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Think Xiaflex is safe? Read this
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08/28/2009 00:43
jimh 
08/28/2009 00:43
jimh 
Re: Think Xiaflex is safe? Read this

I agree with "fingers".


Having had frozen shoulder myself, I think there's a big potential market there for Xiaflex. There is currently no treatment other than cortisone and physical therapy.



09/02/2009 02:54
Guest

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09/02/2009 02:54
Guest

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Re: Think Xiaflex is safe? Read this

Artisthands said:
Re: Think Xiaflex is safe? Read this
In the article at the tiny url there is this statement

"Kaplan also described nerve injury as surprisingly low and added that no one reported temporary numbness."

I was in the III stage clinical study and reported numbness in my finger. It was temporary and it was minor (lasting about six weeks) - but I did have numbness - so Kaplan is incorrect in his statement."

I was also in the stage III clinical trials and they were not well run and I participated at a major university. They cut what was supposed to be a 12 month tiral down to 10 months. The injections-- and the trial protocol was 3 injections directly into the cord-- were extremely painful as was "breaking" the cord. What the risk would be for more than one cord is unknown. When I was asked how much "discomfort" I had, I reported pain and was told "we don't use the "P" word." Several times equipment-- measuring grip strength, degree of contracture, etc. was not available at my appointment and I was told, "let's just say wae took these measurements." Urine specimens -- which supposedly measure Xiaflex in the system -- were taken prior to the injctions-- not after. Many of the doctors running the studies are "consultants" to Auxillium. On top of all this--after less than a year, my finger was back to pre-Xiaflex stage-- you could not tell I'd had it AND my other hand-- which had no contractures eligible when the study started had 5 contractureres--severe ones at that. According to auxilliary personnel at the research site-- PT, study coordinator-- they found Xiaflex less than 50% effective with PIP contractures-- I'd love to see what was submitted to FDA. .

Xiaflex is purposted to cost $5000 per finger whereas NA is under $1000.One of the purported values of Xiaflex is that it lasts longer than conventional surgery-- how do they know when there have been no followup studies and the orignal studies only lasted a year or less?

09/02/2009 11:50
guest

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09/02/2009 11:50
guest

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Re: Think Xiaflex is safe? Read this

It's an interesting story behind Biospec and their original forum. It was designed to study the market for their new product. What they didn't expect was for the Dupuytren's population to organize and search for other treatments which they found in Paris. Then, being proactive, went and pushed for NA to be brought to the US. They recruited Charles Eaton and the ball was rolling. In a sense they created their own competition. With millions invested and years of studies to get to the market they have much to lose if the drug doesn't replace NA. Scary.

09/02/2009 14:55
Mike S

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09/02/2009 14:55
Mike S

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Re: Think Xiaflex is safe? Read this

NA is a one shot deal - not 2X or 3X. NA, in the hands of a skilled practitioner, can work on the PIP joint, even when seriously bent (mine was at 90-95 degrees). NA cost ~$700-800 per finger. In my case, the numbing injections (multiple) did indeed cause pain - significant pain. But my take on it was the doctor wanted me sufficiently numb so that he could do whatever was necessary to break the cord (or cords) causing the contracture without the patient (me) resisting or experiencing pain during the actual "procedure" itself. Once the numbing injections were completed, I felt no (zero) pain or discomfort, the doctor was able to do what was necessary to relieve the contracture, and the result was both a successful outcome and a highly satisfactory overall experience.

09/02/2009 23:11
moondanc 
09/02/2009 23:11
moondanc 
Re: Think Xiaflex is safe? Read this

Mike S said:
"NA is a one shot deal - not 2X or 3X. NA, in the hands of a skilled practitioner, can work on the PIP joint, even when seriously bent (mine was at 90-95 degrees). NA cost ~$700-800 per finger."

I'm glad NA worked for you as a one-shot deal but that's not the case for everyone--and I've two of the most skilled practitioners. I totally believe in NA and strongly suggest that people try it rather than open hand surgery. For me, however, it didn't work as a one-shot deal. I had NA on my RH MCP Joint in 5/2005 with Dr. Eaton. In only 18 months it was back to a 40 degree contracture and I then got into the clinical trials and had Xiaflex. It worked and broke the cord but by early this year--only 12-14 months it was back in my MCP joint AND my PIP joint of my ring finger and progressing to my middle and little fingers.
6 weeks ago I had NA for the second time, this time with Dr. Denkler. The finger was almost straight after the procedure but in just 6 weeks the MCP joint is already nearly 30 degrees contracted. I'm now pursuing radiation therapy for both hands--will start with my RH, then have NA on my left hand--ring finger MCP, index and middle fingers--both MCP and PIP and possibly PIP on my little finger and my palm looks like a mine field--and then after completion of NA, radiation therapy for my left hand.

The strange thing for me is that my DC started 20 years ago, progressed very slowly for 18 years (almost not at all) and then in the last 2-3 years has progressed so fast I can almost see daily changes. I can only hope RT works for me and that a cure is found soon. I'm so glad that so many people have success after just one NA treatment. I've been told that even with open hand surgery removing most of the disease and having extensive skin grafts-- it can still come back.

