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Think Xiaflex is safe? Read this
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09/03/2009 17:25
moondanc 
09/03/2009 17:25
moondanc 
Re: Think Xiaflex is safe? Read this

Quote:



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.



Hi Mike,

Thanks for your explanation and sorry for the agressive tone in my post. I'm a bit upset and anxious these days about my DD. I had totally forgotten about the 2nd visit required the day after the Xiaflex injections-- probably because it was so *%$*$# painful (actually I think the injection of Xiaflex 3 times in different places directly into the cord on the first day was equally as painful). I believe I read on this forum that some trials allowed anesthesia and I can only assume that when Xiaflex is actually approved, docs will use lidocaine or something similar-- at least on "break the cord" day!

I'm glad you mentioned PT because I don't recall reading much on this forum about it and so I'm going to start a new thread with my questions.

Moondanc/Diane

09/03/2009 19:03
moondanc 
09/03/2009 19:03
moondanc 
Re: Think Xiaflex is safe? Read this

Quote:




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.



I have other concerns about Xiaflex:

1.The major researchers at the Stage II trials were/are "consultants" to Xiaflex. At least two of them participated in the Stage III trials and I believe there were several other docs in the Stage III trials who are also "consultants" to Xiaflex. I realize this is the way studies for the FDA are often done but isn't this a major conflict of interest? I would love to see a list of hand surgeons and other docs who are consultants to Auxillium and I'd sure want to know if mine was.

2. Xiaflex appears to be an "easier" treatment for docs to administer (whether this is actually true or not remains to be seen)-- requiring less time, and theoretically, less skill and also producing more income for docs. Will this affect the decision making process of docs currently doing NA?

3. My biggest concern is the short term nature of the Stage III trials-- one year or less. No followup planned. How do they know reoccurence rates? How do they know long-term effectiveness or side-effects? I'm in contact with several others from my trial whose disease appeared to increase in aggressiveness after Xiaflex injections as did mine. It could be coincidence or not--but I think it's important to have some scientific evaluation and as far as I know, there aren't any plans for same. Sigh, I realize most FDA trials are like this and it's only when adverse after-market reports start coming in that we get the full story. It's extremely disconcerting to even contemplate that a drug that's supposed to treat and improve DD could possibly make it much worse.

4. Finally, BioSpecifics and Auxillium have signed a contract with Pfizer, Inc. to market "XIAFLEX for both Dupuytren's disease and Peyronie's disease in the 27 member countries of the European Union and 19 other European and Eurasian countries. In addition, Pfizer will be primarily responsible for regulatory activities for XIAFLEX in these countries."

Read more: http://www.fiercebiotech.com/press-relea...aflex-tm-europe

Pfizer Inc. has just been fined a record-breaking $2.3 billion for illegal drug promotions that plied doctors with free golf, massages, and resort junkets. Authorities called Pfizer a repeat offender, noting it is the company's fourth such settlement of government charges in the last decade. Even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs said the US attorney in MA.

http://www.sfgate.com/cgi-bin/article.cg...L#ixzz0Q4jW1bUY

09/09/2009 17:24
Guest

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09/09/2009 17:24
Guest

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Re: Think Xiaflex is safe? Read this

Quote:



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.



Please consider sending your information and comments to the FDA prior to the 9/16 meeting considering approval. Contact information is below. They are Still taking public comments regardless of what the website says.

Email: nicole.vesely@fda.hhs.gov
Nicole Vesely, Pharm.D.
LT, United States Public Health Service
Advisors and Consultants Staff, HFD-21
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane (Bldg 5630)
Rockville, MD 20857
Phone: (301) 827-6793
Fax: (301) 827-6776


09/09/2009 18:53
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09/09/2009 18:53
Guest

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Re: Think Xiaflex is safe? Read this

I agree, Moondanc, if what you say is true then you could be helping the committee decide if the drug is safe for the market. Because the patent runs out in 2014 they are is a huge hurry to get it out so that their investment can be recouped in a hurry. This information is important and I hope if anyone one else had the same experience they would come forward as well.

09/14/2009 16:52
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09/14/2009 16:52
guest

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Re: Think Xiaflex is safe? Read this

The following is taken from the posting at :http://www.fda.gov/AdvisoryCommittees/Calendar/ucm174629.htm.
I do wonder why it reads that the only option for Dupuytren's is surgery (other than this drug) and never mentions N.A.. Does anyone know who is on this panel and are they aware that N.A. exist?





Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

* Written submissions may be made to the contact person on or before September 1, 2009.
* Oral presentations from the public will be scheduled between approximately 12:45 p.m. to 1:45 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 24, 2009.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 25, 2009.
Contact Information

* Nicole Vesely, Pharm.D.
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093)
Rockville, MD 20857
Phone: 301-827-7001
Fax: 301-827-6776
E-mail: nicole.vesely@fda.hhs.gov

* FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Code: 3014512532
Please call the Information Line for up-to-date information on this meetin

09/15/2009 01:19
moondanc 
09/15/2009 01:19
moondanc 
Re: Think Xiaflex is safe? Read this

Quote:



The following is taken from the posting at :http://www.fda.gov/AdvisoryCommittees/Calendar/ucm174629.htm.
I do wonder why it reads that the only option for Dupuytren's is surgery (other than this drug) and never mentions N.A.. Does anyone know who is on this panel and are they aware that N.A. exist?




