Tuesday, 26 August 2014

The Australian Kalydeco Affair

  1. 1.
    the unjust or prejudicial treatment of different categories of people.

On Thursday 31st July 2014 the Department of Health (DOH) convened with Australian CF Clinicians and Cystic Fibrosis Australia, they met as stakeholders regarding the listing of Kalydeco on the PBS...
Patients "specifically excluded" by the proposed criteria:
"Whilst patients with FEV1 of less than 40% of predicted may also benefit from treatment with  ivacaftor, the extent of the benefit in comparison with standard care is unknown because the main randomised clinical trials did not enrol patients in this category of severity. All stakeholders agreed that data about these patients would become available *over time and therefore, they could be considered for subsidy in the future – that is they do not currently qualify for subsidy based on the evidence presented by the company to the PBAC in seeking the listing of ivacaftor on the PBS. Patients previously treated with ivacaftor would be grandfathered on to the PBS-subsidised treatment, subject to meeting the PBS eligibility criteria described above." - Excerpt of the proposed PBAC/DOH  prescribing criteria.

"Over time" . . . 

Over time . . . these words (among others) linger weeks after I first laid eyes on this report. I have waited to write about the situation to give myself 'time' to come down from a boil to a simmer. The concept of time for people with lung functions below 40% is vastly different from those above 40%. These patients count the months, the days, the nights, the hours, the minutes ... time is not a 'luxury' they have. What time are the DOH exactly referring to?. Even more disturbingly "all stakeholders agreed" ... ?!!

For the record: I am a stakeholder and I object in the strongest possible way to this inhumane criteria.

To add to this inhumane proposal is the DOH's hair splitting rationale for excluding advanced CF patients; "no clinical data" - an excuse I find utterly and completely unacceptable! True, there have not been any clinical trials conducted with patients in this category, however, there is PLENTY of clinical data if the officials bothered to gather and look at it. Vertex's compassionate program which was rolled out after the FDA first approved kalydeco years ago, has all the evidence required to make compelling clinical proof. To not officially acknowledge this is unethical.

Give me a break, call a spade a spade: It's all about the money - not the lack of clinical data!!

Whilst the majority of the report will benefit most eligible Australians who are waiting for kalydeco, it blatantly discriminates against the most vulnerable of the CF community. As officials try to massage the message to our community that overall the proposed criteria is positive and there aren't many people that will be affected right now by this particular (brutal) part of it. Cystic Fibrosis Australia described this meeting as a "success" in their latest kalydeco update. To which I beg to differ and am aghast that the CF advocates are not up in arms defending the rights of the patients who will be "specifically excluded". Maybe in some kind of parallel universe neglecting the very vulnerable is a "success", but not in the world I live in. 

The obvious truth is this preposterous criteria is based on money saving measures, not medicine. Certainly not putting these patients interest/health first! I believe it's wrong, cruel, brutal, callous, unethical, unjust, inhumane ... you get the gist.
Anyone who thinks this is 'okay' or who tries to rationalise that in this instance that there is 'not much hope' for these patients, in my opinion are falling into a mindset of a society being marinated by the eugenics mentality ...and there is nothing more terrifying than being the patient on the receiving end of that particular mentality.

This debacle calls into question the very value of life, or more importantly how Australia values the lives of the most vulnerable in our community. Why is the life of the patient whose FEV1 at 35% on kalydeco worth less than the patient with 130% FEV1? Or 10- 15% for that matter? Just because they have not climbed over the magical '40%' doesn't warrant them to be denied the right to kalydeco.

Some may say, 'well in Australia we have double lung transplants for advanced CF patients'... In terms of a patient waiting for a double lung transplant, kalydeco can enable them to be as strong as possible for this major operation, help their body to absorb as much nutrition from their food as they can, to clear their lungs as much as possible, which could have a very positive effect on mortality rates on the waiting list for transplants. And to state the blatantly obvious, if I had the choice, I would rather take two pills a day than have my organs transplanted + all the other complications that go along with transplants. I know people overseas who have come off the transplant list thanks to kalydeco, indeed, kalydeco saved myself from signing up.
For those who are not eligible for a transplant due to superbug infections for example (i.e. Mycobacterium abscessus), kalydeco gives them the gift of time. By extending their life and bring a quality of life better than they have known in recent years, precious time with their loved ones... There are many other ways to weigh up whether a treatment is helping a patient; weight, energy, appetite, sleep, pain, mental disposition, bone density, blood levels, sweat chloride test, sputum production, cough, infection levels, oxygen saturation levels etc etc etc. These patients deserve a chance, just like their peers in 18 other developed countries. As Birdy sings in her song "we know full well there's just time" ... this is true for every living person - these patients lives, their time, is just as important as anyone else's!

