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Please NICE, please shut up, please

December 1, 2015

What is it with the National Institute for Clinical Excellence (NICE)? Originally it was an authoritative body using objective methods to advise on treatments which worked and which the NHS could afford; things like screening and treating choriocarcinoma, or preventing and treating rhesus disease. It also tackled more difficult areas; screening for Group B streptococcal infection, or new ovarian cancer drugs. These were tricky issues, but by calculating cost per Quality Adjusted Life Year (QALY) NICE usually got a reasonable answer.

Now, it seems, they have an opinion on everything. Even when the data are hopelessly flaky and the issues utterly value-laden.

Last week NICE decided to advise about post menopausal hormone therapy (HT*) (click here). Not whether it works for symptoms in the short term; it does. Nor whether it is harmful in the long term; it is. Not even, the disputed risk/benefit ratio when started soon after the menopause; no-one can say for sure, despite many strong opinions.

No. NICE decide to weigh in on an even trickier question; are doctors currently giving out enough HT, and are enough women taking it? To do this they somehow had to take into account not just the facts, which no-one can agree on, but also the belief of some women in a male conspiracy to deprive them of HT, and the belief of others in a conspiracy of drug manufacturers and doctors to medicalise yet more of women’s life.

If anyone thinks that is an answerable question, they don’t understand it. But NICE was undaunted. Their answer; doctors are not giving out enough HT.’

Apparently they identified “A knowledge gap” among GPs and healthcare professionals, which makes them reluctant to prescribe HT because they “overestimate the risks and contraindications, and underestimate the impact of menopausal symptoms on a woman’s quality of life.” And on the basis of a pressure group’s website (click here) they identified variations in practice and lack of overall provision.

Is that really an evidence-based finding? Read the guidance as carefully as you like. You won’t find objective evidence of under provision there.

Please understand me. I’ve no objection to women, doctors, journalists, drug companies or anyone else weighing in on the HT debate, although they should declare their interests (click here). My objection is to NICE, with all it’s authority, and alleged objectivity, pretending to have discovered that one side of the debate, the HT enthusiast side, is correct. They might be. They might not be. But no-one can possibly know.

NICE is too powerful to get involved in this sort of question. It risks closing down debate. And by joining in a partisan shouting match, NICE debases itself. Please NICE, please shut up, please.

Jim Thornton

Next non clinically indicated Caesareans.

*Hormone replacement therapy (HRT) changed to hormone therapy (HT) Jan 2016

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20 Comments leave one →
  1. December 2, 2015 10:18 am

    How does a Centre for Excellence (NICE) accept low or very low quality evidence or opinion to re-promote the use of HRT? Is that excellent? Since 1962 in England and Wales percentage increases in breast cancer for age groups 25-34, 35-44, 45-54 and 55 -65 have matched increases in use of progestogens and oestrogens with large decreases when hormone use has fallen several times. Proven increases in thrombosis, heart attacks,
    strokes and breast cancers have reduced use for contraception and menopause several times. Breast cancer registrations, and also ovarian cancer registrations, fell immediately,.

    Progestogens and oestrogens are thrombogenic and vasoactive and can dilate veins and cause arterial spasm. As young oral contraceptive users have an increased risk of heart attacks, it is not possible that any particular age group taking HRT can have a reduced risk. The doubt arose due epidemiological findings including randomised double blind WHI trials, which were inevitably flawed because most women had already taken contraceptive or menopausal complaints before being allocated to placebo or hormone use. Selection, exclusion and a lack of never ever users controls as led to totally unscientific confusion over the last 45 years.

    My colleagues and I have made fundamental discoveries and published academic papers since 1962 to 2015. My books are- “The Bitter Pill – how safe is the perfect contraceptive?” and “Sexual Chemistry – understanding our hormones” My website contains scientific lectures including Dr John McLaren-Howard’s important epigenetic discoveries ..

    • Diana permalink
      January 11, 2016 7:25 pm

      Dr. Grant, sorry for my poor english. And of course I don’t have any medical education, I can only read studies which were made by hormone specialists. Don’t you think there have to be a distinction between synthetic estrogens and bioidentical ones, which are used in the modern HRT instead of the horse estrogen, like in the WHI trial?

      Latest french study on HRT where bioidentical estrogen was used, shows that there is almost zero increase in breast cancer amongst the long term users. Why so many doctors still stick on this old WHI study, when there are much more current and significant studies available? Modern and well informed women should all have the choice and the possibility to stop the troublesome symptoms of the menopause.

