NICE has ended any debate about its independence
On Wednesday February 12th 2014 the UK National Institute for Health and Care Excellence (it used to be the National Institute for Clinical Excellence, hence NICE) published draft guidelines on statins. The guidelines have been published today on 18th July 2014. NICE recommends lowering the threshold for giving statins to healthy people with no symptoms of heart disease to anyone deemed to have a 10% risk of developing heart disease over the next 10 years.
All shall be statinated. Resistance is futile
This risk calculation is so heavily dependent on age, by the way, that EVERYONE has a date at which they should be statinated, as Dr Malcolm Kendrick explains here playing with the American risk factor toy, which came out in November 2013.
You can play with the QRISK2 UK toy here to your heart’s content. I’ve just worked out my “must be statinated age”. I’m a non-smoker, no diabetes, no history of heart disease, no atrial fibrillation, no kidney disease, no arthritis, (very) low BP and a BMI of 20-21. I have no idea what my cholesterol and HDL is and could not care less. So I entered what the NHS considers ideal for a cholesterol/HDL ratio of 4 (Honestly – where do they get this nonsense?!)
The result? If I were aged 64 today, my risk over the next 10 years would apparently be 8.2%. Aged 65 it would be 9%. Aged 66 it would be 9.8% and aged 67 is would be 10.7%. (Look how it’s just going up by almost 1% per year). So – somewhere between my 66th and 67th birthday (thankfully a long way away!) I should be on statins.
The key priorities for implementation say that everyone up to the age of 84 should be targeted. Don’t the powers-that-be read patient leaflets? Here’s the patient leaflet for Liptor, cautioning that Lipitor may not be suitable for anyone over the age of 70. That’s because there is much evidence for low cholesterol being especially bad in the elderly – if you fancy living longer that is.
So we all have a statin use-by date – super healthy as I am, mine is 66-67.
Statin conflicts of interest
It took me less than an hour following the NICE publication of the draft guidelines in February to uncover the conflicts of interest of the panel – 8 out of 12 people having clear connections to drug companies. I blogged about it for Health Insight UK here. The Sunday Express covered the conflicts here. And an extraordinary open letter from doctors and academics to NICE and the UK Secretary of State for Health, Jeremy Hunt, raised conflicts as one of many concerns about the then proposed (now finalised) statin guidelines.
I wrote to Jeremy Hunt on 17th February 2014 about the NICE conflicts. Someone replied on 28th February, on Hunt’s behalf, to say “NICE, as an independent body, has its own procedures in place for managing conflicts of interest.” The letter suggested that I raise my concerns with Sir Andrew Dillon – Chief Executive of NICE. So I did. I wrote to him on 5th March, chased on the 7th April and finally received a reply from a communications executive dated 23rd April.
Having set out the details of the conflicts of the Guidelines Development Group in my letter, the four questions I asked were as follows. I’ve summarised the answers I got back from NICE below each question:
Q1) Please can you confirm if you knew about the conflicts of interest on this Guideline Development Group?
Q2) Do you agree that the conflicts, in this case, negate the claim of NICE to be independent and unbiased?
Q3) What action will be taken to redress the bias and conflict in this group and the publication that it produced?
Q4) What steps will be taken to restore NICE to the body it claims to be: “evidence based guidance … created by independent and unbiased advisory committees.”
NICE’s position incredibly seems to be – people just need to declare conflicts and then we carry on knowing their conflicts.
Such arrogance no doubt inspired the academics and doctors to write that open letter, on 10th June, calling upon NICE to rethink their guidelines and to refrain from making these guidelines policy until all trial data (side/adverse effects especially) are shared. The latter are withheld by ‘researchers’ funded by the statin manufacturers under commercial arrangements made with the hand that feeds them.
NICE’s response to the open letter is detailed in the previous link. Probably best summed up by an unprofessional and bizarre mix of attack and defence, but overall dismissal.
And now for bariatric surgery guidelines and conflicts
As soon as I saw the headlines on 11th July 2014, announcing that Christmas had come early for the bariatric surgery industry, I suspected that conflicts would be discoverable (and I was not alone in this, receiving a call from a surgeon friend suspecting the same).
