Yesterday I caught Alice Cooper’s Rock Monsters on MTV. Being a bit of a rock chick and an Alice fan to boot, I settled down to enjoy a bit of head banging.
I was sorely disappointed. Now, it’s true I only tuned it at around #38 (a young, young, young Iron Maiden with Number of the Beast), so maybe all the acts I’m about to name check were included in the dozen or so I missed. But no White Stripes / Dead Weather (or anything else Jack White’s ever laid his hands on)? No System of a Down? No Marilyn Manson? No PJ Harvey? Not even any Rolling Stones or The Who? How is that even possible? Read more »
When I first created the blog attached to my website, my intention was to post interesting snippets about clinical trials and pharmaceuticals and my comments on them. “The world already has hundreds of blogs about translating,” I thought, “and several of them are actually worth reading! No, I’m going to blog about my clients’ world, not mine.”
Good intentions and all that, but really, who has the time? And who would bother reading it anyway? The last 15 months or so have made it clear that the only ones reading my very sporadic words of wisdom are me, the occasional friend and Google’s crawler. (OK, cause and effect may well be involved, I don’t write anything, so nobody reads it, so I’m not encouraged to write anything, yadda yadda.) What’s more, there are already very many blogs dedicated to doing exactly what I intended to do, and they’re better informed and better connected. Read more »
And about time too. The US register has been an invaluable resource over the years, and finally Europe has followed suit. Woohoo.
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.
The European Medical Writers Association is, as its name implies, a network for professional medical writers. Although not specifically aimed at translators, its newsletter does have a section on translation and many of the other articles are also of interest to translators working in this field. EMWA also offers a sector-specific training programme, and I’m looking forward to getting started on that. Topics include the EU Clinical Trials Directive, European Regulatory Procedures, GCP, and the Patient Information Leaflet, to name just a few. Roll on the Spring conference!
EMWA
