Ian Burgess told us about two trials on head lice treatments that had been kept hidden for 14 and 20 years. These trials involved 546 people (mostly children) in Bangladesh and the UK. Dr Burgess’ group managed to publish both of the trials this year in open access journals.
I have been wanting to publish the results of these trials for some time. However, until recently I have been too busy with new work to get down to doing the data mining necessary to pull all the threads together to make the data presentable for a proper peer reviewed evaluation.
The first trial was a comparison between two insecticide products and a combing method for the treatment of head louse infestation in 1997-98. This study involved 228 children and 50 adults from Bedfordshire, UK. I had written a manuscript soon after completion of the trial; however, publication at the time was vetoed by the company’s Medical Director. There was no chance of getting a change of heart until after the company broke up and the product was withdrawn from the market in 2009. So when things became a bit quieter in spring 2013, I dusted off the manuscript, redrafted it completely and submitted to F1000Research.
The editors, being ethical and conscientious, asked me to obtain an authorisation from the sponsor before publishing. Of course that was no easy task since the company no longer existed and most of the involved personnel were either employed elsewhere or retired. However, the bulk of the sponsor’s business had been acquired by another company, so I wrote to them and was eventually able to get in touch with the clinical trial unit of the company. After a couple more months, I received a note saying it was okay to go ahead. F1000Research were happy and the trial was published.
The second trial was an investigation of a head louse repellent in 1994. It involved 105 children and adults in Dhaka, Bangladesh and 163 children in North London, UK. The sponsor was taken over during the study and rather lost interest in the ambiguous results of the trial. The product remained on the market for the next 8 years until that arm of the company was sold off.
All of the sponsor personnel moved on, retired, or died, and the last contact I had with any of them was the trial supervisor saying I could publish the data if I thought it worthwhile. So, as with the previous study, I decided it was time the data saw the light of day. I slowly managed to piece together what had happened from various scraps of information into a manuscript and published the trial in PeerJ.
I hope this is helpful and informative. I have a bigger back catalogue of trials waiting to be published: in one case I haven’t got around to piecing things together and in three other cases I am waiting for the sponsor to agree.
Read other stories of researchers publishing their old data in our recovered trials series.
Burgess IF, Brown CM and Nair P. Comparison of phenothrin mousse, phenothrin lotion, and wet-combing for treatment of head louse infestation in the UK: a pragmatic randomised, controlled, assessor blind trial [v1; ref status: indexed, http://f1000r.es/1px]. F1000Research 2014, 3:158 (doi: 10.12688/f1000research.2026.1)
Burgess et al. (2014), Can head louse repellents really work? Field studies of piperonal 2% spray. PeerJ 2:e351; DOI 10.7717/peerj.351.