On the eve of vital meetings of US Food and Drug Administration advisory panels on the safety of COX-2 inhibitors, a senior official at the agency dropped a bombshell by refusing to present new data on the cardiac risk of painkillers, saying he feels intimidated by his superiors in the FDA.
David Graham, associate director for science and medicine at the FDA’s Office of Drug Safety, who has been critical of the handling of the withdrawal of Merck & Co’s COX-2 inhibitor, Vioxx (rofecoxib) last year [[19/11/04a]], was due to present data from California’s Medicaid programme which looked at more than 15,000 heart attack patients. However, he changed his mind after he received an e-mail from Office of Pharmacoepidemiology and Statistical Science director, Paul Seligman, which said that if Dr Graham continued to press for inclusion of the new data, he would be doing so at his own risk, according to a Reuters report.
Dr Graham told Reuters in an interview that he had not been offered a real choice and “because I feel so threatened by management, it’s not worth taking the risk”. He went on to claim “our findings are important to the safety of a number of marketed pain relievers”. However, the FDA’s line is that it simply prefers to deal with data that has been published yet this is the second time that it has had to respond to accusations that it is bullying its staff [[06/12/04d]], and Dr Graham in particular.
Citing Senator Charles Grassley, chairman of the Senate Finance Committee that held the hearing in November into Vioxx, who quoted from the e-mail sent by Dr Seligman, Reuters noted: “I think we’ve already articulated our preference that your talk cover the key studies in the published literature. Clearly, you would like to cover more than this which is your call.” The senator went on to say in a letter to FDA acting commissioner, Lester Crawford, that “Dr Seligman is clearly saying to Dr Graham ‘proceed at your own risk’.” However, it is agreed that the decision not to present the data was Dr Graham’s alone.
The FDA panels will be reviewing safety data on Vioxx and Merck’s Arcoxia (etoricoxib), Novartis’ Prexige (lumaricoxib), Pfizer’s Celebrex (celecoxib) and Bextra (valdecoxib), as well as Wyeth’s Lodine (etodolac), ibuprofen and naproxen. Arcoxia and Prexige have not yet been approved by the agency.
