Life's Roller Coaster

If I'm missing, or not taking messages sorry – I'm more angry about letting my friends down than YOU will ever be at being let down! Unfortunately that is sometimes a side effect of Cancer! Mea Culpa: may I blame being short fused & grumpy on it too! My first symptoms presented in Nov-1998 – Follow The Trail on >DIARY of CANCER< Immediately Below!

The cancer-sufferer standing against Jeremy Corbyn in his own backyard …

DO MAKE USE of LINKS,

>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

~~~~~~~~~~#########~~~~~~~~~~
The cancer-sufferer standing against Jeremy Corbyn in his own backyard …
~~~~~~~~~~#########~~~~~~~~~~

Posted by:
Greg Lance – Watkins
Greg_L-W

eMail: Greg_L-W@BTconnect.com

https://InfoWebSiteUK.wordpress.com

www.InfoWebSite.UK

~~~~~~~~~~#########~~~~~~~~~~

.

Hi,

Anna’s article below puts into perspective not just the destruction of life as you may know it but in fact the confrontation of one’s own demise. Her article is wide ranging, very personal and in its way has the fascination that is seen in a rodent when confronted by a hungry snake!

On Rebuilding Your Life When Hit By An Exocet.

They were not, as you might imagine, all fellow patients with physical ailments. Exocets arrive in many forms.

For Mrs Blunt, it arrived in the form of her husband’s gleeful public declaration of his love for his homosexual partner. The media were delighted to report on his new relationship. She was left to rebuild her life with her children. An entirely innocent victim of a life shattering Exocet.

For Mrs Travis, it was the announcement that her husband was being investigated by Operation Yewtree. Mrs Travis had done nothing wrong, yet she lost her home, her peace of mind at a time that she was grappling with breast cancer – and her privacy. Her life would never be the same again.

Other who have been kind enough to make contact with me include a man who has recently been cleared of all charges, a totally innocent individual, yet who must still keep his head below the parapet for fear of further publicity so I shall not mention his name; and Rabbi Laura Janner-Klausner who finds time in her busy schedule every day to phone me and keep my spirits up.

That is not to ignore the many good friends I have made whilst running this blog – Gloria Smudd and Blocked Dwarf come to mind in particular, both have given of their time to help me settle into my new home; Andrew Rosthorn, Daedalus Parrot and ‘another’ who shall remain nameless (again with good reason to keep their head below the media parapet)  have given hours of their time to help me stand for election.

It is with those who have found themselves caught up as innocent participants in the whirlwind of false allegations that I feel a particular affinity with. I have a new understanding of what it is like to have your life turned upside down.

My life, their life, can never be the same again. We have done nothing wrong, yet have to accept that there is no road back to our old life – whether it is because, in their case, that the vile accusations will continue to be propagated on an unforgiving internet, their family name forever besmirched; or in my case, that I will never walk again with all the limitations that brings in its wake.

One thing I have quickly learned is to disassociate yourself from those who have a fixed view as to how you should ‘present’ yourself to the public in future.

You have to be true to yourself.

Yet there are many around you only too quick to give you advice as to what you should or shouldn’t be saying, nor how you should be saying it! You can rest assured that my decision to carry on blogging hasn’t gone down well with some people. My decision to ‘go public’ with my story in The Times with James Gillespie and the Mail on Sunday with David Rose in an effort to bring publicity to the issue of people suing the NHS has gone down like a lead balloon in some quarters…..

Fortunately that doesn’t include Mr G who has been a tower of strength for me, not just in terms of what he has had to do for me physically – and I cannot wait to publish the blog post which will carry pictures of the wonderful extension he has built on for me to live in, I am so very proud of what he has done – but he has also supported me mentally; mopping my tears when I have been overwhelmed by self pity, cheering me when I have managed to write a blog post, and, small point, bringing me back photographs of all the little things I can no longer see for myself.

I say ‘small point’ – but have you any idea what a difference it makes to me that he brings back a photograph of what the pub garden looks like now that they have taken down a large tent, rather than merely ‘telling’ me about it? It makes me feel as though I am still part of the wider world.

It was Mr G too, who brought into the hospital that photograph of me at 23, to remind me that that girl was still inside me, even if I could no longer recognise myself in the mirror. (One of the side effects of the massive dose of steroids that I was having at the time, apart from making you talk ten to the dozen in a loud voice, is that they literally change the shape of your jaw and puff out your cheeks, so much so that I nearly screamed the first time I caught sight of myself!)

I have had to get used to the lack of privacy too. I can no longer be alone. There must always be someone with me. No phone call is private. No part of my body is private – I have round the clock care to wash me and dress me. No bodily function is private. That is why it becomes so very important to have some control over some part of my life – and that is where I have some connection with others who have received an Exocet in the backside.

We can’t change the past, can’t change what has happened, but we have control over how we face the future.

Hidden away, licking our wounds; or blazing out in public saying ‘I don’t care what you think, this is the person I am, this is the person I choose to be, this is the person I am – you can either like it or lump it’.

It will come as no surprise to those of you who know me well, to learn that I am choosing the latter path. In fact you could say – the latter path ‘with knobs on’.

As we speak, there are two web experts doing their best to put my blog site back as it was. It can’t be exactly the same, because it will be going on a wordpress.com site rather than a self hosted wordpress.org site and the software is not identical. I’ve chosen not to go the self hosted route this time, because I still have to face the reality that the cancer will kill me at some unspecified time in the future, and if the blog was self hosted, that would mean that it would disappear again.

Thankfully the kind reader who had hosted the archive site is going to host the new site as well, so it will stay up and running when I am gone – it does mean though, that all the comments on all the back posts will disappear. Apparently there is no known piece of software that will scrape both the posts and the comments onto a new WordPress site. Edinburgh University have a full record of all the comments for any serious researchers. I’m just explaining that before someone thinks there is some nefarious reason why there are 0 comments on the old posts.

So, my choice as to how to deal with future is to write; what I want, when I want, how I want. Writing is my window on the world, it allows me to reach out to people from this bed. I hope that you will take the opportunity to comment as well – not just read, for it is that conversation that transports me from this bed into the world that I used to belong to.

A world that was full of people and events and colour.

If you have time – you can make it like that still for me, by telling me of what you have been doing, what you are thinking. I know there were hundreds, nay thousands, of you reading this blog before I closed it in December – if just a few of you take the time to continue that conversation you will be helping me to be part of my old world.

Thank you.

To view the original of this article CLICK HERE

Susanne, who is now 68, has battled her illness, leiomyosarcoma, a rare soft tissue cancer, for six years. After almost killing her several times, it has now attacked her spine, rendering her immobile.

Crushed: Susanne, pictured above in her 20s, was a victim of medical negligence in 1973 when she was given a hysterectomy at the Westminster Hospital when she was admitted for a ¿dilation and curettage¿, a minor operation used to deal with heavy periods 

Crushed: Susanne, pictured above in her 20s,

Perhaps you would like to enjoy the privilege of getting to know Susanne a little better, in her rapidly closing life, however long it will be – see:
https://twitter.com/AnnaRaccoon2017

Regards,
Greg_L-W.

~~~~~~~~~~#########~~~~~~~~~~
Posted by: Greg Lance-Watkins
tel: 44 (0)1594 – 528 337
Calls from ‘Number Withheld’ phones Are Blocked

All unanswered messages are recorded.
Leave your name & a UK land line number & I will return your call.

‘e’Mail Address: Greg_L-W@BTconnect.com

DO MAKE USE of LINKS,
>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

 

Skype: GregL-W

TWITTER: @Greg_LW


I try to make every effort to NOT infringe copyrights in any commercial way & make all corrections of fact brought to my attention by an identifiable individual

Please Be Sure To
.Follow Greg_LW on Twitter.

Re-TWEET my Twitterings

& Publicise My Blogs
To Spread The Facts World Wide
~~~~~~~~~~#########~~~~~~~~~~
Advertisements

10 Things YOU Should Know About Gynaecological Cancers …

DO MAKE USE of LINKS,

>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

>>>>>>THIS IS MY USUAL FULL FORMAT FOR THIS SITE as of 13-Feb-2017<<<<<<
~~~~~~~~~~#########~~~~~~~~~~
10 Things YOU Should Know About Gynaecological Cancers …
~~~~~~~~~~#########~~~~~~~~~~

Posted by:
Greg Lance – Watkins
Greg_L-W

eMail: Greg_L-W@BTconnect.com

https://InfoWebSiteUK.wordpress.com

www.InfoWebSite.UK

~~~~~~~~~~#########~~~~~~~~~~

.

Hi,

10 Things Women Should Know About Gynaecological Cancers

30/04/2017 17:25

Fabrice Poincelet via Getty Images

One day I will write a fun book about gynaecological cancers and looking after our vaginas. Until then, here is a short list of ten things that I think every woman (and man) should know. The icing and decoration is fun, but the cake mixture is serious. Some of the points might be blindingly obvious, in which case, sorry for being so basic. However, I hope everyone who reads this will learn at least one new thing, or be reminded of something they already know but might have forgotten. Vaginas, sex, bleeding, wombs and everything associated with what’s between our legs is not the first choice of conversation for most people, but it is for me. I had cervical cancer just over two years ago, perform comedy about the whole debacle, and now work for The Eve Appeal, a charity that raises awareness and funds for research into gynae (look at me being all snazzy and shortening the word ‘gynaecological’) cancers. This means that most of my life is spent talking about awkward lady things. And I love it. If you enjoy this post, please share it so that we can spread as much knowledge and awareness as possible.

1. There are FIVE gynaecological cancers.

That’s right, five different bits ‘down there’ that can get you entry to the cancer club. They are: womb, ovarian, cervical, vulval and vaginal. Yes, the vagina and vulva are not the same thing. I like to think of the vulva as the letterbox and the vagina as the doormat.

2. If you are bleeding when you shouldn’t be, see your doctor.

Abnormal vaginal bleeding (i.e. bleeding after the menopause, in between periods or after sex) is a symptom of four out of five gynae cancers (not vulval). It’s probably nothing serious, or your boyfriend just has a huge penis, but you need to get it checked out by a doctor just in case.

3. Ovarian cancer is sneaky.

Most ovarian cancer isn’t diagnosed until it has spread outside the ovary. One of the most common symptoms is persistent abdominal bloating, aka ‘puffy tummy’. This is often misdiagnosed as IBS (irritable bowel syndrome) and therefore the cancer is left undiscovered for longer. If you feel bloated for three or more weeks, see your doctor and fingers crossed that you’re just a gassy bitch.

4. GO FOR YOUR SMEAR TEST.

Smear tests save thousands of lives every year in the UK. They can detect abnormal cells that if left untreated, could turn into cervical cancer. Please, please, please don’t avoid your appointment. Yes, it can be a bit awkward having a stranger give you a poke with a bit of plastic, but a few minutes could save your life. So take your knickers off and spread those legs.

5. Hashtag Don’t Judge.

Almost all cervical cancers (plus some vaginal and vulval cancers) are caused by a virus called HPV (Human Papilloma Virus). There are sooo many different strands of HPV, but types 16 and 18 are the ones that can over time, turn cells in your cervix against you, which is a real bugger. HPV is caused through sexual contact. Condoms don’t protect against it entirely and you can get it from just having sex once. Therefore, if someone has HPV it doesn’t mean they are having dick for breakfast, lunch and dinner. Also, if they were, does it even matter? Most people who have had sex will get HPV at some point in their lives and only in very rare cases can the body not get rid of it. Then it might turn into cancer, but it might not. It’s like very unlucky and scary Russian Roulette.

6. Don’t suck, swallow or blow.

Cigarettes. Without going into boring science stuff, you’re twice as likely to get cervical cancer if you smoke, so it’s really not a good idea. I know a menthol cigarette, glass of sauvignon blanc, pub garden and outdoor heater burning the top of your head is the stuff that dreams are made of, and lord I have been guilty of living that dream. But. Just. Don’t.

