Prof David Ralph made a video for our charity to explain the different types of surgery available for Peyronie's Disease, and when each type is warranted. Watch the video here:
Keep up to date with all the news from the British Dupuytren's Society.
Showing posts with label Peyronie's. Show all posts
Showing posts with label Peyronie's. Show all posts
Wednesday, 17 June 2020
Monday, 4 November 2019
Xiapex to be discontinued
Well the news is official. Endo has already discontinued Xiapex in Australia and Asia, and plans to do the same to Europe by the end of 2019. The reason? They won't say. We suspect the higher prices in the US and the pending license for cellulite play a role. Even if they proclaim to be an ethical company, they want more return for their shareholders and bonusses for their CEO's. At the cost of depriving patients, and denying them a treatment that may help keep their hands mobile, straighten their penis, keep their life normal.
This is the letter Endo and Sobi published, but keep in mind Sobi wanted to keep supplying and Endo made the decision one sided.
After de-registration, all enquiries, questions or requests for Named Patient Use of Xiapex must be referred directly to Endo. Contact www.endo.com/contact
Business Unit Director
It has come to my attention that Endo Pharmaceuticals is planning to withdraw Collagenase Clostridium Histolyticum (CCH) injection from the whole of the European market. I sincerely hope I have been misinformed, but would like to express our Societies view on this to make you aware of how we feel about this possible development.
CCH is an important addition to the limited treatment options for Dupuytren's Contracture. The only alternative treatment would be a type of surgical procedure, and not every patient, not every hand or finger is suitable for that. For some patients CCH is their main or indeed only hope of regaining and keeping hand function. Similarly for Peyronie's patients CCH is an important additional treatment option, one that allows non surgical treatment and regaining normal function and appearance of their penis.
We as a charity have spent a lot of time and effort fighting to get CCH accepted by NICE as a treatment for Dupuytren's Contracture, so it is now used by the NHS under the right circumstances. It has been an enormous joint effort of Sobi UK, Auxilium, The British Dupuytren's Society for the patients, the British Society for Surgery of the Hand and the British Association of Hand Therapists for the health care providers to reach an acceptance by NICE.
Withdrawing CCH would leave patients in limbo; there will be Peyronie's patients who are somewhere in the cycle of injections where the treatment can't be finished, and both Dupuytren and Peyronie's patients who have agreed with their physicians that CCH is the best option for them, who will be denied that treatment.
Withdrawing CCH for what may well be profit reasons is reinforcing "Big Pharma's" bad name. Endo Pharmaceuticals has a code of conduct for their employees, that states "Endo is committed to conducting business in an ethical and compliant manner". How can it be ethical to withhold treatment from a large population group, and the group that statistically tends to be the worst affected with the disease the treatment was developed for? You would be turning your back on exactly those patients your treatment is supposed to help.
Endo is supposed to have a commitment to patients and communities, to "provide better access to care for patients". This decision would achieve the opposite of what you aim to achieve according to your Code of Conduct.
Your president Mr Patrick Berry said in his speech in 2017 : "Endo is committed to delivering quality medicines to patients in need". If Endo is withdrawing CCH from the European market in order to have more of the drugs accessible for cellulite treatment (at a higher price), you would be doing the exact opposite of what your president wants. Cellulite is not a disabling condition and does not impact on basic daily activities, whereas Dupuytren's and Peyronie's are disfiguring and impede normal functioning of the affected body part, leaving the patient disabled. Surely patients needs should come before profits in a health care company that professes to have an ethical stance.
Yours
This is the letter Endo and Sobi published, but keep in mind Sobi wanted to keep supplying and Endo made the decision one sided.
Healthcare
Professional Information regarding de-registration of XIAPEX®
Dear
Healthcare Professional
This
letter is to inform you that Sobi will discontinue the
commercialisation of XIAPEX by the end of 2019.
