Living With Mesothelioma -My Diary- A wonderful Mothers Day Treat War Horse More News on the Saatchi Bill

I was dreading traveling to Wexham on Saturday but the M25 was so smooth it seems so weird. We got to Our Sons in good time and we were able to sit out in the sun in the garden.

Enjoying ourselves after a wonderful dinner plenty of wine we just sat back and really relaxed.

Sunday I took my coffee and sat in the garden again before anyone stirred. It must be so funny for them to wake up and MIL is sitting out in the garden. We love it as they live next door to a park and all the wild life comes into the garden. Deers, foxes, squirrels, butterflies, bumble bees all come round to see what you are doing.

DSCF9129

 

The primroses are out.

DSCF9128

 

 

 

My early morning seat in the sun

DSCF9127aa

 

We cleaned the Motorhome as it had Red sand all over it. this tickles me as their drive is my own little CL and its always there for me to use.

DSCF9126

 

 

Lou loves the freedom of a large area and there is a gate to the road so he is very safe.

We were there for my Mothers day treat which was to see War Horse

Since its first performance at the National Theatre in 2007, War Horse has become an international smash hit, capturing the imagination of four million people around the world.

Based on Michael Morpurgo’s novel and adapted for the stage by Nick Stafford, War Horse takes audiences on an extraordinary journey from the fields of rural Devon to the trenches of First World War France. Filled with stirring music and songs, this powerfully moving and imaginative drama is a show of phenomenal inventiveness. At its heart are astonishing life-size puppets by South Africa’s Handspring Puppet Company, who bring breathing, galloping, charging horses to thrilling life on stage.

How can you end up crying at a puppet show. –Easy you dont see the men working the horses and it was so real. We all ended up in tears xx

This was incredible.

We came home and had a wonderful dinner cooked so the whole day was magical. I have sent a Bouquet of flowers now Im home to say thankyou.

We had a good journey home so that was a bonus as well.

Photo: In the Telegraph today: "The fight to win hope for the seriously ill'</p><br /><br /><br /><br />
<p>>>Sign the petition: http://chn.ge/1pqY6lS</p><br /><br /><br /><br />
<p>Please Share

https://www.change.org/en-GB/petitions/jeremy-hunt-department-of-health-33-days-to-change-medical-history

Please keep getting everyone to sign the petition The time is running out xx

Thousands of patients, doctors and charity chiefs are calling on the Department of Health to back Maurice Saatchi’s Medical Innovation Bill, which would give legal protection to doctors who want to try new treatments for patients whose survival chances are poor.

More than 6,000 people have responded to a public consultation by Jeremy Hunt, the Health Secretary, following his statement to MPs that he will enact the Bill at the “earliest opportunity” if the public supports it.

The law currently leaves doctors vulnerable to litigation if they deviate from “standard procedures”, even where those procedures have failed. In response, Lord Saatchi’s Bill sets out a clear procedure for clinicians who want to try innovative treatments, where conventional therapies have proved ineffective. Provided the procedure is followed, clinicians would face no risk of legal action.

Catherine Heap from Chester, whose husband died recently, said in an email to Lord Saatchi:

“I lost my husband at the age of 49 to brain cancer and exactly as you said, once the diagnosis is given, that’s it – there’s either no treatment or antiquated treatment with no prognosis.

“I believe that anything that can be done, even if it only helps a small number of people and their families, should be done. I really hope you get support on this.”

Also supporting the Bill is Henrietta Morton-King, a newly qualified doctor from Cumberland Infirmary, Carlisle. “I recently asked the medical registrar at my hospital what she thought was limiting the NHS in terms of innovation. Her first words were ‘Will my ass get sued?’ Fear of being sued is the new bogeyman.”

Indeed, the number and quality of responses from doctors, patients and health charities has been unprecedented for a Department of Health consultation.

But Lord Saatchi warned that the Bill was not yet certain to be enacted. “We have struck a chord with patients who, subjected to standard procedures, face a poor prognosis,” he said. “They want to know that their doctor can and will try everything.

“Jeremy Hunt and No 10 back the Bill — and it has cross-party support. But there is only one parliamentary session left before the election, and time for new legislation is tight.

“The Government needs to know patients want this Bill. Politicians will only respond if voters demand it. This may well be our only chance.”

While supporting doctors who want to innovate, the Bill also protects vulnerable patients from any doctors who might try to exploit them. It would be a legal requirement for the doctor to get the approval of a panel of senior doctors for any innovative treatment — a higher legal barrier than in current law.

A few respondents have asked Lord Saatchi to ensure the Bill cannot be used for medical experimentation. “I do not want doctors to treat patients like mice,” he said. “This is a consultation and we are listening. We are talking to Jeremy Hunt’s team about how we might make the Bill even clearer and stronger in this regard.”

Consultation on the Bill ends on April 25.

Respond to the consultation at http://saatchibill.tumblr.com orwww.gov.uk/government/news/medical-innovation-doctors-and-patients-encouraged-to-give-views.

Follow @SaatchiBill on Twitter.

The Department of Health has organised public meetings on the Bill in Leeds (April 2) and London (April 10). Book atwww.eventbrite.co.uk/o/department-of-health-england-29231266492

Rays Blog http://mesoandme.wordpress.com/2014/03/31/monday-79/

Living With Mesothelioma -My Diary- Good Night to Ian a brave Mesowarrior -the Saatchi Bill- And a very promising New drug

Its been a very hot day today and we have managed to get out for a wonderful walk. Louis was off lead and so he has had a great run and is shattered now.

I had a phone call and a Women’s Magazine that is doing a very comprehensive Article on me wanted to read through all she had written. It was so good I was crying at my own life story.

She said Oh sorry -but I said -no it is so good you have written it down just as I had said. So she was very happy and thats another interview wrapped up.

Still having my sleep broken up by the pain now so I have to have some stronger Medicines this will be sorted on my appointment.

But life goes on.

It is the day of Ians Funeral and we, the Meso warriors have sent flowers to Grace

Photo: I know Grace wont be looking at my wall today but she is having a delivery of 10 stolen Kisses (10 Roses) from all us Mesowarriors from our flower club. They are for her to brighten her room but also to let her know we are thinking of her

The spray is called 10 secret kisses -Isn’t that lovely.

