Bloodwise Video – Kris Griffin (me)

Long time no see. I hope all is well. Just wanted to drop in with some shameless self promotion and to celebrate my association with Bloodwise (formally Leukaemia and Lymphoma Research).

I recorded this video some time ago now, it’s just been put live. I’m delighted with the results and I’d urge you to have a look at this and the other videos to learn a little more about the lives of blood cancer patients.

Thanks, Kris

Another Day In Westminster

I spent an exhausting day in Westminster meeting parliamentarians this week. Henry Smith MP, Mark Durkan MP and Nic Dakin MP all gave up their valuable time to sit with me in Portcullis House to discuss Khalid Younis, Chronic Myeloid Leukaemia (CML) and the problem we currently face with the lack of an appraisal system for new drugs.

All three MPs were incredibly kind with their time and very supportive. They all agreed to support a letter from Roger Godsiff MP (Khalid’s member of parliament) to the Prime Minister asking him to intervene in Khalid’s case as well as agreeing to submit written parliamentary questions where appropriate. All three were very concerned with the issues I raised and offered lots of advice and opinion on how we can move forward.

It’s great to have days like this. We’ve made friends with more, influential, people who now know about the struggle CML patients face as well as issues facing the wider cancer community. Although to their credit all three men were very aware of the restrictions faced getting the right drugs to the right people in a timely and cost-effective way. I certainly appreciated the balance in conversation; we all know that the funding pot is finite but to have a productive discussion on how to address this in a fair and progressive way, ensures we, as patients, become part of the solution, rather than part of the problem.

I’ll progress this by suggesting some written questions we can submit and go on record by thanking all three gentlemen very much for caring about CML patients.

Best, Kris

This slideshow requires JavaScript.

CML Advocates launch Leukaemia App

CML Advocates Network has launched its new mobile Chronic Myeloid Leukaemia (CML) adherence app called CML Today. It’s for CML patients to help them support adherence to tyrosine kinase inhibitors (TKIs) as well as to track their polymerase chain reaction (PCR) results.

The mobile app is available for FREE in English, French, Spanish, German, Portuguese, Arabic and Hebrew. More languages will follow soon.

The App will allow patients to:

• track the regular intake of their medicine
• remind them to take their prescribed medication
• track their PCR test results and other laboratory parameters
• facilitate patients connect with local support groups in their country.

I’ve downloaded the App for my iPhone and have found it easy to use and very clear; the reminder function is excellent. Whilst there are several Apps that support CML patients this is the only one, to my knowledge, developed by a patient advocacy network. I know the people who have developed it and I trust them, very important with medical data of this nature. This App gets my seal of approval and a big thumbs-up from me. Well done CML Advocates Network.

Find CML Today in the Apple App Store (iphone) and in the Google PlayChronic (Android).

https://itunes.apple.com/de/app/cml-today/id1038000286?l=en&mt=8
https://play.google.com/store/apps/details?id=com.appropo.cml_adherence_app&hl=de

Thanks, Kris

World CML Day 2015

9/22 represents the genetic change of Chromosomes 9 and 22 that is the cause of Chronic Myeloid Leukaemia (CML).
Since 2008, patient organisations around the world have initiated events and projects on “CML Awareness Day” on September 22 to raise awareness of the needs of patients living with CML. Since 2011, the worldwide community unites to celebrate “World CML Day” on that date.  – from CML Advocates Network

Sitting down to write a post for World CML Day, even if there are only a few hours left, is always a daunting prospect. Ultimately it’s not just one day for patients, but I understand the sentiment. For patients like Khalid Younis it brings more attention to his cause to get the drug (ponatinib) he deserves – you can read his story here.

So, when it came to writing I was in danger of either repeating myself or simply bashing governments and organisations again. PING. An email arrives. It’s a blog post from my good friend Greg Stephens, the executive director of the National CML Society in the US. Greg is one of the good guys, a really good guy. That’s the thing about CML, it brings people together. I would be a poorer person for not knowing Greg. His fiery determination, humility and wit makes for great company which come in handy when the sensible people have gone to bed at conference.