      So many doctors are not having any concerns to prescribe antidepressants and sedatives to women who are suffering depressive moods, anxiety, panic attacks or insomnia due to the menopause. Not to mention the loss of proper sexual function due to vaginal atrophy, dryness and dimished sensitivity. The lubricant, which is so often recommended to the suffering women won’t gave them back their ability to enjoy sex pleasure, re-build their vaginas or prevent them loosing urine.

      So which cure do you recommend instead?

  2. Louise permalink
    January 4, 2016 9:24 pm

    Do you have any other answers for women suffering vaginal atrophy, thinning hair, depression, insomnia, double incontinence, sweats, flushes, raised risk of osteoporosis, joint pain, zero libido, dizziness, receding gums and osteoarthritis?
    Do you view these conditions as life enhancing?
    Do you feel that men are healthier without testosterone?
    Do you think women should suffer a severely reduced quality of life.
    What answers can you offer them.
    My Grandmother remarried a widower. His late wife did not have to concern herself with breast cancer. Unable to tolerate menopause she gassed herself and daughter. He found them when he arrived home that evening.

  3. Susan permalink
    January 8, 2016 7:39 pm

    Shouldn’t women be given the option to make this decision for themselves? Why should NICE guidelines be lambasted for their stance? Doctors think nothing of throwing statins and biphosphonates at men and women (both of which carry significant side effect profiles), but you mention the need for desperate relief of menopausal symptoms, and you’d think you’d just asked for heroin or some Class IV substance.

    The implication of the above piece is that NICE is irresponsible in their stance – as if women themselves are not intelligent enough to read available info (somewhat conflicting as it may be) and make an informed choice of their own when deciding whether to ask for HRT. So, is the author’s implication that the NICE standards were just fine BEFORE? Despite the author acknowledging that information is inconclusive, heavily debated, and conflicting? Birth control pills are handed out like candy, but HRT? Heavens, well we can’t have women using THAT!!

    NICE is only stating what women have known for a long time now: menopause is a severely under treated event in most women’s lives. It’s back-burnered in the medical establishment’s minds as a mere nuisance and something to get through. Never mind the lives ruined, jobs lost, families torn apart by the untreated symptoms of this ‘natural’ occurrence. Rather than NICE shutting up, perhaps the author should take his own advice.

  4. January 18, 2016 1:06 pm

    Progesterones and oestrogens are extremely powerful. Whether synthethic or bioidentical progesterone up and down regulates thousands of genes, several times more than oestrogens do. Women who are overweight are more likely to get endometrial cancer due to the endogenous oestrogens in fat stores.There have been remarkably few randomised double blind placebo trials and most have been terminated prematurely because of the increases in cancers and vascular diseases.

    Women have been evolved to cope safely with carefully regulated higher levels of progesterone and oestrogen when they are young and healthy. A natural menopause is a welcome relief from these large and demanding metabolic changes. For 40 years I have been treating deficiencies of essential nutrients to prevent otherwise “unexplained” infertility , recurrent miscarriages, migraines, depression, hot flushes and also treating infections and gut and/or vaginal candida which increase adverse reactions to common foods and chemicals. It is simplistic and dangerous to take extra hormones and ignore what is really happening including finding toxic DNA adducts from cadmium from smoking and nickel from stainless steel, and mercury from dental amalgams which are increased in cancer patients and in women taking hormones. My review lectures of basic discoveries since 1962 are included in my website http://www.harmfromhormones.co.uk In my experience the more severe the symptoms, the more abnormalities can be found with the appropriate biochemical tests. Unfortunately the most revealing test are not yet universally available but avoiding the common social poisons, like alcoholic drinks,and taking nutritional supplements and eating a low allergy high protein diet are a good starting places.

  5. Louise permalink
    January 18, 2016 1:30 pm

    You have no scientific evidence to back your statement. Estradiol deficiency is caused by low estradiol.
    Do you also think that hypothyroid patients can avoid levothyroxine or Diabetics with type 1 can forgo insulin?
    For the record. I am teetotal, do not have mercury fillings, candida and I am a non smoker in a no smoking envirnoment.
    A natural menopause is not a relief for all women but frequently the start of diminished quality of life.
    Hocus Pocus remedies will not relieve the symptoms. Removal of fillings though may be detrimental to the teeth.

  6. Susan permalink
    January 18, 2016 1:46 pm

    Dr. Grant, what exactly is your recommendation for women suffering, then, from horribly severe symtpoms? You would deny them HRT when you yourself state, there are not enough randomised, double-blind, placebo-controlled studies of bioidentical HRT to say yeah or nay? Even when they are making an informed choice?