She is devastated and her two boys so I hope she has manged to be able to get through it all. She has a special friend with her.

Poor Grace has delid the funeral for such a long time as she didn’t want to part from him, so so sad.

DSCF9047

 

This was just days before he died. Marc their son wants to come and see Ray again as they got on so well and Ray said he was a great boy and he was so grown up for his age, he is so unhappy. I haven’t met the eldest lad but I expect he is just as nice.

427461_385409074818184_100000472859203_1477519_1564910131_n

 

 

 

 

 

 

 

 

Goodnight Ian as you pass on to the Rainbow Bridge xx

Embedded image permalink

http://www.accesstomedicine.co.uk/news-and-events/earl-howe-empowers-parliamentary-reception-speech

Earl Howe – Empower’s Parliamentary Reception speech

Earl Howe - Empower’s Parliamentary Reception speech

Thank you, Geoffrey.  I am very pleased to be here today to talk about this important subject.  I do, of course, recognise the concerns raised by the other speakers before me regarding access to new and promising medicines for these terrible conditions.

I would like to assure those present that our priority is to ensure that patients, including those with rare and life threatening or limiting conditions, have access to new and effective treatments on terms that represent value to the NHS and the taxpayer.

Indeed, it was partly with this in mind that we announced the Early Access to Medicines Scheme on 14th March 2014.

 

Early Access to Medicines Scheme

I would like to spend a few minutes setting out the aims of the scheme, which I hope you will agree is an important development.

Through the scheme, the Medicines and Healthcare products Regulatory Agency will provide a scientific opinion on promising new, unlicensed or off-label medicines to treat, diagnose or prevent life threatening or seriously debilitating conditions which do not have adequate treatment options.

Our hope is that the scheme, which will operate within the current regulatory structure, could give patients with these conditions access much sooner to medicines that represent a significant advance in their area of unmet need.

MHRA is responsible for managing the scientific aspects of the scheme, which will follow a two-step process.

Step one includes giving a new medicine a promising innovative medicines designation.

This will provide an early indication that a product may be a possible candidate for early access, based on the available clinical data.  The designation will be issued following an MHRA scientific meeting and could be given several years before the product is licensed.

Companies who wish to move to step two must hold a promising innovative medicines designation and provide further relevant data on their product’s quality, safety and efficacy.

At step two, the MHRA will produce a scientific opinion describing the benefits and risks of the medicine, based on information submitted by the applicant after sufficient data have been gathered from the patients who will benefit from the medicine.

The trigger for an Early Access to Medicines scientific opinion does not necessarily have to be the submission of a dossier for marketing authorisation application, but the availability of a sufficiently compelling case based on the total data and evidence collected to date as assessed by the MHRA.

This is, of course, conditional on data from the development process of the product which indicates that the benefit:risk profile of the medicine is positive.

The scientific opinion will be made available on the MHRA’s website to assist clinicians and patients in making treatment decisions, and to support informed consent by patients to the risks and benefits of the product.

The scheme will be launched and ready to receive applications in April 2014.  I understand that full details, together with guidance, will be published on the MHRA website in due course.

Conclusion

This is an exciting initiative and just one way in which the Government is supportive of improving access to new medicines.

We are also consulting on a draft Medical Innovation Bill which aims to encourage responsible innovation in certain circumstances, and to discourage irresponsible innovation.  The consultation paper was published on 27 February and the consultation period runs until 25 April.  I would encourage anyone with views on the proposals to respond to the consultation.

We continue to support the existing incentives offered at EU level to encourage the development of medicines for small numbers of patients (‘Orphan’ medicines), and the development of the Commission’s plans for adaptive licensing, including their launch of the EMA adaptive licensing pilot on 19 March.

In giving patients access to the next generation of medicines before they are licensed, I hope you will agree that this scheme could help seriously ill patients in areas of unmet clinical need to have earlier access to new and effective medicines.

Thank you.

We Warriors have been discussing a new trial that is appearing in Oxford at the end of the year maybe and we have to find where else

http://news.sciencemag.org/health/2012/03/one-drug-shrink-all-tumors?ref=hp

When mice with human tumors received doses of anti-CD47, which sets the immune system against tumor cells, the cancers shrank and disappeared. A single drug can shrink or cure human breast, ovary, colon, bladder, brain, liver, and prostate tumors that have been transplanted into mice, researchers have found. The treatment, an antibody that blocks a “do not eat” signal normally displayed on tumor cells, coaxes the immune system to destroy the cancer cells.A decade ago, biologist Irving Weissman of the Stanford University School of Medicine in Palo Alto, California, discovered that leukemia cells produce higher levels of a protein called CD47 than do healthy cells. CD47, he and other scientists found, is also displayed on healthy blood cells; it’s a marker that blocks the immune system from destroying them as they circulate. Cancers take advantage of this flag to trick the immune system into ignoring them. In the past few years, Weissman’s lab showed that blocking CD47 with an antibody cured some cases of lymphomas and leukemias in mice by stimulating the immune system to recognize the cancer cells as invaders. Now, he and colleagues have shown that the CD47-blocking antibody may have a far wider impact than just blood cancers. “What we’ve shown is that CD47 isn’t just important on leukemias and lymphomas,” says Weissman. “It’s on every single human primary tumor that we tested.” Moreover, Weissman’s lab found that cancer cells always had higher levels of CD47 than did healthy cells. How much CD47 a tumor made could predict the survival odds of a patient.To determine whether blocking CD47 was beneficial, the scientists exposed tumor cells to macrophages, a type of immune cell, and anti-CD47 molecules in petri dishes. Without the drug, the macrophages ignored the cancerous cells. But when the anti-CD47 was present, the macrophages engulfed and destroyed cancer cells from all tumor types. Next, the team transplanted human tumors into the feet of mice, where tumors can be easily monitored. When they treated the rodents with anti-CD47, the tumors shrank and did not spread to the rest of the body. In mice given human bladder cancer tumors, for example, 10 of 10 untreated mice had cancer that spread to their lymph nodes. Only one of 10 mice treated with anti-CD47 had a lymph node with signs of cancer. Moreover, the implanted tumor often got smaller after treatment—colon cancers transplanted into the mice shrank to less than one-third of their original size, on average. And in five mice with breast cancer tumors, anti-CD47 eliminated all signs of the cancer cells, and the animals remained cancer-free 4 months after the treatment stopped.”We showed that even after the tumor has taken hold, the antibody can either cure the tumor or slow its growth and prevent metastasis,” says Weissman. Although macrophages also attacked blood cells expressing CD47 when mice were given the antibody, the researchers found that the decrease in blood cells was short-lived; the animals turned up production of new blood cells to replace those they lost from the treatment, the team reports online today in the Proceedings of the National Academy of Sciences.Cancer researcher Tyler Jacks of the Massachusetts Institute of Technology in Cambridge says that although the new study is promising, more research is needed to see whether the results hold true in humans. “The microenvironment of a real tumor is quite a bit more complicated than the microenvironment of a transplanted tumor,” he notes, “and it’s possible that a real tumor has additional immune suppressing effects.” Another important question, Jacks says, is how CD47 antibodies would complement existing treatments. “In what ways might they work together and in what ways might they be antagonistic?” Using anti-CD47 in addition to chemotherapy, for example, could be counterproductive if the stress from chemotherapy causes normal cells to produce more CD47 than usual. Weissman’s team has received a $20 million grant from the California Institute for Regenerative Medicine to move the findings from mouse studies to human safety tests. “We have enough data already,” says Weissman, “that I can say I’m confident that this will move to phase I human trials.”

