VanSel Early phase drug trail Cycle 1 Days 22-26: Beauty's only skin deep....

People pay a small fortune for a "chemical peel" to achieve a younger, healthier looking complexion by burning off layers of old skin on their faces.  Steve seems to be having one for free as a side effect of the drugs he is taking!

Actually, it's not a laughing matter...The flush on his face, neck and chest which appeared on Day 18 gradually worsened over the following days and was a bright, angry red with a mix of dry flaky skin and some acne-like pimples by Monday (Day 22) when we visited hospital for Steve's weekly check up and observations. 

Dr Nick prescribed an E45 cream to deal with the dryness and a steroid hydrocortisone cream to counteract the other side effects.  Although the skin was a problem, other side effects of treatment have eased off and all the observations and test results were fine, so Steve was given the go ahead to continue taking the tablets.  

Some people on the clinical trial have experienced eye problems, so eyes are tested regularly whilst taking the trial drugs.  Steve's next eye examination was on Tuesday, Day 23 of the trial.  He was not looking forward to it, partly because it involves bright lights shining right into his eyes which is uncomfortable, plus having stuff put in his eyes to dilate the pupils and stains to show up any any abnormalities.  These blur his vision and make him susceptible to bright light for a while afterwards. This time round he was also very self-conscious about his appearance - his face now an explosion of acne, far worse than the average teenager.

We hoped that dousing himself with E45 cream whenever his skin felt dry and applying the steroid cream as directed would result in some improvement in Steve's skin.  However, as the day wore on it was clear that nothing was changing...if anything, it was getting worse. 

Simple things like touching the skin on his face when blowing his nose or putting a T-shirt on over his head produced a shower of flaky dry skin and make the acne-like pimples weep or bleed.  Steroid cream is not supposed to be used on open wounds so by Wednesday evening, we had decided it was time to contact the hospital the next day for advice and, hopefully, be able to sort out some more effective treatment before the start of weekend when it's more difficult to get hold of people.  

Skin problems aside, we thought we were beginning to get to grips with the dose timing regime: two vandetanib tablets and two selumetanib capsules at 11.30 am and two more selumetanib tablets at 11.30 pm, with fasting two hours before and one hour after taking each dose.  However, a few seconds after coming to bed that evening, Steve suddenly realised that he had taken both sets of drugs at evening dose time, instead of just one.  So another thing to sort out when contacting the hospital ....

On phoning the Early Phase Trials Unit yesterday morning, Dr Ioannis advised Steve not to take his 11.30am dose of vandetanib and asked him to come in to be checked over in the afternoon. We thought it would be a flying visit, so planned to go on afterwards to do the weekly food shop.  As a result, rather than take the bus, we decided to drive. Imagine our horror to find the car wouldn't start - a completely flat battery!

Luckily one of our wonderful neighbours came to the rescue and drove us up to the hospital.  Steve's bloods were taken and observations were done again for the second time this week, including the EGG and blood pressure.  

His blood pressure was raised at 156 over 80. Whether that was as a result of taking too many tablets the night before, the stress of finding the car wouldn't start, or a side effect of the treatment to date we don't know.  However, it's clearly something that needs to be monitored carefully especially as Steve is the first person to be taken this level of drug dose in the dose escalation study and therefore breaking new ground.  

Dr Ioannis looked carefully at Steve's skin problems.  He explained that the trial drugs stop the skin renewing itself in the same way that they stop cancer cells growing and spreading.  As a result, dead skin cells aren't replaced by new healthy cells and this can cause rashes and spots. Sometimes, a nasty bug can get on the skin and start eating the debris, infecting the skin and making the problems worse.  A skin swab was taken to test for this bug, just in case....

Steve has now been prescribed antibiotic tablets and cream/lotion to fight the infection.  He still looks pretty bad, but the puffiness seems to be reducing and the redness appears to be a little more focussed in certain areas rather than all over his face.  

But beauty's only skin deep...what matters is a person's character, rather than his or her appearance.  Steve is my hero for volunteering for this early phase drug trial and keeping going through what would be a difficult patch for anyone.  Let's hope the antibiotics do their job, the infection clears up, the old skin drops off and that he emerges with new skin as fresh as a baby's, and that it helps clear up the cough which has been bothering him recently.

In the meantime, we have decided to put Sunday's birthday celebrations on hold until such time as he feels confident to face the world and we can celebrate with the family.  However, there will be cake for tea and a bottle of something special to drink.  As any meso warrior will tell you, being around to celebrate another birthday is a milestone worth marking.  This year it looks like we will mark it twice - a small celebration with just the two of us on Sunday, and another celebration as and when he feels better!

Just a dead car battery to sort out now.....oh yes, and the food shop.....

Mesothelioma, the media and Mavis

There are some organisations with high profiles which are very good at grabbing media attention, but it is rare to find the eye of the media turning towards an individual blogging away on a small scale and at much more personal level.  

You can bang on for years, trying to raise awareness about something important, but generally the only people who listen are family and friends, and those with a specific interest in the subject you blog about.  As far as the national and international media are concerned, you do not exist.  

