"Translational" medicine

The current buzzword of ‘translational medicine’, as near as I can tell seems to mean trying to insert research cycles as close to the bedside as possible, perhaps even literally as in seeing what happens in a patient, running back to the lab, and then altering treatment based on that running back and forth and scrutiny of results.

That all seems eminently sensible enough when it comes to clinical practice (though it seems so obvious that surely it is how doctors already practice medicine, ever since that mediaeval pervert doctor was tasting people’s urine to see if they had diabetes [mellitus: mmmm yummy, tastes like hunny]) but for clinical development it seems to have limited application, except for perhaps a big exception for critical diseases that involve treatment resistance. I can easily see how with HIV treatment or cancers of known resistance-pathway how you would keep tinkering the treatment as resistance in the patient comes up. But again that seems obvious, and again it is so difficult in practice, to get that through regulatory agencies, that the ideal of trying all sorts of investigational drugs in a row, based on the disease morphotype and resistance profile of the moment, seems a long way off.

I dislike “translational medicine” as a buzzword almost as much as I dislike “biomarker”. Biomarker is all over the industry, but my favourite jibe in response is that dogsh1t is a biomarker, or more palatably, leaves falling off trees is a biomarker of Fall. But, importantly, who cares? When we say biomarker we really just mean surely any molecule of biological origin that is of interest to somebody for some reason. Surely that is close to meaningless as a concept.


We are just watching How To Survive A Plague (http://en.wikipedia.org/wiki/How_to_Survive_a_Plague) which takes me back to my coop job days doing HIV work at St Pauls. Those days still seem like a model of how to keep pressure on regulators to speed up approvals where a disease is undertreated and deadly.

In other news we have the Glivec decision in India. In the mainstream media all the details seem to have been left out in terms of what the real dispute is here with the patent, and the compound and its formulation as this beta-crystalline variant. The Indian court’s finding that the different crystalline polymorph is no different in efficacy and looks like “evergreening” seems fair enough, in my view.http://pipeline.corante.com/archives/2013/04/01/novartis_loses_the_glivec_patent_fight_in_india.php


At the risk of overloading you with URLs, you have this story on the same (excellent BTW) blog:http://pipeline.corante.com/archives/2013/04/02/tecfideras_price.php One is reminded of the story of AZT in the movie above. AZT was just pulled off the shelf, and as we know it hardly works for HIV anyway, with resistance developing in a matter of weeks if I am not wrong. But Burroughs Wellcome still cheekily charged $10,000 a year for it presumably as they had the patent still. But the blogger is at least circumspect about these things – it’s not so simple as a straight ripoff, since companies have to try to maximise the price they get for their patented products.