Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has come under fire after a US senator reportedly accused it of trying to suppress the presentation of a major study at the upcoming COX-2 heart safety review meeting.
Subscribe to our email newsletter
The study was co-written by Dr David Graham, one of the FDA’s own scientists and a long-time critic of COX-2 inhibitors such as Merck & Co’s Vioxx and Pfizer’s Celebrex. It is said to contain information about heart risks associated with a number of painkillers, including the COX-2 class, but Dr Graham is being prevented from presenting information from the study at the meeting, according to reports.
In a letter, Iowa Republican Senator Charles Grassley is believed to have demanded that the FDA issue a formal response as to why it has not made reviewing the study findings a priority.
Meanwhile, the COX-2s debate continues to heat up as Merck and Pfizer offer conflicting safety information. As noted by the FT.com, Pfizer’s submissions to the FDA state that safety concerns are only applicable to Merck’s Vioxx and Arcoxia products, while Merck’s documents maintain the possibility that Vioxx-like cardiovascular risks could be common to the entire COX-2 class.