But there are exceptions to that generality and one of those is fellow meso blogger, Mavis Nye. Mavis writes a daily blog Living with Mesothelioma (link on the right) which has attracted attention far beyond her wide circle of friends in the mesothelioma and motor home communities.  Likewise, the number of people following @grandmamavis on Twitter is rising steadily.  

Mavis works really hard at reaching out to people.  I don't know how long she spends each day sitting in front of the computer sending and reply to e-mails; posting and commenting on Facebook in groups and private messages; writing tweets; publishing her daily blog and such like, but it must be a long time - she is so productive!  

It has paid off in the past, with features in the local and national press, but recently Mavis has hit the national media big time.  Back in January, she was interviewed on the BBC Politics Show, talking about the new Mesothelioma Bill.  She was recently invited to tea with the Director of Corporate Development of Verastem Inc, a major American drug company which is working on the COMMAND clinical drug trial here in the UK.  

More recently, and at his request, she found herself sitting beside Lord Saatchi at the first "Google hangout" televised in the House of Lords on Monday to launch the Saatchi Bill (Medical Innovation Bill).  

She then went on to give interviews to the press and TV. Quite a celebrity :-)  

No wonder she was awarded the Asbestos Diseases Awareness Organisation's Alan Reinstein Award for her commitment to education, advocacy, and support to countless patients and families, and the Independent Asbestos Training Providers (IATP) Meso Warrior Award in 2013.  Where can she go from here, I wonder?

 Read the local press article here!

Mavis has what we need to raise awareness of this awful disease.  Someone who is living through it, helping others all the time while she desperately seeks the answer to the question what next for herself?  Mavis has already had four chemo regimes and her "Mr Nasty" is growing again, albeit slowly according to her last scan back in December 2013. She has exhausted all the usual options but is still willing to put herself forward for innovative treatment, so is a prefect person to help front the Saatchi Bill campaign!  

I usually dedicate blogs to meso warriors with a heavy heart as it is a way of saying goodbye. Yesterday, we said goodbye to another warrior, Ernie and our thoughts and sympathies are with Dot, his wife, and their family and friends.  

But rather than use today's post to say goodbye to another brave warrior, I'm delighted and proud to dedicate this post to someone who is still full of life and determination.  Well done Mavis, meso warrior queen!  

Remembering Dr Andrew Lawson

Dr Andrew Lawson was diagnosed with mesothelioma in 2007, when he was 48 years old. It seems that he was exposed to asbestos as a medical student at Guys Hospital.

Andrew's name came to our attention in March 2010, in a conversion with one of the specialist nurses following a hospital appointment when we had tried, but failed, to make much headway discussing with one of the registrars drug trials which might be open to Steve if his "stable" condition deteriorated.  

I googled the name, found a link in a newspaper article which lead me to an e-mail address, and I made contact.  To my surprise and delight, Andrew replied the same day, giving me his thoughts about clinical trials, surgery and novel treatments and a whole lot of contacts, links and a paper about a drug which showed some promise based on research in mice (Zometa).  

At that time, he was just over three years post-diagnosis, had had standard and other chemo, taken part in an intra pleural gene therapy drug trial in Philadelphia, was taking biphosonates (Zometa) and Celocoxib as a pain killer for an unrelated shoulder injury (Celocoxib is a NSAID which may have some anti-tumour activity). By then, he had less tumour than when originally diagnosed and had cycled across Cambodia for a week.  We were impressed!  

He also drew our attention to "The median isn't the message" by Stephen J Gould.  If you haven't read it, please take a look by clicking this live link. If nothing else, it will help you put those awful mesothelioma survival statistics into perspective.

Our next contact was in September 2010, after I read Andrew's article in Oncology Times Reflections from a Nightmare Patient.  Amongst other things, the article tells of his fight to be treated with Zometa and Celocoxib.  The arguments in the article reflect the discussion currently going on in relation to the Saatchi Bill about the need for innovative treatment.  At that time, Andrew was about to have a pleurectomy, in order to get on a trial of a stem cell based immunotherapy vaccine. 

In December 2010, Andrew told me that he had survived the surgery, albeit with some persisting pain, and was taking part in the drug trail as planned.  After the operation, he had three sets of radiotherapy to treat the solitary metastasis, but it hadn't stopped him enjoying life, including "some" cycling, as he described it (from Bankok to to Phuket!) and skiing, as wells academic things.  

In April 2013, he told me he was doing very well, albeit bothered by the pain from radiotherapy.  He was continuing to take Zometa every two months, and also taking part in the WT-1 vaccine trial. That trial is still recruiting in the USA. You can read about it by clicking here.  

Our last exchange of e-mails was in December 2013, when I had sounded Andrew out about the options open to Steve, now we knew his meso was on the move again.  

At that time, Andrew was on chemo again after a recurrence. But he was almost at 7 years post-diagnosis, 3.5 years pre-surgery and coming up to 3.5 years post surgery.  He described himself as "disabled to some extent" although he had cycled Tuscany that summer!  Near the end of the e-mail he said "recently, I'm dealing with some post treatment issues, but hey, only one child left at school and I'll live to see her fly the nest!"

