A publicly mandated medical terminology with a restrictive license

Update: Good News! In the meantime, I've been contacted by MedDRA (most probably unrelated to this blog post) and after a fruitful discussion it seems to be possible for me to base SIDER on MedDRA.



The world's regulatory agencies are increasingly adopting and mandating a new medical terminology scheme called MedDRA to capture side effects (adverse drug reactions) during the regulatory process. (For example, it is used in CVAR, AERS and other instances at the FDA [pdf], which in turn have been used in recent papers). Sounds great, right? The only problem: The dataset is under an restrictive license (pdf): MedDRA data can only be shared among MedDRA subscribers (source [pdf]). I've clarified this via email with the help desk: one can only share text examples with less than 100 terms as examples, and no numeric codes.

This means: it is not possible to create a public dataset, or supplementary material for a paper, that contains a useful amount of data based on MedDRA. 

Two years ago, I created the SIDER database of drug–side effect relations (published in MSB). By relying only on publicly available drug labels and dictionaries like COSTART (with UMLS License Category 0), we were able to create a dataset that can be shared with everyone. (Disclaimer: we chose the license CC-BY-NC-SA.) If I were to base SIDER on MedDRA, the license would prevent me from making a machine-readable database available for download and further research. Thus, the next version of SIDER cannot be based on the dictionary of medical terms that regulatory agencies use at the moment.

What is especially sad about this is that the license fees themselves are not especially high, companies with an annual revenue less than $1 million have to pay only $190 USD, and I doubt that there are hundreds of subscribers who earn more than $5 billion and thus pay the maximum fee of $62,850 USD. So it would take relatively little financial effort to declare MedDRA a open access database.

IANAL, so it may be possible that a database like SIDER, which essential contains the following records: side effect identifier, side effect name, drug identifier, drug name, is derived enough to not fall under the MedDRA license. I remain doubtful, however, especially after reading the restrictions on UMLS License Category 3, under which MedDRA falls, like: "incorporation of material [...] in any publicly accessible computer-based information system [...] including the Internet; [...] creating derivative works from material from these copyrighted sources".

Information on public health, like drugs and their side effects, should be openly available for research, second only to privacy concerns. I'm not sure how to begin to change this (beyond writing this), but ideas are very welcome.


(Small fnord detail: MSSO, which manages MedDRA, is a subsidiary of the military contractor Northrop Grumman.)

Max Planck Society signs agreement with Springer

In October, I reported that the German Max Planck Society failed to reach a new license agreement with Springer. Now, via heise.de, I learn that they have signed an agreement on January 29, 2008. Here's the press release (there's also a German version).

They details are very sparse, presumably Springer had to come down with the price but they won't state that. However, the press release devotes a lot of space to Open Access, saying that the license agreement "also includes Open Choice™". Open Choice is Springer's author-pays-for-OA program. Now, what does this mean? It doesn't make sense to assume that the agreement talks about access to Open Choice articles, so I guess it must mean that all MPG articles are now going to be published under the Open Choice model. Querying PubMed a bit, I find that the MPG accounted for 6% of the total German research output, so this is certainly an interesting development.

Max Planck Society cancels license agreement with Springer

heise.de reports that the Max Planck Society, a major German research organization with more than 80 institutes, canceled the negotiations for a renewal of a license agreement for online access to SpringerLink with the end of the year. This means that almost 20,000 scientists will not have access to anything published in 1200 journals after the end of the year. (The archive will still be available.)

The reason that the talks failed is that Springer wanted twice the amount the Max Planck Society considered as justifiable, although they say even the justifiable amount was higher than what other publishers charge.

The Max Planck Society is one of the main proponents of the Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. It is the first major research organization that I'm aware of that breaks free of the stranglehold of the publishing industry. The question is, of course: what will happen next? Do they stay firm and begin to cause a shift towards Open Access journals? Or will Springer go down with the price just enough that the contract will be renewed?

Update: heise.de now reports this story in English as well.

Update 2: Well, they have reached an agreement on January 29, 2008.