The British Medical Journal has given a cautious welcome to the announcement by the world’s pharmaceutical companies that they will make results from clinical trials of new drugs publicly available, regardless of the outcome [[07/01/05a]].
However, it adds that “cynically, you might argue that recent alarms about the safety of highly prescribed drugs and subsequent plunges in share price may have inspired this display of virtue,” noting the problems faced by the some of the biggest players in the industry with some of their biggest earners. It cites the safety problems AstraZeneca appears to be having with its lipid-lowerer, Crestor (rosuvastatin), concerns that Pfizer’s COX-2 inhibitor, Celebrex (celecoxib), increases risk of heart attack [[20/12/04a]], and the withdrawal of Merck’s Vioxx (rofecoxib) last October [[01/10/04a]].
The BMJ also notes pressure for full disclosure of trial results, particularly in the USA, is another driver of change and an initiative by leading medical journals to not publish trial results unless the data are included in a public registry [[10/09/04b]]. However, the BMJ acknowledges that it is unclear how successful this move will be, as “there are thousands of other journals for drug companies to choose.”
The key words are “full disclosure” and while “the drug company initiative is a step in a direction that should meet with approval from journals, politicians, and the public,” it needs to be improved. “The sting in the tail is, once again, the voluntary nature of the proposal – unless it is mandatory it will not work or be trusted,” says the journal, which wants to know how the system will be enforced and who will monitor it. If a drug company says it is participating, “how can we be sure it is playing by the rules?” it asks.
The journal also notes that drugmakers can present data on their own websites and worries as to how this information will be harmonised, or how effective the mechanism to link these websites will be, saying that “presenting information on all sorts of different websites in all sorts of different ways will be problematic.”
The BMJ states that “as companies dither over whether or not to join this venture and whether or not to cloak their commercial interests, they should remember that it is participants in those trials... who are as much owners of that ‘proprietary’ information as the companies.” In any case, the journal concludes: “It may take several years to judge this initiative’s success, by which time legislation may have made it mandatory.”