His blog post was a complete inspiration and I asked him if I could post it here, he said yes in the most beautiful way. Here it is, he said things I wanted to say in a much better way. Cheers Greg x

Kris

Some things to ponder on World CML Day
by Greg Stephens

Today, 9/22, is a day that is known well among those of us in the CML community. It’s a day set aside for awareness activities and a time to call attention to the many challenges faced by anyone living with Chronic Myeloid Leukemia. Over the past seven years, today’s awareness initiatives have grown in scope, rising from the first CML Awareness day in Canada to a global emphasis. Right now, activities are going on around the world and key issues are being discussed. So, what are some things to consider on this day set aside as a day of awareness?

First off, it’s not for us. While we benefit from raising awareness, the true purpose for promoting blood cancer and CML awareness (year round, actually) is so the public and those who know nothing about blood cancers can learn more about this group of diseases, recognize the amazing progress that has been made through medical research, have a better understanding of the realities of blood cancer, and dispel myths and misconceptions that may exist. For those of us in the CML community, it’s an opportunity to share our “reality” – truths if you will, with friends and family, medical professionals, the makers of our treatment drugs, and countless others who need to know just how much CML impacts one’s daily life. While there is focused attention on CML, we have a great opportunity and responsibility to create awareness for those outside our community.

Here are a few things to think about:

1. Eighteen! Today, 18 people will be diagnosed with CML* in the United States. There will be 18 more tomorrow and the next day, and the next….all throughout the year.
2. For the majority of those people, their CML will be brought under control with treatment, however, a small portion will not have that experience.
3. The current costs of our CML treatment drugs are unsustainable and many, even WITH insurance coverage and other assistance, are suffering financial ruin as a result.
4. There is no “GOOD” leukemia. Did I just say “GOOD” and LEUKEMIA in the same sentence?
5. Side effects are an ever-present reality that impedes many patient’s daily lives.
6. Drug parity legislation and fair access to oral chemotherapeutic drugs at a national level is needed, now more than ever.
7. Some may be able to achieve a treatment-free remission (TFR) and go months – even years without treatment. Others will be dependent upon treatment for their lifetime.
8. Quality of life issues are widespread and more attention must be focused on addressing them.
9. Learning about CML from reputable resources and becoming knowledgeable about the disease is imperative for anyone diagnosed.
10. We aren’t “finished” with CML – we not only need curative research to continue, we need it to increase.

This list could go on for countless pages and not even begin to cover all the things our community deals with on a daily basis. You probably have a list of your own. It may seem overwhelming, but together we can bring greater awareness to these and other realities we face every day. To succeed, we must look beyond ourselves and our community and boldly speak up so that those who minimize the life with CML or know nothing about it will know the truth. Yes, great things have happened and will continue to happen for our community, but much work remains.

I hope you will join us in making a difference for anyone living with CML.

Greg

CML Horizons 2015 – Barcelona

This year the Chronic Myeloid Leukaemia (CML) Horizons conferences was held in Barcelona. The organisers have made this excellent collection of web streams and documents available for those of you that made have missed things. It’s a wonderful conference and I would highly recommend dipping in and watching some of the presentations; the PDF report is also an excellent read.

Watch the presentations here:

1 May 2015: www.cmladvocates.net/cmlhorizons/cml-horizons-2015/video-streams-day-1-fri

2 May 2015: www.cmladvocates.net/cmlhorizons/cml-horizons-2015/video-streams-day-2

3 May 2015: www.cmladvocates.net/cmlhorizons/cml-horizons-2015/video-streams-day-3

Alternatively, see all sessions as webstream-links and PDFs: www.cmladvocates.net/cmlhorizons/cml-horizons-2015

I’d also like to share the brand new CML Horizons 2015 conference report, which provides a summary of all sessions. www.cmladvocates.net/download/cml-horizons-conferences/cml-horizons-2015/578-cml-horizons-2015-conference-report/file

Finally, the photo gallery of CML Horizons 2015 can be found here: www.cmladvocates.net/cmlhorizons/cml-horizons-2015/photo-gallery

Huge thanks to the steering committee of the CML Advocates network for sharing this and congratulations on another superb year. Kris

Letter to Simon Stevens – Chief Exec of NHS England

A group of charities and advocates (including me) have come together to put a letter in front of Simon Stevens, the chief executive of NHS England to ask him to consider the situation for two CML drugs: bosutinib and posatinib.

