In Reply: As Dr Graham, Dr Goldman, and Drs
Greene and La Vaque point out, the population treated with a drug is more
diverse than the population in which it was initially studied. Nonetheless,
the most serious ADRs, such as those identified by Lasser et al,1
seem best explained by the much more extensive use after marketing and not
by the greater diversity or comorbidity of the treated population, with some
important exceptions. In premarketing clinical trials, drugs known to interact
with the test drug would be scrupulously avoided; this avoidance is not ensured
once the drug is marketed. In addition, few new drugs are studied in pregnant
women. Of the ADRs identified by Lasser et al leading to box warnings or withdrawal,
few (perhaps suprofen, used in dehydrated patients or some of the QT-prolonging
drugs, used in patients with prolonged QT prior to taking the drug) seem principally
related to the larger numbers of people receiving drugs in society.
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