Dear Mr. Dobson,

I am writing to ask if you could agree to refer a complaint to the Ombudsman. It concerns the current "intensive review" of the safety of SSRI antidepressant drugs, and notably the drug paroxetine (Seroxat) made by GlaxoSmithKline. This review was announced in Parliament on 5 December 2002 (c970W), by Health Minister, Hazel Blears MP.

This complaint concerns two matters: the composition of the review team, and the grounds on which the Medicines Control Agency/Committee on Safety of Medicines refused to allow me to attend the meeting of the review team on 21 November.

The complaint is supported by voluminous correspondence between Social Audit and the MCA, but I think it best not to burden you with this unless you feel able to refer the case.

Indeed, my correspondence with these agencies goes back to 1997, at which time I wrote to you, as Health Secretary, to warn of the problem of dependence on SSRIs - one of the main issues now under investigation in the MCA/CSM review. The correspondence comprises several hundred letters, evidence not least of these agencies’ determination to keep me at bay. I proposed meetings on several occasions; they always refused.

1. Social Audit is concerned about the composition of the team appointed to conduct this review:

[a] One of the four CSM members appointed, Professor David Nutt, had personal interests (including a small shareholding) in GlaxoSmithKline. In 1998, he and Dr Baldwin (see below) promoted Seroxat at the company’s launch of this drug for "social anxiety disorder".

Professor Nutt was indeed asked to leave the room during the 21 November discussion of two agenda items but, if this was felt necessary, I question whether his appointment to such an enquiry was appropriate at all.

There are also inconsistencies between the interests Professor Nutt has disclosed as a CSM member, and those disclosed at the 21 November meeting. The CSM website lists current personal interests in two other companies that make SSRIs (Lundbeck and Wyeth) but makes no reference to three others which he disclosed at the meeting on 21 November (Pfizer, Lilly and Solvay). Professor Nutt’s declaration at the meeting on 21 November made no reference to Wyeth and stated that his interest in Lundbeck was non-personal and had lapsed.

[b] One other CSM member on the current review, Dr M. Donaghy, is also a shareholder in GlaxoSmithKline. He declared a personal non-specific interest and was also asked to leave the room at the same time as Professor Nutt.

[c] Dr David Baldwin was an invited expert at the meeting on 21 November and he disclosed personal non-specific interests in Lundbeck. The minutes do not indicate he disclosed other relevant interests, as follows:

Dr Baldwin helped the manufacturers to launch Seroxat for social anxiety disorder, when he reportedly said, "Seroxat is one of the safest drugs ever made." He co-authored two papers on this drug (1999 and 2000) one of which disclosed sponsorship by the manufacturers; the other didn’t but probably should have done. (Baldwin D, et al, (on behalf of the paroxetine study group) Paroxetine in social phobia/social anxiety disorder, Br J Psychiatry 1999 Aug, 175: 120-126. and Baldwin DS, Clinical experience with paroxetine in social anxiety disorder Int Clin Psychopharmacol 2000 July, 15 Suppl 1; S19-24)

Dr Baldwin was principal author of a Wyeth sponsored study, published in 2002. He was also identified as a member of the advisory board of Wyeth (Baldwin DS et al., Can we distinguish anxiety from depression? Psychopharmacol Bull, 2002 Summer, 36 Suppl 2, 158-165.)

Dr Baldwin has been identified also as a member of the Bristol Myers Squibb study group on CN-104-070 (nefazodone) (Baldwin DS et al, A randomised double blind controlled comparison of nefazodone and paroxetine in the treatment of depression: safety, tolerability and efficacy in continuation phase treatment, J Psychopharmacol, 2001 Sept, 15(3), 161-165.)

In 1997, Dr Baldwin co-authored a paper on SSRIs with an employee of Pfizer (Lane R, Baldwin D., Selective serotonin reuptake Inhibitor-Induced serotonin syndrome, J Clin Psychopharmacol, 1997 June, 17(3), 208-221.)

[d] The Chair of the "intensive review" Dr Angus Mackay of the CSM, was one of the signatories of the 1996 MCA/CSM paper that had concluded that "overall, symptoms due to stopping an SSRI are rare" and that reported withdrawal reactions "do not appear to be severe"; that "there was no evidence of habituation..." and that withdrawal symptoms are "relatively mild and do not have features of a physical drug dependency syndrome." In spite of several formal requests to withdraw or modify this paper, its conclusions stand and are still much quoted – though the paper was based on an absurd interpretation of inadequate data. This does not inspire confidence in the outcome of the present review.

2. At the meeting on 21 November, the MCA/CSM invited an expert in the field, Dr. David Healy, to attend. He in turn requested that I accompany him. This was refused and my close colleague, Dr Andrew Herxheimer, joined him.

Independently, both Dr Healy and Dr Herxheimer later asked the MCA (Dr June Raine) why they had refused permission for me to attend. Dr Raine reportedly told them both the reason was "he’s not a scientist".

It is true I am a layman but that was no good reason for excluding me. I contend this was injustice caused by maladministration, relating to unfairness, bias or prejudice on the part of the MCA. I was denied the opportunity to express views and pass on relevant information that the MCA did not have, but should have had. This included information I had gained as an invited participant at the September 2002 meeting of the WHO Expert Committee on Drug Dependence. For the record, among other relevant appointments, I have been also been a member of the WHO Expert Advisory Panel on Drug Policies and Management, for over 10 years.

The nub of these complaints is that this seems to be a highly inappropriate way to conduct what Parliament was told was an intensive review. I hope you will feel able to recommend that the Ombudsman should further investigate this case.

Thank you for your attention.

Yours sincerely,
Charles Medawar

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