In an
editorial this week, The New England Journal of Medicine editors urge Congress to pass PDUFA, calling it "the most important drug-safety legislation in a century," despite expressing misgivings about the relationship created between the FDA and drugmakers by increased user fees. The editors then list what they say a final bill must contain...
- The FDA needs authority to mandate postmarketing safety trials with specific results timetables and to conduct annual safety reviews for the first 3 years after a drug's approval and again at 7 years; Drug ads and labels must include a toll-free telephone number and an Internet address; Substantial penalties for drug ads that overstate efficacy or understate adverse effects; The FDA must be able to mandate changes to labels as new safey and efficacy info becomes available; Every new drug should have a pharmacovigilance plan at the time of approval, and Clinical trials of drugs must be registered in a public database.
What don't the editors insist upon? Mandatory posting of clinical trial results. Oddly, they say nothing about medical devices, despite the recent brouhaha over drug-coated stents, a topic the NEJM pursued in its own pages. And there's no mention of conflicts of interest among FDA advisory committee members, a hot-button issue that even the House bill addresses.
So to the editors - Greg Curfman, Steve Morrissey and Jeff Drazen - we want to know: why don't these topics rate?
9 Comments
Ed,
What, no mention of the WK Goodman Study regarding antidepressants in children...
A review of Placebo controlled clinical trials by FDA and the PDAC that brought about the Black Box warnings.
The study that established a "causal role" of self-mutilation,suicide and violent behaviour.And of course,lets not forget that they lack efficacy.
You published the Simon and Gibbons studies, and gave many a free reign in verbally abusing children and families who were harmed or killed due to the side effects of antidepressants!!!!
This Is Selective Journalism at its Best.....
Ed,
The Journal did publish an editorial regarding trial registration that briefly touches on results posting in the June 28 issue (http://content.nejm.org/cgi/content/full/356/26/2734). They and the other ICMJE editors have certainly had plenty to say about it (and the other things you mention) in the past.
After reading the editorial, it seems they were really giving a broad, 30,000-foot overview of what the FDA should be able to do in order to improve drug safety, and really stayed away from specifics. Basically, it's a call to put the teeth (back) into the FDA. And drilling down to the specifics of what Lisa really is inappropriate in this kind of editorial, otherwise they would have to tackle everyone's issues and the editorial would be several volumes long. (Not to mention they just had a couple of editorials regarding antidepressants.)
And really, If there's anyone I DON'T worry about giving their opinions, it's Drazen, Laine, and the rest of the ICMJE folks. Shrinking violets they are not.
Hi Reality,
Yes, I know. But since they took the trouble to run a laundry list, why not a couple more pertinent items? There's an old saying in journalism that the reader doesn't keep a clipbook, which is to say they don't remember everything that's been published. So if they're going to cite important items, they should've included the others, even if mentioned previously. Unless, of course, these aren't as important. Anyway, thanks for stopping by again.
cheers ed
Reality, Are you missing a sentence ot two,your two liner doesnt make sense.
Lisa,
I'm not sure what you're referring to. Can you be more specific?
Ed,
I definitely think--make that know--that they consider those other things important. But my guess is that they wanted to keep it very simple, with a big enough umbrella for the specifics to full under, but I get what you're saying.
Look at your first post.Curious ast to why you typed my name in...Line 5 of 2nd paragraph
Lisa,
I wrote that because in your post you seemed to indicate that NEJM should have included those points in their editorial, and that they were being selective in what they were writing about the FDA. I see that I left out a word or 2; it should've read "And drilling down to the specifics of what Lisa seems to be asking for..."
My comment was meant to be a polite jab at Ed.Even though it may not have appeared that way.