Joan Smith: Massive payouts over Vioxx are not the answer

Patients should start to assume responsibility for decisions about what drugs they take
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The Independent Online

In the US, bringing a successful court case can be the equivalent of winning the national lottery several times over, as a woman from Texas discovered last week. The woman, whose husband died four years ago after taking the controversial painkiller Vioxx, was awarded a staggering $253.4m (£140.6m) in a case which had been considered one of the weaker claims against the manufacturer, Merck, by lawyers working in the field.

The final sum the widow receives will be decided by a judge, who may reduce it substantially, but the immediate effect of the award will be to encourage people in this country who claim to have suffered damaging side-effects from Vioxx to try and get their cases heard in a US court.

"Why should [my client] sue in the UK and get £30,000 when she could get a multimillion pound settlement in the US?" a spokesman for a British law firm which has around 60 Vioxx cases demanded at the weekend.

I suppose he is only doing his job, which is to get the best deal he can for his clients in this country - widows, widowers and arthritis sufferers who say their health has been wrecked by heart attacks and strokes after being prescribed Vioxx. But the jury's award involves one of those headline-grabbing sums which make people in less affluent countries goggle at the value placed on a single American life.

How many, I wonder, will read on and discover that the punitive damages were based on a 2001 estimate by Merck of the extra profit it would make if it succeeded in delaying a Food and Drug Administration warning on the heart risks of the drug?

In many parts of the world, where adults and children die every day from preventable diseases, the spectacle of the death of one individual triggering a payment on this scale must seem not just fantastic but obscene. Even if it turns out Merck is culpable over the way it marketed Vioxx - evidence given to congressional hearings in the US has revealed that sales reps were told to dodge questions about side-effects - a "fine" of more than $250m would meet the practical needs of a widow many times over.

The question of whether it is morally right that the jury's desire to punish a drug company should have translated into a jackpot for a single claimant has not even begun to be debated. Nor has anyone asked whether an American court is the most appropriate forum for such battles, simplistically presented as helpless victims versus evil drugs companies, to be played out.

This reflects the fact that the only recourse for sick or bereaved people who feel let down by doctors and drug companies is to place themselves in the hands of another set of professionals, namely lawyers, some of whom appear to see court action primarily as a means of making a great deal of money. There is no doubt that many people who took Vioxx are hurt and angry, feelings which lawyers filing compensation claims have no reason to discourage.

British law firms reported a flood of calls from potential clients over the weekend. This is on top of the 4,000 negligence claims already filed worldwide, leading some experts to predict that Vioxx may in the end cost Merck more than $50bn (£27.75bn).

It also has to be said, however, that millions of arthritis sufferers were desperate to get their hands on the new class of anti-inflammatory drugs known as COX-2 inhibitors, which includes Vioxx; these drugs were believed to be more effective than old-style painkillers, while reducing the risk of ulcers and gastric problems which were associated with earlier treatments.

Arthritis is a very painful and sometimes crippling condition, which many of us have witnessed in friends or relatives, and I am not convinced that the researchers who developed Vioxx were motivated solely by the prospect of increasing the company's profits.

Whether the company suppressed data in the late 1990s suggesting that the painkiller was linked to cardiovascular problems, as alleged in the Texas case, is another matter. The drug was finally withdrawn last September, to the dismay of thousands of patients in Europe and the US who had enjoyed its benefits without so far suffering damaging side-effects.

Even some patients who became seriously ill admit that, for the first few months of treatment, Vioxx seemed to be a wonder drug. And while lawyers are now ascribing as many as 60,000 fatalities to the painkiller, that figure has yet to be substantiated - not an easy task, given that the people who were prescribed it were older and more likely to suffer heart attacks than the young volunteers on whom it was tested.

Indeed, as seems to be the case with Seroxat, the anti-depressant which is now being linked with an increase in suicide attempts by adults, the side-effects of some drugs become fully apparent only when they are being used by large numbers of people over longish periods of time. In that sense, the furious reaction that always greets the news of a drug's withdrawal from the market is not entirely logical. It is driven, I think, by two impulses: a widespread distrust of drug companies, which stand to make massive profits from new drugs, and a wholly misplaced belief in the safety of prescription drugs.

This attitude is a throwback to a time when doctors had god-like status, handing out drugs to patients who knew little or nothing about their bodies and would not dream of questioning a prescription. These days, some GPs at least are frank about the fact that no drug is 100 per cent safe and discuss both the probable benefits and potentially harmful side-effects before prescribing. They also know that many patients are quite capable of looking up drugs on the internet, where a massive amount of information from medical journals is easily accessed.

It seems reasonable to argue that as more information becomes available, patients should start to assume some responsibility for decisions about the drugs they take. Yet the myth persists that once a drug has been tested and cleared for use by the general public, nothing should ever go wrong. When it does, lawyers rush to become involved, people whose ill health may have other causes file claims, drug companies concentrate on defending themselves against vast compensation awards, and the truth becomes almost impossible to establish.

At a moment when Vioxx is being vilified as though it were the new Thalidomide, it is still not clear what proportion of patients have their risk of a heart attack doubled after taking it for more than 18 months. Nor has it been established whether some patients might consider that risk worth taking to get relief from chronic pain. Now, thanks to unrealistic expectations about drug safety and multiplying negligence claims, it seems unlikely that they will ever be offered the choice.

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