    “For 40 years I have been treating deficiencies of essential nutrients….” What nutrients, specifically, and how have they helped with relieving the following: osteoporosis, vaginal atrophy, declining estrogen’s effects on the joints/collagen in the body, cystoceles, the increased incidence of heart disease, severe depression, loss of libido, – need I go on? What proof have you – documented, peer-reviewed, using large-scale populations – of people being poisoned by mercury fillings, cadmium, nickel, etc.

    Please provide the citations and evidence to those interested.

  7. January 19, 2016 10:22 am

    Please look at my website http://www.harmfromhormones.co.uk which contains a list of some of my research publications since 1962 in main stream peer reviewed medical journals and two review lectures. The commonest biochemical abnormalities are zinc, magnesium and copper deficiencies which impair the activity of hundreds of enzymes, DNA repair and hormone receptors. Deficiencies of B vitamins, especially folic acid and vitamin B12 and vitamin B6 are common especially in hormone takers. Women are more likely to be deficient in omega-6 polyunsaturated fatty acids whereas we found men were more likely to be deficient in omega-3 PUFAs from fish oils. The website http://www.mercurymadness.org is useful. Highest mercury levels were found in dental nurses and dentists using mercury amalgams. Biolab Medical Unit in London and Acumen laboratory in Devon analyse toxic metals in blood and urine and also toxic DNA adducts. Please also see the website of Dr Sarah Myhill who has published 3 important papers proving that chronic fatigue syndrome is due to mitochondrial dysfunction ( usually caused by deficiencies and toxins) and at least twice as many women are affected than men..

  8. Louise permalink
    January 19, 2016 2:11 pm

    Dr Sarah Myhill was suspended by the GMC and judging by her curious methods I am not surprised in the least.
    Your website contains highly speculative outdated information.
    My vitamin levels have been extensively tested. All found to be in optimal range. Kidney function of a 30 year old. Exceptionally healthy eyes, good spinal health, excellent pulmonary function, great gums and heart in decent shape with low blood pressure.
    All of this achieved without having my teeth messed around with or curious unproven methods of testing for various toxic substances.
    There is a name for this type of medicine, it is Quackery.

  9. January 20, 2016 12:10 pm

    Dr Sarah Myhill was not suspended by the GMC. On the contrary, due to Dr Myhill’s extremely heavy workload, no new patient consultations are currently being accepted.

    My latest publication was in Lancet Oncology November 2015, a Correspondence in response to the world wide Collaborative Group’s meta-analysis of 36 epidemiological studies published from 1987 to 2014 which claimed that oral contraceptives prevented endometrial cancer.1 What is their evidence?

    The median age of 27 276 women developing endometrial cancer was 63 years when
    most oral contraceptive use was long past but recent use of hormones for menopause or breast cancer therapy was more likely. A crucial but still unanswered question was how many women took hormones for any reason when, or near the time that, they developed endometrial cancer compared with an aged-matched group of never users? The distinguished epidemiological authors failed to answer my question.

    Appendix p 5 listed oral contraceptive usage for only 7709 endometrial cancer cases and 37 982 controls. 824 ever user cases (3% of all study cases) were current users or users of oral contraceptives less than 15 years previously. The other 6885 ever user cases took oral contraceptives 15–30 years or more previously. Appendix p 6 showed that 95% of use was in the 1960s and the 1970s.

    An important confounding factor for historical publications is high hysterectomy rates. In 1980, the Walnut Creek Contraceptive Drug Study2 reported that users of oral contraceptives aged 18–39 years were more likely to have hysterectomies than non-users and more reasons for hysterectomy including increases in cervical cancer, menstrual
    disorders, fibroids, anaemia due to blood loss, pelvic inflammatory disease, uterovaginal prolapse, and adenomyosis. Although rare in young women, in the Collaborative Group’s study, appendix p 9 showed that from 1965 to 2014 in 21 developed countries, endometrial cancers doubled in the youngest women, aged 30–39 years (8511–17 438 cases) compared with an increase of 50% for 40–75 year olds.

    The bad effects of using progestogens and oestrogens are overwhelming:-

    Doubling of mortality from breast cancer 1

    Doubling of mortality from ovarian cancer 2

    Doubling of mortality from lung cancer 3

    Doubling of deaths from suicide and suspected suicide 4

    Doubling of cervical adenocarcinomas 5

    4-5 fold increase in invasive cervical cancers 6

    5 fold increase in endometrial cancer (oestrogens) 7

    Doubling (or up to 6 times) of primary venous thrombosis 8

    81% increase in myocardial infarctions (at one year) 9

    44 -55% increase in ischemic strokes 10-11

    Doubling (or up to 5 times) increases in migraine headaches and vascular over-reactivity 12,13