With such an upbeat attitude, I expected Andrew Lawson to carry on cycling and being active in the mesothelioma community for a long time to come.  It was therefore a deep shock to hear yesterday that he had died last week and with much sadness that I dedicate today's blog to Andrew Lawson, doctor, academic, writer, cyclist, meso warrior, husband and father (and probably a lot of other wonderful things too...) It was a privilege to know him, if only in the cyber world.  Thank you Andrew for your words of wisdom and support.  

Andrew was on the Steering group of the Mesothelioma Priority Setting Partnership (PSP).  If you or your loved one has mesothelioma and you do nothing else this week, please complete the PSP survey and help carry on the good work he has started, along with others in the partnership.  

Please click here to compete the survey online or download a PDF copy to print and send in by post.  Thank you.  

Vansel Early Phase Drug Trail Cycle 1 Days 17- 21: Routines and reactions

Just one more dose of selumetanib tonight and Steve will have completed the first week of taking both drugs in the VanSel drug trial.  We have been getting used to changing the pattern of our daily life to fit around the drug trial requirements and facing up to the reality of side effects now that Steve's body has started to react to the treatment.

It's difficult to remember the last occasion when our meal times were regulated over a prolonged period.  We have grown accustomed to eating when hungry and grazing in between if necessary to top up blood sugar levels.  But that has had to change under the new regime.  

Steve must not eat for two hours before and one hour after taking the selumetanib capsules, which he does twice a day at 11.30 am and 11.30 pm.  That effectively means two 3 hour blocks of time every day when only water can pass his lips. Fasting time....

Mornings are generally not too difficult, although long lazy breakfasts finishing after 9.30 am and the occasional brunch are off the agenda for the time being.  However, the evenings have been a bit of a challenge.  It's only when you can't have a glass of wine or a nightcap and a nibble after 9.30pm that you realise how much you miss it!

I'm sure we will get into a new routine over time, but at the moment we find ourselves clock watching and saying, you've only got 5 minutes to finish your food and drain the cup of coffee or glass of wine before the curfew begins.  Not the way to relax and unwind!  

Until we get our eating patterns sorted out at home, we are reluctant to go out for meals where we have little or no control over when food and drink arrives.  I'm sure we will find ways of dealing with this, given time.  But for the moment, we are taking it softly, softly.

As well as establishing and getting used to new routines, we have been watching out for reactions to the trial drugs.  The most obvious side effect is on the gut - stomach cramps from time to time and more visits to the loo, but not so bad that Steve needs to take imodium every day. Nevertheless, he feels a bit vulnerable at the moment and is reluctant to stray far from home.  

On Thursday evening, another reaction manifest itself - a skin rash, which is another common side effect on the VanSel trial. It's more of a flush than a rash, mainly affecting his chest, neck and face.  Not itchy or painful, just noticeable and making him feel rather self-conscious - more ruddy farmer than tanned Adonis! However, the doctor said it's a sign of the drug working, so we are taking that as a positive.  

The change in complexion has gone hand in hand with a slight puffiness around his nose and cheeks, which is more obvious to Steve than to anyone looking at him.  However, the combination of rash and puffiness makes his skin feel tight and wearing glasses somewhat uncomfortable, even though he is using aqueous cream to keep the skin supple and factor 50 sunscreen when outdoors. 

Less easy to define is the feeling of being slightly fuzzy or out of focus in the head; not as sharp as he normally is...and perhaps a bit less energy than usual.

We will discuss all these reactions with the doctor on the next hospital visit for his usual blood tests and observations. However, although slightly unnerving and unsettling, so far these effects are nothing like as debilitating as those Steve experienced on his last two treatment regimes, and for that we are truly grateful.  

The only other thing we are trying to get our heads round is not having an "end date" for the Vansel trial.  Unlike previous treatment regimes, it won't necessarily be over after a specific number of cycles.  If the Vansel combination works for Steve, i.e. the cancer does not grow or spread and he can manage the side effects, then he could carry on taking these drugs beyond the study end date.  

That's got to be good news in terms of progression-free survival.  However, we would have to reconcile ourselves to some permanent life style changes, like many others who have to manage chronic health conditions with medication and new routines. 

But I'm getting way ahead of myself now....we won't know until mid-April when Steve has his next scan whether the drugs are doing the job we hope they are.  All we can do is sit tight and keep our fingers crossed.  Please cross yours too!  

Thank you x

Action stations: Mesothelioma Priority Setting Partnership (PSP); Saatchi Bill; Access to Medicine and the ADAO

I have written previous posts about the Mesothelioma Priority Setting Partnership, and the Saatchi Bill.  Both of those are now gathering momentum.

The PSP has now launched its survey to help inform future research into mesothelioma diagnosis, treatments and care. You can access the survey by following this link (click here).  A report in the Independent newspaper tells you more: Scientists ask for sufferers of the asbestos related cancer mesothelioma to step forward to boost research.

The official launch of the Saatchi Bill takes place in the House of Lords on the afternoon of 24 February.  The Meso Warriors have been invited to attend. Sadly, we can't take part as it clashes with Steve's hospital appointment but we know that our interests will be well represented by Mavis and the other warriors!  

