Open Letter to Dr Fielden: generic imatinib

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Due to a lack of response from Dr Fielden and the number of patients waiting for clarification on aspects of generic imatinib, I’ve taken the decision to make my most recent letter to Dr Fielden public. Let’s hope that he replies to this one. Kris

 

Dr Jonathan Fielden
Director of Specialised Commissioning
NHS England
xxxxx
xxxxxx
xxxxxx xxxxxx

16th February 2017

Dear Dr Fielden,

RE: Imatinib – your reference xxxxxxx

I’m writing in response to my letter dated 21st December 2016 to which I’ve yet to receive a reply. I would appreciate a swift response to this letter given the troubling nature of the contents and the outstanding queries from previous communication.

  1. If a patient who has had a successful period on branded imatinib then switches to generic and cannot tolerate new side effects, are they able to revert to branded imatinib, considering it’ll likely to be cheaper than the other TKIs available?
  2. In a previous letter, you listed Leukaemia Care as an organisation who have been involved in drafting the guidance. Leukaemia Care aren’t aware of any such involvement. Please can you clear this up?
  3. Are you aware of a national shortage of Wockhardt (generic imatinib)? I’ve come across two instances now where patients have been without treatment. If you are aware, why has this happened?
  4. Are you aware of the labelling issue with at least two form of generic imatinib? This is the issue that suggests that the drug, for adults, is for blast crisis only and not chronic or accelerated phases. This issue has the ability to mislead and worry patients. What action are you taking and how did this issue escape what I hope would be a rigorous checking procedure?

Unfortunately, my concern with the process that brought generic imatinib to market is now being realised and I’ve very much like some answers.

Yours sincerely,

 

Kris Griffin (Mr)

 

FAO English Imatinib Patients

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It is vitally important to state that as far as we are aware, all versions of generic imatinib are the bioequivalent of the original drug (meaning they have the exact same active ingredients). If you are taking a generic, under the supervision and recommendation of your consultant, please carry on. Do not stop taking your drugs based on this information. We are CML patients and any clinical advice MUST come from a medical professional.

My good friend Nigel Deekes, who founded the CML-UK Facebook group, was switched to generic imatinib in early January. It appears he was one of the first to switch and being the diligent chap that I know that he is, he read the packaging.

The packaging on at least two of the generic drugs (as we understand it, this does not concern imatinib generics manufactured by Teva and Sandoz) suggest that the drug, for adults, is for blast crisis only and not chronic or accelerated phases. Blast crisis is an advanced form of CML. These generic drugs are not for blast crisis only and if you see this on your box or instructions it DOES NOT mean your disease has progressed. Also, it does not mean that your generic imatinib isn’t working. The generic drugs are the same and are safe but the indication on the leaflet in the box does not cover all phases.

Both Nigel and I agree that this is most unacceptable. Not only does this issue have the ability to mislead and worry patients, it is also indicative of the entire generic switch process. Be mindful that this issue was found by a patient and not through, what should be, a rigorous checking process, administered by NHS England. When we consider the lack of consultation and information provided to patients, this is not surprising.

All things being considered Nigel and I believe that generic imatinib patients who have incorrect information on their box should contact their hospital and ask to be put back on branded imatinib. We believe we are within our rights to do this as the indication on the leaflet is not for our stage of the disease. We could be accused of being pedantic but we want to be clear that patients should be prescribed the correctly licenced drug for our illness. Some patients have already swapped back to branded imatinib without any problems as their hospitals have acknowledged this issue.

The issues will take several months to resolve and at that point, we would recommend patients take up the offer of generic imatinib once again.

Our reasons for refusal are straightforward. We do not want life-saving drugs being used with information on them that has the potential to mislead the patient about their diagnosis. Generic imatinib is not the only drug available for treatment of CML, therefore there is not a risk in reverting back to branded.

If you are a generic imatinib patient please contact your consultant and ask to be put back on branded if your box indication is incorrect.

If you are a branded imatinib patient who is yet to switch, please discuss this issue with your consultant at your next appointment. Please do not be alarmed if your clinician still prescribes generic imatinib, they are able to prescribe ‘off label’ and they will discuss this with you. This information is design to ensure that you are included in this decision-making process.

