Dr Juliette Säwe
Medical Products Agency, Sweden

Few clinical trials are published in peer-reviewed journals at the time a drug is registered; however, the Medical Products Agency (MPA) is planning to make public on their web site all clinical trial results submitted in the dossier. This is in addition to the evaluation monographs, summaries of products characteristics (SPCs), and patient information leaflets (PILs) that MPA has already published on the Internet. PILs, monographs, and overhead presentations are only available in Swedish (http://www.mpa.se/mono/monomatris2.shtml), but the SPCs are also available in English (http://www3.mpa.se/spc/nn_spcindex.html).

Who has access to the information? The industry, the regulators and the scientists. But the different sectors (drug industry, universities, medical agencies, healthcare professionals, patient organizations) have different goals and roles.

Who has the information? The industry and the regulators. The public should know what is in the files, but it can be difficult for the public to gain access to this information. Providing objective, unbiased information is not without difficulty and presents a constant challenge. Medical journals have established rules for publishing trial results in order to avoid such problems, but some doctors still accuse them of not addressing critical issues in an unbiased manner. Even patient organizations are not always an independent source of information because they may get funds from the industry. The problem is that it is the industry that has the information and it is the industry that selects what is published and reported. An example of this is a class study (celecoxib vs. ibuprofen/diclofenac) where celecoxib was shown to be better, even if it is not really better (celecoxib has no advantage over ibuprofen as judged by adverse drug reactions but it may appear to have an advantage if the ibuprofen and diclofenac data are pooled).

To avoid bias, the Declaration of Helsinki (DOH) clearly states that ‘Negative results have to be published...’ (p. 27) [5]. The challenge is to make this information more broadly available. The drug regulatory authorities are in a unique position to do this because they have the information and can cover all drugs. Thus they have the information to put on a web site and are also responsible for making this information (SPCs, PILs, monographs) available.