~ A note to the patients who may be affected by this criteria ~
 I truly hope that this proposed criteria doesn't make you lose heart for your own situation ... I remember when I was very unwell this sort of news would have tipped me over the edge! So I hope that you are staying hopeful and strong because you have every reason to be. Please don't give up fighting for your life and fighting for access to kalydeco. I will continue to fight this criteria and I hope you will fight it with me! Whether you carry G551D or any of the other gating mutations or if you carry DDF508 (because the PBAC have stated this criteria is a precedent for pipeline meds, referring to the Lumacaftor + Kalydeco combo), we can change proposal this if enough people object, we need to fight this together!! I have been in the under 40% category many times before in my life, I know how hard life is - I also know with the right support things can get better, even more so how important kalydeco is when your very unwell! It is worth fighting for ... Please please, write to the officials or ask your loved ones to. Let them know that this is not okay! I mean this is crazy, no other country has such a ridiculous criteria - Australia prides itself on a so called "world class" health care system, well they've dropped the ball on this, but lets just call this proposal a bit of a blip that needs ironing out! We're stakeholders in this, potentially all CF patients in Australia could be affected by this criteria in the long run, let's make a stand and say NO! 
We're not ready to be angels yet and I will never give you up. 

"Don't give me up
Don't give...
Me up" 

Birdy - Not About Angels 

Links to reports:
1) Update on the PBAC review of KALYDECO™(ivacaftor) in Australi

2) CFA Secures A Meeting With Vertex

Saturday, 31 May 2014

Kalydeco for Australians: The Painful Protracted Process

Prepare yourself, it has been, and still is, a   L O N G   L O N G  process, so here I go.....

Since last blogging I have been very busy with the Australian * #YesToKalydeco Campaign. Can you believe it?! Over two years since G551D, CF patients in the US gained access to this life saving drug. Sadly, other than those of us on the compassionate program, Australians are still waiting?!! 'Why' you ask?... simple: Money. Kalydeco costs 300,000 US per patient per year. Currently available in the UK, EU and US, plus a deal has been tentatively struck a couple of days ago between the Canadian government and Vertex, if this eventuated it'll mean 95% of the G551D CF community worldwide have access to kalydeco... while the ink is drying in Canada, back in Australia reports from Vertex say we are their toughest customer yet and the proposed criteria of our PBAC is the most controversial ever, potentially excluding over 40% of Australian G551d  patients.

Saved My Life! 22nd of May marked Two years on Kalydeco

65 Roses Canberra Events: Many thanks to Felicia from CFV ('Cystic Fibrosis Victoria')!
On Wednesday Benjamin and I represented Victoria, together with the lovely Rachelle and Kate, we all travelled to our nations capital to meet with The Hon Peter Dutton, Health Minister of Australia. The 65 Roses events happen annually to raise awareness about the disease and to advocate for better health care for CF patients in Australia. This year, the spotlight was on Kalydeco! 

Ben and I (pictured 3rd from the left, front row) with some of the most dedicated people I know, who travelled from all around Australia to advocate for cystic fibrosis and Kalydeco.

After a restless night, my day started at 3 a.m. My mind was in overdrive, I was reviewing my dot points, trying to clarify in my own mind what was the most concise way to convey such a complex and serious issue. On the briefing given to those who were attending, one suggestion said 'tell the politicians how life with CF affects you' ... this was really thought provoking for me as I generally don't focus too much on the hardships of CF, I prefer to be proactive and get on with life, choosing not to focus on the dark side of CF much because I find it demoralising, plus it would drag everyone else around me down more than it already has. However for this purpose in order to create change, it was important to talk to the politicians to hear what people with CF have to deal with on a daily basis. 

