Data Sharing, Federal Rule of Evidence 702, and the Lions in the Undergrowth

Abstract

Many concerns would find it useful to have a publicly available database recording exposures to particular substances, with contextual information. The European Union's Registration, Evaluations, Authorisation, and restriction of Chemicals regulation has increased interest in this. It has been suggested that journals should require detailed publication of exposure data with papers. But there are problems for researchers, for whom the data are a valuable resource which has been obtained with effort and often ingenuity. The publication could also raise problems of confidentiality and liability, and those who have to put the effort in publication are not those who benefit. Also, there are the problems of hostile critics misusing the information--for example, industry re-analysing data to counter any regulatory implications of a study--and this raises serious wider issues of editorial policy. Two books have recently given examples of industry misuse of science, 'Doubt is their product' by David Michaels and 'Defending the indefensible' by McCullogh and Tweedale. Michaels gives examples of hostile data reanalysis, and among other things, he discusses the impact on journals of US Federal Rule of Evidence 702, which encourages expert witnesses to try to get their testimony material into peer-reviewed journals. This certainly lies behind some submissions to this journal, and Michaels says that it has led to the creation of peer-reviewed journals which have strong industry influence. On the other hand, work funded by industry is not always wrong, papers from other sources are not always free from bias, and the problem for journals is to continue to apply consistent scientific standards in a sea of conflicting interests. It does not seem feasible or desirable for journals to insist on the publication of all the underlying data, although researchers might be encouraged to form consortia to share data.