XIAPEX
is a product owned by Endo Ventures Limited (‘Endo’). Currently,
XIAPEX is commercialised in the
EU and other European and Middle Eastern countries by Sobi. Endo
and Sobi have agreed to terminate the cooperation agreement for
Xiapex effective December 31, 2019. The decision to withdraw is not
based on safety or efficacy concerns.
Endo
and Sobi are committed to managing the de-registration of Xiapex from
the Sobi territories in an ethical and transparent manner and Sobi
will process the withdrawal of the EU Marketing Authorisation, which
will be effective from 1 March, 2020.
Please
be assured that the wellbeing of patients during the discontinuation
process is of paramount importance to Sobi and we are committed to
the safety and comfort of all patients during the process of
transition to other therapies. We want to emphasize that, subject to
product availability from our supplier, Sobi is committed to
providing XIAPEX up until the end of 2019.
We
would like to thank you for your interest in XIAPEX over the years
and deeply regret any inconvenience this may cause you.
If
you have any questions or concerns, please do not hesitate to contact
us at your convenience.
After de-registration, all enquiries, questions or requests for Named Patient Use of Xiapex must be referred directly to Endo. Contact www.endo.com/contact
Yours
Sincerely,
Carolyne
DysonBusiness Unit Director
Sobi
And this is the letter I send to Endo:
It has come to my attention that Endo Pharmaceuticals is planning to withdraw Collagenase Clostridium Histolyticum (CCH) injection from the whole of the European market. I sincerely hope I have been misinformed, but would like to express our Societies view on this to make you aware of how we feel about this possible development.
CCH is an important addition to the limited treatment options for Dupuytren's Contracture. The only alternative treatment would be a type of surgical procedure, and not every patient, not every hand or finger is suitable for that. For some patients CCH is their main or indeed only hope of regaining and keeping hand function. Similarly for Peyronie's patients CCH is an important additional treatment option, one that allows non surgical treatment and regaining normal function and appearance of their penis.
We as a charity have spent a lot of time and effort fighting to get CCH accepted by NICE as a treatment for Dupuytren's Contracture, so it is now used by the NHS under the right circumstances. It has been an enormous joint effort of Sobi UK, Auxilium, The British Dupuytren's Society for the patients, the British Society for Surgery of the Hand and the British Association of Hand Therapists for the health care providers to reach an acceptance by NICE.
By withdrawing CCH from
the UK (and indeed EU) market you are making a mockery of all the
arguments we used to explain why the drug is needed and is a
revolutionary treatment for patients.
There are several trials ongoing or about to start, at least two in the UK, to evaluate the effects directly and long term of CCH compared to some of the surgical options available. These trials have a lot of money and manpower put into them already, and if they can not proceed that will be wasted, careers of the researchers may be damaged and awarding bodies may be reluctant to back similar trials in the future. Important questions will not be answered about the effects of CCH compared to more traditional surgical treatments.
There are several trials ongoing or about to start, at least two in the UK, to evaluate the effects directly and long term of CCH compared to some of the surgical options available. These trials have a lot of money and manpower put into them already, and if they can not proceed that will be wasted, careers of the researchers may be damaged and awarding bodies may be reluctant to back similar trials in the future. Important questions will not be answered about the effects of CCH compared to more traditional surgical treatments.
Withdrawing CCH would leave patients in limbo; there will be Peyronie's patients who are somewhere in the cycle of injections where the treatment can't be finished, and both Dupuytren and Peyronie's patients who have agreed with their physicians that CCH is the best option for them, who will be denied that treatment.
Withdrawing CCH for what may well be profit reasons is reinforcing "Big Pharma's" bad name. Endo Pharmaceuticals has a code of conduct for their employees, that states "Endo is committed to conducting business in an ethical and compliant manner". How can it be ethical to withhold treatment from a large population group, and the group that statistically tends to be the worst affected with the disease the treatment was developed for? You would be turning your back on exactly those patients your treatment is supposed to help.