Flying high to Canberra, contemplating the day that lay ahead

At length I thought about it ... (and yes, it was a downer)... thought about life before kalydeco. Basically for me it came down to I couldn't breath, I couldn't eat properly and I couldn't sleep. Three basic human functions, when they don't function properly the internal domino effect in your body is absolute. CF affects every function of your body in varying degrees, hence why we must work so hard to stay well. For me too I cannot deny a big part of why I became unwell was grief, but that just shows how fragile the situation was, it took just a couple of life changing events to happen, and my mind and body couldn't handle it because of my advanced CF. 

Anyway, one stodgy aeroplane muffin and some full-on turbulence later, we landed! Was straight to the taxi rank and onto Parliament House for the morning tea in the 'Rose Garden' (which ironically had no tea or food, and minimal roses growing, but the sun was shining and there were plenty of pretty pansies! hahaha!).

My good friend and one of my Hero's, Walter, writing in the card for Minister Dutton
Check out Walters inspiring blog:  http://www.coughing4cf.com/

It was a beautiful morning, arriving was slightly intimidating at first, lots of cameras, media, name tags, politicians, officials ... but then from out of this came forth so many familiar faces that I have come to know so well through the kalydeco campaign. What a pleasure it was to meet them in person! Felt like long lost family 


Above: With one of my best friends, Eli 

The Kalydeco power pack! 
From left: Naomi, Myself, Rachelle, Genevieve and Leah

Then suddenly Minister Dutton arrived!! People converged on him, the Minister spoke and listened to many peoples heartfelt stories and pleas for kalydeco. One of the mums speaking with Minister Dutton was my friend Leah who asked "how much is my son's life worth?" to which the Minister replied,"It's priceless". After a time of speaking with patients and parents it was time for the speeches, from officials and of course Minister Dutton himself...

Listening to Minister Dutton speak 

During these speeches Ben and I were supported by our local member of parliament (MP) who stood by my side the entire time, I was honoured he accepted our invitation to attend and to have his support. Once the speeches were over, Minister Dutton was about to leave. Our MP took me by the arm, the crowd parted like the red sea and in a loud commanding voice he said,"Minister Dutton, please allow me to introduce you to one of my constituents".

Ben and I on the rooftop of Parliament   

Suddenly the cameras and people surrounded us, it was a bit overwhelming initially, but Minister Dutton was actually easier to speak with than expected. I showed him a picture of our boys, he asked what their names were.. "Charles, Marcel, Gabriel and Sebastian.. and they are all happy and healthy" I replied. "And are they good boys?" said Minister Dutton. "Yes! they are" I smiled...

My North, South, East and West   The picture I gave to Minister Dutton 

I also gave the health minister my before and after pictures

then I felt tears welling up as I looked at their picture and my voice choking up,"I just want to see my boys grow up".. "Of course you do" said the Health Minister sympathetically. I tried to pull myself together enough to go on to speak with him about the effects kalydeco has had on my health. This brief meeting meant a lot to me as I have been attempting to meet with the health minister for months and months with no luck.
I still hope that I can at least book in a sit down meeting in his office in the near future.

Speaking face to face for the first time with The Health Minister

After the morning event, Naomi, Genevieve and I went to parliament house to meet with the shadow health ministers chief adviser for an hour to discuss the Australian kalydeco situation. She was very supportive and assured us Minister King is aware of the kalydeco situation and will do all she can to help the advance the process. She totally empathises with the cruel situation so many people have found themselves in. She also strongly encouraged the CF community contact their local member of parliament and ask them to raise kalydeco in the senate on their behalf, she emphasised that we must keep the pressure on now!

With my fellow #YesToKalydeco spokespeople, From left: : Myself, Gen and Naomi on the rooftop of Parliament
(p.s. Red was the 65 Roses Day dress code BTW, We don't all shop at the same store! hahaha!)

In the evening we attended an event at Parliament House where we met more senators, members of parliament and PR reps. Regretfully, I don't have many pictures of the night, we were too busy making the most of the opportunity by talking to as many parliamentarians and others as we could. As expected with all parliament events time is precious and very limited, so you better work the room while you can! I lost my voice by the end of it all good and proper! (Pleased to report it has since recovered). The day finally ended at 11:30 p.m. we had been up almost 24 hours and crammed in as much as we humanly could.