7. Losing lady parts doesn’t make you less of a lady.

If you have a gynaecological cancer, chances are you will lose at least some of your ‘lady parts’. Surgery is very likely, so yes, you might have your ovaries, or womb, or cervix, or vagina or vulva partially or entirely removed. I know that’s sad and horrible, but please remember that you are no less of a woman just because you can’t carry a baby, or because you need your labia rebuilt from your arse skin. You’re amazing.

8. Make the jokes.

Oh my god it feels good to laugh, doesn’t it? It’s so much FUN to make jokes about awful things. If you don’t want to, that’s absolutely fine, but if you do laugh at the fact that you have now been fingered by more medical staff than lovers (like I have) then you are my new best friend and let’s go and drink gin.

9. Have a night in.

With yourself. Aside from being on bleeding and bloating patrol, get to know your body. Touch yourself. Yes, that means what you think it means. What does your vagina feel like when you insert your finger(s)? What do your labia feel like when you rub them in between your thumb and index finger? If you do this regularly, you will notice if there is a change and can get a doctor’s opinion if you need to.

10. Everyone handles a cancer diagnosis differently.

If you’ve had ‘that news’ then I’m really, really sorry. It’s scary and weird. Please remember that there is no right or wrong way to ‘have’ cancer. It doesn’t matter if you talk about at every opportunity or never utter a word. Just look after yourself and do whatever is right for you.

To view the original article CLICK HERE

Regards,
Greg_L-W.

~~~~~~~~~~#########~~~~~~~~~~
Posted by: Greg Lance-Watkins
tel: 44 (0)1594 – 528 337
Calls from ‘Number Withheld’ phones Are Blocked

All unanswered messages are recorded.
Leave your name & a UK land line number & I will return your call.

‘e’Mail Address: Greg_L-W@BTconnect.com

DO MAKE USE of LINKS,
>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<


Skype: GregL-W

TWITTER: @Greg_LW

I try to make every effort to NOT infringe copyrights in any commercial way & make all corrections of fact brought to my attention by an identifiable individual

Please Be Sure To
.Follow Greg_LW on Twitter.

Re-TWEET my Twitterings

& Publicise My Blogs
~~~~~~~~~~#########~~~~~~~~~~

Politically Motivated #Cancer_Drugs_Fund was a ‘huge waste of money’ …

DO MAKE USE of LINKS,

>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

 
~~~~~~~~~~#########~~~~~~~~~~
Politically Motivated #Cancer_Drugs_Fund was a ‘huge waste of money’ …
~~~~~~~~~~#########~~~~~~~~~~