*Correction, 2 April 2013: One reference to the compound used to treat mice was previously named as CD47, but in all cases was the antibody to that protein, anti-CD47.

Rays Blog

Living With Mesothelioma -MY Diary- Still plugging the Saatchi Bill. Rays Interview has been published and he has had lovely feedback on it

Having read my Rays interview Im so pleased we are are on Facebook with all the Mesowarriors .  I know I have been a mouthy cow but I have been having a discussion  this afternoon. As I have a feeling people think Im a know it all but I have been the figurehead as I have been unstoppable and people and politicians, newsmen, drug companies, have taken me to their heart even Saatchi has cried with me . I cant stop now as We have to keep the momentum up we have to get that cure for the future. I truly believe that 2014 has already been a great year for Mesothelioma and Asbestos Awareness. I have done it for a selfish reason as I have Mesothelioma and there is no cure but I cant give up.

Then later this afternoon I had a message –You’re doing a fantastic job. My mum was telling me about a lady she had read about fighting for mesothelioma and the Saatchi bill, I recognised the story and realized it was you! I was proud to tell her what an amazing lady you are and how you have done so much for meso sufferers.

 

Here Father has died this week and once again I have been with her from the first time she came on Facebook to find us. So I might have been down and thinking maybe I should pull back from The Warriors. She has pulled me right up and I know what Im doing is very right and I will keep being a figure head. This has come about because Rays Interview with Nancy’s Meredith.

We dont get enough Men Carers talking but Nancy managed to get Ray talking, bless her. We hear the women’s stories as Carers  as women are very open but men clump up. It was aid this week that Ray is called Mr Thatcher I looked puzzled and asked “Why” ” because you are the Iron Lady –well yes I can feel that “And this lady is not for turning”

Ray has Rod Smith an Australian to thank for making him write a blog. They were talking in the early hours on Facebook and Rod suggested Ray wrote it so he did and now it is so widely read and also he has a following of lovely women who complete his Puzzles everyday http://dailypuzzlepage.weebly.com/

 

Mar 27

The Man Behind the Mesothelioma Warrior: Ray Nye Discusses Caring for His WifeAuthor: Nancy Meredith

Label: Featured News

Picture

Patients diagnosed with mesothelioma face a long, demanding battle involving countless doctors’ appointments, extensive tests, surgeries, and chemotherapy treatments – and sometimes that is just the beginning. Managing the illness and all the appointments, on top of taking care of day-to-day living needs, takes the help of a dedicated caregiver.

Although most people picture mothers, wives and daughters as being caregivers, husbands and sons are now almost as likely to be a primary caregiver as their female counterparts.

Caregivers provide nearly constant care for mesothelioma patients as they endure often debilitating treatments. Caregiver duties can include grocery shopping, housekeeping, transportation, meal preparation, management of insurance forms, medical forms and prescriptions, and general care for the patient, as well as emotional support. For many caregivers, this is all done while trying to care for other family members.

Mavis Nye, of Seasalter, England who has been fighting mesothelioma for nearly five years, knows all too well how critical a caregiver is for her care and recovery. Her husband of 53 years, Ray, has been by her side throughout her battle, ensuring that she is cared for and that she doesn’t have to worry about anything other than her recovery.

When asked what day-to-day duties he does for Mavis, Ray said in an email to MesotheliomaHelp that his “list” varies according to how she feels. Although he always ferries her to and from hospitals, treatments and doctors’ appointments, when she is down — which usually happens for a few days during her chemotherapy treatments — Ray does nearly everything around the house. He takes over the feeding and walking of their dog, Louis, helps Mavis get dressed, and although not his strong suit, Ray even took up cooking whatever Mavis requests. But, in reality, Ray said, he does not really follow a list.

“I make it my business to do whatever Mavis asks for, whatever she needs, and if possible before she asks or even knows she wants it,” said Ray.

The Reality of Caregiving
According to the Caregiver Action Network (CAN), more than 90 million family caregivers, or two out of every five adults, in the U.S. fulfill a vital role on the care team. A 2012 article in The Independent, a British newspaper, reports that in England there were 6 million caregivers in 2012, and that number is expected to grow to over 9 million by 2037. About 42% of those caregivers are men, and one in five of full-time caregivers are forced to give up work and support a family member full-time.

Twenty hours per week is the average number of hours family caregivers spend caring for their loved ones, while 13% of family caregivers are providing 40 hours of care a week or more, according to the article “Caregiving in the United States” by the National Alliance for Caregiving, in collaboration with AARP. However, most caregivers do not keep track of the time involved, and whether it is a caregiving duty or simply part of a daily routine is not important to them.

Ray NyeExpert Insight“I have come to terms that it’s my place to do any extra work involved in caring. I don’t think about it anymore, it is just natural.”Share on Facebook A New Role for Older Men
For older men who have been in the traditional role as provider, taking on caregiving can be challenging. Not only do they struggle with giving up their jobs, or cutting down the number of hours they work, but they must quickly shift from being doted on to taking an active role in keeping the household running. For some, that can require picking up basic cooking skills or uncovering where the cleaning supplies are stored.

