US researchers call for moratorium on direct to consumer adverts for prescription drugs

US researchers have used the New England Journal of Medicine to call for a moratorium on direct to consumer advertising of prescription drugs in the world's biggest market, backing up their argument with data negative to both industry and regulator.

10 years ago, the US Food and Drug Administration (FDA) authorised the direct-to-consumer advertising of prescription drugs on television.

Since the case of Merck & Co's Vioxx (rofecoxib), which had been heavily promoted by direct to consumer advertising, the FDA has also been criticised for its methods for controlling advertising.

In this "special article" published in the NEJM on Thursday, the authors have analysed the development of advertising expenditure in the pharmaceutical industry and, alongside this, the FDA's policy of control.

Total promotional expenses increased by 162%, going from US$11.4bn in 1996 to $29.9bn in 2005. Expenditure specific to direct-to-consumer advertising catapulted up by 330% over the same period, going from $985million to $4,237bn. In 2005, this type of advertising represented 14% of all promotional expenditure.

The analysis of 20 drugs which were the objects of the highest expenditure on direct-to-consumer advertising in 2005 (54.4% of the total in 2005) shows that this type of promotion particularly concerns new drugs indicated in chronic diseases and that the advertising campaign most frequently begins the year following approval by the FDA.

By examining the 10 best selling (in terms of turnover) therapeutic classes in the U.S. in 2005, the authors note that for the first two (statins and proton-pump inhibitors), direct advertising represents about one third of expenditure in the promotion of products but for the third (SSRI-type antidepressants) and the fourth (antipsychotics), it only amounts to 10% to 12% of expenditure.

Alongside this, the authors note that the letters sent by the FDA to the companies notifying them that they had violated drug advertising regulations went from 142 in 1997 to "only" 21 in 2006.

However, over the same period, the proportion of regulatory letters mentioning problems with direct-to-consumer advertising went from 15.5% to 33.3%. In nearly 84% of cases, these letters were concerned with advertisements minimising the product's adverse events or exaggerating its effectiveness.

In the U.S., in the context of discussions on draft legislation concerning the safety of medicines, a measure limiting advertising on television was in the end rejected. In Europe, the ban on direct-to-consumer advertising appears to be currently under threat.