An FDA panel has begun to consider whether to remove the lung cancer drug Iressa from the market. As the New York Times reports, the drug "was rapidly approved for use by desperate patients but has now failed to prolong lives in a large clinical trial."
The Times reported that FDA "officials suggested, though, that they would not deprive patients now taking Iressa from continuing to receive it, and panel members did not seem inclined to remove the drug from the market."
In the Times story, Dr. Otis W. Brawley, a panel member and oncologist at Emory University, said that perhaps the drug should not have been approved until it was better understood who could benefit.
"The development of this drug has been mishandled," Dr. Brawley said. "It's been mishandled by AstraZeneca. It's been mishandled by this committee."
"We still haven't figured out how it should be used," he said.
The advocacy group Public Citizen said, in a news release: "The continued use of Iressa "puts all patients at risk for a serious and potentially fatal lung disease that is occurring with a relatively high incidence," said Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group. "Leaving Iressa on the market increases the likelihood that patients will be diverted from an effective therapy to an ineffective therapy, endangering their lives. Keeping a drug on the market while effectively telling people to avoid taking it is not an adequate public health response."