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Objectives: A randomised controlled trial was undertaken to compare the efficacy of topical Calendula officinalis (Calendula) versus standard of care (Sorbolene: 10% glycerine in cetomacragol cream) in reducing the prevalence of radiation-induced dermatitis in women undergoing breast cancer radiotherapy. Methods: A total of 271 women were screened and 82 were randomised. The primary outcome was prevalence of acute radiation-induced dermatitis (RTOG grade 2+) assessed at multiple skin sites. A chi-squared test was conducted for the primary outcome with a worst-case scenario imputation. Results: The recruitment target (n = 178) was not achieved. A total of n = 81 participants were analysed (n = 40 Calendula; n = 41 Sorbolene). There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10). Conclusion: This randomised controlled trial showed no difference between Calendula and standard of care (Sorbolene) for the prevention of radiation-induced dermatitis. However, the study was underpowered (limited recruitment) for the primary comparison. Refereed/Peer-reviewed

Elsevier, publisher of The Lancet, is reviewing its publishing practice after court disclosure that it colluded with Merck to produce a fake journal, the Australasian Journal of Bone and Joint Medicine (AJBJM) to promote rofecoxib and other Merck products. Elsevier has called the incident an “isolated practice led by former employees in a local pharmaceutical services division”. This statement refers to the publication in Australia of nine fake journals, and the registration of another 13. Although Elsevier acknowledged that all the fakes “carried the name ‘journal of’ but lacked proper sponsor disclosures and were not in fact journals and should not have been titled as such”, it further defended its practice on the grounds that the AJBJM was the only one of the fakes bought by a single company. The others, it says, were “published with ads from multiple advertisers and therefore did not call for additional disclosure”. But neither the publication of faked journals nor the setting up of journals for a single advertiser turn out to be isolated to Australia, as revealed by an examination of the website of Excerpta Medica, Elsevier’s pharmaceutical services division. A case study describes how a “company-sponsored journal” was “initially released in December of 2004 to physicians in Europe and Canada” and “now includes versions translated for subscribers in Spain and Greece” for a client competing in a “very crowded and mature” cardiovascular market. From a “shallow base of clinical support”, the journal was designed to “position the client as a market leader” and “prepare the specialist and primary markets for future indications”. The website leaves little doubt that when Excerpta Medica “partner[s] with our clients in the pharmaceutical and biotech industries to educate”, education is a euphemism for marketing. For example, the strategic services off ered on the “Medical education” page include “Product positioning” and “Key opinion leader (KOL) development”. The Lancet is used to sell Excerpta Medica. As recently as June 18, a group managing director wrote: “Communications agencies linked to publishers can leverage the content from within their company”. Describing The Lancet’s symposium series, in which a pharmaceutical company sponsors a meeting where the authors and a “local thought leader” discuss a recently published paper with the audience, he said “The unique assets of the Lancet brand help to attract audiences and give the meetings the required credibility and impact.” Although the relationship between medical publishing and service to the pharmaceutical industry is not unique to Elsevier, we question the compatibility of these two roles.