Another campaign kicks off next month.  Empower Access to Medicine has issued a Call to Action to demonstrate to the Government and Parliament that the lack of progress in drug development affects real people and real lives.  The campaign is hosting a lobby of Parliament on 25 March 4pm-6pm and is looking for patients and/or their families to attend with their constituent MPs so as to get the issue on to the agenda of the back benchers.  If you would like to get involved, please contact the campaign team through the website www.accesstomedicine.co.uk. 

Last but not least, the Asbestos Disease Awareness Organisation (ADAO) invites all meso patients and carers to take part in its survey on the impact of clinical trials on mesothelioma and lung cancer patients.  You can access the survey by clicking on this link then click on the pencil. Closing date 23 February!

Good to see so many things kicking off at this time! 

VanSel1 biological drug trial Cycle 1, Days 15-16: Bloods, drugs and tests

It feels like we have spent the last two days in hospital.  

We knew that Monday would be a long day in Bay 34.  

Bay 34, our "home" for the day on Monday

It was the day when Steve gave "research" bloods for testing over a 24 hour period to see what effect the trial drugs were having on his body and what effect his body was having on the trial drugs. These are called PK samples, short for pharma kinetic (the disposition of a drug in the body over time, used to guide adjustments in the dosage and interval of drugs for maximum therapeutic results and minimum toxic effects).

It was also the day Steve would have all the usual observations (physical examination, blood pressure, temperature, pulse, urine, normal blood tests and an ECG) to make sure he's still OK before starting the second trial drug, selumetanib, in addition to the vandetanib which he has now been taking for two weeks.

Because of all the tests, we were in hospital well before 9 am to make sure that the blood test results were back to get the all clear in time for Steve to take both trial drugs at 11.30 am. This is the dose time that fits in best with our pattern of eating, as he must not eat or drink anything except water for two hours before and one hour after taking the drugs.  

The first set of bloods went missing somewhere in the hospital's pneumatic internal postal system, so a second set of bloods were taken and carried to haematology by hand. However, because of the delay, Steve wasn't allowed to take his drugs until 11.47, pushing the subsequent research blood samples back 17 minutes. Not a long time in the scheme of things, but psychologically it felt a lot longer being closer to the hour than the half hour!  It also meant that Steve would not be able to take his second selumatenib capsule until approaching midnight (as it should be taken at 12 hour intervals).

The rest of the day in hospital was routine if long, with PK research bloods being taken at 30 minutes after the drug dose, then at two, four, six and ten hours after the dose.  We passed the time reading, watching a movie on the laptop, doing sudokus and crosswords (Steve) and taking photos on the iPhone (me) until the battery ran out. 

The Clinical Trials Unit ward was nearly empty when we left the hospital, but by the time we arrived home, Steve had started to feel unwell, visiting the loo and downing imodium tablets with increasing frequency.  When he started feeling nauseous, clammy and dizzy it was clearly time to contact the hospital for advice.  

The body is a strange thing.  In the five minutes or so between phoning the oncology ward and the doctor returning our call, it was like a switch had flipped.  The nausea and dizziness stopped, and Steve suddenly back to "normal". Having talked to the doctor on the phone, it was agreed that there was no need to go back to the hospital that night, although a bed would be available for him should he take a turn for the worse.  

Steve took his second dose of selumetanib approaching midnight, and not long afterwards we went to bed, bucket at the bedside just in case (although I'm pleased to say it was not needed!)

Yesterday morning, we were back in hospital again to give the last PK research blood sample 24 hours after the drug dose and talk through what had happened the evening before with Dr Ioannis.  Only then did we realise that Steve had been told NOT to take the selumetanib the night before when talking to the doctor on the phone, in case he had another bad reaction. In the event no harm had been done as he was, and is, still feeling fine.  

Room 18, our "home" for much of Tuesday

There was the usual fun and games trying to find a vein where the cannula could be inserted.  It took several attempts by two nurses in both arms, but eventually it was sorted out and blood samples taken both for research (the PK bloods) and to check that Steve's liver function had not been affected by the episode the previous evening, before he would be allowed to take the next dose of selumetanib.

Bruises on earlier cannula sites and dressings over Tuesday's failed attempts to insert a new cannula 

As "dose time" approached with no sign of the blood results, there was another discussion with the Dr Ioannis about whether or not to take the second trial drug.  In the end, it was agreed that Steve would take the selumetanib just before the hour "window" of dose time closed so that he could continue with the trial, but would stay in hospital until the blood test results had come back and the doctor was happy that no harm had been done.  So we settled in again, reading newspapers while waiting for the all clear which eventually came mid-afternoon with the news that his bloods were A-OK.  

We have been speculating about what might have caused the episode on Monday night.  It could have been a reaction to the first dose of selumetanib, but in that case, why has he not had a similar reaction with subsequent doses? It could have been a reaction to something he ate, unrelated to the drug trial, and once it was out of his system, all was well.  It could have been a reaction to the imodium taken several times in a short space of time.  The bottom line is we don't know.  But we did the right thing contacting the hospital and that's what we should do if anything like that happens again.

