| Lost password
6 users onlineYou are not loggend in.  Login
Xiaflex marketing and discounts
 1 2
12/12/11 22:16
moondanc 
Xiaflex marketing and discounts

The website below requires registration for the whole story but here's the executive summary from a Nov. 8, 2011 story:
"Executive Summary

The manufacturer expected Xiaflex to take off as a non-invasive, more effective alternative to hand surgery, but the market has been slow to convert, prompting Auxilium to shift around its commercial organization
"
http://www.elsevierbi.com/Publications/T...egy-For-Xiaflex

I cannot vouch at all for this website but it is offering a $1000 co-pay discount for Xiaflex:
http://medicationcoupons.com/medication_...pay-assistance/


If you're deadset on Xiaflex and like to read :-), here's the Xiaflex brochure to help your healthcare provider figure out how to bill for Xiaflex and how to appeal claims:

https://www.xiaflex.com/docs/Practice%20...ess%20Guide.pdf

Here's a news release from Auxilium regarding the LT (3 year) results, Note only 451 patients:

http://www.istockanalyst.com/business/ne...at-assh-meeting

Please note that the results are reported for MP joints and says, " Similar trends were seen through three years with evaluable patients with Proximal Interphalangeal (PIP) joints " No doubt the study has further clarifying information but it's not reported here.

Quoted in the above study is Dr. Philip Blazar (see quote below)

"These data demonstrate the maintenance of success for the 71% of patients who did not recur over three years and a slow return to baseline degree of contracture in recurrent patients following XIAFLEX treatment," said Dr. Philip Blazar, Assistant Professor of Orthopaedic Surgery, Harvard Medical School. "I believe treatment of Dupuytren's patients with XIAFLEX can provide durable outcomes with a low rate of recurrence in the majority of patients."

http://ir.auxilium.com/phoenix.zhtml?c=1...&highlight=

In another press release from Auxilium, Dr. Philip Blazar is called, " one of Dupuytren's key opinion leaders, Drs. Philip Blazar," along with Gary Pess, Bronier Costas, and David Kalainov.

What is a "key opinion leader"-- and what is that doctor's relationship with Auxilium and what is his financial interest?

Moondanc

12/12/11 22:30
moondanc 
Re: Xiaflex marketing and discounts

This is from 2010-- an FDA warning to Auxilium

http://www.bizjournals.com/philadelphia/...14/daily33.html

Here's a partial quote -"The Food and Drug Administration .. has issued a letter to Auxilium Pharmaceuticals Inc. .. stating that the company overstated the effectiveness of its newest drug, Xiaflex."

Here's the actual FDA warning letter (this was posted to the forum in 2010):

http://www.pharmcast.com/WarningLetters/...uticals0610.htm

I believe Auxilium has followed the request of the FDA and changed their marketing techniques but I still find the claims and omissions pretty scary.

Here's some data from this year that I don't believe has yet been published. It's an inquiry as to whether surgery is more difficult after Xiaflex injection:
http://c230337.r37.cf1.rackcdn.com/RF020_abstract.pdf

Here are some of the findings:

"Natural history data and presented CCH [Xiaflex] injection results suggest recurrence in a significant
percentage of patients
after either injection or surgical treatment,"

Moondanc

12/15/11 22:38
altoclef 
Re: Xiaflex marketing and discounts

The FDA letter is quite concerning on more than one front. 98% report adverse effects? As few as 39% achieve straightening after one treatment? I don't care for those odds either way.

A month or so ago I started seeing multi-page full-color ads for Xiaflex in Newsweek magazine. The photo used in the ad shows a hand with the ring finger bent all the way to the palm. My understanding was that Xiaflex was not indicated for anywhere near that severe a contraction. Is that wrong, or is the ad misleading?

12/16/11 04:09
moondanc 
Re: Xiaflex marketing and discounts

Take a look at this--check out the link and read the excerpts I've pasted below:

https://www.xiaflex.com/hcp/XIAFLEX_adverse_events.jsp

in a trial of 249 patients 98% had adverse reactions.


Tendon Rupture or Other Serious Injury to the Injected Extremity

In the controlled and uncontrolled portions of the clinical trials, flexor tendon ruptures occurred after XIAFLEX injection. Injection of XIAFLEX into collagen-containing structures such as tendons or ligaments of the hand may result in damage to those structures and possible permanent injury such as tendon rupture or ligament damage. Therefore, XIAFLEX should be injected only into the collagen cord with a MP or PIP joint contracture, and care should be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand. When injecting a cord affecting a PIP joint of the fifth finger, insert the needle no more than 2 to 3 mm in depth and avoid injecting more than 4 mm distal to the palmar digital crease.

Other XIAFLEX-associated serious local adverse reactions in the controlled and uncontrolled portions of the studies (N=1082) included:
•3 flexor tendon ruptures in small finger PIP joint (0.3%)
•1 pulley ligament injury (0.1%)
•1 complex regional pain syndrome (0.1%)
•1 sensory abnormality of the hand (0.1%)

Allergic Reactions

In the controlled portions of the clinical trials (Studies 1 and 2), a greater proportion of XIAFLEX-treated patients (15%) compared to placebo-treated patients (1%) had mild allergic reactions (pruritus) after up to 3 injections. The incidence of XIAFLEX-associated pruritus increased after more XIAFLEX injections.

