I know, I know, I am terribly behind on the Article Reviews. A fascinating study appeared in the Archives of Internal Medicine today, reporting that serious adverse drug events ("ADEs") tripled between 1998 and 2007, from 34,966 to 89,842. Reported deaths also nearly tripled, rising from 5,519 to 15,107.
What's more, there is ample reason to suspect that these estimates are conservative. First, there is a long tradition of underreporting of ADEs. Where such ADEs occur in relation to clinical trials, there are added financial and academic pressures to downplay an ADE, or, where possible, avoid labeling a side effect an actual ADE. Second, a study published in Drug Safety less than three weeks ago found that "doctors frequently ignored or dismissed patients' concerns about such side effects." Such dismissal feeds into the first problem, because it renders it highly unlikely the physician will deem the side effects ADEs. In turn, this means the side effects are not reported to the FDA.