So here we are, well into the first cycle of the VanSel trial with Steve now taking both trial drugs.  Other than the mini-crisis on Monday evening, which was over within three hours and has not recurred, everything seems to be going well.  

We are hospital-free for the rest of this week, so once we have caught up on things that were set aside over the last two days, we can think about giving ourselves a treat.  Steve has been looking the the National Trust handbook, so who knows where we will end up?  As long as he remembers to take his tablets with him.....

VanSel1 biological drug trail Cycle 1, Days 6 - 14: Watching and waiting

These last two weeks, it feels like we have been on guard duty 24/7 - watching and waiting on a number of fronts, ready to spring into action if necessary.

It's now two weeks into the VanSel1 drug trial and Steve has been taking a daily dose of vandetanib, starting with four days on the "loading dose" of three 100mg tablets, then reducing to two 100mg tablets per day thereafter.  

So far, he hasn't had any noticeable side effects.  The biggest challenge has been getting into the routine of taking the tablets at a particular time each day AND remembering to write it down in his record diary.  The timing hasn't been critical up to now, provided he takes the tablets within a window of an hour.  However, that will change tomorrow.

Tomorrow, Steve will start taking the second trial drug, selumetanib.  He mustn't eat anything for two hours before taking this drug and one hour afterwards.  This makes the timing of the dose much more important!  We have decided on 11.30 am as the best "dose" time for us.  We must finish breakfast by 9.30 am at the latest and not start lunch until after 12.30.  And no elevenses!

If Steve has side effects from the drug trial regime, these are likely to start when taking both drugs. We are preparing ourselves for the worst but hoping for the best, as always.

We have also been on guard duty for other reasons - keeping a close eye on river levels and the rise and fall of flood waters as the top of the food gauge in the stream at the end of our street has submerged, reappeared briefly, only to disappear again as storm, after storm, after storm sweeps in across the Atlantic to batter the British Isles. 

As you can see from the photo below, West Oxford where we live is a relatively small raised area in the middle of the Thames flood plain.  One of the Thames tributaries lies at the end of our street.  The park beyond the stream is at a lower level than the built up residential area, so we expect it to go under water for a few days most winters (and sometimes at other times of the year).  

The Thames in flood through Oxford

However, it has now been under water continuously for more than five weeks, in fact since 4 January when we had our first flood warning, and had been submerged on and off before that over Christmas.  We are told to expect water levels to rise again this week as the rain that fell upstream from us works its way down river. So we watch and wait, hoping that levels will not rise above last week's peak.

We are looking forward to see some green grass again instead of water....On the other hand, perhaps we should get ourselves two kayaks and take to the water like this couple I met at the end of our street a few days ago.  They had paddled through the floods from the other side of the city...

Kayakers arrive at the park at the end of our street

...or join this lot, who paddled across parks, along roads as well as the river into central Oxford from the north!

If you want to see what it was like in the January floods on the main road (Botley Road) at the other end of our street, watch this video! Paul's motor bike passes the end of the road where we live about 2 minutes 14 seconds into the film.  

I'm pleased to say that in the last two weeks, the Fire and Rescue Service have had pumps working at three strategic locations along the main road and we have not been cut off by flood water on Botley Road this time around.

We have also been keeping watch on the winds.  Luckily for us, the worst of the winds have hit elsewhere in the country. But they have still been strong enough to blow down a tree in the park and lift a slate off the roof - only one so far, thank goodness.

And so the watching and waiting goes on....At least the unprecedented weather has taken our mind off the drug trial to an extent.  Day 15 onwards in Cycle 1 could change that. I will keep you posted.  

We are also waiting and watching out for the start of consultation on the Saatchi Bill, aka The Medical Innovation Bill, which I wrote about last week. Click here to see that post.  All the meso bloggers have been getting behind it.  We have even had a thank you on Facebook.  Together we are stronger.  So true!  

Blog Post 500 - a message from Steve

Hello, it’s the 500th post so it must be time for me to write my guest piece again.

Well, I’m still here, still feeling fine, still no apparent side effects from the new drug, and long may that last. I’m pleased to say I’m more worried about the weather than my health.

I’m going to take this opportunity to say a big thank you for all your good wishes over the last few years, I really, really appreciate it.

Well, that’s all folks, talk to you again in a hundred posts time, by which time we’ll probably be in the middle of a drought.

With  ❤  from Steve on Valentine’s Day

Mesothelioma, innovative treatment and the Saatchi Bill

If you are reading this blog, then I don't need to remind you that there is no cure for mesothelioma - yet.  There are "treatments" - radiotherapy, surgery (lung sparing or radical) and chemotherapy, with the gold standard treatment pemetrexed (aka Alimta) and a platinum-based drug such as cisplatin or carboplatin.

What happens if you have had radiotherapy to the ports/tracts following pleurodesis to drain fluid; the tumour has been resected or is not suitable for resection, and/or you have a had one or more chemo regimes and then the mesothelioma comes back and keeps growing?