Endo is supposed to have a commitment to patients and communities, to "provide better access to care for patients". This decision would achieve the opposite of what you aim to achieve according to your Code of Conduct.
Your president Mr Patrick Berry said in his speech in 2017 : "Endo is committed to delivering quality medicines to patients in need". If Endo is withdrawing CCH from the European market in order to have more of the drugs accessible for cellulite treatment (at a higher price), you would be doing the exact opposite of what your president wants. Cellulite is not a disabling condition and does not impact on basic daily activities, whereas Dupuytren's and Peyronie's are disfiguring and impede normal functioning of the affected body part, leaving the patient disabled. Surely patients needs should come before profits in a health care company that professes to have an ethical stance.
Yours
A S Schurer, for the
British Dupuytren's Society
What more can we do? I emailed Endo (ok, to all 10 different email addresses I found online), emailed all news papers that published articles on Xiapex in the last few years that I could find.
I think patients should let Endo know what they think. Email them!! The more comments they get the better. We need to show them that Dupuytren's and Peyronie's patients stand united in the fight for better treatments and eventually hopefully a cure.
What more can we do? I emailed Endo (ok, to all 10 different email addresses I found online), emailed all news papers that published articles on Xiapex in the last few years that I could find.
I think patients should let Endo know what they think. Email them!! The more comments they get the better. We need to show them that Dupuytren's and Peyronie's patients stand united in the fight for better treatments and eventually hopefully a cure.
Monday, 22 May 2017
News for Peyronie's patients
Earlier this month the American Urology Association had a large conference meeting with specialists from all over the world presenting their latest thoughts and trial results. One of the (many) subjects covered was Peyronie's.
Two interesting and encouraging developments:
One: it would seem that using collagenase (Xiapex) is safe in an earlier stage than so far indicated, so maybe patients can get relief earlier and may not have to wait till the condition is stable for two years. This would be off licence treatment, not supported by the manufacturer at this stage. But is it hopeful!
This was presented by Dr James E Anaissie from Tulane, New Orleans.
Two interesting and encouraging developments:
One: it would seem that using collagenase (Xiapex) is safe in an earlier stage than so far indicated, so maybe patients can get relief earlier and may not have to wait till the condition is stable for two years. This would be off licence treatment, not supported by the manufacturer at this stage. But is it hopeful!
This was presented by Dr James E Anaissie from Tulane, New Orleans.
The next very interesting poster was by our trustee Mr David Ralph from London, who has trialled a shortened course of Xiapex injections for Peyronie's, which will give faster relieve and be less costly. The results were excellent, again this would be off licence, not what the manufacturer recommends, but it does seem effective and offers faster results!
I am very happy to see progress is being made in how best to treat Peyronie's patients. Thank you to the doctors devoting their time to this!
Tuesday, 16 August 2016
New trustees
Great news today! We have two new trustees, to help our charity.
Dr George Flanagan, podiatrist surgeon with a special interest in Ledderhose has agreed to join on the Ledderhose side of things, and will be working closely with Gary. Dr Flanagan works in Blackpool NHS hospital, and in private practice in Fylde, and is sure to be an asset to our charity.
Mr David Ralph is joining us on the Peyronie's side. He has already worked with Birgir and Mr John Glees on the recent awareness campaign, and has agreed to become a permanent trustee. He has published extensively on Peyronie's and has a lot of experience treating men with the condition. We are extremely lucky to have him on board.
Welcome gentlemen, thank you so much for your efforts to help in fighting these diseases.
Dr George Flanagan, podiatrist surgeon with a special interest in Ledderhose has agreed to join on the Ledderhose side of things, and will be working closely with Gary. Dr Flanagan works in Blackpool NHS hospital, and in private practice in Fylde, and is sure to be an asset to our charity.
Mr David Ralph is joining us on the Peyronie's side. He has already worked with Birgir and Mr John Glees on the recent awareness campaign, and has agreed to become a permanent trustee. He has published extensively on Peyronie's and has a lot of experience treating men with the condition. We are extremely lucky to have him on board.