The Grand Foyer of Parliament House

For Some odd reason I could not add the video of  Gen Handley's speech from the evening event (?) but nevertheless here's the YouTube link. Please do take the time to watch it, as it was the highlight of the night! Speech link: https://www.youtube.com/watch?v=6FnbB3o1ppw&feature=youtu.be

In front of the Australian Serviceman's memorial;
 "symbolises determination, courage and  the spirit of achievement and hope for the future"

People have asked what I have come away with from this important day in Canberra. Well it's taken me a while to digest all the information and all different points of view that I listened to over the day. 

"First thing's first, I'm the realest" 
Izzy azalea ~

Let's call a spade a spade. The following is not breaking news to anyone, Vertex and the government are "playing chicken" right now. Neither obviously want to back down. Minister Dutton's attendance to both the 65 Roses events was unprecedented, for this we are most appreciative to him. Minister Dutton said the government is committed to resolving this "as quickly as we can", which is pretty open ended! The Prime Minister's message was entirely tokenistic. We were given the political sales pitch about the 20 million dollar research fund that the government have recently created, while I am happy for those who may benefit, it was not relevant to the CF community as none of that funding will go towards our disease as far as we are aware, nor was it relevant for the primary topic in focus, Kalydeco funding now. It hurts because clearly the government have funds, it's just that by results we are not a priority. To put this situation into perspective, Ireland, who have more G551D patients than anywhere in the world and whose economy was devastated by the GFC, has funded kalydeco since June 2012! This fact makes it very difficult for Australians waiting for kalydeco, to accept the continual excuses we have been given since this process began. 

Under the iconic House of Parliament Flag

We were informed that over the days leading up to and after Wednesday vertex and our government were locked in negotiations. We know that vertex have lodged a counter offer of criterias, but the specifics are not known to the public. We asked how to go about arranging access to the full PBAC minutes that were referred to in the Vertex press release regarding Kalydeco, however due to the obvious commercial nature of the discussions vertex aren't releasing all the details, but we are going to attempt to attain them (at least the PBAC condition proposals) under the freedom of information act. In large the patients and their families are kept in the dark. The lack of transparency about the details of this "process", makes the wait more torturous than it already is. Sadly there is no easy answer, but one thing is black and white, if the government don't fund kalydeco people will die prematurely, the longer this nonsense continues the more irreversible damage to CF patients bodies will occur.

Putting it into perspective: Two small Tablets a Day 

Has our trip to Canberra made a difference? Well any publicity is good publicity! So in that sense it will only help with the kalydeco cause. In terms of steps forward, only time will tell. One can only hope that the Australian health ministers heart was moved with compassion by so many of the people who spoke with him, along with many other members of parliament. We hope that Vertex will respond in kind and  match the magic number our government is prepared to pay (whatever that may be?). We appreciate that kalydeco must go through this government process with due diligence, but urge all parties involved to priorities the patients. The CF community are waiting with baited breath for the outcome of this weeks events and meetings between the government and Vertex. The results of these negotiations will provide the answer to our questions, have we made progress or was it just another part of "the process".
For now, our message is simple as it is URGENT

  • Please stop delaying Australians access to Kalydeco
  • Fund Kalydeco with humane and reasonable conditions for all eligible patients
  •  Start saving lives, Please fund Kalydeco NOW!!!

Please watch Kyal's very moving plea for Kalydeco

The last word I want to give to a dear friend, her daughter is 10 and she wanted me to take her story to Canberra with me let the politicians know how seriously Cystic Fibrosis can impact children's lives, this was such a generous contribution particularly because her little girl will not benefit directly from kalydeco:

"My daughter is 10, her days consist of tablets, nebulizers, finger pricks & insulin needles throughout the day for CF related diabetes, been admitted to hospital every 3 months for last 7 yrs- 3 weeks each time- so 84 weeks in total. She has not been at school full time in last year. How do you tell your 10yr that she is going into palliative care?? But now she has been assessed by transplant team in Melbourne & if accepted has to move from across the country to Melbourne to wait for new lungs. The government and drug company are arguing over price & access ability conditions. CF is not just devastating for adults- some children have the rough end of the deal too. Sleeping on couch all day because you're so physically exhausted is not what a 10 year old should be doing. CF is a cruel insidious disease that slowly eats away at your quality of life until one day you wake up in the intensive care unit hoping you get a second chance at life with a transplant!"

