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. 

Comments

[david]

What is this, Gladwellphobia or what? It seems some people before even reading Malcom's articles set to disagree with him. Roy, in this case, is one of them. Malcom is doing a great and amazing job and though he is not perfect he deserves only justified critisms and unfortunately few are forthcoming. David, Tanzania

[david]

Hi Malcolm. When will your next book come out?

[JS Hoyer]

Pedantic quibble: The full name of the journal Munos published in is "Nature Reviews Drug Discovery". There are various different "Nature Reviews" journals.

[Scientist Sailor]

The article is good description of the trial and tribulations of drug discover, cancer or otherwise. Howerver, the people who put elesclomol into the clinic are grossly negligent. Those of us who are schooled in the modern way of doing drug discover would realize that molecule is full of functional groups that are known to cause toxicity.

[Fang]

No offense. I just finished reading your chinese version of outlier, sadly that i found two things bothered me very much.

first one is literal issue at chapter 5, section 8. when you are telling the story of the immigration from eastern europe,sometimes you use their first names, sometimes last names. That is confusing for readers.

second is at chapter 8, section 3. when you described chinese acre, you mentioned that one mu (chinese acre) almost equals to one room of hotel. But I couldn't agree with you. 1 chinese acre=666.666667 square meter. which is much bigger than a room of hotel.

[Joss Paddock]

I just read "The Treatment" and when I got to the last line, I thought, you might have called it "Hope Is A Drug". Perhaps that would be insulting to the field, but it would be a rich multiple-edged lead-in.
I found it refreshing that the article ended in disappointment. So much of your work drips with enthusiasm and success(which is nice). Of course life is full of seeming dead ends too. And then the sun rises.
Personally, I find your voice dependably inspiring.

[Gary]

Sensationalist reporting from Avik Roy methinks!'The Treatment', for me, was an interesting case study in one of two possible drug discovery methods. I'm am under no impression that one method of discovery was preferred over another in the article.
Thanks for 'The Treatment' Malcolm ... an interesting and thoroughly readable article!

[Laughtersme]

Was introduced to your writing from a friend who loaned me "Outliers". I thought it soooo interesting, enlightening, well thought out, well researched and - cool! Bless,

[Vram22]

http://seekingalpha.com/instablog/633236-douglas-krohn/68151-how-to-spot-a-short-biotech-opportunity-part-i

Malcolm, have you looked at this blog. This blog raises serious questions on the Phase I and Phase 2 clinical trials, and I wonder if you looked at it.

Vivek

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Maazing stuff, really good ! I alwasy thought that the body is far more important than we give it credit for !

[Kyla Love]

this comment seems mundane in comparison with above comments but I just want to say how much I love your sense of humour, here as well as in your books. ("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 heard some rumours about a student group at my uni (UBC) trying to recruit you for a speaking engagement. Not sure what the status on that is, but would absolutely LOVE to hear you speak in person.

LOVE

[Naravadee Waravanitcha]

I like how you came up with questions. I asked myself and here is my observation:

Why there is only one type of ketchup and many types of mustard may lie in these reasons combined:
1. Children who eat ketchup are not ones who buy it. A child’s tongue can not differentiate good and better ketchup. A child will use whatever ketchup his Mom put in front of him.
2. Liking bitterness is an acquired taste of adult tongue. When you have purchasing power, you have the power to choose to buy what you like.
3. As we become adult, we were taught that adding ketchup to foods is of poor taste if not a crime in high end Italian restaurant. So the only reason a mother would feed her child ketchup is in hope that the ketchup will make her foods taste better and the child will eat more. But as the child is growing, she will slowly and intentionally take the ketchup away from the dining table for reasons cited. I usually wondered why we only like spinach, mushroom, tofu, bean sprouts and all those things that we used to think were nasty as a child after we became adult and I think it’s the teaching that engrained in our subconscious of what’s healthy and what’s not. Also, I think the experienced taste buds of adult grown to like bitterness and other complexity of tastes.
I think because the Mom is the real purchaser of ketchup so the variety of ketchup are those that make sense to the Moms are i.e. organic, non-MSG, non-preservatives, etc. not taste wise.

Then again if you asked so why there're so many types of cereal? Cereal is a "meal" not a "condiment" and eating cereal as we are growing up is never a bad thing. I guess that's why there are "Frosties" and what's that thing.."Wetabix" or seomthing made from whole grain wheat?

[jon]

I agree with the first post that many critics search for any way they can to discredit Malcolm's work. My guess is a lot of these folks hold themselves in high regard as experts in their fields and don't appreciate Malcolm's theories in Outliers regarding their success or intellect. They will pounce on any little detail they can to deride him. What a shame. Malcolm's approach to problems from a journalistic perspective is extremely refreshing. Keep up the good work.

[Rex Galbraith]

Malcolm

You are the Spot Light in my most recent post on my blog.

I have a blog dedicated to book reviews. It was my hope that you'd be willing to share a comment about your book outliers.
www.rexgalbraith.com

Thanks for your contribution to good writing!

Rex

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[Marnie]

dear Naravadee Waravanitcha,

regarding your above comment:

my daughter is 6 and she loves spinach, mushrooms, and tofu.

i agree with you that the person in charge of purchasing has a lot to do with what a child chooses to eat, but disagree with your assessment of moms and their relationships with ketchup.

"we" is such a broad term....

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The restaurant I opened was Italian, and I remember running out of foods like angel hair pasta, which made my tables less than happy with their dinners. There were nights when we seemed to run out of half the menu.

[Vimax]

Thanks for all you have done for our country and for our civilization. How does 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 really work?

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