It was always going to come to this and battle has now been joined: a US law firm announced three weeks ago that it was taking action on behalf of 35 people complaining of severe distress from paroxetine (Paxil/Seroxat) withdrawal symptoms. Some 1,500 other people have since asked about joining in. It is far from certain that legal action will follow in the UK, but details will be posted on this site if it does.

Why the uncertainty? The nub of it is one crucial difference between the system of civil litigation in the UK and US. When an action is settled in the USA, each side pays its own costs - but in Britain the losing side pays the winner's costs as well as its own. The recent introduction of 'contingency fee' litigation (no win, no fee) in the UK makes no difference. Almost regardless of the strength of the case against them, the drug companies have become virtually untouchable because they are, in financial terms, bottomless pits.

No matter that this was the accident waiting to happen and that the risk has been obvious for years. In fact, the writing has been on the wall since the mid 19th century, when doctors used to prescribe morphine as a cure for opium addiction. Later, they prescribed cocaine for 'morphinomania', and then heroin to treat addiction to cocaine. The list is long and includes virtually drug ever prescribed for psychic distress - each one assumed to present no risk of dependence, often for years after first appearing on the market. The list includes scores of bromides, barbiturates and related drugs and, most recently, the benzodiazepine tranquillisers, like Valium (diazepam), Xanax (alprazolam) and Ativan (lorazepam). (Medawar, 1992). Now history is repeating itself yet again:

"The clear message of history is to beware of any explosive, mass demand for a psychoactive drug, and never to forget that patients don't crave so long as doctors readily prescribe. It is also worth noting that there is still profound confusion over the differences in meaning between "dependence " and "addiction", despite clarification from the World Health Organisation 30 years ago. The Royal Colleges of Psychiatrists and General Practitioners (1992) still insist that "antidepressants are not addictive" and that people are "mistaken in believing they can cause dependence", despite evidence that most antidepressants (unlike cocaine) are associated with a withdrawal syndrome ... What the Royal Colleges are really saying is that antidepressants have no great street value and do not lead to overt drug-seeking behaviour (entirely unsurprising in view of the copious supply). But this does not properly address the concern that both doctors and patients may misinterpret withdrawal symptoms as recrudescence of disease, and then see this as evidence of the effectiveness of the drug and of the need to continue treatment with it. This is what happened with the benzodiazepines, barbiturates and all the rest, and it led to dependence on a grand scale. " (Medawar, 1994)

So long as there are no better alternatives, I have no problem with the manufacturers getting sued - they have much to answer for and most to learn. The drug companies claim they know far more about their drugs than anyone else - and insist they can be trusted even to advertise prescription-only medicines directly to consumers - yet they are still swearing blind that SSRI withdrawal and dependence problems are hardly problems at all.

The drug companies may be the short answer to the question 'Who dunnit?' but others bear major responsibilities as well. Indeed, one might argue that drug companies are nearly incapable of being responsible, if it involves too much rocking their own boat or insufficient feathering of the nest. So what of the role of government - the Department of Health, Medicines Control Agency and Committee on Safety of Medicines? And what about the responsibilities of doctors - and their leadership, above all - to protect people from this kind of thing? They are the ones on whom we should be able to rely.

The chances of government now doing the honourable thing and holding a public enquiry seem small. More likely, history will repeat itself: there has never been a public enquiry in the UK into a serious drug safety problem - not even with thalidomide - and for all its promises, this government is not one to break that mould. It is now too deeply implicated in this mess: it has too much to hide and grossly excessive powers of secrecy to help it do so. Much the same applies to the leadership of medicine, if the Committee on Safety of Medicines is anything to go by. The CSM's contribution to the development of this problem has been substantial, if only though dedicated default.

It shouldn't have come to this, but now there seems no alternative to legal action - and if it happens, it may do some good if only by concentrating official minds. The last round of similar litigation did at least achieve this: "if the popular press and more recently the legal profession had not taken up arms against the over-prescription of tranquillisers, the issue of benzodiazepine dependence would still remain a medical curio only for the pages of medical journals. The media and lawyers have undoubtedly altered prescribing practices, mostly for the better (Hallstrom, 1991).

If legal action is started in the UK, claimants must trust their own judgement in seeking justice, but will need to carefully think things through. The average claim against the NHS takes over five years to settle, and the likelihood of compensation is small - and taking on a major drug company is something else again. The nub of it is well explained in a policy statement from Vickery & Waldner, the US attorneys who recently won a major case against the manufacturers of Paxil in an action for wrongful death:

"Our responsibility - which we take very seriously - is to discourage litigation in all but the most egregious cases. Involving yourself in a lawsuit with defendants with unlimited resources is a mammoth undertaking, sapping most of your emotional, spiritual and economic resources. In the face of tragedy, these resources are already seriously depleted. Our experience is that the pharmaceutical companies will do virtually anything to protect their multibillion dollar drugs. When you sue them, their lawyers will open virtually every closet door in your life and microscopically examine every skeleton. Every aspect of your life - a spouse's drinking problem, a daughters abortion, problems at work - will be blamed for what their drug might have caused. It's not a bit overstating the rigors of litigation to tell you that the process itself might just be worse than the tragedy that caused the filing of the claim."

Though there would be much less exposure for individual claimants in a class action, bear this in mind as you read through the discussion pages on this and many similar websites. There can be little doubt about the strength of many claims - but deserving justice and getting it seem to be two quite different things.

CM September 2001

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