@user714:

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The FDA’s Division of drug Marketing, Advertising, and Communication cited Auxilium for a brochure that it put out on its drug Xiaflex, which was approved in February for the treatment of a disease that impairs hand function called Dupuytren’s contraction. The letter, dated June 10, said the brochure “broadens the indication for Xiaflex, overstates the efficacy of Xiaflex, minimizes the risks associated with the use of Xiaflex and omits material facts.”

Omits material facts? like the fact that NA exists and works better, perhaps?!!!

Edited 06/24/10 00:46

To me the biggest disadvantages of Xiaflex as compared to NA are

1. Much higher cost
2. Reportedly requires two (or even three?) interventions - i.e. more time, more worry/fear, etc.

I can relate to that. Unfortunately there are no conclusive data available on the effect of splinting. In Miami one paper reported no measurable effect of splinting (but to my opinion they looked at the wrong, i.e. insensitive measurements) and another paper showed positive effects of splinting after NA. Personally I believe in splinting and use it even preventively. I also believe -without being able to prove it scientifically - that splinting can push out recurrence. The published Dutch comparison of NA and surgery did not take into account the effect of splinting.

Wolfgang

LubaM.:

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...On a personal note...I had NA twice on same finger and spent many months (both times) at occupational hand therapy, and having seen many patients come in to do hand therapy after surgery, I will avoid surgery at all cost after seeing these patients, in spite of the lesser recurrence rate....I would rather repeat NA as needed because of the ease of the procedure, faster recovery and possibility of repeating as needed. However, when collagenase's long term effects are proven to be successful, I will definitely consider it as well.

I'm very curious about who shared the stories--other than researchers in the Dups study--and supposedly there hasn't been a clinical double bind study although I believe someone posted something last week about recurrence rates. Based on my experience with the researchers--the study was very, very inexact and sloppy with measurements and no way to control other procedures such as NA subsequent to Xiaflex. So if someone had successful NA after a Xiaflex failure, it's counted as a Xiaflex success!



Guest,

What double blind study are you referring to?

jocond:

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I'm very curious about who shared the stories--other than researchers in the Dups study--and supposedly there hasn't been a clinical double bind study although I believe someone posted something last week about recurrence rates. Based on my experience with the researchers--the study was very, very inexact and sloppy with measurements and no way to control other procedures such as NA subsequent to Xiaflex. So if someone had successful NA after a Xiaflex failure, it's counted as a Xiaflex success!