Posted by:
Greg Lance – Watkins
Greg_L-W

eMail: Greg_L-W@BTconnect.com

https://InfoWebSiteUK.wordpress.com

www.InfoWebSite.UK

~~~~~~~~~~#########~~~~~~~~~~

.

Hi,

Cancer Drugs Fund ‘huge waste of money’

Image copyright Thinkstock

The Cancer Drugs Fund in England was a “huge waste of money” and may have caused patients to suffer unnecessarily from the side effects of the drugs, according to UK researchers.

The fund ran from 2010 to 2016, costing £1.27bn, following an election promise made by the Conservatives to pay for cancer drugs the NHS was not funding.

The researchers found only one in five of the treatments was of benefit.

But the Tories said the fund gave patients “precious extra time”.

Nearly 100,000 patients received drugs under the scheme. It was run separately to the normal NHS process for assessing the effectiveness and affordability of new drugs, which is administered by a body called NICE.

The fund was promised by the Conservatives during the 2010 election campaign amid concern patients were not always getting access to the latest drugs.


Five things £1.27bn can pay for in the NHS (over five years)

  • 10,000 nurses
  • 2,500 hospital consultants
  • One of England’s 10 regional ambulance services
  • A one-off pay rise of 2.5% for every member of NHS staff
  • An extra 20 GP surgeries

But lead researcher Prof Richard Sullivan, from King’s College London, described it as “policy on the hoof” because of the way it was announced.

“Populism doesn’t work when you are dealing with complex areas of policy like this. When it was launched it was not monitored properly. It was politically and intellectually lazy.”

He said it was not only politicians who were guilty, but leading doctors and cancer charities for not speaking out against the fund or scrutinising it more.

And he said by the end the initiative had proved to be a “huge waste of money” and a “major policy error”, saying it was telling that in 2015 the committee that controlled the fund started delisting drugs and ended up striking off more than half the treatments from the list.

David CameronImage caption David Cameron announced the Cancer Drugs Fund policy during the 2010 election campaign

The fund was eventually brought under the remit of NICE last year and is now used to pay for treatments it believes there is a case to fund.

The study, which was published in the Annals of Oncology journal, looked at the 47 treatments that were being funded by January 2015, the point at which drugs started to be listed because the cost of the fund was spiralling out of control.

They found only 18% met internationally recognised criteria for being deemed clinically beneficial.

This led them to conclude that a majority of patients may well have suffered because of side effects that the drugs can cause.

This can include anything from hair loss, upset stomachs and swelling in joints to an increased risk of stroke.

Of the drugs where there was some evidence of benefit, the average was an extra 3.2 months of survival.

Emlyn Samuel, of Cancer Research UK, agreed with the researchers that the fund “wasn’t fit for purpose”.

He said the charity would be closely monitoring the impact of the new system administered by NICE.

To view the original article CLICK HERE

On a more informed & informative basis in medical terms – for those seeking more in depth analysis:

Do patient access schemes for high-cost cancer drugs deliver value to society?—lessons from the NHS Cancer Drugs Fund

Background

The NHS Cancer Drugs Fund (CDF) was established in 2010 to reduce delays and improve access to cancer drugs, including those that had been previously appraised but not approved by NICE (National Institute for Health and Care Excellence). After 1.3 billion GBP expenditure, a UK parliamentary review in 2016 rationalized the CDF back into NICE.

Methods

This paper analyses the potential value delivered by the CDF according to six value criteria. This includes validated clinical benefits scales, cost-effectiveness criteria as defined by NICE and an assessment of real-world data. The analysis focuses on 29 cancer drugs approved for 47 indications that could be prescribed through the CDF in January 2015.

Results

Of the 47 CDF approved indications, only 18 (38%) reported a statistically significant OS benefit, with an overall median survival of 3.1 months (1.4–15.7 months). When assessed according to clinical benefit scales, only 23 (48%) and 9 (18%) of the 47 drug indications met ASCO and ESMO criteria, respectively. NICE had previously rejected 26 (55%) of the CDF approved indications because they did not meet cost-effectiveness thresholds. Four drugs—bevacizumab, cetuximab, everolimus and lapatinib—represented the bulk of CDF applications and were approved for a total of 18 separate indications. Thirteen of these indications were subsequently delisted by the CDF in January 2015 due to insufficient evidence for clinical benefit—data which were unchanged since their initial approval.

Conclusions

We conclude the CDF has not delivered meaningful value to patients or society. There is no empirical evidence to support a ‘drug only’ ring fenced cancer fund relative to concomitant investments in other cancer domains such as surgery and radiotherapy, or other noncancer medicines. Reimbursement decisions for all drugs and interventions within cancer care should be made through appropriate health technology appraisal processes.

Introduction

The Cancer Drugs Fund (CDF) was established in 2010 by the UK government to provide patients with access to cancer drugs not available through the NHS, because the drugs had not been appraised, were in the process of being appraised, or had been appraised but not recommended by the National Institute of Health and Care Excellence (NICE). As well as reducing delays and improving access to cancer drugs within the NHS it also offered an opportunity to provide funding for orphan indications or rare conditions that NICE would ordinarily not appraise [1].

The CDF had an initial budget of £50 million per annum with the plan to move towards a value-based pricing scheme by 2014. However, the costs of maintaining the fund rapidly increased, with the budget set at £200 million in 2013/2014, £280 million in 2014/2015, and £340 million in 2015/2016. At the time of its unification with NICE (see Figure 1), the CDF had cost of UK taxpayer a total of £1.27 billion [2], the equivalent of 1 year’s total spend on all cancer drugs in the NHS [3].

Figure 1.

Current status of the CDF Nov 2016.

Despite an extensive public consultation, fundamental issues about whether the CDF was a beneficial and fair public policy decision that actually delivered value have been absent from the discourse. Such analysis is essential to inform pharmaceutical policy in other countries contemplating such patient access pathways for high-cost cancer drugs.

Methods

In this policy analysis, we review the utility of such patient access funds for pharmaceutical agents by assessing the value delivered to both individuals and society by the CDF. Six value criteria have been used in our analysis. This includes an assessment of:

  1. The index trial data that provided the evidence for the drugs’ efficacy
  2. Observational studies assessing the effectiveness of selected CDF approved drugs in ‘real world’ populations
  3. The value of approved drugs according to validated clinical benefit scales developed by The American Society of Clinical Oncology (ASCO) and The European Society for Medical Oncology (ESMO)
  4. Whether the drugs would meet cost-effectiveness thresholds set by NICE
  5. The CDF committee’s own review (in January and November 2015) of drugs they had approved
  6. The value delivered by CDF-approved drugs to NHS patients based on utilization patterns

These criteria were chosen as they provide a multi-dimensional approach to assessing value in the absence of clinical data on outcomes for patients receiving drugs through the CDF. The first measures clinical efficacy based on the index clinical trial data, and the second, the translation of trial efficacy to a real world population in light of the socio-demographic make-up of trial participants. The third criteria goes beyond a simple evaluation of absolute study end-points to assess meaningful benefit according to value scales developed by two professional bodies, ASCO and ESMO.

The fourth looks at the issue of distributive justice by assessing cost-effectiveness according to health technology assessment frameworks, in this case NICE. The fifth criteria, represents an evaluation of the CDF committee’s own audit of each of the approved drugs and indications using their own value framework undertaken in January and November 2015. The sixth and final criteria collates the evidence for value based on patterns of use of CDF drugs (dose, volume) where data is available and the likely benefits that have been derived when considering the index trial data.

We focus on the systemic therapies that were made available and could be prescribed through the CDF prior to the January 2015 update when the fund was first rationalized [4]. Up to this point, 29 drugs had been approved for 47 indications, three of which—bevacizumab (9), cetuximab (4), and everolimus (3)—had been approved for more than two indications.

Results

Did sufficient clinical evidence exist to suggest patients would benefit from CDF approved drugs?

On review of the index trial data for the 47 drug indications approved by the CDF [5–53], only 18 (38%) reported a statistically significant overall survival (OS) benefit (Table 1) [5–7, 9, 13, 14, 18, 20, 23, 26, 27, 38, 41, 44, 45, 47, 50, 51] The median OS benefit was 3.2 months, ranging from 1.4 months (hazard ratio 0.82) for aflibercept in metastatic bowel cancer [6] to 15.7 months (HR 0.68) for pertuzumab in first line metastatic Her-2 positive breast cancer [44].

Table 1

Details of the cancer drugs available through the NHS Cancer Drugs Fund prior to the first update in January 2015

Drug  Site  Indication  Author of index trial [REF]  Primary endpoint (s)  Median age  PS 0/1 (%)  PFS (HR)  OS (HR)  Approval on ASCO criteria  ESMO score  NICE status Jan 2015  CDF status Jan 2015  CDF status Nov 2015 
Abiraterone  Prostate  1st line CRPC (pre chemo)  Ryan 2014 [5 PFS/OS  71  100  8.3 (0.53)  4.3 (0.80)  Yes  Not approved  Approved  Approved 
Aflibercept  Bowel  2nd line metastastic CRC with irinotecan/5FU  Van Cutsem 2012 [6 OS  61  98  2.2 (0.76)  1.4 (0.82)  No  Not approved  Removed  Removed 
Albumin bound paclitaxel  Pancreas  1st line metastatic pancreatic cancer with gemcitabine  Von Hoff 2013 [7 OS  63  KS > 80 = 92%  1.8 (0.69)  1.8 (0.72)  No  Not approved  Approved  Removed 
Axitinib  Renal  2nd line advanced RCC  Motzer 2013 [8 PFS  61  99  2.6 (0.66)  NS  No  Awaiting appraisal  Approved  Approved by NICE therefore removed 
Bevacizumab  Cervix  1st line Metastatic cervical ca  Tewari 2014 [9 OS/Toxicity  46  96  2.3 (0.67)  3.7 (0.71)  Yes  Awaiting appraisal  Approved  Approved 
Bevacizumab  Breast  Metastatic triple negative breast cancer  Miller 2007 [10 PFS  56  98  5.9 (0.6)  NS  No  Not approved  Approved  Removed 
Bevacizumab  Bowel  1st line advanced CRC with 5FU  Cunningham 2013 [11 PFS  76  91  4 (0.53)  NS  No  Not appraised  Removed  Removed 
Bevacizumab  Bowel  1st line metastatic CRC with oxaliplatin based regimen  Saltz 2008 [12 PFS  60  100  1.4 (0.83)  NS  No  Not approved  Removed  Removed 
Bevacizumab  Bowel  1st line metastatic CRC with irinotecan based regimen  Hurwitz 2004 [13 OS  59  99  4.4 (0.54)  4.7 (0.66)  Yes  Not approved  Removed  Removed 
Bevacizumab  Bowel  2nd line/3rd line metastatic CRC with oxaliplatin based chemo  Giantonio 2007 [14 OS  61  96  2.6 (0.61)  2.1 (0.75)  No  Not approved  Approved  Removed 
Bevacizumab  Bowel  3rd line in low grade gliomas of childhood with irinotecan  Gururangan 2013 [15 PFS  8.4  KS > 50 = 100%  PFS 85% at 6 months, 48% at 2 yrs  NR  Uncertain  Not appraised  Approved  Approved 
Bevacizumab  Ovarian  1st line advanced ovarian, peritoneal or fallopian cancer  Burger 2011 [16 PFS  60  93  3.8 (0.72)  NS  No  Not approved  Approved  Approved 
Bevacizumab  Ovarian  2nd line advanced ovarian, fallopian or primary peritoneal cancers (platinum sensitive)  Aghajanian 2012 [17 PFS  61  99.5  4 (0.48)  NS  No  Not approved  Removed  Removed 
Cabazitaxel  Prostate  Metastatic CRPC previously treated with docetaxel  De bono 2010 [18 OS  67  93  1.4 (0.7)  2.4 (0.7)  No  Not approved  Removed  Reinstated 
Cabozantinib  Thyroid  1st line advanced medullary thyroid cancer  Elisei 2013 [19 PFS  55  56% PS = 0  7.2 (0.28)  NS  Yes  Awaiting appraisal  Approved  Approved 
Cetuximab  Head and Neck cancer  Advanced Head and Neck Cancer  Vermoken 2008 [20 OS  57  KS > 80 = 80%  2.3 (0.54)  2.7 (0.8)  No  Not approved  Approved  Approved 
Cetuximab  Bowel  1st line metastatic CRC (K ras wild type) with oxaliplatin or irinotecan based regimens  Tejpar 2012 [21 Pooled subgroup analysis  60  95  1.4 (0.47)  NS  Yes  Not approved for all indications  Approved  Approved 
Cetuximab  Bowel  2nd or 3rd line treatment of metastatic CRC (K ras wild type) with irinotecan  Sobrero 2008 [22 OS  61  94  2.4 (0.69)  NS  No  Not approved  Removed  Removed 
Cetuximab  Bowel  3rd or 4th line metastatic CRC (K ras wild type) as single agent  Karapetis 2008 [23 OS  63  80  1.8 (0.40)  4.7 (0.55)  Yes  Not approved  Approved  Removed 
Crizotinib  Lung  2nd line ALK +ve advanced/metastastic NSCLC  Shaw 2013 [24 PFS  51  92  4.7 (0.49)  NR  Yes  Not approved  Approved  Approved 
Dabrafenib  Melanoma  Unresectable or metastatic melanoma with a BRAF V600 mutation and intolerance to Vemurafenib  Hauschild 2014 [25 PFS  52  66% PS = 0  2.4 (0.3)  NR  Yes  Appraisal ongoing  Approved  Approved by NICE therefore removed 
Enzalutamide  Prostate  1st line CRPC (pre-chemo)  Beer 2014 [26 PFS/OS  72  100  >12 months (0.19)  2.2 (0.71)  Uncertain  Awaiting appraisal  Approved  Approved 
Eribulin  Breast  3rd line metastatic breast cancer  Cortes 2011 [27 OS  55  92  1.5 (0.87)  2.5 (0.81)  No  Not approved  Removed  Reinstated 
Everolimus  Breast  Metastatic breast cancer in combination with exemestane  Baselga 2012 [28]/Piccart 2014 [29 PFS  62  96  4.6 (0.43)  NS  No  Not approved  Removed  Reinstated 
Everolimus  PNET  1st or 2nd line moderately differentiated PNET  Yao 2011/2014 [30,31 PFS  58  97  6.4 (0.27)  NS  No  Awaiting appraisal  Approved  Removed 
Everolimus  PNET  Well differentiated PNET  Yao 2011/2014 [30,31 PFS  58  97  6.4 (0.27)  NS  No  Awaiting appraisal  Removed  Removed 
Everolimus  Renal  Metastatic RCC  Motzer 2010 [32 PFS  61  KS > 80 = 91%  3 (0.33)  NS  No  Not approved  Removed  Reinstated 
Imatinib  Sarcoma (GIST)  Adjuvant therapy for completely resected GIST at high relapse risk  Dematteo 2009 [33 RFS  59  99  RFS gain 13%  NR  Yes  Awaiting appraisal  Approved  Approved by NICE therefore removed 
Lapatinib  Breast  Advanced breast cancer, Her 2 +ve  Geyer 2006 [34]/cameron 2008 [35 PFS  54  100  4 (0.47)  NS  No  Not approved  Removed  Removed 
Panitumimab  Bowel  3rd or 4th line metastatic CRC (Kras wild type) as single agent  Van Cutsem 2007 [36 PFS  62  82  1.1 (0.54)  NS  No  Not approved  Approved  Removed 
Panitumimab  Bowel  1st line metastatic CRC with Folofox 4 or irinotecan (Kras wild type)  Douillard 2010 [37]/Douillard 2014 [38 PFS  62  94  1.4 (0.80)  4.4 (0.88)  Yes  Awaiting appraisal  Approved  Approved 
Pazopinib  Sarcoma  Advanced non-adipocytic soft tissue carcinoma  van der Graaf 2012 [39 PFS  56  100  3 (0.31)  NS  No  Not appraised  Removed  Removed 
