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COX-2 advertising clampdown

A US Food and Drug Administration advisory panel has recommended a tight clampdown on consumer advertising for COX-2 inhibitors.

The rules governing the marketing of COX-2 inhibitors are set to change, after a US Food and Drug Administration (FDA) advisory panel recommended a tight clampdown on consumer advertising for the controversial class of painkillers.

COX-2s have come under increasing scrutiny since Merck pulled Vioxx from the market last year after it was linked with increasing the risk of heart attacks and strokes in patients.

Although the FDA panel stopped short of banning Vioxx and Pfizer's Celebrex and Bextra, a majority of the 32 medical experts called for individually tailored 'black box' warnings for the cardiovascular risk.

Most members said they opposed a return of commercials for the painkillers and wanted regulatory measures, including requiring advertisements devoted to risk warnings, to be imposed.

ìMany on the committee, including myself, were trying to send a very strong message that any kind of direct-to-consumer advertising for these drugs would be inappropriate,î said Alastair Wood, the panel's chairman and a professor at Vanderbilt University.

One panel member, psychologist Louis Morris said he believed part of the public backlash over heart risks and drug safety after Merck pulled Vioxx was in part ìdue to the direct-to-consumer advertising for these drugsî.

Seventeen panel members voted in favour of allowing Vioxx back on to the market, narrowly defeating 15 who voted against.

A Merck spokesman said it was premature to talk about advertising for Vioxx while questions remained over the future of the drug.

However, Pfizer welcomed a possible return to advertising Celebrex and Bextra. John LaMattina, president of the company's global research and development said: ìIf DTC is allowed with all the caveats we would have to give, I think that's appropriate.î

Advertising experts said that Pfizer and Merck were unlikely to recommence advertising until they had completed months of ad research.

ìThey must test to see if the negativity from the black-box warning outweighs the benefit of communicating the positive,î said DTC expert Mel Sokotch.

Celebrex and Vioxx were once among the most heavily advertised prescription medicines in the US. According to TNS Media Intelligence, Merck spent $78m on Vioxx advertising in 2003 and $72m during the first nine months of 2004 leading up to its withdrawal. Pfizer spent 87m on Celebrex ads in 2003 and 71m in the first nine months of 2004.

Meanwhile, UK regulator the Medicines and Healthcare products Regulatory Agency (MHRA) has announced it will name and shame companies which engage in misleading advertising.

The agency has updated its guidelines on advertising to introduce tougher measures against poor practice in the way companies set about their advertising and promotional campaigns.

30th September 2008


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