It began with the publication of a research letter,1 the third paper from a group of researchers in a series concerned with the accountability and transparency of randomised trials.2 3 It led not to debate through the normal scientific forums but to a series of public attacks by a national drug industry body on the integrity of the researchers, culminating in a formal accusation that they were guilty of scientific misconduct.

JAMA published “Constraints on publication rights in industry-related clinical trials” in April 2006. The paper was based on a study of 44 industry initiated randomised trials approved by the scientific and ethics committees for Copenhagen and Frederiksberg in Denmark in 1994-5 and published in 2004.1

The researchers, of whom four worked for the Nordic Cochrane Centre in Denmark and two for the Centre for Statistics in Medicine in Oxford, had chosen to work with the Danish material because they were denied access to trial protocols in the UK. They found that in half of the trials they examined a sponsor had the ability to prevent publication and was in a position to have “recourse to practical or legal obstacles in most of the others.”

Although half of the protocols “noted that the sponsor either owned the data, needed to approve the manuscript, or both” neither of these constraints was mentioned in any of the published papers. The protocols also showed that the sponsor had access to accumulating data in 16 of the trials, although this was disclosed in only one paper. In another 16 trials, the sponsor had the right to end the trial, at any time and for any reason. None of …