Laurie Barclay, MD Oct. 1, 2002
Sounding board articles in the Sept. 26 issue of the New England Journal of Medicine generated significant media controversy about Xigris, or recombinant human activated protein C (HAP-C; drotrecogin alfa), which acts within blood vessels to treat severe sepsis. The authors stated that the data are encouraging but insufficient to make Xigris the standard of care.
The drug’s manufacturer Eli Lilly and Co. countered that this opinion is out of line with the Food and Drug Administration (FDA)’s position and that of other regulatory agencies in multiple countries. Both the FDA and Virginia Commonwealth University (VCU) jumped into the fray, issuing news releases promoting their viewpoints.
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