Is your Doctor in Denial?

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!

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I suspect better post-market reporting of adverse events will happen, just not real soon. The politicians won't push it (they're paid by the pharma companies), but the judicial system might (cost of lawsuits from injured patients) unless the Congress provides protection. Most likely we will need to wait for an egregious outcome from failure to report adverse events involving children. It's a statistical inevitability, but only when the public becomes enraged will the political will be found to address the issue.

Even then the accuracy or the reporting will never be that great. I personally had an experience with a "Doctor in Denial". I was amused by it, but then I'm a flaming cynic so what amuses me would horrify others. A physician performed a vasectomy in an office on yours truly, used no antibiotics during the procedure and prescribed no antibiotics post-surgery; he claimed he never had a problem with infections. Right. So, 72 hours later when my balls were inflamed, he grudgingly prescribed antibiotic, claiming that it wasn't really an infection. He was just doing it to "make me happy". Indeed, I was very happy when the inflammation subsided 24 hours later. I'm reasonably certain that at the at the same time, in his mind, his operational success without antibiotics was unblemished. I'd comment on what I think of physicians in general, but you know what I'm going to say and its probably unfair...but applicable to the majority.

By Uncle Bob (not verified) on 30 Aug 2007 #permalink

The New Zealand pharmacovigilance system seems to be well respected around the world. The problem is that we only have 4 million people. So our ability to detect rare effects or effects in drugs that aren't used by a large number of people is limited.

It does need to be done properly somewhere much larger, like the US.

There should be an end user database for reporting side effects. In other words, patients should be able to go to an FDA website and complain about their drugs.

Citizens can complain to the FDA, who complians to the manufacturer, who sends the doc a form to fill out. Most of the complaints are the old plague of medical toxicology, non-specific symptomology. Stuff like "feeling woozy", nausea, etc. The docs ain't dumb. So they tend not to waste time filling out the forms.

A clue for non-clinicians and the numerically-illiterate: Don't blame the docs or the drug companies. There are very few medical symptoms with are specific to a particular toxic agent. So the noise level is incredibly high.

What show up in post-approval serveillance are idiosyncratic reactions (e.g., liver injury) that are too uncommon to show up in the trials, which typically involve 3K-5K patients, max. So what are you going to do--not approve any new drugs, just in case?