Agency warns of withdrawal risks for patients taking SSRIsBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7479.1365 (Published 09 December 2004) Cite this as: BMJ 2004;329:1365
All rapid responses
Here was a 235-page manuscript report, full of technical jargon and charts, along with tables, diagrams and many references to learned works. The report was presented as the output of a meticulous scientific enquiry that had lasted over eighteen months – about ten times longer than it takes to screen a new drug application.
But the report was released only to journalists, and four days after the launch, copies of the report are still not generally available. Nor is there yet any reference to it on the website of the Committee on Safety of Medicines (CSM), in whose name this review was done. Only the headlines have been reported, so peer review will take time.
The report was launched at a press conference organised by the Department of Health (DoH), at 10.30 on the morning of Monday 6 December. None of the journalists I have spoken to (n=6) had received their (confidential) invitations from the DoH before 5.00pm on the Friday before. One of them charitably suggested that perhaps the authorities were waiting for the London Stock Exchange to close.
However, the global stock market never actually closes, and ‘news management’ probably comes closer to the mark – but yes, I have an axe to grind. Not for the first time, the DoH refused me admission to this briefing on the technically defensible grounds that I am not a member of the press. I have written extensively about the safety of SSRIs for many years, was invited to give evidence to the Working Group, and regularly brief journalists on drug policy and safety issues. I was even for some years a member of the National Union of Journalists - but yes, I no longer carry quite the right cards.
The same exclusion applied to my distinguished colleague, Dr Andrew Herxheimer. He did manage to buttonhole Professor Kent Woods to request admission – but Woods tersely denied any responsibility. He is Chief Executive of the MHRA (Medicines & Healthcare products Regulatory Agency) and was the front man that morning. The DoH is like any other supertanker or juggernaut: changing course requires teamwork and planning. Woods has been in the job for less than a year, easily long enough to appreciate the triumph of process over individual initiative and common sense.
It was a bit cold, but Andrew and I spent a productive several hours on the forecourt of Richmond House (HQ of the DoH), talking to journalists and doing a few interviews. Here we were fortunate: the journalists all trouped out of the briefing about 15 minutes after they’d all filed in. A fire alarm had gone off, so everyone evacuated the building and milled around on the pavement outside for the best part of an hour.
News management? Apart from the decision to engineer a headline response by offering the report only to the press, the presentation was organised to focus strictly on the use of antidepressants. The other two key figures on the podium had not been directly involved in the CSM Review. Their presence would have discouraged questions about the big underlying issue – the performance of the drug manufacturers and regulators themselves.
Alongside Woods was Dr Andrew Dillon, Chief Executive of the National Institute for Clinical Excellence (NICE), whose new guidelines for the treatment of depression were being published that same day. The other was Professor Louis Appleby (National Director for Mental Health), whose main concern would be about the risk of suicide and the need for effective treatment of depression:
“The CSM has delivered one of the most comprehensive reviews of a class of medicines ever to be completed and it has been painstaking work, examining evidence from literally hundreds of clinical trials. What’s important now is that their advice is put into practice. Publication of the NICE guidelines gives us the tools to do the job so that patients and prescribers can together make the best informed decisions.”
The lack of other key players was notable. Where was Professor Gordon Duff, Chairman of the Committee on Safety of Medicines, which had supposedly initiated this review – and in whose name a warning letter to prescribers would be published that same day? Why was there no sign of Professor Ian Weller, Chairman of the CSM’s Expert Working Group whose report was being released? And what had happened to Professor Sir Alastair Breckenridge, Chairman and ‘public face’ of the MHRA and former Chair of the CSM? He was a key figure in this affair and for many years a consultant to the manufacturers of Seroxat (paroxetine), the troublesome drug that prompted this view.
In The Guardian, the redoubtable Sarah Boseley pointed also to the absence of any representative of the Royal College of Psychiatrists or the mental health charity MIND. Richard Brook, its chief executive, had resigned from the expert working group in March. Later, he would tell Panorama: “I have little confidence that the drugs they’re licensing day by day are being licensed in a way I would feel appropriate and what’s even more concerning I have very little confidence in drugs that have been regulated in the past.”
So, one way and another, the headlines won the day. “Tighter warnings on antidepressants” (Reuters); “Are anti-depressants over-prescribed?” (BBC News); “GPs Told to Use Alternatives to Anti-Depressants” (Scotsman); “New guidelines for prescribing antidepressants (Medical News Today); “GPs giving Prozac to thousands who don’t need it” (The Times); “Curb handouts of the happy pills, doctors told” (Daily Mail); and “Regulators Suggest Restricted Use of Drug” (Associated Press)
To date, the regulators (and by extension the drug companies) have managed to evade the scrutiny of their performance that is now urgently overdue. Gloss and spin rule, OK? The authorities have misinformed doctors and prescribers for many years, but now seem to be blaming them.
(This the first instalment of several to come. In due course, please see http://www.socialaudit.org.uk to read on)
Competing interests: No financial interest, but see text reference to axe grinding
Competing interests: No competing interests