Welcome gentlemen, thank you so much for your efforts to help in fighting these diseases.
New trustees
Great news today! We have two new trustees, to help our charity.
Dr George Flanagan, podiatrist surgeon with a special interest in Ledderhose has agreed to join on the Ledderhose side of things, and will be working closely with Gary. Dr Flanagan works in Blackpool NHS hospital, and in private practice in Fylde, and is sure to be an asset to our charity.
Mr David Ralph is joining us on the Peyronie's side. He has already worked with Birgir and Mr John Glees on the recent awareness campaign, and has agreed to become a permanent trustee. He has published extensively on Peyronie's and has a lot of experience treating men with the condition. We are extremely lucky to have him on board.
Welcome gentlemen, thank you so much for your efforts to help in fighting these diseases.
Dr George Flanagan, podiatrist surgeon with a special interest in Ledderhose has agreed to join on the Ledderhose side of things, and will be working closely with Gary. Dr Flanagan works in Blackpool NHS hospital, and in private practice in Fylde, and is sure to be an asset to our charity.
Mr David Ralph is joining us on the Peyronie's side. He has already worked with Birgir and Mr John Glees on the recent awareness campaign, and has agreed to become a permanent trustee. He has published extensively on Peyronie's and has a lot of experience treating men with the condition. We are extremely lucky to have him on board.
Welcome gentlemen, thank you so much for your efforts to help in fighting these diseases.
Tuesday, 28 June 2016
Nice appeal decision!!
We have a decision! It has taken almost 7 months, but NICE have decided that the appeal should be upheald. Not for the whole of the Dupuytren's community, they still prefer patients to have PNF but for those who are not suitable we can argue the case again. https://www.nice.org.uk/guidance/GID-TAG364/documents/appeal-decision So back to appraisal it is.
Anyone who wants to know what the decision was based on, this document gives the arguments and reasoning. And for someone interested in the whole process: the documents can be found here: https://www.nice.org.uk/guidance/indevelopment/gid-tag364/documents
On another note the Pulvertaft Hand Centre in Derby would like to know what patients feel about splinting, especially after PNF. https://www.surveymonkey.co.uk/r/splintingfordupuytrens It is a short survey, so won't take much of your time! Go ahead and do it.
The Peyronie's campaign has reached a lot of people and countries, and we are now considering how to build on that. Our Thunderclap reached the 100 supporters-limit, thank you to everyone who supported! We will keep you informed of any other projects we start, for now it is back to appraisal on Xiapex and hoping NICE makes the right decision on Radiotherapy. Exciting times for Dupuytren's patients.
Anyone who wants to know what the decision was based on, this document gives the arguments and reasoning. And for someone interested in the whole process: the documents can be found here: https://www.nice.org.uk/guidance/indevelopment/gid-tag364/documents
On another note the Pulvertaft Hand Centre in Derby would like to know what patients feel about splinting, especially after PNF. https://www.surveymonkey.co.uk/r/splintingfordupuytrens It is a short survey, so won't take much of your time! Go ahead and do it.
The Peyronie's campaign has reached a lot of people and countries, and we are now considering how to build on that. Our Thunderclap reached the 100 supporters-limit, thank you to everyone who supported! We will keep you informed of any other projects we start, for now it is back to appraisal on Xiapex and hoping NICE makes the right decision on Radiotherapy. Exciting times for Dupuytren's patients.
Monday, 11 April 2016
New advisor for the BDS
While NICE is still deliberating, we have some good news: Mr Stephen Jeffrey LCSP of Ealing Massage Therapy http://www.ealingmassagetherapy.co.uk/Dupuytren-s-Massage.html who has years of experience in massage therapy for Dupuytren's and is happy to share his protocol with therapists the country and indeed the world over has agreed to join our charity in an advisory capacity. Quite a coup!
