Important Lessons from The

For medicines that were meant to relieve pain, Vioxx and its relatives a new generation of anti-inflammatory drugs called the cox a inhibitors are causing spasms all round. Since Vioxx was withdrawn from sale late last year by Merck, its maker, because of its association with an increased risk of nasty cardiovascular side effects, sharp questions have been asked about how big drug firms communicate risks to the wider world, how they market their wares and how effective government regulators are in policing the industry.

The American public now seems to distrust the very firms that are supposed to be helping to lead the fight against disease. The latest example of this came last week in Texas, where a jury awarded the widow of a man who died of a heart arrhythmia, having taken Vioxx for less than a year, $253m in damages.

Merck rightly argues that the scientific facts of the case do not support this verdict, and has vowed to appeal the decision. The award will, in any case, be vastly reduced under Texas law. And yet the verdict, even if overturned, is symptomatic of public attitudes. The jurors were outraged at evidence that Merck may have known of the risks of Vioxx years before it revealed them.

The Texas case is only one of more than 4,000 filed against Merck on Vioxx. Whatever happens in those cases, Merck, like all big drug firms, now faces closer scrutiny and, probably, tighter regulation in America.

This should force the big drug firms to change their business models, sooner rather than later. That is bound to be painful. These firms have been among the most profitable in the world, and much of their profit has been earned in America, where prices are highest. But if they are to continue to thrive, and generate new drugs in the future, they need to move quickly.

Part of the drug firms' problem is that they have not, in fact, been generating enough new drugs. As the flow of genuinely original treatments has slowed to a trickle, the new drugs they have brought to market have tended to resemble those already on sale.

The firms have pushed these with massive marketing efforts, aimed at both doctors and patients, reaching the latter with direct-to-consumer advertising on prime-time television and other media. The irony of Vioxx is that such blockbuster marketing, intended to bring the drug to as many people as possible, has taken it out of the reach of all. Vioxx is not a bad medicine; in fact it is a useful drug for certain patients who suffer dangerous side-effects from other painkillers. But aggressive marketing meant that those who could have found relief on other drugs were given Vioxx and exposed to its risks.

The Vioxx episode has proven so painful for Merck that there are signs other drugmalcers are learning from it. The industry's American trade body, PhxMa, has announced guidelines with a view to more balanced communication of a drug's risks and benefits. Some firms have gone further.

Pfizer has said it will air ads for Viagra only during programmes for which at least 90% of viewers are adults (so goodbye Super-bowl); Bristol-Myers Squibb has promised to refrain from advertising its drugs during their first year on the market.

There are signs, too, that the companies are starting to reconsider the way they sell drugs to doctors, after a backlash against the customary "food, flattery and friendship" on offer. Indeed, they may have little choice.

More of the drugs to emerge from their labs in the future are likely to be for diseases such as cancer, which require detailed marketing to medical specialists for select populations.

And in the longer term the drug industry will have to exploit the trend in medicine towards more personalised treatments. These are being driven by advances in genetics, which will make possible much more accurate diagnoses, and more tailored drugs, for much smaller groups of people. For these kinds of drugs, mass-consumer marketing will be even more inappropriate than it was for Vioxx. The days of the blockbuster drug are numbered.

In the wake of Vioxx and other controversial episodes, the big drug firms not only have to find a better way to market their wares, but also to rebuild their reputations with growing numbers of sceptical Americans.

The best way to do that is to refocus their resources on research rather than marketing, and to come up with genuinely new treatments and more appropriate advice about how to use them. The future of pharmaceuticals lies in drugs that treat not just symptoms, but the underlying cause of a disorder. The pharmaceutical industry should settle for no less a remedy for its own condition.

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