*Please note: some words/names of people featured in this blog are linked to their kalydeco stories or projects. Please 'click' on the words coloured BLUE to be connected to read their stories. 

Wednesday, 16 April 2014

Epic Hassle (but I got by with a little help from saccharomyces boulardii)

"Saccha ... sacch... sacca-what?".. I cannot deny I had to watch a youtube video to get the pronunciation of this right! Saccharomyces boulardii, pronounced: sāk'ə-rō-mī'sēz' or 'SAK a roe MYE sees boo LAR dee eye LYE', got it? Saccharomyces boulardii are “Antidiarrheal microorganisms". Awesome, time to get excited

But first a phage therapy update...

Sorry, not a very exciting update this time. I've been getting loads of people asking how are things going with the bacteriophage therapy (thank you kindly for your enquiries!). Well, all I can say is that the last 7 weeks have been nothing short of an epic hassle!! This eradication venture has not kicked off the way I had planned. BUT that's life. Importantly this was not due to bacteriophages, the 'glitch' was entirely my antibiotic allergies fault. I was re-desensitised Monday 2 weeks ago, but then it failed again

by that Thursday my allergies broke through for the second time this 'tune up'. I was loaded up on antihistamines and a steroid, which were not totally stopping the reaction, but keeping it at bay. The IV's are a very important step of the eradication process, I was resigned to that and completed the course yesterday.

In terms of where the bacteriophage therapy is at, I stopped them when the first desensitisation failed. I did not think that commencing them again until my antibiotic allergies are stabilised/resolved was a good idea. I did not wish to complicate things or compromise the eradication process (or waste the phages!). I am very optimistic this is a great start to the therapy, as my lungs are feeling very good from the ceftazidime, it has created an ideal environment to kick things off for the phages.

Yadda Yadda Yadda... the pseudomonas eradication process is on track, only took a slight  (7 week) detour due to my abx allergies... I have commenced Phage therapy today and will update you more on my pseudomonal 'conscious uncoupling' as it happens.

Meanwhile lets talk about something seemingly unrelated, but I think my recent experiences naturally lead onto this super important subject; Gut Health! 

The same time my allergy fiasco was happening, my regular IV side effect was happening too. My gastrointestinal system was not coping with the IV's ceftazidime and drugs in general. At all. You can fill in the gaps here... 




Anyway, I happened to buy some saccharomyces boulardii (as you do...) after randomly reading about it few months ago working well with probiotics, but hadn't got round to introducing it to my routine... (bare with me, I promise this all ties in). I decided over the weekend to start really mega dosing with it (in addition to my regular probiotics) to relive my gastrointestinal system. By the second dose my bloat was relieved and the next day visits to the bathroom were back to normal. 

I love when things work fast and given how long it's taken for me to get into phage therapy, this little bit of success was magnified (not to mention relieving). A side benefit (a very unexpected improvement), my allergies went down by at least 80%. My wheeze improved, headache gone, the welts were more controlled and when they broke out much more mild than previously. I was off pred (steroid) within a day of starting. 'WOW' and I didn't even take it for that?! I was seriously impressed!! 

Next thing I discovered is there are some very CF specific benefits to this friendly yeast: CFTR expression, inflammation reduction, inhibition of pseudomonas and Staph Aureus infections, inhibits biofilm formation, enzyme stimulation, helps gain weight, acid reflux relief, c-diff and it has anti-mycobacterial properties. 

So what is Saccharomyces Boulardii? 

Saccharomyces boulardii (a.k.a SB) is a probiotic yeast (species name: Saccharomyces cerevisiae) that you take in a capsule or you can use the power in/on room temperature foods; for example, I added it to my son's banana and blueberry smoothies. They didn't notice any nasty flavour at all and drank it down with pleasure (mummy win!)
Unlike probiotics (friendly bacteria) which are killed by antibiotics, SB survives and thrives during antibiotics treatment. Making this a dream come true for people who suffer from Clostridium Difficile (C-diff is basically severe diarrhea and digestive complications caused by antibiotics that have wiped out your gut flora)

