| Lost password
420 users onlineYou are not loggend in.  Login
Xiaflex approved by FDA today
 1 2 3 4 5
 1 2 3 4 5
02/18/2010 07:01
Randy_H 
02/18/2010 07:01
Randy_H 

Re: Xiaflex approved by FDA today

flojo,

While a grass roots effort to educate our GPs should be undertaken (I've done this as well) I don't see this as too significant. Only a small fraction of patients that GPs see will need a procedure. I doubt if my doc will refer more than 2 or 3 patients in the next 10 yeas. No, I believe this really needs to come from the top down. Eaton is in this for the long haul and knows this will take time.

Other things I've done is through word of mouth, saving about 3 people from the knife so far. And of course, this site. It was the earlier BioSpecifics Forum that bought NA to the US in the first place. As the Internet is more and more populated by people likely to get Dups we need to be here. Anyone with commonsense should be able to find us. Goggle Dupuytren and you'll see easy access to this site or other NA providers. This will self refer patients to the NA practioners rewarding them for caring for us.

The NA ball is rolling. Does it have the momentium to compete with XIAFLEX? That's what we will all be watching to see. I think it does.

02/18/2010 17:03
art

not registered

02/18/2010 17:03
art

not registered

Re: Xiaflex approved by FDA today

Randy, you do bring up a good point. Auxilium's website, www.DealingwithDD.com puts NA under the surgical category and has misinformation. They say NA is done with a needlelike blade and is done at weekly intervals ?????

02/18/2010 22:36
Mike S

not registered

02/18/2010 22:36
Mike S

not registered

Re: Xiaflex approved by FDA today

Actually, one of the MAJOR advantages of NA as compared to Xiaflex is that NA is typically performed as a one-time event whereas (per my understanding) Xiaflex generally requires two separate interventions.

02/18/2010 23:33
flojo 
02/18/2010 23:33
flojo 
Re: Xiaflex approved by FDA today

Thanks, Randy. Good points. My dermatologist says he has several patients per year asking what to do. He was very pleased to see how NA straightened my contracture as well as what RT did further so that he can tell his patients. He, as well as my GP, gladly took the information/URL for this website. Maybe it is more of a question that would be asked of dermatologists.
I, too, am educating people by word of mouth. I'm not shy about trying to "train" everybody I can to be able to more or less diagnose it for other people and know that surgery is not the only option. People also know that I can be contacted if they have questions about my treatments. I have handed out the URL for this website to quite a few others. Maybe grassroots will reach as many or more than doctors. Like I, a lot of people have not ideas what the heck is wrong with their hand and don't notice it for quite a while. I've had people have me look at their hands when they hear about mine, and lo and behold, often there are nodules. We can do a lot by word of mouth.
Other points:
#1 - Googling now brings up this site several times on the first page, so it is easier to find. A little over a year ago, that wasn't the
case. Maybe increased activity on this site helps that part.
#2 - We are letting people know the efficacy of NA over surgery, for sure, and likely over Ziaflex as well.
#3 - Auxilium's website should be forced to accurately describe NA. Is that possible? I suppose NA "technically" is surgery, but the description of the procedure is WRONG.

02/19/2010 01:15
jimh 
02/19/2010 01:15
jimh 
Re: Xiaflex approved by FDA today

I read what's on the Auxilum site and I'd say it's basically correct, although somewhat skewed as one would expect. NA is really a minimally invasive surgery. The part about multiple NA sessions weeks apart, I'm not sure about, but maybe some docs are doing that. It could make sense.

Not so long ago we were all pulling for Xiaflex. Now its promise seems to have faded. But some of that is just the result of some poor presentation by Auxilium. They've over-hyped it and tried to price it too high - no doubt feeling investor pressure. The FDA trials showed some problems, those have been over-hyped too, and there could be financial motivations behind some of those statements as well.

