This story caught my eye today:
Legal aid withdrawn from anti-epilepsy drug case
A landmark legal case by families of children with physical and mental disabilities against a multinational pharmaceutical company is likely to be abandoned after legal aid was withdrawn.
The families say manufacturers of an anti-epilepsy drug taken by mothers in pregnancy should pay compensation because the children’s conditions resulted from the medication.
But the government’s Legal Services Commission, which is believed to have provided more than £3m to help the families prepare for the action, decided to end its financial support just three weeks before hearings were due to begin in the high court in London.
The families’ lawyers said the “bitterly disappointing” decision had probably forced the abandonment of the action, which could have potentially paid out compensation reaching tens of millions of pounds. One family accused the commission of being responsible for “a complete waste of time and money”
The story reminded of the attempt a few years to sue the manufacturers of Ativan – Wyeth and Hoffman La-Roche.
One of the litigants in the Wyeth action, Michael Behan made a submission to the Health Select Committee enquiry into the influence of the pharmaceutical industry in August 2004. Here are some extracts from his written submission – I suggest you read the whole thing here and I apologise to Michael for cutting and pasting.
The litigation ran from 1986 to 1996 with a peak of 17,000 complaints. The plaintiffs alleged that the manufacturers were negligent in failing to give adequate warnings of the dangers associated with their products. The manufacturer delayed and complicated the proceedings to the point that the Legal Aid Board could no longer meet the expense of the litigation. Each side spent more than £35m yet not one minute of court time was spent on the merits of the case; the time and the money was spent on technical motions and procedural wranglings. Under pressure from the defendants the LAB withdrew funding from the litigation.
The Legal Aid Board was disbanded in the wake of the benzo litigation and re-constituted as the Legal Services Commission with a new set of regulations.
The failure of the benzo litigation gave the pharmaceutical companies the green light. They had demonstrated they could not be brought to trial and that the evidence against them would not see the light of day. In reality, the consumer has no protection in law against pharmaceutical companies or rogue drugs.
Powerful commercial corporations should not be immune to liability. Such potential liability acts as an incitement to developers of new products to ensure that their product is safe, this is a valuable counterbalance to the temptation to make fast profits. A stream of unwary patients is initiated into drug addiction by trusted doctors. Meanwhile, the Government has tinkered in the face of an enormous problem, and is misled by a flawed system of advisers, experts and regulators.
Once again, no court time – the plantiffs had their legal aid withdrawn and could then not afford to take on the drug companies.
More from Michael: Wyeth and Roche released co-ordinated information on benzos in each country according to the strength and vigilance of the regulatory authorities in that country. Ativan first appeared in the UK in 1972 with warnings well below the level of information in the possession of Wyeth. The minimal warnings and the exaggerated indications for Ativan increased prescribing and therefore sales and profits for Ativan. The Wyeth Ativan Clinical Trials were poor quality and short term; none provide reliable evidence that Ativan is safe, several of the Ativan trials report what were to become the classic Ativan problems.
So, the patient information leaflet glossed over the problems and the clinical trials were poor and short term… all sounding very familiar.
Now let’s move on to the licencing of Ativan – today it would be the MHRA, then it was the MCA (same organisation, different names).
More from Michael: My submission is that Wyeth did not tell the truth when they made their Ativan Licence Application.
The senior members of the licensing authority have what has been quaintly described as a conflict of interest – they receive large amounts of money from the drug companies they regulate. In 1996/97, for example, ten members of the CSM/MCA declared financial links with Wyeth and Brother.
So, the licencing authority was lied to and was also ‘enjoying’ conflicts of interest… all sounding very familiar once again.
To sum up… nothing changes. For Ativan read Seroxat (or any SSRI/SNRI/antipysichotic, the history is chillingly similar). It seems patients will never get justice – it is simply too expensive. The regulators have failed time and again and are too close to the drug companies. Governments do nothing.
Justice is when you get what you deserve. The law is when you get what you pay for.
Just to remind you, the entire submission from Michael Behan can be read here.