In Ray’s case, Mavis tried to make the transition for him as easy as possible. As soon as she was diagnosed with mesothelioma, Mavis went into “overdrive,” said Ray. She bought a new gas stove, because she thought their electric one was too complicated. She replaced their aging microwave with a new one so they did not have to worry about it breaking down. In addition, Ray said, “Mavis replaced saucepans, sorted all her old wardrobe and disposed of it, replaced bedding, and she even planned her own funeral.”

Handing off all the work to Ray is not easy for Mavis. “I still have to fight Mavis to do jobs because she is still so independent, and feels the need to keep going. So I take note and I move in when I see I am needed.”

Ray has an added role of supporting Mavis as she advocates for mesothelioma victims across the UK. With that comes a lot of appearances and appointments for Mavis, as well as requests from reporters. Ray plans out the travel plans, gets Mavis to her destination on time, makes sure she gets back home safely, and he is also her biggest fan.

“He never moans about the long days during my appearances, and he is behind me all the time as I raise awareness,” said Mavis. “I can’t thank Ray enough for always being there for me.”

Elinor Ginzler, AARPExpert Insight Caregiving men, although fewer in number, are just as dedicated, diligent and determined to help their loved one live the best life that he or she can.”Share on Facebook Caregiving and Associated Costs
Caregiving can require serious medical care as well.  According to CAN, almost half of the caregivers must perform “complex medical/nursing tasks for their loved ones – such as managing multiple medications, providing wound care, and operating specialized medical equipment.”

For patients without caregivers, these tasks are typically handled by a medical professional, adding to the cost of the patient’s medical care. The U.S. and British governments acknowledge that caregivers are now crucial to providing care to patients. According to recent studies, U.S. caregivers provide nearly $450 billion worth of unpaid care each year. In England, Britain’s caregivers provide an estimated £119 billion ($197 billion U.S.) of care every year.

However, caring for a loved one suffering from mesothelioma can also come with an emotional cost. For many caregivers, the inability to save their loved one from mesothelioma often turns to guilt, anger and despair. Some even ask, “Why isn’t it me that is sick?”

For male mesothelioma caregivers, who were sometimes the source of the secondhand exposure of asbestos that led to their spouse’s cancer, that question is difficult to shake. Ray is no exception – he has that question in the back of his mind on many days. He and Mavis believe her source of mesothelioma is from washing Ray’s clothes that were covered with fine asbestos dust from work at a dockyard.

“I do often wish that it was me with mesothelioma rather than Mavis — she didn’t ask or deserve it,” said Ray. “It should be me with it. But we can’t change it.”

Honoring Caregivers
Jan Egerton, who lost her over 10-year battle to mesothelioma in January, relied on her husband for many years for support and care. In a blog entry in December, Jan wrote, “To the people who love us and care for us, it is hard, it is emotional and it is wearing you out. Having to care for yourself and someone you love is a task that people don’t understand unless they are doing it themselves. From the bottom of my heart I thank you for caring.”

Each year in the U.S., November is set aside as National Family Caregivers Month as a time to honor and thank all the caregivers. In 2013, President Obama declared in the presidential proclamation: “During National Family Caregivers Month, we thank these tireless heroes for the long, challenging work they perform behind closed doors and without fanfare every day.”

Like Ray, the men who step in to care for their wives do not even hesitate to do anything their loved one needs. For him, it is an honor and a privilege to care for someone who has always been there for him.

“Mavis has always been there for me in our relationship. There is no you or me, only us, and we help each other. I love her.”

Beginning with Mavis’ illness, Mavis and Ray have documented their journey with mesothelioma. Ray writes as a caregiver, whereas Mavis talks about the illness, treatments and her efforts to raise awareness of the dangers of asbestos. Below are the couples’ websites where you can follow them and learn how they manage their life with mesothelioma.

Sources:
AARP – Caregiving: It’s Different for Men
Britain’s Army of Unpaid Carers
Caregiver Action Network

Empowers Write up of the day.

I have so much Info coming in for yesterday’s meeting I just have to make note of Empowers blog as this is their story

 

I had forgotten the words from Stephen Hawking I could hear his voice and the way he would have sounded to us in person xx

“Though I cannot be here with you today I wanted to convey my support for Empower: Access to Medicine and its calls for accelerated access to potentially lifesaving drugs.

“True innovation exists at the frontiers of scientific endeavour – this is as true for medicine as it is for physics. Clinicians and pharmacists must be allowed the space to strive for new discoveries with the support of systems that allow responsible innovation.

“The time has come for medical regulation to match modern medicine. I encourage you to sign Empower’s petition, let’s practically demonstrate that the system can work differently. I wish you every success and good luck”.

On Tuesday 25th March the Empower: Access to Medicine campaign were joined by Health Minister Earl Howe, patients, families, campaigners and biotechs for a hugely successful lobby of Parliament.

Patients, parents, campaigners and politicians come together

Hosted by Geoffrey Clifton-Brown MP, the event heard from parents Ruth Le Gal, Alex Johnson and Emily Crossley, along with GW Pharma chairman, Geoffrey Guy and the Government’s former life sciences adviser, George Freeman MP. More than a hundred people attended the Strangers Dining Room to explore the barriers and opportunities to earlier access to medicines.

Why were they there?

Patient organisations believe that their voice and engagement would make major, positive changes to priorities at several stages in the medical innovation process.

The announcements of a UK Early Access scheme and an Adaptive Licensing Pilot in Europe are hugely positive steps forward – but there is still more to be done to make the development of medical innovations more responsive to patients’ needs.

We are calling on the Government and political parties to unite behind a medical innovation manifesto for patients, to implement a programme that will see patients having a greater voice in their treatment, and to develop more adaptive pathways for clinical research and medical innovation.

The manifesto, produced by the Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI) in conjunction with several patient organisations, is supported by Empower: Access to Medicine and Genetic Alliance UK; and a large number of other patient/disease organisations.

Show your support!

 

Yesterday we had cross party support, and it served as a valuable opportunity to publicly demonstrate our strength of feeling.

We would especially like to thank our speakers, Earl Howe, Geoffrey Clifton-Brown MP, George Freeman MP and Geoffrey Guy of GW Pharma.

