The US Food and Drug Administration has come under fire over claims that it is trying to prevent key clinical trial information from being presented at this week’s advisory panel meeting into the safety of the COX-2 inhibitor class of painkillers, which was triggered by Merck & Co’s withdrawal of Vioxx (rofecoxib), last year [[01/10/04a]].
The New York Times claims that Senator Charles Grassley wrote a latter to Lester Crawford, the FDA’s acting commissioner, demanding an explanation as to why the data, which suggested that Vioxx could have been linked to as many as 140,000 cases of serious heart disease in the five years it was on the market [[26/01/05a]], would not be presented at the hearing. The FDA reportedly defended itself to the paper, saying it had simply asked Dr David Graham – the scientist who has found himself at the centre of the COX-2 furore [[19/11/04a]] – to focus on published data in his presentation. The trial in question published in UK medical journal, The Lancet, earlier this year after the FDA banned the data from being published in the USA [[04/01/05a]], [[26/01/05a]].
However, in an interview with the New York Times, Dr Gurkipal Singh, of the Stanford University School of Medicine, who co-authored the large-scale study with Dr Graham, said that there was “significant new information that will alter the thinking about these drugs.” Dr Singh added: “I don’t understand why they won’t let us present this information.” The paper notes that Dr Graham was “frustrated” that he would not be allowed to present the new study.