The letter sets out the case for the retention of bosutinib on the list of Cancer Drugs Fund (CDF) drugs for CML patients in England, and also argues for ponatinib to be made available, via the CDF, for any patient in England that falls within its licensed use providing their clinician thinks it appropriate and the patient agrees to treatment. This would allow CML patients resident in England to enjoy the same level of access CML patients in Wales and Scotland currently enjoy.

There was a Written Parliamentary Question answered by a Department of Health Minister on Monday that confirmed rumours that have been circulating for some weeks that there will be no new applications for drugs to enter the national CDF in the future. This would effectively make ponatinib unavailable in England to all clinically qualifying patients who do not have the T315i mutation.

NHS England will of course say a clinician can make an exceptional needs application for ponatinib treatment for an individual patient but the success rate to date of this type of application has been negligible.

Finally, it’s important to stress that all patients in England currently being treated by bosutinib or ponatinib via a successful application to the CDF will continue to be able to be treated with either drug until they or their clinician decides otherwise.

I’ve posted the content of the letter below and have also included a download to the PDF. It has also been sent to the Secretary of State for Health. Many thanks to David Ryner at CML Support for spearheading this action.

I’ll keep you posted with any progress. Thanks, Kris

Dear Mr Stevens,

We are writing to you regarding the recent announcements relating to the Cancer Drugs Fund (CDF) and the specific decisions that have been taken on treatments for chronic myeloid leukaemia (CML).

As patient groups representing the concerns of patients with CML, we are particularly alarmed by both the inclusion of CML treatments in the next review of the CDF for delisting at the end of this month, and by the suggestion that there may not be any further meetings of the GDF panel to consider new treatments or indications for the remainder of the 2015/16 financial year.

In particular, I would like to draw your attention to the situation currently facing two medicines which treat patients with more advanced CML, who therefore face severely limited treatment options. Bosutinib is scheduled for review at the next meeting of the CDF panel at the end of this month. Ponatinib, a drug which has never been appraised by NICE due to its small patient population, is only available through the GDF for patients with the T315i mutation, rather than in its full licensed indi. cation. Ponatinib was due to be assessed by the CDF panel for its full licence in June, before the cancellation of the last scheduled meeting.

This situation for those patients needing access to ponatinib is particularly acute; with NHS England’s Commissioning Intentions for 2015/16 committing to producing algorithms for all chemotherapy within the year, ponatinib now faces the prospect of being effectively excluded from the CML algorithm entirely, with the exception of the T35i mutation.

When the threat to bosutinib is factored in and with the exception of the minuscule number exhibiting the T315i mutation, patients in England now face a lack of access to two of the five drugs that are currently available to them. The clinical effectiveness of these drugs in being able to secure optimal responses at speed and scale relative to the current entry level CML inhibitor, imatinib, now over a decade old, is well established.

The Government’s Accelerated Access Review (AAR) demonstrates a welcome recognition that current evaluation processes require revision to ensure they are fit for purpose in assessing the new generation of innovative products, including targeted therapies for CML. We recognise, too, that the CDF needs to adapt its processes to remain in step with the wider Government agenda.

It is therefore bewildering, contradictory and illogical for NHS England’s real time activity to be moving in the opposite direction of travel in reversing, rather than accelerating, access to targeted therapies for CML. This is made even more remarkable given the fact that, relative to other CDF list treatments, the performance of this class of drugs has been considered outstanding when judged against standard measures of survival. As a result, the overwhelming majority of patients are now able to secure decades of benefit from these home-based oral therapies, with their lives returning to near normal (and patients enjoying near-normal life expectancy) following treatment.