We are also incredibly grateful for the support of CASMIGenetic Alliance UKLord Saatchi’s team, the AMRC, the Duchenne Children’s TrustAction DuchenneJoining Jack and of course England Rugby’s Andy Farrell!

Please show your support on change.org

We leave you with this supportive message we had from Professor Stephen Hawking on the day:

“Though I cannot be here with you today I wanted to convey my support for Empower: Access to Medicine and its calls for accelerated access to potentially lifesaving drugs.

“True innovation exists at the frontiers of scientific endeavour – this is as true for medicine as it is for physics. Clinicians and pharmacists must be allowed the space to strive for new discoveries with the support of systems that allow responsible innovation.

“The time has come for medical regulation to match modern medicine. I encourage you to sign Empower’s petition, let’s practically demonstrate that the system can work differently. I wish you every success and good luck”.

 

Best Wishes

Empower: Access to Medicine

Website: http://www.accesstomedicine.co.uk

Living With Mesothelioma -A day At The House of Commons for Empower Fastrack and the Saatchi Bill

Put patients at the heart of medical innovation

We had a good journey into London yesterday but where do all the people come from and where are they all going to. London gets more and more crowded. So many people on the trains they must be earning a fortune. I know it must cost a lot to run but hey there is a lot of money going into the pot.

We did get to the House of Commons by 3.30 which a lovely Security officer did tell me –holding his gun .

We sat on a bench and was able to  see the people. I love people watching. It was as busy as a crowded Store, so many people I didnt realise I always thought it was only for MP,s but no School children go on tours, special groups from abroad and the many meetings that go on in the Committee Rooms who have 2 hours at a time then the next lot go in.

pa1

We were in the Strangers Dining room, what a funny name but it was lovely room. Everywhere is old and Ray said shabby but I say its history.

There were no tables set like this the chairs were all around the room and then some tables with wonderful sandwiches and cakes .

DSCF9122

 

We were welcomed in and I saw friendly faces from the Saatchi Bill meeting a couple of weeks ago. We shook peoples hands and then a really nice man came and spoke to me about medical publications  and he has taken my Telephone number.

Right now we come to why was I there I couldn’t make out what was going on. Everyone standing up talking and thats the way it went on. They are chatting meetings and with your MP invited that is a time when you convince him why you want the Fast Track, guess what, I was told my MP declined. I was not happy with him. I take interest in his political life and he couldn’t spare me 5 minutes. It made me realise that not all the MP,s are interested in Lord Saatchis Bill or Empower. I think those that are interested should contact their Mps and tell him we do need it

Please do us all a favour and tell your MP why you want the Bill –why we NEED the bill http://www.parliament.uk/get-involved/contact-your-mp/contacting-your-mp/

There was many for the medical field and many MPs so it wasnt all a sad day.

3 Ladies spoke to us about their childrens lives. I lady has to take her son to Boston every 4 weeks for treatment, how can that possibly be right.

Its not about cancer its about all diseases so it means so many people will benefit from this.

Lord Hume spoke about the Fast track and all that empower is doing, he is a very dedicated man. This wasnt like on telly where they shout and pronise things that do not happen. This was a man who really cares.

He said something very very interesting and I hope I get this right, I know he follows me on Twitter so I hope he can correct me if I get it wrong.

The infrastructure is actually in the system.  It was the way the NHS worked when it first started. BUT then we came to suing society and the doctors felt vulnerable to the suing culture so system shrunk back to what we have today. The younger doctors just have not been educated with fast track as the older doctors have taught it for so long.

BUT it is still there and can resurrected with no problems.  I hope and pray they do right by us and do reinstate it.

I adored his passion and feel he has been through heartache with the death of someone close.  he had to rush off to the chamber.

That was really it but I did talk to the wife of of the Of a scientist who are testing the HIV drug for cancer they are in the UK  I know its for other cancers but when it is allowed to be trialed once again if a bi-op shows that the cancers are made up of the same characteristics are there then we can ask for it on Mesothelioma. The future does look better if change happens.

http://americablog.com/2013/06/hiv-being-used-to-cure-cancer-leukemia.html

http://www.telegraph.co.uk/women/womens-health/10643116/How-HIV-drug-could-treat-cervical-cancer.html

Almost by chance, Ian Hampson and his wife Lynne discovered in their lab at St Mary’s Hospital, Manchester, that the drug lopinavir, licensed for the treatment of HIV, attacks the strain of human papillomavirus (HPV) that causes virtually all cases of cervical cancer.

An as-yet unpublished clinical trial has found that lopinavir capsules, when inserted into the vagina, appear to kill off abnormal cells in the cervix. There appear to be no side effects.

However, even if further trials are successful, it could be years before this pessary becomes available.

“Clinicians in the UK are understandably cautious about using treatments off-label. And who can blame them? In our litigation culture, it doesn’t pay to take risks,” Dr Hampson says.

Please read all the commonts that people are backing the Saatchi Bill  http://saatchibill.tumblr.com/Support#.UzLtovl_vek The Government launched a public consultation on the Bill on February 27th 2014. The consultation ends on April 25th 2014.

So that was our day and we came out to get the underground back to Victoria I thought 6pm the rush hour was over -Oh don’t you believe it. So much pushing and shoving, so many stairs up and down we looked like two old buggers and felt like it.

Rays knees weren’t doing good and my breathing was so hard but we did get to our train home and so pleased to sit down. Lucky we were on a train that didnt stop to much and we soon got to Whitstable and home.We only ate Beans on Jacket Potato and then straight to bed.

It was a very informative day again and so pleased I went.

Please go in the link at the bottom of the page and sign this very important petition they really do want to know how many want the Bill

Patient organisations believe that their voice and engagement would make major, positive changes to priorities at several stages in the medical innovation process.

The announcements of a UK Early Access scheme and an Adaptive Licensing Pilot in Europe are hugely positive steps forward – but there is still more to be done to make the development of medical innovations more responsive to patients’ needs.

We are calling on the Government and political parties to unite behind a medical innovation manifesto for patients, to implement a programme that will see patients having a greater voice in their treatment, and to develop more adaptive pathways for clinical research and medical innovation.

The manifesto, produced by the Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI) in conjunction with several patient organisations, is supported by Empower: Access to Medicine and Genetic Alliance UK; and a large number of other patient/disease organisations. 

