DEPENDENCE RULES, OK?

SmithKline Beecham failed in their recent attempt to prevent Dr David Healy from giving evidence in the Schell-Tobin case, settled last week in Wyoming – with a $6.4m award against the company, now subject to appeal. Two days after taking paroxetine for insomnia, Donald Schell suffered a violent reaction and killed three members of his family and then himself.

In the course of discovery of confidential company files, Dr Healy examined a series of studies from the 1980s in which - after short exposures - paroxetine had been withdrawn from healthy volunteers. According to Sarah Boseley in the Guardian (11 June, 2001), Healy noted that about half the volunteers suffered "symptoms which suggest they had become physically dependent on the drug". The evidence suggested that "withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines".

SmithKline Beecham has refused to disclose the relevant data, but their spokesman, Dr David Wheadon continues to insist that withdrawal symptoms from paroxetine are "very rare". He told the Guardian, "It is extraordinarily difficult to ferret out if it is a withdrawal effect or resurgence of the disease being treated." This is patently not the reason for the symptoms seen in healthy volunteers – if they were healthy, there could be no question of relapse.

Wheadon’s view also flatly contradicts what the then Chairman of the Committee on Safety of Medicines (CSM) told Social Audit three years ago: "You may be unaware that, in most cases, symptoms associated with paroxetine withdrawal are clearly distinguishable from those of the underlying depressive illness." On this basis, the CSM and the Medicines Control Agency continue to believe that paroxetine is effective in the long-term and that the risk of dependence is slight.

It is now all the more certain that the authorities have failed to protect the public from yet another epidemic of iatrogenic dependence. The evidence on this website overwhelmingly suggests that the authorities were quite unaware of the significance of the healthy volunteer studies. The MCA/CSM review, following publication of The Antidepressant Web, found "no evidence of dependence associated with the SSRIs and related antidepressants" (CSM Minutes, 26 March 1998)

In the meantime, the international pharmaceutical industry trade association, the IFPMA, expresses a keen and enduring lack of interest in matters arising. They appear not to see any risk or problem when senior company spokespeople make product claims to the general public that would be ruled inadmissible if they appeared in advertisements addressed to health professionals. 

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