http://www.latimes.com/news/nation/reports/fda/lat_method001220.htm

Wednesday, December 20, 2000

How Deaths Were Calculated
     Reports of adverse drug reactions to the Food and Drug 
Administration are considered by public health officials to be the 
most reliable early warnings of a product's danger. The reports are 
filed to the FDA by health professionals, consumers and drug 
manufacturers. The Los Angeles Times inspected all reports filed in 
connection with seven drugs that were approved and withdrawn since 
1993. By hand and by computer, The Times counted 1,002 deaths in 
which the filer identified the drug as the leading suspect. Since 
fall 1997, this top category has been termed "primary suspect." The 
Times did not count any death in which the drug was identified as the 
"secondary suspect" or less. The methodology and results were 
reviewed by Sheila R. Weiss, a former FDA epidemiologist who is an 
assistant professor at the University of Maryland's department of 
pharmacy practice and sciences.


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