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Leading article: Drugs companies have brought these troubles upon themselves

Saturday 08 March 2008 01:00 GMT
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It has been another wretched week for the multinational pharmaceuticals industry. It turns out that last month's study from the University of Hull, which revealed some of the best-known antidepressants on the market do little good, was only the first cuckoo cry in a troubled spring for large drug companies.

This week GlaxoSmithKline received serious criticism from the Medicines and Healthcare Regulatory Agency for failing promptly to pass on trial data that showed their antidepressant drug Seroxat exacerbates a risk of suicide in teenagers. This was followed by a promise from the Health minister Dawn Primarolo of new legislation to force the drug companies to disclose any information that could have a bearing on public safety. And just when the pharmaceutical companies might have imagined it could not get any worse, we now have claims of highly dubious practices by Reckitt Benckiser, the manufacturer of the popular indigestion remedy Gaviscon.

It is alleged that Reckitt, when its patent on Gaviscon ran out, sought to string out the process of a cheaper, generic version being brought to market through legal challenges and safety alarms. And this particular firm is unlikely to be alone if it is found to have manipulated patent rules. In January, the European Commission made dawn raids on the world's biggest drug firms to gather evidence of possible anti-competitive behaviour. And three years ago AstraZeneca was fined £40m by the EU for misusing the patent system to delay rival products to one of its drugs entering the market.

Such stalling tactics are different from the sort of abuse identified in the non-publication of unhelpful trial results. But they do illustrate, once again, how the interests of the drugs companies are by no means always aligned with those of the NHS and its patients. In the end, however, it is possible to see only one winner in this struggle. The Government is under immense pressure to cut costs in the NHS. The soaring drugs bill (which now devours 11 per cent of the NHS budget) would have been one of the most obvious targets for savings, even if the pharmaceutical industry had been behaving perfectly transparently and ethically. It is likely that this cost-saving motive was a contributory factor to Ms Primarolo's promise of "immediate steps" to introduce legislation on trial disclosure this week.

In truth, it is hard to see any alternative to some form of compulsion to make the pharmaceutical sector behave. There is clearly powerful commercial pressure within drugs companies to keep information secret. Sadly, these firms seem unable to differentiate between legitimate commercial confidentiality and the kind of secrecy that can endanger public safety. Decisions regarding disclosure need to be taken out of their hands altogether. And the lesson of the Gaviscon affair seems to be that the MHRA needs to take its job of keeping the industry in line much more seriously.

Of course, drugs companies have a right to profit from the products they discover, develop and bring to market at considerable expense. But they can never be allowed to sit on trial data that might cause patients harm. Nor can they be permitted to get away with passing off ineffective medicines as the real thing or stalling the introduction of generic rivals.

The irony is that, through such abuses, the drugs companies have actually been their own worst enemies. They have given the Government a fireproof justification for legislating. And that legislation has growing public support too. It seems likely that the pharmaceuticals industry is going to have to earn its profits the hard way from now on.

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