Ragnar Lofstedt: Drug labels give you a headache

Although no one will agree with all of the recommendations in last week's Sandler and Pickering reports into savings and pensions, the duo must be congratulated for highlighting the consumer confusion caused by complex financial products.

Part of this complexity is due to the regulatory burden on fund managers. The legalistic "explanatory" material increases information at the price of confusion. But this problem stretches way beyond savings and pensions.

Have you ever tried reading all the warning text you get with any medicine? Do you understand it all? Do you feel more reassured after reading it? Probably not.

Pharmaceutical warning labels are becoming more complicated and obscure. This is not entirely the fault of the pharmaceutical companies, which want to ensure that their patients take the doses at appropriate times and are properly warned about the possible side-effects of the medicines they market and sell. Healthy patients can enhance a company's profits and reputation, just as side effects and the consequences of not taking drugs properly can destroy them.

No, the issue of complex medicine labels is chiefly the fault of the lawyers, in particular US ones. Due to the increasing number of medical malpractice suits in the US and regulatory disclosure requirements, pharmaceutical companies have to list all the possible side-effects, even if the likelihood of these occurring is infinitesimal. However, if the potential side- effect is listed, it is harder for a lawyer to sue on the affected patients' behalf as they have, in a sense, been warned.

A similar debate is raging over smokers, who have been suing tobacco companies for in effect making them ill. The companies have responded by pointing out that cigarette packets have carried warnings for more than 30 years, making the smokers' legal challenge much more difficult.

However, the warning labels on most medicines are not as clear or concise as those on cigarette packs. Indeed, reams of medical research literature are devoted to "health illiteracy" and patient confusion.

Clearly, this is not acceptable, but the problem may well get worse before it can get any better as it seems that legal trends are being exported from the US to Europe with perhaps a five-year time lag.

One way of resolving the issue would be to ask pharmaceutical groups to work with patient groups, via independent intermediaries, in addressing how to create future warning labels that actually serve patients' interests. Such labels would identify the information most important to patients, present it in a comprehensible way, and evaluate the result empirically to ensure it works as intended.

Such research is presently being carried out by a team at Carnegie Mellon University in Pittsburgh. It is couched as trying to give patients adequate "mental models" of their conditions and the role of drugs in them. Such patients are better empowered to manage their own health and share decision-making with their physicians.

The results have been good: patients actually understand what they are reading. Of course, the labels would still have to pass muster with corporate legal teams and the regulatory authorities, but it seems the lawyers are favourably inclined as well. Indeed, there are signs that the research team's ideas are being exported to the UK.

So what's next? Instead of waiting for a Sandler-type report on pharmaceutical labels, we could experiment with the mental model or a patient-centred approach to risk communication. British patients deserve it.

Professor Ragnar Lofstedt is the director of King's Centre for Risk Management, King's College London.