The NICE statement was published on line early that afternoon. Fewer than five minutes later, the conflicts were apparent. Follow the link through to details of the draft guidelines and you can see a link through to the “Guideline Development Group” and this reveals that four bariatric doctors and two bariatric surgery patients formed the substantive part of the group. One of the doctors is Head of Obesity and bariatric services at University College London Hospital.
The patients are not just patients – one particularly. Check out this article on Ken Clare who works for Gravitas (bariatric surgeons and clinicians) and runs a web site and forum, funded by Gravitas?, to help people who are considering surgery or have had surgery. Alexandra Blakemore was so pleased to have had surgery, she made a youtube video about it. I have stopped attending obesity conferences because the agendas have been infiltrated by the barbaric surgery industry and their spokespeople (paid and/or given free surgery?) to promote the procedure.
This is a disgrace. There is no way that NICE can continue to claim to be independent, let alone authoritative and evidence based. A guideline group should have NO conflicts whatsoever. A guideline group should be staffed with researchers and statisticians – ideally who know nothing about the drug/intervention in question. Then the data speaks entirely for itself and no prejudice (literally to pre-judge) can enter the debate.
The Nolan Principles of Public Life
I have been an Executive Director at the Welsh Development Agency (2002-2005) and a Non Executive Director at University Wales, Institute Cardiff (2006-2012) and the Wales NHS National Delivery Group (2009-2012). In all of these roles I was bound by The Nolan Principles of Public Life (selflessness,integrity, objectivity, accountability, openness, honesty and leadership). All public roles should carry the same obligation. In my public sector work, the way that conflict of interest worked was that – if you had any connection to any item on the agenda you declared this to the clerk/meeting secretary before, or at the start of, the meeting. When this item came up you left the room. You did not even stay in the room, as your position could inhibit free exchange of views. If your conflict was such that even being a member of the board would be inappropriate (i.e. you could gain in any way from your affiliation with the body), you would not be on the board. Full stop.
At the first meeting of the guideline development group, the conflicts were recorded and ‘addressed’ as follows: “The GDG members verbally declared their DOIs (as per the DOI register) and the Chair agreed there were no conflicts of interest therefore no action was required.”
You may need to read that twice. The group members declared their conflicts and the chair agreed there were no conflicts. This is the same NICE response to the statin conflicts. Yes we were aware of the conflicts, but we saw no problem in these conflicts.
NICE seems to think that one merely needs to declare a conflict and then it no longer need be deemed a conflict. To use a topical, if disturbing, analogy, this would be like Jimmy Savile declaring that he’s a paedophile and then being allowed to play with children because his conflict was known about.
The NICE approach to conflict is an utter disgrace and the Department of Health needs to intervene urgently to establish a medical advisory body that is genuinely independent and evidence-based. Not one that is staffing guideline development groups with conflicted majorities and then publishing the views of these drug/surgery representatives as policy for practitioners to be ordered to adhere to.
p.s. Thank you to The Independent on Sunday for giving me the opportunity to give my view on the bariatric surgery guidelines and conflicts…
29 thoughts on “NICE has ended any debate about its independence”
Thanks for your great website. I wish you got wider publicity, and I will recommend your website widely.
I am an NHS GP and I believe in my patients being well informed about the risks from statins. The 2014 fight at the top of our medical profession led me to read in detail about the facts. I now direct people to Malcolm Kendrick’s book and suggest they make up their own minds. They can be very resistant to change because they believe fat is bad for them. We advise people to follow a diet such as in your books or one of the other low carb/med protein/high good fat eating plans out there like David Perlmutters’ Grain brain or William Davies Wheat Belly. Statins would fail the “friends and family” test if you asked many GPs.
I am becoming a freelance GP soon and if I can be of any help to you in getting the proper message out there please let me know.
Hi Joanne – thank you SO much for such a wonderful message. I’ve just got back from a conference in Norway – LCHF – and the stories people have of being attacked by their doctors for eating real food are quite breathtaking. It’s restored my faith to read this and to hear of the family & friends test for statins causing concern for many GPs.
