Semester Research

[tijames]

I am doing a semester research project on the FDA drug approval process. I was going to focus mainly on Vioxx, and discuss the pros/cons of the FDA process and analyze the technical aspects of the process. However, someone else in my lecture is doing Vioxx, so I would like to do something different. Does anybody have suggestions for other drugs/similar situations? any ideas are welcome...

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[sunny1]

Take a look at Tysabri, to treat MS. It went through a similar situation a few years ago where it was approved and touted as a miracle drug for its effectiveness. But then everything came to a stop after a few related incidents were reported and it was withdrawn from the market. It is now back on the market but with a black box warning.

I think it's a very interesting story personally.

http://www.nationalmssociety.org/site/PageServer?pagename=HOM_RES_tysabri_qanda

Oh - also you can talk about how companies then seek to do more trials and get the drugs approved for other uses, thereby extending any patent I guess.

http://www.webmd.com/ibd-crohns-dis...s/20080114/fda-oks-tysabri-for-crohns-disease

 

[beachblonde]

The Vytorin (zetia + zocor) shenanigans are all over the news right now. You'll find some similar stuff about the efficacy about Effexor XR as well, with a bit of digging.

 

[tijames]

thanks for the suggestions!