Pegylated liposomal doxirubicin  Sarcoma  1st or 2nd line for angiosarcoma  Judson 2001 [40 Toxicity/RR  52  86  NA  NA  Uncertain  Uncertain  Not appraised  Removed  Removed 
Pegylated liposomal doxirubicin  Sarcoma  For patients with sarcoma with cardiac impairment or contraindication to doxorubicin  Judson 2001 [40 Toxicity/RR  52  86  NA  NA  Uncertain  Not appraised  Approved  Approved 
Pemtrexed  Lung  Maintenance post 4 cycles cisplatin/pemetrexed for NSCLC  Ciuleanu 2009 [41 PFS  60  100  1.7 (0.5)  2.8 (0.79)  Yes  Not approved  Removed  Reinstated 
Pemetrexed  Lung  2nd line NSCLC  Hanna 2004 [42 OS  59  88  NS  NS  No  Not approved  Removed  Removed 
Lutetium Octreotate/Yttrium Octreotide  NETs  For inoperable well-differentiated neuroendocrine tumours (NETs) with progressive disease  Kam 2012 [43 Symptoms/tumour regression  NR  NR  NA  NA  No  Not appraised  Approved  Removed 
Pertuzumab  Breast  1st line locally advanced Her2 +ve breast cancer  Swain 2013 [44 PFS  54  99  6.3 (0.69)  15.7 (0.68)  Yes  Not approved  Approved  Approved 
Radium 223  Prostate  CRPC and bone mets, no visceral mets  Parker 2013 [45 OS  71  87  NR  3.6 (0.7)  Yes  Awaiting appraisal  Approved  Approved by NICE therefore removed 
Regorafinib  Sarcoma (GIST)  Imatinib and sunitinib resistant GIST  Demetri 2013 [46 PFS  60  100  3.9 (0.27)  NR  No  Not appraised  Removed  Reinstated 
Sorafenib  Liver  1st line HCC  Llovet 2008 [47 OS/Time to symptom progression  65  92  2.7 (0.58)  2.8 (0.69)  Yes  Not approved  Approved  Approved 
Sorafenib  Thyroid  Metastatic/inoperable thyroid cancer refractory to radioiodine  Brose 2014 [48 PFS  63  97  5 (0.8)  NR  Yes  Not appraised  Approved  Approved 
Sunitinib  PNET  well differentiated PNET  Raymond 2011 [49 PFS  56  100  5.9 (0.42)  Trial stopped early  Uncertain  Not appraised  Approved  Approved 
Temsirolimus  Renal  Advanced RCC  Hudes 2007 [50 OS  59  KS > 70 = 17%  2.4  3.6 (0.73)  Yes  Not approved  Approved  Approved 
Trastuzumab emtansine (Kadcyla)  Breast  Relapsed Her 2 +ve breast cancer  Verma 2012 [51 PFS/OS and safety  53  99  3.2 (0.65)  5.8 (0.68)  Yes  Not approved  Approved  Approved 
Vandetinib  Thyroid  Medullary thyroid ca  Wells 2012 [52 PFS  51  96  11.2 (0.46)  NR  Yes  Not appraised  Approved  Approved 
Vismodegib  Skin  Metastatic basal cell cancer  Sekulic 2012 [53 Objective response rate  62  NR  NA  NA  Uncertain  Not appraised  Approved  Approved 

OS, overall survival (months); PFS, progression free survival (months); HR, median hazard ratio; TTP, Time to progression; ASCO, American Society of Clinical Oncology; ESMO, European Society of Medical Oncology; PS, Eastern cooperative oncology group performance score; KS, Karnofsky score; NR; not reported; NS, not statistically significant; NA, endpoint not assessed; CRC, colorectal cancer; RCC, renal cell cancer; CRPC, castrate resistant prostate cancer; PNET, pancreatic neuroendocrine tumour; HCC, hepatocellular carcinoma; GIS, gastrointestinal stromal tumour; NSCLC, non small cell lung cancer.

Of the remaining 29 indications in the CDF, 17 were approved despite no statistically significant OS benefit being observed in the index trials. These included axitinib [8] bevacizumab (five indications) [10–12, 16, 17], cabozantinib [19], cetuximab (two indications) [21, 22], everolimus (four indications) [29–32], lapatinib [35], panitumimab [36], pazopanib [39], and pemetrexed [42]. The primary end-point of 14 of these studies was PFS, of which five allowed cross-over of the control population at progression to the intervention arm [30–32, 35, 36] and one had significant post-study utilization (49.6%) of the intervention drug among the control arm [22].

12 further indications had been approved without OS data being available. The primary end-point in the index trial for eight of these indications was PFS [15, 24, 25, 33, 36, 46, 48, 49, 52] of which five allowed cross-over of the control population at progression [24, 25, 46, 48, 52]. The other four indications were not able to report any PFS or OS benefit as they were based on noncomparator studies [40, 43, 53].

Given that over half of the drug indications (n =29) approved by the CDF lacked any OS benefit, it is valid to ask whether a gain in PFS is a meaningful surrogate endpoint for OS. While we acknowledge this is a subject of much debate as there are differences of opinion as to what constitutes benefit, there is unanimity that prolongation of OS is an unequivocal benefit and desired [54–57]. From a patient’s perspective, a gain in PFS may not equate to a clinical benefit given the serious toxicities that arise from many of these therapies, including those classified as ‘targeted’ and the fact that progression often occurs without any symptoms such that delaying progression is not delaying symptoms [58].

Furthermore, the extent to which benefits claimed in clinical trials are true can be debated. For end-points such as OS and PFS, it is expected that all patients randomized at the start of the study are followed up until either the end point is reached or the study is completed (intention-to-treat analysis). If a patient is censored prior to the end point being reached, their outcome is estimated based on other patients in the same arm who have not reached the end point, but have been under longer follow-up. This will result in an over-estimation of benefit if their reason for being censored is linked to their prognosis, i.e. toxicity, low participation in follow-up, or the initiation of an alternative therapy [59]. This type of censoring is more common in the assessment of PFS compared with OS where censoring predominantly occurs as a result of a death [60].

In PFS analyses, censoring is often driven by drug toxicity and the extent of censoring as regards PFS has been increasing in many trials (disproportionately so in the experimental arm) rendering the results questionable as to the true benefit observed [61, 62]. Several of the indications for drug funding on the CDF were based on trials in which excessive censoring was a feature [19, 28, 30]. For everolimus plus exemestane in breast cancer, the 4.4 months difference in OS was not significant although the PFS difference of 4.6 months was highly significant albeit in the setting of excessive censoring in the everolimus arm due to toxicity [28, 62].

Could the reported clinical trial benefits be realized in the ‘real world’?

Randomized control trials (RCTs), have strong internal validity through randomization, pre-specified end points and blinding, however their external validity is limited [63]. This is because patients similar to those frequently encountered in a clinical practice are often excluded, raising questions as to the generalizability of clinical trial results to populations, settings or conditions not reflected in the trial [64, 65].

For example, the median age of study participants in the index trials of CDF approved drugs was 60 (Table 1). Over 90% of the study populations had an Eastern cooperative oncology group (ECOG) performance status score of 0 or 1 (or equivalent) in the majority of the trials. The under-representation of men and women over 65 in RCTs is a long-standing issue [66, 67]. As a result, decision-makers are expressing interest in ‘real world data’ [68].

In metastatic renal cell carcinoma (mRCC), data from the ‘real world’ provide a sobering assessment of outcomes. The International Metastatic Renal Cell Carcinoma Database consortium study found that the 35% of patients that did not meet trial eligibility criteria had a disappointing 12.3 months survival compared with 28.4 months survival in those that would have been deemed trial-eligible [69]. A recent study that analysed the SEER 18 (Surveillance, Epidemiology and End Results) registry database to calculate the relative survival rates for advanced RCC patients during 2001–2005, 2006–2007 and 2008–2009 concluded there was no significant improvement in relative survival rates among patients with mRCC in the era of targeted agents [70].

Increased rates of toxicity are also observed in real world populations. A US SEER database study evaluated the effectiveness of adding bevacizumab to first-line combination chemotherapy for Medicare patients (aged 65 years and over) with metastatic colorectal cancer (mCRC) [71]. The data showed unequivocally there was no benefit to adding bevacizumab to FOLFOX-based regimens in this Medicare population, but importantly the addition of bevacizumab increased the risk of stroke (4.9% versus 2.5%, respectively; P<0.01) and GI perforation (2.3% versus 1.0%, respectively; P<0.01).

From a clinical standpoint would oncologists consider the predicted benefits of the CDF approved drugs to be clinically meaningful?

In many cases, the answer appears to be no. In 2014, The American Society of Clinical Oncology (ASCO) published what it considered meaningful clinical benefit in the hopes the design of future clinical trials would produce results that would be valuable for patients, i.e. meaningful improvements in survival, quality of life or both [72]. The ASCO Cancer Research Committee (CRC) that developed the criteria deliberately chose modest threshold to ensure their relevance and attainability. OS was chosen as the primary clinical end-point of interest and minimum gains in survival and HR thresholds were defined for each tumour type, virtually all in the metastatic setting. Secondary end-points included PFS, and thresholds for OS and PFS were adjusted depending on the toxicity profile of the drug.

An analysis of drugs approved by the FDA between 2002 and 2014 for the treatment of solid tumours found that only 42% of the 71 approved drugs met the ASCO or comparable standards [73]. Similarly, only 23 (48%) of the 47 CDF approved drug indications met the very modest ASCO criteria with uncertainty regarding six drug indications (see Table 1).

In 2015, The European Society for Medical Oncology (ESMO), produced further guidelines (following consultation with over 250 of its expert membership) to stipulate the boundaries for meaningful clinical benefit [74]. The scoring scheme was based on:

  • Treatment intent (curative versus noncurative)
  • Expected duration of PFS and OS in the control arm
  • PFS or OS benefit including the hazard ratios
  • Evidence of improved or worsening toxicity profiles
  • Evidence for improvement in quality of life

Cancer drugs indicated in the noncurative setting are scored 1 (lowest) to 5 (highest), and those in the curative setting are graded A (highest) or B (lowest). Drugs scoring 4, 5 or A are considered to provide a high level of proven clinical benefit according to the criteria. Our analysis of the 47 drug indications on the CDF found that only 9 (18%) indications achieved scores of 4, 5 or A, (see Table 1) while 23 (50%) of drug indications scored 2 or less on the ESMO scale, i.e. they were based on study data which had demonstrated limited evidence of clinical benefit. The nine indications that met ESMO criteria for meaningful clinical benefit included, cetuximab for colorectal cancer [23], crizotinib for lung cancer [24], dabrafenib for metastatic melanoma [25], imatinib as adjuvant therapy for GIST [33], pertuzumab and trastuzumab emtansine for breast cancer [44, 51], temsirolimus for renal cell cancer [50], radium 223 for prostate cancer [45] and pegylated doxorubicin for sarcoma [40].

Would an HTA body, in this instance NICE, consider the benefits of drugs on CDF of sufficient value to be reimbursed?

In the UK, NICE is responsible for ensuring rational and fair decisions are made on resource allocations by performing cost effectiveness analyses for new health interventions. The advantage of the cost per QALY is its universality when making decisions regarding the entire spectrum of health care interventions across all specialities [75]. NICE focus on both short and long-term outcomes of treatment and direct patient benefits [76].

We found that 26 (55%) CDF approved drugs had previously been rejected by NICE on the grounds of not meeting cost effectiveness criteria. Three (dabrafenib, imatinib and radium 223) were due to receive approval in early 2015 (Table 1). Seven were awaiting appraisal but draft consultation advice had been issued. Eleven indications had not been appraised and no plans for their assessment were evident. In some cases, this was due to the rarity of the disease (e.g. regorafenib, in soft tissue sarcoma) or their off-label use (bevacizumab third line in paediatric low-grade glioma).

What the CDF committee considered the value of CDF approved drugs to be?

The CDF committee undertook detailed assessment of each of the drugs listed in its access scheme in January and November 2015 using a bespoke framework to assess its value. This included, but was not limited to, PFS, OS, quality of life, toxicity, unmet need and cost [77]. In total, 24 indications (51% of all indications) for 14 drugs were removed from the CDF list following this appraisal, of which six were later reinstated.

Table 2 summarizes details about four drugs whose value to the NHS can be debated: bevacizumab, lapatinib, cetuximab, and everolimus. These four drugs were approved by the CDF for 18 separate indications—bevacizumab (9), cetuximab (4), everolimus (4) and lapatinib (1). Following the initial review of the CDF in January 2015, nine of these indications were delisted. A further four indications were delisted in November 2015, following a subsequent review. The value delivered by bevacizumab in particular is debatable given that six of the nine indications were delisted. Only one of these indications would have met ASCO criteria and none would have achieved the ESMO meaningful clinical benefit criteria, or NICE cost-effective thresholds.

Table 2

Details of four drugs—bevacizumab, cetuximab, everolimus and lapatinib—which were approved by the CDF for 18 separate indications prior to January 2015

Drug  Site  Indication  Author of index trial [REF]  PFS (HR)  OS (HR)  Approval on ASCO criteria  ESMO score  NICE status Jan 2015  CDF status Jan 2015  CDF status Nov 2015 
Bevacizumab  Cervix  1st line metastatic cervical ca  Tewari 2014 [9 2.3 (0.67)  3.7 (0.71)  Yes  Awaiting appraisal  Approved  Approved 
Bevacizumab  Breast  Metastatic triple negative breast cancer  Miller 2007 [10 5.9 (0.6)  NS  No  Not approved  Approved  Removed 
Bevacizumab  Bowel  1st line advanced CRC with 5FU  Cunningham 2013 [11 4 (0.53)  NS  No  Not appraised  Removed  Removed 
Bevacizumab  Bowel  1st line metastatic CRC with oxaliplatin-based regimen  Saltz 2008 [12 1.4 (0.83)  NS  No  Not approved  Removed  Removed 
Bevacizumab  Bowel  1st line metastatic CRC with irinotecan-based regimen  Hurwitz 2004 [13 4.4 (0.54)  4.7 (0.66)  Yes  Not approved  Removed  Removed 
Bevacizumab  Bowel  2nd line/3rd line metastatic CRC with oxaliplatin-based chemo  Giantonio 2007 [14 2.6 (0.61)  2.1 (0.75)  No  Not approved  Approved  Removed 
Bevacizumab  Bowel  3rd line in low-grade gliomas of childhood with irinotecan  Gururangan 2013 [15 PFS 85% at 6 months, 48% at 2 yrs  NR  Uncertain  Not appraised  Approved  Approved 
Bevacizumab  Ovarian  1st line advanced ovarian, peritoneal or fallopian cancer  Burger 2011 [16 3.8 (0.72)  NS  No  Not approved  Approved  Approved 
Bevacizumab  Ovarian  2nd line advanced ovarian, fallopian or primary peritoneal cancers (platinum sensitive)  Aghajanian 2012 [17 4 (0.48)  NS  No  Not approved  Removed  Removed 
Cetuximab  Head and Neck cancer  Advanced head and neck cancer  Vermoken 2008 [20 2.3 (0.54)  2.7 (0.8)  No  Not approved  Approved  Approved 
Cetuximab  Bowel  1st line metastatic CRC (K ras wild-type) with oxaliplatin or irinotecan-based regimens  Tejpar 2012 [21 1.4 (0.47)  NS  Yes  Approved for specific indications  Approved  Approved 