I hope that when the dust settles, Auxilium ends up with a product at a reasonable price, develops some sophisticated protocols for its use, accumulates clinical experience - and that Xiaflex turns out to be a useful treatment. Not all contractures can be released by NA's saw-and-snap technique. Maybe Xiaflex can do some things that NA can't. Don't forget about Lederhose - many of you will get that, too, in time (I already have it). NA can't do anything for it, but if Xiaflex could break down and soften those lumps - that would be fantastic,.

Edited 02/19/10 03:18

02/19/2010 03:04
LubaM. 
02/19/2010 03:04
LubaM. 
Re: Xiaflex approved by FDA today

jimh...

re: "Don't forget about Lederhose - many of you will get that, too, in time (I already have it). NA can't do anything for it, but if Xiaflex could break down and soften those lumps - that would be fantastic,"

____________________________________________________________
I have DD in both hands and also Ledderhose. When I did RT in Nov.09 for my left hand, with Dr. T. in La Jolla, I also did RT on my left foot. I had two large, hard nodules...after the RT the nodules are smaller and softer.

I also wear custom made orthodics for many years... fortunately the nodules never bothered me for walking, I was just hoping to stop the progression and hoped they would get smaller...which they did...

You might want to try RT for your Ledderhose.

02/20/2010 02:56
flojo 
02/20/2010 02:56
flojo 
Re: Xiaflex approved by FDA today

jimh,
My experience with NA was nothing compared to what it sounds like it will be with Xiaflex. After my hand was deadened, I had the procedure done in 20 minutes. Then it was bandaged up, I got my home care instructions and drove myself to my son's house about 45 minutes away. It was a needle, not a knife or a saw. It was only one visit - evaluation, procedure and you're done.
Xiaflex may work well and I hope it does. Depending on what practitioners are trained in it, it could be just fine. I'd still want someone with expert knowledge administering it in my hand. I went for an evaluation to be in clinical trials for Xiaflex, but my contracture was too slight. If NA wasn't available, I would definitely consider Xiaflex.
Just after I had NA last spring, I also participated in the company's survey about whether I'd use Xiaflex. I told them the price would definitely be a factor, but if it could be done near my home, that would also be a positive consideration.
I hope Xiaflex works for Ledderhose's and others that NA won't work on. One thing for sure, it is bringing attention to Dupuytren's disease. The publicity will help us all.

03/14/2010 23:32
neverwin33

not registered

03/14/2010 23:32
neverwin33

not registered

Re: Xiaflex approved by FDA today

Quote:



The goal of the trials was a 5 degree improvement - absolutely insignificant in practical terms. And Auxilium is still talking thousands of dollars for treatment. Will insurers pay for this? If I were at an insurance company making this decision I'd be saying "wait a minute..."



Huh? The primary endpoint was 0-5 degrees of contracture remaining. Learn to read a clinical study before post such rhetoric!


03/17/2010 15:08
dupuytrenwife

not registered

03/17/2010 15:08
dupuytrenwife

not registered

Re: Xiaflex approved by FDA today

just found this site while searching for xiaflex...my husband has duprytren contracture in both his hands and has had it for about 15 years or so. He is left handed and has had his right hand operated on twice and it's always come back (worse each time). He has given up on treatment. We were never told about NA and from reading I think this looks worthwhile...is there anyone who has had my husband's experience with their surgery and has had NA to good results? Thanks for your help.

03/17/2010 18:42
mike59 
03/17/2010 18:42
mike59 
Re: Xiaflex approved by FDA today

My GP knew nothing about Xiaflex, NA, RT. She's sending me to a hand surgeon but I really would like any of the above before surgery.

 1 2 3 4 5
 1 2 3 4 5
practitioners   surgery   information   orphan-designated   treatment   nodules   electro-mechanic   placebo-controlled   procedure   surgeon   biopharmaceutical   Xiaflex   insurance   Dupuytren   patients   Pharmaceuticals   contracture   approved   progression   Auxilium