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…