This ten point programme proposes progress to be made in a range of areas:

Basic research on the causes of diseases: failure to make progress in many areas results from a lack of understanding of the causes of disease. Investments in disease research need to be more strategic with less duplication and a greater sharing of assets and data.

Benefits sought in new medicines: research is often ‘push’-focused, targeted on what professionals in industry believe are easily measureable performance criteria; patients want a more ‘pull’ orientation, prioritising other, ‘quality of life’ and patient-oriented measures.

 

Non-drug innovations:  managing patients’ lives in the later stages of disease requires technologies that need to be more actively developed, tested and reimbursed (example: non-invasive ventilation in Motor Neurone Disease).

Clinical research: there is a major opportunity for creating disease registers (with the support of patient organisations, working with Public Health England) and linking these to tissue banks (working with Medical Research Council, Technology Strategy Board etc).

Regulatory benefit/risk assessments: these should take patients’ views much more systematically into account and also reflect the increasing willingness to bear risk as disease progresses and treatment options narrow.

Adaptive licensing’/development: this early-access to medicines scheme needs to be progressed imaginatively, addressing unsolved problems, such as how prices can reflect additional value proven after initial conditional licensing. We will watch the EMA pilot with interest.

Reimbursement decisions: regulators and payors should take account of forms of evidence besides classic randomised controlled trials (RCTs) and include factors going beyond the cost/quality-adjusted life year (QALY) to reflect the life situation of the patients and their carers.

Point of diagnosis: better support for clinicians on giving diagnoses and developing the doctor-patient relationship is needed. There also needs to be active encouragement for clinicians to be research active if patient willingness to participate is to be maximised.

Adherence: more research is needed into the psychological factors that lead patients (including those with life limiting diseases) to take inappropriate self-treatment strategies and ‘drug holidays.’

Health Systems’ Uptake of Innovation: the challenge will be to create an environment conducive to truly sustainable innovation and service improvement.

To:
UK Government and European Medicines Agency
Put patients at the heart of medical innovationPatient organisations believe that their voice and engagement would make major, positive changes to priorities at several stages in the medical innovation process.The announcements of a UK Early Access scheme and an Adaptive Licensing Pilot in Europe are hugely positive steps forward – but there is still more to be done to make the development of medical innovations more responsive to patients’ needs.We are calling on the Government and political parties to unite behind a medical innovation manifesto for patients, to implement a programme that will see patients having a greater voice in their treatment, and to develop more adaptive pathways for clinical research and medical innovation.The manifesto, produced by the Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI) in conjunction with several patient organisations, is supported by Empower: Access to Medicine and Genetic Alliance UK; and a large number of other patient/disease organisations.

Sincerely,
[Your name]

http://www.change.org/en-GB/petitions/uk-government-and-european-medicines-agency-put-patients-at-the-heart-of-medical-innovation-3?recruiter=75214399&utm_campaign=twitter_link_action_box&utm_medium=twitter&utm_source=share_petition

 

Living With Mesothelioma -My Diary- Another Day at the Commons for Empowers Manifesto for Patient -Driven Medical Innovation

Im doing this Blog in two parts This is the description and why I attended the Meeting that Empower Arranged in the House off  Commons.

https://www.gov.uk/government/news/cutting-edge-drugs-to-be-fast-tracked-to-patients

Press release

State-of-the-art medicines will be fast-tracked to patients thanks to the Early Access to Medicines Scheme.

The scheme will make the UK one of the best countries in the world to capitalise on breakthroughs in medical care.

The Government is determined to strengthen Britain’s science, research and development industry to as part of its long term economic plan.

Severely ill patients with life-threatening and seriously debilitating conditions will be offered the lifeline of trying ground-breaking new edicines years before they would normally reach them.

The Early Access to Medicines scheme will see doctors working with patients to make innovative and promising drugs available as soon the Medicines and Healthcare Products Regulatory Agency – the UK’s regulator – has signalled that the benefits outweigh the risks following an initial scientific assessment.

The scheme is an important addition to the pharmaceutical sector, providing a platform for drugs to be brought to patients at a much faster rate than ever before. The companies will be able to gain experience of their medicines being used in the NHS and work closely with regulators to look at the value of the drugs, gaining guidance and advice much earlier in the regulatory process.

Health Secretary Jeremy Hunt said:

Making Britain the best place in the world for science, research and development is a central part of our long term economic plan. This ground-breaking scheme will provide cutting edge medicines earlier, give hope to patients and their families and save lives. And as part of our strategy for Life Sciences it will create more jobs and opportunities for people, helping secure a better future for our country.

Alongside the Early Access to Medicines scheme, the Department of Health has launched a bank of nearly 75,000 medical research volunteers to make it much easier for researchers to recruit people with specific conditions and a family history of conditions into research and trials.

The BioResource project, funded by the National Institute for Health Research (NIHR) and led from Addenbrooke’s Hospital, part of Cambridge University Hospital’, will focus on heart disease, dementia, infections and rare diseases and was developed as part of the UK’s commitment to life sciences. It could speed-up the development of new treatments and attract international investment as a result of companies having access to a growing bank of tens of thousands of volunteers from across the country who are keen to help medical research.

Mr Hunt added:

Most people are only too happy to altruistically volunteer for medical research if it helps save lives and by linking them with researchers faster, NIHR BioResource will help increase the number of discoveries about diseases and how we can treat them.

The pioneering Early Access to Medicines scheme will be funded by pharmaceutical companies which develop innovative treatments, meaning patients will benefit from world-class breakthroughs at no cost to the NHS.

Once drug manufacturers have received a scientific opinion from the Medicines and Healthcare products Regulatory Agency, doctors will work with patients to prescribe the drugs when appropriate.

In return, the companies will be able to gain experience of their medicines being used in the NHS and work closely with regulators to look at the value of the drugs, gaining guidance and advice much earlier in the regulatory process.

As a result, the process of patient access will be speeded up and new drugs could be made available to patients months or sometimes years before the treatment is licensed.

Companies are expected to invest more in the UK as a result because of their increased confidence that they can work with doctors and patients to get experience of the new medicines and bring drugs to patients quicker. We expect charities and small businesses to also work together to develop new approaches to treating rare and life threatening diseases, which could include cancer, muscular dystrophy and dementia.