Very best wishes – Zoe
My mother had bariatric surgery in 1980. She was over 23 stone at the time. Now, with Mum, I have a real life long term case study of what this surgery does, and I wouldn’t go near it if my life depended upon it. If you need to starve me to make me thin, lock me in a room. Seriously, what she went through after surgery was that bad!!! And today, at 74 years old, she has never been smaller than 12 stone, and hovers around 14-16 stone. She is naturally a petite woman, was 5’4″ and is now shrinking. Even at 14.5 stone, which is where she rested for the longest time, that is a big lady. She has never been fit and healthy since the operation. Is in constant pain every day. She suffered bulimia after almost every meal for years on end, brought on by the constant pain of eating. I know that in some cases this is the only option, but seriously, it has to be the only option to be a worthy one. It is painful, depressing, and extremely complicated. And what is worse, if you really crave the calories, you can drink them.
And I suppose the statin peddling industry is doing this out of kindness for its fellow man. I think I’d rather have a salad.
Cheers Zoe. Keep up the good work.
This whole issue is just getting out of hand. I feel unable to trust doctors/nurses these days, after having worked in NHS for many years. I understood that Nurses were to act as the patient’s advocate, in other words, to speak up for them in difficult situations. But many NHS employees appear to be following the same mantra re: drugs and diet as dictated by NICE, regardless of what they learned in Medical School. It would seem that they are bamboozled by the need to follow guidelines which pop up on computer screens, lest they get sanctioned for speaking their minds. Surely, there has to be room to discuss care on an individual case by case situation….or it that too much to ask? Of course individuals might then mention the awful side effects they experience by ingesting statins….and we can’t have that, can we? Computer says….so, just ignore the patient.
Well done Zoe for finding the original words from NICE. Perhaps NICE can point us to the scientific evidence for their 180 degree turn around. My money is on lot’s of dosh has changed hands. I have one very keen sense of smell, and I am smelling a lot of condemned veal.
Kind regards Eddie
There’s been quite a bit of press lately (at least in America) that it looks like saturated fat doesn’t cause heart disease after all, that sugar is more likely the culprit, and that the cholesterol hypothesis is flawed. I knew there would be a backlash, as so much money is tied to this flawed hypothesis. And I think this is it.
You’re on the right track. Eat whole fresh foods, such as fresh meat, fish, eggs and non starchy vegetables. The sort of food you’re grandmother ate, before supermarkets were full of factory produced, highly processed, high carb/sugar junk. Natural fats that have been ate by man since the beginning of time, with no ill effects. Hardly a day goes by these days without us hearing good quality natural fats are safe, and that sugar and high fructose corn syrup are the leading causes of heart disease.
No one needs to be a rocket scientist to know this. Eat what nature provided us with, not a failed science experiment.
I reckon I am preaching to the converted, no disrespect, but I am a man on a mission.
Kind regards Eddie
Last December, I played with the American toy calculator – it appears to be based less on age and more on gender here. I put in my 55 yr old husband’s numbers and it said that he can wait until his late 60s to be statinized despite some lifelong health issues and a higher-than-average BG. After putting in my numbers (I’m 50), it said that I need to be statinized asap, which is odd because my HDL:trig ratio is 1:1 and everything else is in the normal to low-normal range. So I reversed them (his numbers, my gender/ my numbers, his gender) and suddenly he needed to be statinized asap and I could wait over a decade. Fortunately, we both have doctors who we know will ignore the guidelines.
Glad to be a long-time follower of Dr. Kendrick, Dr. Briffa and you.
Hi Lari – how funny but also how terrible! Has medicine really come to this?!
Keep reading :-)
Best wishes – Zoe
If you’re interested (and haven’t already gone through it), the American calculator is explained in this report: http://circ.ahajournals.org/content/129/25_suppl_2/S49.full.pdf
The next to last page has the coefficient calculations for the equations. The equations themselves are on the final page. If you’re really bored, you can download the calculator in Excel form and see the equations yourself (here, for general reference: http://my.americanheart.org/professional/StatementsGuidelines/Prevention-Guidelines_UCM_457698_SubHomePage.jsp).
You can also unlock all the sheets by a password breaking script: https://uknowit.uwgb.edu/page.php?id=28850
There are two hidden sheets in the file, and those contain the equations. It’s a bit tedious since the programmer doesn’t use cell names, but it’s straightforward otherwise. In short, there are 4 categories: male/female and [African American]/[not African American].
So people are living longer and according to some parts of the media are as healthy as they have ever been. How do you prevent such a burgeoning population and make room for a vibrant younger generation ?? Medicate the old foggies out of the picture !!