Although there were no severe allergic reactions observed in the XIAFLEX studies (eg, those associated with respiratory compromise, hypotension, or end-organ dysfunction), severe reactions including anaphylaxis could occur following XIAFLEX injections. XIAFLEX contains foreign proteins and patients developed IgE-anti-drug antibodies in greater proportions and higher titers with successive XIAFLEX injections. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections.

12/16/11 04:15
hammer 
Re: Xiaflex marketing and discounts

I had to take benedryl for a couple weeks after Xiaflex it itches something fierce.Im in oklahoma for my one month check up.My hand looks awesome,finger is nice and straight.Ill post my measurements when i get home tommarow.Ive been lifting 70 lb boxes at work,so far so good.Dave

12/17/11 17:47
flojo 
Re: Xiaflex marketing and discounts

Is there anything or anywhere that reports the certifications of the docs who did the treatments - were they hand specialists, newbies or GPs treating severe and/or Dupuytren's hands? This makes a huge difference, I think!

12/17/11 23:50
moondanc 
Re: Xiaflex marketing and discounts

flojo:
Is there anything or anywhere that reports the certifications of the docs who did the treatments - were they hand specialists, newbies or GPs treating severe and/or Dupuytren's hands? This makes a huge difference, I think!

The problem I see is not that Xiaflex may be as successful at "breaking" cords as is NA-- the problem is 1) does it last as long as NA (remember the original criticism of NA was that it didn't last as long as surgery but now Xiaflex is being compared to NA in terms of duration) and 2)what are the long-term effects of Xiaflex-- a foreign substance put into the body that causes 90+% of patients injected to immediately have swelling, pain, etc. I want to see the studies that show how long Xiaflex antibodies remain in the blood, how long PIP joint Xiaflex straightening lasts, etc There's a reason Xiaflex can only be used once every 30 days! Remember these trials were conducted on a VERY limited number of patients-- US CORD 1, final FDA approval study-- only 308 patients. I've had contact with five of them who say if they'd known then what they know now they'd NEVER have gotten Xiaflex injected into their bodies mainly because of "Dupuytren flare"-- or what they perceived as a rapid acceleration of the disease.

Remember Xiaflex has only been on the market about 20 months, not nearly long enough to measure long-term effectiveness on a large number of patients. I hope some of the doctors who are using Xiaflex in lots of patients will at least be able to report informally

The trials were NOT conducted with newbies or GPs without experience--that would be totally counter productive in trials where they're trying to prove the drug works. Here's a list of locations and docs for CORD 1:

Members of the Collegenase Option for Reduction of Dupuytren’s (CORD) I Study Group wereEdward Akelman, M.D. (Rhode Island Hospital, Providence, RI); Brian Bear, M.D. (Rockford
Orthopedic Associates, Ltd., Rockford, IL); Mark R. Belsky, M.D. (Newton-Wellesley Hospital,
Newton, MA); Philip Blazar, M.D. (Brigham and Women’s Hospital, Boston, MA); Eric N.
Britton, M.D. (Hand Surgery Associates, Denver, CO); Bronier Costas, M.D. (The Hand and
Upper Extremity Center of Georgia, P.C., Atlanta, GA); Joel L. Frazier, M.D. (Health Research
Institute, Oklahoma City, OK); Vincent Hentz, M.D. (Stanford Hospital and Clinics, Palo Alto,
CA); Robert N. Hotchkiss, M.D. (Hospital for Special Surgery, New York, NY); Lawrence C.
Hurst, M.D. and Marie A. Badalamente, Ph.D. (SUNY at Stony Brook, Department of
Orthopaedics, Stony Brook, NY); F. Thomas D. Kaplan, M.D. (The Indiana Hand Center,
Indianapolis, IN); John Lubahn, M.D. (Hand Microsurgery and Reconstructive Orthopaedics,
Erie, PA); Scott McPherson, M.D. (TRIA Orthopaedic Center, Minneapolis, MN); Roy Meals,
M.D. (Private Practice, Los Angeles, CA); Clayton A. Peimer, M.D. (Marquette General Health
System, Marquette, MI); and Douglas Roeshot, M.D. (University Orthopedics Center, State
College, PA).


The last trial was in Australia. There are current results--from Sept of this year, I think, on the followup studies that have not yet been published although I do know some doctors have seen them. Many of the doctors in the trial were consultants to Auxillium and very familiar with Xiaflex. This link appears to still work for the full journal article:
http://www.nejm.org/doi/full/10.1056/NEJMoa0810866#t=article

This is a link to my old post:

http://www.dupuytren-online.info/Forum_E...ials-0_607.html

"Authors of the study (and I believe all participants in the trials )are:
Lawrence C. Hurst, M.D., Marie A. Badalamente, Ph.D., Vincent R. Hentz, M.D., Robert N. Hotchkiss, M.D., F. Thomas D. Kaplan, M.D., Roy A. Meals, M.D., Theodore M. Smith, Ph.D., John Rodzvilla, M.D.