Cetuximab  Bowel  2nd or 3rd line treatment of metastatic CRC (K ras wild-type) with irinotecan  Sobrero 2008 [22 2.4 (0.69)  NS  No  Not approved  Removed  Removed 
Cetuximab  Bowel  3rd or 4th line metastatic CRC (K ras wild-type) as single agent  Karapetis 2008 [23 1.8 (0.40)  4.7 (0.55)  Yes  Not approved  Approved  Removed 
Everolimus  Breast  Metastatic breast cancer in combination with exemestane  Baselga 2012 [28]/Piccart 2014 [29 4.6 (0.43)  NS  No  Not approved  Removed  Reinstated 
Everolimus  PNET  1st or 2nd line moderately differentiated PNET  Yao 2011/2014 [30, 31 6.4 (0.27)  NS  No  Awaiting appraisal  Approved  Removed 
Everolimus  PNET  Well differentiated PNET  Yao 2011/2014 [30, 31 6.4 (0.27)  NS  No  Awaiting appraisal  Removed  Removed 
Everolimus  Renal  Metastatic RCC  Motzer 2010 [32 3 (0.33)  NS  No  Not approved  Removed  Reinstated 
Lapatinib  Breast  Advanced breast cancer, Her 2 +ve  Geyer 2006 [34]/Cameron 2008 [35 4 (0.47)  NS  No  Not approved  Removed  Removed 

OS, overall survival (months); PFS, progression free survival (months); HR, median hazard ratio; ASCO, American Society of Clinical Oncology; ESMO, European Society of Medical Oncology; NR, not reported; NS, not statistically significant; NA, endpoint not assessed; CRC, colorectal cancer; RCC, renal cell cancer; PNET, pancreatic neuroendocrine tumour.

In this respect, the criteria and value judgements initially used by the CDF has been criticized for its lack of rigour and relevance for prioritizing drugs for reimbursement through the fund [78]. The tabulation also underscores the fluid nature of the CDF and raises questions as to whether approvals were occurring too quickly or are being driven by factors other than academic/scientific considerations.

Is there any evidence that the CDF has been of value to NHS cancer patients?

At the time of commencement in 2010, it was expected that basic outcome data would be collected from April 2012 including the date of treatment cessation, side effects observed, 30-day mortality and date of death/next relapse. However, even after audit data collection became mandatory in 2014, 93% of outcome data was incomplete for 2014–2015 [79].

We therefore have no evidence as to whether recipients of drugs from the CDF derived any meaningful benefit in terms of survival, improved quality of life or decreased episodes of toxicity. As a proxy, we have attempted to define the value achieved by NHS cancer patients receiving cancer drugs through the CDF by assessing actual patterns of drug utilization, in conjunction with their anticipated benefits according to the original trial data.

Stephens and Thomson in 2012 [80] using IMS health dispensing data demonstrated that between April and December 2011, 59% of CDF applications were for five drugs: bevacizumab, lapatinib, sorafenib, cetuximab, and everolimus; a prescribing pattern confirmed by Chamberlain et al. in a subsequent analysis examining the period from October 2007 to October 2012 [81]. No data on the volume of drugs utilized has since been made available, nor information on patient weight or number of cycles completed by each patient.

The study reported that following the introduction of the CDF there were statistically significant increases in utilization of bevacizumab (2-fold), and lapatinib (3-fold), and these together with sorafenib, cetuximab, and sunitinib constituted a significant proportion of drug prescriptions. The exact indication for which these drugs were prescribed remains unknown. Analysis of the volume data found that the growth in drug utilization was lower than expected when compared with the doses and duration of treatment received by patients enrolled in the original RCTs. This is therefore likely to reflect earlier disease progression, or the occurrence of intolerable adverse events, suggesting their clinical effectiveness and tolerability do not match results in the RCTs [82]. In addition, there was evidence of inequitable access to the fund across English regions (2010–2013) and according to age and sex [79, 83].

This then raises concerns that the ‘real benefits’ in fact are not benefits at all since they would never have achieved statistical validity in a RCT or if they did, may not have been of sufficient magnitude to warrant the added toxicity that invariably occurs. Keeping in mind the median OS benefit of CDF-approved indications was 3.1 months can we be sure that 1 month less than this would be statistically better or better enough to favourably tip the risks to benefits scale?

Discussion and policy recommendations

Because some argued that UK lagged behind other Western countries in delivering therapies to cancer patients and this could lead to disparity in outcomes, the CDF was established to ensure access to drugs available in other countries [84]. In this respect, the CDF has delivered its intended aims. However, we would argue from this analysis that the CDF has not provided meaningful value to cancer patients and wider society because the supporting data has been wanting.

The majority of CDF-approved indications have been based on studies that reported minimal to no benefit in survival. Other endorsements have relied on surrogate endpoints such as PFS that remain controversial given inherent flaws in trial design and the increasing abuse of censoring. The thresholds for meaningful clinical benefit proposed by ASCO or ESMO support our argument since the majority of CDF-approved indications were unable to meet these modest levels of efficacy (Table 1).

Patients would find many of the approved indications wanting as regards actual benefit, even before considering the burden of the associated toxicities [85]. Current evidence suggests the majority of cancer patients with a life expectancy ≤4 months prefer treatment that relieves pain and discomfort rather than extending life [86] and that they expect a minimum survival benefit of 3 months in this setting and potentially longer if the therapy is associated with more severe side effects [87, 88].

We must also consider the welfare loss to society from the CDF after expenditure of over one billion pounds [79]. An impact equality assessment of the CDF has been undertaken for patients receiving cancer drugs through the CDF in 2013/2014 (n =19 560)[79]. It reported that the potential benefit of the CDF to cancer patients, estimated at 3500 QALYS, has resulted in overall net harm to population health when one considers the health opportunity costs, with nearly 18 000 QALYS being displaced from patients elsewhere in the NHS [89, 90]. It is important therefore, to tread with caution when arguments are forwarded that all cancer drugs offering meaningful clinical benefit should be funded irrespective of price, without considering issues of value, distributive justice, and fairness. In the NHS, waiting times for diagnostic interventions and elective procedures continue to rise, many of which are directly affecting cancer patients [91].

At its inception, critics argued that the introduction of the CDF would reduce the negotiating power of the NHS, specifically the ability to negotiate fair prices of cancer drugs with pharmaceutical companies [81]. This is no more evident than when one considers the reversals of six indications delisted in January 2015 (see Table 3). None of the reinstated indications meet the criteria for clinical benefit according to the ESMO scale. However, negotiations were prompted by the threat of the drug being delisted, suggesting that the creation of a ring fenced access fund for cancer drugs provides a negative incentive for drug price negotiation. This is especially pertinent given recent evidence that the price of drugs is based on what the market will bear as opposed to the level of its clinical benefit [92]. Cabazitaxel, eribulin, and everolimus (for breast cancer) have all since been approved by NICE as a result of discounts being applied by pharmaceutical companies through the patient access scheme [93–95].

Table 3

Details of the six de-listed drugs, which were re-approved by the CDF following a second review in November 2015

Drug  Site  Indication  Author of index trial [REF]  PFS (HR)  OS (HR)  Approval on ASCO criteria  ESMO score  NICE status Jan 2015  CDF status Jan 2015  CDF status Nov 2015 
Cabazitaxel  Prostate  Metastatic CRPC previously treated with docetaxel  De bono 2010 [18 1.4 (0.7)  2.4 (0.7)  No  Not approved  Removed  Reinstated 
Eribulin  Breast  3rd line metastatic breast cancer  Cortes 2011 [27 1.5 (0.87)  2.5 (0.81)  No  Not approved  Removed  Reinstated 
Everolimus  Breast  Metastatic breast cancer in combination with exemestane  Baselga 2012 [28]/Piccart 2014 [29 4.6 (0.43)  NS  No  Not approved  Removed  Reinstated 
Everolimus  Renal  Metastatic RCC  Motzer 2010 [32 3 (0.33)  NS  No  Not approved  Removed  Reinstated 
Pemtrexed  Lung  Maintenance post 4 cycles cisplatin/pemetrexed for NSCLC  Ciuleanu 2009 [41 1.7 (0.5)  2.8 (0.79)  Yes  Not approved  Removed  Reinstated 
Regorafinib  Sarcoma (GIST)  Imatinib and sunitinib resistant GIST  Demetri 2013 [46 3.9 (0.27)  NR  No  Not appraised  Removed  Reinstated 

OS, overall survival (months); PFS, progression free survival (months); HR, median hazard ratio; ASCO, American Society of Clinical Oncology; ESMO, European Society of Medical Oncology; NR, not reported; NS, not statistically significant; NA, endpoint not assessed; CRC, colorectal cancer; RCC, renal cell cancer; CRPC, castrate resistant prostate cancer; GIST, gastrointestinal stromal tumour; NSCLC, non small cell lung cancer.

Given the evidence set forth, decisions regarding access appear politically motivated. The CDF was created following intense public and political pressure to provide access no matter what the cost or the evidence for their benefit. There was no stated estimation of the ‘number of lives that could be saved’, nor, more realistically, of the number of lives that may be extended. This was a debate played out in the media, limiting the role of NICE as the final arbiter for deciding what constitutes optimal value for society [82]. However, 6 years later, and after considerable expenditure we are now reverting to a pre-existing format, namely an independent health technology appraisal service (i.e. NICE) providing recommendations for NHS commissioning (see Figure 1).

Indeed, the evidence used by the CDF committee to re-appraise the value of drugs in January 2015 was in most cases available prior to the approval process, especially in circumstances where NICE had already undertaken an HTA appraisal. Of the 17 indications delisted in January 2015, 13 were for indications that were previously deemed not cost-effective by NICE (Table 1). A further seven indications were delisted in November 2015 of which five had been rejected following NICE appraisal. While these reversals may seem innocent, if a drug approved for an indication is subsequently deemed of insufficient value as data become available and its benefit is questioned we must acknowledge that it has then been given to patients who may have endured toxicity without any benefit.

Finally, while the stated goal of the CDF was to ‘empower clinicians, and to enable them to use the cancer drugs that they and their patients agree are needed to extend or improve life’, it is reasonable to ask why so many clearly ineffective drugs were prescribed in the first place. The issues are complex and cannot be answered without in-depth qualitative research. However, two factors may be important. The first is the so-called ‘moral hazard’. When patients and providers are shielded from the costs associated with an intervention (through insurance per se), they will be more willing to accept/deliver health care interventions even if the benefits are marginal [96]. Second, decision-making in the context of illness has been shown to be prone to biases resulting in an over-estimation of the level of risk of disease or potential benefits of treatment [97, 98].

Future options

One lesson from this costly saga is the need to strengthen regulatory and reimbursement processes and ensure they remain free from political interference. The use of clinically meaningful benefit thresholds such as that proposed by ASCO and ESMO seems enormously prudent. The ASCO metric in effect calls for minimum OS gains of 2.5–4.5 months or 25–50% gain over existing time scales and the ESMO threshold essentially prioritizes gains in survival (> 3 months with hazard ratios < 0.65), quality of life and reduction in toxicity compared with current standards of care.

We would suggest other countries considering a patient access scheme for drugs awaiting formal health technology appraisal use value frameworks that determine the likely benefit from reimbursement as part of the appraisal process. If drugs are made available pending an appraisal process, this should be accompanied by rigorous collection of outcome data through coverage with evidence development schemes. However, they should not replace assessment of the overall cost-effectiveness, which seeks to ascertain the societal benefit gained from drug reimbursements relative to other health technologies across the disease spectrum.

Improvements on the current system could also be achieved through new payment systems based on the attainment of pre-determined outcomes [99–101] or the introduction of value-based co-payments [102]. Another option would be to link HTA appraisal of the benefits and costs of new drugs with national rebate agreements [89]. The rebate would cover the difference between the manufacturers intended price of the drug and how much the NHS can afford to pay for its intended benefits. This would highlight to pharmaceutical companies of the price the NHS is willing to pay for the benefits offered by a new drug. Companies charging high prices for drugs with limited efficacy, would be expected to pay higher rebates. This would encourage research funders to support cancer clinical trials whose design and end points genuinely look for therapeutic advances that deliver meaningful clinical benefit rather than a low bar for response.

Conclusions

Despite significant expenditure, there remains no evidence that the CDF has delivered meaningful value to NHS cancer patients. We have analysed the value of CDF approved drugs according to six criteria including validated clinical benefit scales, and health technology appraisal from organizations such as NICE. From this, it is clear that the decision-making tools used by the CDF for prioritization of new drugs have failed given that a number of drugs were approved and subsequently delisted based on evidence that previously existed.

We recommend the avoidance of similar ‘ring-fenced’ drug access funds in other countries. The lack of empirical evidence that prioritizing drug expenditure (the greatest cancer care costs after inpatient care) will improve outcomes for cancer patients over and above greater investment in the whole cancer management pathway (screening, diagnostics, radiotherapy, surgery) and reducing access barriers (e.g. co-payments) argue against its widespread adoption. Ultimately, what is most important is that reimbursement decisions for all drugs, procedures and interventions within cancer care are made through appropriate health technology appraisal processes, which use the best available evidence to ensure decisions maximize value for cancer patients and society as a whole.

To view the original of this article, including ‘Reference Data’ CLICK HERE

Funding

None declared.

Disclosure

The authors have declared no conflicts of interest.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Regards,
Greg_L-W.

