Blindsided by TGN 1412


The big news today is that patients in a small Phase I trial of compound TGN 1412 “experienced life-threatening anaphylaxis”:http://www.pharmalive.com/News/index.cfm?articleid=322858&categoryid=21. This despite the trial being conducted according to Good Clinical Practices standards, and the drug having the appropriate preclinical studies.

Reminders to this statistician:

* expect the unexpected
* our process is very good but not perfect
* behind every record in the database, there is a person with a family, feelings, dreams, and history

My condolences to the patients and their families.

*Update 3/18*: BlackTriangle “has more details”:http://www.blacktriangle.org/blog/?p=1308. While some immunologists had problems with their approach (and as Derek Lowe “notes”:http://pipeline.corante.com, it’s hard to know how much of that came _after_ the reactions), the TGN 1412 team was being very careful.

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2 Responses

  1. “behind every record in the database, there is a person with a family, feelings, dreams, and history”

    Wow, good point. Well said.

  2. […] I’ve been reading a bit of the blog Black Triangle in the wake of TGN 1412 adverse drug reaction disaster. Today’s guest post over there is a thoughtful comment on paying people to take experimental drugs. Whether you agree with it or not, there is a lot of good things to think about. […]

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