Hi there,
I wish I weren't qualified to answer this but, sigh, I am. I've had NA twice and collagenase once. The first NA--MCP joint, right finger, right hand- lasted around 2 years. The cord either "rejoined" or developed along side because it was the same finger, same joint that was affected. Then I had collagenase (in a trial), the cord broke but because the trial only allowed three different injection sites, lots of cord remained although my finger did straighten for about a year. All the lumps and skin tethering remained in my palm and on the sides of my fingers after Xiaflex. After Xiaflex, DD progressed in that finger to the PIP joint-- in little over a year-- and I just had NA again-- it worked to release the finger but has already started to contract again. After Xiaflex, I got DD something fierce in my left hand-- none of the fingers in my left hand had contractures severe enough-- or in most cases at all--to qualify for the trial. I'm beginning to think it's not just a coincidence that my disease got aggressive after Xiaflex and I sure wish there were studies and followups longer than 1 year.

I first interviewed for the trials --at Stanford-back in 2/2003-and at that time they wouldn't even acknowledge there was such a thing as NA. I qualified but becausze there was no funding, there were no trials. I was called back in 2005 or 2006--they still wouldn't not acknowledge NA existed--even when I told them I'd had it done. Finally, in 2007, they acknowledged it existed but said the recurrence rate of NA was much earlier than open hand surgery and that Xiaflex was gonna fix it forever, and one of the pluses for Xiaflex was that it had much less recurrence rate than open hand surgery. AFAIK Xiaflex has always been touted as the "ONLY" alternative to OHS


Speaking of Auxillium and Xiaflex-- the stock jumped 20% today based on likely approval. Read all the details here:
http://www.reuters.com/article/marketsNe...20090914?rpc=44

For details on FDA advisory committees, etc.:
http://www.fda.gov/AdvisoryCommittees/Co...ittee/ucm125994

09/15/2009 12:13
guest

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09/15/2009 12:13
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Re: Think Xiaflex is safe? Read this

I think it's time we merged this discussion in with "Money, Money, money makes the World go round."

09/16/2009 03:18
user714

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09/16/2009 03:18
user714

not registered

Re: Think Xiaflex is safe? Read this

what a racket.

Buyer beware.


Too bad they have soooooooooooooooooooooooooooo much money to market this while there is no big money to push NA in a similar fashion -- who's gonna do it, the 25-gauge needle manufacturers?!!!

09/16/2009 04:03
moondanc 
09/16/2009 04:03
moondanc 
Re: Think Xiaflex is safe? Read this

Quote:



what a racket.

Buyer beware.


Too bad they have soooooooooooooooooooooooooooo much money to market this while there is no big money to push NA in a similar fashion -- who's gonna do it, the 25-gauge needle manufacturers?!!!



There's not much to laugh at with Dupuytren's but your remark and TomVirginia's Claw Hands make me chuckle. Please give all the support you can to Wolfgang for this forum and Dr. Eaton for setting up the Dupuytren Foundation, and all their efforts - • Partnering with Scripps Research to establish a Dupuytren DNA Data Bank - this is happening now.
• Partnering with The Dupuytren Society to host an international symposium on Dupuytren's Disease, with an emphasis on promoting efforts to find a cure. The symposium web site is http://www.DupuytrenSymposium.com and the first announcement for researchers to submit papers for presentation goes out this week. The Symposium will be held May 22,23 2010 at the Intercontinental Hotel in Miami.


http://www.dupuytrenfoundation.org/

Soo-- go out and buy somea them 25-gauge needles, read Dr. Eaton's tutorial and "just do it." :-)

http://www.handcenter.org/dupchapter/NAmanual2009.pdf

09/16/2009 16:22
jimh 
09/16/2009 16:22
jimh 
Re: Think Xiaflex is safe? Read this

Auxilium knows all about NA. In their press releases, they're playing fast and loose with the facts when they say surgery is the only alternative - it's not clear whether they're pretending NA doesn't exist, or calling it "surgery". They've spent a ton of money getting this far and they're launching a marketing blitz in hopes of making it back in a hurry. Initially, they're talking about a very high price for Xiaflex but I question whether they'll be able to get it. In the real world they have to compete with NA which is becoming increasing available. Let's hope the result is that the price of Xiaflex comes down rather than the price of NA going up.


NA is just the latest way to sever the cords. Years ago, hand surgeons did "fasciotomy" (cutting the cord) instead of "fasciectomy" (removing all the bad tissue) using conventional instruments and making a fairly large incision. Over time they became convinced that the recurrence rate was too high, and the accumulation of scar tissue made it hard to repeat the process. But today's conventional surgery is an enormous hassle for the patient, requiring months of healing and therapy. Minimally invasive techniques like NA and Xiaflex require no recovery and are more or less easily repeatable.

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