That’s the hed for the Washington Post story on the study that found that doctors ignored or dismissed patients concerns about side effects and didn’t report them to MedWatch (the FDA system for collecting side effects). The Post goes through some reasons for this but I think the end conclusion is that this is a very bad way of going about post-market safety. The data is extremely nosy, mainly due to the fact that not a lot of doctors use it (time, lazyness, or complexity of the forms?). Whatever the reason, events are under reported but I don’t think it’s the doctors’ fault; and while punchy I think the WP hed is inappropriate. There are three things we could do about it.
1) Force companies to finish and submit post-market safety studys. Currently, even if they comit to do one in order to get their drug approved, FDA has no recourse if they never do it. Congress will be fixing this if they ever get off their butts and reauthorize PDUFA. If they don’t do it by October, word on the street (by street I mean those hallways in Dirksen) is that FDA will have to start letting people go. With all the critism the agency is getting, I can’t see congress not passing this in time, but, hey, they’ve done some pretty stupid stuff in the past (even when they are aware of how stupid it is). For this truely to be a fix, post marketing studies would also have to be much more common and broad than they currently are.
2) The FDA could track and get feedback from patients and do the post-market studies themselves. The WP mentions that New Zealand sort of does this. This will take a large budget increase in discressionary $ from congress. Given #1, and the other $ constraints like Iraq, I can’t see this happening any time soon.
3) Managed care could push doctors to start reporting. Hah!