PLEASE do not switch drugs or stop taking medication unless your consultant approves it.

All indication suggests that generic imatinib is good and safe to take under the direction of your consultant. It is the labelling/indication that is wrong.

For more information on generic imatinib and generic drugs please visit these useful resources from Leukaemia Care:

Generic imatinib for chronic myeloid leukaemia patients
Generic medicines – What are your rights?

Thank you.

Kris Griffin & Nigel Deekes

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The Girls – a musical comedy

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Yesterday, Kelly (my wife) and I attended a special performance of The Girls at the Phoenix Theatre in London.

The Girls follows on from smash hit play and film Calendar Girls, the true story of a group of Yorkshire housewives who posed nude in order to raise funds to buy a settee for their local hospital, in memory of one of their husbands. To date, they have raised almost £5million for Bloodwise. This musical comedy shows life in their Yorkshire village, how it happened, the effect on husbands, sons and daughters, and how a group of ordinary ladies achieved something extraordinary.

with the AMAZING Calendar Girls.

Me with the amazing REAL Calendar Girls (2013)

The show has brought together the writing talents of Gary Barlow and Tim Firth; it originally opened at The Grand Theatre in Leeds and The Lowry Theatre, Salford. Now it’s in the West End until April.

We were kindly invited by the producers of the show and by Bloodwise, along with lots of other patients and many health care professionals. This was the first performance at The Phoenix and as we settled into our seats, we weren’t sure what to expect.

The show was a smash; great songs, as you would expect from Gary Barlow, and a fluid, creative set. All of the performance were strong and the time flew by. The incredibly familiar story was brought to life in a way the film and the previous production didn’t, it was all too easy to fall in love with these characters again. The show ended with a magnificent standing ovation from a packed theatre.

The trouble is that it’s an incredibly difficult watch. 24 hours later and I’m still completely and utterly emotionally drained. The scenarios and situations felt all-too-real and I’m not ashamed to say that I spent the majority of the performance with tears streaking down my face.

The subject of blood cancer and an ultimately tragic illness were dealt with respectfully and with great compassion and as a patient, I didn’t feel patronised at all.

My emotional connection wasn’t helped by the fact that I’ve spent time with the real Calendar Girls. At two Bloodwise Impact Days, I’ve been led astray by the girls and their husbands (the boys?) until the early hours. They are incredible company and the relationships I saw on stage were an uncanny reflection of people I’ve spent time with.

This show deserves to play packed houses for the entire run, it’s a wonderful night out. It’s a show where you’ll find real emotional attachment. The people are real…really, real. And the comedy is real, the laughter is real, the passion is real and the potential life-affirming outcome from a tragic illness are real. It’ll make you want to plant a sunflower and toast ‘Clarky’. Congratulations to all involved.

Huge thanks to Bloodwise (especially Andy), the UK’s specialist blood cancer charity, who hosted patients and really looked after us. Bloodwise will receive monies from the production.

www.thegirlsmusical.com
Bloodwise: The Girls

Speaking at the APPG on Blood Cancer (Westminster, London)

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This week I was invited to the Houses of Parliament to speak at the inaugural meeting of the All Party Political Group (APPG) on Blood Cancer. It was a great honour.

I’m not sure it would be entirely fair to document the entire proceedings; the secretariat, Bloodwise, will be documenting the detail in due course. I can say that we heard from the Parliamentary Under Secretary of State for Community Health & Care, David Mowat MP and the meeting was chaired expertly by Henry Smith MP.

The ultimate aim of the APPG will be to conduct enquiries into blood cancer-related issues. I believe that the first enquiry will cover how well (or not so well) the national cancer strategy is working for blood cancer patients (given their specific needs). This would be a great place to start and I applaud the approach.

There were a number of people representing various blood cancer organisations and charities and I hope that we can all pull together, with our parliamentarian counterparts and make a real difference to the lives of blood cancer patients. I’ll keep you posted.

I’ve posted my speech below, it’s not every word but I’m sure that you’ll catch the gist.

All of my best wishes, Kris (Griffin)


SPEECH – Wednesday 18th January 2017, House of Commons

Thank you for inviting me along today. I feel very honoured to be in such distinguished company and to be able to provide the room a patient voice.