~~~~~~~~~~#########~~~~~~~~~~
Posted by: Greg Lance-Watkins
tel: 44 (0)1594 – 528 337
Calls from ‘Number Withheld’ phones Are Blocked

All unanswered messages are recorded.
Leave your name & a UK land line number & I will return your call.

‘e’Mail Address: Greg_L-W@BTconnect.com

DO MAKE USE of LINKS,
>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<


Skype: GregL-W

TWITTER: @Greg_LW

I try to make every effort to NOT infringe copyrights in any commercial way & make all corrections of fact brought to my attention by an identifiable individual

Please Be Sure To
.Follow Greg_LW on Twitter.

Re-TWEET my Twitterings

& Publicise My Blogs
~~~~~~~~~~#########~~~~~~~~~~

Treat life-threatening SEPSIS within the hour, says NICE, to Save Lives & Limbs …

DO MAKE USE of LINKS,

>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

~~~~~~~~~~#########~~~~~~~~~~
Treat life-threatening SEPSIS within the hour, says NICE, to Save Lives & Limbs …
~~~~~~~~~~#########~~~~~~~~~~

Posted by:
Greg Lance – Watkins
Greg_L-W

eMail: Greg_L-W@BTconnect.com

https://InfoWebSiteUK.wordpress.com

www.InfoWebSite.UK

~~~~~~~~~~#########~~~~~~~~~~

.

Hi,

10 March 2017

Treat life-threatening sepsis within the hour, says NICE

NICE is urging hospital staff to treat people with life-threatening sepsis symptoms within one hour.

In a new draft quality standard, NICE says people showing signs of sepsis must be checked carefully. Once someone is classed as high-risk they should be seen by senior staff and given the right treatment within an hour.

Professor Gillian Leng, NICE deputy chief executive, said: “Severe symptoms can develop in sepsis very quickly. If high-risk patients are not identified and treated promptly, people can be left with debilitating problems. In the worst cases, they may die.

“This quality standard highlights priorities in the continued fight to improve sepsis care. We know from recent case reviews that there are inconsistencies in how people’s symptoms are assessed in different settings. More can be done to provide rapid treatment.”

The quality standard highlight areas from NICE’s 2016 sepsis guideline that will help health professionals improve care for those who are at risk of becoming seriously ill.

It stresses that staff in any setting, from GPs to paramedics, should check people for specific signs that will show if their symptoms are life-threatening. This includes taking their temperature or heart rate, or checking for rashes and skin discolouration.

Anyone found to be high-risk should be seen by senior hospital staff immediately. This review would be carried out by an available doctor or nurse who is authorised to prescribe antibiotics.

Dr Ron Daniels BEM, Chief Executive of the UK Sepsis Trust, comments: “An emphasis on timely treatment and diagnosis is crucial if we are to improve outcomes for people with sepsis, and this quality standard could be a hugely impactful reinforcement of the recent guideline recommendation that sepsis is treated with same urgency as heart attacks.” 

NICE says that high-risk sepsis patients should get antibiotics and IV fluid treatment within the hour. If it will take more than an hour to get someone to hospital, GPs or ambulance staff can also administer antibiotics.

Prompt treatment means people are more likely to survive and it reduces the risk of further problems like heart failure or limb amputation.

The 2015 report from the National Confidential Enquiry into Patient Outcome and Death found that 40% of people admitted to A&E with sepsis did not have a timely review by a senior clinician. It also reported avoidable delays in administering antibiotics in more than a quarter (29%) of cases and inconsistencies in early use of intravenous (IV) fluid.

Health Secretary Jeremy Hunt said: “Every death from sepsis is a tragedy, yet too often the warning signs are missed – we need to get far better at spotting sepsis across the NHS and this advice shows how vital it is for clinicians to treat life-threatening symptoms as soon as possible.

sepsis symptoms hospital check in screen

“Our relentless drive to raise awareness of this deadly condition, as well as the tireless efforts of campaigners and families who have lost loved ones, has seen a million leaflets and posters already distributed to GP clinics, hospitals and other public places – helping raise awareness to fight against this devastating condition.”

A recent study from the York Health Economics Consortium suggests that 260,000 people in the UK develop sepsis every year. And the UK Sepsis Trust estimates that sepsis kills around 44,000 people per year.

Not everyone with sepsis will be at risk of getting seriously ill. NICE says that people who are classed as low-risk should get information on what to do if they continue to feel unwell and how to get further medical help.

NICE is asking for views on the draft quality standard. It is out for public consultation until Friday 7 April 2017.

To view the original of this article CLICK HERE

To view additional information on SEPSIS CLICK HERE
Regards,
Greg_L-W.

~~~~~~~~~~#########~~~~~~~~~~
Posted by: Greg Lance-Watkins
tel: 44 (0)1594 – 528 337
Calls from ‘Number Withheld’ phones Are Blocked

All unanswered messages are recorded.
Leave your name & a UK land line number & I will return your call.

‘e’Mail Address: Greg_L-W@BTconnect.com

DO MAKE USE of LINKS,
>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

Also:

ABOUT ME, Details & Links: CLICK HERE
Accuracy & Copyright Statement: CLICK HERE
UKIP Its ASSOCIATES & DETAILS: CLICK HERE
Summary & archive, facts & comments on Ukip: http://Ukip-vs-EUkip.com
General ‘Stuff’: http://GL-W.com
Leave-The-EU Referendum & BreXit Process CLICK HERE
Documents, Essays & Treaties: CLICK HERE
The Hamlet of Stroat: CLICK HERE
Data & The Study of a Wind Turbine Application: CLICK HERE
Health Blog.: CLICK HERE
Chepstow Chat: CLICK HERE
Christopher Story: CLICK HERE
Des Watkins DFC; CdeG: CLICK HERE/
Hollie Greig etc.: CLICK HERE
Psycheocracy: CLICK HERE
The McCann Case: CLICK HERE
The Speculative Society of Edinburgh: CLICK HERE
Stolen Kids, Dunblane: CLICK HERE
Stolen Kids, Bloggers: CLICK HERE
Views I respect & almost Totally Share: CLICK HERE
A Concept of Governance Worthy of Developement: CLICK HERE

Skype: GregL-W

TWITTER: @Greg_LW

Stolen Kids Blogs with links:
http://StolenKids-Bloggers.Blogspot.com
Stolen Oyster with links:
http://StolenOyster-Bloggers.Blogspot.com
Stolen Trust with links:
http://StolenTrust-Bloggers.Blogspot.com
Stolen Childhood with links:
http://StolenChildhood-Bloggers.Blogspot.com
NB:
  1. I NEVER post anonymously on the internet
  2. ALL MY BLOGS & WEB SITES are clearly sourced to me
  3. I do NOT use an obfuscated eMail address to hide behind
  4. I do NOT use or bother reading FaceBook
  5. I DO have a Voice Mail Message System
  6. I ONLY GUARANTEE to answer identifiable eMails
  7. I ONLY GUARANTEE to phone back identifiable UK Land Line Messages
  8. I do NOT accept phone calls from witheld numbers
  9. I Regret due to BT in this area I have a rubbish Broadband connection
  10. I AM opposed to British membership of The EU
  11. I AM opposed to Welsh, Scottish or English Independence within an interdependent UK
  12. I am NOT a WARMIST
  13. I do NOT believe the IPCC Climate Propaganda re Anthropogenic Global Warming
  14. I AM strongly opposed to the subsidy or use of failed technologies eg. WIND TURBINES
  15. I AM IN FAVOUR of rapid research & development of NEW NUCLEAR technologies
  16. I see no evidence to trust POLITICIANS at any level or of any persuasion
  17. I do NOT believe in GODS singular or plural, Bronze Age or Modern
  18. I value the NHS as a HEALTH SERVICE NOT a Lifestyle support
  19. I believe in a DEATH PENALTY for serial or GBH rape.
  20. I believe in a DEATH PENALTY for serial, terrorist, mass or for pleasure murder.
  21. I believe in a DEATH PENALTY for serial gross child abuse including sexual.
  22. I do NOT trust or believe in armed police
  23. I do NOT believe in prolonging human life beyond reasonable expectation of sentient participatory intellectual existence
  24. I believe in EUTHENASIA under clearly defined & legal terms
  25. I try to make every effort to NOT infringe copyrights in any commercial way & make all corrections of fact brought to my attention by an identifiable individual

Please Be Sure To
.Follow Greg_LW on Twitter.

Re-TWEET my Twitterings

& Publicise My Blogs
To Spread The Facts World Wide
~~~~~~~~~~#########~~~~~~~~~~

Enlarged Prostate Treatment Without Surgery …

DO MAKE USE of LINKS,

>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

~~~~~~~~~~#########~~~~~~~~~~
Enlarged Prostate Treatment Without Surgery …
~~~~~~~~~~#########~~~~~~~~~~