Yes of course its conspiracy theory but indeed so is/was mr orwells animal farm.
I don’t get this – mine is 4.2, even though I have type 2 diabetes and I’m overweight. I thought type 2’s would automatically qualify. The only factor I suspect we differ on Zoe is the postcode we live in.
Plus they ask for your cholesterol ratio. I don’t know my cholesterol ratio. I know what they say my cholesterol is. If I put in 6.6, my risk jumps to 6. something. If I add my blood pressure, then it goes to 8 – that I can believe, even though my high blood pressure is unexplainable. I have consistently stopped the behaviours that they told me caused my high blood pressure and I still have high blood pressure.
This is depressing. I don’t want statins, I’m proud of my cholesterol level (they told me my ratio was below normal) so if I have to, I’ll take the tablets away and flush one down a toilet every day. Trouble is, my cholesterol won’t go down then….
Hi Jessica – just put in your details and then play with the age button – that’s what it most depends on. The site opened on a default age of 64, so when I put my BMI etc in – the risk of 8.2% popped up. Then I just added a year and then another year to see when this stupid tool would decide I should go on statins. It just beggars belief that this is what some of our brightest people went to med school for!
No woman should take statins (no human in fact, but that’s another debate). Just read The Great Cholesterol Con by Kendrick and see what he has to say about women and statins!
Best wishes – Zoe
Oh, I know all about The Great Cholesterol Con – I recommended it to my doctor, who said he would have to read it and then didn’t. Just before the whole “Statins are healthy/Statins are unhealthy” debate hit the papers, he said he was unaware of any controversy. I wonder if he is aware now? It worries me when I am apparently more informed than my doctor about medicine, and even more worried that the papers report that the controversy has been solved and statins are safe.
I never want to take them again. I am just about back to normal after my memory issues. I wonder how long my doctor would keep his career if he were unable to remember names of disease or names of medicines. “Oooo, you’ve got…you know…that spotty thing. Itchy. Ermmm…gives you red spots and a…..what’s that called, when you’re really hot? I’l prescribe you some….pills. When I find out what they are called.”
Hi Zoe & Eddie
You may find the original page/quote here and be able to take a screenshot: http://web.archive.org/web/20110201000000*/http://www.nice.org.uk/
Thanks so much Jacqui – we got it – see a reply from me to Michael :-)
My pleasure and glad you got it!
Although I agree with you, Zoe, I think your Savile parallel is OTT. A convicted paedophile is known to have broken the law and acted immorally. Whereas the NICE members are merely known to have accepted money from pharmaceutical manufacturers. It is possible that they are all so unimpeachably honest that this does not influence their recommendations. I doubt whether that is actually the case, but it is theoretically possible.
As to NICE’s very peculiar views, may I suggest that they are explained, to some extent, by modern social attitudes to wealth? Following the USA, more and more British people are coming to believe that rich people must be good and right and trustworthy. After all, we have no other yardsticks left to us.
Hi Tom – it’s an anology – it’s not saying NICE members are anything like Savile. It’s saying the idea that all you have to do is declare conflicts of interests and then they somehow cease to be conflicts of interest is absurd. I think the Savile analogy works to make that point. We need something to make these organisations think about what they’re doing because at the moment I am more shocked by NICE’s reaction to the conflicts of interest than I am by the conflicts of interest!
Best wishes – Zoe
“The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care.”
“NICE guidance helps health and social care professionals deliver the best possible care based on the best available evidence. ”
Whatever happened to “based on the best available evidence”?
Oh, those bastards!
Three years ago on the NICE website. Removed around a year ago.
““The National Institute for Health and Clinical Excellence (NICE) does not recommend the use of target levels of cholesterol for people taking statins for primary prevention of cardiovascular disease. This is because it found no clinical trials in primary prevention that have evaluated the relative and absolute benefits of achieving different cholesterol targets in relation to clinical events.”
Kind regards Eddie
Awesome find Eddie! Hope you got a screen grab :-)
Sorry Zoe no screen shot and link now broken. This was my post on the lowcarb diabetic blog at the time.
