Emma Veitch's blog

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.

The Guardian's front page story from a couple of days ago ("NHS medical research plan threatens patient privacy") looks like it has generated some healthy and opinionated responses from readers, but the government consultation that led up to it has now closed. The story here is that the proposed UK National Health Service constitution - enshrining the principles and values of the NHS - contained, buried amongst other important stuff on issues such as access to services, quality of care, and informed choice, a crucial nugget which could change the way that medical researchers get access to patients' data.

The US has its Office of Research Integrity (ORI), and many Nordic countries (for example, Denmark, Norway, and Sweden) have national bodies that respond to cases of scientific misconduct; but the UK, and very many other countries, have nothing similar. Now the UK Research Integrity Office (UKRIO) has released guidance about what to do in cases of suspected research misconduct for "all organisations engaged in research using funds from funders such as the Research Councils and other government bodies, as well as from charities, overseas funding bodies and the commercial sector". A PDF copy of the guidance can be downloaded here (PDF file).

The Committee on Publication Ethics (COPE), of which PLoS Medicine, and other PLoS journals, are members, has recently released guidance for editors on the thorny topic of "research, audit and service evaluations". This guidance aims to help editors decide how to handle their journal's requirement for ethical review in relation to these types of studies. As outlined by COPE, most journals require that for any research involving human subjects, the study has been approved by a properly constituted ethics committee.

Just spotted an interesting letter in last week's Lancet discussing selective reporting of clinical trials. This may sound like something you've heard many times before (eg here) but in the Lancet letter the authors describe what happenned to trials for which the original protocols were posted on Lancet's own website.