Posted by:
Greg Lance – Watkins
Greg_L-W

eMail: Greg_L-W@BTconnect.com

https://InfoWebSiteUK.wordpress.com

www.InfoWebSite.UK

~~~~~~~~~~#########~~~~~~~~~~

.

Hi,

having had my VERY enlarged Prostate [Benign Prostatic Hyperplasia (BPH)] operated on on Tuesday I was waiting to be TWOCed (Trial Without Catheter) on Wednesday morning in a hospital bed when the hospital paper trolley came round and the front page headline was:

Prostate therapy without surgery: Thousands of men to benefit from new technique that uses plastic beads to block blood supply and shrink the enlarged gland 

  • Successful trial in Portugal being followed up in UK with results due this year
  • If it is successful the technique could be rolled out for routine use on the NHS 
  • Researchers expect it to largely replace surgery as the standard treatment

Tens of thousands of men could benefit from a breakthrough prostate treatment announced today.

The technique uses tiny plastic beads to block the blood supply and shrink the enlarged gland – all without an operation.

A successful trial in Portugal is being followed up in Britain, with results due back later this year. If successful it could be rolled out for routine use on the NHS.

Half of all men over 50 suffer from an enlarged prostate and every year 45,000 have risky surgery to remove part of it.

As well as being painful and invasive, the operation can cause loss of sexual function and even incontinence. The technique uses tiny plastic beads to block the blood supply and shrink the enlarged gland – all without an operation

The technique uses tiny plastic beads to block the blood supply and shrink the enlarged gland – all without an operation

Last night, researchers said they expected the new technique – prostate artery embolisation – to largely replace surgery as the standard treatment.

An enlarged prostate presses on the bladder, while also blocking the urethra. This means sufferers need to make repeated night-time trips to the toilet, often to find they cannot urinate at all.

This can lead to a build-up of toxins that cause severe kidney problems. The bead technique has been tested on 1,000 middle-aged men in Portugal.

Joao Martins Pisco, who led the study at St Louis Hospital in Lisbon, said: ‘Within five years I think this will replace surgery as the standard treatment.

‘Prostate artery embolisation gives men a treatment option that is less invasive than other therapies and allows them to return to their normal lives sooner. 

Time and time again, I see patients who are relieved to find out about prostate artery embolisation because they are not able to tolerate medications due to their side effects.

‘These men also don’t want traditional surgery because it involves greater risks, has possible sexual side effects, and has a recovery time that is relatively long compared to prostate artery embolisation, which is generally performed under local anaesthesia and on an outpatient basis.’

The Portuguese team, which will present its findings at the Society of Interventional Radiology in Washington DC today, concluded the procedure is as effective as surgery and the benefits may last as long. 

Half of all men over 50 suffer from an enlarged prostate and every year 45,000 have risky surgery to remove part of it

Half of all men over 50 suffer from an enlarged prostate and every year 45,000 have risky surgery to remove part of it

Only two patients in the seven-year trial had clinical side effects.

Performed under local anaesthetic, the procedure involves injecting hundreds of 0.2mm plastic beads into an artery in the groin. 

The beads are directed with a thin tube into the blood vessels that flow to the prostate, blocking blood supply to the enlarged gland so that it shrinks.

Dr Pisco added: ‘I have had nine babies born to men who were able to continue their sex lives after having the treatment.’ 

His team saw a 89 per cent success rate six months after surgery, 82 per cent success up to three years, and 78 per cent beyond three years.

Two hundred patients in Southampton General, Guy’s Hospital in London and 16 other clinics are involved in the British trial, which is part-funded by the clinical watchdog NICE.

Dr Nigel Hacking, who is leading the study, said: ‘It is very encouraging. I am always cautious about new techniques but this procedure seems to be showing promise and it seems to be safe.’

Louise de Winter of the Urology Foundation said: ‘This research is very exciting.

‘As the population ages these problems are going to get even more acute.’

An estimated 45,000 men undergo surgery for enlarged prostates every year in the UK.

Dr Pisco claims most of these could be replaced by prostate artery embolisation – although others say the less invasive procedure is not be suitable for all men, and many will have to continue to have surgery.

Two hundred patients in Southampton General (pictured) Guy’s Hospital in London and 16 other clinics are involved in the British trial

Two hundred patients in Southampton General (pictured) Guy’s Hospital in London and 16 other clinics are involved in the British trial

Dr Hacking said that in his own experience, roughly 40 per cent of patients who have embolisation later have to undergo operations.

But having initial embolisation may enable them to delay that operation while retaining sexual function, and this usually means that when they do come to have an operation it is less invasive and there is a lower risk of side effects.

‘Even if they do need to go back and have surgery it’s a smaller operation,’ he said.

Dr Hacking said it was unlikely the procedure will completely replace surgery, because it requires a highly trained interventional radiologist.

‘It is a fiddly procedure and it would be potentially dangerous for someone without the skills to do it,’ he said.

‘But I think it may give men another option alongside surgery.’

Surgery, conducted either with a hot wire or lasers, have a high success rate – but they come with side effects which can include loss of sexual function, bleeding and incontinence.

The symptoms of enlarged prostate include a frequent need to urinate, but also difficulty starting to urinate and difficulty fully emptying a bladder. 

These symptoms, however, also might be a sign of prostate cancer, so anyone in this way should be seen by a urologist.

To view the original article CLICK HERE

 For another take on the same issue but in a different paper, minded this was added 2 days later & is largely a lift from the first article:

Bead treatment can save men from prostate surgery

About 45,000 men are offered surgery to relieve the symptoms of an enlarged prostate every yearJEFF PACHOUD/Getty Images

Doctors have welcomed an “exciting” technique that could spare tens of thousands of men surgery for an uncomfortable prostate problem.

The NHS treatments adviser is studying closely a procedure that injects tiny plastic beads into arteries to block blood flow to the prostate after research found it safe and effective.

About half of older men have an enlarged prostate. Although it is not a serious health threat, sufferers have problems urinating and their nights are disrupted by frequent lavatory visits.

Medication is often used and an estimated 45,000 men a year are offered surgery to cut away part of the prostate and relieve the pressure of the gland against the urethra.

This requires at least a night in hospital. It also often requires several weeks of recuperation and carries the risk of complications.

Now a trial of 1,000 men has found that the less invasive method of starving the prostate appears to be as good as surgery.

Success rates were 89 per cent after six months, 82 per cent after more than a year and 78 per cent after more than three years, researchers told the Society of Interventional Radiology in Washington yesterday. Only two patients suffered side-effects such as pain.

João Martins Pisco, who led the study at St Louis Hospital in Lisbon, told the Daily Mail: “Within five years I think this will replace surgery as the standard treatment. Prostate artery embolisation gives men a treatment option that is less invasive than other therapies and allows them to return to their normal lives sooner.

“Time and time again, I see patients who are relieved to find out about prostate artery embolisation because they are not able to tolerate medications due to their side-effects.

“These men also don’t want traditional surgery because it involves greater risks, has possible sexual side effects, and has a recovery time that is relatively long compared to prostate artery embolisation, which is generally performed under local anaesthesia and on an outpatient basis.”

A British trial is under way with help from the National Institute for Health and Care Excellence (Nice), which will look at whether the method should be routine on the NHS. Nigel Hacking, of University Hospitals Southampton, who is leading the British research, said: “It is very encouraging. I am always cautious about new techniques but this procedure seems to be showing promise and it seems to be safe.”

Louise de Winter, of the Urology Foundation, said: ‘This research is very exciting. As the population ages these problems are going to get even more acute.”

Last year Nice approved a laser treatment for enlarged prostates to destroy excess tissue, achieving the same results as surgery but allowing men to spend a third less time in hospital.

To view the original article CLICK HERE

Regards,
Greg_L-W.

~~~~~~~~~~#########~~~~~~~~~~
Posted by: Greg Lance-Watkins
tel: 44 (0)1594 – 528 337
Calls from ‘Number Withheld’ phones Are Blocked

All unanswered messages are recorded.
Leave your name & a UK land line number & I will return your call.

‘e’Mail Address: Greg_L-W@BTconnect.com

DO MAKE USE of LINKS,
>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

Also:

ABOUT ME, Details & Links: CLICK HERE
Accuracy & Copyright Statement: CLICK HERE
UKIP Its ASSOCIATES & DETAILS: CLICK HERE
Summary & archive, facts & comments on Ukip: http://Ukip-vs-EUkip.com
General ‘Stuff’: http://GL-W.com
Leave-The-EU Referendum & BreXit Process CLICK HERE
Documents, Essays & Treaties: CLICK HERE
The Hamlet of Stroat: CLICK HERE
Data & The Study of a Wind Turbine Application: CLICK HERE
Health Blog.: CLICK HERE
Chepstow Chat: CLICK HERE
Christopher Story: CLICK HERE
Des Watkins DFC; CdeG: CLICK HERE/
Hollie Greig etc.: CLICK HERE
Psycheocracy: CLICK HERE
The McCann Case: CLICK HERE
The Speculative Society of Edinburgh: CLICK HERE
Stolen Kids, Dunblane: CLICK HERE
Stolen Kids, Bloggers: CLICK HERE
Views I respect & almost Totally Share: CLICK HERE
A Concept of Governance Worthy of Developement: CLICK HERE

Skype: GregL-W

TWITTER: @Greg_LW

Stolen Kids Blogs with links:
http://StolenKids-Bloggers.Blogspot.com
Stolen Oyster with links:
http://StolenOyster-Bloggers.Blogspot.com
Stolen Trust with links:
http://StolenTrust-Bloggers.Blogspot.com
Stolen Childhood with links:
http://StolenChildhood-Bloggers.Blogspot.com
NB:
  1. I NEVER post anonymously on the internet
  2. ALL MY BLOGS & WEB SITES are clearly sourced to me
  3. I do NOT use an obfuscated eMail address to hide behind
  4. I do NOT use or bother reading FaceBook
  5. I DO have a Voice Mail Message System
  6. I ONLY GUARANTEE to answer identifiable eMails
  7. I ONLY GUARANTEE to phone back identifiable UK Land Line Messages
  8. I do NOT accept phone calls from witheld numbers
  9. I Regret due to BT in this area I have a rubbish Broadband connection
  10. I AM opposed to British membership of The EU
  11. I AM opposed to Welsh, Scottish or English Independence within an interdependent UK
  12. I am NOT a WARMIST
  13. I do NOT believe the IPCC Climate Propaganda re Anthropogenic Global Warming
  14. I AM strongly opposed to the subsidy or use of failed technologies eg. WIND TURBINES
  15. I AM IN FAVOUR of rapid research & development of NEW NUCLEAR technologies
  16. I see no evidence to trust POLITICIANS at any level or of any persuasion
  17. I do NOT believe in GODS singular or plural, Bronze Age or Modern
  18. I value the NHS as a HEALTH SERVICE NOT a Lifestyle support
  19. I believe in a DEATH PENALTY for serial or GBH rape.
  20. I believe in a DEATH PENALTY for serial, terrorist, mass or for pleasure murder.
  21. I believe in a DEATH PENALTY for serial gross child abuse including sexual.
  22. I do NOT trust or believe in armed police
  23. I do NOT believe in prolonging human life beyond reasonable expectation of sentient participatory intellectual existence
  24. I believe in EUTHENASIA under clearly defined & legal terms
  25. I try to make every effort to NOT infringe copyrights in any commercial way & make all corrections of fact brought to my attention by an identifiable individual

Please Be Sure To
.Follow Greg_LW on Twitter.

Re-TWEET my Twitterings

& Publicise My Blogs
To Spread The Facts World Wide
~~~~~~~~~~#########~~~~~~~~~~

A TURP op. (PROSTATE) Royal Gwent Urology Dept. Day Unit 07-Mar-2017 …

DO MAKE USE of LINKS,

>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

~~~~~~~~~~#########~~~~~~~~~~
A TURP op. (PROSTATE) Royal Gwent Urology Dept. Day Unit 07-Mar-2017 …
~~~~~~~~~~#########~~~~~~~~~~

Posted by:
Greg Lance – Watkins
Greg_L-W

eMail: Greg_L-W@BTconnect.com

https://InfoWebSiteUK.wordpress.com

www.InfoWebSite.UK

~~~~~~~~~~#########~~~~~~~~~~

.

Hi,

a TURP (Trans Urithral Resection of the Prostate)

prostate-03-turp-trans-urithral-resection-of-prostate

Yesterday afternoon I received a phonecall from Steff, in the Gwent Urology Unit, offering me the chance of bringing forward my appointment, due on 23-Mar-2017, for my TURP (Trans Urethral Resection of the Prostate) to tomorrow morning!

Steff suggested that I came into the Urology Day Unit by 10am, having nothing to eat or drink after midnight, so that I could be ready for anaesthetic in the morning if there was any delay or drop out by another patient – meanwhile assuring me that Adam Carter (my consultant urology surgeon) and the consultant anaethetist he had wanted for my op. would deffinitely have an alocated time for me in the afternoon if there was no morning cancellation.

As it turned out my op. was done just before lunch using an epidural anaesthetic – that is the one administered by an injection into the lower back, the downside of this form of anaesthetic, which deadens the nerves roughly below the point of the injection, is that it can, when the patient is taking anti-coagulants as I am, that if ANY mistake is made it can lead to bleeding into the spinal column which in turn CAN lead to long term paralysis!

The advantage, on the other hand is that it does not lead to unconciousness, as with a GA (General Anaesthetic) thus not only does it not leave anaesthetic in the system for a prolongued period after the operation, but it also meant, which I have alwaqys favoured, that I would be fully conscious and able to watch the operation being done on the screen.

Watching the surgeon slice away your own prostate from inside the bladder, whilst chatting about what he is doing, is a VERY strange experience!

The operation went well and just over an hour after the injection in the spine it was finished and after Adam had shown me the glass jar containing all the little bits he had cut away, which was quite a lot, I was transfered from the operating table onto the trolley and wheeled off to recovery where it took quite a while to get my temperature back up!

During the operation there is a constant flow of saline from the stand via the tube, into the bladder and out, sluicing the debris and clearing the blood so that the surgeon can see exactly what he is doing. During the operation I counted around 19 x 2L square plastic bottles of fluid so around 40Ls of relatively cold fluid, which drops the body temperature during the hour of the operation.

Then with a guage 22 three way catheter in place it was off to Ward D5East for a couple of days until the bleeding had slowed down a bit! Eventually, although I was still bleeding quite heavily and still had a 3 way catheter in, Adam Carter responded to my pleas to go home, where I could recover in greater comfort and with much better food! 3 days later the bleeding had reduced dramatically and I went back into the Gwent where despite no allocated ‘slot’ Steff fitted me in between other patients and and removed my catheter so that I could be TWOCed (Trial With Out Catheter), which once I had proved I could safely pass urine I was able to go home.

That is not to say that the bleeding has stopped! Minded that the operation was on the 8th. and it is now the 31st. there is still a small amount of bleeding – I guess mowing the lawn today didn’t help!

That said there seems no doubt that the operation would seem to have been a great success and at least I am not having to get up 3, 4 or 5 times a night to go to the toilet, which was the outcome of having a greatly enlarged prostate! The other great result of the operation was a letter from Adam Carter, the day before yesterday, to tell me that all the tissue he removed from my prostate (the jar!) had been biopsied and had been found to be perfectly normal prostate tissue free of any signs or traces of cancer.

