Quick update on the FDA’s draft policy regarding promotion of off-label drug use, which Gavin blogged about last July. Despite widespread negative publicity in the blogosphere along with opposition from health organisations and consumer advocates, the proposals have now been released as formal guidance from the agency. Essentially this policy now means that drug companies can promote off-label drug use by circulating reprints of journal articles describing those uses to doctors. Providing the FDA’s guidance is followed, FDA does not see the activity as “establishing intent that the product be used for an unapproved new use…” We know, for all the reasons described in Gavin’s blog (and in a recent PLoS Medicine article), that promoting off-label use is potentially harmful to patients. (Note also this week Eli Lilly has been reported in BMJ as settling “the largest individual corporate fine in history”, in relation to off-label promotion of olanzapine). Despite this, the policy is described as only “guidance”, with the document stating that “FDA’s guidance documents do not establish legally enforceable rights or responsibilities”. I, and presumably others, are left wondering how it will be possible for the agency to enforce pharmaceutical promotion in the future.
Archives for January 2009
A rather amazing thing happened this week in the often somewhat sorry state of reporting of medical research
This was a question posed by Denise Grady in an article in the New York Times earlier this month. Her piece outlined the arguments in a PLoS Medicine debate on the ethical responsibilities of doctors towards their patients that was published back in October.
The debate examined the question of whether a surgeon treating patients with cancer whose treatment results are not as good as those at another hospital, has an ethical obligation to tell to his or her patients about the better results at hospitals elsewhere. And although the debate did not attract a lot of attention in the wider media when it was published, it has recently fuelled considerable and thoughtful comment on the New York Times site and on blogs.
After the resounding success of our first ever Open Access Day in 2008, where we had nearly 130 participating organizations from almost 30 countries, we are pleased to announce that this year's events will be scheduled during the week of 19-23 October 2009. Why a week rather than a day?
Tom Tregenza is a Royal Society Research Fellow at the Centre for Ecology & Conservation at the University of Exeter’s Cornwall campus. He recently became the Section Editor for Evolution at PLoS ONE and in this capacity he has already handled 82 manuscripts. We talked over Skype last week about his science and about the world of scientific publishing.
In partnership with the release of today's blog interview with Tom Tregenza, we're also pleased to highlight his top picks of articles in Evolutionary Biology from the 26 where he was the Academic Editor. He also provided helpful notes of explanation as to why he included them in his favorites. We welcome more submissions from this community.
A number of papers published in PLoS ONE in 2008 have been featured in some recent round-ups of the year's best—and quirkiest—research. From worm grunting to an explanation for the superior sound of Stradivarius violins compared with modern violins, as ever, the highlighted articles cover a wide range of different scientific disciplines and topics.