Correspondence between Dr David Healy |
and the Medicines Control Agency |
Letters to and from are listed in date order, newest last. The correspondence began in late 1999 and mainly relates to Dr Healy's concerns about the risk that fluoxetine, paroxetine, sertraline and other SSRIs may induce in a small but significant number of users suicidal feelings or acts, or extreme aggression towards others. The correspondence is telling, not only in relation to this central concern, but also for what it reveals about the methods and stance of the Medicines Control Agency (MCA) - and above all their blind reliance on the manufacturers to provide and interpret data for them.
The turning point comes in June 2001, with the judgement in a Cheyenne, Wyoming court that paroxetine (Paxil/Seroxat) had contributed to the wrongful and violent deaths of Don and Rita Schell and Deborah and Alyssa Tobin and that SmithKline Beecham (now part of Glaxo SmithKline) had been responsible for failures to test and warn. In the course of this case, David Healy (as an expert witness for the Plaintiffs) discovered key company documents, detailing the results of very early studies in which paroxetine had been taken by healthy volunteers.
These not only revealed, for the first time, a high level of agitation, nervousness and extreme restlessness (akathisia) among volunteers - the very symptoms believed to be associated with acts of violence and self-harm - but also clear evidence of a withdrawal syndrome, found "at a much higher rate than occur on benzodiazepines." Because these studies were done on healthy volunteers, there can be no doubt this was a true withdrawal syndrome, rather than 'relapse' - and the implications are profound.
In particular, if SKB knew of the existence of a withdrawal syndrome from the 1980s, how could they make claims for the long-term effectiveness of paroxetine, on the basis of a study which discounted the possibility that withdrawal symptoms existed at all? Healy suggests, "This seems to be close to frankly deceiptful ...". We agree. That study was conducted jointly by a representative of SKB and a member of the Committee on Safety of Medicines (CSM) - and has also been the been the focus of analysis and much correspondence between Social Audit and the MCA/CSM.
Healy to MCA (Dr Keith Jones), 4 November 1999 |
MCA (Dr Jones) to Healy, 7 January 2000 (+ summary of relevant ADROIT ADR reports) |
Healy to MCA (Dr Keith Jones), 19 January 2000 |
MCA (Sarah Wark) to Healy, 22 February 2000 |
Healy to MCA (Sarah Wark), 28 February 2000 |
Healy to MCA/DoH (Dr Keith Jones/Lord Hunt), 3 April 2000 |
MCA (Dr Jones) to Healy, 27 April 2000 |
MCA (Sarah Wark) to Healy, 4 May 2000 |
Healy to MCA (Ms Wark), 8 May 2000 |
MCA (Sarah Wark) to Healy, 26 June 2000 |
Healy to MCA (Sarah Wark), 30 June 2000 |
Healy to MCA (Dr Keith Jones), 5 July 2000 |
MCA (Dr Jones) to Healy, 26 July 2000 (+ summary of ADRs in voluteer studies) |
Healy to MCA (Dr Keith Jones), 3 August 2000 |
MCA (Dr Jones) to Healy, 23 August 2000 (+ reference to 'epidemiological' studies relied on by MCA) |
Healy to MCA (Dr Keith Jones), 1 September 2000 |
Healy to MCA (Dr Keith Jones), 8 September 2000 |
Healy to MCA (Dr Keith Jones), 13 September 2000 |
MCA (Dr Jones) to Healy, 25 September 2000 (proposes a meeting) |
Healy to MCA (Dr June Raine), 20 December, 2000 |
Healy to MCA (Dr June Raine), 5 January 2001 |
Healy to MCA (Dr June Raine), 1 February 2001 |
Healy to MCA (Dr Keith Jones), 12 February 2001 |
MCA (Sarah Wark) to Healy, 23 March 2001 (+Minute of CSM meeting) |
MCA (Dr Raine) to Healy, 27 March 2001 |
Healy to MCA (Dr June Raine), 4 April 2001 |
Healy to MCA (Dr June Raine), 7 June 2001 (Re: early paroxetine studies in volunteers) |
MCA (Dr Raine) to Healy, 8 June 2001 |
Healy to MCA (Dr June Raine), 19 June 2001 (More on early paroxetine studies in volunteers) |
Healy to MCA (Dr June Raine), 2 August 2001 |
Healy to MCA (Dr June Raine) 16 November 2001 |
Healy to DoH (Health Secretary, Alan Milburn), 7 December 2001 |
MCA (Sarah Wark) to Healy, 7 December 2001 |
Healy to MCA (Sarah Wark) 17 December 2001 |
MCA (Sarah Wark) to Healy. 20 December 2001 (formal acknowledgement - excluded) |
MCA (Sarah Wark) to Healy, 25 February 2002 |
Healy to MCA (Sarah Wark), 8 March 2002 (PLUS APPENDIX: SSRIs & MECHANISMS OF SUICIDE) |
MCA (Sarah Wark) to Healy, 15 March 2002 |
Healy to MCA (Sarah Wark), 21 March 2002 |
Healy to DoH (Health Secretary, Alan Milburn), 8 April 2002 |
ANTIDEPRESSANTS AND SUICIDE - Briefing paper, 20 June 2003 |
SSRIs & WITHDRAWAL/DEPENDENCE - Briefing paper, 20 June 2003 |
Healy to Prof I. Weller, Chair of MHRA/CSM review of SSRIs, 27 June 2003 |
Healy to Sarah Wark, MHRA, 5 November 2004 |