Recap: Main ailments people may like to try friendly yeast for...
  • Pseudomonas and Staph Aureus infections (inhibit growth of)
  • CFTR expression
  • Clostridium Difficile
  • Crohns disease
  • Irritable Bowel Syndrome
  • Constipation 
  • Diarrhea 
  • Travelers Diarrhea
  • Aspergillus 
  • Candida
  • Acid Reflux 
  • Bloat
  • Digestion  
  • Immunity
  • Inflammation 
  • Liver support (particularly for those with CF related liver disease)
  • Autism (GAPS protocol) 
  • Acne
  • Yeast Infections
  • Urinary Tract Infections 
  • Food Allergies
  • Lactose Intolerance
  • Gluten Intolerance 
  • Anorexia 
  • Osteoporosis (prevention)
  • Depression
  • Ulcers
  • Weight Loss (promotes gaining the weight back)
  • PMS

All in all I encourage you to look into this amazing probiotic yeast, the more I learn about it the more impressed I am. Such a small and easy addition can make such a massive difference. Because as they say 'your digestive track contains 70% of your overall health'. CF being what it is, makes this my number one priority; to keep my gastrointestinal system as happy and healthy as possible.

until next time... Stay Healthy!

Some Further Reading

"Prevention of Clostridium difficile infection with Saccharomyces boulardii: A systematic review" http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2805518/

"The Search for a Better Treatment for Recurrent Clostridium difficile Disease: Use of High-Dose Vancomycin Combined with Saccharomyces boulardii"

"Saccharomyces boulardii Protease Inhibits the Effects of Clostridium difficile Toxins A and B in Human Colonic Mucosa"

"The effect of probiotics on Clostridium difficile diarrhea." 

"For example, bacteria strains found to help with management of digestion include: L. reuteri ATCC 55730, L. rhamnosus GG, L. casei DN-114 001, and Saccharomyces cerevisiae (boulardii). For treatment of antibiotic-associated diarrhea the most commonly studied strains are S. boulardii or L. rhamnosus GG. The strains found to have benefits for immune support include: B. lactis, L. reuteri, L. rhamnosus GG, and L. casei." 

"Saccharomyces as a vaccine against systemic aspergillosis: ‘the friend of man’ a friend again?" http://jmm.sgmjournals.org/content/60/10/1423.full

"Expression and Purification of the Cystic Fibrosis Transmembrane Conductance Regulator Protein in Saccharomyces cerevisiae"

"Cystic Fibrosis Transmembrane Conductance Regulator Degradation Depends on the Lectins
Htm1p/EDEM and the Cdc48 Protein Complex in Yeast"

"Expression and degradation of the cystic fibrosis transmembrane conductance regulator in Saccharomyces cerevisiae." http://www.ncbi.nlm.nih.gov/pubmed/11396922

"A yeast metal resistance protein similar to human cystic fibrosis transmembrane conductance regulator (CFTR) and multidrug resistance-associated protein." http://www.jbc.org/content/269/36/22853.abstract

"High Prevalence of Anti-Saccharomyces Cerevisiae Antibodies in Cystic Fibrosis Patients after Lung Transplantation" https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0033-1347437

"Cell Wall Integrity Signaling in Saccharomyces cerevisiae" http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1197416/

"Increased levels of anti-glycan antibodies in patients with cystic fibrosis."

"Candida species in cystic fibrosis: A road less


"Probiotic Yogurt Effects on Intestinal Flora of Patients with Chronic Liver Disease"

Saccharomyces boulardii 

Saccharomyces boulardii 

Saccharomyces boulardii 

Saccharomyces boulardii 


Sunday, 23 March 2014

Phages: 'A Miniature Act Of Piracy'

Hello again Dear Readers! 

Just kidding! 

After a long break I am back at the laptop for CFMUDDA with new topics that I find very exciting for my health, I hope will interest you too!  

First of all I would like to thank any of you who have supported the Australian #YesToKalydeco campaign, it has been (and is) a long winded and exhausting process and sadly still not complete, the G551D CF patients of Australia are still awaiting funding approval from The Australian Government... we hope that during the last PBAC meeting a couple of weeks ago a price agreement was struck, but we will not know the fate of kalydeco in Australia until late next month. It is an terribly anxious wait for so many. Please continue your support by signing and sharing the official campaign change.org petition by following this link: https://www.change.org/en-AU/petitions/make-kalydeco-available-to-australians-with-cystic-fibrosis

Thank you!