09/02/2009 23:42
Mike S

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09/02/2009 23:42
Mike S

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Re: Think Xiaflex is safe? Read this

Moondanc,

I didn't mean to imply that NA necessarily lasts forever or that DC does not reoccur. My point was that for a given "event" you only need to do NA one time vs. 2X (or more) for Xiaflex. Sorry to hear about your reoccurance and continued battles. Good luck to you! I too have other signs and symptoms (new nodule) so I'm by no means "free and clear" forever but at least the original NA is holding up (almost 3 years ) thus far and required only one medical "event" (plus PT follow-up) rather than 2 or 3.

09/03/2009 00:55
Randy_H 
09/03/2009 00:55
Randy_H 

Re: Think Xiaflex is safe? Read this

Our Guest a few posts back is quite right.

When I interviewed Eaton he said he was surprised that BioS had allowed their Forum to be commandeered by the NA movement, a movement only made possible by the Forum itself. On the other hand, if you were there, the BioS forum was eventually overrun, first with Trolls (people pretending to be posters that they were not) and then by enough Spam to sink a ship. This effectively closed down the BioS Forum. Was BioS responsible for this themselves? They could have just gone off the air, so who knows. This current Forum was sort of a "life raft" for the active members who left the BioS ship and migrated here.

Thank you BioS for providing the platform that has helped so many with NA. If Xiaflex proves to be less safe and effective than NA, you can bet this Forum will make that known. NA doesn't see like it's going away any time soon. It will be a thorn in the side of those who own Xiaflex. Once can only assume due diligence was done, and if so, NA was *greately* underestimated.

09/03/2009 01:29
flojo 
09/03/2009 01:29
flojo 
Re: Think Xiaflex is safe? Read this

Moondanc/Diane,

RE: "I'm now pursuing radiation therapy for both hands--will start with my RH, then have NA on my left hand--ring finger MCP, index and middle fingers--both MCP and PIP and possibly PIP on my little finger and my palm looks like a mine field--and then after completion of NA, radiation therapy for my left hand."

Do you know anyone who has had NA after RT? I don't see why it would make any difference so far as NA, but I just haven't heard of NA after RT. More cording developed in my thumb between NA in March and RT in July. Reduction of nodules and easing tightness of cords has continued continued to improve, but I don't expect it to completely take away the nodules or cords. My thumb isn't bad enough that I would do NA again. Besides, the whole MCP joint of my thumb is enlarged. I've been told by my doctor that it isn't arthritis.

09/03/2009 16:31
jimh 
09/03/2009 16:31
jimh 
Re: Think Xiaflex is safe? Read this

The reason the BioSpecifics forum was 'commandeered' for NA was that Auxilium never produced a product, or made any progress toward trials, so there was nothing to discuss. It was just an endless cycle of raising money from investors, spending it all without ever getting the trials started, and then finding new investors. After a few years BioSpecifics itself had become a joke on their own forum and all the discussion was about realistic treatment alternatives - surgery and NA. BioSpecifics never participated in their own forum, or posted any current information on their web site. They got what they deserved.

It's disappointing to read accounts of poorly run trials and fudged results for Xiaflex. It's also clear that Auxilium thinks they're going to price their product at the same level as surgery, and at or above NA. Now that I've had an NA treatment I'm losing interest in Xiaflex. Neither one is a permanent solution, something else - like a systemic antifibrotic - will eventuall be the real 'cure'. Watch for a big marketing blitz for Xiaflex in years to come, but keep that list of NA practicioners handy. I think they'll continue to improve and refine NA techniques.

09/03/2009 17:18
moondanc 
09/03/2009 17:18
moondanc 
Re: Think Xiaflex is safe? Read this

Quote:



Moondanc/Diane,

RE: "I'm now pursuing radiation therapy for both hands--will start with my RH, then have NA on my left hand--ring finger MCP, index and middle fingers--both MCP and PIP and possibly PIP on my little finger and my palm looks like a mine field--and then after completion of NA, radiation therapy for my left hand."

Do you know anyone who has had NA after RT? I don't see why it would make any difference so far as NA, but I just haven't heard of NA after RT. More cording developed in my thumb between NA in March and RT in July. Reduction of nodules and easing tightness of cords has continued continued to improve, but I don't expect it to completely take away the nodules or cords. My thumb isn't bad enough that I would do NA again. Besides, the whole MCP joint of my thumb is enlarged. I've been told by my doctor that it isn't arthritis.



Hi Flora,
I was told by my radiologist -- and I think (so much information, so little brain :-) Dr. Denkler also said that it shouldn't be a problem to have NA after radiation. I was the first patient Dr. Denkler ever had that had Xiaflex prior to NA and he wanted to check out my hand first so I had to do a consult with him before scheduling NA. I wish I could have RT on both hands at once but obviously with the contractures on my left hand, I have to wait for NA first.

I have the same problem you're speaking of-- huge enlargement of my MCP joint knuckles. Earlier this year I went to a rheumatologist to make sure it wasn't rheumatoid arthritis and had x-rays that confirmed it wasn't. If it weren't so tragic it would be funny -- and all one can do is laugh at this point--the x-ray tech kept trying to get me to "straighten" my hands so he could take the x-rays despite explaining to him numerous times that I couldnt. My x-ray report also came back with the notation "hands are in flexed position."

Diane

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