Drug Development

 On Forbes.com, the drug industry analyst Avik Roy has written a  comment on my piece "The Treatment"  in last week's New Yorker. A few small points, in response.

 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. 

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[Zheng Chen]

Malcolm-

You are great story teller.I read your books backwards / forwards I found something as wired as clicking test:-)

I know you are so smart, you will figure it out:-)

Blink is the connection between emotion and ration.

Please have fun and discipline your blink:-) I just learned how to disciplined mine. You will be the first(?)current blinker from the cynicism/ non-PhD circle, in western culture. I believe that so strongly. Our Cynicism just need a little discipline. And, you know what, that is easy. Just try from another way:-) Think about your prime picture here:-) Why you put this here(It is a game, I know why you do that). Think from a opposite direction:-)

You are almost there:-)

I know you can discipline yours. I just knowing how to discipline mine.

Good luck!!!

[Zheng Chen]

We are so close to blink the mis-communication in church.
I am sure you must have bad short-term memory. You may have problem with speech or learning. And you just cannot resist the film "The King's Speech" while all your intellectual friends love more "Black Swan."

Correct me if I am wrong:-)

We current cynicism need to "marry"a Buddhist master(they are terribly smart) to a priest(they are sweetest harmless)-- I mean literatually.

[Zheng Chen]

We are the underdogs all long our way.We are harmless sweet dogs who just always believe fairly tales.

I give a big carrot -- Think about Peace Nobel Prize. That is what you looking for.

Take off your running Prime and replace with Jim Colin's three circle. That is the right Prime for us.

Remember do not not push yourself too hard. Your wife loves you.You can discipline your blink by arguing with your smart wife -- and try to control your own temper only.

It is the time for underdogs to team up and take over the alpha dog!!!!

[Zheng Chen]

You just need some tools -- which I am trying to blink my knowledge to help you!

Another tool, speak as fast as you can -- and screwed the damned language -- we learnt this tool already -- just in a hard way. Forget about the grammar or spelling mistakes -- the mistakes are the key for you!!!!

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Try to listen to the pure music you like, the softer the better when your mind is racing.

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Just believe what you believe and play with the anti-ideas for fun only.

This is the wisdom from a real Kongfu Panda in China -- me:-)

[Zheng Chen]

I am another lonely smart and harmless underdog from China with three genius underdogs -- they are professors. As underdogs, we all settled with Virginia Tech though we know Harvard is the place for us just like you and your troop!

Let's combine into one group. Haha, just for fun:)

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I'm trying to sort through the pharm industry myself. It's so hard to know if it's safe to take a drug because the long-term effects of new drugs simply haven't been established.

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バーバリーマフラー
北海道由仁町内の診療所で国が注射器の使い回しを放置したためＣ型肝炎ウイルス感染が多発したとして、バーバリーハンドバッグ
同町の住民らが来年１月にも、国に１人３００万円の慰謝料を求めて札幌地裁に提訴する。提訴予定者は既に１００人を超えており、７日に弁護団が結成された。弁護団によると、バーバリー アウトレットＣ型肝炎感染者の割合が高い地域は国内に同町を含め約５０カ所あるとされ、こうした「地域偏在」を根拠に訴訟を起こすのは全国初という。

　
バーバリーマフラー訴えるのは、町内にあった２カ所の診療所で治療を受けたことがある患者や遺族。バーバリー財布多くは５０～８０年代ごろに「ホット注射」と呼ばれる解熱剤の投与を受けていた。原告側は「どちらの診療所も注射器を水洗いしただけで使い回していた」と指摘。
バーバリー アウトレット世界保健機関（ＷＨＯ）は５３年に注射器を煮沸消毒するよう警告を出したが、国はその後も適切な指導を怠ったと主張している。

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