So onto the other 'happenings'; well last week a very special parcel arrived for me from Tbilisi... 

can you guess what it is??...


3 month supply of my 'bespoke' phages!!

I can't tell you how good it felt to hold these little guys in my hands... I feel I have been waiting since I was 12 years old for this moment! Although I only discovered phages existed more recently, I have been seeking something to effectively 'wipe out' the bugs eating away at my lungs.. October 12, 2012 to be exact, a lovely lady who has now become my friend, posted an article in a CF related Facebook group, this is the article: http://www.scientificamerican.com/article/are-phage-viruses-forgotten-cure-for-superbugs/
I read it and it was like music to my ears!!! 'A 'friendly' virus that eats bacteria' WOW! what a concept! Instant mind blow!! I mean, my whole life viruses have been the enemy, heaven forbid if I caught one, now I have done a 360 and am nebulizing them?! hahaha! Well, make no mistake, only the very special friendly ones!! 

My brain instantly went into overdrive: 'Who? What? Why? Where,? When? and HOW??'

an excellent animation of how phages work

Yes, since that fateful day in October 2012 I have been on. the. hunt. for my phages! See, phages are very picky 'eaters' they only 'eat' one type of bacteria, one strain per-phage. So the Phage Therapy Centre had to go find my particular strain of Pseudomonas Aeruginosa's perfect phage match (otherwise the therapy won't work). Another example, if you culture multiple bacterias, say MRSA, Pseudomonas, Cepacia, you'd require a phage for every strain of bacteria the labs can isolate, then they'd create for you what they call a 'phage cocktail' (no, not the yummy kind of cocktail!).

Onto my pseudo, after years of antibiotic treatments it has become a very resistant and stubborn strain. According to the labs,"behaves quite differently under the microscope to regular pseudomonas.a". That was actually a relief to hear that! No wonder it's been so difficult to eradicate!! Basically is a 'super pseudo'.  

December last year my sputum sample was sent to Tbilisi, Georgia, to be isolated and tested against phages, the clinic came back with disappointing news, no commercial phages 'matched' my pseudomonas. I freaked out for a second, but was quickly assured that this was not the end of the line for me. All it meant was they would need to hunt for a phage match, which could take month and months. I was very nervous they would not be able to find me a match, but 6 weeks later I received very welcomed news: 'we have found a bacteriophage to match your pseudomonas'.

Hip Hip Hooray!!!!!!!!

Fast forward to preparations for phage therapy: So to optimise the therapy and to clean up my lungs ready for cold and flu season, I elected to do a course of IV antibiotics (abx). As some of you may remember, I am severely allergic to all IV abx, so require desensitisation  every time I commence IV treatment. This is a very painstakingly slow process, dot dose's over 4-6 hours whilst my body adjusts (there is a more technical scientific explanation I won't go into now..). I underwent desensitisation 2 weeks ago, all went very well, but unfortunately on day 7 of abx treatment, my allergies broke through (welts on my torso) so the ceftazidime was stopped. I am due for review on Wednesday and we shall work out if I require further abx treatment (another desensitisation) or if I feel confident to not need further treatment. 
Phage therapy is complemented by antibiotics... or should I say antibiotic treatment is complemented by phages? Either way, they are a good team to fight the pseudomonas at every angle! So we have to weigh up whether or not it's worth continuing abx for this reason. We shall see... 

A question I have been asked quite a bit since sharing my bacteriophage journey with my facebook friends is 'Does your CF doctor support your phage endeavours?'. Fair question, I discussed the possibility of having my phage therapy administered in my hospital, my doctor was not personally opposed, however due to the fact phage therapy is not TGA ('TGA' is the Australian 'FDA' US equivalent) approved, the hospital 'red tape' would be endless, rendering it impossible to have the phage therapy administered by my hospital at this stage. I am excited to say though that there are phage therapy trials due to commence (or are being conducted now?) in Australia. One of my great hopes is that one day it will be a standardised therapy offered in all CF clinics, given the superbug epidemics and drug resistance in the CF community, bacteriophage therapy is a very safe and efficient treatment, offers the CF population a lot of hope I think.

