Mary Talley Bowden on pharmaceuticals: what the evidence says · JRE #2335
SUBJECT: PHARMACEUTICALS
Not a true/false call. Every claim is logged with its sources; read the exhibits below.
Well, yes, about 33%. They looked at it over 10 years. 33% had significant safety warnings on the drugs. And it took about four years for those to become recognized.
What the evidence says 01 / RECORD
Bowden's figures track a 2017 JAMA cohort study (Downing et al.) of 222 novel therapeutics approved by the FDA between 2001 and 2010. That study found 71 of them (32.0 percent) had a postmarket safety event, defined as a market withdrawal, a new boxed warning, or an FDA safety communication. The median time from approval to the first such event was 4.2 years (interquartile range 2.5 to 6.0 years), and the study estimated that roughly 31 percent of therapeutics had experienced an event by about 10 years post-approval. Her roughly one-third figure, the four-year median, and the roughly 10-year framing all align with the published results, so the claim is roughly accurate.