Before getting started, I'd like to recommend the discussion going on in the Comments section of the "All the Myriad Ways" post below. If you find the topic of gene patents at all interesting, it's worth keeping up with. Me, I'm just watching for now, feeling like Teresa Nielsen Hayden as the discussion takes off on its own. (I show up in her comments section every so often myself, although I largely stay out of the political discussions because I think they'd throw things at me.)
On to the main topic tonight. There's an article in the latest Nature Reviews: Drug Discovery called "Prospects for Productivity" from Bruce Booth and Rodney Zimmel at McKinsey Consulting. They're talking about the now-familiar drug drought that seems to have affected everyone the last few years. It's real enough, although they make the point (which I've brought up myself, in a column for Contract Pharmamagazine) that people have been complaining about a drug shortage for decades.
Booth and Zimmel do a good job of running down the usual suspects. In their order, they have:
1. Lack of payoff from genomics. This one, they say, has "clearly driven part of the productivity decline." I can second that, because I (and friends of mine around the industry) have seen it at work right in front of them. There was a panic that made everyone start working on genome-derived targets, long before we knew enough to accomplish anything. In most cases, we still don't.
2. Poor chemical libraries. This is an earlier problem, but one whose effects are still working their way through the portfolio. The combinatorial chemistry craze (the craze before genomics, if you're keeping score at home) caused a lot of people to make a lot of compounds that had no chance of ever becoming drugs. Why? Because they could make them! And someone else might make them first! We're smarter now, theoretically. B & Z don't go into the details, but this one hit some companies harder than others, depending on how early and how hard they fell for combichem evangelism. Some careers never really recovered.
3. Tougher regulation. B & Z discount this, for the most part, as whining from the drug companies (not their exact wording!) They're probably right, although they correctly note that seemingly minor changes at the FDA have ended up costing huge amounts of money and time on our end. But this still isn't the major thing hurting us, not that it isn't still fun to complain about.
4. Tougher internal scrutiny. This is a real one, too, although it's hard to quantify. We've gotten more cautious over the years, as we've tried to keep from taking drugs deep into clinical trials before finding out that they have some ruinous problem. The early-stage filters and hurdles we've put in probably work a little too well, though. Unnervingly, there are any number of drugs on the market now that never would have made it through the current regimes. The verdict all depends on how many loser projects we're avoiding at the same time, a number that's pretty much unknowable. Ah, what an industry.
5. Unfulfilled technological hopes. This overlaps with some of their other categories (such as all that genomics money we're never going to see again). But Booth and Zimmel draw special attention to the problem of the industry spending huge amounts on better and better in vitro technology (as in the previous point), only to find that it still doesn't translate well to animal models, much less clinical practice. Presumably, we're eventually going to figure out what we're doing, but we're probably going to hose away still more cash while we're doing it, too.
6. Too big to innovate? Readers will recognize this as a particular favorite of mine, what with my happy attitude toward huge mergers. Proponents of such would do well do digest this quote: "Whether size itself is good or bad for R&D remains to be seen, (Heresy! Says the board at Pfizer! - DBL) but the simple fact is that a greater proportion of innovation is occurring outside the industry leaders." Their estimates show a meaningful decline just over the past seven years or so, which is rather alarming for the big guys.
Not a bad roundup. The article has a lot of other useful stuff in it, too; I highly recommend it. They have a few ideas for getting out of our current fix, which I'll try to get to in a future post. None of them strike me as particularly resonant rallying calls ("Improve investment discipline"), but that doesn't mean that they're wrong, either.