Merck & Co’s share price took another knocking in New York yesterday after US Food and Drug Administration scientist, Dr David Graham, said he was significantly upping his estimates on the number of patients that were harmed as a result of taking the company’s now withdrawn painkiller, Vioxx (rofecoxib) [[01/10/04a]].
Dr Graham, who has found himself at the centre of the furore surrounding drug safety in the USA [[25/11/04b]], told the Financial Times in an interview that he was planning to publish research showing that as many as 139,000 US patients were harmed as a result of taking Vioxx – more than five times the original estimate of almost 28,000 heart attacks or deaths [[07/10/04a]]. The FT believes the research will likely be published in UK medical journal, The Lancet, after the FDA banned the data from being published in the USA. “The FDA has suppressed the paper and maligned me in the media but never responded. The proper place for scientific information is in a peer-reviewed scientific journal,” Dr Graham told the paper in an interview.
The withdrawal of the multi-billion dollar drug has hit Merck hard, with billions wiped off its share price, the firm has also been forced to revise downwards its financial expectations for the coming year [[09/12/04c]], and has also extended a restructuring plan in a bid to save $2 billion by 2008 [[15/12/04a]]. The firm has already been subject of countless lawsuits claiming that it should have acted as soon as it was aware of the risks associated with Vioxx’s use back in 2001 [[04/10/04b]], [[09/02/01a]]. Clearly these latest figures could open the floodgates for even more lawsuits.
- Meanwhile, the FDA has recommended limiting the use of COX-2 inhibitors and non-steroidal anti-inflammatory drugs, as an interim measure ahead of a review of data that is continuing to be collected. The agency says that it is collecting and will be analysing all available information from the most recent studies of Vioxx, Pfizer's Celebrex (celecoxib) and Bextra (valdecoxib), and the generically available, naproxen, and other data for COX-2s and NSAIDs to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005, when the issues will be fully discussed [[20/10/04c]].
- In other news, Alnylam Pharmaceuticals says it has received a $7 million milestone payment from Merck as part of between the two companies to develop RNAi technology, which uses a natural biological mechanism to inhibit the expression of disease-causing genes, and to apply this technology to develop RNAi therapeutics that selectively target human diseases. Last year, the two firms signed a second deal to develop therapies for eye diseases [[01/07/04g]].