Such marked improvements in CML patient outcomes have been achieved by the steady increase in targeted therapies. We believe that to withdraw the opportunity from patients who would benefit from targeted CML therapies such as ponatinib and bosutinib is both discriminatory and perverse and we would strongly urge you to reconsider this decision by NHS England.

cc. Rt Hon Jeremy Hunt MP

Yours sincerely,

David Ryner, Chair, Chronic Myeloid Leukaemia Support Group
Chris West, Head of Media and Public Affairs, Leukaemia & Lymphoma Research
Tony Gavin, Director of Campaigns & Advocacy, Leukaemia Care
Nigel Deekes, CML UK
Kris Griffin, UK CML blogger

Simon Stevens Letter PDF

Jeremy Hunt Letter PDF

Ponatinib Access: Denied

I recently sent in a Freedom of Information request to NHS England to find out how many patients in England had requested ponatinib for chronic myeloid leukaemia and who would not already be entitled to it on the NHS. Currently only patients with the T315l mutation are able to have the drug prescribed by their doctor, with other patients who want the drug having to get a clinician to make a special request (an Individual Funding Request, or IFR) to the Cancer Drugs Fund, which NHS England runs.

I was shocked by the response to my query, that of the 14 patients who requested ponatinib (from April 2013 to March 2015), just 2 of them were granted access to the drug and the other 12 were denied. It seems short-sighted of NHS England not to allow patients access to a drug which could benefit them when others have stopped working, and when the only other option is often a stem cell transplant.

With such small patient numbers NICE won’t even consider appraising ponatinib, the CDF is supposed to act as a support system for patients to access drugs for rarer cancers, but the system clearly currently isn’t working.

Patients in England are again missing out compared to their counterparts in Wales, where the drug is fully approved for all CML patients.

This excellent graphic clearly shows that in the ponatinib PACE trial, patients benefited from ponatinib after they had failed other TKIs at various stages of disease progression.

Ponatinib: Efficacy in patients failing multiple TKIs

I’ve attached a pdf poster that outlines a national study on ponatinib and reports on the efficacy in patients failing multiple TKIs.

The conclusions were:

• Ponatinib has confirmed efficacy in a group of heavily pre-treated patients with CML.
• The probability of achieving cytogenetic response (CCyR) on ponatinib is greater in younger patients, those with prior CCyR and those without early haematological toxicity, confirmed on multivariate analyses (data not shown).
• Event free survival is higher in patients who received fewer TKI prior to treatment with ponatinib.

It makes for interesting study. For reasons of transparency this has been shared with me by an organisation who are working with ARIAD (who manufacture ponatinib).

Thanks, Kris

Download the PDF poster here.

On World CML Day Leukaemia Patients Worldwide Unite

Taken from www.cmladvocates.net – an important hub of CML advocate activity:

On World CML Day 9/22, leukaemia patients worldwide unite to address the courage and hope required to live with chronic myeloid leukaemia, and call for access to best available treatment and care for all patients 

 

Group by group, advocate by advocate, and survivor by survivor: on World CML Day on 22 September, the global patient community is raising awareness about the needs of people living with chronic myeloid leukaemia (CML). Simultaneous events, publications and meetings on all continents put a spotlight on the real needs of patients and their relatives, and demonstrate the power and unity of a unique worldwide community that knows no borders. Their brand-new book “Faces of Courage and Hope” further provides an insight into the journeys of 16 CML patients in 15 countries.  

 

Members of the CML Advocates Network, which is today comprised of 90 patient advocacy groups in 68 countries, are honouring World CML Day on September 22nd 2014 through actionable events taking place in their communities. All events worldwide aim to underscore the importance of the needs of people living with CML. The needs of patients in different regions vary largely – from basic challenges of access to treatment and care, over uncertainty on the quality of treatments, to living with cancer as a chronic disease.
 
Although CML is today often referred to as a model disease how blocking essential mechanisms of a tumour can bring cancer to a halt, not all that glitters is gold. Even though there has been a medical revolution in treating CML over the past decade, not every patient has access to best available treatment and care, and many patients struggle to live with cancer as a chronic, life-long disease.