The Peyronie's survey has finished, we had around 200 responses so that was really good. Thanks to all those who put their embarassment aside and answered the questions. The results will be used for the awareness campaign in a few months. Gemma is working hard on this.
The Dupuytren Foundation is still trying to recruit people worldwide to partake in their research, if you have not done so yet please sign up on http://dupuytrens.org/enroll-in-the-iddb/
We have added a pinterest plug-in to our website, so anyone wanting to use Pinterest can do so.
Our first newsletter has gone out, if you don't want to miss the next one please become a member of the charity.
The Peyronie's survey has finished, we had around 200 responses so that was really good. Thanks to all those who put their embarassment aside and answered the questions. The results will be used for the awareness campaign in a few months. Gemma is working hard on this.
The Dupuytren Foundation is still trying to recruit people worldwide to partake in their research, if you have not done so yet please sign up on http://dupuytrens.org/enroll-in-the-iddb/
We have added a pinterest plug-in to our website, so anyone wanting to use Pinterest can do so.
Our first newsletter has gone out, if you don't want to miss the next one please become a member of the charity.
Tuesday, 5 January 2016
AGM 2015
On 28th December we had our trustee AGM, this year we had a good show, with 6 people joining in the Skype conversation (although we kept loosing at least one).
We discussed a lot, not in the least asking Birgir Gislason to become our trustee for the Peyronie's side. He has been helping us for a while, so it was time we made it official.
A Peyronie's awareness campaign is planned for next year, with Birgir and Dr John Glees very enthousiastic about how they can help. Thank you to both!
Gemma is now our secretariat for the next 6 months, Annemarie remains treasurer. No other changes in the line-up.
We had some good suggestions about how the charity can evolve, and the minutes and financial report wil be put on the website (as soon as I can work out how to do so, lol)
The website is now completely on Wordpress, there are some teething problems but on the whole it has gone very smooth. The IDS had their AGM on 29th December, Anna attended (by telephone conference)
A Scottish MP Martyn Day has asked the Secretary of State for Work and Pensions, what the timescale is for reaching a decision on the proposals to add Dupuytren's Contracture to the list of industrial injuries disablement benefit diseases. The answer is a bit disappointing: The proposal to add Dupuytren’s Contracture is still under consideration and a decision on this will be made in due course.
Still I will email the MP and express our gratitude for him standing up for Dupuytren's patients.
Sunday, 13 September 2015
Waiting for NICE final decision
Almost crunchtime now, next week NICE make their final decision on collagenase use in England on the NHS public. I am not hopeful, but you never know.
We can edit our website again, so I have updated the doctors page with the new information I have, and added a page with tips on how to cope with Dupuytren's or Ledderhose. If anyone has any other good tips email me and I might add them next time! anna@dupuytrens-society.org.uk
Prof Nanchahal in Oxford is starting a clinical trial looking into a novel treatment to stop nodules developing into cords. NIHR ( National institute for health research) has put money aside for a trial comparing collagenase in moderate cases with needle aponeurotomy. So this is all positive!!
For the links just go to our website, they are on the 'home' page.
Birgir has attended a NICE scoping meeting on collagenase treatment for Peyronie's. We are not sure if that is going to progress to an appraisal (ie if NICE is going to consider paying on the NHS).
Gary is running more and more, a tribute to his chosen treatment of radiotherapy for his Ledderhose, a few years ago he would not have been ale to contemplate walking any distance, never mind training for a half marathon. And for those who advocate surgery: that is always an option, but seeing there is always a risk of recurrence and painful scarring, this seemed the better first choice to him. And it worked! Gary will be running his half marathon to raise money for Pancreatic Cancer Uk. Any sponsorship will be welcome, can be done via his Ledderhose blog.
Saturday, 23 November 2013
Meetings
Two days ago I met up with Mark Bell, a representative of Sobi who will be marketing Xiapex in Europe and Asia. He seemed nice, keen and had good knowledge of Dupuytren's and the other conditions Xiapex is being trialled or considered for. I am happy to say we have a Peyronie's patient on our side now, as Mark asked if we support patients with PD and for some reason I feel better letting men discuss that amongst themselves.
