A couple of interesting bits around the blogosphere on the pipeline problem NIH aims to tackle that we wrote about last week.
Over at Corante’s “In the Pipeline,” Derek Lowe points to a new paper out of the Tufts Center for the Study of Drug Development. Analyzing patent history over the last 50 years, the paper posits that oftentimes copycat compounds were in the pipeline before the original was approved: in other words, the “me-too” drug phenomenon may be a case of a race to market, rather than sequential imitation of already successful therapies. Lowe writes:
I've been in the drug industry since 1989, and for every drug class that's been introduced during my career, at least one of the eventual follow-on drugs has already been synthesized before the first one's been approved by the FDA…Lowe's take on the Tufts review suggests we re-examine where we place the emphasis when we talk about a pipeline that lately has created more me-toos than breakthroughs.So the mental picture you'd get from some quarters, of drug companies sitting around and thinking "Hmmm. . .that's a big seller. Let's hang a methyl off it now that those guys have done the work and rake in the cash" is. . .inaccurate. As this paper shows (and as has been the case in my own experience), what happens is that a new therapeutic idea becomes possible or plausible, and everyone takes off at roughly the same time. At most, the later entrants jump in when they've heard that Company X is working in the same area, but that's a long time before Company X's drug (or anyone's) has shown that it's going to really work.
If you wait that long, you'd be better off waiting even longer to see what shortcomings the first drug has out in the real marketplace, and seeing if you can overcome them.
But even if similar compounds went into the pipeline at relatively the same time, how do we re-incentivize risk on the front end, and minimize risk in the post-market phase? And what do we do about a marketing model that’s finely tuned to this R&D trickle, pushing each kissing-cousin compound as the Next Big Thing?
George Miller over at Fierce Pharma Manufacturing wonders whether there’s some middle ground between blaming industry vs. regulators for process-change sloth:
Forbes magazine editor Steve Forbes excoriates the FDA in a recent editorial, blaming a government regulation failure---rather than a market failure, as Congressman Henry Waxman does--for the lack of new antibiotics. Although his chief complaint is with the agency's "increasingly horrific bureaucratic roadblocks" to drug development, his arguments extend to some extent to manufacturing regulation…There’s something here, too, for those of us asking how to thaw a pipeline to produce safe, innovative therapies when the players and the rules look different from political season to political season.I'm not willing to buy into his moving-backwards scenario. But perhaps there's some middle ground that our two political parties might explore between Forbes' doomsday vision and quarter-century guidance updates.
--Kate Petersen, PostScript blogger