    Increases in osteoporosis due to micro-thrombi in bones, mineral deficiencies, and decreases in serum bone alkaline phosphatase 14,15

    An Editorial in the BMJ 16 January 2016 by Professor Martha Hickey17 states that

    Society has strong negative perceptions of female ageing. Wider acceptance that menopause is a normal transition rather than an “oestrogen deficiency syndrome” might be more empowering for women. Women and their healthcare providers should have confidence that most will manage their symptoms without pharmacotherapy. The UK Medicines and Healthcare Products Regulatory Agency estimates that five years’ use of combined MHT results in an excess of serious, potentially life threatening disease (obtained by adding the estimated number of extra cases of breast cancer, ovarian cancer, stroke, coronary heart disease, and venous thromboembolism likely to be caused by MHT

    HRT has been a health disaster for too long.

    1 Chlebowski RT, Anderson GL, Gass M, et al; WHI Investigators. Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women. JAMA 2010;304:1684-92.

    2 Beral V, Bull D, Green J, Reeves G for the Million Women Study Collaborators. Ovarian cancer and hormone replacement therapy in the Million Women Study. Lancet 2007;369:1703-1710.

    3 Chlebowski RT, Schwartz AG, Wakelee H, et al; Women’s Health Initiative Investigators. Oestrogen plus progestin and lung cancer in postmenopausal women (Women’s Health Initiative trial): a post-hoc analysis of a randomised controlled trial. Lancet 2009;374:1243-51.

    4 Price EH. Increased risk of mental illness and suicide in oral contraceptive and hormone replacement therapy in studies. J Nutr Environ Med 1998; 8:121-127.

    5 J Green, A Berrington de Gonzalez, et al.. Risk factors for adenocarcinoma and squamous cell carcinoma of the cervix in women aged 20–44 years: the UK National Case–Control Study of Cervical Cancer. Br J Cancer 2003; 89: 2078–2086.

    6 Zondervan KT, Carpenter LM, Painter R, Vessey MP. Oral contraceptives and cervical cancer–further findings from the Oxford Family Planning Association contraceptive study. Br J Cancer 2003; 89: 2078–2086.

    7 Persson I, Yuen J, Bergkvist L, Schairer C. Cancer incidence and mortality in women receiving estrogen and estrogen-progestin replacement therapy–long-term follow-up of a Swedish cohort. Int J Cancer. 1996;67:327-32.

    8 Daly E, Vessey MP, Hawkins MM, et al. Risk of venous thromboembolism in users of hormone replacement therapy. Lancet 1996; 348:977-80.

    9 Manson JE, Hsia J, Johnson KC, et al; Women’s Health Initiative Investigators. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med 2003;349:523-34.

    10 Hendrix SL, Wassertheil-Smoller S, Johnson KC, et al; WHI Investigators. Effects of conjugated equine estrogen on stroke in the Women’s Health Initiative. Circulation 2006;113:2425-34.

    11 Wassertheil-Smoller S, Hendrix SL, Limacher M, et al; WHI Investigators. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women’s Health Initiative: a randomized trial. JAMA 2003;289:2673-84.

    12 Grant ECG. Relation between headaches from oral contraceptives and development of endometrial arterioles. BMJ 1968;3:402-05.

    13 Grant ECG. The pill, hormone replacement therapy, vascular and mood over-reactivity and mineral imbalance. J Nutr Environ Med 1998;8:105-116.

    14 Little K. Progestogens:thrombosis and osteoporosis. J Nutr Environ Med 1998;8:139-52.

    15 McLaren-Howard J, Grant ECG, Davies S. Hormone replacement therapy and osteoporosis: bone enzymes and nutrient imbalance. J Nutr Environ Med 1998;8:129-38.

    17 Hickey M, Banks E. NICE Guidelines on the menopause. BMJ 2016;352:i191

  10. Louise permalink
    January 20, 2016 1:00 pm

    http://www.bbc.co.uk/news/uk-wales-mid-wales-12170266
    Dr Sarah Mynhill was suspended abd had restrictions placed when the suspension was lifted.
    I will ask you again.
    What sensible answers do you have to prevent menopause related ill health?
    I am not talking about CAM but reputable main stream medicine.

  11. Gary permalink
    January 20, 2016 1:22 pm

    Doubling this and doubling that! Very emotive language. Going from 1 in 1,000,000 to 2 in 1,000,000 is doubling, but it can also be looked at as a 0.000001 percentage point increase.

    • Susan permalink
      January 20, 2016 5:41 pm

      Yes, exactly. It is very deceptive to speak of a risk doubling when it means going from 1 case to 2 cases.