Investment in life sciences and genomics is already improving our understanding of disease and means treatments can be tailored to patients’ individual genetic make-up – providing the right treatment to the right patient. It is expected that charities and pharmaceutical companies will harness this data to develop new drugs.

Harpal Kumar, Chief Executive of Cancer Research UK, said:

Time is of the essence for many cancer patients, particularly those with more advanced disease. It can mean the difference between life and death. Therefore this scheme, which has at its heart the potential to bring promising new medicines to patients faster, is to be warmly welcomed. The scheme should also make it more attractive for life sciences companies to conduct their development activities in the UK, which will bring a multitude of benefits to the population.

Claire Halpin, Empower: Access to Medicine, said:

There is no question that Les Halpin, my husband and founder of the Empower: Access to Medicine campaign, would have recognised this significant step forward on the road to ensuring those patients in desperate need have the opportunity to access treatments they could not in the past.

Empower: Access to Medicine welcomes this announcement and looks forward to working with the Department of Health and the MHRA to make sure that this scheme truly works for those with life-threatening illnesses and unmet clinical need. For many of these patients do not have the luxury of time.

Background

For more information contact the Department of Health press office on 0207 210 5477 / 5738.

Additional quotes

Paul Catchpole, Director of Value and Access at the Association of the British Pharmaceutical Industry (ABPI), said:

The Early Access to Medicines scheme will benefit patients, the NHS and the UK clinical research community, of which our industry is a part. Most importantly, it means that patients with some life-threatening or seriously debilitating conditions, without adequate treatment options, will be able to get faster access to important innovative medicines as these will be made available before launch, following an assessment by the MHRA.

The introduction of the Promising Innovative Medicines (PIM) designation should help make the UK more attractive for investment and growth, with similar merits to the Food and Drug Administration’s (FDA) Breakthrough Therapy Designation in the US. “We note that the scheme is currently unfunded, which is an issue for some companies, and we have called for a one year on joint review of the scheme so that we can appraise its first year and potentially review funding options.

Steve Bates, BioIndustry Association (BIA) Chief Executive Officer:

The BIA supports the government’s decision to introduce a Promising Innovative Medicine (PIM) designation and an Early Access to Medicines Scheme (EAMS) which shows the UK is committed to an “all hands on deck approach” to speedily progress promising innovative therapies to the patients that need them.

As it is currently envisaged, without centrally funded reimbursement, the scheme runs the risk of being under-utilised. The BIA remains committed to working in partnership with all stakeholders to ensure that this is not the case and the scheme remains globally competitive.

Case study – pharmaceutical company.

Summit plc, a UK based pharmaceutical company, is developing treatments for Duchenne muscular dystrophy (‘DMD’), a rare and fatal muscle wasting disease. The Company’s lead drug has finished Phase 1 studies in healthy volunteers and it is now being testing in a Phase 1b study in DMD boys in four hospitals in the UK. The next stage will be a large Phase 2 study in the UK, Europe and the US which is planned to start later in 2014. Early access would be a major boost to this type of programme. Summit could work with MHRA to go through an initial assessment on safety and effectiveness, and if given a Promising Innovative Medicines stamp, then the drug could be offered to patients much quicker than usual. It can also revolutionise the economics of development for these rare diseases such as DMD.

Existing drug licensing process

  • Step one: To begin the process, companies and/or researchers must apply to the MHRA for permission to test drugs in clinical trials, if these trials are to be conducted in the UK. In order to receive permission to conduct a trial, they must first satisfy the MHRA that they have met strict safety criteria.
  • Step two: All the test results from these trials on how well the medicine works and its side effects, plus details of what the medicine contains, how it works in the body, and who it is meant to treat, are then sent to medicines regulatory agencies for detailed assessment. The assessment team is made up of experts from different relevant specialties, each of whom has undergone additional training in medicines assessment. The length of the assessment process depends on:
  • the type of medicine
  • the quality of the initial information supplied by the manufacturer
  • how much further detail is required
  • how soon uncertainties can be resolved

All the information is supplied in electronic format to minimise procedural delays Medicines regulatory agencies such as the MHRA have to comply with strict timeframes and performance targets for the licensing of medicines.

  • Step three: If the authorities are satisfied that the medicine works as it should, and that it is acceptably safe, it is given a marketing authorisation or product licence.

Early Access to Medicines Scheme However, once the scheme is in place, patients who have life threatening or seriously debilitating conditions will be able to benefit much quicker from innovative treatment.

The MHRA is responsible for the scientific aspects of the scheme. The scientific opinion is provided after a two-step evaluation process. Step I, the Promising Innovative Medicines (PIM) Designation and Step II, the Early Access to Medicines Scientific Opinion. The PIM designation provides an early indication that a product may be a possible candidate for the Early Access to Medicines Scheme (based on early clinical data for example from phase II studies). The PIM designation will be issued after a MHRA scientific meeting and could occur several years before licensing. Companies who wish to gain entry into the scientific opinion step can do so if they hold a PIM designation and relevant data on quality, safety and efficacy. The scientific opinion will describe the benefits and risks of the medicine, based on the information submitted to the MHRA by an Applicant. The opinion will support the prescriber to make a decision with the patient on using the medicine, before its licence is approved. Medicines in the Early Access Scheme will typically be commissioned by NHS England through its specialised commissioning arrangements, delivering a single national approach to commissioning.

This is the Fast track above

I will write up tomorrow about all this as there is so much to write of another day At the House of Commons

 

Rays Blog http://mesoandme.wordpress.com/

Living With Mesothelioma -My Diary- 33 Days to go for the Saatchi Bill . London tomorrow to lobby for the Early Access Bill

It has been a lovely Sunny day to day, this is really great no moan about rain again today.

We did our work in the morning and then after Lunch we couldn’t stay in anymore and grabbed Louis and went out to the Park. We were the only ones there so I let him out of the car off lead where he raced around waiting for us to get out. He loves his ball and I love the catcher as I can throw it a long way. Lou races away to find it. Its great to give him so much exercising. The Dog walkers dont seem to be around but they have notices up through the park to keep dogs on leads on the walk as sheep have been hurt and it is lambing time anyway.

 

I put photos on last year where Louis walked through on a lead and he ignored the sheep. He was on a lead I dont know how he would behave of the lead and I  would never try to find out.

