A physician writes about concerns over the fast track approval of new drugs in this week’s BMJ.
Three months after the Food and Drug Administration gave the drug natalizumab accelerated approval for treating relapsing multiple sclerosis, its makers withdrew it after three patients developed life-threatening conditions. Two of them died. The author lists the things that went wrong on the fast track: cumulative safety data weren't available, the trials' end points were dubious, the drug’s mechanism of action was always risky, and the animal model was not suitable.
The drug was licensed by the FDA in 2004 on the basis of short term results from two unpublished trials. The FDA granted approval before final trial and cumulative safety data were available. Natalizumab was predicted to be the leading drug for multiple sclerosis, with estimated annual sales in excess of 2 billion dollars.
The author says this case highlights the potential risks for patients in trials of new drugs where knowledge of long term efficacy, outcome measures, and safety is lacking.
Posted by schwitz at February 21, 2006 07:46 AM | TrackBackThe FDA is always being criticized for being slow and over-bearing, but here is an example of them protecting the public...
Posted by: John J at February 22, 2006 04:23 AM