Your options close down and you are left with best palliative care, unless there is a clinical trial within traveling distance and you meet the eligibility criteria.  Even then, you might receive a placebo rather than the trial drug.  This may well help others in future, but it is unlikely to do much to help you if your cancer is growing rapidly and causing pain, "placebo effect" notwithstanding.

Mesothelioma prognosis is bleak (only 1 in 10 people will be alive three years post diagnosis and only 8 out of 100 will survive 5 years later, according to Cancer Research UK statistics).  However, our experience suggests there is a growing number of long term survivors with two or more chemo regimes and possibly other forms of treatment under their belts and still a lot zest of life left in them.  What options do they have, now they have reached that stage?

This is where the Saatchi Bill (or the Medical Innovation Bill to give it its proper name) could quite literally be a life saver.  It is designed to help doctors innovate so they can advance medical science and find new and better treatments and cures for conditions, including cancers. 

From the patient's perspective, the Bill would free your doctor to consider new treatments and ideas and allow the patient to demand innovative treatment. Armed with the legislation, a patient will be able to say to his or her doctor: ‘Are you trying everything? Can you do anything differently?’ The doctor will no longer need to say he or she cannot risk trying anything new.

According to the Saatchi Bill website:

"Doctors, patients and judges will have much greater clarity as to what is negligent and dangerous practice by clinicians and what is careful and sensible innovation. 

This will have two effects: 

1. It will allow good doctors who have the best interests of their patients at heart to deviate away from standard procedures and innovate, safely and with the protection of the law – as long as what they plan to do follows a clear set of actions. 

2. It will clearly expose the doctor who acts alone and in a reckless way. Courts will be able to adjudicate on good and bad clinical behavior. 

A doctor who follows the correct process will be protected, allowing and encouraging sensible, contained and measured innovation to take place, with patients’ consent. 

A doctor who does not go through the correct procedure and acts alone, as a maverick’ can be clearly and easily identified. 

Over time, the Bill will, we believe, encourage innovation and in turn support the development of better treatments and cures for all manner of diseases, conditions and cancers. It will foster a spirit of innovation, which will advance medical science and discovery in the interests of patients. At the same time it will act against the maverick and the snake oil salesman. 

The Bill will be a catalyst for change."

From the perspective of those with a "rare" cancer, such as mesothelioma, the Bill has a special significance...

 "The Bill is for all doctors and all patients, irrespective of the condition or disease they present with.  However, rarer conditions are a particular issue for doctors, and one with which the Bill is most likely to help.

Standard procedures are based on what is called ‘Big Data’ and evidence-based medicine – that is, they are designed around what is known to work. At least that is the theory. And it is fine when it comes to common conditions, such as diabetes and broken legs, where there are many patients and where theories have been well tested and proved.  

But standard procedures based on rarer conditions, where the data and evidence is patchy is a problem. If there isn’t an evidence base for a disease, it makes innovation difficult – because there are not the numbers of patients available to develop new treatments.It means the standard procedures get repeated, continually fail. And it means, also that less research is carried out because no one wants to spend a billion pounds researching drugs into rare diseases for which the market is small, and scientists often don’t wish to study an area for which there is less funding. 

Big diseases tend to carry the day. This relegates the rarer conditions into a scientific and medical backwater with doctors left able only to repeat their failures. This is why we need to free doctors to innovate, safely, with and for patients". 

 To find out more about the Medical Innovation Bill please visit the Saatchi Bill website by clicking HERE!

Jeremy Hunt, Health Secretary, says he will support the Bill but only if the public support it.  Please show your support! The Government consultation is due to start anyway now, but the Saatchi Bill website is collecting comments now and will forward every comment received to the Department of Health.

 Post Scripts 

• In case you were wondering, the Lord Saatchi who is promoting this Bill is Maurice Saatchi, whose wife Josephine died in 2011 of ovarian cancer...not the Saatchi who used to be married to Nigella Lawson....You can read the background to the Saatchi Bill by clicking HERE!  
• Although the Thames river levels are still high, they are stable for now and we are safe and dry for the time being.  We are watching the weather forecasts carefully; it's not just the rain that falls here but the rainfall in the areas upstream which will affect us here a few days later.  Perhaps I should go to talk to Eric Pickles who is here in Oxford right now as I type...just up the road in fact, on his way to inspect Bullstake Close where we rent a garage which is still under water.....

VanSel Cycle 1, Days 4-5: Blood, blood, glorious blood

Rather than mud, mud, glorious mud (although there's a lot of that about at the moment!) since yesterday morning our waking hours have been dominated by blood, blood, glorious blood.  Not a lot of it, but little and often and in controlled circumstances, at hospital.

Steve has been taking a daily 300mg "loading dose" of vandetamib as part of the VanSel1 drug trial he started on Monday.  The loading dose is reduced to a lower "continuous dose" of 200mg after four days.  This change triggers the first set of research bloods which are tested to see the effect the drug on his body.

Blood samples are taken over a 24 hour period.  The first blood sample was taken before the final "loading" dose of vandetamib to check that he was OK to carry on with the drug.  Further samples were then taken for research purposes.  This happened at 30 minutes after swallowing the tablets, then at two, four, six and twenty four hours after the dose.  This allows the research team to look at what happens to the drug in the body through different times of the day - how the body absorbs the drug; how the drug gets to different parts of the body and how the body breaks down and gets rid of the drug.

