Translation Blog

Don’t publish and be damned

Every two weeks I get The Alchemist, a nice little round-up of the latest news in the chemistry industry delivered direct to my inbox by ChemWeb. The latest edition reports some bad news for Pfizer: apparently, its antidepressant reboxetine doesn’t antidepress.
According to an article in Scientific American, a meta-analysis published in the BMJ concluded that not only does reboxetine simply not work, but Pfizer had failed to publish results from 74% of their patients.

Hmmm. Translating clinical trial contracts is one of my main areas of work, and every one of them includes a clause about the sponsor’s legal obligation to publish the results, and the investigator’s right to publish the results from his or her centre within 12 months if the sponsor hasn’t yet published the global results.
To get a medicinal product authorised in Europe, sponsors are not only required to publish data, but in the case of international trials, must demonstrate that trials conducted outside the EU meet the ethical requirements of 2001/20/EC – which itself includes the requirement that All clinical trials, including bioavailability and bioequivalence studies, shall be designed, conducted and reported (my emphasis) in accordance with the principles of good clinical practice. And of course, good clinical practice itself requires that both positive and negative results be published or made publicly available.

So how the hell did a major pharmaceutical company get away with sitting on three quarters of its results and hence manage to get its allegedly useless drug approved in Europe?

Well, apparently it didn’t: these negative results weren’t published, but they were made available to the regulatory authorities (the reason why reboxetine wasn’t approved in the US, it seems).
So the real culprit here is surely EMEA, for not only failing to ensure that Pfizer acted according to EU laws and actually published all the results, but also failing to realise that the body of data pointed towards the product’s inefficacy.

Nice one, EMEA. Keep up the good work.

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