Sobi is a smaller company than Pfizer but no less committed, and the have some good ideas. They will keep us informed of trial results and published articles and can help finding surgeons who use Collagenase injections if a patient send us a query where to fine one.
Then yesterday was the next meeting with Nice, to discuss the finalised scope for Xiapex and the forthcoming multi-technology appraisal, what they want from us in the way of information and help, how they are going about searching for articles and calculating the improved QALY of patients, that kind of thing. I was impressed with the way everyone at Nice now understood the disease, and the meeting was fruitful.
We also send a letter to Bapras http://www.bapras.org.uk/ last week asking them to review and update the information on their website about Dupuytren's. At the moment it states 'Surgery is the only treatment available for Dupuytren’s Contracture' and we would like that adjusting to mention the different treatments that are available. We shall see what happens.
It's been a busy week, but it was constructive. Anna
Saturday, 4 May 2013
Another big step forward for the website http://www.dupuytrens-society.org/index.html .
We finally have the new layout up and running, now we just need to find all the faulty links etcetera in this one, and that means going through the whole site, checking everything.. Gary has promised to make a start, and I am grateful to him.
Apart from that we have been working on sharing documents and annotations, Mendeley is a very useful program but it would seem both my and Judith's virus scanners/ firewalls have problems allowing it access all the time. So more wrinkles to iron out there. But I'm sure now my laptop is working almost normal again ( that's why I have not written a blog for a while, it suddenly kept freezing up halfway start-up, turned out the last virus scanner update had corrupted something, so it needed registry repairs and a new virus program- no more free ones for me for a while!) we will be able to get on with our list of urgent things to do, and maybe even the less urgent or longterm plans.
Auxilium have as from May taken overmarketing Xiapex, they are the manufacturers but so far Pfizer has marketed it in Europe. So that's a big change, we said our goodbey's to our contact at Pfizer and Judith and I have already met our new contact at Auxilium when we were at the NICE meeting. We'll wait and see how good the contact will be and what they can do for Dupuytren's patients, but they seemed knowledgeable about the condition and related problems like Ledderhose, frozen shoulders, dorsal nodules, Peyronie's etc. And even about cellulite, as there is a trial using Xiapex for that. Maybe once plastic surgeons start using it the cost will come down? Wishful thinking.
Time to go and enjoy some sunshine, it is a bank-holiday weekend and my garden is crying out for some attention.
Anna
We finally have the new layout up and running, now we just need to find all the faulty links etcetera in this one, and that means going through the whole site, checking everything.. Gary has promised to make a start, and I am grateful to him.
Apart from that we have been working on sharing documents and annotations, Mendeley is a very useful program but it would seem both my and Judith's virus scanners/ firewalls have problems allowing it access all the time. So more wrinkles to iron out there. But I'm sure now my laptop is working almost normal again ( that's why I have not written a blog for a while, it suddenly kept freezing up halfway start-up, turned out the last virus scanner update had corrupted something, so it needed registry repairs and a new virus program- no more free ones for me for a while!) we will be able to get on with our list of urgent things to do, and maybe even the less urgent or longterm plans.
Auxilium have as from May taken overmarketing Xiapex, they are the manufacturers but so far Pfizer has marketed it in Europe. So that's a big change, we said our goodbey's to our contact at Pfizer and Judith and I have already met our new contact at Auxilium when we were at the NICE meeting. We'll wait and see how good the contact will be and what they can do for Dupuytren's patients, but they seemed knowledgeable about the condition and related problems like Ledderhose, frozen shoulders, dorsal nodules, Peyronie's etc. And even about cellulite, as there is a trial using Xiapex for that. Maybe once plastic surgeons start using it the cost will come down? Wishful thinking.
Time to go and enjoy some sunshine, it is a bank-holiday weekend and my garden is crying out for some attention.
Anna
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