Less than 2ml of blood is taken at each sample, so not a lot in total.  However, because five samples are taken in one session, a cannula (a bit like a tap which can be turned on and off) is used rather than use a fresh needle every time. The cannula is inserted ready for the first sample and stays in until the last sample of the day has been taken.  

Cannulas are larger and therefore a little more difficult to insert in to a vein than a fine needle.  And that's where the fun began yesterday - trying to find a suitable vein!  The nurses started looking in Steve's right arm, then tried in the left, then back to the right.  After five or six attempts, they finally managed to find a suitable vein that didn't wriggle away (although we found out later that it only worked when Steve was lying down on the bed, rather than sitting up with his arm at a different angle).

The first blood sample check showed that everything was OK. However, Steve wasn't allowed to take the tablets until he had been seen by a doctor.  Although there are two trial doctors, one was in clinic that morning and the other had to look after someone who had come in as an emergency.  Consequently, Steve wasn't seen until later than anticipated and didn't take the tablets until almost one o'clock in the afternoon rather than 11 am, pushing back the timing of the research blood samples by about two hours.  

We had left home before 8.30 am to get to the hospital by 9 o'clock that morning and arrived back home around 7.45 pm, so rather a long day.  However, we  passed the time reading newspapers; doing crosswords; writing a long "to do" list and setting priorities; doing a first draft design for the garden which will need to be reorganised if/when the old shed is replace (always assuming it stops raining for long enough to do the job!); looking through kitchen catalogues in the hope of feeling inspired to do a much needed makeover...

....and watching a film on the laptop Salmon fishing in the Yemen, which is described as "an upstream journey of faith to make the impossible possible".  Very appropriate for someone with mesothelioma taking part in a phase 1 drug trial.....

Today's hospital visit (the third and final visit this week) was shorter and sweeter - the last research blood sample in the 24 hour batch. Just enough time to flick through a photography magazine.....

Steve is now taking the reduced "continuous" dose of vandetamib (two tablets a day instead of three).  We have a hospital-free week to look forward to next week, before returning the week after to start the next part of the study when both drugs (vandetanib and selumetanib) will be taken together for the rest of the cycle.  

In the meantime, Steve has felt no noticeable side effects after taking vandetanib for five days - very different to his last chemo regime which saw him in hospital overnight at the end of the first week.  If anything, he says that food tastes better and so far, he has been more dynamic than usual...ticking off things on the "to do" list at a surprising rate.  And long may it last!

The Mesothelioma Priority Setting Partnership (PSP)

The Mesothelioma Priority Setting Partnership (PSP)  is bringing together people with mesothelioma, their families, carers and the healthcare professionals who treat them to help set priorities for mesothelioma research.

Launched in December 2013 by the James Lind Alliance and funded by the National Institute for Health Research (NIHR), the PSP is being guided by a steering group of mesothelioma patient charities and clinical groups.

The project has been set up to help put mesothelioma research in the spotlight. It aims to identify patients’, families’ and healthcare professionals’ unanswered questions about mesothelioma treatment by asking them to complete a survey, either via this website or on paper.  It will then prioritise the questions that these groups of people agree are the most important. The end result will be a top 10 list of mesothelioma questions for researchers to answer. The PSP will work with the National Institute for Health Research to turn the top 10 priorities into fundable research questions.

The project wants to hear what patients, carers, families and healthcare professionals believe are the most important unanswered questions around the diagnosis, treatment and care of mesothelioma.  It is vital to gather the views of as many people as possible so that the PSP know the topics that are a priority for research to investigate. 

You can help make the project a success by:

• Fill in the online survey or complete a paper copy and send it back once it is available in spring 2014.
• Pass on the information to encourage your family members, support networks, carers or colleagues to fill in the survey.
• Circulate copies of the mesothelioma postcard to relevant groups. Get in touch with the PSP if you’d like some printed copies.
• Keep in touch with the PSP so that the project can invite you to help in the next stage of prioritising the questions that we receive. Whether you’ve taken part in the first survey or not, you can still vote on priorities.

The survey of uncertainties around the diagnosis, treatment and care of mesothelioma will be available from the PSP from spring 2014.

Please contact the PSP if you can help with communicating the survey to as many patients, carers, families and healthcare professionals as possible. 

If you want to know when the survey is available, please join the PSP mailing list by emailing jla@southampton.ac.uk.

Clinical trials: Clearer rules and better protection for patients

Thousands of clinical trials have not reported their results; some have not even been registered.  Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. 

All Trials is a campaign to ensure that the results of all clinical trials are registered and reported.  You can read more and sign the petition by following the link HERE!

There is one last hurdle remaining now in clinical trial reform. The Willmott Report will secure better regulation of clinical trials in Europe, for the benefit of all. It has already been approved by the MEPs Public Health Committee and will go before the European Parliament in April. If passed, the proposed regulation of clinical trials will become law. 

You can help achieve this objective by urging your MEP to vote in favour of the Willmott Report on Clinical Trials Regulation when it goes before the European Parliament on 2nd and 3rd April.   