It’s been 10 years (next month) since my CML diagnosis.

As you can imagine I’ve got many stories to tell about my blood cancer…not all of them bad…

Whilst talking this speech over with a good friend, we discussed a number of things that have happened to me that I could share with you. Not necessarily all bad.

Three CML anecdotes: bat ears, sperm banking, grapefruit.

No, probably best to leave the funny stories well alone, get on with the more serious stuff.

So, I want to tell you about the lad who was helping me out cutting a hedge down in my garden. We had a conversation. I told him that I had leukaemia.
And as he ran down my drive he shouted back, “CAN I CATCH IT?

The problem is, people just don’t get us. The trouble is that it’s not just about taking meds anymore.

My feeling is that with CML being a treatable disease (or controllable), our needs are very different to many other cancers. I don’t believe that the health sector really understands us. Not because they are uncaring, but because we have moved so fast and so far forward.

When our treatment goes well, our wellbeing needs to be looked after and managed. There is a psychological impact of having a cancer diagnosis. Some people manage this better than others. But, this is an invisible problem for us. As we start to treat other blood cancers in a similar way, these are issues that need addressing more and more. It’s why I constantly bang on about personalised treatment. A personalised approach does provide the best outcomes and the best quality of life. I’m sure we can all agree that this is the aim.

Because if we get it right, the economic impact is huge. Potentially you could have people who previously were unable to work, now able to work. 40% of them may not be receiving any treatment at all. 20% (and growing) may be taking generic drugs which are much cheaper.

We are trailblazers and I treat my disease like a superpower. It opens doors and allows me to help people, to ensure that they are represented, to provide a voice. I work everyday and am kept on my toes by an active 5-year-old.

Even though blood cancer is the fifth most common cancer, there are 250,000 people (and growing) living with it in the UK…it’s hard to define…too many types and generally nothing to cut out.

And whilst the treatment for CML…and some other forms of blood cancer are getting more straightforward and successful…we can be in danger of forgetting that there is a real person behind each diagnosis. We forget that people can react differently to news, information, approaches and misinformation.

When I told the members of the CML-UK Facebook group I was speaking today, many of the 2,000 members replied asking me to mention a variety of subjects. I’ll do my best to represent some of those views now:

GENERICS.
No consultation with patients. No formal information. But, imatinib patients are expected to simply switch tablets and accept what they are told…this after being told that patient power is a good thing. What about the months, sometimes years of getting to a good place only to be told to start again. No official reassurances. I’m still waiting to hear if you can go back to a drug that previously worked for you. MUST DO BETTER.

SUPPORT
The psychological scars run deep, as deep as any cancer patient. But, we are the ones with invisible problems, different needs. CML, in particular, is a disease, that doesn’t necessarily have to destroy your life. If the tablets go down well, carry on. I’ve not missed a day of work through CML since diagnosis. So, empower us. We can be your support network. Take a look at the Bloodwise Ambassador scheme and the CML-UK Facebook group for evidence of burgeoning, useful communities.

GENERAL AWARENESS
There are people in the medical profession who still don’t know enough about blood cancers. I know that Leukaemia Care is trying to address this. Just some basic awareness. I was diagnosed by accident, many blood cancers are. If my GP hadn’t been curious…I wouldn’t be here now. Which leads me to…
PERCEPTIONS
Many employers don’t get it. Many patients WANT to work and yet outdated, overly bureaucratic business practices stops them. How can you have cancer, you haven’t lost your hair? And many patients who are unable to work because of devastating side effects, cannot access the benefit system because CML is a “treatable” disease.

INSURANCE
There are some travel insurance policies that we can get. But not life cover. Why? Exclusions? They use the wrong data!
Many traditional cancer patients can get cover after being clear for a number of years. But us? No. Ongoing treatment. And no one wants to listen.

LIVING ON THE EDGE
No matter how many times you’ve gone through it, no matter how robust you are, no matter how long you’ve been undetectable. When you go and pick your bloods up, it still feels like you are rolling the dice. And that, every three months, every six months. In many cases, for a lifetime. It takes some getting your head around.