  12. Susan permalink
    January 20, 2016 2:15 pm

    The bottom line is that ABSOLUTE risk of these diseases in ever or current users of HRT are minimal. Perhaps for every 1,000 women using HRT, an additional 2-5 may experience a cancer as a results of use (this number may vary some depending on the cancer in question) – and the majority of these will be longer terms users (greater than 5 years).

    Shouldn’t a woman be able to make an informed choice of her own?
    In a world where alcohol and tobacco are legal and readily accessible, where deaths DIRECTLY caused by these two substances (completely unequivocal, not merely ‘attributed’ or ‘associated’ as is the case with most ‘findings’ of HRT studies) outstrips by many thousands the deaths from the female cancers you mention, it seems amazingly ludicrous to suggest that a woman cannot make her own, informed choice as to whether to take HRT and accept whatever risks are potentially inherent in doing so.

    By your reasoning/rational, there must then be potentially hundreds of substances currently consumed or used by the general public which should be banned or restricted.

  13. January 21, 2016 9:25 am

    Doctors who practice Ecological Medicine employ the best available scientific tests to diagnose and treat their patients – such as DNA adducts in genomic DNA from leucocytes.1 Structurally similar progestins form DNA adducts in primary cultures of human hepatocytes signifying a genotoxic risk.2,3 DNA adducts also involve cadmium from tobacco smoke, chlorine from tap water, nickel from stainless steel and exhaust gases, disinfectants, pesticides and malondialdehyde from endogenous oxidation.66 Nickel has a high affinity for hormone-binding sites. The risk of cancer is increased if DNA adducts block the multiple tumour suppressor gene.

    1 Howard JM. The detection of DNA adducts (risk factors for DNA damage. A method for genomic DNA, the results and some effects of nutritional intervention, J Nutr Environ Med 2002;12:19-31.
    2 Werner S1, Kunz S, Beckurts T, Heidecke CD, Wolff T, Schwarz LR. Formation of DNA adducts by cyproterone acetate and some structural analogues in primary cultures of human hepatocytes. Mutat Res 1997 Dec 12;395(2-3):179-87.
    3 Hemminki, K. DNA adducts, mutations and cancer. Carcinogenesis,1993; 14,2007–2012.

  14. Louise permalink
    January 21, 2016 1:00 pm

    You are simply evading the questions and providing fresh links of dubious quality. As for Dr Sarah Mynhill, consultation charges to see her ( albeit limited treatment and unproven tests) are a whopping £330 which is more then the cost of seeing most practitioners in Harley Street who have enormous rental costs.
    You are providing everything but the simple answer.
    How do you prevent menopause related disease?

  15. Louise permalink
    January 21, 2016 9:19 pm

    “Society has strong negative perceptions of female ageing. Wider acceptance that menopause is a normal transition rather than an “oestrogen deficiency syndrome” might be more empowering for women. Women and their healthcare providers should have confidence that most will manage their symptoms without pharmacotherapy”

    Too right we have a negative view of menopause. Vaginal atrophy, depression, insomnia, low libido, raised risk of heart disease, metabolic syndrome, oesteoporosis, osteoarthritis.
    Who wants to be a cheer leader for years of health impaired by low estradiol and testosterone?
    Do you think men would be stupid enough to tolerate it?

  16. April 16, 2016 11:44 am

    How do I prevent menopause related disease is how I try to prevent any disease. Most of my medical practice has involved preconception care – usually with couples who have suffered from “unexplained” infertility or recurrent miscarriages, To explain the so far unexplained involves state of the art biochemical tests which seem only to be available at private laboratories.There is usually much to correct in the 3 to 4 months it takes to correct sperm abnormalities when that is possible. In fact very few of the investigations I have carried out in my patients since the 1960s are available on the NHS – not even accurate tests for the very common zinc, magnesium or Vitamin B 12 deficiencies. No one deplores this state of affairs more than I do as there is so much that can be done to prevent children being born with problems or to minimize the effects of inherited biochemical weaknesses. The future is very exciting but environmental pollutants are also contributing to the situation.

  17. Louise permalink
    April 16, 2016 11:58 am

    In other words, the devil is in the detail. Blame environmental pollutants and ignore a hormone deficiency affecting quality of life for a great many women.
    Menopause equates to silence or a few placebo remedies flung at the victim with the injunction to ‘ embrace the change’
    Not much has ‘ changed’ in the new century. Superstition, quackery and put up or shut up.
    NICE is trying to improve things and gets criticised.
    I suspect Jim Thornton will never experience menopause but expects females to suffer it for years of their lives.
    Choice should be freely offered. Bravo to the doctors who raise heads above the parapet and state that treatment should be given to those ŵomen requiring it.

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