Roy is of the impression that that I believe we should abandon rational drug design and, as he puts it, “go back to the old way of doing things: of throwing mud on a wall and seeing what sticks.”
I’m not sure where he gets that idea. “The Treatment” makes it clear that both strategies—rational drug design and mass screening--have a place in drug development. When the biology of a disease is well understood (as in the case of Herceptin and breast cancer) then the former strategy makes sense. But in those cases where it is not, then there is much to be said for following a more serendipitous path. I suspect that most drug development experts would agree with me on this. In fact, it’s probably the case—contra Roy--that one of the most compelling criticisms of the drug industry at the moment is that it has gone too far in the rational direction. In a piece in the December “Nature Reviews,” for example, Bernard Munos writes:
Success in the pharmaceutical industry depends on the random occurrence of a few ‘black swan’ products. Common processes that are standard practice in most companies create little value in an industry dominated by blockbusters. These include developing sales forecasts for new products, which are inaccurate nearly 80% of the time. Another example is portfolio management, which has e been widely adopted by the industry as a risk management tool, but has failed to protect it from patent cliffs. During the past couple of decades, there has been a methodical attempt to codify every facet of the drug business into sophisticated processes, in an effort to reduce the variances and increase the predictability. This has produced a false sense of control over all aspects of the pharmaceutical enterprise, including innovation.
I got the impression from from Roy’s piece that he was trying very hard to disagree with me. (Calling his post "Malcolm Gladwell is Wrong," was one clue). I’m not sure the effort was successful. He points out, for example, that some doubted Synta’s promising phase two data, in the belief that they were an artifact of the trial design: that there were differences in the health status of the control and treatment arms of the study. A good portion of my piece, of course, is devoted to the same general argument. What interested me was in describing the complications and difficulties and in many cases unavoidable issues in trial design that can make a drug look far more promising in early clinical testing than it actually is.
Roy goes on:
One gets the impression that Gladwell followed elesclomol over the years in the hopes of using its story for one of his books: the story of how luck and intuition can lead to pharmaceutical success. But the opposite happened, and the account ended up in The New Yorker instead. In Gladwell's final assessment, the story remained one about luck: but about bad luck instead of good
I do hope my editors at the New Yorker don’t read that and think that I give them my leftovers! And I wish it were the case that I knew what my next book was all about! The truth is that "The Treatment" was always a New Yorker piece. And I had no preconceptions about how the Synta story might end when I began reporting it, except that I guessed that would be a good case study in the many difficulties of coming up with new cancer drugs. Unfortunately for the many thousands of melanoma patients around the world, it was.