Are the kids asleep yet?

Observations on drugs

It's the prize no company wants. But the victor in the Bad Products Awards 2007, organised by the US-based Consumers International (CI), certainly deserved to win. Tough competition came from Mattel for having sold 21 million toys with design faults that included dangerously high levels of lead. Coca-Cola's mineral water that turned out to be tap water earned a mention. But Takeda Pharmaceuticals was a worthy overall champion for its promotion of sleeping pills to children.

The television ads for Takeda's pill, which goes by the name of Rozerem, aired in the US in autumn 2006, just as the school term was beginning. Visuals included shots of textbooks, yellow school buses and children carrying backpacks. A voice-over declared: "Rozerem would like to remind you that it's back to school season," and recommended that viewers "ask your doctor today if Rozerem is right for you". The final shot contained the drug's logo and the tagline "Back to School".

As CI said, announcing the award: "It doesn't take a PhD in marketing to see this is an effort to persuade parents to seek out the sleeping drug for their children - to help them get through the stress of term starting."

Yet Rozerem is approved only for adults. One reason for this, which the marketing folk would have been aware of from the safety label that comes with every packet, is that the drug can affect levels of reproductive hormones such as testosterone. Since it is unclear what would happen if children's hormone levels were disturbed by the pills, regulators had decided the product should be adults-only. What is shocking is what happened next. The answer being: not much. Complaints were made, but the US Food and Drug Admin istration did nothing until March 2007, by which time the ads were no longer running. Takeda got a mild ticking off, which it managed to brush aside by blaming an external marketing firm for acting without its approval.

If this sounds a uniquely American story, think again. At the moment, the US and New Zealand are the only two countries where drug companies can advertise prescription drugs direct to consumers. But the industry has Europe in its sights.

Under proposals being considered by the European Commission, companies would be able to fund non-promotional health education material. To hear industry talk, this would be a win-win solution: companies could inform the public about their products, while patients would get access to educational materials at no cost to the taxpayer.

It will be advertising by the back door. In the US, more than half of the continuing-education courses physicians take after qualifying are paid for by drug companies. One recent study of 17 educational events paid for by drug firms revealed a clear bias in more than half. Speakers would discuss the benefits of a sponsor's drug, for example, but downplay side effects and ignore rival products.

Europe may not not see anything as bad as the Rozerem ads if drug firms are given a hand in generating educational materials. But why take the risk? Public education is best done by public bodies.