TECHNOLOGY FOR CHANGE

Open-Source Pharma?

John Jainschigg | Date: 05-27-09 | Comments

Why don't we have open-source drugs? Are drug companies solely to blame? Or does the open-source model not scale into industries other than IT?

In a post dated May 5, 2009, over at Confused of Calcutta, JP Rangaswami relates the saga of the �polypill��a long-proposed but not-yet-trialed combination of out-of-patent generic statins, blood-pressure meds and aspirin that would (its proponents claim) reduce heart disease by up to 80 percent through a combination of high efficacy, low cost (leading to broad prescription and usage) and simplified dosing (leading to greater compliance).

Why don�t we have the polypill yet? Why is it perpetually five years or more from market? Rangaswami suggests it may be because pharmaceutical makers can�t figure out how to make money from it�that the cost of trialing this combination of generic medications may exceed projections of revenue to be earned from its sale. He circumspectly omits adding what seems an obvious coda: that appearance of a cheap combination drug for the common ailments of hyperlipidemia and hypertension would quickly erode the markets for name-brand single-element cholesterol and high blood-pressure meds.

Except, upon consideration, reality is a little more complicated. First, pharmaceutical makers such as Merck and Pfizer have already introduced combination meds in this category, based on best-selling brands like Zocor and Lipitor, whose patents began expiring around 2006. Release of these new combination pills was and continues to be driven, presumably, both by the mission to provide better therapies and by the fact that a combo of two medications can be patented anew. Arguably, therefore, the polypill already has functional competitors in the marketplace, their prices sustained by high brand recognition of their component drugs, expensively marketed for more than a decade.

Except reality is even more complex. Presumably, it would also be possible to patent a polypill assembled from generic components. So if this truly is a markedly better therapy (as initial trials seem to indicate), the polypill itself could become a protected "new drug" with a long and potentially profitable lifespan. As it happens, the best-known polypill prototype, called "PolyCap," is being trialed by Cadila Pharmaceuticals�an Indian maker of generics�and will end up both being very profitable for the maker and undercutting the prices of combos marketed by Western pharma giants. Cadila is currently marketing its heart out about the success of initial trials and notices in The Lancet and other industry media�reminding us that this race may not be about innovation or the hamstringing of same by trialing protocol, as Rangaswami suggests, but simply about deriving ROI from (or competing with) a long-term marketing effort.

At the conclusion of his post, Rangaswami raises the very interesting idea of applying open-source principles to pharma to facilitate rapid trialing of new drugs, which would then, presumably, be genericized for royalty-free manufacture. Presuming it could be made to have scientific meaning and sufficient rigor, it�s an emotionally tempting concept (barring certain obvious ethical considerations, such as are encountered in overseas trials today). I suspect, however, that the net effect of such efforts would be to the loss of those with intellectual property to protect, and the benefit of those whose costs of labor are smallest.