We have Louis off lead where it is away from the sheep and in a fenced off area. he ia so amusing chances away with the ball –never brings it back. He sits there until I catch up. He is a pointer. So we spent time in the sun it was so nice and peaceful.

As we went back to the car he came running up with a ball that had been thrown away as it was split. Did he care no I threw it and for the first time in his 7 years he bought it back. We couldnt believe it, but everytime we threw it he bought it back until he jumped in the car with it. We roared with laughter –our little boy has grown up.

images

 

 

 

 

 

 

 

 

We came back and I carried I even feel asleep for a half an hour until the phone rang and woke me up. I finished the washing and we are straight again.

I did have a lovely email from Brian the lovely young man from Verastem. He is back in UK and wanted to know if he could come to see us. He said he has missed me.  So sweet.

Coverage Highlights:

191 individual news articles have been generated across the UK with a reach in excess of
30.5 million people
– 5 interviews on prime time UK regional news channels – ITV and BBC
– 168 radio interviews including Sky News Radio, BBC Three Counties and Imagine FM
– 4 items of print coverage
– 14 items of online coverage
– Advertorial in the UK national newspaper The Independent

 Radio Day: A radio day was held where Prof. Fennell and Mavis Nye were available, in
studio, for interviews with UK radio stations.
 Audio feature: Prof. Fennell and Mavis Nye recorded an audio feature which was available
to UK radio stations for three weeks following the campaign launch to secure additional
coverage.
 TV Interview: Prof. Fennell, Mavis Nye and Dr Spicer were interviewed by ITN Connect, a
syndication network that creates footage for national and regional UK broadcast outlets
such as ITV News and Channel 4.
 Saatchi Bill: Lord Saatchi’s Medical Innovation Bill, designed to help doctors innovate new
treatments and cures for cancer and other diseases, was presented at a public consultation
in the House of Lords on 24th
February. Prof. Fennell and Mavis Nye were invited to address
the public and decision makers to highlight the need for better/easier access to treatment.
In particular, they argued the urgent need for more treatment options for mesothelioma
patients. The public consultation featured live on Google hangout and is now available on
YouTube. In addition, Leicester University issued a press release to the UK media announcing
that Prof. Fennell was taking part in the consultation.
 Print and online media: Traditional and new media news outlets were made aware of both
the COMMAND study and Prof. Fennell and Mavis Nye’s involvement in the Saatchi Bill. As a
result, Mavis participated in a number of interviews with her local paper, national paper
Sunday Express and regional BBC News station in the days after her address at the House of
Lords.
 Advertorial: An advertorial was placed in the UK national newspaper, The Independent, as
part of their supplement on rare diseases day on the 28th
February.
 Video interview: Prof. Fennell and Mavis Nye were captured on film discussing
mesothelioma, the Saatchi Bill and the COMMAND study (Prof. Fennell only). The final video
will be made available to both Prof Fennell and Mavis, plus distributed to relevant patient
organisations and mesothelioma bloggers.
3. Media coverage and results
In total the UK media outreach activities generated more than 191 opportunities to read or
hear the news.
Four regional ITV stations featured the ITN Connect interview with Prof Fennell, Mavis and
Dr Spicer. In addition, BBC South East Today conducted an interview with Mavis Nye
focusing on mesothelioma and the Saatchi Bill. Stations which aired the ITN Connect
interview included ITV London, ITV Meridian, ITV Anglia East and ITV Meridian South East.

Five radio interviews were conducted. The interviews were syndicated to an additional 134
regional stations. In addition, a total of 29 radio stations aired the audio feature. Highlights
of the radio coverage included Sky News Radio, BBC 3 Counties, UCB and Pure FM.

The total weekly audience reach for the broadcast stations, both radio and TV, combined
was over 30 million people (Note: The figure is the total weekly audience reach available)

18 pieces of print and online coverage have been generated to date. Online and print
coverage highlights include The Herald, Sunday Express, Kent Online (Kentish Gazette) and
ITV News Online. Total reach was over 661,515 people.
(Note: The figure is the total circulation and monthly unique website visitors available)

In addition to the news stories above, the discussion about mesothelioma and Mavis’
dedication to raising awareness of the dangers of asbestos continues. As a result of the
media day a number of other meso bloggers have written about Mavis’ recent media activity
and linked to her blog, each mentioning the COMMAND study and Verastem by name.

I cant believe we reached so many people and Im proud and honoured that I did. He has given me a whole print out but I cant put it all on here I will try to work out how I can do a link.

—————————————————

I wish Lord Saatchi all the luck as the Bill is getting nearer to being passed (Hopefully) 33  days moire so I will help on the final push.

Harrison Trust has done a wonderful Interview today and he has the life of his son to fight for

Please watch this was the Bill today on TV

 8h

One more day to go! Looking forward to patients, campaigners, pharma, MPs & Peers coming together to ensure for those in need! Tomorrow we are all back in the House of Commons as we have been invited by Empower to lobby I will report back with a blog for the day.

http://www.mhra.gov.uk/Howweregulate/Innovation/EarlieraccesstomedicinesschemeEAMS/index.htm

On 14 March 2014 the Early Access to Medicines Scheme was announced.

Under the scheme, Medicines and Healthcare products Regulatory Agency (MHRA), will give a scientific opinion on a new medicine or indication that has demonstrated a positive risk/benefit balance.

The scheme will begin taking applications from companies from early April 2014. MHRA will provide advice on the scheme when it is launched and we look forward to receiving applications from then.

MHRA has previously consulted on proposals for the scheme. Here is the government response to this consultation.

Government response to the Early Access to Medicines Scheme consultation – March 2014PDF file (opens in new window) (74Kb)

The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.

MHRA is responsible for the scientific aspects of the scheme and the scientific opinion will be provided after a two-step evaluation process:

  • step 1, the promising innovative medicines (PIM) designation
  • step 2, the early access to medicines scientific opinion.

Promising innovative medicines (PIM) designation

The PIM designation will give an indication that a product may be eligible for the Early Access to Medicines Scheme (based on early clinical data). The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed.

Companies who want to move to step 2 must hold a PIM designation and provide further relevant data on quality, safety and efficacy.

Early access to medicines scientific opinion

The scientific opinion will describe the benefits and risks of the medicine, based on the information submitted to MHRA by an applicant after sufficient data have been gathered from the patients who will benefit from the medicine. The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved