Wednesday, March 28, 2007

What's in a name?

Thanks to Pharmagossip, I recently read a GREAT article on how the decks were stacked in the design of the VIGOR trial (Vioxx). The article was originally written by Dr. Robert Burton & published in Salon in March 2005. You can read this article here.

Substantive matters regarding trial design aside, it appears that just the name of a trial can reveal a lot of things under the hood. We now know that VIGOR lacked some RIGOR. This leads to Pharmalyst's rule of thumb regarding trial names for pharma-sponsored trials: The fancier the name of the trial, the more likely it is that the trial design had greater influences from the marketing and biz development arm of the company rather than the scientists. Therefore in all probability, these trials are likely to be testing fancier end-points and are more likely just fodder for the sales pitch.

Don't get me wrong, Pharmalyst is all for having easy to remember names and does not want trials to be named like the inscrutable model numbers that Japanese electronics mfrs come up for their otherwise fine wares. However, the odds are that a trial called the Framingham heart study will be much more useful that something called ASTEROID or PRECISION.

Perhaps I am wrong but I can't help but look at trial names like ILLUMINATE (the torcetrapib trial). Based on some recent ACC-related articles, it looks like Pfizer may have rushed things a bit too much (by doing both the outcomes and imaging parts in parallel). A more cautious approach may have detected the toxicity at an earlier stage. Similarly Astra Zeneca had some great sales ammo touting ASTEROID until a METEOR crashed on it.

Last but not least, I am hoping that PharmaGiles will issue some guidance to pharma on how to name trials :-)

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