Expert View: The world needs drugs companies to get well soon

Regulators are too often on the back foot in crises
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The Independent Online

Big pharma is in a state of crisis. Public trust is at an all-time low. Recent polls show that drugs companies are no more trusted than the insurance, tobacco or oil industries. These days the public views the sector as greedy, putting profits before people's wellbeing and ignoring warnings about the safety of some drugs.

Yet it seems only yesterday that the same group of companies were being lauded for prolonging and saving lives, for developing large-scale, highly skilled workforces in research and development, and for making shareholders and pension funds better off.

So what went wrong and what can the sector do about it?

Big pharma's reputation is intertwined with that of its regulators, and here in particular I refer to the US Food and Drug Administration, the largest pharmaceutical regulator in the world. For many years the FDA was perceived as tough but fair. It had rescued the American public from the thalidomide disaster (which was largely averted in the US, though not in the UK) and had promoted strict scientific standards for drugs testing.

However, more recently, cracks have begun to appear in the FDA's reputation, caused primarily by the increased number of drug recalls and by concerns about a runaway rate of health scares involving prescription drugs. Legislators and politicians became worried and started inquiries into the conduct of the regulator. This process was made more complicated and drawn out because, during these inquiries, the FDA has remained de facto leaderless.

The undermining of the FDA's credibility is occurring at a time when big pharma is having problems of its own. It is suffering from lack of new products in its R&D pipeline, forcing it to rely on ever-heavier marketing of its few blockbusters. In some cases, this has had detrimental effects on public health. (How many of those individuals who took the now-withdrawn painkiller Vioxx actually needed to do so?)

Meanwhile, health professionals and the public are complaining about the rising cost of prescription drugs. More often than not, the media portrays big pharma in a bad light, citing its critics rather than those who defend it, or even neutral observers.

Lawyers, particularly in the US, have closely followed these developments. Realising that drugs companies have deep pockets, they saw an opportunity to target the sector. What they needed was a trigger, and this was duly handed to them by Merck's decision to take Vioxx off the market. Clearly, had the public not lost confidence in the FDA, it is highly unlikely that Merck would be facing 6,500 lawsuits today.

If we are to rebuild trust in the pharmaceutical sector, a three-pronged strategy is needed. First, the industry needs to become much more proactive in its risk communication through up-front "homework". This would involve engaging highly trusted neutral third parties, being transparent about its methods of working, and addressing head on the reasons why the industry is distrusted. Providing drugs free of charge to developing countries, limiting direct-to-consumer advertising and lowering prices for certain essential products would all help to achieve this.

Second, regulators too are often on the back foot in crises, fire-fighting rather than leading from the front. Pharma groups and their regulators need to address this by conducting drugs trials as early as possible, tackling the "information vacuum", communicating with the public frequently and accurately, and actively engaging with academics working in this area.

Finally, the media must become more accurate and less prejudiced in its coverage of big pharma. It needs to focus on the benefits of drugs and not just the risks, and be encouraged to develop media risk communication guidelines, similar to those presently being rolled out by the BBC. After all, the pharmaceutical sector needs regulators to be effective, and this can happen only if they have public trust.

Ragnar Lofstedt is head of the King's Centre for Risk Management, King's College London

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