breach of Clause 2 of the Code of Practice.
The Companys pleading, in relation to Clause 3.2, wholly misses our point. The companys defense is that its briefings and promotional materials complied with the SPC, as that Clause requires. But they have not addressed our point, that compliance with the SPC is necessary, but not in itself sufficient for compliance with the APBI Code. For reasons stated in our Appeal, the companys briefings and promotional materials particularly because they are directed at lay media and patient audiences - are seriously misleading, notably by giving the impression that both the MCA/CSM and EMEA had made some definitive assessment of the dependence problem and arrived at some binding conclusion. GSK had no reason to continue to defend its position that this issue was cut and dried, since they learned that the CSM would be reinvestigating this issue, one month before they wrote to you in response to our Appeal.
It is really quite chilling to read that the Company is unable to find any meaning in the sample of reports from users, claiming that that such evidence is inadmissible under the Code. The collective significance of these reports was a key factor in persuading the CSM to reinvestigate this issue. For the company to argue, in effect, that that there is no problem of the kind that many paroxetine users are reporting reinforces our view that patients have little reason to trust them.
The Company is disingenuous in assessing the finding that five of the top six drugs for which suspected withdrawal reactions have been reported were SSRIs, with paroxetine at No. 1. Again, this was a key factor that persuaded the MCA/CSM to re-investigate the issue, and the Appeal Board will note that this evidence was extrapolated from the ADROIT data specifically at Social Audits instigation. In the light of what we wrote in our Appeal about the significance of the actual numbers, it seems impertinent for GlaxoSmithKline to suggest our concerns are irrelevant and misleading, and we look to the Appeal Board to say so.
The third paragraph in GSKs letter to you of 22nd seems wholly ambiguous, but we reject both possible meanings on the following grounds: [a] It is unacceptable for GSK simply to say they believe "some" of the issues we raised are not relevant, without specifying which, and why; but [b] it would be absurd for the Company to suggest that the critical comments we made about parts of their briefing document are not relevant to the original complaint. Mr. Chandler would/should clearly have relied on statements in the GSK "Reactive Key Messages and Issues Document" (19 December 2001). The central relevance of this document to our complaint is underlined by the fact that the Company sent it to you to defend themselves against the allegations we originally made.
I am hoping we can be represented at the forthcoming appeal by Dr David Healy, Anne Winyard and Dr Andrew Herxheimer; I will confirm names in good time before the Appeal takes place. In this connection please could you respond to our earlier requests relating to the scheduled time for this hearing (we requested an afternoon slot) and to the Chairs consent to our preparing a verbatim note of the proceedings, as he allowed in our previous appeal. We would be prepared to make copies of any transcript available both to the Authority and to GlaxoSmithKline. Many thanks.
Appendix to Social Audit letter of 10 September 2002
In response to our Appeal under the ABPI Code, GlaxoSmithKline has:
CLICK HERE TO READ SUMMARY OF APPEAL OUTCOME