About this Author
DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

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May 3, 2006

Have The Rules Changed?

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Posted by Derek

I'll address this more in tomorrow's post, but everyone should know that there was a potentially very interesting ruling yesterday by the DC Circuit Court of Appeals. Do patients have a right to drugs after Phase I? We might be heading back to the days before efficacy testing was required. . .read this post at Marginal Revolution to get up to speed.

I've spoken about this issue a bit before. Back in 2002 I was very doubtful about the whole idea, but my opinion has been slowly changing. I didn't expect that this is how things would change, but you should never underestimate the courts. More anon.

Comments (2) + TrackBacks (0) | Category: Drug Development


1. Dr Toot on May 3, 2006 3:05 PM writes...

If I glanced at my FierceTech blurb correctly, & that is never a given, I had thought that this issue was in reference to allowing post-Phase 1 drugs to be given to terminally ill persons, provided there was some reasonable chance they might help.

In my opinion, such persons should be given a government-funded option to die in dignity, in a manner of their own choosing. Arguing over allowing them access to Phase 1 drugs is somewhat akin to arguing that Jews should not be forced to wear armbands while on their way to the ovens.

Quite frankly, the dialectic here allows for a sublime example of the difference between those who are truly compassionate, & those who wish to be seen as such and/or convince themselves that they are.

Of course, maybe you're talking about something else, in which case f*ck me.

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2. AMedChemist on May 4, 2006 4:17 PM writes...

Hey Derek,

They referenced your blog in Forbes:

"Patenting big swaths of important biochemical pathway space has the potential to turn drug development into even more of an expensive nightmare than it already is," pharmaceutical chemist Derek Lowe wrote in his blog, In The Pipeline, last month. Lowe, who works for a major pharmaceutical firm, was writing specifically about the Ariad case. Since making that statement, Lowe had posted that he had shorted Ariad's stock ahead of the ruling."


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