You can find contact details for your MEP on your local council website.  

Here is the text of a letter I have sent to our MEPs.  Please feel free to copy, adapt and paste to make it your own.  I will report responses in due course.

Dear ....MEP

I am writing to urge you to support the Willmott Report on the Clinical Trials Regulation.

I have a personal interest in this matter.  In June 2009, my husband was diagnosed with mesothelioma - a cancer caused by exposure to asbestos, for which there is currently no cure. However, we are confident that one day researchers will find a way to deal with this killer disease.  Research and clinical trials looking for a cure for mesothelioma give us a glimmer of hope on a difficult journey.  

On 3 April 2014 you will have the chance to vote in favour of greatly increasing the transparency of data obtained in clinical trials.   Once the regulation is in force all pharmaceutical companies and non-commercial sponsors of clinical trials in the European Union will have to:

• Submit a summary of results to a publicly accessible database, within a year of completing the research
• Submit a summary understandable to a layperson
• Submit the full Clinical Study Reports of trials when applying to put a medicine on the market
• Register or publish old trials, if they want to use them to back up applications for new trials
• Face financial penalties if transparency requirements are not met

These rules will apply regardless of whether the trial was successful, unsuccessful or inconclusive.

Around half of all clinical trials have not been published; some trials have not even been registered. If action is not taken urgently, information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily.  

Please will you help improve patient safety, sound science and the advancement of medicine by voting in favour of the report on 3 April?  

I look forward to writing about this important step forward in the regulation of clinical trials on the blog.  With your support, I know it will happen.  

Thank you.

Kind regards,

World Cancer Day

Find out more by clicking HERE!

VanSel drug trial: Cycle 1 Day 1 of 42

It has begun!

We arrived at hospital about 10.15 am and went straight up to the clinical trials unit where Doctor Nick greeted us and directed us to Bay 37 in one of the four bay wards.  

Soon after we had settled in, Julianna the trial nurse arrived full of smiles and took four sets of blood samples for testing. These had to be checked in the haematology lab before Steve was allowed any medication.  Then the "usual" checks - blood pressure, pulse, temperature and SATS (98% which is good!)

As Julianna disappeared to take the bloods to the lab, Dr Nick arrived to do his physical examination, chat to Steve and ask if we had any questions.  He explained that most people don't experience side effects until they are taking both drugs - vandetanib and selumetanib - which starts on day 15 of the first cycle.  So while it's useful to have a packet of anti-diarrohoea tablets and factor 50 sun screen handy, Steve probably won't need either for a while longer.

Julianna reappeared to talk us through how to keep the medication diary and the timing of taking drugs, as well as the procedure to follow if there are any problems (which I'm pleased to say has improved since October 2012, when Steve was very poorly after his first dose of pemetrexed and carboplatin and it was a bit of a nightmare getting help).  We were given a new "red book" which is a record of his treatment and other useful information, and were almost ready for the off...

Although the drugs arrived on the ward at 11.20 am, Steve couldn't take his first vandetanib tablet until 12.20 pm when his blood tests results had come back and the all clear was given.  

So...Steve popped his first three 100g pills, we put on our coats, said our goodbyes and caught the bus home.  Simple and relatively straightforward.

Over the next few days, he will gradually bring forward the time he takes the tablets by 40-45 minutes, with the aim of getting to 11am as his regular tablet taking time, which is the perfect time to take the selumetanib capsules (no food for two hours before, or one hour after, taking that particular drug).

The next hospital visit later this week will be a long day as Steve will be giving small samples of blood over a 24 hour period for research purposes.  More about that in the next post, unless anything untoward happens in the meantime.  

Until then, we just have to remember to take the tablets at the right time; not to drop any, as there are no spares, and get up in good time for an early start on his next visit.  

So far, so good!

Into the unknown

Our next journey into the unknown starts today.  

We are as prepared as we can be.  

Some loose ends tied up....Framed print delivered for a photograhic exhibition at Linacre College, which opens tomorrow; last piece of work for Guernsey finished and signed off; stocked up on essentials, including factor 50 sun screen and anti diarrhoea medication to deal with two of the most common side effects of the treatment Steve is due to start today, as well as more large candles in case of power cuts due to flooding, which the Environment Agency says might happen later today.  Wellies and sand bags are at the ready!

We spent the day in Bristol yesterday, visiting Steve's mum now into her second week of hospitalisation and catching up with our son for the first time in 2014.  We also spent a wonderful evening on Saturday having a meal with friends Richard and Mary, Anne and Colin.  Good food and wine, and excellent company!  

Not sure when we will be able to do that again.  It all depends on how Steve reacts to the trial drugs. Time will tell.

As we set out into the unknown in a couple of hours, others will be celebrating the life of meso warrior Jan whose journey ended too soon.  We send our love to Gary and Jan's family and friends.  

And now it's time for us to get ready for the next stage of Steve's journey.  When I write again, the first dose of trial drug will have been given and we'll be off....here we go again!

Last but not least, thank you so much for all the messages of support.  It really is appreciated.  Very, very much xx