Recent exchanges over the publication of negative dataÂ continues to draw strong responses from FierceBiotech readers. Here's a sampling:
Wes McDermott, PhD, writes: "Jennie Mather's complaintÂ that negative data is difficult to publish is well taken. Even if traditional journals can be made to accept such a paper, it would likely take more rewriting and shopping around of the manuscript than anyone would want to do. However, there is now a journal which aims to publish all scientific results on purely technical criteria. That journal is PLoS ONE. As they say:
"Too often a journal's decision to publish a paper is dominated by subjective criteria, which can be frustrating and delay the publication of your work. PLoS ONE will publish all papers that are judged to be rigorous and technically sound. Judgments about the importance of any particular paper are then made after publication."
There are already a number of clinical papers published at PLoS ONE. Given its success, I expect other online journals with similar editorial policies to be founded. I don't have any connection with PLoS ONE or PLoS (though I did do a small amount of volunteer work for PLoS a few years ago), but I do like the journals and the open access ethic.
From Lee Buckler: "Further to your ongoing discussion with Jennie Mather, there is the Journal of Negative Results in Biomedicine. I'm not sure it would work to have the FDA force publication. It might be easier to have the NIH tie it as a condition to funding, but that of course only impacts NIH-funded projects. I would think that if there are a sufficient number of respectable, peer-reviewed journals (print and/or online) accepting negative results, that we can count on researcher's motivation for publication to get this data out there. To date I think the primary issue, as Jeannie pointed out, is the lack of journals that accept these papers and perhaps some stigma associated with publishing negative data. I think there is room for one or more journals in the biopharm sector to make it a matter of policy--if not primary focus--to encourage the publication of negative results. Perhaps these exist already and simply need more profile or perhaps, as an industry, we can encourage one or two more publishers to see the opportunity here.
And finally: In general I agree with Dr. Mather's comments. However, mandating publication is fraught with problems as publishers of journals are independent agents and they ultimately need to please their readership to maintain and grow their subscription lists. It is unclear that increasing the number of negative studies will ultimately benefit them.
With respect to the FDA, its has limited resources and can't adequately monitor the increasing tasks Congress has heaped on it over the years without proportionately increasing its annual budget. We do have freedom of the press in this country and editors ultimately control what gets published and what does not. I think it can be strongly argued that such a mandate to force publication would be unconstitutional.
That's from Douglas Winship, vice president-regulatory operations, Catalyst Pharmaceutical Partners. Thanks for all your feedback. - John Carroll