Case AUTH/1318/5/02 Safety of Seroxat (paroxetine)

Thank you for your letter of 5 September, enclosing GlaxoSmithKline’s response to our appeal in the above case.

The Company has failed to address almost all of the issues raised in our Appeal dated 1^st August and we are generally content to rely on the assertions and arguments raised therein. We submit that the Company’s 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 Company’s pleading, in relation to Clause 3.2, wholly misses our point. The company’s 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 company’s 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 third paragraph in GSK’s letter to you of 22^nd 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 Chair’s 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:

• offered no assessment of the collective significance of the sample of 40-odd user reports attached to Social Audit’s complaint, other that to imply they are meaningless.
• made no reference to the possibilities of avoiding the confusion caused by their slavish reliance on specialised, professional definitions (of ‘dependence’, ‘habit forming’, ‘addiction’) that evidently mislead users, probably many professionals too.
• offered no comment on the 1988 WHO statement cited, that says that SSRIs may indeed be drugs of dependence even within the formal definitions on which GSK relies.
• not explained why it rejects the cited definition of ‘dependence’ relied on by DAWN (the US Drug Abuse Warning Network).
• offered no response in relation to Social Audit’s allegations that the terms of its "Reactive Key Messages and Issues Document" (19 December 2001), together with the statements attributed to Mr. Chandler, fail to comply with the WHO Ethical Criteria, IFPMA and EFPIA Codes, and constitute breaches of Clauses 2, 7.2, 7.9, and 20.2 of the ABPI Code
• given no explanation for stating in its "Reactive Key Messages and Issues Document" that, "Seroxat is clearly shown as being neither addictive nor causing dependence" when no such thing has been clearly shown, that statement being both highly misleading and inconsistent with the SPC.
• offered no justification for stating in the same document that "Discontinuation symptoms are completely different to addiction or dependence …", which is also alleged to be highly misleading (because withdrawal symptoms are prime indicators of dependence) and not consistent with the terms of the SPC.

• given no explanation for the further claim that, "The MCA (Medicine Control Agency) and CPMP have concluded that SSRIs do not cause dependency/addiction," which is untrue and also fails to comply with the SPC. The MCA/CSM and CPMP reached no firm conclusion, and are about to reconsider this issue yet again.

• offered no comment on the DAWN data provided, which suggests that there is some significant evidence of misuse of paroxetine, among other SSRIs.

• offered no comment in response to the second of the four arguments by which Social Audit reasoned that, on the balance of probabilities, Mr. Chandler did make remarks very similar or identical to those attributed to him - the key point being that Mr Chandler at no stage denied he made those statements, nor made any effort to explain to a critical complainant that he would not have wished to have been understood to be saying what the journalist in question had recorded.

CLICK HERE TO READ SUMMARY OF APPEAL OUTCOME

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