 

There are obvious disparities in terms of access to treatment and diagnostics. We cannot turn our eyes from the fact that socio-economic barriers are present in many countries, where patients are lost in debates around high drug prices and drug quality of copy drugs, combined with the lack of access to quality diagnostics. Just in May 2014, CML patients worldwide called for quality and consistency when new drugs are introduced to treat their cancer. Since none of the new drugs provide for a cure of CML yet, even in countries where access to expensive cancer treatments is ensured, patients are facing challenges with the impact of a life-long treatment on their quality of life. The community’s goal is clear: All CML patients shall have access to optimal and affordable treatment and care, giving them a quality of life as close as possible to normality. There is still a long way to go.

 

Key initiatives on World CML Day 2014

Again in 2014, plenty of events are being carried out by patient organizations throughout the world in order to raise awareness of the needs of people living with CML worldwide. The initiatives are listed on the CML Advocates Network website at  http://www.cmladvocates.net/worldcmlday2014/worldcmlday2014/initiatives
 
On World CML Day 2014, the CML Advocates Network publishes an English-language book Faces of Courage and Hope that illustrates the faces and cancer journeys of 16 CML patients from 15 countries. Men and women of different ages, ethnicities and backgrounds, each share their unique experience in coping with life-altering circumstances and how they refocused their lives. The book has been shipped to CML patient organizations in 56 countries, and will be available on Amazon.co.uk for worldwide shipping from 22 September 2014. For more information see: http://www.cmladvocates.net/book-faces-of-courage-and-hope

On 9/22, the CML Advocates Network also publishes a patient-friendly summary of the European LeukemiaNET’s CML Treatment Recommendations in English, Italian, French, German, Hebrew, Dutch, Russian, Polish, Spanish, Portuguese and Arabic. The summary will allow patients to understand the consensus recommendations provided by a global group of CML experts, coordinated by the European LeukemiaNET.

In addition, the CML Advocates Network provided buttons with the community’s World CML Day logo – a total of 35,000 ‘World CML Day’ buttons were distributed to organisations in 34 countries on all continents to raise awareness about CML.

22 September – the global date for awareness about CML

The date chosen for World CML Day (9/22) adds symbolic significance to the campaigns of the patient community: World CML Day is honoured on September 22nd because 9/22 represents the genetic change of Chromosomes 9 and 22 that is the cause of Chronic Myeloid Leukemia (CML), a rare cancer that is characterised by an unregulated growth of white blood cells. Just about 15 years ago, CML was a lethal disease for the majority of patients. Nowadays, CML is no longer a death sentence. If patients are treated effectively with recommended treatments, they can have a life expectancy similar to that of the general population.

 

Since 2008, patient organisations around the world have initiated events and projects on World CML Day to raise awareness of the needs of patients living with CML and to sensitize not only the public, but also politicians and medical professionals regarding CML. “All united, all unique!” is the theme that brings the groups together. It is a reminder of how each person and each group experiencing a rare cancer will have their own journey. As Jan Geissler, CML patient and co-founder of the CML Advocates Network shares, “Since the first meeting of a handful of CML groups back in 2003, it is impressive to see the growth in intensity of activity in the CML patient community. Today 90 groups are members of the worldwide network. We are not only meeting once in a year at our CML Horizons conference – we are supporting each other across borders, and are jointly collaborating with all stakeholders, throughout the year. Working together is the key to improving support and care for CML patients in all regions.”

 

Thanks to all the groups around the world participating in World CML Day, together we are, “All united, all unique!”

 

About the CML Advocates Network

The CML Advocates Network is a patient-run network and platform for patient organisations supporting patients and relatives affected by Chronic Myeloid Leukemia (CML). Launched in 2007 by four founding patient organizations, it has now grown to a network of 90 leukaemia patient groups in 68 countries, offering support to patient leaders by sharing of best practice, information and advice for CML patient leaders. Individual patient support as well as country-specific policy work is being covered by its member organisations on the country level. The CML Advocates Network is hosted by the patient-driven, non-profit Leukaemia Patient Advocates Foundation in Bern, Switzerland.