A very reassuring outcome – I can recommend this operation to anyone with Benign prostate enlargement (BPE), also known as benign prostatic hyperplasia (BPH), a condition that affects older men (yep that’s me at 71!). Several friends of mine have had the op. with great outcomes and at the moment a friend of mine in his mid 50s is in The Royal Gloucester hospital with an enlarged prostate, which has inhibitted voiding of the bladder that has led to a severe UTI (Urinary Tract Infection), which in turn led to blocking of the urethra last Sunday night, leading to a blue lit ride in an ambulance, in extreme pain, in the early hours of Monday and now in the early hours of Saturday they finally removed his catheter but are still battling to control the infection and get his temperature down!

I expect that a TURP is very much on the cards for him, once the infection is cleared and his regular urologist can get him a bed in the Royal Gwent for the operation.

In my case – thanks to Adam Carter, Steff and the rest of the team who looked after me in the Gwent.

Regards,
Greg_L-W.

~~~~~~~~~~#########~~~~~~~~~~
Posted by: Greg Lance-Watkins
tel: 44 (0)1594 – 528 337
Calls from ‘Number Withheld’ phones Are Blocked

All unanswered messages are recorded.
Leave your name & a UK land line number & I will return your call.

‘e’Mail Address: Greg_L-W@BTconnect.com

DO MAKE USE of LINKS,
>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

Also:

ABOUT ME, Details & Links: CLICK HERE
Accuracy & Copyright Statement: CLICK HERE
UKIP Its ASSOCIATES & DETAILS: CLICK HERE
Summary & archive, facts & comments on Ukip: http://Ukip-vs-EUkip.com
General ‘Stuff’: http://GL-W.com
Leave-The-EU Referendum & BreXit Process CLICK HERE
Documents, Essays & Treaties: CLICK HERE
The Hamlet of Stroat: CLICK HERE
Data & The Study of a Wind Turbine Application: CLICK HERE
Health Blog.: CLICK HERE
Chepstow Chat: CLICK HERE
Christopher Story: CLICK HERE
Des Watkins DFC; CdeG: CLICK HERE/
Hollie Greig etc.: CLICK HERE
Psycheocracy: CLICK HERE
The McCann Case: CLICK HERE
The Speculative Society of Edinburgh: CLICK HERE
Stolen Kids, Dunblane: CLICK HERE
Stolen Kids, Bloggers: CLICK HERE
Views I respect & almost Totally Share: CLICK HERE
A Concept of Governance Worthy of Developement: CLICK HERE

Skype: GregL-W

TWITTER: @Greg_LW

Stolen Kids Blogs with links:
http://StolenKids-Bloggers.Blogspot.com
Stolen Oyster with links:
http://StolenOyster-Bloggers.Blogspot.com
Stolen Trust with links:
http://StolenTrust-Bloggers.Blogspot.com
Stolen Childhood with links:
http://StolenChildhood-Bloggers.Blogspot.com
NB:
  1. I NEVER post anonymously on the internet
  2. ALL MY BLOGS & WEB SITES are clearly sourced to me
  3. I do NOT use an obfuscated eMail address to hide behind
  4. I do NOT use or bother reading FaceBook
  5. I DO have a Voice Mail Message System
  6. I ONLY GUARANTEE to answer identifiable eMails
  7. I ONLY GUARANTEE to phone back identifiable UK Land Line Messages
  8. I do NOT accept phone calls from witheld numbers
  9. I Regret due to BT in this area I have a rubbish Broadband connection
  10. I AM opposed to British membership of The EU
  11. I AM opposed to Welsh, Scottish or English Independence within an interdependent UK
  12. I am NOT a WARMIST
  13. I do NOT believe the IPCC Climate Propaganda re Anthropogenic Global Warming
  14. I AM strongly opposed to the subsidy or use of failed technologies eg. WIND TURBINES
  15. I AM IN FAVOUR of rapid research & development of NEW NUCLEAR technologies
  16. I see no evidence to trust POLITICIANS at any level or of any persuasion
  17. I do NOT believe in GODS singular or plural, Bronze Age or Modern
  18. I value the NHS as a HEALTH SERVICE NOT a Lifestyle support
  19. I believe in a DEATH PENALTY for serial or GBH rape.
  20. I believe in a DEATH PENALTY for serial, terrorist, mass or for pleasure murder.
  21. I believe in a DEATH PENALTY for serial gross child abuse including sexual.
  22. I do NOT trust or believe in armed police
  23. I do NOT believe in prolonging human life beyond reasonable expectation of sentient participatory intellectual existence
  24. I believe in EUTHENASIA under clearly defined & legal terms
  25. I try to make every effort to NOT infringe copyrights in any commercial way & make all corrections of fact brought to my attention by an identifiable individual

Please Be Sure To
.Follow Greg_LW on Twitter.

Re-TWEET my Twitterings

& Publicise My Blogs
To Spread The Facts World Wide
~~~~~~~~~~#########~~~~~~~~~~

23-Feb-2017 – 10:30hrs. Royal Gwent Urology Dept. Day Unit for A TURP op.

DO MAKE USE of LINKS,

>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

~~~~~~~~~~#########~~~~~~~~~~
23-Feb-2017 – 10:30hrs. Royal Gwent Urology Dept. Day Unit for A TURP op. :
~~~~~~~~~~#########~~~~~~~~~~

Posted by:
Greg Lance – Watkins
Greg_L-W

eMail: Greg_L-W@BTconnect.com

https://InfoWebSiteUK.wordpress.com

www.InfoWebSite.UK

~~~~~~~~~~#########~~~~~~~~~~

.

Hi,

well if I was in any doubt that I needed this op. the numberr of times I woke and had to go to the toilet during the last few nights was fairly convincing! One starts to wonder why one goes to bed if you get up in the morning more tired than you were at bed time, the odd nap not withstanding!

So anyway we got up showered etc. in a less leisurely manner than normal – then checked I had meds. and other kit sorted and off to the Royal Gwent, in Lee’s car the buffeting of Storm Doris was considerably more noticeable than in the Volvo!
Lee dropped me off and ensured that I wasn’t subject to an NHS unscheduled cancellation but all is well and at least I know all the medical staff apart from the young Doctors on rotation! I must have had around 14 or 15 trans urithral procedures for bladder cancer etc. over the years.
This is somewhat more consequential but much the same.
So it was now the waiting game I had to check in in the morning but I am on Adam Carter’s afternoon list due for 14:00hrs.
Registrar Matt came round explained procedure yet again.
Then Catlin (Consultant Anaethatist) was with me for about half an hour! Going through details and facts and finally arriving at the conclusion that she was not happy to do the op. without a direct instruction and further discussion as she felt on a rough estimate that there was a 10 to 15% chance that due to anti coagulents I might well bleed sufficiently to catastophicly drop my haemaglobin level qand supply of oxygen to my heart thus inducing a heart attack that could/would prove fatal for me.
So it was time for all to think again!
I said I believed that the risk was mine to take and if this was the best odds available I would go ahead!
After prolongued conversation with Adam Carter (Head of Urology) who I have had as my consultant for many years and further talk with Catlin we have decided to try to improve the odds by closer contact with my cardiology consultant Patrick and ensuring Catlin & Adam were hands on for the op. and a HDU (High Dependency Unit) bed was available, pre booked for 3 or 4 days, for me so that I can be closely monitored after the op.
So now we are aiming for 23-Mar-2017 to go ahead with everything in place!
If you are reading this as a prospective TURP patient or a friend of someone about to have one DO NOT PANIC – each person is very different and my case is fairly extreme as I have no lefy coronary artery, and have had a massive heart attck as a result and already I am a bit of a miracle to be here atall! My coronary consultant has said I must take anti coagulant daily and this increases bleeding and the risk as a TURP under those circumstances can bleed heavily and take longer to heal. So don’t panic – I’ve had TURPs previously to my heart attack and had absolutely no problems.
Regards,
Greg_L-W.

~~~~~~~~~~#########~~~~~~~~~~
Posted by: Greg Lance-Watkins
tel: 44 (0)1594 – 528 337
Calls from ‘Number Withheld’ phones Are Blocked

All unanswered messages are recorded.
Leave your name & a UK land line number & I will return your call.

‘e’Mail Address: Greg_L-W@BTconnect.com

DO MAKE USE of LINKS,
>SEARCH<
&
>Side Bars<
&
The Top Bar >PAGES<

Also:

ABOUT ME, Details & Links: CLICK HERE
Accuracy & Copyright Statement: CLICK HERE
UKIP Its ASSOCIATES & DETAILS: CLICK HERE
Summary & archive, facts & comments on Ukip: http://Ukip-vs-EUkip.com
General ‘Stuff’: http://GL-W.com
Leave-The-EU Referendum & BreXit Process CLICK HERE
Documents, Essays & Treaties: CLICK HERE
The Hamlet of Stroat: CLICK HERE
Data & The Study of a Wind Turbine Application: CLICK HERE
Health Blog.: CLICK HERE
Chepstow Chat: CLICK HERE
Christopher Story: CLICK HERE
Des Watkins DFC; CdeG: CLICK HERE/
Hollie Greig etc.: CLICK HERE
Psycheocracy: CLICK HERE
The McCann Case: CLICK HERE
The Speculative Society of Edinburgh: CLICK HERE
Stolen Kids, Dunblane: CLICK HERE
Stolen Kids, Bloggers: CLICK HERE
Views I respect & almost Totally Share: CLICK HERE
A Concept of Governance Worthy of Developement: CLICK HERE

Skype: GregL-W

TWITTER: @Greg_LW

Stolen Kids Blogs with links:
http://StolenKids-Bloggers.Blogspot.com
Stolen Oyster with links:
http://StolenOyster-Bloggers.Blogspot.com
Stolen Trust with links:
http://StolenTrust-Bloggers.Blogspot.com
Stolen Childhood with links:
http://StolenChildhood-Bloggers.Blogspot.com
NB:
  1. I NEVER post anonymously on the internet
  2. ALL MY BLOGS & WEB SITES are clearly sourced to me
  3. I do NOT use an obfuscated eMail address to hide behind
  4. I do NOT use or bother reading FaceBook
  5. I DO have a Voice Mail Message System
  6. I ONLY GUARANTEE to answer identifiable eMails
  7. I ONLY GUARANTEE to phone back identifiable UK Land Line Messages
  8. I do NOT accept phone calls from witheld numbers
  9. I Regret due to BT in this area I have a rubbish Broadband connection
  10. I AM opposed to British membership of The EU
  11. I AM opposed to Welsh, Scottish or English Independence within an interdependent UK
  12. I am NOT a WARMIST
  13. I do NOT believe the IPCC Climate Propaganda re Anthropogenic Global Warming
  14. I AM strongly opposed to the subsidy or use of failed technologies eg. WIND TURBINES
  15. I AM IN FAVOUR of rapid research & development of NEW NUCLEAR technologies
  16. I see no evidence to trust POLITICIANS at any level or of any persuasion
  17. I do NOT believe in GODS singular or plural, Bronze Age or Modern
  18. I value the NHS as a HEALTH SERVICE NOT a Lifestyle support
  19. I believe in a DEATH PENALTY for serial or GBH rape.
  20. I believe in a DEATH PENALTY for serial, terrorist, mass or for pleasure murder.
  21. I believe in a DEATH PENALTY for serial gross child abuse including sexual.
  22. I do NOT trust or believe in armed police
  23. I do NOT believe in prolonging human life beyond reasonable expectation of sentient participatory intellectual existence
  24. I believe in EUTHENASIA under clearly defined & legal terms
  25. I try to make every effort to NOT infringe copyrights in any commercial way & make all corrections of fact brought to my attention by an identifiable individual

Please Be Sure To
.Follow Greg_LW on Twitter.

Re-TWEET my Twitterings

& Publicise My Blogs
To Spread The Facts World Wide
~~~~~~~~~~#########~~~~~~~~~~