On one hand, we should congratulate ourselves, we’re getting our head around the science and as for CML, it feels like a winnable battle. But there are many types of blood cancers and we have to keep pushing hard on all fronts.

Blood cancer patients are the front line. In my lifetime I want to see most cancers treated in the same way that my cancer is treated (or better). Many of you have played a part in the journey so far and are certainly responsible for getting the right drugs and treatment to the right people at the right time.

Let’s make sure that these patients are empowered. Let’s not leave them to fight other battles on their own. Let’s fight for their employment rights, look after their well-being, consult them on changes, find insurance and keep breaking walls down.

I’m incredibly grateful that we now have an APPG on Blood Cancer, it has already brought together some fantastic people, here in this room. But, please, let’s keep patient needs central to the agenda.

It is serendipitous that, when my journey started, 10 years ago, after a long walk, Sir Ian Botham told me that I was going to be OK.

He was right. I feel more confident today than I was yesterday, passing the message along and telling my fellow blood cancer patients that it’ll be OK.

That’s what matters. Thank you.

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Kris Griffin speaking at the APPG on Blood Cancer

CML Support Group in Birmingham

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A quick heads-up for all CML patients in the Midlands. Leukaemia Care are holding their first CML support group at the Novotel Birmingham Hotel on Broad Street.

The event is later this month, on Saturday 28th January, and will run from 1030 until 1300. It’s free to attend and Dr Manos Nikolousis, Consultant Haematologist, will be on hand to answer your questions on CML.

Please let Leukaemia Care know if you are attending so they are able to cater for all.

Download the poster as a PDF HERE.

poster

Video: Taking blood

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When I visited the hospital in October 2016 I decided to document my visit for the benefit of other Chronic Myeloid Leukaemia (CML) patients. The video does contain footage of blood being drawn.

I received my results early and my leukaemia continues to be undetectable. I hope that this video helps newly diagnosed patients or patients who have concerns about regular blood tests. Please contact me if you have any comments or questions.


Thanks for watching, Kris

Meeting Colleen Fletcher MP

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Meeting members of the newly formed All Party Parliamentary Group (APPG) on blood cancer is a little like collecting Pokemon. Stick with me. You see, you have to be patient but when you meet them it’s always a deeply fulfilling experience; I’ve yet to find a Zubat (an ultimately useless Pokemon).

The APPG on blood cancer was formed last year. The group will look into the key issues affecting patients with blood cancers and is an acknowledgement that MPs understand that haematological cancers are very different to solid tumours – in the impact they have on patients as well as the need for different kinds of information, support and treatments to be available. Bloodwise will provide the secretariat to the group.

I’ve been fortunate to meet three of the founding officers in the past: Jim Shannon, DUP MP for Strangford, Henry Smith, Conservative MP for Crawley and Jess Phillips, Labour MP for Birmingham, Yardley. Today I met the final member of the founding group, Colleen Fletcher, the Labour MP for Coventry North East.

The founders that I’ve already met have all been touched, in some way, by blood cancer. They are all driven, passionate and keen to make a difference to the lives of blood cancer patients. Colleen Fletcher is no different and her experiences are incredibly raw. Her husband faced a gruelling battle with Acute Myeloid Leukaemia in 2014 which resulted in a stem cell transplant; he is now free of leukaemia.

I was struck by her steely determination, her blunt honesty and her deep knowledge of blood cancer issues. We discussed many things including gardening therapy which she swears helped her husband get through his ordeal, the importance of early diagnosis, importance too of after-care, the inequality of cancer drugs including the issues with getting ponatinib to patients and the advent of patient power.

I’ve been mightily impressed by all four members of the group, Colleen is exceptional. She’s personable and has a voice that oozes confidence and strength; she’s a huge asset to patients and I trust her, absolutely, to represent us fairly and with passion. The group is a perfect storm and the members compliment each other perfectly. It’s good to be taken seriously and I believe that this APPG is a huge advance for blood cancer patients. I applaud all of those involved and offer my support in whatever action they take.

Thanks to Bloodwise for supporting the APPG and for all those involved in pushing the agenda for blood cancer patients.

Kris

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Kris Griffin with Colleen Fletcher MP

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