22 March 2014: My very first bacteriophage therapy!!!! 

Of course safety first: I had my 'survival kit' at the ready if I experienced any anaphylaxis (aka: severe allergic reaction

My stats were all good (my 'normal')....

First 'test' dose: 3ml....

3 puffs of ventolin prior to treatment  ~puff puff puff~ and then 3ml of phages into my nebulizer...

My first dose video... little bit boring, but that's a good thing in this instance; No 'survival kit' required!!

As I am writing this blog I am nebulizing my third full dose of 10ml. Happy to report no seriously adverse effects thus far. Hours after first dose, my lungs started to wheeze a little bit in my right mid-lobe and my stats elevated slightly. During the night after two half doses of phages (5ml each) the friendly viruses 'did their thing'. I woke up with a decent lot of lung inflammation (as expected). No coughing or temperature/fever. Rapid & difficult breathing though. I took 30,000iu vit D3 (to reduce inflammation), 1200mg NAC & 3 puffs of symbicort inhaler, felt MUCH better within minutes. Breathing easy.. Within an hour or so later the action really happened!! I coughed up plugs from where all the wheezing was last night (mid-right lobe)!!!! 

EEEK!!! I was thrilled!!! It's starting to work... 

My hopes are high. I am on kalydeco which gives me the best chance possible to eradicate the pseudomonas. 
I'll be honest, without kalydeco and the fact I am an advanced CF patient, I would not be 

so hopeful for complete eradication (although even for people not on kalydeco, successful control of CF bugs is high), but kalydeco has essentially switched off my CF, my mucus production is down by 95%, my CT scan showed vast improvement since starting kalydeco...all that remains are these wretched pseudo suckers! It's never been tried before but I am going to give it my all to make this work!! 

I will keep you posted on my progress.... 

Thank for reading and I hope you are all keeping well! 

Further Reading: Studies and article links about Bacteriophage's 

"Pulmonary Bacteriophage Therapy on Pseudomonas aeruginosa Cystic Fibrosis Strains: First Steps Towards Treatment and Prevention" 


"Phage Treatment of Human infection" 

"Bacteriophage Therapy" 

nature.com: "Old dogma, new tricks—21st Century phage therapy" 


"Bacteriophages Can Treat and Prevent  pseudomonas aeruginosa Lung Infections"

Aug 8th 2013: "AmpliPhi Presents Data on Bacteriophages in the Treatment of Lung Infections in Cystic Fibrosis"

"Bacteriophages of Pseudomonas aeruginosa: long-term prospects for use in phage therapy."

"Phages may be key in bacteria battle"

"Imperial College of London: Phage Therapy"

"Ampliphi presents encouraging pre-clinical data on the use of phage-based therapies to treat bacterial lung infections"

"Pseudomonas Biofilms, Cystic Fibrosis, and Phage: a Silver Lining?"

"Phage  Applications"

Enterococci ,Escherichia Coli , Proteus , Pseudomonas , Salmonella , Shigella, Staphylococcus, Streptococci    

"Merger to Focus on Phage Therapy to Fight Infections"

The Promise of Bacteriophage Therapy for Burkholderia cepacia 

The Promise of Bacteriophage Therapy for Burkholderia cepacia 

The Promise of Bacteriophage Therapy for Burkholderia cepacia 

"The Promise of Bacteriophage Therapy for Burkholderia Cepacia Complex Respiratory Infections"  http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3417384/

"Toward modern inhalational bacteriophage therapy: nebulization of bacteriophages of Burkholderia cepacia complex"

"Experimental Bacteriophage Therapy Increases Survival of Galleria mellonella Larvae Infected with Clinically Relevant Strains of the Burkholderia cepacia Complex"

"The Forgotten Cure: The Past and Future of Phage Therapy"

The Promise of Bacteriophage Therapy for Burkholderia cepacia 

**Disclaimer: The content in these blog entries are the personal views, opinion and personal health journey of the blogger, not counsel or advice. The words and other con­tent pro­vided in this blog, are not intended and should not be con­strued as med­ical advice. If the reader or any other per­son has a personal med­ical con­cern, he or she should con­sult with their appropriately-licensed physi­cian or other health care worker. Thank you.