 

Members of the CML Advocates Network 

See the list of all 90 member organizations here: http://www.cmladvocates.net/cml-groups-list

World CML Day

Chronic Myeloid Leukemia patients call for quality and consistency when generics are introduced to treat their cancer

PRESS RELEASE (from CML Advocates Network)

On 2-4 May 2014, patient organisations from 58 countries supporting patients and families affected by Chronic Myeloid Leukemia (CML) met in Serbia to learn from medical experts, share best practice in patient advocacy and grow their organisation’s capacity. An important topic of increasing attention discussed between patients and health professionals was the introduction of generics in CML treatment. Patients welcome that generics may improve patient access to more affordable therapies in many countries. However, patients also raise concerns about impact on their cancer when switched between different products for non-medical reasons, if these products’ equivalence in terms of quality and efficacy is uncertain.

With the imatinib patent expiring between 2013 and 2019, the introduction of generic versions is inevitable in many countries. Generics to treat CML have been introduced recently e.g. in Argentina, Bosnia-Herzegovina, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Dominican Republic, Guatemala, Ecuador, Egypt, Estonia, India, Kazakhstan, Lebanon, Latvia, Lithuania, Macedonia, Malta, Nepal, Philippines, Peru, Russia, Romania, Serbia, Slovenia, Slovakia, South Africa, Turkey and Uruguay.

Following intensive discussions at the global CML Advocates Network’s global meeting of representatives of CML patient advocates on 2-4 May, CML patient groups call to governments, health authorities and healthcare professionals to minimize potential uncertainties and risks for patients with the following five measures:

1. No generic drug to treat CML should be provided to patients without reliable proof of quality as well as equivalence of pharmacokinetics and bioavailability. Generic drugs should be approved by the appropriate authorities of the respective country or region, also reflecting a narrow therapeutic range of these cancer drugs.
2. When treating severe cancer diseases like leukemias with generics, further comparative clinical data should be collected, demanded by regulatory bodies, and published, to ensure comparable clinical efficacy of products with the same compound.
3. A CML patient should not be switched between products with the same compound for non-medical reasons, provided this patient already responds optimally to the current product and tolerates it well.
4. If a switch for non-medical reasons between products with the same compound is enforced, this should not happen more frequently than once in a year, to allow a consistent follow-up of responses and side effects on the same CML treatment. If a patient loses its response or experiences a significant increase of toxicities after switching to the other product, the patient must have the option to return to the previous treatment, or switch to another treatment if available.
5. After switching between products with the same compound, more frequent monitoring should be conducted to detect potential differences in effectiveness or side effects early.

This declaration complements the “Baveno Declaration”, signed by more than 50 CML patient organisations in 2008 to call for best practice in CML care, improved access to cancer treatment, and better adherence to international treatment guidelines.

About CML

Chronic Myeloid Leukemia (CML) is a rare cancer affecting blood stem cells. It is a form of leukaemia characterized by the increased and unregulated growth of cells in the bone marrow and the accumulation of these cells in the blood. It is caused by a genetic rearrangement in chromosomes 9 and 22.

Current oral treatments have turned CML from a lethal into a chronic disease. Still in the early 1990s, only every fourth patient survived 10 years following the diagnosis with CML. The introduction of targeted therapies in 2001 have improved the 10-year survival to 84% today, if treated effectively. However, as demonstrated in clinical trials, maintaining a stable response requires continuous effective treatment. Suboptimal dosing, low adherence or cessation of treatment has shown to lead to recurrence and acceleration of the disease in most patients. Performing a bone marrow transplantation is still the only cure of CML, and the only feasible treatment of the disease in advanced phases.

About the CML Advocates Network

The CML Advocates Network is the global network for leaders of Chronic Myeloid Leukemia (CML) patient groups. It connects more than 80 patient organizations in more than 60 countries on all continents. Its aim is to grow capacity in patient advocacy organizations, to stimulate collaboration and best practice sharing, to provide educational resources, and to work with key stakeholders in the area of leukemia care and patient advocacy.

To help patient advocates to understand the background on CML generics, it has launched a Resource & Knowledge Center, pulling together all information that is known to the patient community to date. See www.cmladvocates.net/generics

The CML Advocates Network was set up in 2005 and is run by CML patients and carers. It is hosted by the Leukemia Patient Advocates Foundation, a patient-led global non-profit organization registered in Switzerland.