The more you look into the murky world surrounding cholesterol numbers, and the $30 billion a year statin industry, the more you are amazed how a fraud of such gigantic proportions ever got off the ground. One reading of Dr. Malcolm Kendrick’s book The Cholesterol Con is enough to convince any straight thinking person, statins are the very last thing you need if you want to stay healthy. A few years ago after reading the book, my first thoughts were Kendrick is right, swiftly followed by how come he is still allowed to practice as a GP, how come he had not been struck off. The trouble is, especially in the world of medicine, if you go against the mainstream of medical opinion and especially against the monumental power of big pharma you can rapidly become a marked man. Kendrick has not been struck off, could it be many others believe he is right, could it be the MONICA study proved he was right, could it be NICE knows he is right. Here is what NICE say about cholesterol levels in relation to clinical events.
“The National Institute for Health and Clinical Excellence (NICE) does not recommend the use of target levels of cholesterol for people taking statins for primary prevention of cardiovascular disease. This is because it found no clinical trials in primary prevention that have evaluated the relative and absolute benefits of achieving different cholesterol targets in relation to clinical events.”
So, no one has ever proved the lowering of cholesterol levels has any improvement in health outcomes. As Kendrick said years ago, statins may change what is on your death certificate, but the date of death will probably be the same. So, if you accept statins have not been proved to improve your health, what about the side effects that almost all drugs bring. Well, there is a massive amount of evidence to support they can bring life changing side effects, and the side effects list is long. Don’t get conned, do not aide and abet the fraud.
The last word to Dr.John Briffa.
“Sometimes when talking to someone about their cholesterol, I ask them to ask me what my cholesterol is. Then I answer: “I have no idea, because I never have it checked.” That’s not because I take an ostrich-like stance on matters that relate to my health – it’s because the great likelihood is that knowing my cholesterol numbers would not lead to me having a different view on my health or have any bearing on how I live my life. End of.”
Plus links to NICE and Dr Briffa’s quote.
A comment came in.
“I have just checked out your links with interest. Has anyone else noticed that the link you gave for NICE actually goes to the NHS Evidence site. I was amazed, why on earth are so many people being put on statins?”
The NICE quote was definitely information on the NICE site when I posted it on the blog, possibly a re-direct to the NHS site was made after I posted. Who knows in the often corrupt world of big pharma and the big statin sell.
Keep up your great work, we are winning !
Kind regards Eddie
I looked for the exact quote and found it on one of my own blog posts! https://www.zoeharcombe.com/2012/08/cholesterol-what-does-the-blood-cholesterol-test-actually-measure/comment-page-2/
Funny that the 2008 guidelines said “no evidence” and then a panel stuffed with 8 of 12 cats came to the opposite conclusion. Let’s hope NICE/CTT etc have just gone too far this year (it has been nuts) and that they have accelerated the backlash. Patients are getting much less trusting and much more discerning. Shame that they have to but good on them.
Bye for now – Zoe
If you’ve got the original link, you can probably get a page grab by going to the following website – https://archive.org – they have archive copies of websites. With the original link you can usually go back a to when it was published on the site and find it. If you post the original link, I can probably find it for you at archive.org (if you’re unable to do so yourself). Cheers!
Hi Michael – many thanks for this. We searched on Eddie’s found words and one of the top searches was one of my blogs!
The third link (summary states in red) was no longer going anywhere but hubby did the archive thing yesterday and found this on that fab archive site. We’ve screen grabbed it and made the link work again. It’s now here https://www.zoeharcombe.com/wp-content/uploads/2014/07/Nice-lipid-position-web.png
There are Eddie’s words verbatim! Funny how the NICE position changed so much!
Thanks again – Zoe :-)
Medicine should be reserved for sick people. Doctors are complicit in this scandal, if they atop prescribing drugs that don’t work we would have far fewer people on a downward spiral of medication, side effects and resignation to poor quality of life.We all need to take more responsibility for our own health, decrepitude is not inevitable.
Macey said “prescribing drugs that don’t work we would have far fewer people on a downward spiral of medication”
Agree, don’t tell anyone but !
“A senior executive with Britain’s biggest drugs company has admitted that most prescription medicines do not work on most people who take them. Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline (GSK), said fewer than half of the patients prescribed some of the most expensive drugs actually derived any benefit from them. It is an open secret within the drugs industry that most of its products are ineffective in most patients but this is the first time that such a senior drugs boss has gone public.”
Kind regards Eddie