This is what really jumped out at me:
"Dr. Hurst reports receiving consulting and advisory-board fees and grant support from Auxilium Pharmaceuticals and grant support from BioSpecifics Technologies (and may receive royalty fees pending Food and Drug Administration [FDA] approval); Dr. Badalamente, receiving consulting and advisory-board fees from Auxilium Pharmaceuticals and grant support from BioSpecifics Technologies (and may receive royalty fees pending FDA approval); Dr. Kaplan, receiving consulting and advisory-board fees from Auxilium Pharmaceuticals; Drs. Rodzvilla and Smith, being employees of and holding stock options with Auxilium Pharmaceuticals; and Drs. Meals, Hentz, and Hotchkiss, receiving consulting fees from Auxilium Pharmaceuticals"

http://www.nejm.org/doi/full/10.1056/NEJMc0909497

Edited 12/18/11 00:00

12/18/11 02:39
jocond 
Re: Xiaflex marketing and discounts

Moondanc,

My Dad and I were a part of that study under Dr. Roeshot. I too agree I would never have participated had I known more. My Dad passed away in mid 2010 from leukemia. I often question myself if this helped accelerate his condition and/or caused it. This always weighs on my mind because I talked him into doing the trials with me. We both had the real thing and we came away with straighter fingers but it hurt like hell!!! Mine came back with in 8 to 11 months. Had NA on same fingers one year ago and need to have them done again. I have several cords and nodules in both hands, lumps and bumps on both feet and Peyronies that started about two years ago. The worst part of it is I'm only 43 yrs old.

With that said I will NEVER use the xiaflex again. Thanks for listening or should I say reading.

Joe

12/18/11 03:16
moondanc 
Re: Xiaflex marketing and discounts

jocond:
Moondanc,

My Dad and I were a part of that study under Dr. Roeshot. I too agree I would never have participated had I known more. My Dad passed away in mid 2010 from leukemia. I often question myself if this helped accelerate his condition and/or caused it. This always weighs on my mind because I talked him into doing the trials with me. We both had the real thing and we came away with straighter fingers but it hurt like hell!!! Mine came back with in 8 to 11 months. Had NA on same fingers one year ago and need to have them done again. I have several cords and nodules in both hands, lumps and bumps on both feet and Peyronies that started about two years ago. The worst part of it is I'm only 43 yrs old.

With that said I will NEVER use the xiaflex again. Thanks for listening or should I say reading.

Joe

Hi Joe,
I'm so sorry to hear about your experience and that of your Dad. My sincere condolences on his death. Wow-- 8-11 months is a very short time, I thought I was bad with 18 months. (good thing you didn't participate in the Peyronie's trials that are now ongoing-I've often been tempted to post here and warn the guys about Xiaflex)-- maybe that's something you could do?
http://www.peyroniesforum.net/index.php?topic=903.0

It is really a shame that you are so young. Are you participating in the 5 year followup studies from the FDA trials? - I certainly hope so in order that you can present your experiences and that of your Dad. How many fingers did each of you have done? (I only had one) I can never get a straight answer from the study docs when I go to my yearly appointment as to how they report my experience and whether they attribute my straight fingers to Xiaflex or to the NA I had to have after. Please don't beat yourself up about talking your Dad into the trials. I did as much research as I possibly could prior to enrolling in the trials and I consulted with two top hand surgeons and NA practitioners prior to enrolling as to whether I should--one of them encouraged me to do it, the other said he didn't see any reason why not-- I don't think there was anything else you or I could do.

I would like to get together a group of folks like us and report to the FDA. I actually did send a letter to them prior to Xiaflex approval--didn't help.

Perhaps Xiaflex is the solution for some folks-- I just want to make sure they're fully aware of the possible risks.

Best to you,
Moondanc

12/18/11 05:10
altoclef 
Re: Xiaflex marketing and discounts

This thread and the "After Xiaflex" one are kind of going in the same direction. The information in the other thread about possible systemic problems with connective tissues is scary stuff. (My husband is among the tiny percentage of folks who have survived an aortic dissection. Trust me, that's one medical nightmare you wouldn't wish on anyone.) I have wondered, since the stereotype of Dupuytren's patients is that we are old, what the potential is for Xiaflex-related problems years down the road. Someone who gets the drug in their 40s or 50s has many more years to live with the risks than someone who is 70 or 80 at the time of treatment.

I'm not a candidate for the stuff, as my doctor says it's out of the question because the areas I would need treated would take four or more vials of it- who has that kind of $$$ in any case? My disease is quite aggressive. My hand was absolutely fine a year ago when I had trigger finger surgery: I had significant nodules, cords, and contracture less than three months after that, and even more cropped up after a fasciectomy in May. It sounds like X can be even a better trigger than surgery or other trauma in susceptible people. I hate to think what shape I could be in had I tried it after reading what others here have said.

 1 2

Imprint | Copyright | Privacy protection