| Why waste time with Xiaflex? |
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02/17/2011 19:50
moondanc 
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02/17/2011 19:50
moondanc
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Re: Why waste time with Xiaflex?
Apparently the FDA has some concerns about how Xiaflex is being marketed. In a 2010 letter to Auxillim, the marketers of Xiaflex, FDA warned them about overstating the efficacy, minimizing the risks and omitting material facts and being in violation of the FDA Act. Certainly would give me pause.
http://www.pharmcast.com/WarningLetters/...uticals0610.htm
An excerpt below, read the entire letter at the above link:
"The patient brochure is misleading because it broadens the indication for Xiaflex, overstates the efficacy of Xiaflex, minimizes the risks associated with the use of Xiaflex and omits material facts. Thus, the patient brochure misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a) & 321(n). Cf. 21 CFR 202.1(e)(3)(i); (e)(5) & (e)(6)(i)."
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02/17/2011 21:22
LubaM.
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02/17/2011 21:22
LubaM.
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Re: Why waste time with Xiaflex?
If the above is true....why did FDA approve it in the first place ????
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02/17/2011 21:33
callie
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02/17/2011 21:33
callie
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Re: Why waste time with Xiaflex?
Larry,
You read the quote incorrectly. "In clinical studies, XIAFLEX reduced contracture to straight or near-straight in
44%-64% of patients 30 days after up to 3 injections ..." It doesn't mean that it has to be done every 30 days.
The real interesting part is " compared with 5%-7%
of patients who received injection with placebo (an inactive substance)."
Edited 02/17/11 23:36
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02/17/2011 21:40
moondanc
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02/17/2011 21:40
moondanc
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Re: Why waste time with Xiaflex?
LubaM.:
If the above is true....why did FDA approve it in the first place ????
I wish I knew. And of course the study did not mention NA at all as a comparison/alternative only hand surgery However, you might be surprised if you look at drug studies for a large percentage of medications. Many only show an improvement of 5% or more over drugs currently on the market or over a placebo. Who knows what the FDA standards are for what percentage of improvement there needs to be. They compared Xiaflex to a placebo to show how effecitive it was and of course, it's going to be more effective than a placebo and gives high percentages with comparison but what one really wants to know is how effective is it overall particularly is it effective on the joints and which ones.
Also, of course, studies are extremely small. The last study -Phase III - only had 308 patients! Phase II extension only had 19. In the followup studies measuring the degree of contraction are pretty casual--at least in my case--saying 5 -10 degrees variation doesn't make that much difference to say nothing of the fact I felt like my finger was stretched way back much beyond normal prior to measuring and the fact that it doesn't make any difference anyway since I had 2 NA procedures on that finger after the Xiaflex but despite that I'm still included...
http://www.nejm.org/doi/full/10.1056/NEJMoa0810866
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02/17/2011 23:41
tam1 
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02/17/2011 23:41
tam1
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Re: Why waste time with Xiaflex?
Moondanc, thanks so much for sharing the links on Xiaflex with all of us and for explaining your personal experiences as one of the first people to try the drug before its approval. The FDA warning letter is a good reminder of how marketing hype can misrepresent the reality of a medication; most of us would not have been aware of the communication between the FDA and Auxilium without seeing your link. Have the NA treatments you've done post-Xiaflex helped?
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02/18/2011 03:54
flojo
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02/18/2011 03:54
flojo
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Re: Why waste time with Xiaflex?
For me, the jury is still out on Xiaflex. It will take more time. Look at the different opinions and experiences with surgery and NA. They've both been out a long time. The pharmaceutical company has big $ to put into advertising and making personal contacts by their agents with doctors, so it's getting lots of hype right now.
Time will tell.
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